Today, I learned that George Carlin passed away yesterday at the age of 71. Like others, he had his friends and his opposers. Most notable about this brave and intelligent man, however, was his bravery to go outside what were previously boundaries in regards to his profession.
As a result, some of us learned a little from his presentations. He created awareness through comedy, and he will be missed.
About Me
Monday, June 23, 2008
Wednesday, June 18, 2008
Santa in a Suit
You Have Now Been Sampled
While the pharmaceutical industry’s image and reputation has and appears to continue to suffer, added damage has expressed itself with costly patent expirations. Yet the big pharma task forces still insist that reps provide incredible value, and the more the better, as the drug reps are the givers of gifts, and reciprocity in the form of prescriptions just has to occur.
As a big pharma ex drug rep for over a decade, which during that period the number of drug reps actually tripled, the drug rep’s vocation has become more ridiculous, and possibly void of any true sense of accomplishment due to their customers preventing them from interaction or even presence in order for the drug reps to follow directives of the health care givers, and not their own employers, which is to influence their prescribing habits via direct dialogue along with the giving of gifts. The job has become nothing more than doing lunches and leaving samples at offices, for the most part. My perception formed from my own analysis of how drug reps operate in today’s environment in the medical community has led me to draw such conclusions, which I believe to be accurate.
So they may be named at times in different ways, these promoters will be referred to now only as drug reps, which number close to 100,000 in the U.S. presently to influence close to 1 million prescribers in this country, it is believed, yet is probably less now due to big pharma cutting thousands of reps recently. The cost to the pharmaceutical industry of these drug reps is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes and set their own hours, which I understand is much less than 8 hours a day.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value that are not gifts, but bribes, by definition. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples. Yet I want to be clear on what I am saying: drug reps are some of the smartest people you will meet that do in fact have great paying jobs with great benefits. Most importantly and my opinion, I believe most reps really WANT to do well for their employers, yet are prohibited from doing so now because of how their employers are now viewed in their medical community.
Many years ago, drug reps have used their persuasive, yet ethical, abilities to influence the prescribing habits of doctors in an honest and ethical manner, as they focused on the benefits for the doctor’s patients with a particular drug that the detailer may promote to such a doctor. However presently, most health care providers now simply prevent drug reps to speak with them- now this is especially true when they are in clinic treating and assessing patients. More and more medical establishments are completely banning drug reps from their locations, and I speculate that this is occurring for many reasons, which may include the following:
The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are an incredible waste of their time. Yet they will accept your samples still. The credibility you possibly have thought you had and were perceived as such by doctors as a drug rep is no longer viewed to exist to any noticeable degree by the prescriber. For example and this is based on my experience and my colleagues, doctors view any information you may provide to them as biased and embellished. In my opinion, based on information and belief, their view regarding their assessment of you as a drug rep is accurate due to the statistical gymnastics the employers of drug reps engage in, which effectively and ultimately is permitting and encouraging the drug reps to lie to the doctor and likely are unaware of the statements stated by them are misleading. Doctors by their very nature seek answers objectively. And doctors do in fact find out about drugs through other methods besides the representative of the drug’s maker, such as the internet and experience with certain medications. Most drug reps in this country in particular mostly hire drug reps based on such qualities as the candidate’s looks as well as their personality, overall. Furthermore, it is possible that pharmaceutical companies desire their drug reps to be obedient and to not question what is asked of them. Upon speculation, this can be possibly determined by the background of the candidate, which may indicate they seek popularity as well as are money driven. In addition, most drug reps do not have degrees remotely related to any aspect of anything of a scientific or clinical nature.
During my decade as a drug rep, I would encounter on very rare occasion another rep that may have been a nurse or researcher, and this is concerning that others do not have similar backgrounds because the type of training necessary is rare for a drug rep. In fact, based on my opinion, many do not particularly care to acquire education related to such medical or clinical topics. They learn the basics in order to sell their promoted products. Yet anyone who has ever worked with doctors in a clinical setting, or in a hospital working in a clinical nature, likely they would agree that a drug rep should want to and seek all related to the complexities involved in the restoration of another’s health.
Many drug reps, it is believed, are void of any complete interest in medicine completely, and I believe this to be necessary. In addition, ethical considerations due to their possible deliberate ignorance created by the necessity of what they are required to say or do by their employers may be viewed as a disturbing fallacy as well. This allows them with the encouragement and coercion of their employer to embellish the benefits of their promoted products at times in addition to offering inducements to doctors in various ways- most of all of which are rather covert, yet performed and issued to select prescribers upon instruction of their employer. Examples may be creating a check from your company to a certain supporting doctor and handing this check to thank a doctor for supporting your company’s products for doing little if anything for your employer to justify this check. Or tangible items are given to such prescribers, such as TVs or DVDs which may or may not be utilized in a particular doctor’s office. It happens often, such activities.
From the drug rep’s perspective, it is unlikely they will even consider the possibility to question their pharmaceutical employer due to the great risk of losing income and benefits that they are unlikely to acquire at another place of employment. Because of their consistent and conscious effort to keep their high-paying jobs, the drug reps always appear overtly anxious to please their superiors- regardless of any ethics or legalities regarding any activity they may be required to perform. With big pharma in particular, each drug rep is given a variety of budgets, such as a chunk of cash for doctor office lunches that they are required to spend in a certain period of time. Another chunk of cash may be assigned to a rep to pay assigned or registered speakers of their employer to speak to other prescribers about a disease state related to the drug rep’s promoted product. These activities, in my time with big pharma, were never monitored or questioned by managers or superiors. What I did notice is that my annual raises were greater than others according to the amount I spent for that particular year, as this, according to a big pharma company, was a very objective and noticeable variable with securing and keeping your employment in big pharma.
While legally risky, the drug companies continue to dispense to their reps these large budgets their drug reps are in effect coerced to dispense with complete autonomy and possibly the spending can be fabricated, which is too complicated to fully explain. This design perhaps is why there are now various state and federal disclosure laws that are presently being considered to mandate the release of all funds dispensed from pharmaceutical companies as far as why a company’s funds were spent and for what reason or method. Because, according to the lobbyists of pharma companies, they consistently insist that whatever they spend always is for the benefit of public health. As mentioned earlier, presently such activities are quite covert. Yet if such laws are mandated, it is likely the accounting of pharma companies will become rather creative and incomplete. In summary, as a big pharma drug rep, my budgets were unlimited, and I typically spent more than I made though the activities I have mentioned so far. And this is not an isolated case.
Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies or pharmacies, by providing others identifying numbers of a particular doctor, such as a state license number or DEA number, which allows them to track the scripts a doctor writes not far from real time availability. This data shows the volume of scripts of a particular doctor and what the doctor has been prescribing for the doctor’s patient for their disease state, and this data reveals competitor products to the drug rep as well. Aside from being deceiving and dishonest, the data allows a pharma company to ‘reward’ those doctors who support their products, while treating the other doctors with ‘neglect’, which means the non-supporters of a pharma company will not receive any inducement or remuneration from a particular pharma company. The data, by the way, only reflects numbers linked with particular products, and fortunately is free of patient names- this data that is provided to all drug reps. What has been described is the method typical with all big pharma companies, in my opinion, and I worked for three of them. It appears to be manipulative in a psychological paradigm- a combination of Pavlovian responses combined with positive and negative reinforcement.
So such methods create a toxic culture required to be absorbed by those members of such a pharma company. Furthermore, the tactics implemented by pharma companies vacuum the judgment of prescribers, which may prevent patients from receiving objective treatment. Yet on the most basic level, it is the samples left with prescribers that ultimately determine their prescribing habits- with various inducements to some doctors running close in second place. Yet remarkably, prescribers are prescribing more and more generics, which typically are not sampled to prescribers. I find this comforting that the manipulation efforts of the pharma industry are not as effective as they believe they are in a rather delusional way. Yet what is happening now in regards of branded meds vs. generic meds, insurance companies are flat out paying doctors to switch patients to a generic if one is available, as well as initiating generic medication treatment for their patients. I speculate they are paying doctors for this as a response of what pharma has been doing for quite a long time. From a clinical paradigm, if a medication is providing desired treatment and good tolerability for a particular patient, one could argue it would be unethical to switch treatment for financial gain, further complicated by the fact that most patients are aware that insurance company payments to doctors for this even occur.
It is likely and I believe that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment. In other words, the drug reps have compromised their integrity, ultimately.
It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Because it is obvious that internal controls with such corporations exist on paper often, but clearly are discouraged to be enforced. It is possible that these pharma companies falsely believe that being an ethical company would make them a company without excess profit. One can only speculate on their true motives. Yet it appears that overt greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative. Perhaps most frightening is that most drug reps fail to dig deep enough to realize that what they do at times may damage public health.
“What you don’t do can be a destructive force.” --- Eleanor Roosevelt
Dan Abshear
Author’s note: What has been written was based upon information and belief.
While the pharmaceutical industry’s image and reputation has and appears to continue to suffer, added damage has expressed itself with costly patent expirations. Yet the big pharma task forces still insist that reps provide incredible value, and the more the better, as the drug reps are the givers of gifts, and reciprocity in the form of prescriptions just has to occur.
As a big pharma ex drug rep for over a decade, which during that period the number of drug reps actually tripled, the drug rep’s vocation has become more ridiculous, and possibly void of any true sense of accomplishment due to their customers preventing them from interaction or even presence in order for the drug reps to follow directives of the health care givers, and not their own employers, which is to influence their prescribing habits via direct dialogue along with the giving of gifts. The job has become nothing more than doing lunches and leaving samples at offices, for the most part. My perception formed from my own analysis of how drug reps operate in today’s environment in the medical community has led me to draw such conclusions, which I believe to be accurate.
So they may be named at times in different ways, these promoters will be referred to now only as drug reps, which number close to 100,000 in the U.S. presently to influence close to 1 million prescribers in this country, it is believed, yet is probably less now due to big pharma cutting thousands of reps recently. The cost to the pharmaceutical industry of these drug reps is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes and set their own hours, which I understand is much less than 8 hours a day.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value that are not gifts, but bribes, by definition. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples. Yet I want to be clear on what I am saying: drug reps are some of the smartest people you will meet that do in fact have great paying jobs with great benefits. Most importantly and my opinion, I believe most reps really WANT to do well for their employers, yet are prohibited from doing so now because of how their employers are now viewed in their medical community.
Many years ago, drug reps have used their persuasive, yet ethical, abilities to influence the prescribing habits of doctors in an honest and ethical manner, as they focused on the benefits for the doctor’s patients with a particular drug that the detailer may promote to such a doctor. However presently, most health care providers now simply prevent drug reps to speak with them- now this is especially true when they are in clinic treating and assessing patients. More and more medical establishments are completely banning drug reps from their locations, and I speculate that this is occurring for many reasons, which may include the following:
The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are an incredible waste of their time. Yet they will accept your samples still. The credibility you possibly have thought you had and were perceived as such by doctors as a drug rep is no longer viewed to exist to any noticeable degree by the prescriber. For example and this is based on my experience and my colleagues, doctors view any information you may provide to them as biased and embellished. In my opinion, based on information and belief, their view regarding their assessment of you as a drug rep is accurate due to the statistical gymnastics the employers of drug reps engage in, which effectively and ultimately is permitting and encouraging the drug reps to lie to the doctor and likely are unaware of the statements stated by them are misleading. Doctors by their very nature seek answers objectively. And doctors do in fact find out about drugs through other methods besides the representative of the drug’s maker, such as the internet and experience with certain medications. Most drug reps in this country in particular mostly hire drug reps based on such qualities as the candidate’s looks as well as their personality, overall. Furthermore, it is possible that pharmaceutical companies desire their drug reps to be obedient and to not question what is asked of them. Upon speculation, this can be possibly determined by the background of the candidate, which may indicate they seek popularity as well as are money driven. In addition, most drug reps do not have degrees remotely related to any aspect of anything of a scientific or clinical nature.
During my decade as a drug rep, I would encounter on very rare occasion another rep that may have been a nurse or researcher, and this is concerning that others do not have similar backgrounds because the type of training necessary is rare for a drug rep. In fact, based on my opinion, many do not particularly care to acquire education related to such medical or clinical topics. They learn the basics in order to sell their promoted products. Yet anyone who has ever worked with doctors in a clinical setting, or in a hospital working in a clinical nature, likely they would agree that a drug rep should want to and seek all related to the complexities involved in the restoration of another’s health.
Many drug reps, it is believed, are void of any complete interest in medicine completely, and I believe this to be necessary. In addition, ethical considerations due to their possible deliberate ignorance created by the necessity of what they are required to say or do by their employers may be viewed as a disturbing fallacy as well. This allows them with the encouragement and coercion of their employer to embellish the benefits of their promoted products at times in addition to offering inducements to doctors in various ways- most of all of which are rather covert, yet performed and issued to select prescribers upon instruction of their employer. Examples may be creating a check from your company to a certain supporting doctor and handing this check to thank a doctor for supporting your company’s products for doing little if anything for your employer to justify this check. Or tangible items are given to such prescribers, such as TVs or DVDs which may or may not be utilized in a particular doctor’s office. It happens often, such activities.
From the drug rep’s perspective, it is unlikely they will even consider the possibility to question their pharmaceutical employer due to the great risk of losing income and benefits that they are unlikely to acquire at another place of employment. Because of their consistent and conscious effort to keep their high-paying jobs, the drug reps always appear overtly anxious to please their superiors- regardless of any ethics or legalities regarding any activity they may be required to perform. With big pharma in particular, each drug rep is given a variety of budgets, such as a chunk of cash for doctor office lunches that they are required to spend in a certain period of time. Another chunk of cash may be assigned to a rep to pay assigned or registered speakers of their employer to speak to other prescribers about a disease state related to the drug rep’s promoted product. These activities, in my time with big pharma, were never monitored or questioned by managers or superiors. What I did notice is that my annual raises were greater than others according to the amount I spent for that particular year, as this, according to a big pharma company, was a very objective and noticeable variable with securing and keeping your employment in big pharma.
While legally risky, the drug companies continue to dispense to their reps these large budgets their drug reps are in effect coerced to dispense with complete autonomy and possibly the spending can be fabricated, which is too complicated to fully explain. This design perhaps is why there are now various state and federal disclosure laws that are presently being considered to mandate the release of all funds dispensed from pharmaceutical companies as far as why a company’s funds were spent and for what reason or method. Because, according to the lobbyists of pharma companies, they consistently insist that whatever they spend always is for the benefit of public health. As mentioned earlier, presently such activities are quite covert. Yet if such laws are mandated, it is likely the accounting of pharma companies will become rather creative and incomplete. In summary, as a big pharma drug rep, my budgets were unlimited, and I typically spent more than I made though the activities I have mentioned so far. And this is not an isolated case.
Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies or pharmacies, by providing others identifying numbers of a particular doctor, such as a state license number or DEA number, which allows them to track the scripts a doctor writes not far from real time availability. This data shows the volume of scripts of a particular doctor and what the doctor has been prescribing for the doctor’s patient for their disease state, and this data reveals competitor products to the drug rep as well. Aside from being deceiving and dishonest, the data allows a pharma company to ‘reward’ those doctors who support their products, while treating the other doctors with ‘neglect’, which means the non-supporters of a pharma company will not receive any inducement or remuneration from a particular pharma company. The data, by the way, only reflects numbers linked with particular products, and fortunately is free of patient names- this data that is provided to all drug reps. What has been described is the method typical with all big pharma companies, in my opinion, and I worked for three of them. It appears to be manipulative in a psychological paradigm- a combination of Pavlovian responses combined with positive and negative reinforcement.
So such methods create a toxic culture required to be absorbed by those members of such a pharma company. Furthermore, the tactics implemented by pharma companies vacuum the judgment of prescribers, which may prevent patients from receiving objective treatment. Yet on the most basic level, it is the samples left with prescribers that ultimately determine their prescribing habits- with various inducements to some doctors running close in second place. Yet remarkably, prescribers are prescribing more and more generics, which typically are not sampled to prescribers. I find this comforting that the manipulation efforts of the pharma industry are not as effective as they believe they are in a rather delusional way. Yet what is happening now in regards of branded meds vs. generic meds, insurance companies are flat out paying doctors to switch patients to a generic if one is available, as well as initiating generic medication treatment for their patients. I speculate they are paying doctors for this as a response of what pharma has been doing for quite a long time. From a clinical paradigm, if a medication is providing desired treatment and good tolerability for a particular patient, one could argue it would be unethical to switch treatment for financial gain, further complicated by the fact that most patients are aware that insurance company payments to doctors for this even occur.
It is likely and I believe that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment. In other words, the drug reps have compromised their integrity, ultimately.
It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Because it is obvious that internal controls with such corporations exist on paper often, but clearly are discouraged to be enforced. It is possible that these pharma companies falsely believe that being an ethical company would make them a company without excess profit. One can only speculate on their true motives. Yet it appears that overt greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative. Perhaps most frightening is that most drug reps fail to dig deep enough to realize that what they do at times may damage public health.
“What you don’t do can be a destructive force.” --- Eleanor Roosevelt
Dan Abshear
Author’s note: What has been written was based upon information and belief.
Is the Pharmaeutical Industry Now A Client of the FDA?
The FDA and Its Damaging and Progressive Lack of Citizen Protection
The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications. Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform. Yet the FDA continues to validate what has been posited through their support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should. However the growth of generics is about twice of branded meds annually, though, I believe.
Yet, the presumed intimacy between these two organizations, the FDA and the pharmaceutical industry, does in fact seem to continue to worsen- possibly due to the growth of generics. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval to possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional, to say the least.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, and rarely admit guilt as part of such settlements.
This FDA protocol described and proposed is called, “Good Reprint Practices”, would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest in such training. So this seems to further complicate the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to embellish statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.
However, there is freedom of speech, but in the amendment may be restrictions in regards to public health, as speech should be accurate and objective. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interest what I believe we as citizens demand, and should be enforced than it appears to be presently.
“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
---- Carl Jung
Dan Abshear (author’s note: what has been written was based on information and belief)
The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications. Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform. Yet the FDA continues to validate what has been posited through their support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should. However the growth of generics is about twice of branded meds annually, though, I believe.
Yet, the presumed intimacy between these two organizations, the FDA and the pharmaceutical industry, does in fact seem to continue to worsen- possibly due to the growth of generics. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval to possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional, to say the least.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, and rarely admit guilt as part of such settlements.
This FDA protocol described and proposed is called, “Good Reprint Practices”, would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest in such training. So this seems to further complicate the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to embellish statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.
However, there is freedom of speech, but in the amendment may be restrictions in regards to public health, as speech should be accurate and objective. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interest what I believe we as citizens demand, and should be enforced than it appears to be presently.
“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
---- Carl Jung
Dan Abshear (author’s note: what has been written was based on information and belief)
Wednesday, June 11, 2008
On A Personal Note
I wrote this some time ago about my daughter and hope you enjoy the read:
Source of Light
For many years now, my daughter and I pay a visit to a doughnut shop located in the city in which we live and is in a building that is at least a century old that exists in an older section of this city that we have lived in for close to six years now. These visits typically take place on mornings before she goes to school for the day. This doughnut shop has become a ritualistic experience for both of us, as it is located next to very old train tracks that are still functioning and frequently allow us to experience a train or two to race down these tracks during our visit at this shop, which is entertaining and amazing for both of us.
This whole event allows my daughter on many occasions to express enlightening ideas about complex questions that have plagued mankind for thousands of years, such as the true nature of god. Or the origin of life. Questions that could be considered to be rare, considering that they are authentically originated from a girl who has been at such a young age over these past few years, which has been done since the age of 6.
As a consequence, her thoughts and ideas involving such concepts have been a catalyst for myself, her father, to ponder these very topics with her, which have unfortunately been progressively more infrequent than for this inspiring girl who speaks such thoughts. The dialogues that follow are meaningful and are an examination of both of our lives, as well as others.
So my daughter’s thoughts and ideas have reinvigorated my own contemplation on such ideas and, as a result, have made me more amazed at life itself and less cynical than before these visits began. This, of course, is a very positive trait to have in one’s life. In my case, a life that presently is experiencing the old age of youth, as Victor Hugo once said of one who is forty years of age.
The story above is evidence on the benefits of spending time with your children for the well-being of the chile and parents alike. I remain in a statement of amazement.
Dan Abshear
Source of Light
For many years now, my daughter and I pay a visit to a doughnut shop located in the city in which we live and is in a building that is at least a century old that exists in an older section of this city that we have lived in for close to six years now. These visits typically take place on mornings before she goes to school for the day. This doughnut shop has become a ritualistic experience for both of us, as it is located next to very old train tracks that are still functioning and frequently allow us to experience a train or two to race down these tracks during our visit at this shop, which is entertaining and amazing for both of us.
This whole event allows my daughter on many occasions to express enlightening ideas about complex questions that have plagued mankind for thousands of years, such as the true nature of god. Or the origin of life. Questions that could be considered to be rare, considering that they are authentically originated from a girl who has been at such a young age over these past few years, which has been done since the age of 6.
As a consequence, her thoughts and ideas involving such concepts have been a catalyst for myself, her father, to ponder these very topics with her, which have unfortunately been progressively more infrequent than for this inspiring girl who speaks such thoughts. The dialogues that follow are meaningful and are an examination of both of our lives, as well as others.
So my daughter’s thoughts and ideas have reinvigorated my own contemplation on such ideas and, as a result, have made me more amazed at life itself and less cynical than before these visits began. This, of course, is a very positive trait to have in one’s life. In my case, a life that presently is experiencing the old age of youth, as Victor Hugo once said of one who is forty years of age.
The story above is evidence on the benefits of spending time with your children for the well-being of the chile and parents alike. I remain in a statement of amazement.
Dan Abshear
Monday, June 9, 2008
Extending Life in a Different Way
When a patented med is about to lose its patent, any other company can reverse engineer this particular product rightfully so, and its originator no longer profits off of this med in a very short period of time- usually within the first year of patent loss. Since we are talking about what could be a great loss of pharma profits, such companies initiate such tactics as bogus patent infringement lawsuits- especially when evergreening and other patent extension methods, such as obtaining a pediatric indication fail, perhaps. The industry does not like their profit stream to be inactive.
What exactly is patent infringement? Basically, in this case, the branded pharma company accuses another generic company of plagiarizing thier invention, which with pharma are chemical patents, such as in the case of a branded med, and therefore a generic company having possession of their former branded med are accused of trespassing without permission of the accuser, which again is the branded med. If another med is made, used, or sold without authorization, a patent is infringed, although it is allowed when the patent expires in the pharmaceutical industry. Patent attorneys get involved and file these largely pointless lawsuits which clearly lack merit not because there is an actual issue if the patent is in fact expired of the branded med, which is the case typically. But because by filing such a lawsuit, this wrongfully created case has a mandatory wait period of 2 ½ years with this type of lawsuit to be decided, which means that much more profits of the makers of the branded med for that period of time, which could mean billions for such a pharma company and their branded med. An analogy may be keeping the stock market open a bit longer to benefit a few, perhaps, but it is clearly dishonest.
This is allowed in our legal system and why this occurs, this system flaw, remains a mystery. Patients are coerced to continue to pay high prices of branded drugs due to the generic delays caused by these lawsuits filed by the branded pharma companies, so harm is caused by this tactic to the patients who take these meds. Is it not prevented, such lawsuits, because the lawmakers possibly have been bought by big pharma through lobbying? Is it because of the present administration’s affinity with the pharma industry? One can only speculate.
At one point, pharmaceutical companies’ culture and mission had what were called ethical medical standards. Why? Because it was the right thing to do, since medicine as a practice may be considered both sacred and complex. At times, drugs were created without patents with intent, believe it or not. Jonas Salk and the Polio vaccine is an example of this. Perhaps that was the last time such a noble event happened. Profit motive was not the entire focus, as it appears today with drug companies.
No patent for Dr. Salk? Is that due to some mental illness of this creator? Absolutely not. The intent of Dr. Salk was to have greater availability of this vaccine for the benefit of public health. Dr. Salk believed that life was not a popularity contest. Today, such an act may be considered taboo or psychotic. I applaud his bravery and stance on his discovery, which, by the way, was funded by our government entirely.
Fast forward to today and such atrocious acts such as the lawsuit issue mentioned a moment ago. That once admired ethical industry somehow became possessed with a ‘greed is good’ mentality. Ethical Medical Standards are not visible and likely do not exist anymore, as far as I can observe. Deception, however, does. And the new pharma mentality is encouraged without regard to the optimal health for U.S. citizens. Yet what is stated by pharma (Billy Tauzin, et. al.) opposes what appears to be the case as illustrated by their actions such as what has been described. It’s my belief that U.S. citizens want a return of ethical medical standards, and they deserve this.
“Silence, indifference, and inaction were Hitler’s principal allies--- Lord Jacobovits
Dan Abshear
What exactly is patent infringement? Basically, in this case, the branded pharma company accuses another generic company of plagiarizing thier invention, which with pharma are chemical patents, such as in the case of a branded med, and therefore a generic company having possession of their former branded med are accused of trespassing without permission of the accuser, which again is the branded med. If another med is made, used, or sold without authorization, a patent is infringed, although it is allowed when the patent expires in the pharmaceutical industry. Patent attorneys get involved and file these largely pointless lawsuits which clearly lack merit not because there is an actual issue if the patent is in fact expired of the branded med, which is the case typically. But because by filing such a lawsuit, this wrongfully created case has a mandatory wait period of 2 ½ years with this type of lawsuit to be decided, which means that much more profits of the makers of the branded med for that period of time, which could mean billions for such a pharma company and their branded med. An analogy may be keeping the stock market open a bit longer to benefit a few, perhaps, but it is clearly dishonest.
This is allowed in our legal system and why this occurs, this system flaw, remains a mystery. Patients are coerced to continue to pay high prices of branded drugs due to the generic delays caused by these lawsuits filed by the branded pharma companies, so harm is caused by this tactic to the patients who take these meds. Is it not prevented, such lawsuits, because the lawmakers possibly have been bought by big pharma through lobbying? Is it because of the present administration’s affinity with the pharma industry? One can only speculate.
At one point, pharmaceutical companies’ culture and mission had what were called ethical medical standards. Why? Because it was the right thing to do, since medicine as a practice may be considered both sacred and complex. At times, drugs were created without patents with intent, believe it or not. Jonas Salk and the Polio vaccine is an example of this. Perhaps that was the last time such a noble event happened. Profit motive was not the entire focus, as it appears today with drug companies.
No patent for Dr. Salk? Is that due to some mental illness of this creator? Absolutely not. The intent of Dr. Salk was to have greater availability of this vaccine for the benefit of public health. Dr. Salk believed that life was not a popularity contest. Today, such an act may be considered taboo or psychotic. I applaud his bravery and stance on his discovery, which, by the way, was funded by our government entirely.
Fast forward to today and such atrocious acts such as the lawsuit issue mentioned a moment ago. That once admired ethical industry somehow became possessed with a ‘greed is good’ mentality. Ethical Medical Standards are not visible and likely do not exist anymore, as far as I can observe. Deception, however, does. And the new pharma mentality is encouraged without regard to the optimal health for U.S. citizens. Yet what is stated by pharma (Billy Tauzin, et. al.) opposes what appears to be the case as illustrated by their actions such as what has been described. It’s my belief that U.S. citizens want a return of ethical medical standards, and they deserve this.
“Silence, indifference, and inaction were Hitler’s principal allies--- Lord Jacobovits
Dan Abshear
Demoralized
You Want To Be A Doctor?
Lately in the media, others have said and expressed concern about the apparent shortage of primary care doctors, most notably. Typically, the main reason stated for this shortage is lack of pay of this particular specialty compared with other specialties chosen by potential physicians.
Yet considering the additional attention of shortages of students in some medical schools, one may ask the question as to whether or not people want to be any type of doctor in the first place in the United States. About one third of their lives are spent achieving the requirements of this profession. Reasons for not choosing to enter this profession are several and valid.
There is the issue of long hours- with primary care in particular because of the apparent lack of doctors of this specialty. Such doctors may be over-worked without an expected pay reflecting the work they do. Furthermore, those doctors employed by health care systems are required to see a certain number of patients a day, and receive a monetary bonus if this expectation is exceeded. It seems that most doctors are members of such health care systems. So burnout certainly may occur. And I consider such a requirement mandated by health care systems demeaning to this profession, and leave the doctor without the control that the doctor is entitled to due to their training and experience.
However, the recent increases in hospitalists, who are those doctors that are usually Internal Medicine doctors who specialize in patients presently under hospital care, and they have lessened the load for all doctor specialties for the work they do that the admitting doctors would have to do without their presence. This in itself makes a doctor possibly more effective and efficient in their practice outside of the medical institution.
All doctors, I presume, face a high degree of emotional and physical stress associated with their profession, as stated in the previous paragraph, for example. And this is not to mention the incredible stress associated with patient care in the first place, with some patient cases causing more stress than others
Doctors, due to the changes that have occurred recently in the U.S. health care system, not only have the issue of money to deal with, but also a loss of autonomy regarding patient care combined with loss of respect that may be due in large part to others dictating on how they practice medicine. Ironically and often, these others are not as qualified as the doctor in the first place. This is complicated by the perception that the public, with some who view doctors as having the easy life with their pay and profession, which does not seem to be the case presently.
There are also reasons of malpractice insurance, which is why doctors choose to join health care systems, it is believed, to pick up the tab for this necessity, along with eliminating the concerns of running a practice in a private manner, which historically has been the case, as their offices are owned by the health care system as well.
Up to 90 percent of malpractice cases against a doctor are baseless and without merit, so they are unsuccessful for the plaintiff, yet this still affects the rate the doctor has to pay for malpractice insurance. I understand that simply filing a lawsuit against a doctor, as frivolous as it may be, still increases the malpractice premium of that doctor. This is combined with the amount the doctor has to spend to defend themselves in such cases, which approaches about 100,000 dollars over the course of about 4 years for such cases. A tort reform in Texas in 2004 resulted in annual malpractice premiums reduced by about a third of what they were. Soon afterwards, claims against doctors remarkably dropped by about 50 percent. Some specialties of doctors pay more premiums for malpractice than others. For example, OB/GYN doctors have been known to pay around 300 thousand dollars a year for this insurance. Certain types of surgeons experience a similar high rate of malpractice premiums. Malpractice flaws are catalysts for doctors to practice defensive medicine to avoid potential litigation, which is a waste of health care resources and unneeded patient methods or procedures.
Also, about a third of the U.S. is insured by Medicare, which progressively has lowered what they will reimburse a doctor for regarding the care they give a patient they treat. This fact is recognized by other insurance companies who will eventually follow the recommendations of Medicare, usually, regarding the reimbursement issue, so it seems. This will lead to a doctor having to see even more patients in order to make it financially with their profession, as this has resulted in the overall income of a doctor experiencing a decline of about 10 percent over the last decade.
Furthermore, doctors normally have to pay off the debt acquired from attending medical school and training, which averages well over 100,000 dollars today after their training. About 20 years ago, that debt was only about a fifth of what it is today. Paying this debt off is typically about 2 thousand dollars a month that doctors on average have to pay in order to eliminate this debt in a timely fashion.
There are some who believe that doctors in the U.S. are over-paid. This may be true, but they are not absent of financial concerns as with any other profession.
Most doctors do not recommend their profession to others for such reasons stated in this article presently, and perhaps other reasons not mentioned. This is somewhat understandable, yet extremely unfortunate for the health of the public in the future, especially. There have been cases where doctors do in fact change careers, and get into vocational fields such as medical communications or corporate medical companies. Also, expert witnessing is another consideration for those who choose to leave their profession. Finally, other choices considered include consulting and research. The training of doctors fortunately leaves them with options not involved directly with the flaws of medical care, but this is bad for us as citizens, overall.
No all doctors are dieties. Like others, some are greedy and corrupt, which complicates others in this profession. Personally, I believe that the intentions of most physicians are bonafide. Yet in time, due to the nature of the current health care system, doctors frequently become cynical, demoralized and apathetic. This may be considered a significant concern to the well-being of those in need of restoration of their health, understandably.
Not long ago, the medical profession that has been discussed had overt honor and a clear element of nobility. Such traits are not as visible anymore, which saddens many intimate with the profession needed by many.
“In nothing do men more nearly approach the Gods then in giving health to men.” --- Cicero
Dan Abshear
Lately in the media, others have said and expressed concern about the apparent shortage of primary care doctors, most notably. Typically, the main reason stated for this shortage is lack of pay of this particular specialty compared with other specialties chosen by potential physicians.
Yet considering the additional attention of shortages of students in some medical schools, one may ask the question as to whether or not people want to be any type of doctor in the first place in the United States. About one third of their lives are spent achieving the requirements of this profession. Reasons for not choosing to enter this profession are several and valid.
There is the issue of long hours- with primary care in particular because of the apparent lack of doctors of this specialty. Such doctors may be over-worked without an expected pay reflecting the work they do. Furthermore, those doctors employed by health care systems are required to see a certain number of patients a day, and receive a monetary bonus if this expectation is exceeded. It seems that most doctors are members of such health care systems. So burnout certainly may occur. And I consider such a requirement mandated by health care systems demeaning to this profession, and leave the doctor without the control that the doctor is entitled to due to their training and experience.
However, the recent increases in hospitalists, who are those doctors that are usually Internal Medicine doctors who specialize in patients presently under hospital care, and they have lessened the load for all doctor specialties for the work they do that the admitting doctors would have to do without their presence. This in itself makes a doctor possibly more effective and efficient in their practice outside of the medical institution.
All doctors, I presume, face a high degree of emotional and physical stress associated with their profession, as stated in the previous paragraph, for example. And this is not to mention the incredible stress associated with patient care in the first place, with some patient cases causing more stress than others
Doctors, due to the changes that have occurred recently in the U.S. health care system, not only have the issue of money to deal with, but also a loss of autonomy regarding patient care combined with loss of respect that may be due in large part to others dictating on how they practice medicine. Ironically and often, these others are not as qualified as the doctor in the first place. This is complicated by the perception that the public, with some who view doctors as having the easy life with their pay and profession, which does not seem to be the case presently.
There are also reasons of malpractice insurance, which is why doctors choose to join health care systems, it is believed, to pick up the tab for this necessity, along with eliminating the concerns of running a practice in a private manner, which historically has been the case, as their offices are owned by the health care system as well.
Up to 90 percent of malpractice cases against a doctor are baseless and without merit, so they are unsuccessful for the plaintiff, yet this still affects the rate the doctor has to pay for malpractice insurance. I understand that simply filing a lawsuit against a doctor, as frivolous as it may be, still increases the malpractice premium of that doctor. This is combined with the amount the doctor has to spend to defend themselves in such cases, which approaches about 100,000 dollars over the course of about 4 years for such cases. A tort reform in Texas in 2004 resulted in annual malpractice premiums reduced by about a third of what they were. Soon afterwards, claims against doctors remarkably dropped by about 50 percent. Some specialties of doctors pay more premiums for malpractice than others. For example, OB/GYN doctors have been known to pay around 300 thousand dollars a year for this insurance. Certain types of surgeons experience a similar high rate of malpractice premiums. Malpractice flaws are catalysts for doctors to practice defensive medicine to avoid potential litigation, which is a waste of health care resources and unneeded patient methods or procedures.
Also, about a third of the U.S. is insured by Medicare, which progressively has lowered what they will reimburse a doctor for regarding the care they give a patient they treat. This fact is recognized by other insurance companies who will eventually follow the recommendations of Medicare, usually, regarding the reimbursement issue, so it seems. This will lead to a doctor having to see even more patients in order to make it financially with their profession, as this has resulted in the overall income of a doctor experiencing a decline of about 10 percent over the last decade.
Furthermore, doctors normally have to pay off the debt acquired from attending medical school and training, which averages well over 100,000 dollars today after their training. About 20 years ago, that debt was only about a fifth of what it is today. Paying this debt off is typically about 2 thousand dollars a month that doctors on average have to pay in order to eliminate this debt in a timely fashion.
There are some who believe that doctors in the U.S. are over-paid. This may be true, but they are not absent of financial concerns as with any other profession.
Most doctors do not recommend their profession to others for such reasons stated in this article presently, and perhaps other reasons not mentioned. This is somewhat understandable, yet extremely unfortunate for the health of the public in the future, especially. There have been cases where doctors do in fact change careers, and get into vocational fields such as medical communications or corporate medical companies. Also, expert witnessing is another consideration for those who choose to leave their profession. Finally, other choices considered include consulting and research. The training of doctors fortunately leaves them with options not involved directly with the flaws of medical care, but this is bad for us as citizens, overall.
No all doctors are dieties. Like others, some are greedy and corrupt, which complicates others in this profession. Personally, I believe that the intentions of most physicians are bonafide. Yet in time, due to the nature of the current health care system, doctors frequently become cynical, demoralized and apathetic. This may be considered a significant concern to the well-being of those in need of restoration of their health, understandably.
Not long ago, the medical profession that has been discussed had overt honor and a clear element of nobility. Such traits are not as visible anymore, which saddens many intimate with the profession needed by many.
“In nothing do men more nearly approach the Gods then in giving health to men.” --- Cicero
Dan Abshear
A Cost Issue
The Price of Innovation
Recently, you may have heard or read in mass media sources about the issue of pharmacy benefit managers who have clients that are prescribed biologic medications and then are required to pay a great deal of money for such meds due to the placement of these meds on their PBMs. This is due to their status on the PBM, which is known as Tier 4 status, which requires patients to pay higher co-pays for these meds. Tier 4, which also includes lifestyle meds, is determined by the PBM based on variables such as rebates and discounts from the manufacturer, which are intended to be passed on to the PBM clients. However, in some cases, the PBMs fail to do this, and have been penalized for their self-interest above patient interest as required when this activity is discovered. Regardless, because of the tier 4 status of biologics, very sick patients have to pay a great deal of money for these meds. PBMs, by the way, are pharmacy benefit managers that were created apparently to meet the pharmaceutical needs of employees and are a benefit along with their insurance through their employer.
First of all, biologic meds are specialty meds created differently than other typical meds, and therefore are have a unique molecular complexity that are designed for serious illnesses such as anemia or multiple sclerosis. Because of their uniqueness and exclusivity, they are very expensive- costing thousands a month for the payers. In addition, generics are not authorized to be produced as of yet for these types of meds. Their cost of these biological meds is contributed more for the complex process of their creation, as the material costs are typically less expensive than traditional molecular medications.
Biologics began to be used primarily in the 1980s and now presently make over 60 billion a year, with about 20 percent growth in this market annually. With anemia patients, oncology and dialysis clinics are targets for such meds in this category, as anemia is associated with their treatment and conditions for such diseases.
Yet, some claim that biologic meds benefit patients to only a certain degree, as they extend life of such patients, such as those on chemotherapy or dialysis, by only a few months, so the high cost of the meds is questionable and has been analyzed by others, yet no substitutes exist for biologics, so that’s why the producers of these drugs can charge so much for these products. Efficacy of these biologic meds have also been questioned as well in other treatment aspects aside from life extension.
Then there is the issue of fraud with kickbacks and overuse of some of the biologic meds used to treat anemia in dialysis clinics in particular. On a few occasions, doctors and clinics have been penalized for overusing the meds and for kickbacks in the form of discounts of the manufacturers. Ironically, the dialysis process was never patented, yet the many centers that exist have proven to be very profitable, more for some than others. An example is the situations where dialysis doctors, called nephrologists, have been accused of over-dosing patients with biologic meds to increase their income through their discount arrangement through the manufacturer of such meds, such as those biologics for anemia, and this arrangement is being investigated by regulators and encouraged by the representatives of such meds.
Presently, there are many that approach the FDA to aggressively insist that generic biologics be allowed into the market for the benefit of these critically ill patients, and this would be of great benefit for such patients, and this can be done, as far as the generic creation of these meds. And this situation illustrates one of many flaws in the U.S. Health Care System- when the sickest have to complicate their illnesses by possible financial stress, such as the case with biologic meds. Relief is needed, and should be demanded by the public. After all, why be so sick, and then be financially burdened?
“A little learning is a dangerous thing.” ---- Alexander Pope
Dan Abshear
Recently, you may have heard or read in mass media sources about the issue of pharmacy benefit managers who have clients that are prescribed biologic medications and then are required to pay a great deal of money for such meds due to the placement of these meds on their PBMs. This is due to their status on the PBM, which is known as Tier 4 status, which requires patients to pay higher co-pays for these meds. Tier 4, which also includes lifestyle meds, is determined by the PBM based on variables such as rebates and discounts from the manufacturer, which are intended to be passed on to the PBM clients. However, in some cases, the PBMs fail to do this, and have been penalized for their self-interest above patient interest as required when this activity is discovered. Regardless, because of the tier 4 status of biologics, very sick patients have to pay a great deal of money for these meds. PBMs, by the way, are pharmacy benefit managers that were created apparently to meet the pharmaceutical needs of employees and are a benefit along with their insurance through their employer.
First of all, biologic meds are specialty meds created differently than other typical meds, and therefore are have a unique molecular complexity that are designed for serious illnesses such as anemia or multiple sclerosis. Because of their uniqueness and exclusivity, they are very expensive- costing thousands a month for the payers. In addition, generics are not authorized to be produced as of yet for these types of meds. Their cost of these biological meds is contributed more for the complex process of their creation, as the material costs are typically less expensive than traditional molecular medications.
Biologics began to be used primarily in the 1980s and now presently make over 60 billion a year, with about 20 percent growth in this market annually. With anemia patients, oncology and dialysis clinics are targets for such meds in this category, as anemia is associated with their treatment and conditions for such diseases.
Yet, some claim that biologic meds benefit patients to only a certain degree, as they extend life of such patients, such as those on chemotherapy or dialysis, by only a few months, so the high cost of the meds is questionable and has been analyzed by others, yet no substitutes exist for biologics, so that’s why the producers of these drugs can charge so much for these products. Efficacy of these biologic meds have also been questioned as well in other treatment aspects aside from life extension.
Then there is the issue of fraud with kickbacks and overuse of some of the biologic meds used to treat anemia in dialysis clinics in particular. On a few occasions, doctors and clinics have been penalized for overusing the meds and for kickbacks in the form of discounts of the manufacturers. Ironically, the dialysis process was never patented, yet the many centers that exist have proven to be very profitable, more for some than others. An example is the situations where dialysis doctors, called nephrologists, have been accused of over-dosing patients with biologic meds to increase their income through their discount arrangement through the manufacturer of such meds, such as those biologics for anemia, and this arrangement is being investigated by regulators and encouraged by the representatives of such meds.
Presently, there are many that approach the FDA to aggressively insist that generic biologics be allowed into the market for the benefit of these critically ill patients, and this would be of great benefit for such patients, and this can be done, as far as the generic creation of these meds. And this situation illustrates one of many flaws in the U.S. Health Care System- when the sickest have to complicate their illnesses by possible financial stress, such as the case with biologic meds. Relief is needed, and should be demanded by the public. After all, why be so sick, and then be financially burdened?
“A little learning is a dangerous thing.” ---- Alexander Pope
Dan Abshear
It's Better To Know
The Prevention of Ignorance
Historically, information sources provided to American citizens were limited due to the few methods available to the public. And also this information was subject to being filtered and, in some cases, delayed. This occurred for a number of reasons, which included political ones.
Now, and with great elation, there is the internet.
Soon after the advent of the internet, web logs were created, that are termed ‘blogs’. At that time, about a decade ago, the blogs were referred to as personal journals or diaries visible on line. As time passed, blogs became a media medium, and blog communities evolved on topics that often were not addressed in mainstream media. In addition, blogs provide immediate contributions by others instead of the cumbersomeness of opinion and editorial pieces historically and not always presented in such media forms as newspapers. The authors of blogs vary as far as their backgrounds and intent of what they present are, just as with other media forms. Furthermore, they are not exonerated from the legalities of what is written, such as cases of libel. While we can presume that they like to write, they may not be quality writers.
Yet presently, blogs have become quite a driving force for those with objectives often opposed by others, and are a threat to big business and politics both who presently monitor the progress and content of blogs that provide instant information on events, which might affect their image and activities not yet exposed.
This includes information released from whistleblowers
While one disadvantage of blogs is the potential lack of reliability, blogs however do allow the posting of documents that typically are not created for view of others besides perhaps a select few. For example, blogger Dr. Peter Rost, a whistleblower himself, not long ago posted a newsletter on his blog site given to him by pharmaceutical maker AstraZeneca employees who called themselves the ‘AZ Group of Seven’ to bring to the attention to others the illegal activity of off-label promotion of one of their cancer drugs. Yet this is not what caught the attention of so many with all of the content of this newsletter. It was instead a comment stated by former regional AZ manager Mike Zubalagga, who in this newsletter referred to doctors’ offices as ‘buckets of money’. Again, the statement was authentic and in writing in this newsletter.
Mr. Zubalagga was fired the next day due to this comment. His manager resigned soon afterwards.
And there have been other whistleblower blog cases in addition to this one, so blogs have become a very powerful and threatening medium of information release that does not allow others to prevent such releases. This is true freedom of information, free of alteration or omission. One step closer to social utopia.
Yet again, the information on these blogs should not be taken as absolute truth without proof to verify claims that may be made. Of course, documents that are authentic are in fact proof, as illustrated with the above example. And this, in my opinion, is the blog’s greatest value, combined with the comments on blogs from the growing number of readers who are allowed to contribute to the subject matter so quickly, which fuels the objectives of the blogs.
Because we, the public, have a right to know what we are entitled to know and what we want to know. This is especially true if the information could potentially be adverse to our well-being.
“Information is the seed of an idea, and only grows when it’s watered.” --- Heinz V. Berger
Dan Abshear
Historically, information sources provided to American citizens were limited due to the few methods available to the public. And also this information was subject to being filtered and, in some cases, delayed. This occurred for a number of reasons, which included political ones.
Now, and with great elation, there is the internet.
Soon after the advent of the internet, web logs were created, that are termed ‘blogs’. At that time, about a decade ago, the blogs were referred to as personal journals or diaries visible on line. As time passed, blogs became a media medium, and blog communities evolved on topics that often were not addressed in mainstream media. In addition, blogs provide immediate contributions by others instead of the cumbersomeness of opinion and editorial pieces historically and not always presented in such media forms as newspapers. The authors of blogs vary as far as their backgrounds and intent of what they present are, just as with other media forms. Furthermore, they are not exonerated from the legalities of what is written, such as cases of libel. While we can presume that they like to write, they may not be quality writers.
Yet presently, blogs have become quite a driving force for those with objectives often opposed by others, and are a threat to big business and politics both who presently monitor the progress and content of blogs that provide instant information on events, which might affect their image and activities not yet exposed.
This includes information released from whistleblowers
While one disadvantage of blogs is the potential lack of reliability, blogs however do allow the posting of documents that typically are not created for view of others besides perhaps a select few. For example, blogger Dr. Peter Rost, a whistleblower himself, not long ago posted a newsletter on his blog site given to him by pharmaceutical maker AstraZeneca employees who called themselves the ‘AZ Group of Seven’ to bring to the attention to others the illegal activity of off-label promotion of one of their cancer drugs. Yet this is not what caught the attention of so many with all of the content of this newsletter. It was instead a comment stated by former regional AZ manager Mike Zubalagga, who in this newsletter referred to doctors’ offices as ‘buckets of money’. Again, the statement was authentic and in writing in this newsletter.
Mr. Zubalagga was fired the next day due to this comment. His manager resigned soon afterwards.
And there have been other whistleblower blog cases in addition to this one, so blogs have become a very powerful and threatening medium of information release that does not allow others to prevent such releases. This is true freedom of information, free of alteration or omission. One step closer to social utopia.
Yet again, the information on these blogs should not be taken as absolute truth without proof to verify claims that may be made. Of course, documents that are authentic are in fact proof, as illustrated with the above example. And this, in my opinion, is the blog’s greatest value, combined with the comments on blogs from the growing number of readers who are allowed to contribute to the subject matter so quickly, which fuels the objectives of the blogs.
Because we, the public, have a right to know what we are entitled to know and what we want to know. This is especially true if the information could potentially be adverse to our well-being.
“Information is the seed of an idea, and only grows when it’s watered.” --- Heinz V. Berger
Dan Abshear
For Profit?
The Damage of Legalized Lying
Amazingly, with the pharmaceutical industry, the amount spent by them on marketing is far greater than the amount spent on research and innovation, as it approaches 30 billion annually spent on their marketing efforts, as this presently takes priority over the research and development, so it seems. This includes 5 billion that is spent on drug reps, who implement the tactics of their marketing departments.
Marketing in some form exists with every business regardless of the industry of the business and its purpose. Essentially, marketing in itself is a complex activity- consisting of many specialty elements of various areas and levels, typically of an aggressive nature. However, with the pharmaceutical industry, marketing needs to become more specialized and altered due to the delicate nature of health care in order to prevent harm and ensure quality health care for all. Tactics that ignore such caution and consideration possibly could cause harm to patients in a number of ways, as this occurs presently. And recently, the marketing exposure of the drug industry has become an unfortunate issue for this industry for many reasons that remain a reality aside from what drug PR firms may try and tell us, as presently it seems as if the pharmaceutical industry, once viewed as very ethical, are now viewed as motivated by profit and greed. Such unwise and irresponsible methods include:
1. Advertising directly to the consumer. This method of bypassing what should entirely be decided by the heath care provider, as disregarding the determining factor of the heath care provider can possibly lead to inappropriate prescribing of certain advertised meds due to the demands of an unqualified patient who believed the content of such an advertisement that suggests that they are a candidate for a particular drug involved in the advertisement. Furthermore, it potentially removes the discretion of the provider regarding the best treatment for the patient through such frequent methods of marketing to potential consumers by such advertisements directly to consumers. Assessment of a patient by a health care provider is required and necessary, most believe, in order to determine the best treatment for a patient, as well as the provider considering their medical history as well as other variables necessary to consider the best course of the patient’s treatment. Ignoring this premise could be damaging to the patient seeking treatment through this possible inaccuracies through efforts provided by the marketing departments of drug companies. DTC advertising is now occurring in doctors’ office as well
2. Clinical evidence is the ultimate determining factor for treatment selection, after drug sample availability, and this evidence should be utilized by the provider entirely absent of any marketing techniques implemented by a drug maker, which may include embellishments and lack of necessary evaluation or regulation of such patients. Analysis of such evidence is very necessary for the ultimate benefit of the patient, and should be free of interference.
3. People take issue with the use of celebrities who are paid greatly by some drug companies, possibly to attempt to expand or create a certain medical condition, so the celebrity will discuss a certain disease state determined by who paid such a celebrity. Many examples of this occurring have been noted by others, and can lead to both inappropriate prescribing and over-prescribing of these meds so often promoted to consumers. This may be appropriate if one is attempting to sell a car, but health care is more of an important topic of concern.
4. Education not only trough sponsored doctors of the drug company, but also statements from various medical groups sponsored as well by the industry for purposes of endorsement have been considered inappropriate for the welfare of public health through awareness techniques such as these methods initiated by marketing departments lacking thorough clinical evaluation that is necessarily for the best treatment of patients seeking care or concern of their health. As an ex seasoned big pharma drug rep, I can assure you that education is not the purpose of a pharmaceutical company. Offering various inducements to others tops the list, though. Perhaps research of novel and innovative medications should instead be the focus of pharmaceutical companies.
5. The over-saturation of drug company sales reps who in the past have initiated questionable tactics upon the direction of their marketing department of their drug company employer, regardless of the validity or legality of such tactics that are normally not questioned or known by the drug reps in the first place. Such forms of manipulation include for some time questionable inducements for the health care providers. This is allowed to happen regardless of whether or not it is legal. As a result, many medical establishments are progressively prohibiting the activity or presence of drug reps at their locations. With the pharmaceutical company, sales reps are required by their employers to follow the direction of their marketing departments without exception. And the questioning of these directives is not tolerated by their employers. Because of this, the drug company’s image becomes more damaged as a result. To further illustrate this drug rep description, their employers require them to spend huge amounts of money annually to spend for doctors or to doctors that is void of any benefit for the patients, as the representative is typically void of any medical training or experience.
In the past, the pharmaceutical industry was viewed as research-driven, innovative, and patient focused- entirely for the benefit of patient heath. This is why the industry was at a time viewed as an ethical one. Clearly, this is not the case today. Instead, many view this industry as one with their primary goal is to initiate market-driven profiteering, regardless of the attempts of the industry to convince the public otherwise, as stated previously by the industry’s supporters, who have attempted to place value to the medical community as the goal of the pharmaceutical company. So the view by the public of drug companies has been damaging to what should be a concerning degree because of their tactics and deception. So the pharma industry seems to be in great need of repair and re-evaluation of their purpose. This should performed by action instead of empty statements by the industry. It is the author’s opinion that actions by this industry for the sole benefit for the patients are displaced if they exist, unless my interpretation and perception are flawed greatly. The repair can only be done by the refocus of the industry towards convincing the public of the industry’s concern of their restoration of the patient’s health in several ways. One way is to always make the medical community aware and with conviction that their products are solely for the benefit of the patients, which is rarely discussed in full detail with such people. Fortunately, medications historically have been for this reason and are often necessary for the restoration or benefit of the health of those in medical need. The need should be more clearly defined by those who determine this, and these are the health care providers, who are caregivers, and not marketers. In summary, the medicines now available to us are for the benefit of the patients, and not the developers who should create these medicines for this reason.
“Marketing is the act of making something seem better than it really is” --- Suso Banderas
Dan Abshear
,
.
Amazingly, with the pharmaceutical industry, the amount spent by them on marketing is far greater than the amount spent on research and innovation, as it approaches 30 billion annually spent on their marketing efforts, as this presently takes priority over the research and development, so it seems. This includes 5 billion that is spent on drug reps, who implement the tactics of their marketing departments.
Marketing in some form exists with every business regardless of the industry of the business and its purpose. Essentially, marketing in itself is a complex activity- consisting of many specialty elements of various areas and levels, typically of an aggressive nature. However, with the pharmaceutical industry, marketing needs to become more specialized and altered due to the delicate nature of health care in order to prevent harm and ensure quality health care for all. Tactics that ignore such caution and consideration possibly could cause harm to patients in a number of ways, as this occurs presently. And recently, the marketing exposure of the drug industry has become an unfortunate issue for this industry for many reasons that remain a reality aside from what drug PR firms may try and tell us, as presently it seems as if the pharmaceutical industry, once viewed as very ethical, are now viewed as motivated by profit and greed. Such unwise and irresponsible methods include:
1. Advertising directly to the consumer. This method of bypassing what should entirely be decided by the heath care provider, as disregarding the determining factor of the heath care provider can possibly lead to inappropriate prescribing of certain advertised meds due to the demands of an unqualified patient who believed the content of such an advertisement that suggests that they are a candidate for a particular drug involved in the advertisement. Furthermore, it potentially removes the discretion of the provider regarding the best treatment for the patient through such frequent methods of marketing to potential consumers by such advertisements directly to consumers. Assessment of a patient by a health care provider is required and necessary, most believe, in order to determine the best treatment for a patient, as well as the provider considering their medical history as well as other variables necessary to consider the best course of the patient’s treatment. Ignoring this premise could be damaging to the patient seeking treatment through this possible inaccuracies through efforts provided by the marketing departments of drug companies. DTC advertising is now occurring in doctors’ office as well
2. Clinical evidence is the ultimate determining factor for treatment selection, after drug sample availability, and this evidence should be utilized by the provider entirely absent of any marketing techniques implemented by a drug maker, which may include embellishments and lack of necessary evaluation or regulation of such patients. Analysis of such evidence is very necessary for the ultimate benefit of the patient, and should be free of interference.
3. People take issue with the use of celebrities who are paid greatly by some drug companies, possibly to attempt to expand or create a certain medical condition, so the celebrity will discuss a certain disease state determined by who paid such a celebrity. Many examples of this occurring have been noted by others, and can lead to both inappropriate prescribing and over-prescribing of these meds so often promoted to consumers. This may be appropriate if one is attempting to sell a car, but health care is more of an important topic of concern.
4. Education not only trough sponsored doctors of the drug company, but also statements from various medical groups sponsored as well by the industry for purposes of endorsement have been considered inappropriate for the welfare of public health through awareness techniques such as these methods initiated by marketing departments lacking thorough clinical evaluation that is necessarily for the best treatment of patients seeking care or concern of their health. As an ex seasoned big pharma drug rep, I can assure you that education is not the purpose of a pharmaceutical company. Offering various inducements to others tops the list, though. Perhaps research of novel and innovative medications should instead be the focus of pharmaceutical companies.
5. The over-saturation of drug company sales reps who in the past have initiated questionable tactics upon the direction of their marketing department of their drug company employer, regardless of the validity or legality of such tactics that are normally not questioned or known by the drug reps in the first place. Such forms of manipulation include for some time questionable inducements for the health care providers. This is allowed to happen regardless of whether or not it is legal. As a result, many medical establishments are progressively prohibiting the activity or presence of drug reps at their locations. With the pharmaceutical company, sales reps are required by their employers to follow the direction of their marketing departments without exception. And the questioning of these directives is not tolerated by their employers. Because of this, the drug company’s image becomes more damaged as a result. To further illustrate this drug rep description, their employers require them to spend huge amounts of money annually to spend for doctors or to doctors that is void of any benefit for the patients, as the representative is typically void of any medical training or experience.
In the past, the pharmaceutical industry was viewed as research-driven, innovative, and patient focused- entirely for the benefit of patient heath. This is why the industry was at a time viewed as an ethical one. Clearly, this is not the case today. Instead, many view this industry as one with their primary goal is to initiate market-driven profiteering, regardless of the attempts of the industry to convince the public otherwise, as stated previously by the industry’s supporters, who have attempted to place value to the medical community as the goal of the pharmaceutical company. So the view by the public of drug companies has been damaging to what should be a concerning degree because of their tactics and deception. So the pharma industry seems to be in great need of repair and re-evaluation of their purpose. This should performed by action instead of empty statements by the industry. It is the author’s opinion that actions by this industry for the sole benefit for the patients are displaced if they exist, unless my interpretation and perception are flawed greatly. The repair can only be done by the refocus of the industry towards convincing the public of the industry’s concern of their restoration of the patient’s health in several ways. One way is to always make the medical community aware and with conviction that their products are solely for the benefit of the patients, which is rarely discussed in full detail with such people. Fortunately, medications historically have been for this reason and are often necessary for the restoration or benefit of the health of those in medical need. The need should be more clearly defined by those who determine this, and these are the health care providers, who are caregivers, and not marketers. In summary, the medicines now available to us are for the benefit of the patients, and not the developers who should create these medicines for this reason.
“Marketing is the act of making something seem better than it really is” --- Suso Banderas
Dan Abshear
,
.
Yeah, Me, Too
The Fallacies Associated With Me-Too Medications
“But corruption is neither need based nor greed based. It’s simply opportunity based.” -----
Billy Tauzin, president and C.E.O. of PhRMA, the pharmaceutical industry’s most powerful lobbying group, as Mr. Tauzin stated in Boston recently.
It has been said by others that the pharmaceutical industry should not have government regulation or interference from our government at all because that would drastically limit if not eliminate innovation as well as our health care choices and options, both from the perspective of the doctor and the patient, so the public has been told often by others. Also what has been stated by this industry that their internal controls prevent wrongdoing? So, according to some, the public’s health would be limited and possibly harmed without the copious innovation of this industry. As with other issues we face as citizens, this is another attempt by these others to apparently install fabricated fear in our minds- void of any proof or reason, and is a fallacy.
As it has turned out, the pharmaceutical industry’s lack of innovation in particular has happened and they have appeared to do this on their own, overall, those innovators and lifesavers.
Over the past several years, those few meds created and FDA approved with true therapeutic advantages happened by discovery with government involvement in over half of these meds with clear clinical advantages for certain patients. Conversely, of the new chemical entities approved lately and developed by drug companies, over 50 percent of these have microscopic therapeutic advantage for patients, so I understand upon information and belief. This inefficient drug development by the pharmaceutical industry has created what is now the dominant development strategy of drug companies, and this strategy is known as the intentional development of what are phrased, ‘me too’ drugs.
These drugs essentially are small molecular variations of the original molecule in a particular class of medications. In other words, they tweak the original molecule in order to obtain patent rights for their now new drug project. This me too objective of drug companies now accounts, I believe, for about 80 percent of the research budgets of drug companies. And because the FDA only requires a potential med to be superior to a placebo in their mandatory clinical trials, usually these me too meds are approved- regardless of their necessity for others, or the need for such drugs.
And me too drugs are selected by the drug company for their potential blockbuster status as well as the speculated growth of a particular market, which means making over 1 billion dollars a year on such a drug, at least. For example, statin drugs, for high cholesterol patients, is a multi- billion dollar market. As a result, there are several statin meds now available for use by doctors to prescribe to their patients. Yet, arguably, me too drugs are all essentially very similar in regards to safety, efficacy, and cost, regardless of the class referred to so often saturated with me too meds, with few exceptions. The differences overall are minor once again with most me too drugs, overall. As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning, it is suspected, to falsely claim superiority of their newly approved me too drug over all the other drugs in a particular class both during and after the creation of these me too meds. Also, other classes of meds with several me too drugs may include SSRI anti-depressant drugs, as well as those meds for hypertension. There may be a dozen drugs in a particular class of medications that are all essentially the same in regards to their treatment abilities for patients with such disease states that they treat.
Now, there may be cases where a patient tolerates one drug in a class over another for unknown reasons, so in these few cases, some me too drugs occasionally are beneficial for patients for some reason or another, but should absolutely not be a primary objective of the drug companies to create them as often as they do. Instead, true innovation and discovery should be the focus of pharmaceutical companies, and it does not appear to be the focus of the pharmaceutical industry, presently. It appears that, thanks to the Bayh-Dole Act of 1980, they license molecules from those in the academic world, and then proceed with development of another’s creation they claim as their own.
Further vexing is that competition in the pharmaceutical industry amazingly does not and has not been of any financial benefit for the consumer, as competition normally does create. This fact is greatly demonstrated with other industries and is the apex of business operations. This pharmaceutical industry model is an exception, and the reason for this remains an unknown, as far as the etiology of being deprived of this costly environment of drug spending, yet it can be speculated that the me too drug makers claim uniqueness of their me too drug, which is rather deceptive.
This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely for their own profit, clearly illustrates their focus on these issues over true research and science, so it seems. Innovation, along with ethics, use to define this pharmaceutical industry. Sadly, it seems this is not the case today, which ultimately and potentially deprives potential treatment methods potentially for the public health if the objectives were focused on their true purpose. Yet hopefully, such historical qualities of drug companies will return some time, in time.
Dan Abshear
“But corruption is neither need based nor greed based. It’s simply opportunity based.” -----
Billy Tauzin, president and C.E.O. of PhRMA, the pharmaceutical industry’s most powerful lobbying group, as Mr. Tauzin stated in Boston recently.
It has been said by others that the pharmaceutical industry should not have government regulation or interference from our government at all because that would drastically limit if not eliminate innovation as well as our health care choices and options, both from the perspective of the doctor and the patient, so the public has been told often by others. Also what has been stated by this industry that their internal controls prevent wrongdoing? So, according to some, the public’s health would be limited and possibly harmed without the copious innovation of this industry. As with other issues we face as citizens, this is another attempt by these others to apparently install fabricated fear in our minds- void of any proof or reason, and is a fallacy.
As it has turned out, the pharmaceutical industry’s lack of innovation in particular has happened and they have appeared to do this on their own, overall, those innovators and lifesavers.
Over the past several years, those few meds created and FDA approved with true therapeutic advantages happened by discovery with government involvement in over half of these meds with clear clinical advantages for certain patients. Conversely, of the new chemical entities approved lately and developed by drug companies, over 50 percent of these have microscopic therapeutic advantage for patients, so I understand upon information and belief. This inefficient drug development by the pharmaceutical industry has created what is now the dominant development strategy of drug companies, and this strategy is known as the intentional development of what are phrased, ‘me too’ drugs.
These drugs essentially are small molecular variations of the original molecule in a particular class of medications. In other words, they tweak the original molecule in order to obtain patent rights for their now new drug project. This me too objective of drug companies now accounts, I believe, for about 80 percent of the research budgets of drug companies. And because the FDA only requires a potential med to be superior to a placebo in their mandatory clinical trials, usually these me too meds are approved- regardless of their necessity for others, or the need for such drugs.
And me too drugs are selected by the drug company for their potential blockbuster status as well as the speculated growth of a particular market, which means making over 1 billion dollars a year on such a drug, at least. For example, statin drugs, for high cholesterol patients, is a multi- billion dollar market. As a result, there are several statin meds now available for use by doctors to prescribe to their patients. Yet, arguably, me too drugs are all essentially very similar in regards to safety, efficacy, and cost, regardless of the class referred to so often saturated with me too meds, with few exceptions. The differences overall are minor once again with most me too drugs, overall. As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning, it is suspected, to falsely claim superiority of their newly approved me too drug over all the other drugs in a particular class both during and after the creation of these me too meds. Also, other classes of meds with several me too drugs may include SSRI anti-depressant drugs, as well as those meds for hypertension. There may be a dozen drugs in a particular class of medications that are all essentially the same in regards to their treatment abilities for patients with such disease states that they treat.
Now, there may be cases where a patient tolerates one drug in a class over another for unknown reasons, so in these few cases, some me too drugs occasionally are beneficial for patients for some reason or another, but should absolutely not be a primary objective of the drug companies to create them as often as they do. Instead, true innovation and discovery should be the focus of pharmaceutical companies, and it does not appear to be the focus of the pharmaceutical industry, presently. It appears that, thanks to the Bayh-Dole Act of 1980, they license molecules from those in the academic world, and then proceed with development of another’s creation they claim as their own.
Further vexing is that competition in the pharmaceutical industry amazingly does not and has not been of any financial benefit for the consumer, as competition normally does create. This fact is greatly demonstrated with other industries and is the apex of business operations. This pharmaceutical industry model is an exception, and the reason for this remains an unknown, as far as the etiology of being deprived of this costly environment of drug spending, yet it can be speculated that the me too drug makers claim uniqueness of their me too drug, which is rather deceptive.
This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely for their own profit, clearly illustrates their focus on these issues over true research and science, so it seems. Innovation, along with ethics, use to define this pharmaceutical industry. Sadly, it seems this is not the case today, which ultimately and potentially deprives potential treatment methods potentially for the public health if the objectives were focused on their true purpose. Yet hopefully, such historical qualities of drug companies will return some time, in time.
Dan Abshear
Quick When You Are Sick
Quick When You’re Sick
Recently in the media, issues have been addressed regarding the specialty of primary care or family practice doctors and the shortage of them in the U.S. In summary, reasons for the shortage that exists are due to the specialty not being that profitable for a doctor compared with other specialties. As a consequence, the doctors view the specialty as not a desirable choice apparently quite often, although the specialty is greatly needed in the health care system and for the public health.
As a layperson, I view primary care as ultimately a specialist in nothing in particular, yet knowledgeable in a large variety of medical areas, which I believe, makes them very valuable to those patients seeking restoration of their health. Furthermore, there is a comfort level with those in this specialty compared with other specialties, one could speculate. So the shortage of primary care doctors is in fact disappointing. Perhaps most disappointing is the atrophy of the doctor-patient relationship unique with such doctors.
Yet one possible solution is what is known as retail care clinics, and their popularity was increasing not long ago for a variety of reasons.
First, I’ll offer a definition of a retail clinic: A retail clinic is usually located in a convenient location, such as a shopping area, and are smaller than most doctors’ offices in regards to geographical space. Usually, these clinics are staffed with a nurse practitioner that often have the ability and authority to provide the same quality care as a primary care physician, and do so with the same standards regarding accountability and autonomy. If you happen t o go to one for what may be considered a mild ailment, for example, for such conditions as allergies or the flu, you will notice a unique and pleasant paradigm towards your care at such a clinic:
They are quick. You are normally in and out of there within a half hour or so. This includes a thorough assessment and treatment regimen offered. Unlike typical doctor offices, these clinics are walk-in clinics, so there is no over-booking of patients.
You actually dialogue with your health care provider more so than you have experienced in a traditional doctor’s office due to other doctor offices often being incredibly busy from seeing too many patients during a typical day, as this is coerced and dictated by the health care system that employs these primary care doctors you may have seen in the past, which is typically the case.
The cost of going to such a retail clinic, which is sometimes termed an ‘urgent care light’ clinic, is usually about ¾ the cost of a typical primary care doctor visit.
You will likely notice no decline in the quality of care that you receive. In fact, likely you will experience greater quality on many different levels, both on a personal and clinical level.
Critics of such clinics include the American Medical Association and various medical societies, yet in my opinion, they are simply vexed because of the invasion of these clinics on their turf.
If it is discovered that you need greater medical care or attention than the retail clinic can provide for you during your visit at their urgent care light clinic, you will be referred to a location that can provide the care you are determined to need by the clinic’s heath care provider, who has likely relationships with the hospitals and others in the medical community for which they serve.
So most patients of these retail clinics are pleased with the care they receive from them, which is why they continue to grow in number under different names, as they have become franchises, yet the concept is new, so only time will tell regarding their popularity with various communities.
The clinics provide a response to the shortage of primary care doctors, and possibly are an answer to other problems that exist in the health care system in the U.S. The clinics are more authentic, and are therefore more beneficial for public health in many different ways.
Dan Abshear
“Follow where reason leads.” --- Zeno of Citium
Recently in the media, issues have been addressed regarding the specialty of primary care or family practice doctors and the shortage of them in the U.S. In summary, reasons for the shortage that exists are due to the specialty not being that profitable for a doctor compared with other specialties. As a consequence, the doctors view the specialty as not a desirable choice apparently quite often, although the specialty is greatly needed in the health care system and for the public health.
As a layperson, I view primary care as ultimately a specialist in nothing in particular, yet knowledgeable in a large variety of medical areas, which I believe, makes them very valuable to those patients seeking restoration of their health. Furthermore, there is a comfort level with those in this specialty compared with other specialties, one could speculate. So the shortage of primary care doctors is in fact disappointing. Perhaps most disappointing is the atrophy of the doctor-patient relationship unique with such doctors.
Yet one possible solution is what is known as retail care clinics, and their popularity was increasing not long ago for a variety of reasons.
First, I’ll offer a definition of a retail clinic: A retail clinic is usually located in a convenient location, such as a shopping area, and are smaller than most doctors’ offices in regards to geographical space. Usually, these clinics are staffed with a nurse practitioner that often have the ability and authority to provide the same quality care as a primary care physician, and do so with the same standards regarding accountability and autonomy. If you happen t o go to one for what may be considered a mild ailment, for example, for such conditions as allergies or the flu, you will notice a unique and pleasant paradigm towards your care at such a clinic:
They are quick. You are normally in and out of there within a half hour or so. This includes a thorough assessment and treatment regimen offered. Unlike typical doctor offices, these clinics are walk-in clinics, so there is no over-booking of patients.
You actually dialogue with your health care provider more so than you have experienced in a traditional doctor’s office due to other doctor offices often being incredibly busy from seeing too many patients during a typical day, as this is coerced and dictated by the health care system that employs these primary care doctors you may have seen in the past, which is typically the case.
The cost of going to such a retail clinic, which is sometimes termed an ‘urgent care light’ clinic, is usually about ¾ the cost of a typical primary care doctor visit.
You will likely notice no decline in the quality of care that you receive. In fact, likely you will experience greater quality on many different levels, both on a personal and clinical level.
Critics of such clinics include the American Medical Association and various medical societies, yet in my opinion, they are simply vexed because of the invasion of these clinics on their turf.
If it is discovered that you need greater medical care or attention than the retail clinic can provide for you during your visit at their urgent care light clinic, you will be referred to a location that can provide the care you are determined to need by the clinic’s heath care provider, who has likely relationships with the hospitals and others in the medical community for which they serve.
So most patients of these retail clinics are pleased with the care they receive from them, which is why they continue to grow in number under different names, as they have become franchises, yet the concept is new, so only time will tell regarding their popularity with various communities.
The clinics provide a response to the shortage of primary care doctors, and possibly are an answer to other problems that exist in the health care system in the U.S. The clinics are more authentic, and are therefore more beneficial for public health in many different ways.
Dan Abshear
“Follow where reason leads.” --- Zeno of Citium
Vexed By the Interruption?
While the pharmaceutical industry’s image and reputation has suffered, and has been complicated with their declining profits due to a few reasons, these companies still apparently insist on keeping most of their gift- givers on board. Known presently as simply drug reps today, this job has become a vocation void of a sense of accomplishment, which will be described below.
So they may be named at times in different ways, these promoters will be referred to as drug reps, which number close to 100,000 in the U.S. presently, it is believed. The cost to the pharmaceutical industry of these employees is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples.
While historically drug reps have used their persuasive abilities to influence the prescribing habits of doctors in an honest and ethical manner. However presently, most health care providers now simply refuse to speak with them, or have banned all drug reps permanently from their practices for a number of reasons, including the recommendations from their colleagues. It is possible that this may be due to the following reasons:
1. The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are a waste of their time. Yet they will accept your samples still. The credibility you possibly have as a rep is not considered anymore to be present in your vocation due to various controversies associated with the pharmaceutical industry, it is speculated.
2. Most drug reps in the U.S. are hired for their looks and their personality. As a result, many are somewhat ignorant in regards to anything that is clinically relevant to a medical practice, so doctors seem to know this and have responded in such ways. Most drug reps have college degrees that do not correlate with their profession as a drug rep, which is to say that the clinical training of drug reps is limited. In fact, many consider this of such a serious nature that an Act is presently being considered called the SafeRx Act that would certify pharmaceutical reps, and this would be mandatory. One main reason would be to ensure personal accountability for their tactics and statements, I believe, which may improve the quality and safety of their function in the medical community.
3. Many drug reps, it is believed, are void of any ethical considerations due to ignorance of what they are coerced to do or say to prescribers by their employer, and this allows them to embellish the benefits of their promoted products at times in addition to offering inducements to doctors. This is usually due to the rep being unaware of the consequences of their actions at times, yet at other times what reps say is with premeditated intent for potential financial gain for such a drug rep. Worse yet, due to pressure to keep their high-paying jobs, they always are anxious to please their superiors, who require them to offer various types of inducements to physicians that are designated targets of a particular drug company. Such tactics are especially true with the larger drug companies. These reps are in fact coerced to spend these individual promotional budgets assigned to them by their employer. While legally risky, the drug companies continue to dispense to their reps these large budgets reps have been forced to be responsible for dispensing, and are required to spend these budgets. In fact, so much emphasis is placed on this promotional spending, there seems to be an association between the money a rep spends and the progression that occurs with their career working for their pharmaceutical employer. Disclosure laws are being considered presently to mandate the release of all funds dispensed from pharmaceutical companies, which is to say to allow others to see where their money goes and who it goes to, as it is presently very secretive, overall. It is not unusual for a big drug rep to spend 50 thousand dollars a year for clinic lunches alone. In addition, drug reps hire doctors as speakers for certain disease states, and they find many other ways to spend this money they are required to spend.
4. Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies, which allows them to track the scripts a doctor writes, and the data is free of the patient names. Yet the names the products prescribed are well illustrated and available to the drug reps. This allows reps to tailor their tactical approach with any given doctor, if they see the doctor at all during an office visit. Worse yet, doctors who greatly support the promoted products determined by this data allow reps to reward those doctors who favor the rep’s products that they promote, and this could be considered a form of quid pro quo. Laws are being considered presently to prevent this practice of allowing reps to have this data. Doctors are opposed to the data the reps have as well about them for privacy and deceptive reasons, so they say.
5. Overall, reps can be best described as far as their function goes with their profession is to, whenever possible, manipulate doctors with remuneration or other forms of inducements, as they also continue to sample such doctors along with others their promoted meds. Also, frequent lunches are in fact bought often for doctors’ offices and their staff as a method of access, primarily, as stated earlier with the money reps spend earlier for this type of function. Essentially, because of the income and benefits the drug reps receive that they would likely not be able to obtain with any other job, they are compelled to do such unethical if not illegal tactics mentioned earlier that they perhaps normally would not do in another setting. Usually these drug reps rarely refuse to implement such tactics encouraged to them by their employers.
6. Samples keep the prescriber from selecting what may be their preferred choice of med due to cost savings from samples left with a medical office by a drug rep. In addition, doctors are now being paid by prescription providers, which are called pharmacy benefit managers (PBMs) that are typically owned by a managed care company to have a doctor switch their patients to generic substitutes, if they exist, and this is often not disclosed to such patients. Apparently, these PBM companies are doing this in response to the activities of the branded drug companies, as they continue pay doctors often for various reasons, which are questionable in themselves.
It is likely that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment, ultimately. It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Clearly, greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative.
“What you don’t do can be a destructive force.” --- Eleanor Roosevelt
Dan Abshear
So they may be named at times in different ways, these promoters will be referred to as drug reps, which number close to 100,000 in the U.S. presently, it is believed. The cost to the pharmaceutical industry of these employees is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples.
While historically drug reps have used their persuasive abilities to influence the prescribing habits of doctors in an honest and ethical manner. However presently, most health care providers now simply refuse to speak with them, or have banned all drug reps permanently from their practices for a number of reasons, including the recommendations from their colleagues. It is possible that this may be due to the following reasons:
1. The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are a waste of their time. Yet they will accept your samples still. The credibility you possibly have as a rep is not considered anymore to be present in your vocation due to various controversies associated with the pharmaceutical industry, it is speculated.
2. Most drug reps in the U.S. are hired for their looks and their personality. As a result, many are somewhat ignorant in regards to anything that is clinically relevant to a medical practice, so doctors seem to know this and have responded in such ways. Most drug reps have college degrees that do not correlate with their profession as a drug rep, which is to say that the clinical training of drug reps is limited. In fact, many consider this of such a serious nature that an Act is presently being considered called the SafeRx Act that would certify pharmaceutical reps, and this would be mandatory. One main reason would be to ensure personal accountability for their tactics and statements, I believe, which may improve the quality and safety of their function in the medical community.
3. Many drug reps, it is believed, are void of any ethical considerations due to ignorance of what they are coerced to do or say to prescribers by their employer, and this allows them to embellish the benefits of their promoted products at times in addition to offering inducements to doctors. This is usually due to the rep being unaware of the consequences of their actions at times, yet at other times what reps say is with premeditated intent for potential financial gain for such a drug rep. Worse yet, due to pressure to keep their high-paying jobs, they always are anxious to please their superiors, who require them to offer various types of inducements to physicians that are designated targets of a particular drug company. Such tactics are especially true with the larger drug companies. These reps are in fact coerced to spend these individual promotional budgets assigned to them by their employer. While legally risky, the drug companies continue to dispense to their reps these large budgets reps have been forced to be responsible for dispensing, and are required to spend these budgets. In fact, so much emphasis is placed on this promotional spending, there seems to be an association between the money a rep spends and the progression that occurs with their career working for their pharmaceutical employer. Disclosure laws are being considered presently to mandate the release of all funds dispensed from pharmaceutical companies, which is to say to allow others to see where their money goes and who it goes to, as it is presently very secretive, overall. It is not unusual for a big drug rep to spend 50 thousand dollars a year for clinic lunches alone. In addition, drug reps hire doctors as speakers for certain disease states, and they find many other ways to spend this money they are required to spend.
4. Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies, which allows them to track the scripts a doctor writes, and the data is free of the patient names. Yet the names the products prescribed are well illustrated and available to the drug reps. This allows reps to tailor their tactical approach with any given doctor, if they see the doctor at all during an office visit. Worse yet, doctors who greatly support the promoted products determined by this data allow reps to reward those doctors who favor the rep’s products that they promote, and this could be considered a form of quid pro quo. Laws are being considered presently to prevent this practice of allowing reps to have this data. Doctors are opposed to the data the reps have as well about them for privacy and deceptive reasons, so they say.
5. Overall, reps can be best described as far as their function goes with their profession is to, whenever possible, manipulate doctors with remuneration or other forms of inducements, as they also continue to sample such doctors along with others their promoted meds. Also, frequent lunches are in fact bought often for doctors’ offices and their staff as a method of access, primarily, as stated earlier with the money reps spend earlier for this type of function. Essentially, because of the income and benefits the drug reps receive that they would likely not be able to obtain with any other job, they are compelled to do such unethical if not illegal tactics mentioned earlier that they perhaps normally would not do in another setting. Usually these drug reps rarely refuse to implement such tactics encouraged to them by their employers.
6. Samples keep the prescriber from selecting what may be their preferred choice of med due to cost savings from samples left with a medical office by a drug rep. In addition, doctors are now being paid by prescription providers, which are called pharmacy benefit managers (PBMs) that are typically owned by a managed care company to have a doctor switch their patients to generic substitutes, if they exist, and this is often not disclosed to such patients. Apparently, these PBM companies are doing this in response to the activities of the branded drug companies, as they continue pay doctors often for various reasons, which are questionable in themselves.
It is likely that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment, ultimately. It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Clearly, greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative.
“What you don’t do can be a destructive force.” --- Eleanor Roosevelt
Dan Abshear
An End to the Annoyance
While the pharmaceutical industry’s image and reputation has suffered, and has been complicated with their declining profits due to a few reasons, these companies still apparently insist on keeping most of their gift- givers on board. Known presently as simply drug reps today, this job has become a vocation void of a sense of accomplishment, which will be described below.
So they may be named at times in different ways, these promoters will be referred to as drug reps, which number close to 100,000 in the U.S. presently, it is believed. The cost to the pharmaceutical industry of these employees is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples.
While historically drug reps have used their persuasive abilities to influence the prescribing habits of doctors in an honest and ethical manner. However presently, most health care providers now simply refuse to speak with them, or have banned all drug reps permanently from their practices for a number of reasons, including the recommendations from their colleagues. It is possible that this may be due to the following reasons:
1. The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are a waste of their time. Yet they will accept your samples still. The credibility you possibly have as a rep is not considered anymore to be present in your vocation due to various controversies associated with the pharmaceutical industry, it is speculated.
2. Most drug reps in the U.S. are hired for their looks and their personality. As a result, many are somewhat ignorant in regards to anything that is clinically relevant to a medical practice, so doctors seem to know this and have responded in such ways. Most drug reps have college degrees that do not correlate with their profession as a drug rep, which is to say that the clinical training of drug reps is limited. In fact, many consider this of such a serious nature that an Act is presently being considered called the SafeRx Act that would certify pharmaceutical reps, and this would be mandatory. One main reason would be to ensure personal accountability for their tactics and statements, I believe, which may improve the quality and safety of their function in the medical community.
3. Many drug reps, it is believed, are void of any ethical considerations due to ignorance of what they are coerced to do or say to prescribers by their employer, and this allows them to embellish the benefits of their promoted products at times in addition to offering inducements to doctors. This is usually due to the rep being unaware of the consequences of their actions at times, yet at other times what reps say is with premeditated intent for potential financial gain for such a drug rep. Worse yet, due to pressure to keep their high-paying jobs, they always are anxious to please their superiors, who require them to offer various types of inducements to physicians that are designated targets of a particular drug company. Such tactics are especially true with the larger drug companies. These reps are in fact coerced to spend these individual promotional budgets assigned to them by their employer. While legally risky, the drug companies continue to dispense to their reps these large budgets reps have been forced to be responsible for dispensing, and are required to spend these budgets. In fact, so much emphasis is placed on this promotional spending, there seems to be an association between the money a rep spends and the progression that occurs with their career working for their pharmaceutical employer. Disclosure laws are being considered presently to mandate the release of all funds dispensed from pharmaceutical companies, which is to say to allow others to see where their money goes and who it goes to, as it is presently very secretive, overall. It is not unusual for a big drug rep to spend 50 thousand dollars a year for clinic lunches alone. In addition, drug reps hire doctors as speakers for certain disease states, and they find many other ways to spend this money they are required to spend.
4. Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies, which allows them to track the scripts a doctor writes, and the data is free of the patient names. Yet the names the products prescribed are well illustrated and available to the drug reps. This allows reps to tailor their tactical approach with any given doctor, if they see the doctor at all during an office visit. Worse yet, doctors who greatly support the promoted products determined by this data allow reps to reward those doctors who favor the rep’s products that they promote, and this could be considered a form of quid pro quo. Laws are being considered presently to prevent this practice of allowing reps to have this data. Doctors are opposed to the data the reps have as well about them for privacy and deceptive reasons, so they say.
5. Overall, reps can be best described as far as their function goes with their profession is to, whenever possible, manipulate doctors with remuneration or other forms of inducements, as they also continue to sample such doctors along with others their promoted meds. Also, frequent lunches are in fact bought often for doctors’ offices and their staff as a method of access, primarily, as stated earlier with the money reps spend earlier for this type of function. Essentially, because of the income and benefits the drug reps receive that they would likely not be able to obtain with any other job, they are compelled to do such unethical if not illegal tactics mentioned earlier that they perhaps normally would not do in another setting. Usually these drug reps rarely refuse to implement such tactics encouraged to them by their employers.
6. Samples keep the prescriber from selecting what may be their preferred choice of med due to cost savings from samples left with a medical office by a drug rep. In addition, doctors are now being paid by prescription providers, which are called pharmacy benefit managers (PBMs) that are typically owned by a managed care company to have a doctor switch their patients to generic substitutes, if they exist, and this is often not disclosed to such patients. Apparently, these PBM companies are doing this in response to the activities of the branded drug companies, as they continue pay doctors often for various reasons, which are questionable in themselves.
It is likely that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment, ultimately. It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Clearly, greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative.
“What you don’t do can be a destructive force.” --- Eleanor Roosevelt
Dan Abshear
So they may be named at times in different ways, these promoters will be referred to as drug reps, which number close to 100,000 in the U.S. presently, it is believed. The cost to the pharmaceutical industry of these employees is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples.
While historically drug reps have used their persuasive abilities to influence the prescribing habits of doctors in an honest and ethical manner. However presently, most health care providers now simply refuse to speak with them, or have banned all drug reps permanently from their practices for a number of reasons, including the recommendations from their colleagues. It is possible that this may be due to the following reasons:
1. The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are a waste of their time. Yet they will accept your samples still. The credibility you possibly have as a rep is not considered anymore to be present in your vocation due to various controversies associated with the pharmaceutical industry, it is speculated.
2. Most drug reps in the U.S. are hired for their looks and their personality. As a result, many are somewhat ignorant in regards to anything that is clinically relevant to a medical practice, so doctors seem to know this and have responded in such ways. Most drug reps have college degrees that do not correlate with their profession as a drug rep, which is to say that the clinical training of drug reps is limited. In fact, many consider this of such a serious nature that an Act is presently being considered called the SafeRx Act that would certify pharmaceutical reps, and this would be mandatory. One main reason would be to ensure personal accountability for their tactics and statements, I believe, which may improve the quality and safety of their function in the medical community.
3. Many drug reps, it is believed, are void of any ethical considerations due to ignorance of what they are coerced to do or say to prescribers by their employer, and this allows them to embellish the benefits of their promoted products at times in addition to offering inducements to doctors. This is usually due to the rep being unaware of the consequences of their actions at times, yet at other times what reps say is with premeditated intent for potential financial gain for such a drug rep. Worse yet, due to pressure to keep their high-paying jobs, they always are anxious to please their superiors, who require them to offer various types of inducements to physicians that are designated targets of a particular drug company. Such tactics are especially true with the larger drug companies. These reps are in fact coerced to spend these individual promotional budgets assigned to them by their employer. While legally risky, the drug companies continue to dispense to their reps these large budgets reps have been forced to be responsible for dispensing, and are required to spend these budgets. In fact, so much emphasis is placed on this promotional spending, there seems to be an association between the money a rep spends and the progression that occurs with their career working for their pharmaceutical employer. Disclosure laws are being considered presently to mandate the release of all funds dispensed from pharmaceutical companies, which is to say to allow others to see where their money goes and who it goes to, as it is presently very secretive, overall. It is not unusual for a big drug rep to spend 50 thousand dollars a year for clinic lunches alone. In addition, drug reps hire doctors as speakers for certain disease states, and they find many other ways to spend this money they are required to spend.
4. Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies, which allows them to track the scripts a doctor writes, and the data is free of the patient names. Yet the names the products prescribed are well illustrated and available to the drug reps. This allows reps to tailor their tactical approach with any given doctor, if they see the doctor at all during an office visit. Worse yet, doctors who greatly support the promoted products determined by this data allow reps to reward those doctors who favor the rep’s products that they promote, and this could be considered a form of quid pro quo. Laws are being considered presently to prevent this practice of allowing reps to have this data. Doctors are opposed to the data the reps have as well about them for privacy and deceptive reasons, so they say.
5. Overall, reps can be best described as far as their function goes with their profession is to, whenever possible, manipulate doctors with remuneration or other forms of inducements, as they also continue to sample such doctors along with others their promoted meds. Also, frequent lunches are in fact bought often for doctors’ offices and their staff as a method of access, primarily, as stated earlier with the money reps spend earlier for this type of function. Essentially, because of the income and benefits the drug reps receive that they would likely not be able to obtain with any other job, they are compelled to do such unethical if not illegal tactics mentioned earlier that they perhaps normally would not do in another setting. Usually these drug reps rarely refuse to implement such tactics encouraged to them by their employers.
6. Samples keep the prescriber from selecting what may be their preferred choice of med due to cost savings from samples left with a medical office by a drug rep. In addition, doctors are now being paid by prescription providers, which are called pharmacy benefit managers (PBMs) that are typically owned by a managed care company to have a doctor switch their patients to generic substitutes, if they exist, and this is often not disclosed to such patients. Apparently, these PBM companies are doing this in response to the activities of the branded drug companies, as they continue pay doctors often for various reasons, which are questionable in themselves.
It is likely that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment, ultimately. It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Clearly, greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative.
“What you don’t do can be a destructive force.” --- Eleanor Roosevelt
Dan Abshear
Sweet Innovation
The Pumpers: A New Paradigm in diabetes management
With some diabetic patients, insulin is necessary for their survival. As I recall, a man named Pauescu developed the concept of insulin replacement, and discovered the method of using insulin secreted from pigs as a replacement method for humans. Legend has it that this concept originated in a dream this man had on night several decades ago. Yet presently, this hormone which is naturally produced by the pancreas normally has advanced as far as treatment goes for the diabetic patient who is dependent on insulin for their treatment, and those are type 1 diabetic patients.
Recently, the Denver Bronco’s quarterback, Jay Cutler, was recently diagnosed with diabetes, a disease that affects over 20 million people. As I recall, part of his treatment regimen involves what is called an insulin pump. They are the size of a cell phone, approximately, and the users of such pumps are called, in the diabetic community, ‘pumpers’. Developed primarily for type 1, or insulin-dependent diabetic patients, the pumps can be used by some type 2 diabetic patients if they have some dependence on insulin replacement. The importance of the device is improved management of the disease, which can cause life-threatening consequences if the disease of diabetes is not controlled properly.
The three elements of an insulin pump include the pump itself and its components, such as the insulin tube for delivery of insulin, and a catheter that delivers basal and bolus doses, which are dependent on preset calculations. The amount of insulin is fast or rapid acting to ensure maximal pharmacokinetics to create intensive insulinotherapy for required diabetes management. These insulin amounts are ultimately determined by the patient’s doctor, who is usually an Endocrinologist, including bolus doses determined by the patients glucose level calculated with their carbohydrate intake, also known as the meal- time dose. Furthermore, the amount of insulin delivered by these methods is quite small due to the nature of the medication being rapid acting.
The makers of such pumps tend to partner with associations relevant to the disease of diabetes, as well as local chapters of such organizations as the ADA and Endocrinology societies that may exist, along with contacting diabetes educators frequently at different locations throughout the country. Unfortunately, there are few Endocrinologists in the United States, as it is not one of the more lucrative specialties of a doctor, so treatment of diabetes is dependent on many others who are not doctors, but patient care specialists regarding this disease.
Competing companies are few, as there are approximately 5 insulin pumps in the market, with Medtronic having the largest share of 30 percent, as I understand. Some pumps avoid the possibility of metabolic action therapy due to their dosing precision, in addition, there is at least one pump that has long acting lithium battery that averages about a 6 week lifespan, yet a pump user should have a battery replacement with them at all times. The personalized insulin and carbohydrate ratio provided by insulin pumps greatly reduces any incidence of such complications as hypoglycemia. Also, in addition to storing and recording glucose and carbohydrate values with a back up mechanisms, some insulin pumps have a low basal rate, which I understand is an advantage as well. Regardless, and in my opinion, the ultimate advantages of insulin pumps exist with all that are available to patients presently.
The cartridges of the insulin pumps hold a large number of units of insulin, which is an additional benefit. Further benefits include the fact that the pumps are convenient and reliable- especially if damage is avoided to the pump. Most importantly, the personal service provided to the patients by the caregivers of existing diabetic teams in health care facilities from hospitals to health care centers dedicated to the disease of diabetes ensures proper management of their disease, much to the benefit of those who have diabetes.
The market growth of insulin pumps is anticipated at over 10 percent a year, as only 20 percent of type 1 diabetic patients have utilized these pumps out of over a million type 1 diabetics in the United States. The market is speculated to be greater than one billion dollars and is expected to increase due to speculated growth of the Insulin pump market. Many believe this therapy is superior in comparison with previous treatment options available to diabetic patients, along with being less cumbersome for these patients. Because of this, there is decreased mortality along with increased quality of life for diabetics, as they are assured of better control of their disease in this rather convenient way. This has been proven by better A1C blood tests and glycemic control of diabetic patients.
The steady dosing maintains the patient’s metabolic requirements and decreases long term consequences associated with diabetics. It has also been proven that insulin pumps result in fewer hospitalizations, ER visits, and episodes of hypoglycemia due to the excellent control provided by the insulin pumps while providing the necessary intensive therapy for their disease state. The fast acting insulin used in these pumps is created through genetic engineering, I believe. In addition, patients are encouraged to check their blood sugar greater than three times a day while on the insulin pump. So this system is both friendly to the user and is clearly a very convenient form of treatment for them. The A1C test, by the way, is a blood test that reflects the diabetic patient’s average blood sugar over a period of a few months.
Those who may be interested in insulin pumps will include those described already, along with hospitals, long term care facilities, home health care agencies, pediatricians, and possibly dialysis clinics, to name a few. Most likely, those considered for insulin pumps will be diabetic patients that are unable to achieve compliance with their current treatment regimen, along with other benefits of insulin pumps stated so far.
The diabetes team for a diabetic patient may include an Endocrinologist, a diabetes educator, a dietician, along with the insulin pump representative. Follow ups with this team may include review the progress of the insulin pump for the patient and how the patient is tolerating the treatment. Often, classes can be scheduled through an institution or center regarding insulin pump training a few times a month. Education and training about the insulin pump may include the following:
1. Glycemic control importance and how to prevent and treat as needed
2. Basal and bolus concepts and how they contribute to the treatment
3. Pump basics and strategies. Negative effects stressed to pt. if their pump is not used properly.
4. Importance of knowing blood sugar and why. Definitions of terms like A1C
5. How to deliver a bolus dose after checking carbohydrate intake
6. How to check the pump’s memory
7. Troubleshooting, phone number access, and how to replace battery
8. Emphasize the safety of the insulin pump if operated correctly
9. Keeping a glucagon injection and spare battery with you
Ultimately after training others, it is important that the patient acknowledges understanding of how the device works, as well as the consequences that may occur if directions are not followed that are ultimately determined by the patients doctor. And fortunately, doctors and others who treat diabetes now have a new tool or device to assure compliance and longevity of these patients.
Innovation is a wonderful thing, such as what has been described. Control of such a large and devastating disease is of great importance, so there seems to be a much desired need for pumpers now and likely in the future. Especially for those patients who slack on following their prescribed treatment regimen. And this will have to do until relevant transplants to reverse diabetes become more frequent.
Dan Abshear
With some diabetic patients, insulin is necessary for their survival. As I recall, a man named Pauescu developed the concept of insulin replacement, and discovered the method of using insulin secreted from pigs as a replacement method for humans. Legend has it that this concept originated in a dream this man had on night several decades ago. Yet presently, this hormone which is naturally produced by the pancreas normally has advanced as far as treatment goes for the diabetic patient who is dependent on insulin for their treatment, and those are type 1 diabetic patients.
Recently, the Denver Bronco’s quarterback, Jay Cutler, was recently diagnosed with diabetes, a disease that affects over 20 million people. As I recall, part of his treatment regimen involves what is called an insulin pump. They are the size of a cell phone, approximately, and the users of such pumps are called, in the diabetic community, ‘pumpers’. Developed primarily for type 1, or insulin-dependent diabetic patients, the pumps can be used by some type 2 diabetic patients if they have some dependence on insulin replacement. The importance of the device is improved management of the disease, which can cause life-threatening consequences if the disease of diabetes is not controlled properly.
The three elements of an insulin pump include the pump itself and its components, such as the insulin tube for delivery of insulin, and a catheter that delivers basal and bolus doses, which are dependent on preset calculations. The amount of insulin is fast or rapid acting to ensure maximal pharmacokinetics to create intensive insulinotherapy for required diabetes management. These insulin amounts are ultimately determined by the patient’s doctor, who is usually an Endocrinologist, including bolus doses determined by the patients glucose level calculated with their carbohydrate intake, also known as the meal- time dose. Furthermore, the amount of insulin delivered by these methods is quite small due to the nature of the medication being rapid acting.
The makers of such pumps tend to partner with associations relevant to the disease of diabetes, as well as local chapters of such organizations as the ADA and Endocrinology societies that may exist, along with contacting diabetes educators frequently at different locations throughout the country. Unfortunately, there are few Endocrinologists in the United States, as it is not one of the more lucrative specialties of a doctor, so treatment of diabetes is dependent on many others who are not doctors, but patient care specialists regarding this disease.
Competing companies are few, as there are approximately 5 insulin pumps in the market, with Medtronic having the largest share of 30 percent, as I understand. Some pumps avoid the possibility of metabolic action therapy due to their dosing precision, in addition, there is at least one pump that has long acting lithium battery that averages about a 6 week lifespan, yet a pump user should have a battery replacement with them at all times. The personalized insulin and carbohydrate ratio provided by insulin pumps greatly reduces any incidence of such complications as hypoglycemia. Also, in addition to storing and recording glucose and carbohydrate values with a back up mechanisms, some insulin pumps have a low basal rate, which I understand is an advantage as well. Regardless, and in my opinion, the ultimate advantages of insulin pumps exist with all that are available to patients presently.
The cartridges of the insulin pumps hold a large number of units of insulin, which is an additional benefit. Further benefits include the fact that the pumps are convenient and reliable- especially if damage is avoided to the pump. Most importantly, the personal service provided to the patients by the caregivers of existing diabetic teams in health care facilities from hospitals to health care centers dedicated to the disease of diabetes ensures proper management of their disease, much to the benefit of those who have diabetes.
The market growth of insulin pumps is anticipated at over 10 percent a year, as only 20 percent of type 1 diabetic patients have utilized these pumps out of over a million type 1 diabetics in the United States. The market is speculated to be greater than one billion dollars and is expected to increase due to speculated growth of the Insulin pump market. Many believe this therapy is superior in comparison with previous treatment options available to diabetic patients, along with being less cumbersome for these patients. Because of this, there is decreased mortality along with increased quality of life for diabetics, as they are assured of better control of their disease in this rather convenient way. This has been proven by better A1C blood tests and glycemic control of diabetic patients.
The steady dosing maintains the patient’s metabolic requirements and decreases long term consequences associated with diabetics. It has also been proven that insulin pumps result in fewer hospitalizations, ER visits, and episodes of hypoglycemia due to the excellent control provided by the insulin pumps while providing the necessary intensive therapy for their disease state. The fast acting insulin used in these pumps is created through genetic engineering, I believe. In addition, patients are encouraged to check their blood sugar greater than three times a day while on the insulin pump. So this system is both friendly to the user and is clearly a very convenient form of treatment for them. The A1C test, by the way, is a blood test that reflects the diabetic patient’s average blood sugar over a period of a few months.
Those who may be interested in insulin pumps will include those described already, along with hospitals, long term care facilities, home health care agencies, pediatricians, and possibly dialysis clinics, to name a few. Most likely, those considered for insulin pumps will be diabetic patients that are unable to achieve compliance with their current treatment regimen, along with other benefits of insulin pumps stated so far.
The diabetes team for a diabetic patient may include an Endocrinologist, a diabetes educator, a dietician, along with the insulin pump representative. Follow ups with this team may include review the progress of the insulin pump for the patient and how the patient is tolerating the treatment. Often, classes can be scheduled through an institution or center regarding insulin pump training a few times a month. Education and training about the insulin pump may include the following:
1. Glycemic control importance and how to prevent and treat as needed
2. Basal and bolus concepts and how they contribute to the treatment
3. Pump basics and strategies. Negative effects stressed to pt. if their pump is not used properly.
4. Importance of knowing blood sugar and why. Definitions of terms like A1C
5. How to deliver a bolus dose after checking carbohydrate intake
6. How to check the pump’s memory
7. Troubleshooting, phone number access, and how to replace battery
8. Emphasize the safety of the insulin pump if operated correctly
9. Keeping a glucagon injection and spare battery with you
Ultimately after training others, it is important that the patient acknowledges understanding of how the device works, as well as the consequences that may occur if directions are not followed that are ultimately determined by the patients doctor. And fortunately, doctors and others who treat diabetes now have a new tool or device to assure compliance and longevity of these patients.
Innovation is a wonderful thing, such as what has been described. Control of such a large and devastating disease is of great importance, so there seems to be a much desired need for pumpers now and likely in the future. Especially for those patients who slack on following their prescribed treatment regimen. And this will have to do until relevant transplants to reverse diabetes become more frequent.
Dan Abshear
A Real Super Drug
Take Two Aspirin, And……
Amost on a daily basis, one may read about a new medication being developed or approved for the benefit of patients. At times, these announcements may praise the innovation and novelty of such drugs that are new and possibly available to all in need of it.
But it’s possible the one super drug is not new and really is a super drug. In fact, it’s one of the oldest medications available, and that would be aspirin- the first non-steroidal anti-inflammatory drug (NSAID).
Noted as ASA by doctors typically, aspirin effects have been noted for thousands of years, as the active ingredient comes from the bark of a White Willow tree, and long ago, patients with pain or a fever would chew on this bark for relief. Yet due to the harshness of the natural chemical of this bark, Bayer decided to synthesize it to make it more friendly to the user.
Fast forward to over a hundred years ago and Bayer pharmaceuticals (pronounced ‘Beier’), which is the same company that brought us heroin and mustard gas, as well as methadone. The company originated in Germany, but presently has its U.S. headquarters in New York. Felix Hoffman, seeking to develop an agent for his father’s rheumatism, was involved in the development of what is known now as aspirin. And it was a difficult task to develop this drug, as it was toxic to the stomach due to the nature of the active ingredient again obtained from the bark of the white willow tree. Dr. Hoffman and others at Bayer developed a drug that proved to be tolerable to patients while keeping the active ingredient in tact through a method of delivery developed by Dr. Hoffman’s team at Bayer. After launching the medication, aspirin was priced at about 50 cents an ounce, as at the time it was only available in power form. Soon before 1920, aspirin developed the tablet form of the drug and was then available by prescription. Regardless, aspirin was responsible for one third of sales for Bayer during this time, due to its popularity at that time.
While all drugs have side effects, aspirin is one of very few drugs that provides great efficacy and indications, with limited side effects. In fact, some of aspirin’s additional uses have been recently discovered. This may be why the New York Times called aspirin a wonder drug in the 1960s. In the 1970s, the mechanism of aspirin was isolated, which is the blockage of prostaglandins.
With Aspirin and its potential life-extending benefits:
Aspirin has been associated with decreased risk of asthma and prostate cancer in the elderly. Also, aspirin has been linked with lowering the risk of breast cancer and colon cancer as well. Aspirin is a blood thinner, and has been associated with decreasing the risk of heart attacks and strokes in certain patient populations, as the drug prevents clots. This was first suggested in the 1940s and the FDA suggested that it be the drug of choice for those who experienced a heart attack over a decade ago. Aspirin intake is beneficial for those after coronary bypass procedures. A topical formulation of aspirin was developed recently for those experiencing Herpes pain. The drug has been proven beneficial for those experiencing migraine pains. Aspirin at low doses is taken by many as a preventive drug to decrease cardiovascular incidents that may occur.
Aspirin has been the best selling painkiller since the 1950s. It is not as addictive as other choices for patients regarding pain relief in particular. It is also the most studied drug- with over 3000 scientific papers published worldwide. Also, over 15 billion tablets of aspirin are sold annually, which amounts to about 80 million aspirin tablets consumed daily by others. This amounts to over 16,000 tons of aspirin consumed during this time, or about 70,000 metric tons of aspirin a year. Over a decade ago, a study was performed and concluded that twice as many people would choose aspirin over a computer, given the two choices, because of the benefits of the drug.
Side effects would include GI bleeding if taken in large amounts, along with an association of Reye’s syndrome in children, yet both are relatively rare. Yet all things considered, clearly the benefits of aspirin outweigh any risks of the drug.
Lately, there have been issues with other NSAIDs, such as Cox II inhibitors, without full recollection or knowledge that aspirin is in fact the world’s most widely used drug, and for good reasons.
At times, something newer is not always better
“We might die from medication, but we sure killed all the pain.” --- Conor Oberst
Dan Abshear
Amost on a daily basis, one may read about a new medication being developed or approved for the benefit of patients. At times, these announcements may praise the innovation and novelty of such drugs that are new and possibly available to all in need of it.
But it’s possible the one super drug is not new and really is a super drug. In fact, it’s one of the oldest medications available, and that would be aspirin- the first non-steroidal anti-inflammatory drug (NSAID).
Noted as ASA by doctors typically, aspirin effects have been noted for thousands of years, as the active ingredient comes from the bark of a White Willow tree, and long ago, patients with pain or a fever would chew on this bark for relief. Yet due to the harshness of the natural chemical of this bark, Bayer decided to synthesize it to make it more friendly to the user.
Fast forward to over a hundred years ago and Bayer pharmaceuticals (pronounced ‘Beier’), which is the same company that brought us heroin and mustard gas, as well as methadone. The company originated in Germany, but presently has its U.S. headquarters in New York. Felix Hoffman, seeking to develop an agent for his father’s rheumatism, was involved in the development of what is known now as aspirin. And it was a difficult task to develop this drug, as it was toxic to the stomach due to the nature of the active ingredient again obtained from the bark of the white willow tree. Dr. Hoffman and others at Bayer developed a drug that proved to be tolerable to patients while keeping the active ingredient in tact through a method of delivery developed by Dr. Hoffman’s team at Bayer. After launching the medication, aspirin was priced at about 50 cents an ounce, as at the time it was only available in power form. Soon before 1920, aspirin developed the tablet form of the drug and was then available by prescription. Regardless, aspirin was responsible for one third of sales for Bayer during this time, due to its popularity at that time.
While all drugs have side effects, aspirin is one of very few drugs that provides great efficacy and indications, with limited side effects. In fact, some of aspirin’s additional uses have been recently discovered. This may be why the New York Times called aspirin a wonder drug in the 1960s. In the 1970s, the mechanism of aspirin was isolated, which is the blockage of prostaglandins.
With Aspirin and its potential life-extending benefits:
Aspirin has been associated with decreased risk of asthma and prostate cancer in the elderly. Also, aspirin has been linked with lowering the risk of breast cancer and colon cancer as well. Aspirin is a blood thinner, and has been associated with decreasing the risk of heart attacks and strokes in certain patient populations, as the drug prevents clots. This was first suggested in the 1940s and the FDA suggested that it be the drug of choice for those who experienced a heart attack over a decade ago. Aspirin intake is beneficial for those after coronary bypass procedures. A topical formulation of aspirin was developed recently for those experiencing Herpes pain. The drug has been proven beneficial for those experiencing migraine pains. Aspirin at low doses is taken by many as a preventive drug to decrease cardiovascular incidents that may occur.
Aspirin has been the best selling painkiller since the 1950s. It is not as addictive as other choices for patients regarding pain relief in particular. It is also the most studied drug- with over 3000 scientific papers published worldwide. Also, over 15 billion tablets of aspirin are sold annually, which amounts to about 80 million aspirin tablets consumed daily by others. This amounts to over 16,000 tons of aspirin consumed during this time, or about 70,000 metric tons of aspirin a year. Over a decade ago, a study was performed and concluded that twice as many people would choose aspirin over a computer, given the two choices, because of the benefits of the drug.
Side effects would include GI bleeding if taken in large amounts, along with an association of Reye’s syndrome in children, yet both are relatively rare. Yet all things considered, clearly the benefits of aspirin outweigh any risks of the drug.
Lately, there have been issues with other NSAIDs, such as Cox II inhibitors, without full recollection or knowledge that aspirin is in fact the world’s most widely used drug, and for good reasons.
At times, something newer is not always better
“We might die from medication, but we sure killed all the pain.” --- Conor Oberst
Dan Abshear
Bioequivalent
The Benefits of Generic Medications: Is the Efficacy There?
More now than in the past, generic medications have been encouraged by prescribers at a much higher rate due to the problem of the high cost of branded meds that many find unfair and unreasonable. Branded meds are still prescribed often, though, mainly due to samples of such meds provided at a doctor’s office from the sales reps who promote these meds. Generics typically are not sampled due to lack of funds compared with branded pharmaceutical companies. Yet generics cost a small fraction, such as a third of the cost, of the same branded meds that have the same molecular bioequivalence. Yet not all branded meds have a generic formulation due to patent exclusivity and therefore cannot be produced until the expiration of this patent of the branded med. This is further complicated by possibly a degree of apathy with health care providers, who appear largely demoralized with aspects of the U.S. Health Care System. More likely, however, is that samples do, in fact, help out the patients.
Not long ago, generic meds were not prescribed that often, or produced to a great degree because of the cost of bringing such a med to the market, which at the time required the same protocols as branded meds. Fast forward to 1984, when the Hatch-Waxman Act was introduced, and this Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer, and nothing else included in the approval process. The reduced cost of generic production allowed for more of these meds to saturate the market, and doctors started prescribing more generic meds as a result. Branded pharmaceutical companies were not pleased in large part with this new act, so they devised schemes to extent the patents of their branded meds, through such tactics as reformulation, which is called Evergreening, of their meds and frivolous patent infringement lawsuits, which delay generic availability for a longer period. Yet pharmacies support generic use, as they make more money off of generics compared with branded meds. So delays will not prevent the utilization of generics, overall. Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access, as branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics.
Also, other reasons for increased generic prescribing is due to the awareness and clinical experience of the previous branded med that has been replicated by the generic med. Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- safety being the main concern with some prescribers. So the familiarity of a generic equivalent of a known med creates a more reassuring choice for the prescriber. Available generics are listed in what is called an orange book. It should be available to all health care providers for their access.
Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter meds. This may discourage the use of branded equivalent meds at a greater amount with generic samples available as well as the branded meds. In addition, and in some cases, doctors can order generic samples from the manufacturers. Knowledge is a good thing.
Yet some doctors insist that you get what you pay for, so they are convinced that branded meds are always more efficacious and tolerable than generic meds. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as required for approval. I’m sure it’s possible others have encouraged such doctors to take such a stance void of fact and reason. Yet there may be some truth to decreased efficacy of generic meds over their branded equivalents.
Considering the health care crisis in our country and the over-priced treatment methods in our system, as with branded pharmaceuticals, generic medications should be considered when clinically appropriate for the benefit of those seeking restoration of their health. It would beneficial for patients to become aware of this pharmaceutical system and request generics when being prescribed a med by their health care provider. In other words, they should question authority figures such as doctors are perceived to be, as patients definitely have a right to acquire knowledge and use this for their benefit with situations as their choices for treatment options, as this will be for their financial benefits while improving their well-being with generic medications- an ideal way to reduce health care costs and improve compliance with their meds because generics are an affordable asset to public health.
“What good fortune for those in power that the people do not think.” --- Adolph Hitler
Dan Abshear
More now than in the past, generic medications have been encouraged by prescribers at a much higher rate due to the problem of the high cost of branded meds that many find unfair and unreasonable. Branded meds are still prescribed often, though, mainly due to samples of such meds provided at a doctor’s office from the sales reps who promote these meds. Generics typically are not sampled due to lack of funds compared with branded pharmaceutical companies. Yet generics cost a small fraction, such as a third of the cost, of the same branded meds that have the same molecular bioequivalence. Yet not all branded meds have a generic formulation due to patent exclusivity and therefore cannot be produced until the expiration of this patent of the branded med. This is further complicated by possibly a degree of apathy with health care providers, who appear largely demoralized with aspects of the U.S. Health Care System. More likely, however, is that samples do, in fact, help out the patients.
Not long ago, generic meds were not prescribed that often, or produced to a great degree because of the cost of bringing such a med to the market, which at the time required the same protocols as branded meds. Fast forward to 1984, when the Hatch-Waxman Act was introduced, and this Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer, and nothing else included in the approval process. The reduced cost of generic production allowed for more of these meds to saturate the market, and doctors started prescribing more generic meds as a result. Branded pharmaceutical companies were not pleased in large part with this new act, so they devised schemes to extent the patents of their branded meds, through such tactics as reformulation, which is called Evergreening, of their meds and frivolous patent infringement lawsuits, which delay generic availability for a longer period. Yet pharmacies support generic use, as they make more money off of generics compared with branded meds. So delays will not prevent the utilization of generics, overall. Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access, as branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics.
Also, other reasons for increased generic prescribing is due to the awareness and clinical experience of the previous branded med that has been replicated by the generic med. Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- safety being the main concern with some prescribers. So the familiarity of a generic equivalent of a known med creates a more reassuring choice for the prescriber. Available generics are listed in what is called an orange book. It should be available to all health care providers for their access.
Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter meds. This may discourage the use of branded equivalent meds at a greater amount with generic samples available as well as the branded meds. In addition, and in some cases, doctors can order generic samples from the manufacturers. Knowledge is a good thing.
Yet some doctors insist that you get what you pay for, so they are convinced that branded meds are always more efficacious and tolerable than generic meds. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as required for approval. I’m sure it’s possible others have encouraged such doctors to take such a stance void of fact and reason. Yet there may be some truth to decreased efficacy of generic meds over their branded equivalents.
Considering the health care crisis in our country and the over-priced treatment methods in our system, as with branded pharmaceuticals, generic medications should be considered when clinically appropriate for the benefit of those seeking restoration of their health. It would beneficial for patients to become aware of this pharmaceutical system and request generics when being prescribed a med by their health care provider. In other words, they should question authority figures such as doctors are perceived to be, as patients definitely have a right to acquire knowledge and use this for their benefit with situations as their choices for treatment options, as this will be for their financial benefits while improving their well-being with generic medications- an ideal way to reduce health care costs and improve compliance with their meds because generics are an affordable asset to public health.
“What good fortune for those in power that the people do not think.” --- Adolph Hitler
Dan Abshear
Terminally Ill
Provenge and Our F.D.A.’s Etiology For Not Being Approved
Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men who have prostate cancer in the United States. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant. Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.
Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only. This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown. What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others. A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
William Abshear
Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men who have prostate cancer in the United States. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant. Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.
Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only. This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown. What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others. A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
William Abshear
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