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Tuesday, August 5, 2008

A Quick Break: My Interview Today

Interviewed with a biotech company today. My follow-up letter was as follows:

Dear (removed),

Please share my thanks to (removed) as well for your time (and lunch) this afternoon.

Your investors expect results, and that I will provide. My activities, if chosen to work for you, will always be in the best interest:

1. For Public Health
2. For (removed)
3. For my Region

Public health (patient care) will always be number one if I work for you.

We had discussions about ethics and legalities involved in our industry. By not compromising these variables, I am working for your best interests, and for your employer. This stance has yet to fail me in my profession.

I do need a job, (removed) And I wish to work for you. You will be without regrets if I am chosen.

Thank you,

Dan Abshear
Phone: 636-639-1027

It's amazing how one evolves.

Friday, July 25, 2008

Law 101 Continued: So Now You Know

If illegal wrongdoing becomes fully aware to you, you may want to take legal action to expose this wrongdoing for the well-being of others, possibly. In order to do that, you need evidence, and lots of it. How do you know what you need as evidence?

Burden of Proof is your obligation to prove what you accuse others of in a federal court- with the goal being to atrophy the presumption of innocence of who is now the defendant, as you are the plantiff, who is one who brings allegations to the attention to prosecutors.

Your goal is to show a preponderance of evidence that is beyond a reasonable doubt. This evidence should be clear, thorough, and convincing. This is necessary to validate the allegations you have made likely did or are occuring. For example, original documents that show illegal activity in the written form are of more strength than simply vocalizing your allegations. Such documents are acquired in different ways and take many forms. Regardless, the evidence should be overwhelming to establish merit and etiology.

But now that you know some law basics, you know what to look for and acquire, which is why this series continues.

Soon, you will find out what happens next.

Law 101 continued: A Different Kind of Concert

A concerted action is one that has been planned, arranged, adjusted, and agreed upon between a group in persuance of some design or is accordance with a certain scheme with the purpose being to prepare for implementation. When there is a conspiracy to commit an illegal act, this is what occurs.

A conspiracy involves more than one person, and may include those who are ignorant of the illegal nature of the planned action.

Some never question as to whether or not something is right or wrong. They just know.

More to follow.

Tuesday, July 22, 2008

Law 101 continued: Why There is Not More Focus on Patient Care

Bad Faith us the willful failure of another to repond to the legal obligations they have for the safety of others.

Laches implies a neglect to do that which we would expect another to do do for thier benefit.

Why are others allowed to commit acts on wrongdoing?

Acquiescence is conduct that appears to allow illegal conduct occur because of the tacit acceptance or disregard by others.

The latter occurs due to the autonomy within such corporations as pharmaceutical companies.

It gets more interesting.......

Monday, July 21, 2008

Law 101: The Bribery Statute

The anti-kickback statute, according to the Inspector General, is when one causes another by presentation of something of value to act in ways in regards to thier prescribing habits that potentially disregard the decision may have for the patient who is prescribed. To offer such an item is in itself a violation as it is an illegal inducement, as no gifts should be given in such a way to increase business of the giver. Nor should the prescribers be chosen to receive these bribes according to thier prescription volume or potential increased support for the promoted products of the giver.

This statute was activated in 1972, and is a violation of the false claims act. The items manifest into many forms and concepts, such as sham clinical trials of no scientific value sponsored by the giver's employer, bogus consulting arrangements with the receiver, and paychecks directly to these prescribers. All are implemented to induce these prescribers with economic coercion.

These items of value that are bribes are as secret or tacit as they are clearly a corporate crime with this fraudulent cource of judgement.

Stay tuned......

Law 101 Continued: Bribery Versus Gifting

Any pharmaceutical company will typically use the word, 'gifting' when they bribe others.

Bribery is the voluntary giving of something of significant value and of no medical benefit from a clinical perspective specifically to influence the performance of the prescriber that will be beneficial financially to the giver of the bribe. Typically, the one who bribes seeks out those who are venal and will accept the bribe.

Gifting, however, is the voluntary transfer of property with consideration in which no value is received in return for accepting the gift. In addition, the receiver understands the nature of the gifter and thier inability to control the actions of the receiver.

How many doctors actually receive true gifts?

More to follow......

Law 101 Mid Term Period: The Size of the Lie

Deception is when one convinces another to believe something knowingly void of complete truth. To convince others of these fabrications, the one who deceives exercises propaganda, distraction, secrecy, and concealment in thier efforts to portray necessary elements to create a reality that does not exist.

Deception is not unique to humans, as some other life forms alter thier morphology or appearance in order to exist. Humans, on the other hand, deceive others by choice and not with a survival necessity. This makes deception a targeted and dishonest human behavior that occurs frequently. Such deception is manifested in forms such as betrayal, lying, and fraud. And what such people do can and often harm others- especially if this occurs in the medical community where this devious act could harm patients to benefit the one who chooses to be without authenticity.

Law 101 Continued: So, What's Your Price?

An inducement is a planned method and tactic for a desired action to result due to a giver having and offering something received by another of notable value and expecting that this will be beneficial in some way to the giver. This anticipated return from the giver is not uncommon in the business world, yet likely is illegal with industries such as the pharmaceutical one.

An example would be a representative of a pharmaceutical company giving a doctor's office sponsorship to do clinical trials for this company, and fully expecting favoritism to be given to this company afterwards because of this investment the company has made in this type of situation that the company presumes is quite a prize for such a doctor and thier office.

The trial sponsorship hypothesis is not exactly without a factual basis. On at least one occasion, a top pharmaceutical executive was angry because the results of the clinical trial his company sponsored did not result in favorable results for his products, and this executive believed he deserved positive results he desired because he invested in the trial process. Return on investment in a rather twisted and pathological way, I would say.

Law 101 Continued: More Latin Once Again

Quid Pro Quo is used by legal agents often to describe exchanges between two entities. Meaning, 'this for that', it occurs with an expected exchange of favors between the two. The favors are viewed as an equal transaction during such a substitution.

Illegal in the Pharmaceutical and Health Care world, this tactic can cloud the judgement of prescribers in regards to the care they give thier patients, as well as allowing for bribery or blackmail to surface if the agreement relevant to the exchange sours.

Furthermore, it creates an atmosphere of reciprocity that further clouds the objectivity of a health care provider.

Reciprocity, by the way, is a mutual and cooperative interchange of favors between others that is typical if not expected in a buyer and seller relationship which, obviously, should not exist in regards to those in the health care system who have the ability to affect the care given to others in the medical community.

Law 101 Continues: Similar To Being Employed By Others?

Economic coercion is the planned act or acts of compelling others to behave in an involuntary way that forbids them from utilizing thier own judgement in order to acquire cooperation for others by force. This act of coercion involves pressure and the preceived necessity of a victim of this act. In health care, damage from coercion by others who wish to benefit typically in an economic way include inadequate treatment of patients from doctors who may be coerced along with the misdiagnosis of such doctors as well.

Legally, economic coercion is a violation of the Sherman Anti-Trust act.

Law 101 Continues: An Old and Uncommon Act

The Sherman anti-trust Act was implemented in 1890. It's purposes are to limit monopolies with businesses. And is a deterrent for others to create agreements that increase cost for customers, which include the health care costs of patients.

Of course, health care costs remain an issue in our health care system. So this act could be utilized in a court of law if the conditions suggested violations of this act.

Law 101 Continued: Now What Exactly Is Fraud?

Fraud is harmful deception designed for personal or organizational gain that is typically of a monetary nature. Fraud damages others and is both a criminal and a certain kind of civil law violation called a tort. Regardless, fraud essentially is not only unlawful, but clearly unfair gain acquired by others. In health care industries, fraud can take on many forms- especially regarding the pharmaceutical company.

This misrepresentation is usually performed with deliberate ignorance and reckless disregard for others that embraces all the multifarious means which human ability can devise to gain advantage over another.

Please stand by for more......

A Very Powerful Department: Law 101 Continued

In reality, the United States Department of Justice is a government law enforcement cabinet that enforces violations of laws in the United States through thier eight divisions, which include civil and criminal division. The department is administered by the United States Attorney General. The U.S.D.O.J. is responsible also for all the U.S. attorneys and thier locations.

Also, the Department of Justice enforce this type of law security through seven different law enforcement agencies.

Many question how biased and effective this department actually is, due to a number of variables. Some of which may be valid.

Stay tuned....

Sunday, July 20, 2008

Law 101 Continued: What is a Federal Prosecutor?

A United States Attorney is a public official who represents the government in the prosecution of those suspected of commiting relevant crimes. They are located in the close to 100 United States District offices in the United States, and some are staffed and committed to addressing certain types of crimes better than others. Furthermore, some district offices prosecute false claims acts more than others. In regards to health care government programs, such as Medicaid, Boston and Philadelpia district attorney's offices appear to be the most thorough and assertive in thier investigations of this nature as it relates to health care fraud. This is where whistleblowers typically go to file these types of cases and offer testimony to relevant government officials.

At the same time, most individual states have Medicaid fraud control units that work with thier Attorney Generals for the same purpose on this level.

Yet the complete intention of these public officials, possibly theoritical, is primarily representing all crimes relevant to the public.

These federal attorneys are appointed by the president, which could affect thier enthusiasm in thier restrictions to fully prosecute all crimes that may exist due to this fact, yet this remains largely undermined.

To be continued.......

Law 101 Continued: An Act Rarely Formed

Anyone ever heard of a False Claims Act?

It is a federal law that allows citizens, who are typically insiders of a particular organization, to file actions against potential wrongdoers in that organization. This has to do with qui tam and those who have knowledge restricted to others, as it is typically very secretive, as well as being poorly understood. These people reveal this information to federal prosecutors in hopes that they concur with thier suspicisions of this wrongdoing.

While it applies to all private and government entities, lately the focus seems to be those whistleblowers with intimate knowledge within or involved with health care industry and thier alleged fraudulent activities that have been known to shock and amaze others because of these activities not only increase the cost of healthcare to others, but possibly can harm thier health as well. Finally the cost is staggering such fraud approaches 70 billion dollars per year.

More to follow.

Law 101 Continued: Now It Gets Latin

What is, or has anyone even heard of the phrase, 'qui tam'?

Qui tam basically is one of the least expensive, yet most effective means of preventing goverment fraud by possibly making those who are responsible liable for such fraud thanks in large part to those who are more or less amateur witnesses and investigators.

Who makes these others aware of such wrongdoing? They are the relators discussed in another post. You may recall they are better known as whistleblowers. And what they disclose is done in a number of different paths, some of which are quite creative, yet also have become more frequent.

Thier bravery combined with idealism and consideration for others are rare, yet admirable, traits, one could say.

More to follow....

Law 101: Anyone Ever Heard of a Relator?

No, it's not someone who is involved with the sale and acquisiton of homes.

A relator (pronounced raletor) is a person on whose behalf an action is maintained by government prosecutors as they expose potential criminal wrongdoing of others. Usually, the relator is employed by these others. And they are more known by others as whistleblowers:

A whistleblower is the one who usually reveals wrongdoing within an organization to those in position of authority, and normally provide insider information unaware to the prosecutors. As a result, close to 20 such cases, with the pharmaceutical industry, have been settled in the past several years- each in the amout of hundreds of million dollars. Most of this money goes to state medicaid programs, which are funded by both states and the government. Also, about half of the receipients of Medicaid are children. Overall, there are around 100 million citizens that have our government provide thier health care in some way that costs the United States besides Medicaid and this cost around 500 billion dollars.

The reasons these rare individuals, the whistleblowers, take such action remains a mystery, and are viewed by others in several ways, with both positive and negative tones.

More to follow, which all will relate to a common theme in the posts to come in the future.

Additional Benefits of Knowledge

Where I live, there is a huge flea market every Sunday that has many with various backgrounds selling, for the most part junk. However occasionally, a treasure unknown to the seller is discovered. This has happened to me twice:

First time was a small medicine bottle with the original manaufacturer's label on it that was over 100 years old. That in itself is quite a find, but what made this more unique is that the name of the medication on the label was, 'morophine'. For those of you who don't know, Morophine was sold in any drug store freely, as if one were buying shampoo. I bought it for one dollar. It is worth hundreds of dollars.

The last occasion was when I purchased a hardcover book that was also over 100 years old. What made this book rare is that it was the program schedule for the meeting of the Knights Templar in St. Louis, and the book, like the medicine bottle, is in perfect condition.

Bought it for a buck, and it also is worth hundreds. For those of you who don't know, the Knights Templar were servants to the Pope, and soldiers for him, during the crusades. The group was supposed to have been destroyed in the 14th century.

Knowledge is power in many ways.

Apparently not.

Friday, July 11, 2008

M & M

1. Medicaid
In 2005, Missouri experienced the most severe Medicaid cuts since the program began 30 years from then. Already, near 1 million Missourians are uninsured aside from this Medicaid situation. So Blount chops 100,000 dollars from Medicaid this year from those citizens who needed the medical resources the most. In addition, Blount had another 300,000 dollars robbed from Missouri’s Medicaid patients by having their medical benefits greatly reduced. Why? I heard it was to possibly to build more athletic stadiums in the state of Missouri. Furthermore, Blount created a ‘war room’ for corporate lobbyists to dispense gifts during the state’s legislative session for this egotistical psychopath to enjoy those obsequious to him, yet also seems to enjoy the suffering experienced by others, as illustrated with the Medicaid issue, which was the largest cut of any state in the history of the program for those in the most need of resources he cannot conceptualize or care about, as he should.
Limited income parents suffered the most with this atrocity, as more than 50,000 of them lost medical coverage for their families. And after Blount stated in 2007 that Missouri is now strong, prosperous, and vibrant regarding the state’s budget and the robust economy, he never repaired or acknowledged at all the damage he did to those suffering Missourians in 2005, and never indicated to do what he should have done, which having notable degrees of remorse, regret, and guilt. Remember that most on Medicaid in Missouri are children through what is called the SCHIP Medicaid program.
In the U.S., the total cost of Medicaid is around 300 billion dollars a year. States have their own discretion on how their Medicaid programs are operated, and this is largely unexamined by the other contributor to Medicaid, the federal government, as it should be according to the laws involved with the proper administration of Medicad.
The joy he must experience in seeing or knowing of the suffering of others must continue to elate him, as the Missouri House of Representatives rejected a bill to expand Medicaid coverage greatly needed due to the actions of the governor those years ago recently, simply because he has the ability to do so.
Medicaid is also a necessity for those in need that are residents in the over 500 nursing homes in Missouri. The Nursing Home Inspectors already are accused of ignoring deficiencies in these nursing homes, which may include malnutrition and bed sores of the residents, and the inappropriate use of pharmaceuticals as well. Further unsettling is that such inspections with such reckless disregard normally take place only once a year. The inspectors should be monitored by the GAO because of safety issues in nursing homes that continue and appear unresolved, yet it seems to continue. For example, around 25 percent of Missouri nursing homes were found to have deficiencies recently that were authentic and concerning. The rest of the nation only has a rate of 15 percent. Also, the Nursing homes in the United States are only covered by Medicaid, as typically, nursing homes cost each patient over 5 thousand dollars a month without this much needed support.
Aside from the problems mentioned already with nursing homes, combined by the loneliness and desperation of those who stay at these facilities, the mental disease of dementia is a common disease as we get older and is seen in Nursing homes, and identified with those at these locations, yet are treated inappropriately, if at all, I understand. Basically, dementia is a disease of cognitive and brain dysfunction that usually is not reversible. If it’s the cortical kind of dementia, it is combined with Alzheimer’s disease. If it is the sub cortical kind, look for Parkinson’s disease to be experienced with these patients. Such patients are inappropriately prescribed and given inappropriate if not deadly medications, such as atypical anti-psychotics, which cause high rates of pneumonia and premature death in the elderly population who have dementia.
To complicate Missouri’s health care situation further, and because close to 90 percent of Missouri counties are rural, with most lacking hospitals, there is only one doctor for every 3500 or so residents in such counties in this state. There is something to help called a Certificate of Need, or CON. Issued by regulatory agencies, they authorize healthcare facility creation and expansion as determined by the perceived needs of any community. Only a small number of states seem to have a formal CON process to activate this system, such as the addition of new nursing facility beds. Missouri fortunately is a state that is entitled to this requirement if the providers have a 90 percent occupancy for 4 quarters. Created by the American Health Care Association, the last CON was called a Medicaid payment system clearinghouse. I’m not sure why this was involved with the CON program.
There are around 5 million people in Missouri are and have Medicaid. The state of Missouri pays 20 percent of that bill, with the government paying the rest. While the states manage Medicaid for their state, CMS monitors and regulates the states, but that does not mean that this DHHS division actually does this in a complete and beneficial method for the citizens of Missouri. In 1990, Medicaid came out with the drug rebate program, which helped many. The Missouri Healthnet Division is responsible for making the best of the MO Medicaid funds, with frequent drug utilization reviews to determine the level of access to covered pharmaceuticals, as they manage these funds.
With seniors, government health care programs pay for quite a bit. For example, Long Term Care (LOC) costs Missouri about 2 million dollars a year. About 10 million elderly U.S. residents are in LTC facilities. Only Medicaid pays for this service as well, as mentioned earlier. Homecare is one form of LTC, and preferable to many. The underfunding of Medicare for LTC has increased around 50 percent in less than a decade, which amounts to around 5 billion dollars per year. Missouri is one of the states with the greatest disparity between the actual cost of providing suitable medical care and Medicaid reimbursements. This, of course, is damaging for nursing facility residents who have also had their ‘allowable costs’ progressively lowered as well. The result of this decline means that each individual patient has a daily shortfall of over 20 dollars a day. Missouri ranks about 7 percent in the nation in reference to this type of neglect. Aside from decreased health care quality of the elderly, these people may become very sick and could result in their lifespan shortened due to lack of access of medical attention that may delay the progression of any existing diseases they may have. There are also skilled nursing facility patients, most of who rely on Medicaid to pay for their care and services. The state of Missouri decides what is allowed regarding their care.
To no one’s surprise for the most part, the federal government essentially is disregarding the humane responsibility they have to the citizens in this population in the United States with ensuring they have appropriate health care by allowing such flaws to continue to exist.
The Medicaid for children again is called SCHIP, and was created over 10 years ago. This program is facing funding shortfalls in many states, with Missouri topping the list thanks to the governor. Of course, Bush vetoed a bill for SCHIP expansion and reauthorization recently, and the House was unable to over-ride this veto and some other vetos Blunt has implemented for the benefit of the U.S. citizens. The cost for this SCHIP program for children is around 4 billion dollars a year, and residents are concerned about children not receiving medical attention due to the severe shortages that continue to exist with the state’s Medicaid funds. Some governors, however, appear to be void of such concern, and therefore clearly do not share the concern of their citizens.
2. Medicare
Medicare is primarily health insurance provided by our government for those over 65 years of age, along with other situations, such as those with disabilities. Medicare began the same year Medicaid did, and it was a decent program to implement. About 50 million people in the United States have Medicare, which costs around 300 billion dollars every year. Unfortunately, various market forces have infected Medicare for decades now. However, Medicare has become more confusing for the cardholders over the years. Most recently, a part D was added to assist with paying for prescription drugs.
Since Medicare is the insurance for this population, doctors and others are somewhat reliant on reimbursement from the program, just as they are with other forms of insurance. A few years ago, the Senate Finance Committee passed a spending cut package that dropped over 10 billion dollars from Medicare and Medicaid over the next five years after the package was activated. This was due to the federal government wanting to cut 35 billion from the federal budget. Yet at the same time, the Senators agreed to boost doctors’ Medicare payments by over 10 billion dollars over 5 years that replaced a scheduled 5 percent or so cut that physician groups understandably were opposed to upon becoming aware of it. Furthermore, Medicare randomly assigned the members to a plan they may be completely unaware about until they are denied healthcare at a clinic, perhaps.
Then there is the issue of Medicare Fraud, which the CMS freely admits knowledge of, yet prosecutions seem rare, yet lucrative to the prosecutors with settlement agreements, which averages about a billion dollars a year from the wrongdoers and the settlements they pay. Also, when CMS spoke on this last year, the DHHS announced a pilot program to catch such people who rob taxpayers by over-billing Medicare in the amount of several billions of dollars every year.
There is an issue of doctors having their Medicare reimbursements cut by the Senate Finance Committee. Doctors are reimbursed by Medicare by a list of codes provided to them by CMS to illustrate to doctors that they have the discretion on what the doctor is allowed to collect from Medicare. Late last year, a closed meeting was held to discuss reversing a scheduled reduction in physician fees exceeding 10 percent that was planned to take place at the start of 2008. A one year moratorium regarding this cut was suggested. Physicians were included with many others scheduled for Medicare reductions. Finally in the summer of 2008, a veto-proof passage of a Medicare reform bill halted any Medicare reductions to physicians until at least 2009. At the same time, a Medicare Improvements for Patients and Providers act was passed- designed ultimately to improve Medicare and ensure the health of those on this program. 90 percent of doctors see Medicare patients. It appears the will of the people was acknowledged with the passage of this act. Because seeing Medicare patients as their doctor is no longer affordable for them. And Medicare does have its share of flaws, such as the Medicare Advantage, designed as a solution to the shortfalls of the Medicare program. About 20 percent signed up for Medicare Advantage Medicare part D that was marketed aggressively to seniors regarding their part D element of their Medicare, yet was passed by congress and signed by the president. Now, regulations are being considered by the administration to limit their Medicare entitlements in other ways because of their mistake. Medicare Advantage cuts could deprive seniors of needed pharmaceuticals for the restoration of their health or to delay the progression of an existing disease they may have.
Then there are other cuts that are now in effect with Medicare reimbursement reductions, but were intended to begin shortly after the passing of the Balanced Budget act of 1997, which capped medical therapy for Medicare pts. at a maximum reimbursement of 1500 dollars per session for outpatient services that was initially suppose to be activated in 1999. Thanks to three moratoriums that were allowed after 1999 that provided an extension of the caps requirement until 2005, when the caps were mandated, yet were placed with what was called an ‘exceptions processes. This permits certain types of therapy to exceed the cap limit if the Medicare patient meets certain diagnostic and clinical criteria determined by their relevant health care provider. This process was authorized by the Deficit Reduction act of 2005. The process exception existed though a couple of more acts that were passed and activated until June of 2008. And the therapy sessions max out at a little over 1800 dollars a session at this time of implementation of the caps for services with the exceptions process expired at this point as well.
The intention of both Medicare and Medicaid was to assist others in medical need who are unable to obtain such needs due to their condition or their income. A few bad apples, from doctors to government officials, have contaminated the intent of these programs and health care to those who need it the most is being taken away from them, even though they have done nothing wrong.

Yeah, I’d say that our Health Care System a crisis,

Dan Abshear

MO Health Dept. Head: Jane Drummond
MO Medicaid Director: Steven Renne

Thursday, July 10, 2008

Innovation For Profit, Patient Benefit, or Both?

Innovation in Pharmacology?

Beginning in the 1970, biopharmaceuticals were being researched for conceptual production in those places once called academic institutions. The first biopharmaceutical ever was a synthetic insulin called Humulin made by Genetech in 1982. Later the rights were sold to Eli Lilly for this insulin. Biopharmas are distant and covert relatives of big pharma, yet become intimate with them more often now than ever before due to dry pipelines of big pharma- GSK and Roche in particular, yet most big pharma examine acquisition of biopharma companies for assured profit more than any other reason, they may speculate.

Over 20 biopharma drugs were approved in 2005, I believe. They are overall very effective treatments for very difficult diseases to manage, as they target specific aspects of certain diseases, which limits side effects experienced by the patient placed on therapy with a biopharma drug. There are about a dozen f different classes or mechanisms of action of biopharmaceuticals that have about a half of dozen different types of uses that is always increasing, as lablel alterations of biopharmas are requested soon after the approval of a particular medication by this method that is allowed for further exploration of potential additional uses of thier new drug which, like other biopharmaceuticals, work in novel ways. Some cause apoptosis, or cell death of specific tumor cells. Some cause angiogenesis to occur, which means they cut off the blood supply to tumors. Then some biopharmaceuticals have multiple modes of action that benefit certain patient types and their diseases greatly, as with most biopharma products, the safety and efficacy is evident and reinforced with clinical data and eventual experience with the biopharmaceutical that is chosen to be utilized.

Some biopharmas are more noteworthy than others, such as Enbrel, which was originally created for the many forms of RA- arthritis caused by the patient’s immune system attacking their bodies. At one point, demand exceeded supply for this drug, as the efficacy and safety was evident and demand was unexpected by the manufacturer, so Enbrel was sought out by doctors and patients both due to the clinical data verifying the efficacy and benefits of the drug. Relief from the pain and decreased quality of life was the primary motivation for patients seeking this particular drug. Enbrel was approved in 1998 and produced from what are called monoclonal antibiodies, which is one of several ways in which biopharmaceuticals are produced. In fact, some call the 1990s the biopharmaceutical decade.

Partnering of biopharmaceutical companies and larger pharmaceutical companies began during this decade more as well- however has become even more often of an objective of big pharma recently due to the apparent dry pipelines of big pharma and speculated revenue of the products in development stages. It’s a symbiotic relationship in that big pharma can provide the resources and connections necessary to launch and grow a particular biopharmaceutical drug, with the return on this investment being speculated revenue generated from what should be eventually a blockbuster biopharmaceutical. Typically, big pharma just buys or acquires a biopharmaceutical company of interest to them instead of a merger agreement, so it seems.
Some biopharmaceutical drugs are more profitable than others as well. Biopharmas compose around 10 percent of the pharmaceutical market presently, I understand. And with the government health care programs being the largest U.S. payers for pharmaceuticals, Medicare pays 80 percent of the cost of biopharmaceuticals. One other controversial, yet profitable biopharma class is known as EPOs, with names like Procrit and Epogen, and are for anemia that is experienced in patients on dialysis or who have cancer in particular. Doctors are monetarily incentivized to exceed dosing requirements of these agents for their anemic patients, but this excess causes premature deaths and accelerated cancer progression for the patients that are over-dosed in this way. Once this tactic was exposed, there are now limitations regarding the amounts authorized to be given to particular patients placed on these EPOs. They are hormone biopharmaceutical drugs, which is another type of several classes of biopharmaceuticals.
While biopharmaceuticals are very efficacious and safe, as well as having therapeutic and diagnostic benefits for the very sick, the cost of them is outrageous, some have said. Genzyme has one biopharma that costs a half a billion dollars a year. Yet most biopharmaceuticals cost around 100 grand a year for therapy that provides with some only limited life extension or survival rate of these patents that is only a few months. Furthermore, with cancer drugs, they are used together with chemotherapy for their treatment regimens, so there is no real improvement in the quality of life of some patients on biopharmaceuticals, considering the devastating side effects of chemo treatment. In addition, Co-pays financially drain such patients and their families, yet there is no other choice for therapy because of the avoidance in the creation of biosimiliars, for example. Oncology, by the way, is the primary commercial focus of biopharmaceutical companies now and in the immediate future, so maybe competition will be a cost advantage to such patients in time.

Several years ago, I saw Roy Vagelos, former CEO of Merck, speak to others at Washington University in St. Louis. And during his presentation, he stated something similar regarding the cost of biopharmaceuticals and asked as well about whether or not is the value related to the cost of biopharmaceticals appropriate for such a brief life extension of cancer patients in particular, for the most part. An issue or issues are always associated with new paradigms and innovations. Yet there are only a few biopharmaceuticals out of many available with debatable benefits with the high price tag. It ends up being what the market will bear. Yet the real question is the clinical evidence behind biopharmaceuticals: If a biopharmaceutical stops tumor progression without remarkable survival benefits or improvement in quality of life, is the price tag worth it to the patient? Assuring that a logical construct is examined to conclude that such a drug will be of benefit to a very sick patient will or should be the determining factor on the treatment regimen selected for such a patient.

How do these drugs differ from typical drugs that have been made before this advent of biopharmaceuticals? Unlike the small molecule, synthetic, carbon based pharmaceuticals of yesterday, biopharmaceuticals, classified under what is called Red biotechnology due to this being a medical process in the biotechnology world, essentially are larger and very complex modified proteins derived from living biological materials that vary depending on what medication will be manufactured and for what disease state. In fact, it is difficult to identify the clinically active component of a biopharma drug.

Also, a transformed host cell is developed to synthesize this protein that is altered and then inserted into a selected cell line. The master cell banks, like fingerprints, are each unique and cannot be accurately duplicated, which is why there are no generic biopharmas, yet biosimilar drugs are again a possibility, yet it’s in more of a conceptual phase presently, so it seems. So after this insertion, the molecules are then cultured to produce the desired protein for the eventual biopharmaceutical product. These proteins are very complex and are manufactured from living organisms and material chosen for whatever biopharma may be desired to be created. It is difficult to identify the clinically active component of biopharma drugs. So manufacturing biopharmas is a difficult process, and a small manufacturing change could and has raised safety issues of a particular biopharma in development that manufacturing had a manufacturing flaw of some sort. It takes about 5 years to manufacture a biopharmaceutical. And each class has a different method of production and alteration of life forms to create what the company intends to develop. Yet overall, their development methods are rather effective. What has been described is only one of many ways a biopharmaceutcal is developed.

Another difference is that biopharmas are regulated under what is called the Public Health Service Act, and unlike the FDA, they authorize the marketing of biopharmaceuticals. The Act’s role in monitoring the promotion of biopharmaceuticals is unknown. Safety protocols regarding biopharmaceuticals are a mystery to me as well.

Presently, there are about 200 biopharmaceutical companies, with maybe a little over 10 percent of them are actually profitable presently. The cost of developing a biopharmaceutical exceeds a billion dollars, with about a third actually making it to market. The market size of biopharmaceuticals is rapidly approaching 100 billion dollars a year, with average annual growth between 10 and 20 percent. It has been said that between 20 and 30 biopharmaceuticals make over a billion dollars a year presently. As cancer is the disease focus of biopharma companies overall, between70and 80 percent of cancer drugs are prescribed off-label, so it will be interesting on how these drugs will be used in such disease states.

Regardless of the challenges that are and will be faced by biopharmaceuticals, I’m pleased to see the results and realization of true innovation in pharmacology. Furthermore, I believe others should behave in a similar manner and be inspired by the biopharmaceutical companies and what they have done and continue to do for the benefit of the patients, yet with a hefty profit for thier admirable work in thier creations.

“The progressive development of man is vitally dependent on invention.” --- N. Tesla

Dan Abshear (what has been written is based upon information and belief)

Wednesday, July 9, 2008

Pharmaceuticals: Another P Added To the Marketing Paradigm

The Damage of Legalized Lying

Amazingly, with the pharmaceutical industry as an example, 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 created by their marketing departments. Some biopharmaceuticals place double the amount of revenue into their R and D than typical big pharma corporations.

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 upon demand of the viewer of the advertisement, usually greatly unqualified to dictate their own medicinal treatment, yet makes such a demand simply on belief of a visual medium that clearly lacks accuracy and completeness. 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, as the doctor-patient relationship historically has not been one of unbalanced debate.

2. 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 patient’s complete medical history as well as other variables necessary to consider the best course of any possible treatment initiated by the provider. Ignoring this premise could be damaging to the patient seeking treatment through marketing in this form. DTC advertising is now occurring in doctors’ office as well. Pharmaceutical companies pay a company what may be a million dollars a year to have a TV in a doctor’s waiting room that constantly pitches primarily the sponsor’s desired product.

3. Clinical evidence is the ultimate determining factor for treatment selection, as long as this evidence is proven to be authentic. This is followed by drug sample availability, yet a correctly informed health care provider is the one who will provide the best care to their patients, along with their experience from a historical perspective in their practice.

4. Education not only trough sponsored doctors paid by a drug company, but more authentic methods should be discovered, which mean from the doctor’s own research and review of literature, but also dialogues with the colleagues of the doctor. The Medical Letter is an example of acquiring information free from what may be dangerous bias, regarding pharmacological treatment considerations.

5. As an ex seasoned big pharma drug rep, I can assure you that education is not the purpose of a pharmaceutical company, and they have no interest in this valuable area as demonstrated by their marketing being the apex of their objectives. Offering various inducements to others tops the list, though, with their marketing efforts. Perhaps research of novel and innovative medications should instead be the sole purpose and focus of pharmaceutical companies.

6. 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 regarding the legality of some tactics, further complicated by the public being largely unaware of how big pharma in particular really operates. Such forms of manipulation developed by some drug companies include questionable inducements for the health care providers. This is allowed to happen as well as forced to occur by the pharma company representatives 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, as this is the case presently. To further illustrate this drug rep description of what they are forced to do, 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 necessary to be a true asset in the medical community.

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

The Fallacies of Government Health Care Programs

In 2005, Missouri experienced the most severe Medicaid cuts since the program began 30 years from then. Already, near 1 million Missourians are uninsured. So Blount chops 100,000 from Medicaid this year, who needed the medical resources the most. In addition, Blount had another 300,000 Medicaid patients have their medical benefits greatly reduced. Why? Possibly to build more athletic stadiums in the state of Missouri. Futhermore, Blount created a ‘war room’ for corporate lobbyists to dispense gifts during the state’s legislative session for this egotistical psychopath to enjoy those obsequious to him, yet also seems to enjoy the suffering experienced by others, as illustrated with the Medicaid issue, which was the largest cut of any state in the history of the program for those in the most need of resources he cannot conceptualize or care about, as he should.

Limited income parents suffered the most with this atrocity, as more than 50,000 of them lost medical coverage for their families. And after Blount stated in 2007 that Missouri is now strong, prosperous, and vibrant regarding the state’s budget and the robust economy, he never repaired at all the damage he did to those suffering Missourians in 2005, and never indicated to do what he should have done. Remember that most on Medicaid in Missouri are children. In the U.S., the total cost of Medicaid is around 300 billion dollars a year. States have their own discretion on how their Medicaid programs are operated, and this is largely unexamined by the other contributor to Medicaid, the federal government.

The joy he must experience in seeing or knowing of the suffering of others must continue still, as the Missouri House of Representatives rejected a bill to expand Medicaid coverage greatly needed due to the actions of the governor those years ago.

Medicaid is also a necessity for the over 500 nursing homes in Missouri. The Nursing Home Inspectors already are accused of ignoring deficiencies in these nursing homes, which may include malnutrition and bed sores of the residents, and their inappropriate use of pharmaceuticals as well. Further unsettling is that such inspections normally take place only once a year. The inspectors should be more monitored by the GAO because of safety issues in nursing homes that continue and appear unresolved. For example, around 25 percent of Missouri nursing homes were found to have deficiencies recently. The rest of the nation only has a rate of 15 percent. Also, the Nursing homes in the United States are only covered by Medicaid.

Typically, Nursing Homes cost each patient there over 5000 dollars a month without Medicaid support. Yet patients tend to experience loneliness and displacement due to staying at such facilities, aside from noted neglect of these patients in other obvious ways.

Dementia is a common disease as we get older and is seen in Nursing homes. Basically, it is a disease of cognitive and brain dysfunction that usually is not reversible. If it’s the cortical kind, it is combined with Alzheimer’s disease. If it is the subcortical kind, look for Parkinson’s disease to be experienced for these patients. Such patients are inappropriately prescribed and given medications, such as atypical anti-psychotics, which cause high rates of pneumonia and premature death in the elderly population.

To complicate Missouri’s health care situation further, because close to 90 percent of Missouri counties are rural, with most lacking hospitals, there is only one doctor for every 3500 or so residents in such counties in this state. There is something to help called a Certificate of Need, or CON. Issued by regulatory agencies, they authorize healthcare facility creation and expansion as determined by the perceived needs of any community.

5 million people in Missouri are and have Medicaid. Missouri pays 20 percent of that bill, with the government paying the rest. While the states manage Medicaid for their state, CMS monitors and regulates the states, but that does not mean that this DHHS division actually does this. In 1990 Medicaid came out with the drug rebate program, which helped many. The Missouri Healthnet Division is responsible for making the best of the MO Medicaid funds, with frequent drug utilization reviews to determine the level of access to covered pharmaceuticals.
With Medicaid, over 6 million people in the U.S. also have Medicare, and they are known as ‘dual eligible’s’. In the U.S., over 40 million people have Medicare. Medicare costs 300 billion per year as well.

With seniors, government health care programs pay for quite a bit. Long term care costs Missouri about 2 million dollars a year. About 10 million elderly U.S. residents are in LTC. Only Medicaid pays for this as well, as mentioned earlier. Homecare is one form of LTC, and preferable to many.

The Medicaid for children is called SCHIP, and was created over 10 years ago. This program is facing funding shortfalls in many states, with Missouri topping the list thanks to the governor. Of course, Bush vetoed a bill for SCHIP expansion and reauthorization recently, and the House was unable to over-ride this veto and some others he has implemented for the benefit of the U.S. citizens. The cost for this program for children is around 4 billion dollars a year, and residents are concerned about children not receiving medical attention, perhaps in Missouri in particular. Some governors, however, appear to be void of such concern.

MO Health Dept. Head: Jane Drummond
MO Medicaid Director: Steven Renne

Dan Abshear

Sunday, July 6, 2008

Innovation For An Unfortunate Chronic Illness

An Artificial Kidney for those Who Have Failed Kidneys

Kidneys are necessary human organs, which is probably why humans have two of them, as they are balancing organs for our well being, from a physiological perspective. They remove toxins for the blood and maintain electrolyte balance in our bodies as well, to name a few of the many functions of these what are termed end or target organs that are dependent on our circulatory system as we are dependent on their optimal function for our existence.

While the process of dialysis has been improved over the past century or two, the first actual dialysis center was created by a man named Belding Scribner in the early 1960s. Rumor has it that he never patented his creation so more could have access to this vital procedure location with trained staff.

About ½ a million people are dependent on dialysis devices annually and the cost is completely covered by those with Medicare, as this cost for this treatment approaches or exceeds tens of billions of dollars a year for all of these types of patients. In fact, this is the only medical treatment that s completely financially covered chronic medical treatment by Medicare since the early 1970s. This cost is about a million dollars per patient per year. Hem dialysis is the most beneficial type of dialysis, which removes toxins from the blood of the patient over a period of a few hours about three or four times a week, with anemia being the most common complication of this treatment.

If there are patients who need financial assistance, there is a support group who fortunately have a web site that is: www.aakp.org that has helped more dialysis patients than other similar organizations financially.

While there are now about 5 thousand independent and hospital owned dialysis centers presently in the United States, there is also the possibility of home dialysis that are options as well, as determined by the dialysis patient’s doctor, who is a nephrologist, or kidney doctor.
Non for profit dialysis centers have been shown to have better quality than the for profit centers for a number of reasons- some of which are entirely known and unknown. This is important because monitoring of kidney failure patients is a great responsibility, as the average patient takes about 10 drugs routinely in addition to dialysis treatment and are chronically sick patients typically.

One reason for the large number of medications taken by these patients is due to the two primary causes of kidney failure, which are uncontrolled hypertension and diabetes. With high blood pressure, over time the kidneys become progressively impaired due to nephrosclerosis, which is nephritis that is caused, or causes, restricted blood flow and possibly toxins that aggravate this condition within the failing kidneys of these patients. With diabetes, most can discover the disease by detecting protein in the urine, which is a quite simple urine test. If uncontrolled, diabetic nephropathy develops and progresses to the point of kidney failure. Most dialysis patients are there because of diabetes related effects from under treatment or absence of treatment.

How it is determined regarding the damage of the kidneys of such patients is measured by the suspected kidney impaired patient by their GFR- gloumular filtration rate, which measures their fluid output of these patients. If a patient reaches a GFR of stage5, they usually are placed on dialysis for life support, essentially.

For unclear reasons, the larger the size of a dialysis center, the better patient compliance will be experienced, which means more patients show up for treatment and follow directed protocol regarding their illness.

In addition, nephrology staff members of such centers, which include nephrology nurses, have increasingly greater responsibility. Such courageous and skilled people freely accept rather challenging professions that some are reluctant to challenge themselves in such a way. There is actually an American Nephrology Nurses Association. And there is a dialysis museum in Wisconsin called something close to Dialysis Central.

Aggressively treating dialysis patients is controversial. One issue is those patients with CV disease, as overly aggressive dialysis treatment has been correlated with premature death.
Technology and quality of life continues to improve for these patients, yet an artificial kidney would be great, once developed. This has not become available yet.

So, if you are a health care professional who wishes to challenge themselves and gain the confidence of nephrologists. I would suggest involvement with such a devastating disease that relies on quality and compassionate staff for their livelihood and appropriate treatment. Of course, this means dealing with the stress of treating kidney failure patients.

“Only those who risk going too far with deliberate intent can possibly discover how far they can actually go.” --- T.S. Elliott

Dan Abshear

Monday, June 23, 2008

Painful Comedy

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.

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.

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)

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

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


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

Our R

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

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