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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)

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