Since the US Food and Drug Administration (FDA) has approved this approach, should the trials be succesful, Pfizer would be allowed to market the new torcetrapib-atorvastatin combination as a brand-name drug beyond 2010, when its patent on Lipitor runs out. The FDA approval also would allow Pfizer to avoid the risk of anti-trust litigation, which otherwise might have been engendered by it offering a drug only when "bundled" with another of its products.
The trials would not result in any information about how torcetrapib performs alone, or in combination with a statin other than atorvastatin. Physicians would not have the options of prescribing torcetrapib alone, in combination with generic atorvastatin, or in combination with another statin. Thus this approach would limit scientific data available to physicians and researchers, and would limit therapeutic options for patients.
We previously posted about this issue here, based on a March New York Times article.
Avorn commented,
- "the current trial design may not optimally meet the scientific needs of prescribers, the clinical needs of patients, the economic needs of payers, or the regulatory needs of policymakers. But they superbly meet the business needs of the sponsore - to create new knowledge in a way that will protect the market share of the largest drug company's most important product."
Maybe now that the NIH has strict conflict-of-interest rules, and top NIH officials are no longer allowed to get lucrative consulting contracts with pharmaceutical companies, (see post here), this idea will get more welcome reception there.
He thus advocates having the National Institutes of Health (NIH) start supporting "public-interest" drug trials "fairly comparing competing therapies (especially costly new ones) with clinically realistic alternatives."
ReplyDeleteMaybe now that the NIH has strict conflict-of-interest rules, and top NIH officials are no longer allowed to get lucrative consulting contracts with pharmaceutical companies, (see post here), this idea will get more welcome reception there.
The problem with this is, where's the money going to come from? The NIH has no money to spend funding the type of trials that are required to pass FDA approval.
I think the best, fairest solution was the one proposed by Marcia Angell: all Big pharma companies must contribute cash to a single fund under NIH/government control.
Whenever a candidate drug needs to be tested, the cost of the trial is met with money from this fund.
This way, no company can control the analysis of the trials etc. There is also no conflict between whoever's doing the trial, and the company, because the researcher won't "owe" any of his "salary" to a specific company.
A
It's a sad perpetual cycle - if we did use Marcia Angell's idea of utilizing an unbiased party (if you will) to design and execute clinical trials for drugs so that they are designed and sold in a manner that is for the best interests of the general public - where would the motivation (for the 'pfizers' of the world to design any more drugs at all) go? Would they perhaps - leave all the work (R&D too) to the government and enter another industry where they could once again attain a higher profit margin. In other words - wouldn't Marcia Angell's idea fly in the face of conjuring up the motivation for biotechs anywhere to invest time and money to have the chance to gain a temporary grasp of the market - fly in the face of why patents were created in the first place?
ReplyDeleteMy name is Giulia White and i would like to show you my personal experience with Lipitor.
ReplyDeleteI have taken for 9 years. I am 60 years old. I took 20 mg for 9 years and I told numerous physicians about my pain and stiffness and was told that I had arthritis and to keep taking it. I left it at home by accident when we went on vacation and within 3 days, the pain in my legs began to go away. After 2 weeks I knew it was a very dangerous medication. I went to my new physician and he wanted me to try Pravachol. Afer 4 days on it, I was in a fog and thought I had the flu. I have been off it for just 36 hours and feel better. I am an RN and should have known that I was experiencing side effects with Lipitor, but you listen to your Doctor because you trust him. I now tell my patients to trust what their bodies are telling them. Statins can't be good for anyone but the drug companies!!!!!!!!!! They keep lowering the recommended levels so that almost everyone is considered to have "high" cholesterol. If someone is 30 and on this for 30 or 40 years there is not telling what the long term effects will be.
I have experienced some of these side effects-
Joint and Muscle Pain / Stiffness.
I hope this information will be useful to others,
Giulia White