The excerpt below references recent articles and editorials documenting how clinical research has been manipulated by for-profit companies.
As a mm survivor, my thinking on this subject can be boiled down as follows:
1) I have read that approximately 20% of all perscription medications have been approved by the FDA- 80% have not (asprin, synthroid, etc.)
2) approximately 80% of all clinical trials are sponsored by drug companies-
3) drug companies bias the "evidence" of evidenced-based medicine that oncologists turn to for their recommendatios to patients.
Therefore, I read listservs, articles and studies and the anecdotal evidence that I come across to make decisions for my own treatment-I can only trust myself. Just my opinion. DavidÂ
"What are the lessons from the 2 articles in this issue of JAMA, from other publications that have examined related issues, and from extensive experience with how clinical research has been manipulated by for-profit companies? First, manipulation of studies and misrepresentation of study results could not occur without the cooperation (active and tacit) of clinical researchers, other authors, journal editors, peer reviewers, and the Food and Drug Administration (FDA).â€
“Second, public trust for clinical research is in great jeopardy especially when the extent of how widespread such practices have become is unknown. Although we truly believe that the vast majority of researchers and other authors are honest and have the highest scientific integrity, manipulation of studies and publications by the pharmaceutical and medical device industries is either increasing or there has been more exposure of these practices.â€
Hi, Everyone.
I mentioned the story below on ACOR a few years ago, but it bears repeating. This incident happened more than 30 years ago, so I'm not sure the same thing is happening today, but the JAMA article makes me think it is. A friend of mine I'll call R. (MD/PhD in chemistry), was doing research at the National Institute of Health in a Pharmacology residency program. One day, R's superior came in and grabbed R's data. R. protested that he had not finished his work and could not state cnoclusively what the outcome of his research would be. The superior told R, " It makes no difference. I have to give a speech tomorrow, and I'll make up my own conclusions." My friend, a very sensitive, studious man, was devastated. But, he continued his work at NIH and later took the pharmacology medical boards. And then he applied elsewhere for a pathology residency program. Although R.'s chemistry background made him an ideal pharmacology candidate, he worked instead as a pathologist because he knew that he could not live with the cutthroat nature of pharmacology.
Cathy
Hey Cathy:
It is unfortunate but very true. It is worse now than it was 30 years ago. I have a relative who works at one of the major Pharamceutical Compnaies. You would all recognize the name. This relative has been there since he/she graduated from college and started as a lab technician and then worked his/her way up through the ranks in research over the years. Research was separate from sales and marketing. So early on there was some integrity. At some point after several mergers research and marketinging became alligned, i.e., reaserach was no longer independent it became in service of the sales an marketing efforts of the company. Stock options are spreed liberally so the incentives are to get drugs passed and out the door with as rosie a marekting stratagy as they can pull together using the cherry picked researh results i.e., only report the results that support the marketting strategy. Negative results are ignored or buried. He/she is now in management at a very high level and there are private meetings with non-disclosure agreements signed before hand and the kinds of things that are dicussed relate to the value of the potential market of the drug and wheather or not it will be profitable. Effacacy and safety relative to existing drugs in the market for a particular disease are basically ignored. In one instance it was presented to me that they even had a discussion about a drug that was really very effective that they had bought the rights to and that it worked so well that after a period of time pateints could lower there dosages and actually as their health improved take it only intermetently. This drug competed with an existing drug line for the company that did not work nearly as well, had more side effects and required continuous use to provide the bennefits that it did provide. The analysis went like this: why would the company put out a drug that is better on every scale of efficacy and safety to competes with an already profitable frontline drug that ultimately leads to lower sales volume for the comany because the better drug dosages ultimattely can be reduced over time. The outcome of the meeting was the new and better drug would be shelved "studied more" and die in research while the less effective drug will continue to be pushed in the market. It is all about dollars. At the end of the meeting all notes were taken from the participants and destroyed they singed additional non-dicsosure agreements that basically said that the if the contents of the meeting were ever revealed that who ever reverled them that they would be terminated and all references and to the time and date of the meeting and its particiapants were earased from all files, schedules, etc. Like the meeting never took place. This person has stayed on and over time has become quite wealthy but at the same time I have to say quite cynical and very unhappy. The money is supposed to be the balm to sooth the conscience... but it doesn't really work very well. It is really pretty horrifying when you think about it.
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