In a world of checks and balances, there are procedures that need to be adhered to in order to insure the objectivity of the process. In this case, the stages when a newly-developed drug goes from inception to market. Drug company develops drug. Experimental drug enters scientifically-based clinical trials run by unbiased objective researchers. If all goes well, and the drug shows benefit in the treatment it was designed for, drug gets approved for use. Patient receives drug. Ideally, patient gets better.
Drug company develops drug. Drug company finances clinical trials, and pays researchers who will determine the effectiveness and safety of experimental drug. No need to continue on, the process is now potentially and ethically compromised.
This morning, from many reputable dead tree publications, runs this headline: AP: Researchers Escape Ethics Punishment. Why? According to the National Institutes of Health, "The majority of federal scientists investigated for improperly accepting personal money from drug companies or biotechnology firms escaped serious punishment, and investigators declined to proceed with several cases involving possible crimes."
The next time a reader comes by and extols the virtues of scientific medical research as the gold standard to which all else should be validated, I am simply pointing them to this investigative outcome. We should all be disillusioned and a wee bit angry that the wolves seem to be guarding the barn.











1. The vast majority of clinical trails performed are ones that test one chemotherapeutic regimen against another. Single arm clinical trials provide the tumor response evidence that is the basis for approving new cancer drugs. The randomized, controlled clinical trial may likely remain the standard for evidence of clinical decision-making in cancer medicine, however, observational methods and systematic reviews are clearly useful. Even with the importance of clinical trials, it is crucial to work on reducing their inherent limitations, including uncertain generalizations, and to expand the use of the randomized clinical trial paradigm to areas beyond proving biological activity.
Evidence based medicine, since the 1970's, depended upon the randomized, controlled trial. It rests upon the assumption that evidence should be determined and applied as a basis for medical decision-making. Evidence is based upon quantities, similarities, populations, and averages, rather than qualities, idiosyncracies, individualization, and specifics. It would be surprising if the most ardent supporter of evidence based medicine would ever advocate a randomized trial for an intervention in which an observational study showed remarkable efficacy in preventing a near death situation. Many major medical advances have never been subjected to a prospective randomized study before being introduced into routine management because their beneficial effects have been obvious.
Recognizing the reliability of the evidence upon which clinical practice has increasingly come to depend, the time has come for physicians to reassess the value of direct observation, and to trust more readily both the empirical and intuitive discoveries they make each day in their personal experience, even if those discoveries are contradicted by the best available evidence. There could be nothing more serious than the call for physicians to reconsider what it means to be authentic and true.
Posted at 1:12AM on Sep 24th 2006 by Gregory D. Pawelski