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Here's what I think.

Posted by seldomseen on May 17, 2009, at 18:16:14

In reply to rant about 'health' and stuff, posted by alexandra_k on May 17, 2009, at 0:21:32

I think there is a lot of interplay between the "independent" researcher/physician and the pharmaceutical companies and a tremendous amount of money does flow from pharma into academia/private concerns. However, it does not always translate into a financial conflict of interest, or bad science.

The facts of the matter are that big pharma has the capital to invest in large scale R&D for new therapies. Much more capital than academia - which relies, in the US at least, on the NIH, or non profit foundations for funding.

What big pharma lacks however, is the patient population and infrastructure from which to conduct large phase 3 efficacy clinical trials. Therefore, pharma will contract with institutions (not individuals typically) to conduct these trials. The monies paid to these institutions constitute the bulk of the money exchanged from pharma into the "independent" realm of research.

So, in my mind, the question then becomes, do these monies truly reflect a conflict or a simple contractual agreement? It appears to me as though public opinion would favor the former interpretation rather than the latter. However, I would maintain that, excepting the few egregious exceptions that are often cited, that this contractual arrangement is productive, beneficial and, based on my own personal experience, effective.

So many problems with drugs aren't uncovered until after FDA approval and large scale application. This is just the truth. Sometimes the data collection is flawed, sometimes results are buried, sometimes the FDA just ignores results. However, there is no clinical trial that could ever be big enough to discover everything about a drug - especially if the problem if rare, *or* very common in the general population. New drugs are often considered to be in phase 4 clinical testing even after FDA approval.

As far as psychiatric meds, one of the problems I see in psychiatry today is I think, very similar to a problem in the early days of cancer research. There is a very heterogeneous set of symptoms, causes and mechansms of illness, but no "gold standard" of treatment against which to compare anything. At least cancer had a "hard" outcome for the trials (remission/no remission, dead vs alive). In the field of psychiatry, even the term remission is subjective. I think rather than shotty science and corruption, the problem with psychiatric research is that it is truly in its infancy. Without a doubt, what are considered viable treatments today will be considered untenable within the next 20 years. Just as the cancer field has matured, so will psychiatry I predict.

As far as malaria, well, it is truly a killer in the underdeveloped countries of the world. However, in my opinion, the problem of malaria goes way beyond the realm of big pharma and ultimately must solved politically prior to treatment. How could one even put a drug into trials if there is no established and available health care delivery system in the countries in which malaria is endemic? Is that a problem that pharma could or should solve? Should they go into the business of health care delivery as well?

Finally, (your post was very through provoking) I am ambivalent about the consumer driven versus I suppose provider? driven state of pharmacotherapy today. On the micro (direct advertising) level, I would propose anything that engages the patient in their own care can be beneficial, but a conservative approach is usually in the patient's best interest - even if the provider has to convince the patient of that. On the macro level, these so called designer drugs do sell well and are big revenue generators. It may surprise a lot of people that sildenafil (Viagara) has broad application outside of erectile dysfunction. In fact, it is currently being investigated as a treatment for a pulmonary hypertension - a fatal condition and pregnancy-related hypertension. Guess what? The revenues from the ED sales are driving those clinical trials.

All in all, I think things could be better, of course. However, I am unconvinced that things are as bad as made out to be.





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