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Re: Here's what I think.

Posted by seldomseen on May 18, 2009, at 8:50:49

In reply to Re: Here's what I think., posted by alexandra_k on May 18, 2009, at 7:00:31

"I do agree that the mere fact that there is significant financial flow from pharma to scientific researchers doesn't itself undermine the research (that would be ad hominum). So if there is a problem it must be in the details of the conditions on the financial flow or something like that."

***IMO there is a significant problem when the investigators have a vested interest (other than patient safety and treatment) in the outcome of the study.****

***Regarding study outcomes, statistics and deaths. Most of the time, big pharma is not exclusively responsible for the design of the large clinical trials, but the principal investigators at the performance sites are intimately involved as well. In my opinion, most studies are designed with the premise in mind that there is no difference in the drug, placebo, or gold standard of treatment. The data have to demonstrate that there is a statistical difference. The kicker there is that statistical significance may or may not translate into clinical difference.

Now, having said that it is very difficult to design a trial to specifically determine that there is no difference. In fact, it is virtually impossible scientifically (not statistically) to establish no difference or to say that something doesn't happen. Now, having said this, in the US historically the FDA really didn't pay close attention to efficacy, only that the drug was safe. This *is* changing. It is true that negative results, for the reasons indicated above, are harder to publish - that's why most drugs just simply fade away and we never hear about them again.

Now about deaths. I don't know about all the studies, only those that failed to catch the increase risk of suicide in young adults on some anti-depressants. Soemtimes when a side effect is relatively common in a population (like suicide in depressed individuals) it is very difficult to show a difference in that side effect between placebo and drug unless the increase is very very big. It takes a huge study (usually phase 4) to show a statistical difference. Likewise, the increased incidence of stroke with COX2 inhibitor administration would have been very difficult to catch in phase 3 clinical trials, because the population tested had a high baseline incidence of stroke.

"I thought (could well be wrong) that the 'gold standard' of treatment for psychiatry is the last generation."

*** See, that's the problem I'm talking about. A lot of patients fail treatment with the last generation of psych meds. The gold standard, well, isn't.****

***As far as the cost of medications, as distasteful as it may seem, pharma is well within their rights to set the price as they see fit. I am in agreement with you that the price for HIV (life saving) drugs is perhaps unethical, maybe even considered artifical inflation, due to the emergent need for the drug. However, again, the solution there can also be political. Gov'ts can negotiate with companies to set the price of the drug in that country. Also, as in the case of malaria, the delivery of these drugs into the regions of the world where they are most needed is significantly complicated by lack of infrastructure.***

***This may be very very surprising to hear coming out of my mouth, but, I am opposed to total academic freedom when it comes to medical research. I truly think there *should* be market pressures on scientists and that applied science should be emphasized and funded accordingly. In my experience, most scientists, left to their own devices, are interested in the solving problems and not in the application of their work. Even then, at present, these independent researchers need big pharma for the scale up and mass production of any newly discovered drugs. Again, it's a cooperation between the two.****

***Personally, I am very grateful that sildenafil was developed. Regardless of its original intent, it may prove to be of genuine clinical benefit and turn into a life saving drug.





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