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Re: Here's what I think.

Posted by alexandra_k on May 18, 2009, at 7:00:31

In reply to Here's what I think., posted by seldomseen on May 17, 2009, at 18:16:14

Hey. I'm very interested in what you have to say because you probably know a great deal more about this than me. I'd be interested to run a number of ideas by you and see what you think. It is a little hard for me to assess them (without doing a major study myself).

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.

> 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.

I've heard this said in a number of places and I'd be interested to know what you think:

There is a way of designing a trial such that two outcomes are possible: The first outcome is that there is support for the efficacy of the medication (compared to placebo and alternative medication). The second outcome is that the study failed to find support for the efficacy of the medication (compared to placebo and alternative medication). The crucial thing about this is supposed to be that the second outcome DOESN'T entail or imply that the medication that was trialed is WORSE or MORE HARMFUL than either placebo or alternative medication and it also DOESN'T entail or imply that further studies (maybe 5 in 100) will find the first outcome - that there is support for the efficacy of the medication.

IF this is correct (that there are ways of designing trials such that you either show efficacy or you fail to find efficacy) THEN is it the case that researchers need to design their trials in this fashion in order to obtain pharma funding (or free / subsidized samples of expensive medications) to do the trial? If so, then this would be pharma driving scientific methodology in a way that obviously benefits them (they are required to report HARMFUL findings but they are not required to report FAILURE TO FIND POSITIVE BENEFITS). This is of course important because if you run a study often enough, well, 5 in 100 will give you the result you seek).

Deaths would be something that you would think would be hard to have not show the medication to be positively harmful. But the same studies that showed certain anti-depressants to be more effective than alternative and placebo were the studies that (pharma didn't think) showed certain anti-depressants to result in more deaths in certain age groups. Was it a genuine oversight to fail to pick up on this in the discussion section or would discussing such a thing jepordize ones future research funding?

I do understand that science quite generally really is very messy. I'm particularly interested in this added feature of complexity here, however.

I thought (could well be wrong) that the 'gold standard' of treatment for psychiatry is the last generation. So... If we want to get a new 'erectile dysfunction' medication approved then the way to go about it would be to either show it to be more effective than viagra OR show that it has less harmful side-effects (not quite sure how the latter works out - but I heard the latter was the main reason for the move from MAOI's to SSRI's, major tranquilisers to new gen anti-psychotics, and lithium to alternative mood stabilizers. That efficacy really wasn't any better, but the side-effects were less? Not sure how compatible this is with what I said before).

> 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?

The issue is pharma setting the price that must be paid to obtain the medication in a way that is unrestricted until the patient runs out. Since it is under patient requiring much more than the cost of production. Once currency conversion gets factored in how many months or years or lifetimes worth of wages are required in order for an individual to get the treatment they need? I'm not talking about treating erectile dysfunction in developing nations I'm talking about treating HIV etc.

Yes, one needs to run a profitable business, I understand that. Yes, it costs a lot of money to develop new drugs (and there need to be lots and lots of trials when one is trying to get a good result from a number of trials from a drug that simply isn't terribly effective). Yes, it costs a lot of money to advertise the products (millions if not billions). It is kinda hard to measure 'profit' but really... Are they just making 'profits' or are they basically 'profiteers'?

> Finally, (your post was very through provoking) I am ambivalent about the consumer driven versus I suppose provider? driven state of pharmacotherapy today.

Ideally... I like to think that independent scientists would have the best ideas about where we should focus our attention on research / treatment. At the moment (as a researcher) one does need to alter what one wants to do (or recast it such that one gets funding for it). If there really was 'academic freedom' then... I think that would be a good thing, yeah. I know there are a number of scientists who work in university contexts for the explicit reason that yeah they don't make as much money as they could and yeah they don't have the nicest office or the flashiest equipment but if they develop the effective treatment for cancer or maleria they plan to write it up as a discovery for all to freely make use of rather than the discovery being patented by pharma (such that it won't be available to those who really need it).

> 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.

That doesn't surprise me. Its an pretty expensive medication, there is time remaining on patient, so seems like a good business decision to look into market expansion. (Don't get me wrong I'm sure there are a variety of different scientific hypotheses about the nature of hypertension and the nature of viagra that makes such a study scientifically interesting).




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