Saturday, January 10, 2009

Hard Concept: Not!


It always disturbs me when even alleged good guys don't get it. Today's Boston Glove has an op-ed piece written by Peter J. Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA. In this column Mr. Pitts tries to make the case that a new Massachusetts law which would make clear the relationship between pharmaceutical companies and doctors could have jeopardized important research, but just narrowly avoided it.

The law was intended to provide some transparency in the relationship between medical professionals and drug companies, which is not a bad thing. What worries Mr. Pitts is that too much transparency might be counter-productive, even though the regulations being proposed by Massachusetts would not involve research agreements.

AMID CONCERN that money from drug makers was unduly influencing medicine, Governor Deval Patrick recently signed a law aimed at shedding light on the relationships between pharmaceutical firms and healthcare practitioners.

The Department of Public Health, which is responsible for enforcing the law, recently submitted the regulations it plans on implementing to the Public Health Council, which will vote on it in February.

Along with banning certain gifts, the new regulations would require pharmaceutical companies to disclose payments above $50 made to doctors, scientists, and other medical professionals. This information will be posted on the Internet.

The Department of Public Health has decided, however, to exempt medical research funding from the disclosure requirement. This move should be applauded, as it protects Massachusetts' thriving pharmaceutical industry and ensures that patients receive the best possible care. The Council should vote to make the exemption official.

Excuse me?

Look, I have a bias, one which I freely admit to. I am part of a clinical study on a medication. I know it is sponsored by a pharmaceutical company, and I even know which one, but it took a lot of time, effort, and threats (backed up by flashing my State Bar card) to get that information. I shouldn't have had to go through all that. I don't care that the study is being financed by the company that hopes to market that drug. I just want the study to be fair and, for God's sake and mine, honest. If the drug is effective in treating the condition it hopes to (and it does appear to be that in my case), I want the drug to be approved, but I want that decision to be made on the facts, with NOTHING hidden.

What worries Mr. Cook is that PHARMA members have such lousy reputations at this point that doctors might be loath to be part of any such research projects lest they be tarred with the same reputation. I don't buy that argument. Where most of the abuses have come is in the marketing of drugs, including the abominable use of doctors in lending their names to ghost-written research articles to promote new drugs and therapies. Yes, there's a difference between the marketing and the research departments of pharmaceutical companies, but I fail to see how transparency in both realms would hurt the honest.

Once again, those "in the know" assume that the average consumer is too stupid to know the difference. I think they're wrong. I think the average consumer does appreciate the difference, and will be able to understand even more if the pharmaceutical companies and the doctors involved in research were open about the relationship. And I think that doctors involved in the research need not fear such transparency. In fact, they might even benefit by it.

It's amazing the curative effects that unfiltered sunshine can have on health.



Anonymous Anonymous said...

There's another aspect to the pharma-subsidized research study that is just barely beginning to be talked about: the failure, indeed the refusal, to publicize or even announce negative outcomes of studies.

If they were really interested in the betterment of human health (in pursuit of which none of us would begrudge them profits) they would say "We studied Drug N [as in New] against Drug O [as in old, off or about to go off patent perhaps] and also Drug C [as in that of a Competitor perhaps, if they were really being thorough in pursuit of Science] and regret to report that our drug, while good, has no more or less of a benefit than the other drugs against which it was compared."

But you don't see that. And the researchers who did the study, presumably ethically with all proper constraints, are even forbidden to submit the research to professional journals if it shows a negative result. So the next guy who has the same bright idea that maybe Goop N would be a great treatment for condition X goes right ahead and tackles it, not knowing that it has already failed the test.

this pisses me off. Give doctors all the free samples you want, give them pens and lunches and notepads, I don't give a damn. But publish the negative results out there in front of God and everybody and let the truth be known.

[stomps off, steaming irately]

6:57 PM  

Post a Comment

<< Home