Friday, February 04, 2005

End of the Anechoic Effect: Editorial Reaction to the New NIH Rules

The announcement of the change in NIH conflict of interest rules has created quite a bit of press, maybe finally signaling the end of the "anechoic effect" for this particular story. Oddly enough, the old way of doing business at the NIH has found a few prominent apologists, echoing the troubling reaction by NIH staff I discussed yesterday.

For example, see the commentary by Steven Pearlstein in the Washington Post. Here are a few quotes with my comments.
"A Massachusetts politician once told me, over lunch at Boston's Locke-Ober cafe, that most systems work best when lubricated with a bit of moral ambiguity."
As a Rhode Island resident, I didn't think this was a promising start for a discussion of ethics and research. The moral ambiguity of many politicians has fueled considerable cynicism about politics in general.
"I'm not sure I see the wisdom of drawing a 'bright line,' ... between NIH scientistis doing basic research and commercial enterprises that build upon that research. "
This is a false dichotomy, but seems to be a prevalent argument against the new standards. The false dichotomy is between major financial entanglements with pharma and biotechnology firms and no contact at all with such firms. NIH staff don't need to be paid huge consulting fees over and above their full-time salaries, or hold stock or collect stock options in pharmaceutical and biotech companies to work collaboratively with industry.
"What purpose is served by preventing them (NIH staff) from making a buck by sharing that informal knowledge with profit-making companies?"
The purpose is not having them feel beholden to the profit-making companies for all those bucks they make on the side. But again, why should people who work full-time for the NIH, and get six-figure salaries from the government, need to also "make a buck" from these companies?
"A surprising number of people violated those [existing] rules [requiring disclosing conflicts of interest]. But rather than coping with that by dealing harshly and publicly with a few of the worse offenders, the NIH brass have now caved in to pressure from Capitol Hill to prohibit drug and biotech-related investments and commercial entanglements by their researchers."
It is true that no one has yet dealt harshly with the NIH leaders who made the most money from consulting fees and stock options while supposedly working full time for Uncle Sam. Actually it is not true that the rules prohibit biotech-related investments by NIH staff, since they can still invest indirectly through, for example, mutual funds. Why is it bad in this case to listen to the opinion of Congress?
"But the right question is not whether we should stomp out every last bit of such 'corruption,' but whether the price is worth it. Having a fuzzy line, and giving administrators some flexibility in enforcing it, was probably better for medicine, better for the biotech industry, and certainly better for the Washington economy."
There has been very little research on the effects of conflicts of interest and corruption affecting the leaders of health care organizations, so there is no good data about what might be good for "medicine" or the public. However, it seems reasonable to hypothesize that commerical entanglements are bad because they may sway such NIH leaders, who have considerable power over what science gets done and how it is reported, in favor of their outside benefactors, leading to biased science, biased interpretation of science, and biased science policy. Furthermore, the knowledge that some NIH leaders may be beholden to commercial vested interests outside of the NIH threatens the credibility of all NIH sponsored research, the credibility of the NIH research priorities, and the credibility of NIH efforts to translate and disseminate research results. Finally, knowing that some NIH leaders are financially benefiting from conflicts of interest may clearly demoralize NIH staff, NIH-supported scientists, and researchers seeking NIH support who do not have such conflicts.

Similar was the commentary in Forbes by Thomas P. Stossel MD.
"In the real world, these restrictions (on conflicts of interest) address nearly nonexistent scientific corruption and ultimately impede medical progress by depriving pharmaceutical companies of access to biomedical scholars."
See my comments above. Since there have been few relevant studies, it's not clear how much corruption there is. Again, biomedical companies can easily get access to and collaborate with scholars without paying them personally for consulting or handing them stock options.
"How did financial conflicts-of-interest rules get to be such a big deal? One reason is that the gatekeepers of the medical literature believe it is. Editors of high-profile medical journals vilify the pharmaceutical industry..."
Funny, I have seen criticism that medical journals have been too cozy with that industry. Note that for Stossel the bogey-man seems to be journal editors, while for Pearlstein it was "Capitol Hill."
"The public wants trustworthy science, and it can get that without new ethical rules. Even more, it wants results - lives saved - and it can't get those if commercial sponsorship of research is made difficult, if not impossible."
Again, why should the public will find research more trustworthy if the researcher is getting paid on the side by industry? Again, note the false dichotomy. Industry can certainly sponsor research done at academic organizations by research grants without paying researchers consulting fees in addition to their full-time salaries.

For contrast, see the editorial in the Philadelphia Inquirer. My favorite quotes were:
"The NIH staffers' outside work involved paid consulting, teaching, speaking or writing for private health-care firms - with drugmakes bankrolling many of the deals. Financial arrangements like these, allowed since, 1995, pose a huge conflict for all the 6,000-plus NIH scientists. How so? Because NIH officials' day jobs position them to promote or aid these firms through grants, contracts, and approvals."
"As a group, NIH scientists pulled in millions of dollars in consulting and other fees. With that kind of money at stake, to whose interests were they most attuned - the publics', or their second employers'?
"Institutes' officials must monitor whether an exodus of talent occurs. If so, the correct remedy is better pay - not watering down ethical core standards."
'Nuff said.

1 comment:

InformaticsMD said...

The Wash. Post has been accused of severe moral relativism.

I think their article on this issue makes that accusation irrefutable.