I have to imagine that there are some days where the director of NIH, Dr. Elias Zerhouni, just wants to run down the hallway with his fingers in his ears yelling "LA LA LA LA LA!" In the last year, one of the stickiest issues the NIH has faced and that has gained huge public attention is the dilemma regarding outside compensation to NIH scientists by corporations.
To sum up the issue - until last year, NIH scientists were able to receive a certain amount of compensation from outside corporations, so long as they disclosed that work. Then it came out that maybe two dozen of the thousands of NIH employees (researchers and non-researchers) had received rather hefty sums of money and it wasn't clear in each case whether those amounts were disclosed. Following Congressional hearings on the issue, Dr. Zerhouni placed a moratorium on any scientists receiving outside compensation for their work. In February, a new interim final rule was put in place that allows non-researchers to have up to $15,000 in stock holdings of pharmaceutical companies, and no NIH employee may perform any compensated speaking, editing or writing for a regulated entity or any uncompensated outside employment. In addition, no senior employee may receive any gift or award because of their NIH position that is more than $200 in value.
Oh, who knew how many problems this would bring to NIH ...
In the last few weeks, there have been several editorials and other articles on the issue. For instance, on April 2, 2005, Dr. James Battey, the then-chief of the human stem cell program, resigned because he said that he could not comply with the interim final rule. A family trust that he manages had substantial holdings that would take him out of compliance with the cap on the amount of stock an employee could have. Other researchers in the same article note difficulties they had, such as Dr. Ashani Weeraratna, a cancer researcher who had to turn down a speaking opportunity to present a paper to a physician's group in New York because they would have bought her train ticket that would have cost about $200. The CEO of A&G Pharmaceuticals, a small biotech company, also notes that not having any NIH scientists on its board is a blow because the companies benefit from the scientists' expertise and the credibility that arises from having an NIH scientist conferring with them.
A few days after that article, the Washington Post's editorial board came out with a rather scathing crticism of the new the ethics rules, calling them "overbroad, intrusive and unnecessarily punitive."
At about the same time, Dr. Zerhouni was likely experiencing some whiplash from Congress, as the same congresspeople who had criticised the NIH for being asleep at the wheel suddenly came out saying that the new rule was too strict. Luckily for the NIH, Sen. Specter promised that the committee would be coming up with suggestions for how to fix the rules.
And about a day or 2 later, Dr. Zerhouni told the same committee that he agreed that some modifications were needed to the rules (in particular, the cap on stock holdings).
Interestingly, the LA Times' editorial on April 11 said that Zerhouni should stick with the rules, arguing that without them, the credibility of the agency could be diminished and public faith lost.
And just last week, Michael Leavitt, the new Secretary of Health and Human Services, promised to look into the rules and see where some "softening" may be needed.
So where does this really leave us? Unfortunately, back in the legal morass of carve-outs and safe harbors. It seems to me that some of the rules are a bit too far-reaching - if an NIH researcher or staffer has absolutely nothing to do with a certain company's product, it does seem silly to restrict their investing efforts. I just can't imagine the nightmare that the Office of General Counsel, Ethics Division and the Office of Extramural Research will have to go through in sifting through the various forms to make sure that there are no such conflicts. It sounds like it would take a team of people just to fulfill that obligation (and, on top of a potential $1.5 BN budget cut that would mean getting rid of 400 grants, that doesn't sound too good).
Maybe they can streamline it by putting together categorical lists of what each regulated company develops and researches, and then send out a relevant list to everyone who works in a particular lab that says "Do you own stock in any of these companies? [List]" and then have then attest that whatever info provided is true and accurate, etc. etc. Send that out every year, and pretty soon researchers start to learn what stocks they need to stay away from. Of course, then you might get screaming from the companies who want to protest which list(s) they are on and who is getting those lists.
In the end, it will be difficult to come up with a "perfect" solution. My theory is that the NIH went a bit harsher than needed on the interim final rule just so that when they adjusted, the rule was still fairly. It's like negotiating a deal - one party starts a bit low, the other a bit high, each figuring they'll come out somewhere in the middle.