Thursday, March 31, 2005

NIH Update: Resistance Against New Conflict of Interest Rules Continues

The New England Journal of Medicine this week has a good summary by Robert Steinbrook of the latest developments at the NIH. In particular, it has a clear table of the new, more stringent regulations temporarily put in place by Director Zerhouni.
These included:
  • Prohibition of employment with pharmaceutical and biotechnology companies, research institutions that receive NIH grants and contracts, health care providers and insurers, and related trade, professional, or similar associations
  • Prohibition of compensated teaching or writing for these organizations
  • Prohibition of self-employed business activity involving sale or promotion of products or services of a pharmaceutical or biotechnology company or a health care provider or insurer
  • Prohibition of holding stock in biotechnology or pharmaceutical companies for employees who must file financial disclosure reports, a $15,000 limit in holdings in any one company for other employees
  • Prohibition for senior employees only of the receipt of most awards worth more than $200, and a similar prohibition for all employees of such awards from an organization which is involved with the employees work
  • In general, outside teaching, clinical, scientific writing, and scientific editing activities are permitted as long as they comply with other standards.
It also includes a narrative of how Zerhouni changed his mind about the need for such regulations. Much of its contents has already appeared on Health Care Renewal, but it does have some important new items.
One is that the new regulations at the NIH parallel those already in place at regulatory agencies, such as the Food and Drug Administration and the Securities and Exchange Commission. This was in part driven by the realization that NIH decisions can have "increasingly powerful influence ... on financial markets." Moreover, Zerhouni felt the regulations were in response to activities by high NIH officials that "really were purely and imply what you would call product-endorsement activities, speaking for a company on behalf of a product to entice physicians to prescribe that product at greater levels."

The article also mentions the opposition to these new regulations that Zerhouni has encountered. Furthermore, yesterday, the Washington Post reported that apparently a physician recently nominated to head the National Institute of Environmental Health Sciences now has "serious concerns about taking the job under the new rules." "His primary concenr is that he would be unable to recruit or retain top talent."

The NIH is, as Steinbrook stated, is "regarded as the world's premier biomedical research institution." So, it amazes me that some people don't think the could manage to work in full-time leadership positions at the NIH because they no longer could also work for certain outside organizations, or simultaneously pursue self-employed business activity involving the products of such organization. Are NIH salaries really so low that its high level employees need second jobs to get along economically? Or do people now feel so entitled to lucrative side-employment with industry that the notion of loyal service to the public means nothing? But maybe such people are not those who should be working at "the world's premier biomedical research institution."

1 comment:

Anonymous said...

> But maybe such people are not those who should be working at "the world's premier biomedical research institution."