This past January, Senator Charles Grassley (R-IA) sent letters to Francis S. Collins, M.D., Ph.D., Director of the National Institutes of Health (NIH). One letter regarded conflicts of interest at Baylor University, while the second letter dealt with potential conflicts at the National Institute of Mental Health (NIMH).
In response to these letters, the Executive Director and the Staff Scientist of the Project On Government Oversight (POGO) recently sent a letter to Dr. Collins regarding transparency. The letter came about because Dr. Collins “supported the idea of a database in which NIH grantees’ financial arrangements with outside organizations would be made public.” That promise, which came six months ago, has not been “forcefully implemented,” according to the private nonprofit organization devoted to improving the performance of the federal government.
POGO noted that “transparency is obviously a key part of good government” and that “the public’s health has suffered repeatedly from the lack of transparency in the private financial arrangements of researchers funded by the NIH.” Accordingly, they claimed that a new change in the NIH’s policy on conflicts of interest is coming soon, one which will probably have “strict confidentiality on conflicts of interest as part of the NIH’s policy.” The organization feels however, that such the new rule will actually “no change in the present policy.”
As a result, Danielle Brian, Executive Director of POGO asserted that “a public database where all investigators disclose what kinds of financial arrangements they have with outside organizations” is needed. While we agree with the principle of transparency being good for ensuring patients trust in their physicians, we have seen numerous times where the media uses only the numbers and money to stigmatize legal and ethical work that physicians perform with industry. So any database needs to be sure to explain what kind of services were provided, and show the impact those services will have in training physicians and thus helping treat patients.
NIH Transparency History
When David Willman, an investigative reporter with the Los Angeles Times uncovered “widespread conflicts of interest” at the NIH Intramural program between 2003-2005, Congress acted swiftly. Today, with narrow exceptions, the NIH’s intramural scientists are no longer allowed to make any personally profitable financial arrangements with companies in the health sector. The authors noted that “the problem was solved.”
Another problem however, existed in the Extramural program, in which NIH grantees, were receiving millions of dollars from the manufacturers of drugs and other medical products, discovered through an investigation by Senator Charles Grassley and his staff and by investigative reporters. The authors again noted that once disclosed, the arrangements were ended by their institutions.
Ms. Brian identifies these problems as a “lack of transparency” that has kept the “public in the dark, and denied journalists access to information.” She even asserts that the NIH “is usually kept ignorant of the details,” and only provides guidance to universities and medical schools, instead of exercising real oversight, enforcement, or disciplinary action, which are all left to the institutions. From these comments, the problem clearly seems to be institutional, and not problems with the actual relationships physicians have with industry.
Notice of Proposed Rulemaking
Despite the fact that these relationships are beneficial to patients and physicians, Ms. Brian acknowledges how some “grantees will cheat and some of them will get away with it” because of the large amount of money involved. Due to such concerns, NIH has announced a new rule to “that exerts more control over grantees’ private financial arrangements.” They gave notice of the proposed rulemaking, which seeks to define what constitutes a “Significant Financial Interest (SFI),” which in turn will be used to define financial conflicts of interest in the new rule.
Overall, sixty-eight comments were submitted and posted of which only three of them advocate full public disclosure of grantees’ financial arrangements. Those three comments were submitted by:
- A senior official at the Cleveland Clinic ,which is one of the very few research institutions that already post, on a public website, information about faculty ties to industry;
- Senators Charles Grassley and Herb Kohl; and
- POGO by Dr. Feder
It is important to note that organizations such as the Association of American Medical Colleges (AAMC), the Association of American Universities (AAU), the American Association for the Advancement of Science (AAAS), the Federation of American Societies for Experimental Biology (FASEB), the American Physiological Society (APS), and the American Society of Clinical Oncology (ASCO), all submitted comments and none supported the idea of public disclosure of grantees’ financial arrangements.
The Conflict of Interest report by the IOM
Going against the grain of these institutions, Ms. Brian continues her push for public disclosure by citing the Institute of Medicine (IOM) Conflict of Interest in Medical Research, Education, and Practice report. The report concluded with 14 authors opposing a broad disclosure model and only 3 agreeing with such a practice.
The majority endorsed a model in which the manufacturers of drugs and other medical products would be given the responsibility for disclosing the information about their financial arrangements with grantees and other persons.
Medical Schools
Ms. Brian goes on to discuss how “only a handful of medical schools and universities require the routine public disclosure of information about financial arrangements made by their faculty.” She believes that the failure of these schools to have policies is similar to those of the NIH. Creating such policies would certainly be detrimental to many academic medical centers and academics that depend on industry for supplemental income, funding for clinical studies and all kinds of research.
Sunshine Act
POGO fully supports Senator Grassley’s Physician Sunshine Payment bill, and “believes that public disclosure requirements – requirements that the NIH imposes on grantees and their institutions – should be included in the new rule that will soon be promulgated by the NIH.” Ms. Brian even goes as far as wanting the NIH to “require, as a condition of funding, that researchers make full public disclosure of their private financial arrangements that are directly or indirectly related to their professional responsibilities.”
Conclusion
Ultimately, Ms. Brian reminded Dr. Collins of President’ Obama’s “well-known memorandum on transparency and open government” as a way to urge change in NIH’s policies. What she forgot to mention is the dozens of waivers and exceptions Mr. Obama has made to that policy in order to get the most experienced and highly qualified individuals into the best positions. If that is her idea of transparency, then we could only wonder what kind of qualified and experienced researchers and physicians could work with NIH who has no “interests.”
With the passage of the Senate Healthcare Reform Package yesterday which includes a physician payment sunshine provision, this may be a mute point, but it may not be in the mission of NIH to publish information on the investigators they fund through universities in the intramural program.
Accordingly, letting journalists only use the numbers (money) to attack the legal and ethical work of doctors who are helping train their colleagues is unacceptable. This kind of negative effect will only hurt patients because physicians will have less access to new information and data and they will be less willing to carry out important clinical studies and research because of such attacks for being paid to do such work.