The obvious question was whether Lindsay or Cosman had told Helen Hayes about their conflicts, and if so, whether Helen Hayes had told NIH and reduced, managed or eliminated that conflict as required. Answering this was difficult. I called Lindsay first, but didn't get a clear answer. Cosman refused to speak to me. Officials at Helen Hayes would not agree to speak to me either, nor would those at the grant management agency, Health Research, Inc. (HRI), after my initial contact. Working the other end, at NIH, I got an elliptical answer.

I next turned to the federal Freedom of Information Act (FOIA) and its New York State equivalent, the Freedom of Information Law. From NIH, I requested copies of the conflict of interest paperwork for three of Lindsay's and Cosman's NIH grants. From the New York State Department of Health, I requested the same paperwork as well as the researchers' financial disclosure statements and a number of other records.

NIH processed the FOIA relatively quickly. The results are hard to understand, but they gave me confidence—although not certainty—that HRI and Helen Hayes had not told NIH about any potential conflict of interest with those grants. New York State, however, was not forthcoming. It gave a substantial response a year later, and then only after I had sent a strongly worded appeal, which would have been my precursor to a lawsuit. The documents they sent confirmed that there were no conflicts of interest declared with the grants in question. They also revealed the institutional review board meeting that my investigation had apparently triggered.

NIH advisory committees
I suspected that NIH was not obeying federal regulations when it came to conflicts of interest on its advisory committees. Proving this would be difficult, however.

In the law prohibiting government officials from participating in matters in which they have conflicts of interest, there's a special provision for advisory committee members: If an agency official certifies in writing that the need for an individual's services is so great that it outweighs the potential for a conflict, then the member can serve on the committee in a limited capacity. These certifications, known as 208(b)(3) waivers, are supposed to be made available to the public. But when I used FOIA to request these documents (as well as several other documents related to how NIH manages conflicts of interest), NIH refused to turn them over—not even redacted versions—as they're required to do by law. I appealed, and when the agency didn't respond in a timely manner, I sued in federal court.

In the decision, which came in June, the judge, Gabriel Gorenstein, ordered NIH to turn over the waivers, but allowed the agency to protect other documents, known as recusal lists, from public scrutiny (although they had to turn over redacted versions of the lists during the course of the litigation). This was a bittersweet victory.

The waivers showed that the vast majority of financial entanglements my class and I identified were not declared on the waivers I obtained, which suggested that NIH was being less than diligent about identifying conflicts of interest. NIH insisted, however, that the missing entanglements had been declared on the recusal lists that it refused to reveal. In the course of trying to convince me of the truth of that statement, an NIH official revealed that it had not released several of the recusal lists I had requested.

2 Comments

1. 1. marytormey 07:34 PM 11/23/12

   Research done with donated money should be publicly owned.
   People walk for a cure when really, what they get is outrageously expensive, dangerous and ineffective treatments. All 6 of the products listed below are J&J patented, and you can expect to pay higher insurance rates because of these products.
   Diabetes -Juvenile Diabetes Research Foundation-1970-Rezulin-Artificial pancreases –walk –significant increase in diagnosis since founding of charity.
   
   Cancer-American Cancer Society- 1913-Velcade-Zytiga-walk-significant increase in diagnosis since founding of charity.
   
   Autism-Autism Speaks, Cure Autism Now- 1995-Risperdal-arbaclofen -walk- significant increase in diagnosis since founding of charity.

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2. 2. chasg 04:56 PM 11/30/12

   I commend your professional restraint in hesitating to make accusations. However, there is ample evidence (dozens of books and articles over the last decade) that ethical oversight of research is sloppy, at best, and completely corrupt in many ways and at many levels. In my opinion, and I have been studying and writing about this issue since the 1990s, the problem begins with physicians, many of whom are ethically challenged. Even the honest ones often fail to recognize their conflicts of interest and delude themselves as to their ability to resist influence.
   
   At the level of one's own personal physician, I would urge all patients to demand information and care that is not tainted by drug company or device manufacturer money. A good physician will acknowledge that is hard to do, but will at least make an attempt.

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