This week Senator Grassley sent some more letters, Grassley asks NIH to account for employment of expert advisor, this time he is concerned that National Institutes of Health may be trying to get around its own policies to prevent conflicts of interest by hiring medical experts with ties to industry as contractors rather than full-time employees.
Grassley based his questions for the Director of the NIH, Elias Zernouni, MD on the case of a senior advisor for the National Heart, Lung and Blood Institute within NIH.
Marvin Kostam, MD who is Chief of Cardiology s of Tufts University School of Medicine and Tufts-New England Medical Center, while also acting as a high profile advisor and advocate for a cardiac device company and serving as a consultant to NIH.
Dr Kostam is a legend in the heart failure community and the company he is listed as medical director for Orquis Medical is in early stage development of devices for heart failure. (Not exactly a commercial enterprise yet).
At one point the senator raises questions about a press release that was sent out last week discussing first in man trials on one of their devices. The confusion for the senators staff comes in that he is listed in the press release as Chief of Cardiology at Tuffs. Another point of contention for the Senator was a month after his appointment at NHLBI, Dr. Kostam was listed as Chief of Cardiology at Tuffs in a journal article in circulation one month after he started at NIH. He also listed his Tuff’s affiliation for an FDA panel.
Partially this all can be explained in that Dr. Kostam is on a one year leave of absence from his position at Tuffs to serve as a consultant to NIH, which is only recently investing in heart-failure research. This entitles him to keep his title at Tuffs. So the Articles and FDA panel affiliation would be accurate.
My bet on the Orquis press release is they are a very small company and that the title of Medical Director is not a compensated position for the year he is at NIH, this is only speculation but I would doubt this is much more than a labor of love for Dr. Kostam, espically given that he has been with them since 2003 and they are no where close to having a commerical product.
Senator Grassley raises the fact that in 2006, questions raised by Grassley about the practices of an NIH institute leader led to the official’s departure from the NIH. (if it worked then perhaps it can work again) Grassley also is working to get the National Institutes of Health to meet its obligation as a trustee of tax dollars to do whatever it can to achieve accurate disclosure of the financial relationships between the pharmaceutical and device industry and doctors who conduct medical research with the $24 billion in federal grants awarded each year.
Again the senator is using the tactic of sending out press releases about inquiry letters, this has devastating effects on the physicians in question, and in the end may amount to nothing.
Also on the same day Elias Zerhouni, MD resigned as Director of the NIH, under Doctor Zerhouni, the NIH has increased in size (though not in the last four years due to funding from congress), and instituted conflict of interest policies so that their staff no longer consults or speaks on behalf of industry. Several newspapers applauded Dr, Zerhouni including the New York Times for his efforts to make the NIH more efficient.
My guess is he has had enough letters from Senator Grassley.