This has been a tremendous week of clinical trial presentations and discussions around interventional cardiology at the Transcatheter Cardiovascular Therapeutics (TCT meeting) in Washington DC.
But this week's meeting has also aroused the attention of the Capitol Hill staffs of Senators' Grassley and Kohl. The Senators have sent letters to the Cardiovascular Research Foundation, Columbia University and Companies, during the TCT annual meeting. The letters are requests for information around payments and all transfers of value.
The concern from the Senators' viewpoint is that they would like to see exactly how much CRF has received from industry over the last five years.
This letter is pretty much the same letter we have seen from both Grassley and Kohl in all their investigations of industry. This time however it is a joint letter from both senators (two weeks ago they were sending dueling letters).
Some key points in the letter:
The Senators outline how they have been investigating
Consulting Arrangements
Industry Funding of Continuing Medical Education (CME)
Issues related to non-profits
They also outline how they are actively soliciting support for the Physician Payment Sunshine Act.
Their stated basis upon which they are conducting their investigation are a series of articles in New York Times (2006) and Business Week, plus a quote from Douglas Weaver, President of the American College of Cardiology stating that 38% of the College’s revenues come from industry.
They also quote Jeffrey Moses, MD, a CRF board member and big time interventional clinical trialist, as stating in the NY Times: in regards to stents, safety is not the big issue anymore. The senators challenge this, saying that there are divergent scientific opinions concerning such products, the safety and efficacy of which are a matter of dispute among cardiologists. (This statement from the senators is perhaps their most concerning. Does this mean that because I am a clinical triallist, and get funding for my trials from industry that I am no longer entitled to a public opinion? Please this is America, and we are entitled to some protection under the First Amendment to express our own opinions!)
Of course the Senators ask for an accounting of all industry funding that medical device companies or foundations established by these companies have provided to the CRF.(The term “industry funding” means any transfer of value from a medical device company, including but not limited to grants, donations and sponsorship for meetings or programs.) The request covers from January 2003 to present.
In addition the Senators have requested a list of payments to 22 physicians, background on policies for accepting funding, if any of the funds were restricted and explanations for the nature of the restriction (perhaps paying to get a clinical trial done would be considered a restriction or booth space would be considered a restriction), CV’s of all senior officials and members of CRF Board.
The Senators have also requested "all communications between the CRF and representatives of the following companies (Abbott, Medtronic, Medinol, Boston Scientific, and J&J)." The one on this list that I can’t figure out is Medinol, they are a small Israeli company with no presence in the US market.
Of course the Senators gave them two weeks to get all this information back to them -- in searchable charts of course.
Both the CRF and Columbia University issued statements:
CRF said it would “comply fully” with the information request. “CRF is committed to maintaining the highest standards of integrity in all of its research and educational activities and ensuring independence, objectivity and scientific rigor in all of its programs,” the statement said.
Columbia University Medical Center issued a statement saying it would respond to the request for information. “It is important to note that Columbia University and its Medical Center have conflict of interest policies and procedures in place, and we expect that they are followed by all members of the faculty," the statement said.
The CRF has for years been the leader in conducting clinical trials for interventional cardiology and has the most comprehensive meeting in this field. It would be a pity to see them bogged down in controversy instead of saving patients lives.
Reference Documents
Letters to Cardiovascular Research Foundation
Wall Street Journal Blog: Senators Probe Cardiologists Ties to Stent Makers
Phamalot Story: Senate Probes Columbia Professor and a Non Profit
NY Times: Ties between Doctors and Stent Makers Queried
Columbia University Center for Intravascular Therapy: Faculty List
Cardiovascular Research Foundation List of Faculty
New York Times: Charities Tied to Doctors Get Drug Industry Gifts
New York Times: Heart Stents gets a Reprieve from Doctors
Journal of American College of Cardiology: Understanding Conflicts of Interest
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