Dear Mr. Bollinger:
The United States Senate Special Committee on Aging has jurisdiction over and a duty to, among other things, the continuing study of all matters pertaining to problems and opportunities of older people,
including their health. The Committee on Finance has jurisdiction over the Medicare and Medicaid programs and, accordingly, has a responsibility to the more than 80 million Americans who receive health care coverage under those programs. As Chairman and Ranking Member of these Committees,
respectively, we have a duty to protect the health of Medicare and Medicaid beneficiaries and safeguard taxpayer dollars authorized and appropriated by Congress for those programs.
For the last several years, our Committees have been investigating various aspects of the pharmaceutical and medical device industries, including consulting arrangements and funding for Continuing Medical Education (CME). We have compiled evidence documenting the strong ties between these industries and physicians.
As part of our oversight responsibilities, we have been analyzing the policies and practices that universities and hospitals have in place requiring their physicians to report outside income. We have concluded that there is a lack of transparency in this area.
To help us better understand these relationships, we would appreciate your office providing our Committees the following information detailing the outside income from the following persons from Jan. 1, 2003 to the present:
1. Martin B. Leon, MD;
2. Gregg W. Stone, MD;
3. Jeffrey W. Moses, MD;
4. Mark A. Apfelbaum, MD;
5. Stephane Carlier, MD, PhD;
6. Michael B. Collins, MD;
7. Antonio Colombo, MD;
8. William A. Gray, MD;
9. Ajay J. Kirtane, MD, SM;
10. Susheel K. Kodali, MD;
11. Edward M. Kreps, MD;
12. Warren Sherman, MD;
13. Robert Sommer, MD;
14. Paul Teirstein, MD;
15. Giora Weisz, MD;
16. Gary Mintz, MD;
17. Steven Wolff, MD;
18. Alexandra Lansky, MD;
19. Roxana Mehran, MD;
20. George Dangas, MD;
21. Manuela Negoita, MD; and
22. Victor Yick.
Because reporting practices vary widely from one institution to another, we would appreciate you also placing this income into a chart, detailing compensation from outside sources to the persons referenced above. For each payment to the persons mentioned above from a company or organization,
please provide the following information:
1. Name of payment source;
2. Date of payment;
3. Payment description (CME, honorarium, research support, etc.);
4. Amount of payment; and
5. Annual total from the payment source.
We would also appreciate a report of all funding provided to Columbia University from the following companies and organizations from Jan. 1, 2003 to the present:
a. Abbott Laboratories;
b. Medtronic Inc.;
c. Medinol;
d. Boston Scientific;
e. Johnson & Johnson; and f. Cardiovascular Research Foundation.
Also, please explain the nature of the relationship between Columbia University and the Cardiovascular Research Foundation (CRF). In response to this request, please provide all pertinent documents and communications between the University and CRF. The time span of this request covers Jan. 1, 2003 to the present.
In cooperating with the Committees’ review, no documents, records, data nor information related to these matters shall be destroyed, modified, removed or otherwise made inaccessible to the Committees.
We look forward to hearing from you by no later than Oct. 30, 2008.
Sincerely,
Herb Kohl
Chairman Special Committee on Aging
Charles E. Grassley Ranking Member Committee on Finance
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Oct. 16, 2008
Gregg W. Stone, MD Chairman Cardiovascular Research Foundation
111 East 59th Street New York, NY 10022-1202
Dear Dr. Stone:
The United States Senate Special Committee on Aging has jurisdiction over and a duty to, among other things, the continuing study of all matters pertaining to problems and opportunities of older people,
including their health. The Committee on Finance has jurisdiction over the Medicare and Medicaid programs and, accordingly, has a responsibility to the more than 80 million Americans who receive health care coverage under those programs. As Chairman and Ranking Member of these Committees,
respectively, we have a duty to protect the health of Medicare and Medicaid beneficiaries and safeguard taxpayer dollars authorized and appropriated by Congress for those programs.
For the last several years, our Committees have been investigating various aspects of the pharmaceutical and medical device industries, including consulting arrangements and industry funding for Continuing Medical Education (CME). Our Committee staffs have also examined several issues related to non-profit organizations, and we have read newspaper accounts documenting apparently strong ties between the medical device industry and non-profit organizations. Senator Kohl recently wrote to the American College of Cardiology (ACC) regarding its dealings with your organization. Senator Kohl appreciated the ACC’s response to his letter and one of his staff subsequently attended ACC’s legislative meeting to discuss the Physician Payments Sunshine Act (Sunshine Act), of which we are both sponsors.
The pending Physician Payments Sunshine Act, S.2029, which we introduced last fall, seeks to provide additional transparency by requiring disclosure of financial relationships between these industries and medical professionals.
Based upon reporting in the New York Times1 and Business Week,2 along with other evidence, we are also concerned that funding from the medical device industry may influence the practices of nonprofit organizations that purport to be independent in their viewpoints and actions. For instance, the President of the American College of Cardiology (ACC), Dr. Douglas Weaver, recently wrote in an editorial that industry funding “constitute about 38% of the College’s revenues" and that “without this support, the registration fees for the Annual Scientific Session and i2 Summit would have to be more than double their present amount, and member dues would have to increase substantially."3
Although such associations do not necessarily exert improper influence upon medical practice,
serious questions remain. For instance, despite controversy over the safety and efficacy of stents, CRF board member Dr. Jeffrey W. Moses was quoted by the New York Times stating that, in regard to stents,
“[s]afety is not the big issue any more."4 As you are no doubt aware, there are divergent scientific opinions concerning such products, the safety and efficacy of which are a matter of dispute among cardiologists.
Accordingly, we would appreciate an accounting of industry funding that medical device companies or foundations established by these companies have provided to the Cardiovascular Research Foundation (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, etc.)
This request covers the period of Jan. 1, 2003 to the present.
Because reporting practices vary widely from one charitable organization to another, we would appreciate you also placing this income into a chart, detailing annual amounts of industry funding from pharmaceutical and/or device companies. For each year, please provide the following information for CRF:
1. Name of company;
2. Date of payment;
3. Payment description (CME, honorarium, research support, etc.);
4. Amount of payment; and
5. Annual total from the company.
In addition, please provide a detailed account of payments and/or benefits of any kind that your organization has given to the following persons from Jan. 1, 2003 through the present time:
1. Martin B. Leon, MD;
2. Gregg W. Stone, MD;
3. Jeffrey W. Moses, MD;
4. Mark A. Apfelbaum, MD;
5. Stephane Carlier, MD, PhD;
6. Michael B. Collins, MD;
7. Antonio Colombo, MD;
8. William A. Gray, MD;
9. Ajay J. Kirtane, MD, SM;
10. Susheel K. Kodali, MD;
11. Edward M. Kreps, MD;
12. Warren Sherman, MD;
13. Robert Sommer, MD;
14. Paul Teirstein, MD;
15. Giora Weisz, MD;
16. Gary Mintz, MD;
17. Steven Wolff, MD;
18. Alexandra Lansky, MD;
19. Roxana Mehran, MD;
20. George Dangas, MD;
21. Manuela Negoita, MD; and
22. Victor Yick.
The time period of this request covers Jan. 1, 2003 to the present. For each payment to the physicians mentioned above from a company, please provide the following information:
1. Name of company;
2. Date of payment;
3. Payment description (CME, honorarium, research support, etc.);
4. Amount of payment; and
5. Annual total from the company.
Finally, please explain the CRF’s policies for accepting industry funding by answering the following questions. For each question, please respond by first repeating the enumerated question followed by the appropriate answer.
1. Please describe the policies for accepting industry funding and whether or not the CRF allows companies to place restrictions or provide guidance on how funding will be spent.
2. If the CRF allows companies to place restrictions on industry funding, then please explain all restrictions and/or guidance for each transfer of value from a pharmaceutical company since Jan. 1, 2003. For every transfer of value with a restriction, please provide the following information: year of transfer, name of company, and restriction placed on funding.
3. Please provide the CV’s and financial disclosures filed with the CRF by all senior officials and members of the CRF board.
4. Please provide all communications between the CRF and representatives of the following companies. The time span of this request covers Jan. 1, 2007 to the present.
a. Abbott Laboratories;
b. Medtronic Inc.;
c. Medinol;
d. Boston Scientific; and e. Johnson & Johnson.
In cooperating with the Committees’ review, no documents, records, data or information related to these matters shall be destroyed, modified, removed or otherwise made inaccessible to the Committees.
We look forward to hearing from you by no later than Oct. 30, 2008.
Sincerely,
Herb Kohl
Chairman Special Committee on Aging
Charles E. Grassley Ranking Member Committee on Finance
----------------------------------------------------
1 See, e.g., Reed Abelson, Charities Tied to Doctors Get Drug Industry Gifts, New York Times, June 26, 2008, at A1.
2 See, e.g., Arlene Weintraub and Amy Barret, Medicine in Conflict, Business Week, Oct. 23, 2006, at 76.
3 W. Douglas Weaver, MD, President's Page: Understanding the Implications of Conflict of Interest Issues, 52 J Am Coll Cardiol 1274 (2008).
4 Barnaby J. Feder, A Heart Stent Gets a Reprieve from Doctors, Nov. 12, 2007, nytimes.com quoting Dr.
Jeffrey W. Moses.
