Grassley seeks information about medical school policies for disclosure of financial ties to drug industry

from http://grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=21465

WASHINGTON --- Senator Chuck Grassley has asked 23 medical schools for information about their policies for conflicts of interest and requirements for disclosure of financial relationships between faculty members and the drug industry.

 

Grassley sent his request to the 23 educational institutions that did not respond to an earlier request made by the American Medical Student Association for the same information.  In that case, the schools reportedly replied to a survey by answering either "no response" or "decline to submit policies."  Of the 149 schools asked, 126 provided information to the student association.

 

"There's a lot of skepticism about financial relationships between doctors and drug companies," Grassley said.  "Disclosure of those ties would help to build confidence that there's nothing to hide.  Requiring disclosure is a common sense reform based on the public dollars and public trust at stake in medical training, medical research and the practice of medicine."

 

            Grassley has been working to achieve uniform and universal disclosure of the money that pharmaceutical, medical device and biologic companies give to physicians.  He has conducted extensive oversight of financial relationships, especially among doctors who conduct research with the $24 billion awarded annually in federal grants by the National Institutes of Health.  Institutions receiving these federal dollars are required to track financial relationships, but Grassley has found enforcement of those requirements often to be either lax or in violation.  Grassley also has sponsored reform legislation that would require payments from the drug industry to be publicly reported.  Senator Herb Kohl is the cosponsor of the "Physician Payments Sunshine Act," S.301.

 

            The 23 schools receiving Grassley's letter are:  the Arizona College of Osteopathic Medicine, Edward Via Virginia College of Osteopathic Medicine, Medical College of Georgia School of Medicine, Northeastern Ohio University College of Medicine, Philadelphia College of Osteopathic Medicine, Rocky Vista University College of Osteopathic Medicine, Tulane University School of Medicine, University of Florida College of Medicine, University of Nevada School of Medicine, Albany Medical College, Chicago College of Osteopathic Medicine, Dartmouth Medical School, Howard University College of Medicine, Lake Erie College of Osteopathic Medicine, Louisiana State University School of Medicine - New Orleans, Meharry Medical College, Morehouse School of Medicine, New York College of Osteopathic Medicine of the New York Institute of Technology, Ponce School of Medicine, San Juan Bautista School Of Medicine, University at Buffalo School of Medicine, University of Medicine and Dentistry New Jersey - New Jersey Medical School, University of South Carolina School of Medicine.  The text of the letter is below.

 

 

June 24, 2009

 

Dear Dr. ___________:

 

The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs and, accordingly, a responsibility to the more than 100 million Americans who receive health care coverage under these programs.  As Ranking Member of the Committee, I have a duty to protect the health of Medicare and Medicaid beneficiaries and safeguard taxpayer dollars appropriated for these programs. 

 

As part of my oversight responsibilities, I have been trying to understand the policies and practices that universities and hospitals have in place requiring their physicians to report outside income.  I have seen the lack of transparency and that many are not reporting.

 

            I have also been taking a keen interest in the almost $24 billion annually appropriated to the National Institutes of Health (NIH) to fund grants at various institutions such as yours.  Institutions are required to manage a grantee's conflicts of interest.[1]  But I am learning that this task is made difficult because physicians do not consistently report all the payments received from drug companies.

 

With the recent stimulus bill, the NIH got an additional $10 billion to fund research grants.  As you know, institutions are required to manage a NIH grantee's conflicts of interest.  However, multiple lines of evidence have shown that these regulations are nothing more than talking points that are regularly ignored.

 

Beginning last summer, I began releasing information that made the point that universities are not managing their professors' financial conflicts of interest and that change is needed at the NIH:

 

·         Chairman of psychiatry at Emory failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company's drugs with an NIH grant.  The Health and Human Services Office of Inspector General (HHS OIG) is now investigating.

 

·         Chairman of psychiatry at Stanford received an NIH grant to study a drug, while partially owning a company that was seeking Food and Drug Administration (FDA) approval of that drug.  He was later removed from the grant.

 

·         Three professors at Harvard failed to report almost a million dollars each in outside income while heading up several NIH grants.  Harvard plans to release a report and is working to update their conflict of interest policies.

 

·         Host of a show that ran on the National Public Radio (NPR) satellite station received over a million dollars from pharmaceutical companies to give promotional talks.  The show had received funding from the NIH and has been cancelled.

 

·         Chair of orthopedic surgery at the University of Wisconsin reported taking more than $20,000 from a company every year, for five years.  The actual amount was around $19 million.  The University of Wisconsin is revising its rules.

 

·         Professor at the University of Texas received an NIH grant to study Paxil in kids, while also giving dozens of promotional talks on Paxil.  This matter has been referred to Health and Human Services, Office of the Inspector General.

 

·         Professor at the University of Washington in St. Louis who was formerly at Walter Reed Army Hospital failed to report hundreds of thousands of dollars he had received from a device company to develop their products.

 

To bring some greater transparency to this issue, Senator Kohl and I introduced the Physician Payments Sunshine Act (Act).  This Act will require drug, medical device, and biologics companies to report publicly any payments that they make to doctors, within certain parameters.

 

            I recently learned from an American Medical Student Association report, AMSA PharmFree Scorecard 2009, that your institution either had "no response" or "declined to submit policies" when asked to supply conflicts of interest policies.[2]

 

Accordingly, I request that your institution respond to the following questions and requests for information.  For each response, please repeat the enumerated request and follow with the appropriate answer.

 

1)      A copy of your institution's policy on employee conflict of interest.

 

2)      Please provide any notifications and/or communications to the NIH regarding conflicts of interest and research by professors at your institution.  This request covers the period of January 1, 2004 through the present.  

 

3)      Please provide a total dollar figure for all NIH monies and/or other federal monies annually received by your institution.  This request covers the period of 2004 through 2008. 

 

4)      Please provide a list of all NIH grants and/ or other federal grants received by your institution.  This request covers the period of 2004 through 2008.  For each grant please provide the following:

 

1. Primary Investigator;
2. Grant Title;
3. Grant number;
4. Brief description; and
5. Amount of Award.

 

Thank you again for your cooperation and assistance in this matter.  In cooperating with the Committee's review, no documents, records, data or information related to these matters shall be destroyed, modified, removed or otherwise made inaccessible to the Committee.

 

I look forward to hearing from you by no later than July 15, 2009.

 

Sincerely,

Charles E. Grassley

United States Senator

Ranking Member of the Committee on Finance

 

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[1] Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought, 42 C.F.R.

[2] The AMSA PharmFree Scorecard 2009. June 16, 2009.