Grassley to Medical Groups: Reveal Financial Payments from Device Firms

Sen. Chuck Grassley (R-Iowa) is asking medical organizations for information about payments received from medical device companies.

He has sent a letter to 33 medical groups, including the North American Spine Society and the Heart Rhythm Society.

“These organizations have a lot of influence over public policy, and people rely on their leadership. There’s a strong case for disclosure and the accountability that results,” Grassley said.

Kennesha Baldwin, manager of media and public relations for the Heart Rhythm Society, a Washington, D.C.-based organization that provides science, education and advocacy for cardiac arrhythmia professionals, said to Medical Product Outsourcing, “At this time, the Heart Rhythm Society can only confirm that we have received Senator Grassley’s letter.” She would not comment further.

The North American Spine Society in Burr Ridge, Ill., which educates, educates, researches and serves as an advocate for ethical spine care, confirmed to Medical Product Outsourcing that it has received a letter from Grassley and “is drafting a response.”

Grassley is working for congressional passage of The Physician Payments Sunshine Act, which he has sponsored with Sen. Herb Kohl (D-Wis.). The act would require annual public reporting by drug, device and biologic manufacturers of payments made to physicians nationwide.

The senator’s letters of inquiry were also sent to the American Academy of Orthopaedic Surgeons, the Alzheimer’s Association, the American Academy of Allergy Asthma and Immunology, the American Academy of Dermatology, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Surgeons, the American Dental Association, the American Diabetes Association, the American Dietetic Association, the American Heart Association, the American Hospital Association Inc., the American Medical Association, the American Psychological Association, the American Society of Anesthesiologists, the American Society of Colon and Rectal Surgeons, the American Society of Consultant Pharmacists, the American Society of Health–System Pharmacists, the American Society of Hypertension, Inc., the American Society of Nephrology, the American Society of Plastic Surgeons, Children and Adults with Attention Deficit/Hyperactivity Disorder, Depression and Bipolar Support Alliance, the Heart Rhythm Society, Mental Health America, NARSAD, the National Association of Chain Drug Stores, the National Organization forRare Disorders, Screening for Mental Health Inc., the National Center for Mental Checkups at Columbia University (TeenScreen), The Leukemia and Lymphoma Society and the American Cancer Society.

Here is the text of Grassley’s letter.

December 7, 2009


Dear _________________:


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 authorized by Congress for these programs.

For the last three years, the Committee has been looking into various aspects of the pharmaceutical industry, including consulting arrangements, and industry funding for Continuing Medical Education (CME).My inquiry was spurred, in part by press accounts documenting the lack of transparency in the relationships between the pharmaceutical industry and nonprofit organizations.For instance, in April 2008, The Wall Street Journal reported that industry representatives, including ten major drug companies, formed a coalition to promote looser restrictions on off-label marketing.[1] The coalition asked the National Alliance on Mental Illness (NAMI) to speak in favor of this issue.

On October 6th of this year, I sent letters to all fifty state chapters of NAMI asking them to disclose income from pharmaceutical companies.In that letter, I explained that NAMI National receives almost two-thirds of its funding from the drug industry.[2]I learned recently that a few days after I sent those letters, one of the founders of NAMI and member of the NAMI National Board of Directors emailed his resignation, stating that he was shocked at NAMI’s reliance on pharmaceutical industry funding.In particular he said:“This financial dependency presents a number of problems.”

In response to my concerns, NAMI began to disclose publicly on its website, any amount of funding exceeding $5,000 that it received from pharmaceutical companies and other foundations.This decision in favor of transparency by NAMI is encouraging.

In April of this year, the Institute of Medicine issued a report endorsing transparency and stating that protections against conflicts can be established without inhibiting productive relationships between medicine and industry to improve medical knowledge and care.I am hoping you can assist me in this effort by providing additional insights into these relationships as well as any changes in transparency that your organization may be planning for in the future.Operating with transparency sends a message that there is nothing to hide.

Accordingly,I would appreciate an accounting of industry funding that pharmaceutical, medical device companies, foundations established by these companies or the insurance industry have provided to the (Organization) (The term “industry funding” means any transfer of value, including but not limited to grants, donations, and sponsorship for meetings or programs, etc.)This request covers the period of January 2006 to the present.

Because reporting practices vary widely from one charitable organization to another, I would appreciate you also placing this income into a chart, detailing annual amounts of industry funding.For each year, please provide the following information for(Organization):

1) Year;

2) Name of company;

3) Amount of funding; and

4) Reason(s) that the funding was provided.

In addition, please explain (Organization)policies for accepting industry funding and the disclosure requirements of your top executives and board members by answering the following questions. For each question, please respond by first repeating the enumerated question followed by the appropriate answer.Again, this request covers the period of January 2006 to the present:

1) Please describe the policies for accepting industry funding and whether or not (Organization) allows companies to place restrictions or provide guidance on how funding will be spent.

2) If (Organization) allows companies to place restrictions on industry funding, then please explain all restrictions and/or guidance for each transfer of value from industry.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 explain what policies, if any that(Organization)plans to adopt to ensure transparency of funding in order to provide a greater public trust in the independence of your organization.

4) Please explain your policies on disclosure of outside income by your top executives and board members.

5) Please provide the disclosures of outside income filed with your organizations by your top executives and board members.

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 December 21, 2009.

Sincerely,

Charles E. Grassley
United States Senator
Ranking Member of the Committee on Finance