Grassley renews call for voluntary disclosure by influential disease and medical advocacy groups

 

 

WASHINGTON -- Senator Chuck Grassley is continuing to make the case for public disclosure of industry support for disease and medical advocacy groups.

 

            From 2006 to 2009, these advocacy groups received hundreds of millions of dollars from pharmaceutical, medical device and insurance companies, including $86 million to the American Academy of Family Physicians, for example.

 

“There’s a strong case for disclosure and the accountability that results,” Grassley said.  “These organizations have a lot of influence over the way taxpayer dollars are spent.  They work to sway the legislative debates in Congress, and government agencies such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services rely on guidance from the organizations in writing rules and regulations and determining how public dollars are spent.”

 

Last year, the Physician Payments Sunshine Act, sponsored by Grassley and Senator Herb Kohl, became law and will require, beginning in 2013, the Department of Health and Human Services to post on a public website newly reported payments that drug, device and biologic makers make to physicians.   In his new appeal to the advocacy groups this week, Grassley noted that the Medicare Payment Advisory Commission, known as MedPAC, has recommended similar statutory requirements for patient advocacy organizations.

 

“I agree with MedPAC on the benefit of broader disclosure.  It’s a matter of accountability, and the public’s right to know,” Grassley said.

 

This week, Grassley renewed his challenge to a majority of the leading organizations he had previously urged, in December 2009 and January 2010, to follow the lead of the National Alliance on Mental Illness in voluntarily making public details of the support it receives from industry.  Grassley’s letters this month follow up on responses he received from the groups.

 

“In 2009, after it was revealed that the majority of donations to the National Alliance on Mental Illness came from drug makers, the organization voluntarily set a standard for its peers by publicly posting information on a quarterly basis about outside support,” Grassley said.  “It’s still the case today that most of the leading organizations haven’t done much in the way of disclosures.  Others have, especially the Heart Rhythm Society, and I appreciate the start that’s been made.  But, it’d be better for patients and taxpayers if every organization opted for meaningful transparency and disclosure.”

 

These organizations received the following letter from Grassley this week:  the American Academy of Orthopaedic Surgeons, the American Academy of Dermatology, the American Diabetes Association, the American Heart Association, the American Society of Colon and Rectal Surgeons, the American Society of Consultant Pharmacists, the American Society of Hypertension, Inc., Children and Adults with Attention-Deficit/Hyperactivity Disorder, the Depression and Bipolar Support Alliance, the Heart Rhythm Society, Inc., the Leukemia & Lymphoma Society, Mental Health America, the National Alliance for Research on Schizophrenia and Depression, the National Organization for Rare Disorders, and the North American Spine Society.  See below for links to letters and materials for each organization.

 

May 4, 2011

 

Dear ______________________:

 

In December 2009, I asked for an accounting of industry funding that [  ] receives from pharmaceutical and medical device companies as well as foundations established by these companies or the insurance industry.  I appreciate your response, which I have attached to this letter.  I write today to follow up on any efforts by your organization to improve transparency and accountability in its relationships with the pharmaceutical and device industries.

 

As I stated in my previous letter, I started my inquiry, in part, as a result of accounts documenting the lack of transparency in financial relationships between the pharmaceutical industry and nonprofit health and medical organizations. Specifically, I cited the April 2008 article in The Wall Street Journal, whichreported that industry representatives, including ten major drug companies, had formed a coalition to promote looser restrictions on off-label marketing.[1]  The coalition had asked the National Alliance on Mental Illness (NAMI) to speak in favor of this issue.

 

In response to my concerns in my April 2009 letter to NAMI, NAMI began to voluntarily disclose to the public any amount of funding exceeding $5,000 that it received from pharmaceutical companies and foundations on its website.  Further, NAMI began to provide a brief description of the purpose of the funding on its website.  I commend NAMI for its leadership and had hoped that when I reached out to your organization and 32 others, your organization would follow NAMI’s example and begin posting similar funding information on [  ]’s website.

 

As of the date of this letter, it appears that your organization has taken steps to identify on its website the corporate or industry sponsors and their range of funding support. However, the website does not specify the purposes of that funding.  If [  ] is currently taking steps to further enhance the transparency of its financial relationships with the pharmaceutical and device industries, I would appreciate information regarding those steps. In particular, please state whether or not [ ] will be adding information in the future about the purpose of the funding it receives.  If not, please explain why not. 

 

The Medicare Payment Advisory Commission (MedPAC) recommended in a report to Congress in March 2009 that Congress require that pharmaceutical and device companies report their financial relationships with physician groups, patient organizations, and others. More specifically MedPAC said the following:

 

Given the potential benefits of public reporting, we recommend that the Congress mandate the reporting of comprehensive information on industry relationships with physicians and other health care entities and that the Secretary post this information on a public searchable website.[2]

 

MedPAC then went on to say in Recommendation 5-1 that:

 

The Congress should require all manufacturers and distributors of drugs, biologicals, medical devices, and medical supplies (and their subsidiaries) to report to the Secretary their financial relationship with:…physician groups and other prescribers…patient organizations; and professional organizations.[3] 

 

I look forward to working with you and other health and medical organizations to further increase sunshine on financial relationships.

 

Thank you for your cooperation and attention in this matter.  I would appreciate a response by May 25 , 2011.

 

Sincerely,

Chuck Grassley

United States Senator

Ranking Member of the Committee on the Judiciary

 

 

            Separately, these organizations received the following letter from Grassley this week:  the Alzheimer’s Association, the American Academy of Allergy Asthma & Immunology, the American Academy of Family Physicians, the American Cancer Society, the American College of Obstetricians and Gynecologists, the American College of Surgeons, the American Dental Association, the American Dietetic Association, the American Hospital Association, Inc., the American Medical Association, the American Psychological Association, the American Society of Anesthesiologists, the American Society of Health-System Pharmacists, the American Society of Nephrology, the American Society of Plastic Surgeons, the Infectious Diseases Society of America, the National Association of Chain Drug Stores, and Screening for Mental Health, Inc. See below for links to letters and materials for each organization.

 

May 4, 2011

 

Dear _______________:

 

In December 2009, I asked for an accounting of industry funding that [  ] receives from pharmaceutical and medical device companies as well as foundations established by these companies or the insurance industry.  I appreciate your response, which I have attached to this letter.  I write today to follow up on any efforts by your organization to improve transparency and accountability in its relationships with the pharmaceutical and device industries.

 

As I stated in my previous letter, I started my inquiry, in part, as a result of accounts documenting the lack of transparency in financial relationships between the pharmaceutical industry and nonprofit health and medical organizations. Specifically, I cited the April 2008 article in The Wall Street Journal, whichreported that industry representatives, including ten major drug companies, had formed a coalition to promote looser restrictions on off-label marketing.[4]  The coalition had asked the National Alliance on Mental Illness (NAMI) to speak in favor of this issue.

 

In response to my concerns in my April 2009 letter to NAMI, NAMI began to voluntarily disclose to the public any amount of funding exceeding $5,000 that it received from pharmaceutical companies and foundations on its website.  Further, NAMI began to provide a brief description of the purpose of the funding on its website.  I commend NAMI for its leadership and had hoped that when I reached out to your organization and 32 others, your organization would follow NAMI’s example and begin posting similar funding information on [  ]’s website.

 

As of the date of this letter, it appears that no additional information regarding your organization’s industry funding has been posted on the [  ]’s website. If [  ] is currently taking steps to enhance the transparency of its financial relationships with the pharmaceutical and device industries, I would appreciate information regarding those steps. If not, please explain why your organization does not support the disclosure of funding it receives from pharmaceutical and device companies.

 

The Medicare Payment Advisory Commission (MedPAC) recommended in a report to Congress in March 2009 that Congress require that pharmaceutical and device companies report their financial relationships with physician groups, patient organizations, and others. More specifically MedPAC said the following:

 

Given the potential benefits of public reporting, we recommend that the Congress mandate the reporting of comprehensive information on industry relationships with physicians and other health care entities and that the Secretary post this information on a public searchable website.[5]

 

MedPAC then went on to say in Recommendation 5-1 that:

 

The Congress should require all manufacturers and distributors of drugs, biologicals, medical devices, and medical supplies (and their subsidiaries) to report to the Secretary their financial relationship with:…physician groups and other prescribers…patient organizations; and professional organizations.[6] 

 

I look forward to working with you and other health and medical organizations to further increase sunshine on financial relationships.

 

Thank you for your cooperation and attention in this matter.  I would appreciate a response by May 25, 2011.

 

Sincerely,

Chuck Grassley

United States Senator

Ranking Member of the Committee on the Judiciary

 

 

            TeenScreen is not receiving a second letter from Grassley because in its response to Grassley, the organization said it received no funding from pharmaceutical, medical device or biologic makers.

 

            Beginning in 2007, Grassley conducted extensive congressional oversight of financial relationships between physicians involved in taxpayer-sponsored medical research and drug and device companies.  He found numerous cases where there was a vast disparity between drug-company payments received and reported by leading medical researchers.  In direct response to Grassley’s work, the National Institutes of Health, which distributes $24 billion in federal research dollars every year, proposed new disclosure guidelines for federal grant recipients.  A number of drug companies began disclosing payments to doctors voluntarily.  More than 40 universities nationwide began revising their own disclosure policies.

 

In addition to non-profit patient disease and medical advocacy groups, Grassley also conducted oversight and sought disclosure from medical journals containing ghostwritten articles that originated with drug makers, medical colleges and continuing medical education.

   

-Alzheimer’s Association; Additional Material

 

-American Academy of Allergy Asthma & Immunology; Additional Material

 

-American Academy of Orthopaedic Surgeons; Additional Material; Part 1, Part 2

 

-American Academy of Dermatology; Additional Material

 

-American Academy of Family Physicians; Additional Material

 

-American Cancer Society; Additional Material

 

-The American College of Obstetricians and Gynecologists; Additional Material; Part 1, Part 2

 

-American College of Surgeons; Additional Material

 

-American Dental Association; Additional Material

 

-American Diabetes Association; Additional Material

 

-American Dietetic Association; Additional Material

 

-American Heart Association; Additional Material

 

-American Hospital Association, Inc.; Additional Material

 

-American Medical Association; Additional Material

 

-American Psychological Association; Additional Material

 

-American Society of Anesthesiologists; Additional Material: Part 1, Part 2, Part 3, Part 4, Part 5, Part 6

 

-American Society of Colon and Rectal Surgeons ; Additional Material

 

-American Society of Consultant Pharmacists; Additional Material

 

-American Society of Health-System Pharmacists; Additional Material

 

-American Society of Hypertension, Inc.; Additional Material

 

-The American Society of Nephrology; Additional Material

 

-American Society of Plastic Surgeons; Additional Material

 

-CHADD; Additional Material

 

-Depression and Bipolar Support Alliance; Additional Material

 

-Heart Rhythm Society; Additional Material

 

-Infectious Diseases Society of America; Additional Material

 

-The Leukemia & Lymphoma Society; Additional Material

 

-Mental Health America; Additional Material

 

-NARSAD; Additional Material

 

-National Association of Chain Drug Stores; Additional Material

 

-National Organization for Rare Disorders; Additional Material

 

-North American Spine Society; Additional Material

 

-Screening for Mental Health, Inc.; Additional Material

 

-TeenScreen; Additional Material

 

[1] Alicia Mundy, “Off-Label Use of Drugs Gets a Push --- Big Pharma Lobbies Washington to Relax Rules on Marketing,” The Wall Street Journal, April 18, 2008.

[2]Medicare Payment Advisory Commission, “Public reporting of physicians’ financial relationships,” Report to Congress: Medicare Payment Policy, March 2009.

[3] Id.

[4] Alicia Mundy, “Off-Label Use of Drugs Gets a Push --- Big Pharma Lobbies Washington to Relax Rules on Marketing,” The Wall Street Journal, April 18, 2008.

[5]Medicare Payment Advisory Commission, “Public reporting of physicians’ financial relationships,” Report to Congress: Medicare Payment Policy, March 2009.

[6] Id.