Grassley seeks transparency, unbiased information about cancer drugs and other medicines


            WASHINGTON – Sen. Chuck Grassley wants to know how the Centers for Medicare and Medicaid Services (CMS) assesses the content of the journals of science and medicine that it uses, in part, to make decisions about Medicare payments.

            “I want to make sure the federal government relies on the best available science and that’s science that is peer-reviewed and free of bias,” he said.

            Grassley said his inquiry is prompted by reports that CMS has increased the number of journals that oncologists can cite for justifying payments for off-label cancer prescriptions and procedures.

            “It’s important for both beneficiaries and taxpayers that these journals either publish studies that are independent or require disclosure of financial relationships in any study,” Grassley said.  “Studies published in journals influence payment practices, and it’s been demonstrated that there’s a link between a study’s outcome and its financial support.”

           Grassley is Ranking Member of the Committee on Finance, which is responsible for Medicare legislation and oversight.   He has conducted extensive oversight of the nation’s drug-safety system in recent years.

            Grassley asked his questions of CMS in a letter sent today to the agency’s Acting Administrator.  The text follows below.  A separate attachment contains of a list of several medical journals that publish studies that CMS will accept for determining payments for cancer treatment.

 

November 7, 2007

  

Kerry Weems

 Acting Administrator

 Centers for Medicare and Medicaid Services

 Department of Health and Human Services






 200 Independence Avenue, SW

Washington, D.C. 20201

 

 

Dear Acting Administrator Weems:

            The United States Senate Committee on Finance (Committee) has jurisdiction over, among other things, the Medicare and Medicaid programs.  As Ranking Member of the Committee, I have a responsibility to protect these programs and the more than 80 million beneficiaries who receive health care through them.  This responsibility includes monitoring the Centers for Medicare and Medicaid Services (CMS or Agency) and its justifications for payments.

            I have received reports that CMS plans to increase the number of journals that oncologists can cite for justifying payments for off-label cancer prescriptions and procedures.  While I understand the need for CMS to accept studies from several medical journals, I also have questions about the publishing practices of these journals. 

            The federal government relies on studies published in medical journals.  These studies provide the scientific rationale that supports payments practices regarding specific pharmaceuticals and medical procedures.  Accordingly, I would like to learn more about the journals that CMS relies upon, since studies published in journals influence payment practices.  I have two questions regarding the journals that CMS relies on:



1.                  Does CMS require that the journals which the agency may rely on for establishing Medicare or Medicaid payment have disclosure and conflict of interest policies?  If yes, please explain.  If not, why not?

2.                  Does CMS require that these journals have policies mandating registration of clinical trials prior to publishing results?  If yes, please explain.  If not, why not?

            Conflicts of interest have been proven in peer-reviewed studies to have a significant impact on scientific outcomes.  Accordingly, it is important that scientific journals maintain policies of transparency and financial disclosure.  For over two decades, the medical community has been establishing this link between a study's outcome and its financial support.[1]  In a 2003 finding published in the British Medical Journal, a researcher wrote, "Systematic bias favours products which are made by the company funding the research."[2] 

            Another researcher compared trials that had been funded by a nonprofit against those that had been funded by a company with a financial interest in the scientific results.  As reported in the Journal of the American Medical Association, "conclusions of trials were significantly more likely to recommend the experimental drug as the treatment of choice if trials were funded by for-profit organizations."[3]

            With this issue in mind, it is troubling that few journals require authors to reveal who funded their research. Indeed, a 2001 study examined the top 1000 journals in science and medicine.  The researchers found that only 16% of the journals had conflict of interest policies.[4]  For this reason, I would like to learn more about how CMS selects the journals upon which is relies and how it ensures that this literature is free of bias.

            Further, the editors of several leading medical journals published a statement in JAMA back in 2004.[5]  The editors detailed their concerns that companies were selectively reporting clinical trials. The editors pledged that their journals would require, as a condition for publication, the registry of a clinical trial in a public database before the trial begins.  Also, the President recently signed into law an FDA reform bill requiring companies to register their clinical trials.  I would like to learn if the medical journals on which CMS relies for its payment policies also require registration of clinical trials prior to publishing results.

            While I realize that your Agency does not control the policies of medical journals, I am sure you understand my concern.  The federal government must rely on the best available science-science that is peer-reviewed and free of bias.  I would appreciate a response to this letter by no later than November 20, 2007.  Also, I would appreciate a briefing for my staff on this issue at your earliest convenience.

 

Sincerely,

 

Charles E. Grassley


United States Senator

 

 Ranking Member, Committee on Finance

 

 Medical Journals Accepted for Cancer Treatment

 

[1]        See R.A. Davidson, Source of Funding and Outcome of Clinical Trials. Journal of General Internal Medicine1:155-158 (1986); See also J. Lexchin, L.A. Bero, B. Djulbegovic, & O. Clark, Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review. British Medical Journal 326:1167-1170 (May 31, 2003).

[2]        Lexchin, Bero, Djulbegovic & Clark.

[3]        BodilAls-Nielson et al. Association of funding and conclusions in randomized drug trials. Journal of the American Medical Association 290:921-925 (2003)

[4]        Sheldon Krimsky and L.S. Rothenberg. Conflict of Interest Policies in Science and Medical Journals: Editorial Practices and Author Disclosure. Science and Engineering Ethics 7: 205-218 (2001).

[5]        Catherine D. DeAngelis et al. Clinical Trial Registration: A Statement From the International Committee of Medical Journal Editors. Journal of the American Medical Association (2004) doi:10.1001/jama.292.11.1363