Consumer, health groups urge Congress to not interfere with drug dosing decisions


Wednesday, Oct. 17, 2007

Consumer, health groups urge Congress to not interfere with dosing decisions for drug used by cancer patients

(Washington, DC) – Consumer and health groups today sent a letter to Congress urging it not to interfere with efforts by Medicare and the Food and Drug Administration to determine the proper dosing of a drug used by cancer patients, saying such a move would set bad precedent by placing technical medical decisions in the political arena.
The groups urge Congress to oppose HJ Res. 54 or similar proposals on the useage of erythropoietin stimulating agents (ESAs), noting that there has been evidence that overuse of the drug might speed tumor growth or lead to early death in cancer patients. The text of the letter is below:
Center for Medical Consumers * Center for Science in the Public Interest
Consumers Union * National Research Center for Women & Families
National Women’s Health Network * TMJ Association * US PIRG

Dear Member:
We urge Congress not to interfere in the efforts of the Centers for Medicare & Medicaid Services and the Food and Drug Administration to use the best available science to determine the proper dosing of erythropoietin stimulating agents (ESAs). The safe and proper dosage of this drug in very vulnerable cancer patients is an extremely technical issue. Congress should leave these life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies.
H.J. Res. 54 or similar proposals in the Senate are a direct violation of this principle. The FDA has issued a “black box” label warning against excessive use of ESAs. There is significant evidence that the overuse of ESAs can actually speed tumor growth and early death in cancer patients. After more than a year of study, CMS issued a national coverage decision (NCD) in July that took this latest evidence into account. Congress should not substitute its own judgment for that of CMS and the FDA on these issues.
While it is true that the American Society of Clinical Oncologists, which represents the nation’s cancer physicians, protested the CMS decision, we cannot help but note that companies and physicians make enormous windfall profits from the sale and use of ESAs. Now they are trying to convince Congress that Medicare is denying a needed medical service.
This is not the proper venue for their objections. In late September, CMS invited ASCO to submit evidence to support the agency reopening its coverage decision. It is altogether fitting and proper that physicians in community practice and physicians at CMS who determine payment policy adjudicate their differences in this manner, rather than through Congressional intervention.
We also must note that some provider groups opposed previous reductions in the windfall profits that came from the reimbursement system of various cancer drugs. They said it would radically reduce treatment options and hurt patients. Those statements have been proven untrue. Self-serving arguments about the negative consequences of a proposed payment policy is no substitute for objective, scientific evidence.
Congress should set broad policy objectives and standards for Medicare, but Congressional interference regarding coverage policies for specific medical products would set a terrible precedent. It would encourage companies making medical products as well as medical specialty organizations to constantly ask Members of Congress to override scientific evidence and spend taxpayer dollars needlessly on products whose sale would benefit those companies or specialties more than they benefit patients. In some cases, such overrides could promote the use of medical products in ways that are potentially dangerous to patients because they are unsafe or ineffective.
Health care costs are the leading domestic consumer issue. Congressional interference on individual reimbursement decisions at CMS will just feed those health inflation fires while possibly causing harm to patients.
Please reject H.J. Res. 54.
CONTACT: Bill Vaughan, 202-462-6262
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