"Congress should leave...life-and-death medical decisions to the professional, objective physician-scientists at our nationâ€™s health agencies."
Regular doctors -- those who are not scientists at our nation's health agencies are, by definition, too stupid, corrupt, tainted by Big Pharma to be trusted and consumers, well, why have consumer groups if you could trusts you and me to act on our own behalf. Thank goodness we have people like Merrill Goozner to lead the way.
Mind you,these are the same consumer groups that were screeching during the run up to PDUFA renewal that the FDA is a tool of Big Pharma and can't be trusted to protect the public.
I guess if you say you are a consumer group you can be as hypocritical all you want.
Here's the the post:
Dr. Congress Makes a House Call
GoozNews: October 17, 2007
As I mentioned yesterday, the Food and Drug Administration wrote a strong letter to Capitol Hill last week backing the Center for Medicare and Medicaid Services' restrictions on the use of erythropoietin-stimulating drugs like Aranesp and Procrit during cancer chemotherapy. The FDA black box warning, the letter pointed out, called on oncologists to use the lowest possible dose for avoiding blood transfusions since higher doses of the drugs to boost energy -- which, of course, results in higher sales for their makers, Amgen and J&J -- leads to more deaths and faster tumor growth in cancer patients.
Despite this evidence, Congress is considering a resolution to overturn the CMS payment decision, which went into effect late last month. It has at least 26 co-sponsors already and the drug companies' lobbyists are out in force trying to get it passed. So is the American Society of Clinical Oncologists, whose members profit from greater sales of the drugs.
Yesterday, a coalition of consumer groups including the Center for Medical Consumers, the Center for Science in the Public Interest, Consumers Union,
National Research Center for Women & Families, National Womenâ€™s Health Network, the TMJ Association and U.S. PIRG wrote every member of Congress asking them to vote no on H.J. Res. 54, which would overturn the CMS decision. I thought it worth reprinting here because of the principles at stake, which are outlined in the letter:
October 16, 2007
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 nationâ€™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 â€œblack boxâ€ 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 nationâ€™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.