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Fewer drugs, fewer seniors
The Providence Journal
By ROBERT GOLDBERG
January 9, 2008
A RECENT ARTICLE in Britain’s Daily Mail ran with the title “I won’t let Daddy die: Girl of six raises £4,000 for life-saving drugs the NHS won’t provide.” When Britain’s National Health System said it would not pay for Tarceva, the drug her father needed to fight lung cancer, 6-year-old Chantelle Hill put up posters throughout her neighborhood asking for donations so she could buy the drug herself.
Tarceva is not a cure but it does extend life and improve quality of life.
And it’s used widely by cancer doctors in America. But Britain’s National Institute for Health and Clinical Excellence (NICE), which evaluates what the National Health Service should pay for, found it was not cost-effective.
Now, to save money, America’s Medicare program is willing to let seniors suffer and die sooner from cancer just as in England. As a first step, the Center for Medicare and Medicaid Services (CMS), which runs Medicare, decided to restrict reimbursements for erythropoiesis stimulating agents (ESAs) — drugs that prevent the fatigue from chemotherapy-induced anemia.
In this case, CMS came up with a new standard for paying for new drugs called the Precautionary Principle. This principle, developed by environmental extremists in Europe nearly 20 years ago, states that anything unknown is unsafe and should not be used. CMS asserts that it does not know enough about the safe use of ESAs beyond achieving a specific hemoglobin level. So it won’t pay for anything above that point. No exceptions. If seniors feel fatigued or confused they can pass the hat like Chantelle Hill.
The CMS decision has nothing to do with safety and everything to do with cost. CMS says that ESAs cause cancer and heart problems beyond hitting a hemoglobin target of 10 g/dL. But that claim is based largely on two studies that examined the experimental use of extremely high dosages of ESAs in patients without cancer. The Food and Drug Administration, its European counterpart the European Medicines Agency, and physician groups such as the American Society of Clinical Oncologists recognized the value of these studies in guiding clinical decisions but not restricting them. CMS stands alone in the world in restricting access to ESAs based on a target.
Such a policy assumes that blood transfusions are, for the cost, just as safe and effective as ESAs. To arrive at this conclusion, CMS ignores studies that show that transfusion in critically ill patients is associated with more death and increased tumor growth, increases the risk of infections, and impairs immune response.
Shame on both CMS and the Food and Drug Administration for not discussing the risks of ESAs compared to either its benefits or the risks associated with transfusion.
CMS also says it hasn’t seen evidence that ESAs improve quality of life. Yet cancer researchers have been studying the impact of reduced fatigue on cancer patients for years using standardized measures. Dozens of studies have demonstrated that ESAs improve patient quality of life even in patients whose starting hemoglobin level is over 10.
Seniors who are stronger and don’t have to spend time shuttling to the hospital are better equipped to endure newer and more powerful combinations of cancer drugs in the elderly. Indeed, a recent study conducted by Columbia University’s Frank Lichtenberg found that an aggressive chemotherapy regimen for seniors extends life expectancy by 8 to 12 months.
That powerful therapy — and therefore, that extra year of life — may not have been possible without ESA treatment.
But Medicare doesn’t care. It is willing to return seniors to the dark ages of repeated blood transfusions to establish the Precautionary Principle of medical reimbursement. If no one objects, then CMS and other advocates of greater government control over health-care spending will be able to deny access to new drugs for cancer, Alzheimer’s and other breakthroughs by claiming they need to show they are safe before Medicare will pay for it.
That would take years and deny Medicare patients a whole range of services and drugs that improve well-being and save lives.
Fewer drugs. Fewer seniors.
Maybe that should be Medicare’s slogan for the future.
Robert Goldberg is vice president of the Center for Medicine in the Public Interest. |
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