Anemic Judgment

Published November 29, 2007

If you or a family member were 65 years or older and fighting cancer, would you want the government or your doctor to determine the best course of treatment?

Most people would choose their doctors, but a recent decision by the Centers for Medicare and Medicaid Services (CMS) could mean Medicare will over-rule doctors and refuse to pay for certain critical drugs widely used by cancer patients.

The drugs at issue are “erythropoiesis-stimulating agents,” or ESAs, used to treat anemia, a condition characterized by abnormally low levels of hemoglobin. (Hemoglobin is the part of healthy red blood cells that transports oxygen.) The most prescribed drugs of this type are Aranesp, sold by Amgen, and Procrit, sold by Johnson & Johnson.

Anemia is a common side-effect of chemotherapy. During chemotherapy, fast-replicating cells are killed first. This is why cancer patients lose their hair, intestinal linings, and bone marrow cells. As cancer patients fight for their lives, chemotherapy drains them of energy as the bone marrow cells that produce red blood cells are destroyed. ESAs have been miraculous in quickly restoring the red blood cell and energy levels of cancer patients.

CMS has announced it plans to stop paying for ESAs given to cancer patients undergoing chemotherapy whose hemoglobin level is greater than 10 grams per tenth of a liter of blood, or g/dL. The problem is, conventional medical practice, guidelines of leading medical societies like the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH), and even Food and Drug Administration (FDA) labeling of ESAs call for their use at the lowest dose to avoid transfusion for patients with hemoglobin levels up to 12 g/dl.

ASCO, ASH, and a growing number of Congressmen and Senators have registered their opposition to Medicare’s plan. CMS’s defense is to cite spurious safety concerns, not well-grounded in the scientific literature.

What’s really going on is that CMS is attempting to reduce spending on drugs for senior citizens under Medicare. It is appealing to “evidence-based medicine,” the use of past clinical research to dictate the most efficient ways for doctors to practice medicine. But CMS is not your doctor, and you or your loved ones are not in every way the statistically average patient. This is why the practice of medicine doesn’t always follow, and often must contravene, the findings of published medical research.

In a recent paper co-published by the Center for The New Europe and Center for Medicine in the Public Interest, Jacob Arfwedson and Peter J. Pitts described the shortcomings of evidence-based medicine (EBM):

EBM is stuck in the past, broken and outdated. For the most part it is a retrospective look at clinical studies and head-to-head comparisons of medicines and medical procedures. EBM may involve a careful look at the science. But in practice, it’s very limited. All of these studies are population-based, have rigid exclusion criteria and can’t integrate new information or innovations. Today evidence-based medicine means cost-based medicine. The result is decidedly and transparently a narrow one: to eliminate “practice variation” to what has been known to work–in the past.

The controversy over evidence-based medicine is further advanced in Europe, which has traveled farther down the road to socialized medicine than has the U.S. In European countries, the medical judgments of doctors are routinely over-ruled by budget-minded bureaucrats, creating systems that may cost the public treasury less (though even this is uncertain) but impose enormous and unreported costs on patients who are denied the best available care.

CMS’s decision on cancer medications is an early warning of what our health care system would look like if we make the short-sighted mistake of adopting Europe’s model. Cancer patients and their families cannot afford for their government to be so blind.

Thomas Swiss ( [email protected]) is director of public relations for The Heartland Institute.