Healthy Skepticism Library item: 10152

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Publication type: news

Moss R.
Cancer doctors are paid to prescribe dubious drugs
The Moss Reports - Cancer Decisions Newsletter 2007 May 20
http://www.cancerdecisions.com/052007.html

Full text:

Procrit, Epogen and Aranesp – known collectively as epoetins or ESAs (erythropoiesis stimulating agents) – are among the world’s best-selling drugs, with combined sales of $10 billion last year. In the US, they constitute the single biggest drug expense for Medicare and are given to about a million patients each year to treat the anemia that is caused by cancer chemotherapy or by kidney disease. Two of the world’s largest drug companies, Amgen and Johnson & Johnson, have been paying hundreds of millions of dollars in incentive bonuses to doctors – including medical oncologists – who prescribe the anti-anemia drugs.

Procrit and Aranesp can be very effective in correcting the severe anemia that often accompanies cancer. Epogen is widely used in the treatment of patients with renal (kidney) failure, another situation in which anemia is extremely common. Epoetins have been heavily marketed to both physicians and patients on the basis of their ability to reduce the need for blood transfusions, give patients more energy and improve their quality of life. However, there is an emerging downside to the use of these drugs.

An increasing number of researchers have become concerned that the drugs may increase a patient’s risk of heart attack and strokes. Furthermore, they do not improve the outcome of cancer treatment. In fact, there is growing evidence that they may actually shorten, rather than lengthen, survival. In the light of mounting concern over the dangers of these drugs, the US Food and Drug Administration (FDA) last month belatedly cautioned that epoetins may be unsafe at the commonly used dose levels, and insisted that a “black box” warning be added to the labels and prescribing information for Aranesp, Epogen and Procrit. In mid-May, an FDA advisory committee urged that additional restrictions be put on the use of drugs that treat anemia in cancer patients (Pollack 2007).

The FDA has been very slow to move on the question of epoetin safety. The first indication that the drugs might in fact be harmful came in 1996. A clinical trial sponsored by Amgen was set up to show that dialysis patients would benefit from having their hemoglobin raised to 14 g/dL, which is the level in a healthy person But the trial found instead that patients who were given epoetins to raise their hemoglobin to 14 g/dL suffered more deaths and heart attacks than a group treated with a hemoglobin goal of 10 g/dL. The trail was prematurely stopped. Dr. Anatole Besarab of the Henry Ford Hospital in Michigan, the lead author of that study, told the Times that Amgen and Johnson & Johnson had little incentive to conduct a definitive trial.

A full decade elapsed before FDA finally was spurred to act. On March 9th, 2007 it issued an advisory warning that “an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots [occurred] when ESAs were adjusted to maintain…hemoglobin more than 12 g/dL” (FDA 2007).

The FDA acknowledged that there is a higher chance of death and an increased rate of tumor growth when patients with advanced head and neck cancer who are receiving radiation therapy are given epoetins. Similarly, in patients undergoing chemotherapy for advanced breast cancer, epoetins such as Procrit, when given to push their hemoglobin levels above 12 g/dL, are associated with an increased rate of tumor progression. In addition, patients scheduled for major surgery who were given epoetin showed a higher rate of thromboembolism (blood clots).

FDA also says that when epoetins are given to anemic cancer patients who are not receiving chemotherapy, the need for blood transfusions is not reduced, and there is actually a higher chance of death. Similarly, patients with chronic renal failure have a higher chance of death and an increased risk of blood clots, strokes, heart failure, and heart attacks when epoetin is given to maintain hemoglobin levels of more than 12 g/dL.

Overall, the FDA has explicitly acknowledged that there is no evidence to indicate that epoetins such as Procrit, Epogen or Aranesp either improve patients’ quality of life or extend their survival. Meanwhile, several studies suggest that the drugs actually shorten patients’ lives when used at high doses.

To be concluded, with references, next week.