Sitting on a drug's deadly effects
People being treated for cancer often become anemic, meaning their blood oxygen levels fall too low, which is partly why they feel exhausted during treatment. To ease the anemia — and the fatigue — doctors prescribe erythropoietins, which stimulate the production of red blood cells.
On Friday, the Food and Drug Administration warned that these drugs, sold under the brand names Epogen, Procrit and Aranesp, are doing more harm than good in some cases. Doctors have apparently been over-prescribing the drugs, using them to reverse anemia, instead of just alleviating it enough to avoid blood transfusions.
The agency says that the drugs carry a higher risk of blood clots in the legs and the lungs, could make tumors grow faster, and could even cause people being treated for cancer to die more quickly. The drugs will now be sold with a black-box warning that highlights these risks.
Here's what I don't understand: we first reported on the risks with these drugs in 2003, when a couple of trials unexpectedly showed that people taking erythropoietin died faster than those taking the placebo.
We quoted experts who had found that many tumor cells have receptors for erythropoietin and that the cells grow faster in response to erythropoietin, and we reported — perhaps naively, in retrospect — that the mounting evidence might have an effect on how the drugs are prescribed.
As I said, that was in December 2003, more than three years ago.
Why has it taken so long for the FDA to act?
Comments
There are excellent herbal-mineral preparations in traditional medicines of Indian systems that help to counter anaemia and physical symptoms like vomiting associated with chemotherapy for cancer treament which i have come across through my association with traditional medicine network in this region.I am myself a traditional medicine practitioner and have carried out studies on their efficacy particularly for canacer,inflammation and hepatoprotection through projects involving formal sector expertise associating natural products,chemistry,material science,cancer and pharmacology expets across a multiplicity of institutions in the region.
Posted by: sureshkumar.s | March 14, 2008 03:29 AM
What do we do about the anemia drug controversy?
Most doctors and patients would agree the drugs are very helpful for patients when used to correct "severe" anemia, which can be debilitating and even life-threatening. The drugs reduce the need for somewhat risky blood transfusions and can give patients more energy and improve their quality of life.
''These are drugs that were presumed to be entirely safe, given for supportive care and to improve quality of life,'' not to actually treat cancer, said Dr. Eric Winer, director of breast oncology center at the Dana-Farber Cancer Institute in Boston. ''So any concern that they could shorten someone's life are taken quite seriously.''
There is little evidence that the drugs make much difference for patients with "moderate" anemia. Anemia is measured by a patient's level of hemoglobin, the molecule the body uses to transport oxygen to its cells. Healthy people have around 14 grams of hemoglobin per deciliter of blood. Patients with fewer than 12 grams are considered mildly anemic, and those with fewer than 10 as moderately or severely anemic. The labels on the drugs approved by the FDA encourage doctors to aim for a hemoglobin level of 10 to 12.
Critics of the drugs say their increased use has been driven by profit. According to Dr. John Glaspy, director of UCLA's Outpatient Oncology Clinic, one complicating factor is that oncologists make significant revenue buying cancer drugs from manufacturers and charging patients a higher price for receiving the drugs in their offices. That profit motive could influence some doctors' decisions.
Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, told UPI last year that "probably more than a billion dollars is spent on erythropoietin each year, which makes it one of the most expensive cancer drugs." A six-month course of treatment can cost more than $10,000 per patient.
After this issue had started to be reported, U.S. Oncology took an 8-10 million dollar hit in its first-quarter SEC report last year, including reduced pre-tax income due to lower use of anemia drugs. They also were handicapped by CMS stopping the Medicare Demonstration Project which paid chemotherapy providers $130 per report, per infusional-chemotherapy recipient, on a patient's level of nausea, vomiting, pain and fatigue, something that Congress found out that they were supplying free of charge anyway.
A continuance of the Medicare Demonstration Project would have exacerbated existing economic and clinical problems instead of resolving them by increasing the temptations for physicians to overuse injectable drugs and promise to aggravate the economic problems Congress attempted to fix with the new Medicare law.
A New York Times article reported last year that Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. However, companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. Doctors receive the rebates after they buy the drugs from the companies, but they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors' purchase price.
Although the new Medicare bill tried to curtail this kind of drug concession, private insurers still go along with it. What needs to be done is to remove the profit incentive from the choice of drug treatments. Let's take physicians out of the retail pharmacy business and force them be doctors again!
Gregory D. Pawelski
Posted by: Gregory D. Pawelski | January 17, 2008 03:43 PM
Why has it taken so long? Off the top of my head: the FDA has been churning through directors at a furious pace for the past several years, they've had a series of high-profile screw-ups and scandals distracting them, and when they do actually have someone in charge, the poor schmuck is invariably in the crosshairs of either the right, the left, or both over some abortion/birth control/sex-related issue. And that's before we get to all the usual challenges Federal regulators face.
You're absolutely right, though, the EPO issue should be included on the list of problems. Maybe they could have focused on this instead of developing that dubious black-box warning on antidepressants and teen suicide (a labeling change based on extremely sketchy data, in my opinion).
Posted by: Alan Dove | March 15, 2007 05:50 PM