Monday, November 2, 2009

Amgen and Aranesp: One more example of how drug companies make huge profits by misleading consumers

Just in case you didn't read the Saturday papers, let me call your attention to this article in The Boston Globe about the chickens coming home to roost for Amgen, the California biotech that makes Aranesp, an anti-anemia drug for people with cancer and kidney disease. The Globe's Elizabeth Cooney reports on a study published online in the New England Journal of Medicine finding that Aranesp not only does not reduce cancer deaths or cardiovascular problems in patients (which was the drug's claim to fame), but that people who took it were almost twice as likely to have strokes as patients given a placebo or dummy pill. The results were even worse for people with kidney disease who either had a previous history of cancer or were diagnosed with the disease during the trial; those taking Aranesp had a statistically significant increase in cancer mortality, according to gooznews.

These results, which came from the kind of randomized study considered the gold standard of research and which counter years of aggressive marketing by Amgen, were released hours after the attorneys general from Massachusetts and 14 other states sued Amgen in federal court alleging that the company offered kickbacks to doctors to boost sales of Aranesp. These lawsuits have been several years in the making -- indeed, in an op-ed piece I wrote for The Boston Globe in June 2008, I noted that both Amgen,the maker of Aranesp and another anti-anemia drug Epogen, and Johnson & Johnson, which makes Procrit, a similar drug, have given doctors millions of dollars in rebates over the years for prescribing their drugs. And then I asked: Is it any surprise that all three became blockbuster drugs, with combined sales of nearly $14 billion in 2006?

The Aranesp/Epogen/Procrit scam, which by the way probably caused heart attacks and deaths in many unwitting patients, is a perfect example of the longstanding tendency among medical researchers (who are paid by the drug companies) to ignore or suppress risk information when publishing the results of new drug trials in prominent medical journals. This pattern, which I wrote about in Side Effects, was the topic of a major new study published last week in the Archives of Internal Medicine. As Gooznews first reported, the study found that 47 percent of 133 trials reported in journals like the New England Journal of Medicine, the Journal of the American Medical Association, the British Medical Journal and Lancet omitted numbers of study withdrawals because of adverse effects, while 27 percent failed to describe the seriousness of the adverse effects that were observed.

In an editorial accompanying this finding, the physician researcher John Ioannidis explains why this may be happening: "Perhaps conflicts of interest and marketing rather than science have shaped even the often accepted standard that randomized trials study primarily effectiveness, whereas information on harms from medical interventions can wait for case reports and nonrandomized studies."

Obviously, the state prosecutors who sued Amgen last week agree that marketing and money once again got in the way of giving American consumers what they deserve: the full story about the safety and effectiveness of costly new drugs.

2 comments:

Merrill Goozner said...

Hi Alison,
Thanks for the mention. And look a little deeper into the latest Aranesp trial. As I reported this morning, it showed a statistically significant increase in cancer deaths among patients with chronic kidney disease who also had or have cancer (only 188 in the drug arm of the trial, but still it was statistically significant). That's the major use of Aranesp -- in cancer patients, not kidney disease patients. With a doubling of strokes and a 1000 percent increase in cancer deaths -- you read that right, 14 of 188 in the drug arm; 1 of 160 in the placebo arm -- these drugs are turning out to be major health hazards when not strictly limited to helping patients avoid the need for blood transfusions. The "lifestyle" benefit, which is what they are advertised for ad nauseum on television, turned out to be almost non-existent. See my post today on gooznews.com.

Michael Kirsch, M.D. said...

All agree that conflicts of interest in medicine are a serious ethical issue. We should be cautious about calling for a crusade against them as we could stifle cooperation between the medical community and the pharmaceutical industry. It is easy and fashionable to demonize Pharma, but this effort can morph into OperationOVERKILL. There's a gray area between conflicts and collaboration, and we shouldn't sacrifice the latter in our zeal to eradicate the former. http://bit.ly/1U8X3d