COMMENTS: Killer Pill

A $3bn-a-year pill sold by the pharmaceutical company GlaxoSmithKline may have killed tens of thousands of patients since it was approved eight years ago. The pill, brand name Avandia, lowers a diabetic's levels of blood sugar. Unfortunately, if research by Dr Steven Nissen at the Cleveland Clinic is correct, it also helps cause fatal heart attacks. All three networks led with the prospect of such a calamitous death toll, making it the Story of the Day. For its part Glaxo "strongly disagrees" with Nissen's conclusions and will continue to sell the medicine.

Being the venue for such heavy advertising by Big Pharma, the networks' nightly newscasts are under an obligation to make a special effort when such news breaks. Not only is their audience older than the population at large, and therefore more likely to use prescription drugs; also, their journalism is so surrounded by marketing messages reassuring the audience that medicine will make them better that any plausible contrary message--that it might kill them--needs to be transmitted not only loud and clear, but louder and clearer than a normal news development.

So each newscast acquitted itself ethically by leading with Avandia and following up with an expert interview. ABC and CBS chose their in-house physicians; NBC talked to a professor of medicine at Harvard.

The ethics may have been fine. The statistics were less impressive. ABC's John McKenzie quoted Nissen as having calculated a 64% "increased risk of dying from heart disease compared to patients on other treatments or getting no treatments at all." His anchor Charles Gibson told us that a total of six million diabetes patients have taken Avandia since it was approved and CBS anchor Katie Couric estimated that "about a million" take it now.

So far so good. But that 64% statistic does not mean much without knowing what the heart risk is for diabetics who are not taking Avandia. If it happens to be 1%, then taking the medication merely increases the chance of death to 1.64%, no big deal. Conversely if the non-Avandia risk were to be 60%, then the hike from the medication would be to 98%, a very big deal indeed. NBC's Robert Bazell, to his credit, tried to get an answer from Nissen himself. "How many extra deaths a year could it be causing?" "It certainly would be tens of thousands. The exact magnitude of it remains to be calculated."

Second, even if Avandia does make death from a heart attack more likely, does it make death from diabetes less likely? Both ABC's McKenzie and CBS' Wyatt Andrews quoted Glaxo's assertion that the benefits of taking the drug "continue to outweigh any treatment risks." But here again, none of the reports attached any numbers to those claims.

Over to the physicians for their expert analyses. CBS' Jon LaPook described the Cleveland Clinic's method: "They rolled up a bunch of smaller studies, 42 of them." He insisted: "There are problems with doing that." ABC's Timothy Johnson (at the tail of the McKenzie videostream) questioned the FDA's initial approval of Avandia. It found a benefit solely because laboratory tests proved that it improved blood sugar levels. The FDA ordered no "long-term studies that showed it actually prevented the dreaded complications of diabetes," namely diseases of the heart, the eye and the kidney.

On NBC, Harvard's Jerry Avorn (at the tail of the Bazell videostream), author of Powerful Medicines pointed the finger at the Food & Drug Administration for its failure to monitor the safety of prescription drugs, post-approval. His advice for diabetic users of Avandia was that they should first "call their doctor" and "the second call patients should make is probably to their congressman" to call for a better FDA safety system.


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