Tough Warning Labels, Weak Results


By Amy Barrett It was big news on Apr. 7 when the Food & Drug Administration told Pfizer (PFE) that it would be required to put a severe "black box" warning on its blockbuster drug Celebrex. Studies have linked that painkiller, along with other drugs in the class known as Cox 2 inhibitors, to possible cardiovascular problems. That warning, which will appear prominently on the drug's label, is likely to severely curtail Celebrex sales, which last year hit $3.3 billion.

But in many ways, Celebrex is the exception and not the rule when it comes to tough label warnings. Because of the public nature of the controversy surrounding the Cox 2 drugs, many patients and doctors are likely to be aware of the tough language on the drug's label. But in too many cases, the warnings get overlooked, or even ignored, by physicians and the public. "The FDA puts a lot of stock into what they allow in the labeling," says Dr. Barry Massie, chief of cardiology at the San Francisco Veterans Affairs Medical Center. "But [a lot of] that [information] in fact it doesn't get to the physician."

The problems with the current system are numerous. For one thing, physicians receive letters on any label changes. But many are so busy that these missives can get overlooked. In addition, drug companies send out armies of representatives to promote their drugs -- and many physicians rely on reps as a key source of information. But those salespeople are likely to spend a lot more time talking about the positive aspects of a drug than the negative.

NEGLECTED TESTS. At the same time, the pharmaceutical industry sponsors many of the continuing-education seminars that physicians attend. No surprise that those programs often cast a very favorable light on the sponsoring companies' products.

With doctors overloaded and the information they receive heavily influenced by the pharma industry, some FDA warnings have little impact. Back in 2000, the diabetes drug Rezulin was pulled from the market due to occasional side effects resulting in liver problems. This came despite a series of warnings on the drug's label about the need to perform liver-function tests. A paper published in The Journal of the American Medical Association in 2001 found that fewer than 5% of patients on Rezulin for three months received all the FDA-recommended liver tests.

And more recently, a paper in the journal Circulation raised questions about kidney side effects associated with a heart-failure drug called Natrecor. Its label points out that the drug can affect kidney function in some people. But the VA's Massie says many physicians are actually under the impression that Natrecor is beneficial to the kidneys.

BAD EDUCATION. Clearly, much needs to change. For one thing, the FDA should study exactly how its warnings are reaching physicians and whether more effective ways exist to communicate new dangers.

At the same time, the medical profession needs to attack the problem of commercial control over its continuing-education system. That should include better disclosure about the financial interests of program sponsors as well as a requirement of input from experts who might hold views contrary to those of the sponsor. The current system, dominated by industry funds and agendas, is hardly good medicine. Barrett is BusinessWeek's Philadelphia bureau chief


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