In the wake of Congressional criticism and troubling disclosures about drug safety, the Food and Drug Administration yesterday announced that dozens of popular prescription painkillers must now carry strong warnings of their health risks. (Indirectly, a warning also went out to the news media.)
As the Los Angeles Times reports today, the action “was one of the largest relabeling orders in FDA history.” The Times’ Ricardo Alonso-Zaldivar and Denise Gellene write, “In recent months, critics in Congress and elsewhere have subjected the agency to persistent criticism for relying too much on drug makers to sound the alarm over potential safety threats that surface after drugs have reached the market and are being used by patients.”
The affected drugs are enormously popular with patients and physicians, according to the Wall Street Journal, which notes that world-wide sales of nonsteroidal anti-inflammatory drugs in 2004 amounted to about $12 billion (subscription required). “For drug companies, the shift could presage a higher bar for approval of new products and a more public and confrontational process when problems emerge for drugs already on pharmacy shelves,” write Journal reporters Anna Wilde Mathews and Scott Hensley.
And in its coverage of the FDA, the New York Times reports that “few studies have examined the long-term health effects of most of these medicines, so regulators are groping a bit in the dark.”
The Times’ Gardiner Harris quotes Sen. Charles E. Grassley who oversaw high-profile hearings last fall on the approval of Vioxx. Yesterday’s get-tough decision will be good news, says Grassley, if it “is a turning point and indicates a more independent Food and Drug Administration.”
Hopefully it will also produce a turning point in press coverage of prescription drugs.
In an interview with CJR Daily in December, James B. Steele, co-author of Critical Condition: How Health Care in America Became Big Business — and Bad Medicine, criticized the news media for being a lap-dog of the pharmaceutical and health industries: “The press is filled with tales of the latest wonder drug or a procedure that will dramatically improve our well-being. They read like PR handouts and play to the public’s anxieties about health. There is seldom a hint of skepticism.”
[M]uch of the media’s coverage of prescription drugs, and especially that of television news, has been downright embarrassing. Go back and look at the stories at the time Vioxx was introduced and you will see just how far off the tracks our business goes. Like so many drugs, Vioxx was portrayed as a great breakthrough. But the warning signs were there from the beginning. The news media just failed to examine them. It’s a failure that has been repeated over and over, from hormone replacement therapy to anti-depressants to anti-obesity drugs.
When was the last time you read stories about the latest “miracle drug” that included, among other things, a rundown on the previous work of the researchers who conducted the clinical trials or their ties to the pharmaceutical industry? Or how about the health history of those selected for the clinical trials? Or the placebo effect in the trials? Or a detailed look at side effects beyond the obligatory recitation from the drug maker?
The drug industry is a huge business — and it deserves to be covered like a business. That means asking tough questions, doing background checks, talking to people who aren’t sitting in the corporate front office. It means reading clinical studies and talking to critics as well as boosters. Most of all it requires a huge dose of that basic journalistic elixir: skepticism. Even in the face of pressure to produce a slick read on a hot topic for page one (a temptation the New York Times succumbed to last Sunday).
The FDA’s Dr. Steven Galson yesterday told reporters that it is essential that “the medical and public health community should have confidence in the FDA.” It’s just as important that the larger community have confidence in the news media — but that won’t happen until reporters stop following the very script that Steele outlines above.