Guest article by Ray Collins
The FDA has tolerated, regulated, and now seems to favor direct-to-consumer advertising by pharmaceutical companies, apparently as part the the judicial and regulatory trends toward corporate free speech. Susan Schwartz McDonald posts at National Analysts about her company’s view
The very fact that this particular [FDA] survey [of health care professionals] is on the docket speaks volumes about what many FDA-watchers have already concluded: that the agency has morphed from wary and grudging to comfortable and upbeat about the benefit of allowing pharma to converse with patients. After several decades of experience, the FDA seems ready to conclude that direct-to-consumer advertising (DTC) can do more than bring relevant therapies to broader awareness.
Is DTC advancing the cause of better health care, Dr. McDonald asks later in her post, perhaps unsurprisingly concluding that National Analysts’ market research answers in the affirmative and the upcoming FDA survey will likely do so as well.
A PLoS ONE publication last year, Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing, tells a different story. Ed Silverman at Pharmalot summarizes their data and gives a key quote from a Mount Sinai press release by lead author Deborah Korenstein:
“The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget.”
My view is that the FDA is capitulating to the marketing prowess of the pharmaceutical industry, given budget, personnel, and political restrictions. Their earlier response, the Bad Ad program, failed as do most voluntary reporting schemes. Television DTC ads are perhaps the worst offenders, for reasons having nothing to do with FDA regulatory guidelines. Martha Rosenberg, a health reporter, summarizes some negatives in a post at MedPage’s KevinMD blog.
Theoretically, all the newly and readily available medical information created a better-informed patient. It was the same reason the trailblazing feminist book Our Bodies, Ourselves was published decades earlier—patients have the right to know and be participants in their own healthcare. But three features of DTC advertising probably did more harm than good: diseases were created or overplayed, sometimes called disease du jours, to sell drugs. Risks of disease—fears of getting a condition or the condition getting worse—were whipped up to sell drugs. And extreme drugs were marketed when milder and cheaper drugs would do. The best example of this last point is Vioxx, which was billed as a “super-aspirin” for everyday arthritic or menstrual pain but ended up causing 27,000 heart attacks and sudden cardiac deaths before its removal from the market in 2004.
My question is, who will reward research and development prowess rather than marketing skills?
About the author
Ray Collins is a Medical Editor specializing in editing English translations from numerous languages, including primarily Japanese, Chinese, German, French and Spanish. He lives here in Austin, Texas and has experience editing Genetic Engineering, Clinical Trials, and Process Validation documents, SOPs, Journal Articles and Patents. He has given me permission to republish articles from his personal blog.