Oct. 12, 2005 – Citing a number of deceptive practices in collecting consumer information, a personal privacy advocacy organization is calling for tighter federal regulation of drug-company marketing practices. The call comes in advance of next monthâ€™s US Food and Drug Administration hearing on direct-to-consumer medical product promotions.
According to the Electronic Privacy Information Center (EPIC), FDA regulators need to scrutinize how pharmaceutical companies collect and use consumer information to ensure that the industry is not preying on ailing people. In comments submitted for the hearing, EPIC noted several instances of potentially dangerous direct-to-consumer marketing, including the mailing of free drug samples to current and former users of several medications.
This spring, a Florida judge found that Eli Lilly, a pharmaceutical manufacturer, was acting within the law when it sent samples of Prozac, an anti-depressant, to an unknown number of Florida residents, including people who no longer took the medication and people under the age of eighteen. Similar drug manufacturer practices are hard to quantify and measure, precisely because of the direct-to-consumer model.
According to a September study released by HRA Research, a medical-industry market-analysis firm, over 81 percent of US physicians support some form of moratorium on direct-to-consumer drug marketing, reported Pharmalive, an industry publication. The doctors surveyed acknowledged that the efforts sometimes help patients become better aware of potential treatments, but recommended that a hold be placed on such advertising until physicians become better aware of new drugs.
Many academics and researchers too are concerned over the sway the drug industry is gaining on the public.
In an article published in Nature earlier this month, ten academics expressed deep concern over unreliable information on the efficacy of medicines marketed to the public in the wake of Merckâ€™s decision last year to withdraw Vioxx from the market over long-evidenced suspicion the drug increases risks of heart problems.
In recommending that marketing be put on hold until drug safety and usefulness can be accurately assessed, the Cleveland Clinic Foundationâ€™s Eric Topol told the journal, "The FDA did nothing to assure that the proper trials were conducted, but at the same time allowed mass-marketing campaigns with hundred of millions of dollars supporting direct-to-consumer advertising."
And it isnâ€™t just drugs being marketed directly to consumers. According to a recently published study in Nature by a European biology organization, companies pushing genetic self-testing kits for detecting a variety of medical conditions is on the rise in the US and Europe.
"On the whole, itâ€™s a scary time in medical ethics because of consumer advertising," David Magnus, Director of the Stanford University Center for Biomedical Ethics told the paperâ€™s authors. "Leaving it up to the marketplace is not the optimal way to do medicine."
Recognizing a problem, the Pharmaceutical Research and Manufacturers Association in August issued a set of voluntary marketing guidelines for member companies. Suggested actions drug companies should undertake include seeking FDA approval for direct-to-consumer advertising and spending more time educating health-care workers about drugs and other medical therapeutics.