The Prescription Project Criticizes New PhRMA DTCA Guidelines

Contact: Kathy Melley, 617.275.2861

Boston, MA - 12/10/2008 - PhRMA, the pharmaceutical industry's main trade organization, has announced a set of proposed voluntary guidelines that would change direct-to-consumer advertising (DTCA). The following is the statement of Allan Coukell, Director of Policy for The Prescription Project.

“The new Pharmaceutical Research and Manufacturers of America (PhRMA) DTCA guidelines released today fail to protect consumers from drug risks and do not contribute to public health. As The Prescription Project has pointed out previously, the industry itself can cite no studies showing any health benefits from DTCA.

“These new voluntary guidelines from industry are an attempt to head off more serious consumer protections from a new Congress and the FDA under a new Administration. In fact, just this week [Monday, Dec 8] at a conference hosted by The Prescription Project, Rep Henry Waxman (D-CA), the incoming chairman of the House Energy and Commerce Committee, signaled his interest in further regulating DTCA, including giving FDA the power to prohibit ads for new products.

“Pharmaceuticals (and medical devices) bring complex risks and benefits. Yet many in the medical community believe that DTC provides very little useful information and does more harm than good. Perhaps the most important thing DTCA ads fail to do is tell consumers how well the advertised drug will work. The new PhRMA guidelines don’t address this.

“There are any number of drugs that have been shown to provide little or no meaningful clinical benefit, including certain heavily advertised sleeping pills, cholesterol-lowering agents (for patients without heart disease), allergy treatments, Alzheimer’s drugs - the list goes on.

“Many consumers don’t understand that they aren’t getting complete information from DTCA. One survey (reviewed here) found that 21 percent believed that only ‘extremely effective’ drugs could be marketed directly to consumers. Other mistaken beliefs:

  • 43 percent believed that only ‘completely safe’ drugs could be advertised directly to consumers, and
  • 22 percent thought that advertising of drugs with serious side effects had been banned.
“Of course, no drug is ‘completely safe.’ To effectively equip consumers to interpret DTCA would be to explain that the laundry list of side effects included in drug ads is really only meaningful if you know how serious each is, how likely it is to occur and, again, how to weigh that risk against the potential benefit. Not only that, but advertised drugs are generally new drugs, with risks that may not yet be fully known. The FDA/EthicAd site doesn’t provide this sort of discussion.

“Evidence also shows that when patients request an advertised drug, doctors are likely to prescribe it – even when it isn’t medically appropriate. And that there is much concern that drug companies use ‘help seeking ads’ –ads that mention a disease, but not a drug – to convince some healthy people that they need treatment (think restless legs – a real, but rare condition).

“We shouldn’t sell drugs the way we sell soap. A responsible industry would pull its ads and let good science drive the demand for truly innovative and beneficial therapies.”

Related Sites

(All Fields are required)