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Healthy Skepticism Library item: 14801

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: news

The Prescription Project Criticizes New PhRMA DTCA Guidelines
Pharma Live 2008 Dec 10


The following is the statement of Allan Coukell, Director of Policy for The Prescription Project.

Full text:

“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.”


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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909