PAL and the Prescription Project highlight the risks, costs of DTCA in comments to FDA
Recently, the FDA requested comments on direct-to-consumer (“DTC”) advertising, and its effects upon subsets of the general population, such as the elderly, children, and racial and ethnic minority communities.
PAL and our sister organization, the Prescription Project (www.prescriptionproject.org ) weighed in on the relationship between DTC advertising and the risks and costs of prescription drugs. Our assessment overall was that
“direct-to-consumer advertising produces no proven public health benefits and likely plays a role in driving unnecessary use of pharmaceuticals. Manufacturer-sponsored television advertisements, in particular, are ill-suited to effective communication of risk-benefit information about prescription drugs. Elderly consumers, the less-educated and those with English as a second language may be at particular risk for misunderstanding the potential risks and benefits associated with advertised drugs.”
First, we noted that there is evidence that DTC ads prompt people to discuss advertised conditions and treatments with their doctors – in short, DTC ads work. Why else would the drug companies spend increasing billions each year on drug ads. But, more importantly, we point out that there is no evidence that what ‘works’ to sell drugs is of any benefit for patients. To the contrary, there is abundant evidence of the harm and cost of DTC advertising to consumers.
Populations at risk. Drug companies tend to focus their advertising on new drugs, with the hopes of finding the next billion-dollar block-buster. When successful, ads drive a rapid increase in prescribing that can expose a large number of the public to the health risks and previously-unknown side effects associated with the new drug. (Clinical trials of new drugs that drug companies run as part of getting FDA approval usually involve only a few thousand participants for a short time, usually less than two years. Therefore side effects that are rare, or that emerge only after patients have used a drug for a longer period of time, may only become obvious once the drug is on the market for a while and being taken by millions of people.)
Vioxx: The Poster Child for Drug Usage Driven by Advertisements Developed as a daily-use pain reliever, Vioxx was no more effective than ibuprofen (Advil) or naproxen (Aleve). Its only established improvement over these older, time-tested (and much cheaper!) medicines was a decreased risk of stomach bleeding and ulcers. However, no more than 2-4% of patients are at risk for developing these stomach problems. As a result of the substantial DTC advertising and other aggressive promotion, Vioxx use soared from 1999 until its recall on September 30, 2004. Our comment notes that the rapid explosion of Vioxx use, made possible in part by DTC advertising, was
“responsible for an estimated 88,000 to 140,000 cases of serious coronary heart disease and an estimated 38,000 to 61,000 deaths in the USA.”
Even without these risks, DTC advertising drives up health care costs. DTC advertising promotes medically unnecessary prescribing that offers “little or no meaningful clinical benefit for many patients….” This is true of cholesterol lowering agents, allergy medications, antidepressants, and many other types of heavily advertised drugs.
For instance, we noted one study in which actors went to doctors offices posing as patients, and specifically asked for Paxil after supposedly seeing an ad. Doctors wrote prescriptions for Paxil in very high percentages even when the purported condition was one for which there was little evidence (minor depression), or even no evidence (social adjustment disorder) that Paxil was an effective treatment. This illustrates how DTC advertising helps fuel medically inappropriate use.
Debunking drug industry propaganda that DTC advertising promotes public health In our comments, we took the opportunity to review the many other submissions to the FDA by drug companies which claimed that DTC advertising promotes public health. We noted that most of their purported ‘proof’ were ‘opinion surveys’ of how doctors or patients felt ads helped lead to needed diagnoses or treatment. Only one cited study looked at how often ads lead a patient to seek diagnosis. But we noted that there were no studies proving that DTC ads actually lead to objectively measured, medically necessary and appropriate care.
DTC advertising is not balanced Under federal regulations, promotional materials for prescription drugs must achieve a ‘fair balance’ between showing the benefits of a drug, and its risks. Also, promotional materials must provide adequate warning of the possible risks or adverse side effects.
The heart of the problem with direct to consumer advertising is that it does not achieve this ‘fair balance.’ DTC ads have been shown to focus more on the benefits, and to downplay or undermine the viewer’s understanding of risks. As a result, one study found that patients can accurately describe the benefits of drugs 80% of the time, but can only understand the risks 20% of the time. This is because drug ads spend more time describing a drug’s benefits, using easier language, with frequent repetition. In contrast, drug risks are often presented more quickly, in more difficult language, with other audio and visual distractions.
Our conclusion We recommend that FDA closely examine whether DTC ads can or do achieve a ‘fair balance’ between benefits and risks, given the ads representation of, and the public’s perceptions of, these risks. In addition,
“it must be remembered that DTC advertising drives attention to conditions chosen for their return on investment, not their importance in improving the public health.”
PAL’s and Prescription Project’s comments are here.