Direct to consumer advertising
BMJ 2004; 330 doi: https://doi.org/10.1136/bmj.330.7481.5 (Published 30 December 2004) Cite this as: BMJ 2004;330:5All rapid responses
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Editor –
The editorial by Mansfield et al. [1] raises fundamental concerns about how direct to consumer advertising (DTCA) can cause inappropriate pressures, either to use certain drugs where other choices may be more appropriate, or where benefit information is exaggerated and risk information minimised. As the editorial states, the purpose of DTCA, as with all advertising, is to persuade rather than to inform. The same edition of the BMJ contains a review of switching prescription drugs to over the counter (OTC) [2]. Surely, for some drugs the motive for this switch and these fundamental concerns are the same?
The striking example is Zocor Heart-Pro® 10mg. These tablets may now be supplied OTC by pharmacists in conjunction with necessary lifestyle advice to reduce the risk of a first coronary event in people who are likely to be at moderate risk (10%–15%) of coronary heart disease over the next 10 years. People with this level of risk would not get statin treatment following formal risk assessment in primary care according to the NSF and current NHS policy [3]. But there is no direct evidence that simvastatin 10mg daily works in this group of people; there are no trials of OTC statins and no data on continued adherence to therapy; there is no knowledge on safety of this drug used in the OTC context, and a lack of pharmacovigilance.
Furthermore the adverts for Zocor Heart-Pro® are a prime example of persuasion which promote benefit without clear communication of absolute or personal gain. Recent advertisements in glossy magazines (for example the Guardian Saturday Supplement [4]), and now on television, advise that risk of a cardiovascular event is “one in seven”. They do not give a time interval for this risk (presumably 10 years) or explain the uncertainty of benefit. One estimate from a review of primary prevention studies, using higher doses of statins, is that 71 patients with cardiovascular risk factors have to be treated with a statin for 3-5 years to prevent one heart attack or stroke [5]. Using the one-in-seven risk figure this equates to 88.1 out of a 100 people self-administering the drug having an event compared with 86.7 out of a 100 people not taking the drug. The adverts also fail to advise on potential harms, or that lifestyle changes, such as smoking cessation or increased exercise, are also necessary and may be more appropriate. Mansfield et al. say that DTCA “leaves many people with exaggerated perceptions of the benefits of drugs” [1]. Surely for many Zocor Heart-Pro® is an example of the same problem. Also, in view of the continued cost it is likely that instead of long-term purchase of simvastatin OTC people will increase pressure on their general practitioners to provide it on NHS prescription [6] and thus this OTC switch becomes indirect direct-to-consumer drug promotion.
[1] Mansfield, P. R., B. Mintzes, et al. Direct to consumer advertising. BMJ 2005;330: 5-6.
[2] Cohen, J. P., C. Paquette, et al. Switching prescription drugs to over the counter. BMJ 2005;330: 39-41.
[3] Department of Health. Coronary heart disease. National Service Framework. March 2000.
[4] Zocor Heart-Pro® Advert. “Heart attacks don’t just happen to men, so as a woman I’m taking steps to reduce my risk”. The Guardian Weekend. 27th November, 2005. Page 88.
[5] Editorial. OTC statins: a bad decision for public health. Lancet 2004;363:1659.
[6] Malik NN. Letter: Over-the-counter statins. Lancet 2004;364:411.
Competing interests: None declared
Competing interests: No competing interests
I have long been opposed to the effects that marketing seems to have on drug prescribing. Several years ago a colleague challenged me by raising the question of whether DTC advertising may help encourage patients to see their doctors and, thereby, improve healthcare. I now have a well written response that I can cite thanks to Dr. Mansfield, et.al.
I have to admit to being a bit embarassed that I practice in the only country that allows full DTC advertising of prescription medications; it gives me the opportunity to resolve in this New Year to try to counter that advertising by trying to educate patients and colleagues as best I can and to try to work toward eliminating DTC advertising in the United States.
Competing interests: None declared
Competing interests: No competing interests
Direct to consumer advertising on television is different from drug ads in newspapers and magazines. While television ads mention risks very quickly, the required "brief summary" in print ads includes more detailed information. Unfortunately, such summaries are usually illegible (because of tiny font sizes), unreadable (because of long and complicated sentences), and incomprehensible (because they require consumers to understand specialized research, pharmacological and statistical concepts).1
My readability analysis of six "brief summaries" found them to be written at a graduate school reading level; four "patient summaries" were written at grade 11-12, which was better, but still too difficult for many consumers.2
Cox 2 inhibitors were widely promoted through direct to consumer ads. But how could patients understand Cox 2 risks if they couldn't understand the "brief summary" that described those risks?
At some point, do patients (and their doctors?) choose what ultimately become unsafe drugs because they can't understand the risks? Direct to consumer drug ads aren't just about risks and benefits, but about how patient safety can be compromised by incomprehensible information.
References: 1. Hochhauser M. Consumer-Friendly Patient Information Should Replace DTC Brief Summaries. Product Management Today 2004; 15(1): 26-28.
2. Hochhauser M. Which Prescription for the Illegible and Unreadable DTC Brief Summary--Major Surgery or Euthanasia? Managed Care Quarterly 2002; 10(3): 6-10.
Competing interests: None declared
Competing interests: No competing interests
Correction: When OTC marketing becomes direct to consumer advertising
Apologies for a small error that alters the meaning. This should read:
"Using the one-in-seven risk figure this equates to 88.1 out of a 100 people self-administering the drug having NOT an event compared with 86.7 out of a 100 people not taking the drug".
Competing interests: None declared
Competing interests: No competing interests