CMA calls for controls on prescription-drug advertising aimed at patients

Patrick Sullivan

Canadian Medical Association Journal 1996; 154: 1889-1990

Patrick Sullivan is news and features editor at CMAJ.

In Brief

The CMA Board of Directors has responded to growing physician concern about prescription-drug advertising aimed at patients by issuing a position paper that calls for strict rules governing such ads. It also called for development of a code of behaviour to regulate the advertisements. The paper says this advertising must be evidence based and generic, and must not be related to specific brand names. There is particular concern that the ads often advise patients to seek more information from physicians, which will lead to increased utilization of the health care system. Capped global budgets mean the cost of providing the additional service must be borne by doctors.

En bref

Le Conseil d'administration de l'AMC a réagi à la préoccupation croissante que suscite chez les médecins la publicité relative aux médicaments prescrits qui s'adresse aux patients en publiant un énoncé de principe qui prévoit des règles rigoureuses pour régir la publicité en question. Il a demandé aussi qu'on élabore un code de comportement afin de réglementer les annonces. L'énoncé précise que la publicité doit être fondée sur des données probantes et génériques et qu'elle ne doit pas avoir trait à des marques de commerce précises. Les annonces recommandent souvent aux patients de s'adresser aux médecins pour obtenir d'autres renseignements, ce qui entraînera une utilisation accrue du système de soins de santé. C'est ce qui préoccupe plus particulièrement. Les budgets globaux plafonnés signifient que les médecins doivent assumer le coût de la prestation du service supplémentaire.

Growing physician concern about prescription-drug advertising that is aimed directly at patients has led to the release of a strongly worded position paper by the CMA.

The paper, approved during the May meeting of the Board of Directors, calls for formal studies to define risks, benefits and costs of a drug under field conditions before any advertising is aimed at the public. The CMA is particularly worried that patients will lobby to receive new drugs whose worth is unproved.

Dr. Michael Wyman, past president of the Ontario Medical Association, raised two additional concerns. "Advertising that encourages patients to contact physicians if they want more information about a drug will raise utilization rates during a time of fixed budgets," he said. "The other issue is the growing cost to pharmacare plans across the country."

Other physicians noted that capped global budgets mean that doctors, not drug companies, will have to bear the cost of increased utilization resulting from such advertisements.

Dr. Don Morgan, chair of the Council on Health Care and Promotion that drafted the position paper, said "advertising aimed at patients means more phone calls and patient visits. We could also be faced with a situation where a new product is introduced but there are few data about its effectiveness, yet patients are lobbying to receive it."

The CMA is not alone in taking this stand. In a policy paper, the Consumers' Association of Canada says advertising for pharmaceutical products and for products that make health-related claims "should be subject to guidelines that would ensure that a fair balance between benefits and hazards of the product is provided." It also says the ads should be monitored "to ensure adherence to responsible and ethical marketing practices."

The CMA's Department of Health Care and Promotion, which has been tracking the issue, cites several advertisements that it has received from concerned physicians:

An ad for Adalat P.A. that appeared in the Winnipeg Free Press. (It says to "ask your physician or pharmacist for more information," or to call a toll-free number.)
Televisions ads about migraine pain that invited viewers to call for information.
Magazine ads about menopause (Schering Canada) and Parkinson's disease (Dupont Pharma).
An ad concerning schizophrenia -- it was aimed at patients' families -- that was placed in the Ottawa Citizen.

Dr. Léo-Paul Landry, the CMA secretary general, agrees that physician uneasiness is growing. "Our primary concern is for the quality of care provided to patients," he said. "We recognize that the ads may have a positive potential for increasing patients' access to information, but we think they must be regulated to ensure they provide clear and accurate information and in no way mislead the public."

Currently, drug companies are not allowed to advertise directly to consumers about drugs used to treat a large number of conditions listed in the Food and Drug Act (FDA). This includes most prescription drugs; one obvious exception is Rogaine, which can be advertised directly to consumers because baldness is not on the FDA list.

"Manufacturers are complying with this law by advertising about the condition rather than the drug and by using a toll-free number to offer more information," Morgan observed. "This additional information always mentions that a drug is available, and all materials encourage patients to contact their physicians."

Morgan said the FDA restrictions on advertising probably run counter to the Canadian Charter of Rights and Freedoms -- he noted that legislation restricting tobacco advertising failed to withstand a charter-based challenge. "What we are suggesting is that a code [of behaviour] be developed and that a board be developed to oversee it," said Morgan. "We hope this position paper will encourage manufacturers to develop a code and follow it."

The CMA says:

A code regulating all consumer-related information concerning prescription products, including advertising, should be developed. A body, similar to the Pharmaceutical Advertising Advisory Board that oversees and approves advertising directed at physicians, should be created to control advertising directed at patients.
Before drugs are advertised, independently developed prescribing guidelines must have been completed and made readily available to all prescribers.
All materials developed for the public must be balanced, evidence based and generic and must not be related to a specific brand-name product.
Meaningful sanctions for companies that fail to follow the guidelines must be developed and implemented.

Morgan said the CMA's main goal is to enhance the quality of drug therapy and patient well-being. He warned that this will not happen if patients are pressuring physicians to prescribe relatively new drugs before adequate information is available.

The board also accepted a proposal from the Gender Issues Committee and adopted a definition of women's health that "will be used to guide the association's work in this area." The definition, taken from a CMAJ article by Dr. Susan Phillips (CMAJ 1995; 152: 507-511), states: "Women's health involves women's emotional, social, cultural, spiritual and physical well-being, and it is determined by the social, political and economic context of women's lives as well as biology."

| CMAJ June 15, 1996 (vol 154, no 12) / JAMC le 15 juin 1996 (vol 154, no 12) |