Every year, drug companies spend 100s of millions of dollars on advertising alone, often exceeding expenditures on research and development (Wilkes et al, 2000). Compared to other industries, it is significantly reliant on promotional expenditures, often amounting to 20-30% of sales. Traditionally, promotional efforts for prescription medication were targeted exclusively to physicians, but the industry’s approach evolved over time, pushing towards advertising prescription medication directly to patients through television, magazines, internet, etc.
This marketing strategy, known as direct to consumer advertising (DTCA) is regulated differently across the globe depending on the federal legislation in different countries. The role of DTCA has generated a great deal of controversy and ethical concerns, such as the possibility of maximizing profit at the expense of clear and honest information provided to the public. Since advertising regarding medication has an influence on public’s decisions regarding something as serious as health, the need to present accurate information is especially crucial.
This paper will review the debate on this topic and the regulatory systems that govern DTCA. The first section will discuss the competing interests of the pharmaceutical companies and the public, along with the ethical issues that arise. The second section will discuss the regulation of DTC in different countries, with a special focus on Canada. Competing interests While the industry claims to be supporting the education of customers, the desire for profit is undoubtedly a driving factor in the push for DTC. Industry has been quite successful in this respect.
For example, advertising nicotine patches directly to consumers turned patches into an 800 million dollar category (Hollond, 1999). An interest in profit is not a negative thing in and of itself. It is no secret that the industry exists to make a profit. Allowing the pharmaceutical companies to make profits is a way of positively reinforcing the practice of drug development, from which society will benefit. With a motive for profit, however, the content of the information in advertisements may suffer in quality, in such a way that works against the good of the patients (Hollond, 1999).
An advertisement by Pfizer, the manufacturer of the cholesterol-lowering drug Lipitor, demonstrates the industry’s ability to cloud information and influence consumers, even without mention of the drug name. Their television ad tells a story of a healthy, young man who died unexpectedly of a heart attack, leaving his family grief-stricken. The campaign asks: “Which would you rather have, a cholesterol test or a final exam? ” leaving the viewer with the idea that cholesterol tests and subsequent drug treatment could prevent premature death from heart attacks in healthy people.
The problem, however, is that the message contradicts existing research evidence. A 2003 meta-analysis of studies of cholesterol-lowering drugs in people without previous heart disease found no difference in mortality between those taking the drug and those on a placebo (FCRSS, 2007). In addition to providing misleading information, the public may suffer from DTCA simply due to the lack of information available; most major advertising campaigns begin within the first year that a medicine is introduced onto the market, a time in which the major side effects have yet to be detected.
Vioxx, an arthritis drug marketed by Merck & Co. , had been prescribed to over 80 million people world wide, but was taken off the market in 2004 due the risk of cardiac arrest and stroke associated with long-term use. An additional concern in regards to DTCA is the over-consommation of drugs. Researchers have found that some ads promote unnecessary medicalization of normal life, such as promoting drug treatment for baldness, pre-menstrual syndrome, shyness, etc.
Fibanserin for example, a drug originally developed for treating depression, had been found in some clinical trials to increase female sex drive, and became the centre of a marketing campaign for the company Sprout. It was approved by the FDA in 2015, but only after two attempts of bringing the drug to market had failed. The drug has been met with a great deal of controversy due to its minimal benefits and lack of long-term data on safety, along with its unpleasant side effects, such as fainting and low blood pressure, and negative interactions with alcohol.
In addition, many argue that female libido is something that is simply part of normal life and does not warrant medicalization, especially when the benefits only marginally outweigh the risks. With this particular drug, Sprout managed to capitalize on the social implication of the drug, creating websites such as “Women deserve” and “Even score”; some argue that the FDA’s approval was simply giving in to the pressure (Le Devoir, 2015).
Despite the concerns held by many opponents of DTCA, some argue that it is an excellent way to meet the growing demand for medical information, empowering consumers through education of health conditions and possible treatments. According to “Prevention Magazine”, more than 53 million consumers talked to their physicians about a medicine they had seen advertised, and an additional 49 million sought information form another source, such as the Internet. Conversations with doctors are vital for identifying diseases, especially since some of these may be serious conditions.
For example, 8 million undiagnosed cases of diabetes exist among adults in the US, and only 10 out of 30 million of Americans with high cholesterol take cholesterol-lowering drugs (Holmer, 1999). However, while the conversation between the patient and the doctor is beneficial, a 2005 study in the U. S. found that patients who ask for an advertised drug are likely to receive prescriptions for it whether or not they show symptoms of the illness. DTC may help to educate patients, but does nothing to reinforce the physician’s obligation to provide evidence-based treatment (FCRSS, 2007).
Regulation High regulation in DTC is seen across the globe, prohibited in all countries expect for the United States (“US”) and New Zealand. In Canada, advertising of prescription drugs is governed by Health Canada under the Food and Drugs Act and the Food and Drug Regulations. Selon article C. 01. 044 RAD, toute publicite aupres du grand public ne peut porter que sur le nom propre, le nom usuel, le prix et la quantite de la drogue (Sante Canada, 2015).
The law extends only to advertisements distributed in Canada to encourage sales in Canadian territory, but does not protect against any of the infiltrating ads from the US. With Canada’s proximity to the US, print media can cross the border, and broadcasted television can reach Canadian households. In 2008, an article in the Canadian Medical Association Journal criticized the lack of enforcement, saying “Apparently, direct-to-consumer advertising is prohibited only for Canadian media and businesses,” since “American companies operate under American rules in Canada.
The lack of enforcement of Canadian law threatens to undermine Canada’s position in defending Canadian regulations from legal challenges. While some argue that laws in Canada regarding DTC are too lax, efforts are still sought to extend them. In 2007, CanWest Media launched a lawsuit against the federal government on the grounds that the laws regarding DTC were “unconstitutional” and against the Charter of Rights and freedoms.
Due to the financial difficulties of the plaintiff, the case stalled without resolution. Bill C-51 (39th Parliament), while it did not become law, would have taken the ban on DTCA out of the hands of Parliament, leaving decisions regarding the prohibition of DTCA up to the discretion of the Minister of XXXX and beyond the oversight of Parliament. The Bill died with the 2008 election and the government has not announced when it will be brought back. (Rouillard-Labbe & Scott 2009).