DrugsIntroduction

Direct-to-consumer (DTC) advertising, defined as “The use of mass media—eg, TV, magazines, newspapers, and the internet to publicly promote drugs, medical devices or other products which, by law, require a prescription, which targets consumers, with the intent of having a patient request the product by name,” is legally permitted in only two countries, the United States and New Zealand. This form of advertising directed toward patients has remained controversial among public health officials, physicians, and the public all over the world since 1985 when it became legal in the US.

Background

Since 1992, European legislation has banned advertisement to the public of prescription medicines. The main reason for the ban of DTC advertising in Europe as stated by the Health Action International of Europe is: “Unless there is clear evidence of lack of harm and of health benefits, the prohibition against direct-to-consumer advertising of prescription drugs should be maintained. The European Union is committed to the precautionary principle. This principle is as relevant to advertising policies with health consequences as to direct chemical exposures.” Most recently, however, the European community has considered regulatory changes to ease current restrictions on DTC advertising.

Issue

Should Europe preserve the ban on direct-to-consumer advertising of prescription drugs?

Rule

Europe should preserve the ban on direct-to-consumer advertising of prescription drugs if:

  1. The advertising leads to inappropriate prescribing by physicians  AND
  2. It fails to provide unbiased and accurate information

 Analysis

Inappropriate Prescribing

According to an article on BMJ.com, DTC advertising encourages people to seek medical attention for conditions or symptoms that may normally go untreated, including asymptomatic diseases. As a result, DTC advertising can lead to excessive prescription requests and, if a physician is unable to change a patient’s perception of the benefits of a drug, this situation may lead to inappropriate prescribing. According to the article, patients who are more heavily exposed to DTC advertising request more brand‑name advertised drugs and, therefore, prompt physicians to prescribe medications inappropriately even if the physicians have reservations about the particular treatment or believe that an alternative treatment is a better option.

An example of this is an advertisement run by GlaxoSmithKline for the antidepressant Paxil in the New York Times in October 2001, 1-month after the World Trade Center attack. Many people living in New York felt anxious after such a catastrophe; therefore, such advertising can hardly be justified. The heavy endorsement of Paxil and the enormous increase in prescriptions after 9/11 to people suffering from depression or post‑traumatic stress disorder led to skyrocketing sales of the drug–great for the company, perhaps not so much for the people.

In a Harvard Medical School study, 643 physicians surveyed believe DTC advertising encourages patients to seek unnecessary treatments and to make unwarranted requests. In addition, the survey found that 39% of DTC advertising visits resulted in the physicians actually prescribing the medicine even though they also recommended lifestyle changes or alternative treatments. In another survey, physicians judged 49% of requests based on DTC ads to be clinically inappropriate.

Another example comes from a randomized, controlled study conducted to determine the effects of patients’ DTC-related requests on physicians’ initial treatment choices in patients suffering from symptoms of depression. Results of the study indicated that patients’ requests had a profound effect on physician prescribing in disorders related to depression. The study demonstrated that patients who requested branded medications based on DTC ads were over 50% more likely to obtain a prescription for that drug where alternatives or generics may have been better options.

Inaccurate Information

According to the Division of Drug Marketing, Advertising, and Communication (US FDA), DTC ads are commonly found to violate US law because they contain inaccurate and misleading information. The most common reasons for inaccurate information are typically an exaggeration of benefits and minimization of risks.

 Television

In 1998, more than half of drug products advertised on TV violated regulatory standards. Today that number is even higher. Television ads in particular spend significantly less time on a drug’s risks than on its benefits. In 2005 per a ruling from a federal judge, GSK was forced to remove all television ads that claimed that Paxil was non-habit-forming based on the fact that the ads were misleading and inaccurate. Approximately 5,000 people in the US have filed lawsuits against GlaxoSmithKline since Paxil became available, and the company has paid billions of dollars to resolve these lawsuits. In 2012 in what is known as the largest healthcare fraud settlement in US history, GSK agreed to plead guilty to criminal indictment on promoting the sale of Paxil (and Wellbutrin) through DTC adverstising.

Print

A spot check of print ads conducted by the New Zealand Ministry of Health found that nearly all cases of ads submitted for review had risk information that was absent, incomplete, or illegible. A letter written by the US FDA to GSK in June 2001 claimed that a print advertisement for Avandia was misleading because the risk information was presented under the header “Strengthen your body’s own ability to help control blood sugar.” According to the FDA, this kind of advertisement purposely minimized the risks associated with Avandia treatment.

Web

A study conducted to examine pharmaceutical websites of 44 leading DTC advertised drugs to determine the extent to which risk information was completely communicated found that, although benefit information was frequently accessible on the first page, risk information typically required several clicks to access and was often incomplete.

Additionally, regardless of the type of advertisement, the recommended reading level for all pharmaceutical ads should be eighth-grade, and often the majority of ad content exceeds the eighth-grade reading level and can lead to potential health discrimination.

Conclusion

Direct-to-consumer advertising of prescription drugs many times leads to inappropriate prescribing and provides inaccurate information; therefore, Europe should continue to preserve the ban.

For more information on this issue, contact the Kulkarni Law Firm.