VIOXX: The Costs of Advertising Prescription Drugs

The drugs Vioxx, Bextra and Celebrex became available on the U.S. prescription drug market in the late 1990s as a breakthrough type of arthritis treatment and acute painkiller. Vioxx manufacturer Merck Co., Inc. and Pfizer, manufacturer of Bextra and Celebrex, were direct competitors in this particular class of NSAID COX-2 inhibitors.

 

In their efforts to effectively market their new drugs, both companies engaged in aggressive advertising which, according to the U.S. Food and Drug Administration, touted the benefits of the drug while minimizing the risks. In September 2004, Merck voluntarily pulled Vioxx from the market due to its link to heart attacks and strokes.  

 

Direct-to-Consumer Advertising

For several years, prescription drugs were advertised only to the prescribing doctors. However, in the 1980s, drug companies began to target consumers with their ads; such "direct-to-consumer advertising" has since become a powerful marketing tool for drug manufacturers. Currently, the United States and New Zealand are the only two countries which allow the "direct-to-consumer" advertising of prescription drugs.

 

Regulation of Prescription Drug Advertising in the United States

In the U.S., prescription drug advertising is regulated by the federal Food and Drug Administration (FDA). In general, the FDA requires drug advertisers to make only those claims which are supported by scientific evidence and which are not inconsistent with FDA-approved labels. In addition, the ads may not be false or misleading. Ads should include the risks of the drug as well as the benefits. Placing unfair emphasis on the benefits is not permitted. In print ads, this balance of information is generally accomplished by including the entire "risk" section of the FDA-approved label directly on the advertisement. However, brief television or radio ads usually do not have "time" to include such lengthy informative segments.

 

Television or Radio Advertisements

Prior to 1997, drug companies were allowed to advertise their drugs on television using short spots, but the FDA required them to include specific information about their possible associated health risks. However, in 1997, the FDA began to allow drug manufacturers to "refer" consumers to four sources to obtain additional information on their own. These four sources include:

• The consumer's doctor;
• A toll-free number;
• A reference to a print ad; and
•  A Web site.

Reference to these sources thus discharges the drug company's obligation to extensively inform consumers directly within the TV or radio ad.

 

Effects of Prescription Drug Advertising

The related, but competitive painkillers, Vioxx and Celebrex, are among the most heavily advertised drugs in history. The drug companies have spent more money and engaged in more product promotion than Coca-Cola, Pepsi or Budweiser. Perhaps in connection with this heavy advertising, COX-2 inhibitors are also the most frequently prescribed drugs in the industry. However, Merck pulled Vioxx from the market due to findings that it was linked to heart attacks and strokes, especially when it taken in high doses or for long periods of time. 

 

Many experts currently argue that the increase in drug ads directly to consumers has led to an increase in the popularity, exposure and prescription of dangerous drugs. The aggressive and widespread advertising of prescription drug competitors is said to be conducted before the drugs build up a safety-track record. Experts argue that the FDA should eliminate the option of drug companies to use direct-to-consumer ads.

 

FDA Warns against the Misleading Advertising of Vioxx

On September 17, 2001, the FDA sent Merck CEO, Raymond Gilmartin, an eight page warning letter with regard to Merck's advertising of Vioxx according to a study called "VIGOR." Merck advertised that Vioxx, as compared to a less expensive, related drug, naproxen, resulted in similar pain killing relief with less gastrointestinal complications or side effects. While that result may have been true, there was also some data that indicated Vioxx may be associated with increased cardiovascular (CV) problems, such as heart attacks, blood clots and strokes. However, Merck claimed that the CV events were not an adverse result of Vioxx. Rather, Merck reported that those effects were due to the especially cardio-protective effects of naproxen.

 

The FDA warning letter demanded that Merck cease promoting Vioxx to doctors for unapproved uses and ordered the company to send letters to the medical community regarding certain deceptions. Specifically, the FDA letter stated that Merck had "engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed" in the VIGOR study. Further, the letter told Merck that its marketing campaign discounted the fact that trial patients on Vioxx had a four to five-fold increase adverse CV occurrences than did patients on naproxen. Finally, the FDA urged that Merck's claim of the cardio-protective effects of naproxen should be stated as a "hypothesis" rather than a conclusion.

 

Free Speech Concerns

Although drug ads have no constitutionally protected right to make false or misleading claims, drug companies do have some free speech constitutional rights in promoting their products. Drug manufacturers argue that direct-to-consumer ads are a useful tool to educate and inform the public about the availability of innovative and beneficial medications. Ultimately, the FDA may be reluctant to tread on drug companies' free speech rights. However, tightening regulations on direct-to-consumer advertising is being considered by the FDA advisory panel, which is currently undergoing certain reforms.

 

FDA Strengthens Warnings on NSAIDS
On April 7, 2005, Bextra was withdrawn from the market, due to concerns over serious and potentially fatal skin reactions to the drug. In addition, the FDA announced that Celebrex and all other prescription NSAIDS must carry a black-box warning on the label regarding the increased risk of CV side effects. The FDA also asked manufacturers of non-prescription NSAIDS to include information clarifying the risks of CV side effects, serious skin reactions and gastrointestinal bleeding.

 

The FDA advised that users of prescription NSAIDS should consult with their physicians about their treatment options, and to take the lowest effective dose. The FDA further stated that users of over-the-counter NSAIDS should follow the directions on the product carefully, and not exceed the recommended dosage or take the drug for an extended period of time.