Worst Pills, Best Pills

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Drug Ads Fail to Present Risk Information

Worst Pills, Best Pills Newsletter article April, 2006

In the past year, when the FDA found a drug company violating false and misleading advertising laws, it was most often because the ads failed to disclose adequate information about a drug’s risks. The lack of good information for consumers about the risks of drugs is one reason why we first published Worst Pills, Best Pillsin 1988. We expanded our work with the launch of Worst Pills, Best Pills News in 1995, and now our Web site www.worstpills.org, all with the mission of giving prescription...

In the past year, when the FDA found a drug company violating false and misleading advertising laws, it was most often because the ads failed to disclose adequate information about a drug’s risks. The lack of good information for consumers about the risks of drugs is one reason why we first published Worst Pills, Best Pillsin 1988. We expanded our work with the launch of Worst Pills, Best Pills News in 1995, and now our Web site www.worstpills.org, all with the mission of giving prescription drug consumers access to reliable risk information about their drugs that is often only seen by physicians and pharmacists. Sometimes, even these health professionals do not receive adequate information to assess risks.

Our reason is simple common sense. The only individual at risk of suffering an adverse drug reaction is the consumer, not the doctor who writes the prescription or the pharmacist who dispenses the drug. Most potential adverse drug reactions are known and are thus preventable. Unfortunately, most consumers are left in dark about how to avoid preventable harm from the prescription drugs they are prescribed.

The director of the division of the FDA that is responsible for monitoring the truthfulness of drug company advertising, the Division of Drug Marketing, Advertising, and Communications (DDMAC), told the Pharmaceutical Marketing Compliance Congress held in Washington, D.C., in January 2006 that 82 percent of drug advertising violations were because inadequate risk information was presented in the ads. This figure covers both direct-to-consumer (DTC) advertising and ads going directly to healthcare professionals.

The DDMAC director also indicated that 43 percent of the violations issued by the agency cited, among other violations, misleading effectiveness claims, with a similar percentage related to misleading comparative claims (stating, for example, that one drug is more effective than another).

Drug manufacturers can only legally advertise the information that is contained in a drug’s professional product labeling. The company must provide the FDA with research supporting their claims of effectiveness and superiority in order for them to be included in the product’s label. The FDA reviews and either approves or denies the claims based on their review.

If a pharmacist, physician, or advertisement claims that an expensive new drug is better than older drugs, you can check the Worst Pills, Best Pills sources given above to see if their claims are supported by evidence. You can also check the drug’s professional product labeling yourself. Chances are that you will find nothing in the drug’s professional label and can conclude that there is no reliable evidence that the new drug is any better than drugs that have been on the market for years.    

You can find professional product labels on our Web site www.worstpills.org, on the FDA’s Web site, or in the local library by looking at the Physicians’ Desk Reference (PDR). The PDR is a compilation of professional product labels.

What You Can Do

Before you take any new drug, check Worst Pills, Best Pills sources or the drug’s professional product labeling.