Opinion: A dangerous loophole for drug ads needs to be closed

A loophole in prescription drug regulation exposes American consumers to false and misleading claims of drug ads via on-line businesses promoting potent drugs without accurate information about their risks and benefits.

Many countries prohibit direct-to-consumer advertising of prescription drugs. The United States allows it, but only if pharmaceutical companies comply with standards for accuracy and balance established and enforced by the Food and Drug Administration.

Almost everyone who watches television has seen drug ads, but most may not be aware of some of the requirements for them. Pharmaceutical companies can claim only benefits that have been approved by the FDA after an independent evaluation of supporting scientific evidence. Ads must balance accurate claims about benefits with descriptions of common and serious risks.

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Some companies that violate these regulations are required to publish corrective advertising or have been ordered to remove false and misleading claims.

It’s a different story on websites and social media platforms, where ads for prescription drugs can target consumers with exaggerated or misleading claims of benefits. They may also omit essential risk information. Some examples:

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  • Clinics offer infusions of the anesthetic ketamine for psychiatric disorders claiming they will “transform your life,” even though the FDA has never approved these hallucinogenic treatments for this purpose.
  • Clinics tout injections of testosterone, saying it will make men “feel young and energetic again.”
  • Sites offer an online evaluation for attention-deficit/hyperactivity disorder (ADHD) and continuing prescriptions for amphetamine stimulants to treat it but fail to include the FDA-mandated warning that these controlled substances have a high potential for abuse and addiction.

How did the online universe become a cauldron of medical misinformation about prescription drugs? Blame it on the loophole in law and regulation.

False and misleading ads about almost any marketed product are prohibited by law and subject to enforcement by the Federal Trade Commission. Prescription drug advertising is an exception — it is directly regulated by the FDA. But in the 1980s, when the FDA first opened the door to direct-to-consumer advertising, the only significant business entities promoting prescription drugs were pharmaceutical companies, and the primary outlets for drug ads were television, radio, and print media such as newspapers and magazines. As a result, advertising regulations for prescription drugs were focused on entities “that manufacture, distribute, or pack” prescription drugs.

Today, though, there are other kinds of businesses advertising or promoting prescription drugs. As part of a two-year investigation into the emerging use of ketamine for scores of psychiatric disorders, we identified hundreds of clinics that offer ketamine infusions at doses that induce a hallucinogenic experience. But the risks of ketamine are substantial and the benefits open to question, as we described in a review in the journal Pharmacotherapy.

Some telehealth startups are also taking advantage of loosely regulated prescription drug marketing. According to investigative reports in the Wall Street Journal and Bloomberg, one company recruited thousands of people with aggressive advertising to provide them with amphetamine stimulants, rated as among the most potentially addictive drugs, to treat ADHD and other problems. According to those investigations, one startup recruited so many people that several major pharmacy chains started refusing to fill their prescriptions.

A network of more than 50 centers is currently advertising testosterone replacement therapy to men. New startups are offering telemedicine prescriptions for antidepressant drugs after an on-line evaluation. Unapproved and not-fully-tested drug formulations created by compounding pharmacies are also being advertised nationwide.

There are good reasons for the extensive regulation of prescription drug advertising. People with disorders that impair their quality of life or threaten death are vulnerable to false and misleading claims that appear to offer hope. Fueling such yearnings with exaggerated — or simply erroneous — claims of possible benefits also increases the likelihood of inappropriate or dangerous use.

The U.S.’s now-obsolete system to regulate the promotion of prescription drugs needs to be updated to deal with the many new avenues through which prescription drugs are advertised, prescribed, and dispensed. Current prescription drug advertising regulations and enforcement should apply to all business entities — not just the companies that make drugs — that are advertising and providing people with prescription drugs. The FDA needs to provide clear guidance to emerging business entities that explains what is expected from drug ads on websites and social media that aims to recruit people to supply them with prescription drugs.

Regulatory loopholes mean that millions of consumers are being persuaded to take potent prescription drugs based on exaggerated claims of benefits that may not exist and assurances of safety that are simply false.

Thomas J. Moore is a faculty associate at the Johns Hopkins Bloomberg School of Public Health and a professorial lecturer in the Department of Epidemiology at the George Washington University Milken Institute School of Public Health. G. Caleb Alexander is an internist and professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health.


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Source: STAT