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A recent article on a popular health-related website extolled the benefits of treating depression in children with specific drugs. Another on the same site promoted two new medical devices for treating migraine headaches. It would not be surprising to find such promotional materials on the websites of pharmaceutical and medical device companies, but these articles appeared on the homepage of the Food and Drug Administration (FDA), the agency responsible for regulating these medical...
A recent article on a popular health-related website extolled the benefits of treating depression in children with specific drugs. Another on the same site promoted two new medical devices for treating migraine headaches. It would not be surprising to find such promotional materials on the websites of pharmaceutical and medical device companies, but these articles appeared on the homepage of the Food and Drug Administration (FDA), the agency responsible for regulating these medical products.
The first consumer-directed article, “FDA: Don’t Leave Childhood Depression Untreated,” was published on the FDA’s homepage on Sept. 10.[1] Although it also mentions psychotherapy, the piece emphasizes treatment with antidepressant drugs, noting:
Treatments for depression often include psychotherapy and medication. FDA has approved two drugs—fluoxetine (Prozac) and escitalopram (Lexapro)—to treat depression in children.
In the article, Dr. Mitchel Mathis, the director of the FDA’s Division of Psychiatry Products, states, “A lot of kids respond very well to drugs.” The article concludes by saying, “Medications help patients [with depression] recover sooner and more completely.” Such a broad, unqualified statement exaggerates the benefits of antidepressant drugs for childhood depression and likely would have been considered by the FDA to be a violation of advertising regulations had it been made by the companies that sell PROZAC and LEXAPRO.
The second article, “Treating Migraines: More Ways to Fight the Pain,” appeared on the FDA’s homepage one week later.[2] This piece promoted two medical devices, one that delivers magnetic stimulation and the other electrical nerve stimulation to the head. Both were approved by the FDA in the past year. The article stated:
People who don’t tolerate drug treatments well might find relief by using [one of these devices]. Both devices have been shown in clinical studies to be effective and pose minimal risks … when used according to their labeling. There’s a great need for these noninvasive devices because many anti-migraine drugs have side effects that some patients can’t tolerate.
As the public health agency charged with ensuring that drugs and medical devices marketed in the U.S. are safe and effective, the FDA must maintain itself as an objective, independent regulator of the pharmaceutical and medical device industries. This promotion of drugs and medical devices reflects a continuing trend in which the FDA views itself more as a partner with industry than as a regulator of it. By inappropriately hawking the medical products it regulates, the agency undermines its objectivity and independence.
References
[1] Food and Drug Administration. FDA: Don’t leave childhood depression untreated. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm413161.htm. Accessed September 21, 2014.
[2] Food and Drug Administration. Treating migraines: More ways to fight the pain. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm414707.htm. Accessed September 21, 2014.
