Toward a Regulation Revolution

SANDRO LUNA

In the United States alone, Americans spend $11 billion annually on antidepressants. (1) These drugs have extensive side effects including nausea, weight gain, decreased sex drive, insomnia, and anxiety. (2) In fact, the FDA mandates that all antidepressants carry a “black box” notice, the strictest label warning for prescription drugs due to an increased risk of suicide. (2) Worst of all, some studies suggest that major depression medications are actually no better than placebos. In analyzing the effectiveness of the most common antidepressants, a 2012 study by Tania Huedo-Medina and her colleagues at Harvard Medical School and the University of Connecticut finds that the effectiveness over a placebo for each drug tested falls below the National Institute for Health and Clinical Excellence’s clinical significance threshold. (3)

How should we confront this problem? Reforming FDA standards for antidepressant efficacy could be the answer. We should consider expanding the requirements for independent substantiation—that is, the requirement that multiple studies yield the same result. At the moment, only one to two studies corroborating a drug’s effectiveness are required for approval. But as Huedo-Medina and her team showed, drugs often pass this minimum efficacy threshold and make their way to the market without being substantially better than placebos. Increasing the minimum number of required studies may be the shift we need to make antidepressants on the market safe and effective. If a drug is rushed to become profitable at the cost of reduced efficacy, the medicine’s true purpose is lost along the fast track to approval.

To ensure that patients receive the best care, we must resist marketable efficiency for the sake of refining antidepressant effectiveness.

Alprazolam, an antidepressant medication. Photo by Steve Snodgrass via Flickr, Creative Commons Attribution.

The most notable drawback to this proposal is slower antidepressant rollout. Drug performance is in a delicate balance with efficient approval practices. The FDA acknowledges the two sides of this idea; its Guidance for Industry document states, “the public is best served by the development of sound evidence of effectiveness in an efficient manner.” (4) Although bolstered approval conditions would be more costly and time consuming, we must keep in mind that many people are wasting their money paying for ineffective antidepressants. To ensure that patients receive the best care, we must resist marketable efficiency for the sake of refining antidepressant effectiveness.

A reevaluation of the efficacy versus efficiency dichotomy is necessary to open up a new discussion among government officials, the FDA, and researchers regarding the current state of antidepressant medications. Greater approval regulations could impact mental health globally by improving the treatments available for depression. Our brains, and the world’s well being, deserve no less.

Works Cited:

  1. “The Use of Medicines in the United States: Review of 2011.” IMS Health. Apr. 2012. Web. 27 Mar. 2015.
  2. “Depression (major Depressive Disorder) Tests and Diagnosis.” Mayo Clinic, 21 Feb. 2014. Web. 3 Dec. 2014.
  3. Huedo-Medina, Tania B., Blair T. Johnson, and Irving Kirsch. ‘Kirsch et Al.’s (2008) Calculations Are Correct: Reconsidering Fountoulakis & Möller’s Re-Analysis of the Kirsch Data.’ The International Journal of Neuropsychopharmacology 15.08 (2012): 1193–1198. Web.
  4. “Guidance Compliance Regulatory Information.” Food and Drug Administration, 1 May 1998. Web. 2 Nov. 2014.

Sandro Luna is a staff writer for Brevia. He can be reached at aaluna@stanford.edu.