Follow-Up Studies on Approved Drugs Show Neutral and Negative Long-Term Effects

Follow-Up Studies on Approved Drugs Show Neutral and Negative Long-Term Effects

A recent study published by Harlan Krumholz and Joseph Ross, researchers at Yale School of Medicine, have worked interdisciplinarily to investigate the effects of FDA approved drugs. They combined their decades of respective experience in cardiology and primary care to document a trend of cardiovascular drug approvals based solely on intermediate, or surrogate, markers. For example, an intermediate marker for a drug that claims to decrease heart attacks would explore a drug’s performance in reducing cholesterol levels, without exploring its overall effect on patient outcomes [1].  This method allows pharmaceutical companies to get their potentially life saving drugs to market faster, but may come with unexpected and deadly consequences.

Krumholz and Ross’ study explores 157 cardiovascular drugs with seemingly favorable results based on intermediate markers, of which “only a quarter of these studies ever had a major follow-up study using patient outcomes” [1]. Furthermore, among those where patient outcomes were analyzed “almost half reversed the initial conclusion” [1].  Other studies based on surrogate markers have shown parallel results with minimal long-term benefits and even negative outcomes, including death.

The ultimate barrier to drug’s benefits are time. In response to critics Robert Califf, former FDA Commissioner, has stated that “one must question the simplistic approach to reducing standards for evidence across the board advocated by some,” citing the FDA’s accelerated approval program as an alternative to choosing speed over evidence. Additionally, groups such as the Patient-Centered Research Foundation are working to set a standard of data accumulation aided by technology [3]. In this way drugs can be tested with relevant data in a streamlined manner to get to approval without sacrificing precision.  

References:

  1. Harlan Krumholz and Joseph Ross, “Taking Shortcuts in Drug Testing Can Put Patients At Risk,” last modified April 4, 2017, http://www.npr.org/sections/health-shots/2017/04/04/522583228/taking-shortcuts-in-drug-testing-can-put-patients-at-risk
  2. Robert Califf, “Warning About Shortcuts in Drug Development,” last modified March 21, 2017, http://jaha.ahajournals.org/content/6/3/e005737
  3. http://www.pcrfoundation.org/, accessed April 7, 2017
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