What the US government should be doing – but isn’t – to guard against unsafe prescription drugs

Documents released in an Ohio court case last month, in a landmark, multi-district opioid lawsuit, gave new insight into an unparalleled opioid epidemic in the United States. It revealed that between 2006 and 2012, some 76 billion opioid pills were distributed in the United States — more than 200 pills for every man, woman and child.

It paints a damning picture of the tension between drug company profits and patient safety during the time opioid sales were climbing dramatically. In one 2009 exchange, a pharmaceutical company representative emailed a colleague at another company to alert him to a pill shipment. “Keep ’em comin’!” was the response. “Flyin’ out of there. It’s like people are addicted to these things or something. Oh, wait, people are.”

According to Charles L. Bennett et al. in an editorial published in the Los Angeles Times, the failings are at every point in the system, starting with drug approvals. But the authors believe there is a particularly serious problem with the mechanisms for identifying, monitoring and disseminating information about issues with a drug after its release.

They suggest a good starting point for reforming the system would be increased transparency about drugs already recognised as particularly dangerous. These drugs, currently numbering about 70 (including opioids), carry the FDA’s so-called 'black box warning,' intended to alert patients and their doctors to the high risks associated with the drugs. But that is not enough. The authors propose a 'black box' database or 'registry,' publicly available and simple to use, that would contain extensive information about where, by whom and for what purpose black box drugs are prescribed, as well as where and in what quantities such drugs are being distributed and sold. Information about adverse side effects, culled from the myriad of government databases that now collect them, would also be consolidated in an open form and format.

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Source: Los Angeles Times, 8 August 2019