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FDA Studies On Opioid Education Were Flawed

Studies on doctor education in the opioid epidemic were flawed, and hindsight, as they say, is 20/20. And although the FDA has lobbied heavy criticism and the pharmaceutical industry has paid fines, they are not without blame. They took years to investigate the makers and distributors of Oxycontin. Instead of protecting consumers, the federal agency instead left its own bumbling paper trail for opioid education oversight, according to a New York Times report.

The FDA, documents reveal, did little to stop overprescribing and, in fact, created a study that failed to be accurate by design, according to Caleb Alexander, the senior author of the study. “It’s unclear why the FDA didn’t insist upon a more scientifically rigorous evaluation of this safety program.” This means that it’s unclear if any studies were correct.

What Studies Were Done on the Safety Programs?

In 2007, Congress gave the FDA authority to require drug manufacturers to train physicians to safely prescribe certain dangerous drugs, such as opioids and other addictive painkillers. The bill was meant to breach a gap and prevent agency lapses in oversight of drugs like Vioxx, a popular painkiller that places thousands of people at risk of death. (Vioxx was pulled from the market in 2004, and it was revealed it could cause serious heart problems.) Doctor education programs were the heart of the study.

The new law meant the FDA would design a risk management program for all potentially dangerous drugs so that doctors could accurately assess the risk.  This agency power was meant to give the agency more control over drugmakers, but the FDA didn’t wield it the way it was intended.

Oxycontin was just one drug the FDA needed to monitor. There were a lot of drugs that needed safety programs developed as well. At least 60 drugs on the market need special physician training to be prescribed or including the narcolepsy drugs, heart drugs, HIV drugs, antipsychotics, and drugs that could cause severe birth defects.

Oxycontin Failures and the FDA

The FDA program should have helped over 100,000 doctors who prescribed the drugs learn more about how to safely prescribe the drug and how to educate patients on the dangers of abuse.

However, when Johns Hopkins research pored through thousands of pages of internal FDA documents obtained through the Freedom of Information Act, all they could find was poor study designs without any clear outcomes, and no way to measure any success. The FDA had approved the designs and never noticed that there was little way to measure outcomes.

Jeremy Kahn, a spokesman for the Food and Drug Administration, admitted that the initial studies were lacking, told the times, “We understand and acknowledge that there is still much work to do to bring down opioid abuse.” There are still new studies and projects outstanding.