Drugs

FDA, Others Responsible for ‘Opioid Epidemic’: Kessler

Former FDA commissioner David Kessler told the CBS Evening News 5/9 that FDA shares responsibility for the nation’s opioid epidemic, along with drug companies and doctors. “We didn’t see these drugs for what they truly are,” Kessler said in discussing what he terms “one of the great mistakes of modern medicine.”

From 1999 to 2014, the report says, sales of opioids quadrupled in the U.S., as did the number of opioid-related overdose deaths. “There was a notion,” Kessler said, “that pain was the fifth vital sign, you wanted to relieve pain, that that was the essential. You dosed until the pain was alleviated.”

Kessler said that approach was a costly mistake, with 78 people now dying each day from overdosing on painkillers. He noted that the Centers for Disease Control didn’t issue prescription guidelines until two months ago. The guidelines recommend that doctors try over-the-counter pain medications before prescribing more limited quantities of opioids, but don’t require doctors to comply.

Asked if the guidelines are strong enough, Kessler replied, “We’ll see. This is an American condition. This is an American disease.”

The report says that in the 21 years since OxyContin entered the market, it has generated over $35 billion in sales. “The inappropriate promotion of drugs contributed significantly to this epidemic,” Kessler said. “Because drug companies took a small piece, a sliver of science, and widely promoted it as not being addictive. That was false.”

Kessler said that while “pill mills” exist, some two-thirds of painkiller prescriptions are written by well-intentioned doctors trying to do right by their patients. “Everybody has to do better,” he declared. “The CDC guidelines need to be implemented. Pharmaceutical companies need not over-promote. Doctors need to prescribe more wisely in a more limited way. But it’s going to take a societal shift. It’s bigger than any one of those steps, in order to change this epidemic.”

Asked about his responsibility when he was commissioner, Kessler said the epidemic took hold after his 1997 departure from the agency, but also said he should have pushed for stricter prescription practices when he was there.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome