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Former FDA Commish Kessler Slams Docs, #FDA for Opioid Epidemic

Former FDA Commish Kessler Slams Docs, #FDA for Opioid Epidemic | Pharma Industry Regulation |

BEGINNING in the late 1990s, pharmaceutical companies selling high-dose opioids seized upon a notion, based on flimsy scientific evidence, that regardless of the length of treatment, patients would not become addicted to opioids.

It has proved to be one of the biggest mistakes in modern medicine.

An epidemic of prescription drug abuse has swept across the country as a result, and one of the latest victims, according to The New York Times, may have been Prince.

The paper reported that he had developed a problem with prescription painkillers, and that just before his death, friends sought urgent medical help from a California doctor who specializes in treating people addicted to pain medication. Whether pain pills played a role in his death won’t be known until the results of an autopsy are released.

How did we get this so wrong?

The so-called proof that patients would not become addicted was based on a limited number of patients. This was coupled with the idea that opioids should be used for a broad range of indications — including all types of moderate to severe pain when, in fact, they don’t work against all forms of chronic pain.

Equally dangerous was the notion that there was virtually no dose ceiling. The mantra was: “Prescribe until patients achieve pain relief.” And then there was the flawed concept of pseudoaddiction: If the patient comes in and is showing signs of drug seeking, that doesn’t mean the patient is actually addicted to opioids; it more likely means that he or she just needs more opioids to control pain. So the first response should be to prescribe more.

In turn, the Food and Drug Administration relied too heavily on doctors to figure out how to appropriately prescribe these medicines. For many of them, a pill was an expedient way to try to help their patients. Figures published by the Centers for Disease Control and Prevention for the period 2008 to 2011 show that among those who were at the highest risk of overdose, 27 percent used their own prescriptions and another 49 percent either got or bought opioids from friends and relatives. Only 15 percent bought them from a drug dealer.

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