Absolute must-read: LA Times on the myth of OxyContin’s 12-hour analgesic effect

May 7, 2016, 9:15 pm


Quick: how long does a dose of Oxycontin provide pain relief?

Most clinicians would probably say 12 hours, since the drug was extensively marketed as a twice-daily opioid analgesic and the manufacturer — Purdue Pharma — cited this originally unique convenience factor as justifying its high cost, which could exceed $630 a bottle.

In an explosive and masterfully written investigative piece by Harriet Ryan, Lisa Girion and Scott Glover,  the Los Angeles Times reported this week that in most patients the duration of the analgesic effect for OxyContin does not last nearly as long as claimed, and that this discrepancy may bear a large part of the blame for the current epidemic of opioid-related overdoses and deaths. The paper makes a number of bombshell allegations:

  • Purdue Pharma has known about this so-called “12-hour problem” from the time the drug began to be marketed, since early clinical trials had indicated that in many patients pain relief lasted only 8 hours or less.
  • Despite this, Purdue aggressively insisted that Oxycontin should only be prescribed for bid (twice daily) dosage to maintain a competitive business advantage.
  • The company and its sales representatives told physicians that if patients complained that pain relief wore off earlier than 12 hours, they should prescribe a higher bid dose rather than increasing the dosing frequency. As a result, many patients ended up on dangerously high doses of Oxycontin, were at increased risk for overdose,  were overly-sedated during much of the day, and still experienced breakthrough pain and withdrawal symptoms when the drug wore off before 12 hours were up.
  • Most importantly, the article cites experts who say that the recurring cycle of pain-relief/euphoria followed by renewed pain and withdrawal symptoms was a set-up for disaster, a scenario that one researcher called a “perfect recipe for addiction.”

The article is full of appalling facts and anecdotes:

  • The ongoing epidemic of opioid overdoses, often seen to have started when OxyContin was approved in 1995, has been associated with almost 200,000 deaths.
  • The doctor who led the Food and Drug Administration’s review of OxyContin, “left the FDA and within two years, was working for Purdue in new product development, according to his sworn testimony in a lawsuit . . .”
  • “Sales reps pitched the drug to family doctors and general practitioners to treat common conditions such as back aches and knee pain. Their hook was the convenience of twice-a-day dosing.”
  • “Company officials worried that if Oxycontin wasn’t seen as a 12-hour drug, insurance companies and hospital would balk at paying hundreds of dollars a bottle.”
  • “In an August 1996 memo headlined “$$$$$$$$$$$$$ It’s Bonus Time in the Neighborhood!” a manager reminded Tennessee reps that raising dosage strength was the key to a big payday.”
  • One Canadian study concluded that patients on higher doses of OxyContin had one chance in 32 of a fatal overdose.

This devastating article is one of the best pieces of medical reporting I’ve every seen. Absolutely, absolutely a must-read.

The Times’ editorial about the article is also well worth reading

To read my Emergency Medicine News column on “The Dark Truth Behind Pain as the Fifth Vital Sign,” click here.