US Senator Calls on Feds to Investigate Purdue Pharma Over OxyContin Time-Effectiveness Claims

This article was produced in collaboration with AlterNet and first appeared here.

A US senator has called for a federal investigation of Purdue Pharma, the manufacturer of OxyContin, in the wake of reports that the money-making pain reliever wears off early in many patients, leaving them exposed to pain and increased risk of addiction.

Sen. Edward Markey (D-MA) Friday sent letters to the Justice Department, the Food and Drug Administration, and the Federal Trade Commission urging them to begin probes of the Connecticut-based drug maker.

The move comes in the wake of a Los Angeles Times investigation into Purdue Pharma's claim that OxyContin relieves pain for 12 hours, which was one of the drug's main selling points. But the Times found that the effects often wear off before that, leaving patients cycling between relief and intense pain and suffering from opiate withdrawals before their next scheduled pill.

The Times also found that Purdue knew about the problem since OxyContin first appeared in 1996, but continued to claim that it worked for the full 12 hours in part to protect its revenues. The newspaper reported that when faced with the problem, Purdue instructed doctors to prescribe stronger doses, not more frequent ones. Stronger doses of opioid pain relievers are more likely to be implicated in overdose deaths.

"These are serious allegations," Markey wrote in his letter to Attorney General Loretta Lynch. "They raise questions about ongoing deception by Purdue, harm to the public, continued costs to the United States, and the availability of further judicial recourse against Purdue. If upon investigation these allegations are substantiated, the Department should take legal action" against the drug company.

Purdue has rejected the Times' findings, noting that the FDA had approved OxyContin as a 12-hour drug.

"We promote our medicines only within the parameters approved by FDA and, given FDA has not approved OxyContin for eight-hour use, we do not recommend that dosing to prescribers," the statement said.

That's not good enough for Markey, who represents a state hard-hit by problems with prescription opioids and heroin. More than 1,300 people died from opioid overdoses in the state last year, according to the state Department of Public Health.

In his letter to the FDA and FTC, Markey called Purdue "the leading culprit in the current opioid and heroin overdose epidemic" and accused it of making "false and misleading claims about the longevity of OxyContin's pain-relieving properties."

The FDA and FTC should "investigate these claims and take action to protect patients and consumers from the harm caused by Purdue Pharma's deceptive marketing materials."

Justice, FDA, and FTC all say they are studying Markey's letter.

Washington, DC
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Finally!

As a former user of oxycontin, which my dose was at 4 x 80 mg a day plus breakthru meds, and was also told that indeed it lasted 12 hours, but, was given it every 8 hours as it did not last the 12 hours at all. I was lucky it lasted 6 hours, and the rx'ing dr would have given me 5 x 80mg, had the insurance company said it would pay for it.  I was told that many complaints were issued against the so called 12hour dosing , especially after it made it abuse tolerant, which changed the formula even more. So when taking the 80mg started to have with drawals at 6 hours! I totally understand that many could have overdosed because of this, and then the patient, while still in pain, would take another dose, which could put tem over the edge. These patients did no wrong, just had pain, was given meds which were to last 12 hours but, did not. At the very least it was false advertising. What is worse is that the fda went along with it!, Hmm, is it that there are people in control of these things with big pharma ties? Or owe favors for their contributions? All I know is they didnt do as advertised , so that of course it made it easier to be abused, unintentionally or intentionally.. How could they have gotten approval as they knew back then the issues with it? HMM.Well, it seems its easier to do that now, since the fda is headed by a big pharma employee, ceo> Things like this will continue to happen, until the people in charge are either held accountable for their actions, or removed and replaced with people that have no financial interests in big pharma, or, the other side of the business, the rehab centers, or take any financial gains from the people that make the decisions for us. The cdc is a whole other subject on the same theme. Trying to get rules passed on the down low, then getting caught, but, because of their interests, financial, in suboxone and rehab centers, which is a success rate of what 3%? Hmm. Just makes ya wanna go hmm. The so called system is shady.

Oxycontin does not last 12-Hr...

In my medical experience, patients do not get sufficient pain relief for 12 hrs when taking Oxycontin.  Every eight hours is a more realistic dosing schedule.  But since regular generic oxycodone tablets last 4 hours (and are a lot cheaper), that does not give Oxycontin much of an advantage.   Thus the 12-hour duration claim to maintain Perdue Pharma's market share.  This puts patients in a bind, however, as they are blamed for taking the medicine too soon. Hmm, they must be abusers (conclude the misinformed practitioners) so dismiss them from the practice - they deserve the pain of withdrawal. 

James Stewart Campbell, MD., Doctor of MEDesign

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