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Abandoned painkiller, Numorphan, makes a deadly comeback
When the prescription opioid painkiller Numorphan in pill form was taken off the market 36 years ago in 1979, most people working in addiction treatment breathed a sigh of relief.
Throughout the 1960s and ‘70s, Numorphan (generic name oxymorphone) was seen to be responsible for countless thousands of addictions and overdose injuries and deaths. One of the most commonly abused prescription opioids at the time, the pills were usually dissolved and injected by addicts, many of whom preferred it to heroin.
By 1979, swayed by the wave of oxymorphone addictions and deaths across the country attributable to Numorphan, the FDA and the drug’s maker, Endo Pharmaceuticals, removed Numorphan tablets from the market. The injection and suppository forms of Numorphan were allowed to stay on the market and are still in use today.
So after a deadly 20-year run – it had been approved in 1959 – the pill form of Numorphan disappeared from pharmacy shelves in drug stores and hospitals across the country. Neither the FDA nor the drug maker admitted any connection to the 20-years-long Numorphan epidemic for its removal.
But then, in 2006, for some utterly inexplicable reason (well, on the surface at least) the FDA approved Endo Pharmaceutical’s application to approve the same drug all over again, but under a new trade name – Opana.
The FDA approved both Opana immediate-release and Opana ER for extended release. And then in 2011 the agency approved an “abuse-deterrent” version which, as with similar pills like abuse deterrent OxyContin, abusers are easily defeating the anti-injection properties of and are shooting up Opana like there’s no tomorrow.
The effects of Opana abuse are closer to those of morphine than of other widely abused opioids like OxyContin (extended release oxycodone). According to NYPress.com, OxyContin has “a more stimulating effect” than Opana, which can cause users to fall asleep. Like morphine, Opana’s greatest danger to abusers is the possibility of respiratory depression, the major cause of overdose death.
In addition to the ever-present risk of overdose, sharing needles among a large group of Opana abusers has been found responsible for a massive outbreak of HIV and hepatitis C infections in rural Austin, Indiana, and several Appalachian states.
The new Opana, according to a report in MedPage Today, is also associated with a blood-clotting disorder and permanent organ damage, problems that didn’t occur with injection abuse of earlier version of the drug, Numorphan, or injection of generic oxymorphone.
In addition to the tragedies associated with addiction and spread of disease, there’s another disturbing aspect of this whole Opana thing. When the FDA approved Opana, there already were dozens of other narcotic painkillers on the market. And plenty of them were already complicit in tons of cases of crime, abuse, overdose and deaths.
Why in the world would there need to be yet another opioid painkiller on the market, and one with a proven track record of destruction?
“There certainly didn’t seem to be a need for it,” said James Roberts, MD, a professor of emergency medicine at Drexel University College of Medicine in Philadelphia. As quoted in MedPage Today, Roberts added that “there are plenty of narcotics around for pain relief.”
As we’ve reported in earlier blogs and articles, the Milwaukee Journal Sentinel and MedPage Today collaborated on an investigation of oxymorphone’s “re-appearance” on the market. The investigative reporters observed a pattern of drug approvals over a decade or more, including “cozy relationships between regulators and drug company executives and the use of questionable clinical testing methods allowed by the FDA.”
Throughout the 2000s, records show, there were regular meetings of drug company execs, federal regulators and various academics involved in drug development, under the auspices of an organization funded by pain drug companies. These meetings were the subject of a 2013 Journal Sentinel/MedPage Today investigation. And Opana’s Endo Pharmaceuticals was a frequent attendee.
“The nation’s leading pharmaceutical companies paid entry fees running into the tens of thousands of dollars to attend invitation only conferences with FDA and NIH officials,” the reporters wrote. “Entry to these meetings was secured by annual fees from $20,000 to as high as $35,000. The drug companies that paid those fees were guaranteed the right to send a representative to the annual meetings.” And many of the academics invited to these closed-door meetings were offered payments of about $3,000 to attend.
The ostensible purpose of the meetings has been to come up with ways to fast-track drug trials – cutting back on almost every aspect of testing, even removing test subjects who suffer from side effects from the statistical outcomes.
Another thing: When Endo tried to get Opana approved in 2003, reports MedPage Today, the FDA said the drug didn’t appear effective enough in clinical trials. And there were safety concerns after several pain patients overdosed on the drug and had to be revived with emergency doses of naloxone.
Endo promptly removed anyone from the study who didn’t respond well to the drug, and the FDA approved it.
These approaches “essentially stack the deck in favor of the drug,” says MedPage Today. “More importantly, experts say, drugs tested that way are not likely to reflect what will happen when a drug gets on the market and is prescribed for large numbers of people.”
“It’s in fact cheating,” said Patrick McGrath, PhD, a pediatric pain expert at the Dalhousie University in Halifax, Nova Scotia.
The whole affair reeks of something resembling “pay to play” – not how the FDA is authorized to protect the American public from harm. For its part, the FDA denies any pay-to-play funny business.
But there’s no explanation to justify the approval of yet another dangerously addictive opioid painkiller into a world already awash in painkillers, a world already crushed by a prescription painkiller addiction epidemic.
Meanwhile, doctors are writing close to 800,000 Opana prescriptions a year. And Endo Pharmaceuticals is grossing an average $450 million a year.
And thousands of opioid addicts are finding plenty of Opana to go around, too.
If you or someone you care about is in trouble with drugs or alcohol, call Novus and get the help you need.
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