person:andrew kolodny

FDA takes fresh look at whether opioids are effective for chronic pain - The Washington Post
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The Food and Drug Administration will require drug companies to study whether prescription opioids are effective in quelling chronic pain — another step in the government’s efforts to rein in use of the narcotics that spawned the drug epidemic.

Some studies already indicate that opioids are ineffective for pain beyond 12 weeks and many experts say long-term use can cause addiction, by prompting patients to build up tolerance to the drugs and seek higher doses. But conclusive, controlled research is scarce.

A finding of ineffectiveness in more rigorous studies supervised by the FDA could allow the agency to change the labeling on some opioids, impose special rules for prescribing, dispensing and taking them, and even prohibit their use in some cases, according to FDA Commissioner Scott Gottlieb.

But at least one longtime critic of the FDA’s response to the opioid crisis expressed frustration with the move. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, said the FDA already has all the research it needs — and authority under existing law — to tighten restrictions on the use of opioids for chronic pain by changing instructions for how they should be prescribed.

“Here we go again,” Kolodny said in an interview. “That’s exactly what the FDA said to us in 2013. . . . Five years later, we don’t have the studies and another FDA commissioner says, ‘We’re going to do the studies.’ ”

In 2013, after Kolodny’s group complained that opioids should be labeled unsafe and ineffective for chronic pain, the FDA ordered similar research, including an attempt to determine whether painkillers cause hyperalgesia. Gottlieb said those studies were difficult to carry out because, at the time, the FDA had authority only to require post-market studies of safety, rather than effectiveness.

On Sunday, the CBS program “60 Minutes” explored the FDA’s decision in 2001 to allow long-term use of OxyContin despite the lack of research showing it was safe and effective. Gottlieb conceded that “it’s regrettable we didn’t do this many years ago.”

The vast majority of opioid prescriptions written in 2017 were for generic versions of the drugs. The research would be required only of companies that produce brand-name narcotics; generic producers would be required to adopt the same changes.

#Opioides #USA #FDA #Efficacité

Opioid billionaire granted patent for addiction treatment | Financial Times
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Purdue owner Richard Sackler listed as inventor of drug to wean addicts off painkillers
Richard Sackler’s family owns Purdue Pharma, the company behind the opioid painkiller OxyContin © Reuters

David Crow in New York

A billionaire pharmaceuticals executive who has been blamed for spurring the US opioid crisis stands to profit from the epidemic after he patented a new treatment for drug addicts.

Richard Sackler, whose family owns Purdue Pharma, the company behind the notorious painkiller OxyContin, was granted a patent earlier this year for a reformulation of a drug used to wean addicts off opioids.

The invention is a novel form of buprenorphine, a mild opiate that controls drug cravings, which is often given as a substitute to people hooked on heroin or opioid painkillers such as OxyContin.

The new formulation as described in Dr Sackler’s patent could end up proving lucrative thanks to a steady increase in the number of addicts being treated with buprenorphine, which is seen as a better alternative to other opioid substitutes such as methadone.

Last year, the leading version of buprenorphine, which is sold under the brand name Suboxone, generated $877m in US sales for Indivior, the British pharmaceuticals group that makes it.

Before the opioid crisis, the Sackler family was primarily known for its philanthropy, emerging as one of the largest donors to arts institutions in the US and UK. But the rising number of addictions and deaths has highlighted the family’s ownership of Purdue, which some members have tried to shy away from.

It’s reprehensible what Purdue Pharma has done to our public health
Luke Nasta, director of Camelot

Dr Sackler’s patent, which was granted by the US Patent and Trademark Office in January, acknowledges the threat posed by the opioid crisis, which claimed more than 42,000 lives in 2016.

“While opioids have always been known to be useful in pain treatment, they also display an addictive potential,” the patent states. “Thus, if opioids are taken by healthy human subjects with a drug-seeking behaviour they may lead to psychological as well as physical dependence.”

It adds: “The constant pressures upon addicts to procure money for buying drugs and the concomitant criminal activities have been increasingly recognised as a major factor that counteracts efficient and long-lasting withdrawal and abstinence from drugs.”

However, the patent makes no mention of the fact that Purdue Pharma has been hit with more than a thousand lawsuits for allegedly fuelling the epidemic — allegations the company and the Sackler family deny.

“It’s reprehensible what Purdue Pharma has done to our public health,” said Luke Nasta, director of Camelot, an addiction treatment centre in Staten Island, New York. He said the Sackler family “shouldn’t be allowed to peddle any more synthetic opiates — and that includes opioid substitutes”.

Buprenorphine is prescribed to opioid addicts in tablets or thin film strips that dissolve under the tongue in less than seven minutes. These “sublingual” formulations are used to stop drug abusers from hoarding a stockpile of pills they can sell or use to get high at a later date.

The patent describes a new, improved form of buprenorphine that would come in a wafer that disintegrated more quickly than existing versions — perhaps in just a few seconds.

The original application was made by Purdue Pharma and Dr Sackler is listed as one of the inventors alongside five others, some of whom work or have worked for the Sackler’s group of drug companies.

“Drug addicts sometimes still try to divert these sublingual buprenorphine tablets by removing them from the mouth,” the patent application stated. “There remains a need for other . . . abuse-resistant dosage forms.”
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In June, the Massachusetts attorney-general filed a lawsuit against Dr Sackler and seven other members of the Sackler family, which accused them of engaging in a “deadly, deceptive scheme to sell opioids”.

Purdue and the family deny the allegations and Purdue said it intends to file a motion to dismiss. The company points out that OxyContin was, and still is, approved by the US Food and Drug Administration.

“We believe it is inappropriate for [Massachusetts] to substitute its judgment for the judgment of the regulatory, scientific and medical experts at FDA,” it said in a recent statement to the Financial Times.

Andrew Kolodny, a professor from Brandeis University who has been a vocal advocate for greater use of buprenorphine to battle the opioid crisis, said the idea Dr Sackler “could get richer” from the patent was “very disturbing”. He added: “Perhaps the profits off this patent should be used to pay any judgment or settlement down the line.”

Earlier this week, Purdue donated $3.4m to boost access to naloxone, an antidote given to people who have just overdosed on opioids.

#Opioides #Cynisme #Capitalisme_sauvage #Brevets #Sackler