The Food and Drug Administration will ask pharmaceutical companies to investigate whether prescription opioids are effective in combating chronic pain – a new step in the government's efforts to limit the use of narcotic drugs that cause the epidemic. drug.
Some studies already indicate that opioids are ineffective at relieving pain beyond 12 weeks and many experts claim that long-term use can result in dependence, prompting patients to develop tolerance to drugs and to look for higher doses. But conclusive and controlled research is rare.
The discovery of inefficiency in more rigorous studies supervised by the FDA could allow the agency to change the labeling of some opioids, to impose special rules for the prescription, dispensing and taking these opioids, or even banning their use in some cases, according to FDA Commissioner Scott Gottlieb.
"We will impose a mandate on existing products. . . to answer the question people have been asking for years: is your effectiveness decreasing and can this loss of efficiency lead to addiction, "Gottlieb said in an interview.
But at least one long-time critic of the FDA's response to the opioid crisis has expressed frustration with this initiative. Andrew Kolodny, director of prescribing doctors for responsible opioids, said the FDA already had all the necessary research – and authority under current legislation – to tighten restrictions on the drug. use of opioids for the treatment of chronic pain by modifying instructions on how to prescribe them.
"Here we are," Kolodny said in an interview. "This is exactly what the FDA told us in 2013 … . Five years later, we do not have studies, and another FDA commissioner said, "We are going to study."
Gottlieb said the new research targeted all immediate-acting, long-acting, and sustained-release opioid tablets taken by patients outside health care facilities. This would cover products already on the market and new applications, said Gottlieb. Analgesics used in the short term in hospitals, for example. Opioid analgesics were originally designed to relieve acute pain associated with cancer and end-of-life care, but by the end of the 1990s, drug companies were able to convince doctors to offer them for a wide variety of diseases. less serious.
Each manufacturer would be required to sponsor unbiased and controlled research of its opioid products, probably in universities, he said.
The FDA is also asking for a second study, said Gottlieb, to determine if opioids can Actually make users more sensitive to pain, a condition called hyperalgesia. The work of a consortium of companies is well underway and work is expected to begin shortly, he said.
In 2013, after Kolodny's group complained that opioids should be considered dangerous and ineffective for the treatment of chronic pain, the FDA commissioned similar research, particularly to try to determine if the painkillers were causing pain. hyperalgesia. Gottlieb said these studies were difficult to perform because, at the time, the FDA had authority only to require post-marketing studies on safety rather than effectiveness.
On Sunday, CBS's "60 Minutes" program explored the FDA's 2001 decision to allow long-term use of OxyContin despite lack of research demonstrating that it was safe and effective. Gottlieb conceded that it was "unfortunate that we did not do this many years ago".
The vast majority of opioid prescriptions written in 2017 involved generic versions of drugs. Research would only be required for companies that produce brand-name narcotics; generic producers would be required to adopt the same changes.
The FDA has acquired the power to require effectiveness research in an article of the Patient and Community Assistance Act, passed in October. Previously, Gottlieb said, the FDA could only order drug safety studies on the market, but the new power also allows for efficacy studies.
He added that pharmaceutical companies would soon be informed of the new requirement. A spokesman for Purdue Pharma, the company that pleaded guilty in 2007 to misleading opioids, declined to comment. A spokeswoman for the industry lobby, Pharmaceutical Research and Manufacturers of America, did not return an email requesting a comment.
Gottlieb had previously said the FDA should play a more active role in the fight against the opioid crisis, which claimed the lives of 47,600 people overdoses in 2017. In November, when the FDA approved a new powerful opioid, Dsuvia had been the subject of criticism. ability to take into account the benefits and adverse effects of an opioid on public health, its risk of being diverted to abusers, and to determine whether it has unique benefits before deciding to future applications.
After peaking in 2012 at more than 255 million, the number of opioid prescriptions written each year has fallen sharply to reach 191.2 million in 2017, according to the Centers for Control and Disease Control. disease prevention, and the number of overdose deaths of prescription narcotics has also stabilized. Nevertheless, the number of overdose deaths from opioids is six times higher than in 1999, with more users succumbing to heroin and, in recent years, to illicit fentanyl.