In a move that may have more to do with politics than healthcare, the U.S. Food and Drug Administration has set aside the advice of its own experts by endorsing the CDC’s controversial guidelines for opioid prescribing
The move is part of several sweeping changes the FDA is making in its opioid policies, including some that the agency has resisted in the past.
The most significant change is support for the CDC’s proposed opioid guidelines, which are designed to combat the so-called epidemic of opioid addiction and overdoses.
“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco.
This sounds silly, considering how little science has been involved comment by Zyp Czyk
In a news release issued late Thursday, Califf said FDA would
“re-examine the risk-benefit paradigm for opioids,”
Who’s risk-benefits? Mr. Califfs? Mine? That ratio is highly dependent on the individual, yet they intend to make all opioid therapy standard, even though they claim to want individualized medicine. What hypocrites!
use tougher language in warning labels on extended release opioids, and
I can’t imagine abusers and addicts reading the label, much less caring what it says.
prioritize development of non-opioid alternatives for pain.
However, until that happens we will still need opioids for pain.
The FDA also promised to convene an expert advisory committee before approving any new drug applications for opioids that do not have abuse deterrent properties, one of Manchin’s key demands.
This statement is heavily focused on the potential harms of opioids.
Though it says they will seek to balance individual and societal risks, it seems that the need to prevent people from making poor choices will be given priority over providing care to individual pain sufferers for whom opioid therapy has proven to be an essential element of care
The FDA’s opioid policy changes are further outlined in a “special report” in the New England Journal of Medicine that was co-authored by Califf.
“Accordingly, we are supporting the CDC’s Guideline for Prescribing Opioids for Chronic Pain. The draft guideline received extensive public comment, and we look forward to participating in the process when the CDC finalizes it soon.
We are also supporting the Surgeon General’s efforts to engage the clinical community in a concerted approach to curbing inappropriate prescribing and proactively treating opioid addiction, while reinforcing evidence-based approaches to treating pain in a manner that spares the use of opioids.
Until clinicians stop prescribing opioids far in excess of clinical need, this crisis will continue unabated.”
Who’s clinical need? It doesn’t make sense to force a subjective factor into some arbitrary standard.
“I think we need to recognize that CDC wants to substantially limit opioid prescribing. Period,” said Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products, at a December meeting of a federal pain research panel.
Hertz said the evidence cited to support the guidelines was “low to very low and that’s a problem.” Other panel members said they were “appalled” by the guidelines, calling them an “embarrassment to the government.”
“I guess it shouldn’t surprise me that the FDA is selling out by endorsing the CDC guidelines,” said Kim Miller, a pain sufferer and patient activist.
“Could it be the FDA was not wanting to be made to look irrelevant in light of the CDC taking care of what many see as the FDA’s territory? Either way, it’s an extremely gloomy looking horizon if you’re a pain patient. Just when you think it can’t get any worse, it always does.”
“It is a sad day for chronic pain patients in this country. The unintended consequences of these guidelines will bring about a true epidemic; not the media manufactured so-called epidemic of overdoses from opioids,” said Chrystal Weaver, a Florida woman who suffers from Complex Regional Pain Syndrome.
“The last figure I heard quoted for veterans taking their life is around 42 per day. When you take away the only tool we have to help lessen the pain from war injuries you’ll see that number skyrocket