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Canadian Doctors Urge Caution After FDA Approves Controversial New Opioid Pill

Analysis by Dr. Joseph Mercola

There’s a new pain pill about to enter the U.S. market, and Canadian doctors are criticizing the U.S. Food and Drug Administration (FDA) for approving it. The drug, Dsuvia, dissolves under your tongue and is five to 10 times more powerful than fentanyl, a pain medication that, along with regular opioids like Oxycontin, has been the source of tens of thousands of deaths in the U.S.

Yahoo! said FDA commissioner Dr. Scott Gottlieb told CBS News the FDA’s decision was influenced by the U.S. Department of Defense, which wants the drug available for battlefield scenarios. Gottlieb said the drug will have “tight restrictions” and will only be available in hospital situations.

Here we go again. It hasn’t even been a year since we talked about the leap in opioid deaths that occurred when synthetic forms of fentanyl started making an appearance in the drug black markets. Fentanyl, too, was supposed to be strictly regulated, hard to get and only available in critical care situations.

But it didn’t stay that way. And, in case the FDA needs reminding, fentanyl — which is nearly 1,000 percent more powerful than morphine — caused a 50 percent rise in deadly overdoses in just one year, from 2013 to 2014. From there, the following year, deaths rose by an astounding 72 percent!

Yet, despite FDA “strict” regulations, as they did with Oxycontin, in no time at all illicit dealers figured out a way to both manufacture these drugs and distribute them. You can only ask: What is the FDA thinking? If nothing else, if the defense department needs a drug for battlefields, why not limit its distribution to the department for battlefields only, with distribution to other hospital settings given on a one-by-one, request basis?

We don’t need reminding that the opioid epidemic is a war on its own, and the deaths left on that battlefield are mounting by the day. Canada is right to question and severely criticize the FDA for putting its head in the sand and approving this drug, especially when we have solid evidence that the FDA has no control over what happens once a drug is approved.

It’s also intriguing that Canada should be the country to bring this up, seeing that our neighbor to the north just legalized for public use a very safe pain medication that doesn’t kill people, in the form of marijuana. (Should I mention that the recent elections in the U.S. also legalized marijuana in at least two states?)

Canada does another thing that the FDA should take notice of, and that is in the form of “transitional” pain services, which offer Canadians taking opioids follow-up care to help them wean off the drugs. These services use a variety of methods, including nonopioid medications, exercise, acupuncture and mindfulness training, which has been shown to help patients with pain-related stress and disability, allowing them to wean off opioids successfully.

In the U.S., Stanford University offers a similar program, but it leaves long-term opioid users in a pinch. The bottom line is, while there is a need and a use for critical care patient use of strong pain drugs (such as in battlefields or if you have cancer, to name two clear instances), there is also a need to address chronic pain on a wide, sweeping basis — and that isn’t something the FDA seems intent on doing, unless of course it involves pumping up the pocketbooks of drug companies. And that is something the FDA seems to do quite well.

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