FDA Called Lax in Curbing Use of Powerful Class of Opioids

FDA Called Lax in Curbing Use of Powerful Class of Opioids


The drugs were approved for cancer patients, but have been prescribed to patients with migraine and back pain, a New York Times investigation reveals.

A class of drugs for cancer patients experiencing “breakthrough pain,” (sudden and sharp onrushes of pain despite the use of standard round-the-clock pain medications), have been prescribed to patients with back pain and migraine, putting them at high risk for addiction, a New York Times investigation says.  

The drugs contain fentanyl, a narcotic up to 50 times stronger than heroin and 100 times stronger than morphine and include Actiq and Fentora, made by Cephalon, and Subsys, made by Insys Therapeutics. The drugs are called T.I.R.F.s (for transmucosal immediate-release fentanyl).

But in what’s being described as a fox guarding the hen house blunder, the FDA in 2011 charged a consortium of drug companies making the products with regulating their use. TheTimes looked at approximately 5,000 pages of documents that researchers at Johns Hopkins University obtained through the Freedom of Information Act. They showed widespread off-label prescribing of the drugs that the FDA did not intervene to prevent. 

Andrew Kolodny, MD, an opioid policy researcher at Brandeis University, told the newspaper that “if any opioids were going to be tightly regulated, it would be these. They had the fox guarding the hen house, people were getting hurt—and the FDA sat by and watched this happen.”

Janet Woodcock, MD, the director of the Center for Drug Evaluation and Research at the FDA, told the newspaper that “the information we have isn’t very good, but it seems to indicate people who aren’t cancer patients are getting this and people who aren’t opioid tolerant are getting this.”

About 115 people in the United States die every day from overdosing on opioids, according to the National Institute on Drug Abuse.

In December 2011, the FDA created a safety program overseeing the use of T.I.R.F.s. “The program required doctors to undergo training for prescribing T.I.R.F.s and to sign a form saying they understood that prescribing to other patients can be dangerous,” the Times reports. “To administer the program, the consortium hired McKesson, a large national distributor that supplies drugs, including T.I.R.F.s, to pharmaceutical retailers.”

McKeeson released a statement in the wake of the investigation saying that it was just doing its job as a third-party administrator and that it was following requirements “developed jointly by the manufacturers and the FDA with ultimate approval resting with the FDA. McKesson administers the program according to these FDA requirements.”

A majority of prescription meds are prescribed “off-label”… because in order the the pharma to get a specific indication for a particular medication they would have to complete clinical trial for the specific disease.  Once the FDA approves a medication to be prescribed, it is considered “safe” for humans and doctors are allowed to prescribe the med for anything they believe will help resolve the health issues for their pts.

Neurontin/Gabapentin was originally approved to treat seizures, but today it is routinely used for neuropathy.

Just how does a pt become opiate tolerant if they are never prescribed a opiate… cancer pts do not become “opiate tolerant” just because they are diagnosed with cancer ?

4 Responses

  1. Agree that somebody needs to do something about Klonody.

  2. How can you have a “opiate epidemic” if no one dies? Do we really think a mistake was made. Those of us who are opioid tolerant has to jump through hoops just to have our meds reduced. I have no argument with Cancer pts. But, one of the differences between us and them, they are fighting a terrible disease. We are fighting the “politics of Pain.” When they lose their pain Thankfully is over. When we lose we have to just live with it. To be clear No disrespect to those who are fighting Cancer, we all have lost loved ones, those who have survived have scars. For us we may have decades to walk this earth, undermedicated.

  3. Why do agencies and organizations keep distinguishing between cancer and non-cancer pain??!? PAIN IS PAIN regardless of the cause. WHY IS ONE PAIN TREATED AND ANOTHER IGNORED??!? I can guarantee that I would be more then willing to get cancer and die rather then be forced into taking my life to stop the pain.

    Now, I have heard that chronic pain from cancer treatment may end up in the same boat as chronic pain. People considering treatment for cancer should add this into the decision to fight cancer or not to fight. If a cancer patient has to live in the same pain of those with 3rd stage adhesive arachnoiditis, they will regret fighting cancer to now be left to suffer in incurable severe pain.

  4. Kolonody who has zero education in pain management is sharing his vast scope of ignorance again. Fentnyl is NOT an opiod. The DEA announced the deaths from fentnyl were from illegally manufactured street narcotics where fentnyl a non opiod narcotic is hidden inside pills made to look like opiods which are sold through drug cartels on the street by drug dealers. They market these non opiod fentnyl as a cheap high to people who have severe drug addiction or who are experimenting as young people at parties with drugs. THAT is who is dying of drug overdose. THAT what is killing them. Insurance executive Kolonody needs to get out of the business of destroying the lives of pain patients and focus on his only area of expertise- running multi billion dollar insurance company that gets doctors out of malpractice claims and running addiction centers. Shame on that man who is causing widespread misinformation

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