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Tuesday, March 15, 2016

The First National Standard for Prescription Painkillers -- Finally!



 
Ninety-five percent of the world's opioids are consumed in the United States. Enough hydrocodone — the opioid in Vicodin, Norco, Lortab and other drugs —was prescribed in 2010 to medicate every person in the nation around the clock for a month.

I remember writing a blog entry in early 2013 encouraging people to sign a petition I drafted to the Food and Drug Administration urging mandatory training for doctors who prescribed opioids. An FDA advisory committee (including the drug czar) had recommended mandatory training; however, the FDA saying mandatory training would be “potentially burdensome,” expressed concern that not enough doctors would volunteer their time. And, the FDA overruled the advisory board.

My blog entry for petition: http://allthingswildlyconsidered.blogspot.com/2013/02/fda-and-big-pharma-in-bed-sign-petition.html .

Instead of requiring mandatory training, the FDA decided that voluntary training for opioids with a goal of having 60 percent of the nation’s doctors who prescribe opioids take the courses within three years, was satisfactory to the public and sufficiently “unburdensome” to the medical community.

Not only did the FDA refuse to require doctors to take mandatory training on opioids, but also they relied upon industry-sponsored medical education for administering the voluntary training. You see, the very pharmaceutical companies that manufacture opioids are in charge of funding and administering the FDA’s Risk Evaluation and Mitigation Strategies programs.
 
Please understand that the FDA does no testing on new pharmaceutical products itself, but relies on the reports produced from the testing carried out by drug manufacturers. In too many cases the drug manufacturers ignore or downplay possible side effects in these reports in order to get permission to put their drug on the market.

As they continue to push for higher profits and higher distribution, pharmaceutical companies actually use REMS for a marketing tool to convince consumers of their utmost concern for public safety. Meanwhile, their lobby groups boast of their ability to “craft” legislation with the FDA. Along with the financial lobbies, the pharmaceutical and health products industries have historically been some of the biggest and most powerful lobbies in Washington. Drug companies enjoy more power and influence in America than with any other government in the world.

Jim Ryser, singer-songwriter who has played with John Mellencamp and Hall and Oates among others, offers an interesting perspective: Ryser says, “The ‘war’ (against drug abuse) should be on the pharmaceutical industry, misinformation about addiction and pain, and those who misuse science to exploit illness to make money. It's rampant.”

Jim Ryser was born with spina bifida, and he has undergone 55 surgeries. To cope, he turned to painkillers. He received opioid treatment for 18 years, resulting in addiction for, in his own opinion, 17 of them. He signed a $7 million record deal in 1988 with legend Clive Davis, Arista Records' president. Ryser graduated in the top 10 of 3,000 Indiana University College of Arts and Sciences graduates, even with an IV Demerol habit.

Today, Ryser has been 15 years sober from all mood-altering drugs, including alcohol. He is presently the manager of the Pain Services and Chemical Dependency at IU Health Methodist Hospital. Yet, he still has chronic pain. Now, he talks about redirecting his focus to reduce this pain. He credits taking up hunting for much of his improvement.

Listen to Ryser tell it like it is. He says ...

Clinicians are paid in part if their scores are favorable for the way pain is managed. The easiest way to manage pain by today's standards is to add more opioids. As a patient, I am "rounded on" and asked about my pain, which is also considered as "the fifth vital sign." I fill out a survey that asks about my pain treatment, and the clinician may not be paid a portion if I answer in the negative.

That sets the clinician up to make sure my pain is managed, usually with more opioids. Pain, by the way, is not a vital sign. It cannot be measured. I will go to my grave trying to change that, because it sets both patient and clinician up to fail. Function, on the other hand, can be measured. That can be a commonality in the goal of reducing overmedication with opioids and getting a person back home and off opioids as soon as possible.”
 
(Jim Ryser. “Addicts are set up to die by today's medical standards.”
Indy Star. February 22, 2014.)

Today, March 15, 2016, the federal government published the first national standard for prescription painkillers in an attempt to combat the country’s prescription drug abuse crisis. The Centers for Disease Control and Prevention released the nonbinding rules to address use of medications known as opioids. 

The guidelines, which align with previous recommendations from addiction experts, suggest that primary care doctors first use ibuprofen and aspirin to treat pain. They also recommend that opioid treatment for short-term pain should last three days and not longer than seven days, less than current common prescriptions lasting two weeks to a month, the New York Times reported.
 
“It’s become increasingly clear that opioids carry substantial risk but only uncertain benefits — especially compared with other treatments for chronic pain,” said Thomas Frieden, CDC director.
 
(Katie Reilly. CDC Releases National Standards for Prescription Painkillers.”
Time. March 15, 2016.)
  
Amen and Hallelujah! May this step, although just a first, tiny movement, lead to more action that changes the way the FDA, the Pharmaceutical industry, lobbyists, and uninformed or criminal doctors conduct themselves.

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