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States revolt against powerful new painkiller

States-Painkillers

BARRE, Vt. (AP) -- State officials fighting a well-publicized battle against heroin and prescription drug abuse are revolting against a powerful new painkiller that law enforcement and public health officials fear could worsen an already acute drug problem.

On Thursday, Vermont Gov. Peter Shumlin announced an emergency order that would make it harder for physicians to prescribe a new class of drugs that includes Zohydro. Many feel the extended-release pill is prone to abuse, because it's not tamper resistant and contains up to five times more of the narcotic hydrocodone than previously available in other pills.

The Food and Drug Administration approved the drug last fall and it hit the market last month.

Shumlin didn't go as far as Massachusetts Gov. Deval Patrick, who last week ordered an outright ban on prescribing and dispensing Zohydro until it is marketed in a form that is difficult to abuse. But Shumlin and Vermont Health Commissioner Dr. Harry Chen both questioned the FDA approval.

"It's not like we don't have painkillers in America," Shumlin said. "So you know, we're just saying `Hey, we understand we don't control the FDA, but we do have some influence in Vermont,'" he said.

Prescription drug abuse is the nation's fastest growing drug problem with more than 4.5 million Americans abusing pain relievers, according to a 2013 Drug Enforcement Administration report.

Law enforcement and public health officials say for many people, prescription painkiller abuse can pave the way to heroin addiction. In January, Shumlin devoted the bulk of his State of the State address to Vermont's "full blown heroin crisis."

The backlash against Zohydro has been growing since last year, when the FDA approved the drug against the recommendation of an internal advisory committee.

Late last year, 28 state attorneys general signed a letter asking the FDA to revoke the drug's approval or require the manufacturer to reformulate the drug so it is more difficult for abusers to crush for snorting or injection.

U.S. Sen. Joe Manchin, D-W.Va., and Rep. Stephen Lynch, D-Mass., introduced legislation that would compel the FDA to withdraw the drug.

Zohydro belongs to a family of medicines known as opiates or opioids. Others include morphine, heroin and oxycodone, the painkiller in OxyContin.

Its painkilling power comes from hydrocodone. Other medications, such as Vicodin, contain the same narcotic but also include acetaminophen, the active ingredient in Tylenol.

San Diego-based Zogenix, which makes Zohydro, said the drug is no more potent, per milligram, than other hydrocodone medications. The company also said it set up a board of experts to guard against abuse and that its sales representatives are not being paid based on the volume, but rather on their efforts to ensure prescribers, pharmacists and patients understand the medication's risks and benefits.

The FDA said Zohydro meets its standards and provides an important treatment option for patients with chronic pain. The agency, which in 2010 approved a crush-resistant version of OxyContin to try to discourage abuse, also points out that abuse-deterrent formulations of Zohydro are in the early stages of development.

Shumlin said he chose strict regulation over an outright ban, at least in part to avoid what could be expensive litigation.

"I expect that Massachusetts is likely to confront that and we really wanted to get something done quickly," Shumlin said.

Vermont's emergency rule to prescribe Zohydro includes requirements that prescribers conduct a thorough medical evaluation and risk assessment.

---

Associated Press reporter Wilson Ring in Montpelier, Vt., contributed to this report.

© 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. Learn more about our Privacy Policy and Terms of Use.

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Jack April 05 2014 at 2:13 AM

I,too, suffer from chronic back & knee pain, aside from all the little things that I don't even
mention.

Last Nov. I had my right knee replaced. I'm still suffering significant pain to the point where I cannot walk normally or go up & down stairs normally. If I sit for more than 20 minutes or so I cannot get up and walk at all because of the pain, which lessens after I limp & hop around for a few minutes but still hurts pretty bad.

EXAMPLE: Back in the 80's I used to ride my 12-speed 35 - 50 miles a day. Today I can't even turn the pedals one turn on the physical therapy bike because I can't bend the knee without excruciating pain.

WORK?? Forget about that! I demoed my abilities to my boss and he agrees with me: there's no way I can do my job, which requires me to be on my feet & running around from 5:30 AM to 7PM daily. Lucky for me he's a good sport and a good man. He told me to just let him know when I was ready and my job would be waiting for me! God bless him! Right now it REALLY sucks to be me but it would be worse if I lost my job over this!!

Here's the thing: my doc won't authorize any more pain meds after 3 months because he says we have too many drug addicts out there. Well, I'm not a drug addict, either physically or mentally. I don't suffer from any kind of withdrawl symptoms. I have no interest in getting 'high' or staying 'high.' But no matter what I say he refuses me.

I would just like to manage my pain . . . especially when I goto physical therapy! They push, pull, yank & crank my right leg / knee trying to get it to loosen up & be pain free. You should see me as I writhe in pain on the table as they work on me. It's embarrassing because I can't stop myself from grunting & groaning.

So . . . I realize I'm just venting and nothing will come of it.

I just wanted to let the world know that there are indeed certain chronic pain situations that should be evaluated on their own merit.

My impression from my doc is he's taken a certain position and won't deviate from it, come hell, high water, or me yelping out in pain as I'm being tortured at P.T.

Sucks to be me.

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7 replies
max April 04 2014 at 10:51 PM

well now the people who bad mouth the ones with chornic pain should walk in our shoes for a while, I worked for a coal company for 39 years and I have 6 disks herniated two bad knees and can not walk without severe pain. I am lucky that I can sleep about two hours at a time. if it was not for the pain medicine that a pain clinic gives me for the pain . life would not even be worth living. surgry is out of the question due to heart problems. also I have ra and can not take medicine for that they said you will have to put up with It.
so you people who down us do us a favor, shut up and walk a while in our shoes,if you can. you take walking for granted try and struggle even to get to the bath room , put on your cloths with out tears in your eyes, watch your grandchildren play and all you can do is watch. try it then you will shut up about the ones with the pain that we have and there is nothing surgical that can be done, try it you will not like it one bit

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1 reply
wildfurry max April 05 2014 at 1:24 AM

Isn't it such a terrible injustice, Max, how people judge you because you have to subject your very painful life to any easement of pain medications? Why or how in the world these people who seem to know about our own bodies (gee, guess they have Superman's X-ray vision) have the audacity to spank our butts because of traumatic bodily injuries and taking a doctor's suggested advisement of the right pain killing dosage has made me seriously question their ignorance, hypocrisy and shameful behavior. Yes, please, all of you who feel you have the right to tell us what to do, just stfu and leave people in real pain alone.

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Charlee April 05 2014 at 3:31 PM

I wish some of these sanctimonius politicians had to live with chronic pain. Do their laws keep the drugs out of the abusers hands? No, they will find it one way or the other. All this does is ensure that lawabiding citizens can continue to suffer.

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dave.crosby April 04 2014 at 10:31 PM

I am a diabled USA Army veteran , I can not believe that they will not allow some thing that could alive me or others from sever pain with this kind of medicine . I have been told I will be stuck using
a pain reliever that does not do the job and leave me in this pain . I am without sleep because of this pain and have trouble doing anything because of this pain . Some one please help !

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tomcimmaron April 04 2014 at 10:21 PM

1 have bad pain with back from hard work over the years and I am 74 now and my back hurts all the time and without my pains pills or I can hardly stand it. You hurt long enough and see what you will do to stop the pain. I have to take urine test I go to the doctor. 1 am afraid if you really hurt you think twice about being against the people who need it. 1 am able to li ve a normal life with my pain medicne.

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1 reply
b19821 tomcimmaron April 04 2014 at 10:30 PM

Oh, I have been there. I don't take the stuff. Having my second knee replaced this month.

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1 reply
compsultinc b19821 April 04 2014 at 11:33 PM

Well, there is NO cure for me or surgery to do. Good lick with yours and I wish you true relief and better quality of life. I truly would want to be in your shoes than mine. Mine is last stage, terminal and NO 'happy ending'.

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stick4013 April 04 2014 at 10:07 PM

I wont bore you with details but I have chronic pain now and I will for the rest of my life. I am sick and tired of "paying the price" for abusers. This is 2014. There is no reason to endure severe pain.... I dont want to get high. I just want some relief..... These people should spend a day or two in my shoes

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1 reply
trickeru stick4013 April 04 2014 at 10:40 PM

You got that right am in pain every day and no relief . it sucks been in pain all time .Like ,I tell them I wish you could be in my shoes one day and see how ,I feel. Doctor think I'm abuser drugs ..I just hate the pills and the pain.

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1 reply
compsultinc trickeru April 04 2014 at 11:34 PM

I understand!

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Vanbooks April 04 2014 at 9:39 PM

What the hell is wrong with trying to relieve chronic pain? Over the counter drugs can be abused as well. They also do not work for me. Just like gun control if the bad guys want it, they will get it and the people like me either experience pain, get the lowest level pain medication a doctor can prescribe or reach out for illegal drugs. I flat out told my doctor either give me what I need or I will get it off the streets. I am supposed to take 6 hydroncodone a day but I take 1 or 2 and usually at bedtime. I get 200 valium a month and each time I try to wean off the drug I have problems. What this means is that I need the medication. I am supposed to take 6-8 a day but now I have learned to take 1-2 if I feel like a panic attack is coming on and within 10 minutes I am fine. The great physician GOD, does not want his creation to be walking around half crazed but it must be pretty important to let us know over and over again, there will be NO pain in Heaven. The problem we have after becoming a licensed Insurance agent is the liability risks doctors face now and all the publicity whis is 90% scare tactics. If I drink cleaning solutions I can die or sometime if you take too many drugs off the racks I could die. Doctors should have a limit on what they pay out and the Pharmaceutical GIANTS should bear the large part of liability. I have said over and over if I had to live in pain everyday, I could not do it and would rather take my life. The government does not like prescription pain medications because most people like me would prefer a tiny pill over running to FEDERAL controlled alcohol stores such as ABC. Why does no one have concern that they call it ABC stores? Children learn ABC's when they are in first grade and I wonder if this name was choosen to attract the kids. Pharmaceutical companies hide most of their profits in off shore accounts and the government is not doing anything about it, maybe that is why they want to crush the drug market. Our wonderful government wants us to get hooked on alcohol because they make a fortune on it. Almost every drinker has received a DUI. It's a money making scam because the government makes money off the alcohol, tickets, courts and it feeds the attorney's very well. Set up a DEF store for marijuana, GHI store for narcotic drugs and the list can go on and I bet no bad press would appear and the government could waste even more of our hard earned money. Better yet, let's go back to the cowboy days when tons of those guys drank and had an occasional gun fight (in most cases both sliggers missed one another). George Washington grew and even smoke Hemp, although he used it for other purposes. Many of our national heroes do it now and have since the beginning of time. Zombies are the talk today from nuclear fallout, the way the news reports this is that Zombies are already taken over. Now if you believe in Zombies, you probably have taken too much of something. If I am in pain, I will find something to help

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1 reply
Sue Ellen Vanbooks April 05 2014 at 12:26 AM

A. Freakin. Men.

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1 reply
Sue Ellen Sue Ellen April 05 2014 at 12:27 AM

(except for the Zombies)

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fred April 04 2014 at 9:33 PM

When 4 CVS pharmacy stores lose 37,000- no misprint: thirty seven thousand!!- Vicodin tablets in California, that is NOT the people needing pain medication 's abuse; that is the abuse of the suppliers, shippers and employees. Crack down on the folks doing the sloppy handling, NOT the people in need.

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compsultinc April 04 2014 at 9:20 PM

Contrary to more popular beliefs, Chronic pain patients do NOT get a 'high'. The pain seems to 'eat' the painkiller giving relief, but just being 'normal' as can be. Before me dr started me on painkillers, I was sent to psychologist for 'risk assessment' for addiction. I was stated a NO risk. Periodically, over the years, I have taken myself, without dr permission off of them. Its because I get tired of living around 'dosage' times. I try to 'make it' as long as I can with the pain and back on. There is NO surgery or cure for my disease and I am in last stages which is 'terminal'. So, most INFORMED dr's know this and 'watch' keeping their patients as comfortable as possible. TRUE Chronic pain sufferer's are NOT addicts. I am so tired of the gov't scaring the drs.

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1 reply
gasmanrobe compsultinc April 04 2014 at 9:34 PM

you are so right.i have spinal stenosis and ra all over my body.i stopped getting high off my meds years ago .now its i hope today my pills work or its gonna be hell to pay just to get up.i can understand about the abuse but believe me the state and the feds know who really needs them if they check with dr.s

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mikco99 April 04 2014 at 9:11 PM

Let these lawmakers suffer from a nice dose of chronic pain for a couple of years. I am really tired of justifying my use of pain meds. I mentioned to the pain clinic Dr. about addiction and he said that there is a difference between addiction and dependency. He asked if I was addicted to my diabetes medication, or my high blood pressure medication, or was I dependent on them. Law makers should find something else to do to justify their existence.

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