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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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pnutsnshamrocks April 05 2014 at 2:12 AM

They took away the best pain killer ever...Darvon and Darvocet, we need a replacement for those in acute chronic pain. Just because drug addicts can't keep their hands off of this medication, it shouldn't be pulled from the hands of those who need it. Addicts will get anything they can, but those in pain cannot??? That isnt fair!!

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king At one rock pnutsnshamrocks April 05 2014 at 6:36 AM

Darvocet and Darvon were horrible pain killers...Many people on them were still in bad pain and took more than what was prescribed. The thing with those were, In high dosage, they became toxic and people were dropping dead...Good Riddance

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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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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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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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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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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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Sue Ellen Vanbooks April 05 2014 at 12:26 AM

A. Freakin. Men.

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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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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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philsun73 April 04 2014 at 8:59 PM

Those who can sit back not knowing what pain is; and place a ban on a new pain medication, because they are afraid that it can be abused would be the first to want it if they had the pain that other's experience. Dr. Kervokian had plenty of takers for assisted suicide, because of the constant pain that they were enduring.. Wouldn't it have been better to have a medication available that would suppress that pain, and give them some comfort in life, than to have a Dr. assist in their suicide for the only way to stop the pain? I'm not going to say what my condition is; but frankly I do not wish it on anybody.

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b19821 philsun73 April 04 2014 at 9:29 PM

I understand what you are saying, but after being treated in a pain clinic for 10 years, I say most of the people that went there were fooling themselves. And as for the pain doctors that claim a difference between addiction and dependance, I call B.S.. You are probably the 1 in 20 that I say at my "HIGHLY RESPECTABLE" clinic.

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JOHN R PEOPLES, April 04 2014 at 8:47 PM

All these people have no idea what it is like to live with CHRONIC PAIN. MOST TRUE sufferers do not abuse the medication and depend on it to have "somewhatof a life" it is the kids on the street and the illegal market that has caused DR's to be reluctant to prescribe a level of medication needed for fear of DEA audits. No one, that I know of has conducted a survey of suicides due to the lack of control of cronic pain. Chronic pain can and does destroy families,relationships, and adds to the government disability cost. Every 5 to 7 years we go through a cycle of under perscribing normal perscribing and under prescribing because of the iilegal market. Criminals will get it weather Drs prescribe it or not. all this does is hurt the people who really need it. Cancer and Hospice patients have no problem getting pain relief, it the ones that are not terminal and have no other option that suffer from these people who know very little about a subject they act like they know alot. Leave the true pain management DR's alone, let them prescribe the amount patients need! We all have to sign contracts are subject to random drug screening and medication checks. the government has no right to tell me or my DR how much pain medication I need or get. DR's are keen to the "fakers" , let them take care of the real Pain sufferers or someone will find the suicide level of CronicPain Suffers sky rocket. Zohydro is nothing new.an existing medication in a diffrent pill. the Crooks will get it just like they got Oxycotin so that no DR would prescribe it and generic manufacturers quite making it for fear of law suits. Leave the truely needy alone and go after the criminals. Your need to try to keep this off the "street" does nothing but hurt people who need it. criminals will get it regardless of what the governemt does. They get Herion dont they and it is not prescribed. Use comon sence and leave us, the real chronic painsufferers and their DR's alone.

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b19821 JOHN R PEOPLES, April 04 2014 at 8:57 PM

I went to a really well respected pain clinic in the state of Washington. The Dr. who ran the clinic and other Drs that worked there were all very knowledgeable. MOST of the patients there were ALL addicted to one or more painkillers and most all had issues making it thru the month on their regular prescription. Every month most or all of them justified their habits exactly as you describe. IF what you are saying is true, from my experience, you are one of FEW. I used to justify the same exact issues every month. If you have that kind of pain, you need an operation. I did that for 10 years, kind of hard to fool me. We di not need a drug that is 5X stronger released to the public. Might as well pass go and start on heroine.

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b19821 b19821 April 04 2014 at 9:23 PM

I understand there are those who could use pain relief. I am saying from my experience, there are just not that many. I have seen the inner workings of a pain clinic. I sat around in my "highly respectable" pain clinic and listened to the phone calls, the excuses, signed the contracts, bla bla bla...you should sometime have a one on one conversation with a person who is NOT a doctor who whors in a GOOD pain clinic. That will open your eyes to the truth!!!

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gasmanrobe b19821 April 04 2014 at 9:41 PM

another reason for my ailment was a botched operation and you say to get another?hahahaha boy you stupid.im not letting another fool cut me again.

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