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heroin in a capsule hysteria again

Once again, hysteria hits the media with this article that i read, it is unbelievable the hysteria and misconceptions that are with this drug what is actually weaker than oxycontin. hydrocodone is weaker than oxycodone and they are more upset with this narcotic than oxy. will it ever stop? no it will get worse and worse then before we know it all narcotics will be banned. hysteria on my part, maybe maybe not. but it is happening now.

WASHINGTON – State and federal lawmakers are working in tandem to get the controversial painkiller Zohydro ER permanently shelved, even as the head of the Food and Drug Administration defends the agency’s decision to approve the powerful opiate some critics call “heroin in a capsule.”

Since its approval last October, Zohydro, an extended-release form of hydrocodone, has come under scrutiny from members of Congress, state attorneys general, doctors and addiction specialists who have worked to block the pill from being sold in the U.S.

FDA Commissioner Margaret Hamburg strongly defends the agency’s approval, arguing that Zohydro’s benefits outweigh the negative consequences. Simply put, she says, people in pain need more options.

But others, like Sen. Joe Manchin, D-W.Va., say the agency should rescind its approval of the painkiller. Manchin, whose home state leads the nation in prescription overdoses and abuse, has worked with New York Sen. Chuck Schumer to overturn the approval.

The lawmakers have called on outgoing Health and Human Services chief Kathleen Sebelius to force the FDA to rescind its approval, citing the alleged danger of the drug and as well as the growing abuse of prescription drugs in the country. Overdoses from prescription drugs have risen steadily over the past decade and account for an estimated 16,000 deaths a year in the United States.

Three Republican lawmakers -- Sens. Mitch McConnell of Kentucky, Lamar Alexander of Tennessee and Tom Coburn of Oklahoma -- have also joined the call.

In March, Manchin submitted legislation, the “Act to Ban Zohydro,” which offered a 13-point argument on why the federal agency should rescind its approval.

Among his complaints, which have been echoed by doctors and others in the medical field, is the potential for abuse and addiction.

According to the Institute of Medicine, 100 million adult Americans suffer chronic pain every year, and the cost to the nation is between $560 billion and $635 billion annually.

Zohydro ER involves a powerful formula of hydrocodone, the opiate that’s the main ingredient in Vicodin. Critics argue that Zohydro’s potency makes it dangerous and open to abuse because it lacks a tamper-resistant feature which lets it be ground up, snorted or injected.

On Thursday, Hamburg called the “recent attention” by state policymakers on opioid abuse “commendable” on her FDA Voice Blog, but said instead of blocking the sale of Zohydro based on a fear of abuse and addiction, providers should screen patients before they prescribe the drug and while they are on it.

Zogenix Inc., the San Diego, Calif.-based company behind the drug, says it has “taken extraordinary steps to support the appropriate use of Zohydro ER through a voluntary, comprehensive set of educational tools and safeguards to augment the FDA industry mandated class-wide Risk Evaluation Mitigation Strategy (REMS) for extended-release opioids.”

The company also adds that as part of their continued effort to provide “additional safeguards against potential diversion, overdose and misuse of Zoyhydro ER,”

Zogenix has created a board of experts, though it does not say what those experts will do.

The company also says it provides consumers taking Zohydro ER “access to free locking pill bottle caps and discounted safe-storage units to prevent others in the home from obtaining easy access to medicine that was not prescribed for them.”

The FDA’s decision in October 2013 to approve Zohydro over the objections of its staff and advisory committee raised eyebrows in the medical community, with many questioning the motivation behind green-lighting the drug.

Others, though, questioned Manchin’s motives, since his campaign to kill Zohydro could benefit his daughter, Heather Manchin Bresch, the CEO at rival pharmaceutical company Mylan.

Melanie Sloan, executive director at Citizens for Responsibility and Ethics in Washington, told FoxNews.com that Manchin’s push has more to do with the skyrocketing number of prescription overdoses in his state than any type of financial gain for his daughter. She also said Manchin has spoken against drugs Mylan has introduced too.

“His state has a lot of overdoses,” Sloan said. “He had to get on board with this and push for the ban.”

The fight against Zohydro is also being fought on the state level.

So far, 29 states have asked the federal agency to reverse its decision.

Vermont Gov. Peter Shumlin announced an emergency order that would make it illegal for doctors there to prescribe the drug.

I have 4 fusions from L5-3, the latest last May '12 where they fixed my disc that broke.They went through my side this time. I take 40 mg of oxycontin 4x a day and 4 fenatyl lollipops 300 micro gms 4x a day.


  • My two cents , are just that, two cents, but given the sheer number of recent heroin od's and deaths in my county in the last year and a half, 30 in the last year, which is about 10% of the cases brought into the medical examiner's office, leaves me wondering just how many of those, were related to patients who used an illegal and often lethal street drug, because they suddenly were not able to get proper pain management?
    Heroin has made a resurgence in it's use around us lately and in many other areas across the country......and often, too often, we are hearing and seeing deaths. Too often, there were histories of some of them being pain patients, who couldn't find a doctor......now, why that is, I don't know......but according to the information I am aware of, they were on pain meds at one time but for whatever reason now are not.......so they are turning to heroin. I have to believe that some of them were legitimate pain patients, and while I don't know the reason that they were no longer on pain medications, the idea that someone would turn to a substance with a long, long history of deaths and overdoses related to it's use, is frightening......
    I wish those who create and advocate for these bans and stupid laws, would have the foresight to see what the implications and ramifications of these laws that are pushed through with no real concept of the negative impact that passing them creates.
    I am not one who believes that misusing or abusing opiates is ever a good thing, and I am vocal about it, but this recent rash of non sensical deaths and over doses has me wondering how it is possible to document which of these deaths are directly related to the untreated pain that some of them were attempting to self medicate by the use of a street drug?
  • My pennies go with your cents Sandi. I decided to be very open about my brothers death. He 'chose' to take his life with my fathers prescription pain medications. It was not an accident but he is a statistic on one of those lists. He had suffered physical pain for years but it was the emotional that pushed him over the edge. Since I have started talking about this I am amazed how many families share this heart wrenching experience & uncontrolled pain was frequently a factor.

    You guys know I'm not an advocate for handing out narcotics lightly but I have to confess, I can feel my attitude changing. I find myself wondering what is the lesser of the 2 evils, over prescribing or under? I know in a perfect world doctors would have some scientific crystal ball & always make the right call but that's not the case. So many leave pain management because of perceived lack of treatment. Depression goes hand in hand with chronic pain & I believe that needs to be better addressed but patients self medicating on the street are never going to get any support at all.

    I'm still torn between the two arguments but 'the times they are a changing' & not for the better. Let's be sensitive, it's heartbreaking to realize what people are going through. Most of us are in control of our own lives & I don't know if nature or nurture enables us to do do this. We are fortunate.
    Osteoarthritis & DDD.
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  • EnglishGirlEEnglishGirl Posts: 1,825
    edited 05/04/2014 - 5:17 AM
    I was discussing Zohydro with my pain management doctor. He will prescribe but only if a patient has a record of unmanageable side effects with other medications. This basically means he won't because of the current situation. Most side effects can be managed by adding more medications. He was very sad that he is being influenced by public opinion. He has some patients (including myself) that 'could' benefit from this medication but, in his words, he doesn't want to "go there until the dust settles".

    That specific medication is harder to argue because it does not contain any tamper proof measures. Most do not understand why this was released to market in its current form. The idea that "1 pill could kill a child" is rediculous, any 1 of my meds would kill my kids!. We should all store our meds responsibly. This isn't "heroin in a capsule" (we have that in England with good results) its just Hydrocodone in an ER form.
    Osteoarthritis & DDD.
  • sandisandi Posts: 6,269
    edited 05/04/2014 - 5:53 AM
    I am sorry for the loss of your brother and even sorrier that he felt that that was his only option. The most recent death here was what appears to be a direct result of untreated pain......he was seeing a doctor, moved to this state and now , several months later, is dead......due to a heroin overdose but his family stated unequivocally that he was not able to get his pain managed by a doctor here.....It makes me sad and breaks my heart for his family, and for those others who I must assume have also died for similar reasons.
    As to the overmedicated thing- I think that the worst thing that any doctor can do is allow a patient to get to extremely high levels of narcotics. If medication isn't working for a patient at 200 mg per day total, why would the doctor allow them to continue to escalate? Why not change the medication? Or use adjunct therapies? Why use two short acting or immediate release medications, instead of a long acting one for baseline pain and keep the IR versions for acute episodes?
    I know that tolerance becomes an issue, but one easy way to mitigate that occurring is simply to rotate to another opiate...doing that, decreases tolerance issues drastically.....will one opiate work as well as another? Maybe not, but maybe it will stop patients from getting to ridiculous dosages 6 months into being in pain management......I read other forums for pain /spine issues, always have......and I have seen posters, new to pain management who started out on meds at a nominal dose, and getting great pain relief, but after reading for a few weeks to a few months, they have gone from 5 mg oxycodone or vicoden, to hundreds of milligrams in a few months time.......one particular patient was getting 270-30 mg Roxicodone, I can't recall the amount of methadone (think it was 90-120 mg of methadone per day), and I believe it was 6-2 mg tablets of a benzo........from one doctor. The conditions he was given this amount of medication for was DDD, and a disc bulge....The patient became furious when his former doctor retired and the new doctor wouldn't give him the same meds, at the same dosage....The original doctor did him no favors by allowing that kind of dosage of opiates over a short period of time....and the mixture of benzo's and the methadone can be fatal....let alone adding 270 mg 4 of oxycodone to the mix. No one needs that amount of immediate release medication for "breakthrough" pain....
    Another, started out on Nucynta, 50 mg........was loving the way it relieved his "pain", made him happy, cheerful, gave him energy---in 4 short months, he was taking 600 mg per day, and admittedly abusing the meds, running out two or three weeks early....but his doctor was so understanding and gave him lots of "leeway " in adjusting his dosage.....and just kept writing him new prescriptions......
    I look at those situations and I place the blame solidly on the doctors that allowed that to occur......Yes, some people metabolize opiates a bit differently and some opiates work better than others, but to allow a patient to get to those ridiculous amounts of medications is definately overmedicating/ self medicating.......those doses aren't to treat pain, they are to treat the demanding patient who is too big of a headache to try to reign in..
    If a relatively new patient is coming in and despite dosage adjustments to a moderate level of opiates isn't relieving their "pain" , doctors should and are supposed to not continue to use that medication, and either try others or if those fail as well use other modalities. If the patient is laying in bed, not doing anything other than using pills to help themselves, then maybe opiates aren't the answer in those cases.........the risk /benefit scenario comes into play....
    Then on the flip side, we have other patients who have legit conditions, who should be given the option to at least trial opiates to see how they do...if they are able to function in their daily lives,or return to work, and take care of their families, those people should have the option open to them....
  • but all of these recent heroin related deaths are really concerning me..........and it is making me incredibly sad, for them, for their families, and makes me wonder how many of them were not "addicts' in the traditional sense, but pain patients who weren't being treated.
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  • Very true Sandi. We've talked about being on high doses & crazy numbers of different meds in the past. My doc was definitely doing me no favors. I was thinking more of the doctors who now refuse to prescribe any narcotic medications for any reason.

    A friend of a friend is a pain management doctor who has recently left the clinic he was working at to open his own practice. He admitted that he doesn't want the issues that come with prescribing these days so his 'plan' is to have his patients GP's prescribe narcotics if they wish to continue using them but his stance in general is very anti-narcotics. He talks about narcotics causing pain & lowered immunity..you know? All of 'those' studdies. I appears that an increasing number of doctors are taking that stand. I know pain management is a relatively new field. I live in a very new area & I'm amazed by how many new clinics are opening in the strip malls & medical complexes around here. It seems like physical therapy practices are becoming PM clinics. A GP who used to refer a patient for PT is now sending them to PM so there is less prescribing & more focus on alternative therapies because they are frequently seeing less serious cases than in the past. I thought this was great in some ways but now I'm questioning it.

    I'm a true believer in 'The Blend'. There is no level of narcotics that will give a comparable level of functioning but I am becoming afraid that my doctors may move or change their practices & stop prescribing. I know that I would not be able to function without my meds & my only option would be to return to England & rely on that support system to help raise my children. Others do not have that option..where will they turn?

    Maybe I'm being over influenced by spending time here & reading the problems some are facing. I don't know but I fear the times are changing...
    Osteoarthritis & DDD.
  • I rotate my medications. There is a level that I've fixed in my mind that I will never go above. Like you, I don't understand why doctors don't follow this practice. I was told in England that rotation rather than escalation is now part of the European guidelines for prescribing.
    Osteoarthritis & DDD.
  • a little of the subject but i have always been an advocate of legalizing heroin in the US. for the most part it is in england and it is probably the most effective pain med. the guy in the movie lone survivor about the seal whose whole team was killed and he was saved by afghan villagers who gave him heroin for his wounds said it was better than morphine for him. if some one is going to use it legally or illegal, keep it under govt control and tax the heck out of it and keep it out of the hands of the gangs
    i have always been a libretarian when it comes to legalizing drugs.
    I have 4 fusions from L5-3, the latest last May '12 where they fixed my disc that broke.They went through my side this time. I take 40 mg of oxycontin 4x a day and 4 fenatyl lollipops 300 micro gms 4x a day.
  • I know what you mean Jon but just for anyone reading & getting the wrong end of the stick... Heroin isn't 'legalized' or 'decriminalized' like marijuana in many European countries. There is a prescription heroin which like methadone has proven to be a highly effective pain med which (studdies show) helps with nerve related pain better than most other narcotics. The war on drugs is a mess. Overcrowding prisons isn't the answer & what Jon is saying really isn't off track. When 'the system' treats addiction as a sickness that needs treatment it not only efficiently helps those with 'just' addiction, it also finds those who are self medicating for a variety of illnesses both mental & physical. Spending millions throwing these people into prison every month isn't 'working' by any definition.
    Osteoarthritis & DDD.
  • if someone wants it they will get it. might as well control it and tax it. the amount of taxes would help take care of the debt and take it out of the hands of gangs. but the hysteria about legalizing drugs wont do that ever. the old police chief here was for the legalization of drugs and went on national tv to espouse it.
    I have 4 fusions from L5-3, the latest last May '12 where they fixed my disc that broke.They went through my side this time. I take 40 mg of oxycontin 4x a day and 4 fenatyl lollipops 300 micro gms 4x a day.
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