Doctors Say New Pain Pill Is "Genuinely Frightening" 294
Hugh Pickens DOT Com writes "Stephanie Smith reports at CNN that a coalition of more than 40 health care, consumer and addiction treatment groups is urging the Food and Drug Administration to revoke approval of the new prescription pain drug Zohydro, a hydrocodone-based drug set to become available to patients in March. 'You're talking about a drug that's somewhere in the neighborhood of five times more potent than what we're dealing with now,' says Dr. Stephen Anderson, a Washington emergency room physician who is not part of the most recent petition to the FDA about the drug. 'I'm five times more concerned, solely based on potency.' The concerns echoed by all groups are broadly about the drug's potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will amplify already-rising overdose numbers. 'In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid (PDF),' the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.
Zohydro's maker, Zogenix, and the FDA say the drug's benefits outweigh its risks and in their petition to the FDA for approval, Zogenix representatives say the drug fills a critical need for people suffering from chronic pain who are at risk for liver toxicity and cited examples of patients who might benefit from Zohydro: a 46-year-old male with chronic back and leg pain who had two failed back surgeries; a 52-year-old female with metastatic breast cancer experiencing diffuse pain; a 32-year-old woman with multiple orthopedic fractures. 'There's a lot of misinformation being put out there by people who don't have all the facts,' says Dr. Brad Galer, executive vice president and chief medical officer at Zogenix. 'We're talking about patients that are in bed, depressed, can't sleep, can't work, can't interact with their loved ones — it's a very significant medical health problem that is being ignored.'"
Zohydro's maker, Zogenix, and the FDA say the drug's benefits outweigh its risks and in their petition to the FDA for approval, Zogenix representatives say the drug fills a critical need for people suffering from chronic pain who are at risk for liver toxicity and cited examples of patients who might benefit from Zohydro: a 46-year-old male with chronic back and leg pain who had two failed back surgeries; a 52-year-old female with metastatic breast cancer experiencing diffuse pain; a 32-year-old woman with multiple orthopedic fractures. 'There's a lot of misinformation being put out there by people who don't have all the facts,' says Dr. Brad Galer, executive vice president and chief medical officer at Zogenix. 'We're talking about patients that are in bed, depressed, can't sleep, can't work, can't interact with their loved ones — it's a very significant medical health problem that is being ignored.'"
Re:It's just a tool I guess (Score:5, Interesting)
Posting anonymously for obvious reasons: I actually participated in the drug study of this medication as a patient. I thought it was terribly ineffective for me. I will say up-front that I do not think that my body metabolizes hydro or oxycodone properly. Here was my experience:
I was on a duragesic patch (25 micrograms of fentanyl transdermally, patch is worn for 72 hours). For some reason the patch did not last the full 72 hours so I was on a 48 hour dosing schedule. I felt relatively good. My pain level was manageable and I was not drowsy or loopy. I felt like a normal human being again. I was very content with my treatment. The big issue was that both that medication and my arthritis medication were not covered by my insurance and I was paying $200 a month for my meds. So when I heard about the trial I decided to give it a go.
They started me on 20mg of the med, which was slightly less than the equivalent dose from my patch. I could not get out of bed for three days I was in so much pain (turns out it was partial withdrawal symptoms that was amplifying my pain). The medication was not delivering what my body considered to be an equivalent dose. I stepped up after 3 days. I was still in a lot of pain. I stepped up again, and again all the way up to 120mg doses. At that point it was the equivalent dose of the highest duragesic patch and still I was miserable. At that point I requested that I be released from the study and returned to my pain management doctor's care. At that point, the 25microgram patch was no longer sufficient and I had to step up to the next dose. But again I felt like a normal human being with manageable pain.
In my opinion the fentanyl patch was much more convenient, stable, and provided exponentially better relief. This medicine was garbage for me. However, that does not mean that it can't be useful to some. If they formulate it like the oxycodone ER, in a way that helps prevent crushing, chewing, or other abuse then it may have pharmacological value.
I will say that I believe that fentanyl can be a terrible, terrible drug. I had a procedure that brought my pain levels down to the point that I was in no pain with the fentanyl. I decided to stop the medication. That was hell on earth. I thought I was going to lose my job. I could not sleep, I had no appetite. I felt like a zombie. The doctor gave me oxycodone to help me step down from the last patch and at 2x the dosing the doctor recommended I had no relief from the withdrawal symptoms. I ached for relief so badly that I had to destroy all of the oxycodone to prevent myself from taking too much. I went cold turkey. It took almost a year for my body to return to normal. Without the medication I still have pain but I refuse to go back on. My doctor just writes me a script for a very small monthly supply of oxycodone that I use in case of emergency.
Re:It's just a tool I guess (Score:4, Interesting)
Can be used for good, can be used for bad.
Both heroin and cocaine were originally developed as medicine. Turns out that their potential for misuse far, far outweighs any medical benefit.
As far as new pain medicines go - why not just go back to using heroin? Cheap to make, easily available in generic form, and it's side effects are well known.
Re: It's just a tool I guess (Score:5, Interesting)
Re:It's just a tool I guess (Score:3, Interesting)
My mum was given Heroin while in hospital recovering from surgery(*). Best thing she'd ever had for pain.
((*) they tell you it's "diamorphine" :-))
Re:It's just a tool I guess (Score:5, Interesting)
Sometimes regulating the hell out of things decreases its availability for good use and jump starts the black market for bad use.
Just look at the current refer madness - that's at least starting to somewhat abate. There was just a story yesterday about the Annapolis police chief, who quoted a DailyCurrant article to a State committee about a coroner who had to put five college students in body bags before breakfast (due to marijuana overdose). The Chief later apologized, half heartedly, but the level of rank incompetence is astonishing - he doesn't even know enough about the topic to spot satire, but he's happy to cage people [wikipedia.org] for it anyway.
Meanwhile, suffering patients [youtube.com] often can't even get a little bit of pain relief (without facing criminal charges).
Re:It's just a tool I guess (Score:4, Interesting)
Both heroin and cocaine were originally developed as medicine. Turns out that their potential for misuse far, far outweighs any medical benefit.
And yet they both are still used in medicine (http://www.medicinenet.com/cocaine_hydrochloride-topical/article.htm). While marijuana is classified by the US feds as having no medical use. Go figure.
Re:It's just a tool I guess (Score:2, Interesting)
But in this case preventing "bad use" actually means trying to prevent people from harming themselves. Stopping self-harm can be morally good, but isn't really morally required. However, when an effort to prevent self-harm actually causes harm, that effort is purely immoral. The war on drugs is immoral.
If society is going to be on the hook for providing food stamps, welfare, and "free" health care to people who turn themselves into total derelicts through drug abuse, damn right drug abuse should be illegal.
If you want drug use to be legal, then you damn well shouldn't be protected from the consequences of drug abuse. You wanna put that crap into yourself? Then if you turn into a derelict addict, no health care, no food stamps, no methadone, NOTHING.
You did it to yourself, you deal with it. ALL of it.
Re:It's just a tool I guess (Score:3, Interesting)
No one wants to punish people for victim-less crimes. We just fall prey as a society for the giant enforcement and correction industry and can no longer differentiate between what is actual crime and what is a money-making scheme.
Class extermination is the only true vice of the war on drugs. Which is why Meth has the worst reputation at the moment. Meth has brought lawlessness to predominantly white communities and turned them into drug-based ghettos. And heroin use increase in white communities is a result of controlled prescription drugs restrictions where people with real problems no longer have a safe venue to manage their pain or their addiction developed by improper administration of the pain pills turns them to the black market.
Not once I was ever prescribed pain pills was I given a plan on how to safely come off of them. Once the pain went away, it's like I hit a wall at 40 miles an hour. Fortunately I was able to handle that but a lot of people can't and they end up unable to live a safe life.
This is really just a patent extender (Score:4, Interesting)
From my view of this "new" drug, it looks to me like it's just hydrocodone in a time-release form, without any acetaminophen in it. The intention of this drug company is take a medication that is now generic and produce a novel, patented form that can be sold at a premium. The fear that some doctors have is that each pill contains a large amount of hydrocodone, so if your intent was to abuse, you could crush it and get the full dose all at once, without the liver-poisoning acetaminophen. I don't really see how it's any different from plain oxycodone in that regard.
Mod parent up (Score:4, Interesting)
I don't know why you got modded "flamebait". My current doctor and my previous one both told me exactly the same thing. They said they can't prescribe opiates without acetaminophen or their practices will systematically harassed by the government's drug warriors, and they can't help people if they are driven out of business.
Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, says "Zogenix is working on an abuse-deterrent version of Zohydro that should become available in three years."
To me, that says as soon as they add toxicity it'll be acceptable. Because in the USA, the goal of punishing addicts has become more important than the goal of helping people in pain. Authoritarianism is ascendant over compassion.
You can thank Ronald Reagan for that. (Score:2, Interesting)
In the United States, the Sentencing Reform Act of 1984 explicitly states that imprisonment is not an appropriate means of promoting correction and rehabilitation. [gpo.gov] In other words, according to both Congress and the Supreme Court, prison is useless for rehabilitation, and judges are legally barred from considering prison as a rehabilitative measure. Our official incarceration policy exists solely to punish behavior, never to correct it or prevent future crimes. This has always seemed to me like the keystone [slate.com] of the "Reagan Revolution", with Ted Kennedy and Ronald Reagan allying to fundamentally derail the American Dream of an optimally free society, so it seems very appropriate that it was passed in 1984.