Doctors Say New Pain Pill Is "Genuinely Frightening"

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.'"

Comments

It's just a tool I guess

[dimko]

Can be used for good, can be used for bad. Just regulate the hell out of it. Let it be.

Re:It's just a tool I guess

[SJHillman]

Sometimes regulating the hell out of things decreases its availability for good use and jump starts the black market for bad use.

Re:It's just a tool I guess

[Anonymous Coward]

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

[Anonymous Coward]

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.

Re:It's just a tool I guess

[sunderland56]

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

[deadweight]

You are not the only one. I got some oxycodone for a neck issue from my doctor and I ended up shitcanning it. Advil worked better and the oxycodone just made me itch, disturbed my sleep, and did not much for pain relief. I do feel for addicts, but I could be addicted to hitting my thumb with a hammer easier than the *codones. My cat got a fentanyl patch after cancer surgery and he was out there. He would just pass out in random places.

Re: It's just a tool I guess

[parrini]

Are you shure you were not in the control group?

Re:It's just a tool I guess

[SJHillman]

It's pretty rare that "self-harm" only harms the person doing it, especially with addictive substances. They may be the only one suffering the physical effects, but there's emotional, financial, social, etc, etc effects that radiate out to their family, friends, co-workers and more. It's not as obvious as second-hand smoke from cigarettes, but the detrimental effects are still there.

Re:It's just a tool I guess

[jovius]

Heroin is used as a medicine in some countries; in UK for example.

Re:It's just a tool I guess

[SJHillman]

The point is that "regulate the hell out of it" is a pretty shitty blanket solution to the problem.

Re:It's just a tool I guess

[Anonymous Coward]

Cocaine is schedule two in the United States; it's used most commonly in nasal surgery. There's nothing else that really provides its combination of local analgesia and vasoconstriction. Herion is still available for medical use outside of the US as Paramorphan.

All opiate narcotics essentially work the same way, and there are many in use in the US that are far more potent than morphine or dihydromorphine. Look up "fentanyl" or "sufentanil". Potency just tells you the amount of dose you need to achieve a certain effect, not the potential for dependency or addiction, which is essentially the same for all opiates (but can differ dramatically from individual to individual). It's a bit of a mistake to regard substances as intrincally addictive; it's more realistic to consider some people intrinsically addictable.

Re:It's just a tool I guess

[kilfarsnar]

It's pretty rare that "self-harm" only harms the person doing it, especially with addictive substances. They may be the only one suffering the physical effects, but there's emotional, financial, social, etc, etc effects that radiate out to their family, friends, co-workers and more. It's not as obvious as second-hand smoke from cigarettes, but the detrimental effects are still there.

That's true and good to recognize, but not an argument for continuing the war on drugs. The answer to the question of how to deal with such people is not to throw them in jail, compounding the problem, but to actually help them with the aim of getting them to a healthy mental and physical state. Unfortunately, out society seems more interested in punishing people than helping them.

Re:It's just a tool I guess

[Anonymous Coward]

Emotional

And my mother would have a heart attack if I took up skydiving. Should we ban skydiving?

financial, social

A lot of those effects are a result of the war on drugs itself.

Re:It's just a tool I guess

[Eunuchswear]

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

[bill_mcgonigle]

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 for it anyway.

Meanwhile, suffering patients often can't even get a little bit of pain relief (without facing criminal charges).

Re:It's just a tool I guess

[Anonymous Coward]

I agree that "regulate the hell out of it" is a bad solution but "let's just keep it illegal so we don't have to regulate it"
is an even worse solution because "illegal" is basically synonymous with "regulated out of existence".

Re:It's just a tool I guess

[SJHillman]

If you're addicted to skydiving to the point where you're ignoring safety protocols, someone should intervene on your behalf. I never said we should outright ban anything. My only point was that there's rarely such a thing as drugs only harming the person taking them.

Re:It's just a tool I guess

[sribe]

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

[rmdingler]

I don't presume to know how close you've ever been to full-on drug addiction,

but in my own admittedly small sampling,

many an addict's confinement is the only time in their adult lives they're not using. A great friend passed last year at the ripe old age of 48, but his life was probably extended a decade by frequent periods of abstinence as a guest of the County and State.

Re:It's just a tool I guess

[SJHillman]

I agree that the war on drugs is stupid and causes more harm than good. However, the counter argument that "people should be allowed to do things that only hurts themselves" is pretty poor in the case of most addictions (including but definitely not limited to drugs). Personally, I think people should be allowed to do whatever they want as long as there's no adverse affects to those around them. Unfortunately, most people only think of the immediate physical effects (e.g. secondhand smoke) and don't think of the more long-term effects, especially those which are harder to quantify.

Re:It's just a tool I guess

[Anonymous Coward]

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

[jonnythan]

The control group in a drug study would not place someone currently on strong medication onto no medication. That would violate the ethical principle of equipoise. The subjects in the control group wouldn't be given a placebo; that would be horrendously unethical. They would be given either the current gold standard of care or the new drug/procedure being tested. The researchers and subjects would both be blinded to which they were receiving. For instance, an RCT comparing hydrocodone to a new med would have both arms take a new pill, but both pills look identical. One would contain the medication they've been taking and the other would contain the new drug. That's not what the OP is talking about though.

I'm not super experienced in clincal trials, but the study the OP was a part of doesn't sound like a double-blinded RCT; it sounds more like a limited-rollout experimental kind of clinical trial, where certain people are allowed to elect to try out the drug. This is not really a scientific experiment that would have a control group, but a limited opt-in rollout of the drug.

Re:It's just a tool I guess

[Mashdar]

Confinement is certainly a good thing for some, but jails/prisons seem like the wrong setting for non-violent addiction-related issues. The focus of prisons (from my limited observation) is rarely to rehabilitate.

Re:It's just a tool I guess

[causality]

I agree that the war on drugs is stupid and causes more harm than good. However, the counter argument that "people should be allowed to do things that only hurts themselves" is pretty poor in the case of most addictions (including but definitely not limited to drugs).

The question is whether jail is an environment that will make them better people and help them overcome these problems. A related question is whether armed police, not doctors/therapists, should be the ones we send to deal with people who have not used fraud or violence against another person.

Unfortunately, most people only think of the immediate physical effects (e.g. secondhand smoke) and don't think of the more long-term effects, especially those which are harder to quantify.

It's hard to think of a more damaging long-term effect than expanding the definition of "crime" to include "something other than using force/fraud to harm another human being", the subsequent mutilation of the Fourth Amendment, the asset forfeiture abuses that continue to happen, and the increasingly aggressive paramilitary police that even the law-abiding are afraid of. Ask an older person about what police used to be like sometime.

Re:It's just a tool I guess

[causality]

I agree that "regulate the hell out of it" is a bad solution but "let's just keep it illegal so we don't have to regulate it" is an even worse solution because "illegal" is basically synonymous with "regulated out of existence".

If by "regulated out of existence" you mean "supplied by the black market" with all the problems that go along with that, then yes.

Re: It's just a tool I guess

[wisnoskij]

But putting them on a placebo is far safer than putting them on these new untested drugs. Often the placebo will actually also do better at curing/treating the patient, as well as avoiding the nasty, often deadly, side-effects. There are prescription drugs out there right now that have been clinically prove to do a less good job at their purpose than a placebo, so some random untested drug that in all likelihood has serious side effects, and has yet to be proven to be even minimally more effective than a placebo is less safe than a placebo.

I do not see how something that is more likely than not to be a superior treatment can be considered in violation of ethics.

Re:It's just a tool I guess

[causality]

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.

The cannabis plant is too easy to cultivate and has too many non-drug uses that threaten several powerful industries with lots of lobbyists. That's why something with demonstrated medical use that is practically impossible to overdose on is listed as a Schedule I. That's the only reason why.

Re:It's just a tool I guess

[Derec01]

This seems a little better than that, if I'm understanding it correctly. The drug would never be mass-produced if its approval is revoked, and it's doubtful that the company would let its production method out AND that it would come to someone with the capabilities of producing it illicitly.

It's hard to have a black market if no one makes the drug for any legal use.

Re:It's just a tool I guess

[Anonymous Coward]

Exactly. Drug addicts should be sent to rehabilitation centers, not prisons. They need medical help, not punitive justice.

Re: It's just a tool I guess

[jonnythan]

Do some reading on "clinical equipoise" and you'll start to get it.

Re:It's just a tool I guess

[Zero__Kelvin]

You seem to be under the mistaken impression that jail is drug free, and that the "confinement" of which you speak can only be acheived with prison. There are plenty of lock-in treatment facilities. Prison / Jail is never the answer, and every single claim that they make that your loved one will get "help" in prison is a straight bullshit lie. Anyone who gets clean in jail and stays that way when they leave does so in spite of, and not because of, the prison system.

Re: It's just a tool I guess

[u38cg]

I hope you never have to go on opiates to manage chronic pain, but one positive side effect is you would realise how damn stupid you sound right now.

Re:It's just a tool I guess

[EzInKy]

Which puts society on the hook for their room and board when they get put in jail, numnuts! Understand and fix the root of the problem, which might be human being's natural tendency to avoid pain and other stressors such as hunger and poverty.

Re:It's just a tool I guess

[sribe]

That's the only reason why.

No it's not; you're forgetting Richard Nixon's white-hot hatred of hippies ;-)

Re:It's just a tool I guess

[Zero__Kelvin]

"Turns out that their potential for misuse far, far outweighs any medical benefit."

That doesn't "turn out" to be true at all. It "turns out" that when society is confronted with a choice between the truth and their highly biased propoganda induced viewpoint, they form absurd conclusions like: "Turns out that their potential for misuse far, far outweighs any medical benefit."

Let's start with the ridiculous term "mis-use". Who the hell are you to tell me what "mis-use" is for me? If I want to use cocaine to get high, then I snort it and get high, guess what! I didn't "mis-use" it. I used it for exactly what I intended to use it for. You can take your belief that it is your right to decide what is "mis-use" for me and shove it right up your ass.

Re: It's just a tool I guess

[flynt]

The Phase III study "Study 801" of the compound under discussion did have an open-label run-in period, *and* was placebo controlled.

I believe the ct.gov link below is the study under consideration. Regardless, the press release mentions the placebo control.

http://clinicaltrials.gov/ct2/...

http://ir.zogenix.com/phoenix....

From the last link:

Zohydro ER was studied in over 1,100 people living with chronic pain who participated in the pivotal Phase 3 efficacy study or an open-label Phase 3 long-term safety study. The efficacy study that enrolled over 500 subjects with chronic low back pain met the primary endpoint in demonstrating that treatment with Zohydro ER resulted in significantly improved chronic pain relief compared to placebo.

Re:It's just a tool I guess

[Impy the Impiuos Imp]

Biggest dose did nothing? Did your study have a placebo group that you might have been in?

Re:It's just a tool I guess

[SecurityGuy]

Interesting. I had the same experience with one of the oxycodone + NSAID combos. I forget which one. Might have been vicodin. Anyway, I had a severe toothache that was going to be a Monday morning root canal. Oxycodone over the weekend was the pain management plan. I found it was less effective than the 600 mg of ibuprofin, so I quit using the oxycodone and went back to the IB. I was still in pain, but less pain.

Re:It's just a tool I guess

[interkin3tic]

You say the potential for misuse outweighs any benefit, but then suggest we go back to at least one of them? I am confuse.

Re:It's just a tool I guess

[kilfarsnar]

I don't presume to know how close you've ever been to full-on drug addiction,

but in my own admittedly small sampling,

many an addict's confinement is the only time in their adult lives they're not using. A great friend passed last year at the ripe old age of 48, but his life was probably extended a decade by frequent periods of abstinence as a guest of the County and State.

I have been very close to addiction. I have watched a good friend put heroin into his arm, and had another die of "massive organ failure" after many years of drug use. There was a time when at least half of my friends were in AA. I agree that some people need confinement to stop using, at least temporarily. But I think that's what we have inpatient rehab for. Confine someone if you must, but don't put them in jail. Prison is not an environment conducive to improving one's mental and physical health; it just makes things worse.

Re:It's just a tool I guess

[l0n3s0m3phr34k]

I know of people who specifically get arrested just to smuggle drugs into jail, so yeah...and several of the "rehab centers" in my town are awash with pills...even crooked staff. On top of this is 4-6% population is genetically inclined for opiod addiction. Some of these "severe pain" patients may someday find themselves; after surgery and recovery, puking up for days on end, hot / cold flashes, massive mood swings, extreme agitation at everything, inability to remember where they just "put down something", passing out while doing whatever (especially just sitting there), and many more issues that only hit AFTER you try to quit.

Inevitably, these will quickly work their way to the street. Pharmacorp's have NO ABILITY to control their distribution after they leave the factory, and will be, within months of this drugs approval, lying to doctors about "off label" usage and getting them to replace weaker pain-pills with these. And their not effecting the liver will be a huge addict draw...many older addicts can't really take lortabs, whatever due to other drugs in them.

Re:It's just a tool I guess

[Zero__Kelvin]

"It's hard to have a black market if no one makes the drug for any legal use."

Someone should invent Crystal Meth!

Re:It's just a tool I guess

[Immerman]

> My only point was that there's rarely such a thing as drug addiction only harming the person taking them.
FTFY. Let's keep the focus on the actual problem shall we? Nobody raises a stink about somebody having an occasional drink or two, enjoying a chocolate bar, or pounding caffeine at work, and all of those are every bit as much a drug as anything on the prohibited list. Hell, caffeine consumption is usually evidence of someone with a full-on addiction, the stuff habituates you faster than heroin IIRC, and yet I've never heard of anyone trying to ban the stuff.

Re:It's just a tool I guess

[l0n3s0m3phr34k]

Even though I feel most of this is pure rhetoric, there is a grain of truth. I have a friend who is 37, on social security disability, because she was given too many pain pills by doctors and they "enabled" her addiction. That's what the SSI doc said at the hearing...her lump sum was around $35K.

Re:It's just a tool I guess

[l0n3s0m3phr34k]

And I'll bet a chunk of them are already addicted to opiates but just don't realize it yet, like Rush. If you go in for some surgery, you might be one of the "lucky" genetic addicts but you won't know until your script runs out...

Re:It's just a tool I guess

[l0n3s0m3phr34k]

HAHAHA your cat...they gave my cat a tiny bottle of liquid Tramadol, it was very funny watching him nod off and fall off stuff for awhile!

Re:It's just a tool I guess

[jamstar7]

I don't presume to know how close you've ever been to full-on drug addiction,

but in my own admittedly small sampling,

many an addict's confinement is the only time in their adult lives they're not using. A great friend passed last year at the ripe old age of 48, but his life was probably extended a decade by frequent periods of abstinence as a guest of the County and State.

Problem with simple confinement is, it doesn't fix the problems, just delays the next dose. And don't think for a minute that jails and prisons are drug-free. They're not. Drugs are available, just at insanely high prices due to scarcity.

Speaking as a recovering addict, you need to fix the cause, not the symptoms. Incarceration does neither, and tags the 'offender' with a felony rap, making it that much harder for them to reintegrate to society by blocking employment opportunities when they get back to the streets. End results? The 'offender' ends up back in jail.

Re:It's just a tool I guess

[ehiris]

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.

Re:It's just a tool I guess

[l0n3s0m3phr34k]

Many of the actual Zohydro overdoses probably will be mis-classified as well. Unless the police find them with a bottle of it, how exactly will they tell Zohydro from Oxycontin or heroin once it's absorbed in the bloodstream?

Re:It's just a tool I guess

[mog007]

In the United States, heroin is a schedule 1 drug. Which means it's illegal to use it for recreational, medical, or research purposes.

Even if heroin were a better choice, it's illegal to reintroduce it.

Re:It's just a tool I guess

[gfxguy]

Agree completely with 'causality,' but have no mod points. I'm sorry if it hurts friends and family, and if they deem an intervention is necessary, then that's fine... using government to mandate behavior that doesn't violate the rights of others, however, is not.

Re:It's just a tool I guess

[Kjella]

I agree that the war on drugs is stupid and causes more harm than good. However, the counter argument that "people should be allowed to do things that only hurts themselves" is pretty poor in the case of most addictions (including but definitely not limited to drugs). Personally, I think people should be allowed to do whatever they want as long as there's no adverse affects to those around them. Unfortunately, most people only think of the immediate physical effects (e.g. secondhand smoke) and don't think of the more long-term effects, especially those which are harder to quantify.

If you just make it broad and vague enough practically everything will have some adverse effect on something. Or if not with certainty then with for some of the people some of the time and the increased risk meaning an increased risk. Or it's not by itself harmful but is somehow a gateway or stepping stone to something which might have adverse effects.

For example, take alcohol and let's forget all the health effects. Alcohol drinking is probably the leading cause of public urination which is clearly some form of adverse effect. It's also known that it lowers the inhibitions to violence in some people, so in the wrong situation it can clearly lead to adverse consequences. And obviously drinking is a prerequisite to drunk driving, which we all agree is bad so it's a gateway to adverse consequences. If you start putting enough bullshit like that together you can make almost anything seem bad. And I just wanted a beer.

If you preemtively need to take everyone's freedom away to avoid the risk that they'll someone infringe on someone else's freedom you're throwing the baby out with the bathwater. If I want to get drunk, I should be able to get drunk. If I'm becoming drunk and disorderly, drunk and violent or drunk and driving then you can stop me. And even assuming I've got an addiction and is borderline alcoholic, what good does being a borderline alcoholic and a criminal help me? No, I disagree with you it's my life and my right to fuck it up. If I want to go to McD and supersize it every day until I'm 500 pounds and die from obesity that should be my choice.

As for covering the costs of public healthcare, well I'd rather pay it rather than have the health nazi police trying to measure how healthy I'm living and metering out an appropriate tax/insurance premium. A truly "fair" distribution of costs would also involve a truly invasive surveillance society where I couldn't enjoy the pleasure of drinking my own beer in my own house without somebody recording it and adjusting my risk profile. But hey, I'm willing to put that to a vote if you are...

Re:It's just a tool I guess

[Mr D from 63]

I agree that the war on drugs is stupid and causes more harm than good. However, the counter argument that "people should be allowed to do things that only hurts themselves" is pretty poor in the case of most addictions (including but definitely not limited to drugs). Personally, I think people should be allowed to do whatever they want.........

Why not treat drugs like any other product. Sell it legally, with reasonable regulatory restraints like age limits and prescription requirements where applicable. Then, if someone gets addicted or hurt in any way, simply sue the living crap out of the manufacturer and/or delivering entity.

Re:It's just a tool I guess

[coolsnowmen]

As other people have noted there is a difference between detox in confinement and putting them in jail as a criminal. Getting out of prison is not like getting out of detox. You are a criminal now, and can't get a job, and in some places can't vote, get certain types of public assistance... basically, you get fucked.

Re:It's just a tool I guess

[gfxguy]

I've had several shoulder surgeries and was prescribed both oxy- and hydro-codone. I experienced the itching, but it worked great, and the OTC pain relievers did nothing. I still suffer, in fact; I never became addicted - once it ran out I tried all the non-opiate alternatives the doctor prescribed. None of them worked. I live in pain every day, but most days are completely bearable. When I do feel pain, the other medications don't help. I know that if I work out or do yard work or something, I can take the non-opiates and stave off the terrible pain I would feel hours later, but when I already have pain they are ineffective. I haven't had any of the "strong" stuff in over a year and a half... and yet, if I mention that the other drugs don't help to my doctor, it's obvious to me he thinks I'm pill shopping.

I mention it because the biggest complaint I see against this over-the-top, for-your-own-good regulation is that the people who are actually in pain are treated like criminals and often denied medications that would make life more bearable. I admit I've managed without, so I'm not including me in that list... but I understand the position completely.

Frankly, even before my surgeries, I never agreed with the war on drugs; I do not agree with vice laws in general.

Re:It's just a tool I guess

[causality]

That's the only reason why.

No it's not; you're forgetting Richard Nixon's white-hot hatred of hippies ;-)

One could also mention the blatantly racist methods used to promote prohibition of both cannabis and cocaine. But like Nixon's control-freak hatred, that was a means to an end. The lobbyists I mentioned wield the real power in Washington and decide what becomes or remains the law of the land.

Re:It's just a tool I guess

[sunderland56]

Heroin has already become massively popular as a recreational drug; so there is no downside to using it in medicine.

A brand new drug meant solely for medical use - e.g. oxycontin - *will* become a street drug. There are many pharmacies that have been robbed or broken into just for the oxycontin; it is so bad in this area that many of them prominently display signs saying "We do not fill Oxycontin prescriptions - no Oxycontin on the premises". I think the point here is not to create another drug that will cause the same problems.

Re: It's just a tool I guess

[ColdWetDog]

Just to be pedant, but hydrocodone (the active ingredient in The Fine Drug) is similar, but different from oxycodone, the active ingredient in Oxycontin, the long acting formulation.

The Big Deal about TFD is that it is the first pure hydrocodone product available (in the US at least). All other hydrocodone containing medications have been mixed with acetaminophen (paracetamol to you people that insist on driving on the wrong side of the road) or ibuprofen. The theory is that adding another drug with different analgesic properties increases the analgesic effect (true) and that 'adulterating' the opiate with another drug makes it harder to abuse since you will, at some point or another, die of liver failure (acetaminophen) or a GI bleed (ibuprofen) - which isn't true.

So, unleashing this drug, free from contaminating tylenol, will cause a massive uptick in hydrocodone addicts.

Which is probably not true. However, the need for long acting hydrocodone is limited at best. While there are people that can take hydrocodone and not oxycodone, you have several other long drugs in long acting formulations for chronic pain (fentanyl, morphine).

The drug WILL be popular among the abuser community because there are some people who want to keep their livers intact.

As has been described here, the current War on Drugs (TM, patent pending US Drug Enforcement Administration) is a total failure and a more rational approach to drug use is needed. But what do you expect from a country that has a Bureau of Alcohol, Tobacco and Firearms as well as a Drug Enforcement Administration. If you were naive to the US you might think these federal agencies were promoting these issues. Double plusungood.

For folks with access to Science, there is a timely article on this subject.

Re:It's just a tool I guess

[ColdWetDog]

The really screwball thing about marijuana and the feds is that plain old marijuana-in-a-baggie is a DEA Schedule I drug (no medical use, high risk of abuse). The concentrated form of the active ingredient in marijuana (THC) is a Schedule III drug (limited abuse potential, you can call the drug in over the phone, you can get refills unlike Schedule II drugs like The Fine Drug in TFA).

Pharmacology is hard. It's not that hard.

Re:It's just a tool I guess

[ColdWetDog]

The DEA could reschedule heroin (or marijuana, another Schedule I drug). It is planning on rescheduling all hydrocodone containing products from Schedule III to Schedule II (most restrictive). So it's just an administrative rule.

Re:It's just a tool I guess

[noh8rz10]

the war on drugs is fine, but it needs to be a war on drug dealers specifically. anybody who has ever sold or given drugs to another person. brought a joint to a party? no freedom for you! just like forgiving the downloaders but going after the up loaders.

Re:It's just a tool I guess

[sribe]

One could also mention the blatantly racist methods used to promote prohibition of both cannabis and cocaine. But like Nixon's control-freak hatred, that was a means to an end. The lobbyists I mentioned wield the real power in Washington and decide what becomes or remains the law of the land.

Well, we're really talking about a long time span. The blatantly racist methods were used to initially ban marijuana, and were clearly carried out by legislators who had been bought and paid for by the lobbyists. But I don't think the promotion to Schedule 1, about 40 years later IIRC, was pushed by any lobbyists--it was a pure executive branch thing, and based on the flimsiest of pretend science.

Re:It's just a tool I guess

[ColdWetDog]

Unless the police find them with a bottle of it, how exactly will they tell Zohydro from Oxycontin or heroin once it's absorbed in the bloodstream?

Toxicology tests. It's easy.

Re:It's just a tool I guess

[gfxguy]

Agreed... the more we let society baby us, the more society is allowed to dictate our personal behaviors. I don't see why people don't get that.

Re:It's just a tool I guess

[noh8rz10]

Ask an older person about what police used to be like sometime.

i don't get it because I don't know. what would an older person say?

Re:It's just a tool I guess

[gfxguy]

I'm not a fan of recreational drug use, but I don't see why someone should require someone else's permission to do something. In other words, prescriptions are great for two reasons: the doctor knows better than me what will help, and I acknowledge that; and you can get your insurance company to pay for it (or at least offset your deductible) because the doctor actually prescribed it. But I've never felt a prescription should be necessary to obtain a drug. Then again, I don't agree with vice laws at all, even if I don't recreationally use drugs or solicit prostitutes.

Re: It's just a tool I guess

[Joey Vegetables]

I agree with you for the most part, but just an important factual error here: one most certainly WILL die from a sufficient excess of acetaminophen/paracetemol, possibly days or weeks later, and it is not a fun or pretty death.

If the goal is to exploit the synergistic effects of NSAIDs plus opiates, there are substances such as acetylcysteine which can be added to acetaminophen/paracetemol which make it vastly less toxic, by stimulating production of glutathione, which conjugates the most toxic of its metabolites (NAPQI) into relatively harmless byproducts and thus prevent death by liver failure.

If the goal is to reduce the abuse potential, I'd think that adding low doses of a cumulative but relatively mild poison, maybe an emetic, would do the trick . . something that would cause discomfort but no permanent damage. I'm not quite sure what would work in that capacity, but, given how toxic acetominophen becomes once glutathione stores are depleted, I'd think practically anything would work better for that purpose than that.

(Disclaimer: IANAD or other medical professional.)

Re:It's just a tool I guess

[LongearedBat]

They often need more than medical help. They often need counseling and help to get back on track. But what they don't need is punishment for being addicts.

(Punishment for committing drug related crimes is a different matter.)

Re:It's just a tool I guess

[SJHillman]

When the hell did I say anything about jail?

Re:It's just a tool I guess

[LongearedBat]

Prison / Jail is never the answer, and every single claim that they make that your loved one will get "help" in prison is a straight bullshit lie.

Agreed, and not just for drug use, but generally.

Modern society ought to have advanced enough by now to have other, better ways than the fairly archaic prison system. We have found a few alternatives (such as the Swiss system of drug rehab). But we need more options for other types of problems. I think it's time we made a serious effort to find better alternatives that yield better outcomes.

Re:It's just a tool I guess

[Bryan Ischo]

Lucky dog. I took a business trip to the U.K. and developed an abscess on the airplane. By the time I landed I was in excruciating, nearly panic inducing pain. And I had a week long business trip to attend to. I went to a public dentist and they wouldn't do anything for the pain - they gave me some antibiotic pills that they said should take care of the abscess in two or three days. And in the meantime? Just deal with the pain.

I maxed out on ibuprofin and acetominophen, alternating taking about 50% above maximum dose of each every two hours. I would get a slight relief, bringing the pain to almost bearable for about half an hour, and then it would go back up to full pain level. I would sit and rock back and forth in front of the computer in unbearable pain and focus enough energy to concentrate on my job for a few minutes at a time.

I didn't sleep for nearly two days (was badly jetlagged anyway) and not a morsel of food entered my mouth for about 50 hours.

This all started on Wednesday. On Friday night I started to feel a little better, was able to even fall asleep and then on Saturday I woke up and ... the pain was gone. Hallelujah! Coincidentally the two days of rainy crappy weather were over and the sun was out. Just in time for me to enjoy the driving trip to Cardiff I had planned for myself.

When I got back to CA my doctor did a root canal. This was on a tooth that had already had a root canal 7 years earlier but his conclusion was "I guess I missed some nerve endings the first time around".

Alls well that ends well I suppose but ... I would have *killed* for some real painkillers at the time. I've never taken vicodin or any kind of opiate at all, and generally would never want to, but in this case ... I would have made the exception.

Re:It's just a tool I guess

[Bryan Ischo]

I don't use illegal drugs and have no interest in doing so but ... right on. I fully support your right to use whatever substance you want on yourself in whatever way you choose. I agree that the language surrounding the drug debate is heavily skewed towards the presumption of a certain anti-drug viewpoint, and I think it's unfortunate that most people are incapable of the strength of resolve necessary to put their own personal fears aside and engage in the discussion on drugs in a logical, open minded manner.

Re:It's just a tool I guess

[QRDeNameland]

But I don't think the promotion to Schedule 1, about 40 years later IIRC, was pushed by any lobbyists--it was a pure executive branch thing, and based on the flimsiest of pretend science.

Sorry to say, but you are mistaken on several counts. The scheduling of drugs only came about with the Controlled Substances Act in 1970, passed by Congress (i.e., lobbyists were surely involved) and signed into law by Nixon. Marijuana was Schedule I from day one and has remained so, even though Part F of the umbrella legislation (the Comprehensive Drug Abuse Prevention and Control Act of 1970) known as the Shafer Commission, tasked to study the problem of marijuana abuse, recommended decriminalization (which Nixon famously ignored).

Re:It's just a tool I guess

[asmkm22]

Something in the black market is still harder to come by for criminals than if it were freely available. The only part of your argument that makes sense is that it decreases the available for good uses.

Re:It's just a tool I guess

[SJHillman]

The black market sales may be harder to come by, but the money from those sales tends to be used to fund other things that most of society would rather not be funded.

Re:It's just a tool I guess

[bob8766]

I don't presume to know how close you've ever been to full-on drug addiction,

but in my own admittedly small sampling,

many an addict's confinement is the only time in their adult lives they're not using. A great friend passed last year at the ripe old age of 48, but his life was probably extended a decade by frequent periods of abstinence as a guest of the County and State.

At a cost of hundreds of thousands of dollars to the taxpayer. So tell me: Is that a better deal than rehabilitation which would not only cost less, but allow him to stay in the work force contributing to the tax base instead of drawing from it?

Re:It's just a tool I guess

[ediron2]

While I agree that having a felony record is cruel baggage to a recovering addict, being stripped of rights for a time is effective when other things fail. My state has a program that is only open to 'use' type drug prisoners. It's hard to get into, it's strict, it focuses on changing habits, breaking away from toxic relationships, and skills needed to hold down a job, plus the usual drug treatment and 12-step program. It has helped a few people I know.

Back before Reagan, institutionalization was similar. It was reviled for some pretty good reasons. But there has to be a midway that takes control of people wanting/needing help but doesn't label them felons. Oh, and that doesn't break the bank: not everyone can afford Betty Ford. This is another time where money can buy you out of a hellish fate: "I know I need help, your honor." "Well, you're broke, so if I send you to prison for a year to 18 months, in 14 months you should get into the program. Hope you survive being labelled a Felon." vs. "I know I need help, your honor - I've booked myself into Betty Ford Center." "Well, I think we can go with a suspended sentence, which I'll expunge from your record if you stay clean."

Re:It's just a tool I guess

[dryeo]

My Dad, when he was alive and having grown up around the time of WWII in England considered the police as a force that was there to help. Get a flat tire on your bicycle, go to the police station. Get lost, go to the police station. Get falling down drunk, a nice police man would walk you home and so on.
Totally different attitude to the police compared to when I grew up where the attitude was to avoid the police at all costs.

Re:It's just a tool I guess

[nojayuk]

You could have bought low-dose codeine/ibuprofen or codeine/paracetamol tablets over-the-counter at a pharmacy in the UK. (Reaches into drawer -- Boots own-brand 200mg ibuprofen and 12.8mg codeine tablets, pack of 16 costs about 8 bucks US IIRC, the duty pharamcist would make sure you understood the dosage limits etc. before selling them to you). They would probably done a better job controlling your dental pain than ibuprofen by itself. Anything over 12.8mg of codeine compounded takes a doctor's prescription, usually 30mg (trade name Solpadol) for chronic pain but they are prescribed readily. My landlord gets them for painful gout flareups, for example.

I use the 12.8mg formulation to cope with very occasional migraines, occasionally I raid my landlord's stash of 30mg Solpadol if it's promising to be a bad one. I make sure I don't travel with them to certain countries though as possession of any codeine compound is a criminal offence in some places, like Japan.

Re:It's just a tool I guess

[Urza9814]

It's pretty rare that "self-harm" only harms the person doing it, especially with addictive substances. They may be the only one suffering the physical effects, but there's emotional, financial, social, etc, etc effects that radiate out to their family, friends, co-workers and more. It's not as obvious as second-hand smoke from cigarettes, but the detrimental effects are still there.

That's far too vague to be of any use in determining *law* though. By that metric you could also argue in favor of banning freakin' dialysis or other life support methods, as there are certainly plenty of cases where those cause greater emotional, financial, and social damage to others by prolonging the inevitable, at an astronomical cost...

Sure, it sucks, but these effects are the kind that other people take on *voluntarily*. They're free to walk away from the addict at any time. In a sense you can consider many of the side-effects to be forms of self-harm as well. Compare this to a *real* crime like homicide...generally nobody *chooses* to be murdered, or willingly buys a gun for a murderer....

Re:It's just a tool I guess

[gIobaljustin]

There is pretty much *nothing* that doesn't have at least an indirect effect on other people. People often get hurt while playing sports, climbing mountains for fun, or doing plenty of other activities that are allowed, and when they do, it can have adverse effects on those around them and even cost taxpayers money. Does that mean everything that isn't strictly necessary for survival or health should be banned? No, because this attitude is anti-freedom. In the land of the free and the home of the brave, we should be willing to accept harm in the name of freedom.

Re:It's just a tool I guess

[noh8rz10]

for me, a caucasian white-collar no drugs no dui etc, i'm like the most neutral person ever and i loathe them. when they're not trying to boost the benjamins by giving speeding and jaywalking tickets (yes, I saw them giving a jaywalking ticket a couple weeks ago!) they just want to get you in the system, not actually provide any help. drunk in public? no walk home. instead arrest, convict, misdemeanor, $$ for lawyer. avoid at all costs.

Re:It's just a tool I guess

[gIobaljustin]

That's idiotic.

Re:It's just a tool I guess

[rk]

You sure he wasn't using in jail? My brother-in-law has been in prison for 20+ years and says that getting drugs in prison isn't a particularly hard thing to do.

Re:It's just a tool I guess

[noh8rz10]

-1 disagree. it's the first thing anybody has said on this thread. go for the pushers. put them in jail. get the users treatment.

Re:It's just a tool I guess

[rmdingler]

Some people, regardless of resources and family support, are never ever going to stop using if left to their own volition.

No matter what you do.

Most, if not all, of these people are aware during a rare sober moment that they are choosing their drug of choice over virtually everything else.

And they still succumb to temptation.

Call it what you want: a lack of will, a chemical imbalance, a genetic predisposition...the result is the same. No amount of counseling or drug legalization is going to fix it.

Re:It's just a tool I guess

[rmdingler]

There's a Red or two in every jail, prison, or restrictive society who can get things.

Prison guards are not so well compensated that they are above bribery, but here's the thing: Most incarcerated humans lack the financial resources of El Chapo.

Many are left with begging family for commissary money so they might supplement their prison cuisine with some Ramen soup or a Reeces, and many more than that have long since burned the familial bridge and have nothing.

Re:It's just a tool I guess

[stephenmac7]

"Regular the hell out of it" and "Let it be" are contradictory.

Re:It's just a tool I guess

[DROP TABLE users]

simple.hydrocodone metabolizes hydromorphone. Oxycodone to oxymorphone, heroin to morphine. It's more complex than that.short version=a blood test. but not to worry.zohydro only gos up to 50mg.that's not alot.about like taking 33mg oxycodone.just better on your liver than taking a hand full of vicodin a day

Re:It's just a tool I guess

[Mashdar]

According to the link below, approximately 5% of people in state prisons in 2012 were incarcerated for possession with no other crime. http://www.drugwarfacts.org/cm... I think it is highly dependent on where you live and the color of your skin. There is a huge racial disparity in police letting offenders off with a warning.

Re:It's just a tool I guess

[david_thornley]

The problem is that this can be extended to lots of things.

I eat too much. I don't exercise enough. I sometimes drink sugared pop. I don't always get enough sleep. This is normally because of decisions I make at any individual moment.

All of that is bad for my health. It increases my health care costs. It increases the risk that I will be unable to provide for myself. In short, if I were forced to exercise, if Coca-Cola were prohibited, etc., there would be savings to society. For that matter, my brother would have required a lot less medical care if he hadn't taken up skydiving (or at least if he'd done that landing right).

Now, I'm pretty near the end of the slippery slope here, but I'm not comfortable with saying to somebody else that, since their habits are worse than mine, if not different in quality, that they are screwed.

Moreover, we'll always have drug addicts. Do we want to keep them on the streets, forced to make their livings and acquire their drugs through any means possible, legal or illegal. I think we're all better off keeping them as mostly non-desperate members of society. Is it cheaper to give somebody food assistance, or to require that person to rob others to get enough money to eat?

Re:It's just a tool I guess

[Dread_ed]

Very true. However, in addition to the obvious harm caused by ridiculous prison sentences, court costs, fines, and the inevitable medical problems from tainted and impure illicit chemicals, there are negative repercussions from the stigma and mental attitudes towards individuals with substance abuse problems. These attitudes are perpetuated and heavily reinforced by criminalization. The feelings of "they deserve what they get" and "well they shouldn't be doing drugs" when someone with substance abuse issues meets an untimely fate or experiences catastrophic problems is insufficient to fostering individual and societal health. These attitudes cause harm to addicted individuals and society alike.

Bear in mind that many of the addicted have untreated mental health issues that prevent them from interfacing with society normally. They "cope" with their mental problems, which could be easily addressed by any number of widely available pharmaceuticals, with illicit drug use. Many of these individuals could be returned to happy, healthy, productive members of society if they were able to interface with medical professionals that could not only help them with their addiction, but also address the underlying problems that led them down the path to addiction initially. The main roadblock to identifying, treating, and ultimately healing these people is directly traceable to the criminalization of drugs.

The irony is that criminalization doesn't stop them from acquiring and using drugs, it just stops them from getting off of drugs.

Re:It's just a tool I guess

[Fjandr]

It may not have been that the drug was incapable of meeting your pain needs. I was on the fentanyl transdermal patch as well, and was having absorption issues resulting in the patch wearing out unpredictably. When I moved back to oxycodone from fentanyl, I went through basically the same thing you describe when you switched to Zohydro. In addition, I also went through intense opiate withdrawal despite being on opiate therapy (again, pretty much as you describe, though shorter in length). There are certain people who fentanyl affects that way. It's phenomenal when it works right, and hell when it doesn't.

I'm glad I wasn't on fentanyl for long enough to go through the lengthy withdrawal you did; I got off it in relatively short order and will not ever again use the transdermal form.

Re:It's just a tool I guess

[Fjandr]

You cannot use non-opiate placebos for control in opiate trials. Not only would it be blindingly obvious to everyone involved who was on the control, it would also violate every standard of medical ethics.

Re:It's just a tool I guess

[Fjandr]

Yeah, that was one thing that annoyed me about the article. 5x the strength of what? Codeine? Hydrocodone? Morphine? Oxycodone? Hydromorphone? Fentanyl? Buprenorphine? Carfentanil?

For an actual answer, according to the description of the person above claiming to have been in the trial (assuming they're correct in the dosing comparison) it's about half the potency of oxycodone.

Well, duh

[Rik Sweeney]

Of course a pain pill is going to frighten people, who the hell is going to take something that causes them discomfort?

(It's worth noting that I may have only read the title of this article)

Re:Well, duh

[Mr D from 63]

It won't hurt to try.

Re:Well, duh

[Thanshin]

"Scary pills are painful to doctors!" - Jhon Deo, DAA (National Dyslexia Association)

Bravo

[tomxor]

Two opinions in 1 summary that wasn't painfully biased to read !

on the bright side

[Hecatonchire]

if it's so potent, you can use it as a lethal injection drug, without being bothered by EU regulation.

Re:Well then

[deadweight]

Seriously now: Doses are not the same for all. Even worse, apparently just TWO of these could be fatal to some people.

Misinformation

[kruach aum]

'There's a lot of misinformation being put out there by people who don't have all the facts,'

I wish I knew how often this was actually true and relevant compared to all the times it isn't.

Problem is, they're probably both right

[jratcliffe]

Put it on the market, and some people will abuse it and OD on it. Keep it off the market, and some people will suffer extreme pain needlessly. Honestly, I don't envy the FDA team that has to make this call.

Re:Problem is, they're probably both right

[ILongForDarkness]

The same war on drugs crowd are the ones that say ACA has death panels and push to prevent any tolerance for euthanasia. They simply don't care if the patient is in pain as long as their moral sensibilities don't get offended.

Re:Problem is, they're probably both right

[WillyWanker]

The problem isn't the people that OD, it's the people that become long-term addicts. Cause they can be anyone -- your neighbor, your kid's teacher, some guy driving behind you. You create an entire underclass of people that are continually addicted to pain pills, no different than those addicted to meth, who will do anything for their next fix. These people are far more dangerous than those that just OD and die.

Re:Problem is, they're probably both right

[l0n3s0m3phr34k]

It is actually way different from "meth". Meth is nasty, made in a trailer or some home-made lab. Zohydro is in a clean regulated factory. Meth can, within a few months, destroy your skin and teeth but I doubt Zohydro is the same. But yeah, in terms of just the addict behavior they do / will have many similarities, although Zohydro will cost much more.

Re:Problem is, they're probably both right

[ILongForDarkness]

Yes because currently peoples lack of apathy in this area has prevented an legalization. Some issues are heated enough and should remain so (abortion, drug legalization and regulation, euthanasia etc) so that constant pressure is put on government/industries to do what is is tolerable and no more to the populous. Not the lowest common denominator of bigot|paranoid|religious zealot|environmentalist wingding but a reasonable approximation of the "reasonable actor"'s opinions. Not doing anything in case you offend someone or because someone someday might expand the legal grants should remove the freedom of the unoffended to act today in their personal (and the only one that matters IMO) best interests. We have government and a process for generating legislation for a reason. Not passing a better legislation because someone else might come along and pass a bad one later isn't governing its sticking your head in the sand so you don't ever have to have a stance on an issue that differs from the most vocal minority on any given issue.

Re:Problem is, they're probably both right

[kumanopuusan]

I'm personally against the current policy of drug control. That said, you know you have a rotten argument when you stop talking about policies and start talking about the people who don't agree with you.

Re:Problem is, they're probably both right

[ILongForDarkness]

It is the existence of vocal fringe groups that allow|create bad policies. Non-terminally ill people (the majority of voters) may have an abstract reason for wanting good pain meds in the future (it could be me suffering one day). Generally speaking the people in the no camp on most "progressive" issues have a less abstract reason for wanting their way: it is somehow evil that is their moral responsibility to wipe out. You can't give good reasons for changed policies to some groups: some groups have their policies handed to them literally on stone tablets and don't care what your argument is because they have a higher power who doesn't have to seem rational to us because His ways are not our ways. Not giving the for camp what they want only makes them moderately more happy with you as an elected official. Giving the against camp what they want both makes it more likely they'll vote for you and equally important stops their phone calls.

Re:Problem is, they're probably both right

[ILongForDarkness]

Oh but it is. The people on the linked letter are addiction treatment facilities and the like. They claim their concern stems from the increased addiction by patients and general public to opiates and, the not surprisingly given the correlation between the two, increased overdoses. Indeed drugs that even when used under medical supervision have a tendency to lead to addictions need to be tightly controlled. But I'd say it isn't the existence of the drugs that are meeting a medical need that is the problem, its the failure in the controls. Perhaps the newest batch of drugs should only be prescribed to terminal cases (if your dead in 2 months it doesn't much matter if you get addicted), or come with a mandatory requirement for substance abuse counseling afterwards/during treatment. This would drastically increase the cost of treating with these types of substances but perhaps when the nuclear option is needed for pain it is the price that must be paid.

Paging Dexter Morgan

[gelfling]

the stuff he uses is 1,000x more potent than morphine

Re:Paging Dexter Morgan

[SecurityGuy]

M99, aka etorphine. I enjoyed that show and had to look it up to see if it's real. It is.

Re:Paging Dexter Morgan

[gelfling]

Don't get me started. W.T.F.?

Higher potency?

[Hrrrg]

As a physician, I am not sure I understand the concern after reading the article. After all, if a drug is higher potency, you just prescribe less of it. Higher potency does not equal higher efficacy (efficacy if the maximum effect that a drug can produce, potency refers to how much of the drug it takes to get that effect). We already have a ton of highly addictive opioids on the market, and hydrocodone is hardly one of the most effective narcotics. If the main ingredient is hydrocodone, how can it be more potent than other hydrocodone containing drugs? Maybe the concern is that it will be easier to get than other narcotics, but hydrocodone is being switched to the more-restrictive Schedule II drug class like oxycodone. Maybe this pill provides a higher dose of hydrocodone than existing medications? The article doesn't say. No doubt people will abuse this new pill, but it is not clear to me why it is thought that this will cause more addiction than already exists...

Re:Higher potency?

[king neckbeard]

I think the issue is that this drug doesn't have acetaminophen, so someone in chronic pain and a high tolerance can take a lot of it without destroying their liver. This also means that it's safer for recreational usage, which theoretically is a concern since they've removed a consequence of addiction.

Re:Higher potency?

[geogob]

I had at first trouble as well understanding the concern, which I have initially related back to me not being a physician. But if I put my engineer hat back on, I start to understand what the issue is (I deal all the time with people having issues, they can't correctly describe or explain). My believe, and I hope someone here can confirm or infirm this, is that the potency is not that much the issue, but rather the variance of the potency. In order word how different is the potency of the drug for different patients, which make dosage very difficult. Albeit this view might be biased, then it is the only logical explanation I personally can find for having an issue with the approval of this drug.

When I read the article, I have the impression that the a lot of different half-arguments are put fore in attempt to convince the reader, through which the real arguments gets diluted and lost.

Re:Higher potency?

[bluefoxlucid]

People don't understand drugs. They don't understand that drugs have a window of pharmacological effectiveness, where you need a dose of X to get the desired effect but T is toxic. There's T1 T2 T3 etc, some drugs are really short-window or complex: T1 may be less than X, and the drug may have constant side effects--prednizone does this, it makes a LOT of people psychotic at normal doses that aren't even high enough to function as a viable treatment for some of its use cases. T2 may be something like euphoria--methylphenedate and dexamphetamine both have a short window between "treats ADHD" and "euphoria" (getting you high), which is undesirable. T3 may be outright toxicity--kills your liver. There may be more or less.

That's not a technical description of course: the industry doesn't use those kinds of terms or talk about multiple toxicity levels T1 less than X less than T2 less than T3.... Normal side effects like anxiety, fatigue, etc. aren't usually called "toxic effects" but if something caused these effects without benefit it would be called a poison.

A drug that's stronger doesn't necessarily mean it's more dangerous. Phenylpiracetam for example is fucking awesome for treating ADHD, in my experience (it's experimental and unscheduled, I bought some, it works for me; I want Hopkins to do a study). Much higher effectiveness, stabilizes psychosis instead of causing it, and it takes a LOT more than an effective dose to start causing toxicity. Side effects are extremely mild. Compare this to just "stronger amphetamines": you would likely get more side effects, more toxicity, and less leeway between an effective dose and a toxic dose. You might be able to model a modified amphetamine that has side effects at higher doses but otherwise functions normally, and thus it would be more effective than dex and safer to use.

So a painkiller that's "5 times as potent" just tells me it will dull pain as well as 5 doses of codeine or whatever. Is it 5 times as addictive, i.e. Phenibut is 10 times as addictive as Valium (why the hell is it legal)? Does it destroy your kidneys? Is it prone to cause your heart to relax (uh)? What's the actual problem?

Re:Higher potency?

[weave]

I take Vicoprofen (for migraine pain). It's mixed with Ibuprofen instead of Tylenol. It still makes me sick all day after taking it. No idea why people abuse it.

For me it comes down to a choice between being in horrible agony all day or having no pain but stuck in bed feeling dizzy and like shit all day. I'll take that over the pain.

Now there may be some anti-nausea I can take to counteract some of the negative affects, but I haven't asked my doctor about that because the effects now ensure I won't abuse it and I don't want to know otherwise I guess.

Re:Higher potency?

[Sipper]

I take Vicoprofen (for migraine pain). It's mixed with Ibuprofen instead of Tylenol. It still makes me sick all day after taking it. No idea why people abuse it.

For me it comes down to a choice between being in horrible agony all day or having no pain but stuck in bed feeling dizzy and like shit all day. I'll take that over the pain.

Now there may be some anti-nausea I can take to counteract some of the negative affects, but I haven't asked my doctor about that because the effects now ensure I won't abuse it and I don't want to know otherwise I guess.

I ended up having temporary facial palsy (i.e. half my face drooped and didn't work) after taking Ibuprofin for a week for severe headache pain related to heat stroke. I also felt dizzy and sick while taking the Ibuprofin, but the headache pain without meds was unbearable. After the headache pain from effects of heat stroke passed I was able to stop taking Ibuprofin, and a week later the facal palsy went away. I can't know for sure that the Ibuprofin caused the palsy, but some number of people that take Ibuprofin report having palsy from it.

The nastiest thing about the facial palsy was that on the side of my face that had the palsy the eyelid didn't "auto-blink" anymore, so the eye would get dry. It was especially noticable on long drives. To wet the eye I would have to consciously close both eyes at once -- for whatever reason that still worked. It's a bit mentally draining to have to constantly remember to close both eyes to wet them.

Hopefully you'll never run into this problem.

Re:Higher potency?

[weave]

Thanks for the warning. I don't take it often enough to probably hit that. The ibuprofen dose is only 200mg, which is one OTC pill.

I pretty much take maybe 1 or 2 a week at most as needed, but they keep me out of the hospital or urgent care place so it's worth it.

(Annoys me that pain pills are hard to get for people who really need them because some people abuse them...)

Re:Higher potency?

[Zero__Kelvin]

The problem is that you are not an actual moron so you will be unable to understand their objections.

Re:Higher potency?

[l0n3s0m3phr34k]

Not quite. There are two main problems. One, missing Acetaminophen (like Vicoden). so many long-term addicts who WERE staying away from stuff because of liver toxicity now don't have to worry about it, and new "abusers" will see that as a "good thing" to go find it for illicit use; that's just the way an addict's brains is logically. Two, it's crushable...meaning it can be snorted or shot up easily. THIS is what's going to kill people...especially missing the acetaminophen. Of course, an enterprising addict might know how to remove acetaminophen from whatever (addicts can get pretty creative with freezers and such)...I can guarantee that if I actually still talked to those people their already in the know and will be hunting for this very soon.

Re:Higher potency?

[tgibbs]

You are correct. You take the dose to achieve pain relief, and for most opioids, the abused dose follows in proportion. In terms of abuse risk, it doesn't matter whether the standard dose is a milligram or a microgram, because the abused dose is proportional to the pain reliving dose. Other factors, such as pharmacokinetics and oral availability, can be important, but potency has nothing to do with it.

Re:Higher potency?

[Sipper]

Thanks for the warning. I don't take it often enough to probably hit that. The ibuprofen dose is only 200mg, which is one OTC pill.

I pretty much take maybe 1 or 2 a week at most as needed, but they keep me out of the hospital or urgent care place so it's worth it.

(Annoys me that pain pills are hard to get for people who really need them because some people abuse them...)

I believe I was taking 2 200 mg pills every 6 hours for a full week straight. (Even if I had to get up in the middle of the night if necessary to take another 2 pills.) Unfortunately that's what it required to make the unbearable headache pain subside. I tried only taking 1 pill, that wouldn't cut it. I've never experienced a headache like that before or since.

Heat stroke also messes up your electrolytes too, so I had to eat bananas nuts and sports drinks for several days, during which everything tasted like metal until I got the electrolytes back. And during that time my face was still drooping from palsy, so drinking without spilling it out of my mouth onto my shirt was a challenge. I can look back on it now and laugh a bit, but at the time it was frightening. Also couldn't whistle, drinking from a straw was extremely difficult too because one side of my mouth couldn't close.

If you're only taking an Ibuprofin here and there I'm sure you won't run into what I did. ;-)

Re:Higher potency?

[weave]

Damn, that doesn't sound like much fun. Sorry you had to go through that. :(

Re:Higher potency?

[Sipper]

Damn, that doesn't sound like much fun. Sorry you had to go through that. :(

No, definitely wasn't.

Thankfully I'm okay and I don't think I'm worse for wear. For a time I was worried that I might have gotten brain damage from it (I know a couple of people that got brain damage from high fevers), but after this happened I went back to college and was able to complete a masters degree in electrical engineering with a high GPA, so I think I'm fine. ;-)

Re:Well then

[Anonymous Coward]

Even worse, apparently just TWO of these could be fatal to some people.

how terrible. we can't let people have something they could hurt themselves with!

Less people will die of liver failure

[damonlab]

This is not as "genuinely frightening" as the number of people that die of liver failure due to overdose or overuse of acetaminophen. The only difference between this "new" drug and the ones currently on the market is that this one does not contain acetaminophen. Old drug = hydrocodone + acetaminophen. This drug = hydrocodone only.

Re:Less people will die of liver failure

[JayBat]

Bingo. -Jay-

Needed

[wisnoskij]

It sounds like there are many use cases where it is basically necessary. Their are people out their who need more powerful drugs, and this is simply safer than taking 20 Tylenol a day.

It would seem extremely reactionary and short sited of healthcare professionals ban this drug because it might increase the risk to abusers over the short term.

Re:Needed

[Eunuchswear]

Their are people out their who need more powerful drugs, and this is simply safer than taking 20 Tylenol a day.

Cyanide is probably safer than taking 20 tylenol a day.

WTF.

The fact is it's not a new drug

[EdwinFreed]

This is just a stronger formulation of hydrocodone than what was previously available. The summary makes it sound like a new type of opiate.

A new opiate could, depending on its characteristics, be a most welcome addition. Existing opiates have a lot of drawbacks.

But this? Not nearly as significant as the summary would indicate. On either side of the argument.

Re:The fact is it's not a new drug

[rhazz]

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

Seems to me that this line sums things up nicely. The problem is not the new drug, it is the over-prescribing of the existing drugs.

Re:The fact is it's not a new drug

[Anonymous Coward]

The difference here being the old formulation of Hydrocodone was only sold at most in formulations of 10mg per pill (in pressed pills, compounded pills are a different story), the rest of the pill being APAP (aka Tylenol) which is another painkiller but is used in this instance to deter abuse (which it does not, most people are aware they can filter it out using cold water and a coffee filter). So not only could people abuse it easily if they knew how, but those who didn't were doomed to liver damage if they tried (and many people arent aware of the dangers that come with an overdose of APAP).

Legitimate patients of medications like this (like Vicodin, Lortab, Loracet, etc) have to take this medication multiple times a day to keep out of pain and some of them have to take just up to the maximum limit of APAP every day. These people are doing damage to their liver and bodies every day because of the old anti-abuse mechanism which doesn't even work.

Now we have this new medication, Zohydro. Zohydro comes in many mg amounts, the lowest being 10mg (which is equal to one maximum strength Lortab, an existing medication containing hydrocodone) and the highest being 50mg (not enough for an opiate naive person to overdose on). There is no harmful anti-abuse mechanism built in like the old formulation. This formula uses a gelling agent to prevent users from crushing and snorting/parachuting/injecting the dose and let me tell you from personal experience with similar gelling systems, they work.

For legitimate patients this new medication is a godsend, yet another tool in the arsenal for doctors to combat chronic pain that doesn't always respond to each opiate equally. And what is great about Zohydro is the fact that you are combing two very desirable features into one medication: Extended release and quick onset. Hydrocodone has a relatively short half life when compared to other opioids that are used for around-the-clock pain management and this gives it the advantage of a faster onset of action while the time release ensures it stays in your system around the clock, releasing only whats needed slowly over the day.

Now lets compare Zohydro to a medication which is being prescribed more and more these days for around-the-clock management of severe chronic pain: Methadone. Both medications will provide around the clock management of chronic pain but there are very drastic differences between them. If I am in severe pain right now and I took my prescribed dosage of methadone it would take over an hour for the medication to start working IF i've been taking it consistently the last few days. If this is my first time taking the methadone it will take even longer since it has to build up in your fatty tissue before it makes it into your blood stream in full force. To get to this steady state it takes a couple days of constant dosing.

Now lets compare that to Zohydro. If I am in severe pain and I take my prescribed dosage of Zohydro I will feel pain relief within the next 30 minutes and it will continue all day until my next dose of Zohydro. There is no difference between the first dose and the next dose, unlike methadone.

Now lets talk about the dangers. Methadone has been known to be extremely dangerous when it comes to the variability with which is enters your system. Methadone doesn't always steadily release slowly over time and in some patients it can suddenly release massive amounts into your system and cause an adverse reaction (a mild overdose if the patient is already taking a high dose compared to their tolerance level). Not only that but methadone is still causing respiratory depression long after its analgesic effects have worn off, an effect which has led to overdoses. Nobody cared about this medication when it was being approved for pain management. And nobody cares to say anything now about the myriad of other opioid medications with similarly dangerous profiles, Zohydro not being one of them.

On the grand scale of pain management with opioids Zohydro is mu

Re:The fact is it's not a new drug

[JayBat]

Ah, I didn't look hard enough; made in dosages from 10-50mg per capsule.

The problem? Not poisonous by design.

[PvtVoid]

The reason everybody is so up in arms is that the opiate is not mixed with acetominophen. The only purpose of putting acetominophen in an opiate painkiller is to make it so it will fry your liver if you take more of it than it was designed for. Basically, such drugs are designed to be deliberately fatal to addicts. So much for "do no harm".

Re:The problem? Not poisonous by design.

[CastrTroy]

It can be more dangerous to more than just addicts. They put acetaminophen/Tylenol in a lot of medications. If patients don't pay attention to which medications contain acetaminophen then they could overdose by accident. The difference between the maximum daily dose and fatal dose is not that big. People who don't realized their opiates contain acetaminophen could also be taking cold medicine or tylenol (you know, for the pain), and end up doing a lot of damage to their body.

Re:The problem? Not poisonous by design.

[Anonymous Coward]

The only purpose of putting acetominophen in an opiate painkiller is to make it so it will fry your liver if you take more of it than it was designed for.

That's very interesting, Doctor... whatwasyourname?

Re:The problem? Not poisonous by design.

[king neckbeard]

The acetaminophen supposedly has an advantage in pain treatment, but if that were the sole purpose, you could just advise them to take some Tylenol in addition to their pain pill. That would almost certainly work out better, and would be far easier to scale for chronic pain patients.

Another bizarre thing done to prevent abuse is the inclusion of dangerous chemicals in otherwise fairly safe recreational substances, such as canned air.or nitrous oxide.

Re:The problem? Not poisonous by design.

[bluefoxlucid]

I hate acetominophen, and ibuprofen gives me headaches. Naproxin works best but I rarely take it because dosing NSAIDs is ridiculous. For naproxen you need 8 hour spaced 100mg doses, but usually you need 200mg on the first dose to get it to work. Don't take more than 300mg/day. How the fuck do I keep this running for 24 hours without overdosing? Fortunately the first dose usually solves the problem: the inflammation goes away, so the pain stops, and the irritation causing inflammation stops (i.e. inflammation causes pressure on inflamed tissue, so if the original irritant is gone the problem self-perpetuates), so the inflammation doesn't return, and the problem is fixed for real.

Re:The problem? Not poisonous by design.

[ILongForDarkness]

Or methanol to rubbing alcohol as a preventative measure. Admittedly drinking alcohol itself is a poison but there is little reason to add impurities to research grade alcohol other than to protect the interests of distillers (and government tax revenue). Because: someone working in a lab wouldn't know to add ~2 units of water for each 1 unit of alcohol.

Re:The problem? Not poisonous by design.

[fulldecent]

Interesting. Citation?

Re:The problem? Not poisonous by design.

[bill_mcgonigle]

They put acetaminophen/Tylenol in a lot of medications

This is so bad to the point that I've found it necessary to order some of the constituent ingredients of various cold remedies off Amazon because I can only get them locally compounded with acetaminophen (paracetamol for our overseas folks) in the big name brands and their store-brand copycats. Fortunately, you can get a couple hundred doses of, say, expectorant, for the cost of a dozen doses of compounded gelcaps. Mix and match in the others as needed - taking drugs you don't need is at best silly.

Re:The problem? Not poisonous by design.

[compro01]

For naproxen...Don't take more than 300mg/day.

Huh? The typical prescription naproxen dosing I see is 500mg every 12 hours or 325mg every 8.

Re:The problem? Not poisonous by design.

[bluefoxlucid]

Naproxen Sodium comes in 100mg doses, blue tablets, with the standard directions of "Take one every 8 hours, you may take two for the first dose, do not exceed three per day." I've never seen it prescription, but this seems silly: you can just buy naproxin and take 5 of them at once instead of a prescription 500mg.

Re:The problem? Not poisonous by design.

[Zero__Kelvin]

House here. He's right and you're a moron.

Re:The problem? Not poisonous by design.

[compro01]

I've never seen 100mg naproxen. Up here, OTC naproxen is 220mg and says take 1 every 12 hours, though you'll realistically want one every 8-10 hours.

Re:The problem? Not poisonous by design.

[JayBat]

Exactly right. -Jay-

Re:Opiates are SO hard to sell

[SJHillman]

The argument for why it's legal is right in the summary if you care to read. They acknowledge the risks, but feel the benefits outweigh it. It's the same argument that was used to give marijuana the push to become legal for medicinal use. As far as I know, nobody has provided an argument in favor of heroin's benefits outweighing it's drawbacks.

He forgot the most obvious thing:

[fredrated]

think of the children!

The articles.

[Anonymous Coward]

The articles give a lot of voice to the critics.

But do they talk to folks who are suffering from pain so much that they'd rather die?

Hardly. They're mentioned in passing.

Everybody is so afraid of the criminals and the occasional overdose, folks who could realy benefit from this drug may be screwed.

But do any of these physcians, law enforement, attourney generals, and every other critic offer a solution to this "opioid addiction epidemic"? Nope.

Do they suggest that possibly there's something going on in our society that gives folks the desire to abuse? Nope!

Addiction is considered a character flaw in our society - lack of willpower - even by most medical professionals.

When you actually talk to these addicted folks, you hear the same stories over and over: child abuse, sexual abuse, violence, care givers that had their own addictions, neglect, etc ...

And it's not just the poor. I've seen some really screwed up kids because their parents were worshipping the bitch Goddess Success and pretty much left the kids to babysitters and then left to their own devices. And they wonder why the kid blows through his trust buying drugs.

We're a shallow and cruel society that eats up its kids and then they turn into fucked up adults.

Oh, and not all are drug addicts or alcoholics. Gambling, over eating, buying shit, ... there is plenty of addictive behavior in this society.

Re:The articles.

[kilfarsnar]

I wish I had mod points today. Well said!

That's okay

[wonkey_monkey]

Just give the patient a fear pill.

Drug warriors are going to hate this medication

[Applehu Akbar]

Therefore I'm in favor ot it.

by doctors?

[wasteoid]

Sounds like DICE is testing their grass-roots bots, although this one is seems to be set all the way to snake handler.

Re:Well then

[lazlo]

This doesn't make any sense to me either. Current pills containing hydrocodone are a mixture with other drugs, mostly other drugs that have a higher toxicity, and part of the reason for that is to keep people from taking too many of them. If you OD on Vicodin, it's not the 5mg of hydrocodone that kills you, it's the 500mg of acetaminophen. For a 50kg person, you can get to a reasonably toxic quantity of acetaminophen (200 mg/kg) with 20 vicodin, which gives you a dose of 100mg of hydrocodone, or 2 mg/kg. Quick googling found this: http://toxnet.nlm.nih.gov/cgi-bin/sis/search/a?dbs+hsdb:@term+@DOCNO+3097 that gives animal toxicity studies showing an LD50 for hydrocodone in the range of 86 mg/kg (mice) to 375 mg/kg (rats). Granted, you certainly don't want to take anything *near* to the LD50 of any drug, but the highest dosage for a Zohydro pill is 50 mg. For a 50kg person to get a dose of 1/4 the mouse LD50 would be over 20 pills. As noted, if those 20 pills were vicodin, then they would also be toxic, but only because of the acetaminophen. And really, if you're downing 20 of *any* prescription painkiller, you almost certainly have a different goal in mind than temporary pain relief. I just really don't see this as causing much harm, and potentially helping a fairly specific set of people who need it.

hey cancer patient

[ILongForDarkness]

your lack of pain frightens me. Cut it out.

Re:Some people overuse pain killers today

[bluefoxlucid]

Body builders abuse pain drugs so they can rep harder. It's stupid.

Stupidest thing I've ever read. It's not 5 times..

[p00kiethebear]

It's only five times the dose of other hydrocodone tablets available. Doctors are going to always over prescribe opioids. If this one wasn't available then it would be a different one. I will say though that hydrocodone has a much more euphoric high. It might make it more desirable over existing oxycodone options. It should be noted that doctors already prescribe hydrocodone in these doses. This just means that chronic pain patients will only need to take 1 pill instead of five.

Just because one new tablet becomes available doesn't mean there is going to be a sudden mass explosion in the number of pain pills available on the street. If people weren't ODing on this drug then they'd be ODing on one that's already available. But somehow we interpret people dying from overdose on a new pain killer as being 'added' deaths. When statistically the death would have happened on one pill or the other.

Time released

[Charliemopps]

The problem with this drug isn't the potency. It's that it's time released like Oxycontin. Oxycontin was billed the same way this drug is... the same arguments. Doctors didn't think much of it at the time and used it. What we found out however is that opiates that are time released are orders of magnitude more addictive than just getting a "hit" by taking an immediate release.

Now, I'm pretty libertarian, and feel that people should be able to destroy their lives in any such way they feel. But lets at least understand the basis of the fear before we start arguing about it.

Re:Time released

[Zero__Kelvin]

" What we found out however is that opiates that are time released are orders of magnitude more addictive than just getting a "hit" by taking an immediate release."

You better check your methods, because you didn't find out shit. Time released Opiates are no more addictive than Opiates in non time-released form? Why? Because the addict is going to do his own time releasing. Either way his system is staying full of Opiates. He doesn't wait until there are none in his system before doing more. It simply doesn't work that way. An addict using a time released pill and one with non-time released have the exact same condition. A constant supply of opiates in their system. Good luck figuring out where you went wrong!

Re:Time released

[p00kiethebear]

^This

Re:Time released

[Fjandr]

Standard release opiates are far more potent, because they are absorbed far more quickly. An SR tablet produces 3x the concentration as an ER tablet, because they're metabolized 3x as quickly.

Or perhaps the opiates I use are voodoo and work in exactly the opposite manner they do for everyone else.

Pain pill

[Yakust]

I don't think I want to take a pain pill...

Probably current best treatment

[Anonymous Coward]

I don't know for this specific instance, but generally for studies like this, the control is not a placebo but current best treatment.

3 people vs 250 million

[Arkiel]

Yeah, when you're arguing for a drug that effectively adds another abuse risk to society at large, maybe you want to cite more than three people who benefit from it? Does anyone with liver failure need this drug? About how many people suffer from recognizable chronic pain and liver failure together?

Re:3 people vs 250 million

[Zero__Kelvin]

"Yeah, when you're arguing for a drug that effectively adds another abuse risk to society at large, maybe you want to cite more than three people who benefit from it?"

When they are doing that we'll get back to you. Right now they are just claiming that taking 1 pill is more dangerous than taking 5 that each have 1/5th the potency. In other words, they are idiots who neither understand addiction or math.

Re:3 people vs 250 million

[thedonger]

Yeah, when you're arguing for a drug that effectively adds another abuse risk to society at large, maybe you want to cite more than three people who benefit from it? Does anyone with liver failure need this drug? About how many people suffer from recognizable chronic pain and liver failure together?

They are trying to humanize the issue, much like when a politician drags Grandma Winnie on the stump circuit as his example of the frail, old widow who can no longer afford her Depends undergarments. One would think that if they are a month away from FDA approval then they provided more than anecdotes to support their claims.

Re:Typical Pharmaceutical Co. Logic

[king neckbeard]

What if we do know why someone is in so much pain and they need a drug this powerful? There are people that will be in pain all of their lives, the nature of opiates ensures that they will eventually get used to their current dosage, and if they take more of the existing pills, their livers will be destroyed.

last thing?

[nitehawk214]

the very last thing the country needs is a new, dangerous, high-dose opioid

Unless, of course, you are in serious chronic pain. Then, according to Dr. Stephen Anderson and friends, fuck you. You are obviously faking it because if they can't imagine needing this drug in the emergency room, then it must be useless to everyone.

Re:last thing?

[Anonymous Coward]

Those are about the only kind of people, those like him who don't care if people suffer, that I wish would get into a terrible car wreck that twists and wrecks their spine, herniates a few discs, even fractures a vertebrae or two; not to the point of paralysis of course, but enough that they seriously understand daily chronic intense pain properly, and stop denying it to people who genuinely need it who are in hell. Then we'll see how anti-pain pill they are.

I've got messed up discs myself and take lortab (as mentioned upthread, certainly not the strongest stuff), but gee, I've managed to take the prescribed amount, and no more, for years on end. I started to slip some while ago, but pulled back with sheer willpower- no intervention, no detox.. just growing up about it.

And anyone who says Ibuprofen or Tylenol works better for them is likely a DEA shill or got placebos, because that's a load of crap. I can understand the nausea, yes, but to say opioids are less effective than over the counter counter analgesics is ridiculous.

Re:last thing?

[ToddInSF]

This is not a new drug, though, you're just buying into drug company PR.

You can get the same exact drug for a whole lot less, in doses that are significantly safer, that are not in the newly patented time-release form, which is simple to abuse and OD on, by just grinding up the very high dose capsules.

So no, this is not about a new necessary ER drug AT ALL. This is not about refusing people who need pain meds treatment. This is about PR and profit over lives, period.

Everybody here needs to look at the list of those 40+ organizations and stop being such fucking tools for big pharma. These are not organizations for the most part with an agenda to keep people in pain or facilitate a war on drugs. These are patient-oriented organizations doing their job -advocating for people who need safe meds.

Re:last thing?

[Fjandr]

And anyone who says Ibuprofen or Tylenol works better for them is likely a DEA shill or got placebos, because that's a load of crap. I can understand the nausea, yes, but to say opioids are less effective than over the counter counter analgesics is ridiculous.

That's not entirely true. There are people who do not metabolize opioids effectively. They are, however, very rare. I'd guess most people who say the above actually have little or no experience with opiate painkillers, and are instead spouting BS they heard from someone else in order to look informed.

Don't outlaw it, just highly regulate it

[davidwr]

I think there is a classification for drugs that can only be administered in tightly-controlled, supervised settings.

Perhaps this drug should be classified this way, at least for the first year or two.

Re:Don't outlaw it, just highly regulate it

[jeffmflanagan]

So that bed-ridden people in terrible pain have to be dragged into a clinic? That sounds cruel to me.

Re:Typical Pharmaceutical Co. Logic

[nitehawk214]

No need to find out why these people are in so much pain that they need a drug this powerful. This pill will make everything better! Healthy people are not profitable, after all.

Says the person that has never visited a hospice in their life, or seen a loved one build up a tolerance to fentanyl that they cannot be awake and not in pain. There are people that are dying, and we know why they are dying... and there still isn't a damn thing we can do about it. (it's usually advanced cancer)

But no, every new drug produced by pharmaceutics companies is part of some conspiracy to produce maintenance drugs and not cures.

Re:Opiates are SO hard to sell

[nitehawk214]

It's funny that drugs are so great when they are released by profiteering pharma companies. But smoke a doob and OMG what about the children! That pill there is many many many times the strength of heroin. It will undoubtedly create many many new addicts just like oxycontin. That pill will kill good people and addict good people. A company will gladly make money on that pill and market it with hundreds of thousands of dollars to doctors.

We should all make pills for a living and profit off of peoples sorrowful addictions.

It will also save good people terrible pain. What is your solution?
Ban all drugs that anyone could be abused? (and to hell with anyone that needs them)
Ban companies and doctors from making a profit? (and ensure nobody develops drugs or becomes doctors)

I am not saying that the current practices of companies are not a problem, but can't we have some middle ground here? Regulate companies from abusing their power, while allowing them enough profit to actually develop new treatments.

Because

[WillyWanker]

Getting all these poor people addicted to your high-potency opioids is SURELY going to make their lives better! Oh, and fatten your wallet. The latter being the most important part.

Misinformation???

[oh_my_080980980]

You mean from the FDA-appointed scientific advisory panel which voted against its approval.....hmmm.....

Re:Vicodin++ ??

[p00kiethebear]

Yes. That is essentially it. Now pain patients will only have to take one pill instead of 5.

I'm sceptical

[Bohnanza]

I'll just have to try some before I make up my mind about it.

Pain must be a good thing

[Anonymous Coward]

So, some doctors want their patients to suffer only because some people might abuse the drug? Assholes.

Is the abuse problem really that big a deal?

[ErichTheRed]

I know "drugs are evil" and all, but I genuinely don't understand why people are so panicked about people abusing prescription pain killers. The reality is that there's a huge demand for pain medication, both for legitimate and abuse purposes. Just like the other wars on drugs, it's impossible to stop. Therefore, I'm of the mind that we shouldn't do anything...and that's coming from a very left-wing, big-government type. We should focus on providing abusers safe drugs, and spend the money we save on enforcement on treatment for the people who really want to get off drugs. I've never touched drugs, but I can't blame someone who has a crappy life and no prospects of it getting better from doing so.

Providing pain medication addicts with a preparation that won't destroy their liver (due to the included acetaminophen in other meds) would be a start. There's no fix for the demand problem, and reducing supply just drives up the price.

The reality is that the future is looking pretty bleak -- unemployment is going to be incredibly high as even safe middle class jobs are automated. Unless we want a revolution, it might be time to start loosening the restrictions on controlled substances. When unemployment goes up past 30, 40% and higher, governments are going to have angry mobs on their hands unless they have something to keep them occupied...

Re:Is the abuse problem really that big a deal?

[ToddInSF]

Hydrocodone in this form is going to kill a lot of people, that's the issue here. When your per dose amount is high enough that it can easily kill by simply grinding up the capsule, that's a real problem.

At least adding acetaminophen to hydrocodone has some marginal positive impact, while rendering the hydrocodone relatively unusable. This form is going to just ratchet-up tolerance in people with severe addictions even higher.

What people don't seem to understand is that the lethal dose of a drug changes as your tolerance increases and an addict requires more and more of the drug. Simply making available a pure form of the drug so that they can ratchet that amount up high and higher so easily is going to kill a lot of people. How high do you want addicts to increase their consumption ? To twice the lethal dose it takes to kill someone that isn't taking the drug ? To ten times ? To twenty times ?

People seem to believe that the drugs themselves in their pure form are safe. This is not true and has never been true. It's insane to make it easy to supply people with enormous doses of relatively pure drugs so that they can continuously increase their dose to the point that they need to take a single dose that would kill ten drug naive people, and then pretend that living your life taking those doses isn't going to shorten your life significantly anyway.

The only people that want this are the drug companies that make a huge profit because they've managed to get a patent for doing basically nothing, and addicts. And stupid people that place some bullshit ideal above a comprehension of the reality.

Re:Vicodin++ ??

[Zero__Kelvin]

No. Vicodin has Acetominiphen. It is however Hydrocodone++

Re:Opiates are SO hard to sell

[l0n3s0m3phr34k]

You can't really inject marijuana though, unlike Zohydro. And two "hits" of pot won't kill you, but this could. But, it will probably be around $50-$80 on the street per pill (50mg and all)...

Re:Vicodin++ ??

[p00kiethebear]

Most people use the term interchangeably but thank you for your correction. Yes it is five times the highest dose hydrocodone pill.

Re:of course it'll be approved...

[Connie_Lingus]

right...what's required to watch TV shows is an interest in the contrived bullshit rehashed melo-drama pro-police state propaganda that's spoon fed to couch potatoes to numb their minds for a while...

they have yet to invent a device that could accurately measure my massive indifference to that sort of thing.

and what the fuck is a hipster? is that like calling someone a dork or a nerd or something??

My story is just like yours...

[Anonymous Coward]

Many people have not experience such severe pain that they will need a drug such as this. After a failed back surgery, and a battle with cancer, I, too, have been using the fentanyl patch. Part of the purpose of this drug, which is hydrocodone without the added acetaminophen, is to allow chronic pain users to take it, without destroying their liver in the process. Many people don't know the long-term damage that acetaminophen can do. Some people have pain so bad that they cannot get out of bed. Their lives are ruined...they cannot work, enjoy life, even move or interact with family. And further regulating this drug, which I am sure will happen, will simply make the lives of those who need it miserable. Their pain docs will be put on quotas, and patients will be denied meds simply because "too many" of their pain doc's patients are already on it. The recreational opiod drug users ruin it for everyone.

This is really just a patent extender

[un4given]

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.

Re:Well then

[JavaLord]

This doesn't make any sense to me either. Current pills containing hydrocodone are a mixture with other drugs, mostly other drugs that have a higher toxicity, and part of the reason for that is to keep people from taking too many of them. If you OD on Vicodin, it's not the 5mg of hydrocodone that kills you, it's the 500mg of acetaminophen. For a 50kg person, you can get to a reasonably toxic quantity of acetaminophen (200 mg/kg) with 20 vicodin, which gives you a dose of 100mg of hydrocodone, or 2 mg/kg. Quick googling found this: http://toxnet.nlm.nih.gov/cgi-... that gives animal toxicity studies showing an LD50 for hydrocodone in the range of 86 mg/kg (mice) to 375 mg/kg (rats). Granted, you certainly don't want to take anything *near* to the LD50 of any drug, but the highest dosage for a Zohydro pill is 50 mg. For a 50kg person to get a dose of 1/4 the mouse LD50 would be over 20 pills. As noted, if those 20 pills were vicodin, then they would also be toxic, but only because of the acetaminophen. And really, if you're downing 20 of *any* prescription painkiller, you almost certainly have a different goal in mind than temporary pain relief. I just really don't see this as causing much harm, and potentially helping a fairly specific set of people who need it.

People who are intent on abusing pills can get around the acetaminophen simply by breaking the pills up, putting them in cold water, and running them through a coffee filter. This is known as cold water extraction.

Part of the reason for the acetaminophen in painkillers is because of a loophole in the 1970 Controlled Substances Act that classified pure Hydrocodone as a strictly controlled Schedule II drug (Which Zohydro will fall under). However, Hydrocodone combination products, such as Vicodin, which contains Hydrocodone and acetaminophen, into the less strict Schedule III classification. As a Schedule III drug, combination drugs such as Vicodin can be refilled as many as five times, while Schedule II drugs can be filled only once.

So why is there so much pushback against Zohydro, when it clearly fits a need and will be more difficult to obtain and abuse than Vicodin? I think it might have to do with the fact that it's put out by a tiny company (Zogenix) rather than one of the big players. Teva Pharmaceuticals who literally spent millions on lobbying last year has a competing product "TD Hydrocodone" which they're trying to get to market, but Zogenix beat them to it. If Zohydro were delayed for a little while, perhaps they could get to market with their competing drug and given their vastly larger resources they'd likely win market share. Another large company Purdue Pharma (the makers of OxyContin) also have something in the works

Re:Well then

[ColdWetDog]

Seriously now:
Doses are not the same for all. Even worse,

True

apparently just TWO of these could be fatal to some people.

Maybe for a hamster or a 90 pound, 90 year old woman. 20 mg of hydrocodone is the same as 4 standard strength Vicodin tablets. Very unlikely to be dangerous.

Mod parent up

[Medievalist]

The reason everybody is so up in arms is that the opiate is not mixed with acetominophen. The only purpose of putting acetominophen in an opiate painkiller is to make it so it will fry your liver if you take more of it than it was designed for. Basically, such drugs are designed to be deliberately fatal to addicts. So much for "do no harm".

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.

Re:Mod parent up

[Bryan Ischo]

While I agree that the only reason to put acetominophen into opiates is to ensure that the drug cannot be taken beyond a certain dosage without damaging the patient's liver, I do wonder if the reason really is just a vindictive desire to harm addicts as others are stating.

More logical to me is the conclusion that the authorities just want doctors to have to be careful with their prescriptions. If there were no acetominophen doctors could be pretty liberal in how they prescribe dosages with little consequence. But add some acetophinophen, and now doctors have to be very aware that there is a certain maximum dosage built into the drug, and they cannot prescribe at a higher dosage without risking being fined or jailed or sued or whatever it is that happens to doctors that mis-prescribe dangerous drugs.

I suspect that the powers that be have decided that the maximum reasonably beneficial dosage of an opiate is X mg per day, and so they require that enough acetominophen be added so that X mg per day is also the maximum safe dosage. In doing so they limit the ability of any doctor to prescribe more than what they had believed was the maximum beneficial dose. Likely they chose X mg per day because studies shows that it was the dosage that would be beneficial in the majority of cases, and don't see the need for anyone to go above X mg per day and unnecessarily take a larger risk of addiction.

That sounds more reasonable to me than just wanting to hurt addicts.

You can thank Ronald Reagan for that.

[Medievalist]

The focus of prisons (from my limited observation) is rarely to rehabilitate.

In the United States, the Sentencing Reform Act of 1984 explicitly states that imprisonment is not an appropriate means of promoting correction and rehabilitation. 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 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.

Placebo

[phorm]

Does a placebo have to be something which has no effect? For somebody who is coming off of another painkiller, wouldn't a better placebo be what they're already taking?

The stupid! It hurts!

[sirwired]

Giving pure placebos works for some mental health drugs, OTC-dose pain relievers, cholesterol meds, sexual dysfunction drugs, etc. Basically, if the problem could be "in your head", or the drug is intended to be taken by healthy people on a prophylactic basis, the control in a drug trial can safely be a sugar pill. Also eligible for sugar-pill placebos are conditions for which there is no current treatment.

For conditions in which there IS an effective treatment, it is considered unethical to give a placebo during a trial (as in, you'd never give sterile water to a diabetic taking insulin in a trial for a new form of insulin.) And giving a placebo to somebody where going off their current med would be blindingly obvious is simply ineffective. Nobody currently on high-dose opiates is going to somehow not notice they are not receiving a sugar-pill. The withdrawl symptoms are obvious, painful, and aren't going to go away with sheer willpower thinking you are receiving a different opiate.

I Want A New Drug

[Nyder]

I want a new drug
One that won't make me sick
One that won't make me crash my car
Or make me feel three feet thick

I want a new drug
One that won't hurt my head
One that won't make my mouth too dry
Or make my eyes too red

One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you

I want a new drug
One that won't spill
One that don't cost too much
Or come in a pill

I want a new drug
One that won't go away
One that won't keep me up all night
One that won't make me sleep all day

One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
I'm alone with you baby

I want a new drug
One that does what it should
One that won't make me feel too bad
One that won't make me feel too good

I want a new drug
One with no doubt
One that won't make me talk too much
Or make my face break out

One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
All alone with you
All alone with you, yea, yea

huh?

[Khashishi]

Five times more potent means you can use five times less dosage, right? I don't see what the issue is.

Re:huh?

[rbc76]

Wrong. It's five times more potent because it has five times more hydrocodone. As far as potency is concerned, hydrocodone is metabolized into the much more potent hydromorphone, which itself is available by prescription for a much lower cost.

acetaminophen

[tgibbs]

The notion that inclusion of acetaminophen deters abuse of Vicodin has been a miserable failure. Vicodin is widely abused. Many users either do not understand the risk of acetaminophen to the liver or their craving for the drug overrides their caution. Moreover, it is particular popular among adolescents and teenagers, because it is widely available in their parents' medicine cabinets. I've even heard from teenagers who are under the impression that the acetaminophen enhances the "high."

Nice things gone?

[kwbauer]

So we can't have nice things because somebody might abuse them? I for one hope that never becomes the universal logic because I really enjoy some of my nice things like my car, my computer and access to the internet. All of those are readily abused to harm others.

Yep, A Real Ethical Problem

[Toad-san]

IF you're one dead-set on controlling others and their lives. Me, I'm a firm believer in "Darwin Rules". Make sure the truth is out there (e.g., if it's addictive like other medications that one horror story above describes). But if some damned fool is set on destroying his life (and possibly his liver, teeth, eyes, brain, etc.) with drug abuse .. hey .. I'm not standing in his way, not for a minute.

Truly unnecessary medication

[rbc76]

I am a physician, and part of what I do is to treat patients with chronic pain. However, this drug is completely unnecessary. The problem with Zohydro is that it is an extremely expensive medication. There are much cheaper alternatives which are more potent, there are much cheaper alternatives which are less potent, and you can get a much cheaper pill with exactly the same active ingredient mixed with Tylenol. As a result, I see no role for this medication. To make matters worse, I see a lot of patients who think that hydrocodone is somehow safer than other narcotics. This simply isn't true. An overdose on hydrocodone will kill you as surely as an overdose of oxycodone, morphine or hydromorphone. Making larger doses available of a narcotic which is wrongly perceived to be "safe" opens the door to large numbers of deaths from overdose, whether accidental or recreational. While I have no qualms about treating chronic pain, I don't plan on writing a single prescription for this drug.

sciatica I have is equal to this.

[ralphaostrander]

I am going to cut your leg off with a chain saw in 1/8 inch slices for the next 1/2 a year or so. What pill would you like before we get started. All these people have never suffered real pain. These people are ignorant, for example if you show up in ER with 27 percent of you burned as I did they give you all they got as fast as they can. These burns do not hurt at all compared to sciatica, and they will not even move if you suffer this because they cant see it like a burn so it bothers them too via sight. The world was a better place when you could mix up your own laudanum. And that is a mother fucking fact.

Thats some awesome logic...

[YoungManKlaus]

"its five times stronger, so its five times as dangerous" ... rather than: "awesome, we can give out one fifth the dosage to get the same effect" (which is normally pretty epic for side effects).

Re:OMFG

[BrokenSoldier]

No, you don't. The associated baggage isn' t worth it.

Not even stronger...

[JayBat]

Zohydro is 10mg time-release hydrocodone. 10/325 hydrocodone/acetaminophen (often brand name Norco) or 10/300 (Vicodin HP) are commonly prescribed in the US for post-op pain.

I'm in the US, and was prescribed 10/325 Norco after outpatient hernia surgery last year. Hated that shit; nausea, impenetrable constipation, pain relief using max dosage was slightly less effective than max dosage OTC ibuprofen, and absolutely no trace of anything even vaguely resembling a high.

The difference with Zohydro is no contaminant acetaminophen, so no risk of liver damage.

Hrrrg, it's 10mg time-release. n/t

[JayBat]

So it's much like 10/325 Norco or 10/300 Vicodin HP, but without the acetaminophen.

Pure fear mongering

[DROP TABLE users]

zohydo is nothing new.The U.S. has been using hydrocodone since the 40's. And while larger than current hydrocodone formulations. A 50mg zohydro, which would require removing the time release mechanism. to get the full 50mg. Is roughly the equivalent of taking 33mg of oxycodone. But the people who are against this drug because its "new". Would rather have people who may already have reduced liver function. Take the same dosage of hydrocodone over the course of a day. With with 2500mg+ APAP on top of it. That in turn leads to more liver damage,kidney damage,stomach bleeding and/or death. I guess the suffering of the elderly is unimportant. When you're thinking of the children..../rant

Concern does not match Action

[WillAffleckUW]

Sometimes action can cause people to legislate certain useful drugs as "illegal" or "controlled", when this is an emotional or societal reaction, not a neutral risk-based and behavior-based weighing of risks.

Addiction is tied to addictive behavior, not "strength".

I'd rather see detailed pharmacological studies before leaping into the "demon drug" category. Historically, we've failed on this measure many times.

But Zohydro IS hydrocodone...

[ToddInSF]

It is NOT a "new" drug, it is NOT "indicated for use as an as-needed analgesic." It's just time-released hydrocodone bitartrate.

The over 40 organizations requesting it's FDA approval being reconsidered are NOT organizations that are pro "war on drugs", these are patient-oriented advocacy groups for the most part.

A time-release version of hydrocodone bitartrate IS extremely dangerous in the wrong hands. It's ridiculously easy to abuse, to OD on, and is a very real hazard to the public.

People posting hare seem to think this is some revolutionary new drug - it simply is NOT. There is nothing "new" about this drug at all, except that it's hydrocodone bitartrate stuck into microspheres so that it's gradually released over 12 hours. That's it. That's all. So the entire dialogue here about the war on drugs and people not caring about pain management and all that garbage is entirely misplaced and irrelevant.

This is a well known schedule II drug in a new delivery form that required very little money to develop, and the bulk of funds spent to get it approved are PR related. Patient advocacy groups are pushing-back at this kind of parasitic behaviour by drug companies because it always results in more deaths and more ER visits.

I'm more than a bit shocked and dissapointed at the highly rated comments here, clearly slashdot is NOT the place where you're going to find well informed or even competent people talking about the insane antics of the drug companies, much less the organizations that oversee the FDA's abysmal failures and infiltration by people who's primary interest are profits, and NOT the patient...

Re:Hmm placebo?

[Fjandr]

Looks like you're not aware of how opiates work.

Re:Typical Pharmaceutical Co. Logic

[Fjandr]

Visit a chronic pain clinic. Until then, fuck right the hell off.

Jefferson said judge people by their acts

[Medievalist]

We can't say for sure, of course; lacking mind-reading prowess we'll have to judge the regulatory powers-that-be by what they do and say.

But currently the government is trying to clamp down even harder on the distribution of the painkillers that some of us actually require (in my case, only occasionally, thank God). Their stated reason is that when patients are prescribed narcotic painkillers, and the government makes it harder to get narcotics, many of these patients then turn to heroin, because it is more readily and cheaply obtained. Then, many of these sufferers become heroin addicts, which in turn causes harm to their families, their communities, and themselves.

The government regulators bluntly state that this process means there should be more restrictions on prescription painkillers. Try, for example, this google search.

So, they know that as they restrict access to painkillers, and make use of heavy doses of painkillers more dangerous and harmful, they are actively driving pain sufferers towards illegal heroin use. They know this, and they say so. So the response is to increase restrictions on painkillers? Judging them by their actions, these people have a strong desire to do harm, specifically by pushing people suffering extreme pain into the heroin trade.

Either that, or they are incredibly, dangerously stupid.