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

[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

[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

[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

[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

[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

[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

[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

[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

[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

[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

[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

[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

[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

[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

[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.

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

[Thanshin]

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

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.

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?

[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?

[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.

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.

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.

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: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.

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 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.

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.

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.

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.

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: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.

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...

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.

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.