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Doctors Say New Pain Pill Is "Genuinely Frightening"

samzenpus posted about 8 months ago | from the take-your-medicine dept.

Medicine 294

Hugh Pickens DOT Com writes "Stephanie Smith reports at CNN that a coalition of more than 40 health care, consumer and addiction treatment groups is urging the Food and Drug Administration to revoke approval of the new prescription pain drug Zohydro, a hydrocodone-based drug set to become available to patients in March. 'You're talking about a drug that's somewhere in the neighborhood of five times more potent than what we're dealing with now,' says Dr. Stephen Anderson, a Washington emergency room physician who is not part of the most recent petition to the FDA about the drug. 'I'm five times more concerned, solely based on potency.' The concerns echoed by all groups are broadly about the drug's potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will amplify already-rising overdose numbers. 'In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid (PDF),' the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.

Zohydro's maker, Zogenix, and the FDA say the drug's benefits outweigh its risks and in their petition to the FDA for approval, Zogenix representatives say the drug fills a critical need for people suffering from chronic pain who are at risk for liver toxicity and cited examples of patients who might benefit from Zohydro: a 46-year-old male with chronic back and leg pain who had two failed back surgeries; a 52-year-old female with metastatic breast cancer experiencing diffuse pain; a 32-year-old woman with multiple orthopedic fractures. 'There's a lot of misinformation being put out there by people who don't have all the facts,' says Dr. Brad Galer, executive vice president and chief medical officer at Zogenix. 'We're talking about patients that are in bed, depressed, can't sleep, can't work, can't interact with their loved ones — it's a very significant medical health problem that is being ignored.'"

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It's just a tool I guess (5, Insightful)

dimko (1166489) | about 8 months ago | (#46356089)

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 (5, Insightful)

SJHillman (1966756) | about 8 months ago | (#46356113)

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 (5, Insightful)

Anonymous Coward | about 8 months ago | (#46356237)

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 (4, Insightful)

SJHillman (1966756) | about 8 months ago | (#46356313)

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 (4, Insightful)

kilfarsnar (561956) | about 8 months ago | (#46356425)

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 (3, Insightful)

rmdingler (1955220) | about 8 months ago | (#46356709)

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 (5, Insightful)

Mashdar (876825) | about 8 months ago | (#46356803)

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 (5, Insightful)

Anonymous Coward | about 8 months ago | (#46356979)

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 (3, Insightful)

SJHillman (1966756) | about 8 months ago | (#46356711)

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 (2)

causality (777677) | about 8 months ago | (#46356899)

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 (1)

Anonymous Coward | about 8 months ago | (#46356485)

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 (2)

SJHillman (1966756) | about 8 months ago | (#46356659)

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 (-1)

Anonymous Coward | about 8 months ago | (#46356813)

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.

The positive effect is that humans have no natural predators to cull the herd. All drugs should be legal and available and cheap. You would still go to a doctor for most of them because it's so stupid not to get expert help for something like heart medicine. Overdosing on narcotics is Darwin's method of removing the irresponsible and stupid who have no sense and no impulse control and no ability to think about the consequences of their actions, not even when it's in their own self interest. Since they do it to themselves there is no victim and therefore no crime and that's why it's none of the govt's business.

We need drugs for this because obesity takes far too long. It's great because you as an individual get to choose whether you will be one of the morons or not. Adult people should be able to vote with their feet and their wallets and then reap the consequences. Anything else is not freedom but license. Adults who make bad decisions and cause harm to themselves are not victims, do not deserve your sympathy, and should be upheld as examples of what not to become. I for one also don't want the tyrannical police-nanny state that these people tend to demand because they don't want to make decisions for themselves.

Re:It's just a tool I guess (2, Interesting)

Anonymous Coward | about 8 months ago | (#46356741)

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 (0)

Anonymous Coward | about 8 months ago | (#46356303)

And sometimes it doesn't. Your point?

Re:It's just a tool I guess (1)

SJHillman (1966756) | about 8 months ago | (#46356371)

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 (1)

Anonymous Coward | about 8 months ago | (#46356643)

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 (2)

causality (777677) | about 8 months ago | (#46356913)

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 (0)

Anonymous Coward | about 8 months ago | (#46356915)

"illegal" is basically synonymous with "regulated out of existence"

Most of the actual voters who support the war on drugs are probably somewhere between believing this is true and wishing it were.

Re:It's just a tool I guess (5, Interesting)

bill_mcgonigle (4333) | about 8 months ago | (#46356557)

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

Just look at the current refer madness - that's at least starting to somewhat abate. There was just a story yesterday about the Annapolis police chief, who quoted a DailyCurrant article to a State committee about a coroner who had to put five college students in body bags before breakfast (due to marijuana overdose). The Chief later apologized, half heartedly, but the level of rank incompetence is astonishing - he doesn't even know enough about the topic to spot satire, but he's happy to cage people [wikipedia.org] for it anyway.

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

Re:It's just a tool I guess (0)

Anonymous Coward | about 8 months ago | (#46356591)

IMO, the more addictive something is, the higher security it needs from the precursor materials to delivery.

Like with alcohol and pot, the precursors are just plants, and outright banning growing anything that can be used as food crop or cloth/fiber crop makes no sense at all. But the higher-potency versions of everything is controlled by small amounts of people or corporations, and they want it to stay that way.

So the best way to solve both problems is to just never produce the product in the first place. That doesn't help anyone however.
So the next best way is to make sure there is no middle men. If someone needs a high potency drug, it is manufactured in tightly controlled amounts and delivered right to the patient personally. Maybe some kind of special division of USPS,UPS,Fedex,DHL,etc could be formed for medications, where the couriers and packages look the same as normal, but delivery people involved are trained armed law enforcement/security guards that travel in pairs, not your average high-school dropout.

And before anyone gets in a snit about that comment. When I worked for a call center, there were people who were ex-posties who would share stories about the idiots who would stupidly try to smuggle drugs through the postal system. Hint... drugs need tightly controlled environmental conditions, and pot reveals itself because the postal system is not environmentally controlled. When someone comes to work at 9am monday morning and smells pot in the package room, the cops are called. If you've watched the reality shows about customers enforcement officers, you'd also realize how futile it is to smuggle drugs, again because there is pretty much no possible way of removing all traces of drugs from the packaging, even if you go through quite the effort to hide the drugs.

Re:It's just a tool I guess (1)

Derec01 (1668942) | about 8 months ago | (#46356971)

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 (5, Interesting)

Anonymous Coward | about 8 months ago | (#46356195)

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 (2)

deadweight (681827) | about 8 months ago | (#46356277)

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 (5, Interesting)

parrini (840878) | about 8 months ago | (#46356301)

Are you shure you were not in the control group?

Probably current best treatment (5, Informative)

Anonymous Coward | about 8 months ago | (#46356745)

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

Re: It's just a tool I guess (4, Informative)

jonnythan (79727) | about 8 months ago | (#46356791)

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 (1)

wisnoskij (1206448) | about 8 months ago | (#46356921)

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 (0)

Anonymous Coward | about 8 months ago | (#46356975)

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.

The only thing untested about this drug was the ER format. This is identical to oxycodone ER (Oxycontin I believe is the tradename). There is nothing new or magical about hydrocodone itself. The difference is in the dosage and making sure that it is released at the correct rate. To be a study participant you already had to be opioid tolerant. I'm sure the reason for that was to decrease the chance of an overdose from non-abusive behavior.

Re: It's just a tool I guess (0)

Anonymous Coward | about 8 months ago | (#46356859)

Are you shure you were not in the control group?

It would be cruel and irresponsible to put someone in a control group (placebo) for pain management. And furthermore they assured me that there were no control groups. They did frequent blood tests and I had an electronic diary I used for measuring its effectiveness.

Re:It's just a tool I guess (0)

Anonymous Coward | about 8 months ago | (#46356521)

*reads*
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.

*sees*
I want you to run home and I want you to call the E.R. of North Bank General Hospital, 932-1000. Tell them to set up OR6 immediately and contact anesthesiologist Isadore Turek 472-2112 beep 12. Have him send an ambulance with a paramedic crew, light IV, D5NW-KVO. You got it?

Re:It's just a tool I guess (3, Interesting)

sunderland56 (621843) | about 8 months ago | (#46356253)

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 (2)

jovius (974690) | about 8 months ago | (#46356359)

Heroin is used as a medicine in some countries; in UK for example [wikipedia.org] .

Re:It's just a tool I guess (2, Informative)

Anonymous Coward | about 8 months ago | (#46356403)

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 (3, Interesting)

Eunuchswear (210685) | about 8 months ago | (#46356551)

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 (3, Interesting)

sribe (304414) | about 8 months ago | (#46356695)

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 (4, Informative)

causality (777677) | about 8 months ago | (#46356957)

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 (0)

Anonymous Coward | about 8 months ago | (#46356567)

Just like Oxycontin, right?

I'm betting after a slew of overdoses from it in the first 6 months, nothing happens. I find it strange that, even with the fairly strict DEA rules with regard to pain medication prescription writing, that there is still loads if it out there on the streets. Market trumps regulation I guess.

Well, duh (5, Funny)

Rik Sweeney (471717) | about 8 months ago | (#46356099)

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 (1)

Mr D from 63 (3395377) | about 8 months ago | (#46356111)

It won't hurt to try.

Re:Well, duh (2)

Thanshin (1188877) | about 8 months ago | (#46356145)

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

Bravo (1)

tomxor (2379126) | about 8 months ago | (#46356109)

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

on the bright side (1)

Hecatonchire (1131519) | about 8 months ago | (#46356115)

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

Well then (0)

lagomorpha2 (1376475) | about 8 months ago | (#46356123)

"They say they fear that Zohydro — especially at higher doses — will amplify already-rising overdose numbers."

Then proscribe the correct doses you insensitive clod!

Re:Well then (1)

deadweight (681827) | about 8 months ago | (#46356141)

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

Re:Well then (1)

Anonymous Coward | about 8 months ago | (#46356215)

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!

Re:Well then (1)

lazlo (15906) | about 8 months ago | (#46356473)

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.

of course it'll be approved... (-1, Troll)

Connie_Lingus (317691) | about 8 months ago | (#46356133)

...don't people realize that perhaps millions of judges, lawyers and other lawmakers/professionals pop opiates on a daily basis?

of course, unlike the "street addict", they legally and comfortably take THEIR meds using their employee (often the government) provided health-care plans and avoid the $300 doctor office change the "poor junkies" can't seem to come up with...

and lord, are they concerned about their livers because, you know, all those cocktail parties...

Re:of course it'll be approved... (0)

Anonymous Coward | about 8 months ago | (#46356305)

You watch far too much television.

Hint: the world is often not like Hollywood's version of it.

Re:of course it'll be approved... (0)

Connie_Lingus (317691) | about 8 months ago | (#46356937)

lol...i dont even own a television AC...and im sorry you don't even know whats going on around you.

we already know about opiates 'managing' pain (0)

Anonymous Coward | about 8 months ago | (#46356135)

adds physical as well as spiritual constipation to our mix. plus street kids love the pills without the tylenol etc in them,,, we are so servicious. conversely, we deprive the truly pained proper care now due to over regulation, as the jails & rehabs fill with the recreational users...

Re: we already know about opiates 'managing' pain (0)

Anonymous Coward | about 8 months ago | (#46356219)

Talking about drugs which are easy to kill yourself with. Fucking Tylenol, if I was subscribed an opiate I'd certainly prefer something without that shit.

raped by doctors (0)

TempleOS (3394245) | about 8 months ago | (#46356153)

Doctors rape me. I'm depressed because I'm force medicated with meds that make me a zombie and impotant. I am in a CIA prison. God will avenge ,me. God says... recount feverishness bidden wayfaring harmony meditated exposed pricks pricked speaking greatly forsooth Guide permitted login unruly believeth ulcerous mind- sponge Prodigality frightful Tomorrow to-day soldier persons softened meditating slew A enticed admit proffer hurt cleansest mercifully resend Fathers tellest An Presence purchase flesh

by doctors? (1)

wasteoid (1897370) | about 8 months ago | (#46356443)

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

Misinformation (1)

kruach aum (1934852) | about 8 months ago | (#46356155)

'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.

The fact is it's not a new drug (2)

EdwinFreed (1084059) | about 8 months ago | (#46356275)

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.

Opiates are SO hard to sell (0)

Anonymous Coward | about 8 months ago | (#46356173)

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.

Re:Opiates are SO hard to sell (2)

SJHillman (1966756) | about 8 months ago | (#46356285)

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.

Re:Opiates are SO hard to sell (-1)

Anonymous Coward | about 8 months ago | (#46356325)

> 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!

Stop being such a retard. Everyone not in a coma realizes there is a big problem with prescription drugs. As in, everyone. As in, everyone who is not a faggot like you.

In other words, stop behaving like a douche. It just makes you look... like an asshole.

Problem is, they're probably both right (5, Insightful)

jratcliffe (208809) | about 8 months ago | (#46356177)

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.

The articles. (5, Insightful)

Anonymous Coward | about 8 months ago | (#46356309)

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. (1)

kilfarsnar (561956) | about 8 months ago | (#46356725)

I wish I had mod points today. Well said!

Re:Problem is, they're probably both right (4, Informative)

ILongForDarkness (1134931) | about 8 months ago | (#46356663)

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.

Paging Dexter Morgan (1)

gelfling (6534) | about 8 months ago | (#46356187)

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

Higher potency? (4, Insightful)

Hrrrg (565259) | about 8 months ago | (#46356211)

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? (2)

king neckbeard (1801738) | about 8 months ago | (#46356339)

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? (1)

weave (48069) | about 8 months ago | (#46356693)

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? (1)

Sipper (462582) | about 8 months ago | (#46356983)

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? (1)

geogob (569250) | about 8 months ago | (#46356343)

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? (2)

bluefoxlucid (723572) | about 8 months ago | (#46356531)

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?

Less people will die of liver failure (2)

damonlab (931917) | about 8 months ago | (#46356225)

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 (2)

wisnoskij (1206448) | about 8 months ago | (#46356271)

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 (1)

Eunuchswear (210685) | about 8 months ago | (#46356583)

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 problem? Not poisonous by design. (1, Flamebait)

PvtVoid (1252388) | about 8 months ago | (#46356279)

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. (2)

CastrTroy (595695) | about 8 months ago | (#46356355)

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. (1)

bill_mcgonigle (4333) | about 8 months ago | (#46356769)

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. (1)

Anonymous Coward | about 8 months ago | (#46356379)

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. (1)

king neckbeard (1801738) | about 8 months ago | (#46356429)

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. (1)

bluefoxlucid (723572) | about 8 months ago | (#46356561)

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. (1)

ILongForDarkness (1134931) | about 8 months ago | (#46356633)

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. (0)

Anonymous Coward | about 8 months ago | (#46356651)

Mod up. Correct.
It is also expensive. The British use good old fashioned opiates for hospices that are cheap.
Naturally the drug companies dont like this, and want to charge 10-500 times out of national health budgets fo r their bottom line.

The debate is nonsense. Legalise Euthanasia or make effective non-toxic drugs available. One or the other.

Re:The problem? Not poisonous by design. (1)

fulldecent (598482) | about 8 months ago | (#46356735)

Interesting. Citation?

He forgot the most obvious thing: (1)

fredrated (639554) | about 8 months ago | (#46356295)

think of the children!

That's okay (1)

wonkey_monkey (2592601) | about 8 months ago | (#46356341)

Just give the patient a fear pill.

Some people overuse pain killers today (0)

Anonymous Coward | about 8 months ago | (#46356395)

I think most people use pain killers the correct way. But some do get used to not having pain and choose to continue to increase dosage and frequency to sustain a pain free
life. Not all pain is bad, and in fact its a natural way of the body telling you that you need to either reduce your activity or you have a problem.
Much of these issues directly affect the Liver that must process the pain medicines. Its really too bad for people who cannot find better ways to treat pain.
I think doctors are much to blame also, as they are the ones who prescribe these medications to their patients. These "last resort" medications always come with risks.

Re:Some people overuse pain killers today (1)

bluefoxlucid (723572) | about 8 months ago | (#46356565)

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

Drug warriors are going to hate this medication (1, Insightful)

Applehu Akbar (2968043) | about 8 months ago | (#46356397)

Therefore I'm in favor ot it.

Typical Pharmaceutical Co. Logic (0)

Anonymous Coward | about 8 months ago | (#46356481)

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.

Re:Typical Pharmaceutical Co. Logic (1)

king neckbeard (1801738) | about 8 months ago | (#46356799)

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.

Re:Typical Pharmaceutical Co. Logic (2)

nitehawk214 (222219) | about 8 months ago | (#46356963)

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.

hey cancer patient (1)

ILongForDarkness (1134931) | about 8 months ago | (#46356563)

your lack of pain frightens me. Cut it out.

Stupidest thing I've ever read. It's not 5 times.. (2)

p00kiethebear (569781) | about 8 months ago | (#46356669)

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 (1)

Charliemopps (1157495) | about 8 months ago | (#46356733)

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.

Pain pill (1)

Yakust (652563) | about 8 months ago | (#46356743)

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

Do not believe it (0)

Anonymous Coward | about 8 months ago | (#46356783)

I was taking hydrocodone for chronic pain for over two years and was severely depressed. I quit taking the antidepressants AND the pain pills. Now I still have about the same level of pain as I did when taking the pills but I feel so much better that there is no comparison.

3 people vs 250 million (1)

Arkiel (741871) | about 8 months ago | (#46356789)

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?

Vicodin++ ?? (0)

Anonymous Coward | about 8 months ago | (#46356817)

I don't understand. Isn't this just, well, Vicodin++?

pain (1)

tleaf100 (2020038) | about 8 months ago | (#46356885)

i am in exactly the same position as one of those mentioned in article,i have two vertebrea destroyed in my lower spine that are affecting nerves and blood supply to left leg and surgery has failed,i also have necrotic arthritis in left knee and hip which is also affecting my right leg now as well,i have older injuries that are starting to fail and although i have attended three seperate pain control clinics i am still having to take codeine phosphate by the handful,i have now been taking codeine for nearly 20 years and can handle silly amounts because my body likes opiates and converts codeine very well,but dose is now three times what it was and some medical folk are getting stroppy about prescribing me the amount i need 200x30mg per week,itwould be nice to have something to go onto instead,if only for short periods.

last thing? (5, Insightful)

nitehawk214 (222219) | about 8 months ago | (#46356923)

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 (2)

davidwr (791652) | about 8 months ago | (#46356931)

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.

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