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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.'"
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.'"
Can be used for good, can be used for bad. Just regulate the hell out of it. Let it be.
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)
Summation 2
Two opinions in 1 summary that wasn't painfully biased to read !
if it's so potent, you can use it as a lethal injection drug, without being bothered by EU regulation.
"They say they fear that Zohydro — especially at higher doses — will amplify already-rising overdose numbers."
Then proscribe the correct doses you insensitive clod!
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...
'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.
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.
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 stuff he uses is 1,000x more potent than morphine
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...
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.
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.
Troll is not a replacement for I disagree.
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.
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".
think of the children!
You watch far too much television.
Hint: the world is often not like Hollywood's version of it.
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.
Just give the patient a fear pill.
systemd is Roko's Basilisk.
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.
Therefore I'm in favor ot it.
Sounds like DICE is testing their grass-roots bots, although this one is seems to be set all the way to snake handler.
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.
your lack of pain frightens me. Cut it out.
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.
The Blade Itself
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.
I don't think I want to take a pain pill...
I don't know for this specific instance, but generally for studies like this, the control is not a placebo but current best treatment.
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.
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?
I don't understand. Isn't this just, well, Vicodin++?
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.
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.
I'm a good cook. I'm a fantastic eater. - Steven Brust
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.
Knowledge is how to play a game, intelligence is how to win, wisdom is knowing what game to play.
lol...i dont even own a television AC...and im sorry you don't even know whats going on around you.
never bring a twinkie to a food fight.
Were the patients in this study in places where medical marijuana is available? I know it's not a cure all but given the supposed benefits for other sorts of pain and discomfort, I wonder if they tried this first?
Getting all these poor people addicted to your high-potency opioids is SURELY going to make their lives better! Oh, and fatten your wallet. The latter being the most important part.
You mean from the FDA-appointed scientific advisory panel which voted against its approval.....hmmm.....
I'll just have to try some before I make up my mind about it.
-----
Sorry, I'm only a 1336 h4x0r.
>lol...i dont even own a television AC /.. We all *know* that an actual television is not required to watch TV shows.
1) Hipster detected
2) You're a dumbass. This is fucking
So, some doctors want their patients to suffer only because some people might abuse the drug? Assholes.
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...
What the problem is: The stated problem for this drug is potential for abuse, yet people with chronic pain will benefit.
Now brainstorm solutions that allow those who need the drug to obtain it and keep it from those who would abuse it.
There are physicians who prescribe any and all drugs to anyone and contribute to abuse and deaths daily.
Perhaps there's potential for a partial solution there. There must be more.
right...what's required to watch TV shows is an interest in the contrived bullshit rehashed melo-drama pro-police state propaganda that's spoon fed to couch potatoes to numb their minds for a while...
they have yet to invent a device that could accurately measure my massive indifference to that sort of thing.
and what the fuck is a hipster? is that like calling someone a dork or a nerd or something??
never bring a twinkie to a food fight.
Many people have not experience such severe pain that they will need a drug such as this. After a failed back surgery, and a battle with cancer, I, too, have been using the fentanyl patch. Part of the purpose of this drug, which is hydrocodone without the added acetaminophen, is to allow chronic pain users to take it, without destroying their liver in the process. Many people don't know the long-term damage that acetaminophen can do. Some people have pain so bad that they cannot get out of bed. Their lives are ruined...they cannot work, enjoy life, even move or interact with family. And further regulating this drug, which I am sure will happen, will simply make the lives of those who need it miserable. Their pain docs will be put on quotas, and patients will be denied meds simply because "too many" of their pain doc's patients are already on it. The recreational opiod drug users ruin it for everyone.
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.
Looks like you got the placebo. Sorry bud.
http://bash.org/?4753
Currently people with pain management issues are being slowly killed by the liver destruction that vicodin and friends inflict. The approved drugs contain acetaminophen, and acetaminophen overdose is a leading cause of liver failure in the USa, with nearly two-thirds of those cases being caused by use of prescription pain pills like vicodin.
But doctors don't want to prescribe a relatively safe narcotic, like codeine, because the DEA will hassle them constantly. So instead, they prescribe tylenol 3 or vicodin or something like that, which draws less government attention and harassment, and slowly poison the patient.
I have been on narcotic prescriptions for thirty years, and because I am very careful I have not become physically addicted. I rarely take narcotics more than once every two months. However, when I have an extreme pain episode, I might take as many as eight high potency vicodins in order to prevent putting a gun to my head. That is not a figure of speech, it's reality. If I did not have the ability to stop the pain and attendant disorientation I would almost certainly kill myself after the first three or four hours of involuntary non-stop screaming.
The only difference between this medication and the medications I am already prescribed is the absence of toxic analgesics.
If I could get this pill, maybe I could live to see my daughter graduate from college, or even see grandchildren. Under the current medication regime, I cannot expect my liver to last that long.
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.
In the United States, the Sentencing Reform Act of 1984 explicitly states that imprisonment is not an appropriate means of promoting correction and rehabilitation. In other words, according to both Congress and the Supreme Court, prison is useless for rehabilitation, and judges are legally barred from considering prison as a rehabilitative measure. Our official incarceration policy exists solely to punish behavior, never to correct it or prevent future crimes. This has always seemed to me like the keystone of the "Reagan Revolution", with Ted Kennedy and Ronald Reagan allying to fundamentally derail the American Dream of an optimally free society, so it seems very appropriate that it was passed in 1984.
Does a placebo have to be something which has no effect? For somebody who is coming off of another painkiller, wouldn't a better placebo be what they're already taking?
Giving pure placebos works for some mental health drugs, OTC-dose pain relievers, cholesterol meds, sexual dysfunction drugs, etc. Basically, if the problem could be "in your head", or the drug is intended to be taken by healthy people on a prophylactic basis, the control in a drug trial can safely be a sugar pill. Also eligible for sugar-pill placebos are conditions for which there is no current treatment.
For conditions in which there IS an effective treatment, it is considered unethical to give a placebo during a trial (as in, you'd never give sterile water to a diabetic taking insulin in a trial for a new form of insulin.) And giving a placebo to somebody where going off their current med would be blindingly obvious is simply ineffective. Nobody currently on high-dose opiates is going to somehow not notice they are not receiving a sugar-pill. The withdrawl symptoms are obvious, painful, and aren't going to go away with sheer willpower thinking you are receiving a different opiate.
I want a new drug
One that won't make me sick
One that won't make me crash my car
Or make me feel three feet thick
I want a new drug
One that won't hurt my head
One that won't make my mouth too dry
Or make my eyes too red
One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
I want a new drug
One that won't spill
One that don't cost too much
Or come in a pill
I want a new drug
One that won't go away
One that won't keep me up all night
One that won't make me sleep all day
One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
I'm alone with you baby
I want a new drug
One that does what it should
One that won't make me feel too bad
One that won't make me feel too good
I want a new drug
One with no doubt
One that won't make me talk too much
Or make my face break out
One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
All alone with you
All alone with you, yea, yea
Be seeing you...
So,,
What happened to news for nerds and stuff that matters??
I am so sad @ the state of affairs regarding this (yahoo clone). /. I am sad to say, where did you go?? is ther an alternative?? /. had some of the brightest and most intelligent individuals @ the controls.
pls help me satisfiy my need for relevant information..
If I want yahoo crap I'll go to yahoo..
this is BS..
Why is it that most if naught all tech publications are able to retain their original content/subject matter?
And here I thought
Sad days indeede..
thanks Dice..
whats up next, job search tips and how every link regarding that subject points to the Dice website..
ya know its intersing, almost sadistic the fact that I am almost accepting this type of behavior (surfacing the faults of the current /. community).
Almost like a strange behavior that people know its there,
but cannot study or quantify it. Liek a fart in an elevator, you know its there, but there is no way to analyze or track it.. but you know its there
Five times more potent means you can use five times less dosage, right? I don't see what the issue is.
Why not use something completely safe that is impossible to overdose on and is easy to grow in yourself? It is ludicrous for a plant to be illegal. Marijuana is a solution to many pain problems as well as anxiety, depression, etc.
I want a new drug,
I want a new drug
One that won't make me sick
One that won't make me crash my car
Or make me feel three feet thick
I want a new drug
One that won't hurt my head
One that won't make my mouth too dry
Or make my eyes too red
One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
I want a new drug
One that won't spill
One that don't cost too much
Or come in a pill
I want a new drug
One that won't go away
One that won't keep me up all night
One that won't make me sleep all day
One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
I'm alone with you baby
I want a new drug
One that does what it should
One that won't make me feel too bad
One that won't make me feel too good
I want a new drug
One with no doubt
One that won't make me talk too much
Or make my face break out
One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
All alone with you
All alone with you, yea, yea
The notion that inclusion of acetaminophen deters abuse of Vicodin has been a miserable failure. Vicodin is widely abused. Many users either do not understand the risk of acetaminophen to the liver or their craving for the drug overrides their caution. Moreover, it is particular popular among adolescents and teenagers, because it is widely available in their parents' medicine cabinets. I've even heard from teenagers who are under the impression that the acetaminophen enhances the "high."
So we can't have nice things because somebody might abuse them? I for one hope that never becomes the universal logic because I really enjoy some of my nice things like my car, my computer and access to the internet. All of those are readily abused to harm others.
And banning drugs like this makes it better because ....?
IF you're one dead-set on controlling others and their lives. Me, I'm a firm believer in "Darwin Rules". Make sure the truth is out there (e.g., if it's addictive like other medications that one horror story above describes). But if some damned fool is set on destroying his life (and possibly his liver, teeth, eyes, brain, etc.) with drug abuse .. hey .. I'm not standing in his way, not for a minute.
Show me the evidence. There is no demonstrated medical use for marijuana for chronic pain, just lots of anecdotal tales. In Canada, it can be used medicinally, but there is no strength or indication it is tested well for. This leaves the medical community to be on the hook for potential harms without documented benefit and no guideline as to what is appropriate use.
I'll come off as callous here. For non-palliative chronic pain, level of pain is not the metric we should be chasing. There will be people on massive doses of opioids that will still have pain. If the medication does not improve function, it doesn't have value. There is no level of pain where just a little more opioid might not make you feel just a touch better, so there will always be an escalation of dose. Further, there is no objective measurement of pain, so it becomes impossible to determine use for management of pain vs misuse for euphoria even for the person taking it. For many on opioids, the side-effects lead to less function - less ability to drive, interact, concentrate, work, acheive tasks. However, if you can get more done in the day without a increase in pain or discomfort, then we have a worthwhile agent. Dose should be titrated to lowest effective dose for improved function.
I am a physician, and part of what I do is to treat patients with chronic pain. However, this drug is completely unnecessary. The problem with Zohydro is that it is an extremely expensive medication. There are much cheaper alternatives which are more potent, there are much cheaper alternatives which are less potent, and you can get a much cheaper pill with exactly the same active ingredient mixed with Tylenol. As a result, I see no role for this medication. To make matters worse, I see a lot of patients who think that hydrocodone is somehow safer than other narcotics. This simply isn't true. An overdose on hydrocodone will kill you as surely as an overdose of oxycodone, morphine or hydromorphone. Making larger doses available of a narcotic which is wrongly perceived to be "safe" opens the door to large numbers of deaths from overdose, whether accidental or recreational. While I have no qualms about treating chronic pain, I don't plan on writing a single prescription for this drug.
Yes send them to the camps, its doubleplusgood citizen! Or you could just leave them the fuck alone if they aren't harming anyone but themselves, but that would be against big mommy, can't have that.
I am going to cut your leg off with a chain saw in 1/8 inch slices for the next 1/2 a year or so. What pill would you like before we get started. All these people have never suffered real pain. These people are ignorant, for example if you show up in ER with 27 percent of you burned as I did they give you all they got as fast as they can. These burns do not hurt at all compared to sciatica, and they will not even move if you suffer this because they cant see it like a burn so it bothers them too via sight. The world was a better place when you could mix up your own laudanum. And that is a mother fucking fact.
I want some of that shit!
"its five times stronger, so its five times as dangerous" ... rather than: "awesome, we can give out one fifth the dosage to get the same effect" (which is normally pretty epic for side effects).
I'm in the US, and was prescribed 10/325 Norco after outpatient hernia surgery last year. Hated that shit; nausea, impenetrable constipation, pain relief using max dosage was slightly less effective than max dosage OTC ibuprofen, and absolutely no trace of anything even vaguely resembling a high.
The difference with Zohydro is no contaminant acetaminophen, so no risk of liver damage.
So it's much like 10/325 Norco or 10/300 Vicodin HP, but without the acetaminophen.
zohydo is nothing new.The U.S. has been using hydrocodone since the 40's. And while larger than current hydrocodone formulations. A 50mg zohydro, which would require removing the time release mechanism. to get the full 50mg. Is roughly the equivalent of taking 33mg of oxycodone. But the people who are against this drug because its "new". Would rather have people who may already have reduced liver function. Take the same dosage of hydrocodone over the course of a day. With with 2500mg+ APAP on top of it. That in turn leads to more liver damage,kidney damage,stomach bleeding and/or death. I guess the suffering of the elderly is unimportant. When you're thinking of the children..../rant
Sometimes action can cause people to legislate certain useful drugs as "illegal" or "controlled", when this is an emotional or societal reaction, not a neutral risk-based and behavior-based weighing of risks.
Addiction is tied to addictive behavior, not "strength".
I'd rather see detailed pharmacological studies before leaping into the "demon drug" category. Historically, we've failed on this measure many times.
-- Tigger warning: This post may contain tiggers! --
Is what this comes down to...
Look, I'd expect people here to be a bit more skeptical than the comments here indicate.
Making this out to be an issue of regulation vs. freedom to fuck-up your life issue is absurd.
Comparisons of this drug to anything else is likewise an absurdity.
The patent system encourages new drugs with untested and unknown impact on the population to be constantly created, while suppressing the drugs that go off-patent, because the PR dollars, which I might point-out in most cases FAR EXCEED the development dollars for the new drugs, are not there for the off-patent drugs. Which are extremely well tested and well known drugs.
What you're doing is falling for corporate PR here.
Back in the 80's the attitude that most physicians had was that new drugs were just too risky to subject themselves and their families to, for at least a few years, until some data came back as a result of their use int he general population.
There were exceptions, for instance, the drug Zomax (Zomepirac). It was approved by the FDA in 1980, and withdrawn from the market in '83 due to its tendency to cause serious anaphylaxis in an unpredictable subset of the patient population. It killed people. It was thought safe and revolutionary, like this latest pain medication. Some of that subset that took it were physicians. The wiki article on it omits a great deal of the news of it's removal from the market at the time, which is pretty typical of wikipedia article editing when it comes to big pharma interests. But if you dig around, you can read some fascinating articles about the events that transpired.
There are MANY other examples of this happening in the US over the years, but you'd never know it from the pharmaceutical industry PR machine and it's paid and willing apologists.
Disclosure of my interests regarding this issue : past experience as a patient that's been prescribed several similar drugs int he past which have had deleterious long term impact on my quality of life. I have no recourse, because the drugs in question were removed from the market and the drug companies involved are experts at covering their asses. You can end up with medical problems that result from taking drugs like these that are not as profound as the reasons they were removed from the market, and never be able to prove they caused long term problems.
So. Caveat emptor.
It is NOT a "new" drug, it is NOT "indicated for use as an as-needed analgesic." It's just time-released hydrocodone bitartrate.
The over 40 organizations requesting it's FDA approval being reconsidered are NOT organizations that are pro "war on drugs", these are patient-oriented advocacy groups for the most part.
A time-release version of hydrocodone bitartrate IS extremely dangerous in the wrong hands. It's ridiculously easy to abuse, to OD on, and is a very real hazard to the public.
People posting hare seem to think this is some revolutionary new drug - it simply is NOT. There is nothing "new" about this drug at all, except that it's hydrocodone bitartrate stuck into microspheres so that it's gradually released over 12 hours. That's it. That's all. So the entire dialogue here about the war on drugs and people not caring about pain management and all that garbage is entirely misplaced and irrelevant.
This is a well known schedule II drug in a new delivery form that required very little money to develop, and the bulk of funds spent to get it approved are PR related. Patient advocacy groups are pushing-back at this kind of parasitic behaviour by drug companies because it always results in more deaths and more ER visits.
I'm more than a bit shocked and dissapointed at the highly rated comments here, clearly slashdot is NOT the place where you're going to find well informed or even competent people talking about the insane antics of the drug companies, much less the organizations that oversee the FDA's abysmal failures and infiltration by people who's primary interest are profits, and NOT the patient...
We can't say for sure, of course; lacking mind-reading prowess we'll have to judge the regulatory powers-that-be by what they do and say.
But currently the government is trying to clamp down even harder on the distribution of the painkillers that some of us actually require (in my case, only occasionally, thank God). Their stated reason is that when patients are prescribed narcotic painkillers, and the government makes it harder to get narcotics, many of these patients then turn to heroin, because it is more readily and cheaply obtained. Then, many of these sufferers become heroin addicts, which in turn causes harm to their families, their communities, and themselves.
The government regulators bluntly state that this process means there should be more restrictions on prescription painkillers. Try, for example, this google search.
So, they know that as they restrict access to painkillers, and make use of heavy doses of painkillers more dangerous and harmful, they are actively driving pain sufferers towards illegal heroin use. They know this, and they say so. So the response is to increase restrictions on painkillers? Judging them by their actions, these people have a strong desire to do harm, specifically by pushing people suffering extreme pain into the heroin trade.
Either that, or they are incredibly, dangerously stupid.