Doctors Say New Pain Pill Is "Genuinely Frightening" 294
Hugh Pickens DOT Com writes "Stephanie Smith reports at CNN that a coalition of more than 40 health care, consumer and addiction treatment groups is urging the Food and Drug Administration to revoke approval of the new prescription pain drug Zohydro, a hydrocodone-based drug set to become available to patients in March. 'You're talking about a drug that's somewhere in the neighborhood of five times more potent than what we're dealing with now,' says Dr. Stephen Anderson, a Washington emergency room physician who is not part of the most recent petition to the FDA about the drug. 'I'm five times more concerned, solely based on potency.' The concerns echoed by all groups are broadly about the drug's potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will amplify already-rising overdose numbers. 'In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid (PDF),' the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.
Zohydro's maker, Zogenix, and the FDA say the drug's benefits outweigh its risks and in their petition to the FDA for approval, Zogenix representatives say the drug fills a critical need for people suffering from chronic pain who are at risk for liver toxicity and cited examples of patients who might benefit from Zohydro: a 46-year-old male with chronic back and leg pain who had two failed back surgeries; a 52-year-old female with metastatic breast cancer experiencing diffuse pain; a 32-year-old woman with multiple orthopedic fractures. 'There's a lot of misinformation being put out there by people who don't have all the facts,' says Dr. Brad Galer, executive vice president and chief medical officer at Zogenix. 'We're talking about patients that are in bed, depressed, can't sleep, can't work, can't interact with their loved ones — it's a very significant medical health problem that is being ignored.'"
Zohydro's maker, Zogenix, and the FDA say the drug's benefits outweigh its risks and in their petition to the FDA for approval, Zogenix representatives say the drug fills a critical need for people suffering from chronic pain who are at risk for liver toxicity and cited examples of patients who might benefit from Zohydro: a 46-year-old male with chronic back and leg pain who had two failed back surgeries; a 52-year-old female with metastatic breast cancer experiencing diffuse pain; a 32-year-old woman with multiple orthopedic fractures. 'There's a lot of misinformation being put out there by people who don't have all the facts,' says Dr. Brad Galer, executive vice president and chief medical officer at Zogenix. 'We're talking about patients that are in bed, depressed, can't sleep, can't work, can't interact with their loved ones — it's a very significant medical health problem that is being ignored.'"
It's just a tool I guess (Score:5, Insightful)
Re:It's just a tool I guess (Score:5, Insightful)
Sometimes regulating the hell out of things decreases its availability for good use and jump starts the black market for bad use.
Problem is, they're probably both right (Score:5, Insightful)
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.
Higher potency? (Score:4, Insightful)
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:It's just a tool I guess (Score:5, Insightful)
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.
The articles. (Score:5, Insightful)
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:It's just a tool I guess (Score:4, Insightful)
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.
Drug warriors are going to hate this medication (Score:2, Insightful)
Therefore I'm in favor ot it.
Re:It's just a tool I guess (Score:5, Insightful)
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 (Score:3, Insightful)
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 (Score:4, Insightful)
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 (Score:5, Insightful)
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.
last thing? (Score:5, Insightful)
the very last thing the country needs is a new, dangerous, high-dose opioid
Unless, of course, you are in serious chronic pain. Then, according to Dr. Stephen Anderson and friends, fuck you. You are obviously faking it because if they can't imagine needing this drug in the emergency room, then it must be useless to everyone.
Re:It's just a tool I guess (Score:5, Insightful)
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 (Score:5, Insightful)
Pain must be a good thing (Score:3, Insightful)
So, some doctors want their patients to suffer only because some people might abuse the drug? Assholes.
Is the abuse problem really that big a deal? (Score:5, Insightful)
I know "drugs are evil" and all, but I genuinely don't understand why people are so panicked about people abusing prescription pain killers. The reality is that there's a huge demand for pain medication, both for legitimate and abuse purposes. Just like the other wars on drugs, it's impossible to stop. Therefore, I'm of the mind that we shouldn't do anything...and that's coming from a very left-wing, big-government type. We should focus on providing abusers safe drugs, and spend the money we save on enforcement on treatment for the people who really want to get off drugs. I've never touched drugs, but I can't blame someone who has a crappy life and no prospects of it getting better from doing so.
Providing pain medication addicts with a preparation that won't destroy their liver (due to the included acetaminophen in other meds) would be a start. There's no fix for the demand problem, and reducing supply just drives up the price.
The reality is that the future is looking pretty bleak -- unemployment is going to be incredibly high as even safe middle class jobs are automated. Unless we want a revolution, it might be time to start loosening the restrictions on controlled substances. When unemployment goes up past 30, 40% and higher, governments are going to have angry mobs on their hands unless they have something to keep them occupied...
Re:It's just a tool I guess (Score:5, Insightful)
I don't presume to know how close you've ever been to full-on drug addiction,
but in my own admittedly small sampling,
many an addict's confinement is the only time in their adult lives they're not using. A great friend passed last year at the ripe old age of 48, but his life was probably extended a decade by frequent periods of abstinence as a guest of the County and State.
Problem with simple confinement is, it doesn't fix the problems, just delays the next dose. And don't think for a minute that jails and prisons are drug-free. They're not. Drugs are available, just at insanely high prices due to scarcity.
Speaking as a recovering addict, you need to fix the cause, not the symptoms. Incarceration does neither, and tags the 'offender' with a felony rap, making it that much harder for them to reintegrate to society by blocking employment opportunities when they get back to the streets. End results? The 'offender' ends up back in jail.
Re:It's just a tool I guess (Score:5, Insightful)