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.'"
Re:It's just a tool I guess (Score:2, Informative)
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:Problem is, they're probably both right (Score:5, Informative)
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.
Probably current best treatment (Score:5, Informative)
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 (Score:5, Informative)
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 (Score:5, Informative)
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 (Score:5, Informative)
I don't presume to know how close you've ever been to full-on drug addiction,
but in my own admittedly small sampling,
many an addict's confinement is the only time in their adult lives they're not using. A great friend passed last year at the ripe old age of 48, but his life was probably extended a decade by frequent periods of abstinence as a guest of the County and State.
I have been very close to addiction. I have watched a good friend put heroin into his arm, and had another die of "massive organ failure" after many years of drug use. There was a time when at least half of my friends were in AA. I agree that some people need confinement to stop using, at least temporarily. But I think that's what we have inpatient rehab for. Confine someone if you must, but don't put them in jail. Prison is not an environment conducive to improving one's mental and physical health; it just makes things worse.
Re: It's just a tool I guess (Score:4, Informative)
Just to be pedant, but hydrocodone (the active ingredient in The Fine Drug) is similar, but different from oxycodone, the active ingredient in Oxycontin, the long acting formulation.
The Big Deal about TFD is that it is the first pure hydrocodone product available (in the US at least). All other hydrocodone containing medications have been mixed with acetaminophen (paracetamol to you people that insist on driving on the wrong side of the road) or ibuprofen. The theory is that adding another drug with different analgesic properties increases the analgesic effect (true) and that 'adulterating' the opiate with another drug makes it harder to abuse since you will, at some point or another, die of liver failure (acetaminophen) or a GI bleed (ibuprofen) - which isn't true.
So, unleashing this drug, free from contaminating tylenol, will cause a massive uptick in hydrocodone addicts.
Which is probably not true. However, the need for long acting hydrocodone is limited at best. While there are people that can take hydrocodone and not oxycodone, you have several other long drugs in long acting formulations for chronic pain (fentanyl, morphine).
The drug WILL be popular among the abuser community because there are some people who want to keep their livers intact.
As has been described here, the current War on Drugs (TM, patent pending US Drug Enforcement Administration) is a total failure and a more rational approach to drug use is needed. But what do you expect from a country that has a Bureau of Alcohol, Tobacco and Firearms as well as a Drug Enforcement Administration. If you were naive to the US you might think these federal agencies were promoting these issues. Double plusungood.
For folks with access to Science, there is a timely article [sciencemag.org] on this subject.