Last night when I was looking for what I’d read previously about the Zohydro™ER issue, I couldn’t find what I was looking for. Here are a few of the articles I couldn’t find:
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Emails point to ‘troubling’ relationship between drug firms, regulators.
Milwaukee Journal Sentinal, October 6, 2013 -
Pharmaceutical firms paid to attend meetings of panel that advises FDA.
Washington Post, October 6, 2013 -
FDA and Pharma: Emails Raise Pay-for-Play Concerns.
MedpageToday, October 7, 2014 -
Why Did the F.D.A. Approve a New Pain Drug?
New York Times, December 3, 2013hat tip to George Dawson…
I can’t locate the emails themselves, just their description. I’m not sure what I think about all of this. I recently filled out a questionnaire from PharmedOut which asked me to list the twenty essential medications you’d take to a situation where that was all you had to practice with. An opioid was one of the first things I thought of – kidney stones, heart attacks, pulmonary edema, broken bones, herniated discs, etc. They are definitely essential to practice. And they work. When I was in the Air Force stationed in the UK, we used a British Formulary and instead of Morphine, we had Heroin. And it was a fine choice in the situations mentioned above but universally habituating. But the problem is in relation to chronic pain, not acute use – problems like severe back pain. Some things I’ve picked up along the way:
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I’m personally a chronic back pain person with a back full of hardware. After my first back event, I was sent home with a bottle of Percocet – "two every six hours as needed for pain" it said. I sure had pain, so I took two, and reached the following conclusion. There was never going to be a minute for the rest of my days when a couple of those wouldn’t feel like a fine idea. So I threw them away. They were too good. My point is that their addictive potential is impressive.
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Later in life, I had some pain situations where I simply had to take something [after a couple of back surgeries, for a dental abscess or two, etc]. I learned that when you have big time pain, they are mostly pain pills. The euphoric effects aren’t so noticable then. But for lesser pain, they become happy pills too. I learned that with an excruciating dental abscess. The first pill after it began to get better was when I got that "uh-oh" feeling and tapered off.
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After using narcotics for more than two days, I think it’s best to assume physical dependence and taper rather than stop. My assumption, by the way, is that anyone can become addicted to narcotics. It’s an equal opportunity drug.
Whenever I’ve prescribed narcotics, I’ve always talked about addiction potential, physical dependence, and withdrawal up front. I’ve described tapering and written small prescriptions with a large instruction section. If I’ve created any chronic addicts, I don’t know it. I’ve never prescribed narcotics long term, referring those patients who have shown up to legitimate pain clinics or Methadone programs. My point is that opiates are both an essential part of medical practice and a dangerous part of medical practice. Because I got tired of being hit up on for narcotics, I withdrew that part of my DEA license. Why would a volunteer psychiatrist ever need to prescribe narcotics? I mention my personal take because I think every doctor can tell a similar story and has to come to some decision about these drugs, developing a personal intuition about their use. They’re like the corticosteroids – miraculous short term and potentially devastating long term.
So, back to Zohydro™ER. As best I can tell, Zohydro™ER got lobbied through the FDA [still looking for those emails]. On the other hand, this argument is probably administratively correct:
Bob Rappaport, the director of the F.D.A’s Division of Anesthesia, Analgesia, and Addiction Products, observed at the meeting that it was reasonable to anticipate that a single-entity hydrocodone product “will contribute to the already critical public-health problem of prescription opioid abuse and misuse.” But he also chastised the expert panel for some of their more pointedly critical remarks about Zohydro ER, observing that they were “punishing this company and this drug because of the sins of the previous developers and their products” and that “from a regulatory standpoint, that’s not something we can do.” He explained that as long as the drug met F.D.A. requirements, it ought to pass muster; Zohydro ER could not be scapegoated simply by virtue of being an opioid. “We are obligated at the agency to operate within the regulatory framework,” he said, “and that includes providing a level playing field for industry. We don’t have a choice by that. It’s the law.”
This opens a very large can of worms, one that comes up frequently. The FDA deals primarily with the pharmaceutical industry, and in capitalist USA, the consideration of the industry needs is often on the front burner. Make restrictions too tight, and industry fails. In our world, industry develops the drugs. Make them too loose, and commerce carries the day – and people can get hurt or killed.Without a system like this, there’s no incentive to develop drugs and we stagnate. With such a system, double binds like this are inevitable. Rarely do we see a new drug that doesn’t have something about it that throws a monkey wrench into the equation. But the issue with Zohydro™ER seems to me to transcend the argument put forward by Bob Rapaport above. It has to do with a hierarchy of values. Zohydro™ER is not a "me too" drug. It’s a "me too much" drug.
H
ydrocodone generally comes in 5.0 mg, 7.5 mg, and 10.0 mg pills. Zohydro™ER comes in capsules. "Each Zohydro ER capsule contains either 10, 15, 20, 30, 40, or 50 mg of hydrocodone bitartrate USP." Its assets are that it doesn’t have Acetaminophen and one doesn’t have to take as many pills or take them as often. The downside is that some of those pills could easily be lethal to people who are not tolerant or to children. They will be worth a mint on the street where bigger is better. I expect the drug culture people see them as something like a new iPhone – a potential blockbuster. The risk/benefit ratio is much higher than the pills on the market already. And in the hierarchy of values, surely "do no harm" trumps convenience every time.
This drug isn’t dangerous because of the "sins of the previous developers and their products." It’s dangerous all by itself. Bob Rappaport, the director of the F.D.A’s Division of Anesthesia, Analgesia, and Addiction Products already knows it’s dangerous – saying "at the meeting that it was reasonable to anticipate that a single-entity hydrocodone product ‘will contribute to the already critical public-health problem of prescription opioid abuse and misuse.‘" But then he goes on to get all picky about the mandates and regulations. It seems to me that the problem isn’t the regulations, it’s Bob Rappaport, who has lost sight of some fundamental priorities. It’s hard to imagine someone in his position making this argument about this drug in this country at this time.
One word:
Actiq
A bad drug then, this is a bad idea now.
Steve Lucas
A lot people firmly believe that what’s good for business is good for the country.
No shortage of bad ideas at the FDA. The COI story here is as opaque as it gets. Congress sets the budget so industry lobbyists exert their influence there. Not the first time there have been problems with opioids. From Hawthorne’s Inside the FDA:”A federal study in 2002 found that nearly 2 million people had used OxyContin without a genuine medical need…..So by letting cheap generic copies onto the market in March 2004, the FDA was acting like a drug pusher declaring a half-price sale. The agency acknowledged the “potential for abuse, misuse, and diversion” in an unusual press release accompanying the approval. It noted that generic manufacturers had promised to include some sort of risk management safeguards but nothing specific was spelled out. Eight months later the FDA announced a pilot project to use specific labels with tiny radio frequency electronic tags on bottles of OxyContin and a few other drugs to track shipments and prevent theft…… However that would not stop people with legitimate prescriptions from abusing pills or selling them via underground networks among other tactics.” (pp 275-276).
So it is 12 years later and the FDA has not learned anything right down to the promise of a “tamper proof” Zohydro at some point in the future.
http://real-psychiatry.blogspot.com/2014/01/latest-bad-ideas-from-fda-zohydro-and.html
Frightening are the people on Oxy and Percocet or Darvocet. A pharmacist friend talks about people walking around with enough medication to knock down a horse, and he should know, he raises horses.
Steve Lucas
I would add (and I apologize if this is a repeat), that Melody Peterson reports on the roll out of branded Oxycontin. It is included in her excellent book, “Our Daily Meds.” It was the same story. KOL’s were wined and dined by the drug company, Purdue Pharmaceuticals founded by psychiatrist, Dr. Arthur Sackler. This resulted in many reports – in the professional and lay press – on how pain is under treated. Like low T, indigestion, female sexual dysfunction, weak bones, hyperactive bladders – we essentially were convinced we had a new problem – under treated pain. The drug was introduced with the promise that it was less addictive. This goes on and on. Physicians just say they are trying to help people and they are following the evidence. Patients demand the help promised on TV. I agree with Dr. Dawson that there are powerful forces outside of the consultation room that influence these problems but – and I am not sure if we have a disagreement or I am misunderstanding – I still think that us lowly doctors have an obligation to take responsibility for their parts in this system. With regard to psychiatric practice, I only see defensiveness on the part of psychiatric leadership (guild and academic).
Let us not forget that it’s not Congress or the FDA who writes prescriptions for painkillers and gives them to patients who shouldn’t get them, it’s physicians who are the last mile in the drug distribution network. Why are they so gullible about drug safety?
Overprescribing has little to do with drug safety.
http://real-psychiatry.blogspot.com/2014/01/the-great-unconscious-why-rems-are.html
There is a precedent that shows what the FDA can do if they have the willpower and that is the amphetamine weight loss epidemic of the 1960s and 1970s. Their reaction essentially stopped the practice:
“Then, in 1973, with the country struggling with a long-running epidemic of amphetamine abuse, the FDA, concerned about the abuse potential of the amphetamine congeners and their transient efficacy, limited the indication of all obesity drugs to short-term use (ie, a few weeks)”
http://circ.ahajournals.org/content/125/17/2156.full
I hope everyone will pile on and sign the petition against Zohydro approval, fielded by the same groups that launched the letter to the FDA:
http://www.change.org/petitions/reconsider-approval-of-dangerous-new-opioid-zohydro
Then do yourself a favor and click through the comments for five or ten minutes. It’s nothing short of devastating. The parade of dead fathers, husbands, mothers, sisters, friends … And of course kids. Lots and lots of kids. “Epidemic” doesn’t begin to describe this.
Moreover, it’s clear that many, many of the fallen started out as “legitimate pain patients” getting these drugs from a doctor for back pain, knee surgery, arthritis, you name it. Andrew Kolodny of Physicians for Responsible Opioid Prescribing has pushed to make this clear: There is no division between the need to cut off the supply to “dope addicts” and keep the medicine flowing to “legitimate pain patients.” These drugs may be essential for post surgical and other acute pain, but they are a lousy way to treat chronic pain.
http://www.huffingtonpost.com/andrew-kolodny-md/zohydro-the-fdaapproved-p_b_4855964.html
It must be either the gummint or the patients responsible for overprescribing of all kinds of drugs. The brain attached to the hand writing the prescription has nothing to do with it.
In your last post, Mickey, you mentioned that the abuse of drugs can be regional and can depend on a sheriff, even. Why is that? Why in some areas are there a lot of people collecting arrowheads because they’re not too hard to find out in the country in Arkansas where meth is wildly popular? Why did so many people start using cocaine regularly when companies started testing employees for drugs and could detect marijuana smoked once weeks ago? Why is drug abuse often more common and more serious in rural areas than in the city?
Perhaps the answer to a lot of drug abuse is jobs and better living in a society that respects health and mental wellness more than the concerns of the people who exploit our labor and/or our mental/emotional problems.
Remember the Rat Park study?
http://en.wikipedia.org/wiki/Rat_Park
The study was replicated with humans and had the same results?
http://forensicpsychologist.blogspot.com/2013/06/summer-reading-and-more.html
Heroin and cocaine being illegal, has not stopped their use. Perhaps better access to rehabilitation and better information on addiction— not just scary stories— would save a lot of lives that would other be lost.
If nothing else works as well, I see no reason to deny those of us with chronic pain an opiate. I’ve never gotten a euphoric effect from them. Though I hate morphine with the power of a thousand suns and stopped it suddenly, oxy is working o.k. It takes the edge off, and that edge makes the difference between waking and sleeping. If the hormone replacements I just started help to quell the waves of pain I feel throughout my body when I use, for instance, a light sheet when it’s 52 degrees Fahrenheit in my living room and I’m down to a t-shirt, short tights, and no socks; then I’ll work at stopping the trazodone first. If that works, I’ll start tapering very carefully off of the oxy. The amitriptyline would likely be the hardest to come off and would take a much longer time to do so, even though it’s not a narcotic.
Surely, medical doctors have the sense not to prescribe willy-nilly and for cash business on the side. Chronic pain is chronic pain— it doesn’t really compare to taking a drug for the drug’s effect when there is no pain.
Wiley,
While I agree that social, educational, and every other kind of deprivation explains the high incidence of rural and inner-city drug abuse, There’s also an Appalachian thing that dates to the settling of the mountains. They were anti-government whiskey runners from Ireland, and there is a tradition that runs through to the thunder road days. NASACAR started here with races between the whiskey runners in the 40s and 50s. These mountain forests are littered with old rusting stills. It continues with meth labs today. And the anti-any-kind-of-government sentiment is still in the culture. I don’t mean to romanticize it, but they do.
I agree with your point about pain management, and it’s hard to do. The drug users know how to play sick. I thought I could tell the difference, and I was wrong. I got fooled more times that I want to admit. That’s why I gave up my narcotics license. We now have a pain clinic run by a neurologist and the Georgia Narcotics people send a pharmacist who has access to criminal records. It has been a positive development because the doctor doesn’t have to be suspicious of his patients. I just hated that part.
Chronic opiate use is itself reasonable benign if people don’t do the kind of crazy things users do with drugs. And these Zohydro pills are just too damn big and they’re going to be on the streets. I had two recovering meth addicts at the clinic today that they said they’d heard about some new “super pill” in their recovery groups already. In neither case did I bring it up. They did in an uh-oh way.
So there are cash business doctors. But the users are always looking for doctors they can fool too. And here in the mountains, it’s a big deal. I just hope the neurologist will keep doing it. It has been a boon for all of us – patients and doctors alike…
Not sure how benign it is … from my melancholy perch in the workers comp system I have seen too many back-surgery patients on a downhill path using nothing but legitimately prescribed drugs. Looks like there’s compelling evidence for the “hyperalgesia” effect in which long-term exposure to opiates makes you MORE sensitive to pain, not less. Then there’s depression, cognitive decline, osteoporosis, hypogonadism … most of the testosterone prescribing in this country is bogus, but if you do run across non-elderly men with actual testosterone deficiencies, expect many if not most to be on Oxy.
This article by a California doc, “Are we making pain patients worse?” struck me as very sound. She points out that we’re forgetting things that we’ve known about opiates for oh, maybe a couple of thousand years …
http://www.scma.org/magazine/articles/?articleid=423
Dr. Dawson – I don’t misunderstand you; I plain don’t understand you.
Here’s my attempt to grasp your thought process. There’s a 3-legged stool of drug abuse upheld by Big Pharma, MDs [of all kinds] and the public. Each leg bears responsibility for holding it up. If trying to break an individual leg is not working, concentrating on dissolving the glue that binds all together [the FDA] or on putting pressure on all three legs combined [too much weight] would be a more productive approach than kicking at any one leg.
If you are still reading this thread, please let me know if I am anywhere remotely close with this analogy. Thanks.
Note that Seymour Hoffman died from the unholy three: opiates, benzos, and stimulants, and doubt the heroin was the larger of two opiates in his system, nah, it was prescription opiates simultaneously too.
And don’t forget the benzos.
What have the American Psychiatry Association, the American Academy of Addiction Psychiatry, and the American Society of Addiction Medicine said about this? This is exactly the sort of thing they should be decrying as responsible medical specialty organizations.
David Healy among others signed the petition at http://www.citizen.org/hrg2185
Zogenix stock is falling.
http://tinyurl.com/nh6lx8h
A financial update webcast will be held on March 5.
http://tinyurl.com/oaec2s2