New potent pain pill approval is ‘frightening’

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Zohydro, a hydrocodone-based drug is the latest in a long line of painkillers called opioid analgesics.

A potent little painkiller is causing a big stir.

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 prescription drug Zohydro.

The hydrocodone-based drug is the latest in a long line of painkillers called opioid analgesics. The FDA approved the medication last fall to treat chronic pain, and it is set to become available to patients in March.

“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,” the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.

“Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”

One addiction expert who signed the letter was more forthright.

“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It will kill people as soon as it’s released.”

The letter is the latest in a series of entreaties to the FDA related to Zohydro.

In December, 29 state attorneys general sent a similar letter to the FDA. The month before, members of Congress asked the agency to review its decision to approve the drug.

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.

“This could be the next OxyContin,” says a petition on Change.org asking the FDA to reconsider.

According to the Centers for Disease Control and Prevention, prescription opioid deaths more than quadrupled since 1999 — there were 4,030 deaths involving the drugs in 1999, compared with 16,651 in 2010.

“You’re talking about a drug that’s somewhere in the neighborhood of five times more potent than what we’re dealing with now,” said 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.”

Both Zohydro’s maker, Zogenix, and the FDA assert the drug’s benefits outweigh its risks.

“We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids,” said Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, in an e-mail. “In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.”

Galer said the company will focus its commercial efforts on a small group of doctors with good experience prescribing opioids, so that only appropriate chronic pain patients would receive the drug.

Advocates for pain patients say that concerns about abuse, while valid for some, are not necessarily an issue for those patients.

“We know that a person with pain is not a person who abuses medications,” said Dr. Paul Gileno, founder and president of the U.S. Pain Foundation, a group that receives some funding in unrestricted grants from the pharmaceutical industry. “A person with pain is a person suffering to get pain relief in order to live a fulfilling life.”

In their petition to the FDA for approval, Zogenix representatives 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.

If Zohydro follows in the footsteps of its opioid-containing predecessors, such a narrow, focused patient group may expand — to patients with low back pain, fibromyalgia, arthritis or countless other chronic conditions.

“The problem is, it costs a lot of money bringing a drug through clinical trials and then bringing it to market,” said Anderson, past president of the Washington chapter of the American College of Emergency Physicians. “You have to anticipate (the drug company) being able to market and get its money back.

“I see this as a marketing ploy where eventually it’s ‘I’ve got bigger, I’ve got stronger, why don’t you prescribe this,’ and I’m terrified of that.”

Bigger, stronger opioids — especially those containing hydrocodone — are a concern. Hydrocodone (Zohydro’s sole ingredient) is one of the most frequently prescribed — and abused — opioids.

For that reason, in October, the FDA said it intended to shift hydrocodone-containing drugs from Schedule III to Schedule II. That rescheduling (still pending approval by the Drug Enforcement Administration) would mean much stricter dispensing and prescribing rules for hydrocodone-containing products.

At the time of that recommendation, the FDA posted a statement on its website that it “… has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”

A day after announcing the proposed drug schedule change for hydrocodone, the FDA announced Zohydro’s approval. It was a confusing juxtaposition, some say.

“Shocking, outrageous and genuinely frightening,” said Kolodny of the Physicians for Responsible Opioid Prescribing.

FDA spokeswoman Morgan Liscinsky said that Zohydro’s approval was separate and distinct from the agency’s recommendation about rescheduling hydrocodone-containing products.

“I find great difficulty (with) the wisdom of the FDA’s approval in terms of protecting the public’s health,” said Dr. Alex Cahana, professor of pain medicine at the University of Washington in Seattle, who was not among those who signed the letter to the FDA. “Risk-benefit thinking suggests that not everything we can do, we should do.”

Zohydro will enter the market already classified as a Schedule II — one reason both the FDA and the drug’s maker are confident it will not contribute to the broader overdose problem.

Zohydro’s labeling will feature warnings about abuse, addiction and misuse, and Galer said Zogenix is working on an abuse-deterrent version of Zohydro that should become available in three years.

None of those precautions has assuaged concerns. Anderson said that while a small subset of patients may benefit from Zohydro, unleashing such a potent drug in the current environment is unsafe.

“Put more of this kind of drug out on the street and, I’ll see more overdoses related to this, no question,” Anderson said.

16 comments

  • JT

    Killthepoor, I don’t see you blog in very often, but when you do, it’s thought-provoking. Where are you on this one? Love to see what you have to say about this…

  • Karl Davis

    Those who want to abuse substances will always find something to abuse. It’s important to treat chronic pain for those who are seriously ill, and I value helping them more than I value trying to close every last door for somebody who is looking for something to abuse. I agree with this approval.

  • John Warren

    The “abuser lobby” is always ready to “protect” their “poor, ill public” with never a thought about the people for whom analgesics are properly intended: those is pain. I’ve had severe idiopathic neuropathy for years, and these bleeding hearts and their allies in law enforcement and government have made my life hell.

    For once, let’s think of the good citizens rather than the criminals. The addicts choose to become addicted. The choose to take more and more substance. They have a choice. I, and the people like me, didn’t choose to hurt why are we less worth of consideration?

    What is the difference between torturing someone and forcing someone to live in pain? I don’t see one.

    • FaithC

      I agree and well said. I know someone who has conic pain. Most of the time they can deal with it and over the counter pain meds help. But there are times that the pain becomes so severe that they just sit and cry. It is those times that pain relief, as talked about in this article, is necessary for them.
      I will assume those who want to block the sale of such pain meds have never needed them.

    • Joseph Smith

      Addiction is a life long sickness its not a choice it starts with one pill for a broke bone and then bam ur hooked and need it to function and to even be happy. When u get the flu u take meds RIGHT.

  • Nautical Winds

    I’d love to know how people even get a doctor to prescribe a narcotic for pain anymore. I’ve been suffering from chronic back pain for 6 years now. Most I can get my physician to do is suggest I take 800mg of ibuprofen twice a day and a pat on my head.

    I prefer to keep my kidneys and liver intact so 800mg of anything isn’t going to happen. I deal with the pain but can tell you, it literally drives me to tears getting out of bed some mornings.

    • John Warren

      I completely agree. The ATF has created a climate of fear that is very hard for anyone to overcome. Recently, the police had an informant hound a doctor for almost half a year in order to trick him into prescribing drugs. They supplied her with all the “right” answer so when he eventually decided to see if they would help he was arrested and they pulled his license (http://www.palmbeachpost.com/news/news/crime-law/state-suspends-boca-raton-psychiatrists-license-fo/nWXX9/)

      To protect my doctor, I regularly visit a neurologist who then writes a report to her saying that my dosage is needed and appropriate. It costs more but I really want to protect her.

  • Eve

    obviously none of you have had an opiate addict in your family. Let’s get one thing straight. The majority of people who are addicted to opiates are the ones that are taking it for their pain!! These are not people who sought out a drug to get addicted to it!! The doctors prescribed these drugs in the past, pharmaceutical companies knew how highly addictive they were but they saw a huge $$$ market.

    People who do try to quit by using other methods ie, MJ are prosecuted for growing it even if they have a med licence to do so!! We need to all open our eyes and really look at this opiate epidemic and see what the truth really is.

    • JT

      Thank you, Eve. But what you’re asking people to do is think, and let’s be honest, that’s not going to happen. See, if we blame the addicts and label them as sick, degenerate junkies, then we don’t have to think about how complex this issue is. We don’t have to wonder about how frequently these pills are prescribed by doctors or handed out by pain clinics, nor do we have to think about what role the drug companies/manufacturers/advertisers have in this. We also do not have to be concerned with the social issues (like poverty, addictive personalities/mental illnesses) that preclude addiction. We grossly oversimplify the problem and assign a moral precedence to an issue that is amoral. Further, hating people for their situation absolves us of the responsibility of sympathy and empathy. We do the same with the poor–they obviously chose this lifestyle, to screw them. Same thing with addicts. Because everyone knows that those addicted to opiates woke up one morning and decided their life’s ambition was to be a junky, right?

    • John Warren

      As it is I have to travel to my doctor’s office once a month to get a printed superscription that I then have to carry to a specific pharmacy. If they are out, I have to wait. Do you really want me to have to do this four times a day?

  • norma

    The drug abuse are making it hard for those of us who live daily with pain that keeps us from living a normal life. More and more drs are not trusting their patients enough to help them manage the pain and the suspect everyone of being a junky if you even ask for pain meds and if you suggest the dose be increased they want to send you to rehab. That’s why i suffer and now take nothing and wait for the end.

  • Robin

    Have any of cared for cancer patients, COPD patients, heart patients or chronic pain patients? If you haven’t, shadow a Hospice nurse one day or watch the poor souls trying to walk in to a Pain Center. Strong drugs are needed! Weak minded people looking for crutches and excuses are making living and dying hell for the truly needy. People let themselves become addicted. I took STRONG drugs when I needed them and weaned off when I felt better. I am in pain daily but don’t abuse prescription drugs. People make choices then blame others. Addicts make themselves drugs don’t make them.

  • Will Grant

    And you, “JT” come off as a very unmanly “white knight”

    “Eve” is already pregnant from a married black man, so give up trying to lay your game on her.

Comments are closed.