a very big rat…

Posted on Wednesday 26 February 2014

If you work in the medical field, you know that prescription narcotics have become a major drug of abuse in the US. When I started working in a charity clinic in Appalachia, I was stunned by the number of people on Narcotics and how many times I was asked for a refill. When I renewed my DEA license last time, I relinquished my certification for the opioids altogether. So now when asked, I can simply say, "I am not licensed to prescribe those drugs." There must be a grapevine, because after a couple of months, they stopped asking. While doing that helped my mental health, it didn’t do much for drug abuse in the county since I never prescribed them anyway. Up here, illicit drug use is almost a cultural phenomenon [replacing the moonshine made in these mountains a generation ago]. The main drug here was Methamphetamine when I first came a decade ago, but a new Sheriff seems to have shut down most of the meth labs. Now it’s prescription pills. I don’t know where they come from exactly – bad doctors? pain clinics? Mexico? other points south? Thefts? Wherever it is, they’re plenty available.

Comes now Zohydro™ER. It’s a long acting Hydrocodone with no acetaminophen [No acetaminophen is a good thing. Acetaminophen can be toxic to the liver. It’s the -cet in Preco-cet, Darvo-cet, etc.]. People are understandably up in arms about this drug coming on the market:
They all say the same thing. Why, in the midst of an opiate use epidemic, would the FDA approve a new, potent, long-acting narcotic? This from PublicCitizen:
Feb. 26, 2014
Dozens of Groups, Experts Call on FDA to Withdraw Its Approval of Zohydro, Supercharged Opioid

WASHINGTON, D.C. – More than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs today called on the U.S. Food and Drug Administration (FDA) to revoke its approval of Zohydro, an opioid so powerful that a single dose could kill a child. The FDA approved the drug in October against the advice of its own advisory committee, which voted 11-2 against allowing Zohydro, made by Zogenix and Alkermes, to be sold. It is the first single-ingredient hydrocodone drug ever to be approved. Other drugs, such as Vicodin, combine hydrocodone and acetaminophen. Zohydro is scheduled to be available in March.

Earlier this month, three U.S. senators raised concerns about the drug and asked the FDA to explain how it will prevent misuse. Writing on behalf of “groups on the front-line of the nation’s opioid addiction epidemic,” the organizations said there is no need for another high-dose opioid. “Too many people have already become addicted to similar opioid medications and too many lives have been lost,” said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. “The FDA should exercise its responsibility to protect the public’s health by reversing its approval of Zohydro.”

“I’m worried about their plan to market the drug for back pain and other common problems,” said Judy Rummler, chair of the FED UP! Coalition and president of the Steve Rummler Hope Foundation.  Judy’s son Steve died of a drug overdose in 2011.  He had become addicted to the painkillers that were prescribed to him for his chronic back pain. Opioid prescriptions have skyrocketed in recent years. The U.S. has just 5 percent of the world’s population but is consuming more than 99 percent of the world’s hydrocodone. Opioid addiction and overdose deaths have increased commensurately.

“The capsules will contain a whopping dose of hydrocodone,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids. Jackson lost his 18-year-old daughter to a single dose of OxyContin. “It’s crazy to let this drug go on the market as it undoubtedly will become the next OxyContin that will fuel the opioid addiction epidemic.” Added Dr. Michael Carome, director of Public Citizen’s Health Research Group, “I’m amazed that the FDA would approve a dangerous new opioid over the strong objection of its advisory panel. In the midst of a severe epidemic of opioid addiction and overdose deaths, this is the last thing we need.” 

The letter is available at http://www.citizen.org/hrg2185.
And this from this morning’s NPR Morning Edition:
LAURA SULLIVAN, BYLINE: When Zohydro is released next month, it will be one of the most powerful prescription painkillers on the market. It’s highest dosage will contain five to 10 times as much hydrocodone as the widely used Vicodin. The drug company’s literature says an adult could overdose on two capsules. A child could die from swallowing just one pill.
DR. MICHAEL CAROME: People are going to die from this drug.
SULLIVAN: Dr. Michael Carome is the director of Health Research for Public Citizen.
CAROME: We are in the midst of a public health crisis. There is an epidemic of opioid addiction resulting in thousands of deaths. And the last thing we need now is another high-potent, high-dose, long-acting opioid drug, Zohydro, that will simply feed the epidemic.
SULLIVAN: Overdose deaths and addiction rates from prescription painkillers similar to Zohydro have grown dramatically in recent years. Carome and 41 other healthcare advocates are asking the FDA to remove its approval of the drug. Zohydro is a crushable pill. That means it’s snortable and, some experts say, more prone to abuse than other drugs like the new versions of Oxycontin, which are no longer crushable. The drug company Zogenix is marketing the drug.
DR. BRAD GALER: There’s a lot of misinformation being put out there by people who don’t have all the facts.
SULLIVAN: Dr. Brad Galer is the company’s chief medical officer. He says they will introduce a non-crushable version of Zohydro in three years. And the company will closely monitor prescription transfer abuse. But he says millions legitimately need this drug.
GALER: 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.
SULLIVAN: That argument isn’t sitting will with public health advocates. Dr. Andrew Kolodny is chief medical officer at the Phoenix House Foundation.
DR. ANDREW KOLODNY: We have many opiate formulations on the market. There’s absolutely no need for a new opioid formulation.
SULLIVAN: FDA’s own advisory panels seem to agree. The panel voted 11-to-2 not to approve the drug. Then in November, top FDA officials overruled that panel. And that’s where things get complicated. Last fall, a series of emails were made public from a Freedom of Information Act request. They were emails between two professors who had, for a decade, organized private meetings between FDA officials and drug companies who make pain medicine. The drug companies pay the professors thousands of dollars to attend. And here’s what has critics concerned. One of those companies was Zohydro’s original manufacturer, Elan Corporation. Zogenix wasn’t in the picture yet but went on to partner with Elan.
Dr. Kolodny of Phoenix House Foundation.
KOLODNY: When those emails surfaced, I think for many of us there was a sense of a-ha.
SULLIVAN: Elan has a new owner and the company did not respond to requests for comment. In a statement, the FDA said the meetings did not address specific drugs and that the FDA took part to develop better research methods. The statement says those research methods may have benefitted companies making pain drugs but that they also benefitted patients. Zohydro’s Dr. Galer attended the meetings when he worked for another drug company.
GALER: Those actually were looking at old studies to improve patient care.
SULLIVAN: So I asked him: But if the drug manufacturers are sitting in a room with FDA officials talking about pain drugs, and they’re there because they spent 20 to 30 thousand dollars to be in the room, and some of the other advocates aren’t allowed in that room at the same time, does that raise any concerns for you that that could be a conflict of interest?
GALER: Well, again, I’m here as chief medical officer for Zogenix. Zogenix was not involved whatsoever. All I can say is that this medication, Zohydro ER, will benefit many patients…
We don’t yet know this whole story, but there’s a hue and cry so loud that we’re surely going to know it soon. The smell of a very big rat permeates these reports…
    February 27, 2014 | 1:15 AM

    “They were emails between two professors who had, for a decade, organized private meetings between FDA officials and drug companies who make pain medicine….”

    Why would this need to happen when the company has 5 lobbyists that they pay $110K to?

    The other issue that the FDA decision to reject the scientific committee’s recommendation was described as being secondary to their own bureaucratic structure. From the Division Director:

    “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.”


    Steve Lucas
    February 27, 2014 | 7:03 AM

    We were having problems with an elderly friend’s behavior and strange health issues prior to her death. Once she was given a home health aid who monitored her medications it was learned that she was self medicating with Oxy and other pain medications. The slurred speech and other behaviors mimicked diabetic symptoms, but there were never any test results showing a level high enough to generate these behaviors.

    Talking to a friend about the situation he stopped, grabbed my arm, and said I could tell no one about her medications. An elderly woman living alone was a prime target for thieves and she would simply be pushed aside in their quest for those medications.

    Troubling was she knew that if she complained about her gout the doctor would raise her medication levels. The doctor knew that raising her medication levels would keep her quiet and so the circle repeated itself.

    Recent discussions in the popular press have highlighted the deaths of several high profile personalities and their struggle with drug addiction. One consistent point has been that having been off drugs for awhile their tolerance has declined, and when they return they go back to their old dosage, or the drugs have increased in potency, with the result of death.

    This is a bad idea just like the lollypop pain med of a few years ago.

    Steve Lucas

    February 27, 2014 | 7:05 AM

    Thanks, Mickey.

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