Proposed Senate Bill to Ban New Painkiller
Proposed Senate Bill to Ban New Painkiller

Even before the U.S. Food and Drug Administration (FDA) approved Zohydro extended release in October 2013, Sen. Joe Manchin (D-W.Va.) has opposed the drug. On March 13, Manchin announced a plan to ban the potent painkiller through Congress.

“I have tried reasoning with the FDA, and I’ve repeatedly requested the agency change its course on this dangerous drug. Their refusal to budge forces me to introduce legislation,” Manchin said in a statement.

Zohydro ER is designed to deliver a steady dose of pain relief for hours on end. According to drug maker Zogenix, the drug is formulated specifically for patients in severe pain who require constant, long-term treatment where typical opioids are inadequate.

Although the drug bears a new FDA warning label detailing the heightened risks and safety concerns, critics believe Zohydro still presents a big opportunity for abuse, given already high rates of addiction and overdose deaths related to conventional prescription opioids.

“The last thing we need is a drug on the market with ten times the hydrocodone of Vicodin and Lortab, with the capability of killing an individual in just two tablets,” Manchin said.

Opioid Controversy

Opium has a long history as a medicine and intoxicant, and attitudes toward it varied widely in the ancient world. Modern opioid drugs emerged in 1805, when a German pharmacist assistant isolated a chemical in the opium plant to produce morphine, named after Morpheus, Greek god of dreams.

The medical community has since struggled with how best to balance the ruinous and even fatal results that can come from opioid medications with its powerful pain relieving effects.

According to the Substance Abuse and Mental Health Services Administration, hydrocodone products are the most commonly prescribed opioid analgesics in the United States, as well as the most widely abused. Hydrocodone-heavy Zohydro won FDA approval despite an 11 to 2 recommendation against it from the agency’s outside advisory panel.

In her Senate testimony last week, FDA Commissioner Dr. Margaret Hamburg said the agency recognizes that Zohydro “is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy.”

But critics believe safety standards to guard against Zohydro abuse still fall short. FDA restricts Zohydro to prescription-only and no refills allowed, but unlike other powerful prescription opioids it is not formulated to deter abuse.

However, a similar drug might make the grade. Purdue Pharma, manufacturer of the widely prescribed painkiller OxyContin, announced on March 12 that it had a concentrated hydrocodone product that was also tamper-resistant.

According to a statement, the new pharmaceutical is “designed to be unattractive to drug seekers,” because the tablets are more difficult to make into powder for snorting or injection.

  • OneOtherPerson

    Congress needs to stay out of the medical field altogether, whether it’s in women’s health issues or drug manufacture.
    Regulating medicine because they want to regulate morality is wrong no matter what side of the isle thy’re on.

  • InternetReader

    Chronic pain sufferers never chose to live in agony each day. Whether
    it is physical trauma, cancer, arthritis or some other condition, we
    live in pain every hour of every day. Of course the excruciating pain we
    suffer is irrelevant because an addict voluntarily and illegally
    chooses to abuse drugs and alcohol. If making drugs illegal stopped
    abuse, then no one would use heroin or cocaine. Prohibiting Zohydro will
    not fix addiction problems, but it will cause physical torture for
    patients like me.

    I have had surgeries and used virtually every medication available
    (morphine, oxycodone, etc.). The only thing doctors can do for me is try
    and lessen the pain, and for me hydrocodone is the only medication that
    works well. I got my Zohydro prescription filled last week, and it is
    truly wonderful to be able to walk around without debilitating pain!

    I don’t know about some of the other politicians, but West Virginia
    Senator Joe Manchin’s push to ban Zohydro is quintessential corruption.
    Manchin’s daughter is Heather Bresch, who is the CEO of Mylan
    Pharmaceuticals. Mylan competes with Zohydro’s manufacturer Zogenix, and
    they are the second largest contributor to Manchin’s campaign
    committee. If I send Manchin a six-figure check, will he criminalize my
    business competition too?

    • AskandTell

      I agree with your post with the exception of drawing a conclusion that Manchin’s viewpoint is based on his daughter’s company. Doesn’t Mylan Pharmaceuticals manufacture generic drugs? I can’t see how shutting down the production of Zohydro would benefit Mylan unless it has something to do with the way the patent was written.

      • InternetReader

        Thanks for the reply. Let me offer a few explanations. Anecdotally, prior to Zohydro I used MS Contin. It was never very effective for my pain management, but it was the best option available. Most of the prescriptions from my pharmacy were manufactured by Mylan. I am now one fewer customer, but I’m sure I’m not alone.

        Zohydro is the biggest moneymaker for Zogenix, and if it is pulled it would weaken the company if not bankrupt them (they laid off 37% of their workforce last summer waiting for Zohydro’s approval). There are a host of reasons why this could interest Mylan. Maybe they are interested in buying the company, buying some of their patents, hiring away some of their talent, a combination of these or something different entirely. At the very least, it looks incredibly suspect for a company with such strong personal and monetary connections with a U.S. Senator to now try and destroy or greatly damage a rival company.

        As for Manchin, these huge conflicts of interest should be investigated by the media. Unfortunately, I have seen zero media coverage. In fact, the only mention I have seen is Forbes contributor Melanie Haiken reply in the comments that more research is required. I am skeptical that there is no connection because of past allegations of him using his influence to make money in the coal industry.

  • Chiron

    WRT, the elected representatives of the people on stuff like modern medicine:

    Stupid is as stupid does.

    The genie has left the bottle long ago.

  • Michael Schubert

    Absolutely there is a medical need. Before Zohydro, patients starting pain therapy were prescribed Hydrocodone/APAP. Hydrocodone is considered the ‘starter’ opioid. Unfortunately, the APAP part damages one liver over time and doctors have to switch the patient to an Extended Release opioid. Previously, the next least potent was OxyContin. Now that Zohydro is on the market, the doctor can switch the patient to an extended release formulation of the medicine they are currently taking instead of exposing the patient to a stronger, more powerful opioid like OxyContin, Morphine, Exalgo, Fentanyl, Opana, etc. Many patients are unable to function or work on these strong opioids, so they continue taking 1 or 2 Hydrocodone/APAP 10/325mg every 4 hours, even though the acetaminophen can seriously damage the liver. Zohydro is a much safer option. Unfortunately, Sen Manchin’s daughter is CEO of Mylan, who currently markets 9 opioid medicines, including Hydrocodone/APAP and Extended Release Morphine (non-tamper resistant!!). Mylan is also Sen Manchins #2 campaign contributor. This bill is obviously trying to destroy Mylans competition, since it only targets Zohydro, a long acting formulation of Mylan’s Hydrocodone, and no mention of other stronger, non-abuse deterrent opioids like Mylan’s Extended Release Morphine(non-abuse deterrent!!). Sen Manchin should resign, no Senator in their right mind will sign a bill to help Manchins daughter’s company profit and Manchin’s stock holdings in Mylan to increase in value. This bill is dead in committee…

  • Sherry Stephens

    Totally not understanding why the media is not all over Manchin — at the very least, his continuing to mislead both the public and elected officials with incorrect information about Zohydro, and at the worst, his conflict of interest and corruption vis a vis Mylan.

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