Former State Senator Steve Tolman, Activists Will Protest Lift on Zohydro Ban

Families of addicts are heading to the State House to call attention to the controversial drug.

After a federal judge struck down Governor Deval Patrick’s attempts to ban the powerful painkiller Zohydro from being distributed to Massachusetts’s patients, family members of addicts decided they couldn’t just stand by and watch as more opioid pills hit the streets.

In response, they’re planning a protest at the State House—and it’s going to be “big.”

With the backing of former State Senator Steve Tolman, members of Learn to Cope, an advocacy group that aims to curb the heroin problem by raising awareness about the impacts it’s having across the state, say they’ll stage a peaceful protest on Beacon Hill on April 29, and make their message loud and clear: ” The release of [Zohydro] will cause more addiction and more death.”

Joanne Peterson, founder and executive director of Learn to Cope, is organizing the event, called “Massachusetts Says No to Zohydro.” In a message to Boston, she said she expects this particular protest—based on a federal judge’s recent controversial ruling to allow its distribution, despite warnings from state leaders—to be “big.”

The organized event is in response to a preliminary injunction granted by a federal judge this week, which blocked Patrick from imposing the ban on Zohydro. The company that makes the drug, Zogenix, Inc., filed for a temporary restraining order in court after Patrick first announced his intended plans to stop the drug from being prescribed during a press conference earlier this month addressing the current opioid epidemic in Massachusetts.

Ultimately, the judge sided with the makers of Zohydro, who argued in a court filing that Patrick’s attempts were unconstitutional, and the Federal Drug Administration, which had already approved of the drug, had power over Patrick’s ban.

Regardless of the ruling, members of Learn to Cope think it’s important to continue to call attention to the powerful drug, citing the fact that it’s not tamper-proof and can be easily crushed and snorted by people who weren’t prescribed the medicine.

The group has also rallied support from Tolman, president of the Massachusetts AFL-CIO, who said he has seen the opiate addiction problem “rip families apart and devastate communities” for decades, and adding Zohydro to the mix will further exasperate that. “I have witnessed it, I have lived it, and I have come to the conclusion that the only way we are going to change this pattern is to start to stand up against,” he said. “We do not need more synthetic heroin in our communities, we need less of it. We’ve got a problem that almost overnight turns very good people into the devil, and evil people that have no concern. Me and many people have seen that. And Zohydro will add to it. Why do we need another drug that’s Vicodin on steroids? Why do we need something like that?”

Boston City Councilor Steve Murphy has also vowed to attend the protest in Boston on April 29. According to the group’s Facebook page, nearly 100 people have committed to going, and Peterson thinks that number will grow in the coming weeks. “We feel Zohydro is like a Weapon of Mass Destruction! Many states are opposing this drug being released! We need to ban together all states in this country and let our concerns and our voices be heard,” she said on the event page.

  • Dr. Rob

    Spend more time at home helping your loved ones deal with the addictions instead of looking for someone to blame may be a good place to start.Peoplle like this kill me, junkies do drugs cause they choose too period…….If people really need help blaming a company who is making a product that is helping people in need is not the answer.If you ban this drug all that will happen is people who need it wont get it because of some junkie who will just find another way to get high.Most addiction issues have more deep rooted causes look for the answers closer to home and stop blaming others for your problems its called PERSONEL RESPONSIBILITY PEOPLE

    • Scruffy Fitch

      Dear Dr. Rob,

      You may benefit by taking another course in morals and ethics. Everyone can benefit from over-feeding our self-interest, and trying to improve the lives of others. We need to work together. We have the best country in the world, but we need to be able to see past what we perceive makes us happy, and be able to see life through the eyes of others to understand truly the true definition of happiness.

      Scruffy

  • davidbecker2

    Junkies are people- it is quite glib and ignorant to say a junkie does it because they want to. That’s like saying a person commits suicide because they want to. Don’t ignorant and uncaring people like to mock the failings of others- as if they had no failings of their own.
    How those with identity foreclosure spend so little time forming their ignorant opinions of others. Their dorsolateral prefrontal cortexes and right insula more dysfunctional then the junkies they make fun of. How cold and ignorant drug companies and doctors can be when it comes to addiction issues.

  • Ken Edwards

    It’s amazing that the entire New England heroin and opioid abuse phenomenon is the fault of a pain medication that been available for less than two months with no overdoses or deaths reported that I’m aware of. The argument is that the introduction of a new opioid product will make the problem worse. Unfortunately, that knee jerk response is not supported by any evidence. And of course, all the hype trying to make Zohydro out to be stronger than any other medication is without merit. When will people start to ask where all this hype is coming from?

    • Scruffy Fitch

      The answer, from individuals who wish to make bags of money without concern for their fellowman. This may include you, can you look at yourself in the mirror and see a good person looking back. A person concerned about the future of our great country.

      Scruffy

      • Ken Edwards

        Zogenix is not a threat to our great country. The fourth estate abdicating professionalism in the early days of this misinformation campaign does concern me.

        • Scruffy Fitch

          Ken,

          Please read the comments recently posted. I wish you all the success in the world

          Scruffy.

  • Scruffy Fitch

    Yes it is true my name is Scruffy and I am a Peekapoo.

    Look, the issue is that Zogenix is a poorly run company; they should have been working diligently on an abuse deterrence for Zohydro rather than trying to market their nitrogen inject-able delivery device for Sumatriptan (this is a niche market, within a niche market, within a niche market). They wasted six months of time before reducing their sales force and implementing additional cost savings measures. I was very vocal two years ago with how management was mismanaging their limited cash reserves, and what they should have been doing at the time to conserve their cash. Guess what? They need to go to the well again because they will be out of cash in July. Thus, they would have been six-months further ahead if they had followed the correct course.

    The problem is that Zogenix execs now believe (through
    cognitive dissonance) that Zohydro is absolutely necessary right now in the health system, yet we have multiple choices other than Zohydro to help control pain.

    Moreover, Purdue’s OXY has the only abuse deterrent in its core that the FDA likes. Thus, in regard to the FDA they are all over the map on this subject, and I am unable to trust anything they state with regard to Zohydro. Additionally, the approval was based on a specific group of patients numbering 30,000 not the entire nation who may run to Zohydro to nullify a back twinge.

    Therefore, Zogenix got by protest what they have earned and deserve, and I hope this protest continues to grow. Zohydro must have some kind of antagonist in its core, and we must protect the population and society from the damage this particular drug is more than capable of inflicting. This is not a complex legal argument requiring mirrors and smoke and glass. It is about repairing the moral fabric of our wonderful society that is in disrepair. I applaud Governor Patrick, other governors, AG’s, state and federal senators, pain doctors, experts, and other states for what they understand to be the real truth in this argument, and for having the courage to speak out against Zohydro.

    Scruffy Fitch

    • Ken Edwards

      Current abuse deterrent technology is junk. If Zogenix had gone the plastic polymer route nothing would be different. Abusers will always find a way around any technology. They didn’t make a ADF to start with, because the FDA didn’t say they had to. If/when they come up with a new ADF, if it interferes with the opioid like current technologies, I’m not sure it’s fair to legitimate pain sufferers to be forced to develop a tolerance to an extra high dosage just to deter abuse.

      • Scruffy Fitch

        Ken,

        The “so called” safety panel is a joke you will find Zohydro material in GP offices. This is a fact, and it gives you an idea what is truly important from Zogenix’s perspective. Thus, Zogenix must be held accountable. The best thing for society right now is
        that Zohydro is pulled right now, and given the green light from the FDA when they have an adequate mechanism placed in its core.

        Again, Zogenix will need 120 million in July to support their ongoing cash need. Thus, do they go back to the top three or four shareholders and (further) dilute the stock at $2.10 – 2.25 per share in July?

        You have to consider that Zogenix is fighting a financial battle right now, and they will likely continue to step over the line to assuage their shareholders.

        Additionally, if they are truly an intelligent team of business executives, and the role of their sales-force (each paid approximately 120K per month) is to hand out education material, then I ask are they spending their investor’s money wisely?

        Legitimate pain sufferers have other alternatives to use. Keep on pushing me please! Those individuals who have the courage to speak out against Zohydro are hero’s in my book.

        I am not long or short Zogenix. I am not favoring Purdue as a company, just its deterrence technology. I believe we need to be doing the right thing for the good of society. I believe the Governor’s ban was a step in the right direction in this regard.

        Scruffy

        • Ken Edwards

          I’m not sure what cash needs you are referring to. They plan to go the Relday and Zoh ADF trials alone, but that will pay off down the road. It is true the sales reps are paid based on provider education, which is admirable. Judge Zobel recognized Zohydro’s “special attributes,” being the only ER formulation without acetaminophen. Other opioids are at least as potent and available in higher mg strength without abuse deterrent. I have yet to see a reason to single out hydorcodone or Zohydro. Zogenix does not consider it’s safety panel a joke. Yes they are paid for their work, but the contributions are real. There will be no dilution, no buyout. Time will make this farce go away.

          • Scruffy Fitch

            Ken,

            Please read the comment I have just posted. I hope this explains things clearly. I wish you all the best.

            Scruffy.

        • Ken Edwards

          Do you realize the quota percentage of hydrocodone allotted to Zohydro is less than one percent of the US production quota for the year? As a “first step,” this is a lot of effort for what amounts to something less than a token gesture, just to attack the new guy on the block because he’s an easy target. This is no way to make public policy. I’m not pushing, just being reasonable.

          • Scruffy Fitch

            Ken,

            I get that you a passionate about this subject. I am equally passionate in my opposition to Zohydro. Much of what I know about the subject (especially the ultimate FDA approval process makes very little sense).

            You have to admit it is incredible that opponents to the drug remain energized, and it appears the opposition continues to gather strength.

            I believe you can answer all your questions by examination of this fact, and by digging a little bit deeper into the subject of opioid abuse. Moreover, examine some of Senator Manchin’s comments as they are interesting, but ignore the conflict of interest allegations as there are many powerful voices making similar comments to Manchin’s.

            I do wish you all the success in the world, it is through conflict that we learn. The more we examine all sides of an argument, and remove our self-interest from the equation the more we learn from a conflict. Again, I admit that I know very little about very little and I am willing to examine all sides of this argument and apologize to ALL when I am wrong.

            Scruffy

  • Scruffy Fitch

    Hi all … Scruffy again, and I stress I am a Peekapoo (Pekinese / Poodle). I love treats, but I am a little worried about this new pain drug Zohydro, and what I am about to say may give others additional cause for concern. Excuse me for a moment, I have an itch … Somehow I have earned an advanced degree from a top university.

    Anyway, I wish to add to my previous posts. It is important to recognize that Zogenix is using a network of friendly docs to make a positive case for Zohydro. Moreover, the mantra they are suggesting is that Zohydro is a novel pain medication that fills an important medical need. This is beyond ridiculous because docs have a multitude of medication options (in fact too many opioids to choose from). This pain medication is hardly novel other than the fact that it can be crushed and dose dumped. If the medication is used in accordance with how it won FDA approval (as an end of life option), and distributed to no more than 30,000 patients and under very strict controls then what the FDA is offering those patients makes sense.

    However, we are not stupid, despite the company trying to suggest otherwise. The reality is that Zohydro education material is being distributed to General Practitioners and their PA’s throughout
    this great nation and this is troubling.

    Best,

    Scruffy

    • Ken Edwards

      Do you really see the 10 mg dosage of Zohydro as an end-of-life medication? Over 12 hours, I see it as weaker than 5 mg Vicodin without the 900-1200 mg of acetaminophen over the same 12 hours. Yes, the 50 mg is for extreme cases.

      • Scruffy Fitch

        Ken,

        Please read the comment I have just posted. I hope this explains things clearly. I wish you all the best.

        Best,

        Scruffy.

  • Michael Schubert

    How is Zohydro “more lethal” than generic Opana, hydromorphone, Roxicodone, methadone, morphine, or fentanyl, all more potent opiates on the market when compared mg to mg with Zohydro?!?!? I’d really like to know. Here’s the facts below. Every single one of the 100 MILLION pain patients in this country wish reporters would do more accurate journalism.
    This hydrocodone in Zohydro, hydrocodone bitartrate, is the EXACT SAME HYDROCODONE as in all the hydrocodone products on the market now that are Schedule III substances classified by the DEA. First of all, out of all the extended release opiate pain medicines on the market, Hydrocodone, the main ingredient in Zohydro, is the LEAST POTENT milligram for milligram. This can easily be verified by looking at an opiate conversion chart, such as here: http://www.globalrph.com/narcotic.htm . I found it shocking to read so many articles, many of which were commented on by doctors, that failed to use proper drug comparisons. Oxycodone is almost twice as strong as hydrocodone, which means Zohydro is a much weaker substitute for oxycodone (which is already on the market). The anti-Zohydro groups need to pay attention and understand the significance of this truth. Every Zohydro prescription will take the place of a more potent opiate. Wouldn’t doctors want to start patients that need opiate therapy on the least potent med first? Another potent opiate, generic oxymorphone is widely available without abuse-deterrent features and much, much cheaper than Zohydro. Oxymorphone is approximately twice as potent as oxycodone. It is more lipophilic than morphine, allowing for a faster onset of action. It is available as an injection and as oral formulations: immediate-release (Opana) and sustained-release (Opana ER). Because it has a longer half-life than morphine, hydromorphone, and oxycodone, the immediate-release product may be dosed at longer intervals (up to every six hours).
    According to USA Today, Opana overtook oxycontin as the painkiller most abused in the U.S. I would assume that the activists who are protesting Zohydro would protest these much more potent drugs before complaining about Zohydro.
    Read about Opiate medications here from US PHARMACIST: http://www.uspharmacist.com/continuing_education/ceviewtest/lessonid/105473/
    Morphine, which is available in strengths up to 200mg and DOES NOT have abuse-deterrent features, must be one of the alternative medicines they are talking about. Morphine is 3 TIMES MORE POTENT WHEN INJECTED. So crushing a 200mg Extended Release Morphine tablet and injecting it would be just like taking 600mg orally!!! According to the math in the articles by reporters, this would KILL SIX PEOPLE. Any mention of Extended Release Morphine without tamper-resistant features? Actually, there is only ONE extended release opiate with abuse deterrents approved by the FDA, Purdue’s OxyContin. What they don’t tell you is the deterrent is made from a plastic polymer and causes severe side effects. Google “new OP OxyContin pain side effects” and read accounts from THOUSANDS of pain patients that suffered from the re formulation in pain forums. What about hydrocodone? Per US PHARMACIST, “Hydrocodone is only available in combination with non-opioids. Compared with codeine, it provides significantly more pain relief and a longer duration of action. Hydrocodone is a prodrug metabolized by CYP2D6, with analgesic effects dependent on its active metabolite hydromorphone.” Hydrocodone needs to pass through the liver to create the active metabolite, injecting or snorting does not create a “rush” because the active metabolite has not been created yet. Other drugs such as Vyvanse use this method to PREVENT abuse. Ever wonder why legitimate medical injectable hydrocodone has never been on the market? Because it needs to pass through the liver first. An addict injecting hydrocodone would still get high, but no “rush” like from injecting morphine, oxycodone or oxymorphone. Hydrocodone is water-soluble and passes through the blood-brain barrier slower. At 80% oral bioavailability, injecting or insuffilating hydrocodone is pointless, except on a full stomach. In comparison, Morphine is between 20-40% bio available orally, that’s why addicts inject morphine and others because it’s MUCH stronger and NOT WATER SOLUBLE.
    So why did the advisory board vote against this? They were tasked with determining its SAFETY WHEN TAKEN AS DIRECTED AND EFFECTIVENESS. During the hearing, the FDA could be heard numerous times telling this advisory board to get back to their task, not giving opinions that were not their jobs. Abuse deterrent features can be defeated ridiculously easy, google “OxyContin microwave”. The FDA has recently stated that it does no good to label something abuse deterrent if it does not do that, and it does absolutely nothing to stop the far most common route they abuse it, taking the drug ORALLY INTACT. Authors also fail to mention the other strengths of Zohydro. It comes in 10,15,20, 30 & 40 milligram strengths also, and is released OVER THE COURSE OF 12 hours. So instead of taking one or two hydrocodone/APAP pills every 4 hours, the Zohydro patient takes ONE every 12 hours. One monthly prescription for 60 Zohydro pills replaces 360 hydrocodone/APAP pills!!!! Zohydro takes 6 times as many hydrocodone pills out of circulation! Isn’t this what abuse crusaders want?!?!
    So why are people like Sen Manchin of West Virginia trying so hard to get Zohydro off the market? Let’s see, The political charge against Zohydro is currently led by Senator Joe Manchin (D-WVA), who is the father of Heather Manchin Bresch. Ms. Bresch is the CEO of Mylan (MYL), which coincidentally manufactures generic hydrocodone – a direct competitor to Zohydro. Is this not a conflict worthy of our attention? Mylan Pharmaceuticals also happens to be Manchin’s #2 campaign contributor! Source: https://www.opensecrets.org/politicians/summary.php?cid=N00032838
    Mylan sells Hydrocodone/APAP, ONE OF THEIR TOP SELLERS, and would lose significant market share to Zohydro. A United States Senator has significant political pull, notice how no other opiate (especially hydrocodone/APAP!) was under scrutiny even though some like Fentanyl are mixed with heroin and is 300 times more potent than hydrocodone? Mylan makes those opiate medications! Also Purdue makes $600MILLION per quarter from OxyContin and would lose major market share to Zohydro. Purdue makes political contributions, funds patient advocacy groups and hires teams of medical professionals as consultants.
    What about Zohydro? No one mentioned that Zogenix provides a locking pill bottle, an extremely inexpensive medicine safe ($15), and a subscription to Pain Patient Magazine (includes tips how to manage pain, safeguard medications, monitor medicine intake, etc). How many other drug companies include items like these with their opiate prescriptions? NONE! So by taking this off the market, these officials, reporters, crusaders, etc would rather have pain patients such as MYSELF take more potent medicines that don’t include items to safeguard my prescription? After reading all the FACTS above, and checking them out yourself, why do you think the real reason certain individuals want Zohydro, the least potent extended release opiate that includes ways to safeguard the medicine, off the market?!?

    Michael Schubert

    • Scruffy Fitch

      Michael,

      I wish you good luck.

      Scruffy

  • Michael Schubert

    I suspect that there would be more pain patients at this gathering if they weren’t in too much pain to attend. What a cowardly group of people. First, disregard the 100 MILLION Americans in pain that had no choice to live with horrific pain and instead try to protect criminal addicts from themselves. Secondly, blame an inanimate object for an addicts or their own failings. It’s always easier to point the finger and blame someone/something else then to look in the mirror and admit you failed. Finally, the 100 MILLION pain patients that this medicine was designed to help are in too much pain to attend this event, and the organizers know it. The organizers will have a chance to spread lies and misinformation without anyone there to state the facts. I posted the science below, which is all backed up by facts. Tell the organizers to back up their clams with facts

  • Scruffy Fitch

    Hi Ken and others who have posted,

    Firstly, I get it that you have some kind of passion for the company. They have a couple of good products in Relday and Sumalvel Dose
    Pro. However, they are not innovators as a company. They purchased this technology. They purchased the molecule to develop Zohydro, and their market is limited to the United States and Canada (a huge market).

    Secondly, in another post I state that I am a 30-year student of
    the market. Well I also have multiple securities licenses in multiple
    countries; however, I will always be a student of the markets until I expire.

    Thirdly, I have founded several public companies from scratch.
    One of the companies that I founded reached a billion dollar (plus) in
    market cap; however, I agree that I know very little about very little, but I have accumulated a little experience over my lifetime. I am not wealthy any more, but I could be if that was my desire.

    Fourth, I have been writing about Zogenix’s balance sheet and cash requirements and stock price and have been extremely accurate on everything that I have stated. When the stock price dropped to $1.28
    with significant volume, I predicted that initial floor. I also publically stated that Zogenix must conserve cash about six-nine months prior to the eventual first round of lay-offs. At that time, the executive management was emotionally invested in their products, but the quarterly financial drain was touching 22 million.

    There are multiple opioid options without acetaminophen. I am an opponent of Zohydro because it is another “me-to” drug that can be crushed, snorted, injected and will contribute to addiction and heroin use. Docs have other options to use right now without inserting Zohydro into the mix. Have you ever used opioids? Have you
    experienced how quickly a 10mg dose of something needs to be adjusted to 25mg to be useful? Have you experienced withdrawal
    symptoms from opioids? I will preface that I do not drink alcohol, smoke, or participate in the recreational drug scene. However, I was placed on a high dosage of morphine for a period because I had several bulging and herniated discs in my lower lumbar. I was taking about 200mg of long acting morphine at one point. My approach to removing myself from addictive medicine is to go completely “cold turkey.” It was clear to me the morphine was killing me. For father’s day my son treated me to a professional baseball outing. He
    spent a lot of his hard earned money and got us great seats. However, I spent 95% of the game with my head deeply inserted into a toilet bowl used by well over a million people. As we walked to my car I found myself stopping frequently, I found myself bent over low brush at the edge of the sidewalk, and the people walking behind us were likely in a state of disbelief and ill. I have many other stories that I could share, but I am one of the lucky ones. I have unusually strong willpower. For instance, I quit drinking alcohol cold turkey for
    similar reasons twenty-five years ago.

    I hope this helps you understand that the subject of drug addiction contains elements that are well beyond potential financial benefits or possible avarice. Zohydro should not have been approved in its
    present form without an antagonist in its core. We need to be more responsible, less concerned for our own self-interest, and more concerned for the interest of our society as a whole. That is what America is all about, that is the greatness of America that I see, and what I love about this amazing country and that is what is missing within the elements contained deep within this argument. Again, the people that are speaking out against this drug are heroes in my book; I hope they continue speaking out with the same veracity. Black-stone and the other investors have the resources to wait a couple
    of years, but many of the big players associated to Zogenix want the company to create an exit strategy for them as quick a feasibly possible. I pray that they will have a little patience while this matter sorts itself out.

    Scruffy