Drug Maker Blames ‘Misinformation’ for Zohydro Controversy

Drug Maker Blames ‘Misinformation’ for Zohydro Controversy

The CEO of a company that recently introduced a new and more potent opioid painkiller is blaming “false and misleading statements” – including allegations by a U.S. senator — for the continuing controversy over the drug.

“This misinformation has created negative perceptions about Zohydro ER,” wrote Roger Hawley, CEO of San Diego-based Zogenix (NASDAQ: ZGNX) in a letter to shareholders.

Zogenix-ZohydroExtended release Zohydro is the first pure hydrocodone painkiller sold in the U.S. Unlike other hydrocodone products such as Vicodin, it does not contain acetaminophen – which can cause liver damage at high doses.

Addiction treatment experts have claimed Zohydro is 5 to 10 times more potent than Vicodin and have warned it is more likely to be abused by drug addicts because it does not come in a tamper resistant formula.

There is also controversy over the Food and Drug Administration’s decision to approve Zohydro over the objections of its staff and advisory committee, which warned Zohydro could be abused even more than currently available hydrocodone products.

“Critics of Zohydro ER have claimed that this treatment is 10 times stronger than other opioids, 10 times more ‘lethal’ than other hydrocodone prescription drugs, and that this is the strongest opioid available,” Hawley said in his letter to shareholders.

“All are gross misstatements and fail to consider each of the very different FDA-approved indications of each product and do not acknowledge that these products are used to treat a different severity of pain as reflected by their individual prescribing labels. The fact is, there are other extended-release opioids which are of higher strengths than Zohydro ER.”

Hawley also referred to another controversy over seminars conducted by two medical professors. Pharmaceutical companies paid as much as $25,000 to be at the meetings, which were attended by FDA officials involved in clinical drug trials, many of them involving prescription painkillers.

West Virginia Sen. Joe Manchin has been especially critical of the meetings.

“These allegations clearly demonstrate a conflict of interest by allowing pharmaceutical companies to have undue influence over the FDA’s decision making process,” wrote Sen. Joe Manchin, a West Virginia Democrat, in a letter last October to FDA commissioner Margaret Hamburg.

This month Sen. Manchin went even further, suggesting in a letter to Health and Human Services Secretary Kathleen Sebelius that Zohydro was approved by the FDA as a result of the meetings. He also introduced a bill in Congress to force the FDA to withdraw its approval of Zohydro.

Sen. Joe Manchin (D-WV)

Sen. Joe Manchin (D-WV)

“I am deeply troubled that the reason for Zohydro ER’s approval may be linked to allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay thousands of dollars for the privilege to attend private meetings with FDA officials,” Sen. Manchin wrote.

“If true, we have an alarming explanation for the indefensible decision of the FDA to approve Zohydro.”

In his letter to shareholders, Hawley denied that anyone with Zogenix even attended the meetings.

“Without justification, inaccurate allegations have been made that Zogenix paid a university to arrange meetings with the FDA to secure approval of Zohydro ER,” wrote Hawley.

“The university in question has declared for the record that, in the meetings it arranged with FDA officials, no representation from Zogenix was present, nor was the company or its products ever discussed. In fact, Zogenix did not even exist as a company at the time of these meetings.”

Some pain patients who want access to Zohydro have told National Pain Report that it is Sen. Manchin who has a conflict of interest.

The senator’s daughter, Heather Bresch, is the CEO of Mylan Inc. (NASDAQ:MYL) a Pittsburgh-based pharmaceutical company that is one of the largest generic drug manufacturers in the world. One of Mylan’s top-selling drugs is a hydrocodone product containing acetaminophen.

Campaign records show that political action committees or individuals associated with Mylan have donated $127,000 to Manchin in the last five years — making Mylan the senator’s second largest corporate contributor.

“It’s obvious to anyone there is an agenda behind this,” wrote one pain patient who asked not to be identified. “(Manchin’s bill) is poorly written and contains outrageous claims. No senator would want to be associated with this bill, with his connections to Mylan so obvious.”

The husband of a woman who suffers from chronic back pain also questioned Manchin’s motives for opposing Zohydro.

“I have been outraged at the actions of a few, particularly Senator Manchin, who appears obsessed with derailing this new choice,” he wrote in an email to National Pain Report.

“But it was when I saw the connection between him, his daughter, Mylan, and significant (6 figure) campaign donations from his daughters company, well, that was too much. It would appear clear his effort is to remove a competitor in the guise of saving an abuser. “

Repeated calls and emails to Sen. Manchin’s office for comment were not returned.

Mylan’s corporate communications office also did not respond to National Pain Report’s requests for an interview with Heather Bresch.

Sen. Manchin has been sharply critical of other FDA actions related to painkillers – not just Zohydro. He has been a vocal supporter of reclassifying all hydrocodone products as Schedule II controlled substances, which would make them harder to obtain.  Last month, the Drug Enforcement Administration  published in the Federal Register a formal proposal to reschedule hydrocodone combination products from Schedule III to Schedule II.

Rescheduling would affect dozens of pain medications, including Vicodin, Lortab, Norco, and the generic hydrocodone produced by Mylan. Zohydro is already classified as a Schedule II drug.

Authored by: Pat Anson, Editor

There are 10 comments for this article
  1. Gregory at 10:43 pm

    I agree this is a great drug for those like me who have been taking norco for. 6 years and I just can’t handle all of the acetametaphen anymore the only problem I have is I can’t afford this medication and Medicare won’t cover and they say a generic will never be made? I would love to try zohydro but yea I don’t have 400 dollars for a 30 day percription!!! So what are people in my situation suppose to do? And I don’t have any other options because hydrocodone is the only pain med I can tolerate I’ve been perscribed others but for one reason or another I couldn’t take them. So it’s back to Norco and it does really concern me due to being in it for so long and the condition of my kidneys and liver in the long run. How can I get Medicare to cover? Will they ever ??

  2. The General at 2:59 pm

    imeant to mention that zohydro made by zogenix is only medication that offers relief without the damaging acetaminophen.For this reason only i give zohydro two thumbs up,well done ,great job.As far as how efective it is to individuals we shall know soon,including myself.Proper prescribing and monitoring of patient should be top of list for at least the first three months or so ,especially if your taking various meds and even if your taking vitamin supplements always check with your Dr. Again God Bless all .

  3. The General at 2:47 pm

    Im happy to here that there are some people out there on my side the responcible user,not abuser t.y.v.m.I have to say though regarding our past experience with oxycontin,that should have been lessoned learned .however im on board with zogenix so long as they stay on path of making zohydro Tamper Proof.i do not agree with the time period,not only is a couple years to long ,we all know lives are at stake here.Honestly it should have been made tamper proof from day one but because people are week and easy manipulated with a bit of money,cash they give in to yes when we all dam well know it should be NO,NO,and efn, NO>.Be good all God Bless!!
    .

  4. William at 2:46 pm

    By the way oxy became a media darling because of how it sounds. Hydromorphone does not sound as sexy. Truth.

  5. William at 2:44 pm

    These goons are looking on the wrong side of the road. People in chronic pain need medication to live. Government is blind to this and think they are super heroes trying to save the world from a big bad drug. It is not a bad drug. Everytime one is released it is looked upon as a menace to society. Like a villain of sorts. National Chronic Pain Registry. It will happen and people will finally get the treatment they need. Once you are registered, they can’t say no. Hopefully someone will put this idea forward and help everyone out there who is suffering as we speak.

  6. Jason Warner at 4:59 pm

    Here we go again with the same old crap in regards to political & monetary gain from these politicians without a thought to the legitimate chronic sufferers. This disgusts me and I am filing a complaint with his office. I am so PLEASED that you nailed this Politician with his pants down. If anyone is represented by his district there’s a new movement on Bill Maher blog site called “Flip a District.” Here is the link..GET RID OF HIM NEXT ELECTION
    http://www.real-time-with-bill-maher-blog.com/index/2014/1/31/test

  7. C at 4:10 pm

    Why is Zohydro being singled out to ban??? Why not ban Oxycontin, Fentanyl, morphine, Opana, Vicodin type meds, benzodiazepams, Percocet and any other drugs asso w/drug addiction & abuse? Why not focus on Heroin, meth, alcohol, cocaine and deal with all these substances which have actual documentation for abuse/overdoses and associated deaths?

    Because it is a never ending “war” to try to put out fires rather than address the underlying causes; the diseases of addiction, depression, anxiety, the socio-economic stresses of unemployment, crime, poverty, poor education and issues which can push people further into possible drug abuse.

    Banning a single new narcotic is not the answer. It only penalizes legitimate chronic pain patients (and those that Zohydro can help) because of a small percentage of abusers who will only look to the next drug to abuse & mix with alcohol and illicit substances to create a new high from the stresses of life. And it gives “hero” status to politicians, media as though they helped “solve” a problem, when really, they haven’t addressed the underlying social/psych problems. Much easier to target/blame a small company’s drug, than tackle huge societal issue that is so much larger than Zogenix.

    What happened with alcohol prohibition? Bootleggers made/sold moonshine. The truth is, getting high & addiction to substances has been around for centuries…there will always be a percentage of people who engage, the real question is, who makes money off this? Big pharma, Purdue, Mylan (Sen Manchin’s dtg’s company that makes hydrocodone narc med in direct competition to Zohydro), Endo, etc and they are lobbying to push Zohydro out (but not their own narcotic which are just as strong & abused)

    Narcotic pain meds can alleviate horrible pain, and for those with cancer, terminal illness and chronic pain who cannot tolerate tylenol, Zohydro may help them. Despite the misinformed and fear-mongers waving flags, hydrocodone is an appropriate pain med for many patients.

  8. John Roman at 10:56 am

    FINALLY someone wrote an article with the TRUTH included. Thank you! Senator Manchin has an addiction. An addiction to corruption! Probably why his state is so messed up.

  9. D at 10:55 am

    So much misinformation only hurts legitimate patient need. Responsible patients should not be penalized for the inappropriate use by those who abuse, divert or misuse medicine. Zohydro is the only single ingredient pain med available and offers a viable alternative to millions. From the liver foundation in 2010, over 30 million have liver disease and should not take acetaminophen. That does not count those with kidney disease and allergies to ibuprofen, acetaminophen and aspirin, found in ALL other pain meds. There is a NEED for this single ingredient pain medicine.