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Joseph H. Saunders
Joseph H. Saunders
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Zohydro: FDA and Greedy Drug Companies Ignore Public Health

15 comments

The United States consumes more than 80 percent of the global supply of opioids, and overdoses from prescription opioid drugs kill nearly 17,000 Americans every year. This averages out to approximately one overdose death every 30 minutes. In the midst of this painkiller epidemic I find myself questioning why the US Food and Drug Administration, over the objections of its medical advisory board, recently approved Zohydro, a new drug that has 5 to 10 times more of the heroin-like opioid hydrocodone than Vicodin?

 

I also have to question why the FDA would ignore a petition from the governors of Massachusetts, Vermont, New Hampshire, Rhode Island and Connecticut asking the U.S. Department of Health and Human Services to rescind approval of Zohydro. These New England governors argued that the approval of the prescription painkiller should have been reversed because of the “epidemic” of opioid addiction that is spreading through their states. They emphasized that the abuse and misuse of opioid painkillers is fueling not only a wave of addiction and crime, but is also serving as a bridge to a growing heroin trade.

 

These arguments fell on ears that have been deafened for decades by a pharmaceutical industry that had convinced doctors they had been allowing patients to suffer needlessly because of an overblown fear of addiction. In the midst of the worst crisis of prescription drug addiction and overdoses in US history, Big Pharma, still easily managed to convince the FDA to approve a highly addictive drug like Zohydro.

 

While the FDA has argued that there is a legitimate need for these drugs, it has chosen to downplay the tension between the twin challenges of chronic pain and addiction. Drug makers in turn have been aggressive in promoting these opiate-based painkillers and with good reason — in 2012 alone these drugs made more than $9 billion in revenue.

 

Zohydro belongs to a class of opioid painkillers that includes hydrocodone and its cousin, oxycodone. The numbers on these drugs are staggering. In 2010, the same year the combination of hydrocodone and acetaminophen became the most widely prescribed drug in the country, over 16,000 people died from overdosing on opioids. In the United States patients consume 99 percent of the worlds hydrocodone, the opioid in Vicodin, and 80 percent of the worlds hydrocodone, the opioid in Percocet and OxyContin.

 

When OxyContin was released in 1996, reports quickly surfaced that the medication was being misappropriated and abused. It had been designed to release medication over a slow period of time, but addicted individuals soon realized that by crushing up and snorting the tablets, they could receive the entire dosage all at once.

 

During this same time there was also a dramatic spike in heroin overdoses. Make no mistake; the familial ties between opioid painkillers and heroin are unmistakable. According to the CDC, currently three out of every four new heroin users report having first used prescription painkillers. Many heroin addicts had begun taking painkillers for legitimate reasons, but had never been properly counseled regarding the drugs addictive properties. The pharmaceutical industry has convinced many doctors that the problem is a few “drug seeking patients” downplaying the serious dangers of addiction to the average patient.

 

Within a few years of OxyContin’s release, widespread problems with narcotic painkillers began to surface nationwide. In 2003 The New York Times reported that, according to a government survey, more than 20 percent of 18- to 25-year-olds abused prescription pain medication, up from only 7 percent in 1992. There were increasing reports of physicians prescribing opioid painkillers in unusually large quantities, and “pill mills” began appearing, most notably in Florida.

 

While there was a sharp rise in the abuse of narcotic painkillers the pharmaceutical industry was concurrently promoting greater use of their narcotic medications. Leading manufacturers helped fund the American Academy of Pain Management and The American Pain Society – both groups advocated for the use of opioids as a tool for managing pain. The American Pain Society helped reclassify pain as a “fifth vital sign” that would be routinely measured along side along the four traditional ones: body temperature, blood pressure, heart rate, and breathing rate. The unique difference is that pain was the only vital sign to be self-reported using the now familiar zero-to 10 rating – a useful diagnostic tool, but one that could be easily manipulated and abused. In 1998 model guidelines were developed and widely adapted by state medical boards that codified the use of opioids as standard pain treatment practice. When these guidelines, which had been developed by agencies directly funded by the drug companies, were updated in 2004, sales of opioid painkillers rose dramatically.

 

Drug companies had routinely relied on false claims to promote the sales of painkillers. These false statements typically highlighted the safety of the drugs while ignoring the addictive and life-threatening properties. Many of the claims were based on the research of Dr. Russell Portenoy, a prominent proponent of the use of narcotic painkillers. The validity of Dr. Portenoy’s research was later called into question when it was revealed that drug manufacturers had backed his work.

 

These false claims over the safety of narcotic painkillers eventually led to one of the largest settlements ever by a pharmaceutical company when Purdue Pharma, the maker of OxyContin agreed to pay about $600 million in fines. The company pled guilty to criminal charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused. Other drug manufacturers were charged and paid fines, but opioid painkillers, including OxyContin, still remain widely prescribed.

 

Some preventive changes have been made, such as many of the painkillers are now dispensed in forms that don’t allow for them to be snorted or injected; yet addiction to these drugs still continues to grow.

 

This is why it came as a shock that the FDA, over the objections of it’s own advisory board and the CDC, has chosen to approve Zohydro. In their objections to the drug, several groups accused the FDA of being out of sync with a country overwhelmed by a drug crisis caused by narcotic painkillers. The CDC highlighted that opioid painkillers are widely over-prescribed and have recommended that these high-powered painkillers be reserved for cancer patients and end-of-life care. But most prescriptions are still being written for arthritis and back pain.

 

There are indeed legitimate uses for opioids in pain management, but experts estimate that only a small fraction, 2 percent, is actually being given to people with malignant pain. The drug companies have created a false market for painkillers that has ravaged our society. Their answer to that problem is to introduce a new, more powerful, and highly addictive drug that most experts agree we don’t need.

 

As Zohydro enters the market I would ask the drug companies to pause and reflect – how much money do they really need to make? How many lives will be ruined before they finally admit they are responsible for the devastating public health crisis they have created?

15 Comments

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  1. Gogo says:
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    Near 50 billion pills or units were prescribed to nearly 100 million Americans last year and maybe 15k attributed deaths. that is roughly 1 one hundredth of 1 percent. Viagra and Cialis may kill at about half that rate and they are not based based on an addictive molecule.

    Plus Zohydro will have an abuse deterrent formula approved by the FDA for sale in the next 30 days. In the meantime Zohydro is one of the tightest lay controlled prescriptions anyone can get, it is expensive, and it represents only .004 of 1 percent of the above 50 billion. Also it hasn’t killed anyone on record.

    The fact that you haven’t mentioned any of the dozen companies whose products represent that 50 billion on larger terms, whose products have killed 10s of thousands, makes the purpose of your piece highly suspect.

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    I have been writing about the prescription opioid/heroin epidemic destroying a generation of our young for 13 years now. I too am “suspect” but not about the facts in the writer’s article, but rather on the comment from “gogo” who does not have his facts correct. My guess is it is generated by the billion $$$$$ pharma business.

  3. Damon Smith says:
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    And yet data from cdc and radars shows opioid deaths plateuing. What do you think is causing this ? Do ADFS contribute?

  4. Damon Smith says:
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    GoGos comments are valid. Concentrating on a controlled release formulation when the majority of drug sold is immediate release is perhaps misleading. Immediate release formulations are cheaper (streetrx.com) and have none of the abuse deterrent features the FDA is looking for ( though not yet mandating). Focussing on Controlled release formulations ( which are not broken out in CDC or RADARS data may be ignoring the underlying trend and may be a reason why death (16.2k to 2013) are plateauing.

  5. Gogo says:
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    you are all missing the point. Yes, I agree that there is likely a lot of abuse and misuse by patients, prescribers, and criminals. But the fact is there will always be a proportion of the society that will abuse drugs, any drugs, legal or illegal…that is why you see a jump in street heroin now that there is more focus on prescription opiates. heroin is now the cheap yuppy choice, when Cochin was the choice 20 years ago.

    Yes mylan, purdue, endo, etc. are making billions, but this is, to some degree, at the expense of the old Cali cartel. Now somebody in Afghanistan and Burma is getting part of the US market instead.

    Focusing on companies, like Zogenix, that makes an extended release, soon to be abuse deterrent pill, that is both expensive and highly controlled and monitored is foolish. This is the type of product that will better treat the legitimate patient, while deterring the use by those looking for a cheap high. What they need to ban is the dirt cheap, non abuse deterrent, generic pills that can be taken a dozen at a time and still be cheaper and much easier to get than Zohydro ER. The FDA knows this…also the DEA has placed a cap on how much product Zogenix can sell, and it is about 200 million worth of product in a 10 billion market. the company sold about 30 million in Zohydro in 2014, and lost about 50 million doing so.

    So again, why is the focus not on the generic providers or purdue who are making billions. If you want to stop the abuse you would be pushing for generics to be banned and only allow abuse deterrent extended release expensive products on the market. The amount of prescriptions would drop drastically, although street heroin would skyrocket in use.

    Most lawyers are very savvy, so it is reasonable to assume that these attacks stem from the generic firms that are never mentioned and have the most to lose but who also spread the most money around.

    By the way, a kid who had his spine blown apart in the same country some of this product is produced may actually need it, even if they are not dying of Cancer. Sure the is a lot of bad Rx’s, but again in a market of 50 billion pills per year you are going to have major problems…that is simple human nature.

    So stop attacking the micro cap company who is doing things correctly and go after the real problem makers and maybe we won’t call you out

  6. G A says:
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    GoGo, please revise to include the ‘gateway’ deaths and recalculate/revise/re-publish. And please leave out the ED obfuscation unless you want to discuss medical errors and how death due to overdose now surpasses traffic fatalities. I do believe your flawed arguments typify the same snake oil marketing that got us into this mess.

  7. Eduardo says:
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    This would have been timely a year ago. Now it’s just old misinformation (5-10 time stronger) and misdirection (laying the sins of other companies at the feet of a new one with an impressive safe use record after more than ten months). Zogenix is proving that REMS done right can work. Did you even try to contact the company?

  8. Gogo says:
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    Eduardo,

    Exactly….why is this being written about 16 days from when the FDA is scheduled to approve a safer version of Zohydro when only a few percent of the billions of pills prescribed last year have any abuse deterrence properties. The FDA has to approve these new formulas and they are patented, so why aren’t people like marianne and ga publicly trying to speed that process.

    These people want us to believe that they want all opiates off the market, but they attack a drug that is being prescribed safely and represents less than a tenth of one percent of the pills prescribed.

    It doesn’t make sense, so we can only assume they are tring to protect the business of the incumbents, the business of selling mass amounts of 25 cent opiated pills.

    If they are worried about high school kids stealing relatives pills as a gateway drugs, they need to wake up…high school kids can get whatever they want. You are responsible for your kids until they hit 18, then they are responsible for themselves. anybody who takes a drug without googling it first is a neophyte

  9. Gogo says:
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    More than 50 percent of prescription opiate related deaths are reported in cases where the person also had some combination of cocaine, street heroine, benzos, and or alcohol in their system. Given this fact and the fact that deaths due to bad prescription drug interactions, especially in the over 65 group, kills more than 100k people each year in the US, it doesn’t take a brain surgeon to figure out that this issue is more complicated than the activists admit publicly.

    If you are 70 years old and have a massive herniated disc in your spine, and decide a risky operation is not the way to go…but instead take oxycodone or hydrocodone along with a physical therapy program….people like Marianne need to explain why that person, who represents 10’s of thousands per year, shouldn’t have access to an extended release pill like Zohydro, that may free them from taking half a dozen pills over the course of a day and also not sleeping due to break out pain in the middle of the night.

    If the drug is being monitored and prescribed correctly, please give me your reasoning. Also why are you singling out Zohydro and not Purdues Hysingla?

    My guess is that Marianne knows that Purdue might buy Zohydro and then use their dual patent positions to corner the market as the FDA starts to restrict generics and Purdue defends its patent portfolio based on anti abuse technology. The market might get smaller for these drugs, a good thing, but Purdue would win the end game and she obviously has pipriorities there…

    In the mean time, Medicaid, Medicare, VA, blues, Aetna, express scripts, CVS, etc…, they want dirt cheap generics, not safer, better performing…But 10-20 times more expensive drugs.
    Starting to get the picture…

  10. Eduardo says:
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    Go Go,
    Going back to June 2009, when an FDA panel narrowly voted to recommend to the FDA that Vicoden and Percocet be banned, there has not been a realistic hydrocodone alternative. While acetaminophen is a diabolical abuse deterrent, it was all they had. Now with the approval of Hysingla’s in October and the Alkermes formulation of Zohydro ER likely in the next few weeks, both with real physical abuse deterrent properties, the FDA can start acting on that recommendation if they are so inclined. They followed through on the HCP reschedule to CII, so who knows.

  11. Ron Williamson says:
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    I find the problem for people like me who actually need a drug like Oxycodone and are having a hard time getting my prescriptions filled is a real problem in my state of Florida. I have 2 herniated disc, L-4,L5. and now have arthritis in my lower back and neck. I have been on this medication for many years. My pain management doctor tells me that because of people who are selling these drugs or are abusing them, it is going to make it extra difficult for me to get my scripts filled now. Also my doctor is only allowed to write my scripts out for a certain amount now. He says he is being told that he can only prescribe so many pills to me monthly now, so I am the one who is suffering because of people who sell this drug. My question is why should people who need this drug to somewhat function on a daily basis be put in this predicament? It is not fair that I have my prescription lowered because of a few people who are selling Oxycodone to make a buck. I have to cut my pills in half when I start running low. If you suffer from back pain, you know what I am talking about. I suffer enough taking these pills as they only mask the pain to begin with. I am still in pain taking the pills. But, when I consider having the operation, and knowing that I will still have to take some kind of painkiller afterwards, it’s a no brainer. I know 2 people who have had back operations and they are worse off now than before. Granted, some people do get relief from surgery. But considering I would have to have a metal bridge put in my back, and in 5-7 years have more surgery because of the bridge and the screws they use, which tear at your spine and the screws after so many years, tear at your disc, I would rather take the pills. Anyone else having a problem getting the amount of pills they need on a monthly basis to control their pain? I have MRI’s X rays, you name it, showing my disc problem. One doctor even said I had the spine of a 90 yr. old man. We should be able to get the pain meds we need. Instead, doctors are forced to cut down on the amount they are allowed to prescribe us. This is not right. Am curious if anyone else is in my situation where you can’t get the right amount of painkillers needed to control your pain monthly. We need to be able to get pills to control pain, not so we can sell them on the street corner.

  12. Gogo says:
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    Ron,

    I have experience with herniations, so I feel your pain. You need to go get an extended release pill like Zohydro and see how it works for you. if you take a larger dose you may be able to get through a day on one pill , so at sixty pills you may be able to see the doctor much less. Hysingla could work but doesn’t seem to be as effective assuming you get relief from hydrocodone

  13. UKliving says:
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    I’ve read this whole piece. It surely is no coincidence that Mr. Saunders, who conveniently advertises his telephone number!! under his picture, has written this hit piece at a time when the FDA are about to decide on Zohydro. U.S. ambulance chasing “snake oil salesman” Attorneys doing was they do best these days. Wonder how many Billboards are carrying this guys picture? LOL

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    I thank every one for the important comments. There are a number of sides to this issue. Chronic pain patients certainly need access to pain relief. However, I know that the doctors on the advisory panel who voted 12-2 not to approve Zohydro considered the benefits to chronic pain patients. They balanced the risks versus the benefits of the drug. In the interest of full disclosure, I am a member of a board of directors of a large non-profit drug treatment facility and my brother died of a heroin overdose many years ago. I am not seeking to bring any lawsuits involving Zohydro. Again, I thank every one for the informed discussion about the issue.

  15. Gogo says:
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    Mr. Saunders,

    Having some experience with loved ones an addiction, your loss is palpable, however, with respect…this piece is highly suspicious and smacks of an orchestrated hit piece.

    Now that Zohydro has an FDA approved abuse deterrent formula, I assume you will start advocating for its use over the millions of generic opioids being subscribed?

    By the way, this false focus on the Advisory Panel, by your group has damaged the process as the FDA is under no obligation to take such recommendations and will likely convene far less ACs in the future.