oxy·s”…

Posted on Monday 30 July 2012

After the settlements or fines for misbehavior by the drug companies, critics make the same two points. The fine was "too low" considering the profit margin [the "cost of business" argument] and "this won’t stop until they punish the people who did it". Those arguments might be gaining at least some traction with the escalating size of the settlements [GSK, J&J]. And now this:
Purdue Execs Can Be Excluded From Programs
Pharmalot
By Ed Silverman
July 27th, 2012

A federal appeals court ruled today that the US Department of Health & Human Services can legally exclude three former Purdue Pharma execs from doing business with federal healthcare programs such as Medicare and Medicaid, because the drugmaker illegally branded the powerful painkiller OxyContin. However, the court disagreed that HHS sufficiently explained its decision to exclude the executives for 12 years, and sent the matter back to the agency for reconsideration. The executives singled out in the Purdue case were Michael Friedman, Paul Goldenheim and Howard Udell. The case has been closely watched because the exclusions would make it impossible for an executive to continue a career in the pharmaceutical industry, as just about every drugmaker does business with the US government in some fashion…

For those who may not recall, the government claimed Purdue Frederick, a subsidiary of Purdue Pharma, misled patients, regulators and doctors about the addictive risks of OxyContin. In 2007, the subsidiary pled guilty to felony misbranding as part of a settlement and was automatically debarred from winning new government contracts. The parent company, which avoided criminal charges by striking a so-called nonprosecution agreement and paying $600 million in fines, was allowed to pursue contracts. Meanwhile, the three former execs were ordered to disgorge a total of $34 million, although the drugmaker actually paid this amount, while the trio avoided jail time. The former execs later argued, however, they were innocent third parties, because there was no personal wrongdoing and that excluding them from doing business with federal health care programs was inconsistent with the law. They also maintained the 12-year exclusion, which was reduced from 20 years, was unreasonable…

I didn’t have any reason to keep up with the varieties of narcotics in my practice, but I do recall the introduction of OxyContin because of a specific patient. Actually, he was a former psychotherapy patient who later developed throat cancer requiring an operation and radiation. He’d been put on OxyContin [which I’d never heard of at the time]. He called me, almost incoherent and agitated one evening. I ended up talking to his wife [an MD]. She said he was on the new OxyContin because it was "less addicting" and it had been raised to 150 mg/day [a huge dose] to control his pain. He had tried to lower the dose abruptly. We decided he was in withdrawal and she gave him his former dose. In the interim, I looked up OxyContin and it was advertised as having a low addiction potential.

What is OxyContin? Here are the structures of Heroin, Morphine, and Codeine – the naturally occurring opiates from the Opium Poppy. Below them are the two semisynthetics I was familiar with, Hydrocodone [Vicodin] and Oxycodone [Percodan]:

Not much different. So where is OxyContin? It’s just Oxycodone in a time release pill. When I found that out, I couldn’t figure any reason that it would be any less addicting than Percodan, and indeed, that turned out to be the case with this patient. It took a very long time with a slow taper to get him off the drug. He and I decided that the "less addicting" part wasn’t right. I later mentioned this story to a surgeon friend who said something like, "Are you kidding! That drug is one of the worst." He went on to describe having the same experience of patients needing escalating doses, then having trouble detoxing. Anecdotes all – sure enough. But in these days of shaky official information, sometimes it’s the only information you can trust. Now, years later, we all know that OxyContin is highly addictive [and is a premium street drug – known as "oxy·s"].

I mention that experience to highlight that this was a flagrant case of false advertising. And the justice system didn’t just slap their wrists ["In 2007, the subsidiary pled guilty to felony misbranding as part of a settlement and was automatically debarred from winning new government contracts"]. But here’s the important part. "Meanwhile, the three former execs were ordered to disgorge a total of $34 million, although the drugmaker actually paid this amount, while the trio avoided jail time" again didn’t directly punish the people who perpetrated the fraudulent misbranding. But they were excluded from doing business with federal healthcare programs. And on appeal, the court ruled that "the US Department of Health & Human Services can legally exclude three former Purdue Pharma execs from doing business with federal healthcare programs such as Medicare and Medicaid, because the drugmaker illegally branded the powerful painkiller OxyContin." That’s a good thing. We’d like for those guys to be thrown in jail, but at least  the court upheld HHS’s right to exclude offenders from further Pharma careers. It’s a start.

This was a flagrant [and stupid] scheme to increase profits. It was stupid because it was so obviously wrong. But hopefully it will start the trend of punishing the perpetrators, rather than allowing the company to pass the punishments on to the stockholders, while the actual wrong-doers hold on to their sales bonuses. The "cost of doing business" is going up…
  1.  
    tess
    July 31, 2012 | 11:41 AM
     

    “But in these days of shaky official information, sometimes it’s the only information you can trust.”

    🙂 OH, how ironic this is, when so many “scientists” turn up their noses at anything less than a randomized controlled trial….

  2.  
    July 31, 2012 | 3:12 PM
     

    Read an article recently claiming that after the drug companies started making oxycontin crush-proof many oxycontin addicts are now using heroin because “heroine mimics the effects of oxycontin.”

  3.  
    July 31, 2012 | 6:44 PM
     

    “heroine mimics the effects of oxycontin”

    I hadn’t heard that one but I don’t doubt it. I don’t know anyone who will prescribe it, not because it’s not a good pain med, but because it’s so addicting and so prone to abuse. It’s remarkable that they thought they could get away with saying it had a low addiction potential – simply amazing…

  4.  
    July 31, 2012 | 6:54 PM
     

    I’ve been prescribed it for pain, but do my best not to take it as prescribed. The fact that I don’t like the effects of narcotics is a bit daunting for me. One of the last things I did before going completely insane was throw a bottle of morphine at the wall while shouting “basta!”. I hated it. Sometimes I have to take oxycontin to take the edge off the pain so I can sleep. I have no idea if it effects most people differently or if a lot of people just really like feeling dissociated and disconnected.

  5.  
    August 1, 2012 | 9:47 AM
     

    It is incredible what lengths people will go to to deny reality. Here in Washington State because of the cost of Oxy the Washington State PHARMACY AND THERAPEUTICS COMMITTEE designated Methadone as a preferred drug for chronic pain—because it is so cheap. This committee is made up of M.D.s and pharmacists; these professionals discussed the number of deaths and the obviously unethical prescribing practices of some 35 ‘professionals’ from 2005 until last December without taking any action…In fact, no action was taken until after the Seattle Times published a three part series reporting the thousands of deaths caused by methadone— “So this is sort of in the three faces of medicine. The issue is not just opiates. The issue is who are getting these opiates? And then this is a slide that shows the ratio…” apparently, over half of the deaths were people with dual diagnoses: substance abuse or alcoholism diagnosis and a diagnosed mental illness and were people on Medicaid…
    http://involuntarytransformation.blogspot.com/2012/06/medicaid-fraud-and-failure-of-medical.html

  6.  
    August 1, 2012 | 7:43 PM
     

    Thanks for the warning about methadone, Becky. It shocked me when my V.A. doctor told me it was an option.

  7.  
    August 2, 2012 | 6:29 PM
     

    What does “doing business with federal healthcare programs” mean?? If the individual execs can’t do it, can’t they appoint somebody else in the company to sign the papers? There’s something about the phrasing of that ban that’s suspicious.

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