PAINKILLER LAW BLOG: Fear, Dread and a Warm Welcome – Here Comes Zohydro

How can a drug about to hit the market be feared, dreaded, welcomed and deemed medically necessary, all at the same time? It’s complicated, so if the new “super painkiller” Zohydro had human feelings, it would definitely be in the midst of an identity crisis. In this post I’ll talk about the Zohydro kerfuffle, and why it’s more proof that in most cases, “blame” for prescription drug addiction lies with the drugs themselves, not the doctors who’ve prescribed them.

First, what is a “kerfuffle?” It’s a brouhaha. Commotion. Turmoil. Uproar. Hubbub. I learned the word from The Onion. Second, why the kerfuffle over Zohydro? Because Zohydro, a new opioid painkiller approved by the FDA and slated for market entry soon, is ten times more powerful than Oxycontin or Vicodin, and it contains no abuse-deterrent formulations. This has policymakers and even some medical societies worried that the drug will – well, how to say it gently? – kill or injure a lot of people who will be using it. Though the drug is slated to be used as a painkiller of last resort for patients who cannot get relief from other medication, its potency and its emergence on the market in an era of high rates of addiction, overdose and death from opioid painkillers are indeed cause for concern.

Last year, an FDA panel opposed approving Zohydro; the FDA itself then went against its panel’s recommendation and green-lighted the drug. The drug’s approval has been the subject of controversy ever since, and this week U.S. Senator Charles Schumer (D – N.Y.) asked the Dept. of Health and Human Services to reverse the FDA’s decision. Good luck, Chuck; the Congressmen from Big Pharma likely have a different view.

The controversy swirling around Zohydro got me thinking about doctors who prescribe opioid painkillers, and of law enforcement efforts to “do something” about the prescription drug crisis. To me, at the core of the Zohydro debate is the widespread belief that the drug’s mere availability will further aggravate an already serious public health problem. Is the worry that doctors, however cautiously, may be prescribing it? Or is it that Zohydro will exist at all? My answer is that people are worried about Zohydro’s very existence. To date, media reports haven’t much discussed the role doctors may play in prescribing the drug; reports instead have focused on how Zohydro’s very presence in the market will automatically impact the prescription drug crisis.

Isn’t this a powerful indicator that the problem could be the drug itself? After all, doctors would be directed to follow protocols, guidelines, safety measures and other steps in assessing patients’ eligibility and need for the drug, its effectiveness, and any problems that might arise in treatment. If that part of the discussion is so irrelevant in the minds of Zohydro critics, then doesn’t it stand to reason that doctors ordinarily aren’t the problem? Yes, it does, in case you’re on the fence about that one. I have long believed that in all but the extraordinary, outlier case, prescribers aren’t the problem so much as the drugs they’re prescribing are. The Zohydro kerfuffle is but one more piece of evidence that aggressively targeting legitimate doctors is the wrong way to go, especially when the same law enforcement agents who self-righteously kick in office doors and hold slanderous press conferences refuse to look past their own noses for the real roots of the problem.

Read More

PAINKILLER LAW: Opioid Prescribers! The CDC Just Warned You, and Gave You a Defense.

Today’s Los Angeles Times reports that Dr. Tom Frieden, head of the national Centers for Disease Control, condemns widespread prescribing of opioid/narcotic painkillers as dangerous and inappropriate. But if you read his remarks, he’s not only warning opioid prescribers, he’s giving them a ready defense against an accusation. Any medical provider who writes for opioids needs to pay attention or risk DEA, law enforcement and Medical Board wrath – criminal prosecution, conviction and imprisonment for drug dealing or homicide, and loss of license. MD’s, DO’s, PA’s, NP’s – now or never, take heed!

Frieden said two things which jumped out at me. First, here’s his bottom-line take on the U.S. epidemic of prescription drug abuse:

“These are dangerous medications, and they should be reserved for situations like severe cancer pain. In many other situations, the risks far outweigh the benefits. Prescribing an opiate may be condemning a patient to lifelong addiction and life-threatening complications.”

That’s the warning. The scientific evidence and widespread belief developing across the country are that these drugs should never have been recommended or made available to treat chronic pain. In the face of mounting evidence of the medical inadvisability of treating chronic pain (however that’s defined for each patient) with highly addictive, powerful narcotics, any provider who continues to prescribe high rates of these medications takes an ever-increasing chance of being accused of “operating outside the accepted standard of practice” or “prescribing without a legitimate medical purpose.” And as I’ve explained in this blog’s posts, if in the view of the DEA or a prosecutor you are “prescribing without a legitimate medical purpose” but you’re still prescribing like crazy, then you’re just dealing drugs. So the lesson from the CDC is to know what you’re doing, in light of the evolving prevailing science, or don’t do it. The CDC’s warning will have a big ripple effect, I’m sure, and that wouldn’t be such a bad thing, as long as ethical medical providers aren’t unfairly targeted for investigation and prosecution.

But Dr. Frieden also gave medical providers a powerful defense, a compelling argument to make in the face of criminal or administrative investigation. Here’s what he said:

“When I went to medical school, the one thing they told me about pain was if you give a patient in pain an opiate painkiller, they will not become addicted. And that was completely wrong.”

That’s a great argument, a legitimate defense, for a medical provider who faces official scrutiny over their narcotic prescription-writing. Today’s providers were all trained to treat pain as “the fifth vital sign,” and to take patient complaints about pain very seriously and respond accordingly. But if what you were taught about pain medication way back when is newly shown to have been wrong, then up until now, what crime did you commit by following accepted and scientifically validated medical practice? None, to my mind. The science changes, and with it, your obligation to keep up with the news and not put patients at risk. But who can righteously accuse you of having willfully neglected patient safety in the past, just because you followed what you were taught and what was at the time the prevailing state of medical knowledge?

The response by pain management medical providers or anyone who writes scrips for chronic pain has to be: (a) know the law, know the science, know what’s changing and stay in line with it, and (b) consider scaling back a pain practice unless even from the most skeptical perspective, you’re doing everything right. This may mean reforming your business model, it may impact income, it may mean a big change in how you’re currently practicing medicine. But a new business model sure beats an indictment or the initiation of license revocation proceedings if you insist on sticking with old ways in the face of new, possible life-saving information about patient safety.

Read More

PAINKILLER LAW: DOCS AFRAID, SAYS LA TIMES

An important article in today’s Los Angeles Times raises important questions and doubts about the appropriateness of prosecuting healthcare providers when a patient fatally overdoses on prescription painkillers.  In Los Angeles County now, Dr. Hsiu-Ying “Lisa” Tseng has been charged with triple murder – murder! – in the overdose deaths of three patients to whom she prescribed pain medication.  I have always thought these charges are excessive, and I think it’s a dangerous precedent to start prosecuting MD’s, DO’s and PA’s for something as grave as murder.  The theory of murder is that the patient was addicted, the doctor knew it, the doctor kept writing prescriptions, the patient overdosed fatally, and the doctor was so reckless and indifferent to human life by writing the scrips that the doctor may as well have wanted or intended to kill the patient.  The theory is ridiculous, and shame on the District Attorney’s Office for leading the grieving families of the patients to believe “justice will be done” in the form of a murder conviction.  I predict the DA will fail at trial; whether a lesser theory of homicide will succeed, I don’t know.  But murder?  That’s way over the top.

Don’t let anything close to this happen to you.  Call the Meister Law Offices at 213.293.3737 for a free consultation about Painkiller Law:  Criminal Law Compliance for Healthcare Providers, or email us at info@painkillerlaw.com.

Read More