PAINKILLER LAW BLOG: The FDA’s Original Blessing Isn’t a Pain Doc’s Original Sin

Doctors who prescribe opioid painkillers to chronic pain patients are, as we know, the subject of intense regulatory and law enforcement scrutiny today. Many of my doctor-clients are under investigation or being charged for supposed crimes arising out of their prescription writing. While every case is different, to me there is a universally applicable defense that should be raised on doctors’ behalf in court against a criminal charge.

That defense relates to lack of criminal intent, since opioids’ addictive power was not known or acknowledged until years after the drugs’ approval for mass use. Today, a criminal charge is at its essence a misguided and ill-considered way of blaming doctors for not having seen the future, for not having foreseen what would happen, even though government regulators and even the drug manufacturing companies didn’t see the abuse crisis coming, either.

The FDA originally blessed the prescribing of powerful and potentially addictive medication for chronic pain. We now know that the scientific evidence offered by Big Pharma about the safety of the medications for chronic pain was incomplete at best, wrong at worst. There are attempts being made today by counsel in various parts of the country to uncover any possible funny business or overly cozy relationships which may have existed between government regulators and private business (Pharma advocates) during the drugs’ approval process years ago. Is this the Erin Brockovich-like scandal waiting to break? Could be.

Whether or not a scandal exists or will be revealed, though, it still must be noted that doctors were the ones who were told by the FDA and the pharmaceutical companies that drugs like Oxycontin and other opioid-based painkillers were safe and effective for chronic pain. The addiction risk was significantly downplayed or underestimated by regulators and manufacturers. The drug companies unleashed a marketing and advertising juggernaut to persuade patients that the miracle pain drugs had at last arrived. That was then; this is now. And now that we know the drugs so frequently lead to addiction, we can change the advice and practice guidelines given to doctors, but we cannot hold them legally accountable for not knowing what the rest of us didn’t know, either – or what some people in the game may not have revealed – years ago.

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VOICE OF REASON VS. CALL TO ARMS: THE CALIF. MEDICAL/PHARMACY BOARDS’ CONFERENCE ON PRESCRIPTION DRUG ABUSE

Recently I attended a conference sponsored by the California Medical Board and Board of Pharmacy. I think I was the only criminal defense lawyer in the room. The two-day event was entitled, “Joint Forum to Promote Appropriate Prescribing and Dispensing,” and was supposed to help healthcare providers and pharmacists know the law of controlled substance prescriptions, so they could follow the law and care for patients better. But that didn’t happen. Instead, during a Q and A with high-ranking Board officials on a panel, one attendee put it perfectly: The Boards are in “punitive” mode, “waiting to pounce” on prescribers and providers. That really was the unmistakable and highly regrettable message of the conference. In this post and several to follow, I’ll explain.

The voice of reason was heard briefly in the conference’s opening session. It belonged to the White House Office of National Drug Control Policy, better known as the Drug Czar. The speaker from the Office listed ways to screen for potential abuse, advice for effective patient monitoring, relevant CME, and other tools doctors could use in caring for patients while helping to curb abuse.

The speaker’s final suggestion was the most interesting, to me: He advised providers to regularly prescribe naloxone, the “anti-overdose” drug that has helped save the lives of accidental opiate overdose patients around the country. Great idea! But there’s also a downside, which I pointed out to the speaker: In today’s aggressive enforcement environment, the DEA and Medical Board might view writing for naloxone as prima facie evidence of excessive opioid prescribing. After all, if a doctor felt a patient was at risk of overdosing, why did the doctor write the opioid scrip at all? And why did a pharmacist fill it? What I fear, and what the official acknowledged could be a real issue, is that a provider’s or pharmacist’s act of patient protection could be used against them in a federal or state criminal investigation. That, to put it technically, would be totally uncool. And unfair. And inadvisable as policy and practice.

When the Drug Czar’s office had concluded its remarks, the DEA assumed the microphone. With that transition, the voice of reason gave way to a one-sided call to arms against the very professions represented by the conference’s attendees. More on this in the next post.

info@painkillerlaw.com MEISTER LAW OFFICES 213.293.3737

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PAINKILLER LAW: Fear and Self-Loathing in the Medical Academy

A recent article by Drs. Zachary Meisel and Jeanmarie Perrone, who teach at the University of Pennsylvania Medical School, asks whether “conscientious and well trained” doctors are to blame for prescription drug abuse. The authors say “yes.” That is, they say doctors are partially to blame, but the authors stay silent on why anyone else might be. That silence is damning, the good professors’ assessment is wrong, and their article is of great concern.

Not only is Rx abuse far too complex a problem to “blame” on any one constituency, but even more critically, it is always unsettling and even scary when one or two members of a profession presume to apologize on behalf of their colleagues nationwide for some perceived wrong. Today across the country we are seeing what the White House Drug Czar has called an “epidemic” of Rx abuse. We are also in response seeing a misplaced, hamfisted law enforcement approach to what is, in all but the most extreme cases, a public health problem. Federal and state law enforcement agencies will only be emboldened by an article whose glittering generalities
help legitimize the illegitimate and ill-advised belief that routinely going after doctors for alleged criminal conduct is the solution.

So are doctors to blame? In PAINKILLER LAW’s view, no, except in the most extreme cases. If a healthcare provider screens a patient carefully, does a thorough exam and makes an informed diagnosis, prescribes within the boundaries of established safety for an approved drug, counsels the patient on the possibility of addiction, monitors the patient conscientiously, verifies with any available prescription drug database, and uses his or her best judgment about how the patient is doing, what is the basis for a criminal charge against that doctor in the event of addiction or an overdose? Can the authors enlighten us, please, before asserting that good doctors are partly to blame?

Who else might be to “blame?” Patients themselves? That notion borders on blasphemy within the White House Drug Czar‘s Office; don’t be “blaming the victim,” the reasoning goes. What about Big Pharma? The drug companies marketed the pain-relieving powers of Oxy and its many opioid cousins back in the late 1980′s and early 1990′s. Were they wrong about the pain-relief qualities of the medications? Did they purposely understate the potentially addictive qualities of the drugs? What about medical schools and the philosophical and educational change that took place around the same time, so that med students would be trained to acknowledge and treat severe pain? Should we indict your school’s Academic Senate?

The point is, it’s too easy, suspiciously easy, to blame doctors, and that’s precisely what should make folks like Professors Meisel and Perrone think twice and choose their words carefully before they effectively if inadvertently bless today’s ill-conceived law enforcement priorities. Because if they’ve ever written a pain scrip themselves, they may have just made what an excitable cop or prosecutor might call a confession.

PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS. 213.293.3737 info@painkillerlaw.com

The Meister Law Offices

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PAINKILLER LAW: Red Ribbon Week Is About Prevention, Not Prosecution

This week has been Red Ribbon Week, the nationally observed period devoted to substance abuse prevention, and originally dedicated to the memory of slain U.S. DEA agent Enrique “Kiki” Camarena, who was murdered by a Mexican drug cartel in 1985. During Red Ribbon Week, kids and adults across the country wear a red ribbon to make a public statement about staying away from drugs, and to honor U.S. law enforcement agents who have been killed in the line of duty. But this week’s message from the White House Drug Czar should send shivers down the spine of any healthcare provider writing for prescription painkillers. Here’s why:

If you are a healthcare provider writing prescriptions for Schedule II through I painkillers, you normally needn’t think that the memory of Kiki Camarena would impact how law enforcement views you. After all, Camarena, a tough and experienced D.E.A. agent stationed in Guadalajara in the 1980′s and investigating a vast drug trafficking conspiracy reaching into the Mexican government and Army, was going after serious criminals – not your neighborhood internist or local urgent care provider. Kiki’s targets were cocaine, heroin, and big shipments of marijuana – not legitimate prescriptions written lawfully by licensed professionals. His cover was betrayed, he was kidnapped, brutally tortured, and murdered by vicious criminals, some of whom later stood trial in the United States. None of this should have anything to do with the average healthcare practitioner’s life, beyond respectfully remembering Camarena’s bravery, courage and sacrifice.

But in today’s hyper-aggressive investigative environment, with the Feds waxing on about “dope dealers with a medical license,” the line between legitimate providers and illicit traffickers is purposely being muddled by law enforcement in the name of “going after” prescription drug abuse. Look no further than the White House Office of National Drug Control Policy this past week, when its director took to YouTube and urged people observing Red Ribbon Week to bear in mind the new scourges of “teenage alcohol abuse, and prescription drug abuse.” His good faith statement about drug abuse prevention is quickly belied by the bellicose and over-the-top language used by the law enforcement agencies now under pressure to “crack down” by investigating, prosecuting or initiating administrative/licensing proceedings against healthcare providers. In an atmosphere of hysteria, which will only get worse, healthcare providers must protect themselves from government abuse undertaken in the name of stopping drug abuse.

PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS, is here to help. PAINKILLER LAW is a comprehensive service of the Meister Law Offices, and is the industry pioneer and leader in criminal law compliance for providers writing painkiller prescriptions. Don’t be lulled into thinking you will never face DEA or Medical Board scrutiny for your prescription writing. And don’t bury your head in the sand hoping nothing will happen the next time a patient makes a bogus complaint about something you did relating to a pain prescription. Call us today at 213.293.3737, or write us at info@painkillerlaw.com for a free consultation. It’s good preventative medicine.

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PAINKILLER LAW: DRUG CZAR SAYS SCRIP ABUSE STILL AN EPIDEMIC

The White House Drug Czar today released a report lauding what the WH a decrease in prescription painkiller abuse.  But he quickly added that in the view of the federal government, prescription painkiller abuse is still at “epidemic” levels and that enforcement against it will continue.

What does this mean for you as a healthcare provider?  It means everything the Feds and state and local authorities are doing now will continue.  From document requests, to prescription rate monitoring via database and by anecdotal and other evidence, to sting operations of suspected corrupt practitioners, current efforts will not abate.  What if you are, like most practitioners, ethical and not corrupt?  You need to be vigilant in your efforts to comply with the federal and state criminal laws regulating the prescription of Schedule II painkillers.  From patient intake to prescription monitoring to informed consent to treatment review, to knowing that “FDA” recommendations morph into “requirements” if they find you out of compliance, you need to protect yourself and your practice.  Remember:  While the world’s greatest neurosurgeon can get inside a DEA agent’s brain to operate, the doctor still won’t know what the agent is thinking, or how certain things in an office or on a prescription monitoring list look from the standpoint of law enforcement.  Be careful; be prepared; be in compliance.

Painkiller Law: Criminal Law Compliance for Healthcare Providers, is a service of the Meister Law Offices and can help you verify, achieve and maintain compliance with the criminal law of prescribing Schedule II pain medication.  Call us at 213.293.3737 for a free consultation, or email us at info@painkillerlaw.com.  Don’t become the Drug Czar’s next poster child.

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