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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PAINKILLER LAW: Yet More Evidence That the Drug is the Problem

Yet more evidence has emerged that long-acting extended release opioids for chronic pain should never have been marketed as safe, effective and generally non-addictive. To avoid criminal liability, malpractice suits or Medical Board actions, medical providers who prescribe opioids for their patients have to change with the changing science. To ignore the changing science – major developments emerge pretty much weekly now – is to risk imperiling patients with outdated information, and to consequently put your liberty and livelihood in great danger. If you’re out of the loop on information that could save your patients’ lives, when you had the chance to come up to speed and you ignored or passed on the opportunity, imagine how easy you’ll have made it for the DEA, or your licensing board, to nab you. I’ve said this before, and I say it again because there’s more important news to share about this.

Here’s what we know so far:

-The Centers for Disease Control believe that too many doctors are prescribing too many opioids to too many patients;

-The AMA concurs, to the great disappointment of pharmaceutical manufacturers;

-The FDA has ordered new labeling for long-acting extended release opioids to better warn providers and patients of the dangers of addiction and abuse;

-Johns Hopkins Medical School has concluded that even though opioid prescriptions have skyrocketed, fewer patients are actually experiencing pain relief.

And now, Exhibit 5: The National Pain Report on September 23, 2013 says that “a drug increasingly being used to treat opioid addiction may be fueling a new epidemic of diversion, overdose, addiction and death in the U.S.” The article talks about buprenorphine, known by its brand name, Suboxone, and how it is not only being prescribed by some doctors who don’t know what they’re doing, but that it’s also being sold on the street by heroin dealers because it reportedly softens any withdrawal symptoms between doses or highs.

And still, pharmaceutical manufacturers would have patients and physicians believe that the problem is not with the drugs themselves. Instead we see the same old acronyms like “the 5 R’s, or “S.A.F.E. N.A.R.C.” or other catchy phrases that do what they can, but which ultimately miss the point, in favor of the idea that the patient and the doctor can be in complete control in any prescribing or treatment scenario. Patients and doctors can’t be, because the drugs are too powerful. The nation’s prescription drug abuse epidemic and the weekly scientific bombshells prove this.

So what to do, if you are a medical provider? First, if you’re not in pain management, don’t get into it unless you are Board certified and fully trained by a body other than a self-interested, profit-motivated provider advocacy group. Such groups will sell you on taking the easy way, and that will ultimately disserve your patients and you. Second, if you already have a pain management practice, read and incorporate all the new scientific data into your practice without delay, so that you can show any law enforcement investigators that when the science changed, you changed with it. And third, even though the current assessment, treatment, monitoring and other compliance/patient safety tools are valid and should continue to be utilized, know that they’re increasingly being revealed as inadequate. They are no match for the immense power of the drugs they seek to keep in check. So relying on them alone will, as the science continues to advance, leave you high and dry when it comes to defending yourself against criminal, malpractice, or Medical Board scrutiny.

info@painkillerlaw.com MEISTER LAW OFFICES 213.293.3737

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PAINKILLER LAW: Old Habits Die Hard, but Die They Must

The unmistakeable, tectonic shift in the medical establishment’s thinking about opioid prescribing continues to reverberate across the country. The medical community and law enforcement are starting to be of one mind, with the CDC‘s recent game-changer of a statement that too many doctors prescribe too many opioids to too many patients for too many things. As I have been writing, medical providers and insurance carriers and risk managers and medical malpractice lawyers need to change with the changing science, or get run over by the oncoming train of opioid-prescribing reform. Today’s post is a case in point of who could get pulverized.

NPR has reported that according to recent studies, many primary care doctors prescribe opioids for back pain when the accepted normal beginning course of treatment should be ibuprofen and physical therapy. The studies cite a number of possible reasons for tossing aside other treatments in favor of narcotics: Economics, insurance-reimbursement pressures facing doctors, online ratings by patients and the need to keep patients happy (or face online criticism and fewer referrals), and other factors. The studies note that with 1 in 10 primary care visits scheduled because of patient back pain, that’s a lot of opioids being prescribed when they shouldn’t be.

Medical providers who even a few months ago would have treated with opioids now need to wake up and smell the coffee, Mrs. Bueller. It’s no longer sufficient justification in light of the CDC’s new position on opioid prescription rates. As it is written:

“You want to be able to say, ‘When the science changed, so did I.’”

I wrote that two posts ago; I just wanted you to think I was quoting Scripture. I will continue to urge providers and the professionals who support and defend them to immediately and thoroughly evaluate all aspects of their opioid prescribing, in light of the CDC’s new position – which has since been cited favorably by the AMA. Any professional association, medical society or advocacy group that tells you times haven’t changed is not keeping up with current events, and may as well be directing you to stand on the train track and not move, no matter what. Stay up to speed, seek help in evaluating your practice or the advice you give your insureds or clients, and modify accordingly — today.

info@painkillerlaw.com MEISTER LAW OFFICES 213.293.3737

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PAINKILLER LAW: HAVE YOUR EAR TO THE TRAIN TRACK, AND KNOW WHAT’S COMING.

Comedian Chris Rock has a great bit about why we should all be vigilant for evidence of prejudice or bigotry. As he puts it, when illegal aliens are targeted, “I start listening, because I know blacks and Jews are next.” Then he looks at his watch and adds, “That train’s never late!” This lesson of vigilance is extra important today for all medical providers who prescribe opioids for chronic pain.

For months now, law enforcement has been leading the charge against so-called corrupt doctors and others who prescribe what are viewed as excessive amounts of opioids. In my view, as you know from previous PAINKILLER LAW blog posts, law enforcement’s leadership in this area amounts to putting the cart before the horse: Cops should not be telling doctors how to treat patients. But very recently there has been a slew of crucial developments that sends an unmistakable signal to prescribers, to the risk managers who help insure them, and to the malpractice defense attorneys who defend them. Attention must be paid, or prescribers will get in trouble, risk managers will write a lot more checks, and malpractice attorneys will not prevail using old arguments. And, of course, patients could be unsafe.

To have your ear to the train tracks on this issue is to know that now the scientific evidence is starting to match law enforcement thinking. This means a provider who does not keep up with scientific advances, and information provided by a source other than the pharmaceutical industry, risks getting run over by the oncoming locomotive of opioid reform.

Consider developments from just the past two weeks:

-The Centers for Disease Control’s director declares that too many doctors are prescribing too many opioids for too many people, with deadly impact and little patient improvement.

-The American Medical Association’s new recommendations on opioid prescribing acknowledge the CDC’s position and urge a significant shift in direction by opioid prescribers.

-A Harvard Medical School study finds it inconclusive that opioids are effective in the treatment of chronic pain.

These statements and studies have profound implications: If you as an opioid prescriber practiced in a way that even six months ago was roughly in compliance with the state of scientific knowledge, it would be harder to pin a crime on you if something went terribly wrong with a patient. But now, in the face of evidence from leading scientific and medical authorities which up-ends previous thinking about opioids for chronic pain, a practitioner who doesn’t adjust and adapt and possibly wholesale reform his or her methods of practice is putting themselves on a perilous path. It’s time for opioid prescribers nationwide to shift their practice methods to reflect and incorporate the CDC’s and AMA’s statement and recommendations. To ignore the advancing science is to invite law enforcement scrutiny, and deny yourself the chance to say, “As soon as the science changed, so did I.” Don’t get hit by an oncoming train.

info@painkillerlaw.com MEISTER LAW OFFICES 213.293.3737

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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.

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