PHARMACIST STEVE

America’s Opiate War: The Medical Luddites vs. People in Pain – By Robert Wilbur – Truthout – June 3, 2012

Even way back in 2012, the DEA was interfering with the medical practice of pain management.

When I published my first paper in clinical psychopharmacology in 1980 with a psychiatrist collaborator, the physician-patient relationship was still virtually sacrosanct.

But with frightening hubris, narcs from the Drug Enforcement Administration (DEA), are now muscling into the practice of medicine.

At this writing, politicians are preparing to launch what may turn into a witch hunt on the medical profession and the medical professionals at the FDA.

Specifically, the May 16, 2012, issue of Pharmalot reports that the Senate Finance Committee is cranking up to probe “an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers.” The targets are drug manufacturers, physicians and patient advocacy groups.

It’s odd that he mentions patient advocacy groups specifically, but these groups set themselves up for this by taking so much money from the pharmaceutical industry.

There are only a few small groups, like ATIP, that don’t take such funds.

The Centers for Disease Control (CDC) claims that, in 2008 alone, 15,000 people died from prescription opiate painkillers.

To get some perspective on a number like this, Truthout spoke with one of most respected forensic pathologists in the country, Michael Baden MD. Dr. Baden, formerly chief medical examiner for the City of New York

Baden made several points.

First, CDC statistics for mortality are predicated on poor data, namely death certificates. There are no uniform diagnostic standards for filling out death certificates and, indeed, the certificates themselves vary from jurisdiction to jurisdiction.

The situation is all the more dismal because,

in the US these days, only 5 percent of bodies are autopsied – the only definitive way to arrive at the cause of death.

A corollary is that, absent an autopsy, we don’t know how much drug – if any – is present in the body. Usually, Dr. Baden suggested, when the signer of the death certificate finds a bottle of an opiate, he or she then attributes the death to its contents.

What makes the CDC’s reliance on death certificates even more problematic is that the signer of the death certificate in many jurisdictions need not even be a physician: he or she can be a non-physician coroner (generally an elective office), an emergency medical technician, an undertaker or even a cop.

Dr. Baden observed that a death may be caused by several factors and, indeed, most death certificates list a line for the putative primary cause and several lines for even more putative secondary causes. This applies with particular force to opiates, because most people are not junkies; they are taking opiates for an illness and that illness may be a primary or contributory cause of death … but we’ll never know without an autopsy.

so long as cops and undertakers can play pathologist and autopsies are the exception, the certificates’ accuracy is problematic

There is one cause of death from opiates that Baden considers very important, but which you can’t identify from the CDC data: Suicide.

Even if the signatory recognizes that they have a suicide on their hands, they often do not record it to spare the feelings of the dead person’s loved ones.

So, it just goes down as an opiate death, even though many suicides are accomplished with a potpourri of opiates, sleeping pills, anxiolytics and – to wash it all down – alcohol. Dr. Baden thinks that suicide is underestimated to a significant degree.

the lethality of opiates requires examination.

One revealing recent study found that most deaths from prescription opiates occurred when the patient was also taking methadone – though CDC statistics fail to reflect drug interactions. The opiate is usually fingered as the culprit.

The other major toxic effect of opiates is respiratory depression, but this effect only occurs in much higher doses and is the cause of death by suicide.

Adding alcohol, in particular, potentiates the respiratory depression, and throwing in sleeping pills and sedatives doesn’t help. Much is being made in the press of death by accidental overdose, but it seems likely that many of these cases are suicides.

Unfortunately, people can develop tolerance to the analgesic effect of opiates, but not to its potentially lethal effect on the breathing center of the brain.

John D. Loeser’s career spans 46 years as a neurosurgeon and pain specialist, most of that time at the University of Washington (UW). Loeser wears his laurels lightly, but he is a man of firm views.

Maria A. Sullivan MD, PhD is associate professor of clinical psychiatry at Columbia University and New York State Psychiatric Institute (NYSPI). She is both a psychiatrist and a psychologist and is board certified in addiction psychiatry and in adult psychiatry and neurology. Like Dr. Loeser, she gave of her time both generously and authoritatively.

Loeser made it emphatically clear that he does not welcome the increasing “policing” of medicine by the DEA.

He believes that the proper body for regulating opiate prescribing practices is the FDA because its scientists possess the knowledge of pharmacology and medicine that DEA agents and politicians lack.

This is precisely the problem: politicians and DEA agents have no clue how opioids work, how much legitimate doses can vary, how many people have a genetic inability to metabolize opioids.well.

Dr. Loeser said that he would not sit in judgment on the dose a particular patient might need, provided the medication was prescribed appropriately. For example, many patients with cancer require substantially higher doses, or more powerful narcotics like Fentanyl.

Dr. Loeser’s criterion: “Is an opiate the best available treatment for this patient at this time?”

Feelgoods – physicians who derive their livelihood from writing prescriptions for controlled substances – are not the problem, he said – there aren’t enough of them around to make a dent in the body count, and the average person in pain probably wouldn’t know how to find one.

That is so true. Neither I nor many other legitimate pain patients know of these doctors that supposedly hand out opioids freely. Instead we’re stuck with doctors reluctant to prescribe, pain contracts, and constant suspicion.

A related and real problem, Dr. Sullivan told me, is diversion: one person gets a prescription for OxyContin, Percocet, or Vicodin and sells the pills at a profit.

Pain medicine specialists aren’t the problem either. They are highly trained, board certified specialists who work with the patient’s primary care physician or specialist (an oncologist or an orthopedist, for example) to solve tough pain problems.

Yes, they prescribe opiates, but also nonsteroidal anti-inflammatory agents, muscle relaxants, Neurontin, cortisone injections, relaxation training and some use acupuncture.

The problem, said Loeser, is the “primary care docs” who know little about pain and bought into a “huge push” from drug companies to hand out pills, most notoriously OxyContin, for chronic conditions. It is well known that many doctors learn about new drugs from drug company sales reps, not respected journals like JAMA or the New England Journal of Medicine.

So, what’s the right way? A careful history. A thorough examination and appropriate tests and radiology when indicated. An attempt to correct the cause of the pain. A trial of non-opiate pain medicine before resorting to opiates.

This is the norm for us legitimate patients. We’ve tried all the other methods of pain management but they did not work for us. Opioids do.

Dr. Loeser told Truthout that opiates are actually underutilized by physicians and hospitals for treating acute conditions with adequate doses owing to the unfounded fear of getting patients hooked. Acute means 30 days or fewer on an opiate for situations such as postoperative pain, injuries healing, awaiting an operation or lab work, dental work, and so forth. Within a time frame of 30 days, a patient should have no trouble tapering off the opiate.

And this is what hundreds of thousands of Americans do every year. They have surgery, get opioids prescribed for post-op pain, take however much they need and then stop.

Of course, these leftover pills can fall into the wrong hands, but if opioids were as addictive as they are made out to be, there would never be “leftover” pills. If there are really so many leftover pills causing all the overdoses, it proves that the vast majority of people who get prescriptions do NOT become addicted.

Dr. Sullivan said that uncontrolled pain leads to adverse outcomes, especially in elderly patients who comprise a majority of postsurgical patients.

For instance, pain-induced tachycardia (abnormally rapid heart beat) can cause a heart attack. Uncontrolled pain also increases the risk of delirium (Morrison, 2003), prolongs hospital stays and makes it difficult for the patient to resume a normal life.

Human laboratory studies have shown that administering opiates does not precipitate an addiction in patients without a history of drug abuse (Corner et. al, 2010); such folks were found to use an opiate only when they felt pain.

Dr. Loeser said, “We don’t know why, but a subgroup of chronic pain patients doesn’t respond to recognized treatment for their condition.” This is the fraction that needs opiates and Dr. Loeser thinks it is small – certainly fewer than 50 percent of chronic patients.

But as Dr. Loeser said, Big Pharma taught willing general practitioners and primary care providers that opiates were the answer to all pain symptoms. Such prescribing papers over symptoms (and complaints) and clears demanding pain patients out of the office.

Dr. Loeser readily agreed with the statement that the majority of chronic pain patients who require opiates, sometimes for years, sometimes for life, use them responsibly, without jacking up the dose and continue to experience sustained relief. So, I asked why some people became junkies; why, specifically, that very first pill is “like discovering Heaven,” a description I had encountered about a first drink in my research on alcoholism.

Dr. Loeser said that, just as there are a fraction of chronic patients, probably small, for whom therapy with opiates is appropriate, so there is another fraction, also probably small, for whom opiates are “a disaster.”

Dr. Loeser thinks the reason is genetic and pointed to the example of Native Americans, who disproportionately become disinhibited and violent on alcohol.

The anti-opiate (or pro-pain) crowd that Dr. Loeser and many of his distinguished colleagues oppose would have us believe that every patient is a potential junkie.

It simply is not so, any more than that every person who has a couple of drinks with dinner is a drunk.

In 1995, the small drug company Purdue Pharma marketed a long-acting formulation of oxycodone under the brand name OxyContin.

It came in a generous variety of strengths, and one capsule[?] would maintain a reasonably constant blood level for 24 hours.

I’m surprised the author didn’t know that OxyContin is a tablet, not a capsule.

The time-delay chemistry was poorly conceived. The capsules could be chewed up and the contents ingested – one whole day’s supply of oxycodone swimming to the brain in a single heavy hit.

And aficionados of OxyContin soon found faster, more gratifying ways of experiencing the drug: snorting the powder; rubbing it in the gums; dissolving it in water and mainlining it.

Intentional abuse did not come to light right away, but another problem with OxyContin was apparently obvious to FDA medical officers, because it is reflected in the package insert

OxyContin was approved for moderate to severe pain in chronically ill patients who required round-the-clock pain medication.

The latter stipulation is important because many patients with chronic pain have good days and bad days, in which case they might need only one or two Percocet, or perhaps even none at all

With OxyContin, on the other hand, the patient is exposed to a relentless 24-hour opiate assault. This increases the likelihood of developing tolerance and physical dependence.

This is why I never took opioids “round-the-clock” or at scheduled intervals. I believe that taking pain medication constantly is inappropriate for many pain patients who experience varying levels of pain.

By letting my opioids wear off each night I believe I developed much less tolerance than expected.

Within a few years of OxyContin’s introduction, it was becoming clear that Purdue Pharma’s spokespeople were lying in a big way about the safety of Purdue’s only big seller.

in 2007, Purdue paid a fine of $600 million and three of its top executives shelled out $24.5 million to stay out of jail.

Everybody had pleaded guilty to “misbranding,” defined as lying or making claims not approved by the FDA, as reflected in the official labeling. To cap it off, the FDA required Purdue Pharma to come up with a new, long-acting formulation that is no more vulnerable to tampering than ordinary oxycodone tablets; such a product was approved by the FDA in April 2010.

When the FDA considers whether to approve a drug for marketing, it must balance a drug’s safety against its efficacy.

The noisiest con is Sidney M. Wolfe MD, formerly director of Ralph Nader’s Health Research Group and now director of its umbrella organization, Public Citizen

Wolfe is a medical Luddite, who would weight the scales so heavily in favor of safety that we would get few effective new drugs.

He is proud to be known as the FDA’s nemesis and boasts that he killed 14 drugs. Wolfe and other activists like him seem to crave a world of perfect safety, but the reality is that the best a regulatory agency can do is predicate its decisions on the evidence in front of it

While it is perfectly proper for Wolfe to testify before the FDA as often as he wishes, it is another matter for him to testify in the House and Senate for the purpose of trying to get from the politicians what he can’t get from the FDA.

One physician who isn’t the least bit shy about his views is Andrew Kolodny.

At the mention of Kolodny’s name, Dr. Loeser laughed: “Kolodny occupies the far end of the spectrum” of the anti-opiate fringe, and he added, “He believes nobody should have opiates unless they’re about to die.” And if you want opiates from Kolodny, you’d better be dying of cancer.

Kolodny was the subject of a puff-piece interview in Pharmalot (May 16, 2012), where he betrayed an abysmal ignorance of pharmacology, and Pharmalot failed to ask for documentation of his more outré assertions, such as this one:

“There’s increasing evidence that opioids are neither safe nor effective for the majority of people with non-cancer pain.”

Kolodny seems to be afraid that even cancer patients were in danger of getting too much relief, as he told Pharmalot: “To increase use of opiates for cancer care, Purdue paid thought leaders to encourage prescribing more opioids.” Cancer pain is the most important indication for OxyContin.

Kolodny condemned the FDA for having “no teeth” because it declined to impose Draconian restrictions on opiate prescribing after hearing testimony from pain specialists and patients with chronic pain who required opiates for relief.

Jane C. Ballantyne MD, professor of anesthesiology and pain management at the University of Washington, …as well as a member of PROP, shared some of her thoughts with me in an exchange of emails

I asked her if she thought cancer was the only indication for opiates. Her reply: “Cancer only is a little too narrow, but pain should be severe and intractable (in other words, failed all attempts with non-opioid and non-medical treatments) before opioids are used.”

This is the common course for legitimate pain patients who explore every other avenue of relief before taking opioids.

I asked Dr. Ballantyne whether she thought the FDA, not the DEA or Capitol Hill, is the appropriate agency to regulate opiate prescribing. Her reply: “The FDA has not heeded early warning signs that prescription opioid abuse is becoming a public health problem in the US, so I do not agree that the FDA alone has been or can be effective.”

Ballantyne also contravened the view that opiates are being underprescribed for acute pain, the evidence notwithstanding. She insists that opiates are “grossly overutilized” and reiterates that they should only be utilized for pain that is “severe and intractable.”

This is a physician with responsibility for training future doctors in pain management.

And her PROP leader’s voice has inspired some very unhealthy comments, like this one from Original Industry Insider in the pages of Pharmalot: “Maybe if we let them go cold turkey in a basement shooting gallery and puke their guts out for three days, the addiction problem might change for the better.”

There is no doubt that opiates are addictive, but to what degree? In her email, Dr. Ballantyne wrote: “… opioids are much more addictive than alcohol, which puts opioid users at higher risk than alcohol users.”

Except for a patient who has been treated with an opiate for only a few days or a week – for something like dentistry, some types of post-op pain, injuries etc. – it is best to taper the dose down gradually at the rate of 10 percent per day.

I’m glad it’s now recognized that this speed of tapering is ridiculous. The reduction should be 10% per week or more.

Dr. Sullivan told Truthout that opiate detoxification can be accomplished on an inpatient or outpatient basis using buprenorphine, a synthetic opiate with which Dr. Sullivan has done extensive research, for just one injection daily to mitigate the withdrawal syndrome.

Dr. Sullivan notes that clonidine, a blood-pressure-lowering medication, is a useful addition to the treatment regimen. Probably the reason is that clonidine can relieve the “physical” symptoms of withdrawal, such as anxiety, tremor, palpitations, sweating and so forth

Dr. Sullivan found that naltrexone substantially increases the rates of abstinence – as much as 60 percent at six months, a figure that is much better than methadone maintenance.

This article invites several conclusions:

Narcs and politicians are not qualified to meddle in the practice of medicine because, as Dr. Loeser put it, they don’t know enough. By contrast, the medical officers at the FDA are specialists in various categories of drugs; they have the expertise to draw evidence-based conclusions from the available data. It follows that the regulation of drugs must be the province of the FDA, not the DEA or Capitol Hill

No worthwhile purpose is served with hysterical rhetoric about an “epidemic” of prescription opiate abuse because, as Dr. Baden explained, the CDC’s conclusions are predicated on dubious data. It is unquestionably true that, in recent years, there has been an upward trend in opiate prescribing and a parallel trend in deaths from these pain killers. However:

Opiates are underutilized for people with acute pain;

Opiates are inappropriately overprescribed for chronic pain, mainly by primary care providers who use these drugs as a Band-Aid to cover symptoms instead of seeking and treating the cause of the pain, although an unknown fraction of chronic patients are going to require long-term or permanent opiate therapy;

The only predictable consequence of policing and politicizing the prescribing practices of physicians will be to intimidate them, thereby depriving patients with real pain issues of the medications they need; it follows that physicians and patients must join forces and kick back hard at those would diminish the role of the FDA as the only appropriate regulatory agency for drugs and challenge the heated rhetoric, errors and misrepresentations of PROP and it members;

The overwhelming majority of patients on opiates for chronic pain use their medication responsibly. As Drs. Loeser and Sullivan attest, that unknown but small fraction of patients who get hooked from their first dose probably have a genetic deficit;

It is essential to get Big Pharma out of the lucrative racket of “educating” physicians by reps and complicit doctors.

Dr. Sullivan drew Truthout’s attention to evidence-based guidelines for the appropriate prescribing of opiates, and continuing medical education credits could be offered by medical societies to doctors who master these guidelines;

Perhaps most important, the politicians should increase the FDA’s budget, and the medical Luddites should eschew pronouncements on matters for which they evince a major paucity of knowledge.
Author: Robert Wilbur did research in biological psychiatry for many years. He also writes for popular magazines and newsletters. He is active in progressive politics, especially opposition to the Middle East wars and capital punishment, and fighting for animal rights.

Filed under: General Problems