Saturday, November 10, 2018

Anatomy of the Opioid Crisis

I am hardly expert on this matter, but America’s opioid crisis deserves close examination. How did we get to the point where so many Americans are addicted to prescription pain medication? It’s a terrifying story, a story of systemic corruption, not the kind that is visited by Mexican drug gangs, but the kind that is promoted by well-intentioned physicians, mentally challenged administrators and pharmaceutical manufacturers.

Decide as you wish how corrupt they all were. Decide how much it was just all about drug company profits. Decide for yourself how much of it was the fault of bureaucracies and how much of it was the fault of physicians who found it easier to prescribe a pain pill than to talk to a patient.

The story deserves close attention. Author Chris McGreal has done so in his book American Overdose. The Guardian has printed a long excerpt. I found it compelling. It is well worth your attention.

It all began with well-intentioned physicians. As might be understandable, they wanted to alleviate their patients' pain, especially those suffering from cancer:

Doctors such as Russell Portenoy at the Memorial Sloan Kettering Cancer Center in New York saw how effective morphine was in easing the pain of dying cancer patients thanks to the hospice movement that came out of the UK in the 1970s….

As Portenoy saw it, opiates were effective painkillers through most of recorded history and it was only outdated fears about addiction that prevented the drugs still playing that role.

These physicians preached the gospel of pain killing. It identified a problem that was not as much of a problem as they thought and pretended that they could solve it. Better yet, they rejected the idea that people could become addicted to opioids. It was a large mistake:

These new evangelists painted a picture of a nation awash in chronic pain that could be relieved if only the medical profession would overcome its prejudices. They constructed a web of claims they said were rooted in science to back their case, including an assertion that the risk of addiction from narcotic painkillers was “less than 1%” and that dosages could be increased without limit until the pain was overcome. But the evidence was, at best, thin and in time would not stand up to detailed scrutiny. One theory, promoted by Dr David Haddox, was that patients genuinely experiencing pain could not become addicted to opioids because the pain neutralised the euphoria caused by the narcotic. He said that what looked to prescribing doctors like a patient hooked on the drug was “pseudo-addiction”.

Doctors like Russell Portnoy preached for freedom from pain. He even called it a basic human right:

Portenoy toured the country, describing opioids as a gift from nature and promoting access to narcotics as a moral argument. Being pain-free was a human right, he said. In 1993, he told the New York Times of a “growing literature showing that these drugs can be used for a long time, with few side-effects, and that addiction and abuse are not a problem”.

Long after the epidemic took hold, and the death toll rose into the hundreds of thousands in the US, Portenoy admitted that there was little basis for this claim and that he had been more interested in changing attitudes to opioids among doctors than in scientific rigour.

“In essence, this was education to destigmatise and because the primary goal was to destigmatise, we often left evidence behind,” he admitted years later as the scale of the epidemic unfolded.

Guess what? He didn’t mean it. He ignored the science because he wanted to change attitudes… and to establish himself as a great religious leader.

British trained Harvard physician Jane Ballantyne had originally touted the virtue of opioids. In time she changed her mind:

But then Ballantyne began to see signs in her patients that experience wasn’t matching theory. Doctors were told they could repeatedly ratchet up the dosage of narcotics and switch to a new and powerful drug, OxyContin, without endangering the patient, because the pain, in effect, cancelled out the risk of addiction. To her dismay, Ballantyne saw that many of her patients were not better off when taking the drugs and were showing signs of dependence.

Among those patients on high doses over months and years, Ballantyne heard from one after another that the more drugs they took, the worse their pain became. But if they tried to stop or cut back on the pills, their pain also worsened. They were trapped.

“You had never seen people in such agony as these people on high doses of opiates,” she told me. “And we thought it’s not just because of the underlying pain; it’s to do with the medication.”

Note well, using drugs that promised to free people from pain was causing more and more pain. But, by then, too many people had too much of a financial interest in prescribing these drugs. Not only the manufacturers but physicians who could make more money writing quickie prescriptions than talking with their patients:

As the evidence that opioids were not delivering as promised piled up, the Harvard specialist began to record her findings. By then, though, there were other powerful forces with a big financial stake in the wider prescribing of painkilling drugs. Pharmaceutical companies are not slow to spot an opportunity and the push for wider prescribing of opioids had not gone unnoticed by the drug-makers, including the manufacturer of OxyContin, Purdue Pharma, which rapidly came to play a central role in the epidemic.

As the influence of the opioid evangelists grew, and restraints on prescribing loosened, the pharmaceutical industry moved to the fore with a push to make opioids the default treatment for pain, and to take advantage of the huge profits to be made from mass prescribing of a drug that was cheap to produce.

A group called the American Pain Society signed on. It had been funded by the drug companies, but they surely wanted to enhance its own importance. After all, member physicians do not cure; they help to manage pain. Thus, they do not occupy the higher rungs of the medical status hierarchy:

The American Pain Society, a body partially funded by pharmaceutical companies, was pushing the concept of pain as the “fifth vital sign”, alongside other measures of health such as heart rate and blood pressure….

The APS wanted the practice of checking pain as a vital sign as a matter of routine adopted in American hospitals. The key was to win over the Joint Commission for Accreditation of Healthcare Organizations, which certifies about 20,000 hospitals and clinics in the US. Its stamp of approval is the gateway for medical facilities to tap into the huge pot of federal money paying for healthcare for older, disabled and poor people. Hospitals are careful not to get on the wrong side of the joint commission’s “best practices” or to fail its regular performance reviews.

Yes, indeed. They needed to win over the commission that accredited healthcare organizations.

In response to what it called “the national outcry about the widespread problem of under-treatment” – an outcry in good part generated by drug manufacturers – the commission issued new standards for pain care in 2001. Hospital administrators picked over the document to ensure they understood exactly what was required….

The commission told hospitals they would be expected to meet the new standards for pain management at their next accreditation survey. Purdue Pharma was ready. The company offered to distribute materials to educate doctors in pain management for free. This amounted to exclusive rights to indoctrinate medical staff. A training video asserted that there is “no evidence that addiction is a significant issue when persons are given opioids for pain control”, and claimed that some clinicians had “inaccurate and exaggerated concerns about addiction, tolerance and risk of death”. Neither claim was true.

Some doctors questioned the value of patient self-assessment, but the commission’s regulations soon came to be viewed as a rigid standard. In time, pain as the fifth vital sign worked its way into hospital culture. New generations of nurses, steeped in the opioid orthodoxy, sometimes came to see pain as more important than other health indicators.

What happened when freedom from pain became a human right and when pain became a leading health indicator?

One consequence was that people with relatively minor pain were increasingly directed toward medicinal treatment while consideration of safer or more effective alternatives, such as physiotherapy, were marginalised. Another, said Chou, was the increased expectation that pain can be eliminated. Chasing the lowest score on the pain chart often came at the expense of quality of life as opioid doses increased. “It’s better to have a little bit of pain and be functional than to have no pain and be completely unfunctional,” said Chou.

Insurance companies joined the party and told physicians that they needed to prescribe more medication… the better to lower costs:

Health insurance companies piled yet more pressure on doctors to follow the path of least resistance. This meant cutting consultation times and payments for more costly forms of pain treatment in favour of the direct approach: drugs….

It took a determined doctor to resist the pressure to prescribe. Physicians could spend half an hour pressing a person to take more responsibility for their own health – eat better, exercise more, drink less, find ways to deal with stress – only to watch an unhappy patient make their views known on the satisfaction survey and face a dressing down from hospital management. Or they could quickly do what the patient came in for: give them a pill and get full marks….

Emergency departments became beacons for the opioid dependent, who quickly learned to game the system to get drugs on top of their prescriptions. They turned up feigning pain, knowing harassed medical staff under pressure of time and the commission’s standards were likely to prescribe narcotics and move on without too many questions.

The pain society assured physicians that they would not face disciplinary action for prescribing these narcotics, regardless the consequences:

The American Pain Society and Haddox, who was by then working for Purdue Pharma, were instrumental in writing a policy document reassuring doctors they would not face disciplinary action for prescribing narcotics, even in large quantities. The industry latched on to the Federation of State Medical Boards because of its influence over the health policy of individual US states which regulate how doctors practise medicine.

Note the importance of the Federation of State Medical Boards:

Over the following decade, the FSMB took close to $2m (£1.52m) from the drug industry, which mostly went to promote the guidelines and to finance a book, Responsible Opioid Prescribing, written with the oversight and advice of a clutch of doctors who were strong advocates of wider use of prescription narcotics. The book was sold to state medical boards and health departments for distribution to physicians, clinics and hospitals. The drug industry paid for the publication but the FSMB kept the $270,000 profits from sales.

Within a few years, the model guidelines were adopted in full or in part by 35 states, and the floodgates were open to mass prescribing of what Drug Enforcement Administration agents came to call “heroin in a pill”. Opioids were soon the default treatment even for relatively minor pain. Dentists gave them to teenagers after pulling their wisdom teeth. Not just one or two days’ worth of pills, but a fortnight or a month’s worth, which, if they did not draw the intended recipient in, frequently sat in the medicine cabinet waiting to be discovered by someone else in the family. The lack of caution in prescribing left an impression among the users that the drugs were harmless, and some people shared them with others as easily as they might an aspirin. Prescribing escalated year on year. So did profits. OxyContin sales passed $1bn a year in 2000. Three years later they were twice that. Other opioid makers were pulling in huge profits too.

Dr. Ballantyne tried to sound the alarm:

In 2003, she co-authored an article in the New England Journal of Medicine highlighting the dearth of comprehensive trials and saying that two important questions remained unanswered even as mass prescribing of opioids took off. Do they work long term? Are higher doses safe to take year after year? The drug industry and opioid evangelists said yes, but where was the evidence for it?...

Ballantyne wrote that there was evidence that putting some patients on serial prescriptions of strong opioids has the opposite of the intended effect. High doses not only build up a tolerance to the drug, but cause increased sensitivity to pain. The drugs were defeating themselves.

Her assessment seemed to warn that if there was an epidemic of pain, it was partly driven by the cure. On top of that, there was evidence that the drugs were toxic. Then came the conclusion that stuck a dagger into the heart of the campaign for wider opioid prescribing. “Whereas it was previously thought that unlimited dose escalation was at least safe, evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective,” she wrote.

Amazingly, the treatment was worse that the disease. Treating pain with opioids was causing increased sensitivity to pain. Ballantyne explained:

“When the 2003 New England journal article came out, I thought it was going to make the medical community sit up and say: ‘Wow. These drugs that we’ve been thinking are helping people are not. We have a real problem.’ But the medical community didn’t at all say: ‘Wow,’” Ballantyne said with half a laugh, 15 years later.


“People in my field who had been, like me, taught we have to do this – people who’d been lobbying to try and increase opiate use, like the palliative care physicians – said: ‘What are you doing? We worked so hard to get to this point, and now you’re going to turn it all around. They become so rattled when you suggest you shouldn’t give the opiates – it’s partly people in the pain field and especially people in pharma – because it’s big business.”

Ignored, Ballantyne soldiered on:

Ballantyne continued to collect data and publish ever more detailed insights into the impact of painkillers. A less rapacious drug industry might have paused in its headlong charge to sell opioids, and less blinkered and compliant regulators might have determined that this was the moment to weigh the claims made in favour of permitting such widespread prescribing.

Instead the pharmaceutical companies took the warnings as a challenge to their business interests. Through the 2000s, industry poured money into a political strategy to keep the drugs flowing. It funded front groups and studies to claim that there was indeed an epidemic – but it was of untreated pain. The millions coping with chronic pain were the real victims, the industry said, not the “abusers” hooked on opioids they often bought on the black market or obtained from crooked doctors. That one frequently became the other was conveniently overlooked.

In the end, physicians became drug pushers:

By 2010, doctors in the US were writing more than 200m opioid prescriptions a year. As the prescribing rose, so did the death toll. Last year, more than 72,000 Americans died of drug overdoses, the vast majority from opioids, nearly 10 times the number at the time Ballantyne published her warning.

The head of the FDA at the time OxyContin was approved for distribution two decades ago, Dr David Kessler, later described the opioid crisis as an “epidemic we failed to foresee”. “It has proved to be one of the biggest mistakes in modern medicine,” he said.

Kessler was wrong. It wasn’t a mistake. It was a betrayal.

One might ask oneself who was in charge of the FDA in 2010, but that would not be very nice.

20 comments:

Anonymous said...

A healthy amount of addiction is a natural sign of being alive. Pain is the same. Too much or too little is a problem with almost anything.

Anonymous said...
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Christopher B said...

The problem with this theses of 'why opiods' is that it generally ignores most opiod ODs are from fentanyl, often when mixed with other drugs at street level, not oxycodone and other widely prescribed pain medications. It also trades on the myth that 'Big Pharma' and unethical doctors are behind most of the issues we have with health care in the US, not that they are the entirely predictable outcome ofof t over use of third party payors for health care financing.

Dr. Irredeemable Dreg said...

To begin with, I have been using and teaching statistics for over 30 years. So stow the lectures for my benefit about correlation and causality.

The correlation between the increased abuse of opioids and Medicaid expansion is stunning. When physicians are underpaid, patient load is increasing relative to the supply of providers, and the approved pharmacopeia is limited, one shouldn't be surprised when corners are cut. Medical care delivery systems designed by Congress and a gaggle of professional bureaucrats was never going to work; e.g., the VA and the Indian Health Service.

As CB notes, the most acute national overdose problem is with fentanyl and street drug concoctions. BUT... the fact is that between '07 and '12 (interesting years, eh?), 780,000,000 doses of hydrocodone were shipped to WV alone, my home state. The total state population, including children, is less than 2M. Most of the pain pill overdoses have been in four (of 55) counties, and all four are southern (former) coalfield counties, rural and poor, with heavy welfare dependency and high unemployment. The health care sector of the state economy has vastly outperformed any other sector since 2014 (another interesting year). When I visit my family, it's easy to believe that the biggest single state industry is health care, because there's a pain clinic on every corner. And, BTW, obesity - and I mean major lardass obesity that demands a scooter at Wal-Mart, not just fat folks - is off the scale, and virtually every convenience store offers hot fried chicken under the lights and sports an EBT sign in the window.

Anything you subsidize, you will get more of.

Stuart Schneiderman said...

I would add, anything you destigmatize you also get more of.

Dr. Irredeemable Dreg said...

Agreed.

Ares Olympus said...

What's most amazing is the duration of the problem, while we still can't seem to stop it. I suppose the money is just too good, and the short term benefits of pain relief too attractive.

I broke my collarbone in a bike accident in 2005 and was prescribed vicodin for at least 2 weeks. I didn't even know what was in it, or that it could be addictive, only recently looked it up to see it contains an opioid, hydrocodone. I used less than half of it, and saved the rest for a few years unused. I remember at the emergency room, they asked my pain level 1-10, and I think I said 3 when I wasn't moving. When an intern stood me up and tried to put a shoulder brace on me, I could have said 10, but I think "good pain" is the sort that says "Don't do that!", while bad pain keeps hurting no matter what you do.

Dorothy Margraf said...

I think the article can be covered by the opening sentence. "I am hardly expert on this matter, but America’s opioid crisis deserves close examination." Better it should have been written by someone an expert in the field. The article appears to be written by someone not knowledgeable in the field of medicine, but very skilled in doing internet research. When doctors must be more responsive to the government than they are to their patients, we are in big trouble. Someone get out the literature on bioethics and the eugenics movement. In addition, we need to find out who stands to make big money in the legalization of marijuana as a much easier to get, legal pain killer. We need more information on who is bringing fentanyl into this country in such large amounts that are killing so many people. Doctors I've talked to know this demonization of opioids is one big scam and, again, it would be interesting to know who is behind it.

The comments are more informative than the article. Well, with exception of simplistic terms like 'good pain' and "bad pain" based on one experience with pain and silly comments about fat people and fried chicken.

Anonymous said...

Dorothy Margraf,

The problem is biology itself is a WEAPON, as such its future appears to belong to governments, MICs, large corporations (and their networks), intelligence, and the engineering scientists on their payrolls.

Individual doctors and patients CANNOT compete against this reality.

Sam L. said...

I had heart surgery and was sent home with oxycodone. The next day I was pain-free. After a month, I took all the oxy to the local P.D.'s drug dump.

Dr. Irredeemable Dreg said...

Officer Margraf of the Comment Thread Police just arrived, demanding more information. They are the guys who put the "dud" in "dudgeon".

ASM826 said...

My mother died of cancer in hospice two years ago. Her last couple of months were made comfortable, and then as the end neared, tolerable by morphine. If she had not had it, she would have died screaming. In the effort to deal with the abuse of opioids and the problems it brings, let's not forget that there is a use to these drugs in relieving the suffering of those in incurable pain.

Anonymous said...

ASM826, abuse of opioids far more terrifying than small arms.

Every report of Opioid addiction seems to encounter the hardest time avoiding it for good once they have ceased using it. Apparent relapse is easy, even if it was many months. Possibly worse that quitting alcohol.

I have not experience with opioids other than a codeine-tylenol prescription which didn't help pain at all but instead made my skin crawl and itch. So I gave up on it and learned to like the pain with some ibuprofen.

Thanks for sharing your story ASM.

Stuart Schneiderman said...

For those who are discomfited by the fact that I am not an expert, if they had read more carefully they would have seen that I do not offer my views... I summarize and report the analysis of an expert in the field...

Anonymous said...

It is not just opioids. My wife is currently withdrawing from Ativan. It was so blithely and readily prescribed, who would have thought it to be so destructive? After not-very-exhaustive internet research, one comes to the conclusion that it is a veritable scourge, withdrawal from which is often described by those with personal knowledge as worse and more difficult than heroin addiction. Look it up if you doubt me; a simple google inquiry about benzo withdrawal should satisfy any curiosity. Yet doctors prescribe benzos (Ativan, Valium, etc.) at staggeringly high rates. Same with SSRI's. We have, in fact become a nation of mind-numbed robots. So sad.

Stuart Schneiderman said...

It's been over three decades since Barbara Gordon exposed the addictive quality of Valium in her book, I'm Dancing as Fast as I Can.... I had thought that most physicians had gotten the message... but apparently not.

Anonymous said...
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Sensory Bounce said...
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Anonymous said...

Generally, I agree with most of the content on this blog. Wonderful insight that I appreciate.

I do not, however, agree with the conclusions presented in the referenced citations. The number of accidental deaths related to drug overdoses, and in particular those invovling opiods, has increased every year since the newer restrictions were placed on prescription opiods such as oxycodone and hydrocodone. These drugs are dangerous when abused, not necessarily when prescribed, as NIDA estimates that 8-12% of people prescribed opiods for pain develop an opiod use disorder.

If the opiod crisis, as defined by the number of overdose deaths, was fueled by the over-prescribing and over-consumption of these opiods, then the curtailing the prescribing of these medications should have seen a sharp decline in the number of overdose deaths attributed to these medications. We do not. Instead, the rate of overdose deaths caused by presecription opiods remained nearly constant from 2010-2017.

For example, see https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates, which shows death rates greatly increased after enactment of the new presecribing guidelines and limitations on opiod prescriptions.

The culprits are heroin and fentanyl, whether alone or in combination. In 2017, fentanyl is attributed to 30,000 deaths from overdose, whereas heroin is attributed to 16,000 deaths from overdose (these groupings are not mutually exclusive). Note also there is a dramatic increase in deaths involving cocaine and methamphetamine during the same 2010-2017 period. These death rates, and their increases since 2010, are unlikely related to the overprescribing of opiods for pain relief.

More importantly, from 2010-2017 the number of deaths from prescription opiods remained constant while the number of deaths from illicit opiods drastically increased. The net effect of limiting opiod prescriptions was to cause more pain to patients--there was no harm reduction.

Why is this even a story? What prescription opiod epidemic? I do not see one--only an illicit drug overdose epidmic can be seen from the data estimates from 2010-2017.

Instead, we need to consider the number of annual deaths and costs related to smoking (480,000 people; $300 billion) and alcohol (88,000 people; $249 billion), so that we can keep the "prescription opiod epidemic" (19,354 people; $78.5 billion) in perspective.

Give the patients their pain relief.

MikeyParks said...

Look closely at the anti-big pharma movement and you'll find anti-Capitalist fingerprints. It amazes me how many people who should know better buy into this ruse.