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As Portenoy saw it, opiates were effective painkillers through most of recorded history and it was only outdated fears about addiction that prevented the drugs still playing that role.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