1 Boring Old Man

• the ouvert message: an injunction to perform a certain action
• the covert message: an equally firm but veiled injunction to not follow the ouvert message

• the imperative: although there’s nothing right to do, there is a powerful injunction to act, do something
• the covenant of silence: although in an impossible situation, the strongest message is that you can’t acknowledge the impossibility

The best response to a double bind comes from those great Greek Philosophers – When on the horns of a dilemma, go between the horns. What that usually means is to ignore the first three elements, and break the covenant of silence by talking about all the impossibilities. With chronic pain patients, that means talking about the limitations of the medications and the real dangers ahead, forming a working alliance to find the best compromise between-the-horns that sticks to the do-no-harm ethic. It’s the reason for pain clinics which, when run responsibly, provide maximal safe relief. This is no small deal. Chronic pain can be a show-stopper, bringing the best of us to our knees.

In the long ago time when I was in medical school, the wisdom was then that narcotics (that is, drugs like morphine or heroin, the latter not legal) should only be used in severe acute pain, like that due to bad trauma or occurring post-operatively, or for the pain of terminal illnesses, like cancer. The reason their use was so restricted was that the drugs were believed to cause frequent adverse effects, from severe constipation, to addiction, to respiratory depression and death. However, starting in the 1990s, the conventional wisdom changed. Suddenly, the focus was on the under-treatment of chronic, but not malignant pain, and it became permissible, or even preferable, to use potent narcotics for this purpose. Physicians like me who were very conservative in their use of narcotics were chastised for under-treating pain. The Wall Street Journal article explained how this radical change in approach was apparently engineered by a few key opinion leaders, particularly Dr Russell Portenoy…

Unfortunately, as the article made clear, the radical change that seemed so odd to some of us physicians who were trained before the 1990s was not driven by any good evidence from clinical research. Per the WSJ:

Because doctors feared they were dangerous and addictive, opioids were long reserved mainly for cancer patients. But Dr. Portenoy argued that they could be also safely be taken for months or years by people suffering from chronic pain. Among the assertions he and his followers made in the 1990s: Less than 1% of opioid users became addicted, the drugs were easy to discontinue and overdoses were extremely rare in pain patients.

However, Dr Portenoy’s contention seemed to be based only on a small case-series of patients, lacking any sort of control group, and too small and likely too selective to generalize, particularly to patients with chronic, non-malignant pain.

In 1986, at the age of 31, he co-wrote a seminal paper arguing that opioids could also be used in the much larger group of people without cancer who suffered chronic pain. The paper was based on just 38 cases and included several caveats. Nevertheless, it opened the door to much broader prescribing of the drugs for more common complaints such as nerve or back pain.

Dr Portenoy also cited:

"the statistic that less than 1% of opioid users became addicted."
Today, even proponents of opioid use say that figure was wrong. ‘It’s obviously crazy to think that only 1% of the population is at risk for opioid addiction,’ said Lynn Webster, president-elect of the American Academy of Pain Medicine, one of the publishers of the 1996 statement. ‘It’s just not true.’ The figure came from a single-paragraph report in the New England Journal of Medicine in 1980 describing hospitalized patients briefly given opioids.

The reference here appears to be a letter to the New England Journal of Medicine. This was literally one paragraph long, so the methods of the research it reported cannot be rigorously evaluated…

In 1998, the Federation of State Medical Boards released a recommended policy reassuring doctors that they wouldn’t face regulatory action for prescribing even large amounts of narcotics, as long as it was in the course of medical treatment. In 2004 the group called on state medical boards to make undertreatment of pain punishable for the first time.

In 2001, the Joint Commission, [JCAHO] which accredits U.S. hospitals, issued new standards telling hospitals to regularly ask patients about pain and to make treating it a priority. The now-familiar pain scale was introduced in many hospitals, with patients being asked to rate their pain from one to 10 and circle a smiling or frowning face. The Joint Commission published a guide sponsored by Purdue Pharma. ‘Some clinicians have inaccurate and exaggerated concerns" about addiction, tolerance and risk of death, the guide said. "This attitude prevails despite the fact there is no evidence that addiction is a significant issue when persons are given opioids for pain control.’

Meanwhile, Dr Portenoy was personally profiting from his relationships with pharmaceutical companies:

Over his career, Dr. Portenoy has disclosed relationships with more than a dozen companies, most of which produce opioid painkillers. ‘My viewpoint is that I can have those relationships, they would benefit my educational mission, they benefit in my research mission, and to some extent, they can benefit my own pocketbook, without producing in me any tendency to engage in undue influence or misinformation,’ he said. Dr. Portenoy and Beth Israel declined to provide details of their funding by drug companies. A 2007 fundraising prospectus from Dr. Portenoy’s program shows that his program received millions of dollars over the preceding decade in funding from opioid makers including Endo, Abbott Laboratories, Cephalon, Purdue Pharma and Johnson & Johnson.

Since the campaign to "destigmatize" narcotics began, the US has seen what many have called an epidemic of narcotic adverse effects. The WSJ article provided graphs showing that narcotic related deaths and hospital admissions both increased more than five times since 1999. As the WSJ put it,

…some specialists now question whether the drugs should be prescribed so freely for months or years to people with chronic pain that isn’t related to cancer, as Dr. Portenoy proposed 25 years ago. "People lost sight of the fact that these are dangerous drugs that are highly addictive," said Jane Ballantyne, a pain specialist at the University of Washington. She once agreed with Dr. Portenoy and proponents of broad opioid use but now believes they need to be used more selectively.

Now, Dr. Portenoy and other pain doctors who promoted the drugs say they erred by overstating the drugs’ benefits and glossing over risks. ‘Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,’ Dr. Portenoy said in an interview with The Wall Street Journal. ‘We didn’t know then what we know now’…

‘Data about the effectiveness of opioids does not exist,’ Dr. Portenoy said in his recent Journal interview. To get a painkiller approved, companies must prove that it is better at reducing pain than a sugar pill during short trials often lasting less than 12 weeks. ‘Do they work for five years, 10 years, 20 years?’ Dr. Portenoy said in the Journal interview. ‘We’re at the level of anecdote’…

‘I gave innumerable lectures in the late 1980s and ’90s about addiction that weren’t true,’ Dr. Portenoy said in a 2010 videotaped interview with a fellow doctor. The Journal reviewed the conversation, much of which is previously unpublished…

In it, Dr. Portenoy said it was ‘quite scary’ to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. ‘Clearly, if I had an inkling of what I know now then, I wouldn’t have spoken in the way that I spoke. It was clearly the wrong thing to do,’ Dr. Portenoy said in the recording…

… I would note, however, that two ways the headlong rush to over-use of narcotics could have been derailed would have been: – employment of extreme skepticism of people paid by narcotics manufacturers advocating increased use of these drugs, no matter how distinguished, scholarly, or influential these people appear to be. This suggests the need for general skepticism of people with financial relationships with health care corporations pushing the goods or services these corporations provide, or pushing policies that would aid the selling of those goods or services – a rigorous evidence-based medicine approach, meaning making clinical and policy decisions based on the best evidence found by systematic search from rigorously evaluated clinical research about the benefits and harms of these decisions, informed by patients’ values. Such an approach would have revealed there was never any good clinical evidence to support long-term use of narcotics for chronic, non-malignant pain, the particular "innovation" being pushed in this case…

But this story is much bigger than just the issue of narcotics. It’s the whole issue of what we now call KOLs [a PHARMA term] being able to exert an enormous influence on medical practice. That’s particularly true in psychiatry as we’ve seen ad nauseum with antidepressants, mood stabilizers, and the atypical antipsychotics – KOLs backed [and paid] by PHARMA making recommendations that are both lucrative but dangerous. From the outside, it may look as if physicians are just fools, sheep herded by the unscrupulous. But if you think about it, no practicing physician could know all of medicine from experience. We rely on the medical literature. And that literature has been co-opted by the KOL/PHARMA system at a shameful level.

Here is where Dr. Portnenoy’s mea culpa hardly extends far enough. He seems to have learned that the safety profile of opiates is not as rosy as he made it out to be 10 and 20 years ago. But he does not seem to have gained any perspective on the dangers of being bribed by industry. He told the interviewer, "My viewpoint is that I can have those [financial] relationships, they would benefit my educational mission, they benefit my research mission, and to some extent, they can benefit my own pocketbook, without producing in me any tendency to engage in undue influence or misinformation." Well, since Dr. Portenoy began his career, new evidence has emerged about the efficacy and safety of narcotics in chronic pain. New evidence has also emerged about the degree to which docs are influenced by Pharma money, even if they deny it. Dr. Portenoy seriously needs a refresher course in the latter body of evidence, just as he seems to have had some helpful re-education regarding the first.

So I would argue that the case of the legal narcotics pushers underlines the need for utmost transparency about conflicts of interest affecting people and organizations that advocate for particular approaches to health care, and to the management of individual patients; continuing movement to bar at least the most egregious conflicts, as per the Institute of Medicine report on the topic (look here); and the need for the very skeptical, rigorous application of true evidence-based medicine approaches.