The Man-made Opioid Epidemic: Part 5 – Quality Control of AMA Federation Societies.

Posted on | December 9, 2015 | 2 Comments

CDC: Rx Drug Overdoses

Mike Magee

“Since the desire of man to alter his state of consciousness is as old as human history, and technology continues to provide a breathtaking array of drugs capable of producing everything from oblivion to nirvana, I think it safe to assume that we may never win a ‘war’ against drugs.”     Senator Moynihan

When Senator Daniel Patrick Moynihan voiced the words above, he was referring back to 1971, when President Nixon famously declared a “war on drugs”. That “war” in its first decade took on a hard edge, as small offenses led to long sentences and “three strikes you’re out” became the law of the land for most of the next four decades. Between 1980 and 2009, incarcerations of mostly young, and mostly black men, rose from 40,000 to a half million.

That remarkable overreach was ignited, in part, by the moderate Republican Governor of New York, Nelson Rockefeller, who was the standard bearer for the state from 1959 until 1973, when he was selected by Gerald Ford for the vice presidency of the United States. Two years earlier, Gov. Rockefeller had witnessed the infamous prison riot at the state’s Attica prison, which was apparently enough to radicalize the usually mild mannered leader. The Rockefeller Laws were subsequently passed in New York state, and the inmate population of 12,500 grew to a record high of 72,584 by the end of the century.

It would be another decade before those laws were swept aside in 2009. This occurred, not coincidentally, with a now infamous spike in opioid prescription drug abuse. This time however, the faces were largely white, not black; the epicenters were not urban, but rural and suburban; and the drugs were legal in origin, not illegal – at least in the beginning.

As I’ve catalogued in the first 4 parts of this series, The Man-made Opioid Epidemic, there was ample warning of a problem as early as 1997, centered around the over-prescribing and oft-denied abuse potential of Oxycontin. The company, Purdue Pharma, and hired guns like Rudolph Guilliani, and helpful advocates and supporters within medical leadership, managed to fight off regulators for over a decade. By 2007, charges and fines against the company stuck. But with the offending product and others like it remaining on the market, and state monitoring databases still in infant form, drug fatality rates reached a remarkable 43,982 by 2013.

A majority (56%) of these were from opioids – 2/3 prescription drugs and 1/3 opium in the form of street heroin. The heroin, evidence shows, was a late add-on. The most common 1st offender, studies now reveal, was a legal prescription to white patients (90% of the time) for Oxycontin. Once hooked, street heroin became a far more affordable alternative. In the year that included 8,257 heroin-related deaths (2013), an estimated 330,000 Americans were regularly purchasing the illegal drug on streets across our nation.

The reaction to the current problem, compared to its parent in 1973, has been far more cerebral and considered. The current Administration has pledged $12 billion to prevention and treatment. Several thousand non-violent inmates, imprisoned for drug-offenses, have been released. There is a definite swing toward treatment over punishment. The use of buprenorphine and methadone to treat addiction, laws enabling family and friends to administer Narcan themselves to family members, and the recent approval of nasal naloxone (Narcan), a life-saving antagonist to opioid overdose, as well as the movement to promote joint prescribing of that antidote drug at the time of opioid prescription, has been vigorously applauded by the AMA and many others.

Less notable is evidence of a significant internal examination of the rather startling and complicit failures of the medical profession and pharmaceutical industry in this episode. Purdue Pharma, fined and forced to come clean in 2007,  still stands. Oxycontin is still available, though less prescribed and with prominent “black box” warnings on its label. The company apparently still sees financial opportunity on the horizon for addiction proof opioids, and currently has new patents pending. Since 2010, J. David Haddox, M.D., Vice-President of Health Policy, has filed six separate patents for new opioid time release technologies.

The ability to prescribe is central to the identity and authority of the medical profession. As such, it is a primary policy concern for the American Medical Association, of which I, and my father before me, have been lifelong members. Commendably, the AMA this year has come out in opposition to DTC advertising, noting that the US and New Zealand are the only two nations that allow mass broadcast marketing of prescription drugs. They have also encouraged physicians to support broad availability of the opioid antidote, naloxone, and to support treatment over incarceration of addicted patients. Finally , they have somewhat grudgingly endorsed the Prescription Drug Monitoring Programs (PDMPs), which they had opposed in the past due to mandatory physician requirements to consult databases prior to prescribing opioids.

While these approaches all have merit, they deflect energy from more systemic and permanent preventive solutions. What requires addressing are the fundamental building blocks of the financial conflict of interest that set the stage for driving consumer demand and physician supply of prescription opioid drugs.

A simple examination of the Oxycontin experience reveals that this company, and others like it, carefully followed Arthur Sackler’s 1950’s playbook.

Step 1. Create a quasi-medical organization for legitimacy.

Step 2. Provide funding to the organization to sponsor quasi-academic vehicles (journals and CME programs) to publish supportive articles, and then re-educate practitioners toward the medicalization of your target condition and the need for treatment of this condition with your therapy.

Step 3. Expand the number of professional and consumer organizations to create momentum, demand, and implied consensus.

Step 4. Integrate these programs with mainstream intelligentsia by ample funding in high end medical journals and generous philanthropic support of brand institutions, so that by simple name association, you reinforce your own brand’s integrity.

Step 5. When over-prescribing ignites a backlash, generously and magnanimously participate in the corrective steps, which you yourself made necessary.

Specifically, the seeds of the current Man-made Opioid Epidemic were planted in 1983 with creation of the American Association of Pain Medicine and its subsequent inclusion in the AMA Federation. Over the next few years, with active funding from Purdue Pharma, articles and speeches emanating from this organization, and a sibling at the University of Wisconsin, advanced the theory, utilizing data from scientifically unsound publications, that chronic pain was being massively under-treated and that opioids could be safely employed without addicting patients.

One of the lead professionals was a paid speaker of Purdue Pharma in those early years while an officer in the AMA specialty society (and its president in 1998) and a lead in the University of Wisconsin group. Within a short period of time, he would become an employee of the company, and a lead proponent, to this day, of their drug, Oxycontin. He and the company’s leadership used the carefully nurtured, and AMA endorsed “pain specialists” (a group of diverse psychiatrists, neurologists, anesthesiologists, emergency medicine specialists, and oncologists – all of whom already had their own specialty organizations), to aggressively re-educate and inculturate primary care physicians to pain, the “fifth vital sign”, using marketing presentations masked as CME offerings. The messaging was reinforced and legitimized by company-supported peer review articles and advertising buys in top shelf medical journals. At the same time, Purdue Pharma expanded support for a wide range of other AMA specialty societies.

Currently there are 121 national societies listed within the AMA Federation. They are not all equal. There are long-standing giants including two I have belonged to, the American College of Surgeons and the American Urologic Association. But there are also more recent entries like the American College of Mohs Surgery (dedicated to advancing the skin cancer treatment approaches championed by Frederic E. Mohs M.D.), the Spine Intervention Society (dedicated to the practice of interventional procedures in the diagnosis and treatment of spine pain) , and the Undersea and Hyperbaric Medical Society (dedicated to the science of undersea diving activities and hyperbaric oxygen therapy).

The area of pain management is especially well-represented within the AMA Federation. Beyond the historic societies that cover psychiatry, neurology, anesthesiology, emergency medicine, physical medicine and rehabilitation, and oncology (all of whom have strands devoted to pain management), there are also The American Academy of Pain Medicine (1983), The American Academy of Hospice and Palliative Medicine (1988), the American Society of Addiction Medicine (1988), and The American Society of Interventional Pain Physicians (1998).

How does one become a National Society member of the AMA Federation? You apply for membership, and are aided by a set of online guidelines including a sample letter of application. A heavy emphasis is played on advancing individual AMA memberships, sending elected delegates to participate in the AMA House of Delegates meetings, and supporting advocacy positions held by the AMA.

According to their sample letter, “a specialty organization must demonstrate that it has 1,000 or more AMA members; or …that it has a minimum of 100 AMA members and that twenty percent (20%) of its physician members who are eligible for AMA membership are members of the AMA.” The society members need not be all physicians, only a majority of the voting members need be physicians. They must be voluntary and have paid dues. According to the sample letter, “The organization must cooperate with the AMA toward increasing its AMA membership, particularly if it is at a level of less than 50%.” As for standing, the organization must have been in existence for at least 5 years prior to application, hold at least 1 meeting a year, and “represent a field of medicine that has recognized scientific validity” and be “national in scope”.

In terms of quality control (educational offerings, conflict of interest, financial management), the Guidelines for Admission mention only that a national medical society member of the Federation “not be in conflict with the constitution and bylaws of the American Medical Association.” There is a 5 year recertification requirement. For example, the American Academy of Pain Management was re-certified in 2013, and the next review is scheduled for 2018. But the review is only “designed to verify: 1) that AMA membership within the specialty society is sufficient for continued eligibility in the AMA House of Delegates and, 2) that the specialty society meets the guidelines and by-law requirements for representation in the House of Delegates.” Member databases are carefully checked against AMA member databases. But there appear to be no educational quality monitors, financial reporting, or ethics-based data measures required for either approval or recertification.

This laissez-faire approach to Federation expansion and quality management has left the AMA’s Federation highly vulnerable to commercial manipulation by organizations like Purdue Pharma. Official recognition by the AMA, as was seen with the American Academy of Pain Medicine, can anchor a commercial, profit-driven, integrated public affairs and government relations campaign that puts patients at risk and can end in disaster.

If there is one important take-away from this Man-made Opioid Epidemic, it is that the AMA should critically examine the quality control and oversight of their own National Medical Societies. Questions that the AMA Board of  Trustees need to address include:

1. As with 501C3’s, should each national member be required to submit a full financial report, including educational offerings, and complete list of sponsors each year?

2. Should leadership of participating member organizations be required to complete and sign-off on a conflict of interest online program each year to maintain membership?

3. Should Federation member websites be required to include a “sponsor” heading in their navigation bar displaying a complete list of commercial sponsors/advertisers which provided financial/in-kind support for operations, CME funding, public affairs funding, and/or journal advertisements, for the past 5 years, including donations to the member organization and any associated Foundations?

4. Should the results of that annual declaration be available on the AMA public website?

5. Has the AMA ever decertified a Federation National Medical Society? Which, when, and why?

6. Should the AMA establish formal Quality Assessment of their Federation members focused not on membership, but on educational, financial, and ethical performance.

7. Should the AMA commission, as they did with the Sunbeam scandal in 1997, an independent report examining the role of its Federation member organization in the current Man-made Opioid Epidemic, and steps that might be taken to better protect American patients from recurrences like these in the future?

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