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Notebook Medicine

Jessica Hill/AP

(Jessica Hill/AP)

Medicine

Anatomy of an epidemic

Diagnosing the causes of the opioid crisis 

Massachusetts officials are suing Purdue Pharma, maker of OxyContin, alleging that its sales tactics fueled a surge in opioid addiction. Massachusetts is also suing the Sackler family, which owns and runs Purdue Pharma. The lawsuit underscores the controversy over the pills: Did the increase in opioid prescriptions reflect doctors finally addressing untreated pain or becoming tools for sales at any cost?

Psychiatrist and addiction specialist Anna Lembke argues in the 2016 book Drug Dealer, MD that doctors believed they were finally addressing pain issues. They viewed as outdated the World Health Organization’s 1986 guidelines, which advised doctors to start with non-opioid drugs (like Tylenol and Motrin), proceed if necessary to opioids like codeine, and reserve stronger opioids like morphine for when other drugs failed.

But had medical opinion changed or was propaganda at work? New guidelines emphasized aggressive pain control, but those guidelines stemmed from Big Pharma. Lembke discovered that the Federation of State Medical Boards (FSMB) received almost $2 million in support from opioid makers. The FSMB in turn “urged state medical boards to punish doctors for undertreating pain. Doctors lived in fear of disciplinary action from the board, and the lawsuit that usually followed, if they denied a patient opioid painkillers.”

In 1999 the Department of Veterans Affairs declared pain level to be the “fifth vital sign,” which meant it had to be checked whenever a nurse or doctor checked a patient’s vitals. In 2001 the Joint Commission on Accreditation of Healthcare Organizations said appropriate (i.e., aggressive) pain control would be a factor in maintaining accreditation. 

Doctors listened: A University of Southern California study found American opioid prescribing rose 471 percent between 1996 and 2012. Purdue offered various educational and promotional materials, even via the Joint Commission’s own website. Purdue’s representatives canvassed the country, promoting OxyContin as an ideal choice with a time-release formulation that was both convenient and less likely to produce addiction.

OxyContin may have been convenient, but time proved that it certainly was addictive—especially when users realized that crushing the original version of the pills released all of the active ingredient at once. (A 2010 reformulation later addressed the problem.) A burgeoning street market for the drug showed addicts knew about this feature. Potential profits induced many people to get prescriptions and illegally resell them.

Some doctors remained skeptical of the fifth-vital-sign approach. A 2006 study found the new dispensation did not improve pain control, but the CDC took a decade to issue guidelines calling for reduced opioid use. Yet even before those restrictions, patients who had grown dependent on opioids often sought illegal sources when they could no longer get prescriptions. That’s even more dangerous now that drug gangs have learned to counterfeit popular prescriptions: When the musician Prince died of an overdose in 2016, pills found with him bore a code for generic Vicodin, but proved to contain fentanyl and two other drugs.

Both Lembke and the CDC guidelines offer practical advice: nonpharmacological and non-opioid pain management whenever possible, rational opioid prescribing to prevent further addiction, and—perhaps most important now—strategies to help those already addicted.

But why stop there? Let’s replace our society’s current addiction to rules and guidelines with a commonsense understanding that life after the Fall can’t be entirely devoid of pain, any more than corporate funding can be entirely without strings. Let’s bring back the idea of doctors and patients knowing each other, as individuals, and of doctors using that relationship to help encourage patients as they manage their pain, one day at a time.

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Alfie Evans is remembered by supporters (Christopher Furlong/Getty Images)

Medicine

Death wishes

Severely ill patients are more than collections of usable organs

Alfie Evans died on April 28 at 23 months old, and the British boy’s case has reopened old questions: Who has the right to veto further care? What happens where conflicts of interest arise, as when Terri Schiavo’s husband fought to withhold water and nutrition while living with another woman and standing to inherit over $700,000 from his wife’s medical trust fund? And most fundamentally: What is life, or quality of life?

“Life” is easy to define intuitively, but more challenging to define for patients whose ailments primarily affect the brain. If life depends on self-awareness, are people with Alzheimer’s, or who are mentally ill and suffer from delusions, dead? If it depends on the ability to perform given “activities of daily living”—or any activities of daily living at all—are those with disabilities dead?

In 1968, bioethicist Henry Beecher’s committee published its proposed answers to those questions in the Journal of the American Medical Association, focusing on “irreversible destruction of the brain” as equivalent to death. The committee gave two reasons for its answer: first, to relieve the financial and social burden of care it viewed as futile, and second, to address controversies about obtaining organs for transplant. A New Yorker article states that an earlier draft spoke more bluntly: “There is great need for the tissues and organs of the hopelessly comatose in order to restore to health those who are still salvageable.”

Such attitudes have long made the organ-procurement world both hero and villain to some, and the same article quoted Peter Singer—the Princeton bioethics professor who has attempted to justify infanticide—as stating that brain death is “a concept so desirable in its consequences that it is unthinkable to give up, and so shaky on its foundations that it can scarcely be supported. … [It is] an ethical choice masquerading as a medical fact.” A recent movement has questioned the idea of brain death, and a New Jersey law allows families with religious objections to insist that doctors not declare a patient dead until the patient’s heart stops. The family of Jahi McMath, a teenager originally declared brain-dead in California, used such an exception to continue her care in New Jersey—for over four years.

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A Narcan nasal device, which delivers naloxone (Mary Altaffer/AP)

Medicine

Pricing power?

Corporate and nonprofit groups hope to bring down the cost of lifesaving drugs

As the opioid crisis rages on, police officers in many areas have one more weapon: New laws permit them to give the rescue drug Narcan (naloxone) to overdose victims without waiting for paramedics. It works, and it saves lives—Leana Wen, the health commissioner of Baltimore City, credits the drug with saving 14,000 people since 2015 in her city alone. But that success comes at a cost, and Wen goes on to state in a Washington Post op-ed that her city is now rationing the drug.

Naloxone’s patent protection expired decades ago, and the drug itself retails for perhaps $15 a vial—and often less for organizations that buy in bulk. But giving that vial to an overdose victim would require an injection, so rescuers without medical training normally receive nasal sprays or auto-injectors instead. Even with steep discounts for public providers, brand-name Narcan nasal spray costs $37.50 per use; the other ready-to-use naloxone, the Evzio auto-injector, costs them $180 each. Multiplying those numbers by thousands of prospective uses has led many departments to cobble together their own naloxone nasal sprays, using generic pre-filled syringes and atomizers.

Wen argues that the government should invoke its rarely used ability to bypass the patent system in exchange for “reasonable compensation” to patent holders, but at least generic forms of naloxone exist: Diabetics who need insulin and asthmatics who need albuterol inhalers have no generic choices in America, even though the patents for both original forms expired decades ago. Dr. Jeremy Greene, a professor at Johns Hopkins, cited a newer-is-better attitude in a 2015 Journal of the American Medical Association article as the main reason why older animal-derived insulin products are no longer available here. He added in an NPR interview that “we don’t believe that there is a conspiracy to keep insulin expensive.”

The situation is murkier for albuterol inhalers. Generic albuterol itself remains widely available at modest prices—but only in vials for nebulizers, whose size makes them unpopular as a rescue treatment. What happened to the iconic inhalers from years ago? They’re still around, but since the propellant has changed from CFCs, and since any new formulation is eligible for patent once more, generic albuterol inhalers disappeared from the American market in 2008.

New corporate and nonprofit market players hope to disrupt the status quo: A consortium of hospitals has teamed up with the VA to start a nonprofit generic-drug manufacturer, arguing in the New England Journal of Medicine that since older drugs often cost very little to manufacture, their nonprofit will be able to sustain itself while charging far below current prices for medicines. To help drugs reach the generic market, the Initiative for Medicines, Access, and Knowledge plans legal challenges to patents it considers questionable. The biggest news, however, is how those drugs will ultimately reach consumers: Amazon’s purchase of online pharmacy PillPack gives it a pharmacy license for all 50 states.

If this array of new market players brings back affordable generic insulin, it would bring the drug’s journey full circle. When surgeon Dr. Frederick Banting and medical student Charles Best first isolated insulin from animals in 1921, they sold their discovery to the University of Toronto, putting the wellbeing of diabetics above their own profit. The price they charged, for a discovery that would yield a Nobel Prize two years later: one dollar.

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