News Roundup: May 4, 2018

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Credit: Charlotte (Unsplash)

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By Roger Parloff

This week’s New York Times Magazine story about Insys Therapeutics—whose founder and six top former officials have all been criminally charged under the Racketeer Influenced and Corrupt Organizations Act—is a rip-roaring yarn, but one that also reveals severe problems with US pharmaceutical marketing practices.

Also, this week, there are important stories about hospital emergency rooms grappling with the fact that simply stabilizing and discharging opioid overdose victims—the prevailing national practice—is callous vis-à-vis patients and financially unsustainable for the institutions.

Finally, yet another opioid litigation front opened up this week, relating to insurance; an FDA-approved miracle device looks like a Bridge too far; and a veterinarian was arraigned for a heroin smuggling scheme that you’ll wish I hadn’t told you about. (It involves puppies.)

Insys Therapeutics

Because Insys Therapeutics’s main product, Subsys—a fentanyl mouth spray—did not come to market until 2012, when opioid prescribing in the US was already peaking, the company does not play a central role in the more than 600 lawsuits that municipalities have filed against opioid manufacturers. Usually, it’s not even named as a defendant. Nevertheless, as Evan Hughes’ story in the New York Times Magazine shows, there’s a strong case to be made that Insys was the worst actor of them all.

In fact, federal prosecutors in Boston are making that case, having charged founder John Kapoor, former CEO Michael Babich, and five other former top officials with criminal RICO violations stemming from allegedly bribing doctors around the country to prescribe Subsys to inappropriate patients. Some 11 physicians have also been charged so far, and several have been convicted and are already serving prison terms.

Like many pharmaceutical companies, Insys paid “key opinion leader” doctors to participate in a “speaker” program, to explain their products to other doctors. But the practice appears to have gotten a little crude at Insys. The company would pay for speaking events at upscale steakhouses, but there would not necessarily be any audience in attendance. “We pay doctors to write scripts,” an Insys sales manager allegedly explained to a trainee quoted in the article. Ten of the top speakers made at least $200,000 each, Hughes writes.

The most amazing part of the tale comes at the end. (Spoiler alert.) One alleged pill mill in Mobile, Ala.—whose physicians owned their own pharmacy—was purveying so much Subsys that wholesale drug distributors stopped supplying any more of it to the pharmacy, heeding the DEA’s rules against suspicious shipments. At that point, feeling the pinch from loss of sales, Kapoor and Babich allegedly paid an in-person visit to the physicians in Mobile. An agreement was then allegedly struck whereby Insys would by-pass the wholesalers, and ship directly to the doctors’ pharmacy. (The two doctors were sentenced to 20 and 21 years in prison last May. They maintain their innocence, and have appealed. Kapoor, Babich, and the other former Insys officials have pleaded not guilty and also maintain their innocence.)

Treatment

When an overdose victim is brought into an emergency room in most US hospitals, the patient is stabilized and then discharged. Addiction treatment has traditionally been considered behaviorial, not medical, and, therefore, not the hospital’s bailiwick.

In his book Overcoming Opioid Addiction, which came out this week, Columbia addiction psychiatrist Adam Bisaga argues that more needs to be done at these crucial moments. “One third of opioid users who overdosed in [one] year did so again the following year,” he writes. “Half of heroin injectors who survived an overdose will have a fatal overdose at some point.”

“You have a chance in the ER to do something to prevent it,” Bisaga told Opioid Watch in a two-part interview we ran this week. “And if this was any other medical disorder, you would feel legally and ethically compelled to do that.” (Bisaga also argues that, given the lethality of opioid use disorder and the clear superiority of medication-assisted treatment over abstinence-based, 12-step programs alone, it is no longer ethical to refer patients to most drug treatment centers in the US.)

While avoiding patient death is the main reason to push treatment more aggressively in ERs, the New York Times and PBS each carried stories this week about another reason to do so: the expense. Each reported on the enormous costs of performing repeated heart-valve operations—about $150,000 a shot—on patients suffering from endocarditis, caused by IV drug use, who come back again and again.

In New Jersey, hospitals are now having former-addicts, known as recovery specialists, try to persuade overdose patients to seek treatment, as we report this week. Baltimore hospitals are also using these peer counselors and, better still, are offering to begin medication-assisted treatment right in the ER, according to an editorial in the Baltimore Sun by the city’s mayor and health commissioner. They claim that “nearly all of our 11 emergency departments now offer medication-assisted treatment on demand to patients with opioid addiction, something true of no other major city in America.”

Chronic Pain

Human Rights Watch is conducting an investigation into whether US reforms designed to curb the opioid epidemic, including the CDC’s 2016 guidelines on opioid prescribing, are now violating the human rights of chronic pain patients, by making it too difficult for them to obtain their medication. The Pain News Network reported on this in March, and invited its membership to share their experiences to HRW. (The PNN story was later updated to say that HRW had been so “flooded with responses” that they didn’t need any more.)

Charles Lane writes an op-ed in the Washington Post this week in which he expresses skepticism about HRW’s project. “Alleged unintended consequences of justifiable and, indeed, moderate public-health policies just do not belong in the same moral conversation as deliberate human rights violations such as police brutality or torture,” Lane writes.

Also of Note

  • A new set of federal lawsuits was filed this week against opioid manufacturers and distributors, per the Wall Street Journal and Bloomberg. Proposed statewide class actions were filed in California, Illinois, Massachusetts, New Jersey and New York on behalf of businesses and individuals who claim that the opioid crisis has increased the cost of their health insurance premiums, deductibles, co-pays. The lead lawyer bringing them is Travis Lenkner, of Keller Lenkner in Chicago. (Lenkner also started a litigation finance firm, which he sold to a bigger litigation finance firm, Burford Capital, where he remains a senior adviser.)
  • NPR has a disturbing story about a $595 medical device that some Indiana politicians are apparently very excited about. It’s called The Bridge, and it’s made by Innovative Health Solutions of Versailles, Indiana. It’s a “nerve stimulator” that’s placed behind the ear and, it is claimed, helps relieve opioid withdrawal symptoms. The FDA approved it to relieve pain in 2014 and then approved it again to treat withdrawal last November. But the second approval was based on “a clinical trialthat skirted FDA rules and ethical norms” and involved no placebo controls, the article asserts. One study author failed to disclose a patent application on the device, and the other, a pediatric gastroenterologist, is now an officer of the company selling it, NPR says.
  • Public Citizen and the Baltimore City Health Department are urging the Trump Administration to use a rarely invoked federal power (called “government use authority”) to, in essence, buy out the patents on Narcan and Evzio (naloxone in spray and injectable forms, respectively). That way, generic manufacturers could sell it and bring the price down. The last government official to threaten to use the power was HHS Secretary Tommy Thompson, who did so with respect to ciprofloxacin in 2001, during a post-9/11 anthrax scare. In response, Bayer cut the drug’s price in half, according to Public Citizen.
  • Bloomberg reports on Intel’s attempt to use blockchain technology—a technology that underpins digital currencies, like Bitcoin—to help fight the opioid epidemic. I don’t really understand the concept, but it sounds like Intel wants to create a cross between a national prescription drug monitoring program and the DEA’s ARCOS controlled-substance tracking system. McKesson and Johnson & Johnson are now testing the technology, Bloomberg says.
  • Many publications reported the news that synthetic drugs are now responsible for more overdose deaths than prescription drugs. Although this is a very important fact, I don’t believe it is news. The reports were triggered by a JAMA research letter relying on National Vital Statistics System data that were published by the CDC last December.
  • On Tuesday top drug distributor executives will be grilled before the House Energy & Commerce Committee in an event that promises to create photo ops reminiscent of the 1994 hearing at which tobacco executives swore that nicotine was not addictive. The companies are McKessonAmerisourceBergenCardinal HealthMiami-Luken, and HD Smith.
  • Two Colorado nurses were jailed for stealing fentanyl, morphine, and hydromorphone from three hospitals where they worked, apparently for their own use, per the Denver Post. To hide their thefts of liquid drugs, they would dilute the remaining supply with saline or tap water, endangering patients.
  • According to the New York Post’s Page SixKanye West “Reveal[ed] he became addicted to opioids after liposuction.”
  • Health Affairs Blog has a detailed story about the challenges of treating mothers and babies on Medicaid during the opioid crisis. It says that Medicaid covers half of all births and 80 percent of all Neonatal Abstinence Syndrome babies.
  • NYC Mayor Bill de Blasio wants to set up four safe-injection sites in NYC, according to the New York Times. San Francisco, Philadelphia, and Seattle have all said they, too, want such sites. San Francisco seems closest to implementation, possibly by late summer or fall. Federal law might prohibit these projects under the “crackhouse statute,” which makes it “illegal to own, rent or operate a location for the purpose of unlawfully using a controlled substance.”
  • Pulitzer Prize-winning journalist Eric Eyre, of the Charleston Gazette-Mail, reveals that West Virginia AG Patrick Morrissey’s wife lobbied federal legislators on issues relating to hydrocodone (the opioid present in Vicodin and Lortab) on behalf of Cardinal Health. Cardinal Health had previously denied she had done so, but now acknowledges it was mistaken. When Morrissey won election in 2012 he inherited the previous AG’s suit against Cardinal Health—the biggest drug supplier to West Virginia—but Morrissey recused himself in July 2013 after the the Gazette-Mail revealed that Cardinal Health had paid for his inaugural party.
  • The May/June issue of Foreign Affairs carries a 4,000 word article warning the world to take steps to stop the American epidemic from going global. The article, by Keith Humphreys, Jonathan Caulkins, and Vanda Felbab-Brown, mentions both the aggressive efforts of Purdue Pharma’s affiliate, Mundipharma, to market opioids abroad, and the influx of synthetic opioids from China and elsewhere. The authors believe that the latter influx is causing a “bifurcation in the international drug markets”: “In affluent places where heroin is expensive, including Canada, the United States, and Europe, users might switch to cheaper synthetics. That would leave countries that grow poppies, such as Afghanistan and Myanmar, primarily supplying neighboring countries with high addiction rates, such as China, Iran, Pakistan, and Russia.” The authors discuss the potential geopolitical impacts of these changes.
  • Colombian veterinarian was arraigned in Brooklyn federal court this week, according to the New York Times. He was charged with having tried, 12 years earlier, to smuggle heroin into this country sewed into the folds of skin along the bellies of at least eight puppies. He implanted about a pound of heroin in each dog. Five of the puppies ran away, and three died of infections. slug

 

 

 

 

 

 

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