Even as more felony charges may follow in drug epidemic, sleep med warning suggests pill popping stays too popular

Five top executives at a major drug maker have been convicted of criminal racketeering for their aggressive and deceptive marketing of a fentanyl spray in a case that prosecutors long have said may warn corporate leaders about their culpability in the nation’s opioid painkiller crisis.

Federal jurors deliberated for 15 days before finding guilty John Kapoor, founder and CEO of drug maker Insys (shown at right). Jurors also convicted Richard M. Simon, former Insys national director of sales; Sunrise Lee and Joseph A. Rowan, both former regional sales directors; and Michael J. Gurry, former vice president of managed markets. As the New York Times described the case against them:

During the 10-week trial, federal prosecutors had detailed Insys’s audacious marketing plan — which included paying doctors for sham educational talks and luring others with lap dances — to spur sales of Subsys, an under-the-tongue spray approved to treat patients with cancer. Company executives were accused of paying doctors to write prescriptions for a much wider pool of patients than the drug was approved for, and of misleading insurance companies so they would cover the potent and pricey medication. With the drug’s sales soaring, Insys became a darling of Wall Street, generating annual sales at one point of more than $300 million.

Prosecutors said the Insys convictions may lead them to pursue other criminal actions involving drug makers, firms that stand at the pinnacle of the nation’s prescription drug operations. Andrew E. Lelling, the United States attorney in Massachusetts who pursued the case, told the newspaper: “Just as we would with street-level drug dealers, we will hold pharmaceutical executives responsible for fueling the opioid epidemic by recklessly and illegally distributing these drugs, especially while conspiring to commit racketeering along the way.”

That language echoed what other of his colleagues said when some of them criminally charged the CEO and an executive of the nation’s sixth largest drug distribution firm for inundating areas with painkillers, while others filed cases against scores of doctors for writing excessive prescriptions for opioids for profit and sex.

The threat of criminal cases and hard prison time can only crank up the heat on Big Pharma to resolve an avalanche of civil lawsuits from states, counties, cities, Indian tribes, as well as individuals who claim billions of dollars in injury from powerful and addictive prescription painkillers. Opioids and the illicit drugs that they act as gateways for have caused hundreds of thousands of overdose deaths and may lead to hundreds of thousands more.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the carnage that has been inflicted on them by dangerous drugs, notably meds that took so many down in the long, tragic descent of the current opioid crisis. Justice demands that Big Pharma, doctors, nurses, hospitals, insurers, and many others be held accountable for the nation’s drug plague.

It is worth repeating that President Trump and his administration, as well as Congress and federal health agencies, have not done nearly enough to provide the leadership and resources in the opioids’ war. The president’s premature success claims are unhelpful and send wrong signals about the huge challenges that persist in attacking this drug epidemic.

Pill popping is too easy

We all need to step up to this cause, as another pharma-related matter informs. The federal Food and Drug Administration caught medical specialists off guard by ordering some of the toughest warnings possible to be part of the labels for prescription sleep medications, dubbed “z-class drugs.” They are brand formulations of the generic somniferous drug zolpidem.

Most Americans, especially the more affluent among us who may travel long distances and be under enough stress as to suffer insomnia, know the z drugs as Ambien, Lunesta, and Sonata. The FDA has ordered “black box” labeling on these drugs to warn of their risks, the New York Times reported that:

The drugs’ side effects [include] risky behaviors, such as sleepwalking and sleep driving, that can lead to injury and even death … people using the drugs take [these kinds of] risks without being fully awake. The agency said such reactions were rare but could lead to injuries or death; it advised doctors not to prescribe the drugs to people who have had such side effects in the past.

Specialists told the newspaper they were surprised by the FDA crackdown because the agency has warned for years about the sleep meds’ perils. The FDA said its review of medical literature and reported cases found that patients had experienced but often did not recall their “accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts.”

Still, the lax attitudes about Ambien and pill popping, in general, among a well-heeled crowd — Washington politicos and the White House press corps — surfaced during the doomed attempt by Trump to elevate Ronny Jackson from his role as presidential physician (to both the incumbent and his predecessor, President Obama) to head the giant, complicated Department of Veterans Affairs. Jackson was accused of and criticized harshly for casually and regularly dispensing sleeping pills and a prescription med for wakefulness to Obama administration staff and members of the press corps during grueling overseas trips.

Jackson’s nomination for the VA post wasn’t decided by the “Candy Man” drug claims against him but rather his lack of experience and training for running one of the larger health systems in the nation.  The ho-hum defense of prescription drug use he generated in Washington remains notable still: How can we rid ourselves and our country of not only the opioid crisis but also our problematic propensity to turn too easily and quickly to drugs and pills?

Source: https://www.jdsupra.com/legalnews/big-pharma-executives-convicted-of-84831/