Doctors, Big Pharma and FDA ripped for bungling control of potent painkillers

fentanylA steady flow of news reports shows how our nation’s opioid crisis can be fairly blamed on just about every actor in the medical field that should have known better: Big Pharma, doctors, hospitals, and regulators. It’s been a toxic mix of incompetence, indifference and out-and-out  deceptive conduct that produced the epidemic that now claims tens of thousands of American lives each year.

Take, for instance, the drug fentanyl, a lab-created painkiller 100 times more powerful than morphine. How did it escape the confines of legitimate prescription pain control to become a killer street drug? The Washington Post reports, based on research from Johns Hopkins experts, on how doctors, hospitals, and the federal Food and Drug Administration bungled a plan to safeguard the administration of this highly potent drug that had obvious abuse potential from the day it came onto the market.

Meantime, two other news organizations — the Pulitzer Prize-winning investigative website Pro Publica and the online health site Stat — have pried loose disturbing, sealed court testimony, showing how a wealthy, philanthropic family approved a lethal deceit about the potency of OxyContin, a billion-dollar opioid pushed relentlessly by Purdue, the Big Pharma firm they owned.

Fentanyl mishandled

The Johns Hopkins study, as described by the newspaper, may be notably damning of bad acts by doctors and the FDA with fentanyl, because alarms already were ringing about opioid abuses in 2012 — the year that researchers in Baltimore went back to, scrutinizing thousands of records they obtained through Freedom of Information Act requests.

Doctors and regulators knew fentanyl not only packed a wallop as a pain killer, they also knew they needed to avoid using it with patients already treated with and tolerant of other opioids. Elaborate protocols were set up to head off inappropriate prescribing.

The system failed. “Researchers found that between 34.6 percent and 55.4 percent of patients shouldn’t have received the drugs” but did, the newspaper reported.

Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins University Bloomberg School of Public Health, and one of the leaders of the study, told the Washington Post that, ‘The whole purpose of this [safe] distribution system was to prevent exactly what we found. [The prescribing that occurred] should never happen. It’s a never event. And yet we found it was happening in 50 percent’ of the cases.

Doctors got special training and were supposed to exercise great care in prescribing fentanyl. They didn’t. The FDA knew that safety systems it signed off on weren’t working. Regulators failed to act or react. Big Pharma, which was supposed to assist in monitoring fentanyl prescribing, simply booted out of this role. The researchers found zero cases where drug makers, as they were supposed to, reported or cut off doctors or hospitals for inappropriate fentanyl prescribing.

The newspaper notes that the founder of Insys, a major maker of a form of fentanyl that is supposed to be sprayed under the tongue for cancer pain relief, is now on trial in Boston on racketeering charges. That case has produced jaw-dropping revelations, including the Big Pharma firm’s hiring of a one-time stripper as a sales executive who gave customers lap dances and how Insys created a rap video to motivate its sales staff.

Big Pharma deceit

Meantime, Pro Publica and Stat obtained and published a long-sought, previously sealed copy of sworn testimony from a Kentucky court case showing how  Dr. Richard Sackler, a member of the billionaire family that founded and still controls OxyContin maker Purdue Pharmaceutical, endorsed a fateful deceit about its most lucrative product.

As OxyContin launched, Sackler agreed with company executives that Purdue should let doctors assume this painkiller was less potent than morphine. Sales staff should be encouraged to fuzzy up their in-person pitches on the true strength of OxyContin — more powerful than morphine — because that would make doctors more likely to prescribe it, court records show. (Morphine’s potency was limited then for patients, for example, in end-stage cancer, the Wall Street Journal notes.) Sackler was eager for doctors, too, to disbelieve that the company’s painkiller made patients high or gave them a “buzz.”

The falsehoods were key, the company would later agree in a $600 million federal case it lost, to the wildfire spread of OxyContin. It also was wrongly promoted as a drug that lasted longer, needed to be taken less often, and wasn’t as addictive as it proved  — lethally — to be.

A wave of lawsuits has focused on how Purdue and its controlling family hyped OxyContin, the news organizations reported, adding, “Aggressive marketing of OxyContin is blamed by some analysts for fostering a national crisis that has resulted in 200,000 overdose deaths related to prescription opioids since 1999.”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the wreckage that has been inflicted on them and their loved ones by dangerous drugs, especially opioids. Overdoses of this type of powerful medication, especially fentanyl, and of illicit street drugs like heroin, set tragic records in 2018. This has become a leading cause of death for Americans younger than 55.

Big Pharma, doctors, hospitals, insurers, and others in medicine played unacceptable parts in creating the opioid crisis, and they, along with regulators and lawmakers, must step up in much more robust fashion to stop the mayhem. FDA Commissioner Scott Gottlieb should be questioned about the Johns Hopkins research and held to account for the agency’s lax oversight of fentanyl. As for the Sacklers, they are beginning to see the unwinding of decades of efforts to enshrine their family name through donations to the arts, medicine, and science.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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