Addiction

June 16, 2019

For Insys, infamy in two opioid crisis firsts: convicted founder and bankruptcy

Insys Therapeutics, a drug maker that peddled powerful and addictive painkillers in sordid ways, entered yet another phase of its penalties for its criminal conduct: The firm in quick fashion agreed first to pay $225 million to resolve federal bribery charges, then promptly sought bankruptcy protection.

Federal prosecutors, who earlier had won criminal racketeering convictions against the firm’s CEO and other Insys executives, emphasized that the Big Pharma firm hasn’t declared itself insolvent in its bankruptcy action and will pay up for damages caused by Susbsys, its chief product.

Subsys is a liquid containing the super potent painkiller fentanyl. It is administered as a drop under the tongue and was supposed to benefit cancer patients with grueling pain. Instead, Insys CEO John Kapoor “used speaker’s fees and lap dances to lure doctors into prescribing Subsys for far more patients than the drug was approved for and cheated insurers into covering prescriptions for the costly medication,” the Washington Post reported. Kapoor and other Insys execs await sentencing after their federal felony convictions.

May 14, 2019

Hundreds of moms die of preventable pregnancy-related complications

by Patrick A. Malone

Hundreds of mothers die of preventable pregnancy-related complications up to a year after delivering their babies, with black and native women experiencing notably high maternal morality risks.

The needless deaths of around 700 women nationwide each year due to cardiovascular conditions, infections, hemorrhages and other complications related to their pregnancies underscores the importance of improving maternal care, especially in increasing its access and quality, the federal Centers for Disease Control reported in a new study.

The Washington Post quoted Anne Schuchat, the CDC’s principal deputy director, commenting on the agency data:

May 13, 2019

Wave of hip implant, opioid, talc suits tarnish a famed ‘family’ brand

by Patrick A. Malone

If consumers ever considered Johnson and Johnson just to be a family friendly health brand, the conglomerate’s legal challenges on three fronts—with problematic medical devices and drugs—may disabuse them of warm and fuzzy views.

As Bloomberg News Service reported, J&J will pay $1 billion to try to extricate itself from 95% of 6,000 lawsuits against it over defective metal-on-metal hip implants that not only caused patients great pain but also had to be surgically removed and replaced. The company still must resolve thousands of suits with patients who haven’t had replacement operations or whose implants were only partially metal.

J&J has battled over its Pinnacle implant from its DePuy unit for at least four years, losing sizable cases in Texas to patients who convinced judges and juries that the medical device maker had misled them about their artificial hips’ durability and risks, including assertions that it caused metal poisoning.

May 8, 2019

Big Pharma executives convicted of criminal racketeering with opioid sales

by Patrick A. Malone

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:

May 7, 2019

Did FDA just let Big Tobacco put another burn on Americans’ health?

by Patrick A. Malone

Federal regulators appear to be getting caught flat-footed yet again as Big Tobacco’s harms metastasize before their very eyes. The federal Food and Drug Administration has given a qualified go-ahead to Philip Morris International to sell a device that heats but does not burn tobacco, a process that appears to expose users to fewer harmful toxins.

Still, the iQOS gadget packs the same wallop of highly addictive nicotine as does a standard, tobacco-burning cigarette. And the FDA decided it would be regulated just as cigarettes are, thereby restricting its sales and marketing to young people.

Big Tobacco executives talked up iQOS (eye-kos) as yet another way for smokers of their proven and deadly burned tobacco cigarettes to get unhooked from them and to lessen their health harms.

March 17, 2019

A lesson on vaping from sugary drinks of yore: Crack down on Big Tobacco

by Patrick A. Malone

Those who are senior enough to remember the allures of sweet drinks like Tang, Hawaiian Punch, and Kool-Aid also may need to be sage enough to share a deep, evidence-based distrust and disapproval for the nefarious actions of Big Sugar and Big Tobacco. Those suspicions may need to be renewed in regulators’ crackdowns on vaping, its flavorings, and flavored tobacco cigarettes.

Yes, the federal Food and Drug Administration now has formally detailed its plan to curb the soaring youthful purchases and uses of e-cigarettes for vaping, telling merchants that they soon will be required to keep these goods, including flavored liquids that the devices catalyze, in separate walled off areas of stores and away from those age 18 and younger. This will affect not only big retailers like Walgreens and Wal-Marts but also gas stations and convenience stores.

Online vendors soon will be required to have mechanisms, so proof of age becomes part of cyber buys of e-cigarettes and their associated products.

March 11, 2019

With FDA chief gone, doubts rise on battles on nicotine, opioids, drug costs

by Patrick A. Malone

The Trump Administration has lost yet another top health official: So, what happens now with key policies pushed by Scott Gottlieb, the departing federal Food and Drug Administration commissioner, to battle teen nicotine abuse, cut skyrocketing drug costs, and attack the opioid crisis?

Administration officials insist Gottlieb wasn’t ousted, and the physician and onetime Big Pharma insider said he resigned from his post after a year on the job because he wanted to spend more time with his family (they hadn’t moved from Connecticut to join him in the nation’s capital).

Though Gottlieb received mixed or favorable media coverage as he leaves, his effect on the nation’s health is as cloudy as many high school vaping spots.

March 8, 2019

Catching up on your sleep this weekend? It doesn’t work, researchers find

by Patrick A. Malone

Americans may put off to the weekend catching up on sports scores, store sales, the latest news and more. But there’s a health essential that new research suggests cannot be put off for the weekend: a good night’s sleep.

The study, conducted at the University of Colorado and published in the science journal “Current Biology,” focused on a small group: three dozen healthy adults, split into three groups, with one allowed to sleep nine hours nightly, another getting just five hours of slumber, and a third with a staggered schedule. The last group, for five days, got five hours of sleep, followed by two days in which they could snooze for as long as they wished. They had to return, though, to the five-day cycle of five-hour slumbers.

Researchers followed their subjects for nine-day spans. The results will be un-welcome for proponents of weekend catch-up sleep, because it didn’t help in the ways that many of us would wish. As the Washington Post reported, those “who were limited to five hours of sleep on weekdays gained nearly three pounds over two weeks and experienced metabolic disruption that would increase their risk for diabetes over the long term. While weekend recovery sleep had some benefits after a single week of insufficient sleep, those gains were wiped out when people plunged right back into their same sleep-deprived schedule the next Monday.”

March 5, 2019

For soaring drug costs and overdoses, officials offer blame and shame

by Patrick A. Malone

As tens of thousands of Americans die from overdoses and many millions struggle with skyrocketing prescription medication costs, lawmakers and regulators in the nation’s capital plodded along with procedural steps they claimed would help attack what voters insist are some of their top public policy priorities.

On Capitol Hill, seven of Big Pharma’s top executives danced and dodged with members of a U.S. Senate Committee about who is to blame for the relentless rise and unaffordable cost of American drugs. Media reports of the Senate Finance hearing called it “political theater,” and it offered lawmakers a chance to vent at execs from AbbVie, AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, Merck, Pfizer, and Sanofi.

Sen. Ron Wyden, the senior Democrat on the committee from Oregon (shown above), blasted Big Pharma, telling the stone-faced corporate suits arrayed before him, “You’re willing to sit by and hose the American consumer while giving price breaks to consumers overseas,” the New York Times reported. He added that Big Pharma attempts to justify its prices, when so many patients cannot afford them, are “morally repugnant.” Sen. Bill Cassidy (R-La.) decried sky-high U.S. drug prices, especially compared with lower rates for patients elsewhere, saying, “It is almost as if the taxpayer has ‘stupid’ written on their face.”

February 26, 2019

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

by Patrick A. Malone

A 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.