Articles Posted in Product Safety

drughearing-300x172As 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.”

davincirobot-300x176The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and other cancer-related procedures without caution, regulators warn.

The FDA acted after studies have shown that minimally invasive procedures for early-stage cervical cancer, many robot-aided, were more likely than standard, large-incision surgeries to result in recurrences of the disease and deaths.

Regulators also may have been prodded by their poor history in halting harms to women with so-called keyhole procedures, particularly the nightmares the FDA was slow to react to involving minimally invasive hysterectomies and a tissue-grinding tool called a morcellator.

vamps-300x169Funny the mischief that can happen with a little blood and spit. Seemingly unrelated medical stories last week brought home the lesson of the law of unintended consequences. Those consequences abound everywhere, in health care most especially. So with blood, we’re learning about a bizarre new fountain-of-youth treatment, with echoes of vampires, for seniors who ought to know better.   And with spit, we’re learning how seemingly harmless genetic tests can raise from the dead some disturbing revelations about our deceased family members.

Bunk about blood transfusions

The federal Food and Drug Administration has warned older Americans about a new kind of anti-aging bunk flying out of the Silicon Valley: blood transfusions. Companies, dancing on a fine legal line, have hinted that seniors could benefit by getting transfusions of young people’s blood and blood products.

fdachiefgottlieb-300x300Punked, dunked, and owned — if you’re young enough, that’s how you say your team has crushed a competitor. The lingo might well describe, too, the situation for now between e-cigarette maker Juul and Scott Gottlieb, commissioner of the federal Food and Drug Administration.

He has talked tougher and tougher with Juul as part of the FDA’s crackdown on vaping and e-cigarettes, a craze among the young that is eroding decades of efforts by health advocates to reduce Americans exposure to and abuse of nicotine and cancer-causing cigarettes and other tobacco products.

Gottlieb has told Juul officials he may summon them to his offices in the nation’s capital for more scoldings, this after the agency has chased and chastised vendors across the country, including Walgreen’s and Circle K stores, about keeping vaping products, e-cigarettes, and tobacco out of minors’ hands.

noop-300x158Seniors and their friends and companions should consider reality versus magical thinking about the power of pills. The blunt truth: Over-the-counter dietary supplements can’t cure diseases. Not  Alzheimer’s, not cancer, not diabetes, not any known disease. They don’t extend your lifespan either.

Scott Gottlieb, commissioner of the federal Food and Drug Administration, not only has warned a dozen companies to stop making reckless health claims about supplements, he also told Congress his agency needs greater authority to regulate what the New York Times reported has become a “$40 billion industry, which sells as many as 80,000 kinds of powders and pills with little federal scrutiny. These products range from benign substances like vitamin C or fish oil to more risky mineral, herbal and botanical concoctions that can be fatal.”

Gottlieb told the newspaper that regulators have been reluctant to rein in the wildfire spread of supplements and their wilder claims. But the public health is at such risk now that Congress must step in.

brady-281x300If you’re such a die-hard fan you slogged through that pro football championship that was perfect for the new Year of the Boar, please don’t be so sheepish in your celebrity adoration as to get gulled by quarterback Tom Brady’s health and diet bunk.

His oddball theories well might go into a flaming dumpster, along with  notions about special drinks and excess hydration, and yet more broadcast goop from that princess of health woo, Gwyneth Paltrow.

Sure, Brady’s Superbowl LIII win may have made him the goat (greatest of all time) in National Football League history with six rings. He got there, and may stay there, not only with rare individual gifts, hard work, and special talents, but also with peculiar practices, as Vox, an online news site reported:

hospitalprices-300x162Patients and reformers attacking skyrocketing health care costs may want to focus less on doctors and more on big, shiny hospitals, where in just five years prices soared by 42 percent for inpatient care versus the still sizable 18 percent price hikes that MDs scored.

Those findings are part of a new study that examined medical costs based on actual payments, focusing on common procedures like deliveries of babies (vaginal and cesarean), colonoscopies, and knee replacements.  “Hospital prices grew much faster than physician prices for inpatient and outpatient hospital-based care in the period 2007–14 … The same pattern was present for all four of our procedures,” wrote the researchers from Yale, MIT, and Carnegie Mellon. They found that hospital costs also spiked for outpatient care, increasing 25 percent, versus 6 percent for doctors.

This meant that for a knee replacement costing $30,000 or so, the doctors’ mean price was almost $4,900, while the hospital price was almost $25,000. For a $13,000 C-section, the doctor’s mean price was $4,600, while the figure for hospitals was $8,300. These numbers were derived from analyzing hundreds of thousands of procedures.

HepatitisCInvestigators have teased out yet another damaging thread in the villainous web of harms of the opioid crisis. A spike in hepatitis C infections is a costly, long-term, and major health consequence of the hype and disastrous reformulation of OxyContin, the powerful painkiller made by Purdue Pharmaceuticals owned by the wealthy Sackler family.

Purdue, in the 1990s, promoted and sold OxyContin to doctors and hospitals in a relentless campaign that stressed how this drug was supposedly safer and longer acting, releasing its potent effects over as long as a 12-hour span instead of requiring many pills that needed to be taken more often.

Although those claims of the drug’s benefits were dubious to start, patients — especially those abusing the highly addictive prescription medication — found they could get around OxyContin’s delayed release, getting an immediate jolt or walloping high, by crushing their pills. They then snorted Oxy as a powder or mixed it with a liquid and injected it.

puffdad-265x300The federal Food and Drug Administration failed to protect the nation’s young against Big Tobacco’s harms with slow-poke responses to the rise of e-cigarettes, as well as tardy regulation of flavorings for combustible cigarettes and liquids used in “smokeless” vaping, health advocates say.

The American Lung Association, in its annual “State of Tobacco Control” report, ripped FDA Commissioner Scott Gottlieb and his agency for postponing oversight of e-cigarettes and vaping — a hard-won crackdown approved in the Obama Administration — to further study the harms of the devices and practices.

While the agency dawdled, e-cigarette makers, notably the firm behind the small Juul device, stormed the youth market, luring American teens to a raging, e-cigarette fad. Many became addicted to vaping and harmful nicotine, as a result. As the lung association describes it:

cbpbust-300x200If  anyone around doubts still the threat that the opioid crisis poses to the nation, a drug bust involving a vegetable truck in Arizona should provide powerful persuasion: Federal agents, suspicious about the vehicle’s floor, loosed a drug-sniffing dog, resulting in the seizure of not just 395 pounds of methamphetamines but also 254 pounds of fentanyl.

Fentanyl is a synthetic opioid, a lab-created super drug that experts say is 50 times stronger than heroin and up to 100 times more potent than morphine. It packs a wallop for users in tiny grains or flecks.

The record-setting seizure at the Arizona border stop amounted to 144 or so kilograms of fentanyl, with drug enforcement officials estimating that just 1 kilogram of fentanyl can produce 1 million fatal doses. That means just this one bust had the potential to cause 144 million deaths.

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