Heart Disease

June 3, 2019

As doctors warned UNC about heart surgery program, kids kept dying

Although big hospitals may love to pat themselves on the back and boost their profits and professional standings by claiming to offer “comprehensive” services, children may suffer and die due to the reality versus the hubris of institutions’ excessive initiatives with specialized care.

Officials at the University of North Carolina blew past anguished warnings from their own pediatric cardiology staff of significant problems in the pediatric heart surgery program at the medical center’s children’s hospital, the New York Times reported. Brushing aside their concerns about a lack of resources within and to support the program, UNC declined to make public, as most similar specialty efforts do, key performance measures. They would show that the UNC pediatric heart surgery program had a higher death rate than “nearly all 82 institutions that do publicly report” this and other measures of patient care.

The newspaper, in a rare move, has internal tape recordings of doctors disputing among themselves whether dwindling resources, staff departures, and other problems meant that UNC should do what many of the specialists demanded — take a long hard look at what was going wrong, and, in the meantime, refer sick kids to other institutions to safeguard their care.

May 31, 2019

FDA’s dubious oversight of heart devices: hidden complaints and shaky tests

by Patrick A. Malone

Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the greatest risk. With certain heart pumps and defibrillator units, both implanted in patients, the Federal Food and Drug Administration deserves criticism for putting the interests of device makers ahead of patients, excellent stories by the Kaiser Health News Service and Axios show.

KHN reporter Christina Jewett followed up her investigation into how FDA bureaucrats let device makers file 1.1 million reports of injuries or malfunctions with their products to a little-known internal agency database, discovering how this practice contributed to what one cardiologist described as “the worst cardiac device problem” he has seen in a quarter-century of practice.

The incidents involved the Sprint Fidelis, a small device surgically installed in hundreds of thousands of patients to monitor and supposedly to administer small shocks to deal with their irregular heartbeat. Instead, the device — especially due to problems with its corroding and cracking electrical leads — gave patients random jolts, failed to perform in genuine emergencies, and led to a torrent of complaints and deaths. Doctors, medical researchers, and patients forced into wide public view the substantial defects of the defibrillator, including in congressional hearings.

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 29, 2019

Doctors retreat on low-dose aspirin advice, underscoring that one size seldom fits all

by Patrick A. Malone

After persuading as many as 7 in 10 American adults to take a daily low dose of a common painkiller to protect against heart disease and cancer, experts now say it is time for more nuanced advice on who should and who shouldn’t take the daily baby aspirin regimen.

Recent studies have shown that the believed protective benefits of low-dose aspirin need to be balanced against the risks of bleeding caused by the drug, the American Heart Association and the American College of Cardiology have declared.

Here is who should NOT go on low-dose daily aspirin:

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 15, 2019

In celebrity death and diagnosis, cautions for all on stroke and cancer

by Patrick A. Malone

For Americans of a certain age, the power of celebrity and sad news — the early death of acting heart-throb Luke Perry and the announced Stage 4 cancer diagnosis of game show host Alex Trebek — may offer important health warnings about two leading causes of death: strokes and cancer.

Strokes kill 140,000 Americans each year—that’s 1 out of every 20 deaths, the federal Centers for Disease Control and Prevention reports. The agency says, “Someone in the United States has a stroke every 40 seconds. Every 4 minutes, someone dies of stroke. Every year, more than 795,000 people in the United States have a stroke. About 610,000 of these are first or new strokes.”

The condition mostly affects those 65 and older, but strokes can occur in younger people, with the New York Times reporting that “seven in one million Americans under age 50 die annually from strokes caused by a blocked blood vessel, and nine per million die from a brain hemorrhage, the two main types of strokes.”

February 22, 2019

When Juul won ‘nicotine arms race,’ did it ace out FDA regulatory threats, too?

by Patrick A. Malone

Punked, 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.

February 14, 2019

Putting a little ‘heart’ into public investments in health really can pay off

by Patrick A. Malone

Take heart, Americans. Taking care of ourselves makes a difference, making us healthier — and saving us money. New research supports policies for spending on the wellness of the elderly, improving heart care, and how smart interventions can reduce rising overall health costs.

This evidence-based approach to figuring the government’s optimal role in individuals’ health also may provide a rebuke of sorts to the way that partisans are imposing draconian new rules to curtail medical assistance for the working poor, poor, aged, and chronically ill Americans.

The rare good news about the nation’s health care costs traces to investigators’ efforts to determine why, in contrast to expectations that spending would leap, Americans’ $3.5 trillion annual medical expenditures increased only slightly. They drilled down, focusing on an area where the “sharpest slowdown” occurred in their research period, 1999-2012: Medicare, a federal program that now enrolls roughly 15 percent of the U.S. population, with beneficiaries 65 and older.

February 8, 2019

FDA ripped for failures on e-cigarettes and flavors for vaping and smoking

by Patrick A. Malone

The 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:

November 16, 2018

FDA to play yet more catch-up to crack down on e-cigarettes and flavorings

by Patrick A. Malone

Uncle Sam will rip a page from Big Tobacco’s marketing playbook, targeting the taste and buying-ease of nicotine-containing products with tough new restrictions aimed at better protecting kids. Will these latest steps, however, snuff out the increasingly risky youth vaping craze and long problematic menthol cigarettes and cigars? Or are officials too late and being more helpful than not to tobacco interests?

The Washington Post first reported the outlines of plans by the federal Food and Drug Administration to crack on the hot youth trend of using e-cigarettes by barring sales at gas stations and convenience stores like 7-Eleven of certain flavored liquids and devices used in vaping.

But the FDA, in its formal policy announcement, retreated from that tough stance. Instead, the agency says it will require gas stations and convenience stores to require age verification and keep specified products away from the under-aged. It is unclear if this means vendors simply can stash these items under the counters, or if they must be kept in separate adults-only areas.