Heart Disease Category Archives — DC Medical Malpractice & Patient Safety Blog Published by Washington, D.C. Personal Injury Lawyers

May 6, 2022

A major reversal on long-held view of low-dose aspirin’s heart benefits

Aspirin has gotten its crown knocked askew as a cheap, effective low-dose heart problem preventer for older Americans.

That’s because the U.S. Preventive Services Task Force has weighed the evidence, heard the comments, and recommended against patients 60 and older taking the common drug to avert cardiovascular diseases. The experts gave this purportedly protective step a “D” grade.

The USPSTF is an elite, independent, and influential group of experts who advise the federal government, insurers, and clinicians about the safety and effectiveness of medical tests and procedures based on rigorous consideration of their merits.

March 18, 2022

As ‘synthetic’ nicotine loophole shuts, warnings about cannabis edibles

by Patrick A. Malone

Grownups have gotten stark reminders why they must stay vigilant against buck-raking enterprises that exploit young people’s experimentation with intoxicants. Even as Congress has shut a legal loophole used by the vaping industry to keep addicting its customers to harmful nicotine, other dealers are pushing candy-like marijuana edibles on youths.

In passing a $1.5 trillion bill to keep funding the federal government, lawmakers on Capitol Hill also extended the authority of the federal Food and Drug Administration to regulate not only nicotine from tobacco but also its synthetic varieties.

This was not an esoteric matter of chemistry or pharmacology. It became a flashpoint between regulators anxious to crackdown on harmful vaping and vendors who tweaked their products, so customers could get potent, addictive jolts from nicotine purportedly was made in a lab. This, vendors claimed, put their vaping devices — notably the pen-like “Puff Bar” that surged in popularity among youths — beyond FDA oversight.

January 11, 2022

Poor FDA communication harms patients, taxpayers, other agencies

by Patrick A. Malone

Critics are slamming the federal Food and Drug Administration for dropping the ball in informing the U.S. officials who run the Medicare, Medicaid, and veterans’ health programs about crucial regulatory decisions, leading the federal government apparently to pay hundreds of millions of dollars for patients to get a defective heart device and potentially to pay billions of dollars for a prescription medication targeted at Alzheimer’s but with questionable evidence of its effectiveness.

FDA officials insist that they acted in patients’ best interests when they posted on an agency website, along with thousands of other public communications, a warning letter issued to the maker of the HeartWare Ventricular Assist Device, or HVAD. That missive told the device maker HeartWare — and later its acquiring company Medtronic — that the FDA found serious problems with the HVAD tied to patient injuries and deaths.

The FDA eventually would amass “thousands of reports of suspicious deaths and injuries and more than a dozen high-risk safety alerts from the manufacturer,” ProPublica, the Pulitzer Prize-winning investigative new site found. “One horrifying device failure after another” led HVAD’s maker to halt the manufacture of the supposed life-sustaining heart pump. The firm has agreed to a long-term plan to deal with the calamity of patients who now cannot have the defective device removed.

October 23, 2021

Cut the salt in prepared and packaged food, U.S. urges makers and sellers

by Patrick A. Malone

Americans of all ages adore fast food and prepared meals, but one of the lures is these tasty items are loaded with salt. Now federal regulators have proposed new guidelines that they say could save millions of lives by reducing the salt content of commercially prepared and packaged foods.

The Food and Drug Administration’s standards, directed at food that flies out of restaurants, as well as from grocery freezers and shelves, seeks to get manufacturers, restaurants, and food services to help people cut their sodium intake by 12% in the next 2.5 years.

That may seem like a slight amount, but it could have significant effects, the New York Times reported:

October 19, 2021

Daily low-dose aspirin? Rethink its risks vs. benefits, experts advise

by Patrick A. Malone

Aspirin may not be the easy, cheap, daily wonder drug that doctors once thought it might be: New research has led medical experts to rethink and caution against the low-dose regimen followed by tens of millions of patients in hopes of preventing heart and colon conditions.

Those popping aspirin as a safeguard should talk to their doctors, pronto, about continuing to do so — and they should not suddenly quit, on their own. For the middle-aged and mostly healthy, who once might have been routinely advised to do so, doctors should refrain from recommending they take regular low doses, an elite expert advisory panel says.

The U.S. Preventive Services Task Force (USPSTF), independent and respect advisors on medical tests and protective procedures, says that evidence has built that aspirin’s risks of causing problematic internal bleeding (in the brain and gastric tract) exceeds its benefits in thinning the blood and reducing heart and colon conditions. As the New York Times reported:

September 15, 2021

FDA snuffs out cloud of e-cigarette and vaping products but delays big ruling

by Patrick A. Malone

The federal Food and Drug Administration punted on a scheduled showdown over e-cigarettes, delaying decisions on whether to allow Juul and other market-dominating firms to keep selling trendy “smokeless” devices while also banning millions of vaping products from other, mostly smaller manufacturers.

The agency argued with a defensive and defiant tone that it had acted on 6.5 million filings and 93% of the requests for approval to market e-cigarette and vaping-related products, rejecting most (including millions of flawed applications from a single applicant).

But the FDA said it needed more time — how much it didn’t say — to weigh evidence from big e-cigarette makers who hold sway over 40% of the market. They claim their products’ benefits in helping adults stop smoking tobacco, especially killer cigarettes, outweighs the harms they cause to young people, likely addicting new generations to health-damaging nicotine and opening a gateway to tobacco and marijuana consumption.

August 13, 2021

Risky heart pump shows how FDA fails patients on medical device regulation

by Patrick A. Malone

The federal Food and Drug Administration too often fails to protect patients from defective and dangerous medical devices because it lets manufacturers self-police themselves, cozies up to companies rather than trying to compel safety fixes, and inadequately informs the public and medical community about problem products.

If that sounds like too broad and harsh an indictment of poor performance by a purported watchdog agency, just read the deep dig by ProPublica, the Pulitzer Prize-winning investigative journalism site, into the FDA’s record with the HeartWare Ventricular Assist Device, or HVAD.

ProPublica details the unacceptable actions that put thousands of patients at risk with a heart pump that cost $80,000, required major surgery, and that the FDA knew had significant problems but still allowed highly vulnerable people to have implanted. As reporter Neil Bedi found:

June 16, 2021

Prince George’s County finally gets new hospital to replace 75-year-old facility

by Patrick A. Malone

Poorer communities of color in the region around the nation’s capital are inching toward getting more equitable hospital care — with new facilities slowly coming online to replace decrepit and risky institutions.

Politicians and public leaders in Maryland celebrated a decade-long fight to see the opening in Largo of a new hospital, a “620,000-square-foot, glass-paneled facility [that] will replace the 75-year-old Prince George’s Hospital Center in Cheverly,” the Washington Post reported.

The new University of Maryland Capital Region Medical Center, near the Largo Town Center Metro station, had been stalled for years in political and regulatory battles over its size and funding. It will be part of the University of Maryland Medical System’s network of 13 hospitals, and officials hope it will anchor major development in Largo.

May 5, 2021

U.S. will ban targeted health menace of menthol cigarettes and flavored cigars

by Patrick A. Malone

The Biden Administration will ban menthol cigarettes and flavored cigars with new regulations to be issued within the next year — actions that Big Tobacco is expected to battle but which proponents say could have big health benefits for those who have been targeted to buy and use these products.

Smoking is a leading cause of death in this country, and especially among African Americans, with critics saying cigarette makers have exploited communities of color, the poor, and LGBTQ people with flavorings to popularize damaging goods. As the Washington Post reported of the announced plans of the federal Food and Drug Administration:

“[Its] menthol ban would reduce health disparities between white and black smokers. About 85% of African American smokers use menthol cigarettes, three times the rate of white smokers, and their rate of quitting smoking has not declined as quickly as it has for whites. As a result, black smokers suffer disproportionate rates of disease and death. Similarly … the effort to remove menthol and flavorings from small cigars [is] a way to prevent young people from starting the smoking habit and helping them quit. The small cigars are increasingly popular with young smokers; more high school smokers now use small cigars than cigarettes.”

March 5, 2021

Panicked over prediabetes? For older patients, more evidence to say: Not to worry

by Patrick A. Malone

It’s not an invitation to pile on the ice cream, cake, and candy. But older adults may get to say pshaw to the finger-wagging they may have endured from doctors and loved ones about their raised blood sugar levels and the condition that specialists ginned up to caution them about it: prediabetes.

As the New York Times reported, a newly published study by researchers at Johns Hopkins and elsewhere looked at data over six years on almost 3,500 older patients with elevated blood sugar measurements and found they “were far more likely to have their blood sugar levels return to normal than to progress to diabetes. And they were no more likely to die during the follow-up period than their peers with normal blood sugar.”

This is an important finding, the newspaper reported, quoting Elizabeth Selvin, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health in Baltimore and the senior author on the study: