Poison

September 16, 2018

Is FDA’s new crackdown on e-cigarettes too little, too late?

Has one of the nation’s top health watchdogs awoken too late, barked too little, and, maybe won’t bite enough as Big Tobacco and its allies have addicted a generation of young people to nicotine?

Scott Gottlieb, commissioner of the federal Food and Drug Administration, captured extensive media attention by hitting the alarm button about “epidemic” vaping and teens’ use of e-cigarettes, notably the wildly trendy Juul device and others of its kind.

He said the FDA has acted against 1,300 retailers for peddling e-cigarettes and their liquid flavorings to underage customers. More key: The agency has told Juul and other leading makers that they have 60 days to show how they can keep their products out of the hands of customers 18 and younger — or the FDA may ban them from the market.

January 3, 2018

FDA caught dawdling in key duty of getting contaminated foods off shelves

by Patrick A. Malone

Watchdogs have caught the Federal Food and Drug Administration dogging one of its most basic and important tasks — getting contaminated and potentially dangerous foods off the shelves quickly.

Federal inspectors spot-checked several dozen recalls among 1,557 the agency conducted between 2012 and 2015, partly to see how the FDA used wider powers given to it under the Obama Administration to protect American consumers from food-borne illness.

The agency dawdled for weeks and even months, adding to delays that might increase the risks of harms to the public, said investigators under the inspector general of the Department of Health and Human Services. As the New York Times reported:

December 29, 2017

As opioid crisis worsens, fentanyl is killing African Americans in DC & Baltimore

by Patrick A. Malone

2017 ends with yet more grim news about the nation’s opioid drug epidemic — not only that its toll keeps rising, it now is afflicting African Americans as never before. They had been less harmed by this crisis but the scourge is spreading to them, notably in spots like the District of Columbia and Baltimore.

Reporters for the New York Times’ “Upshot” feature dove into new data from the federal Centers for Disease Control and Prevention on opioid drug-related deaths. They found the official numbers not only reaffirmed a sharp increase in drug fatalities in 2016 but also showed that “the drug death rate is rising most steeply among blacks, with those between the ages of 45 and 64 among the hardest hit.” As the newspaper reported:

Drug deaths among blacks in urban counties rose by 41 percent in 2016, far outpacing any other racial or ethnic group. In those same counties, the drug death rate among whites rose by 19 percent. The [new CDC] data … suggests that the common perception of the epidemic as an almost entirely white problem rooted in over-prescription of painkillers is no longer accurate, as fentanyl, often stealthily, invades broader swaths of the country and its population.

September 6, 2016

FDA warns against prescribing of opioids with anti-anxiety pills

by Patrick A. Malone

The federal government has issued one of its toughest warnings against the dual prescribing and use of opioid painkillers like oxycodone and hydrocodone with benzodiazepines. Benzos are muscle relaxants and anti-anxiety meds more commonly known by brand names like Valium and Xanax.

The Food and Drug Administration said tandem prescriptions of these medications soared 41 percent between 2002 and 2014, meaning more than 2.5 million patients taking the powerful painkillers also received doctors’ orders for benzodiazepines.

“The rate of emergency department visits involving non-medical use of both drug classes increased significantly,” the FDA said, “with overdose deaths (from taking prescribed or greater than prescribed doses) involving both drug classes nearly tripling during that period.”

September 21, 2015

Tylenol’s Dangers Are Back in the News

by Patrick A. Malone

This is an old story, but a new one too. Tylenol and store-brand versions of acetaminophen (Tylenol’s active ingredient) are the leading cause of acute liver failure, leading to death or transplant, in the United States. That’s been known for a decade, thanks to pioneering work by Dr. William Lee of University of Texas-Southwestern Medical Center. The question is what to do about it, and that’s the new/old story.

Six years ago, an FDA advisory panel recommended that Extra Strength Tylenol (500 mg per pill) should lose its over-the-counter (OTC) status and be available only by prescription. That’s because of Tylenol’s narrow margin of safety. OTC drugs are supposed to be so safe that you can swallow a little more than the recommended dose and not worry about it. Not so with acetaminophen.

Twenty years ago, when I brought a lawsuit for a client of mine who lost his liver to ordinary doses of Tylenol — two tablets of Extra Strength Tylenol four times a day for several days, or four grams a day, the then recommended maximum daily dose — the McNeil Consumer Product subdivision of Johnson & Johnson fought our case hard. Impossible, McNeil said of our client’s injury. Four grams a day is absolutely safe, the company contended. (Our victory in that case was a bitter pill for plaintiff Tony Benedi, as the Washington Post reported back then.)

September 16, 2015

FDA Warns Companies About Powdered Caffeine

by Patrick A. Malone

We Americans love our energy-boosting drinks, never mind that so many have been shown to pose threats of heart disease, high blood pressure and other problems for some people. The newest form of caffeine-infusion is a powder that the FDA has determined is potentially harmful enough to issue a warning.

The feds sent the letter alert to five producers of pure powdered caffeine, which packs more of a punch than people should absorb. As reported by the New York Times, a teaspoon of caffeine powder equals about 28 cups of coffee; a tablespoon can be lethal. One 100-gram package (about 3.5 ounces) can supply as much caffeine as 400 “tall” cups of Starbucks coffee, 1,250 cans of Red Bull or 3,000 cans of Coke.

“Last year,” according to The Times, “two otherwise healthy young men died after using too much, prompting the agency to warn of the potential dangers.”

July 22, 2015

Doctor Who Defrauded and Disabled Is Sentenced to Prison

by Patrick A. Malone

In a particularly offensive and harmful misuse of professional authority, a doctor in Detroit was sentenced earlier this month to 45 years in prison for defrauding insurance companies of millions of dollars and poisoning hundreds of patients with chemotherapy treatments when they didn’t even have cancer.

Those weren’t the only crimes committed by Dr. Farid Fata, whose sordid tale was recounted by the Detroit Free Press last week. Rather than helping terminal patients die peacefully, he ordered unnecessary treatments that prolonged their suffering. And rather than treating true cancer patients properly, he withheld appropriate treatments if he made more money doing that than by addressing their need.

He was arrested two years ago and last year he pleaded guilty to fraud, money laundering and conspiracy to pay and receive kickbacks. His federal prison sentence reflects the violation of more than 550 patients’ trust and a more than $17 million haul from fraudulent billings. Federal prosecutors said it was the most egregious case of medical fraud they had ever seen.

July 16, 2015

FDA Expresses E-Cigarette Concerns for Kids

by Patrick A. Malone

The popularity of electronic cigarettes has grown a lot faster than the body of science about their potential health effects. But the toxicity of nicotine is well known, and the FDA is raising concern about how e-cigarette nicotine could affect children.

The agency has put the e-cig industry on notice that it plans to require nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing electronic cigarette liquid products.

The feds also are considering the same alerts for a range of nonsmokable tobacco products, including dissolvables, lotions, gels and drinks.

July 6, 2015

MRI Contrast Drugs Might Harm Your Brain

by Patrick A. Malone

Magnetic resonance imaging (MRI) is a body scan that provides detailed images particularly good for viewing soft tissue (versus a traditional X-ray that’s better for seeing bone). Sometimes, drugs are injected before you have an MRI to add contrast, making the images sharper. But some of the drugs in those agents might be toxic.

We recently wrote about another risk of certain diagnostic scans including MRIs, when people are not told about the risks of radiation. Now, according to ProPublica.org, it seems as though the brain can be damaged by a heavy metal the contrast drugs contain called gadolinium.

Marcie Jacobs, a woman profiled in the story, had a family history of breast cancer. In 2001, she decided to have an MRI for preventive care. She was injected with a contrast agent, and later began experiencing strange cognitive effects. At first they were fairly minor, like forgetting about work meetings.

October 8, 2014

FDA Wants to Revise Food Safety Regulations

by Patrick A. Malone

The Food Safety Modernization Act (FSMA) was passed in 2011, but it has yet to be fully enacted. And as of last month, the FDA announced plans to revise rules for its implementation after getting complaints by the agricultural industry that the food safety rules proposed earlier this year are too harsh.

The FSMA was devised to improve the safety of the U.S. food supply and to prevent such outbreaks of food-borne illness as we’ve seen in recent years attributed to peanut butter, cantaloupes and spinach. The revisions to the act, according to the FDA are a response to thousands of comments and feedback from public meetings where farmers and food-industry experts were well-represented.

As explained by AboutLawsuits.com, the FDA proposed the rules in May, primarily for four key areas: produce safety, preventive controls for human food, preventive controls for animal food, and foreign supplier verification. The FDA is the agency that defines the regulations that put the law into effect.