Articles Posted in Product Safety

alcohol-248x300When topics like booze and health flow together, common sense seems to disappear. So let’s give credit to the context-restoring efforts of Aaron Carroll— a pediatrics faculty member at Indiana University medical school, a health policy researcher, and a writer for the New York Times’ “Upshot” column—and healthnewsreview.org, a health information watch dog site.

Both addressed a “panic” in certain quarters generated by a new caution issued by the American Society of Clinical Oncologists. The respected organization of cancer medical specialists said that even light alcohol consumption can add to drinkers’ cancer risks.

As Carroll summarized the cancer experts warning:

urine-sample-cup-263x300With opioid drugs now the leading cause of death for Americans 50 and younger and killing more than 64,000 people last year, was it inevitable that some shady characters are profiteering off the miseries of those struggling to get off potent painkillers?

And is it predictable that key politicians keep talking big but still haven’t backed up their boasts with the money and means to attack a public health crisis that is claiming more lives than cars or guns and at a faster pace than HIV-AIDS did at the peak of that epidemic?

Americans have plenty cause to be — forgive the vulgar word play — pissed off at the doctors and labs that are raking in profits on urine testing for drugs. This business has exploded but with little or no oversight. As reporters Fred Schulte and Elizabeth Lucas have written:

Marijuana-206x300Let’s give them their just deserts and dispatch them with alacrity. In this week’s hokum alert:

epipen-300x119Big Pharma’s rapacious profit-seeking can seem to hit no bounds, even if it afflicts millions: Just consider what federal and state regulators are mulling about the makers of a popular anti-allergy therapy and those who supply a critical diabetes medication.

The federal Food and Drug Administration has replied to Bloomberg News Service that, so far, in 2017, it has recorded 228 reports of EpiPen or EpiPen Jr. failures, and the failure of EpiPens to deploy correctly has been cited in seven deaths through mid-September.

The agency said it is monitoring closely these “adverse event complaints.” These are unconfirmed reports that do not necessarily tie a product to a harm. But they might constitute sufficient grounds to investigate further and to potentially order product recalls, though, so far, the FDA says it believes patients can keep using EpiPens on the market without worry.

Darkchocolate-300x180Although most of our elders have preached at us from a chapel of common sense, dietary nonsense seems to rain on our heads faster than the autumn leaves.  It ought to go without saying that dark chocolate really isn’t a health food. And, to repeat again something that many pregnant women ought to know already: Getting your placenta commercially prepared after your baby’s born, and eating it isn’t a great idea.

Vox, the online news site, deserves credit for debunking a long campaign by candy makers and Big Sugar to persuade consumers that dark cocoa products somehow are “superfoods” like red wine, blueberries, and avocados.

Special interests, Vox reports, have poured tens of millions of dollars into “nutrition research” that purports to show chocolate’s health benefits. The problem is the science here is less than objective and sound: “Here at Vox, we examined 100 Mars-funded health studies, and found they overwhelmingly drew glowing conclusions about cocoa and chocolate — promoting everything from chocolate’s heart health benefits to cocoa’s ability to fight disease.” The Vox story later points out:

marino-300x169Some powerful political players deserve a big dose of public condemnation for bungling and stalling the nation’s desperately needed war on the epidemic abuse of opioid drugs.

President Trump  can step up for the first of a series of smacks for nominating yet another dubious candidate for one of the nation’s high offices—in this case the “drug czar,” who plays a critical role in the campaign to curb the tens of thousands of deaths now blamed on opioids’ abuse.

Trump had put up for the position Tom Marino, a Pennsylvania Republican congressman (photo above). The president spoke with enthusiasm on his behalf. He did so even after CBS TV’s “60 Minutes” and the Washington Post put out their joint investigation of Marino, showing how the congressman had acted as a Big Pharma tool. Marino arm-twisted the federal Drug Enforcement Agency and congressional colleagues to get a law passed that gutted regulators’ authority to prevent Big Pharma’s wholesale distributors from flooding parts of the country with tens of millions of opioid doses, drugs that caused untold addictions and deaths.

Collinslab-300x300Is Uncle Sam launching a way to speed and improve   cancer treatments so they get to patients sooner—or is Big Pharma about to fleece taxpayers, yet again? The National Institutes of Health should carefully consider its just announced, five-year public-private partnership with a dozen drug makers, the “Partnership for Accelerating Cancer Therapies” or PACT.

Under this agreement, the makers each will pony up $1 million annually or a total of $55 million over the term of the accord. The NIH, in turn, will provide $160 million of its formidable research support.

The aim is to “identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer,” the agency says.

pacemaker-300x186Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents innovative, life changing and lifesaving products from reaching the public. Most of this criticism has been targeted at the federal Food and Drug Administration, which under the Trump Administration, has promised to speed and ease its industry oversight.

But internal watchdogs for the Health and Human Services department have provided a rebuke to the move-faster crowd, detailing the costly cleanup—paid for by taxpayers like you and me— that results from defective medical devices.

The HHS inspector general’s office, in what some patient advocates are calling “a drop in the bucket” of the magnitude of this concern, has found that Medicare paid “at least $1.5 billion over a decade to replace seven types of defective heart devices [that] apparently failed for thousands of patients,” according to a story by Pro Publica, the Pulitzer Prize-winning investigative reporting web site.

ravensLet’s give a hurrah for Maryland health officials — they threw a red flag at a high-tech startup that planned with the Baltimore Ravens football team to serve up a mass genetic screening test at a recent game. The blunt reality is this would have been genetic malarkey.

This incident should serve as a reminder, caveat emptor, to consumers, even in settings of good cheer. It should offer a caution to those who stage big public events, like sports leagues, that health matters and highly personal and confidential medical information isn’t handled well at spectacles.

Shall we also offer a Bronx cheer for Orig3N, a Boston company that offers direct-to-consumer “genetic testing,” and talks on its web site about everything from organ donation to regenerative and personalized medicine as well as its commitment to public service? The company, a new Ravens sponsor, planned a recent promotional Sunday when it would offer its mouth swab tests to 55,000 fans flocking to the contest against the Cleveland Browns.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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