Articles Posted in Product Safety

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.

kaiser-drugs-300x225Big Pharma and medical device makers have mastered the art of crying “Poor me!” complaining without end about the time and costs of getting products to the market and the need for regulators to lighten up. New information, however, undercuts this industry whine—and it reminds that the nation’s watchdogs need, if anything, to be tougher and more vigilant.

Let’s start with new research, published in JAMA Internal Medicine, that calls into question Big Pharma’s long-espoused position that its whopping prices (which the public wants official action on—see graphic) are warranted because a new drug costs upward of $3 billion to research and develop. But based on a scrutiny of public information about expenses to develop 10 new cancer drugs—among the most costly to get to market—researchers found drug makers’ R&D costs were far less — closer to $650 million.

Although independent experts praised the new study, drug makers challenged the cheaper R&D estimates, with backing from Tufts researchers’ who had set the earlier, pricier benchmark. It’s difficult to make apples and oranges comparisons. That’s because Big Pharma wants any tally of its drug development expenses to include its costly failures.

Heroin-Fentanyl-vials-NHSPFL-1600x900-300x169A Missouri  Senator has accused Insys Therapeutics, a major drug maker, of conducting a sneaky campaign to get more pain-wracked cancer patients to use its synthetic and super powerful opioid drug, thus helping to fuel the wildfire spread of increasingly lethal and debilitating prescription pain killers.

Sen. Claire McCaskill and investigators from a Senate committee, as well as federal prosecutors, have painted a harsh picture of how Insys created a special unit to boost sales and use of Subsys, its spray form of the potent painkiller fentanyl.

Through an elaborate ruse—which included carefully crafted scripts and bogus phone numbers—Insys workers contacted prescription benefit management (PBM) firms, making them believe they were patients seeking a required pre-approval for their doctors to prescribe them Subsys.

jjbabypowder-150x150What exactly causes cancer? That may be, recent news reports indicate:

eclipsepm-300x270e2-150x150e1-150x150Did you find the full solar eclipse to be thrilling and energizing? Hope so. And even if not,  you can start planning to see the next one in 2019 in South America and parts of Asia, or in 2024 in eastern Canada, the central U.S., and part of Mexico.

If you got your hands on good, protective optical gear for the Great American Eclipse, such as the special glasses that complied with the ISO 12312-2 safety standards, store it well, and it should be good to go, even a few years from now.

Or you might want to donate them—the global nonprofit Astronomers Without Borders group is putting on a big online push to collect the give-away glasses for youngsters in the developing world for so they safely can watch the next total eclipse in their areas. Smithsonian Magazine says the group in 2013 rounded up, then donated thousands of such specs so youngsters in west and central Africa could watch a celestial event that year.

fish-300x232If you’re an expectant mom trying to diversify your diet and to eat healthier this summer, two federal agencies are offering evidence-based advice about seafood dining: Use a little caution with servings of certain fish like king mackerel, marlin, shark, swordfish, and bigeye tuna that tend to carry higher levels of problematic mercury.

The federal Food and Drug Administration and Environmental Protection Agency have teamed up to revise their safe fish guidelines and to offer these in a handy guide to not only pregnant women but to all parents really.

The agencies say that fish can be a tasty, protein- and nutrient-rich part of Americans’ diets with grown-ups and kids encouraged to eat two to three servings or roughly 8- to 12-ounces-per-week. But fish also carry mercury traces, which “can be harmful to the brain and nervous system if a person is exposed to too much of it over time.”

eclipse-300x235Weather permitting, Washingtonians soon will get a good view of a full eclipse of the sun — not the whole thing but a good chunk. Here’s hoping that all viewers of this much-anticipated astronomical event take due precautions so they don’t damage their eyesight.

Residents around the nation’s capital can expect to see an 81 percent blockage of the sun at the peak of the Aug. 21 eclipse, not the full solar cover or “totality” that millions of Americans are planning and traveling to view in peak spots that fall in a 70-mile wide swath across the country from Oregon to South Carolina.

Be warned: Don’t think just because the sun overhead is mostly blocked that it is safe even then to stare upwards with unprotected eyes. That might leave a careless viewer in the district with crescent-shaped burns on the back of the eyes, says a vision expert and longtime aficionado who says he has seen 19 eclipses.

cig-300x225The nation’s long war on one of its leading preventable killers has taken a surprising tactical turn, as the head of the federal Food and Drug Administration has declared that tobacco companies will face new regulations aimed at slashing nicotine in cigarettes.

FDA Commissioner Scott Gottlieb argues that cutting the noxious and addictive nicotine will help Americans unhook themselves from tobacco use, prompting less cigarette smoking, and, potentially increasing the use of possibly less harmful health vices, like nonburning “e-cigarettes” for vaping.

Gottlieb, at the same time, put further off a planned FDA crackdown on e-cigarette makers, delaying for several years requirements that they disclose ingredients in their colorful, flavored vaping liquids and demonstrate that they and other e-cigarette products do not cause health harms.

ExpiredDrug-300x225Americans each year needlessly toss hundreds of millions of dollars in costly, valuable, and still potent drugs, a wasteful practice driven by a “myth,” the mistaken belief in and scrupulous adherence to already debunked product expiration dates.

Drug discards, including of medications that may be in short supply nationwide, occur all along the distribution chain, from corner druggists up to giant health system pharmacies.

The practice flies in the face of known evidence, much of it developed, verified, and shared by the same force that presses for expired meds to get tossed: Uncle Sam.

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