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gabapentin-300x158A widely prescribed drug, formally approved only for limited uses but now dispensed for many nerve-related conditions, can put patients at serious risk of breathing problems, especially if they are aged, suffer from all too common chronic obstructive pulmonary disease, or may also be taking opioid pain killers or other medications that depress the central nervous system.

That’s a toughened new warning about gabapentin and pregabalin from the federal Food and Drug Administration, which says it will require new packaging and cautions for the drugs. They may be better known in their branded versions as Neurontin, Gralise, Horizant (gabapentin) or Lyrica and Lyrica CR (pregabalin).

The nerve meds have been subject to “growing” medical “use as well as misuse and abuse,” the FDA said in a statement, adding:

cpsc-150x150One of the nation’s top consumer protection agencies cozied up to the businesses it was supposed to watch over, leaving children and other consumers vulnerable to significant harms.

That’s the disturbing conclusion of congressional staffers reporting to Maria Cantwell, the ranking Democrat on a U.S. Senate committee with oversight responsibilities for the Consumer Product Safety Commission.

The Democratic staffers ripped the agency, headed by a Republican appointee who has since resigned, for its poor performance with high-profile cases involving Britax’s BOB jogging stroller, Fisher-Price’s Rock ‘n Play inclined sleeper, and the safety of residential elevators.

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Elite researchers — professors and staff with ties to 20 of the nation’s top universities and the respected National Institutes of Health — may be failing to be as candid as institutions and laws require about their potential professional conflicts of interest, notably the significant sums they get from Big Pharma and medical device makers.

ProPublica, the Pulitzer Prize-winning investigative organization, and the Los Angeles Times jointly scrutinized the experts’ required disclosures, finding they not only fall short. They may fail to give the public a fair view of the credibility of their findings. And, in California, they may be a unique rip-off of the state’s top university system. The “UCs” provide research faculty with costly facilities and other support, as well as sharing its global renown — in exchange for revenue the experts may earn outside the system.

In total, after examining records on tens of thousands of university scholars and NIH experts, ProPublica not only has made public its “Dollars for Profs” database, it also quotes federal watchdogs as estimating that with the NIH alone, conflicts of interest with agency grants amounts to $1 billion.

cannabisleaf-281x300Fans of marijuana and its related products may want to take careful note of developments regarding their health and safety effects.

Federal researchers are racing to trace thousands of cases of lung damage and dozens of deaths to so-called smokeless consumption of tetrahydrocannabinol or THC, the ingredient that produces the marijuana high. Other federal officials also are warning about cannabidiol or CBD — a derivative of marijuana or its cousin hemp — and its burgeoning and unapproved use in an array of products on the market.

To be sure, because blue-nose attitudes blocked rigorous research on marijuana and other drugs, medical scientists have been scrupulous in declining to make sweeping declarations about grass and its potential benefits or harms.

shooting-300x201When it comes to key health concerns of the American public, President Trump and his administration have offered evidence anew that whatever they say may not last to the next political moment, that inaction is its own powerful kind of action, and that what officials say they’re doing may be exactly the opposite.

This is not intended as partisan commentary. It reflects the turn of a few news cycles and how Trump and his officials have dealt with:

  • The outbreak of serious lung illnesses and deaths tied to vaping

drugtruvada-300x200When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers:

Expensive brands may not be manufactured by name firms, and instead, may be cranked out in dirty and risky secondary facilities. And the research that leads to expensive products may have been ripped off from federal scientists funded by taxpayers who aren’t getting paid back.

Sydney Lupkin of the independent, nonpartisan Kaiser Health News service deserves credit for expanding public attention on growing concerns over the safety and quality in drug manufacturing beyond generics and on to costly, blue chip branded prescription medications. As she reported of the Federal Food and Drug Administration:

sugarspoon-300x211Grownups shouldn’t be surprised that child obesity is a major and rising concern for 1 in 5 of the nation’s young, putting their short- and long-term health at serious peril: That’s because Big Sugar and major food makers persist in  a costly, relentless barrage on kids and adults for unhealthful products, notably sweet drinks that hook children into hard-to-break habits for a lifetime.

Although pediatricians and nutrition experts keep warning that babies and tots, especially, should get much lower amounts of sugar in various forms in their daily diet, almost “two-thirds of the $2.2 billion in beverages marketed to children contained added sweeteners, according to a report released last week by the Rudd Center for Food Policy & Obesity at the University of Connecticut,” the New York Times reported.

Rudd researchers found that just three food industry titans sprinkled $21 million in advertising for sugary liquids.

breastimplantAngry women, anxious that officials were failing to protect their health, besieged a federal Food and Drug Administration hearing in the spring. That unusual outcry may have helped push regulators off their bureaucratic backsides, getting them finally to warn about risks of one of the most commonly used medical devices for women: breast implants.

But will a similar gender uprising be required to quash a rising and dubious medical testing of women, the so-called “3D mammogram?”

The FDA’s sudden, fast stepping on breast implants is occurring after years of inaction. Under new rules proposed by the agency, the devices’ packaging would be required to carry “boxed warnings,” the FDA’s most serious caution.  The agency also would call on surgeons to step up their discussions with women about implant risks, including for rare cancers. As the Washington Post reported, doctors also would be told to tell patients:

cardformedicare-300x188Americans in coming weeks will make important decisions on the national and personal level about how best to safeguard themselves and their loved ones with a crucial component of the U.S. health care system: their insurance coverage.

Though the exact timing of the open enrollment season varies by geography and plan, it’s that key time for millions who get their coverage via Medicare and may wish to make changes. These are important weeks, too, for many who obtain health insurance under the Affordable Care Act, aka Obamacare. Many workers are hearing a lot from their human resources folks about their employer-provided plans.

It’s clear from the political polling and the sometimes-dreary Democratic presidential debates that there’s huge interest and lots of devil in the details about Americans’ health insurance options.

Risperdal-300x150When regular citizens get together in the civil justice system to deliberate difficult claims about complex matters, they may not get everything just right to the satisfaction of the disputing parties. But jurors’ wisdom and findings should not be taken lightly, especially by Big Pharma.

That’s why Johnson & Johnson — and other drug makers — may want to heed the message in a just-announced $8-billion verdict in a Philadelphia courtroom in a case involving a young Baltimore patient and Risperdal, a prescription antipsychotic medication.

It’s true that the whopping award to Nicholas Murray, now 26, likely will be reduced, probably substantially for J&J, a company that has built its brand on being “family friendly.”

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