fda-300x125Pro-business and anti-consumer  lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed and some even killed already by defective and dangerous medical devices.

The dispute focuses on a provision to triple the time that companies would get to report product issues to the federal Food and Drug, giving medical device makers three months to do so, rather than 30 days as now required. They still must report to the agency immediately any incident in which a patient is harmed.

Although consumer safety advocates are decrying the oversight changes that GOP members of Congress are pressing, medical device makers are downplaying the regulatory shifts, saying they will eliminate needless bureaucracy. They say that if lawmakers don’t approve the rule changes it may sink the broader and crucial legislation they’re embedded in. The House has just approved and sent to the U.S. Senate the bigger FDA bill, which also provides 60 percent of the fee-based funds for agency drug and medical device reviews.

anesthesia-300x153Some of the very medical specialists who are supposed to put patients to sleep experience big problems themselves staying awake, with more than half of anesthetic trainees reporting in a new national survey in Britain that they had crashed their cars or nearly done so while headed home after long night shifts.

American doctors’ social media responses to this new research indicate that work weariness and drowsy driving are perils for practitioners on this side of the Atlantic, too.

The doctors’ complaints also underscores the irrationality of recent decisions by American medical educators to reinstate long shifts for interns and residents, trainees who play important—and sleep-deprived— front-line roles in providing medical services to too many patients in academic medical centers and hospitals nationwide.

Pinocchio_Smoking-300x169Tougher ratings for movies targeting teen-agers and higher cigarette taxes may be two good ways to crack down on Big Tobacco’s persistent and harmful peddling of its poisonous wares, health experts say, based on information flowing from the sprawling Golden State.

The federal Centers for Disease Control and Prevention has just assessed Hollywood’s progress in reducing depictions of tobacco in the movies, finding that, under pressure from anti-smoking campaigns,  Tinsel Town had slashed its showing of the use or implied use of cigarettes, cigars, pipes, hookah, smokeless tobacco products and electronic cigarettes from 2005 to 2010. But that progress has reversed since then, and now, based on top 10 grossing movies in any calendar week, cinematic depictions of tobacco use has soared by 80 percent.

Although pictures rated G or PG, those films most accessible to the broadest movie-going audiences, saw reductions in their showing of smoking and other tobacco use, depictions of these negative health practices rose sharply in movies aimed more at teenagers and older youths  in those works with ratings of PG-13 (by 43 percent) and R (by 90 percent).

opioid-graficAlthough Americans may like to think that it doesn’t or shouldn’t matter as much as it does, where they live can have major effects on their health. Geography isn’t an absolute determinant, but key differences have been discerned in how it affects the prescribing dangerous opioid drugs, cancer death rates, some air pollution harms, and risks of insect-related infections. Let’s look at specifics:

Opioid prescribing dips but data show big regional differences

The federal Centers for Disease Control and Prevention has provided a rare glimmer of good news about the nation’s epidemic of powerful painkiller abuse, finding that the peak of doctors’ opioid drug prescribing appears to have occurred in 2010 and has dropped sharply since.

kessler-203x300Even as congressional Republicans advance their counter-factual campaign to strip patients who have been harmed while seeking medical services of their rights to seek legal redress, another state appeals court has rejected key GOP arguments about medical malpractice lawsuits.

An appellate court in Wisconsin has declared unconstitutional that state’s $750,000 cap on non-economic damages, reinstating a jury’s decision that a Milwaukee woman and her husband should be paid $16.5 million for their pain and suffering after emergency doctors failed to inform her fully about the severity of a strep infection she had and that led to the amputation of her arms and legs.

The jury assessed total damages against the doctors and their insurers of $25.3 million, including $8 million for the medical and other care the 57-year-old mother of four will require for the rest of her life. But the defendants appealed the total, arguing the couple, under Wisconsin law, should get no more than $750,000 for non-economic harms like pain and suffering.

Nursing-home-holding-hands-300x200Federal regulators need to ramp up their oversight of nursing homes, big time, with recent news reports and studies finding persistent abuses of elderly patients, including during crackdowns on problem operators, and facilities failing to care for vulnerable charges so they don’t lapse into emergency or hospital care.

Jordan Rau and the independent Kaiser Health News Service deserve kudos for digging into Uncle Sam’s “special focus status,” in which the nation’s “most dangerous” nursing homes get an ultimatum to correct major and continuing harms to patients or they may lose crucial Medicaid and Medicare funds from the federal government.

Rau found that more than half of the 528 homes deemed since 2014 to require the supposedly stringent “special focus” from regulators and that still are operating have since harmed patients or put them in jeopardy in the last three years.

Just under half of American adults get their news mostly from local television, and this is especially true for the older among us who also happen to be the heaviest users of medical services. But with local TV content hitting new highs for sheer volume—an average of 5.7 hours every day—watchdog groups are expressing a growing concern about the integrity of broadcast health information.

Healthnewsreview.org, an independent, nonprofit group that works on the public’s behalf to improve the depth, quality, and accuracy of health information, has reported with increasing urgency about pay to play, sponsored, and industry influenced and manipulated medical news.

goop-248x300Mocking the vanity, self-absorption, and stupidity of the rich and celebrities may be too feckless a sport. But the tragic spin-offs of the sweeping misinformation their hype mechanisms can generate sometimes just cannot be ignored.

If you can take it, New York magazine has put out a detailed story on “The Wellness Epidemic,” a deep dive into the cult-like affectations of affluent Americans who spend way too much time worrying they might be sick—and dabbling with remedies that might make most readers with an inkling of common sense spit up a little.

Why pay a second’s attention to this hypochondria and Goop, the fantasy empire of wealthy and beautiful Gwyneth Paltrow? Because she’s the actress who’s not only selling millions of dollars in beauty supplies and vitamins and supplements of suspect health value, she’s also sharing with a sadly rapt global audience her nonsensical views on the benefits and necessities of fecal transplants and putting a $66 jade egg into one’s private parts.

dna-208x300Pathologists are the medical specialists whom few patients ever meet, but they play increasingly important roles in treatment decisions. Some new reports raise concerns about systematic errors in the path lab.

The New York Times painted a surprisingly distanced picture of the work of pathologists in a recent report on these medical doctors who are trained to interpret an array of laboratory tests and often microscopic materials to determine the care for complex diseases.

The paper found that the specialists and their labs mislabeled and mixed up patient samples and results, as well as sometimes contaminating them—yes, rarely, but with potentially significant harms. Erroneous results could lead to misdiagnoses, resulting in patients getting wrong or ineffective treatment, especially for cancers, experts say.

overdose-300x225Taken from a most favorable point of view, Big Pharma and doctors tried to address a big physical problem for patients when they pushed ahead in recent years with potent painkillers. But now, it’s those troubled Americans’ mental health woes that  officials may need to deal with to better battle what has become an epidemic of opioid drug abuse.

It’s a crisis that may worsen still and claim as many as 650,000 lives in the next decade, says the online health information site, Stat, which consulted 10 leading experts to develop its forecast.

Stat and other news organizations also have reported on newly published research showing the depths of the mental health challenges of those who abuse opioid drugs, with adults with a mental illness each year receiving more than half of the 115 million opioid prescriptions in the United States.

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