Articles Posted in Conflicts of Interest

defib-st-judeThe serious, slowly disclosed problems of a manufacturer and its implanted heart defibrillators may offer more needed cautions to Food and Drug Administration critics who want regulators to rush the oversight of drug and medical device makers and make the agency more welcoming to big business.

St. Jude Medical, the New York Times has reported, has received a written rebuke that the FDA has hit the wall with the company and wants it to deal with its product problems. The agency says it is fed up because the company has dawdled for years in letting patients, as well as its senior management and medical advisory board know that it long has experienced major woes with its heart devices batteries.

St. Jude has been forced to issue recall notices on hundreds of thousands of its defibrillators. Hundreds of cases have been reported in which their batteries died unexpectedly. Dozens of patients have suffered “adverse effects,” and at least two deaths have been attributed to device failures.

IMG_1029-300x201At a time when drug costs are skyrocketing and Americans are demanding relief, President Trump’s nominee to be the chief regulator of Big Pharma and medical device makers says he initially must sidestep a lot of oversight of the industry because his deep ties to it might cause conflicts of interest.

Scott Gottlieb made his ethics disclosure as he gets set for congressional vetting of his appointment as head of the federal Food and Drug Administration.

Critics question if Gottlieb, a physician, is too cozy to crack down on excesses in an industry in which he has worked for most of his career and that has paid him millions of dollars. He has pledged to speed up FDA drug and medical device reviews, and to slash the agency’s bureaucracy and red tape.

Tom_Price_official_Transition_portrait-240x300Doctors should hold the prime role in the nation’s medical policy making, Tom Price, the orthopedist who is the Trump Administration’s top health expert, has insisted. But will the U.S. Health and Human Services Secretary heed top experts in his field, writing in some of medicine’s leading journals, that he and GOP partisans lack real evidence for their assault on patients’ rights to seek legal redress when injured by medical care?

Experts from the Stanford University’s medical and law schools have just written in The New England Journal of Medicine that “this an odd time for [Price and] Congress to be considering malpractice reform.” Why? As they noted:

Malpractice environments are currently stable: the incidence of paid claims has shrunk by half in the past decade, indemnity-payment levels have declined or plateaued, and many physicians pay less for liability insurance than they did a decade ago. Price has claimed that defensive medicine is responsible for a quarter of U.S. health care spending — about $650 billion — but the best estimates are closer to $50 billion. So is a push for liability reform at this moment inappropriate? We don’t think so.”

Donald_Trump-1-225x300A GOP assault on American health care has been turned aside, for now. But major questions have been exposed that will need answering if we as a country are ever to come together over health care. Do we recognize that health care—comprising 17.5 percent of the Gross Domestic Product and trillions of dollars in spending annually— has become so costly, complicated, and critical that each of us, at some point in our lives, must have some assistance from all the rest of the collective us?

In short: Do we believe that health care is a right?

All other civilized countries answered that question long ago in the affirmative and have implemented systems that guarantee everyone living within their borders (or even visitors from places like the USA) a basic package of health care.  But we here in the United States still struggle with the world’s most expensive health care system that delivers care to a smaller percentage of its residents than anywhere else and that gets worse outcomes than most other advanced countries.

Foxx-275x300Call it creepy or maybe a too-early April Fool’s joke. What else can be said about a Republican-backed measure, advancing in the House of Representatives, that puts Big Brother in charge— big time —in many workplaces via so-called wellness programs?

It’s called the  “Preserving Employee Wellness Programs Act.” This Orwell-inspired bill,  pushed by North Carolina Republican Congresswoman Virginia Foxx, gives employers scary control over their workers. Employees who participate in job-related health programs can be compelled to undergo genetic tests, and to provide the results to employers, albeit in supposedly anonymized fashion. If they fail to do so, they could face thousands of dollars in fines.

Disclosure of extremely personal, private medical information has been barred by the 2008 Genetic Information Nondiscrimination Act, aka GINA. It arose partly after a 1998 court case, in which clerical and administrative workers were allowed to sue their employer for requiring testing for “highly private and sensitive medical genetic information such as syphilis, sickle cell trait, and pregnancy” without their consent or knowledge during a general employee health exam. GINA has been key in blocking employers from tapping into genetic and other confidential medical information as part of increasingly popular but largely ineffective workplace wellness programs. Because most Americans, more than 155 million of them, get their health insurance at work, many companies have launched and expanded such programs as way to reduce their coverage costs.

PrecisionHealth-300x108It’s a $50-million business with a roster of blue-chip consultants who would be an envied faculty at most any major university. But look closely at the activities of Precision Health Economics because this firm’s esteemed academic economists, for big bucks, are boosting Big Pharma’s efforts to justify some of its sky-high prices for its products to policy-makers, regulators, and lawmakers.

Pro Publica, the Pulitzer Prize-winning online investigative site, deserves credit for raising questions about yet another area in which ordinary Americans may be outgunned by special-interest money. Big Pharma already has earned notoriety for seeking to advance its causes by paying physicians, underwriting patient advocacy groups—and now retaining high-powered economists.

Economists play a key role in providing expert views on drugs, their prices, and markets, all of which are increasingly controversial issues as Americans struggle to afford medications that can cost $1,000 a day or tens of thousands of dollars for treatment regimens lasting for a few months.

http://www.protectpatientsblog.com/wp-content/uploads/sites/69/2016/09/Food_and_Drug_Administration_logo.svg_-300x129.pngTo hear some powerful proponents tell it, Uncle Sam needs to really hurry up the government’s approval of drugs and medical devices. He’s got to make oversight over them easier, lighter, and less complex.

But consider just some of the health news in recent days:

nhlDo the leaders of professional hockey need to spend some time in the penalty box? It might seem so based on a report in the New York Times that the National Hockey League, as it battles its own players in court over the harms caused by repetitive head injuries, is adopting the dubious legal playbook used by pro football, Big Tobacco and Big Sugar.

The $4-billion-a-year NHL, it seems, has taken off its mitts, thrown them on the ice, and is throwing blows to challenge the ever-mounting, evidence-based research that finds that concussions are detrimental to brain health and can lead to the disease known as chronic traumatic encephalopathy or CTE.

The National Football League, after years of CTE denial, including efforts to undercut its medical science and to attack its researchers, conceded that repeated head trauma harmed its players, and pro football settled with them for more than $1 billion.

thomas-price-225Republicans jammed through their health policy guru in the middle of the night, and they and their new HHS Secretary are still trying to figure out what to do with the Affordable Care Act, aka Obamacare. Insurance markets are on the brink of chaos, and the mess is angering increasing number of Americans who may soon see their costs rise, their medical care decline, and their health imperiled.

The president and the speaker of the house continue to be at odds as to the timing of the GOP’s long-promised pledge to repeal and replace Obamacare, with the timeline stretching to the year’s end or beyond before the public gets to see the outlines or details of Republicans’ Trumpcare.

Proposals for ACA ‘repair’

sen-collins-288x300Bill_Cassidy_headshot-237x300Will the partisans who promised and now can’t deliver on a blitzkrieg to repeal and replace the Affordable Care Act, aka Obamacare, end up deeply dividing the country in even more disturbing ways?

GOP leaders, after conceding that they cannot legislate their hoped-for Obamacare replacement until much later this year (reversing their pledge to do so on Day One of the new Administration), huddled in Philadelphia, nervously, to develop strategies and tactics. As they develop “Trumpcare,” they’re confronting growing and significant restiveness about the potential destructiveness of their current course, including the possibility their repeal may cost 43,000 American lives annually.

Meantime, the health care policy proposals that have floated up, including the Patient Freedom Act of 2017 from Republican senators Susan Collins of Maine and Bill Cassidy of Louisiana, raise as many questions as they offer, including:

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