Conflicts of Interest

December 12, 2019

Top experts, by failing to disclose conflicts of interest, shortchange taxpayers

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.

December 8, 2019

Investigations rip FDA for laxity on asbestos-tainted talc and medical devices

by Patrick A. Malone

When it comes to medical products — devices put in or substances put on our bodies — consumers may be ill-served by the federal regulators who are supposed to protect them from injury.

The federal Food and Drug Administration has taken a double hit in recent news reports, with an investigation by Reuters news service raising big doubts about the agency’s oversight of products with supposedly safe talc — but that long may have been tainted with disease-causing asbestos. The Kaiser Health News service, meantime, has followed up on the wave of lawsuits and research that has resulted from its discovery that the FDA for years allowed device makers to hide from public view a million complaints about medical devices.

The scathing findings in these two reports, combined with other deep digs into agency work, might well prompt members of Congress to conduct hearings into whether the FDA is acting as the watchdog that the public deserves or as a lap kitten beholden to the rich, powerful, and booming medical device industry.

November 26, 2019

Ignore doctors’ malpractice claims history? The U.S. did. 66 patients died. It cost $55 million.

by Patrick A. Malone

Although doctors, hospitals, and insurers may howl about the professional harms they claim to suffer due to medical malpractice lawsuits, research studies show that it’s just a tiny slice of MDs who lose in court and must pay up for injuring patients. Further, the data show that the problem few doctors don’t rack up one, but two or three malpractice losses before they even start to see their work curtailed.

Common sense would suggest that if judges and juries find doctors’ conduct egregious enough to slap “frequent flyers” with multiple losing malpractice verdicts, these MDs might best be parted of the privilege of treating patients. Not only doesn’t that occur often enough, a Wall Street Journal investigation has shown the terrible consequences that can result for patients and taxpayers alike when it doesn’t.

The federal government, the newspaper reported, long has struggled to provide promised care through the Indian Health Service (IHS) to those who live on rugged, spare, and sprawling reservation lands. This obligation to provide such medical services is embedded in the Constitution and old treaties. But if it’s tough to get doctors to practice in rural America — where the hours may be extra long and the pay decidedly lower than cities — it had become a nightmare for the IHS to fill its many vacancies.

November 24, 2019

On vaping, gun violence, and health insurance, the big talk flows, but action, not so much

by Patrick A. Malone

When 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

October 15, 2019

In U.S. health care, experts assail $1 trillion-plus in waste, fraud and abuse

by Patrick A. Malone

Politicians almost by reflex decry the skyrocketing cost of U.S. health care by blaming much of it on waste, fraud, abuse. They, alas, really may be on to something, newly published research shows.

Health care experts, including a medical leader of health insurer Humana, “combed through 54 studies and reports published since 2012 that estimated the waste or savings from changes in practice and policy,” leading them to some jaw-dropping calculations about how well spent is the $3.5 trillion or so that Americans drop on health care, the New York Times reported.

Answer: Really badly. The researchers, in their published work, estimated that 20%-25% of American health care spending is wasteful. That turns into giant sums, fast, as the newspaper reported, including:

October 1, 2019

Health care plagued by cases of a persistent pathology — unmitigated gall

by Patrick A. Malone

There seems to be a never-ending outbreak of a certain kind of pathology in the United States. Big Pharma has it and spreads it around, a lot. So, too, do public health figures. Let’s call this scourge what it is — unmitigated gall.

The problem with this nasty condition is that it afflicts the rest of us. Just consider how stomach-churning these shenanigans can be:

Penalties for bogus prescribing of ‘little red pills’ on elderly dementia patients

September 22, 2019

It’s a season to get ripe view of money-grasping Big Pharma and plutocrats

by Patrick A. Malone

For those who get a rise out of following the plight of plundering plutocrats, forget about pop culture shows like Succession, Dynasty, or Empire. Instead, it may be worth peeking in on the true-life Sackler family saga. It also underscores the truth of this idea: Never get between Big Pharma and a buck.

The Sackler story, turning on the fate of the family’s Purdue pharmaceutical firm and a fortune estimated at $13 billion, has been ripe with recent developments, including a potential settlement of thousands of claims by states, counties, cities, Indian tribes, and others — all claiming billions of dollars in damages due to the maker’s aggressive and less than accurate sales and marketing of its prescription painkiller OxyContin.

With a federal judge in Ohio consolidating and pushing a “global resolution” of a giant number of opioid-related lawsuits, Purdue and the Sacklers announced a tentative settlement of many of the governments-filed claims. Roughly half the plaintiffs were eager to get what money they could — to not only help constituents staggered by damages due to opioids, overdoses, and addictions, but also to refill government coffers depleted by the huge costs of dealing with nightmares caused by the painkillers.

August 22, 2019

Do health care’s perverse incentives lure MDs into deliberate misdiagnosis for profit?

by Patrick A. Malone

When doctors become medical outliers, shouldn’t hospitals, colleagues, insurers, and the rest of us ask how and why an individual practitioner diverges so much from the way others provide care?

Olga Khazan details for the Atlantic magazine the disturbing charges involving Yasser Awaad, a pediatric neurologist at a hospital in Dearborn, Mich. As she describes him, for a decade he racked up hundreds of cases in which he is accused by patients of “intentionally misreading their EEGs and misdiagnosing them with epilepsy in childhood, all to increase his pay.” Khazan says his case “shines a light on the grim world of health-care fraud—specifically, the growing number of doctors who are accused of performing unnecessary procedures, sometimes for their own personal gain.”

In the malpractice cases that are unfolding against him, Awaad’s pay has become a central issue, with evidence showing his hospital contract rewarded him for boosting the number of screenings he ordered and diagnoses he made. Jurors have been told that Awaad, whose salary increased from 1997 to 2007 from $185,000 annually to $300,000, “turned that EEG machine into an ATM.” He earned bonuses exceeding $200,000, if he hit billing targets.

August 20, 2019

As NFL talks up lesser head harms, study shows repeated slams injure brains

by Patrick A. Malone

Although commentators and pro football itself have argued that rule changes by the National Football League have notably reduced possible head harms, new evidence from college athletes shows that even knocks that aren’t severe enough to be deemed concussions may injure young brains.

Those findings come from a University of Rochester study based on brain scans and helmet data from members of the school’s Division III football team (shown above), the New York Times reported.

Researchers scanned the athletes’ mid-brain area twice, once before the season kicked off and at its end. They did so because that region would most likely show the effects of impacts, including those that might be tougher to gauge in other areas of the brain. They also compiled data from special equipment on players’ helmets, registering the number and intensity of every impact — not just from player collisions but also when athletes hit the ground.

August 14, 2019

For patients’ sake, U.S. must slap down Big Pharma chiseling on tests, trials

by Patrick A. Malone

Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back — hard.

The concerning incidents involve “pay to play” clinical trials and “manipulated” data submitted to the federal Food and Drug Administration by maker Novartis as part of the approval process for a gene therapy drug with a sky-high price.

Neither instance, officials insist, had immediate effects in endangering patients. But both show extreme practices and conduct that regulators should slam to a halt.