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The New FDA Commissioner

That the appointment of Scott Gottlieb to head the FDA has elicited a decidedly mixed response is a good thing. I fear consensus as much as the late Christopher Hitchens loved dissent which, he believed, was an indicator of a healthy democracy, which means that rather than facing the morgue, the US might be going through her healthiest days in these times.

Gottlieb has served on the boards of industry, and earned a nifty pocket money doing so. Detractors argue that he’s unfit to head the FDA because of his financial conflict of interest (FCOI). I will not revisit the arguments for and against physician’s FCOI with industry, because all arguments for and against have been made, and it’s unlikely that anyone’s mind will change with new evidence or new arguments. Suffice it to say that both sides have plausible arguments, and we’ll never know the truth, because to know the real impact of physician’s FCOI with industry we need parallel universes with everything held constant, except the degree of physician ties with industry, and measure the net benefits to society in terms of morbidity, mortality, drug prices, and innovations.

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Interview with Mark Pauly: Part 2

President Trump and Obamacare

 

 

Healthcare reformers, like the wives of King Henry the 8th, have a thankless job. In a curious inversion of the Tudors, President Trump, who has promised to make healthcare great again, finds himself in the same predicament as the King’s sixth wife who knew what she had to do, just didn’t know how she could do it any differently. Dr. Mark V. Pauly (MVP), Professor of Economics at the University of Pennsylvania, believes President Trump’s options are neither exhaustive, nor exhausted.

The Interview

SJ: I’m quoting from your book Healthcare Reform without side effects “with community rating…doors are open for political and special interests to lobby…Imagination will be stifled…political rent seeking will be rampant.” When I read this paragraph I checked the publication date of your book. It was not 2016. It was 2008 – before the passage of the ACA.

MVP: Unfortunately, the book wasn’t published soon enough before the ACA.

SJ: What, in a nutshell, is the problem with the ACA?

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Interview with Mark Pauly: Part 1

Community Rating – The Worst Possible Way To Do a Good Thing

I have a grudging respect for health economists, “grudging” because, like many doctors, I want my pieties unchecked. Health economists check our pieties with quantitative truths. They describe the way the healthcare world is – a view from 29, 000 feet, pour cold water on the way we think the world should be, and guide, with abundant disclaimers, the way we can make things better. It’s unwise climbing Everest without a Sherpa, nor is it wise reforming healthcare without listening to health economists from across the political spectrum.

President Trump, along with the Republican House and Senate, will be dismantling the Affordable Care Act (ACA). In a sense, President Trump is not just descending Everest, a treacherous feat in its own right, but scaling a peak arguably more dangerous than Everest. Despite their differences, Mr. Obama and Mr. Trump share one commonality – an implicit distrust of the health insurance industry.

How did the American health insurance industry become so vilified? This is, in part, because necessity is the father of all vilification. Insurers are a necessary evil in a country where there’s still deep mistrust of the government. Partly, this is because we transfer our angst about the uncertainty of our future, the dice which plays with our lives, to insurers who are in the business of rolling the dice. But mostly it’s because the misdeeds of the insurance market have been grossly exaggerated, and the benefits of the market have been attenuated by a few damning anecdotes. This is what Mark V. Pauly (MVP), Professor of Health Economics at the University of Pennsylvania, and one of the most eminent health economists of his generation, believes.

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Should Cleveland Clinic’s Anti-Vax Physician Lose His Medical License?

Years ago, when I was less inflexible, I took up Pilates. My instructor, Jim, a charming chap with an infectious laughter, was a 911 truther. I’d egg him on to hear about his conspiracy theories. Jim believed that 911 was concocted by Bush and Haliburton so that the U.S. could invade Iraq to capture their oil. He thought that United Flight 93 never took off. Whatever happened after 911 became the motivation for 911. He was the sort of person who would have concluded that Mahatma Gandhi plotted the Second World War to free India from British rule.

I began to suspect that Jim was, to put it charitably, nice but dim. But he wasn’t that dim. He corrected me when I once, innocently, underpaid him. He was also smart at advertising and when he met my wife, he told her that she should join me for Pilates because it would strengthen our marital bond. My wife politely declined the bond strengthening. He was also very cued up with the nutritional sciences and warned me, without leaving a trace of irony, “don’t believe everything you read about diets.”

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Homme Fatale

Halfway through the “Bell Curve,” which is an analysis of differences in intelligence between races, I realized what had been bothering me about Charles Murray’s thesis. It wasn’t the accuracy of his analysis, which concerned me, too. It was that he analyzed. The truth, I used to believe, was always beautiful, whether it was what happened in the multiverse at T equals zero, or the historical counterfactual if Neville Chamberlain hadn’t signed the peace accord with Adolph Hitler. After reading Murray’s book, I realized that the truth can be irrelevant, ugly, and utterly useless. Even if the average intelligence of races was truly different, so what? Surely, civilized people must judge each other as individuals, regardless of the veracity of the statistical baggage of their ethnicities.

Murray was castigated, deservedly, for swallowing the bell curve uncritically. But his detractors missed one point. Murray wasn’t just wrong because he was factually wrong or for inquiring. In fact, it was worse, because Murray, it turned out, was wronger than wrong.

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Lead Time Bias and Court Rooms

By SAURABH JHA MD

In 2014, a jury in Massachusetts awarded $ 16.7 million in damages to the daughter of a Bostonian lady who died from lung cancer at 47, for a missed cancer on a chest x-ray. The verdict reminds me of the words of John Bradford, the heretic, who was burnt at the stakes: “There, but for the grace of God go I.” Many radiologists will sympathize with both the patient who died prematurely, and the radiologist who missed a 15-mm nodule on her chest x-ray when she presented with cough to the emergency department few months earlier.

The damages are instructive of the tension between the Affordable Care Act’s push for both resource stewardship and patient-centeredness, and between missed diagnosis and waste. But the verdict speaks of the ineffectualness of evidence-based medicine (EBM) in court. If EBM is a science, then this science is least helpful when most needed, i.e. when trying to influence public opinion.

EBM tells us that had the patient’s cancer been detected thirteen months before it actually was, it would have made little difference to her survival, statistically speaking. Researchers from Mayo Clinic examining the impact of frequent chest x rays in screening for lung cancer in a large number of smokers found that the intensively screened group knew about their cancers earlier, had more cancers removed, but did not live longer as a result. This is known as lead time bias, where early detection means more time knowing that one has the cancer, not more time one is actually alive. This means had the nodule been seen on the patient’s initial chest x-ray she would probably, though not certainly, not have survived much beyond 47.

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Two Nations Separated by 5.3 mm

A popular meme is that the U.S. spends more on healthcare than other developed nations but has nothing to show for that spending. This is different from saying that the U.S. spends more, but achieves something, but the something it achieves is so little that it isn’t worth the public purse. The latter is difficult to assert because the asserter must then say how little is too little in regards to how much is spent, and why. It is easier believing the excess spending has no effect whatsoever, zilch in fact, because this absolves one from having to apply a value judgment on how much a life is worth. This meme, a convenient heuristic, like other convenient heuristics, is wrong.

A recent study looked at trends and outcomes in the management of abdominal aortic aneurysm (AAA) in the U.S. and the U.K. An aneurysm, dilation of the aorta, is more likely to burst the bigger it gets. Aneurysms should be repaired before they rupture because the mortality of ruptured aneurysms can be 50 %. The study, which analyzed several databases that recorded surgery, size of aneurysms, and cause of death, found that Americans repair twice as many aneurysms as the Brits, and the repaired AAAs are smaller, on average, in the U.S. Between 2005-2012 elective AAA repair (i.e. repair of non-ruptured aneurysms) increased from 27 to 32 per 100, 000 in the U.K, and from 58 to 64 per 100, 000 in the U.S.

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Precision Primary Prevention

If you’re going to indulge in anticipatory medicine, it is best to anticipate those at highest risk. An elegant study by Wald et al in the NEJM shows how precision primary prevention can be done. The researchers screened toddlers, who presented routinely to their general practitioners for vaccinations, for an uncommon, but not rare, familial predisposition to high cholesterol known as heterozygous familial hypercholesterolemia (FH), in which premature cardiovascular death can be deferred by statins and lifestyle changes. Blood drawn from the toddlers by a heel prick was tested for serum cholesterol and genetic mutations indicative of heterozygous familial hypercholesterolemia (FH). The parents of toddlers who met criteria for FH were also tested for cholesterol and genetic mutations. Obviously identifying affected parents, and increasing their longevity, is also beneficial for their children.Continue reading…

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