Category: Health

FTC Retaliated Against, and Destroyed, Innocent Firm that Stood Up for Rule of Law

(p. A17) Sometimes winning is still losing. That is certainly true for companies that find themselves caught in the cross hairs of the federal government. Since 2013, my organization has defended one such company, the cancer-screening LabMD, against meritless allegations from the Federal Trade Commission. Last Friday, [November 13, 2015] the FTC’s chief administrative-law judge dismissed the agency’s complaint. But it was too late. The reputational damage and expense of a six-year federal investigation forced LabMD to close last year.
. . .
Unlike many other companies in similar situations, . . . , LabMD refused to cave and in 2012 went public with the ordeal. In what appeared to be retaliation, the FTC sued LabMD in 2013, alleging that the company engaged in “unreasonable” data-security practices that amounted to an “unfair” trade practice by not taking reasonable steps to protect patient information. FTC officials publicly attacked LabMD and imposed arduous demands on the doctors who used the company’s diagnostic services. In just one example, the FTC subpoenaed a Florida oncology lab to produce documents and appear for depositions before government lawyers–all at the doctors’ expense.
Yet after years of investigation and enforcement action, the FTC never produced a single patient or doctor who suffered or who alleged identity theft or harm because of LabMD’s data-security practices. The FTC never claimed that LabMD violated HIPAA regulations, and until 2014–four years after its investigation began–never offered any data-security standards with which LabMD failed to comply.
. . .
. . . , the FTC is likely to simply disregard the 92-page decision–which weighed witness credibility and the law–and side with commission staff. That’s the still greater injustice: The FTC is not bound by administrative-law judge rulings. In fact, the agency has disregarded every adverse ruling over the past two decades, according to a February analysis by former FTC Commissioner Joshua Wright. Defendants’ only recourse is appealing in federal court, a fresh burden in legal fees.
That’s what happens when a federal agency serves as its own detective, prosecutor, judge, jury and executioner. As Mr. Wright observed, the FTC’s record is “a strong sign of an unhealthy and biased institutional process.” And he puts it perhaps most powerfully: “Even bank robbery prosecutions have less predictable outcomes than administrative adjudication at the FTC.” Winning against the federal government should never require losing so much.

For the full commentary, see:
DAN EPSTEIN. “Hounded Out of Business by Regulators; The company LabMD finally won its six-year battle with the FTC, but vindication came too late.” The Wall Street Journal (Fri., Nov. 20, 2015): A17.
(Note: ellipses, and bracketed date, added.)
(Note: the online version of the commentary was updated on Nov. 19, 2015.)

Lives Lost Due to Peer Review Delays

(p. A25) In this age of instant information, medicine remains anchored in the practice of releasing new knowledge at a deliberate pace. It’s time for medical scientists to think differently about how quickly they alert the public to breakthrough findings.
Last week the National Institutes of Health announced that it had prematurely ended a large national study of how best to treat people with high blood pressure because of its exceptional results.
In this trial of more than 9,000 people age 50 and older with high blood pressure, an aggressive treatment strategy to keep systolic blood pressure below 120 was compared with a conventional one aimed at keeping it below 140. The subjects all had a high risk of heart attacks, stroke and heart failure. The N.I.H. concluded, six years into a planned eight-year study, that for these patients, pushing blood pressure down far below currently recommended levels was very beneficial.
. . .

The new information may justify a more vigorous strategy for treating blood pressure, but for now doctors and patients have been left with incomplete results, some headlines and considerable uncertainty about whether to modify current treatments.
Medicine needs to change its approach to releasing new, important information. Throughout science we are seeing more rapid modes of communication. The traditional approach was not to publish until everything was finalized and ready to be chiseled in stone. But these sorts of delays are unnecessary with the Internet. Moreover, although all the trial data has yet to be tabulated, an analysis was considered sufficiently definitive to lead independent experts to stop the multimillion-dollar study.
We believe that when there is such strong evidence for a major public health condition, there should be rapid release of the information that led to the decision to stop the trial. This approach could easily be accomplished by placing the data on the N.I.H. website or publishing the data on such platforms as bioRxiv.org, which enables fast, open review by the medical community.
. . .
Kudos to the scientists who conducted such a large, complex and important study with what will be likely to have lifesaving consequences for a condition that can be treated easily in most patients. Now the medical community needs to adopt a new approach in situations like this one to disseminate lifesaving results in a timely, comprehensive and transparent way. Lives depend on it.

For the full commentary, see:
ERIC J. TOPOL and HARLAN M. KRUMHOLZ. “Don’t Sit on Medical Breakthroughs.” The New York Times (Fri., SEPT. 17, 2015): A25.
(Note: ellipses added.)
(Note: the online version of the commentary has the date SEPT. 17, 2015, and the title “Don’t Delay News of Medical Breakthroughs.”)

“Strong-Willed Scientists Overstated the Significance of Their Studies”

The New York Times seems open to the idea that strong-willed scientists might overstate their results in science food studies. I wonder if The New York Times would be open to the same possibility in science climate studies?

(p. A19) For two generations, Americans ate fewer eggs and other animal products because policy makers told them that fat and cholesterol were bad for their health. Now both dogmas have been debunked in quick succession.
. . .
Epidemiological data can be used to suggest hypotheses but not to prove them.
Instead of accepting that this evidence was inadequate to give sound advice, strong-willed scientists overstated the significance of their studies.
Much of the epidemiological data underpinning the government’s dietary advice comes from studies run by Harvard’s school of public health. In 2011, directors of the National Institute of Statistical Sciences analyzed many of Harvard’s most important findings and found that they could not be reproduced in clinical trials.
It’s no surprise that longstanding nutritional guidelines are now being challenged.
In 2013, government advice to reduce salt intake (which remains in the current report) was contradicted by an authoritative Institute of Medicine study. And several recent meta-analyses have cast serious doubt on whether saturated fats are linked to heart disease, as the dietary guidelines continue to assert.
Uncertain science should no longer guide our nutrition policy. Indeed, cutting fat and cholesterol, as Americans have conscientiously done, may have even worsened our health.

For the full commentary, see:
NINA TEICHOLZ. “The Government’s Bad Diet Advice.” The New York Times (Sat., FEB. 21, 2015): A19.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date FEB. 20, 2015.)

Entrepreneurs Creating Healthy, Tasty Meat, Without Killing Animals

(p. B2) “The next couple of years will be exciting ones,” says Joseph D. Puglisi, a Stanford University professor of structural biology who is working on meat alternatives. “We can use a broad range of plant protein sources and create a palette of textures and tastes — for example, jerky, cured meats, sausage, pork.”
“The true challenge will be to recreate more complex pieces of meat that are the pinnacle of the meat industry,” he added. “I believe that plausible, good-tasting steaks and pork loins are only a matter of time.”
Puglisi is advising Beyond Meat, a start-up that is a leader in the field, with investments from Bill Gates and both Biz Stone and Ev Williams of Twitter fame, not to mention Kleiner Perkins Caufield & Byers, the venture capital firm that backed Google and Amazon. Beyond Meat says its sales are doubling each year.
“We’re really focused on the mainstream,” said Ethan Brown, the founder of Beyond Meat, over a lunch of fake chili, meatballs and hamburgers.
. . .
“We want to create the next great American meat company,” Brown says. “That’s the dream.”
. . .
The mainstream food industry isn’t saying much publicly. But recently released documents from the American Egg Board, a quasi-governmental body, show it regarded Hampton Creek’s egg-free “Just Mayo” spread as a “major threat.” In one internal email, an Egg Board executive jokingly suggests hiring a hit man to deal with Hampton Creek.
. . .
. . . if I can still enjoy a juicy burger now and then, while boosting my health, helping the environment and avoiding the brutalizing of farm animals, hey, I’m in!

For the full commentary, see:
Nicholas Kristof. “The (Fake) Meat Revolution.” The New York Times, SundayReview Section (Sun., SEPT. 20, 2015): 11.
(Note: the online version of the commentary has the date SEPT. 19, 2015.)

John Paul Stapp Thumbed His Nose at the Precautionary Principle

(p. C7) In the early 19th century, a science professor in London named Dionysus Lardner rejected the future of high-speed train travel because, he said, “passengers, unable to breathe, would die of asphyxia.” A contemporary, the famed engineer Thomas Tredgold, agreed, noting “that any general system of conveying passengers . . . [traveling] at a velocity exceeding 10 miles an hour, or thereabouts, is extremely improbable.”
The current land speed for a human being is 763 miles an hour, or thereabouts, thanks in large part to the brilliance, bravery and dedication of a U.S. Air Force lieutenant colonel named John Paul Stapp, a wonderfully iconoclastic medical doctor, innovator and renegade consumer activist who repeatedly put his own life in peril in search of the line beyond which human survival at speed really was “extremely improbable.”
. . .
Initial tests were carried out on a crash-test dummy named Oscar Eightball, then chimpanzees and pigs. There was plenty of trial and error–the term “Murphy’s Law” was coined during the Gee Whiz experiments–until Stapp couldn’t resist strapping himself into the Gee Whiz to experience firsthand what the cold data could never reveal: what it felt like. On May 5, 1948, for example, he “took a peak deceleration of an astounding twenty-four times the force of gravity,” the author writes. “This was the equivalent of a full stop from 75 miles per hour in just seven feet or, in other words, freeway speed to zero in the length of a very tall man.”
Stapp endured a total of 26 rides on the Gee Whiz over the course of 50 months, measuring an array of physiological factors as well as testing prototype helmets and safety belts. Along the way he suffered a broken wrist, torn rib cartilage, a bruised collarbone, a fractured coccyx, busted capillaries in both eyes and six cracked dental fillings. Colleagues became increasingly concerned for his health every time he staggered, gamely, off the sled, but, according to Mr. Ryan, he never lost his sense of humor, nor did these ordeals stop Dr. Stapp from voluntarily making house calls at night for families stationed on the desolate air base.
. . .
After 29 harrowing trips down the track, Stapp prepared for one grand finale, what he called the “Big Run,” hoping to achieve 600 miles per hour, the speed beyond which many scientists suspected that human survivability was–really, this time–highly improbable. On Dec. 10, 1954, Sonic Wind marked a speed of 639 miles per hour, faster than a .45 caliber bullet shot from a pistol. Film footage of the test shows the sled rocketing past an overhead jet plane that was filming the event. The Big Run temporarily blinded Stapp, and he turned blue for a few days, but the experiment landed him on the cover of Time magazine as the fastest man on earth. The record stood for the next 30 years.

For the full review, see:
PATRICK COOKE. “Faster Than a Speeding Bullet–Really.” The Wall Street Journal (Sat., Aug. 22, 2015): C7.
(Note: first ellipsis, and bracketed word, in original; other ellipses added.)
(Note: the online version of the review has the date Aug. 21, 2015.)

The book under review, is:
Ryan, Craig. Sonic Wind: The Story of John Paul Stapp and How a Renegade Doctor Became the Fastest Man on Earth. New York: Liveright Publishing Corp., 2015.

Increasing Recalls of Organic Food Due to Bacterial Contamination

(p. B3) New data collected by Stericycle, a company that handles recalls for businesses, shows a sharp jump in the number of recalls of organic food products.
Organic food products accounted for 7 percent of all food units recalled so far this year, compared with 2 percent of those recalled last year, according to data from the Food and Drug Administration and the Department of Agriculture that Stericycle uses to compile its quarterly report on recalls.
In 2012 and 2013, only 1 percent of total units of food recalled were organic.
Kevin Pollack, a vice president at Stericycle, said the growing consumer and corporate demand for organic ingredients was at least partly responsible for the increase.
“What’s striking is that since 2012, all organic recalls have been driven by bacterial contamination, like salmonella, listeria and hepatitis A, rather than a problem with a label,” Mr. Pollack said. “This is a fairly serious and really important issue because a lot of consumers just aren’t aware of it.”

For the full story, see:
STEPHANIE STROM. “Private Analysis Shows a Sharp Increase in the Number of Organic Food Recalls.” The New York Times (Fri., Aug. 21, 2015): B3.
(Note: the online version of the story has the date AUG. 20, 2015, and has the title “Recalls of Organic Food on the Rise, Report Says.” The last paragraph quoted above differs in the print and online versions; the version quoted is the print version. The online version of the paragraph is: “According to Stericycle, 87 percent of organic recalls since 2012 were for bacterial contamination, like salmonella and listeria, rather than a problem with a label. “This is a fairly serious and really important issue because a lot of consumers just aren’t aware of it,” Mr. Pollack said.”)

In Health Care We Need More than Incremental Steps; We Need Cures

(p. 8A) In 1998, I went to the doctor so fatigued I was unable to get out of bed. He sent me home diagnosed with multiple sclerosis but without so much as a treatment plan, a prescription or what I needed most: hope. Come back when it gets worse, he said, the medical equivalent of a pat on the head.
. . .
We need advocates unwilling to tolerate the old silos who insist on pushing neurologic science into a new era of breakthroughs. We need private funders with the vision to place big bets, often on long odds, with bigger payouts, perhaps a vaccine for MS or Alzheimer’s, on the other side.
At a time when the horizons of science have never spread wider, researchers and their supporters must rethink both the goals and the model of scientific research. It is a time for bold ambitions, not incremental steps.
Millions have experienced moments like the one I did in 1998. We owe these patients more than incremental progress. Ultimately, we owe them cures.

For the full commentary, see:
Ann Romney. “Bold Innovators Needed to Boost Health Research.” USA Today (Mon., October 16, 2014): 4A.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date October 16, 2014, and the title “Ann Romney: Health Research Needs Boost from Bold Innovators.”)

Conflict-of-Interest Politics Reduces Medical Collaboration with Industry and Slows Down Cures

(p. A15) The reality of modern medicine, Dr. Stossel argues, is that private industry is the engine of innovation, with productivity and new advances dependent on relationships between commercial interests and academic and research medicine. Companies, not universities or research with federal funding, run 85% of the medical-products pipeline. “We all inevitably have conflicts all the time. You only stop having conflicts when you’re dead. The only conflict-free situation is the grave,” he says.
The pursuit of the illusion “to be pure, to be priestly, to be supposedly uncorrupted by the profit motive,” Dr. Stossel says, often has the effect of banishing or else discounting the expertise of the people who know the most but whose integrity and objectivity are allegedly compromised by industry ties. What ought to matter more, he adds, is simply “Results. Competence. LeBron James–it’s putting the ball in the basket.”
. . .
Zero-tolerance conflict-of-interest editorial policies, Dr. Stossel says, suppress and distort debate by withholding positions of authority. “If you have an industry connection, if you really understand the topic, you can’t say anything,” he notes. “If you’re an editor, and you have an ideological predilection, you have all this power and you can say anything you want.”
Dr. Stossel is equally scorching about the drug and device companies and their trade organizations, which he says drift around like Rodney Dangerfield, complaining they don’t get no respect. They prefer not to be confrontational, they rarely fight back against the conflict-of-interest scolds. “They’re laying responsibility by default to the patients, the people who actually have a first-hand connection to whatever the disease is: ‘Goddammit, I want a cure.’ ”
Which is the larger point: The to-and-fro between publications not meant for lay readers can seem arcane, but the product of conflict-of-interest politics is fewer cures and new therapies. The predisposition against selling out to industry is pervasive, while reputations can be ruined overnight when researchers find themselves in a page-one exposé or hauled before Congress, even if there is no evidence of misconduct or bias.
Better, then, to conform in the cloisters than risk offending the conflict-of-interest orthodoxy–or translating some basic-research insight into a new treatment for patients. Dr. Rosenbaum reports: “The result is a stifling of honest discourse and potential discouragement of productive collaborations. . . . More strikingly, some of the young, talented physician-investigators I spoke with expressed worry about how any industry relationship would affect their careers.”
. . .
‘Pharmaphobia”–part polemic, part analytic investigation, a history of medicine and a memoir–deserves a wide readership. . . . “I’d rather get a conversation started with people who are smarter than I am about how complicated and granular and nuanced and unpredictable discovery is. Let’s not slow it down.”

For the full interview, see:
JOSEPH RAGO. “The Weekend Interview with Tom Stossel; A Cure for ‘Conflict of Interest’ Mania; A crusading physician says medical progress is hampered by a holier-than-thou ‘moralistic bullying.’.” The Wall Street Journal (Sat., June 27, 2015): A15.
(Note: ellipses added.)
(Note: the online version of the interview has the date June 26, 2015, and has the title “A Cure for ‘Conflict of Interest’ Mania; A crusading physician says medical progress is hampered by a holier-than-thou ‘moralistic bullying.’.”)

The book mentioned in the interview, is:
Stossel, Thomas P. Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation. Lanham, MS: Rowman & Littlefield Publishers, 2015.

How to Be an Effective Expert Witness

(p. B16) Dr. David Sackett, whose clinical trials proved the value of taking aspirin in preventing heart attacks and strokes, and who helped pioneer the use of exacting statistical data in treating patients, died on May 13 [2015] in Markdale, Ontario.
. . .
His colleagues also appreciated his sense of humor. He recalled that while he was testifying in a case as an expert witness, a lawyer handed him a research paper supposedly proving the safety of a drug that was in dispute. He read the paper and concluded that it was flawed.
“Well, I could take several more days and show you dozens more papers on this topic, but the jury would probably want to lynch me,” the lawyer insisted.
“I would welcome that,” Dr. Sackett said.
“Well, we could meet after the trial and go over these papers together,” the lawyer suggested.
To which Dr. Sackett replied, “No, I meant that I would welcome the lynching.”

For the full obituary, see:
SAM ROBERTS. “Dr. David Sackett, a Health Care Innovator, Dies at 80.” The New York Times (Thurs., May 21, 2015): B16.
(Note: ellipsis, and bracketed year, added.)
(Note: the date of the online version of the obituary is MAY 19, 2015, and has the title “Dr. David Sackett, Who Proved Aspirin Helps Prevent Heart Attacks, Dies at 80.”)

The Bureaucratic Absurdities of Socialized Medicine

(p. 13) Reading “Do No Harm,” Henry Marsh’s frank and absorbing narrative of his life in neurosurgery, it was easy to imagine him at the table. The men, and increasingly women, who slice back the scalp, open the skull and enter the brain to extract tumors, clip aneurysms and liberate nerves, share a certain ego required for such work. They typically are bold and blunt, viewing themselves as emperors of the clinical world. Marsh adds irony to this characterization, made clear in the opening line of the book, “I often have to cut into the brain and it is something I hate doing.”
. . .
Britain’s National Health Service is a socialized system, and Marsh chafes at new rigid rules imposed by its administrators. He is particularly incensed by a mandatory dress code: Neurosurgeons are subject to disciplinary action for wearing a wristwatch. There is scant evidence that this item contributes to hospital infections, but he is shadowed on ward rounds by a bureaucrat who takes notes on his dress and behavior. The reign of the emperor is ending, but Marsh refuses to comply and serve as a myrmidon.
Clinical practice is becoming a theater of the absurd for patients as well. Hospital charts are filled with N.H.S. forms detailing irrelevant aspects of care. Searching for a patient’s operative note, Marsh finds documentation she passed a “Type 4 turd.” He shows her an elaborate stool chart “colored a somber and appropriate brown, each sheet with a graphically illustrated guide to the seven different types of turd. . . . She looked at the document with disbelief and burst out laughing.”

For the full review, see:
JEROME GROOPMAN. “Consider the Comma.” The New York Times Book Review (Sun., MAY 24, 2015): 13.
(Note: ellipsis between paragraphs, added; ellipsis within paragraph, in original.)
(Note: the online version of the review has the date MAY 21, 2015, and has the title “‘Do No Harm,’ by Henry Marsh.”)

(p. C6) Amid the life-or-death dramas of neurosurgery in this book are some blackly comic scenes recounting the absurdities of hospital bureaucracy in the National Health Service: not just chronic bed shortages (which mean long waits and frantic juggling of surgery schedules), but also what Dr. Marsh calls a “loss of regimental spirit” and ridiculous meetings, like a slide presentation from “a young man with a background in catering telling me I should develop empathy, keep focused and stay calm.”

For the full review, see:
MICHIKO KAKUTANI. “From a Surgeon, Exhilarations and Regrets.” The New York Times (Tues., MAY 19, 2015): C1 & C6.
(Note: the online version of the review has the date MAY 18, 2015, and has the title “Books of The Times; Review: In ‘Do No Harm,’ a Brain Surgeon Tells All.”)

The book under review, in both reviews, is:
Marsh, Henry. Do No Harm: Stories of Life, Death, and Brain Surgery. New York: Thomas Dunne Books/St. Martin’s Press, 2015.

Empathy for the Absent

In Practical Wisdom the authors argue for empathy and against rules. There is something to be said for their argument.
But we tend to empathize with those who are present and not those we do not see or even know.
For example in academic tenure and promotion decisions, slack is often cut for colleagues who already have their foot in the door. We know them, their troubles and challenges. So they are tenured and promoted and given salary increases and perks even though there are others outside the door who may have greater productivity and even greater troubles and challenges.
Charlie Munger in an interview at the University of Michigan spoke of how hard it is for physicians to hold their peers responsible when they are incompetent or negligent. They have empathy for their peers, knowing their troubles and challenges. And Munger also says few physicians are willing to suffer the long-lasting “ill will” from their peers who have been held accountable. They do not know so well the patients who suffer, and one way or another, the patients are soon out of sight.
Just as in academics we do not know so well the students who suffer; or the able scholars who suffer, standing outside the door.
Following rules seems unsympathetic and lacking in empathy. But it may be the best way to show empathy for the absent.

The book mentioned is:
Schwartz, Barry, and Kenneth Sharpe. Practical Wisdom: The Right Way to Do the Right Thing. New York: Riverhead Books, 2010.

The interview with Munger is:
Quick, Rebecca (interviewer). “A Conversation with Charlie Munger.” University of Michigan Ross School of Business, Sept. 14, 2010.