Category: Health

Consumers Vote “No” on Costly Organic Smoothies “Made of Swiss Chard, Cashew Milk and Himalayan Salt”

(p. D1) As recently as last month, one could hardly throw a lentil in New York City without hitting an Organic Avenue storefront, with its orange banner, stick-figure logo and promise of better living through $9 cayenne-infused lemonade.
Kat Schamens, a yoga teacher and fitness-apparel designer, liked it that way. “I would always think, ‘I can’t wait to go in and get my chickpea soup,’ ” she said.
In mid-October, Ms. Schamens learned that Organic Avenue’s 10 stores had been shuttered and that the company had filed for bankruptcy. “I kind of freaked out,” she said. “I was distraught. I lost my yoga for a minute.”
. . .
(p. D7) The loyalty of devotees like Ms. Schamens and Ms. Kerin notwithstanding, there is an admitted emperor’s new clothes quality to paying $25 for a lunch of vegetable shavings and a smoothie made of Swiss chard, cashew milk and Himalayan salt.
“You can’t get people to crave this food,” the former investor said. “You can’t build a long-term business off what Gwyneth Paltrow likes.”
Some researchers began to publish studies questioning the necessity and safety of juice cleanses. And the fashion world started to feel pushback from nutritionists and eating-disorder activists against its support of juicing in early 2013, after the Council of Fashion Designers of America announced a 50 percent discount for models on Organic Avenue juices during New York Fashion Week.

For the full story, see:
KATHERINE ROSMAN. “How Organic Avenue Lost All Its Juice.” The New York Times (Sun., NOV. 5, 2015): D1 & D7.
(Note: ellipsis added.)
(Note: the online version of the story has the date NOV. 4, 2015.)

FDA Forces Child to Go to London to Get Drug to Fight His Cancer

(p. A15) How far would you go to get a drug that could save your child’s life? Across an ocean? That is exactly what the federal government is forcing some American families with dying children to do.
In 2012, when Diego Morris was 11 years old, he was diagnosed with a deadly cancer in his leg called osteosarcoma. Doctors at St. Jude Children’s Research Hospital in Memphis, Tenn., removed the tumor, but the prognosis was poor. There was a significant risk that even extensive chemotherapy after surgery would not prevent the cancer from returning.
Fortunately, a team of doctors at MD Anderson Cancer Center in Houston and Memorial Sloan Kettering Cancer Center in New York City had developed a revolutionary new drug, mifamurtide (MTP), that can prevent osteosarcoma from coming back. A study by Dr. Eugenie Kleinerman of MD Anderson and Dr. Paul Meyers of Sloan Kettering showed the drug resulted in a 30% reduction in the osteosarcoma mortality rate at eight years after diagnosis.
The drug was approved in 2009 by the European Medicines Agency and is currently the standard of care in Europe, Israel and many other countries. In 2012 it received the prestigious Prix Galien Award, the gold medal for pharmaceutical research and development in the United Kingdom.
MPT was exactly what Diego needed. But there was one problem: The drug was not available in America because the Food and Drug Administration had rejected it, demanding additional studies. That meant that Diego had to travel from Phoenix to London to get the drug he needed to save his life–a drug that was available in almost every industrialized nation and should have been available in the U.S.

For the full commentary, see:

DARCY OLSEN. “Winning the Right to Save Your Own Life; As the FDA dawdles, 24 states pass ‘right-to-try’ laws giving terminally ill patients access to drugs.” The Wall Street Journal (Fri., Nov. 27, 2015): A15.
(Note: the online version of the commentary has the date Nov. 26, 2015.)

Olsen’s commentary is related to her book:
Olsen, Darcy. The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need. New York: HarperCollins Publishers, 2015.

Cuomo Bans the Fracking that Could Revive New York’s Southern Tier

(p. A25) CONKLIN, N.Y. — The main grocery store here was replaced by a Family Dollar store, already faded. The historic front of the town hall, a castle no less, is crumbling, and donations are being solicited. The funds earmarked to strip off the lead paint from the castle’s exterior went instead to clear mold from the basement.
This town of roughly 5,500 residents looks alarmingly like dozens of other towns and cities in New York’s Southern Tier, a vast part of the state that runs parallel to Pennsylvania. Years ago, the region was a manufacturing powerhouse, a place where firms like General Electric and Westinghouse thrived. But over time companies have downsized, or left altogether, lured abroad or to states with lower taxes and fewer regulations.
. . .
In western New York, . . . , Gov. Andrew M. Cuomo, a Democrat, pledged $1 billion in 2012 to support economic development. Since then, he has poured hundreds of millions of dollars into numerous Buffalo-area projects.
The Southern Tier has proved to be a harder fix. It is predominantly rural and lacks a significant population core that typically attracts the private sector.
The region is resource rich, but landowners are angry the government will not let them capitalize on it. Some had pinned their hopes of an economic revival on the prospect of the state’s authorizing hydraulic fracturing, known as fracking; many of them can recite the payment formula gas companies were proposing: $500 a month per acre.
But the Cuomo administration, citing health risks, decided last year to ban the practice, leaving some farmers contemplating logging the timber on their land, a move that could destroy swaths of pristine forest.

For the full story, see:
SUSANNE CRAIG. “Former Hub of Manufacturing Ponders Next Act.” The New York Times (Weds., SEPT. 30, 2015): A20-A21.
(Note: ellipses added.)
(Note: the online version of the story has the date SEPT. 29, 2015, and has the title “New York’s Southern Tier, Once a Home for Big Business, Is Struggling.”)

FDA Has No Right to Stop the Terminally Ill from Seeking Cures

(p. C4) Ms. Olsen notes that “today, about 40 percent of cancer patients attempt to enroll in clinical trials, but only about 3 percent end up participating. That means that the vast majority don’t make the cut, whether because they fail to meet the strict criteria, or a trial is thousands of miles from their home.” Many of those who don’t get these experimental drugs are the sickest patients because they are deemed “too sick to be useful for the study.”
Ms. Olsen argues that terminally ill patients should be able to access such drugs–at their own risk and outside the context of FDA-required studies–if the companies are willing to provide them, and the book’s title alludes to her proposed remedy: the state-by-state campaign the Goldwater Institute is leading to pass “Right to Try” legislation. The bills would allow terminally ill patients who have “exhausted all conventional treatment options” to access an experimental treatment if their doctors believe it is “the best medical option to extend or save the patients’ life” and “the treatment has successfully completed basic safety testing and is part of the FDA’s ongoing evaluation and approval process.” Insurers, critically, would not be required to cover the treatment–a significant hurdle, largely unexplored here, since such costs could be significant.
The think tank’s campaign has been incredibly successful, with 24 states passing Right to Try laws to date. Still, Ms. Olsen doesn’t present such laws as a panacea. She doesn’t expect experimental treatments to always–or even often–work for terminally ill patients. But she believes that some chance is better than the alternative. “If you have the Right to Die, you have the Right to Try,” Ms. Olsen writes. “And you don’t have to wait on Washington to secure it.”
Yet therein lies the book’s main shortcoming. Washington, it turns out, has a fair bit of say here. Courts have found that the FDA’s powers to regulate drug development are extraordinarily broad. Many changes Ms. Olsen champions won’t be possible without congressional action to revamp the FDA’s drug development process and find new ways of paying for experimental drugs that would make widespread access sustainable for patients, companies and insurers. These issues, though touched on, are not grappled with in detail.

For the full review, see:
PAUL HOWARD. “BOOKSHELF; Hail Mary Medicine; Patients spend their last days pleading with reluctant drug companies and the FDA to get access to treatments that could save their lives.” The Wall Street Journal (Fri., Nov. 13, 2015): C4.
(Note: ellipses added.)
(Note: the online version of the review has the date Nov. 12, 2015.)

The book under review, is:
Olsen, Darcy. The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need. New York: HarperCollins Publishers, 2015.

Health Care Mandate “Freezes You at a Time When You Need to Be Moving Fast”

(p. B4) When LaRonda Hunter opened a Fantastic Sams hair salon 10 years ago in Saginaw, Tex., a suburb of Fort Worth, she envisioned it as the first of what would eventually be a small regional collection of salons. As her sales grew, so did her business, which now encompasses four locations — but her plans for a fifth salon are frozen, perhaps permanently.

Starting in January, the Affordable Care Act requires businesses with 50 or more full-time-equivalent employees to offer workers health insurance or face penalties that can exceed $2,000 per employee. Ms. Hunter, who has 45 employees, is determined not to cross that threshold. Paying for health insurance would wipe out her company’s profit and the five-figure salary she pays herself from it, she said.
“The margins are not big enough within our industry to support it,” she said. “It’s not that I don’t want to — I love my employees, and I want to do everything I can for them — but the numbers just don’t work.”
. . .
For some business owners on the edge of the cutoff, the mandate is forcing them to weigh very carefully the price of growing bigger.
“There’s kind of a deer-in-headlights moment for those who say, ‘I have this new potential client, but if I bring them on, I have to hire five additional people,'” said Philip P. Noftsinger, the payroll unit president at CBIZ, a financial services provider for businesses. “They’re really trying to assess how much the 50th employee is going to cost.”
. . .
For businesses that use many seasonal, variable-hour or temporary workers, like those in the hospitality industry, simply figuring out how many qualifying employees they have can be a challenge.
“I think companies are going to have to work with their payroll processor for the basic data, and then their accountant or attorney about what certain items mean,” Mr. Prince said.
The expense and distraction of all that paperwork is one of the biggest frustrations for one business owner, Joseph P. Sergio. His industrial cleaning company, Polar Clean, which is based in South Bend, Ind., but dispatches teams nationally, has just under 50 core employees. One of its business lines is disaster restoration, and after a flood or hurricane, its temporary staff balloons.
Mr. Sergio offers health insurance to his permanent staff, but the premiums have risen so quickly that he had to switch to a more restrictive plan, with a higher deductible. He is reluctant to go over the 50-employee line and incur all of the new rules that come with it. That makes bidding for new jobs an arduous and risky exercise.
“I’ve had to pull my controller and a couple of top people to sit and spend days going through this,” he said. “If you ramp up, and it pushes you over 50, there’s all these unknown costs and complicated rules. Are we really going to be able to benefit from going after that opportunity? It freezes you at a time when you need to be moving fast.”

For the full story, see:
STACY COWLEY. “ENTREPRENEURSHIP; Health Care Law Leads Business Owners to Rethink Plans for Growth.” The New York Times (Thurs., NOV. 19, 2015): B4.
(Note: ellipses added.)
(Note: the online version of the story has the date NOV. 18, 2015, and has the title “ENTREPRENEURSHIP; Health Care Law Forces Businesses to Consider Growth’s Costs.”)

Bike Helmet Regulations Hurt Health

(p. D1) . . . many cycling advocates have taken a surprising position: They are pushing back against mandatory bike-helmet laws in the U.S. and elsewhere. They say mandatory helmet laws, particularly for adults, make cycling less convenient and seem less safe, thus hindering the larger public-health gains of more people riding bikes.
All-ages helmet laws might actually make cycling more dangerous, some cyclists say, by decreasing ridership. Research shows that the more cyclists there are on the road, the fewer crashes there are. Academics theorize that as drivers become used to seeing bikes on a street, they watch more closely for them.
. . .
Piet de Jong, a professor in the department of applied finance and actuarial studies at Sydney’s Macquarie University, actually calculated the trade-off of mandatory helmet laws. In a 2012 paper in the journal Risk Analysis, he weighed the reduction of head injuries against increased morbidity due to foregone exercise from reduced cycling.
Dr. de Jong concluded that mandatory bike-helmet laws “have a net negative health impact.” That is in part because many people cycle to work or for errands, experts say. People tend to replace that type of cycling not with another physical activity such as a trip to the gym, but with a ride in a car.

For the full story, see:
RACHEL BACHMAN. “The Helmet-Law Backlash.” The Wall Street Journal (Tues., Oct. 13, 2015): D1 & D4.
(Note: ellipses added.)
(Note: the online version of the article was dated Oct. 12, 2015, and has the title “Do Bike Helmet Laws Do More Harm Than Good?”)

Humans Suffered from Plague by at Least 5,000 Years Ago

(p. D4) Historians and microbiologists alike have searched for decades for the origins of plague. Until now, the first clear evidence of Yersinia pestis infection was the Plague of Justinian in the 6th century, which severely weakened the Byzantine Empire.
But in a new study, published on Thursday [Oct. 22, 2015] in the journal Cell, researchers report that the bacterium was infecting people as long as 5,000 years ago.

For the full story, see:
“Archaeology: Plagues Said to Have Hit During Bronze Age.” The New York Times (Tues., OCT. 27, 2015): D4.
(Note: bracketed date added.)
(Note: the much shorter online version of the story has the date OCT. 22 (sic), 2015, and has the title “In Ancient DNA, Evidence of Plague Much Earlier Than Previously Known.” The passage quoted above is from the online version.)

The academic article mentioned in the passages quoted above, is:
Rasmussen, Simon, Morten Erik Allentoft, Kasper Nielsen, Ludovic Orlando, Martin Sikora, Karl-Göran Sjögren, Anders Gorm Pedersen, Mikkel Schubert, Alex Van Dam, Christian Moliin Outzen Kapel, Henrik Bjørn Nielsen, Søren Brunak, Pavel Avetisyan, Andrey Epimakhov, Mikhail Viktorovich Khalyapin, Artak Gnuni, Aivar Kriiska, Irena Lasak, Mait Metspalu, Vyacheslav Moiseyev, Andrei Gromov, Dalia Pokutta, Lehti Saag, Liivi Varul, Levon Yepiskoposyan, Thomas Sicheritz-Pontén, Robert A Foley, Marta Mirazón Lahr, Rasmus Nielsen, Kristian Kristiansen, and Eske Willerslev. “Early Divergent Strains of Yersinia Pestis in Eurasia 5,000 Years Ago.” Cell 163, no. 3 (Oct. 2015): 571-82.

What If Steve Jobs Ran the I.C.U.?

We’d like to think that medical intensity and competence in the real world mirror the intensity and competence of television shows like ER and House. But too often it is like the horrible surreal story told below. What if we deregulated medicine to open it to the product and process innovations of intense innovative entrepreneurs like Steve Jobs, Jeff Bezos, and Sam Walton?

(p. 7) Omaha — I’ve been watching the monitor for hours. Natalie’s asleep now and I’m worried about her pulse. It’s edging above 140 beats per minute again and her blood oxygen saturation is becoming dangerously low. I’m convinced that she’s slipping into shock. She needs more fluids. I ring for the nurse.

I know about stuff like septic shock because for more than 20 years I was a transplant surgeon, and some of our patients got incredibly sick after surgery. So when I’m sitting in an I.C.U. in Omaha terrified that Natalie, my 17-year-old daughter, might die, I know what I’m talking about. I tell the nurse that Natalie needs to get another slug of intravenous fluids, and fast.
The nurse says she’ll call the doctor. Fifteen minutes later I find her in the lounge at a computer, and over her shoulder I see a screen full of makeup products. When I ask if we can get that fluid going, I startle her. She says she called the resident and told him the vital signs, but that he thought things were stable.
“He said to hold off for now,” she says.
“Get me two bags of saline. Now,” I tell her.
She says, “I’m calling my supervisor,” and she runs out of the lounge.
. . .
I know I shouldn’t be my daughter’s doctor. They taught us the problems with that during my first week in medical school.
. . .
But right now, I don’t care about any of that. I’m the one with experience taking care of really sick patients, and if I know she needs more fluids, she’s going to get them.
I break into the crash cart, a box on wheels full of stuff they use to resuscitate patients. I pull out two liters of saline solution and run both into Natalie’s IV in less than 20 minutes. Natalie’s pulse slows and her blood pressure rises. An hour later, after the nursing supervisor and on-call resident finally arrive, I’ve finished infusing a third liter. Natalie finally looks better.
This wasn’t the first time during Natalie’s illness eight years ago that I broke my promise to just be her dad. It started a week earlier when she came into the den and showed me the blood she’d coughed up. I suspect a father without my experience might have chalked it up to flu. Maybe because I was a transplant surgeon, and always considered the worst possible cause whenever a patient had a hiccup, I took her to the hospital. I was worried the blood meant she had a bacterial pneumonia, a bad one. And it did.
On the way to the hospital, Natalie took a deep breath and looked at me. “Am I going to die?” she asked. I’m convinced that she would have been dead before morning had I not been a doctor, and one who could recognize septic shock when it affected a normal teenager.

For the full commentary, see:
BUD SHAW. “A Doctor at His Daughter’s Hospital Bed.” The New York Times, SundayReview Section (Sun., SEPT. 6, 2015): 7.
(Note: ellipses added.)
(Note: the online version of the commentary has the date SEPT. 5, 2015.)

The commentary quoted above is adapted from the book:
Shaw, Bud. Last Night in the Or: A Transplant Surgeon’s Odyssey. New York: Plume, 2015.

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.)