Category: Health

Regulations Slow Eradication of Cancer

(p. D3) . . . the triumph of chemotherapy for Hodgkin’s and then for many other tumors opened an interlocking series of dilemmas. In the clinic and the hospital, the new protocols demanded that doctors muster the courage to make their patients very sick in order to make them well. But how sick was too sick? The risks and benefits of the powerful treatments now needed careful, deliberate assessment at every stage of the disease.
Similar questions dogged those who developed, evaluated and regulated the drugs. How poisonous could these agents safely be? How assiduously should desperate patients be saved by their government from pharmaceutical risk?
Dr. DeVita stands firmly among those affirming cancer patients’ right to aggressive treatment. One particular exchange summarizes his philosophy: “Do your patients speak to you after you do this to them?” one skeptic asked him early on. “The answer is yes,” he replied, “and for a lot longer.”
The regulatory caution of the Food and Drug Administration has been a thorn in his side for decades: “I’d like to be able to say that as cancer drugs have become increasingly more complex and sophisticated, the F.D.A. has as well. But it has not.” In fact, he writes, “the rate-limiting step in eradicating cancer today is not the science but the regulatory environment we work in.”

For the full review, see:
ABIGAIL ZUGER, M.D. “An Unbowed Warrior.” The New York Times (Tues., Dec.. 1, 2015): D3.
(Note: ellipsis added.)
(Note: the online version of the review has the date NOV. 30, 2015, and has the title “Review: Science and Politics Collide in ‘The Death of Cancer’.”)

The book under review, is:
DeVita, Vincent T., and Elizabeth DeVita-Raeburn. The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable–and How We Can Get There. New York: Sarah Crichton Books, 2015.

Anti-GMO Chipotle No Longer Wears Health Halo

(p. A13) . . . if you need an anecdote for how the year unfolded for the anti-GMO movement, look no further than Chipotle. Last spring the fast food company announced with great fanfare that it would take GMO ingredients off its menu. It was all downhill after that. As was quickly pointed out, Chipotle wasn’t being fully truthful, since its soft drinks and cheese contain genetically modified ingredients, and its meat comes from animals fed genetically modified grains. A lawsuit filed in California, which is pending, accused Chipotle of false advertising and deceptive marketing.
Then cases of food-borne illnesses hit Chipotle locations across the country. Supporters of traditional agriculture, who have felt maligned by the burrito company, started keeping a tally of the number of people sickened by Chipotle’s food (ongoing, but more than 300) versus the number sickened by GMOs (zero). As the year winds to a close, the company that once wore the restaurant industry’s health halo is apologizing, preparing for lawsuits, recentralizing its vegetable preparation and cutting locally sourced ingredients.

For the full commentary, see:
JULIE KELLY. “The March of Genetic Food Progress; ‘Farmaceuticals’ and other GM products are slowly being approved, despite political scare campaigns.” The Wall Street Journal (Weds., Dec. 30, 2015): A13.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date Dec. 29, 2015.)

Parents Set Up For-Profit Companies for Quicker Cures

(p. B1) Karen Aiach was working as a management consultant when she learned that her first daughter, Ornella, had Sanfilippo syndrome, a rare disease in which a missing enzyme causes toxic substances to build up in the body.

Ornella was 6 months old, and the prognosis was grim: She would develop mentally and physically to between ages 2 and 4, plateau and then lose whatever she had learned. She would become extremely hyperactive and develop sleeping disorders. Most likely she would not live past 15.
Within two years of the diagnosis, Ms. Aiach, who lives in a Paris suburb, had quit her consulting job to learn everything she could about the disease. She hired a neurobiologist to guide her in the world of medical research. And when she learned that few treatments were in the works, she founded a company called Lysogene to focus on genetic therapy.
Instead of raising money and awareness by setting up a nonprofit foundation, a more typical route, she opted to start a for-profit company to seek treatments, if not a cure. Far from common, what Ms. Aiach and other parents like her are trying is to leverage their wealth, contacts and the hope of sophisticated investors to jump-start research into rare diseases.
. . .
(p. B4) . . . with some rare diseases, where minimal research has been done, a little effort goes a long way.
Nicole Boice, who founded Global Genes, one of the leading rare-disease patient advocacy organizations, said even small investments can have meaningful impacts.
“You can start moving the needle with $3,500,” she said. “That leads you to the next $25,000, and then to innovation grants and funding at $100,000. That starts the interest from biotech.”
Gradually, parents like Matt Wilsey, a technology entrepreneur, have made headway. First, his family spent the better part of four years trying to figure out what afflicted his daughter, Grace, now 6. Even after her genome was sequenced, the first diagnosis turned out to be wrong. Grace, it finally was determined, was the second person in the world known to have a deficiency in the gene known as NGLY1.
“We went around the country,” Mr. Wilsey said. “We were just trying to find one doctor who had seen another patient with these symptoms.” After years of efforts, several dozen children have been found to have the same deficiency.
“Our goal is to find a cure,” said Mr. Wilsey, who lives in the San Francisco area.
“A lot of people in science dismiss that because cures are rare. But when I say cures, they’re not going to be astronauts. They’re going to be leading some sort of independent life. They’re going to be able to eat without choking. They’re going to be able to take a bath without drowning. They’re going to be able to communicate, whether with some assistive device or not.”
These parents also had a successful model to follow. In 1998, John Crowley left his job at Bristol-Myers Squibb to start a biotechnology company to search for a treatment for Pompe disease, a neuromuscular disorder that two of his children had. Within four years, the company, Novazyme Pharmaceuticals, had devised a treatment that he credits with saving their lives. His story was immortalized in the 2010 film “Extraordinary Measures,” starring Harrison Ford. And his company was bought by the pharmaceutical giant Genzyme for $137.5 million in 2001.

For the full story, see:
PAUL SULLIVAN. “Wealth Matters; Parents of Children With Rare Diseases Find Hope in For-Profit Companies.” The New York Times (Sat., DEC. 26, 2015): B1 & B4.
(Note: ellipsis added.)
(Note: the online version of the story has the date DEC. 25, 2015, and has the title “Wealth Matters; Building a Company to Treat a Rare Disease.”)

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.