Category: Health

NIH and FDA Should Allow Gene Editors to Cure Diseases

(p. A15) Should Americans be allowed to edit their DNA to prevent genetic diseases in their children? That question, which once might have sounded like science fiction, is stirring debate as breakthroughs bring the idea closer to reality. Bioethicists and activists, worried about falling down the slippery slope to genetically modified Olympic athletes, are calling for more regulation.
The bigger concern is exactly the opposite–that this kind of excessive introspection will cause patients to suffer and even die needlessly. Anachronistic restrictions at the Food and Drug Administration and the National Institutes of Health effectively ban gene-editing research in human embryos that would lead to implantation and births. These prohibitions are inhibiting critical clinical research and should be lifted immediately.
. . .
What’s holding researchers back, at least in America, is outmoded regulations. The FDA is blocked by law from accepting applications for research involving gene editing of the human germ line–meaning eggs, sperm and embryos. The NIH, whose approval also would be needed, is similarly barred from even considering applications to conduct such experiments in humans. These rules date as far back as the 1970s, when the technology was in its infancy. It’s easy to invoke hypothetical fears when actual lifesaving interventions are decades away.
Today they aren’t–and desperate patients deserve access to whatever cures this technology may be able to provide. The public thinks so, too. A survey this summer found that nearly two-thirds of Americans support therapeutic gene editing–in somatic and germ-line cells alike. Popular opinion is in tune with scientific reality. Legislators and regulators need to catch up.

For the full commentary, see:
Henry I. Miller. “Gene Editing Is Here, and Desperate Patients Want It; Two-thirds of Americans support therapeutic use, but regulators are still stuck in the 1970s.” The Wall Street Journal (Fri., OCT. 13, 2017): A15.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date OCT. 12, 2017.)

After 30 Years, Medical Entrepreneur Rosenberg’s Slow Hunch Pays Off

(p. B3) In the another significant development, the cancer institute’s prominent cancer researcher and chief of surgery, Steven A. Rosenberg, detailed for the first time an immunotherapy success against metastatic breast cancer, in a talk earlier this month.
In the lecture at a Boston meeting of the American Association of Cancer Research, Dr. Rosenberg reported on the first patient with metastatic breast cancer who is disease-free nearly two years after her first immunotherapy treatment. In the therapy, a person’s own cells are multiplied billions of times and reinfused into the patient. Dr. Rosenberg’s lab has already reported successes in treatment of melanoma, lymphoma, colorectal cancer and bile-duct cancer.
That patient is Judy Perkins, a 51-year-old structural engineer from Port St. Lucie, Fla. She was diagnosed with metastatic cancer–cancer that spread beyond the original location–in 2013.
. . .
Ms. Perkins is only one case. But the fact that she had metastatic breast cancer that is no longer detectable makes it very consequential. It follows reports from the Rosenberg lab about other internal-organ cancers, specifically colorectal and bile-duct.
. . .
Dr. Rosenberg’s interest in immunotherapy was piqued three decades ago, when he was struck by a chance encounter with a stomach-cancer patient who improbably recovered despite no treatment. This became a lifelong quest to discover how that patient had in effect cured himself. Scores of recoveries at the cancer institute of melanoma and lymphoma patients followed after immunotherapy treatment from his lab.
Now, his lab is exploring the promise of treating and accomplishing tumor regressions in far-more-common solid-tumor cancers of internal organs, including the breast, colon and bile-duct.

For the full story, see:
Thomas M. Burton. “Immunotherapy Treatments for Cancer Gain Momentum.” The Wall Street Journal (Fri., Oct. 13, 2017): B3.
(Note: ellipses added.)
(Note: the online version of the story has the date Oct. 12, 2017.)

Some Bacteria May Promote Cancer

(p. A15) A mysterious bacterium found in up to half of all colon tumors also travels with the cancer as it spreads, researchers reported on Thursday [Nov. 23, 2017].
Whether the bacterium, called Fusobacterium nucleatum, actually plays a role in causing or spurring the growth of cancer is not known. But the new study, published in the journal Science, also shows that an antibiotic that squelches this organism slows the growth of cancer cells in mice.
Scientists are increasingly suspicious that there may be a link: another type of bacteria has been discovered in pancreatic cancer cells. In both types of cancer, most tumors host bacteria; however, only a small proportion of the cells in any single tumor are infected.
“The whole idea of bacteria in tumors is fascinating and unexpected,” said Dr. Bert Vogelstein, a colon cancer researcher at Johns Hopkins.
The colon cancer story began in 2011, when Dr. Matthew Meyerson of the Dana-Farber Cancer Institute and Dr. Robert A. Holt of Simon Fraser University in British Columbia independently reported finding Fusobacteria, which normally inhabit the mouth, in human colon cancers.
That instigated a rush to confirm. Researchers around the world reported finding Fusobacteria in colon cancers, but their work only raised more questions. The new paper, by Dr. Meyerson and his colleagues, provides some answers.
. . .
Dr. Vogelstein suggests that instead of directly causing cancer, Fusobacteria might be altering patients’ immune response — and perhaps their response to treatments that use the immune system to destroy cancers.
Alternately, perhaps the bacteria are acting more directly by secreting chemicals that spur growth in nearby cancer cells, Dr. Relman said.
“It is not unreasonable to say Fusobacterium is promoting or contributing to colon cancer,” he said.
Are Fusobacteria guilty of causing cancer? If this were a criminal case, where the jury had to be convinced beyond a reasonable doubt, Dr. Meyerson said he would have to acquit.
But if it were a civil case, judged on the preponderance of the evidence, his vote would be different: Fusobacteria are guilty.

For the full story, see:
GINA KOLATA. “Study Suggests Bacteria Have Key Role in Cancer.” The New York Times (Sat., NOV. 25, 2017): A15.
(Note: ellipsis, and bracketed date, added.)
(Note: the online version of the story has the date NOV. 23, 2017, and has the title “Why Is This Bacterium Hiding in Human Tumors?”)

The Science article, discussed in the passages quoted above, is:
Bullman, Susan, Chandra S. Pedamallu, Ewa Sicinska, Thomas E. Clancy, Xiaoyang Zhang, Diana Cai, Donna Neuberg, Katherine Huang, Fatima Guevara, Timothy Nelson, Otari Chipashvili, Timothy Hagan, Mark Walker, Aruna Ramachandran, Begoña Diosdado, Garazi Serna, Nuria Mulet, Stefania Landolfi, Santiago Ramon y Cajal, Roberta Fasani, Andrew J. Aguirre, Kimmie Ng, Elena Élez, Shuji Ogino, Josep Tabernero, Charles S. Fuchs, William C. Hahn, Paolo Nuciforo, and Matthew Meyerson. “Analysis of Fusobacterium Persistence and Antibiotic Response in Colorectal Cancer.” Science (posted online (ahead of publication) on Nov. 23, 2017).

More Cures If Local Physicians Can Conduct Clinical Trials

(p. A17) The good news is that technology innovations are moving us toward modern clinical trial designs. Electronic health records, now common in U.S. medical practices, allow physicians to collect timely and detailed data that could be used for exploring ways of bringing clinical research directly to patients. Those records are becoming the technological building blocks of a new research model based on real-world evidence, which aims to provide insights regarding the usage and potential benefits or risks of a drug by analyzing patient data collected as part of routine delivery of care.
Real-world evidence captures the experience of real-world patients, who are generally more diverse than the selective cohorts enrolled in clinical trials. Additionally, real-world data from electronic health records may be used after a drug’s approval to answer important questions about its use. Researchers can, for example, search through anonymized data from patients taking a specific cancer drug to see whether those with a certain tumor mutation respond better or worse than other patients. Such information could help doctors personalize therapies based on the patient’s genomic makeup.
Moving clinical research to a doctor’s office, the point of routine care, may also address the difficulties patients and doctors face with off-label drugs. If local physicians can participate in conducting real-world randomized clinical trials in their own practices, new uses of approved drugs could be carefully studied, potentially generating evidence supporting approval of a new use. Real-world clinical trials could also limit disruptions to patients’ lives by reducing the need for long-distance travel.

For the full commentary, see:
Amy Abernethy and Sean Khozin. “Clinical Drug Trials May Be Coming to Your Doctor’s Office; Electronic medical records make possible a new research model based on real-world evidence.” The Wall Street Journal (Weds., Sept. 13, 2017): A17.
(Note: the online version of the commentary has the date Sept. 12, 2017.)

Nursing Unions “Keep Aides from Encroaching on Their Turf”

(p. B2) There are a few reasons long-term care is such a bad job. “Most people see it as glorified babysitting,” said Robert Espinoza, vice president for policy at PHI, an advocacy group for personal care workers that also develops advanced training curriculums to improve the quality of the work force.
The fact that most workers are immigrant women does not help the occupation’s status. Occupational rules that reserve even simple tasks for nurses, like delivering an insulin shot or even putting drops into a patient’s eye, also act as a barrier against providing care workers with better training.
. . .
. . . there are the powerful nursing unions, ready to fight tooth and nail to keep aides from encroaching on their turf. Carol Raphael, former chief executive of the Visiting Nurse Service of New York, the largest home health agency in the United States, told Professor Osterman that when the association tried to expand the role of home-care aides, the “nurses went bonkers.”

For the full commentary, see:
Porter, Eduardo. “ECONOMIC SCENE; Rethinking Home Health Care as a Path to the Middle Class.” The New York Times (Weds., AUG. 30, 2017): B1-B2.
(Note: ellipses added.)
(Note: the online version of the commentary has the date AUG. 29, 2017, and has the title “ECONOMIC SCENE; Home Health Care: Shouldn’t It Be Work Worth Doing?”)

“There Comes a Time When You Get Tired of Being a Slave”

(p. A1) RIO DE JANEIRO — In a rare act of collective defiance, scores of Cuban doctors working overseas to make money for their families and their country are suing to break ranks with the Cuban government, demanding to be released from what one judge called a “form of slave labor.”
Thousands of Cuban doctors work abroad under contracts with the Cuban authorities. Countries like Brazil pay the island’s Communist government millions of dollars every month to provide the medical services, effectively making the doctors Cuba’s most valuable export.
But the doctors get a small cut of that money, and a growing number of them in Brazil have begun to rebel. In the last year, at least 150 Cuban doctors have filed lawsuits in Brazilian courts to challenge the arrangement, demanding to be treated as independent contractors who earn full salaries, not agents of the Cuban state.
“When you leave Cuba for the first time, you discover many things that you had been blind to,” said Yaili Jiménez Gutierrez, one of the doctors who filed suit. “There comes a time when you get tired of being a slave.”
. . .
(p. A10) . . . , Dr. Jiménez, 34, found the work rewarding, but also began to harbor feelings of resentment.
“You are trained in Cuba and our education is free, health care is free, but at what price?” she said. “You wind up paying for it your whole life.”
. . .
“We keep one another strong,” said Dr. Jiménez, who says she has been unemployed since being fired in June and is now barred from re-entering Cuba for eight years.
Dr. Álvarez and her husband were among the lucky ones to keep their jobs and get what amounted to a huge pay raise. They also managed to bring their children to Brazil.
“It’s sad to leave your family and friends and your homeland,” she said. “But here we’re in a country where you’re free, where no one asks you where you’re going, or tells you what you have to do. In Cuba, your life is dictated by the government.”

For the full story, see:
ERNESTO LONDOÑO. “‘Slave Labor'”: Cuban Doctors Rebel in Brazil.” The New York Times (Fri., SEPT. 29, 2017): A1 & A10.
(Note: ellipses added.)
(Note: the online version of the story has the title “Cuban Doctors Revolt: ‘You Get Tired of Being a Slave’.”)

Washington, D.C. Regulators Protect Citizens from Goat Yoga

GoatYogaInGlendaleCalifornia2017-10-09.jpg“Goat yoga has spread nationwide since last year. Practitioners in Glendale, Calif., in May.” Source of caption and photo: online version of the WSJ article quoted and cited below.

(p. A1) WASHINGTON–Young goats have on occasion grazed in the Historic Congressional Cemetery, deployed to keep down brush. A yoga instructor has been holding weekly classes in the chapel.

Goats and yoga go together, as any modern yogi knows. So, cemetery staff proposed this spring, why not combine them and bring inner peace to all on the grounds?
“I asked the farmer if there’s any harm to the goats doing yoga,” says Kelly Carnes, who teaches the discipline on the cemetery grounds. “She said quite the opposite–the baby goats just love to interact with humans.”
Gruff was the response from District of Columbia officials. District policy, they decreed, prohibited the human-animal contact goat yoga presented: “At this time the request for the event with the inclusion of baby goats has been denied.”
. . .
(p. A12) This spring at the Congressional Cemetery, Ms. Carnes read about goat yoga and raised the idea with participants in her “yoga mortis” classes at the cemetery. They were “crazy to try it,” she says.
She spoke with Paul Williams, president of the nonprofit that manages the cemetery, about trying it with the goats they had twice hired over the past several years to eat down unwanted plants.
The cemetery planned to hold goat classes in a pen in a grassy area. In June, Mr. Williams sought permission from the health department.
The “no” came that month. The capital’s health code, says Dr. Vito DelVento, manager of the District of Columbia Department of Health’s animal-services program, bans animals beyond common household pets from within district limits.
. . .
Then there’s Washington’s “no touch” policy barring direct contact between humans and animals beyond household pets.
“Baby goats are probably one of the most fun animal species–they are a blast,” says Dr. DelVento, who has farm animals outside the District and has raised goats. “But the fact that we have baby goats jumping on people and interacting with people obviously violates our ‘no touch’ policy.”
Mr. Williams says he will try again next year when Mrs. Bowen has a fresh herd of kids. He will seek a no-touch-policy exemption.
“We’re really trying to offer a service,” says Mrs. Bowen, “that is good for people’s mental health and physical health.”

For the full story, see:
Daniel Nasaw. “The Kids Are Not Alright: Bureaucrats Buck Goat Yoga.” The Wall Street Jounal (Sat., OCT. 2, 2017): A1 & A12.
(Note: ellipses added.)
(Note: the online version of the story has the date OCT. 1, 2017, and has the title “Goat Yoga, Meet the Zoning Board.”)

Every Dog Should Have His Day, Including Togo

(p. A23) Central Park in New York has two Columbus statues, one a 76-foot-tall whopper at, um, Columbus Circle. The park is a sort of mass market for historical markers — 29 statues, along with multitudinous plaques, busts, carved panels and memorial groves. Most of them are accompanied by critics. A park official once told me the only noncontroversial statue on the premises was Balto, the hero sled dog.
Balto was famous for bringing critical diphtheria serum to the then almost unreachable town of Nome, Alaska, in the winter in 1925. He was a real celebrity in his time. But I am sorry to tell you that he actually has had detractors.
“It was almost more than I could bear when the ‘newspaper dog’ Balto received a statue for his ‘glorious achievements,'” sniped sled driver Leonhard Seppala, whose team ran the longest stretch of the 674-mile Serum Run. Seppala felt very strongly that his lead dog, Togo, was the true hero of the day.
On your behalf I have been looking into this controversy, and I would say it’s possible Togo’s cheerleaders had a point.

For the full commentary, see:

Collins, Gail. “Dogs, Saints and Columbus Day.” The New York Times (Sat., Oct. 7, 2017): A23.
(Note: the online version of the commentary has the date Oct. 6, 2017,)

Animals Can Benefit from Humane Animal Research

(p. A17) Dog owners may soon be able to add years to their pets’ lives, thanks to an experimental antiaging pill. In tests on mice the medication, rapamycin, has been shown to lengthen lifespans up to 60%. Now scientists at the University of Washington’s Dog Aging Project are studying whether it works in canines.
Initial reports indicate the drug improves heart health. Researchers speculate that if larger trials are successful, rapamycin could extend a dog’s life by five years. Animal lovers the world over must be jumping up and down in excitement, right?
Wrong. In fact, many animal-rights groups strongly oppose the studies–as they do almost any studies involving animals.
. . .
If these groups truly advocate for animals, their logic is backward. Nearly 70% of American households have pets. Those animals’ food and vaccines all have been developed through humane research and testing with lab animals.
. . .
Animals are living longer, healthier lives because of these scientists. Discouraging studies condemns animals to unnecessary suffering and death from preventable illnesses. Real animal lovers should be proud to support animal research.

For the full commentary, see:
Matthew R. Bailey. “Love Your Dog, Support Animal Research; Endangered species as well as pets benefit from humane testing.” The Wall Street Journal (Mon., Sept. 18, 2017): A17.
(Note: ellipses added.)
(Note: the online version of the commentary has the date Sept. 17, 2017.)

Costs Rise in Single-Payer Health Countries

(p. A25) As Democrats and other policy makers debate the merits of Senator Sanders’s proposal, here are a few important observations about international systems that they ought to consider.
First, a vanishingly small number of countries actually have single-payer systems. . . .
. . .
Some of the highest-rated international systems rely on private health insurers for most health care coverage — Germany’s, for example, is something like Obamacare exchanges for everyone, but significantly simpler and truly universal. The Netherlands and Switzerland have both moved recently to add more competition and flexibility to systems that were already built on the use of private insurers.
Second, single-payer countries have also failed to control rising health care costs. This is important, given that Mr. Sanders’s proposal was released without a cost estimate or financing plan. For historical reasons, many other countries started with lower levels of health care spending than we did. Several analyses have shown that this has almost nothing to do with higher administrative costs or corporate profits in the United States and almost everything to do with the higher cost of health care services and the higher salaries of providers here.
Although they started at a lower base — with, for example, doctors and nurses receiving lower salaries — countries around the world have all struggled with rising costs. From 1990 to 2012, the United States’ rate of health care cost growth was below that of many countries, including Japan and Britain. In 2015, the Organization for Economic Cooperation and Development warned that rising health care costs across all countries were unsustainable.behavior, more hotel rooms are available to individuals and families who need them most.”
Third, it is simply untrue that single-payer systems produce a better quality of care across the board.

For the full commentary, see:
LANHEE J. CHEN and MICAH WEINBERG. “‘Medicare for All’ Is No Miracle Cure.” The New York Times (Tues., Sept. 19, 2017): A25.
(Note: ellipses added.)
(Note: the online version of the commentary has the title “The Sanders Single-Payer Plan Is No Miracle Cure.”)

Regulations Reduce Health Care Quality and Increase Health Care Cost

(p. A15) There are two million home health aides in the U.S. They spend more time with the elderly and disabled than anyone else, and their skills are essential to their clients’ quality of life. Yet these aides are poorly trained, and their national median wage is only a smidgen more than $10 an hour.
The reason? State regulations–in particular, Nurse Practice Acts–require registered nurses to perform even routine home-care tasks like administering eyedrops. That duty might not require a nursing degree, but defenders of the current system say aides lack the proper training. “What if they put in the cat’s eyedrops instead?” a health-care consultant asked me. In another conversation, the CEO of a managed-care insurance company wrote off home-care aides as “minimum wage people.”
But aides could do more. With less regulation and better training, they could become as integral to health-care teams as doctors and nurses. That could improve the quality of care while saving buckets of money for everyone involved.
. . .
. . . the potential cost savings are considerable. There are 2.3 million Medicaid patients receiving long-term care at home. Imagine if even half of them replaced one hourlong nurse’s visit a month with a stop by a trained aide. Assuming the nurse makes $35 an hour and the aide $15, that’s an immediate savings of roughly $275 million a year.

For the full commentary, see:
Paul Osterman. “Why Home Care Costs Too Much; Regulations often require that nurses do simple tasks like administer eyedrops.” The Wall Street Journal (Weds., Sept. 13, 2017): A15.
(Note: ellipses added.)
(Note: the online version of the commentary has the date Sept. 12, 2017.)

The commentary, quoted above, is related to the author’s book:
Osterman, Paul. Who Will Care for Us? Long-Term Care and the Long-Term Workforce. New York: Russell Sage Foundation, 2017.