Category: Health

Fewer Regulations Allow Faster Chinese Cancer Innovation

(p. A1) HANGZHOU, China–In a hospital west of Shanghai, Wu Shixiu since March has been trying to treat cancer patients using a promising new gene-editing tool.
U.S. scientists helped devise the tool, known as Crispr-Cas9, which has captured global attention since a 2012 report said it can be used to edit DNA. Doctors haven’t been allowed to use it in human trials in America. That isn’t the case for Dr. Wu and others in China.
In a quirk of the globalized technology arena, Dr. Wu can forge ahead with the tool because he faces few regulatory hurdles to testing it on humans. His hospital’s review board took just an afternoon to sign off on his trial. He didn’t need national regulators’ approval and has few reporting requirements.
Dr. Wu’s team at Hangzhou Cancer Hospital has been drawing blood from esophageal-cancer patients, shipping it by high-speed rail to a lab that modifies disease-fighting cells using Crispr-Cas9 by deleting a gene that interferes with the immune system’s ability to fight cancer. His team then infuses the cells (p. A10) back into the patients, hoping the reprogrammed DNA will destroy the disease.
In contrast, what’s expected to be the first human Crispr trial outside China has yet to begin. The University of Pennsylvania has spent nearly two years addressing federal and other requirements, including numerous safety checks designed to minimize risks to patients. While Penn hasn’t received final federal clearance to proceed, “we hope to get clearance soon,” a Penn spokeswoman said.
“China shouldn’t have been the first one to do it,” says Dr. Wu, 53, an oncologist and president of Hangzhou Cancer Hospital. “But there are fewer restrictions.”

For the full story, see:
Rana, Preetika, Amy Dockser Marcus and Wenxin Fan. “China Races Ahead In Gene Editing.” The Wall Street Journal (Monday, January 22, 2018): A1 & A10.
(Note: the online version of the story has the date Jan. 21, 2018, and has the title “China, Unhampered by Rules, Races Ahead in Gene-Editing Trials.”)

Canada’s Single-Payer System Causes “Suffering and Deaths of People on Wait Lists”

(p. A17) Canada’s single-payer health-care system, known as Medicare, is notoriously sluggish. But private clinics like Cambie are prohibited from charging most patients for operations that public hospitals provide free. Dr. Day is challenging that prohibition before the provincial Supreme Court.
. . .
People stuck on Medicare waiting lists can only dream of timely care. Last year, the median wait between referral from a general practitioner and treatment from a specialist was 21.2 weeks, or about five months–more than double the wait a quarter-century ago. Worse, the provincial governments lie about the extent of the problem. The official clock starts only when a surgeon books the patient, not when a general practitioner makes the referral. That adds months and sometimes much longer. In November [2017] an Ontario woman learned she’d have to wait 4½ years to see a neurologist.
. . .
Dr. Day’s lawsuit aims to overturn these provisions. It alleges that the government’s legal restrictions on private care are to blame for the needless “suffering and deaths of people on wait lists.” Dr. Day argues that the current system violates citizens’ rights to “life, liberty, and security of the person,” as guaranteed by the Canadian Charter of Rights and Freedoms, the equivalent of the U.S. Bill of Rights.

For the full commentary, see:
Sally C. Pipes. “Single-Payer Health Care Isn’t Worth Waiting For; An orthopedic surgeon challenges Canada’s ban on most privately funded procedures.” The Wall Street Journal (Monday, January 22, 2018): A17.
(Note: ellipses, and bracketed year, added.)
(Note: the online version of the commentary has the date Jan. 21, 2018.)

No Known Maximum Life Span

(p. D3) Since 1900, average life expectancy around the globe has more than doubled, thanks to better public health, sanitation and food supplies. But a new study of long-lived Italians indicates that we have yet to reach the upper bound of human longevity.
“If there’s a fixed biological limit, we are not close to it,” said Elisabetta Barbi, a demographer at the University of Rome. Dr. Barbi and her colleagues published their research Thursday [sic] in the journal Science.
. . .
Dr. Barbi and her colleagues combed through Italy’s records to find every citizen who had reached the age of 105 between 2009 and 2015. To validate their ages, the researchers tracked down their birth certificates.
The team ended up with a database of 3,836 elderly Italians. The researchers tracked down death certificates for those who died in the study period and determined the rate at which various age groups were dying.
It’s long been known that the death rate starts out somewhat high in infancy and falls during the early years of life. It climbs again among people in their thirties, finally skyrocketing among those in their seventies and eighties.
. . .
Among extremely old Italians, they discovered, the death rate stops rising — the curve abruptly flattens into a plateau.
The researchers also found that people who were born in later years have a slightly lower mortality rate when they reach 105.
“The plateau is sinking over time,” said Kenneth W. Wachter, a demographer at the University of California, Berkeley, who co-authored the new study. “Improvements in mortality extend even to these extreme ages.”
“We’re not approaching any maximum life span for humans yet,” he added.

For the full story, see:
Zimmer, Carl. “What Is the Limit of Our Life Span?” The New York Times (Tuesday, July 3, 2018): D3.
(Note: ellipses added.)
(Note: the online version of the story has the date June 28, 2018, and has the title “How Long Can We Live? The Limit Hasn’t Been Reached, Study Finds.” The NYT article says the Science article was published on “Thursday,” but the citation for it that I found says it was published on Fri., June 29, 2018.)

The Science article mentioned above, is:
Barbi, Elisabetta, Francesco Lagona, Marco Marsili, James W. Vaupel, and Kenneth W. Wachter. “The Plateau of Human Mortality: Demography of Longevity Pioneers.” Science 360, no. 6396 (June 29, 2018): 1459-61.

“A Big Step Toward Regenerative Medicine”

(p. C9) Mr. Zimmer, a New York Times science columnist and author, is careful and well-informed. So when he says that research is overturning things you were taught in biology classes, he’s worth heeding. Acquired traits can be inherited. Biological time can turn backward.
. . .
The bigger breakthroughs are more fundamental. One is the development of induced pluripotent stem cells. By adding four proteins to adult cells, scientists have learned how to make them embryonic–“turning back developmental time,” as Mr. Zimmer puts it. This is a big step toward regenerative medicine, which can grow spare parts customized for your body. It also creates new ways of making babies.
. . .
Another breakthrough is gene editing. Through a process called Crispr, which tags DNA segments for deletion, we’re learning how to program cells to make specific changes to their genomes. We’re also learning how to program organisms to pass down these editing instructions to their progeny. Experiments have shown that this technology could, at some point, cure hereditary diseases such as cystic fibrosis. In addition, scientists think it could wipe out destructive rodents and malaria-carrying mosquitoes.

For the full review, see:
William Saletan. “‘Biology’s Strange New World. Acquired traits can be inherited. Biological time can turn backward. And monsters are real.” The Wall Street Journal (Saturday, June 30, 2018): C9.
(Note: ellipses added.)
(Note: the online version of the review has the date June 28, 2018, and has the title “”She Has Her Mother’s Laugh’ Review: Biology’s Strange New World. Acquired traits can be inherited. Biological time can turn backward. And monsters are real.”)

The book under review, is:
Zimmer, Carl. She Has Her Mother’s Laugh: The Powers, Perversions, and Potential of Heredity. New York: Dutton, 2018.

Experimental Immunotherapy Holds Hope of Curing Metastasized Solid Tumor Cancers

(p. B3) WASHINGTON–A novel immunotherapy method led to complete regression of breast cancer in a metastatic patient unresponsive to all other treatments, National Cancer Institute researchers said, suggesting a way to reverse some other internal-organ cancers.
The findings, from the NCI laboratory headed by Steven A. Rosenberg, were published Monday in the medical journal Nature Medicine.
The scientific report largely focused on the course of treatment for one patient, Judy Perkins of Port St. Lucie, Fla.
. . .
The research remains experimental, Dr. Rosenberg said in an interview.
“But because this new approach to immunotherapy is dependent on mutations, not on cancer type, it is in a sense a blueprint we can use for the treatment of many types of cancer,” he said. “This could be the future of immunotherapy.”
Dr. Rosenberg, who has investigated for three decades how the immune system can be employed to fight cancer, said he is hopeful this approach “holds the best opportunities for finding effective immunotherapies for patients with the solid tumors that last year caused over 500,000 deaths in this country.”

For the full story, see:
Thomas M. Burton. “Cancer-Fighting ‘Blueprint’ Seen.” The Wall Street Journal (Tuesday, June 5, 2018): B3.
(Note: ellipsis added.)
(Note: the online version of the story has the date June 4, 2018, and has the title “Novel Immunotherapy Method Led to Complete Regression of Breast Cancer in Patient.”)

Hot Students Learn Less

More evidence on why air conditioning increases our mental acuity:

(p. A5) Hot weather makes it more difficult for high-school students to learn, a new study suggests.
. . .
The study was circulated by the National Bureau of Economic Research as a working paper by Mr. Goodman and three other researchers.
They found that, on average, every increase of 1 degree Fahrenheit in the average temperature during the school year reduced learning by about 1%.

For the full story, see:
Ben Leubsdorf. “Heat Found to Hurt Studies.” The Wall Street Journal (Friday, June 8, 2018): A5.
(Note: ellipsis added.)
(Note: the online version of the story has the date June 7, 2018, and has the title “American Students Don’t Learn Well When It’s Hot Outside.” The online version is substantially longer, and in some places has different wording, than the print version. Where the wording of a quoted passage differs, my quotation above follows the print version.)

The NBER paper, mentioned above, is:
Goodman, Joshua, Michael Hurwitz, Jisung Park, and Jonathan Smith. “Heat and Learning.” National Bureau of Economic Research (NBER) Working Paper Series, # 24639, May 2018.

Lack of “Air-Conditioning Can Be Deadly”

(p. A10) The number of air-conditioners worldwide is predicted to soar from 1.6 billion units today to 5.6 billion units by midcentury, according to a report issued Tuesday by the International Energy Agency.
. . .
While 90 percent of American households have air-conditioning, “When we look in fact at the hot countries in the world, in Africa, Asia, Latin America and the Middle East, where about 2.8 billion people live, only about 8 percent of the population owns an air-conditioner,” said Fatih Birol, executive director of the energy agency.
As incomes in those countries rise, however, more people are installing air-conditioners in their homes. The energy agency predicts much of the growth in air-conditioning will occur in India, China and Indonesia.
Some of the spread is simply being driven by a desire for comfort in parts of the world that have always been hot.
. . .
And when it gets hot, forgoing air-conditioning can be deadly. The heat wave that plagued Chicago in 1995 killed more than 700 people, while the 2003 European heat wave and 2010 Russian heat wave killed tens of thousands each.

For the full story, see:
Kendra Pierre-Louis. “World Tries to Stay Cool, but It Could Warm Earth.” The New York Times (Friday, May 18, 2018): A10.
(Note: ellipses added.)
(Note: the online version of the story has the date May 15, 2018, and has the title “The World Wants Air-Conditioning. That Could Warm the World.”)

Ancient Skeletons Harbor a Common Cause of Liver Cancer

(p. A9) Scientists reported on Wednesday [May 9, 2018] that they have recovered DNA from the oldest viruses known to have infected humans — and have succeeded in resurrecting some of them in the laboratory.
The viruses were all strains of hepatitis B. Two teams of researchers independently discovered its DNA in 15 ancient skeletons, the oldest a farmer who lived 7,000 years ago in what is now Germany.
Until now, the oldest viral DNA ever recovered from human remains was just 450 years old.
The research may provide clues to the continuing evolution of hepatitis B, a plague that infects an estimated 257 million people worldwide and contributes to an epidemic of liver cancer.
. . .
Chronic infections can lead to liver cancer. Each year, the World Health Organization estimates, hepatitis B kills 887,000 people. Researchers have long wondered how it became a worldwide menace.
. . .
. . . the skeletons in which the Cambridge geneticists found hepatitis range from 820 to 4,500 years old. The research, published in the journal Nature, demonstrates that hepatitis B existed across Europe and Asia as early as the Bronze Age.
. . .
Johannes Krause and his colleagues examined DNA extracted from the teeth of 53 ancient people in what is now Germany. Three of them were infected with hepatitis B, it turned out: one who lived about 1,000 years ago, a second person who lived 5,300 years ago and a third who lived 7,000 years ago.
. . .
Dr. Krause and his colleagues found that their Stone Age viruses were most closely related to strains of hepatitis B found today only in chimpanzees and gorillas.
He speculated that the virus jumped from apes to humans early in the history of our species in Africa. “It’s more likely this is really an old pathogen in humans for the last hundred thousand years or more,” he said.

For the full story, see:
Zimmer, Carl. “In Ancient Skeletons, Scientists Discover a Modern Foe: Hepatitis B.” The New York Times (Thursday, May 10, 2018): A9.
(Note: ellipses, and bracketed date, added.)
(Note: the online version of the story has the date MAY 9, 2018. The print version cited above is the National Edition.)

The paper by the Cambridge geneticists, mentioned above, is:
Mühlemann, Barbara, Terry C. Jones, Peter de Barros Damgaard, Morten E. Allentoft, Irina Shevnina, Andrey Logvin, Emma Usmanova, Irina P. Panyushkina, Bazartseren Boldgiv, Tsevel Bazartseren, Kadicha Tashbaeva, Victor Merz, Nina Lau, Václav Smrčka, Dmitry Voyakin, Egor Kitov, Andrey Epimakhov, Dalia Pokutta, Magdolna Vicze, T. Douglas Price, Vyacheslav Moiseyev, Anders J. Hansen, Ludovic Orlando, Simon Rasmussen, Martin Sikora, Lasse Vinner, Albert D. M. E. Osterhaus, Derek J. Smith, Dieter Glebe, Ron A. M. Fouchier, Christian Drosten, Karl-Göran Sjögren, Kristian Kristiansen, and Eske Willerslev. “Ancient Hepatitis B Viruses from the Bronze Age to the Medieval Period.” Nature 557, no. 7705 (May 9, 2018): 418-23.

The paper co-authored by Krause, and mentioned above, is:
Krause-Kyora, Ben, Julian Susat, Felix M. Key, Denise Kühnert, Esther Bosse, Alexander Immel, Christoph Rinne, Sabin-Christin Kornell, Diego Yepes, Sören Franzenburg, Henrike O. Heyne, Thomas Meier, Sandra Lösch, Harald Meller, Susanne Friederich, Nicole Nicklisch, Kurt W. Alt, Stefan Schreiber, Andreas Tholey, Alexander Herbig, Almut Nebel, and Johannes Krause. “Neolithic and Medieval Virus Genomes Reveal Complex Evolution of Hepatitis B.” eLife 7 (2018): e36666.

Retail Clinics Grow as Office Visits to Physicians Decline

(p. 1) Is the doctor in?
In this new medical age of urgent care centers and retail clinics, that’s not a simple question. Nor does it have a simple answer, as primary care doctors become increasingly scarce.
“You call the doctor’s office to book an appointment,” said Matt Feit, a 45-year-old screenwriter in Los Angeles who visited an urgent care center eight times last year. “They’re only open Monday through Friday from these hours to those hours, and, generally, they’re not the hours I’m free or I have to take time off from my job.
“I can go just about anytime to urgent care,” he continued, “and my co-pay is exactly the same as if I went to my primary doctor.”
That’s one reason big players like CVS Health, the drugstore chain, and most recently Walmart, the giant retailer, are eyeing deals with Aetna and Humana, respectively, to use their stores to deliver medical care.
People are flocking to retail clinics and urgent care centers in strip malls or shopping centers, where simple health needs can usually be tended to by health professionals like nurse practitioners or physician assistants much more cheaply than in a doctor’s office. Some 12,000 are already scattered across the country, according to Merchant Medicine, a consulting firm.
On the other side, office visits to primary care doctors declined 18 percent from 2012 to 2016, even as visits to specialists increased, insurance data analyzed by the Health Care Cost Institute shows.

For the full story, see:
REED ABELSON and JULIE CRESWELL. “Merger Medicine and the Disappearing Doctor.” The New York Times, SundayBusiness Section (Sunday, April 8, 2018): 1 & 7.
(Note: the online version of the story has the date APRIL 7, 2018, and has the title “The Disappearing Doctor: How Mega-Mergers Are Changing the Business of Medical Care.”)

Big Pharma Is Mellow about FDA Obstacles to Innovation

It sometimes appears that big pharma is comfortable with the hugely expensive FDA drug approval process. Perhaps big pharma firms have learned how to navigate the process and have the resources to do so. And perhaps the process discourages disruptive innovations from small medical startups that have not learned how to navigate the process, and do not have the resources to do so. If so, then the puzzling indifference of big pharma indicated in the passages quoted below, becomes easier to understand.
(There’s a wonderful recent TV ad from big pharma supporting innovation by quoting the Dylan Thomas poem saying we should “rage, rage against the dying of the light.” If only they really meant it.)

(p. A13) In recent years, the arrival of breakthrough drugs for everything from cancer to rare diseases has led to a surge in the number of patients wanting early access to treatments. The pleas — sometimes driven by viral social media campaigns — have proved vexing for companies that have invested millions to get a drug to market and are wary of doing anything to jeopardize their chances.

Today, companies’ policies on granting early access to drugs are a confusing patchwork that tends to favor affluent and well-connected patients at leading medical centers, who have the resources and know-how to navigate the system.
“You have to be pretty sophisticated,” said Dr. Arthur L. Caplan, a bioethicist at New York University who has been working with companies, including Johnson & Johnson, to develop better early-access programs. But the bill passed this week, he said, “does somewhere between nothing and absolutely nothing to help you.”
The bill’s passage represented a victory for proponents of “right to try,” a campaign championed by Vice President Mike Pence and initiated by the Goldwater Institute, a libertarian think tank that favors limiting the scope of the F.D.A. At least 38 states have passed local versions of right-to-try laws, which allow patients to sidestep F.D.A. approval once they have received permission from a company.
The right-to-try measures are opposed by a broad coalition of groups, which contend the bill will not help patients and will undermine the authority of the primary regulatory agency, the F.D.A. Four former F.D.A. commissioners, including two each from Democratic and Republican administrations, oppose the bills, as do dozens of patient groups, including the American Cancer Society Cancer Action Network and the American Lung Association.
The pharmaceutical industry, while not taking a position on the issue, has been circumspect. A spokesman for its main lobbying group, the Pharmaceutical Research and Manufacturers of America, said on Friday, “We believe any legislation must truly benefit and protect patients and not disrupt the future of clinical trials, U.S. Food and Drug Administration oversight and the research and approval of new medicines.”
. . .
The F.D.A. already approves 99 percent of such applications, and the agency has streamlined the approval process. Drug companies also have many other reasons to bar access — often, companies do not have enough extra product to give to patients, or they worry that the logistical work of granting access could slow efforts to get the drug approved, when it would become available to any patient who needed it.
There is also the possibility that the drug does not work — many experimental products fail in late-stage trials.
. . .
“In our view, the F.D.A. plays a really important role,” Dr. Joanne Waldstreicher, the chief medical officer of Johnson & Johnson, said in an interview Thursday. Johnson & Johnson initiated a program in 2015 that delegates decisions about early access to a program set up by Dr. Caplan. The F.D.A., Dr. Waldstreicher said, has “information that we don’t have necessarily; they see safety and efficacy information on products that may be similar.”

For the full story, see:
KATIE THOMAS. “For Terminally Ill People, a Convoluted Procedure Just to Give Drugs a Try.” The New York Times (Saturday, March 24, 2018): A13.
(Note: ellipses added.)
(Note: the online version of the story has the date March 23, 2018, and has the title “Why Can’t Dying Patients Get the Drugs They Want?”)

On Strokes, Doctors Decide for Patients, Even When Patient’s Family Knows More

(p. D1) It was one of those findings that would change medicine, Dr. Christopher Lewandowski thought.
For years, doctors had tried — and failed — to find a treatment that would preserve the brains of stroke patients. The task was beginning to seem hopeless: Once a clot blocked a blood vessel supplying the brain, its cells quickly began to die. Patients and their families could only pray that the damage would not be too extensive.
But then a large federal clinical trial proved that a so-called clot-buster drug, tissue plasminogen activator (T.P.A.), could prevent brain injury after a stroke by opening up the blocked vessel. Dr. Lewandowski, an emergency medicine physician at Henry Ford Health System in Detroit and the trial’s principal investigator, was ecstatic.
“We felt the data was so strong we didn’t have to explain it” in the published report, he said.
He was wrong. That groundbreaking clinical trial concluded 22 years ago, yet Dr. Lewandowski and others are still trying to explain the data to a powerful contingent of doubters.
The skeptics teach medical students that T.P.A.is dangerous, causing brain hemorrhages, and that the studies that found a benefit were deeply flawed. Better to just let a stroke run its course, they say.
It’s a perspective with real-world consequences. Close to 700,000 patients have strokes caused by blood clots each year and could be helped by T.P.A. Yet up to 30 percent of stroke victims who arrive at hospitals on time and are perfect candidates for the clot-buster do not receive it.
The result: paralysis and muscle weakness; impaired cognition, speech or vision; emotional and behavioral dysfunction; and many other permanent neurological injuries.
Stroke treatment guidelines issued by the American Heart Association and the American Stroke Association strongly endorse T.P.A. for patients after they’ve been properly evaluated. But treatment must start within three hours (in some cases, four(p. D4)-and-a-half hours) of the stroke’s onset, and the sooner, the better.
A number of medical societies also endorse the treatment as highly effective in reducing disability. The drug can cause or exacerbate cerebral hemorrhage, or bleeding in the brain — a real risk. But in most stroke patients it prevents brain injury, and in any event, rates of cerebral hemorrhage have declined as doctors have gained experience over the years.
. . .
About a decade ago, Dr. Lewandowski was at work when he got a call that his father had had a stroke — his right side was paralyzed. But his father had gotten to the hospital within 45 minutes, well inside the window to receive T.P.A.
Dr. Lewandowski told his mother to make the family’s wishes very clear. They wanted the emergency room doctor to give the clot-buster to his dad. The doctor refused.
“He told my mom that he doesn’t believe in the drug and he is not giving it. He doesn’t care who I am,” Dr. Lewandowski said.
“I got in my car and drove 400 miles to the hospital,” he recalled. But by the time he got there, it was too late. The treatment window had closed.
His father had a facial droop and slurred speech. His right arm and right leg flopped about uselessly. His stroke scale was 7, moderately disabling, but he survived for a few more years.
“It was very difficult for me personally,” Dr. Lewandowski recalled. “I had spent so much of my professional life working on this treatment. It actually worked.”
“I felt like I had let my dad down.”

For the full story, see:

GINA KOLATA. “A Stroke Treatment Mired in Controversy.” The New York Times (Tuesday, March 27, 2018): D1 & D4.
(Note: ellipsis added.)
(Note: the online version of the story has the date MARCH 26, 2018, and has the title “For Many Strokes, There’s an Effective Treatment. Why Aren’t Some Doctors Offering It?”)