Friday, 26 April 2019

Ageism: A ‘Prevalent and Insidious’ Health Threat

The World Health Organization has begun four studies intended to define ageism and identify ways to combat it.

-By Paula Span - NYT


It happened about a year ago. I stepped off the subway and spotted an ad on the station wall for a food delivery service. It read: “When you want a whole cake to yourself because you’re turning 30, which is basically 50, which is basically dead.”

After a bunch of us squawked about the ad on social media, the company apologized for what it called attempted humor and what I’d call ageism.

Maybe you recall another media campaign last fall intended to encourage young people’s participation in the midterm elections. In pursuit of this laudable goal, marketers invoked every negative stereotype of old people selfish, addled, unconcerned about the future to scare their juniors into voting.

Adweek called it “comically savage.” I’d drop the “comically.”

And such jabs constitute mere microaggressions compared to the forms ageism often takes: pervasive employment discrimination, biased health care, media caricatures or invisibility. When internalized by older adults themselves, ageist views can lead to poorer mental and physical health.

“It’s an incredibly prevalent and insidious problem,” said Alana Officer, who leads the World Health Organization’s global campaign against ageism, which it defines as “stereotyping, prejudice and discrimination” based on age. “It affects not only individuals, but how we think about policies.”

As a first step in the campaign, announced in 2016, W.H.O. has invested half a million dollars in research. Four teams around the world are collecting and assessing the available evidence on ageism its causes and health consequences, how to combat it, and how best to measure it.

Their work will appear in a United Nations report to be published within a year, and will culminate in international mobilization, organizers hope.

One of the research groups, at Cornell University, has already completed its task, and is about to publish its study in the American Journal of Public Health. It brings surprisingly good news.

The team spent a year and a half sifting through dozens of articles, from the 1970s through last year, evaluating anti-ageism programs. Such efforts popped up around the country in the years after psychiatrist and gerontologist Dr. Robert Butler coined the term ageism in 1969. 

“But are they doing any good?” asked Karl Pillemer, a gerontologist and senior author of the study. “Do interventions that purport to change people’s attitudes about ageism actually work?”

The researchers analyzed 64 studies, most conducted in the United States, involving 6,124 participants, from preschoolers to young adults. The investigators classified about a third of the programs studied as intergenerational, meaning they created contacts between young and old that, in theory, could lessen prejudice.

Another third or so were educational, teaching facts about aging as a way to challenge stereotypes and myths. The remainder combined both approaches.

These were small, inexpensive, local efforts, pointed out the study’s lead author, David Burnes, now a gerontologist at the University of Toronto. They included:

•A program in which undergraduate psychology students corresponded with older adults by email, developing deepening relationships over six weeks. 

•A gardening project that brought fourth-graders to a Tennessee senior center twice weekly for a month.

•A four-session program in an Australian high school, incorporating discussions, games and role-playing about aging and adult development. 

Almost universally, after such interventions, participants showed significantly less ageism on attitude tests and greater knowledge of aging than comparison groups that hadn’t taken part. The combined educational and intergenerational approach proved the most effective.

“The message is loud and clear,” Dr. Pillemer said. “Ageist attitudes don’t seem as baked in as we think. They may be relatively malleable.”

That matters, because ageism is hardly benign. “These stereotypes can have direct impact on older people’s health and function,” said Becca Levy, a social psychologist at the Yale School of Public Health, and the leader of the W.H.O.-sponsored review of studies on health consequences.

The research her group is reviewing will include her own important work on ageism, conducted over 20 years. Dr. Levy has shown that older people who see aging in positive terms are much more likely to recover from disability than those who believe negative age stereotypes. 

They’re also more likely to practice preventive health measures such as eating well and exercising. They experience less depression and anxiety. They live longer. 

Recently, Dr. Levy and her colleagues have been looking into ageism and cognition. 

“With negative stereotypes, older people have a higher risk of dementia,” she said. “They have greater accumulations of plaques and tangles in the brain, the biomarkers of Alzheimer’s disease, and a reduced size of the hippocampus,” the part of the brain associated with memory.

So this is no joke. Yet “there’s a lot of social acceptance of ageism,” Dr. Levy noted, pointing to television, social media and everyday interactions. Although studies have found that children as young as three or four already hold ageist ideas, now “we have research showing that we can overcome it.”

Key questions remain unanswered. The studies the Cornell group analyzed followed participants for an average of 15 weeks, so we don’t know how long the positive effects of such interventions last. There’s scant data, too, on how to shift older people’s own internalized ageism.

Nor do we know whether and how positive attitudes translate to action. Will less ageist citizens support stronger enforcement of laws against workplace age discrimination? Or defend Medicare and Social Security from heedless budget cutters?

But seeing how even short-lived interventions can move the attitudinal needle, I’m encouraged to continue my personal anti-ageism campaign. (Author and activist Ashton Applewhite has established a helpful online clearinghouse called Old School.)

It’s not always easy to find the balance between shrugging off offensive messages and counterproductive scolding, but individuals can speak up about ageist generalizations.

We can argue the merits of one or another politician without rejecting candidates simply because they’re too old (or too young). We can distribute atta-girls and atta-boys to those unafraid to show their true faces and hair color (while acknowledging that, yes, the labor market sometimes dictates otherwise). 

We can gently protest when even beloved friends and family succumb to stereotypical thinking.

A few months back, during the relaxation phase of my morning exercise class, the instructor asked us against a background of dreamy music to visualize floating down the Seine on a romantic evening. Picture the moon, she intoned. Imagine that you’re 30.

Well. She meant it jokingly, but every student in the class was at least a couple of decades past that (as was she), yet remained capable of enjoying moonlight in Paris. 

A discussion ensued. Point made. Point taken.

Religious Objections to the Measles Vaccine? Get the Shots, Faith Leaders Say

Devout parents who are worried about vaccines often object to ingredients from pigs or fetuses. But the leaders of major faiths have examined these fears and still vigorously endorse vaccination.

-By Donald G. McNeil Jr. - NYT

A demonstrator in Rockland County, N.Y., after officials banned unvaccinated children from public spaces. The Anti-Defamation League has strongly objected to the appropriation of Holocaust symbols by vaccine critics.CreditCreditMike Segar/Reuters

The measles outbreak in the United States is now the largest since the disease was declared eliminated here 19 years ago. The return of this scourge has been driven by one factor in particular: misinformation, spread by vaccine critics, that scares parents into not immunizing their children.

Along with rumors that vaccines cause autism or that the trace amounts of mercury and aluminum in them are dangerous falsehoods that were long ago debunked have come innuendos aimed at deeply religious parents.

Vaccines, the activists say, contain ingredients made from pigs, dogs, monkeys and aborted fetuses. Indeed, most of those assertions are based in fact. Ingredient lists published by the Centers for Disease Control and Prevention and the Institute for Vaccine Safety at Johns Hopkins show that vaccines may contain these elements (although any residual DNA is present only at the parts-per-million level).

Nonetheless, vaccination is endorsed by top Jewish and Islamic scholars, and by the Vatican. Religious authorities have meticulously studied how vaccines are made and what is in them, and still have ruled that they do not violate Jewish, Islamic or Catholic law.

Although no vaccine is without side effects, immunization is one of the greatest advances in medicine. The World Health Organization estimates that vaccines have saved more than 10 million lives in just the last decade. 

A policeman guarded health workers as they administered polio vaccine in Karachi, Pakistan, in 2016.CreditShahzaib Akber/European Pressphoto Agency

“Since it is proven that vaccines are effective to prevent the spread of disease, it is an obligation upon every father to vaccinate his children,” Rabbi Moshe Sternbuch, vice president of the Rabbinical Court in Jerusalem, recently wrote in an open letter to the dean of a major Orthodox yeshiva in the United States.

Vaccines are highly purified, but they still may contain isolated cells or traces of DNA from the human or animal cells they were grown in. Those “growth media” include cell lines originally derived often decades ago from monkey or dog kidneys, moth caterpillars, calf blood, or the immature tissues of aborted human fetuses. (The widely circulated assertion that vaccines contain rat DNA is untrue.)

Some vaccines grown in eggs or using dairy products contain residual egg or casein proteins. And in some vaccines, the manufacturers add small doses of gelatin made from pig skin to prevent damage from heat or freeze-drying.

As New York’s current measles outbreak has spread, the more obscure ingredients of the measles vaccine which is often delivered in a shot mixed with vaccines against mumps, rubella and chickenpox have become an issue for some Orthodox Jews.

“The Vaccine Safety Handbook,” published by the anti-vaccine group Peach, has several pages aimed at them, including lists of vaccine ingredients derived from animals that Jews are forbidden to eat.

But kosher dietary laws are “just a total nonissue” with regard to vaccines, said Dr. Naor Bar-Zeev, a professor of international health and vaccine science at the Johns Hopkins Bloomberg School of Public Health. “All these complex laws apply to food ingested by mouth and are not in any way relevant to injected material.”

Observant Jews may inject insulin derived from pig pancreas or have pig valves implanted in a failing heart, Dr. Bar-Zeev noted. They may also take oral vaccines, such as those against rotavirus, polio and cholera, even if they contain pork gelatin, because they are considered medicine, not food.

Some Jewish scholars have also ruled that “denatured” substances like gelatin are not subject to the same restrictions as pork flesh.

Vaccine ingredients are not just an issue among Orthodox Jews. Because Islam also forbids eating pork, alarms about gelatin and porcine viral DNA have hampered vaccination in some Muslim countries.

Some older vaccines contained cow gelatin, but manufacturers changed to pork after studies found it triggered fewer dangerous reactions in children with gelatin allergies. In a typical vaccine dose, only about three one-hundredths of a teaspoon is gelatin.

In 1995, a meeting of 112 leading Islamic scholars considered many ingested substances, including alcohol, rennet and even nutmeg, and approved the use of porcine gelatin in medicines.

“Gelatin formed as a result of the transformation of the bones, skin and tendons of a judicially impure animal is pure, and it is judicially permissible to eat it,” the Islamic Organization for Medical Sciences ruled.

Ingredients were not the central focus of opinions recently delivered by prominent Orthodox scholars, including Rabbi Sternbuch and Rabbi Asher Weiss, chief authority on medical law for Shaare Tzedek Medical Center in Jerusalem.

Both rabbis not only endorsed existing vaccines but said mandatory vaccination was justified, as was excluding unvaccinated children from yeshivas.

Rabbi Weiss reiterated the commandment that children must be removed from danger, and Rabbi Sternbuch cited the principle of pikuach nefesh, which holds that, to save a life or prevent permanent organ damage, any transgression against Jewish law other than idolatry, incest or murder is permitted.

More than 200 years ago, Rabbi Weiss noted in a recent article, Rabbi Israel Lifschitz, author of a famous commentary on oral Jewish law, declared that Dr. Edward Jenner, the English inventor of the smallpox vaccine, was “one of the righteous among nations” for saving thousands of lives. 

The current measles epidemic among Orthodox Jews in Israel, Britain and this country was triggered in part by a pilgrimage last fall to the Ukrainian grave of Rabbi Nachman, founder of the Breslov branch of Hasidism. 

Rabbi Nachman was himself a strong vaccination advocate. Failing to vaccinate children against smallpox before they were three months old “is like spilling blood,” he wrote.

Earlier generations of Orthodox scholars had ruled that vaccination was “permissible and proper,” Rabbi Weiss also said, even with the crude early vaccines that sometimes killed recipients.

Grown in ‘immortal' cells


Vaccines against viral diseases are made from viruses, which are just protein shells containing short stretches of DNA or RNA and can multiply only when grown in broths of live cells. Those cells are unusual in that they must be “immortal” that is, able to replicate for decades without suffering “cell death,” the aging process. 

(The best-known example is HeLa cells, which were isolated from a tumor in a woman named Henrietta Lacks, who died in 1951. More than 50 million tons of HeLa cells have since been grown for use in cancer research.)

The cells also must be free of cancer and viruses, which is one reason the ancestor cells come from fetuses that have never been exposed to pathogens fetuses that were removed in sterile surgical environments, not from miscarriages.

Several common childhood vaccines are grown in the MRC-5 and WI-38 cell lines, which are fetal cells that, had they matured, would have become tissues in lungs the organ in which diseases such as chickenpox and rubella first proliferate.

The MRC-5 line originated with a male fetus aborted in Britain in 1964 because the mother suffered psychiatric problems, and WI-38 came from a female fetus aborted in Sweden in 1962 because the parents felt they had too many children. 

In 2005, replying to a request for guidance from Children of God for Life, a Florida-based Catholic group, the Vatican said vaccines grown in those cells continued to pose ethical problems “even though this evil was carried out 40 years ago.”

Catholics, the Vatican said, must choose alternative vaccines if they exist and press vaccine companies to make alternatives.

Nonetheless, because there are no alternatives, the use of existing vaccines particularly against rubella, the Vatican ruled was “morally justified” because of the higher need to protect children and pregnant women.

The Vatican reiterated that position as recently as two years ago in guidelines for Catholic health workers.

Mormons, Episcopalians, Lutherans and many other Christian denominations endorse vaccines, require them in their schools and distribute them at their missionary hospitals.

High authorities of all other major religions back vaccination, according to a study by Dorit R. Reiss, a medical law expert at the University of California Hastings Law School, and a paper in the journal Vaccine by John D. Grabenstein, an employee of Merck’s vaccine division.

Among Buddhists, the Dalai Lama has personally given polio vaccine to children to further the world polio-eradication drive. One of the first accounts of variolation an ancient form of smallpox prevention was from an 11th century Buddhist nun, who blew ground smallpox scabs into the noses of her patients.

Although the Vatican would like vaccine companies to replace old cell lines with new ones, that is extremely unlikely, experts said. Human fetal tissue would presumably still be required.

The multiyear testing process also would have to start all over again — and anything other than a product perfect the first time could endanger the thousands of infants it would have to be tested in.

“It would probably cost a vaccine company over a billion dollars,” said Dr. Paul A. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “And they’d be competing against themselves. There is absolutely no incentive.”


Monday, 22 April 2019

The Giants at the Heart of the Opioid Crisis

-By Danny Hakim, William K. Rashbaum and Roni Caryn Rabin - NYT

The headquarters of McKesson Corporation, the drug distributing giant, in San Francisco.CreditCreditAnastasiia Sapon for The New York Times

There are the Sacklers, the family that controls Purdue Pharma, the maker of OxyContin. There are the doctors who ran pill mills, and the rogue pharmacists who churned out opioid orders by the thousands.

But the daunting financial muscle that has driven the spread of prescription opioids in the United States comes from the distributors companies that act as middlemen, trucking medications of all kinds from vast warehouses to hospitals, clinics and drugstores.

The industry’s giants, Cardinal Health, McKesson and AmerisourceBergen, are all among the 15 largest American companies by revenue. Together, they distribute more than 90 percent of the nation’s drug and medical supplies.

New civil suits from the attorneys general in New York, Vermont and Washington State accuse distributors of brazenly devising systems to evade regulators. They allege that the companies warned many pharmacies at risk of being reported to the Drug Enforcement Administration, helped others to increase and circumvent limits on how many opioids they were allowed to buy, and often gave advance notice on the rare occasions they performed audits.

Three-fourths of prescriptions at a Queens pharmacy supplied by Amerisource were written by doctors who were later indicted or convicted, the New York complaint said. For more than five years, Cardinal shipped to a pharmacy with the highest oxycodone volume in Suffolk County, N.Y., despite continually flagging its orders as suspicious. McKesson kept shipping to two pharmacies six years after learning that they had been filling prescriptions from doctors who were likely engaging in crimes. The shipments stopped only last year, after the doctors were indicted.

“How do the C.E.O.s of these companies sleep at night?” Bob Ferguson, Washington’s attorney general, said at a recent news conference.

Executives of drug distribution companies testified before a House hearing on the opioid crisis in May 2018. From left, George Barrett of Cardinal Health; Dr. Joseph Mastandrea of Miami-Luken Inc.; John Hammergren of McKesson; J. Christopher Smith of H.D. Smith Wholesale Drug Company; and Steven Collis of AmerisourceBergen Corporation.CreditAlex Brandon/Associated Press

Now, in what could be a test case, the United States attorney’s office for the Southern District of New York and the D.E.A. are wrapping up an investigation that appears likely to result in the first criminal case involving a major opioid distributor, Rochester Drug Cooperative, one of the 10 largest, people familiar with the matter said. The investigation began with an examination of possible crimes including wire and mail fraud and various drug violations, according to three people with knowledge of a federal grand jury subpoena served on Rochester in 2017, but it remains unclear what charges might be brought.

The state lawsuits also present evidence that government at all levels has been ineffective at policing the distributors. For the first decade of the crisis, the three largest companies did not even have meaningful programs to monitor suspicious orders, despite being required by federal law to track narcotics and to look out for spikes in orders and cash payments. Since then they have promised and failed to build robust systems to prevent widespread opioid abuse.

The distributors rebutted the new allegations.

“We reject the state’s suggestion that our employees circumvented safeguards to increase sales,” Kristin Chasen, a spokeswoman for McKesson, said in a statement. Cardinal, in its statement, said it had “developed and implemented a constantly adaptive and rigorous system to combat controlled substance diversion.”

Amerisource put the onus on the D.E.A., which it said receives data on all orders shipped and notifications of suspicious ones. “It defies common sense for distributors such as AmerisourceBergen to be singled out,” the company said in a statement.

In the two decades since OxyContin was introduced in 1996, there have been nearly 218,000 overdose deaths related to prescription opioids, according to the Centers for Disease Control and Prevention. While overdose deaths continue to rise, the number of opioid prescriptions has been falling since 2012.

But that is mostly because of a classification change that made drugs like Vicodin (which mix opioids with milder drugs) Schedule II narcotics, which placed more restrictions on prescribing them. Oxycodone, the powerful narcotic that is the main ingredient in OxyContin, was already a Schedule II drug and its sales have continued to rise, according to figures compiled by Iqvia, a health data provider.

The three largest distributors sold 1.6 billion oxycodone pills in New York alone between 2010 and 2018. It was distributors, said the office of Attorney General Letitia James of New York, who “jammed open the floodgates.”

A page from the complaint filed by the New York attorney general’s office.

A lack of deterrence


In 2017, after years of allegedly flouting legal requirements to monitor suspicious orders of opioids, McKesson agreed to a $150 million settlement with the Justice Department, a record for a distributor.

For most businesses, $150 million would be a lot of money. At McKesson, it was less than the $159 million retirement package the company granted its longtime chief executive, John H. Hammergren, in 2013. (After a public backlash — a Forbes headline asked if it was “The World’s Most Outrageous Pension Deal?” the company later reduced the package to $114 million.)

It was among a string of settlements, and others came far cheaper.

In 2008, McKesson, which supplies Walmart, paid $13.25 million and Cardinal, the main CVS supplier, paid $34 million to settle federal claims that they had been filling suspicious orders.

Before 2007, only two of Cardinal’s roughly 40,000 employees were dedicated to addressing the problem, according to court filings. One McKesson compliance officer complained that asking for resources was like “asking for a Ferrari,” according to New York’s lawsuit.

More settlements followed, but little changed. Cardinal paid a total of $64 million in settlements with the Justice Department in 2012, 2016 and 2017, with similar agreements struck by its rivals. The policing of opioid sales continued to be largely delegated by law to the distributors.

The companies created order volume thresholds for different drugs that would trigger reporting to the D.E.A., but some were so lofty that they resulted in relatively few such reports, the complaints said.

Or they worked around them. In one industry practice, known as “cutting,” Cardinal canceled pharmacy orders “that exceeded a threshold” and allowed “a subsequent, often smaller order,” Vermont’s complaint said.

Brandi Martin, a Cardinal spokeswoman, said that “cut orders are reported to the D.E.A.” and were not “a tactic to avoid reporting.”

Egregious moves spurred limited responses, according to the complaints. McKesson allowed one pharmacy a fivefold oxycodone increase over six months, then refused another request for an 80 percent increase. The company continued shipping to the pharmacy anyway, even after a rival stopped.

McKesson, in its statement, said it was continuing “to enhance and evolve” its compliance efforts.

By last year, executives were summoned by Congress. Both Mr. Hammergren, of McKesson, and George Barrett, the executive chairman of Cardinal at the time and its former chief executive, played down their roles in the supply chain.

During the hearings, Representative Kathy Castor, a Florida Democrat, picked out a single drugstore in rural West Virginia that had been swamped with opioids 4,000 pills a day at one point from Cardinal, 5,000 from McKesson.

“Don’t you take responsibility?” she asked, adding, “You saw that paying the penalties on your settlement agreements was a cost worth paying because you were making so much money?”

“I wish we had moved earlier to stop shipping to that pharmacy,” Mr. Barrett said at the hearing. Mr. Hammergren echoed that, saying, “I would have liked to have made a decision faster.”

Ms. Castor was not satisfied. “This was the opposite of due diligence,” she said.

A criminal inquiry


There was little enthusiasm for policing opioids at Rochester Drug Cooperative, New York’s complaint alleges.

For years, only two people at Rochester were assigned to compliance, and one had other responsibilities. Amid discussions about hiring a compliance consultant, Laurence F. Doud III wrote in an email when he was the company’s chief executive that it was “making me ill as to how much this is going to cost.”

Mr. Doud is now suing Rochester, claiming wrongful termination and contending it conspired to blame him for conduct that the D.E.A. and federal prosecutors in New York are investigating in the criminal inquiry. (His suit was previously reported by The Democrat and Chronicle of the city of Rochester.) The current chief executive, Joseph Brennan, is on leave.

Rochester is a cooperative of pharmacies, so monitoring suspicious orders meant monitoring its own members. But it had practices that were similar to those of its larger rivals. Rochester’s upper limits on how many pills pharmacies could buy were “invariably so high that customers could not reach them unless their order volumes tripled from their historical purchasing patterns, rendering the system virtually useless,” New York alleges.

Sales were brisk. Between 2010 and 2018, Rochester sold 143 million oxycodone pills in New York.

The company added a Queens pharmacy with numerous cash buyers as a customer in 2016. The pharmacy was also filling prescriptions from out-of-state doctors and one who had been arrested over oxycodone prescribing practices, the complaint says.

In 2013, Rochester continued shipping to a pharmacy run by a pediatrician who had surfaced in headlines as running a pill mill, according to the complaint. In an email, one Rochester consultant called the situation “a stick of dynamite waiting for the D.E.A. to light the fuse.” The shipments continued.

In a $360,000 settlement in 2015, Rochester admitted that it had failed to report thousands of opioid transactions over five years. The subsequent criminal inquiry sought records including loans and lines of credit that Rochester had extended to its customers, according to people with knowledge of the 2017 subpoena.

Criminal charges are soon expected, with the company and current and former executives under scrutiny, the three people familiar with the matter said. They, like those with knowledge of the subpoena, spoke on the condition of anonymity because of the developing investigation. Such a prosecution would appear to be the first time a major distributor has been held criminally responsible in connection with opioids.

The D.E.A. and the office of Geoffrey S. Berman, United States attorney for the Southern District of New York, declined to comment on the inquiry.

Jeff Eller, a Rochester spokesman, declined to answer specific questions, citing the investigation, but he said that Rochester’s compliance department is more than six times larger than it was in 2013 and that the company “will continue to make a significant investment.”

A failure to regulate


Louis Crisafi’s opioid of choice was Actiq, a powerful fentanyl lollipop.

He allegedly left wrappers around the office, which was a bad idea, since he was a senior investigator for the Bureau of Narcotics Enforcement, a branch of the New York State Department of Health that monitors opioid sales.

Mr. Crisafi’s fentanyl use was noticed at work by several other investigators and was among the topics of a 2008 report issued by the state inspector general that raised concerns about the bureau, where many investigators reported to a pharmacist. (Mr. Crisafi, who left the bureau at the time, said he had a legal prescription and never used opioids on the job.)

States have had trouble policing opioid use even among their own. Like similar agencies elsewhere, the New York narcotics bureau was ill-equipped, with fewer than 20 investigators overseeing distributors and manufacturers, along with the state’s 5,586 pharmacies and more than 120,000 prescribers.

Kenneth Post, a former director of the bureau, said it does not belong in the Health Department, which has close ties with health care providers.

“They’re policing their own, and it doesn’t work,” said Mr. Post, who left the agency in 2010. The Health Department called him a “disgruntled former employee.”

A 2012 audit by the state Comptroller’s Office found that the bureau had overlooked hundreds of thousands of flawed opioid prescriptions over two years.

The Health Department said in a statement that the bureau had only “limited investigatory” power, deflecting responsibility “to federal, state and local law enforcement.”

At the federal level, the D.E.A. does not closely monitor the millions of transactions involving controlled substances, said Paul T. Farrell, a lawyer who represents municipalities in lawsuits against drugmakers.

“The D.E.A. is not the T.S.A., which is responsible for looking at every passenger going through and screening out those who are threats,” he said, referring to the Transportation Security Administration. Instead, he said that “once a tip is made,” the D.E.A. will “reconstruct what actually happened.”

In a statement, the D.E.A. said investigations are presented to federal prosecutors, who choose “the appropriate litigation strategy.”

Distributors have marshaled lobbyists, contributing $1.5 million to sponsors and co-sponsors of a 2016 law thwarting the D.E.A.’s efforts to freeze suspicious drug shipments.

Distributors have also lined up lobbyists with ties to Gov. Andrew M. Cuomo of New York, where lawmakers included $100 million in opioid taxes or surcharges in two consecutive budgets, though last year’s measure is tied up in court. They have hired two firms founded or co-founded by onetime aides to former Gov. Mario M. Cuomo as well as Mercury Group, whose executives include former advisers to the current governor.

For now, distributors remain largely in control.

“It’s not a good system,” said Dr. Andrew Kolodny, an addiction expert. “It’s the fox guarding the henhouse.”


Thursday, 18 April 2019

Don’t Count on 23andMe to Detect Most Breast Cancer Risks, Study Warns

-By Heather Murphy - NYT

More than 10 million people have signed up for 23andMe. Many are initially drawn in by ancestry data, but later opt in for health risk tests.CreditCreditGeorge Frey/Reuters

In 2010, Dr. Pamela Munster mailed her saliva to 23andMe, a relatively new DNA testing company, and later opted in for a BRCA test. As an oncologist, she knew a mutation of this gene would put her at high risk for breast and ovarian cancer. She was relieved by the negative result.

Two years later, after she learned she had breast cancer, she took a more complete genetic test from a different lab. This time it was positive.

A study of 100,000 people released earlier this month suggested that this experience could be widespread. Nearly 90 percent of participants who carried a BRCA mutation would have been missed by 23andMe’s test, geneticists found.

23andMe’s testing formula for this risk is built around just three genetic variants, most prevalent among Ashkenazi Jews. The new study demonstrated that most people carry other mutations of the gene, something many doctors have long suspected.

“It’s as if you offered a pregnancy test, but only the Jewish women would turn positive,” said Dr. Munster, who is the co-leader of the Center for BRCA Research at the University of California, San Francisco. She was not involved in the new study, which was conducted by Invitae, a diagnostic company.

23andMe said response to the study by its potential competitor had been overblown because the site makes it clear that it is testing only for three of the mutations.

Dr. Munster said that 23andMe was “not doing anything actively deceptive.” But she is still concerned that many customers do not grasp the limits of mail-in genetic testing.

23andMe now has more than 10 million customers. Even if only a small percentage take the test, that’s thousands who could be misled.

Mary-Claire King, a professor at the University of Washington who discovered the region on the genome that became known as BRCA1, had a more blunt assessment of the Food and Drug Administration’s decision to allow the test.

“The F.D.A. should not have permitted this out-of-date approach to be used for medical purposes,” Dr. King said. “Misleading, falsely reassuring results from their incomplete testing can cost women’s lives.”

How was the study conducted?

The study, which was presented at the American College of Medical Genetics and Genomics annual meeting and has not been peer reviewed, was built around more than 100,000 patients who underwent breast cancer risk testing with Invitae, a diagnostic company.

Despite the lack of peer review and Invitae’s potential role as a business competitor, genetic medicine experts not affiliated with Invitae said in interviews that they found the work to be credible, particularly as the company’s findings echo other, smaller studies.

23andMe’s test focuses on BRCA1 and BRCA2, genes involved in suppressing growth of abnormal cells. Specifically, it looks for three notorious genetic variants, known as founder mutations. Invitae’s analysts expanded their search to include thousands of other variants.

Dr. Susan Klugman, vice president for clinical genetics at the American College of Medical Genetics and Genomics, likened it to a broader spell-check. Whereas 23andMe looks for errors in a few paragraphs, the Invitae analysts used more advanced genetic technology to search through 25 chapters. (Dr. Klugman was not involved in the Invitae study.)

In about 5,000 subjects, analysts identified at least one variant known to significantly increase an individual’s risk of breast and ovarian cancer. Among the Ashkenazi Jews in the positive group, 81 percent had one of the three founder mutations, suggesting that 23andMe’s test could be helpful for them. Among the rest, 94 percent carried variants that would have failed to be detected by 23andMe.

Why create a test that misses so many people?

One reason is purely technical: To return to the literary metaphor, 23andMe isn’t set up to scan entire genetic books the way some labs are. So even if the company wanted to look for other variants, that would not be possible without changing its approach, said Dr. Robert C. Green, a professor at Harvard Medical School.

Dr. Green said that limitation is not necessarily a problem.

“I think people have the right to their own genetic information, but with that right comes a responsibility,” he said. “If you are going to go around the medical mainstream, read the caveats.”

Dr. Jeffrey Pollard, 23andMe’s director of medical affairs, said that the company’s focus was far from arbitrary.

“We test for these three variants since they are three of the most well-studied and carry clear, documented risk for breast and ovarian cancer,” he said. “About one in 40 individuals of Ashkenazi Jewish descent has one of these three variants. Women with one of these variants have a 45 to 85 percent chance of developing breast cancer by age 70.”

The company warns customers that it is not testing for all variants, and its approach has been approved by the F.D.A., he said. (The company said that data on how many people have taken its test was not available.)

Do online genetic tests also give false positives?

Yes. Alongside the primary study, Invitae analysts also presented a smaller study investigating this question, built around 102 patients. All participants had been told that they had a mutation of the gene from a mail-in test or other online analysis service. (Whether they used 23andMe or another service was not documented. Based on their reading of the data, 23andMe analysts insisted their company’s results were not a part of the study.)

In nearly half of the patients, Invitae could not confirm the presence of a mutation. That means that had these patients not taken a second test, they would have gone on thinking that they were at greater risk for inherited cancer than they really were.

A positive result can be a major life event: Some people may opt to get a preventive mastectomy or hysterectomy. Others may increase the frequency of their doctors’ visits or alter other habits.

Another small study published last year produced similar results for other inherited illnesses. Forty percent of individuals who tested positive for genetic variants associated with Parkinson’s disease, late-onset Alzheimer’s disease and a number of other diseases using mail-in genetic tests were negative in a confirmation test.

So why offer online genetic health tests?

One of the primary arguments for genetic testing that does not involve a physician is that it reaches people who would not do it otherwise. Around one in 25 American adults has now taken an at-home ancestry test.

Regardless of who does the test, talking to a genetic counselor or medical geneticist is advisable, Dr. Klugman said. Genetic counselors can help patients make sense of their results, and sometimes they sniff out incorrect findings.

In 2017, for example, a genetic counselor was skeptical of tests showing that two patients from a family with a history of Lynch syndrome, which increases the risk of several types of cancer, did not carry the mutation. Retesting showed they did.

In that case, the faulty results could not be blamed on a mail-in test: Invitae, the company behind the recent studies, produced the incorrect results. In an email last week, the company said that it had corrected the reports and learned from the mistake.


F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women

-By Sheila Kaplan and Matthew Goldstein - NYT

The Food and Drug Administration said there was insufficient evidence that mesh worked better than surgery to repair pelvic organ prolapse.CreditCreditBoston Scientific

The Food and Drug Administration on Tuesday ordered the two remaining medical device companies selling surgical mesh for the repair of pelvic organ prolapse to stop all sales and distribution in the United States.

It is the most stringent action the F.D.A. has taken in the lengthy legal and medical battles over vaginal mesh, a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area.

The agency issued the decision against the two companies, Boston Scientific and Coloplast, at a time when multimillion-dollar verdicts against manufacturers of the devices continue to be awarded or upheld on appeal.

Litigation over pelvic mesh, also called transvaginal mesh, ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly $8 billion to resolve the claims of more than 100,000 women.

For years, women and legal advocates have tried to persuade the F.D.A. that the pelvic mesh implant causes harm. As the number of serious complications increased significantly, the F.D.A. reclassified this type of pelvic mesh as high risk in 2016 and told manufacturers to submit more evidence that the devices were safe and would benefit patients with the condition.

In announcing its decision on Tuesday, the F.D.A. said that Boston Scientific and Coloplast, a Danish company, had not demonstrated a reasonable assurance of safety and effectiveness for the devices.

“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse,” said Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health. “We couldn’t assure women that these devices were safe and effective long term.”

Deborah Kotz, a spokeswoman for the agency, said the two medical device companies had 10 days to submit a plan for how the mesh devices will be withdrawn from the market.

Shanin Specter, a lawyer who has won numerous big jury verdicts against firms that manufactured the pelvic mesh, said the F.D.A. should extend the decision to include mesh devices used for treatment of some urinary conditions.

“This is a good step forward,” he said. “But mesh used to treat stress incontinence also continues to devastate thousands of women, and the F.D.A. should act decisively there, too.”

Boston Scientific, which had filed two applications for its devices, criticized the agency’s action. “We are deeply disappointed by the F.D.A.’s decision on our premarket approval applications” for two products, said Kate Haranis, a spokeswoman for the company. The company, she added, believes that “the inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”

Ms. Haranis said its transvaginal mesh product portfolio accounts for roughly $25 million in sales annually, or about 1 percent of the company’s total sales. Its stock fell a little more than 4 percent on the news.

Lina Danstrup, a spokeswoman for Coloplast, said in an email that Restorelle DirectFix Anterior, the affected device, represents about 0.2 percent of group revenues. Coloplast’s stock also fell slightly on Tuesday.

Gynecologists have been implanting surgical mesh to repair pelvic organ prolapse since the 1970s, and they began using it for transvaginal repair of the condition in the 1990s. The mesh is implanted in the vaginal wall; complications have included bleeding, pain, inflammation and dislodging or protrusion through the wall that can cause infection. Many women have required a second surgery to repair the damage.

Mr. Specter said the mesh device used in pelvic organ prolapse surgery tends to be larger and more injury-producing than the devices used in surgery to treat stress urinary incontinence.

But even the small mesh devices have an unacceptably high complication rate, he said, in the range of 5 to 15 percent. “There was never a need for these mesh products,” he said, noting there is an alternative surgical procedure using a patient’s own tissue.

The disputes over the safety of pelvic mesh have gone on for more than a decade. Until Tuesday, the F.D.A. had never formally demanded that the products be taken off the market, but it had issued several warnings about the devices. The agency said earlier that it had received reports of more than 10,000 complaints of serious injury and nearly 80 deaths as of last year.

Women who have already had the devices implanted and are not having problems with them should not take any action, other than to continue regular doctor visits, Ms. Kotz, the F.D.A. spokeswoman, said.

It has been estimated that nearly 10 million women worldwide have received mesh implants to treat weakening pelvic muscles and alleviate urinary incontinence. Roughly 10 to 15 percent have suffered complications, in some cases requiring the mesh to be removed.

In light of the litigation, warnings and complaints from women about severe pain and bleeding from mesh implants, some manufacturers, including Johnson & Johnson, had voluntarily stopped selling them.

More than 100,000 people filed claims against the major manufacturers in federal and state courts. Although some of the settlement figures have been large, women have complained that lawyers have taken a lot of the settlement money. Documents reviewed by The New York Times and interviews indicated that the average settlement for each woman was less than $60,000.

“If this had happened at the very outset of the litigation, we might have seen higher settlement values,” said Elizabeth Chamblee Burch, a law professor at the University of Georgia and an expert in pelvic mesh litigation. “It could help with the remaining cases. The plaintiffs themselves see this as a pretty huge victory and a victory that they wish had come a lot sooner.”

In recent years, sales of the pelvic mesh had declined as companies stopped selling the devices and the costs of litigation mounted. From 2010 to 2017, sales in the United States amounted to about $600 million, according to some estimates.


Employee Wellness Programs Yield Little Benefit, Study Shows

-By Reed Abelson - NYT

Researchers followed thousands of BJ’s Wholesale Club employees for a year to monitor the effects of wellness programs. Although many who enrolled in the programs reported exercising more often and eating more healthfully, the study did not find significant medical care savings.CreditCreditMel Evans/Associated Press

Companies have long embraced workplace wellness programs as a way to improve workers’ health and reduce overall medical spending, but a new study may prompt employers to rethink those efforts.

The study, published on Tuesday in JAMA, a medical journal, looked at the experience of 33,000 workers at BJ’s Wholesale Club, a retailer, over a year and a half.

While workers who enrolled in the wellness program reported that they learned to exercise more and watch their weight, the research found no significant differences in outcomes like lower blood pressure or sugar levels and other health measures. And it found no significant reduction in workers’ health care costs.

“These findings may temper expectations about the financial return on investment that wellness programs can deliver in the short term,” conclude the study’s authors, Dr. Zirui Song, a health policy researcher at Harvard Medical School, and Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.

Most employers 82 percent of companies with more than 200 workers — offer some sort of wellness program like smoking cessation or weight management, according to the latest survey by the Kaiser Family Foundation. Companies often encourage participation in these programs by dangling some sort of financial carrot, ranging from a gift card if you track your steps to a significant discount off what you pay toward your health insurance.

“Wellness is this multibillion-dollar industry where there has been a really weak evidence base of what these programs do,” Dr. Baicker said.

Some programs have prompted concerns over employees’ privacy and the use of health data by third parties, like vendors selling these workplace plans. Lawsuits have been filed that forced employers to retreat from offering incentives for reaching specific goals.

Nearly all the studies to date had been observational and have largely concluded that the programs save some money for employers. But this study randomly assigned employees to a wellness program and compared their results with those of employees who were not enrolled in such efforts.

Employers looking for a quick reduction in their health care spending will be disappointed, Dr. Baicker said.

But there were some encouraging notes among those who adopted healthier behaviors. “We’ve seen that necessary first step,” she said. And those alterations could later lead to better overall health and lower medical expenses.

“It is not the final verdict on workplace wellness programs,” Dr. Song cautioned, calling the research “still a young field.” The authors are now analyzing three years of data from the wellness program to see if there are any longer-term effects.

BJ’s Wholesale Club referred all questions to the researchers.

There has been a shift in emphasis in what companies offer, including addressing broader issues like emotional well-being, said Brian Marcotte, the chief executive of the National Business Group on Health, which represents large employers that offer insurance coverage to their workers.

More recent programs provide a variety of techniques aimed at reducing stress or helping employees better manage their finances, tools that are aimed at increasing workers’ productivity, he said.

In a departure from previous wellness program policies, employers are now less likely to dictate what their work force should do in favor of offering workers a range of programs aimed at addressing their individual needs. “It’s really hard to engage someone on their physical health” if the person is depressed or struggling with debt, Mr. Marcotte said.

But wellness has also raised concerns that employers are pressuring workers to participate in these programs and that the private health data being gathered could be inappropriately shared with employers.

AARP, the consumer advocacy group for older Americans, sued the federal government in 2016, arguing that the rules governing the programs violated anti-discrimination laws aimed at protecting workers’ medical information. The group won its lawsuit, and the government has not yet issued new rules that would govern these programs.


10 Years After an Exercise Study, Benefits Persist

The benefits of exercise may last longer than many of us might expect.

-By Gretchen Reynolds - NYT


The workouts we completed years ago may continue to influence and improve our health today, according to a fascinating new study of the current lives and health of people who joined an exercise study a decade before.

The findings suggest that the benefits of exercise can be more persistent than many of us might expect, even if people are not exercising to the same extent as they previously did. But the impacts also may depend on the types and amounts of exercise involved.

In medicine, lingering health consequences from experiments, known as legacy effects, are common and often commendable. Participants in past diabetes experiments, for instance, whose blood sugar was tightly controlled with diet, drugs or other methods, often had better heart health years later than diabetics outside of the study, even though the volunteers’ blood-sugar levels had risen in the interim.

But whether exercise studies likewise produce legacy effects has been unknown, although the issue matters. We know from other science and disheartening personal experience that we lose much of our fitness and associated health benefits if we stop or reduce how much we exercise over the years.

But do all of those gains disappear, or might exercise change us in some ways that stick with us?

For the new study, which was published this week in Frontiers in Physiology, scientists at Duke University decided to find out. Most of the researchers had been involved a decade earlier in a large-scale exercise experiment called Strride (for Studies Targeting Risk Reduction Interventions through Defined Exercise).

In that experiment, which ran from 1998 to 2003, hundreds of sedentary, overweight volunteers between the ages of 40 and 60 had remained inactive as a control group or begun exercising.

Their exercise was either moderate, such as walking, or more vigorous, comparable to jogging, and lasted until people had burned at least several hundred calories per workout. Volunteers completed three session of their assigned workout each week for eight months, while scientists tracked changes to their aerobic fitness, blood pressure, insulin sensitivity and waist circumference.

In general, each of those health markers improved in the people who exercised and not in the controls.

The scientists then said farewell and did not get in touch with the participants again until about a decade later, when they contacted volunteers who still lived near Duke and asked if they would join a reunion study. More than a hundred, representing each of the exercise and control groups, said, sure.

These men and women returned to the lab for new tests of their aerobic fitness and metabolic health. They also completed questionnaires about their current medical condition and medications and how often they exercised each week.

Then the researchers started comparing results and found telling differences.

Most of the men and women from the control group, who had not exercised 10 years before, had larger waistlines now, while the exercisers displayed little if any middle-aged spread compared to their decade-earlier selves.

Those from the control group also were less fit now. Most had lost about 10 percent of their aerobic capacity, which is typical of the declines seen after about age 40, when most of us will lose about 1 percent of our fitness annually.

But those men and women who had exercised vigorously for eight months during Strride retained substantially more fitness. On average, their aerobic capacity had fallen by only about 5 percent, compared to when they had joined the Strride study, and those few who reported still exercising at least four times a week were more fit now than they had been a decade before.

Interestingly, those Strride volunteers who had walked meaning their exercise had been moderate, not intense did not seem to have enjoyed the same lasting fitness benefits as those who had exercised more vigorously. Most of them had shed about 10 percent of their aerobic capacity during the past decade, much like the controls.

On the other hand, they showed surprisingly persistent improvements in their metabolic health, more so than among the intense exercisers. The walkers from 10 years ago still had healthier blood pressures and insulin sensitivity than they had had before joining Strride, even if they rarely exercised now. They had also had relatively healthier metabolisms than the men and women who had exercised intensely all those years before.

Taken as a whole, these results suggest that “exercise is a powerful modulator of health, and some effects can be quite enduring,” says William Kraus, a professor of medicine and cardiology at Duke, who oversaw the new study.

But the effects also can differ, depending on how hard someone works out, he says. To build and maintain high endurance, we may have to sweat and strain. But to better our metabolic health, a walk likely will do.

Of course, this study does not explain how exercise alters our body in ways that last. We may, in part, be building a physiological reserve, Dr. Kraus says. Raise aerobic capacity or improve insulin sensitivity with exercise, and even as those measures decline later with inactivity and age, we will be better off than if we had never worked out.

Exercise also probably leaves long-lasting imprints on our genes and cells that affect health, Dr. Kraus says.

He and his colleagues hope to investigate those issues in coming studies, so that we can better appreciate how past exercise might echo through our bodies well into the future.


A Drug-Resistant Fungus, How a Chicago Woman Fell Victim to Candida Auris

The mysterious infection has appeared at hospitals around the world, but few institutions or families have discussed their experience.

-By Matt Richtel - NYT

Stephanie Spoor, center, with her husband, Gregory, left, during a bedside wedding ceremony of her son, Zack, to his new wife, Carley (right), at Northwestern Memorial Hospital in Chicago. Ms. Spoor died just a few days later.CreditCreditSpoor family photo

Gregory Spoor got the distressing news about his wife on the morning of Jan. 16 while standing outside her room in the intensive care unit at Northwestern Memorial Hospital in Chicago. The doctor explained that Stephanie Spoor, 64, had contracted a “rare, very rare, fungus.”

The physician said the fungus was called Candida auris, and it appeared to have entered her bloodstream through a catheter or other intravenous line during her treatment. Mr. Spoor sent a text to the couple’s four children.

“Hey guys, I’m very sorry to do this via text but you need to know and not fair to wait until all of us are together,” he wrote. “The fungus mom has is the worst possible and can be terminal.”

He added: “It is a day to day issue so I don’t have any more answers or info at this time.”

Mr. Spoor, 67, an executive at a plumbing equipment company, wasn’t the only one with few answers. C. auris, a germ that typically is resistant to major antifungal medications, has been quietly confounding doctors, hospitals and infectious disease scientists around the world.

First identified in the ear of a woman in Japan in 2009 (“auris” is Latin for “ear”), the germ has spread around the globe, mostly appearing in hospitals and nursing homes, where it afflicts people with weakened immune systems.

Nearly 600 cases of C. auris have been reported in the United States, the majority of them in New York, New Jersey and Illinois. According to the Centers for Disease Control and Prevention, nearly half of people who contract the illness die within 90 days. But the true death rate is difficult to quantify because most patients have other medical conditions and their deaths may be attributed to other causes.

About 90 percent of C. auris strains are resistant to at least one drug, and 30 percent are resistant to two or more of the three major classes of antifungal drugs. However, on Tuesday, the C.D.C. confirmed that it has learned in the last month of the first known cases in the United States of so-called “pan-resistant” C. auris a strain resistant to all major antifungals, said Dr. Tom Chiller, head of the agency’s fungal division, in an interview.

Such cases have been seen in several countries, including India and South Africa, but the two new cases, from New York State, have not been reported previously. Dr. Chiller said that it appeared that, in each case, the germ evolved during treatment and became pan-resistant, confirming a fear that the infection will continue to develop more effective defenses.

“It’s happening and it’s going to happen,” Dr. Chiller said. “That’s why we need to remain vigilant and rapidly identify and control these infections.”

It often has been hard to gather details about the path of C. auris because hospitals and nursing homes have been unwilling to publicly disclose outbreaks or discuss cases, creating a culture of secrecy around the infection. States have kept confidential the locations of hospitals where outbreaks have occurred, citing patient confidentiality and a risk of unnecessarily scaring the public.

Ms. Spoor’s family contacted The New York Times to share details of her case after reading an article in the newspaper about the emergence of C. auris and the growing threat of drug resistant infections. Her experience sheds some light on the experience of dealing with the new health threat.

A petri dish of cultured Candida auris, right. When Ms. Spoor’s infection didn’t respond to antifungal medications, she was told to get her affairs in order.CreditCenters for Disease Control and Prevention

Northwestern Memorial has not issued any public announcement that it had cases of C. auris. The Illinois Department of Public Health confirmed Ms. Spoor’s case after the family gave officials permission to discuss it with The Times. But it would not disclose the identities of what it called “numerous” hospitals and nursing homes that have reported a total of 158 cases in the state since 2016.

Northwestern Memorial declined to answer any questions from The Times about Ms. Spoor’s case, despite receiving permission from the Spoor family to cooperate.

The hospital also declined to respond to questions about how many C. auris cases it has treated, whether there were any current cases, what precautions it was taking and other queries.

“After careful consideration, we are going to pass on participating in this story,” Christopher King, a hospital spokesman, wrote in an email in response to questions.

Generally, health care institutions have said that they do not want to worry the public unnecessarily, given that they are working hard to control the spread of the infection and also that the germ is not a health threat to the general public. The people at the greatest risk are those who have compromised immune systems, typically through illness and age, and who are in hospitals and nursing homes where many infections are carried and transmitted.

Ms. Spoor’s tale reveals the powerlessness of patients and institutions in the face of resistant infections.

Late last year, Ms. Spoor began experiencing shortness of breath and appeared to be having a surge of symptoms from lupus, an autoimmune disorder she had been diagnosed with years earlier but that did not seem to disrupt her daily life. Now, her lungs were having trouble absorbing oxygen.

Ms. Spoor’s family kept a detailed diary of the events, at her request. She went to Northwestern Memorial Hospital, a highly ranked academic medical center affiliated with Northwestern University. There, in mid-December, she had a biopsy that led to complications: The wound bled and she went into cardiac arrest. She was revived and put on a device called an extracorporeal membrane oxygenation machine to help her breathe.

That machine was considered a way station to help Ms. Spoor survive until she could receive a lung transplant. She felt hopeful she would be able to see her youngest son, Zack, get married in a ceremony planned for June.

But a month later, a blood test found C. auris. Ms. Spoor’s medical records, which the family shared with The Times, contained a note in mid-January in bold type: “This is a highly transmissible fungus that has a propensity to develop resistance.” The records continued, again in bold type, that it was necessary to “discuss with nurses to maintain diligent contact precautions and limited visitors if possible.”

Those records indicated that the hospital suspected Ms. Spoor picked up the infection from one of the tubes inserted into her body.

Ms. Spoor’s son Nicholas, 40, a Chicago architect, said that the day his mother was diagnosed with C. auris, he noticed the nurses and doctors in full protective aprons and gloves, using bleach to wipe off their feet when they entered and left the room. Everything in the room had a white glaze, he said, from the chemicals used to clean it.

“It was like a laboratory,” he said.

But the family was hopeful. A doctor told them, Nicholas recalled, “that the strain they had had at Northwestern had been susceptible to the drug cocktail they were currently giving her, and they expected it to clear up.”

Indeed, according to the medical records, initial lab tests suggested that the strain of C. auris that had infected Ms. Spoor’s bloodstream was susceptible to the hospital’s drug treatment.

The records also included hints of doubt. “Limited literature on C. auris indicates a relatively high mortality and this pathogen may be difficult to eradicate,” a Jan. 19 notation said.

Over the latter half of January, doctors and nurses furiously tried to treat the fungus, but it kept growing back. The drugs weren’t working. Ms. Spoor appeared fatigued, the family said, but was not showing any other particularly obvious signs of infection.

Barely two months earlier, before her biopsy, Ms. Spoor had been thrilled to accept an early Christmas present from the family: She attended a speech by Michelle Obama at the United Center in downtown Chicago.

Now, in the early days of February, she and her family were being told to put her affairs in order. A doctor told Ms. Spoor that there was nothing more to be done. A transplant wasn’t realistic until she was clear of C. auris, but there seemed to be no effective treatment for the infection.

On Feb. 8, their grief was suspended briefly and the atmosphere in her hospital room turned celebratory. The Spoors’ youngest son, Zack, married his fiancĂ©e, Carley, in a wedding ceremony at her bedside.

Bride and groom wore protective blue hospital gowns over their formal wear, and blue gloves. After the chaplain pronounced them husband and wife, said a blessing and an “Amen,” Ms. Spoor grinned as if she had beat the devil at cards.

A few days later, after consulting with the family, doctors removed Ms. Spoor from the oxygenation machine — her life support, essentially. In the hours before, Ms. Spoor said there was one last person she’d like to speak with: her son Nicholas, with whom she had not yet had a final heart-to-heart conversation.

“She just said what you’d expect a mom to say to you in that situation,” Mr. Spoor recounted. He tried to elaborate, but began to cry: “I can’t talk about it. She just said the exact right thing.”

Ms. Spoor died on Feb. 11. Her death certificate describes the cause as respiratory failure.

Dr. Rosalind Ramsey-Goldman, a rheumatologist who treated Ms. Spoor, said she felt for the family. “Understandably, her family has had a hard time dealing with their loss,” she said. “And as providers, we too were saddened by the events that transpired, and that we were not able to help her when she had this infection.”

Ms. Spoor’s husband, Greg, said he bore no grudge against the hospital and, in fact, found its care exceptional. He said he wished that he had known to ask about C. auris and the precautions the hospital was taking.

“It was something that we didn’t even know was out there, and then it happened and it was one of the major reasons she died,” said her son Nicholas. “If you’re not sharing the data about the patients, that’s an issue.”


State govt to test efficacy of antiviral Favipiravir for treatment of Covid patients

A health department official said, “The health minister issued a direction to rope in a team of doctors for assessing the effectiveness of F...