Andrew Jacobs

The death shook the emerging field of fecal microbiota transplants, or FMT, a revolutionary procedure that transfers feces from healthy donors to the bowels of sick patients in an effort to restore their microbiome, the community of beneficial bacteria and other organisms that dwell in the intestines.

Fecal microbiota transplants remain unapproved by the Food and Drug Administration, but the treatment has proved highly effective in combating a deadly bacterial infection known as Clostridium difficile, which kills thousands of Americans annually. Researchers have also been exploring its use for conditions ranging from Alzheimers to autism.

Dr. Elizabeth L. Hohmann, the lead author of the article and an infectious disease specialist who oversees fecal transplant trials at Mass General, expressed remorse over her lab’s failure to test stool from a donor that had been stored in a freezer for several months.

“It’s been professionally very challenging,” she said in an interview. “But this is a cautionary tale about the risks of cutting edge projects.”

After doctors reported the incidents to the FDA, the agency issued a nationwide alert to health care providers and patients about the risks of the procedure and urged researchers to suspend fecal transplants until labs could safely screen for drug-resistant microbes. Many projects have since resumed.

The patients at Mass General fell ill from E. coli bacteria that produced an enzyme called extended-spectrum beta-lactamase, which made the bacteria resistant to multiple antibiotics. The bacteria are often harmless in healthy people but can wreak havoc on those with compromised immune systems.

The New England Journal article provided a detailed, up-close look at how doctors at Mass General administered encapsulated stool from a donor whose feces had been successfully used to treat scores of patients with C. diff, a debilitating bacterial infection that tends to strike hospitalized patients who have been treated with multiple rounds of antibiotics.

Doctors at Mass General had been testing stool donations for a multitude of infectious bugs, following FDA protocols. In January, the agency tightened the screening standards to include a number of emergent organisms like the drug-resistant strain of E. coli.

The problem, Hohmann said, was that the FDA did not instruct doctors to test or destroy older material kept in storage. “It wasn’t obvious to a lot of smart people here,” she said. “We didn’t think to go back in time.”

The patients sickened by the compromised feces were participating in two separate experimental trials last spring. One patient, a 69-year-old man with end-stage liver disease, received capsules over the course of three weeks. The other, a 73-year-old man with a rare blood cancer, was given the capsules before undergoing a bone marrow transplant. Both men had also been administered antibiotics.

The men turned feverish soon afterward. The liver patient developed pneumonia that tests later determined was caused by the drug-resistant E. coli strain. He was treated with a powerful antibiotic and eventually recovered.

The cancer patient, who had taken drugs to suppress his immune system as part of the bone marrow transplant, declined more precipitously. Eight days after his last FMT dose, he was placed on a ventilator. He died two days later from a severe bloodstream infection.

Genomic sequencing tests later confirmed that the organisms came from the same donor. Looking back at their actions, the doctors acknowledged in the article that the decision to give both men antibiotics before their fecal transplants might have provided an opportunity for the drug-resistant E. coli strain to thrive.

“We’ve been going through a lot of 20-20 hindsight here,” Hohmann said.

The incident prompted widespread angst among patients and practitioners in the rapidly evolving field of fecal microbiota transplantation.

Dr. Ari Grinspan, a gastroenterologist at Mt. Sinai Hospital in New York who helped pioneer fecal transplants for C. diff, said he received a flood of panicked calls and emails from former patients who thought they might have received compromised stool.

“What happened was horrific, but it’s reminded us that we have to be vigilant about screening protocols,” he said.

The cases have also heightened tensions that have pitted doctors who perform fecal transplants against drug companies that are developing new microbiota therapies derived from human stool. Those companies have been pressing the FDA to more tightly regulate the procedure as a new drug, a move that some doctors and patient advocates fear would give companies proprietary control over the active ingredients in transplanted feces.

The FDA will hold a public hearing next week in Washington to better understand the risks and benefits of the therapy. For now, the agency allows fecal transplants for C. diff patients who have not responded to standard therapies, an approach known as enforcement discretion.

In a statement yesterday, the agency said: “The FDA would like to clarify that the use of FMT to treat C. difficile remains investigational at this time and the efficacy and safety of this intervention have not yet been established.”

Unlike Mass General, which produces its own fecal transplant material, most of the treatments used by doctors in the United States come from OpenBiome, a nonprofit stool bank in Cambridge, Massachusetts that has provided 50,000 doses in recent years without any reported serious adverse events related to the material, according to Carolyn Edelstein, the executive director.

OpenBiome has been testing donors for the drug-resistant strain of E. coli since 2016, she said, adding that fewer than 3% of prospective donors make it through the rigorous screening.

In an era of mounting antimicrobial resistance, many doctors said the incident underscored the challenges presented by organisms that are constantly evolving in their effort to survive the onslaught of antibiotics used in medicine and agriculture. Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota, said his lab had also been testing for the E. coli strain, but there is always a fear a newly virulent bug will slip through the screening process.

“This is a potential issue that could even be existential and we need to address it head on and always be ahead of the game,” said Khoruts.

This article originally appeared in

Doctors Detail Cause of Death for Recipient of a Fecal Transplant

In a frank and public act of self-examination, a group of doctors at Massachusetts General Hospital published an article Wednesday in the New England Journal of Medicine detailing the missteps that led to the death of a cancer patient who received a fecal transplant as part of an experimental trial. The man who died, and another who became severely ill, had received fecal matter from a donor whose stool turned out to contain a type of E. coli bacteria that was resistant to multiple antibiotic...

The cases have also heightened tensions that have pitted doctors who perform fecal transplants against drug companies that are developing new microbiota therapies derived from human stool. Those companies have been pressing the FDA to regulate the procedure as a new drug, a move that some fear would give companies proprietary control over the active ingredients in transplanted feces.

The FDA will hold a public hearing next week in Washington as part of the agency’s quest for a new regulatory approach. For now, the agency allows fecal transplants for C. diff patients who have not responded to standard therapies, an approach known as enforcement discretion.

Unlike Mass General, which produces its own fecal transplant material, most of the treatments used by doctors in the United States come from OpenBiome, a nonprofit stool bank in Cambridge, Massachusetts that has provided 50,000 doses in recent years without any reported adverse events, according to Carolyn Edelstein, the executive director.

How Contaminated Stool Stored in a Freezer Left a Fecal Transplant Patient Dead

Drug-resistant infections already claim 700,000 lives a year, including 230,000 deaths from drug-resistant tuberculosis, the report said. The rampant overuse of antibiotics and antifungal medicines in humans, livestock and agriculture is accelerating a crisis that is poorly understood by the public and largely ignored by world leaders. Without concerted action, a U.N. panel said, resistant infections could kill 10 million people annually by 2050 and trigger an economic slowdown to rival the global financial crisis of 2008.

The problem threatens people around the world. During the next 30 years, U.N. experts said, 2.4 million people in Europe, North America and Australia could die from drug-resistant infections, making routine hospital procedures like knee-replacement surgery and child birth far riskier than they are today.

“This is a silent tsunami,” said Dr. Haileyesus Getahun, director of the U.N. Interagency Coordination Group on Antimicrobial Resistance, which spent two years working on the report. “We are not seeing the political momentum we’ve seen in other public health emergencies, but if we don’t act now, antimicrobial resistance will have a disastrous impact within a generation.”

The group, a collaboration of public health experts, government ministers and industry officials, called for the creation of an independent body with the stature and funding of the U.N.’s panel on climate change.

The report’s dire predictions seek to raise public awareness and shake political leaders into action. It proposes a series of measures that health officials say could help stem the rise of drug-resistant pathogens. The recommendations include a worldwide ban on the use of medically important antibiotics for promoting growth in farm animals; financial incentives for drug companies to develop new antimicrobial compounds; and more stringent rules to limit the sale of antibiotics in countries where drugs can often be bought at convenience stores without a prescription.

The report also highlights underappreciated factors in the spread of drug-resistant germs: the lack of clean water and inadequate sewage systems that sicken millions of people in the developing world. Many of them are too poor to see a doctor and instead buy cheap antibiotics from street vendors with little medical expertise. Sometimes they unknowingly purchase counterfeit drugs, a problem that leads to millions of deaths, most of them in Africa.

To reduce outbreaks of infectious disease, the report says, wealthier nations should help poor countries pay for improvements to public hygiene, and ensure greater access to vaccines and properly manufactured antibiotics.

Health officials are struggling to understand the scope of the problem because many countries are ill-equipped to monitor drug-resistant infections. In a survey the United Nations conducted for the report, 39 of 146 nations were unable to provide data on the use of antimicrobials in animals, which experts say is a major driver of resistance in humans as resistant bacteria get transferred to people through contaminated food and water.

“We are flying pretty blind and working hard to get some clear vision,” said Sally Davies, the chief medical officer of England and a leader of the U.N. panel.

As a first step, the report calls on member states of the United Nations to create national stewardship plans to reduce the unnecessary use of antimicrobials.

A key element of the report is a call for new incentives to encourage the development of antimicrobial medicines. Between 2010 and 2014, six new antimicrobial drugs were approved, most of them additions to existing drug classes, according to the World Health Organization. By contrast, 19 new antimicrobial drugs were approved between 1980 and 1984.

The dearth of new drugs is tied to the perverse economics of antimicrobial resistance and the free market. It can cost a half-billion dollars to develop a new compound, but doctors are discouraged from using the drugs to reduce the possibility that the targeted pathogens will become resistant. Even when doctors prescribe the drugs, most patients take them for a week or two, limiting a drug company’s ability to earn back its initial investment.

“Everyone agrees that there is an absolute need for new antibiotics, but there is no sustainable market,” said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers &amp; Associations.

Incentives to develop new drugs could include generous government financing for research, or regulatory changes that would increase reimbursements for newly approved antibiotics considered medically important. According to the World Bank, such investments would quickly pay for themselves; it notes that containing antimicrobial resistance costs $9 billion annually.

“I applaud the U.N. for at least putting incentives on the map, but there needs to be more than talk,” said Cueni, who also chairs the AMR Industry Alliance, a trade group working to address the problem of antimicrobial resistance. “What’s needed is money.”

Still, many public health advocates said the report was an important step in elevating a crisis that has failed to garner the attention of other global problems like climate change and AIDS.

Lance Price, director of the Antibiotic Resistance Action Center at George Washington University, said he worried the report might not gain much traction with the Trump administration, which has been averse to multilateral cooperation.

Fear, he said, was the key to changing the status quo.

“Even if you don’t care about the suffering of people who drink unclean water and get resistant infections, you still have to recognize that these bacteria don’t recognize international borders,” he said. “They will come here, and they will kill us. We have to let people know that the problem is closer than they think.”

This article originally appeared in <a href="https://www.nytimes.com/2019/04/29/health/un-drug-resistance-antibiotics.html" id="3efce12f-bc55-315e-a8d1-914bee13667d">The New York Times</a>.

With more and more common medications losing their ability to fight dangerous infections, and few new drugs in the pipeline, the world is facing an imminent crisis that could lead to millions of deaths, a surge in global poverty and an even wider gap between rich and poor countries, the United Nations warned in a report Monday.

U.N. Issues Urgent Warning on the Growing Peril of Drug-Resistant Infections

In one of the largest surveys of data on global dietary habits and longevity, researchers found that consuming vegetables, fruits, fish and whole grains was strongly associated with a longer life — and that people who skimped on such healthy foods were more likely to die before their time.

The study, published Wednesday in the British journal The Lancet, concluded that one-fifth of deaths around the world were associated with poor diets — defined as those short on fresh vegetables, seeds and nuts but heavy in sugar, salt and trans fats.

In 2017, that came to 11 million deaths that could have been avoided, the researchers said. Most of those, around 10 million, were from cardiovascular disease, researchers found. The next biggest diet-related killers were cancer, with 913,000 deaths, and Type 2 diabetes, which claimed 339,000 lives.

“These numbers are really striking,” said Dr. Francesco Branca, the top nutritionist at the World Health Organization, who was not involved in the study. “This should be a wake-up call for the world.”

The study, which was funded by the Bill &amp; Melinda Gates Foundation, covered global eating habits from 1990 to 2017 and tracked consumption in 15 categories — including milk, processed meat, seafood, sodium and fiber.

Researchers analyzed data from 195 countries and found that Papua New Guinea, Afghanistan and the Marshall Islands had among the highest proportion of diet-related deaths, while France, Spain and Peru had some of the lowest rates. The United States ranked 43rd. China was among the worst at 140.

The study found a tenfold difference between countries with the highest and lowest rates of diet-related deaths. For example, Uzbekistan had 892 deaths per 100,000 people compared with 89 in Israel.

Beyond its sobering conclusion, the study was notable for what it prescribed: Rather than browbeating people to reduce their consumption of the fats and sugars that are correlated with illness and premature death, the authors determined that adding healthier foods to global diets was a more effective way to reduce mortality.

That’s because the gap between the amount of nourishing foods people should eat but don’t is much greater than that between the levels of harmful things they regularly put in their mouths but shouldn’t, said Dr. Ashkan Afshin, an epidemiologist at the University of Washington who was the paper’s lead author. For example, he noted that global average intake of red meat was 27 grams a day, slightly higher than the recommended daily limit of 23 grams. But when it comes to eating healthful nuts and seeds, most people eat on average 3 grams, far less than the 21 grams considered optimal.

The only exception was excess salt, which the research said was highly correlated with illness and death.

“To me, this study says that it’s time to change the conversation both at the policy level and among the general public,” Afshin said.

He and other experts said the findings underlined the importance of national policies to boost the availability of fruits and vegetables, especially in low-income countries where fresh produce can be costlier than processed food. Large food companies should be pressured to create healthier products, the experts said, and doctors should be encouraged to discuss the importance of a good diet with their patients.

“Let’s not just focus on the things we should be cutting out of our diet because to be honest, we’ve tried that for a while,” said Dr. Nita Gandhi Forouhi, an epidemiologist at University of Cambridge School of Clinical Medicine who wrote a commentary that accompanied study.

Not everyone agreed with the study’s central recommendations. Dr. Arun Gupta, a pediatrician and nutrition activist in India, said he thought the authors should have placed more emphasis on the role that food companies play in the spread of unhealthy foods. “My fear is that this will take the pressure off industry, who can use the report to say, ‘We’re doing nothing wrong,’” he said.

The study had some limitations. There were notable gaps in diet-related data from poorer nations and some of the deaths, the authors noted, could have been attributed to more than one dietary factor, leading to an overestimation of the burden of diseases attributable to diet.

Still, nutrition and health experts who read the report said its key findings were irrefutable. “This further builds the evidence base around the fact that diet is killing us,” said Corinna Hawkes, director of the Center for Food Policy at City, University of London.

Forouhi, the Cambridge epidemiologist, said she hoped that at the very least, the national ranking of diet-related mortality would jolt some countries into action, especially those without national dietary surveys. “Perhaps by naming and shaming, some of the countries at the bottom of the list will be inspired to do better,” she said. “At the very least, they can learn from countries near the top.”

This article originally appeared in <a href="https://www.nytimes.com/2019/04/03/science/diet-disease-deaths.html" id="6cac4ead-ffa3-39f7-adc8-54cec2cd026f">The New York Times</a>.

Mom is right when she says to eat your peas.

Eat Your Veggies: Study Finds Poor Diets Linked to 1 in 5 Deaths

The clash is over the future of fecal microbiota transplants, or FMT, a revolutionary treatment that has proved remarkably effective in treating Clostridioides difficile, a debilitating bacterial infection that strikes 500,000 Americans a year and kills 30,000.

The therapy transfers fecal matter from healthy donors into the bowels of ailing patients, restoring the beneficial works of the community of gut microbes that have been decimated by antibiotics. Scientists see potential for using these organisms to treat diseases like diabetes and cancer.

At the heart of the controversy is a question of classification: Are the fecal microbiota that cure C. diff a drug, or are they more akin to organs, tissues and blood products that are transferred from the healthy to treat the sick? The answer will determine how the Food and Drug Administration regulates the procedure, how much it costs and who gets to profit.

In 2013, the FDA announced a draft decision to regulate the therapy as a new drug but said it would continue to study the matter before reaching a final decision — which is expected to happen soon. Critics say that approach is based on outdated science and could lead to increased costs for patients, most of whom currently rely on a nonprofit stool bank in Cambridge. At stake, some researchers says, is the future of pioneering therapies that harness the human microbiome — the trillions of organisms that colonize the body and are increasingly seen as critical for healthy brain development and immune function.

“People have good reason to worry because for many patients, fecal transplants are a matter of life and death,” said Catherine Duff, founder of the Fecal Transplant Foundation, a patients group. “The concern is that corporate greed will get in the way of patient access.”

As the FDA nears a final decision, both sides are ramping up the pressure. More than 40 prominent gastroenterologists and infectious disease doctors recently wrote to the agency, urging it to rethink its approach.

Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota, said he feared the FDA was favoring the interests of what he calls the “poop drug cartel,” a group of companies seeking approval for new ways to deliver the active ingredients in transplanted feces. Three of the companies, Rebiotix, Seres Therapeutics and Vedanta Biosciences, have raised tens of millions of dollars from investors, and they recently formed an association to advance their interests with the FDA.

“An obscene amount of money is being thrown around by companies trying to profit off of what nature made,” said Khoruts. “I don’t think there are clear villains here, but I worry that the regulators are not caught up on the latest science and that the interests of investors may be exceeding those of patients.”

Pharmaceutical executives and some doctors argue that the drug model will help ensure the efficacy and long-term safety of a therapy whose mechanics remain poorly understood.

“The first principle of medicine is do no harm, and at the moment we don’t have a long-term track record of FMT’s adverse effects,” said Dr. Sahil Khanna, an associate professor of gastroenterology at the Mayo Clinic who has conducted industry-funded clinical trials on fecal transplants. “We also need to move away from transferring poo from one person to another.”

Experts in the field of bioethics and many doctors are pressing the FDA to come up with a new regulatory category that reflects the groundbreaking nature of microbiota therapies.

Much like the fight over prescription drug prices, the “poop wars,” as one doctor described it, mirrors long-running tensions in U.S. health care between pharmaceutical companies and patients.

Human feces, it turns out, are a potential gold mine, for both medical researchers and drugmakers.

According to the analytical firm GlobalData, the market for drug-based treatments for C. diff is expected to reach $1.7 billion by 2026, up from $630 million in 2016. The growth is tied to soaring rates of C. diff, which parallel the overuse of antibiotics, leaving patients more vulnerable to the infection.

Inspired by the success of fecal transplants for C. diff, scientists are racing to develop similar treatments for an array of ailments and disorders, among them obesity, autism, ulcerative colitis, and Alzheimer’s and Parkinson’s diseases.

Investors, too, have taken note, and they are pouring tens of millions of dollars into startups chasing the next microbiota breakthrough.

“The whole field is screaming forward faster than anyone could have imagined,” said Lee A. Jones, chief executive of Rebiotix, which is testing two products to treat C. diff. “The microbiome has the potential to change the way we look at and treat disease.”

Such exuberance is a far cry from what researchers experienced when they first tried to sell the curative power of human feces.

Mark Smith, a microbiologist at the Massachusetts Institute of Technology, was halfway through his pitch with a group of pharmaceutical executives when one of them interrupted to ask if the meeting was a prank. “I can’t believe you wasted my time with this crazy idea,” the man said, Smith later recalled.

That was 2012. Later that year he helped found OpenBiome, the nonprofit stool bank that now supplies most of the fecal matter for transplants in the United States. Three years ago, he started his own drug company, Finch Therapeutics, which has raised $77 million.

Over the last decade, tens of thousands of Americans with C. diff have been cured through fecal transplants, often with a single dose that can bring patients back from the brink of death. The treatment has more than an 80 percent success rate, according to several studies, and many patients feel better within hours of receiving the procedure, which is usually administered through colonoscopy or capsules containing desiccated fecal matter.

The FDA has not formally approved the therapy, but it has suspended enforcement of its rules for patients who have failed on antibiotics while it figures out the best way to regulate a regimen that, until recently, was sometimes performed at home by desperate patients using an enema, saline and a relative’s stool. Duff, the head of the C. diff patients group, credits her own recovery from the disease to a homemade concoction her husband created with his own stool in the kitchen blender.

The FDA declined to comment for this article. Until the agency finalizes its decision, many insurance companies will not cover the therapy.

Treating fecal transplants like a new drug requires pharmaceutical companies to submit proposed products to an exhaustive investigative process to assess their efficacy and safety, which can cost millions of dollars.

Critics fear that designation would allow a drug company to gain the exclusive right to sell a fecal transplant treatment for up to 12 years, a move they say would stymie innovation.

Some also worry that patients unable to afford a company’s proprietary therapy could turn to home remedies, putting them at risk for pathogens in unscreened stool.

For now, most of the material used in fecal transplants comes from OpenBiome, the public stool bank in Cambridge that embraces its mission with both humor and gravitas. Giant poop emojis decorate its offices, conference rooms are named after sections of the intestinal tract and employee birthday cakes invariably come in one flavor: chocolate.

The organization produces 900 to 1,000 monthly treatments, most of them bottled liquids that are packed in dry ice and sent overnight to clinics across the country. Any unpleasant odors are confined to an airtight production facility, where employees in white hazmat suits gingerly handle clear plastic bags filled with a mud-colored slurry.

The material comes from donors who earn $40 a pop and must pass intensive screenings and regular medical checkups. “It’s harder to become a stool donor than it is to get into MIT,” said Carolyn Edelstein, who runs the organization.

In 2012, Edelstein created OpenBiome with Smith, now her fiance, after her cousin contracted recurrent C. diff and, facing a six-month wait for the procedure, did it at home with a roommate’s stool.

A few months later they started OpenBiome with seed money from a foundation and sent out six treatments that first year. “It’s been a wild ride,” Edelstein said as she showed off a room full of mammoth freezers that hold thousands of screened stool samples.

But OpenBiome and other stool banks are facing an uncertain future. Drug companies, which have been struggling to funnel patients into the clinical studies that are required for FDA approval, would like federal officials to restrict the stool bank’s ability to distribute fecal matter in the hope that more patients will enroll in their trials.

The FDA has ramped up oversight of OpenBiome’s production, leading to more rigorous testing and higher prices, which will double to $1,600 this month.

Patient advocates expect those prices to jump exponentially should the FDA grant market exclusivity to one of the companies that are in the final stages of testing alternatives to raw stool transplants.

“It is very frustrating to see hyperregulation again ruining a good thing in health care,” said Dr. Colleen Kelly, a gastroenterologist at the Brown University medical school.

Her patients share her worry. Stephen Shaw, 66, a retired truck driver, spent much of last year tethered to a toilet as he battled C. diff. A diabetic, Shaw acquired the intestinal affliction the way many people do: during hospitalization for a series of infections treated with repeated rounds of antibiotics.

“I couldn’t go anywhere for fear I was going to blast out,” he said, recalling the many times he soiled himself. “My life was destroyed.”

In late December, Kelly administered a fecal transplant via colonoscopy, and within hours, Shaw started feeling better. By Christmas his bowel movements had returned to normal.

“I never imagined the solution to my nightmare could be so simple,” he said. “I just hope Big Pharma doesn’t make it unaffordable for the people like me.”

This article originally appeared in <a href="https://www.nytimes.com/2019/03/03/health/fecal-transplants-fda-microbiome.html" id="27fa0ea0-e7b6-3ed5-af93-455ea8c936b3">The New York Times</a>.

CAMBRIDGE, Mass. — There’s a new war raging in health care, with hundreds of millions of dollars at stake and thousands of lives in the balance. The battle, pitting drug companies against doctors and patient advocates, is being fought over the unlikeliest of substances: human excrement.

Drug Companies and Doctors Battle Over the Future of Fecal Transplants

<h1>PHILADELPHIA — Jeff Foster, 58, a retired security guard with an abiding sweet tooth and a generous paunch, scowled as he considered the cornucopia of refrigerated soft drinks at his local convenience store.</h1>

“It’s just not right,” he said, complaining that prices on his favorite brands had nearly doubled since a tax on sweetened beverages went into effect here two years ago.

Then he did something that might make public health experts beam. He headed to the cash register, leaving behind the two-liter bottle of Day’s Champagne Cola he coveted.

“I’m on a fixed income so I have to watch my spending,” said Foster, who has high blood pressure. “Plus my doctor says I’ve got to lose weight.”

Three years ago, Philadelphia became the first major American city to enact a tax on sugary beverages, products that contribute to the nation’s epidemic of obesity, diabetes and heart disease. When Philadelphians go to the polls Tuesday in primary elections for mayor and City Council, they will be indirectly voting on its survival.

Though not on the ballot, the soda tax has become a heated issue in the city’s local elections this year, with emotions fanned in part by anti-soda tax television commercials and online ads paid for by the beverage industry. The two Democrats challenging Mayor Jim Kenney oppose the tax, as do a score of City Council hopefuls who decry the 1.5 cent-per-ounce tax as an unfair burden on the city’s poorest residents. The levy, on average, adds about 30% to the cost of sweetened beverages.

“In my district, 95% of the residents hate it,” said Councilwoman María Quiñones-Sánchez, who has introduced legislation that would study the tax and come up with possible alternatives. “The people who buy $7 lattes say the poor should be drinking water, but no one is considering the fact that my constituents live in food deserts with no access to fresh fruit and vegetables.”

Across the country, advocates and opponents of taxes on sugary beverages have been closely following the twists and turns that have bedeviled Philadelphia’s ambitious experiment, a legislative hallmark of Kenney’s first term that has raised $200 million for education and infrastructure programs.

In the months before its approval in July 2016, the beverage industry, allied with grocery store owners and the Teamsters union, poured $10.6 million into the fight against the measure; supporters spent $2 million, much of it from Michael Bloomberg, the former New York mayor who has been a generous backer of soda tax initiatives across the country.

In a cash-strapped city where a quarter of all residents live in poverty, Kenney sold the tax as a revenue generator, not a nanny-state gambit to change unhealthy habits. The City Council approved the measure 13-4.

Opponents immediately took their case to the courts, but in July the Pennsylvania Supreme Court rejected their argument that the tax is illegal. The decision freed up millions of dollars in soda tax revenue that had been held in escrow and directed it toward creating 4,000 prekindergarten slots, 12 new community schools and an ambitious program to rebuild the city’s crumbling libraries and recreation centers. Next year the city plans to add another 1,000 pre-K seats.

“It’s been an absolute success,” the mayor said Friday after visiting a museum that was hosting dozens of children from the city’s expanded pre-K program. He said he was not especially worried about the future of the tax, and he had harsh words for the beverage industry, which last month spent more than $600,000 in its campaign to turn public opinion against the measure.

“This is all about rich white men who want to become even wealthier and who want to deny many kids of color an opportunity for an education,” he said.

Industry executives say the tax is a failure and that it goes against the will of the people. “Beverage taxes hurt working families, small local business and their employees,” said William Dermody, a spokesman from the American Beverage Association, which news reports indicate has spent more than $1 million on the city elections from April 2 through May 6. “And polls show a majority of Philadelphians want it repealed.”

In a city with some of the nation’s highest rates of obesity and Type 2 diabetes, public health experts have a different concern: whether the tax is having a significant impact on people’s consumption habits.

A study published last week in the medical journal JAMA found that the law dampened supermarket sales of sweetened beverages by 38%; a study by Stanford University’s Graduate School of Business, published in January, put that number at 22%. Other studies have found less significant effect. Experts say it could be years to determine whether the policy has improved the overall health of the city’s residents.

Christina A. Roberto, the lead author of the JAMA study, said Philadelphia’s results far outpaced those in other places that have adopted beverage taxes in recent years, among them Berkeley, California, and Mexico, which have since experienced a roughly 10% reduction in soda sales.

“We are losing the war against chronic diseases, so it’s rare to see something that has this kind of impact,” said Roberto, a health policy expert at the University of Pennsylvania’s medical school. “It’s not surprising that if you raise the price of something, people will buy less of it.”

More than 40 countries have adopted soda taxes, and since 2014, seven municipalities in the United States and the Navajo Nation have embraced such measures.

The industry has been pushing back aggressively, most notably at the state level, where it has persuaded legislatures in Arizona, Michigan and California to pass laws that bar municipalities from adopting soda taxes. It has also backed statewide ballot measures to ban such taxes, with mixed success.

But Dr. Jim Krieger, executive director of the advocacy group Healthy Food America, said the dynamic could change next year, when California and a number of New England states are expected to take up statewide soda tax legislation. “The momentum is building,” he said. “If a state like California were to adopt a tax, that would be a game-changer.”

Even supporters say Philadelphia’s measure has flaws. For starters, it covers any beverage with added sweeteners, including diet sodas and fruit juices that have modest amounts of artificial sweeteners. Critics say that sends out a muddled message about the importance of avoiding sugar. And because the tax only applies to liquids, it does not cover powdered drink mixes, which have seen a spike in sales as price-sensitive shoppers find ways to avoid the tax.

The other problem was on display last week at the Acme supermarket in Bala Cynwyd, a town just across the city line that was buzzing with shoppers, their carts laden with 12 packs of Sprite, jugs of Sunny Delight and a kaleidoscopic array of Gatorades. Russ Bompartito, the store director, said employees could barely keep up with the demand from customers who drive in from the city to stock up on beverages.

The store has rejiggered its displays, placing towers of soda at the end of every aisle, and a basement storage area has been taken over by pallets of beverages that delivery trucks have to replenish several times a day.

“It’s been a real headache,” he said.

Out in the parking lot, Carol Marks, 60, a postal worker from North Philadelphia who makes the trip twice a month, was loading her trunk with cases of fruit flavored Ginger Ale. “Who doesn’t want to save money?” asked Marks, who has diabetes and is out on disability. “This tax is ridiculous.”

Jim Perkins, president of Acme, which has 16 stores in and around Philadelphia, echoed the complaints of business leaders who say the benefits of the tax have been illusory because many residents simply leave the city to buy beverages. He said soda sales at his stores have plummeted 52% and many stores have seen an overall drop in business.

“What concerns us is not just the sugary drinks, but it’s that you’ve lost the customer who is buying milk, meat and other staples,” he said. “You’ve lost the whole consumer.”

Mayor Kenney says he has a solution to that problem: a statewide beverage tax, though the prospects of such a measure appear dim given Republican control of the Legislature.

In the meantime, residents like Foster, the security guard, are bearing the brunt of the tax. Without access to a car, he does much of his shopping at the 10 Brothers Food Mart, a corner store that stocks mostly packaged food and sells no fresh produce.

Despite his disdain for the measure, Foster acknowledged the tax was having the desired effect. He helps take care of his five grandchildren, who clamor for the fluorescent blue bottles of Little Hug, a sugary drink that now costs 50 cents, double its previous price.

“They just drink this stuff like it’s water,” he said. “Now if I could only get them to drink water.”

This article originally appeared in <a id="d56cad54-178c-4b8c-b896-a591867baf5d" href="https://www.nytimes.com/2019/05/20/health/soda-tax-philadelphia.html">The New York Times</a>.

Why Tuesday's City Primary Could Mean the End of Philadelphia's Soda Tax

Then he did something that might make public health experts beam. He headed to the cash register, leaving behind the two-liter bottle of Day’s Champagne Cola he coveted.

Why Tuesday's city primary could mean the end of Philadelphia's soda tax

Describing sweetened drinks as “a grave health threat to children and adolescents,” the American Academy of Pediatrics and the American Heart Association issued a set of bold policy recommendations they say are necessary to stem the epidemic of Type 2 diabetes, cancer, cardiovascular disease and other diet-related illnesses responsible for tens of thousands of premature deaths and billions of dollars in annual health care costs.

The organizations say such measures are needed if the United States is to adhere to federal dietary guidelines recommending that added sugars make up less than 10 percent of the total calories consumed by children and adolescents. The figure now stands at 17 percent, with nearly half of that coming from sugary sports drinks, carbonated sodas and fruit-flavored beverages, according to studies. The guidelines do not include sugars found naturally in 100 percent fruit juices.

“Sugary drinks are empty calories and they are the low-hanging fruit in the fight against childhood obesity,” said Dr. Sheela Magge, a pediatric endocrinologist at Johns Hopkins Children’s Center who took part in crafting the recommendations.

The statement, more than two years in the making, reflects the growing sense of urgency among doctors — and the frustration over what many describe as government inaction in the face of a national health emergency.

“I’ve seen 2-year-olds with fatty liver disease and teenagers with Type 2 diabetes,” said Dr. Natalie Muth, a California pediatrician and a lead author of the recommendations. “These are diseases we used to see in their grandparents. It’s frustrating because as pediatricians we feel like we’re doing everything we can, but it’s hard to compete with a $800-million-a-year marketing strategy by the soda industry.”

The recommendations embrace a range of initiatives, some of them untested — like federal curbs on junk food advertising — and measures like soda taxes that have been effective in reducing soda consumption.

Most are likely to face resistance from the powerful beverage industry, which has fought back vigorously against any government efforts to dampen consumption of sugar-laden drinks.

Still, some of the policy suggestions would be relatively easy to achieve, like increased funding for public education programs to highlight the dangers of excess sugar consumption or changes to the federal food program that serves millions of poor children. The Supplemental Nutrition Program, or SNAP, pays for 20 million servings of sugary drinks a day, at an annual cost of $4 billion. Barring recipients from using benefits to buy unhealthy beverages, researchers say, could prevent 52,000 deaths from Type 2 diabetes.

Other small, symbolic steps they recommend could have an outsize effect, like encouraging health care institutions to remove sugary drinks from cafeteria menus and vending machines.

“As with the ban on tobacco, leadership by hospitals and health plans to eliminate the sale of sugary drinks can improve the health of their employees, increase public awareness about the contribution of sugary drinks to obesity, and thereby change social norms,” the medical groups said.

William Dermody, a spokesman for the American Beverage Association, said sugary drinks were being unfairly blamed for soaring rates of obesity and diabetes, and he said there were better ways to discourage sugar consumption among children. The industry, he noted, was focused on creating healthier products, including bottled water and low-sugar drinks, part of an industry initiative to cut by 20 percent the calorie count in beverages by 2025.

“America’s beverage companies believe there’s a better way to help reduce the amount of sugar consumers get from beverages and it includes putting parents in the driver’s seat to decide what’s best for their children,” he said in a statement.

But parents, especially those who work long hours, are not always around to police what their children are drinking. When it comes to teenagers, the challenge is even greater.

“Parents can only do so much, especially in single-parent households,” Magge of Johns Hopkins said.

Jim Krieger, executive director of Healthy Food America, said the industry could not be trusted to oversee the consumption of the unhealthy products it depends on for its profits.

Take, for example, the initiative to voluntarily reduce the sugar content in beverages. Krieger said the effort was off to a slow start, with only a 3 percent reduction since the effort began in 2014.

Although sugary soda consumption in the United States has dropped since 2000, recent data suggests the decline has plateaued in recent years and rates remain stubbornly high in poor communities, and especially among minority adolescents. According to the Centers for Disease Control and Prevention, the obesity rate is nearly 19 percent among the poorest Americans ages 2 to 19, 8 percentage points higher than those in wealthier communities.

Federal studies have also shown that beverage companies spend a disproportionate share of their marketing dollars on campaigns aimed at minority youth, and researchers say such advertisements have been growing in recent years despite a voluntary, industrywide initiative to reduce ads for unhealthy products.

Many public health advocates have called for federal regulation, much like the 1971 rule that banned cigarette ads on radio and television. The medical associations acknowledged that such restrictions would face an uphill battle but suggested Congress could modify tax laws that allow beverage companies to deduct advertising costs for unhealthy food and beverages.

State governments, they added, could enact rules that ban the marketing of such foods in and around schools and prohibit the makers of sugary drinks from sponsoring youth sporting events.

But when it comes to curbing the zeal for sugary drinks, the medical groups say that higher taxes hold the greatest promise to change habits. From Mexico to Chile and from Philadelphia to Berkeley, California, the introduction of soda taxes in recent years has led to significant declines in soda consumption, with a 10 percent tax on average associated with a 7 percent drop in consumption, according to researchers.

Another study found that soda taxes, if widely enacted, could prevent more than a half-million cases of childhood obesity.

The medical associations’ recommendations acknowledge that soda taxes would disproportionately affect the poor but that such communities would stand to benefit if the revenue was spent to enhance early education and programs that subsidize the price of healthy food and beverages.

Benjamin Winig, vice president for law and policy at ChangeLab Solutions, an advocacy group, said he hoped the new recommendations would help build the political will needed to overcome increasingly muscular pushback from beverage manufacturers.

Faced with a surge of local soda taxes, the industry has been backing so-called pre-emptive legislation at the state level that prohibits municipalities from creating taxes on food and beverages. The effort has been successful in states including California, Michigan and Washington.

In the end, though, he said local municipalities were in the best position to address the growing crisis of childhood obesity.

“The public health community is winning, but it’s a very difficult battle,” he said. “Our kids are getting sick and dying and what we really need is for government to step up their mission to keep people safe.”

This article originally appeared in <a id="259b368b-7581-494f-a9ba-d183df7bbda1" href="https://www.nytimes.com/2019/03/25/health/soda-taxes-sugary-drinks-advertising.html">The New York Times</a>.

Two top medical groups call for soda taxes and advertising curbs on sugary drinks

Two of the country’s leading medical groups Monday issued a call to arms against the soda industry, urging legislators and policymakers to embrace taxes, warning labels and advertising restrictions to deter young people from consuming the sugary beverages that are increasingly linked to the nation’s crisis of obesity and chronic disease.

<h1>For ambitious young scientists trying to start their own research labs, winning a prestigious grant from the National Institutes of Health can be career making.</h1>

But when it comes to the size of those awards, men are often rewarded with bigger grants than women, according to a study published Tuesday in JAMA, which found that men who were the principal investigators on research projects received $41,000 more than women.

The disparity was even greater at the nation’s top universities. At Yale, women received $68,800 less than men, and at Brown, the median disparity was $76,500. Overall, the median NIH award for female researchers was roughly $126,600, compared with $167,700 for men.

The study, by researchers at Northwestern University, confirms long-standing disparities between men and women in the field of science. In recent years, a cavalcade of studies has documented biases that favor male researchers in hiring, pay, prize money, speaking invitations and even the effusiveness displayed in letters of recommendation.

“It’s disappointing, but identifying the problem is a step toward solving the problem,” said Cori Bargmann, a neuroscientist who runs the $3 billion science arm of the Chan Zuckerberg Initiative, a philanthropic organization, and who was not involved in the study.

In a statement, the NIH did not dispute the study’s findings and said it was working to address the funding disparities and, more broadly, the gender inequities that bedevil women in the field.

“We have and continue to support efforts to understand the barriers and factors faced by women scientists and to implement interventions to overcome them,” it said.

Only one in five applicants for an NIH grant lands one, an achievement that can be crucial in whether a young researcher succeeds or drops out of the field.

“That first grant is monumentally important and determines your trajectory,” said Carolina Abdala, a head and neck specialist at the University of Southern California, who won her first NIH grant in 1998. “It can help get you on the tenure track and it gets you into that club of successful scientists who can procure their own funding, which makes it easier to change jobs.”

But the size of the grant can also be important in determining the scale and ambition of a junior researcher’s first lab. Teresa K. Woodruff, a co-author of the JAMA study, said that having less money put women at a disadvantage, making it harder to hire graduate students and buy lab equipment.

“It means women are working harder with less money to get to the same level as men,” said Woodruff, a researcher at the Northwestern University Feinberg School of Medicine. “If we had the same footing, the engine of science would move a little faster toward the promise of basic science and medical cures.”

The study analyzed 54,000 grants awarded from 2006 to 2017 and used key benchmarks to ensure recipients were at similar points in their careers. Among the top 50 institutions funded by the NIH, the researchers found that women received median awards of $94,000 compared with $135,000 for men. At the Big Ten schools, including Penn State, the University of Michigan and Northwestern, female principal investigators received a median grant of $66,000 compared with $148,000 for men.

There was one exception to the pattern; in a curious twist, the study found that women who were applying for individual research grants received nearly $16,000 more than male applicants. Woodruff noted that such grants made up only 11 percent of NIH grant money, but said more research was needed into funding disparities.

This article originally appeared in <a id="16b8e679-4816-4150-93f6-5442f7c2eda3" href="https://www.nytimes.com/2019/03/05/science/women-scientists-grants.html">The New York Times</a>.

Another obstacle for women in science: Men get more federal grant money

The disparity was even greater at the nation’s top universities. At Yale, women received $68,800 less than men, and at Brown, the median disparity was $76,500.

<h1>CAMBRIDGE, Mass. — There’s a new war raging in health care, with hundreds of millions of dollars at stake and thousands of lives in the balance. The battle, pitting drug companies against doctors and patient advocates, is being fought over the unlikeliest of substances: human excrement.</h1>

This article originally appeared in <a id="182ab9c1-dcdf-406d-bbae-b42b122e20c2" href="https://www.nytimes.com/2019/03/03/health/fecal-transplants-fda-microbiome.html">The New York Times</a>.

Drug companies and doctors battle over the future of fecal transplants