After Russia invaded Ukraine, the West responded, sending military weaponry and aid to the embattled nation. But as the war drags on, there is also a need for doctors. One nonprofit is sending American surgeons to Ukraine, and Ukrainian surgeons to train in the United States. Iryna Solomko has the story, narrated by Anna Rice. VOA footage by Pavlo Terekhov.
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Science
science and health news
Growing community of breast milk donors in Uganda gives mothers hope
KAMPALA, Uganda — Early last year, Caroline Ikendi was in distress after undergoing an emergency Caesarean section to remove one stillborn baby and save two others. Doctors said one of the preterm babies had a 2% chance of living.
If the babies didn’t get breast milk — which she didn’t have — Ikendi could lose them as well.
Thus began a desperate search for breast milk donors. She was lucky with a neighbor, a woman with a newborn baby to feed who was willing to donate a few milliliters at a time.
“You go and plead for milk. You are like, ‘Please help me, help my child,'” Ikendi told The Associated Press.
The neighbor helped until Ikendi heard about a Ugandan group that collects breast milk and donates it to mothers like her. Soon the ATTA Breastmilk Community was giving the breast milk she needed, free of charge, until her babies were strong enough to be discharged from the hospital.
ATTA Breastmilk Community was launched in 2021 in the Ugandan capital, Kampala, by a woman who had struggled like Ikendi without getting support. The registered nonprofit, backed by grants from organizations and individuals, is the only group outside a hospital setting in Uganda that conserves breast milk in substantial amounts.
ATTA, as the group is known, receives calls for support from hospitals and homes with babies born too soon or too sick to latch onto their mothers’ breasts.
More than 200 mothers have donated breast milk to support more than 450 babies since July 2021, with over 600 liters of milk delivered for babies in that period, according to ATTA’s records.
In a measure of efforts to build a reliable community, many donors have given multiple times while others help to find new ones, said ATTA administrator Racheal Akugizibwe.
“We are an emergency fix,” Akugizibwe said. “As the mother is working on their own production, we are giving (her) milk. But we do it under the directive and under the support of a lactation specialist and the medical people.”
She added: “Every mother who has given us milk, they are kind of attached to us. They are we; we are them. That’s what makes it a community.”
ATTA makes calls for donors via social media apps like Instagram. Women who want to donate must provide samples for testing, including for HIV and hepatitis B and C, and there are formal conversations during which ATTA tries to learn more about potential donors and motivations. Those who pass the screening are given storage bags and instructed in safe handling.
Akugizibwe spoke of ATTA’s humble beginnings in the home of its founder, Tracy Ahumuza, who would store the milk in her freezer. Ahumuza started the group amid personal grief: She hadn’t been able to produce breast milk for her newborn who battled life-threatening complications. Days later, after the baby died, she started lactating.
She asked health workers, “Where do I put the milk that I have now?'” Akugizibwe said. “They told her, ‘All we can do for you is give you tablets to dry it out.’ She’s like, ‘No, but if I needed it and I didn’t get it, someone could need it.'”
In the beginning, ATTA would match a donor to a recipient, but it proved unsustainable because of the pressure it put on donors. ATTA then started collecting and storing breast milk, and donors and recipients don’t know each other.
Akugizibwe said the group gets more requests for support than it can meet. Challenges include procuring storage bags in large quantities as well as the costs of testing. And donors are required to own freezers, a financial obstacle for some.
“The demand is extremely, extremely high,” Akugizibwe said, “but the supply is low.”
Lelah Wamala, a chef and mother of three in Kampala who twice has donated milk, said she was spurred to act when, while having a baby in 2022, she saw mothers whose premature babies were dying because they didn’t have milk.
Being a donor is a time-consuming responsibility, “but this is the right thing to do,” she said.
Via motorcycle courier on Kampala’s busy streets, breast milk from donors is taken to ATTA’s storage and delivered to parents in need.
ATTA’s goal is to set up a full-fledged breast milk bank with the ability to pasteurize. The service is necessary in a country where an unknown number of women suffer for lack of lactation support, said Dr. Doreen Mazakpwe, a lactation specialist who collaborates with ATTA.
Mazakpwe cited a range of lactation issues mothers can face, from sore nipples to babies born too sick or too weak to suckle and stimulate milk production.
If both mother and baby are healthy, “this mother should be able to produce as much milk as the baby needs because we work on the principle of supply and demand,” said Mazakpwe, a consultant with a private hospital outside Kampala. “So, in situations where there’s a delay in putting the baby on the breast, or the baby is not fed frequently enough … you can eventually have an issue where you have low supply.”
Mazakpwe said she advises mothers on how to establish their own supply within about a month of receiving donated breast milk, and sometimes all that’s needed is to hold the baby the right way. When mothers start lactating, it frees up supply for new ones who need ATTA’s help, she said.
Akugizibwe said their work is challenging in a socially conservative society where such a pioneering service raises eyebrows. Questions, even from recipients, include fears that babies who drink donated breast milk might inherit the bad habits of their benefactors.
In addition, “If you don’t breastfeed there is a lot of negativity,” said Ikendi, whose premature babies survived on donated milk. “Society looks at you as though you’ve just literally refused to breastfeed.”
She spoke of struggling even when she knew she had no choice after seeing her babies in the intensive care unit for the first time. Through the glass she saw they were so tiny, on oxygen therapy and bleeding from their noses. The babies, a boy and a girl, had been removed at seven months.
Ikendi’s babies received donated breast milk for two months.
One recent morning, an emotional Ikendi held her children as she described how the donated milk “contributed 100% to our babies’ growth.”
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Climate crisis creates a health crisis, WHO reports
GENEVA — Scientific evidence documented in a series of articles presented by the World Health Organization this week highlights the harmful impact of climate change at key stages of the human life cycle.
“These provide important scientific evidence on how the health of pregnant women, newborns, children, adolescents and older people is affected by air pollution and different climate hazards, including wildfires, flooding and extreme heat,” Anayda Portela, director of the WHO’s department of maternal, newborn, child and adolescent health and aging, said at a briefing Friday for journalists in Geneva.
“This evidence is critically important, because it shows the leading health risks for each of these groups for these different climate events,” Portela said.
She noted that the collection of articles published in the Journal of Global Health shows that climate-related health risks “have been crucially underestimated” for younger and older people and during pregnancy, “with serious, often life-threatening implications.”
The studies find that climate-related natural hazards have some “serious mental and physical health impacts” in pregnancy, and for younger and older people.
For example, the authors note that preterm births, which now are the leading cause of childhood deaths, “increase during heatwaves, while older people are more likely to suffer heart attacks or respiratory distress.”
They report that heatwaves also “affect cognitive function and therefore learning for children and adolescents.”
The World Meteorological Organization’s State of Global Climate report confirms 2023 as the hottest year on record and predicts that global temperatures over “the entire five-year 2024-2028 period will exceed 1.5 degrees centigrade above the pre-industrial era,” which scientists warn could lead to rapid and irreversible changes in the climate.
According to the World Health Organization, between 2030 and 2050, climate change is projected to cause approximately “250,000 additional deaths per year from malnutrition, malaria, diarrhea and heat stress alone.”
Portela also warned that air pollution increases the likelihood of high blood pressure during pregnancy, low birth weight, preterm birth and negative impacts on fetal brain and lung development.
“It raises risk of respiratory illness among children and older people,” she said, adding that they also face greater risks of “cancer, cardiovascular disease and pneumonia.”
The studies detail the many noxious effects on mental and physical well-being from climate-related natural disasters, including flooding and drought, as well as wildfires, which have been shown to increase respiratory disorders and cardiovascular mortality rates for older people.
“There is an urgent need to mitigate climate change by reducing greenhouse gas emissions and to build climate resilience, to take specific actions that protect health at these various life stages,” Portela said.
Authors of the reports note that “few climate adaptation measures are tailored for the specific needs of women, infants, children and adolescents,” as well as older people who may have mobility and cognitive constraints.
Nevertheless, the WHO urges governments to prioritize climate change as a health issue, pointing out several specific actions they can take to promote and protect health at different life stages.
For example, this could include flexibility around work hours, preparing childcare and educational systems for extreme weather events and rising temperatures, and informing people and communities about various measures that can protect vulnerable people during heatwaves and periods of worsening air pollution.
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In many US cities, Black and Latino neighborhoods have less access to pharmacies
MONTGOMERY, Alabama — Parts of the north side of Montgomery are defined by what it has lost: restaurants, grocery stores and a convenient pharmacy, the latter of which closed five years ago.
People who still live in the historically Black neighborhood of Newtown, like Sharon Harris, are frustrated. She goes to a different location of the same pharmacy chain, which is four miles from her home.
“You have to come back sometimes,” she said, “and then they wait so long to fill the prescription.”
In cities across the U.S., major retail pharmacies have closed hundreds of stores over the past few years and independents can’t always afford to stay open. That can leave residents of color without easy access to a business that provides not only prescriptions but also fundamental public health services like vaccinations, over-the-counter medicines and even food.
Closures create “a situation where there’s not just (a lack of) investment in terms of pharmacy development and expansion, but there’s no incentive to stay in those neighborhoods,” said Dima Qato, a professor of clinical pharmacy at the University of Southern California who has studied pharmacy access.
And an Associated Press analysis of licensing data from 44 states, data from the National Council for Prescription Drug Programs and the American Community Survey shows residents of neighborhoods that are majority Black and Hispanic have fewer pharmacies per capita than people who live in mostly white neighborhoods.
MAC Pharmacy is the only one serving about 20,000 people in a majority Black ZIP code in Cleveland. George Tadross, the part-owner and pharmacy manager, said he is adamant about making things as as easy as possible for his mostly older customers — sometimes by organizing their medications by day for them.
“You have to have a pharmacist to talk to,” he said. “My philosophy in the pharmacy business is you know your doctor, he knows everything about you. You need to know your pharmacist as well (because) the pharmacist is the only one that sees the whole medical treatment plan you have.”
Pharmacists play a role in managing chronic diseases like diabetes and heart-related issues, which Black and Hispanic people are more likely to be diagnosed with.
And when pharmacists or pharmacy technicians reflect their customer base — by speaking the same language or understanding the community — it can be easier to build a strong rapport and trust, said Jasmine Gonzalvo, who teaches at Purdue University’s College of Pharmacy and has researched the needs of Spanish-speaking patients at pharmacies.
She noted that if people don’t feel comfortable asking questions about the medication, then it might mean they don’t take it or don’t take it correctly.
“You don’t get a refill,” Gonzalvo said, “simply because there were barriers in the way of your communicating and feeling safe in that relationship with your pharmacist.”
That’s why Bert’s Pharmacy in Elizabeth, New Jersey, has “Spanish- and English-speaking staff all the time,” said owner and pharmacist Prakash Patel said. His business is located in an ZIP code where nearly 70% of the residents are Hispanic.
“We want to make sure, too, they understood everything,” Patel said. “We have Spanish-language labels for them, we print all the instructions in Spanish for them.”
In Montgomery, where Harris lives, the city is working on a development plan for the north side. A retail analysis in the plan shows a small pharmacy could generate $1.5 million in sales a year.
“There’s an opportunity there because you have what I call a captive market,” said Bob Gibbs, the director of Gibbs Planning Group, which did the analysis. “People that live in a lot of these neighborhoods have limited access to transportation … and they’re very loyal to local businesses that will treat them with respect.
“They will go out of their way just to go there. And they just don’t like having to drive … two miles to go to a drugstore. That’s unfair.”
Harris, though, doesn’t have much hope a new pharmacy will open.
“I don’t see it,” she said. “As long as they have (that CVS) they think it’s OK. … Everybody is waiting for them to do something on this side.”
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Former astronaut who took iconic photo of Earth dies in plane crash
seattle, washington — Retired Major General William Anders, the former Apollo 8 astronaut who took the iconic “Earthrise” photo showing the planet as a shadowed blue marble from space in 1968, was killed Friday when the plane he was piloting alone plummeted into the waters off the San Juan Islands in Washington state. He was 90. His son, Greg Anders, confirmed the death to The Associated Press.
“The family is devastated,” Greg Anders said. “He was a great pilot, and we will miss him terribly.”
Anders said the photo was his most significant contribution to the space program, given the ecological and philosophical impact it had, along with making sure the Apollo 8 command module and service module worked.
A report came in around 11:40 a.m. local time that an older-model plane had crashed into the water and had sunk near the north end of Jones Island, San Juan County Sheriff Eric Peter said.
Only the pilot was on board the Beech A45 airplane at the time, according to the Federal Aviation Association.
William Anders said in a 1997 NASA oral history interview that he didn’t think the Apollo 8 mission was risk-free but there were important national, patriotic and exploration reasons for going ahead.
He estimated there was about a one-in-three chance that the crew wouldn’t make it back and the same chance the mission would be a success and the same chance that the mission wouldn’t start to begin with. He said he suspected Christopher Columbus sailed with worse odds.
He recounted how the Earth looked fragile and seemingly physically insignificant yet was home.
“We’d been going backwards and upside down, didn’t really see the Earth or the sun, and when we rolled around and came around and saw the first Earthrise,” he said. “That certainly was, by far, the most impressive thing. To see this very delicate, colorful orb which to me looked like a Christmas tree ornament coming up over this very stark, ugly lunar landscape really contrasted.”
The National Transportation Safety Board and FAA are investigating the crash.
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UN development agency installing solar energy at Zimbabwean clinics, hospitals
Zimbabwe is facing long hours of power cuts due to its dilapidated infrastructure and the impact of recurring droughts on hydropower. To help, the United Nations Development Program is installing solar panels on government-owned health facilities. Columbus Mavhunga reports from Bulawayo.
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SpaceX’s mega rocket completes its fourth test flight from Texas without exploding
Boca Chica, Texas — SpaceX’s mega Starship rocket completed its first full test flight Thursday, returning to Earth without exploding after blasting off from Texas.
The previous three test flights ended in explosions of the rocket and the spacecraft. This time, both managed to splash down in a controlled fashion.
The world’s largest and most powerful rocket — almost 121 meters tall — was empty as it soared above the Gulf of Mexico and headed east on a flight to the Indian Ocean.
Minutes after Thursday morning’s liftoff, the first-stage booster separated from the spacecraft and splashed into the gulf precisely as planned, after firing its engines.
An hour later, live views showed parts of the spacecraft breaking away during the intense heat of reentry, but it remained intact enough to transmit data all the way to its targeted splashdown site in the Indian Ocean.
“And we have splashdown!” SpaceX launch commentator Kate Tice announced from Mission Control at company headquarters in California.
It was a critical milestone in the company’s plan to eventually return Starship’s Super Heavy booster to its launch site for reuse.
SpaceX came close to avoiding explosion in March, but lost contact with the spacecraft as it careened out of space and blew up short of its goal. The booster also ruptured in flight, a quarter-mile above the gulf.
Last year’s two test flights ended in explosions shortly after blasting off from the southern tip of Texas near the Mexican border. The first one cratered the pad at Boca Chica Beach and hurled debris for thousands of feet (meters).
SpaceX upgraded the software and made some rocket-flyback changes to improve the odds. The Federal Aviation Administration signed off Tuesday on this fourth demo, saying all safety requirements had been met.
Starship is designed to be fully reusable. That’s why SpaceX wants to control the booster’s entry into the gulf and the spacecraft’s descent into the Indian Ocean — it’s intended as practice for planned future landings. Nothing is being recovered from Thursday’s flight.
NASA has ordered a pair of Starships for two moon-landing missions by astronauts, on tap for later this decade. Each moon crew will rely on NASA’s own rocket and capsule to leave Earth, but meet up with Starship in lunar orbit for the ride down to the surface.
SpaceX already is selling tourist trips around the moon. The first private lunar customer, a Japanese tycoon, pulled out of the trip with his entourage last week, citing the oft-delayed schedule.
SpaceX’s founder and CEO has grander plans: Musk envisions fleets of Starships launching people and the infrastructure necessary to build a city on Mars.
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War traumatizes, haunts both Israeli and Palestinian children
Many Israeli and Palestinian children are suffering from trauma because of the October 7 Hamas attack on Israel and the ensuing eight months of war between the two sides. Therapists in both communities say the emotional scars could linger for years. Linda Gradstein reports from Jerusalem.
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Novo Nordisk braces for generic challenge to Ozempic, Wegovy in China
SHANGHAI, China — Novo Nordisk is facing the prospect of intensifying competition in the promising Chinese market, where drugmakers are developing at least 15 generic versions of its diabetes drug Ozempic and weight loss treatment Wegovy, clinical trial records showed.
The Danish drugmaker has high hopes that demand for its blockbuster drugs will surge in China, which is estimated to have the world’s highest number of people who are overweight or obese.
Ozempic won approval from China in 2021, and Novo Nordisk saw sales of the drug in the greater China region double to $698 million last year. It is expecting Wegovy to be approved this year.
But the patent on semaglutide, the active ingredient in both Wegovy and Ozempic, expires in China in 2026. Novo is also in the midst of a legal fight in the country over the patent.
An adverse court ruling could make it lose its semaglutide exclusivity even sooner and turn China into the first major market where Novo is stripped of patent protection for the drugs.
Those circumstances have drawn several Chinese drugmakers to the fray. At least 11 semaglutide drug candidates from Chinese firms are in the final stages of clinical trials, according to records in a clinical trial database reviewed by Reuters.
“Ozempic has witnessed unprecedented success in mainland China … and with patent expiry so close, Chinese drugmakers are looking to capitalize (on) this segment as soon as possible,” said Karan Verma, a health care research and data analyst at information services provider Clarivate.
Front-runner Hangzhou Jiuyuan Gene Engineering has already developed one treatment that it says has “similar clinical efficacy and safety” as Ozempic and applied for approval for sale in April. The company has not published efficacy data and did not respond to a request for information.
The company said in January that it expected approval in the second half of 2025, but it cautioned that it would not be able to commercialize the drug before Novo’s patent expires in 2026, unless a Chinese court makes a final ruling that the patent is invalid.
The Danish company’s semaglutide patent is expiring in China far ahead of its expiry in key markets such as Japan, Europe and the U.S. Analysts attribute variations in patent expiry timelines to term extensions Novo has won in specific regions.
Even more pressing for Novo is the China patent office’s 2022 ruling that the patent is invalid for reasons related to experimental data availability, which the company has challenged.
China’s top court said it was not able to say when verdicts are likely ready.
A Novo spokesperson said it “welcomes healthy competition” and was awaiting a court decision on its patent case. The spokesperson did not answer follow-up queries on the matter.
Other Chinese drugmakers who are running the final stages of clinical trials for Ozempic generics include United Laboratories, CSPC Pharmaceutical Group, Huadong Medicine and a subsidiary of Sihuan Pharmaceutical Holdings Group.
CSPC said in May it expected approval for its semaglutide diabetes drug in 2026.
Brokerage Jefferies estimated in an October report that semaglutide drugs from United Laboratories will be launched for diabetes in 2025 and obesity in 2027. United Laboratories did not respond to a request for comment.
Impact on prices
The number of adults who are overweight or obese in China is projected to reach 540 million and 150 million, respectively, in 2030, up 2.8 and 7.5 times from 2000 levels, according to a 2020 study by Chinese public health researchers.
If shown to be as safe and effective as Novo’s, Chinese drugmakers’ products will increase competition and bring down prices, analysts say.
Goldman Sachs analysts estimated in an August report that generics could lead to a price reduction of around 25% for semaglutide in China. The weekly Ozempic injection costs around $100 for each 3mL dose through China’s public hospital network, Clarivate’s Verma said.
Novo acknowledges the intensifying competition.
“In 2026 and 2027 we might see a few more players showing up due to the clinical trials” in progress, Maziar Mike Doustdar, a Novo executive vice president, told investors in March, referring to the China market.
But he also questioned the capability of some of the players to provide meaningful volumes, adding, “We will watch it as we get closer.”
Novo also faces competition from internationally well-known firms, including Eli Lilly, whose diabetes drug Mounjaro received approval from China in May. HSBC analysts expect China’s approval this year or in the first half of 2025 for Lilly’s weight loss drug with the same active ingredient.
Eli Lilly did not reply to a request for a comment on Chinese approval of the drug, which in the U.S. is called Zepbound.
Supplies of both Wegovy and Zepbound remain constrained, but the companies have been increasing production.
Zuo Ya-Jun, general manager of weight loss drugmaker Shanghai Benemae Pharmaceutical, said a product being competitive would depend on distinguishing features such as efficacy, durability of the treatment and a company’s sales abilities.
“It will be a market with fierce competition, but who will be [the leader] is hard to say,” she said.
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UN chief warns target to limit global warming is slipping away
NEW YORK — The U.N. secretary-general said Wednesday that the world is “at a moment of truth” to reach targets in the 2015 Paris climate accord to limit global warming, as the planet has just experienced the 12 hottest consecutive months on record.
“The truth is, almost ten years since the Paris Agreement was adopted, the target of limiting long-term global warming to 1.5 degrees Celsius is hanging by a thread,” Antonio Guterres told an audience at New York’s American Museum of Natural History, where exhibits about extinct dinosaurs offered their own planetary warning.
“The World Meteorological Organization reports today that there is an 80% chance the global annual average temperature will exceed the 1.5-degree limit in at least one of the next five years,” he said.
“We are playing Russian roulette with our planet,” he warned in a special climate speech under the museum’s famous blue whale, marking World Environment Day.
The U.N. chief said the richest 1% of countries are emitting as much pollution as two-thirds of all humanity.
He said the planet is emitting around 40 billion tons of carbon dioxide annually and will burn through its remaining “carbon budget” of around 200 billion tons well before 2030. Guterres also said global emissions need to fall 9% each year between now and 2030 in order to keep the 1.5 degree Celsius limit alive. Last year, they rose by 1%.
The bill for the climate crisis will keep growing without meaningful action.
“Even if emissions hit zero tomorrow, a recent study found that climate chaos will still cost at least $38 trillion a year by 2050,” Guterres said.
Fossil fuels
The climate crisis has been a signature issue of Guterres’ tenure since becoming the world’s top diplomat seven-and-a-half years ago. He has repeatedly called for the phasing out of coal and other fossil fuels in favor of cleaner renewable energies like wind and solar power — which already produce nearly a third of the world’s electricity.
He raised the ante Wednesday, urging banks to stop financing oil, coal and gas and invest in renewables instead. He called on countries to ban advertising from fossil fuel producers and said news and technology platforms should stop taking their advertising.
“I call on leaders in the fossil fuel industry to understand that if you are not in the fast lane to clean energy transformation, you are driving your business into a dead end — and taking us all with you,” the U.N. chief said, adding that the oil and gas industry invested only 2.5% of its total spending on clean energy in the last year.
He urged public relations companies and lobbyists to stop enabling the industry’s “planetary destruction” and drop those clients.
“Many in the fossil fuel industry have shamelessly greenwashed, even as they have sought to delay climate action — with lobbying, legal threats, and massive ad campaigns,” he said.
Leveling the field
The secretary-general reiterated his stance that those who have contributed the least to the climate crisis are suffering the most — mainly poorer nations in Africa and small island states. The G20 major economies produce 80% of the world’s emissions.
“It is a disgrace that the most vulnerable are being left stranded, struggling desperately to deal with a climate crisis they did nothing to create,” he said.
Guterres warned that the difference between 1.5 and 2 degrees could mean survival or extinction for some small island nations and coastal communities.
“1.5 degrees is not a target. It is not a goal. It is a physical limit,” he said.
Global warming is already hurting the planet’s oceans, their coral reefs and marine ecosystems, and melting sea ice. Across the globe, severe floods, droughts, heatwaves, wildfires, and other climate-related catastrophes are becoming all too frequent.
The secretary-general said there must be more financing and technical support from richer countries to mitigate climate impacts and invest in renewables for lower income states. He also said a global early warning system must be in place by 2027, to protect everyone on Earth from hazardous weather, water or climate events.
He urged citizens to continue to make their voices heard and said it is time for leaders to decide whose side they are on.
“Now is the time to mobilize; now is the time to act; now is the time to deliver,” he said to a standing ovation. “This is our moment of truth.”
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Panel rejects psychedelic drug MDMA as a PTSD treatment
washington — Federal health advisers voted Tuesday against a first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD, handing a potentially major setback to advocates who had hoped to win a landmark federal approval and bring the banned drugs into the medical mainstream.
The panel of advisers to the Food and Drug Administration sided 10-1 against the overall benefits of MDMA when used to treat post-traumatic stress disorder. They cited flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse.
“It seems like there are so many problems with the data — each one alone might be OK, but when you pile them on top of each other … there’s just a lot of questions I would have about how effective the treatment is,” said Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs.
The FDA is not required to follow the group’s advice and is expected to make its final decision by August, but the negative opinion could strengthen FDA’s rationale for rejecting the treatment.
The vote followed hours of pointed questions and criticisms about the research submitted on MDMA — sometimes called ecstasy or molly. Panelists pointed to flawed studies that could have skewed the results, missing follow-up data on patient outcomes, and a lack of diversity among participants. The vast majority of patients studied were white, with only five Black patients receiving MDMA, raising questions about the generalizability of the results.
“The fact that this study has so many white participants is problematic because I don’t want something to roll out that only helps this one group,” said Elizabeth Joniak-Grant, the group’s patient representative.
The FDA advisers also drew attention to allegations of misconduct in the trials that have recently surfaced in news stories and a report by the nonprofit Institute for Clinical and Economic Review, which evaluates experimental drug treatments. The incidents include a 2018 report of apparent sexual misconduct by a therapist interacting with a patient.
Lykos Therapeutics, the company behind the study, said it previously reported the incident to the FDA and regulators in Canada, where the therapist is based. Lykos is essentially a corporate spinoff of the nation’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies, or MAPS, which funded the studies. The group was founded in 1986 to promote the benefits of MDMA and other mind-altering substances.
MDMA is the first in a series of psychedelics — including LSD and psilocybin — that are expected to come before the FDA in the next few years. The panel’s negative ruling could further derail financial investments in the fledgling industry, which has mainly been funded by a small number of wealthy backers.
MDMA’s main effect is triggering feelings of intimacy, connection and euphoria. When used to enhance talk therapy, the drug appears to help patients process their trauma and let go of disturbing thoughts and memories.
But the panel struggled with the reliability of those results, given the difficulties of objectively testing psychedelic drugs.
Because MDMA causes intense, psychological experiences, almost all patients in two key studies of the drug were able to guess whether they had received the MDMA or a dummy pill. That’s the opposite of the approach generally required for high-quality drug research, in which bias is minimized by “blinding” patients and researchers to whether they received the drug under investigation.
“I’m not convinced at all that this drug is effective based on the data I saw,” said Dr. Rajesh Narendran, a University of Pittsburgh psychiatrist who chaired the panel.
Panelists also noted the difficulty of knowing how much of patients’ improvement came from MDMA versus simply undergoing the extensive therapy, which totaled more than 80 hours for many patients. Results were further marred by other complicating factors, including a large number of patients who had previously used MDMA or other psychedelics drugs recreationally.
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