Denise Grady

Without the transplant, performed last month, the patient “would have faced certain death,” Dr. Hassan Nemeh, who led the surgical team, said during a news conference at the hospital.

The patient’s lungs were scarred, stiffened, pocked with dead spots and extremely inflamed, he said. On a CT scan before the surgery, the patient’s chest appeared almost empty, as if the lungs had vanished. Normal lungs look dark on imaging because they are full of air; the patient’s lungs were not visible because they were not working. There was no air.

“What I saw in his lungs is like nothing I’ve seen before, and I’ve been doing lung transplants for 20 years,” Nemeh said. He added, “This is an evil I haven’t faced before.”

He called the case a preventable tragedy caused by “a senseless type of product that needs to be fought.”

The patient is recovering well and is up and about now, but still in the hospital. His name is being withheld to protect his privacy, but he and his family wanted to release information about his case in the hope that it might persuade others to quit vaping or never start, hospital officials said.

A doctor at the briefing read a statement from the family, which said, in part: “We asked Henry Ford doctors to share that the horrific life-threatening effects of vaping are very real! Our family could never have imagined being at the center of the largest adolescent public health crisis to face our country in decades.”

Patients with organ transplants need a lifelong regimen of medicines to suppress the immune system to prevent rejection. Dr. Lisa Allenspach, a lung specialist at the Henry Ford Hospital, said that the median survival rate after a lung transplant is seven years, but that rate has been steadily improving.

The patient’s youth and good health before this illness should work in his favor, she said, adding, “We’re hopeful that he will be alive and well for a long time.”

The doctors declined to say what products the patient had been vaping, how long he had been doing it or how often. About 86% of the patients with lung injuries in this outbreak had vaped THC, the chemical in marijuana that makes people high.

The case is the first transplant reported in the nationwide outbreak of vaping-related lung injuries, and it highlights the severity of an illness that, as of Nov. 5, had sickened 2,051 people and killed 40.

“I believe we are just beginning to see the tip of the iceberg,” Allenspach said.

Researchers have described the lung damage from vaping as chemical burns, similar to the injuries in people who have inhaled toxic fumes in industrial accidents, or in soldiers attacked with mustard gas in World War I.

The patients’ surgery was performed on Oct. 15. The doctors said they could not reveal any information about the source except to say that the donor had been healthy.

Health officials investigating the outbreak described a major advance last week: Researchers found a “very strong culprit,” a form of vitamin E, in the lungs of patients who had the vaping illness. The substance, vitamin E acetate, is sometimes used by illicit sellers to “cut” or dilute THC and increase profits.

The vitamin compound is thick and sticky. Precisely how it might damage the lungs is not yet known, and health authorities say it is still possible that other chemicals added to vaping fluids may also contribute to lung disease.

The doctors in Detroit did not say whether the compound had been found in the patient’s lungs.

This article originally appeared in

Facing 'Certain Death,' Boy With Vaping Injury Gets Double Lung Transplant

A 17-year-old boy whose lungs were irreversibly damaged by vaping received a double-lung transplant at the Henry Ford Hospital in Detroit, a lifesaving measure taken when a patient’s own lungs are diseased or damaged beyond repair and there is no other hope of survival, doctors said Tuesday.

But the agency left open the possibility that other chemicals or toxins could also be causing the severe respiratory ailments.

The report is based on finding the vitamin compound in fluid samples taken from the lungs of 29 patients who had the lung disease.

“For the first time, we have detected a potential toxin of concern, vitamin E acetate, from biological samples from patients,” with lung damage linked to vaping, Dr. Anne Schuchat, principal deputy director of the CDC, said at a news briefing. The samples, she said, “provided evidence of vitamin E acetate at the primary site of injury in the lungs.”

Samples taken from the patients were also tested for plant oils, petroleum distillates like mineral oil and other potentially harmful substances, which were “notably not detected,” the CDC said. The findings are being published in Friday’s Morbidity and Mortality Weekly Report.

About 70% of the patients are male, 79% are younger than 35 and 86% say that they have vaped THC.

Many of the products used by those who became ill were illicitly obtained, public health experts have said, by patients who bought them from friends or on the street. Vaping oils typically include other additives, solvents and flavor enhancers. Vitamin E acetate is sometimes added to dilute the THC to increase profits or as a thickening agent. Health investigators have said since nearly the beginning of the outbreak in mid-August that some ingredients, including vitamin E acetate, could be responsible for some of the lung illness cases.

State health officials in New York had first identified vitamin E acetate from several samples collected in August that were analyzed by the Wadsworth Center lab.

Vaping Illnesses Linked to Vitamin E Acetate, CDC Says

Vitamin E acetate, an ingredient added to THC-based products, has been identified as a “very strong culprit” in the vaping-related lung injuries that have sickened 2,051 people and killed 39, the Centers for Disease Control and Prevention said Friday.

“I can’t stress enough the seriousness of these lung injuries associated with e-cigarettes or vaping products,” Dr. Anne Schuchat, principal deputy director of the federal Centers for Disease Control and Prevention, said at a news briefing. “We are not seeing a meaningful drop-off in new cases, and unfortunately many more people have been hospitalized with lung injury each week.”

A new concern has come to light. She said a handful of patients, fewer than five, were hospitalized for vaping illness, recovered and went home, and then wound up back in the hospital again, from five to 55 days later. The reason is not yet known, she said. One possibility is that the patients may have started vaping again.

Schuchat said those cases highlight the importance of follow-up for patients who have been treated for vaping-related illnesses. The CDC says they should see doctors no later than a week or two after leaving the hospital, and some may need referrals for counseling for marijuana use disorder, a form of dependence.

Of the 1,299 cases reported to the CDC since mid-August, 70% of the patients are male, and 80% are under 35 years old. The majority, 76%, have vaped THC, the psychoactive ingredient in marijuana, and many have also used nicotine. Twenty-nine deaths have been reported. Only Alaska has no reported cases.

The cause of the illnesses is not known, and the CDC says no vaping products can be considered safe. Schuchat said there might turn out to be more than one cause, and it might take months to find the answer.

Health officials have given the illness a formal name, “e-cigarette, or vaping, product use associated lung injury,” or Evali.

The start of the flu season may make it harder to diagnose cases, because some symptoms of lung damage from vaping — cough, shortness of breath, fever — can mimic those of influenza. The CDC recommends testing patients with those symptoms for flu and other respiratory infections, but it is possible for patients to have both a lung injury from vaping and the flu or some other viral or bacterial ailment affecting their lungs.

Many patients with vaping illness also have stomach pain, nausea, vomiting and diarrhea, and it is important to ask people with those symptoms about vaping.

Doctors should “strongly consider” admitting patients to the hospital if they have become ill after vaping and are short of breath, have underlying illnesses that could affect their lungs or their blood oxygen level is less than 95%, the CDC said. That level, called oxygen saturation, can be measured with a device clipped to the fingertip, the agency said in its Morbidity and Mortality Weekly Report, published Friday.

The report also said that some patients who initially had mild symptoms then deteriorated rapidly within 48 hours. And many patients who ended up in the hospital had previously been sent home after seeking help at emergency rooms or clinics.

Because the vaping illnesses often involve severe inflammation in the lungs, many patients have been treated with corticosteroid drugs. But the report said it was not known whether the drugs really helped or whether the patients might have recovered on their own. And corticosteroids can increase the risk of infection.

The report says that “in some circumstances,” it might be best to avoid corticosteroids in patients who are being tested for illnesses like fungal pneumonia, which could worsen with the drugs. But the report also says that in patients who are severely ill, it may be necessary to give them corticosteroids along with other drugs to fight infection.

Patients who have had high doses of corticosteroids may need to see a specialist in endocrinology to help minimize or manage the side effects.

Patients older than 50 who become ill after vaping tend to be sicker than younger ones: more likely to need ventilators and to stay longer in the hospital. These older patients may need special consideration, the report said, adding that a quick diagnosis, treatment with steroids and consultation with specialists in pulmonary and critical care “might be lifesaving in this patient population.”

Dr. Ned Sharpless, acting commissioner of the Food and Drug Administration, said his agency had received more than 700 samples of vaping products for testing. So far, the cause of the outbreak has not been identified. The tests have found varying levels of THC and nicotine in different products, and some of the THC products also contain vitamin E acetate, which some sellers use to dilute the THC.

As illnesses and deaths linked to vaping continue to rise, health experts Friday updated their advice to doctors on how best to recognize symptoms and treat patients, and warned that the start of the flu season would make it harder to arrive at the right diagnosis.

No Drop in Vaping Cases, CDC Says

The illnesses are widespread, with cases reported from 46 states so far, and the U.S. Virgin Islands. Ten states have reported deaths.

Based on 373 cases where data on the patients was available, the CDC says that nearly three-quarters were male, two-thirds were 18 years to 34 years old and 16% were younger than 18 years.

People with the illnesses become weak and short of breath. Many need supplemental oxygen and treatment in intensive care units, and in some the lung damage is so severe that they must be placed on ventilators to keep them alive while their lungs recover. In a few cases, lung function has been so poor that ventilators were not enough, and the patients also had to be connected to machines that pump oxygen directly into the bloodstream.

Most of the patients have recovered enough to go home after days or weeks in the hospital, but doctors say it is too soon to tell whether they will suffer permanent damage to their lungs.

The case count started to snowball in August after health officials made the connection between vaping and the lung problems, and reported it publicly. Doctors around the country then began to realize it might explain some of the odd, pneumonia-like illnesses they were seeing in otherwise healthy people, and many began to question their patients about vaping.

Many people who became sick have said they were vaping THC, the ingredient in marijuana that induces a high, but some patients report vaping only nicotine. Some of the patients who died were older and had underlying illnesses, health officials have said.

No specific ingredients or devices have been identified as the cause of the illnesses, and health experts say multiple devices or ingredients may be involved. Investigations are being conducted by the CDC, Food and Drug Administration and state health departments.

At a hearing Wednesday before a subcommittee of the House Energy and Commerce Committee, a CDC official said she was “extremely frustrated” at the pace of the investigation. “I wish we had answers already,” said Dr. Anne Schuchat, the principal deputy director of the CDC. “I actually think there may be a very complex set of root causes here that are going to be difficult for us to address as a nation. And we need to take it very seriously.”

Schuchat told the panel members that the agency’s investigation was difficult because the suppliers of the THC products were underground and did not operate legally. The problem is compounded by a growing population of young people who are addicted to vaping, she said.

“We have a very vulnerable population and a very challenging supply chain to address,” she said.

Vaping-Related Illnesses Climb to 805, CDC Says

The number of people with lung illnesses linked to vaping has risen to 805, from last week’s figure of 530 cases, and 12 people have died, compared to a total of seven last week, the Centers for Disease Control and Prevention reported on Thursday.

The FDA decision, based on an increasing number of cases and deaths from the implant-associated cancer, lags far behind action in Europe, where the Allergan devices were effectively banned late last year.

Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the FDA said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.

“The data regarding deaths was particularly informative of our decisions,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

The disease is anaplastic large-cell lymphoma, a rare cancer of the immune system. It is not breast cancer, but develops in tissue around the implant. In most cases, removing the implant and the scar tissue around it cures the cancer, but if it is not detected early it can spread and kill the patient. The condition has occurred with implants placed for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer. The FDA first recognized the link to breast implants in 2011.

The lymphoma is rare, given that millions of women have breast implants. Breast enlargement is the most popular type of plastic surgery in the United States, with more than 300,000 operations performed in 2017, a 3% increase over 2016, according to the most recent data from the American Society of Plastic Surgeons. About 100,000 other women received implants in 2017 during reconstructive surgery after mastectomy for breast cancer in the United States.

Despite the low incidence of the lymphoma, the FDA said in a safety communication for patients that “at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing” the disease.

The Biocell textured implants carry a risk that is about six times that of other textured implants sold in the United States, the agency said. Hundreds of thousands of women in the United States have Biocell implants, Dr. Binita Ashar, director of the FDA’s Office of Surgical and Infection Control Devices, said at a news briefing on Wednesday about the recall.

The main symptoms of the lymphoma are usually swelling and fluid accumulation around the implant. If those symptoms occur, the fluid should be drained and tested for the cancer.

Women who have these implants, but no symptoms, do not need to have them removed, the FDA said. The recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergan, a major international manufacturer of breast implants.

“Patient safety is a priority for Allergan,” the company said in a statement, “and patients are advised to speak with their plastic surgeon about the risk and benefits of their implant type should they have any concerns.”

Dr. Mark Clemens, a plastic surgeon at the M.D. Anderson Cancer Center in Houston, who has been studying the lymphoma, said he supported the FDA’s decision. “We have tried to give them all the data and the information that they need to make this decision,” he said.

The agency held two days of emotionally charged meetings about breast implants in March, hearing from women who had had lymphoma and others who had developed debilitating symptoms like pain and fatigue after receiving implants, which the FDA had acknowledged might occur. The lymphoma patients called for a ban on textured implants.

But in May, the agency declined to ban the implants, saying that the lymphoma risk was low and that there was not enough data to justify taking the devices off the market. But a significant increase in the number of cases and deaths led the agency to act on Wednesday.

Raylene Hollrah was treated for the implant-associated lymphoma in 2013 and has become an advocate for patients. “It’s a win for us, finally,” she said. “We’ve been advocating for a long time, and it’s the right thing to be done. We’re just disappointed it took this long.”

Hollrah, who testified at the FDA meeting in March, added, “Our work is not done yet.” She said she and other advocates heard from patients every day seeking help with lymphoma, including some who had implants that were not part of the recall. Many of those patients had received incorrect diagnoses or had difficulty getting doctors to take their symptoms seriously.

The recalled devices listed by the FDA are Biocell products including: Natrelle saline-filled breast implants, Natrelle silicone-filled breast implants, Natrelle Inspira silicone-filled breast implants and Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants. The recall also includes tissue expanders used by patients before breast augmentation or reconstruction, including Natrelle 133 Plus tissue expander and Natrelle 133 tissue expander with suture tabs.

The stock price of Allergan, which makes an array of products like Botox and treatments for dry eyes, dipped slightly on the news. It was down about 0.3% midday Wednesday.

FDA officials said they were continuing to monitor the incidence of lymphoma linked to other types of implants and would take action if needed.

They also said they were considering changes to the labeling of breast implants, like adding a black-box warning to draw attention to the risks, and requiring doctors and patients considering the surgery to go over a checklist to help women understand the benefits and risks of the devices.

The contents of the implant, silicone or saline, are not a factor in the lymphoma. The covering or shell of the implant, which can be either smooth or textured, is the key. Textured implants, which have a slightly roughened surface that adheres to tissue and helps hold the device in place, have been singled out as the cause of the lymphoma.

Why the texturing leads to cancer in some patients is not known. Some people may be genetically predisposed to have an inflammatory reaction to the texturing that can gradually lead to cancer, Clemens, the plastic surgeon, said.

Although several companies make textured implants, a great majority of the lymphoma cases have occurred in women with the Allergan products.

Allergan’s textured implants account for only about 5% of the implants used in the United States, but have been much more common in Europe, where they have already been recalled by many countries. Worldwide, 38 countries have banned textured implants, Clemens said.

Allergan said on Wednesday that it was halting sales of the textured implants worldwide.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” said Diana Zuckerman, president of the National Center for Health Research, who has studied implants.

She added that the recall would reduce the risk but not eliminate it, because some women with other types of implants also had the lymphoma.

This article originally appeared in <a href="https://www.nytimes.com/2019/07/24/health/breast-implants-cancer-recall.html" id="3ceb9762-2a2f-3ff6-ac00-b7ad6941661e">The New York Times</a>.

Textured breast implants made by Allergan that have been linked to an unusual cancer are being recalled in the United States at the request of the Food and Drug Administration, and will also be recalled globally, the agency announced on Wednesday.

Breast Implants Linked to Rare Cancer Are Recalled Worldwide

Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan implants, the FDA said. Of the 33 deaths, the agency said the data it had collected showed that the type of implant was known in 13 cases and in 12 of those cases it was made by Allergan.

Women who have these implants, but no symptoms, do not need to have them removed, the FDA said. The recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergan.

The recalled devices are Biocell products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients before breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

The disease linked to the implants is anaplastic large-cell lymphoma, a rare cancer of the immune system. It is not breast cancer, but it develops in tissue around the implant. In most cases, removing the implant and the scar tissue around it cure the cancer, but if it is not detected early it can spread and kill the patient. The condition has occurred in women who have gotten implants for cosmetic breast enlargement, and in women who received them for reconstruction after mastectomy for breast cancer.

The main symptom of the lymphoma is usually swelling and fluid accumulation around the implant. If those symptoms occur, the fluid should be drained and tested for the cancer.

Although several companies make textured implants, the great majority of the lymphoma cases have occurred in women with the Allergan products.

Textured implants account for only about 5% of the implants used in the United States, but have been much more common in Europe, where they have already been recalled by many countries.

Textured breast implants made by Allergan, linked to an unusual cancer, are being recalled in the United States at the request of the Food and Drug Administration, the agency announced Wednesday.

The covering or shell of textured implants, which have a slightly roughened surface that adheres to tissue and helps hold the device in place, have been singled out as the cause of the lymphoma.

<h1>A federal judge Tuesday issued a permanent injunction against U.S. Stem Cell, a Sunrise, Florida, clinic accused of blinding three patients by injecting a fat extract into their eyes.</h1>

The company is just one of hundreds of businesses that have sprung up around the country offering to treat a wide array of illnesses with products they say contain stem cells that have healing and regenerative properties. Medical experts say there is no proof that such treatments work.

Many of those clinics, like U.S. Stem Cell, use extracts from fat. Others use patients’ own bone marrow, and some use cord blood or other birth tissue like amniotic membranes.

Although the injunction applies only to one company, it is widely seen as a warning to others that perform similar procedures.

The injunction stated that U.S. Stem Cell’s fat extracts are legally a drug, subject to regulation by the Food and Drug Administration. The clinic can no longer produce or market the extracts unless it meets the FDA’s standards for good manufacturing practice.

U.S. Stem Cell had claimed that it could treat neurological, autoimmune, orthopedic and degenerative diseases, including Parkinson’s, amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig’s disease), lung and heart disease, back problems, arthritis and other ailments. The clinic had been performing liposuction on patients to suck out belly fat, then processing the fat to extract what it said were stem cells and then injecting the extract back into patients.

The company’s chief scientific officer, Kristin C. Comella, had argued that the extracts contained patients’ own cells, and therefore were not a drug and were exempt from regulation by the FDA.

The judge, Ursula Ungaro of U.S. District Court for the Southern District of Florida, granted the FDA its request for an injunction June 3. The agency had sought to stop the clinic’s use of the procedure beginning in May 2018.

U.S. Stem Cell said at the time of the initial ruling that it would stop using the fat extracts. But the company also said it would continue offering treatments produced from birth tissues and bone marrow.

In response to the final order issued Tuesday, the company issued a statement saying it was pleased that the judge had limited the injunction to procedures involving fat extracts.

In that order, Ungaro detailed the steps the company would have to take to resume the procedure using fat cell extracts. U.S. Stem Cell would have to hire, at its own expense, an independent expert to inspect its facility and manufacturing methods, and certify to the FDA that it was complying with the agency’s rules.

The agency would also have to inspect the facility, at the company’s expense. If the company passed the inspection, it would then have to hire an auditor to inspect the facility at least once every six months for two years, and then at least once a year after that.

If the company failed to comply, the FDA could order it to stop manufacturing and recall its products and could fine it $15,000 for each violation and $15,000 a day for as long as the violation continues.

The FDA said the injunction “sends a strong message to others” who manufacture unapproved stem cell products.

In a statement, Dr. Norman E. (Ned) Sharpless, the acting FDA commissioner, and Dr. Peter Marks, director of the agency’s biologics center, said: “We know that there are clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biological products. The FDA has consistently stated that this is not true, and the result of this case proves that.”

The statement also said that the companies have been taking advantage of patients, “many in vulnerable positions with chronic or terminal diseases.”

Legal experts say the judge’s ruling suggests that the FDA is also likely to win an injunction that it has requested against another stem-cell business, Cell Surgical Network, a California company with dozens of affiliates around the country.

This article originally appeared in <a href="https://www.nytimes.com/2019/06/25/health/stem-cells-fda-injunction.html" link="null" target="_blank">The New York Times</a>.

Judge halts treatments at Florida stem cell clinic

Many of those clinics, like U.S. Stem Cell, use extracts from fat. Others use patients’ own bone marrow, and some use cord blood or other birth tissue like amniotic membranes.

<h1>Two patients contracted severe infections, and one of them died, from fecal transplants that contained drug-resistant bacteria, the Food and Drug Administration reported Thursday.</h1>

As a result, the agency is halting a number of clinical trials until the researchers conducting them can demonstrate that they have procedures in place to screen donated stool for dangerous organisms, said Dr. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research. He did not specify how many trials would be suspended but said it was “not just a few.”

Fecal transplants have come into increasing use to treat severe intestinal disorders, particularly an infection caused by a bacterium called Clostridium difficile, which can be deadly and tends to occur in hospitalized patients who have been heavily treated with antibiotics. The idea behind the transplants is to use stool from a healthy donor to restore the normal balance of bacteria and other organisms in the intestine, the microbiome.

In some cases, the transplants have worked quickly and saved the lives of patients who were wasting away with uncontrollable diarrhea. But the procedure is not approved by the FDA and is considered experimental.

In the newly reported cases, both patients’ immune systems were already compromised at the time of the transplant, the FDA said. The agency would not explain why they were immunocompromised, why they were given the transplants, who performed the procedures or when or where the cases occurred.

Both transplants came from the same donor’s fecal matter. The report does not state whether the fecal material was given in liquid form as an infusion into the digestive tract or swallowed as pills.

Other samples from the same donor were tested after the patients got sick. The samples were found to harbor the same dangerous germs found in the patients, known as multi-drug-resistant organisms. They were E. coli bacteria that produced an enzyme called extended-spectrum beta-lactamase, which makes them resistant to multiple antibiotics. The stool had not been tested for the germs before being given to the patients.

The FDA on Thursday issued a warning to researchers that stool from donors in studies of fecal transplantation should be screened for drug-resistant microbes and not used if those were present. It is also warning patients that the procedure can be risky, is not approved by the agency and should be used only as a last resort when C. difficile does not respond to standard treatments.

Marks said the agency was trying to strike a balance between giving patients who need the treatment access to it while also establishing safeguards to protect them from infection. In a statement, he said, “While we support this area of scientific discovery, it’s important to note that fecal microbiota for transplantation does not come without risk.”

The patients received treatment as part of a clinical trial, and the researchers conducting the trial reported the cases as adverse events to the FDA, which they were required to do. But the rules governing this kind of experiment prohibit the FDA from revealing details about the treatment or who provided it.

This article originally appeared in <a href="https://www.nytimes.com/2019/06/13/health/fecal-transplant-death.html" target="_blank">The New York Times</a>.

Fecal Donation Tied to Death of a Patient

In some cases, the transplants have worked quickly and saved the lives of patients who were wasting away with uncontrollable diarrhea. But the procedure is not approved by the FDA and is considered experimental.

Fecal donation tied to death of a patient

<h1>Dr. Leonard Bailey, who elicited both admiration and outrage by transplanting the heart of a baboon into a dying infant in 1984, died May 12 at his home in Redlands, California. He was 76.</h1>

The cause was neck and throat cancer, his son Brooks said.

Although Bailey went on to pioneer human heart transplants for infants, and to build a renowned center for children’s cardiac surgery at Loma Linda University in Southern California, he remained best known to the public as the doctor behind the wrenching story of the infant known as Baby Fae.

Called Baby Fae at the time to protect her privacy, she was later identified as Stephanie Fae Beauclair. She was born in Barstow, California, on Oct. 14, 1984, with little more than half a heart. She had a fatal birth defect called hypoplastic left heart syndrome, in which the main pumping chamber of the heart does not develop. She was quickly transferred to Loma Linda.

At the time, babies with the condition lived only a few weeks, if that long. Surgery to try to repair the defect had poor results. Two infant heart transplants involving other patients had been tried at other hospitals, and failed. Donor hearts were vanishingly rare. A doctor told Stephanie’s mother, Teresa Beauclair, that she could keep her daughter in the hospital until the end or take her home to die.

Beauclair decided to take Stephanie home to Barstow. The doctor gave her a card with the telephone number of the coroner to call when the time came. She was 24, with a 2 1/2-year-old son, and had broken up with the children’s father two weeks before Stephanie’s birth.

Bailey had been away when Stephanie was admitted to Loma Linda, but when he returned, a colleague told him about her, thinking she might be eligible for a procedure that Bailey was studying: transplanting a heart from a young baboon into an infant. The hospital’s ethics board had given permission for five such operations. Bailey agreed that the colleague could call Beauclair about the surgery.

“I wondered if the doctor was a mad scientist,” Beauclair said in the 2009 documentary “Stephanie’s Heart: The Story of Baby Fae.” “But when you get down to it, it’s just an organ. A lifesaving organ.”

She, her mother and a friend bundled Stephanie up and drove 75 miles south to Loma Linda. They met with Bailey, and he stayed up all night with them in his office, answering their questions and explaining the years of cross-species research he had conducted, transplanting lamb hearts into baby goats. Stephanie’s father did not attend the meeting, but Beauclair recorded it for him, and they ultimately decided together to go ahead.

“I knew she was going to die, and I had to try,” Beauclair said in a telephone interview. “If I hadn’t tried, I always would have wondered, could we have saved her? Until you’re faced with that, you don’t know what you’ll do.”

Bailey emphasized that the operation would be highly experimental, and Beauclair said she had understood that the transplant might be rejected.

“But somebody has to be first somewhere at some point,” she said in the interview.

Bailey had six young baboons, and he conducted various tests to identify one with tissue that seemed most immunologically compatible with Stephanie’s. But the animals’ blood type did not match the infant’s — something that Bailey later called “a tactical error with catastrophic consequences.”

The operation took place Oct. 26, 1984. At first, Stephanie seemed to thrive. During a news conference at the hospital, Bailey was ebullient, describing her as a “beautiful, healthy baby” whose transplanted heart was doing “everything it should.”

Baby Fae made headlines around the world. The public was enchanted by her. But reactions to the surgery ranged from awe to horror.

Some saw it as a courageous first step toward saving the lives of people with failing hearts. Others considered it reckless, asked why a human donor had not been sought and suggested that the baby’s parents had not understood what they were getting into and therefore had not given truly informed consent.

“I may have been young and naïve,” Beauclair said in the documentary, “but I wasn’t dumb.”

Animal rights groups said killing the baboon was immoral and held demonstrations outside the hospital and Bailey’s home. He and the hospital received threats.

“This wasn’t a wild whim,” Dr. Roger Hadley, dean of Loma Linda University School of Medicine, said in an interview. “He had worked for years on doing cross-species transplants in animals. We had a whole lab of animals who had somebody else’s heart.”

Hadley added that the hospital at Loma Linda is faith-based — the hospital and the university are run by the Seventh-day Adventist Church — and said that all its ethicists and theologians had thought that the transplant was the right thing to do.

“We stood by him here,” he said.

By the time Baby Fae came along, it was abundantly clear that transplants could save lives, especially with the use of cyclosporine, a powerful anti-rejection drug that had recently become available. But organ donors were in short supply. Long before Baby Fae, a surgeon had transplanted a chimpanzee heart into a person; the transplant failed. Other surgeons had experimented with transplanting kidneys from chimpanzees into humans. The longest surviving recipient lived nine months and was well enough to go back to work.

Stephanie’s initial rally after the surgery did not last. Rejection and organ failure set in, and she died Nov. 15, 1984. She had survived for 21 days.

Her case helped focus concern on the plight of babies born with fatal heart defects, and the desperate need for organs. The next year, Bailey performed the first successful heart transplant in an infant, from a human donor. He went on to perform 375 more over the course of his career, as well as other types of pediatric heart surgery. He continued operating until 2017.

Because of growing ethical concerns about experimenting on primates, research on using them as a source of organ transplants has mostly been abandoned. But efforts are underway to genetically alter pigs to make their organs compatible with humans.

Leonard Lee Bailey was born Aug. 28, 1942, in Takoma Park, Maryland, to Nelson Bailey, a chef, and Catherine (Long) Bailey, a nurse.

He graduated from Columbia Union College (now Washington Adventist University) in Takoma Park in 1964 and earned his medical degree from Loma Linda University School of Medicine in 1969.

In 1966, he married Nancy Schroeder, who attended nursing school while he went to medical school. She died in April. They had two sons, Brooks and Connor, who survive him, along with two granddaughters and his sister, Joan Bailey. Two brothers, Nelson and Donald, died before him.

Bailey’s lifelong passion for infant heart surgery began in the 1970s, while he was training in thoracic and cardiovascular surgery at the Hospital for Sick Children in Toronto and saw many babies die from congenital heart defects. He returned to Loma Linda University in 1976 as an assistant professor and performed more than 200 experimental transplants on infant research animals.

Nancy Bailey had left her nursing career to raise her sons but later returned to work as a nursing consultant and then became the manager for tennis player Bobby Riggs.

About a year after Stephanie’s death, Beauclair and her son, Beau, moved back to her home state, Kansas, to be closer to family. Years later, she had Stephanie’s body disinterred and moved to a grave in Kansas. She had two more children, now grown, and went back to school. She works full time as a nurse.

For a time, she remained close to Bailey and his wife.

“To think of all the children he saved over the years,” Beauclair said. “I always said he was the heart of hearts.”

This article originally appeared in <a id="8915d28c-2ace-4bb2-bc52-cb1ddef79f47" href="https://www.nytimes.com/2019/05/22/obituaries/dr-leonard-bailey-dead.html">The New York Times</a>.

Dr. Leonard Bailey, who gave a baby a baboon's heart, dies at 76

Called Baby Fae at the time to protect her privacy, she was later identified as Stephanie Fae Beauclair.

The technology is a work in progress, not ready for widespread use, but the new report, published Monday in the journal Nature Medicine, offers a glimpse of the future of artificial intelligence in medicine.

One of the most promising areas is recognizing patterns and interpreting images — the same skills that humans use to read microscope slides, X-rays, MRIs and other medical scans.

By feeding huge amounts of data from medical imaging into systems called artificial neural networks, researchers can train computers to recognize patterns linked to a specific condition, like pneumonia, cancer or a wrist fracture that would be hard for a person to see. The system follows an algorithm, or set of instructions, and learns as it goes. The more data it receives, the better it becomes at interpretation.

The process, known as deep learning, is already being used in many applications, like enabling computers to understand speech and identify objects so that a self-driving car will recognize a stop sign and distinguish a pedestrian from a telephone pole. In medicine, Google has already created systems to help pathologists read microscope slides to diagnose cancer, and to help ophthalmologists detect eye disease in people with diabetes.

“We have some of the biggest computers in the world,” said Dr. Daniel Tse, a project manager at Google and an author of the journal article. “We started wanting to push the boundaries of basic science to find interesting and cool applications to work on.”

In the new study, the researchers applied artificial intelligence to CT scans used to screen people for lung cancer, which caused 160,000 deaths in the United States last year and 1.7 million worldwide. The scans are recommended for people at high risk because of a long history of smoking.

Studies have found that screening can reduce the risk of dying from lung cancer. In addition to finding definite cancers, the scans can also identify spots that might later become cancer, so that radiologists can sort patients into risk groups and decide whether they need biopsies or more frequent follow-up scans to keep track of the suspect regions.

But the test has pitfalls: It can miss tumors, or mistake benign spots for malignancies and push patients into invasive, risky procedures like lung biopsies or surgery. And radiologists looking at the same scan may have different opinions about it.

The researchers thought computers might do better. They created a neural network, with multiple layers of processing, and trained it by giving it many CT scans from patients whose diagnoses were known: Some had lung cancer, some did not, and some had nodules that later turned cancerous.

Then, they began to test its diagnostic skill.

“The whole experimentation process is like a student in school,” Tse said. “We’re using a large data set for training, giving it lessons and pop quizzes so it can begin to learn for itself what is cancer, and what will or will not be cancer in the future. We gave it a final exam on data it’s never seen after we spent a lot of time training, and the result we saw on final exam — it got an A.”

Tested against 6,716 cases with known diagnoses, the system was 94% accurate. Pitted against six expert radiologists, when no prior scan was available, the deep learning model beat the doctors: It had fewer false positives and false negatives. When an earlier scan was available, the system and the doctors were neck and neck.

The ability to process vast amounts of data may make it possible for artificial intelligence to recognize subtle patterns that humans simply cannot see.

“It may start out as something we can’t see, but that may open up new lines of inquiry,” said Dr. Mozziyar Etemadi, a research assistant professor of anesthesiology at Northwestern University Feinberg School of Medicine, and an author of the study.

Dr. Eric Topol, director of the Scripps Research Translational Institute in La Jolla, California, who has written extensively about artificial intelligence in medicine, said, “I’m pretty confident that what they’ve found is going to be useful, but it’s got to be proven.” Topol was not involved in the study.

Given the high rate of false positives and false negatives on the lung scans as currently performed, he said, “Lung CT for smokers, it’s so bad that it’s hard to make it worse.”

Asked if artificial intelligence would put radiologists out of business, Topol said, “Gosh, no!”

The idea is to help doctors, not replace them.

“It will make their lives easier,” he said. “Across the board, there’s a 30% rate of false negatives, things missed. It shouldn’t be hard to bring that number down.”

There are potential hazards, though. A radiologist who misreads a scan may harm one patient, but a flawed AI system in widespread use could injure many, Topol warned. Before they are unleashed on the public, he said, the systems should be studied rigorously, with the results published in peer-reviewed journals, and tested in the real world to make sure they work as well there as they did in the lab.

And even if they pass those tests, they still have to be monitored to detect hacking or software glitches, he said.

Shravya Shetty, a software engineer at Google and an author of the study, said, “How do you present the results in a way that builds trust with radiologists?” The answer, she said, will be to “show them what’s under the hood.”

Another issue is: If an AI system is approved by the Food and Drug Administration, and then, as expected, keeps changing with experience and the processing of more data, will its maker need to apply for approval again? If so, how often?

The lung-screening neural network is not ready for the clinic yet.

“We are collaborating with institutions around the world to get a sense of how the technology can be implemented into clinical practice in a productive way,” Tse said. “We don’t want to get ahead of ourselves.”

This article originally appeared in <a id="997941a4-c084-3cfc-a6a8-7533c2b42c06" href="https://www.nytimes.com/2019/05/20/health/cancer-artificial-intelligence-ct-scans.html">The New York Times</a>.

AI took a test to detect lung cancer, it got an A

Computers were as good or better than doctors at detecting tiny lung cancers on CT scans, in a study by researchers from Google and several medical centers.

The agency’s latest effort, like most of its previous ones, consisted only of letters to companies and clinics. One letter warned a company making products from umbilical-cord blood that it was violating federal law, and other letters told 20 clinics and stem-cell makers that they appeared to be subject to FDA review for approval and that they should contact the agency about how to comply.

The agency’s regulators have essentially been playing whack-a-mole with hundreds of stem-cell clinics and manufacturers that have sprung up around the country in recent years to sell treatments for an array of ailments, like sore knees or failing hearts, with no real proof that they are safe or effective. The treatments cost thousands of dollars, and most patients pay out of pocket because insurers refuse to cover unapproved therapies.

Some products have proved dangerous, blinding several patients and causing severe infections in at least a dozen people, some spending weeks in the hospital.

Stem cells are cells that can develop into a variety of specialized forms, like tissue or blood. Many of these clinics offer treatments billed as novel stem-cell therapies that are derived from cells in the blood, fat or birth tissue.

While legitimate research on stem cells has tremendous promise, some “bad actors” are trying to cash in on patients’ hopes with “purported therapies,” according to a statement by Dr. Scott Gottlieb, the FDA commissioner, and Dr. Peter Marks, director of the agency’s biologics center. The proliferation of rogue clinics has long been a concern of Gottlieb, who announced his resignation last month and will leave his post on Friday.

In the past year, the statement said, the FDA has sent “regulatory correspondence” to 45 manufacturers and health care providers that market stem cells. The agency also said two lawsuits were pending. One is against U.S. Stem Cell Clinic of Sunrise, Florida, where three patients lost their sight after having stem cells injected into their eyes.

The other lawsuit is against the California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, and the Cell Surgical Network Corporation of Rancho Mirage, which treated cancer patients with a stem-cell product made with smallpox vaccine. The FDA said the product was risky.

Denise Grady

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