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.

The government did not publicly announce its decisions in recent months to allow two labs to resume their projects. The new go-ahead was first reported in the journal Science.

The lack of information about the decision and how it was made have provoked outrage from some scientists, who oppose the research because they say it could create mutant viruses that might cause deadly pandemics if they were unleashed by lab accidents or terrorism. The research sparked worldwide fears when it was first revealed in 2011.

Two research teams, in Wisconsin and the Netherlands, have been told by the Department of Health and Human Services that their work is eligible for research funding from the U.S. government. The Wisconsin group was notified in October, and the Dutch group in January, a spokeswoman for HHS said in an email.

Despite requests from The New York Times on Thursday and Friday, officials from HHS did not explain why they had not announced their decisions on the two labs at the time they were made.

Spokeswomen for HHS and the National Institutes of Health said the decision to lift the moratorium had already been announced in December 2017, when the NIH disclosed that the studies would be allowed, but only after newly created expert panels judged each proposal to be safe and scientifically sound.

At that time, the government had not yet approved any specific projects.

The NIH said it does not generally issue news releases to announce new research grants, but does post them on its NIH Reporter website.

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said it was a sound decision to let the research resume. The money for some of the Wisconsin research — $605,206 — will come from his institute.

“Look, everyone said we needed a system for this kind of research to be vetted, vetted by outsiders who were experts,” he said. “So we got a system.”

Marc Lipsitch of Harvard and Tom Inglesby of Johns Hopkins University said the workings of that system should be made public.

“Making decisions to approve potentially dangerous research in secret betrays the government’s responsibility to inform and involve the public when approving endeavors, whether scientific or otherwise, that could put health and lives at risk,” the scientists wrote in The Washington Post on Wednesday.

In an interview, Lipsitch said lab accidents do occur, often involving human errors that biosafety and security measures cannot prevent. In several cases, he said, people mistakenly sent germ samples from a lab thinking they had been inactivated when the samples were actually live and dangerous.

“This is a global issue, and standards we set in the United States will be imitated, whether they are high or low,” Lipsitch said. “The people at risk are not only Americans. If there’s a big pandemic, it’s a big pandemic for everybody. This needs to be decided at the global level, between governments and the World Health Organization.”

A global furor erupted in 2011 when two labs revealed that they had altered a deadly type of bird flu virus in a way that made it more contagious among ferrets, which catch the flu in much the same way people do and are used to study how it might spread among humans.

One lab was led by Yoshihiro Kawaoka, at the University of Wisconsin-Madison, and the other by Ron Fouchier, at the Erasmus Medical Center in Rotterdam.

That particular bird flu, a type called H5N1, rarely jumps from birds to humans, but is highly lethal when it does. Infected people do not seem to spread the disease to others, but if it did become transmissible between humans, it could cause a pandemic with an enormously high death rate.

Flu viruses in nature mutate a lot, sometimes changing how contagious and how deadly they are. Researchers say that manipulating those traits in the lab could identify specific genetic changes that make a virus more dangerous.

Some scientists strongly defended the importance of the research cleared to proceed.

“Dr. Kawaoka’s goals for the project include understanding what molecular changes to the virus could render it capable of becoming pandemic in people so that public health officials can monitor for these changes in nature and begin to stockpile vaccines and antivirals to combat it,” Rebecca L. Moritz, a microbiologist specializing in biosafety and biosecurity who works with Kawaoka, said in an email.

“The project could also yield further insights into highly pathogenic influenza viruses and lead to the development of new vaccines or antiviral drugs.”

Moritz said there were many layers of security at the university lab in Madison to prevent release of the virus. She said the research was regulated by about a half-dozen boards from the government and the university. Employees have to pass a background check by the FBI and be approved by a federal agency that specializes in dangerous pathogens.

People experimenting with the viruses work in a closed lab, completely covered by spacesuitlike garments and hoods with their own purified air supply. They must take a decontaminating shower before leaving the lab.

Moritz said local fire departments were directed not to enter the virus lab for any reason and if there was a fire, to let it burn. If someone working in the virus lab has a medical crisis, “first-responders are not able to reach them until they have been decontaminated by qualified lab staff,” she said.

The bird flu studies have not yet resumed. Once HHS approves such projects, the National Institutes of Health decides whether to pay for them. NIH has agreed to support the Wisconsin work but has not yet decided on the studies in the Netherlands.

Fouchier could not be reached for comment by The Times. He told Science that the NIH decision was expected after an inspection of his lab, scheduled for March.

Fauci said of Kawaoka: “Yoshi went through the appropriate vetting exercise. It went through multiple layers of review and examination. It wasn’t as if we all changed our minds and said, ‘Oops, never mind, go ahead and do it.’ They got very appropriately vetted with all the appropriate caveats.”

This article originally appeared in <a href="https://www.nytimes.com/2019/03/01/health/bird-flu-pandemic.html" id="062901ea-cd79-39d9-a256-7eb6a414b514">The New York Times</a>.

Research that could make flu viruses more dangerous, and that the government suspended in 2014 because of safety concerns, has been approved to begin again, federal officials have confirmed.

Studies of Deadly Flu Virus, Once Banned, Are Set to Resume

About 6 million to 7 million people in the United States have come down with the illness so far, with half of them sick enough to have seen doctors, according to estimates released Friday by the Centers for Disease Control and Prevention. Some 69,000 to 84,000 ended up in the hospital during the period from Oct. 1 through Jan. 5.

“Flu activity is widespread in many states,” Dr. Alicia Fry, from the CDC’s influenza division, said in an interview. “We expect several more weeks of flu season.”

The number of deaths from flu this season has not yet been determined. But Fry said the flu was widespread in 30 states, especially in the Southeast, and is moving northward. And the number of hospitalizations so far this season “is a reminder that flu can cause severe illness,” she added.

The very young, the very old, pregnant women and people with underlying health problems have the highest risk of becoming seriously ill and needing hospitalization for the flu, according to the CDC.

“It’s really not too late to get vaccinated,” Fry said.

The vaccine needs about two weeks to take effect, she said, but is still worth getting because the flu season is expected to drag on longer than that.

“People who are very sick or who are at high risk of serious flu complications and get flu symptoms should see a health care provider quickly for possible treatment with a flu antiviral drug,” the CDC said in a statement.

Although influenza has already caused deaths this season, the figure has not been released because there is not enough information yet to make a reliable estimate. Nor is it possible to determine yet how this flu season compares to others, as this is the first time that the CDC has provided flu estimates while the season is still underway.

Fry said her team had decided to gather and report the numbers early because they realized that people found the data useful. From now on, updated totals will be published every Friday.

This article originally appeared in <a href="https://www.nytimes.com/2019/01/11/health/flu-widespread-cdc-.html" id="4e2a441e-57a5-3ed9-aff5-1fc855ec0236">The New York Times</a>.

The flu season is going strong.

The Flu Is Widespread in the U.S., and It's Not Too Late to Get Vaccinated

About 6 million to 7 million people in the United States have come down with the illness so far, with half of them sick enough to have seen doctors, according to estimates released Friday by the Centers for Disease Control and Prevention.

Some 69,000 to 84,000 ended up in the hospital during the period from Oct. 1 through Jan. 5.

The CDC is not affected by the partial government shutdown.

The last flu season was particularly deadly, with the most cases reported since 2009. Nearly 80,000 people died in the United States.

Despite the warnings, many people still do not realize how dangerous the flu can be. The death last month of Bre Payton, 26, a writer for a conservative online newsmagazine and a guest commentator on the Fox News Channel, came as a shock to many. She died after becoming ill with the flu and developing encephalitis, a brain inflammation.

The very young, the very old, pregnant women and people with underlying health problems have the highest risk of becoming seriously ill and needing hospitalization for the flu, according to the CDC. In healthy people, the sickness usually lasts three to five days, but the cough can linger.

The vaccine needs about two weeks to take effect, she said, but is still worth getting because the flu season is expected to drag on longer than that. The effectiveness of this year’s vaccine is not known yet, but in past years, Fry said, vaccination against the same type of flu now circulating — known as H1N1 — was about 50 percent to 60 percent effective at reducing the likelihood of a person needing to visit the doctor with symptoms.

Antiviral drugs, available by prescription only, can shorten the illness slightly and lessen its severity, but they work best if taken as early as possible after symptoms appear. In a statement, the CDC said, “People who are very sick or who are at high risk of serious flu complications and get flu symptoms should see a health care provider quickly for possible treatment with a flu antiviral drug.”

Although influenza has already caused deaths this season, the figure has not been released because there is not enough information yet to make a reliable estimate, said Carrie Reed, who led the applied research and modeling team that produced the estimates. Nor is it possible to determine how this flu season compares to others based on these numbers, as this is the first time that the CDC has provided flu estimates while the season is still underway. In the past, the totals were released after the flu season had ended.

Fry said her team had decided to gather and report the numbers early because they realized that people found the data useful. From now on, updated totals will be published every Friday in the CDC’s weekly FluView report.

Even though flu viruses contain only eight genes, compared with about 20,000 in humans, they manage to wreak a great deal of havoc. During the last flu season, from 2017 to 2018, about 48.8 million people caught the illness, 22.7 million saw a doctor, 959,000 were hospitalized and 79,400 died. The number of cases last season was the highest since the 2009 H1N1 pandemic, when 60 million people got sick.

Fry said it was not possible to use the current estimates to project what the total number of cases might be this season.

“We are very actively pursuing methods to forecast what could be happening in the short term and when the season might peak,” Fry said. “We won’t know for several more weeks whether it’s peaked.”

The estimates are based on data collected from a surveillance network that counts flu-related hospitalizations in parts of 13 states scattered around the country, covering about 27 million people, or 8.5 percent of the U.S. population.

Flu Is Widespread in the U.S.

(The company has no connection with Genentech, the biotechnology corporation.)

The FDA said Thursday it had also written to 20 clinics that offer unapproved stem cell treatments, warning them that such products are generally regulated by the agency and encouraging the clinics to contact federal regulators before November 2020, when enforcement will tighten. The names of the clinics have not been released.

Hundreds of clinics have sprung up around the country, offering treatments supposedly containing stem cells, to treat a wide variety of ailments, including arthritis, eye disorders, Parkinson’s disease and lung problems. The treatments are marketed as having curative or healing properties, but there is no proof they work or are safe.

Clinics offering the treatments claim they are not drugs and therefore do not need FDA approval, but in some cases the agency disagrees. In November 2017, it gave the clinics three years to come into compliance, and said during that period it would use “enforcement discretion"— giving the industry some leeway but cracking down on clinics that harmed patients.

In May, the FDA sought permanent injunctions against two stem cell clinics. U.S. Stem Cell Clinic LLC of Sunrise, Florida, had treated three patients who lost their sight after stem cells were injected into their eyes. The California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, had been administering a combination of smallpox vaccine and stem cells to cancer patients.

The people who became ill after receiving the Genetech products had been given injections into their knees, shoulders or spines to treat painful conditions like arthritis or injuries. They contracted infections in their bloodstreams or joints, and all were hospitalized.

Tests of unopened vials of the cord-blood products taken from clinics giving the shots found the same types of microbes that had infected the patients, which included E. coli and other fecal bacteria.

The cases were described in a report published online Thursday by researchers at the Centers for Disease Control and Prevention, who wrote, “this investigation highlights the serious potential risks to patients of stem cell therapies administered for unapproved and unproven uses.”

Genetech could not be reached for comment.

This article originally appeared in <a href="https://www.nytimes.com/2018/12/20/health/stem-cell-shots-bacteria-fda.html" id="41c35d8e-3e69-3842-ac1f-9fae9fe2bbf6">The New York Times</a>.

Twelve patients became seriously ill after receiving injections that supposedly contained stem cells from umbilical cord blood, according to the Food and Drug Administration, which issued a warning to the California company, Genetech, that made the blood product they were given.

12 People Hospitalized With Infections From Stem Cell Shots

“We’re going to be going in and inspecting more stem cell operators this year,” Dr. Scott Gottlieb, the agency’s commissioner, said in an email. “We’re focused on outfits that may be engaging in unsafe practices and haven’t been working with FDA to come into compliance with the laws they’re subject to. Unfortunately, there are too many firms that fit this description.”

In May, the FDA sought permanent injunctions against two stem cell clinics. One, U.S. Stem Cell Clinic LLC of Sunrise, Florida, had treated three patients who lost their sight after stem cells were injected into their eyes. The other, the California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, had been administering a combination of smallpox vaccine and stem cells to cancer patients.

One patient spent 58 days in the hospital with a bloodstream infection, a spinal abscess and other spinal problems. Another, with an infected knee, was hospitalized for 30 days. The shortest stay was four days; others lasted 12, 15 or 35 days.

Seven cases occurred in Texas, four in Florida and one in Arizona, mostly August and September. Eleven patients were treated at private clinics specializing in pain or orthopedics, and one — the patient who was hospitalized for 58 days — was treated at an ambulatory surgery center.

In September, health departments in Texas and Florida traced some of the infections to a California company called Liveyon, which distributed Genetech products. Liveyon issued a recall.

The FDA had already inspected Genetech in June, and determined it did not have the licensing or new drug applications required for its products. Cleaning and quality control were also poor, the agency said, increasing the risk of contamination with germs.

The FDA inspector gave the company a written list of the problems, and the agency said Genetech responded in August.

In a letter dated Nov. 29, the FDA told the president of Genetech, whom it identified as Edwin N. Pinos, that its responses did not correct the many problems that had been found. It gave the company 15 more working days — which ended Thursday — to take further steps. And it warned that failure to comply could result in “regulatory action without further notice,” including an injunction or the seizure of its products.

In a letter last week that read like a shot across the bow, the National Institutes of Health warned the University California, San Francisco, that its $2 million contract for research involving the tissue, previously renewed for a year at a time, would be extended for only 90 days and might then be canceled.

University scientists had used fetal tissue to create so-called humanized mice, which can then be used to test drugs and vaccines. The university has played a key role in testing antiviral drugs to treat HIV infection. And researchers say the mice, which essentially have a complete human immune system, are indispensable.

Scientists who do this work sometimes receive threats, so UCSF has asked that its researchers not be named for security reasons. The events there were first reported by The Washington Post.

The notice to the university was part of a larger push by the Department of Health and Human Services — which oversees the National Institutes of Health and the Food and Drug Administration — to limit use of the tissue.

HHS issued a statement in September saying it would conduct a “comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations.” The statement cited “serious regulatory, moral, and ethical considerations” and said the department “is continuing to review whether adequate alternatives exist to the use of human fetal tissue in HHS-funded research and will ensure that efforts to develop such alternatives are funded and accelerated.”

The department has also ordered researchers at the FDA and the NIH to stop purchasing fetal tissue and has begun reviewing government grants and contracts awarded to outside researchers who use the tissue. On Monday, the NIH said it would spend $20 million over the next two years to fund research seeking alternatives to fetal tissue.

The ban on fetal tissue purchases at the NIH, first reported by Science Insider, has already hobbled experiments on HIV.

UCSF was the first outside research center affected. The work there came under scrutiny because its contract was up for renewal. That contract is now being reviewed, and no decision has been made about whether to continue it, according to Caitlin Oakley, a spokeswoman for HHS. She described the department as “pro-life, pro-science.”

Oakley declined to say whether similar letters would be sent to other researchers who have government grants or contracts, but she wrote in an email, “Again, the review is ongoing and when we have more to announce on the progress of the review, we will.”

She also said that the department has met with scientists, anti-abortion groups, ethicists, doctors, researchers and patient groups, among others.

Opponents of the research consider it immoral, a desecration of human body parts and an ugly byproduct of abortion.

Emails between the department and the NIH, obtained by The New York Times, indicate that Adm. Brett P. Giroir, the assistant secretary for health at HHS, was deeply involved in the push to limit the research. Giroir, who was appointed by President Donald Trump and confirmed in February 2018, is a physician and researcher who has worked in government, academia and industry.

The NIH spends about $100 million a year of its $37 billion budget on projects that involve fetal tissue. The tissue is used to test drugs, develop vaccines and study cancer, AIDS, Parkinson’s disease, birth defects, blindness and other disorders. For much of that work, scientists say, there is no substitute for fetal tissue.

Carrie Wolinetz, associate director for science policy at the NIH, said that because HIV can infect only human immune cells, humanized mice are essential for studying the virus and testing drugs to combat it. Currently, only fetal tissue has all the components — cells from the thymus gland, bone marrow and liver — needed to create a human immune system in mice.

Researchers inject the cells into certain strains of mice and then wait for them to “engraft” — be accepted by the animal’s body — and start functioning, much like a transplant.

“Right now we don’t have a good alternative, but in the coming years we might be able to create humanized mice without fetal tissue,” Wolinetz said. “NIH is very involved in the whole issue of finding alternatives.”

Alternative approaches will probably involve genetically altering certain types of adult cells in hopes of reprogramming them to produce the tissue needed for research, she said.

The last notable challenge to experiments involving fetal tissue occurred in 2015 when an anti-abortion group, the Center for Medical Progress, released disturbing videos its members had secretly made while posing as employees of Advanced Bioscience Resources, a California company that processes fetal tissue, and discussing its purchase with a doctor from a Planned Parenthood clinic that performed abortions.

The videos led to congressional investigations into fetal tissue research and also to invasion of privacy charges in California against the people who made the video. The case has not been tried yet.

Anti-abortion groups stepped up their efforts in June after the FDA posted a notice describing its $16,000 contract to purchase fetal tissue from Advanced Bioscience Resources. The FDA planned to use the tissue to create humanized mice, as it had done in the past.

A conservative online news site, CNS News, sent the FDA 20 questions and posted them online, among them a query about “the total number of donor babies who are expected to donate their tissue to the FDA.” The site also asked whether women were being informed “that tissue taken from their aborted baby will be transplanted into a mouse.”

The FDA replied in July with a statement saying the tissue was obtained legally and ethically, used in a small fraction of its total research and “has been used in situations where it is critical to understanding how the human immune system responds to certain drugs and biologics.”

But in September, a coalition of anti-abortion groups wrote to HHS Secretary Alex Azar to denounce the contract, saying, “It is completely unacceptable to discover that the FDA is using federal tax dollars and fomenting demand for human body parts taken from babies who are aborted.”

Around the same time, 85 Republican members of Congress wrote a letter to Dr. Scott Gottlieb, head of the FDA, stating: “Unborn children are not commodities to be bought and sold. The practice of conducting research using the body parts of children whose lives have been violently ended by abortion is abhorrent.”

On the other side, 64 academic and medical organizations weighed in with a letter to leaders of the House and Senate defending the research. That group included Harvard, Yale, Brown, Stanford, Johns Hopkins and other major universities, as well as the American Academy of Pediatrics and the American Association for the Advancement of Science.

“Fetal tissue research has been critical for scientific and medical advances that have saved the lives of millions of people, including the development of vaccines against polio, rubella, measles, chickenpox, adenovirus, rabies, and treatments for debilitating diseases such as rheumatoid arthritis, cystic fibrosis and hemophilia,” the group said in its letter.

The letter added that the tissue had also been crucial in developing treatments for HIV infection and for studying how the Zika virus causes brain damage in developing fetuses. And, the letter said, “cells in fetal tissue have unique and valuable properties that often cannot be replaced by other cell types.”

Miscarriages are not a suitable source of the tissue, the letter said, because some involve genetic abnormalities that would interfere with research and because miscarriages occur in circumstances that would make it hard to collect the tissue.

On Sept. 24, HHS announced that the contract had been canceled, and that its broad review of the research would begin.

Should the government pay for medical research that uses tissue from aborted fetuses? This debate, ever smoldering, has erupted again, pitting anti-abortion forces in the Trump administration against scientists who say the tissue is essential for studies that benefit millions of patients.

Denise Grady

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