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Friday, December 8, 2023

'Bellevue Hospital Churns Poor Patients Through Weight-Loss Surgery'

 In the windowless basement of a Manhattan church last month, Bellevue Hospital hosted a fashion show.

Dozens of weight-loss surgery patients, some in evening gowns, strutted down a red carpet. While their “before” photos were projected on a screen, an M.C. read testimonials about how the operations had remade their lives.

Addressing the cheering crowd, Bellevue’s chief medical officer boasted about a remarkable number. The overwhelmed public hospital, which routinely treats gunshot and stabbing wounds, was on track to perform a record 3,000 weight-loss surgeries this year.

“We have a lot to be proud of,” the executive, Dr. Nathan Link, said.

Bariatric surgery is a major operation that, for the right patients, can ward off heart diseasediabetes and strokes. Bellevue, which serves a disproportionately poor and obese population, says the operations have saved many lives.

But a New York Times investigation found that the bariatric program, led by surgeons with financial incentives to perform more operations, has become a high-speed assembly line that has endangered some patients and compromised urgent care for others. And because most of the hospital’s patients are on Medicaid or uninsured, taxpayers foot the bill.

The surgery shrinks patients’ stomachs and requires them to radically change how and what they eat. Even some successful operations can lead to a lifetime of stomach cramps and debilitating acid reflux.

For that reason, hospitals often require surgical candidates to try to lose weight on their own and go through months of screening and preparation for the procedure and its aftermath.

Bellevue, however, frequently cuts corners as it hustles patients through the process, according to the Times investigation, which is based on interviews with 70 Bellevue employees, patients and executives from New York City’s hospital and correctional systems, as well as internal hospital documents, court filings and medical records.

Prospective patients often receive tentative surgery dates after attending a single informational session, filling out a worksheet and speaking briefly with a doctor. Meetings to assess patients’ mental health sometimes last just 10 minutes. Many patients said in interviews that they had agreed to surgeries without fully grasping the risks.

In its zeal to increase volume, the hospital has operated on people whose body mass indexes were too low for them to qualify for surgery under standard medical guidelines, according to eight doctors and nurses involved in the operations. It has recruited patients from New York City’s Rikers Island jail complex who have virtually no chance of maintaining the required diets after surgery. Two prisoners told The Times that they had become malnourished and regretted having the operation.

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A woman wearing a low-cut bright red dress holds one hand high, her other hand on her hip, while an audience applauds. A screen in the background reads, in part, "12th Annual Bariatric Celebration and Red Carpet Runway Show."
Bellevue Hospital in Manhattan hosts a fashion show for patients who undergo bariatric surgery.Credit...Maansi Srivastava/The New York Times
A woman wearing a low-cut bright red dress holds one hand high, her other hand on her hip, while an audience applauds. A screen in the background reads, in part, "12th Annual Bariatric Celebration and Red Carpet Runway Show."
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A bariatric surgery patient, in a tight yellow dress with a very short skirt and no sleeves, struts down a red carpet with red velvet rope during the fashion show to a clapping crowd.
Bellevue’s celebration for patients to show off their newly slim bodies.Credit...Maansi Srivastava/The New York Times
A bariatric surgery patient, in a tight yellow dress with a very short skirt and no sleeves, struts down a red carpet with red velvet rope during the fashion show to a clapping crowd.

Two of Bellevue’s bariatric surgeons often race each other to see how many operations they can perform in a day, at times even relying on unlicensed equipment technicians to assist them, The Times found. Anesthesiologists sometimes reduce doses of pain medication so that patients wake up sooner and operating rooms can be cleared faster. This year, as the volume of operations surged, doctors accidentally operated on a pregnant woman after medical staff neglected to check her test results.

The bariatric department has an incentive to move fast. The hospital receives at least $11,000, and sometimes much more, for most weight-loss surgeries. And unlike many doctors at Bellevue, who get paid flat salaries, the bariatric surgeons earn more money when they perform more operations.

“It’s all about the numbers,” said Dr. Carmen Kloer, who worked with Bellevue’s bariatric department as a medical resident before quitting in October. “They are just churning through cases.”

Since 2008, Bellevue has performed more than 17,000 weight-loss procedures. In the first year of the pandemic, nearly 1,200 patients underwent bariatric surgery, nearly as many as the roughly 1,400 who were hospitalized for Covid — even though the hospital halted elective operations for three months of the year. Weight-loss surgeries now account for one of every five operations at Bellevue.

Some bariatric patients have contracted life-threatening infections. One spent a month in a coma after her surgeon accidentally nicked her spleen. Another died.

Bellevue publicly reports rates of complications from bariatric surgery that are on a par with the national average. But those figures capture only certain serious problems in the month after surgery. They don’t include longer-term problems like ulcers, hernias and weight gain.

Nor does Bellevue’s complication data cover surgeries this year, when volumes soared to what some doctors and other medical staff regarded as dangerously high levels.

The booming bariatric practice has also crowded out other services, with the hospital repeatedly delaying urgent surgeries for patients with stab wounds and broken bones, The Times found.

Christopher Miller, a spokesman for Bellevue, said the bariatric program was a much-needed service for patients who often struggle to get medical care. 

“There’s an incredible need and demand for this surgery,” he said. He cited a report this year from the American College of Surgeons that praised Bellevue for running “a very high-volume program without sacrificing quality.” The review, based largely on data provided by Bellevue, was part of a routine accreditation process.

Mr. Miller denied that Bellevue operated on unqualified patients or that it rushed them through screening and approval. He said the hospital prided itself on having made its surgical processes more organized and efficient.

Mr. Miller accused The Times of cherry-picking negative examples and painting an inaccurate picture of a successful public health program. “We are saving lives in large numbers” and improving patients’ quality of life, he said. “To frame this any other way is wrong and a disservice to our patients, our employees and New Yorkers.”


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An exterior view of Bellevue Hospital includes an old iron gate on which its name is written, with a modern overpass lit brightly overhead.
Most of Bellevue’s patients are uninsured or on Medicaid, which pays at least $11,000 for most weight-loss surgeries.Credit...Maansi Srivastava/The New York Times
An exterior view of Bellevue Hospital includes an old iron gate on which its name is written, with a modern overpass lit brightly overhead.

In 2007, Bellevue recruited a young surgeon named Manish Parikh to help the hospital open a new department.

Until then, Bellevue’s doctors had referred potential bariatric surgery patients to the city’s private hospitals. Now executives wanted Bellevue to treat those patients. Because of the large amounts that Medicaid pays for bariatric surgeries, the program might even turn a profit for the chronically underfunded hospital.

To get the program off the ground, Bellevue enlisted Dr. Parikh, who had recently finished his medical residency at New York University. N.Y.U. already ran a bustling weight-loss surgery program.

After surgeries began in 2008, Bellevue agreed to pay Dr. Parikh in part based on volume.

Aaron Cohen, the hospital’s chief financial officer from 1995 to 2015, recalled being impressed that Dr. Parikh continuously set and then met higher targets for how many surgeries he could do.

“If he committed to doing 100 cases, he hit 100 cases,” Mr. Cohen said. “The whole time I was there, he never missed a target.”

In 2020, the team performed 1,192 procedures. The next year there were 2,071. This year Bellevue is on track for 3,000.

Dr. Parikh did not respond to requests for comment. Mr. Miller said that paying doctors based on volume was “extremely common” and that Bellevue operated only on medically appropriate patients.

Bariatric surgery has been gaining popularity nationwide, increasing by 66 percent from 2011 to 2021, according to the American Society for Metabolic and Bariatric Surgery — though not nearly at the pace of Bellevue.

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Dr. Manish Parikh signs certificates at the fashion show for three patients who stand with him at a covered table in the busy church basement.
Dr. Manish Parikh, second from left, at the fashion show.Credit...Maansi Srivastava/The New York Times
Dr. Manish Parikh signs certificates at the fashion show for three patients who stand with him at a covered table in the busy church basement.

Dr. John Morton, who heads the bariatric surgery program at Yale and was a former president of the society, said Bellevue’s volume was “exceptional.” He was unaware of any other hospital performing so many weight-loss operations.

Bellevue doesn’t publicly disclose how much money it brings in from bariatric surgeries. Based on Medicaid reimbursement rates, The Times conservatively estimated that Bellevue stands to earn at least $34 million this year.

At this year’s celebration of its bariatric program, Bellevue set up a gala-style backdrop for newly slim patients to take photographs that would later appear on the hospital’s social media pages. Some patients held signs with phrases like “I Feel Bari Good Today.”

Alvaro Macias-Rodriguez walked the runway wearing tight black pants and a big smile. He said that before surgery last year, he had weighed 330 pounds, putting him at heightened risk of liver cancer. Since the operation, he said, he has lost nearly 100 pounds.

“I don’t know where I would be without it,” Mr. Macias-Rodriguez said as pop music blared.

He praised what he said was Bellevue’s swift approval process, saying it was much faster than the yearlong wait he had faced at another Manhattan hospital.


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Melody Vargas, lying in a hospital bed and in a hospital gown, takes a selfie while receiving a kiss on the forehead from a loved one.
Melody Vargas’s mother encouraged her to look into bariatric surgery, which she had in 2016. Ms. Vargas described the process as “crowded and rushed.”Credit...via Melody Vargas
Melody Vargas, lying in a hospital bed and in a hospital gown, takes a selfie while receiving a kiss on the forehead from a loved one.

Bariatric surgery is a serious undertaking. Patients must severely restrict their diets for the rest of their lives.

Before surgery, many hospitals require that patients spend months trying to lose weight through exercise and diet. The theory is that if they can’t adopt a healthy lifestyle before surgery, their odds of doing so afterward are low. Patients must go through a lengthy approval process, including counseling and visits with nutritionists.

At Bellevue, the process is often compressed. More than a dozen patients said it took about three months from their first appointment to their operation. That speed has caused some doctors to worry that the hospital is not doing enough to prepare patients.

“Some people benefit from surgery, but the amount that have no idea what they’re getting into is huge,” said Dr. Kloer, the former Bellevue surgeon.

Medical guidelines published last year by the professional society for bariatric surgeons recommend the operation only for severely obese patients. They should have a body mass index, which is based on a combination of weight and height, of at least 35 or, if the patients have certain other medical conditions, at least 30.

But eight doctors and nurses said they participated in surgeries on patients whose medical charts showed that their B.M.I.s were below 30.

And 15 current and former Bellevue employees questioned whether patients were being adequately informed about the risks of bariatric surgery. Some patients said they weren’t even sure what type of surgery they had undergone.

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A view looking down on Ms. Vargas’s abdomen, which is covered in scars and dressed wounds, with a tube extending from a bandage.
After bariatric surgery, Ms. Vargas said she faced months of complications that required multiple I.C.U. stays at Bellevue.Credit...via Melody Vargas
A view looking down on Ms. Vargas’s abdomen, which is covered in scars and dressed wounds, with a tube extending from a bandage.

Melody Vargas said she didn’t recall being told about any risks before her 2016 operation. She was 28 and weighed more than 400 pounds when her mother encouraged her to look into the surgery. She described the preparation process as “crowded and rushed,” starting with the first time she talked to a doctor, at an information session packed with at least 60 people.

“It was like you’re at a McDonald’s, and you choose what food you want,” Ms. Vargas said. “They make it seem like the operation is really nothing serious.”

Days after her operation, she said, she was in the intensive care unit with a life-threatening infection that required emergency surgery. For six months, she relied on feeding tubes for nutrition.

Mr. Miller said patients signed forms acknowledging the risks of bariatric surgery. “The information is discussed at several points,” he said, during a screening process that typically lasts three to six months. He said that the time frame was consistent with other hospitals’ and that all patients meet eligibility guidelines set by the American Society for Metabolic and Bariatric Surgery.

Yet employees sometimes ignore signs that a patient might not be ready for surgery. When Bernadette arrived for surgery in 2020, she was asked if she had followed doctors’ orders to stick to a two-week liquid diet. No, she recalled replying. In fact, she had eaten Chinese food the night before.

The operation went forward anyway, said Bernadette, who asked that her last name be withheld for privacy reasons. Mr. Miller said he could not comment on specific patients.


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A hand reaches for a gold-bordered, hand-lettered sign that reads, “I Feel Bari Good Today.”
Bellevue employees said some surgeons squeeze up to six or seven bariatric operations into a single day.Credit...Maansi Srivastava/The New York Times
A hand reaches for a gold-bordered, hand-lettered sign that reads, “I Feel Bari Good Today.”

The overriding principle of the bariatric department, according to more than two dozen Bellevue employees, is to operate on as many patients as possible as quickly as possible.

“Two female bariatric surgeons involve their residents in a well-known daily ‘race,’” a manager wrote in 2021 to Bellevue leadership, outlining a variety of concerns about the hospital’s operating rooms. Six other employees said they knew about the race.

Mr. Miller said Bellevue’s bariatric surgeries were only slightly faster — about 10 minutes quicker on a roughly hourlong procedure — than the national average.

Doctors, nurses and other hospital staff described a hurried process to get patients into surgery and swiftly turn over rooms. That allows surgeons to squeeze up to six or seven patients into a single day.

When they have been short on assistants, bariatric surgeons at times have asked equipment technicians, who were not hospital employees or licensed to treat patients, to scrub in and participate in surgeries, two Bellevue doctors said.

Mr. Miller did not dispute the doctors’ accounts.

Earlier this year, Bellevue’s staff forgot to check a patient’s pregnancy test before surgery, four employees said. It was positive. After the procedure, doctors counseled her about potentially terminating the pregnancy because her body might not be able to absorb enough nutrients to support the growing fetus.

Dr. Anthony Petrick, who leads a committee that accredits Bellevue’s bariatric program, said operating on a pregnant patient was an egregious error. “This should never happen,” he said.

Mr. Miller declined to comment on the patient’s case.

In another case this fall, bariatric surgeons realized before surgery that they had the wrong patient in the operating room, according to four Bellevue employees.

Three anesthesiologists said surgeons chastised them when patients took too long to wake up. So they lowered the doses of pain medication, giving just enough to carry patients through the surgery. Some patients woke up in intense pain.

Mr. Miller denied that surgeons pressured anesthesiologists.

On other occasions, five doctors said, they saw Dr. Julia Park, a weight-loss surgeon, pinch and slap patients’ bellies to rouse them from anesthesia.

“We have no knowledge of this,” Mr. Miller said. Dr. Park did not respond to requests for comment.

In 2015 Bellevue promoted Dr. Parikh, giving him control over all of the hospital’s operating rooms. While life-threatening emergencies always got priority, patients with minor stab wounds, broken bones and detached fingers regularly waited hours for surgery because bariatric surgeons were occupying so many operating rooms, according to more than a dozen doctors and other employees.

One day in October, for example, a patient arrived at Bellevue with shattered ribs but could not be operated on because bariatric surgeons were occupying multiple rooms, according to an employee who was there. (That day, bariatric surgeons performed 16 weight-loss surgeries, according to surgical schedules reviewed by The Times.) The rib surgery was pushed to the next day, the employee said.

Mr. Miller said the hospital had dedicated operating rooms for emergencies. “The bariatric surgery program never blocks an emergency surgery from proceeding,” he said.


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An exterior view of the Rikers Island jail complex at dusk.
Detainees at Rikers often struggle to get even rudimentary medical care, but 11 were taken to Bellevue for elective bariatric surgery.Credit...José A. Alvarado Jr. for The New York Times
An exterior view of the Rikers Island jail complex at dusk.

Early one morning in February, a guard clanged on the door of David Mustiga’s jail cell on Rikers Island. Soon, the 43-year-old was shackled and put on a bus to Bellevue.

Rikers detainees often struggle to get even rudimentary medical care. But Mr. Mustiga and 10 other prisoners have undergone elective bariatric surgery at Bellevue, often spending weeks in the hospital.

Even in the best conditions, recovering from bariatric surgery is tough. Trying to recuperate in jail, where detainees have little control over what they eat or how fast they eat it, is especially difficult.

Mr. Miller said patients from Rikers were “screened and assessed like all others” and were kept at Bellevue until they were ready to eat the types of food that were available at the jail.

Mr. Mustiga, who was later convicted of drug trafficking, weighed more than 300 pounds and had high blood pressure. He had been excited months earlier when a staff member at the Rikers medical clinic first told him about the benefits of bariatric surgery. He said no one had warned him about the challenges of recovering while incarcerated.

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A copy of instructions reads at the top, "Make an Exercise Schedule" and offers a "sample activity log."
Mr. Mustiga received a pamphlet from Bellevue advised him to try a Zumba dance class.Credit...via David Mustiga
A copy of instructions reads at the top, "Make an Exercise Schedule" and offers a "sample activity log."

When Mr. Mustiga boarded the bus to Bellevue, he thought it was for a brief visit to get bloodwork in preparation for surgery. Instead, he was admitted to the hospital’s locked prison ward and placed on a liquid diet.

There, he met another patient waiting for bariatric surgery, Luis Perez. The men bonded over their dieting ordeals and teamed up to steal scraps from their neighbors’ hospital trays.

Mr. Perez, who was awaiting sentencing for drug possession, had surgery first. Afterward, he told Mr. Mustiga that the pain was worse than when he had been hit by a car and lost his arm above the elbow.

Mr. Mustiga panicked. He said he had tried to back out of the surgery, but a doctor told him that this was his only shot at getting the procedure and that if he didn’t follow through, he would be sent back to the jail immediately.

Mr. Mustiga said he often used the same pressure tactics on his drug customers. “Tell someone it’s their last shot, and they find their wallet pretty quickly,” Mr. Mustiga said.

He decided to have the operation.

After surgery, patients are supposed to consume small, protein-rich meals.

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A photo of Luis Perez, in a black T-shirt, with his wife, who is holding on to his arm and wearing a face mask. Mr. Perez’s face mask is pulled down on his chin and he is wearing a New York Yankees baseball cap.
Luis Perez said he suffered complications after his surgery.Credit...via Annette Martínez
A photo of Luis Perez, in a black T-shirt, with his wife, who is holding on to his arm and wearing a face mask. Mr. Perez’s face mask is pulled down on his chin and he is wearing a New York Yankees baseball cap.

Back at Rikers, Mr. Mustiga bartered cigarettes for protein powder. He reviewed a Bellevue pamphlet outlining dos and don’ts after surgery. It suggested that he eat nonfat Greek yogurt or drink eight cups of Crystal Light. Exercise tips included trying a Zumba dance class.

Mr. Mustiga wasn’t getting proper nutrition. He said he lost more than 100 pounds in less than six months — a rate of weight loss that can be dangerous. His hair fell out in clumps, and his medical records show he was receiving iron supplements for anemia.

This summer, Mr. Perez was transferred to Franklin Correctional, a prison near the Canadian border, to serve a four-year sentence.

During a visit in August with two Times reporters, Mr. Perez’s skin was sallow. He said he was not getting enough protein and could not eat without vomiting. He worried the surgery had made him a target in prison, where size matters for protection.

Two months later, Mr. Perez was badly beaten. He said his attackers stole the protein powder he had been saving up.


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A portrait of Jasmine Nieves, who wears a red-orange jacket over a low-necked shirt with a necklace. A single tear streaks down her cheek.
Jasmine Nieves said she called Bellevue to complain about her pain but that no one responded.Credit...Maansi Srivastava/The New York Times
A portrait of Jasmine Nieves, who wears a red-orange jacket over a low-necked shirt with a necklace. A single tear streaks down her cheek.
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Jasmine Nieves seen in a mirror pulling up her shirt to show her abdomen, which bears scars from multiple procedures.
Ms. Nieves spent a year in and out of hospitals after her surgery.Credit...Maansi Srivastava/The New York Times
Jasmine Nieves seen in a mirror pulling up her shirt to show her abdomen, which bears scars from multiple procedures.

In 2022, Bellevue reported that 3 percent of bariatric patients were readmitted to the hospital within a month of their operation. Experts said that rate appeared to be consistent with other high-quality programs, although it didn’t account for longer-term problems associated with the surgery.

After her operation in 2015, Jasmine Nieves was in agony. The 30-year-old repeatedly called Bellevue’s bariatric clinic to report her pain, but she said nobody answered.

A few months later, her sister discovered Ms. Nieves passed out on a couch. At a hospital in Brooklyn, a CT scan revealed that the operation had caused fluid to pool in her abdomen, requiring emergency surgery, according to her medical records.

She spent the next year in and out of hospitals, at one point needing a feeding tube because she could no longer eat solids.

Ms. Nieves filed a malpractice lawsuit against Bellevue, which was dismissed after she missed multiple court dates. Her claims were never adjudicated.

Mr. Miller declined to comment, citing privacy restrictions.

In 2021, Magaly Rojas, then 43, ended up in a monthlong medically induced coma after her bariatric surgeon, Dr. Park, punctured her spleen, according to a malpractice lawsuit she later filed.

She was in the hospital for 75 days. By the time she returned home, her 1-year-old daughter didn’t recognize her. She was about 109 pounds, down from 236, according to her brother.

Ms. Rojas couldn’t go back to work because she could not control her bowels. She and her three young children are at risk of losing their apartment.

Ms. Rojas’s lawsuit is pending. Bellevue disputes her claims.

Soraya de Oliveira, 53, underwent bariatric surgery in 2018. Shortly afterward, staff discovered her stomach was filling with blood.

Doctors performed two emergency surgeries, but she died days later. Her family filed a wrongful-death lawsuit. Bellevue settled.

Mr. Miller said the hospital’s number of deaths associated with bariatric surgery was below the national average. Only two patients had died, he said.

FDA Inspections of Foreign Drug Manufacturers Haven't Bounced Back After Pandemic

 The FDA hasn't recovered from its pause in foreign drug manufacturer inspections during the COVID-19 pandemic, with inspections in 2022 remaining "well below" pre-pandemic surveillance levels, a study found.

Researchers tracking a decade of FDA inspections observed an expected decline in inspections in 2020, but 2 years later foreign inspections remained 79% lower than 2019, and domestic inspections remained 35% lower, without any "corresponding reduction in drug manufacturing or imports," David Ridley, PhD, of Duke University in Durham, North Carolina, and co-authors wrote in Health Affairsopens in a new tab or window.

While the study does not include 2023 data, Ridley noted that fiscal year 2023 inspection rates changed little since 2022, based on publicly available information.

"No one would be surprised that there was a big fall in inspections in 2020 -- much of the world shut down -- but we are surprised to see that those inspections had not bounced back in 2022," Ridley told MedPage Today.

Prior to 2020, the average inspection in foreign countries was between 5 and 8 inspector-days; post-pandemic, that average increased to between 7 and 15 inspector-days, the authors noted. They defined inspector-days as "the total number of days required to complete an inspection by all assigned investigators." For instance, a 2-day inspection with two inspectors would count as 4 inspector-days.

Domestically, the average number of inspector-days also grew between 2012 to 2019 and 2020 to 2022. Among the inspections that did happen, the share of inspections which led to an "official action indicated" (OAI) -- which is the "most severe classification" indicating an unsatisfactory level of compliance -- increased.

Foreign Versus Domestic Inspections

In 2019, roughly 14% of domestic and 9% of foreign inspections resulted in an OAI finding. In 2021, rates for both doubled, though the authors observed "a partial reversal in this trend" in 2022, the study noted.

Prior to the pandemic, foreign inspections were increasing and domestic inspections were falling, the researchers noted. In 2012, there were 648 foreign and 1,392 domestic inspections, but in 2019, foreign inspections grew to 954 and domestic inspections dropped to 738.

However, after the FDA issued revised guidance in 2020, overall inspections declined significantly and by 2022, inspections, especially those conducted overseas, failed to recover, the authors noted. The agency did not inspect any drug manufacturing facilities in China or India from April 2020 to March 2021, they stressed.

The decline in foreign inspections is perhaps the most concerning data in the analysis, Ridley observed. Although the FDA appears to have the overall inspector resources, it isn't clear they are "optimally allocating" them; they "don't seem to be sending them abroad, even in 2022 and 2023," he said.

"[M]any of these foreign establishments haven't been visited by the FDA in years, and I think the longer the lag between inspections, the more the potential for manufacturers to get sloppy or ... to compromise on quality," he added.

Study Details

Ridley and co-authors leveraged data on inspections conducted by the FDA's Office of Regulatory Affairs from 2012 to 2022 obtained through a Freedom of Information Act request.

To measure the intensity of inspections, the researchers used the average number of inspector-days per inspection by region per month. They also examined the share of inspections resulting in an "official action indication" finding, which occurs when "there is an unsatisfactory level of compliance with current good manufacturing practices."

The study underscores the need to explore alternative methods for ensuring drug safety, the authors said. They called for the FDA to prioritize foreign inspections, hire more inspectors who can travel, and leverage technology to supplement remote inspections. They also urged the agency to continue to use "mutual recognition agreements" with other countries to make use of their inspection reports and to "share the drug quality assurance burden."

A key takeaway is that FDA inspections of foreign drugmakers are both "rare and announced," Ridley said. In addition, the agency rarely tests drugs itself. But some purchasers, including Kaiser Permanente and the Department of Defense, have begun paying labs to test drugs for them, Ridley noted. "So, there is a role for your retail pharmacy chain, or ... others... to test a few of the drugs and then to choose which manufacturers they trust based on the outcomes of the test," he said.

In an emailed response to MedPage Today, an FDA spokesperson stated that "the American public should rest assured that the drugs they rely on are high-quality, safe, and effective. Protecting patients is the highest priority of the FDA and the agency remains committed to using all available tools to oversee the safety, effectiveness, and quality of FDA-regulated drug products."

"Drugs intended for the U.S. market manufactured outside the U.S. must meet the same standards as drugs made in the U.S.," the spokesperson said. "We remain committed to using all available tools to oversee the safety and quality of FDA-regulated products and help ensure that Americans have access to essential and innovative therapies. Additionally, we continue to adjust our processes and guidance as necessary to maintain the appropriate level of review to ensure the safety of FDA-regulated products."

A study limitation was that the researchers did not observe the actual resources available for inspection activities and relied on aggregated data about budget and staffing to design proxy measures. The doubling of official actions may be due to the lag between inspections, but also could be because the FDA focused on the most potentially problematic establishments, Ridley noted.

Disclosures

The authors thank M. Usaid Awan and Yue Zhang for helpful insights. The authors did not receive external funding for the research.

Primary Source

Health Affairs

Source Reference: opens in a new tab or windowCuddy E, et al "FDA global drug inspections: Surveillance of manufacturing establishments remains well below pre-COVID-19 levels" Health Aff 2023: DOI: 10.1377/hlthaff.2023.00686.


https://www.medpagetoday.com/washington-watch/fdageneral/107770

Casgevy vs. Lyfgenia: The Battle of the Sickle Cell Gene Therapies Has Begun

 As a business journalism publication, BioSpace doesn’t get many news days like we had on Friday. Not just one but two major FDA approvals happened simultaneously for the first cell-based gene therapies to treat patients with sickle cell disease.   

While the FDA’s decision regarding Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy was expected on Friday, the regulator’s verdict on bluebird bio’s Lyfgenia was a bit of a surprise as the PDUFA date was set for Dec. 20. Of course, who can blame the FDA for taking the opportunity to approve two milestone gene therapies for sickle cell disease on the same day. It made for a hell of an announcement from the agency—and early enough in the day to be included in BioSpace’s email newsletter (which I appreciated).

However, at the same time, I felt bad for bluebird having to share the limelight with Vertex and CRISPR, denying the company its own spotlight for an otherwise impressive one-time gene therapy—despite a black-box warning related to certain cases of blood cancer in patients treated with the drug.

Casgevy, on the other hand, got the regulatory go-ahead for what is the first CRISPR-based gene editing therapy for sickle cell disease. It’s a historic, groundbreaking distinction, not to take anything away from Lyfgenia—based on the Nobel Prize-winning CRISPR/Cas9 technology, which has its own potential off-target effects that are a sobering reminder that even good gene edits can go bad.

As I said, initially I felt bad that bluebird stood in the shadow of the day’s other big news—that is until I saw what the company is looking to charge for Lyfgenia. While Vertex and partner CRISPR said on Friday that Casgevy would be available at a U.S. list price of $2.2 million per patient, bluebird set the wholesale acquisition cost of Lyfgenia in the U.S. at $3.1 million. That’s where I believe bluebird made a strategic error—on pricing. It’s a mistake that has already cost the company, whose shares fell 40% Friday. Not surprisingly, in a research note, Evercore analysts gave the advantage to Casgevy due to its lack of a black-box label and lower price.

One company this week that was not afraid to shell out big bucks was AbbVie, which continued its buying spree by purchasing Cerevel Therapeutics for $8.7 billion. That news followed AbbVie’s Nov. 30 announcement that it was acquiring ImmunoGen for $10.1 billion for its antibody-drug conjugate Elahere, which was granted FDA accelerated approval last year, and a pipeline of promising next-generation ADCs—as the industry’s appetite for ADC technology appears to be insatiable.  

Wall Street analysts told Reuters that AbbVie’s bet on Cerevel is risky but smart, raising concerns that Cerevel’s pipeline overlaps too much with AbbVie products and making a Federal Trade Commission approval of the acquisition potentially problematic. We’ll see if the deal gets through the FTC!      

https://www.biospace.com/article/casgevy-vs-lyfgenia-the-battle-of-the-sickle-cell-gene-therapies-has-begun/