Category Archives: We’re In the News

F.D.A. names a new chief of medical devices

In the News, News Stories & Editorials, Uncategorized, We're In the News

Christina Jewett, The New York Times, Oct. 22, 2024

The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division.

Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators.

She will also confront the challenge of restoring credibility to a division clouded by ethical lapses of Dr. Jeffrey Shuren, her predecessor, and of navigating her way in an agency with close ties to the industry.

In addition, Dr. Tarver is assuming the position at a time of stunning technological advancement, overseeing research and potential approvals of devices meant to tap into brain signals to restore speech and movement.

The division reviews thousands of medical products that are central to medical diagnosis and surgery, like DNA tests and surgical staplers. Other devices are implanted in the body for decades, including pacemakers and hip prostheses. The division has a budget of about $790 million and a staff of about 2,500.

A 15-year veteran of the agency, Dr. Tarver is viewed by those inside the F.D.A. as a candidate who would sharpen the division’s focus on safety and quality. She is an ophthalmologist who continues to treat patients on the weekends, and she is also trained as an epidemiologist and has developed ways to measure patient preference in medical care.

“Dr. Tarver demonstrates a true passion about data, science, medicine and the evidence, all of which are critical to supporting and driving the F.D.A.’s decisions,” Dr. Robert Califf said in an announcement to agency staff Tuesday. “She works to build collaboration and transparency in achieving the strategic priorities for the center and the agency.”

Dr. Tarver said in a statement that she was honored to lead the division and planned to “remain committed in our service to public health and ensuring all patients in the U.S. have access to high-quality, safe and effective medical devices.”

Dr. Shuren headed the division for 15 years and has been credited with speeding the pace of approvals and solidifying the United States as a destination for medical device study and innovation. He has also been divisive, facing pressure from the start of his tenure to strengthen lax device-approval standards. Those calls have continued unabated over the years. The American Medical Association, a major doctors group, voted in 2023 on a resolution urging the agency to raise the bar on product authorizations and to more carefully monitor the safety of approved products.

 

Dr. Shuren announced his retirement in July, and the agency has said he will leave by the end of the year.

An investigation by The New York Times found that his official work had overlapped for years with that of his wife, Allison Shuren, a lawyer for major medical device companies. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have sought authorization or stepped aside in some matters, but asserted that the lapses had not affected regulatory decisions.

In recent weeks, two lawmakers called on the inspector general of the Health and Human Services Department to investigate whether those matters were “simply an appearance of impropriety or actual inappropriate and unethical conduct.”

Before joining the agency in 2009, Dr. Tarver had been an assistant professor at the Johns Hopkins School of Medicine.

At the F.D.A., she became a medical officer in the ophthalmology unit, and then took on other roles, including working with the division’s patient engagement advisory committee.

Dr. Tarver later moved on to an F.D.A. office focused on emergency preparedness and response as well as digital health.

Maria Gmitro, president of the Breast Implant Safety Alliance, said she had been impressed with Dr. Tarver’s warmth and willingness to listen. Ms. Gmitro said she had raised concerns about whether women were aware that they received recalled breast implants that were associated with rare cases of blood cancer.

Ms. Gmitro said Dr. Tarver helped her group in a practical manner, working to open access to data on age and gender for an analyst examining reports of harm related to breast implants.

“So we are very optimistic with Dr. Tarver being in this position,” Ms. Gmitro said. “I’m hopeful about the progress that can happen.”

Diana Zuckerman, president of the National Center for Health Research, a nonprofit that tracks F.D.A. device policy, said she had found Dr. Tarver to be concerned about patient safety and “in making sure that patients understand the risks and benefits” of devices.

Scott Whitaker, president of AdvaMed, the largest device industry trade association, said the group was pleased with Dr. Tarver’s appointment.

[….]

Dr. Tarver will face skepticism from advocates for people who have had unwanted symptoms after LASIK surgery, such as distorted vision and eye pain.

Dr. Tarver was a leader in the agency’s ophthalmology division for years and played a role in F.D.A.-backed research on the procedure. Yet after more than 15 years of advocacy and an agency proposal in 2022 to strengthen warnings to prospective patients, no change has come about, said Paula Cofer, who suffered harm from LASIK and served as a patient representative on a 2008 panel on the matter.

The F.D.A. has said it is still reviewing comments submitted on the 2022 proposal. Among its opponents are clients of Dr. Shuren’s wife, which include a group of prolific laser surgeons and a company that makes LASIK lasers.

“She’s been involved in LASIK device policy at the agency for what, 15 years, and during this time, the agency has failed to act on evidence of high rates of harm to the public due to LASIK devices,” Ms. Cofer said. “This is just not passing the smell test.”

To read the entire New York Times article, click here.

High Levels of Toxic Flame Retardants Found in Toys, Kitchen Utensils Made From Black Plastic

News Stories & Editorials, Uncategorized, We're In the News

Researchers found flame retardants, linked to carcinogenicity, endocrine disruption, neurotoxicity, and reproductive harm, in toys, take-out containers and kitchen utensils made from black-colored plastic.

Michael Nevradakis Ph.D., The Defender, October 2, 2024

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website.

Some common household products made from black-colored plastic — including toys, take-out food containers and kitchen utensils — contain high levels of toxic flame retardants, according to a study published Tuesday in the journal Chemosphere.

The contamination stems from the improper recycling of electronic products like televisions, whose casings are made from black plastic. When plastic casings containing flame retardants are mixed with other plastics during recycling, the contaminants make their way into the end product.

Toxic-Free Future and the Amsterdam Institute for Life and Environment conducted the study.

Megan Liu, science and policy manager for Toxic-Free Future, told The Defender:

“These flame retardants are hazardous because they are associated with a range of negative health effects, including carcinogenicity, endocrine disruption, neurotoxicity, and reproductive harm.

“The findings of flame retardants in children’s toys are of particular concern, because flame retardants have been found to leach from toys into children’s saliva.”

The researchers examined 203 products manufactured from black-colored plastics. They screened the products for bromine, a man-made chemical used in flame retardants.

Products containing 50 parts per million of bromine were further analyzed for the presence of brominated flame retardants, organophosphate flame retardants and plastic polymers.

The results showed that toxic flame retardants were present in 85% of the products analyzed, with concentrations reaching 22,800 milligrams per kilogram The contaminants detected included decabromodiphenyl ether, or decaBDE, a compound commonly used in the casings of electronics before the U.S. Environmental Protection Agency (EPA) banned it in 2021.

 

One compound, decabromodiphenyl ether, or BDE-209, was commonly found in black-colored plastic kitchen utensils at an average level of 34,700 nanograms per day, “exceeding estimates for intake from dust and diet.”

A 2014 study published in the journal Frontiers in Genetics found that BDE-209 has highly carcinogenic effects on humans.

Other contaminants detected include compound 2,4,6-tribromophenol, which has been detected in human breast milk, according to a 2023 study published in the journal Environmental Pollution.

According to a study published by JAMA Network Open in April, people with high concentrations of polybrominated diphenyl ethers or PBDE, a common flame retardant, are approximately 300% more likely to die from cancer compared to people with the lowest levels. DecaBDE belongs to this category of flame retardants.

Dr. Leonardo Trasande, a professor of pediatrics and population health at NYU Langone Health, told CNN that brominated flame retardants are of particular concern due to high levels of toxic contaminants that can remain in the human body for years.

“I’m not aware of any safe level of brominated flame retardants,” Trasande said. Earlier this year, Trasande co-authored a study, published in the Journal of the Endocrine Society, finding that such contaminants cost the U.S. healthcare system up to $249 billion in 2018 alone.

‘Mistakes in the recycling of electronic waste’ are behind widespread contamination

According to the Toxic-Free Future study, the presence of toxic flame retardants in a wide range of household and commercial products “indicates that recycling, without the necessary transparency and restrictions to ensure safety, is resulting in unexpected exposure to toxic flame retardants in household items.”

“Flame retardants are a highly hazardous class of chemicals, but they are still allowed for use in products like electronics, and as a result of dirty electronic-waste recycling, we’re seeing flame retardants appear in unexpected products, like our kitchen utensils, food service ware, and hair accessories,” Liu said.

Diana Zuckerman, Ph.D., president of the National Center for Health Research, told The Defender that the findings of this study are “worrying” and reflect the need for better regulation of plastic recycling and toxins in plastics.

Zuckerman said:

“It’s become increasingly obvious that the public has been misled about the effectiveness and safety of recycling plastics and it is no longer possible to trust the information that we’ve been given, most of which comes from industry.

“For that reason, the FDA [U.S. Food and Drug Administration] and EPA need to scrutinize the safety of all plastic products used with foods, instead of the vague reassurances the agencies have been offering.”

According to Liu, the study focused on black-colored plastic “because we hypothesized that the black plastic used for television casings and electronic enclosures, which flame retardants are intentionally added to, were being recycled into non-electronic, household products.”

 

The study noted that the styrene-based plastics typically used in the casings of electronics contained “significantly higher levels” of toxic flame retardants, compared to plastics like polypropylene and nylon, which are less frequently used for such casings.

“It appears the plastics used to make the consumer products were contaminated with flame retardants due to mistakes in the recycling of electronic waste,” Liu told CNN.

The study focused on items such as kitchen utensils and toys “because of high-risk exposure concerns” and frequent use by children, Liu said:

“Kitchen utensils are things we use on a regular, maybe even daily basis, and studies have shown that flame retardants can leach out of kitchen utensils into our food.

“Children also play with toys for extended periods of time, so it’s important to think about the compounded exposures we might be getting from these products, as well as other products that may contain flame retardants, when thinking about how this is affecting people, especially vulnerable populations like children.”

Liu separately told CNN that studies specifically testing food contact materials, such as black plastic kitchen utensils or take-out containers, hadn’t previously been conducted.

According to the study, lax regulation in the U.S. has helped contribute to the widespread contamination:

“A lack of transparency related to chemicals in products and limited restrictions on use of FRs [flame retardants] in electronics have led to widespread use and dissemination of harmful FRs.

“Despite the lack of transparency and restrictions, plastics from electronics are often recycled and can be incorporated in household items that do not require flame retardancy, resulting in potentially high and unnecessary exposure.”

For instance, Liu told CNN that decaBDE was found in 70% of the samples tested in the study, at levels up to 1,200 times higher than the European Union’s limit of 10 parts per million. The contamination persists despite the EPA’s ban on decaBDE in 2021.

According to CNN, decaBDE is linked to “cancer, endocrine and thyroid issues, fetal and child development and neurobehavioral function and reproductive and immune system toxicity.”

High levels of toxic flame retardants found in toys, sushi trays

Aside from their use in casings for electronics, flame retardants are also commonly used in furniture, car upholstery, infant car seats, carpet padding, foam-padded yoga mats and padded baby items, according to the National Institute of Environmental Health Sciences.

These flame retardants can “leach from products into the air and then attach to dust, food, and water, which can be ingested,” the institute noted.

But according to the study, toxic flame retardants can be found in many more items commonly found in homes — including children’s toys.

Liu told CNN, “A product with one of the highest levels of flame retardants were black plastic pirate coin beads that kids wear.” This product had up to 22,800 parts per million of total flame retardants, which Liu said was “almost 3% by weight.”

Another product identified as highly contaminated were black plastic sushi trays. Liu told CNN such items contain 11,900 parts per million of decaBDE.

 

Calls for stronger regulations against toxic contaminants in plastics

Liu told The Defender the latest findings demonstrate the need for stronger regulations on hazardous chemicals and materials entering the recycling stream. She said she is unaware of any such regulations in the U.S.

“What we need is our state and federal government, along with retailers, to ban these harmful chemicals and materials,” Liu said. “We need policy and market change to increase the transparency of what’s being used in the supply chain, including for recycled materials, as well as require the use of safer solutions.”

“Taking these steps and turning off the tap on toxic chemicals and plastics will help protect the health of women and children,” Liu said.

She noted that the study’s results were published “at a critical time when leaders around the world are negotiating a Global Plastics Treaty.”

The proposed treaty has a stated goal of ending “plastic pollution by 2040 through a circular economy where all plastics are responsibly managed during production, use, and end-of-life, enabling a climate-neutral plastics industry.”

The ongoing negotiations for this treaty come two years after the United Nations Environment Assembly passed a resolution, endorsed by 175 nation states, to end plastic pollution. The resolution calls for the completion of a legally binding international treaty by the end of 2024.

Such a treaty “will chart a course for how quickly and effectively the plastics crisis is addressed,” Liu said.

In the meantime, Liu suggested people “reduce any uses of plastics,” including replacing plastic kitchen utensils “with safer options, like wood or stainless steel.” Plastic containers should be replaced with glass containers.

“When possible, choosing plastic-free when purchasing any item can help reduce your overall exposure to harmful additives in plastic,” Liu said.

Regular cleaning and ventilating will also help “clear out any flame retardants accumulating in dust or air,” as will “frequent handwashing, regular wet-dusting and mopping, and vacuuming,” Liu added.

Zuckerman advised the public not to “microwave food in any kind of plastic,” adding that “we’ve been advising that for well more than a decade.”

“But the onus shouldn’t fall onto consumers,” Liu said. “We can’t shop our way out of this problem. We need policies that restrict the use of the most hazardous chemicals and plastics at the corporate and government level.”

Zuckerman said it’s “unrealistic to offer advice to individual consumers because the information we need is not currently available.”

“What we all need is independent research, scrutiny and oversight to take unsafe products off the market.”

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. 

FDA to launch ‘active’ monitoring system to improve medical device safety

News Stories & Editorials, We're In the News

Mary Chris Jaklevic, Association of Healthcare Journalists, September 18, 2024

A congressional watchdog agency has reported that the FDA is launching a surveillance system to actively look for safety problems with medical devices — 12 years after it was mandated to do so.

The new system aims to detect potential safety issues nearly in real time by monitoring data like electronic health records and billing claims. That data is sometimes called real-world evidence (RWE).

Until now, the FDA has relied largely on spotty reports from manufacturers, hospitals, nursing homes and patients, which has resulted in underreporting and delays in identifying harmful products.

Often, physicians and patients aren’t warned in time. Surgical mesh, CPAP machines, and metal joint implants are just a few of the problematic devices that have been highlighted in news reports about their widespread harms.

Yet some experts are skeptical that the advent of active monitoring will do much to improve medical device safety. Journalists should continue to be watchdogs for medical device safety. Here are some factors.

Active surveillance will have a slow start.

In a report issued in July, the U.S. General Accounting Office said the FDA plans to begin actively monitoring two types of devices for safety issues this year: the duodenoscope, a lighted tube used for viewing the small intestine; and robotically assisted surgical devices used in gallbladder removal. The GAO said the FDA plans to expand to 18 or more devices by 2028.

That’s a tiny fraction of the more than 6,000 types of medical devices that the FDA regulates. Madris Kinard, MBA, chief executive officer of Device Events, a software service for tracking medical device adverse events, noted in an email that the FDA is “far behind” in implementing what the agency has heralded as a “collaborative national evaluation system for health technology.”

Tracking RWE for two products by the end of this year “doesn’t begin to scratch the surface” of objectives established by the National Evaluation System for health Technology, an organization that has been working with the FDA to establish the active surveillance system, she added.

Key narrative details could be missed.

The new system uses resources that could be directed to enforce requirements that hospitals and device makers promptly submit reports to the FDA’s MAUDE database, Kinard said.

“MAUDE is more proactive than is understood because often a malfunction appears that, if it were to happen again, could cause serious injury or death,” she said, adding that MAUDE “also contains a narrative that is publicly available and provides context for the event,” which active surveillance may not provide.

Implementation challenges remain.

According to the GAO report, the FDA has encountered “key challenges” of inadequate funding and limited use of unique device identifiers in electronic health records and billing claims, impeding the identification of patients who have a particular device. The GAO outlined steps that the FDA is taking to address those challenges.

Diana Zuckerman, Ph.D., president of the National Center for Health Research, a public health watchdog group, said in an interview that Congress and the FDA could do more to resolve those issues. For example, she said, the FDA could require a percentage of device makers’ user fees to support safety monitoring despite industry objections.

More surveillance doesn’t address lax standards for new devices.

Surveillance does not address a basic issue: few, if any medical devices enter the marketplace with rigorous testing to show that they are safe or effective.

That’s in part because the FDA “clears” most devices via the Premarket Notification pathway known as 510(k),  which requires manufacturers only to show that a device is “substantially equivalent” to another product that is already on the market. The FDA often defines that broadly to include substantial differences in materials, shape, size or mechanism of action.

In 2016, Congress reduced standards of evidence for device approval via the 21st Century Cures Act.  Zuckerman said she expects some lawmakers to push for legislation that will further lower the bar this fall. For journalists, she said, “This would be the time to bring some attention to what Congress is doing and what they’ve done in the past.”

What questions should journalists be asking?

Investigative journalist Jeanne Lenzer, who wrote the book, “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It,“ said via email that journalists should ask questions about the new active surveillance system.

Lenzer offered the following:

  • The FDA has partnered with 18 hospitals and a pharmacy chain to share data for postmarket surveillance. What proportion of all hospitals and pharmacies does this represent, and might there be problems identifying safety risks due to inadequate numbers of patients?
  • How will reporting be complicated by the fact that patients frequently change providers and insurers or fail to seek care if they become uninsured?
  • Will this new system help patients who have been implanted with devices that do not have a unique identifier?
  • Why, after more than two decades of recognizing the problem, isn’t there a plan to have mandatory tracking of unique device identifiers for all higher and high-risk devices?
  • Does Congress need to grant the FDA the power to require manufacturers to maintain mandatory registries for all higher-risk devices and more funding to carry out postmarket surveillance?

 

Read the full Association of Healthcare Journalists Article here.

The untold trauma of thousands of women suffering from ‘Breast Implant Illness’, leaving them in agony for years… yet some doctors refuse to accept it is real

News Stories & Editorials, We're In the News

Isabelle Stanley, The Daily Mail, September 9, 2024

When mother-of-three Holly took the drastic step of having both her breasts removed, she did so believing it might save her life.

Breast cancer had claimed her mother when Holly was just 14 and her own chances of developing the disease now stood close to 90 percent.

Yet within months of the surgery and the breast reconstruction that followed, Holly felt like she was closer to death than ever before – struggling with a range of debilitating conditions including chronic pain, blurred vision and difficulty breathing.

‘I kept getting sicker and sicker,’ she told DailyMail.com. ‘I felt like I was going to die.’

It wasn’t until Holly, 57, stumbled across a Facebook support group with 50,000 women whose symptoms matched her own that she believed she had finally discovered the cause of her illness: Breast Implant Illness, or BII.

There is little support for sufferers, with some medical professionals preferring to dismiss BII entirely, but an increasing number of women – from working moms to celebrities – are speaking out about their experiences.

Crystal Hefner, wife of late Playboy founder, Hugh Hefner, had her breast implants removed in 2016 at the age of 38 telling Facebook followers that ‘my breast implants slowly poisoned me’.

Another former Playboy model and alleged former mistress of Donald Trump, Karen McDougal, had hers taken out the same year.

‘I would get sick every couple of months and be sick for six to eight weeks at a time,’ McDougal told People magazine at the time. ‘It just never went away.’

Still, despite these stories and BII cases being reported around the world for more than 30 years, the condition is neither widely researched nor well understood.

It is thought by medical professionals to be caused by either auto-immune or inflammatory responses to implants which, in turn, trigger a series of mental and physical conditions such as anxiety, rashes and chronic pain.

And the skyrocketing number of cases of women having their breast implants removed is difficult to ignore.

‘Removals have been going up for the last five years,’ confirms Dr Scot Glasberg, president of research group The Plastic Surgery Foundation.

Some 250,000 American women receive implants each year, and as many as 74,000 had their implants removed in 2023, a 40 percent increase from 2019, according to the latest data from The Aesthetic Society, a global organization of plastic surgeons.

Dr Glasberg says there is a ‘host of reasons’ behind the rise. ‘[Yet] the biggest is that women are worried about breast implant-related tumors and concerned over breast implant illness.’

BII has been reported by women regardless of whether their breast implants remain intact or rupture and leak. And the physical toll can be crippling.

It certainly was for Holly, who found herself so sick she couldn’t work while racking up $100,000 in medical bills.

She saw dozens of specialists in the ten years that followed the onset of her BII, yet none of them could figure out what was wrong.

[….]

Many plastic surgeons question whether the condition is truly real – ‘Unfortunately, it hasn’t reached the status of a defined illness [widely recognized by the medical community],’ Dr Glasberg said.

[….]

This lack of concrete medical advice has left thousands of American women with nowhere to go, resorting to online forums and support groups for guidance.

One such group, Breast Implant Illness and Healing by Nicole, has more than 190,000 members, receiving over 70 posts a day from women sharing symptoms and asking for advice.

Abbey Williamson, 28, from Columbus, Ohio, first discovered the group after multiple specialists told her she was ‘crazy’ for linking her debilitating symptoms to BII.

The police officer and mother-of-one had silicone implants put in in 2020 after feeding her daughter changed the shape of her breasts and left her self-conscious.

Abbey soon became sick, collapsing at work and on patrol and even having to be hospitalized.

[….]

‘I had doctors roll their eyes at me when I mentioned BII,’ Abbey told DailyMail.com. As her symptoms got worse, her friend who is a nurse recommended she join the Facebook group.

‘I scrolled for hours and just read women’s posts about the same thing. Honestly, that page quite literally saved my life, and changed my life, because I don’t know if I would ever have made the decision to explant had I not had that community.’

Abbey had her implants removed in 2023 and claims that her symptoms disappeared almost immediately.

‘I remember coming out of surgery and it was like I could see again,’ she said, ‘the rashes went away, I had no more joint pain, I could work out again.

‘I have not passed out or had a single episode like that since they were removed.’

The disbelieving attitude of health care professionals is a common theme among the women who spoke to DailyMail.com.

‘Women tell me they go to their doctors and say I don’t know what’s wrong with me,’ says Diana Zuckerman PhD, founder of the National Center for Health Research, ‘and doctors say, well you’re getting older, you’re 30.

‘Or they say ‘you’ve got children, you’re not getting enough sleep’.

‘It’s a combination of women not being listened to and doctors not knowing what to do, especially plastic surgeons being defensive and not helpful.’

Breast implants are a billion-dollar industry, bringing in an estimated $1.54 billion in revenue in 2021 alone, according to The Aesthetic Society.

‘There’s enormous money and pressure against doing better research,’ says Zuckerman, ‘there is so much money on the other side of this issue.’

Now, as more independent tests are done, the results are rather different, she says. And the picture they paint is increasingly damning.

One 2020 study, published in the Annals of Plastic Surgery by plastic surgeon Dr Lu-Jean Fang of 750 women with BII, found removing the implants caused a statistical improvement in every one of their symptoms.

Fang said the results showed the condition is real and that women’s symptoms are very likely caused by their implants.

‘This is real,’ agrees Zuckerman, ‘and it can be very serious, but we still don’t know how often it happens.

The Food and Drug Administration now lists the condition as a potential side effect of breast implants – a major step forward, according to BII believers.

‘Symptoms such as fatigue, memory loss, rash, ‘brain fog,’ and joint pain may be associated with breast implants,’ states the FDA’s official website.

And around five years ago, the FDA required doctors provide patients with a checklist of potential complications, although Zuckerman says this doesn’t always happen and might be counteracted by the surgeons assuring their clients they are still safe.

‘As is true with all informed consent forms, patients often don’t read them carefully and what they remember is what the doctor told them,’ she says.

Holly and Abbey claim that they were never explicitly warned about the risks by their doctors.

‘Maybe it was in the terms and conditions small print, but they never told me,’ insists Holly, who says she’d been assured that her silicone implants were ‘lifetime devices’ that would leave her feeling healthy and looking the same.

[….]

In 2022 – 12 years after the operation – and with her condition finally confirmed by a plastic surgeon, 57-year-old Holly joined the soaring number of American women having silicone implants removed from their bodies.

[….]

‘With the implants I had 30 symptoms,’ Holly tells the Mail through her tears. ‘Afterwards, I could breathe again. I could finally take a deep breath.’

Read the whole article here.

He Regulated Medical Devices. His Wife Represented Their Makers.

In the News, News Stories & Editorials, We're In the News

Christina Jewett, The New York Times, August 20, 2024

When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.

But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.

One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.

Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it’s not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.

In a review of thousands of pages of court documents and F.D.A. records and dozens of interviews with current and former agency staff members and advocates, The Times identified some clients and several instances in which the Shurens’ roles intersected.

Her partner at the helm of the firm’s life sciences team began representing Theranos, the discredited blood testing company, in 2015, demanding that the F.D.A. halt an inspection at its sites in California. While Dr. Shuren said he was recused from the matter, court records suggested he remained involved.

In another case, Ms. Shuren’s firm was working on a $63 billion acquisition of the company Allergan in 2019 when Dr. Shuren initially declined to urge a recall of the company’s breast implants tied to a rare cancer.

The couple’s work overlapped again in 2022 when Dr. Shuren announced a proposal to strengthen warnings given to patients preparing for LASIK vision correction surgery. Two of Ms. Shuren’s clients opposed the plan; the recommendations have yet to be put in place.

In response to inquiries over several weeks about these cases, the F.D.A. initially said it had no indication that Dr. Shuren had violated ethics rules and needed time to “substantively evaluate” follow-up questions from The Times. In a statement Friday, Shannon P. Hatch, an F.D.A. spokeswoman, said the agency had found that “it appears there were certain instances from about 10 years ago for which Dr. Shuren should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias.”

Ms. Hatch confirmed that the lapses occurred in the Theranos case as well as another one identified by The Times involving Alcon, an eye care drug and device company that was a client of Ms. Shuren’s.

In 2014, Alcon went before an agency committee convened to advise on whether to approve a lens implanted in the eye. According to a meeting transcript, Dr. Shuren signed off on the appointment of eight new voting members and a new chairman for the hearing, which recommended approval.

Ms. Hatch said the agency “has no indication that any F.D.A. regulatory decisions were impacted by Dr. Shuren’s wife’s employment nor that Dr. Shuren made any decisions in the interest of parties other than the public served by the F.D.A.”

While the agency conducts a nationwide search for Dr. Shuren’s replacement, he will work in the commissioner’s office to help ensure a smooth transition, according to the July statement by Dr. Califf announcing his retirement.

The F.D.A. said Friday, “Dr. Shuren has been advised of the need to exercise greater caution in matters concerning his recusal obligations and will be provided additional administrative support to better ensure future compliance.”

Neither Dr. Shuren nor Ms. Shuren responded to requests for interviews.

When The Times initially requested Dr. Shuren’s ethics records from the division he led, an official in the information disclosure unit wrote that the request was “complex” and would take up to two years to fill. Four months later, the F.D.A. provided an agreement that turned out to be two pages long after a lawyer for The Times had requested that a branch of the F.D.A. other than Dr. Shuren’s address the matter.

During the decade and a half of overlapping career trajectories, “Dr. Shuren has not requested, nor has he received any waiver or agency authorization to participate in any particular matter relating to his wife’s employment or any of her clients,” Mr. Felberbaum said.

[….]

Ms. Shuren earned from $1 million to $5 million, according to her husband’s financial disclosure form in 2018, the only one that estimated her income. Dr. Shuren’s F.D.A. salary is $400,000 a year.

Dr. Shuren led an office with about 2,500 staff members and a budget of about $790 million. He oversaw thousands of devices, ranging from tests to detect blood-lead levels to IV infusion pumps to ventilators.

Dr. Peter Lurie, a former F.D.A. associate commissioner, said he hoped the next division chief would shape a legacy that is more impartial toward device companies.

A surge in injuries

Early in his tenure, Dr. Shuren dismissed criticism from the business community over what it viewed as the slow pace of device approvals compared with Europe. Citing Europe’s lower standards and safety problems, he told The Times in 2011 that the F.D.A. would stand firm.

“We don’t use our people as guinea pigs in the U.S.,” he said at the time.

But congressional leaders on both sides of the aisle pressured the agency for faster medical device approvals. By 2014, Dr. Shuren pledged to make the United States the first place for device makers to sell their products.

[….]

In a recent presentation, he boasted that the number of first-in-the-world approvals had soared to 125 in 2023, from 25 in 2009.

“Do things now come here first?” he asked at a conference in May, referring to the new devices. “The answer is yes.”

Over time, Dr. Shuren drew closer to the medical device industry. In 2012, he co-founded a nonprofit called the Medical Device Innovation Consortium with a former executive from Medtronic, a leading device company.

To do so, Dr. Shuren secured a waiver from agency ethics rules, which prohibit federal officials from serving on boards of nonprofits to avoid divided loyalties or interests.

Most of the consortium’s board members were device industry executives, and many of its staff members had previously worked for the industry’s lobbying organizations.

As a board member, Dr. Shuren expanded the nonprofit while facing disturbing episodes at the agency over harm done by medical devices. Thousands of women reported injuries and side effects from Essure devices — small metal birth-control implants that dislodged from the fallopian tubes, tore delicate anatomy or caused allergic reactions. Other women were outraged to discover that an F.D.A.-cleared device called a power morcellator used to pulverize uterine growths might have actually spread their cancer.

Dr. Shuren promised in 2019 that a consortium project called NEST, or the National Evaluation System for Health Technology, would “empower the F.D.A. to more quickly identify, communicate and act on new or increased medical device safety concerns.”

The group has “obviously failed to do that,” said Diana Zuckerman, the president of the National Center for Health Research, a consumer watchdog group.

Agency critics have compared the NEST effort to a fox guarding a henhouse, citing the industry’s leadership at the consortium and a lack of specific safety accomplishments.

Last year, the American Medical Association, the nation’s largest physician group, raised “serious safety concerns” about medical devices, highlighting secrecy around reports of device-related injuries and a system that allowed many devices onto the market with little to no testing in humans.

The F.D.A. defended its approval process, saying it had increasingly sought more evidence before clearing products for sale. Regarding NEST, the agency noted a report by the U.S. Government Accountability Office, a watchdog agency, that said the program would begin monitoring the safety of two types of medical devices in December.

Medical specialists have also raised concerns about the safety and effectiveness of some devices approved during Dr. Shuren’s tenure. They include the CoolSculpting device, which was meant to zap fat but disfigured some people, and the Q-Collar sports safety device, which some experts say may offer little protection from injuries to the brain.

[….]
But safety issues multiplied on his watch. The most urgent F.D.A. recalls of devices that can cause serious injury or death have ticked up, to nearly 100 so far this year, from 29 in 2012, the first year such measures were tracked in an agency database. In March, a heart device was recalled after 49 deaths were linked to a specific concern.

Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012, according to Device Events, a company that makes F.D.A. data user-friendly for subscribers.

Dr. Hooman Noorchashm, a Harvard-trained cardiothoracic surgeon, said he believes the problems are a result of low standards and deference to industry. He emerged as a critic of Dr. Shuren’s after his wife died of a cancer that he said was spread by a power morcellator.

“Essentially,” he said, “he’s pumping medical products into the U.S. marketplace, outside of an evidence-based paradigm.”

Theranos hires Ms. Shuren’s team

When Dr. Shuren was named acting director of the medical device division in 2009, agency lawyers drafted an ethics agreement to prevent conflicts of interest involving his wife and her law firm. Top officials were to screen potential issues of concern, and other agency officials were to take the lead in such cases, according to the document.

[….]

A major test occurred in 2015. Daniel A. Kracov, Ms. Shuren’s partner in running the firm’s drug and device team, began representing Theranos.

At the time, he was challenging the F.D.A.’s authority to conduct an inspection at two Theranos offices in California. F.D.A. officials were concerned that the company was shipping its “nanotainer” blood-storage device without agency clearance. Theranos records for 2015 and 2016 show a $1.6 million payment to Arnold & Porter for legal services.

Dr. Shuren said around that time that he was recused from dealing with Theranos, recalled Alberto Gutierrez, then the F.D.A.’s senior scientist on diagnostic tests. But Dr. Gutierrez said he had not been informed that the agency expected another official to step in for Dr. Shuren, and Dr. Gutierrez continued to send him periodic emails about Theranos. Walter Brown, a lawyer for Mr. Balwani, gave the judge 91 documents that he said proved Dr. Shuren was dealing with Theranos matters.

Alison Daw, a lawyer representing the F.D.A., argued that Dr. Shuren had not had substantial involvement.

[….]

Breast implants tied to cancer

In the spring of 2019, the drug and device maker Allergan was under scrutiny at the F.D.A.: Women were developing a rare form of lymphoma linked to the company’s textured breast implants, which had been recalled by more than 30 countries.

At the same time, Arnold & Porter was engaged in legal issues involving Allergan. In April, a member of Ms. Shuren’s team began to defend Allergan in a California lawsuit over Botox pricing. The firm was also ushering AbbVie through a $63 billion acquisition of Allergan — a success Ms. Shuren’s team highlights on the firm’s website.

Mr. Felberbaum said Dr. Shuren was not aware of either the Botox case or the acquisition.

[….]

In May, Dr. Shuren and another F.D.A. official announced that the implants would not be recalled. In June, AbbVie announced its decision to purchase Allergan for $63 billion.

In July, Dr. Shuren and the other official reversed course and said that they would urge a recall, citing additional reports of injuries and deaths related to the lymphoma. Ms. Baumann of Arnold & Porter said that the firm represented AbbVie over antitrust questions and that Ms. Shuren had not worked on the matter.

[…]

To read the entire article, click here.

Open Letter to the FDA: You’re Protecting the Wrong People

News Stories & Editorials, We're In the News

Suzanne B. Robotti, MedShadow, July 23, 2024

The FDA revealed on June 18, 2024, that an unnamed number of drugs on the market right now were approved based on potentially fraudulent testing and data.1 This means there’s a risk that these medications may not be safe or effective.

The name of the testing company that produced falsified data—Synapse Labs Pvt. Ltd. (Synapse) in Pune, India—was divulged by the FDA but not the names of the hundreds of drugs that were tested by them or, more specifically, the drugs for which data was found to be fake. Why? The agency said that information surrounding how, where, and by whom any drugs are tested is “confidential commercial information.”

Are you shocked? I am. And I think we all should be.

By withholding drug names, the FDA is saying that a pharmaceutical company’s right to confidentiality is more important than people’s safety. It’s protecting pharmaceutical companies’ trade secrets and reputations, while failing at its core mission: ensuring that all drugs sold in the United States are both safe and effective. As Diana Zuckerman, PhD, President of the National Center for Health Research, succinctly said: “This is an outrageous situation where companies are notified but patients aren’t.”

Not only are these drugs still on the market and able to be prescribed, the FDA is giving all companies who used Synapse Labs a full year to retest elsewhere and resubmit that new data in order to retain their approved status.

Another disturbing fact: While most of the hundreds of drugs under question are generic versions of existing prescription drugs, some new drug applications incorporated Synapse-prepared (and potentially fraudulent) data. While there are ways for the consumer to check to see if generic drugs have been compromised—we’ll tell you how in the next section—it’s impossible for someone to check if a new drug was passed through based on faulty data. As a member of an FDA Advisory Committee that reviewed selected new drugs before the FDA approved or rejected them, I’m aghast to learn that the studies we were handed to review for new drugs may have been falsified!

Here’s How to Check If Your Drug Is Still Safe and Effective

Unfortunately, MedShadow doesn’t know of any way to find out if the brand-name drug you are taking is one of the drugs in question. If you are concerned about the safety, efficacy, or side effects of any medication, it’s a good idea to consult your health care professional and your pharmacist.

However, there are ways to check affected generic drugs. Generic drugs are an important part of the drug market, accounting for nine out of ten prescriptions filled.2 Generic alternatives to brand-name drugs ensure competition that can lower the cost of drugs and limit shortages of medicines.

The FDA reviews and potentially approves generic versions of a brand drug.3 Many drugs have multiple manufacturers–each with a slightly different generic version of the brand name drug–but all are deemed to be equivalent to the original in efficacy and safety. If, for any reason, the FDA no longer considers the data sufficient to determine whether the drug is equivalent to the original, it gives the drug a “BX” designation. You can call your pharmacist or doctor and ask if your generic’s therapeutic equivalent (TE) status has been changed to BX or you can look up your medications yourself here.4 To search for your specific drug, you’ll need the “applicant holder” (the manufacturer of your specific drug), which can be found on the bottle or packaging, often in fine print.

But to be clear, you will not find a neat list that reveals the Synapse-tested drugs that may be falsified. You will find many drugs from years past that retain their generic designation from the FDA and other drugs from which the FDA has withdrawn or downgraded its equivalency designation, including some generic versions of Cialis (tadalafil), Viagra (sildenafil), and Lipitor (atorvastatin).

The European Union decided to be more transparent than the FDA and published a list of generic drugs in question.5,6 Anyone in the U.S. is free to explore it, too, of course, and I encourage you to do so. (Note, though, that drugs may have different names in Europe and the database is very difficult to navigate.) Unfortunately, the list is limited to generics.

Do Generic Drugs Work and Are They Safe?

According to the FDA website: “FDA’s review process ensures that generic medications perform the same way in the human body and have the same intended use as the name brand medication. Health care professionals and consumers can be assured that FDA-approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs.”7

But this assurance to the American public is useless if doctors and patients can’t be sure these standards are enforced. In the case of generics, which are so prevalent, these must be equivalent to the brand-name drugs in dosage, effectiveness and safety.

This matters enormously because if the contents of a drug don’t precisely match the listed ingredients, then the person taking that drug is at risk of:

  • Not receiving enough of the drug to be effective
  • Taking in the drug at a level that could be toxic or harmful
  • Taking in ingredients not listed, potentially causing an allergic reaction or consuming ingredients that are not approved for human use
  • Taking in substitute ingredients that have a similar effect but are cheaper and potentially not indicated for your condition

In database research done recently by Bloomberg, the media outlet speculated that generics for Cialis, Viagra, and Lipitor might have been in the fraudulent Synapse group because their therapeutic equivalence rating was changed during the window of time that fit the Synapse alert.

An Urgent Call to Action for Drug Safety

Here at MedShadow, an independent nonprofit, we work to make sure that Americans are educated about, and can protect themselves from, harmful side effects of prescription drugs. This is hard enough to do when regulatory agencies are doing their jobs well.

So I want to offer suggestions to help us all be safer while we wait for more meaningful action from the FDA.  Be extra vigilant about noticing any new reactions to any medication (generic or brand-name) you are taking. For example, if you’re on a blood pressure pill, take your pressure at home every few days to compare your readings to the past. High blood pressure can cause headaches and chest pain, while low blood pressure creates a risk of dizziness, falling and fainting. If your usual medication seems to be ineffective or creating bad outcomes, talk to your doctor right away.

This Synapse fraud is a serious breach of public trust. It’s not just a case of a contractor not doing a good job, say, painting your living room. The FDA has our health in its hands. But now we are asked to accept fraud by a lab that claimed to be testing our medications. We have a right to know what we are putting into our bodies and the effect this may have as far as science knows. And we have a right to know it now.

The FDA’s mission is simple and clear: all drugs need to be both safe and effective. Withdrawing drugs from the market that do not meet this standard may be difficult, but it must be done. Having served on the FDA Drug Safety and Risk Management Advisory Committee, I know that the FDA exists to protect the public, not the pharmaceutical companies. But now is a moment when the FDA needs to demonstrate that commitment with decisive action.

Read the article on MedShadow here.

 

1. U.S. FOOD AND DRUG ADMINISTRATION. (2024, JUNE 18). NOTIFICATION TO PHARMACEUTICAL COMPANIES: CLINICAL AND BIOANALYTICAL STUDIES CONDUCTED BY SYNAPSE LABS PVT. LTD. ARE UNACCEPTABLE. FDA.

2. U.S. FOOD AND DRUG ADMINISTRATION. (2023, APRIL 21). GENERIC DRUGS. FDA.

3. U.S. FOOD AND DRUG ADMINISTRATION. (2021, MARCH 16). GENERIC DRUGS: QUESTIONS & ANSWERS. FDA.

4. U.S. FOOD AND DRUG ADMINISTRATION. (2024). ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS. FDA.

5. EUROPEAN MEDICINES AGENCY. (2024, JUNE 5). SYNAPSE – REFERRAL. EMA.

6. EUROPEAN MEDICINES AGENCY. (2024). SYNAPSE – ARTICLE 31 REFERRAL: LIST OF MEDICINES CONCERNED BY THE PROCEDURE (ANNEX I). EMA.

7. U.S. FOOD AND DRUG ADMINISTRATION. (2023, APRIL 21). OVERVIEW & BASICS. FDA.

Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs

News Stories & Editorials, We're In the News

Peter Doshi, BMJ, July 1, 2024

During his final three years at the US Food and Drug Administration the physician scientist Doran Fink’s work focused on reviewing covid-19 vaccines. But a decade after joining the agency Fink had accepted a job with Moderna, the covid vaccine manufacturer, and was undergoing mandatory FDA exit requirements. As he left for the private sector, the FDA’s ethics programme staff emailed him guidelines on post-employment restrictions, “tailored to your situation.”

The email, obtained by The BMJ under a freedom of information request, explained that, although US law prohibits a variety of types of lobbying contact, “they do not prohibit the former employee from other activities, including working ‘behind the scenes.’”

The legal ability to work “behind the scenes” is enshrined in federal regulations and highlights a “critical, critical loophole” in US revolving door policy, says a leading consumer advocate. Craig Holman, a government affairs lobbyist for the organisation Public Citizen, told The BMJ that the rules forbid various forms of direct lobbying contact but permit lobbying activity that is indirect.

“So, people will leave government service and can immediately start doing influence peddling and lobbying,” Holman explained. “They can even run a lobbying campaign, as long as they don’t actually pick up the telephone and make the contact with their former officials—and that’s exactly the advice that’s being given here.”

Diana Zuckerman, president of the non-profit National Center for Health Research and a decades long regulatory policy analyst, was surprised to learn of the FDA’s advice. “I guess I had this vision that they actually had meaningful restrictions on what people could do for at least a year” after federal service, she said. Advice given behind the scenes, Zuckerman argues, is precisely “what makes FDA scientists and staff valuable.”

The documents obtained by The BMJ show that the FDA’s advice regarding work done “behind the scenes” was not limited to a single email but appeared several times in emails to Fink and in emails to Jaya Goswami, an FDA medical officer who reviewed Moderna’s covid vaccine before leaving for a position with the manufacturer

[….]

The FDA’s guidance seems to be part of the standard boilerplate advice sent to employees by FDA staff responsible for ethical compliance. It has also been included, since June 2017, on an FDA web page detailing post-employment restrictions.4

Zuckerman finds FDA’s proactive provision of advice on behind-the-scenes work particularly troubling. “I just think that this is the key to the revolving door … It’s one thing to know it happens, and it’s another thing to know that the [FDA] ethics folks are saying, ‘Don’t worry, you can do this.’”

Peter Lurie, president of the Center for Science in the Public Interest in Washington, DC, and former associate commissioner at the FDA, suspects that in providing employees with advice on behind-the-scenes work the FDA ethics staff were simply carrying out their proper function. “It seems to me that the job of the ethics office is to interpret the law for the outgoing person, and that is what they are doing,” he says.

But Lurie expressed concern over the perils of allowing behind-the-scenes work. “It does seem contrary to the public interest that an ex-official would be quarterbacking activities behind the scenes, especially for a ‘particular matter’ on which they had worked. As a practical matter, this policy likely plays out in a way that advances the interests of big pharma, as that’s where many officials head after FDA.”

[….]

Last month US lawmakers introduced bills to amend the law regulating restrictions on departing employees. Both bills seek to prohibit former health sector employees from serving on the boards of manufacturers of drugs, biological products, or devices after public service. [….]  So far, none of the bills have passed.

To read the original BMJ article with footnotes and additional information, click here.

FDA Brings Lab Tests Under Its Oversight

News Stories & Editorials, We're In the News

Judy George, MedPage Today, April 29, 2024

The FDA issued its final rule to regulate laboratory-developed tests (LDTs), the agency said Monday.

LDTs are in vitro diagnostic products (IVDs) designed, manufactured, and used within a single clinical laboratory. They can be used to measure or detect markers like proteins, glucose, cholesterol, or DNA to help provide information about a patient’s health, including diagnosing, monitoring, or determining treatments.

Historically, the FDA has generally exercised enforcement discretion for most LDTs, meaning it has not enforced applicable requirements. LDTs were certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and regulated by the Centers for Medicare & Medicaid Services, which did not require the tests to show clinical validity.

The final rule amends existing regulations and makes explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. It phases out the agency’s enforcement discretion so IVDs manufactured by a lab largely would be treated the same as other IVDs.

“LDTs are being used more widely than ever before — for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s,” FDA Commissioner Robert Califf, MD, said in a statement. “The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work.”

A growing body of evidence indicates that some LDTs raise public health concerns because they don’t provide accurate test results or don’t perform as well as FDA-authorized tests, said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a press conference.

[….]

Comments posted on the agency’s proposed rule helped shape the FDA’s thinking, leading to a 4-year phase-out period of the FDA’s general discretion approach, Shuren pointed out. “After this phase-out, the FDA generally will expect IVDs manufactured by either a non-laboratory or laboratory to meet the same requirements, though certain IVDs manufactured by a laboratory may fall within one of the agency’s target enforcement discretion policies,” he said.

Those discretion policies extend to LDTs that were marketed before the final rule was issued, certain tests that may help meet an unmet need, and LDTs approved by the New York State’s Clinical Laboratory Evaluation Program (CLEP).

The FDA’s final rule was met with mixed reviews. “We strongly support FDA’s decision to regulate lab-developed tests because it is unconscionable that thousands of tests are being used by patients and consumers that have never been evaluated by independent experts to make sure they are accurate,” said Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, D.C.

“Unfortunately, this final rule has compromised on a crucial issue: it ‘grandfathers’ the thousands of tests — some dangerously inaccurate — that are already on the market, rather than requiring them to be proven to accurately diagnose serious medical conditions or genetic vulnerabilities,” Zuckerman told MedPage Today. “The previously proposed version of this LDT rule did not have that giant, deadly loophole — a loophole that was also in the VALID Act that Congress had considered on lab-developed tests.”

Last month, several speakers at a House subcommittee hearing voiced concerns that, if the FDA proposed rule passed, labs would incur significant costs to meet compliance.

[….]

Others saw the final rule today as a step forward. “The FDA is putting patients first by beginning to make many lab test developers prove their tests are accurate and clinically reliable before they are offered for use on patients,” said Patricia Kelmar, JD, of the public advocacy group U.S. PIRG.

[….]

To read the entire article in MedPage Today, click here.

Feds declare turf, rubber playgrounds “generally safe’

News Stories & Editorials, We're In the News

Ellie Borst, Politico E&E NEWS, April 18, 2024

Toxic heavy metals or associated air pollutants from recycled tire crumbs used for synthetic turf and rubber playgrounds “generally” do not put people at risk of illnesses, according to a long-awaited federal report.

A joint effort by EPA, the Centers for Disease Control and Prevention, and the Consumer Product Safety Commission, the report is the first comprehensive study on the risks of harmful chemical exposure on turf fields or rubber playgrounds and comes more than eight years after the three federal agencies first teamed up.

“Although chemicals are present in the tire crumbs, as expected, and exposures can occur, those exposures are likely limited,” Annette Guiseppi-Elie, national program director for EPA’s Chemical Safety for Sustainability research program, said during a webinar Wednesday.

Researchers studied 25 participants, both adults and children, playing on three synthetic turf fields over different durations and temperatures to see if they would be exposed to dangerous levels of chemicals well-known for human health harms.

The report reinforces EPA’s long-held stance that turf or rubber play areas are safe.

Concerns over the issue surfaced decades ago when researchers found the recycled tire crumbs, also a popular infill material for turf fields, contained traces of neurotoxic metals such as lead and zinc. Those concerns ballooned in 2016 following a “60 Minutes” report that aired the stories of former high school football players who said their cancer diagnoses could be traced back to turf fields.

Diana Zuckerman, president for the National Center for Health Research, said the report was “very disappointing” and “not a credible response” to concerns.

“I had hoped this report would be more cautious in saying this is what we know, this is what we don’t know,” Zuckerman said. “When they said this was generally not a problem … it means that most people won’t have a problem, but it doesn’t mean that nobody will have a problem. And it doesn’t mean that hardly anybody will have a problem. We don’t know how many people are playing on these fields that may be vulnerable.”

Melanie Taylor, president and CEO of the Synthetic Turf Council, said the council was “pleased to see it reaffirms what other research has shown: synthetic turf and its system components are safe.”

The report did not measure exposure to “forever chemicals,” or PFAS, a recent point of controversy in the “turf wars” due to the chemicals’ connections to cancer and other serious health effects.

[….]

To read the entire report, click here.

Why journalists should scrutinize the FDA’s accelerated drug approval process

In the News, News Stories & Editorials, We're In the News

Association of Health Care Journalists
Mary Chris Jaklevic
March 7, 2024

Last month, the FDA withdrew its approval of multiple myeloma drug Pepaxto, three years after the medication was okayed under the agency’s accelerated approval program.

Although the move didn’t get much notice, it marked the FDA’s first use of its new authority to stamp out instances in which drugs can maintain their marketing authorization despite little evidence that they help patients.

That nagging problem of ineffective and potentially harmful drugs lingering on the market factored into the intense backlash against the FDA’s greenlighting in 2021 of Aduhelm, a pricy Alzheimer’s drug with worrisome side effects and very weak evidence of clinical benefit.

Reform legislation passed in late 2022 addressed flaws in the accelerated approval pathway, which has been in use since 1992 and accounted for 16% of new drug approvals in 2023. Still, some experts say the new law doesn’t do enough to protect patients.

The upshot is that journalists still need to be diligent about covering the limited evidence on which accelerated approvals are often based.

What the new law does

In exchange for earlier market access for products for serious conditions that address an unmet need, drugmakers promise to conduct post-approval confirmatory studies, with the aim of ultimately converting to traditional approval.

But too often manufacturers fail in their obligation to promptly complete confirmatory studies or get a negative result, resulting in what’s been termed a “dangling” approval.

Until now, it has been difficult for the FDA to rescind an approval, although some drugs are voluntarily withdrawn from the market by their manufacturers.

The new law established clear procedures for the FDA to withdraw accelerated approvals and empowered the agency to require that a confirmatory trial be underway before accelerated approval is granted.

The law also added transparency. If the FDA does not require a post-approval study, it must publish its rationale. Sponsors must submit progress reports on confirmatory research, which the FDA must post online.

[….]

How Congress fell short

The law didn’t take steps to strengthen the evidence base that is required for accelerated approvals, which many advocates would like to see. Opponents of such measures contend that looser standards amount to a trade-off that benefits patients with severe or life-threatening diseases.

[….]

Although the FDA can do some of these things on its own, codifying them in law would protect against legal challenges that are likely if the Supreme Court decides to limit the regulatory powers of federal agencies.

What journalists can do 

It’s up to journalists to inform the public about the quality of evidence on which a drug is approved.

For example, accelerated approvals are typically based on improvement of a biomarker or other surrogate endpoint, but that surrogate may not have been proven to reliably predict a clinical benefit. Such was the case with Aduhelm, which was approved based on its ability to reduce beta-amyloid plaque in the brain, which is not associated with improved cognitive function.

Other problems to highlight in your reporting:

  • The FDA may allow a sponsor to use a surrogate market as its primary endpoint in a confirmatory trial, which means that patients and physicians may never know whether a drug really helps patients live better or longer.
  • The FDA in recent years has largely abandoned the gold standard of two large randomized controlled trials, and may allow trials with no control arm or a small number of patients.

Big-picture issues to follow

The FDA continues to face industry pressure to expand accelerated approvals into areas such as neurological disease and gene therapy.

[….].

News coverage can also focus on how forcefully the FDA wields its new power to jumpstart confirmatory research and rescind approvals.  

The recent withdrawal of Pepaxto was a relatively easy call, said Diana Zuckerman, Ph.D., of the National Center for Health Research, a not-for-profit think tank that focuses on patient safety. By the time the FDA acted, the manufacturer had already pulled Pepaxto off the U.S. market. The reason: confirmatory research showed that rather than helping patients, it shortened their lives. 

Zuckerman said it’s worrisome that Pepaxto was okayed for patients, only to prove dangerous a few months later. With accelerated approval, she said, “There are too many loopholes that have harmed patients.”

To read the entire article, click here Journalists need to scrutinize the FDA’s accelerated drug approvals | Association of Health Care Journalists (healthjournalism.org)