Category Archives: News Stories & Editorials

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

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

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’

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

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)

FDA Warned of Overstepping Authority With Lab Test Rule Proposal

Nyah Phengsitthy, Bloomberg Law, December 7, 2023


Federal efforts to bring laboratory tests to detect Covid-19, blood infections, cancers, and more under FDA authority received intense scrutiny from stakeholders that indicate significant legal hurdles for the final regulation.

The Food and Drug Administration this week faced heavy pushback on its proposed rule (RIN 0910-AI85) that would hand the agency explicit authority to regulate medical tests that come from a single laboratory, also known as lab-developed tests (LDTs). If finalized, the FDA could label LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act, requiring the products to face additional rigorous review before being marketed.

The proposal follows concerns about risks associated with new tests that have entered the market in recent years, according to the FDA. The move also trails Congress’ failure to include provisions in a 2022 year-end spending bill that would have clarified the agency’s authority over LDTs.

Clinical lab groups, academic centers, and members of Congress question the FDA’s power to regulate LDTs. The agency, which received thousands of comments on the rule by the Dec. 4 deadline, seemingly faces a rocky path forward amid litigation threats in the early rulemaking stages.

“The litigation over the LDTs rule has the potential to be the most significant litigation FDA has seen since the legal fight over the regulation of tobacco products in the ‘90s,” said Stacy Cline Amin, a partner at Morrison Foerster and the FDA’s former chief counsel.

“[….]

The FDA’s rule would amend its regulations to make explicit that LDTs are in vitro diagnostics (IVDs) and are devices under the FDCA, including when the manufacturer is a laboratory.

The rule also puts in place a four-year phase-out period on the agency’s general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.

That power shouldn’t be handed to the FDA, the American Clinical Laboratory Association said in its comments.

The association, which represents the nation’s largest commercial reference laboratories such as LabCorp, Quest Diagnostics, and Mayo Clinic, argue the agency should be denied statutory authority and that any expansion of its role should be tailored by Congress.

[….]

The Association for Diagnostics & Laboratory Medicine said LDTs already face regulation under the Centers for Medicare & Medicaid Services’ Clinical Laboratory Improvement Amendments of 1988, along with complementary state laws that interact with CLIA.

But those welcoming the FDA’s rule like the Center for Science in the Public Interest and the National Center for Health Research say that oversight isn’t enough.

“There’s nobody at CMS that’s saying what the sensitivity and specificity is in the test—how many false positives, how many false negatives,” said Diana Zuckerman, president of the National Center for Health Research.

That specific information will determine if a product does more harm than good, or vice versa, Zuckerman said.

“It’s not their job and that’s the kind of information that FDA needs,” she added.

Additional oversight would also ensure health-care providers and patients can rely on accurate tests, proponents say. According to the proposal, many laboratories fail to perform appropriate or adequate validation studies, which has shown data demonstrating their test doesn’t work as intended.

“The results of these mistakes will be people being told that they have diseases that they don’t have, and therefore getting treatments that they don’t need,” said Peter Lurie, president of the Center for Science in the Public Interest.

“If you don’t get the diagnosis, you won’t get the treatment,” said Lurie, who served as the FDA’s former associate commissioner for public health strategy and analysis.

‘Gauntlet’ to Congress

The FDA declining to extend the comment period on the proposal raises speculation that it’s trying to finalize certain rules in advance of the next election cycle, according to some attorneys and industry groups.

The agency’s push comes after its previous failed attempts to move forward with a successful framework to regulate LDTs. In 2014, the agency released a draft guidance that would have set the path forward, but a 2017 white paper from the FDA explained the numerous differences on the framework, which the agency declined to finalize.

[….]

To read the entire article, click here.

Who gets to decide who receives experimental medical treatments?

Jessica Hamzelou, MIT Technology Review, August 10, 2023


Max was only a toddler when his parents noticed there was “something different” about the way he moved. He was slower than other kids his age, and he struggled to jump. He couldn’t run.

Blood tests suggested he might have a genetic disease— one that affected a key muscle protein. Max’s dad, Tao Wang, a researcher for a climate philanthropy organization, says he and his wife were initially in denial. It took them a few months to take Max for the genetic test that confirmed their fears: he had Duchenne muscular dystrophy.

Duchenne is a rare disease that tends to affect young boys. It’s progressive—those affected lose muscle function as they get older. There is no cure. Many people with the disorder require wheelchairs well before they reach their 20s. Most do not survive beyond their 30s.

Max’s diagnosis hit Wang and his wife “like a tornado,” he says. But eventually one of his doctors mentioned a clinical trial that he was eligible for. The trial was for an experimental gene therapy designed to replace the missing muscle protein with a shortened, engineered version that might help slow his decline or even reverse it. Enrolling Max in the trial was a no-brainer for Wang. “We were willing to try anything that could change the course [of the disease] and give us some hope,” he says.

That was more than two years ago. Today, Max is an active eight-year-old, says Wang. He runs, jumps, climbs stairs without difficulty, and even enjoys hiking. “He’s a totally different kid,” says Wang.

The gene therapy he received was recently considered for accelerated approval by the US Food and Drug Administration. Such approvals, reserved for therapies targeting serious conditions that lack existing treatments, require less clinical trial data than standard approvals.

While the process can work well, it doesn’t always. And in this case, the data is not particularly compelling. The drug failed a randomized clinical trial—it was found to be no better than a placebo.

Still, many affected by Duchenne are clamoring for access to the treatment. At an FDA advisory committee meeting in May set up to evaluate its merits, multiple parents of children with Duchenne pleaded with the organization to approve the drug immediately—months before the results of another clinical trial were due. On June 22, the FDA granted conditional approval for the drug for four- and five-year-old boys.

Between 2009 and 2022, 48 cancer drugs received accelerated approval to treat 66 conditions—and 15 of those approvals have since been withdrawn.

This drug isn’t the only one to have been approved on weak evidence. There has been a trend toward lowering the bar for new medicines, and it is becoming easier for people to access treatments that might not help them—and could harm them. Anecdotes appear to be overpowering evidence in decisions on drug approval. As a result, we’re ending up with some drugs that don’t work.

[….]

Expanding access

There’s a difficult balance to be reached between protecting people from the unknown effects of a new treatment and enabling access to something potentially life-saving. Trying an experimental drug could cure a person’s disease. It could also end up making no difference, or even doing harm. And if companies struggle to get funding following a bad outcome, it could delay progress in an entire research field—perhaps slowing future drug approvals.

In the US, most experimental treatments are accessed through the FDA. Starting in the 1960s and ’70s, drug manufacturers had to prove to the agency that their products actually worked, and that the benefits of taking them would outweigh any risks. “That really closed the door on patients’ being able to access drugs on a speculative basis,” says Christopher Robertson, a specialist in health law at Boston University.

It makes sense to set a high bar of evidence for new medicines. But the way you weigh risks and benefits can change when you receive a devastating diagnosis. And it wasn’t long before people with terminal illnesses started asking for access to unapproved, experimental drugs.

[….]

Today, there are lots of ways people might access experimental drugs on an individual basis. Perhaps the most obvious way is by taking part in a clinical trial. Early-stage trials typically offer low doses to healthy volunteers to make sure new drugs are safe before they are offered to people with the condition the drugs are ultimately meant to treat. Some trials are “open label,” where everyone knows who is getting what. The gold standard is trials that are randomized, placebo controlled, and blinded: some volunteers get the drug, some get the placebo, and no one—not even the doctors administering the drugs—knows who is getting what until after the results have been collected. These are the kinds of studies you need to do to tell if a drug is really going to help people.

But clinical trials aren’t an option for everyone who might want to try an unproven treatment. Trials tend to have strict criteria about who is eligible depending on their age and health status, for example. Geography and timing matter, too—a person who wants to try a certain drug might live too far from where the trial is being conducted, or might have missed the enrollment window.

Instead, such people can apply to the FDA under the organization’s expanded access program, also known as “compassionate use.” The FDA approves almost all such requests. It then comes down to the drug manufacturer to decide whether to sell the person the drug at cost (it is not allowed to make a profit), offer it for free, or deny the request altogether.

Another option is to make a request under the Right to Try Act. The law, passed in 2018, establishes a new route for people with life-threatening conditions to access experimental drugs—one that bypasses the FDA. Its introduction was viewed by many as a political stunt, given that the FDA has rarely been the barrier to getting hold of such medicines. Under Right to Try, companies still have the choice of whether or not to provide the drug to a patient.

When a patient is denied access through one of these pathways, it can make headlines. “It’s almost always the same story,” says Alison Bateman-House, an ethicist who researches access to investigational medical products at New York University’s Grossman School of Medicine. In this story, someone is fighting for access to a drug and being denied it by “cold and heartless” pharma or the FDA, she says. The story is always about “patients valiantly struggling for something that would undoubtedly help them if they could just get to it.”

But in reality, things aren’t quite so simple. When companies decide not to offer someone a drug, you can’t really blame them for making that decision, says Bateman-House. After all, the people making such requests are usually incredibly ill. If someone were to die after taking that drug, not only would it look bad, but it could also put off investors from funding further development. “If you have a case in the media where somebody gets compassionate use and then something bad happens to them, investors run away,” says Bateman-House. “It’s a business risk.”

FDA approval of a drug means it can be sold and prescribed—crucially, it’s no longer experimental. Which is why many see approval as the best way to get hold of a promising new treatment.

As part of a standard approval process, which should take 10 months or less, the FDA will ask to see clinical trial evidence that the drug is both safe and effective. Collecting this kind of evidence can be a long and expensive process. But there are shortcuts for desperate situations, such as the outbreak of covid-19 or rare and fatal diseases—and for serious diseases with few treatment options, like Duchenne.

Anecdotes vs. evidence 

Max accessed his drug through a clinical trial. The treatment, then called SRP-9001, was developed by the pharmaceutical company Sarepta and is designed to replace dystrophin, the protein missing in children with Duchenne muscular dystrophy. The protein is thought to protect muscle cells from damage when the muscles contract. Without it, muscles become damaged and start to degenerate.

The dystrophin protein has a huge genetic sequence—it’s too long for the entire thing to fit into a virus, the usual means of delivering new genetic material into a person’s body. So the team at Sarepta designed a shorter version, which they call micro-dystrophin. The code for the protein is delivered by means of a single intravenous infusion.

The company planned to develop the therapy to treat patients with Duchenne who could still walk. And it had a way to potentially fast-track the approval process.

Usually, before a drug can be approved, it will go through several clinical trials. But accelerated approval offers a shortcut for companies that can show that their drug is desperately needed, safe, and supported by compelling preliminary evidence.

For this kind of approval, drug companies don’t need to show that a treatment has improved anyone’s health—they just need to show improvement in some biomarker related to the disease (in Sarepta’s case, the levels of the micro-dystrophin protein in people’s muscle).

There’s an important proviso: the company must promise to continue studying the drug, and to provide “confirmatory trial evidence.”

This process can work well. But in recent years, it has been a “disaster,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit that assesses research on health issues. Zuckerman believes the bar of evidence for accelerated approval has been dropping. 

Many drugs approved via this process are later found ineffective. Some have even been shown to leave people worse off. For example, between 2009 and 2022, 48 cancer drugs received accelerated approval to treat 66 conditions—and 15 of those approvals have since been withdrawn.

Melfulfen was one of these. The drug was granted accelerated approval for multiple myeloma in February 2021. Just five months later, the FDA issued an alert following the release of trial results suggesting that people taking the drug had a higher risk of death. In October 2021, the company that made the drug announced it was to be taken off the market.

There are other examples. Take Makena, a treatment meant to reduce the risk of preterm birth. The drug was granted accelerated approval in 2011 on the basis of results from a small trial. Larger, later studies suggested it didn’t work after all. Earlier this year, the FDA withdrew approval for the drug. But it had already been prescribed to hundreds of thousands of people—nearly 310,000 women were given the drug between 2011 and 2020 alone.

And then there’s Aduhelm. The drug was developed as a treatment for Alzheimer’s disease. When trial data was presented to an FDA advisory committee, 10 of 11 panel members voted against approval. The 11th was uncertain. There was no convincing evidence that the drug slowed cognitive decline, the majority of the members found. “There was not any real evidence that this drug was going to help patients,” says Zuckerman.

Despite that, the FDA gave Aduhelm accelerated approval in 2021. The drug went on the market at a price of $56,000 a year. Three of the committee members resigned in response to the FDA’s approval. And in April 2022, the Centers for Medicare & Medicaid Services announced that Medicare would only cover treatment that was administered as part of a clinical trial. The case demonstrates that accelerated approval is no guarantee a drug will become easier to access.

The other important issue is cost. Before a drug is approved, people might be able to get it through expanded access—usually for free. But once the drug is approved, many people who want it will have to pay. And new treatments—especially gene therapies—don’t tend to be cheap. We’re talking hundreds of thousands, or even millions, of dollars. “No patient or families should have to pay for a drug that’s not proven to work,” says Zuckerman.

What about SRP-9001? On May 12, the FDA held an advisory committee meeting to assess whether the data supported accelerated approval. During the nine-hour virtual meeting, scientists, doctors, statisticians, ethicists, and patient advocates presented the data collected so far, and shared their opinions.

Sarepta had results from three clinical trials of the drug in boys with Duchenne. Only one of the three—involving 41 volunteers aged four to seven—was randomized, blinded, and placebo controlled.

Scientists will tell you that’s the only study you can draw conclusions from. And unfortunately, that trial did not go particularly well—by the end of 48 weeks, the children who got the drug were not doing any better than those who got a placebo.

But videos presented by parents whose children had taken the drug told a different story.

[….]

But the difference is not statistically significant for the results the trial was designed to collect. And there are some safety concerns. While most of the boys developed only “mild” side effects, like vomiting, nausea, and fever, a few experienced more serious, although temporary, problems. There were a total of nine serious complications among the 85 volunteers. One boy had heart inflammation. Another developed an immune disease that damages muscle fibers.

On top of all that, as things currently stand, receiving one gene therapy limits future gene therapy options. That’s because the virus used to deliver the therapy causes the body to mount an immune response. Many gene therapies rely on a type called adeno-associated virus, or AAV. If a more effective gene therapy that uses the same virus comes along in the coming years, those who have taken this drug won’t be able to take the newer treatment.

Despite all this, the committee voted 8–6 in favor of granting the drug an accelerated approval. Many committee members highlighted the impact of the stories and videos shared by parents like Brent Furbee.

“Now, I don’t know whether those boys got placebo or whether they got the drug, but I suspect that they got the drug,” a neurologist named Anthony Amato told the audience.

“Those videos, anecdotal as they are … are substantial evidence of effectiveness,” said committee member Donald B. Kohn, a stem-cell biologist.

The drugs don’t work?

Powerful as they are, individual experiences are just that. “If you look at the evidentiary hierarchy, anecdote is considered the lowest level of evidence,” says Bateman-House. “It’s certainly nowhere near clinical-trial-level evidence.”

This is not the way we should be approving drugs, says Zuckerman. And it’s not the first time Sarepta has had a drug approved on the basis of weak evidence, either. 

The company has already received FDA approval to sell three other drugs for Duchenne, all of them designed to skip over faulty exons—bits of DNA that code for a protein. Such drugs should allow cells to make a longer form of a protein that more closely resembles dystrophin.

The first of these “exon-skipping” drugs, Exondys 51, was granted accelerated approval in 2016—despite the fact that the clinical trial was not placebo controlled and included only 12 boys. “I’ve never seen anything like it,” says Zuckerman. She points out that the study was far too small to be able to prove the drug worked. In her view, 2016 was “a turning point” for FDA approvals based on low-quality evidence—“It was so extreme,” she says.

[….]

But for many in the scientific community, that data still needs to be confirmed. “The clinical benefit still has not been confirmed for any of the four,” Mike Singer, a clinical reviewer in the FDA’s Office of Therapeutic Products, told the advisory committee in May.

“All of them are wanted by the families, but none of them have ever been proven to work,” says Zuckerman.  

[….]

Selling hope

On June 22, just over a month after the committee meeting, the FDA approved SRP-9001, now called Elevidys. It will cost $3.2 million for the one-off treatment, before any potential discounts. For the time being, the approval is restricted to four- and five-year-olds. It was granted with a reminder to the company to complete the ongoing trials and report back on the results.

[….]

Doctors may end up agreeing that a drug—even one that is unlikely to work—is better than nothing. “In the American psyche, that is the approach that [doctors and] patients are pushed toward,” says Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania. “We have all this language that you’re ‘fighting against the disease,’ and that you should try everything.”

“I can’t tell you how many FDA advisory committee meetings I’ve been to where the public-comment patients are saying something like ‘This is giving me hope,’” says Zuckerman. “Sometimes hope helps people do better. It certainly helps them feel better. And we all want hope. But in medicine, isn’t it better to have hope based on evidence rather than hope based on hype?”

A desperate decision

A drug approved on weak data might offer nothing more than false hope at a high price, Zuckerman says: “It is not fair for patients and their families to [potentially] have to go into bankruptcy for a drug that isn’t even proven to work.” 

The best way for people to access experimental treatments is still through clinical trials, says Bateman-House. Robertson, the health law expert, agrees, and adds that trials should be “bigger, faster, and more inclusive.” If a drug looks as if it’s working, perhaps companies could allow more volunteers to join the trial, for example.

Their reasoning is that people affected by devastating diseases should be protected from ineffective and possibly harmful treatments—even if they want them. Review boards assess how ethical clinical trials are before signing off on them. Participants can’t be charged for drugs they take in clinical trials. And they are carefully monitored by medical professionals during their participation.

That doesn’t mean people who are desperate for treatments are incapable of making good decisions. “They are stuck with bad choices,” says Fernandez Lynch.

To read the entire article, see here 

 

A Special Report: Can Breast Implants Cause Chronic Disease?

Julia Halpert, HealthCentral: October 25, 2022

With new FDA warnings, troubling research, and a growing online population sharing stories and symptoms, experts and women with implants weigh in.

JENNIFER JOHNSON, 43, of Wilcox, NE, underwent a preventative double-mastectomy—a surgical procedure that removes all tissue from both breasts—in July 2008 at age 29 after learning she carried the BRCA2 genetic mutation.

Research shows that having BRCA2 increases risk of developing breast cancer (BC) by 45%. Johnson’s family history didn’t make her keen to play the odds: Her mother died from the disease at 34, as did her sister Debbie at 39, while another sister, Valerie, was diagnosed with BC in her 40s and, thankfully, is still here. After Johnson’s doctor told her that her own chances of facing a similar fate were exceedingly high, she chose the double-mastectomy as the safer bet.

The surgery didn’t spare her, however. A post-op pathology report found that Johnson already had an aggressive type of breast cancer (“stage 1, triple-negative, grade 3”) in her right breast that required immediate treatment.

Her plastic surgeon was “adamant,” she says, that she get breast implants to return her body to normal, since she was so young. She got silicone implants on her 30th birthday. Within several months, she began experiencing intermittent, aching pain in her muscles and joints, as well as “shooting, stabbing pains” in her chest, she reports. She also battled rashes and severe fatigue. “I basically felt like I was dying a slow death, like my body was just giving out slowly over time,” she recalls.

A team of specialists told her nothing was wrong. But her symptoms continued—leaving her distraught. After four years of this, she had her implants removed (known as explant surgery). To her great relief, “I started feeling better right away,” she says. “Every single symptom disappeared within a year.”

Johnson is among those who have experienced what’s colloquially known as breast implant illness (BII), when significant health issues—fatigue, chest pain, hair loss, headaches, chills, photosensitivity, rash, chronic joint pain, among other symptoms—arise after getting implants.

[….]

We asked women who’ve undergone reconstruction or done elective breast implant surgery to share their experiences. We also polled breast health experts on their thoughts about this popular cosmetic surgery being done in the U.S. and around the world—and its potential implications for the chronic community.

SAFETY CONCERNS

Are Breast Implants Safe? Or Not?

In October 2021, the FDA issued new restrictions for breast implants, including a mandated box warning on the product label to inform patients of significant health risks, such as an increased cancer risk; a checklist of items that health care providers should discuss with patients as they consider implants; updated silicone gel-filled breast implant rupture screening recommendations; and a list of specific materials used to create the implant.

Then, this past September, the FDA issued a safety communication following reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas in the scar tissue that had formed around breast implants, noting that “currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown.” A spokesperson for the agency added, “The FDA recognizes that many patients’ symptoms may take years to develop, and patients may not be aware of the risk of SCC … We will keep the public informed as significant new information becomes available about SCC and lymphoma variants in the breast implant capsule.”

[….]

PATIENT REPORTS

Implants Remain Popular, Yet Some Patients Suffer

Safety issues haven’t dimmed enthusiasm for breast implants. According to a 2020 report by the American Society of Plastic Surgeons (ASPS), there were 137,808 implants provided for breast reconstruction and 193,073 for cosmetic surgery in this country alone. Silicone implants were used in 84% of breast augmentations, while saline implants were used in 16% of such procedures in 2020.

Mark Clemens, M.D., a professor of plastic surgery at MD Anderson in Houston, TX, who has led several MD Anderson-based safety studies on breast implants, says the recent FDA communication shouldn’t alter the perception of breast implant safety. He believes that it was done out of abundance of caution to inform, not frighten, women. When it comes to breast implants, “the vast majority of women will be completely healthy [after getting them] and won’t have any issues,” he says. However, he urges women who notice any signs of abnormality—asymmetry between breasts, the firming of a breast, or a palpable mass or a fluid collection—to consult a physician to ensure there’s nothing wrong.

Diana Zuckerman, Ph.D., president of the National Center for Health Research, a Washington, D.C.-based nonprofit organization that draws from scientific studies to improve public policy and medical oversight in the U.S., believes more independent research is required before an accurate safety assessment can be made. She says that nearly all the research being done on breast implant safety has been conducted by the very hospitals and plastic surgery organizations that either offer reconstruction and elective implant procedures as a service, or represent the surgeons who are paid to perform them—a big source of revenue and conflict of interest, leaving troubling questions of inherent bias being baked into the results.

“I can’t emphasize enough how much resistance there has been from the plastic surgeons’ medical societies and the implant manufacturers” to doing more and better research on implants, Zuckerman says. While some plastic surgeons have vocalized their concerns over the need for better information for their patients, “the medical societies—the major sources of information that FDA officials rely on—have been vehemently opposed,” she reports. “Their usual mantras are some variation of ‘breast implants are the most studied medical device in history’; hundreds of studies prove they are very safe’; and ‘so-called breast implant illness symptoms are common symptoms caused by aging and other factors, not by the implants.’” Implant manufacturers say the same thing—not coincidentally, Zuckerman adds.

Nicole Daruda, age 58 and living in Vancouver Island in Canada, openly doubts the industry’s safety claims. “Breast implants are linked to autoimmune symptoms and diseases and many other health problems,” she maintains. Daruda got cohesive gel implants in 2005 and saw her once excellent health “decimated by breast implants.” Within the first few years of having them she says she experienced fatigue, brain fog, various infections, food allergies, and hypothyroidism, with more symptoms appearing each year.

Daruda had her implants removed in 2013, and within four years she says all of her symptoms resolved. She started the Facebook group, Breast Implant Illness and Healing by Nicole, in April 2015 to provide a forum for women experiencing health issues after having implants to support and talk to each other. The group now has more than 170,000 members. Daruda says that she’s heard from thousands of women on her social media platform who report their health has improved after getting their implants removed.

[….]

IMPLANTS AND LYMPHOMA

What You Need to Know About Lymphoma

According to the FDA, as of September 2020, more than 700 people worldwide have been diagnosed with breast implant-associated anaplastic large cell lymphoma, an uncommon cancer. The agency found that the women with textured breast implants have a small but increased risk of developing this disease. The working theory, Dr. Glasberg explains, is that the texturing on the implant drives inflammation, which causes a change in the capsule around the implant that then develops into lymphoma.

Despite his belief that breast implants are safe for the vast majority of women, Dr. Clemens authored a 2021 study that examined eight cases of Epstein–Barr virus-positive large B-cell lymphoma associated with breast implants “and we’ve been trying to understand these better,” he says. (The eight women in the study were all patients at MD Anderson, a medical center that offers breast reconstruction and elective breast implant surgery, who were among the 30 known cases in the world of this type of lymphoma, per the FDA tally.) Increased awareness, combined with more pathology testing of scar tissue, plus physicians and patients being aware of breast implant-associated issues has “drawn our attention to looking for these other diseases,” he says.

IMPLANTS AND AUTOIMMUNE DISEASE

Breast Implants and Autoimmune Disease

Autoimmune issues arise when the body mistakenly attacks its own healthy tissue, causing damaging inflammation and often chronic pain and fatigue, among other symptoms, some of them disabling and/or permanent.

In 2018, MD Anderson conducted the largest study to date to explore long-term safety outcomes of breast implants, finding an association, though not a causation, with some rare diseases, including the autoimmune disorders Sjögren’s syndrome, rheumatoid arthritis (RA), and scleroderma. What’s more, researchers in the Netherlands found that more than two-thirds of women with autoimmune symptoms who had their breast implants removed experienced a reduction in symptoms.

That same year an Israeli study—research that Zuckerman says is both independent and well-designed—compared more than 24,000 breast implant patients to more than 98,000 women without breast implants but who shared similar demographic traits and reported a 22% increase in several autoimmune and rheumatic disorders, as diagnosed by their physicians and reported in their medical records. In addition, the same study reported a 60% increased risk of Sjögren’s syndrome, multiple sclerosis (MS), and sarcoidosis among those with implants, as well.

Dr. Clemens, the principal investigator of the large MD Anderson study, points out that some of those diseases in his study were self-reported by study participants, and not necessarily diagnosed by a physician—a limitation of the research. He doesn’t believe the findings are cause for concern. “The vast majority of patients with implants do not experience these symptoms or diseases,” he says. “However, it is important that they are aware of these conditions so that if they note any changes or have concerns, they can discuss with their treating physician.”

Then again, a 2021 study on breast implants and respiratory health found that 74% of participants who had their breast implants removed showed significant improvements on at least three of the six pulmonary function tests performed—an objective, not self-reported, medical tool.

For her part, Zuckerman notes that research is often funded by implant manufacturers and used to argue that breast implant illness is not real. A major weakness of most BII studies, a report by her organization found, is that they evaluate only diagnosed diseases. The reason why women decide to have their implants surgically removed and not replaced, she explains, is often due to symptoms of autoimmune and connective tissue diseases, rather than official diagnoses.

“The women and their doctors often report a constellation of symptoms that do not fit the exact criteria of known diseases,” she explains, adding that most people aren’t hospitalized for the autoimmune issues most associated with BII. Without symptoms that perfectly fit a specific diagnosis, many women will not have a diagnosis logged into medical records.

[….]

REMOVING YOUR IMPLANTS

Can Implant Removal Mean a Return to Health?

Some women, who can find no other explanation for their symptoms, like Johnson, are having their implants removed. In 2020, 22,676 explants were performed on reconstruction patients in the U.S., per the ASPS. Johnson says she was forced to find a different plastic surgeon to perform the procedure, since the one who put them in didn’t believe they caused health issues.

“He stood back looking at my chest and said, ‘I did an amazing job on those and really don’t want to take them out,’” she recalls.

[….]

Zuckerman believes the health rebound after explant surgery may be higher than the plastic surgery industry acknowledges. Since 2015, her organization has been contacted by more than 4,500 women who had breast implants they wanted removed due to rupture, breast pain, or medical symptoms caused, they believed, by their implants. NCHR was asked to advocate with health insurance companies, Medicare, and Medicaid to cover the costs of implant removal, she adds, since many of the women could not afford explant surgery.

[….]

To read the entire article, click here.

Opinion: Are Turf Fields a Safe Place for Kids to Play in Westfield?

Dr. Diana Zuckerman, PH.D, Tap into Westfield: September 12, 2022


As a mother, I used to think that artificial turf and rubber playground surfaces were a clever and attractive alternative to grass fields. As a scientist, however, I learned that my children were being exposed to unsafe chemicals without my knowledge or consent.  I recently wrote to the mayor, superintendent of schools and members of the Westfield Town Council and Board of Education to share scientific information about artificial turf and playground surfaces. I want to provide the same information to you, so you can determine what is best for Westfield.

As president of the National Center for Health Research, I have testified about these products to local, state and federal agencies and legislators; parents; and others who want to ensure that our children are not exposed to dangerous chemicals that can harm them now or as they grow up. Our nonprofit think tank includes scientists, physicians and health experts who conduct studies and scrutinize research conducted by others. We explain scientific and medical information that can be used to improve policies, programs, services and products.

Toxic Chemicals in Artificial Turf and Infill Materials

In recent years, scientists have learned about lead and PFAS in artificial turf, as well as the risks of some of the newer infill materials that are available to replace tire crumb and that are used in rubber playground surfaces. Tire crumb and rubber have well-known risks, containing chemicals that increase obesity; contribute to early puberty; cause attention problems such as ADHD; exacerbate asthma; and eventually cause cancer. However, the plastic grass itself has dangerous levels of lead, PFAS, and other toxic chemicals as well.

PFAS are of particular concern because they enter the body and the environment as “forever chemicals.” They are not metabolized and do not deteriorate, accumulating over the years. PFAS can cause liver damage and other serious health problems.  PFAS from artificial turf can get into groundwater, streams, etc. and from there into drinking water. New Jersey has one of the most stringent standards for PFAS in drinking water.

Replacing tire waste with silica, zeolite and other infill materials also has substantial risks.  For example, it is well known that “particulate matter” can cause lung problems and eventually cause lung cancer.

Evidence of Harm vs. Evidence of Safety

Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, hormone-disrupting chemicals (found in artificial turf and plastic) can be dangerous at very low levels, and also when they combine with other exposures in our environment.  That is why the U.S. Consumer Product Safety Commission has banned these chemicals from toys, pacifiers, teething toys and other products used by young children.

Companies that sell and install artificial turf often claim there is “no evidence children are harmed” or “no evidence that the fields cause cancer.” This is often misunderstood as meaning the products are safe or are proven to not cause harm. Neither is true.

It is true that there no clear evidence that an artificial turf field has caused specific children to develop cancer. However, the statement is misleading because it is virtually impossible to prove any chemical exposure causes one specific individual to develop cancer.

As an epidemiologist, I can tell you that for decades there was no evidence that smoking or 9/11 exposures caused cancer. It took many years to develop that evidence, and the same will be true for artificial turf.

We know that the materials used in artificial turf and rubber playground surfaces contain carcinogens.  When children are exposed to those carcinogens day after day, week after week, and year after year, it increases the chances of our children developing cancer, either in the next few years or later as adults. That should be adequate reason not to install them in your community.

I grew up in New Jersey and know that when the weather is warm and/or sunny, it is usually quite pleasant to be outside. But when the temperature above the grass is 80 degrees Fahrenheit, artificial turf and rubber playground surfaces can reach 150 degrees or higher. A sunny 90-degree day could exceed 160 degrees on these surfaces. These temperatures can cause “heat poisoning” as well as burns.

Bottom Line

There have never been any safety tests required prior to sale that prove that any artificial turf products are safe for children who play on them regularly. In many cases, the materials used are not publicly disclosed, making independent research difficult to conduct. None of these products are proven to be as safe as natural grass in well-constructed fields.

Officials in communities all over the country have been misled by artificial turf salespeople and scientists hired to lobby. They were erroneously told that these products are safe. On the contrary, there is clear scientific evidence that these materials are harmful. The only question is how much exposure is likely to be harmful to which children? We should not be willing to take such a risk. Our children deserve better.

I am not paid to write to you or to speak at meetings on this topic. I do so because I care about the health of my children and yours.

To read the entire op-ed on the Tap on Westfield website, click here.

Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust

Celine Castronuovo and Jeannie Baumann, Bloomberg Law, August, 26, 2022


A House report detailing coordinated attempts by Trump White House officials to influence the FDA’s pandemic response underscores the need for more transparency at an agency that’s facing historically low public trust, health policy analysts say.

The House Select Subcommittee on the Coronavirus Crisis said this week that advisers to former President Donald Trump sought to build support for hydroxychloroquine as a Covid-19 treatment, despite limited evidence on its efficacy. The report serves as a reminder of how allegations of behind-the-scenes political pressure can influence the public’s perception of federal health agencies’ independence.

“When things are happening behind closed doors, it’s easier for people to try to mess with the FDA,” said Joshua M. Sharfstein, who served as the FDA’s second-in-command during the first two years of the Obama administration.

“The more transparent FDA is, the harder it is for someone to come in and try to interfere with decisions,” he added.

The report comes as positive ratings of the US public health system dropped by nearly 10 percentage points over the past decade, according to a May 2021 joint study by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Former federal officials and policy watchers say the FDA must maintain transparency in decision making to prevent external influence, especially as the agency oversees several ongoing health priorities—including authorization requests for omicron-specific Covid-19 vaccines and responses to the growing monkeypox outbreak.

The latest findings have garnered mixed reactions, with some policy watchers saying it shows the FDA defended scientific evidence in the face of efforts to politicize health policy. Others say any reports of attempted political interference is damaging to public trust in the FDA and other agencies.

FDA Commissioner Robert M. Califf has said he will make combating health misinformation a priority of his tenure. And “throughout the pandemic, the FDA career staff has worked around-the-clock to make the best, science-based decisions on behalf of the American people in a rapidly evolving and unprecedented public health emergency,” agency spokesman Michael Felberbaum said in an emailed statement.

Building Resiliency

The subcommittee’s document, which also alleges efforts to promote convalescent plasma as a Covid-19 treatment ahead of the 2020 Republican National Convention, marks the second in a series unveiling findings from an investigation into Trump administration interference with federal health agency pandemic responses.

Many of the Trump administration’s alleged attempts to interfere happened behind closed doors, though the report found the FDA stood up to pressure to keep hydroxychloriquine around after data showed it lacked efficacy as a Covid-19 treatment. The FDA authorized the drug in March 2020 as a treatment for certain hospitalized Covid-19 patients. It revoked the emergency use authorization in June 2020.

Meanwhile, the FDA muscled guidance past the White House that made clear the agency wouldn’t let politics tamper with its decisions, all while facing pressure to authorize vaccines before the 2020 election.

Former FDA Commissioner Stephen Hahn said in an interview with the subcommittee that chief of staff Mark Meadows and other White House officials had “objections” to vaccine guidance language requiring that manufacturers submit at least two months of follow-up safety data for late-stage clinical trials. Hahn said he resisted attempts to change the guidance because “any changes would be obviously reported and would further reduce vaccine confidence.”

[….]

Fighting Misinformation

Califf’s efforts to highlight the dangers of the pandemic’s rise in health misinformation is one way to rebuild public trust in the FDA, although the overall effort will be a challenge, policy analysts say.

“There are some people for whom I think it will be difficult, if not impossible, to regain their trust,” Diana Zuckerman, president of the National Center for Health Research and a former senior policy adviser to the Clinton White House, said. “It’s not really that much the fault of anything that the FDA did; it’s the fault of the misinformation they’re getting from news sources or social media.”

Califf wrote in an Aug. 22 article in the Journal of the American Medical Association that “the global information environment has been contaminated by misinformation and disinformation.”

“The FDA must be more proactive in preempting and countering misinformation,” he said, adding that there’s also a need for “collaboration across sectors to create an information environment in which decisions” by “consumers, patients, and clinicians are more likely to be informed by reliable information based on high-quality evidence from trustworthy sources.”

Zuckerman argued that “Commissioner Califf has made it clear that he will not let the FDA’s reputation be undermined by misinformation.”

“He’s not going to have a political hack telling him what to do or say, and he’s shown a commitment to focusing on the science and protecting the reputation of the FDA,” she said.

To read the entire article, click here.

Toxic chemicals lurk at playgrounds

Ariel Wittenberg, E&E News: July 8, 2022


When Diana Zuckerman was growing up, there was dirt underneath the slides. Her children played on playgrounds placed atop sand and mulch. But, today, when she drives around her Bethesda, Md., neighborhood, Zuckerman sees [many] rubber playgrounds.

The sight concerns Zuckerman, because as president for the National Center for Health Research she has testified in front of multiple municipal and even state governments about the toxic chemicals that can lurk in rubber playground surfaces.

The chemicals can include neurotoxins like lead and other heavy metals, as well as carcinogenic chemicals like polyaromatic hydrocarbons, endocrine-disrupting chemicals like phthalates, and chemicals linked to other organ damage like volatile organic compounds and PFAS, or per- and polyfluoroalkyl substances.

“All these rubber surfaces, they can be very pretty, and when you know nothing, you think it’s great because if my child fell on it, it is so spongy and pretty and safe,” she said. “But we actually don’t believe that it’s safe from the chemical exposure perspective.”

Concerns about modern playground surfaces were first raised decades ago, when recycled tire crumb rubber became a popular playground surface. The recycled tires often contained lead and other heavy metals, and public health experts were especially concerned that using the bite-sized material on playgrounds could unnecessarily expose small children, particularly toddlers, who are prone to putting objects in their mouths.

Nowadays, many municipalities searching for new playground surfaces know enough to stay away from tire crumb rubber.

But many continue to install what’s called “pour in place” rubber, flat, spongy rubber surfaces that can contain other chemicals of concern, like polyaromatic hydrocarbons, phthalates, and volatile organic compounds. Those more solid rubber surfaces can also contain additives and binders that could harm the health of children, though the exact chemicals vary by manufacturer.

Artificial turf, long-popular on athletic fields, has also been marketed as a playground surface. Some PFAS are used to manufacture the plastic grass blades (Greenwire, Dec. 8, 2021).

Sarah Evans, an assistant professor of environmental medicine and public health at Mount Sinai Hospital in New York City, says those poured in place rubber playgrounds still pose exposure risks to kids. Children could pick up chemicals on their hands as they play and then accidentally ingest them when they eat meals or snacks at the playground.

“We are very concerned about that,” she said. “And we don’t have a good handle of what is in those products.”

Indeed, the exact risks rubberized playgrounds pose to children are unknown, in part because the federal government’s efforts to investigate the issue have been stalled by both the Trump administration and the coronavirus pandemic.

In 2016 EPA completed a report looking specifically at tire crumb rubber playgrounds meant only to explain the best ways to test such surfaces for chemicals. A second report meant to characterize potential human exposure to tire crumb rubber has never been released.

[….]

In the absence of federal action, industry has continued to say that all playground surfacing options are safe.

[….]

Evans, at Mount Sinai, said she also hears from parents who are concerned that their cities and towns have already installed rubber playgrounds.

Playing outside, even on a rubber playground, can be very important for kids’ development. So, rather than eschew the playground altogether, Evans recommends that parents be extra vigilant if their children play on rubberized surfaces and make sure hands are washed before children eat or as soon as they get home. Kids who play on crumb rubber should shake out their clothes and change when they come home.

 To read the entire article, click here.