All posts by CPTFadmin

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

July 23, 2024News Stories & Editorials, We're In the NewsCPTFadmin

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

July 1, 2024News Stories & Editorials, We're In the NewsCPTFadmin

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.

CPTF Testimony at the FDA Listening Session on Advisory Committee Meetings

June 13, 2024Policy, Testimony & BriefingsCPTFadmin

June 13, 2024

Hello, my name is Laura Lytle. I am the Health Policy Director for the National Center for Health Research (NCHR), a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies, treatments, and products are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

I am grateful for the time today to share NCHR insights on the composition of FDA Advisory Committees. It’s crucial to ensure that these committees are composed of individuals who can provide objective, science-based recommendations. Here are our key areas of concern:

Consumer Representatives: Some consumer representatives lack the necessary scientific expertise to effectively analyze data and critique research design. Additionally, some may have affiliations with industry or products under review, which could lead to conflicts of interest. It’s essential to ensure that consumer representatives truly represent the consumer perspective and possess the required scientific competence. According to FDA guidance, candidates for these positions should meet two criteria: the ability to analyze scientific data and critique research design, and an affiliation with and active participation in independent consumer and community-based organizations, or a history of advocating for the public interest. Many consumer representatives selected would be better suited for positions as patient or industry representatives because they lack the necessary ability to analyze scientific data and critique research design, and many have strong ties to industry or the products they are reviewing. This can lead to conflicts of interest or an inability to make decisions in a scientifically neutral manner.

Financial Conflicts of Interest: The current FDA policy on conflicts of interest is too narrow, allowing individuals with recent financial ties to the industry they are reviewing to serve on Advisory Committees. Transparent disclosure of all financial ties to the company whose product is crucial to maintaining objectivity and trust.

Thank you for your dedication to this important issue and for your time today.

Test page

May 20, 2024UncategorizedCPTFadmin

Cover for Cancer Prevention and Treatment Fund

620

Cancer Prevention and Treatment Fund

The Cancer Prevention and Treatment Fund is saving lives everyday through research, help, and hope. http://www.cancer5k.com

This message is only visible to admins.
Problem displaying Facebook posts.
Click to show error

Error: No posts available for this Facebook ID

FDA Brings Lab Tests Under Its Oversight

April 29, 2024News Stories & Editorials, We're In the NewsCPTFadmin

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.

Testimony of Dr. Diana Zuckerman at the Tobacco Products Scientific Advisory Committee Meeting on General Snus

April 27, 2024Policy, Testimony & BriefingsCPTFadmin

June 26, 2024

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our center is a nonprofit public health think tank that scrutinizes the safety and effectiveness of medical and consumer products, and we don’t accept funding from companies that make those products. Our largest program focuses on cancer prevention and treatment.

Thank you for the opportunity to share my views today. My expertise is based on my current work as well as my post-doc training in epidemiology and public health, and as a former faculty member and researcher at Yale and Harvard. I’ve also previously served as professional staff in the US House of Representatives and US Senate, at the Dept of Health and Human Services, and the White House. I’m a founding Board member of the nonprofit Alliance for a Stronger FDA, which educates Congress about the need to financially support the essential work of the FDA.

The question today is whether General snus should continue to be labeled as safer than other tobacco products. I will focus on the scientific evidence, which I personally found challenging due to lack of some key information. So, I will raise the questions that weren’t a focus of the FDA review, and I respectfully encourage you to try to get the answers to these questions today. Several panel members and previous speakers have already asked some of these questions.

We all know the risks of smoking, including cancer, lung disease, and cardiovascular diseases.
Equally important: Most smokers start smoking as children or teenagers and most of these diseases are diagnosed decades later – usually in the patients 50’s or 60’s or even later. That’s more than 30 years later—often 40 or 50 years later, or even later.

In contrast, the data being discussed today found:

A significant increase in several serious cardiovascular diseases, and these were diagnosed in studies that followed relatively young white men. For example the Araghi et al. study published in 2022 included 9 million person years of study, which sounds impressive, but averaged 22 years, including some men that were followed for only 5 years

- Those results indicate some serious risks are evident apparently at a younger age than found with cigarettes.

There was no increase found in oral cancers, despite previous evidence that smokeless tobacco can cause oral cancers. However, oral cancers usually develop in people in their 50’s or older, and many of the individuals in these studies were younger. My question is whether the follow-up for these individuals in any of these studies is long enough to draw conclusions about oral cancer. In addition, information provided in previous research indicate that snus in Sweden differs from snus sold in the U.S. and therefore the data provided on Swedish consumers may differ from the impact on U.S. consumers. I hope you will ask that question.

Bottom line:

How good is the evidence that using the General snus sold in the U.S. is safer than smoking cigarettes in either the shorter term (10 or 20 years) or longer term (30, 40, or 50 years)?
How often do General snus users also use other tobacco products or switch to other tobacco products? Apparently the answer is often, so does the nicotine in General snus make it more difficult to quit tobacco use and instead result in continued use of snus and other tobacco products?
Can the information available be understood by teenagers or adults who consider using snus if it has a modified risk claim – which will be perceived as a seal of approval by the FDA? If the lack of information makes it so difficult for me to make sense of the risks of snus, I have to assume they will too.

Thank you for the opportunity to share these views. I encourage you to ask these questions and make sure the answers make sense.

Feds declare turf, rubber playgrounds “generally safe’

April 18, 2024News Stories & Editorials, We're In the NewsCPTFadmin

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.

Guest Lecture by Diana Zuckerman for Georgetown University Grad Students

April 10, 2024Environmental ExposuresCPTFadmin

April 10, 2024

Today I will talk about Chemicals and Heavy Metals in Artificial Turf, Playgrounds, and Neighborhood Lawns: Policies vs. Scientific Evidence.

I’m Dr. Diana Zuckerman and I’m president of the National Center for Health Research. Our nonprofit research center and think tank is staffed by scientists, medical professionals, and public health experts. We conduct and explain research that can improve the health and safety of adults and children. We do not accept funding from companies whose products we evaluate, so we have no conflicts of interest.

Artificial turf and rubber tiles, mulch, and rubber playground surfaces contain lead, PFAS and other risky hormone-disrupting chemicals (EDCs) and heavy metals. Crumb rubber is used for turf infill and rubber mulch and tiles and contain lead and EDCs. When we look at the beautiful rubber playground surfaces, such as the one pictured here, they look very inviting. They feel spongy and that seems especially safe when small children fall. But what happens when children are exposed day after day, week after week, and year after year? This is especially true for playgrounds used daily by daycare centers and elementary schools.

Some playground surfaces are covered with recycled tire mulch or “virgin rubber.” contain lead? They vary in color. None are tested for metals or chemicals before they are sold.

Poured in Place (PIP) is a very popular type of surface for playgrounds, and consists of what looks like a solid rubber surface, but underneath the surface is recycled tire mulch. Sometimes the top surface may be virgin rubber, but sometimes it is also made of recycled tire mulch. Testing has shown chemicals and heavy metals, even in dust on the surface.

Rubber playground surfaces contain hormone-disrupting chemicals that can cause or exacerbate:

Attention deficits
Early puberty (and infertility in adults)
Obesity
Asthma and allergies
And eventually cancer

Don’t be fooled by how they look when they are new

These photos show what happens to these very attractive rubber surfaces after a few years. The rubber surfaces deteriorate, especially where children are most active. Some examples are at the foot of a slide, where children land when they go down the slide. But the top layer also wears off in other areas where children play or when the top layer cracks due to the weather. The black you see is recycled tire mulch. I’m not sure what the gray color on the ground is – probably the tire mulch washed away and left the hard surface underneath.

What’s below the rubber surface? Recycled tire mulch can be on the top layer of a playground surface or just below the top PIP (poured in place) solid layer. You can see that in these close-up photos. The surface on the left is made of pieces of rubber of different colors, whereas the top layer surface on the right looks orange from a distance but is actually from pieces of rubber that are yellow and red. But look at what is under the surface. The black is recycled rubber mulch. It looks a bit like licorice. You can also see some color pieces of rubber that are mixed in with the black. That looks like candy. And small children like to play with it, and put it in their mouths.

From the ground into the air

When lead dust is found on the surface of playgrounds, officials often try to solve the problem by power washing the dust off the surface. But where does the lead dust go when it is washed away? The lead goes onto the dirt and sometimes into streams and ground water. And of course, new lead dust will form on the surface after the previous dust is washed off.

In this photo you can see black specks which is tire crumb used as infill in an artificial turf field. Did any of you watch the Superbowl this year? That field used artificial turf, and although the plastic grass was nice and green, you could see black areas where the tire crumb infill was very visible. And you could also see some of that infill flying around the feet of the players during the game.

Whether we’re talking about playgrounds or artificial turf fields, children and athletes breathe in the lead, chemicals, and particulate matter when they play. And small children eat pieces.

In a study of aerosolized particulate matter from artificial turf, a University of Georgia faculty member found particulate matter that contained arsenic, cadmium, chromium, and lead.1

Safety Tests

This photo of a new playground in Maryland shows the surface is made of recycled tire crumb that was dyed green. Given the chances of tire pieces containing lead ending up in children’s clothes, on their hands, and in their mouths, this is probably the most unsafe playground possible.

No tests on human health were conducted prior to this product getting on the market. Fortunately, several of us were invited by families in that community to speak at their town forum, and I’m glad to say that all these playground surfaces were replaced with a safe alternative called engineered wood fiber. But meanwhile, we learned that there is a playground at NIH where very sick children play – kids that are so sick that they are undergoing treatment at NIH – that were also made with loose tire crumb similar to this.

U.S. government agencies restrict lead and some phthalates in numerous other children’s products. Agencies are starting to restrict PFAS. But these substances, VOCs, and other heavy metals are not restricted in artificial turf, rubber tiles, mulch, or playgrounds.

Here’s a sign that the D.C. government put up at artificial turf fields using recycled tire mulch as an infill. It’s in English and Spanish. If only toddlers could read!

The Consumer Product Safety Commission has warnings on their website that says:

Avoid mouth contact with playground surfacing materials, including mouthing, chewing, or swallowing playground rubber. This may pose a choking hazard, regardless of chemical exposure
Avoid eating food or drinking beverages while directly on playground surfaces, and wash hands before handling food.
Limit the time at a playground on extremely hot days.
Clean hands and other areas of exposed skin after visiting the playground, and consider changing clothes if evidence of tire materials (e.g., black marks or dust) is visible on fabrics.
Clean any toys that were used on a playground after the visit.

These are very clear and important warnings, but how realistic are they. Will busy parents and caregivers of young children really immediately wash children’s clothes and toys after going to a playground?

Another issue is how hot artificial turf and playgrounds covered with rubber can get. You can see from this photo that on a warm and sunny day in the Washington, DC area, when the air and grass were about 90 degrees, the artificial turf and playground were 180 degrees! That is unusually hot, but I’ve frequently measured temperatures of 150 or 160 degrees when the air is less hot or the weather is less sunny, which is also dangerously hot.

Where does tire mulch infill go when it rains? Or when they can no longer be used?

In this photo, a heavy rain caused the recycled tire infill to wash off the artificial turf field onto other play areas nearby. I’m glad to say that the father who took this photo got his kids off the tire crumb right after the photo was taken. But this gives you an idea of how much tire mulch infill there is, and it has to go somewhere. And it can’t be recycled, and in many cases it eventually gets into streams and ground water. And by the way, when the infill washes off like this, the entire artificial turf field has to be replaced. They can’t just replace the infill that has washed off. Since these fields cost about $2 million dollars, this is a very expensive problem, because the fields don’t last 10 years as is often promised.

The companies claim that the old synthetic turf and tire crumb are recycled, but most of these materials can’t be recycled. As you can see, it often ends up in a dumpster, and from there to a landfill. They still contain lead and toxic chemicals.

Recycled Tire Crumb at Home

As you can see in this photo, recycled tire crumb is now being sold directly to consumers for use in their yards. One company calls its product “PlaySafer Rubber Mulch” because they advertise it as being safe if your child falls. They don’t mention the chemicals or heavy metals in their products, and how unsafe they can be. And of course, rubber mulch to put around trees and shrubs has become so popular at places like Home Depot that many if not most bags of mulch that they advertise are not natural products made of wood or pine – they are rubber.

In this photo, you can see floor tiles made of recycled rubber, which are also widely available at Home Depot and other stores. They are proudly described as recycled rubber and therefore environmentally friendly, but if you want to find out that they are made of recycled tires you need to check the manufacturers’ websites to find that information. I don’t mean to pick on Home Depot – I mention it because these stores are in communities across the country. We are especially concerned about these tiles when used in daycare centers, playrooms, exercise rooms, or basements, because those rooms may have no windows or windows that are not usually opened.

Myth, reality and alternatives

Does artificial turf need watering? YES.
- If you don’t water it regularly, the warranty will be voided.
Does it use pesticides and herbicides? YES.
- Many assume that artificial turf doesn’t need pesticides, but actually many such fields are treated with pesticides when they are being made, before they are installed. Think of it like wall-to-wall carpeting, which looks like one enormous piece of carpet but is actually made up of many smaller pieces that are sewn together. To prevent weeds from destroying the artificial turf, pesticides are needed to prevent weeds from growing along the seams of the carpet.
Does it pass all required safety tests? YES
Are there any required safety tests? NO

Engineered wood fiber, which is what is shown in this photo, feels as spongy as rubber when installed correctly on playgrounds and has no lead or any other dangerous chemicals. It does not cause splinters, even though it is wood. And it is ADA compliant. Here’s a photo of a playground covered with engineered wood fiber.

And of course, the alternative to rubber mulch around plants is the natural wood mulch that is used around shrubs, flowers, and other plants. And yet rubber mulch is increasingly popular at stores like Home Depot.

Challenges to Safeguards

There are many reasons why there are so few regulations protecting children and adults from these materials.

Recycling tires is big business
Artificial turf is big business, with each field costing at least $1 million, and often $2 million or more
There are thousands of PFAS chemicals and companies that claim there is “no PFAS” in their products have tested only a few – perhaps 3-6 of the thousands of PFAS chemicals
Testing some PFAS in liquid is well established but testing PFAS in materials is more controversial. In addition, safe limits have not been established for some heavy metals for childhood exposures or in some cases for adults, making policies difficult to implement.
Voters like convenience and choices and they don’t like government telling them what to do.

I’d be glad to answer any questions.

References

1. Shalat, S.L. (2011). An Evaluation of Potential Exposures to Lead and Other Metals as the Result of Aerosolized Particulate Matter from Artificial Turf Playing Fields, Final Report. Submitted to NJ Department of Environmental Protection, July 14, 2011. https://www.nj.gov/dep/dsr/publications/artificial-turf-report.pdf

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

March 11, 2024In the News, News Stories & Editorials, We're In the NewsCPTFadmin

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)

What’s the Deal with Keratin Treatments and Other Hair Straighteners?

February 28, 2024Cancer PreventionCPTFadmin

Have you ever gotten a keratin treatment? A Brazilian Blowout? Maybe you’ve heard that they make hair silky smooth and relaxed and are expensive. Or maybe you’ve heard that they can cause cancer. Are the risks greater than the benefits? And what products are the FDA planning to ban in April 2024?

What is a Keratin Treatment?

Keratin is a protein found in the hair, nails, and skin. Keratin affects your hair texture and whether it is straight, wavy, or curly. Using chemicals to change the molecules in coiled or curly hair to make it straight or wavy is known as relaxing the hair. In a keratin treatment, cream containing formaldehyde, or methylene glycol (a chemical that releases formaldehyde when used in hair straightening) is brushed into the hair, which is then blown dry and flat-ironed. The combination of formaldehyde, heat, and compression causes straight keratin in the cream to bind to the keratin in the hair, making curly or wavy hair more relaxed.^[1]

Why is Formaldehyde a Problem?

Formaldehyde is a colorless, strong-smelling gas that causes health problems when inhaled, sprayed into the eyes, or absorbed through the skin. It can irritate the eyes, nose, and throat, cause coughing and wheezing, and trigger a severe allergic reaction of the skin, eyes, and respiratory tract.^[2] Some people have also reported that it caused headaches, dizziness, nausea, chest pains, vomiting, and rashes. ^[3]^[14] Repeated exposure at high levels has been linked to various cancers, including leukemia, uterine cancer, and ovarian cancer. ^{[4] [5]}^[14] Formaldehyde is released at highly concentrated levels when it is heated, so stylists that perform keratin treatments and customers that repeatedly get them are at a greatest risk for these health problems.^[4]That’s why the FDA has been raising alarm as early as 2010 and has plans to ban hair smoothing products with formaldehyde in April 2024.^[14][15]

Which Products and Ingredients are Dangerous?

The New York State Department of Health list the following as some of the companies that sell one or more products that contain formaldehyde: Brazilian Blowout Solution,Cadiveu Brazilian Thermal Reconstruction, Coppola Keratin, QOD GOLD Solution and many more. See the full list of products here. Many of these products have been banned in the E.U. and Canada due to their health risks.^[8]

All of these treatments contain either formaldehyde or another chemical that releases formaldehyde when heated. The following chemicals are all considered formaldehyde by OSHA: methylene glycol, formalin, methylene oxide, paraform, formic aldehyde, methanal, oxomethane, oxymethylene, or CAS Number 50-00-0.^[6]There are also other hair products, such as conditioners and hair sprays, that contain keratin but do not contain any form of formaldehyde, and do not require heat activation. They just leave keratin on the outside of your hair, rather than binding the molecules together. So, it’s best to read the ingredients label before taking any product home, to make sure that you aren’t exposing yourself to formaldehyde, whether it’s listed as formaldehyde, methylene glycol or by one of these other names.

It’s important to know that Keratin is not the only hair straightener that is dangerous. A 2022 study indicated a possible link between the use of chemical hair straighteners and uterine cancer. Researchers found women who applied chemical straightening products on their hair at least four or more times a year were more than twice as likely to develop uterine cancer compared to those that did not, and that Black women were at higher risk. ^[9]^[14]Following the 2022 NIH study, a lawsuit was filed against L’Oreal and other beauty companies for selling chemical hair straightening products. ^[10]

Isn’t a Brazilian Blowout “Formaldehyde-Free”? No!

Brazilian Blowout is one of the most common brands of keratin treatments. As a result of the 2010 controversy over formaldehyde in keratin treatments, Brazilian Blowout created a formula that they advertised as “formaldehyde-free.” While there is no formaldehyde listed in the ingredients, the main chemical used is methylene glycol, which releases formaldehyde when it is heated during the treatment process. Because of this, the FDA issued a warning letter to Brazilian Blowout in 2011 saying that the product is “misbranded” because the “formaldehyde-free” label is false or misleading.^{[11] [15]}Brazilian Blowout is actually one of the most dangerous treatments because almost 12% of the product is basically formaldehyde hiding under another name, and contains three times as much formaldehyde as most other keratin treatments.^[6]Five other keratin treatments labeled “formaldehyde-free” were also found to contain formaldehyde levels up to five times the recommended amount.^[12]

In response to the FDA’s letter, Brazilian Blowout changed the labeling on their original formula to warn consumers about health risks, and created an alternative product called Brazilian Blowout ZERO+, which does not contain any formaldehyde.^[15] But according to a company representative, the new product does not leave the hair as smooth as the original.^[1]

Risks to Stylists and Customers

Because stylists are at greatest risk for formaldehyde exposure, the national Occupational Safety and Health Administration (OSHA) set a standard for the amount of formaldehyde allowed in the air. ^[16] If workers have been exposed to more than a specified amount of formaldehyde, their health must be monitored and they must be reassigned to a job with significantly less exposure. The salon is required to install ventilation systems, use lower heat settings on blow dryers, and monitor formaldehyde levels at all times using a Consumer Sampling and Analysis Kit.^[3] Other workers should also be trained annually to safely handle chemicals and be provided personal protective equipment, including gloves, aprons, and eyewash stations.^[2]Learn more about OSHA’s recommendations for formaldehyde exposure here.

If you are a hairdresser who wants to protect your workers from the health risks of formaldehyde, don’t offer keratin treatments at your salon. If you just thinking of getting regular keratin treatments for yourself (Brazilian Blowout recommends getting treatments every 12 weeks), remember that will put yourself and others at greater risk for irritation, allergic reactions, and even cancer. Regardless, with the FDA’s announcement to ban hair-smoothing products that contain formaldehyde, products that contain or create formaldehyde as an ingredient will not be legally available soon. ^[14][15]

If you want to straighten your hair, remember that using a flat iron releases water vapor, which is much safer for your health. Of course, any form of straightening will damage hair and should be used sparingly, alternating with protective hairstyles that don’t require altering hair’s natural texture, such as braids or gentle twists. These will give your hair (as well as your skin and sinuses) a break from harsh chemicals and heating elements.

We agree with other experts who say that the FDA should have prohibited the use of formaldehyde in hair straightening products years ago. The FDA started to do so in 2016, but for reasons that are not clear, that decision was blockeduntil 2024! ^[14]We also urge the Federal Trade Commission to crack down on false advertising by products labeled as “formaldehyde-free.”

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

Environmental Working Group. Best options for straight hair, Hair Straighteners. ewg.org. http://www.ewg.org/hair-straighteners/our-report/how-to-get-straight-hair-whats-the-best-option/. April 2011.
Occupational Safety and Health Administration. OSHA Fact Sheet: Formaldehyde. Osha.gov. https://www.osha.gov/OshDoc/data_General_Facts/formaldehyde-factsheet.pdf. April 2011.
S. Food & Drug Administration. Hair-Smoothing Products That Release Formaldehyde When Heated. Fda.gov. https://www.fda.gov/cosmetics/cosmetic-products/hair-smoothing-products-release-formaldehyde-when-heated#:~:text=A%20hair%20straightening%20or%20smoothing,the%20air%20as%20a%20gas. Updated August 24, 2020.
National Cancer Institute. Formaldehyde and Cancer Risk. Cancer.gov. https://www.cancer.gov/about-cancer/causes-prevention/risk/substances/formaldehyde/formaldehyde-fact-sheet#what-has-been-done-to-protect-workers-from-formaldehyde Updated June 10, 2011.
Schwilk E, et. al. Formaldehyde and leukemia: an updated meta-analysis and evaluation of bias. Journal of Occupational and Environmental Medicine. 2010;52(9):878-886. https://journals.lww.com/joem/Abstract/2010/09000/Formaldehyde_and_Leukemia__An_Updated.5.aspx.
Environmental Working Group. Brands that hide formaldehyde. ewg.org. http://www.ewg.org/hair-straighteners/our-report/hair-straighteners-that-hide-formaldehyde/. April 2011.
New York State Department of Health. Consumer Health Alert: Hair Straightening Products and Formaldehyde. health.ny.gov. https://www.health.ny.gov/environmental/chemicals/formaldehyde/docs/consumer.pdf. Updated Feb 2024.
Women’s Voices for the Earth. Hair Straightening Products Containing Formaldehyde. womensvoices.org. https://www.womensvoices.org/safe-salons/brazilian-blowout/hair-straightening-products-containing-formaldehyde/. Updated January, 2018.
National Institute of Health. Hair straightening chemicals are associated with higher uterine cancer risk. https://www.nih.gov/news-events/news-releases/hair-straightening-chemicals-associated-higher-uterine-cancer-risk. 17 October 2022.
Melillo, Gianna. Lawsuit against L’Oreal, beauty companies alleges hair straightening products cause uterine cancer. The Hill. October 25th, 2022. https://thehill.com/changing-america/well-being/prevention-cures/3703073-lawsuit-against-loreal-beauty-companies-alleges-hair-straightening-products-cause-uterine-cancer/
S. Food and Drug Administration. Warning Letter: Brazilian Blowout 8/22/11. College Park, MD: U.S. Food and Drug Administration; August 22, 2011. https://www.fdalabelcompliance.com/letters/ucm270809.
Maneli MH, Smith P, Khumalo, NP. Elevated formaldehyde concentration in “Brazilian keratin type” hair-straightening products: A cross-sectional study. Journal of the American Academy of Dermatology. 2013;70(2):276-280. https://www.jaad.org/article/S0190-9622(13)01135-3/fulltext#back-bib7
Rabin RC. The FDA Wanted to Ban Some Hair Straighteners. It Never Happened. The New York Times. October 21, 2020. https://www.nytimes.com/2020/10/21/health/brazilian-blowout-formaldehyde-fda.html.Rabin, R. C., & Jewett, C. (2023, October
F.D.A. Plans to Ban Hair Straighteners With Formaldehyde. The New York Times. https://www.nytimes.com/2023/10/16/health/hair-straighteners-black-women-fda.html
Nutrition, C. for F. S. and A. (2022). Hair Smoothing Products That Release Formaldehyde When Heated. FDA. https://www.fda.gov/cosmetics/cosmetic-products/hair-smoothing-products-release-formaldehyde-when-heated
1910.1048—Formaldehyde. | Occupational Safety and Health Administration. (n.d.). Retrieved February 15, 2024, from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1048