Category Archives: Uncategorized

A Tiny Lab Finds Danger on Drugstore Shelves While the FDA Lags Behind

November 9, 2022Uncategorized, We're In the NewsCPTFadmin

Anna Edney, Bloomberg News, November 9, 2022

David Light can’t wait to show off his tchotchkes. The curly haired scientist lights up with boyish enthusiasm when he picks up a black coffee mug from the endless array of memorabilia in his office. It’s emblazoned with the trademark lettering of Zantac, the blockbuster heartburn drug. He quickly moves on to a Zantac wine glass from 1983, when the heartburn drug was approved for sale in the US, and then a white and blue Zantac Swiss army knife. A globe, then a t-shirt, next a hat — all stamped with the drug’s branding.

One floor above his office is the lab where groundbreaking Zantac research took place. But Light didn’t create Zantac — he nearly destroyed it. In the process, he’s also become a stand-in, protecting the American public from cancer-causing chemicals in place of a federal regulator that’s failed to do the job.

Light is the co-founder and chief executive officer of Valisure, the independent testing lab that first released research showing that Zantac and its generic forms were contaminated with a toxic chemical known to cause cancer. The findings, published in 2019, helped lead to massive recalls and eventual market withdrawal. Some two dozen companies were selling versions of the drug at the time.

Valisure truly shot into the public eye last year when it was the first to warn that some widely used hand sanitizers had high levels of carcinogens. Next came the lab’s evidence of leukemia-causing benzene in sunscreens. Then Valisure alerted consumers to dangerous chemicals in spray antiperspirants, and, more recently, dry shampoos. The lab has also warned of contaminants in a popular diabetes treatment. Procter & Gamble Co., Johnson & Johnson, Unilever Plc, CVS Health Corp. and Beiersdorf AG have all issued recalls or halted sales following Valisure’s findings.

In the course of just three years, Valisure’s quest to hunt down cancer-causing chemicals in everyday products has impacted pharmaceuticals and consumer goods in markets worth an estimated $9 billion that touch the lives of tens of millions of Americans.

“I feel that we’ve already saved many lives,” Light said. “When such big numbers of people are exposed, years of exposure with a well-defined carcinogen, there is no doubt there’s unacceptable risk.”

On every step of that journey, the Food and Drug Administration, the agency responsible for safeguarding consumers from these problems, has lagged behind the small lab.

[….]

Impurity Testing

The testing done by Valisure is routine and can be run by any company that makes pharmaceuticals. On a recent visit, a scientist in a white lab coat replicated the experiment on an older version of Zantac at Valisure’s lab in Connecticut. A vial of milky pink liquid disappears into a machine that costs more than some luxury cars. The liquid is vaporized and separated into its various components. After several minutes, there’s a readout on a nearby computer screen: There’s a tall peak, like an irregular rhythm on a heartrate monitor. The figure indicates high impurity levels.

Valisure first released its Zantac findings to the public in September 2019. It took roughly seven months for the FDA to finally force the drugmakers to pull Zantac products off the market.

GSK Plc, the creator and original seller of Zantac, maintains that there is “no consistent or reliable evidence” the drug “increases the risk for any type of cancer,” the company said in an emailed statement. Sanofi, the most recent seller of the non-prescription version of the drug, said it “stands by the safety of the medicine today.”

Powerful Regulator

As problems with carcinogen-laden medications and consumer products continue to fall through the cracks, the FDA maintains it is up to companies to ensure their products are safe. The situation highlights one of the biggest challenges at the agency: It doesn’t conduct much testing for these types of contaminants.

“FDA doesn’t do routine testing,” said Scott Knoer, who served as the CEO of the American Pharmacists Association for two years before stepping down in June.

“I had always believed anything in the US was safe,” Knoer said. “It was not as thorough as I guess previous perception was.”

The FDA takes a risk-based approach to quality testing, said Harrison, the agency spokeswoman. Each year it focuses on analyzing a few dozen products with already known issues. For example, the agency tested many hand sanitizers in the year that ended Sept. 30, 2021.

Pharmaceutical Fees

The FDA has an enormous purview, overseeing not just food and drugs, but also medical devices, tobacco and cosmetics. Despite that, its budget is just half that of the Environmental Protection Agency or the Internal Revenue Service. And about two-thirds of the funding the FDA receives for its drug activities comes from user fees paid by pharmaceutical companies. Since the early 1990s, the FDA and drugmakers have negotiated a deal every five years that Congress then approves. That agreement between the FDA and drugmakers dictates what the FDA can then do with those user fees.

It costs a drug company more than $3 million in fees to submit a new drug application to the FDA for review. In exchange, the agency has to meet review deadlines to help speed up the application process. This all means the regulator has far fewer funds to put toward making sure drugs already on the market are safe. It also means the industry gets a lot of deference.

“User fees provide access to FDA decision-makers in ways that foster a cozier relationship between FDA and industry,” said Diana Zuckerman, president of the National Center for Health Research, a think tank that focuses on the safety of medical and consumer products.

The agency has taken heat in the last year and a half for approving an Alzheimer’s disease drug that wasn’t fully proven to work, leading to accusations that the body is too beholden to the drug industry. The FDA also let clear signs of problems at an Abbott Laboratories’ infant formula plant slip by for almost five months before overseeing a recall and temporary closure of the factory in February, which ultimately led to a national formula crisis. These fiascoes have consumed the agency at a time when it’s been overwhelmed by the race to approve Covid-19 treatments and vaccines. All the while, recalls of sunscreen, antiperspirants, hand sanitizers and dry shampoo keep piling up.

[….]

Carcinogens and Where They’re Found

Rather than embrace Valisure as a partner in protecting the public, the FDA instead turned combative.

On May 24, 2021, Valisure released its findings showing cancer-causing chemicals in sunscreens. Two days later, two FDA inspectors showed up at the lab, according to agency documents. They brought an FDA lawyer with them for three of the 11 days they were at Valisure. The three FDA employees were deployed to the Valisure lab at a time when the regulator was focused on conducting its most critical inspections amid a pandemic backlog.

Valisure has about 20 employees who work in an office space of about 6,000 square feet in New Haven, Connecticut. The FDA, to compare, operates in 3.1 million square feet of office and lab space on a sprawling campus in Silver Spring, Maryland. It has 18,000 employees and a $6 billion annual budget.

To read entire article, click here.

A Special Report: Can Breast Implants Cause Chronic Disease?

October 26, 2022News Stories & Editorials, Uncategorized, We're In the NewsCPTFadmin

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.

Diana Zuckerman Statement on the Role of FDA in Health Inequities Meeting of the National Academy of Medicine

August 25, 2022Policy, Testimony & Briefings, UncategorizedCPTFadmin

July 26, 2022

Thank you for the opportunity to speak today on how current FDA policies contribute to health inequities.

The National Center for Health Research is a nonprofit think tank founded in 1999 that conducts research and scrutinizes research conducted by others to evaluate medical products, procedures, and policies. We do not accept funding from companies whose products we evaluate.

There are many reasons for health inequities in the U.S., but today I will focus on one that usually gets no attention: Federal laws regarding diversity in clinical trials.

The U.S. Department of Health and Human Services requires research studies to include people representing diverse racial and ethnic backgrounds. This is not always enforced, but the requirement is in the law and NIH, CDC, SAMHSA and other agencies make an effort to abide by this law.

The one exception among federal public health agencies is the FDA, which encourages but does not require diversity in clinical trials. They justify this because the agency doesn’t pay for the studies – the companies that make the products pay for the studies. However, taxpayers do pay for FDA staff that regulate these products, and taxpayers also pay for the products themselves.

Our NCHR Study of Racial Diversity

To see the impact of the lack of a requirement for FDA, we examined 22 of the highest risk medical devices reviewed by the FDA Advisory Panels for 4 recent years. We found:

The number of nonwhite patients in key trials ranged from 4 (3%) to 6,788 (17%).

Of 19 treatment devices, only 7 had analyses for racial groups for effectiveness and only 3 for safety.

69% to 99% of the patients in the studies were White. The number of nonwhites was as low as 4; 1 for Hispanics.

There were too few patients in most racial or ethnic groups to draw meaningful conclusions.

Even when subgroup analyses were conducted, their conclusions were often discredited by the FDA, blamed on chance differences due to small sample size. If there was a lack of diversity or even when racial or ethnic differences were significant, that information was were often not included on the label, which is the main source of information for physicians and patients.

Recent Examples from the FDA

When the FDA reviewed the data on Aduhelm for Alzheimer’s Disease, they focused on 2 studies comparing placebo to high and low dosage:

Study 301: 8 Black patients (half of 1%) and 37 Hispanic patients (2%)
Study 302: 11 Black patients (less than 1%) and 67 Hispanic patients (4%)

When the FDA reviewed data on the Reducer circulatory system device for angina, they found that there were no Black or Hispanic patients, and more than 80% of the patients were White or male, or both. And yet, most patients with angina are not White males.

Why is Diversity Important in Clinical Trials?

Response to treatment can vary due to genetics, health habits, metabolism, body part size/shape and other factors. If you exclude certain groups, you don’t know what works best for them. Keep in mind that you need enough patients to study safety and effectiveness for patients in each group.

Example – Lutonix drug-coated balloon catheter to open blocked arteries

You can see on this graph that the device seemed effective compared to the control group when men and women were combined. However, you can also see that the device was only effective for men, not for women. In fact, women did better with placebo. This is an example of how evaluating safety and effectiveness for a specific demographic group can provide information that is completely different from an analysis of a diverse group as a whole.

Shortcomings of Very Small Samples

When the racial or ethnic group is very small, the results may not be generalizable to the larger population that those patients represent. A few outliers can have an outsized effect on the outcomes – resulting in significant differences where they do not exist. Or, real differences may be apparent but not be statistically significant because the sample lacks statistical power.

If an analysis is conducted on a small number of patients of a particular ethnic group, any differences could easily be due to chance. For example, the graphic below shows that the new drug seems to be more effective than an older drug (40% effective compared to 30% effective) , but that difference is not statistically significant. However, if the same difference was based on a much larger sample, it would be statistically significant.

In conclusion, when the FDA approves a medical product that has not been evaluated on a relatively large number of patients in a specific racial or ethnic group, it is not possible to conclude whether the product is safe or effective for members of that group. If the FDA does not require adequate diversity in clinical trials used as the basis for FDA approval, then the agency should only approve those products for the types of individuals studied. That precision in approval decisions would create the incentive needed for companies to improve diversity in their trials and conduct appropriate subgroup analyses.

Reference
1. Fox-Rawlings SR, Gottschalk LB, Doamekpor LA & Zuckerman DM. (2018) Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients? Milbank Quarterly, Vol 96 (3) 499-529.

NCHR Comments on Recommended Diversity Plan to Improve Enrollment of Racial and Ethnic Minorities in Clinical Trials

August 11, 2022UncategorizedCPTFadmin

June 13, 2022.

National Center for Health Research’s Comments on Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials [FDA-2021-D-0789]

We are writing to express our views on the Food and Drug Administration’s (FDA) draft guidance to provide recommendations to sponsors developing medical products on the approach for developing a plan to enroll representative numbers of participants from underrepresented racial and ethnic populations.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments 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.

We strongly support the proposed recommendations which provide specific, actionable guidance for sponsors to develop a meaningful Race and Ethnicity Diversity Plan. In particular, we appreciate the proposed recommendation for sponsors to clearly define and justify enrollment goals for underrepresented racial and ethnic minority populations. Most important, representation in a trial must be adequate to conduct appropriate subgroup analyses on efficacy and safety. For example, if a minority group is 20% of the patient population but there are only 100 patients in the entire study, 20 patients would be 20% but would not be sufficient to determine safety or efficacy for that group.

It is thus encouraging that the draft proposal recommends that sponsors provide any available evidence describing disparities in health outcomes related to the drug or therapy, but acknowledges that the lack of this evidence should not be grounds to ignore the importance of diversity. For too long, many clinically meaningful disparities in the efficacy of drugs or therapies in minority populations have been hidden by a lack of data. Thus, it is crucial to ensure that sponsors describe existing research on similarities and differences in how the disease or condition under study is experienced by racial and ethnic minorities, and identify potential gaps in existing data.

The goal is for the inclusion of these recommendations to improve the accountability of sponsors to make real and sustainable improvements in the representation of minorities in trials. However, to truly hold sponsors accountable, this draft proposal should go further by providing meaningful incentives for sponsors to follow the recommendations outlined. The most meaningful incentive within current law would be that FDA make it clear that the agency will not approve medical products for all populations if the product was not adequately tested for safety and efficacy on sufficient numbers of patients representing major demographic subgroups.

National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.

National Center for Health Research’s Public Comment on AHRQ Draft Review on Partial Breast Irradiation and Whole Breast Irradiation for Breast Cancer

July 29, 2022UncategorizedCPTFadmin

July 29, 2022

We are writing to express our views on the AHRQ Draft Comparative Effectiveness Review comparing Partial Breast Irradiation (PBI) to Whole Breast Irradiation (WBI) as a treatment for early-stage breast cancer.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments 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.

We agree with the AHRQ review that clinical trials provide sufficient evidence that PBI is a valuable treatment option for select patients with early-stage breast cancer. Patient outcomes for several types of PBI did not differ significantly from WBI patients in terms of ipsilateral breast recurrence (IBR), overall survival, and cancer-free survival at 5 and 10 years. However, IORT PBI patients did have higher levels of recurrence (IBR) than WBI patients, despite no difference in overall survival or cancer-free survival. Overall, PBI patients have fewer acute adverse effects, lower transportation costs and days away from work, and fewer financial strains, making it a more convenient therapy option compared to WBI.

However, there are numerous types of PBI, and the data are not adequate on the effectiveness of each one of them compared to WBI. In addition, we agree with the AHRQ review that there is currently insufficient data to draw conclusions about the risks and benefits of different types of PBI compared to each other or to WBI for women who are diverse in terms of patient, tumor, and treatment characteristics. Outcomes at 15 and 20 years are also important to evaluate. For these reasons, more research is necessary to provide the most useful information to patients considering breast irradiation.

For more information, please contact Dr. Diana Zuckerman at dz@center4research.org.

These machines to help people breathe were recalled a year ago. Many still use them

July 11, 2022UncategorizedCPTFadmin

Emily Alpert Reyes, Los Angeles Times, June 23, 2022

In Rochester, N.Y., Diane Coleman has relied on a machine to help her stay alive, but she worries that it might be slowly undermining her health.

Her ventilator was among millions of breathing devices that Philips Respironics recalled last summer over safety concerns about numerous models of its ventilators, BiPAP and CPAP machines.

The reason: Polyester-based polyurethane foam used to muffle noise in those machines could degrade, giving off chemical gases and bits of black debris that could be swallowed or inhaled.

The possible risks: headaches, dizziness, nausea, irritated eyes and airways, and “toxic or cancer-causing effects,” according to federal regulators. The Food and Drug Administration put the recall in its most serious category, involving “a reasonable probability” that a product “will cause serious adverse health consequences or death.”

Yet a year later, many patients are still awaiting replacements — and some are using the recalled machines despite those possible risks.

Coleman said her machine underwent some initial repairs, but she is seeking a new one after federal regulators sought more safety testing of the replacement foam used for such fixes. The 68-year-old, who is president and chief executive of the disability rights group Not Dead Yet, has a form of muscular dystrophy and uses her ventilator roughly 22 hours each day.

She is nervous about how it could affect her, but “it’s not like I can stop using it.”

[….]

The devices are commonly used to treat sleep apnea, a disorder in which breathing is repeatedly interrupted during sleep, which can increase the risk of heart problems and leave people dangerously drowsy during the day. The FDA has advised patients who use the recalled CPAP or BiPAP machines to talk to their doctors about whether to stop.

Tom Wilson, who administers a Facebook support group for CPAP users affected by the recall, said he has read comments from group members who say they haven’t had any communication with Philips despite registering their devices with the company as much as a year ago. Some have paid out of pocket to get other devices.

[….]

“They’ve botched the whole thing,” said Dena Young, senior counsel at Berger Montague, who said that most of the people represented by her firm had not gotten a replacement or repair. As they wait, “some of them are still using the Philips because they don’t have a choice.”

Federal investigators have also taken interest: In April, Philips said the U.S. Department of Justice had subpoenaed the company in regards to events leading to the recall.

Consumer safety advocates argue that the halting process underscores the shortcomings of the recall system, which relies heavily on private companies to inform consumers and take action.

“It isn’t actually easy for the FDA to take products off the market,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit research center that has raised concerns about the safety of medical products. “It should be a lot easier than it is.”

But the actions that the FDA has taken so far in the Philips recall also show that the agency “has more power in recalls than they usually use,” Zuckerman said.

The FDA’s Center for Devices and Radiological Health told Philips last month that it was seeking to order the company to turn in a plan that could include not only repairing and replacing the recalled devices, but also providing refunds. In a November report, an FDA investigator found that Philips had failed to start taking appropriate action years earlier when the company first became aware the foam could be breaking down. Emails showed that the company was aware of “foam degradation issues” as early as October 2015, the FDA investigator found.

Within three years, more emails indicated that Philips had gotten more complaints about crumbling foam in ventilators and said that testing had confirmed that it broke down in high heat and high humidity, but the firm “made the decision not to change the design,” according to the FDA report in November. The FDA investigator noted that dating to 2008, Philips had gotten more than 222,000 consumer complaints that included keywords such as “contaminants, particles, foam, debris, airway, particulate, airpath and black.”

[….]

This year, the FDA found that Philips’ efforts to alert patients were insufficient, concluding that many patients were probably still unaware of the health risks nine months after the recall had begun. In March, it ordered the company to notify health professionals, device distributors and users of the recalled machines after estimating that only 50% of patients and consumers who had gotten recalled CPAPs and BiPAPs within the last five years had registered with the company for a replacement.

[….]

In Philadelphia, Meghann Luczkowski likewise worried about what would happen if Miles, her 8-year-old son, were switched to a different ventilator. Miles has a rare form of dwarfism that causes a “floppy airway” that needs to be reopened with mechanical ventilation. He had briefly been put on a different ventilator in the past but couldn’t maintain safe levels of oxygen and suffered “blue spells” in which his skin changed color.

His Philips machine has been “his lifeline,” allowing him to live at home with his family. But Luczkowski said they had begun noticing black buildup when they changed a filter in the machine.

“It’s a very scary thing to hear that the machine that keeps your child alive could suddenly be the thing that’s harming them,” Luczkowski said.

[….]

Concerns have continued to mount. From April 2021 through April 2022, federal regulators have gotten more than 21,000 reports about medical issues potentially tied to the recalled devices — or malfunctions likely to cause injuries if they recurred — including 124 reports linking them to deaths. Cancer has been a stated concern: Since 2020, more than 1,100 such reports about Philips CPAP or BiPAP machines have included the words “cancer,” “tumor” or “tumour,” said Madris Kinard, chief executive of Device Events, which gathers data to track problems with medical devices.

Those medical device reports, which can be submitted by health professionals and patients as well as manufacturers, do not require verification that the device caused the injury or death; Philips stressed that submitting such reports “is not evidence that the device caused or contributed to the adverse outcome or event.”

However, Zuckerman said “it’s assumed that a lot of deaths and other serious injuries don’t get reported at all.”

In La Quinta, Matthew P. Stone counts himself as relatively lucky. The 61-year-old, who had been using a Philips CPAP machine for sleep apnea, had been able to fall back on an old device from another manufacturer.

But Stone, like others, has been galled by the way the recall has played out. At one point, Stone said, he tried to lodge a complaint with federal regulators and was referred to a Southern California number that kept cutting out before he could leave a message.

“I am so incredibly disappointed,” he said, “at the lack of advocacy by anybody involved.”

To read the entire article, click here.

Who Should You Believe? A critique of the Aesthetic Society’s view of Breast Implant Illness

June 2, 2022Testimony & Briefings, UncategorizedCPTFadmin

By Diana Zuckerman, PhD.

An article entitled “A Practical Guide to Managing Patients With Systemic Symptoms and Breast Implants” was published in the Aesthetic Surgery Journal, (Volume 42, Issue 4, April 2022, Pages 397–407). This is a journal of the Aesthetic Society, which is the second largest association of plastic surgeons. The authors are Patricia McGuire, MD, Daniel J Clauw, MD, Jason Hammer, MD, Melinda Haws, MD, and William P Adams, Jr, MD

There are many outrageous articles denying the existence of breast implant illness, but this may be the worst since it was published after major studies documented that breast implant illness exists. The authors are prominent plastic surgeons who are members of the Aesthetic Society and/or the American Society of Plastic Surgeons (ASPS), which are the two major associations for plastic surgeons. All but one of the authors have financial ties to companies that make breast implants.

The theme of the article is clearly stated in the summary: “Numerous studies have explored the possibility of an association between breast implants and systemic symptoms potentially linked to exposure to silicone. Some studies show no direct association whereas others provide insufficient scientific evidence to prove or disprove an association. Nonetheless, some patients with breast implants remain concerned about the possible role of their implants in systemic symptoms they may be experiencing. This paper provides a practical approach for plastic surgeons in managing patients with breast implants who present with systemic symptoms, including recommendations for patient counseling, clinical and laboratory assessment of symptoms, and/or referral. Integral components of patient counseling include listening attentively, providing unbiased information, and discussing the risks and benefits of options for evaluation and treatment.”

In reality, there are numerous studies in major medical journals that show a “direct association” between breast implant illness and diagnosed diseases with similar symptoms. But the plastic surgeons who wrote the article are saying there is no evidence. They are also saying that since patients mistakenly think BII is real, surgeons should assure them that although BII it is not proven, research is underway to study the issue. That gaslighting is intended to show the patients that their surgeon is open-minded.

You might ask what is the evidence that the authors use to conclude that BII is not real? To me as a researcher, this is the most mind-boggling part. In addition to misquoting a 22-year old report from the Institute of Medicine – a report that is extremely outdated — and including a few individual case studies that just happen to all illustrate the authors’ view that breast implant illness isn’t real — the authors made several major errors:

#1. They state that “In 2019, an FDA advisory panel on breast implant safety determined that there is currently insufficient evidence of a causal relationship between breast implants and the diagnosis of rheumatologic disease or [connective tissue disease].” They footnote this statement with a document that was written by the FDA before the FDA advisory panel met in 2019 and which did not draw any such conclusions.

#2. They state that “a number of epidemiological studies taken together are felt by many experts in the field to represent convincing evidence that there is no link between SBIs and auto-immune diseases.” The authors support that statement by listing 9 articles that they do not discuss. Almost all of the articles were funded by implant manufacturers and/or plastic surgeons, and 3 were published more than 20 years ago, based on poorly designed studies. One study was described as a study of 55,000 women, but in reality a large percentage of the patients dropped out before the study was completed. Most outrageous of all, the last 2 studies listed actually concluded the opposite to what the plastic surgeons claimed: The Israeli study and the Baylor study that both concluded that several autoimmune diseases with symptoms similar to BII are significantly increased after women get breast implants.

#3. They mistakenly conclude that since women with saline breast implants also report BII symptoms, the symptoms are not related to the silicone shell. This is a ridiculous statement since all breast implants have silicone shells.

#4. In contrast to their uncritical acceptance of poorly designed and biased studies funded by implant manufacturers and surgeons with financial ties to those implant makers, when the authors briefly mention studies showing that women with BII symptoms that improve after their implants are removed, they speculate (without evidence) that such improvement might be temporary. It is notable that they didn’t even mention the 2021 study by Dr. Feng and her colleagues, which showed significant improvement in lung function after explant surgery. That is no accident, since this Aesthetic Society article was published many months later.

There are too many other careless errors in the article to list them all. I can’t help but wonder if the authors read any of the studies they were supposedly quoting. While urging plastic surgeons to pretend to be open-minded, the authors are anything but. They repeatedly misrepresent research findings in order to support their biased view that the symptoms of breast implant illness are not caused by breast implants.

In summary: This article makes it clear that the Aesthetic Society is encouraging their members to “gaslight” patients with BII, rather than help them get explanted. Women who are seeking well-informed plastic surgeons should avoid the authors and think twice before believing anything they hear from plastic surgeons that belong to the Aesthetic Society, since the journal is published by that medical group.

NCHR Comments on the MDUFA V Commitment Letter

April 25, 2022Legislation, Uncategorizedcommitment letter, MDUFA, user feesCPTFadmin

April 21, 2022

The National Center for Health Research (NCHR) appreciates the opportunity to provide public comments on the Medical Device User Fee Amendments (MDUFA) V Commitment letter, and to express our substantial concerns with the overall process as well as the shortcomings of the Commitment letter.

NCHR is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues and health policies, with particular focus on ensuring that treatments are safe and effective for 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.

The negotiations between the Food and Drug Administration (FDA) and medical device industry are unlike regulatory processes at other federal agencies. The typical process is more transparent and includes meaningful stakeholder engagement and feedback from the public. The fact that the very industries being regulated by the FDA meet behind closed doors with FDA staff to negotiate a Commitment Letter, with no members of the public allowed to be in the room or have access to a transcript or recording, raises important questions about why industry has more say in FDA policies and practices than other Stakeholders. We previously pointed out the lack of transparency and the lack of meeting minutes, which we were told would be publicly available – but weren’t.

This proposed Commitment letter, although late, has already been delivered to Members of Congress. The House Energy & Commerce Subcommittee on Health held a hearing on March 30, 2022, on the contents of the proposed Commitment Letter. It seems disingenuous to request public feedback, at this week’s meeting or in writing, at this late point in the process.

In addition to the lack of transparency in the process and lack of public representation in negotiations between FDA and the medical device industry, the Commitment Letter fails to include any performance measures specifically linked to patient safety. Given the lack of safety or effectiveness data prior to clearance or approval of more than 95% of medical devices, post-market surveillance is crucially important. And yet, the Commitment Letter provides no requirement for financial support for post-market monitoring of studies or MAUDE reports, putting patients at risk for years to come.

Despite our lack of confidence in the FDA’s negotiated agreement with industry, below are our specific recommendations for your consideration as you finalize the MDUFA V Commitment Letter:

Include performance measures tied to device safety, such as total time to recall a device following adverse event reporting.
Direct any additional funds earned by FDA for meeting premarket performance goals to post-market surveillance activities.
The total product life cycle advisory program (TAP) should include post-market activities to truly capture the full life cycle. This is becoming even more important as devices become more complex and technology rapidly changes. User fees should be used to support technology systems to monitor devices. Based on the description in the proposed Commitment Letter, TAP would focus on early communication with industry to troubleshoot potential issues with applications, but not to monitor the devices once they are on the market.
Diversity and accessibility performance measures should be included in the proposed Commitment Letter.
1. Industry could be provided a discount on fees if certain diversity performance goals are met in a PMA application.
2. Industry should be required to include a detailed plan on potential device recalls. The plan should include how information will be shared with patients and what steps will be taken to ensure the information is presented in a timely manner and accessible formats.

When Congress required that stakeholders have the opportunity to participate in the MDUFA V reauthorization process, they intended that our participation would be meaningful. This is the final opportunity for the FDA to fulfill that obligation in MDUFA V.

NCHR Letter to Members of the Board of the Los Gatos Union School District on Artificial Turf and Playgrounds

April 19, 2022Environmental Exposures, UncategorizedCPTFadmin

National Center for Health Research, April 18th, 2022

Dear Superintendent Johnson and Members of the Board of the Los Gatos Union School District:

I am writing to share scientific information about artificial turf and playground surfaces, which I am confident will help you determine what is best for the children and adults in your community.

As President of the National Center for Health Research, I am writing at the request of many of your constituents to share the information we have provided to Members of Congress, state and federal agencies, state and local legislators, parents, and others who want to ensure that our children are not exposed to dangerous chemicals when they play on artificial turf or playgrounds. Our nonprofit think tank is located in Washington, D.C. Our scientists, physicians, and health experts conduct studies and scrutinize research. Our goal is to explain scientific and medical information that can be used to improve policies, programs, services, and products.

We understand that these issues are hotly debated, but some information is more accurate than others. For example, if you look at the maintenance contract for an artificial field, you will see that it needs to be watered regularly to prevent it from becoming dangerously hard and to keep its warranty in place. In other words, grass fields and artificial turf fields both require water, but well-designed grass fields will last much longer and be more cost-effective.

In the last few years, scientists have learned more 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. Tire crumb has well-known risks, containing chemicals that have the potential to 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,” which means that they are not metabolized and do not deteriorate, accumulating over the years. Replacing tire waste with silica, zeolite, and other materials also has substantial risks. For example, it is well known that “particulate matter” can cause lung problems and eventually cause lung cancer. For that reason, silica and zeolite are of great concern.

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products. Despite claims to the contrary, none have concluded that artificial turf is safe. Although the Trump Administration’s EPA stated that there was no conclusive evidence that the levels of chemicals in artificial turf was harmful to children, they explained that their research was based on assumptions and that they had not conducted or reviewed studies of children exposed to artificial turf.

Lead

As you probably know, the American Academy of Pediatrics states that no level of lead exposure should be considered safe for children, because lead can cause cognitive damage even at low levels. Some children are more vulnerable than others, and that can be difficult or even impossible to predict. Since lead has been found in tire crumb as well as in new synthetic rubber, it is not surprising

that numerous artificial turf fields and playground surfaces made with either tire crumb or “virgin” rubber have been found to contain lead. However, the Centers for Disease Control and Prevention (CDC) also warns that the “plastic grass” made with nylon or some other materials also contains lead. Whether from infill, plastic grass, or rubber playground surfaces, the lead doesn’t just stay on the surface. With wear, the materials turn to dust containing lead and other chemicals that is invisible to the eye and is inhaled by children when they play.

Why are chemicals that are banned from children’s toys allowed in artificial turf and rubber playground surfaces?

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals (also called EDCs). There is very good evidence regarding these chemicals in tire crumb, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment (OEHHA).¹However, rubber playground surfaces contain many of the same dangerous chemicals as tire crumb, since they are very similar materials, all made from petroleum.

A 2018 report by Yale scientists detected 92 chemicals in samples from 6 different artificial turf companies. Unfortunately, the health risks of most of these chemicals had never been studied. However, 20% of the chemicals that had been tested are classified as probable carcinogens and 40% are irritants that can cause asthma or other breathing problems, or can irritate skin or eyes.²

There are numerous studies indicating that endocrine-disrupting chemicals (also called hormone-disrupting chemicals) found in rubber and plastic cause serious health problems. Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, hormone-disrupting chemicals can be dangerous at very low levels, and the exposures can also be dangerous when they combine with other exposures in our environment.

That is why the Consumer Product Safety Commission has banned numerous endocrine-disrupting chemicals from toys and products used by children. The products involved, such as pacifiers and teething toys, are banned even though they would result in very short-term exposures compared to artificial turf or playground surfaces.

A report warning about possible harm to people who are exposed to rubber and other hormone disrupting chemicals at work explains that these chemicals “can mimic or block hormones and disrupt the body’s normal function, resulting in the potential for numerous health effects. Similar to hormones, endocrine-disrupting chemicals can function at very low doses in a tissue-specific manner and may exert non-traditional dose–response because of the complicated dynamics of hormone receptor occupancy and saturation.”³

Studies are beginning to demonstrate the contribution of skin exposure to the development of respiratory sensitization and altered pulmonary function. Not only does skin exposure have the potential to contribute to total body burden of a chemical, but also the skin is a highly biologically active organ capable of chemical metabolism and the initiation of a cascade of immunological events, potentially leading to adverse outcomes in other organ systems.

Scientific Evidence of Cancer and Other Systemic Harm

It is essential to distinguish between evidence of harm and evidence of safety. 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 also tell you that for decades there was no evidence that smoking or Agent Orange caused cancer. It took many years to develop that evidence, and the same will be true for artificial turf.

I have testified about the risks of these materials at the U.S. Consumer Product Safety Commission as well as state legislatures and city councils. I am sorry to say that I have repeatedly seen and heard scientists paid by the turf industry and other turf industry lobbyists say things that are absolutely false. They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true).

However, we know that the materials being used in artificial turf and rubber playground surfaces contain carcinogens, and when children are exposed to those carcinogens day after day, week after week, and year after year, they increase 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. That’s why I have spoken out about the risks of artificial turf in my community and on a national level. The question must be asked: if they had all the facts, would your community choose to spend millions of dollars on fields that are less safe than well-designed natural grass fields?

Dangerously Hot and Hard Fields

When the weather is warm and/or sunny, it is usually quite pleasant to be outside – as long as you aren’t on artificial turf or an outdoor rubber surface. Even when the temperature above the grass is 80 degrees Fahrenheit, artificial turf can reach 150 degrees or higher. Obviously, a 90 degree day is likely to be even hotter than 150 degrees on turf. That can cause “heat poisoning” as well as burns.

Artificial turf fields get hard as well. Turf companies recommend annual tests at 10 locations on each turf field, using something called a Gmax score. A Gmax score over 200 is considered extremely dangerous, and it is considered by industry to pose a death risk. However, the synthetic turf industry and American Society for Testing and Materials (ASTM), suggest scores should be even lower — below 165 to ensure safety comparable to a grass field. Will your community pay to have these tests conducted annually on all your public artificial turf fields?

The hardness of natural grass fields is substantially influenced by rain and other weather; if the field gets hard, rain or watering will make it safe again. In contrast, once an artificial turf field has a Gmax score above 165, it needs to be replaced because while the scores can vary somewhat due to weather, the scores will inevitably get higher because the turf will get harder. Gmax testing involves testing 10 different areas of a playing fields, to make sure all are considered safe. Some officials average those 10 scores to determine safety; however, experts explain that is not appropriate. If a child (or adult) falls, it can be at the hardest part of the field, which is why safety is supposed to be determined by the score of the hardest part of the field.

Environmental Issues

In addition to the health risks to school children and athletes, approximately three tons of infill materials migrate off of each synthetic turf field into the greater environment each year. About 2-5 metric tons of infill must be replaced every year for each field, meaning that tons of the infill have migrated off the field into grass, water, and our homes.⁴ The fields also continuously shed microplastics as the plastic blades break down.^5,6 These materials may contain additives such as PAHs, flame retardants, and UV inhibitors, which can be toxic to marine and aquatic life. Microplastics are known to migrate into the oceans, the food chain, and drinking water, and they can absorb and concentrate other toxins from the environment.^7,8,9

Synthetic surfaces also create heat islands.^10,11 In contrast, organically managed natural grass saves energy by dissipating heat, cooling the air, and reducing energy to cool nearby buildings. Natural grass and soil protect groundwater quality; biodegrade polluting chemicals and bacteria; reduce surface water runoff; abate noise; and reduce glare.¹²

Alternative Infills

Envirofill artificial turf fields are advertised as “cooler” and “safer,” but our research indicates that these fields are still at least 30-50 degrees hotter than natural grass. Envirofill is composed of materials resembling plastic polymer pellets (similar in appearance to tic tacs) with silica inside. Silica is classified as a hazardous material according to OSHA regulations, and the American Academy of Pediatrics specifically recommends avoiding it on playgrounds. The manufacturers and vendors of these products claim that the silica stays inside the plastic coating. However, sunlight and the grinding force from playing on the field breaks down the plastic coating. For that reason, even the product warranty admits that only 70% of the silica will remain encapsulated. The other 30% can be very harmful as children are exposed to it in the air as particulate matter that can harm the lungs.

In addition, the Envirofill pellets and some other infill have been coated with an antibacterial called triclosan. Triclosan is registered as a pesticide with the EPA, and the FDA has banned triclosan from soaps because manufacturers were not able to prove that it is safe for long-term use. Research shows a link to liver and inhalation toxicity and hormone disruption. The manufacturer of Envirofill says that the company no longer uses triclosan, but they provide no scientific evidence that the antibacterial they are now using is any safer than triclosan. Microscopic particles of this synthetic turf infill will be inhaled by children, and visible and invisible particles come off of the field, ending up in shoes, socks, pockets, and hair.

In response to the concerns of educated parents and government officials, other new materials are now being used for infill instead of tire crumb and other very controversial materials. However, all the materials being used (such as zeolite, corn husks, and Corkonut) have raised concerns, and none are proven to be as safe or effective as well-designed grass fields.

Conclusions

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.

I have cited several relevant scientific articles on artificial turf in this letter, and there are numerous studies and growing evidence of the harm caused by these synthetic materials. I would be happy to provide additional information upon request (dz@center4research.org).

I am not paid to write this statement. I am one of the many parents and scientists who are very concerned about the impact of artificial fields on our children. Your decision about artificial turf and playground surfaces can save lives and improve the health of children in your community. You owe it to your community to make sure that you know the risks of artificial turf and do all you can to protect your children from both the known risks and the suspected risks. Your decisions about artificial turf will be cited by other communities, making it even more important that your decision is based on scientific evidence, not on sales pitches by individuals with conflicts of interest.

Officials in communities all over the country have been misled by artificial turf salespeople. 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.

Sincerely,

Diana Zuckerman, PhD

President

References

State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007. http://www.calrecycle.ca.gov/publications/Documents/Tires%5C62206013.pdf
Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water, Air, & Soil Pollution. 2018;229:64. https://doi.org/10.1007/s11270-018-3711-7
Anderson SE and Meade BJ. Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals. Environmental Health Insights. 2014; 8(Suppl 1):51–62. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/
York T. Greener grass awaits: Environmental & fiscal responsibility team up in synthetic turf. Recreation Management. February 2012. http://recmanagement.com/feature_print.php?fid=201202fe02
Magnusson K, Eliasson K, Fråne A, et al. Swedish sources and pathways for microplastics to the marine environment, a review of existing data. Stockholm: IVL- Swedish Environmental Research Institute. 2016. https://www.naturvardsverket.se/upload/miljoarbete-i-samhallet/miljoarbete-i-sverige/regeringsuppdrag/utslapp-mikroplaster-havet/RU-mikroplaster-english-5-april-2017.pdf
Kole PJ, Löhr AJ, Van Belleghem FGAJ, Ragas AMJ. Wear and tear of tyres: A stealthy source of microplastics in the environment. International Journal of Environmental Research Public Health. 2017;14(10):pii: E1265. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
Kosuth M, Mason SA, Wattenberg EV. Anthropogenic contamination of tap water, beer, and sea salt. PLoS One. 2018,13(4): e0194970. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895013/
Oehlmann J, Schulte-Oehlmann U, Kloas W et al. A critical analysis of the biological impacts of plasticizers on wildlife. Philosophical Transactions of the Royal Society B. 2009;364:2047–2062. http://rstb.royalsocietypublishing.org/content/364/1526/2047
Thompson RC, Moore CJ, vom Saal FS, Swan SH. Plastics, the environment and human health: Current consensus and future trends. Philosophical Transactions of the Royal Society B. 2009;364:2153–2166. https://royalsocietypublishing.org/doi/full/10.1098/rstb.2009.0053
Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 2014;72:895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
Stier JC, Steinke K, Ervin EH, Higginson FR, McMaugh PE. Turfgrass benefits and issues. Turfgrass: Biology, Use, and Management, Agronomy Monograph 56. American Society of Agronomy, Crop Science Society of America, Soil Science Society of America. 2013;105–145. https://dl.sciencesocieties.org/publications/books/tocs/agronomymonogra/turfgrassbiolog

She’s the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants

February 22, 2022Breast Cancer, In the News, News Stories & Editorials, Uncategorized, We're In the NewsCPTFadmin

Bianca Buono and Katie Wilcox, Arizona News 12 NBC: February 22, 2022

PHOENIX — Migraines. Headaches. Insomnia. Difficulty breathing. Trouble swallowing.

Robyn Towt survived three bouts with cancer. But it was breast implants that made her the sickest.

“I couldn’t figure out what was wrong with me,” Towt said.

At first, it was a mystery. She had recently survived breast cancer then had a double mastectomy with breast reconstruction. The cancer was gone, so why was she feeling so badly?

“My entire team of doctors failed me,” Towt said.

Towt said her team of doctors never mentioned that her breast implants could cause those side effects. She started doing her own research, desperate to figure out why she was feeling this way.

[….]

Undisclosed risks

Diana Zuckerman, president of the National Center for Health Research, has been outspoken about the dangers of implants for years.

“One of the things that’s been so tragic for all these years is how many women got sicker and sicker and sicker, year after year after year, going to doctors saying what’s wrong with me and the doctor saying, you know, I don’t know, do these tests and try to figure it out,” Zuckerman said.

“And then they finally discover on social media, that there are tens of thousands of women with exactly the same health problems they have, who also happen to have breast implants, and then they get their implants out, and they get better.”

Zuckerman has been pushing for acknowledgment from the FDA that breast implant illness exists, advocating for more research around what exactly causes it and pushing for transparency when it comes to the risks.

She says the FDA took a step in the right direction last year when the agency announced breast implants would be equipped with a black box warning.

The FDA boxed warning informs patients of the following:

Breast implants are not considered lifetime devices
The chance of developing complications increases over time
Some complications will require more surgery
Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL
Breast implants have been associated with systemic symptoms

“They’re going to have what’s called a black box warning, that’s like the kind of warning you see on cigarette packages that tell you cigarettes can kill you,” Zuckerman said.

Arizona’s first-of-its-kind bill

Even still, that warning wasn’t always relayed by plastic surgeons to patients. That’s why lawmakers in Arizona decided to take matters into their own hands.

“We have to do something,” said state Sen. Michelle Ugenti-Rita.

Consultations for breast augmentations look different now in Arizona than they did a year ago.

That’s because a first-of-its-kind bill has passed in Arizona created to protect women against a badly kept secret involving breast augmentation surgery: breast implant illness.

“I was shocked to learn that there were so many women with very very similar stories and experiences. And yet there was nothing being done from the medical community’s perspective and point of view,” Ugenti-Rita said.

[….]

To read the entire article click here.