Category Archives: Uncategorized

Everything You Need To Know to Choose Safe Cosmetic Products

Uncategorized

Andrea Sun, MS

Do you know how to pick out the right makeup or skincare products for yourself? Cosmetic products are used by everyone of all ages. They include shampoo, shaving products, and moisturizing creams, as well as make-up, nail polish, and anti-aging products. Promotional videos for cosmetic products are popular among influencers on social media platforms like YouTube and Instagram. Some studies show that the revenue in the U.S. Beauty & Personal Care market will exceed an astonishing $92 billion by the end of 2023.[1]

U.S. consumers use an average of 6 to 12 cosmetic products daily, containing nearly 200 chemicals. With so many choices, and so many potentially risky chemicals, it’s essential to know what to look for when buying these products. Current regulations address some safety concerns for cosmetic products, but many gaps remain.

What are some of the regulations that protect us?

The U.S. has some regulations regarding the manufacturing and selling of cosmetics. Let’s look at what makes cosmetics different from drugs and what might be helpful information when you shop or read the label on a product.

The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as articles intended to make the human body more attractive. Lipsticks, nail polishes, perfumes, skin moisturizers, toothpaste, deodorants, and shampoos are especially popular cosmetics. However, there are some topical products that are sold without prescriptions in drug stores that are not considered cosmetics – they are considered drugs. Drugs are defined as products that can cure, mitigate, treat, or prevent diseases or affect the body’s function. For example, products such as hair loss treatment shampoo and acne medications are considered over-the-counter drugs instead of cosmetics. They are regulated by the FDA to make sure that they are safe and effective.

If a product makes you look better and treats your disease or improves your body’s function, it is both a cosmetic and a drug. One example is anti-dandruff shampoos, since they clean your hair and treat dandruff. Other products, such as deodorants containing antiperspirants, moisturizers, and makeup with sun-protection claims, are also drugs and cosmetics. These are also regulated by the FDA to determine if they are safe and effective.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires manufacturers to list products’ ingredients and manufacturing information, report serious adverse events such as life-threatening reactions, and renew registered facility information at FDA. This law will go into effect on December 29, 2023. Another law, the Fair Packaging and Labeling Act (FPLA), works with MoCRA to ensure consumers receive accurate information. It requires clear labeling of essential information, such as the product’s name and manufacturer and sets standards for quantities and measurements to enable easy comparison across different products. The law also protects consumers from misleading information by prohibiting deceptive packaging or labeling and gives various government agencies the authority to enforce these rules.

The effect of cosmetics on environmental pollution is also limited through regulation. The Microbead-Free Waters Act of 2015 prohibits the manufacturing, packaging, and distributing of rinse-off cosmetics containing plastic microbeads. These tiny plastic particles usually appear in personal care products like facial scrubs, toothpaste, and body washes for their exfoliating properties. However, they pose significant environmental problems, since they could easily pass through water treatment facilities and end up in rivers and oceans. Marine animals could mistake them for food, which would endanger the food chain.

Cosmetic substances that cause health concerns

U.S. regulations require the disclosure of ingredients, but do not set limits on what chemicals can be included in these products. That means that ingredients known or suspected to cause cancer could be in cosmetics that are legally sold in the U.S. This includes chemicals like formaldehyde and formaldehyde-releasers, parabens, phthalates, fragrance, diethanolamine (DEA), and other heavy metals.

● Formaldehyde
Formaldehyde is added to many personal care products to prevent bacteria from growing. Customers sometimes find it in nail polish, shampoo, and body washes. Exposure to low levels can irritate people’s eyes, nose, and throat. However, hair stylists and manicurists who are regularly exposed are more likely to eventually develop nose and throat cancers. A 2019 study in Brazil looked at 23 beauty salons to understand the exposure of hairdressers to formaldehyde and its effects. The result shows that 17% of salons had exceeded the formaldehyde level that is considered safe. Over 65% of the hairdressers reported work-related health issues like eye irritation, skin problems, headaches, limb pain, and breathing difficulties. [8]

● Parabens
Parabens are preservatives commonly used in water-based products. Shampoos, conditioners, face washes, toothpaste, and other cosmetics contain low levels of parabens. Studies on animals indicate that parabens can imitate the actions of the hormone estrogen.[3] that paraben exposure may increase the chances of developing breast cancer in women and disturbances in male reproductive systems. [2]

● Phthalates
Phthalates are chemicals that mimic hormones and are linked to birth defects in animals, especially in the male reproductive system, and are also considered a potential cause for early puberty in boys and girls. They also can increase obesity in children. Personal care product manufacturers started to phase out the direct use of phthalates in 2018 when the U.S. Consumer Product Safety Commission restricted six types of phthalates in children’s toys and child care products after learning about its risks in hormone function and fertility impairment. However, phthalates are still in many products, especially those that smell good.

● Fragrances
Fragrance ingredients are common in self-care products such as shower gels, shampoos, body lotions, and shaving creams. They sometimes are even in products labeled “unscented.” This is because manufacturers are not obligated to label the fragrance in the ingredient list if the amount added is just enough to cover the unpleasant smell of other ingredients versus giving the product a noticeable scent. In the U.S., manufacturers can list fragrance and flavor ingredients as “Fragrance” or “Flavor.” The fragrance is usually a company’s “trade secret,” so they do not need to disclose it. Diethyl phthalate, or DEP, is the phthalate commonly used in fragrance products and is not proven to harm people’s health.

● Diethanolamine
Diethanolamine, also called DEA, is an emulsifier in creamy or foamy products like shampoos and shaving creams. Its reaction with other preservatives in personal care products will form nitrosamines, a human carcinogen according to the International Agency for Research on Cancer and the U.S. National Toxicology Program. Europe and Canada prohibit DEA in cosmetics. Why doesn’t the U.S. FDA?

● Heavy metals
Personal care products such as lipstick, whitening toothpaste, eyeliner, and nail polish often contain heavy metals, including lead, arsenic, mercury, aluminum, zinc, chromium, and iron. Exposure to some of these metals can raise health concerns, particularly affecting the reproductive, immune, and nervous systems. Though “plant-source derived” might sound safe to many customers, several ingredients, such as cottonseed oils and rice derivatives, may contain heavy metals such as lead and mercury, which can harm fertility, cause brain damage, and harm breathing. Sometimes metals are deliberately added to cosmetics; for example chromium is commonly found in eye shadows, blushes, and concealers.

Cosmetics and the Environment

Ingredients from cosmetics can harm our environment. Products such as makeup remover wipes, exfoliating scrubs with microbeads, face sheet masks, skin-whitening creams, and sprays and mists contain non-biodegradable ingredients and chemicals that can harm the environment, waterways, marine life, and even the ozone layer. A 2023 study suggested that microplastics, tiny plastic particles between 100 nm and 5 mm, can move up the food chain from small sea creatures to larger ones, carrying harmful pollutants that could end up in humans.[4]

Additionally, triclosan (TCS), an antimicrobial substance that is often in shampoos, detergents, hand soaps, toothpaste, sunscreen, and deodorants, can also damage the environment. A 2020 study shows that people are more likely to have TCS in their blood, urine, and breast milk if they apply personal care products containing TCS.[5] This can harm human health and our environment, causing an itchy rash, decreased sperm production, and tumors. If TCS is in the environment, it becomes highly poisonous during wastewater treatment, accumulating in animals, plants, and algae, disrupting the ecosystem.

Does consistent exposure to cosmetics harm beauticians’ health?

Hair stylists, manicurists, aestheticians, and other beauticians are constantly exposed to chemicals and heat in their working environments. Do they have a higher risk of some diseases due to these exposures? What can they do to protect themselves from these exposures during work?

A 2021 study examined the chemical and physical conditions in hair salons and assessed the health risks of volatile organic compounds (VOCs) for hairdressers.[6] VOCs are organic chemical components in hair spray that carry substances that can cause heart disease, irritation, insomnia, and nerve damage. This exposure also increases the chances of developing cancer. Installing exhaust ventilation is one of the most effective methods to lower the VOC concentration in the salon. Nail professionals in U.S. salons are also frequently exposed to dangerous chemicals in adhesives, lacquers, removers, moisturizers, and other salon items that can cause breathing problems, rashes, liver complications, reproductive issues, and even cancer. Chemicals found in nail products, such as acetone in nail polish remover, formaldehyde in nail polish and nail hardener, and toluene fingernail glue, can cause headaches, dizziness, allergic reactions, and harm the fetus during pregnancy. For that reason, nail salons should be required to make sure products are 3-free (free from toluene, formaldehyde, and dibutyl phthalate) and free from acid. Nail professionals should always review product labels and instructions when using nail products. [7]

So, what can you do to protect yourself while enjoying personal care products?

1. Read ingredient labels and remember that Ingredients appear in order from highest to lowest concentration. Pay attention to ingredients with higher concentration and avoid those you are allergic to or that can cause environmental problems. See ingredients you want to avoid in cosmetics.
2. When it comes to self-care routine, more is not necessarily better. Skin irritation can occur when layering products. Applying daily makeup without adequately removing it might also disrupt the skin’s protective barrier and cause eye infections and premature aging. Therefore, it is important to build a simple yet effective routine that works well for you and stick with it. Read here for more skin care tips.
3. Choose traditional nail polish over gel polish. Acetone is used to remove gel polish. Traditional nail polish is strong and doesn’t require remover made with acetone. If you use a remover made with acetone, soak a cotton ball in it to remove the polish. Read more here.
4. Cosmetic products that are less dangerous are usually better for the environment as well. Products with sustainable packaging such as refillable and reusable cosmetics can reduce plastic pollution.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

1. Beauty & Personal Care – United States. Statista. https://www.statista.com/outlook/cmo/beauty-personal-care/united-states
2. Sheikh, Knvul. Many Personal Care Products Contain Harmful Chemicals. Here’s What to Do About It. New York Times. 2023.
3. Hager, E., Chen, J., & Zhao, L. Minireview: Parabens Exposure and Breast Cancer. International journal of environmental research and public health, 19(3), 1873. https://doi.org/10.3390/ijerph19031873
4. Zhou, Yuwen., Ashokkumar, Veeramuthu., & Amobonye, Ayodeji. Current Research Trends on Cosmetic Microplastic Pollution and Its Impacts on the Ecosystem: A Review. Environmental Pollution. Vol. 320. 2023. https://doi.org/10.1016/j.envpol.2023.121106
5. Bilal, Muhammad., Mehmood, Shahid., & Lqbal, Hafiz. The Beast of Beauty: Environmental and Health Concerns of Toxic Components in Cosmetics. Cosmetics. 2020, 7(1), 13. https://doi.org/10.3390/cosmetics7010013
6. Senthong, P., & Wittayasilp, S. Working Conditions and Health Risk Assessment in Hair Salons. Environmental health insights, 15, 11786302211026772. 2021. https://doi.org/10.1177/11786302211026772
7. Health Hazards in Nail Salons. Occupational Safety and Health Administration. n.d. https://www.osha.gov/nail-salons/chemical-hazards
8. Pexe, M. E., Marcante, A., Luz, M. S., Fernandes, P. H. M., Neto, F. C., Sato, A. P. S., & Olympio, K. P. K. Hairdressers are exposed to high concentrations of formaldehyde during the hair straightening procedure. Environmental science and pollution research international, 2019; 26(26), 27319–27329. https://doi.org/10.1007/s11356-019-05402-9

US Mammogram Update Sparks Concern, Reignites Debates

Breast Cancer, Uncategorized

Kerry Dooley Young, Medcape, July 19, 2023

A recent update to the US recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.

The US Preventive Services Task Force (USPSTF) is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.

The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.

The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design (V-BID) at the University of Michigan, Ann Arbor, told Medscape.

For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.

However, Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screening mammogram.

A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs those with the highest.

[….]

The Ongoing Debates

Concerns over the costs of potential follow-up tests are not the only issues experts have highlighted since USPSTF released its updated draft guidance on screening mammography.

The task force’s proposed update has also reignited questions and uncertainties surrounding when to screen, how often, and what types are best.

When it comes to frequency, the major organizations that provide screening guidance don’t see eye to eye. The USPSTF recommends breast cancer screening every other year, while the American College of Radiology (ACR) recommends screening every year because that approach leads to saves “the most lives.”

At this time, the American College of Obstetricians and Gynecologists (ACOG) guidance currently teeters in the middle, suggesting either annual or biennial screening and highlighting the pros and cons of either approach. According to ACOG, “annual screening intervals appear to result in the least number of breast cancer deaths, particularly in younger women, but at the cost of additional callbacks and biopsies.”

When to begin screening represents another point of contention. While some experts, such as ACOG, agree with the task force’s decision to lower the screening start age to 40, others point to the need for greater nuance on setting the appropriate screening age. The main issue: the task force’s draft sets a uniform age to begin screening, but the risk for breast cancer and breast cancer mortality is not uniform across different racial and ethnic groups.

A recent study published in JAMA Network Open found that, among women aged 40 to 49, breast cancer mortality was highest among Black women (27 deaths per 100,000 person-years) followed by White women (15 deaths per 100,000 person-years). Based on a recommended screening age of 50, the authors suggested that Black women should start screening at age 42, whereas White women could start at 51.

“These findings suggest that health policy makers and clinicians could consider an alternative, race and ethnicity–adapted approach in which Black female patients start screening earlier,” write Tianhui Chen, PhD, of China’s Zhejiang Cancer Hospital and co-authors of the study.

Weighing in on the guidance, the nonprofit National Center for Health Research urged the task force to consider suggesting different screening schedules based on race and ethnicity data. That would mean the recommendation to start at age 40 should only apply to Black women and other groups with higher-than-average risk for breast cancer at a younger age.

“Women are capable of understanding why the age to start mammography screening may be different for women with different risk factors,” the National Center for Health Research wrote in a comment to USPSTF, provided to Medscape by request. “What is confusing is when some physician groups recommend annual mammograms for all women starting at age 40, even though the data do not support that recommendation.”

While the ACR agreed with the task force’s recommendation to lower the screening age, the organization suggested starting risk assessments based on racial variations in breast cancer incidence and death even earlier. Specifically, the ACR recommended that high-risk groups, such as Black women, get risk assessments by age 25 to determine whether mammography before age 40 is needed.

  Screening options for women with dense breasts may be some of the most challenging to weigh. Having dense breasts increases an individual’s risk for breast cancer, and mammography alone is not as effective at identifying breast cancer among these women. However, the evidence on the benefits vs harms of additional screening beyond mammography remains mixed.

As a result, the task force decided to maintain its “I” grade on additional screening beyond mammography for these women — a grade that indicates insufficient evidence to determine the benefits and harms for a service.

The task force largely based its decision on the findings of two key reports. One report from the Cancer Intervention and Surveillance Modeling Network, which modeled potential outcomes of different screening strategies, indicated that extra screening might reduce breast cancer mortality in those with dense breasts, but at a cost of more false-positive reports.

The second report, a review from the Kaiser Permanente Evidence-based Practice Center, reaffirmed the benefits of routine mammography for reducing deaths from breast cancer, but found no solid evidence that different strategies — including supplemental screening in women with denser breasts — lowered breast cancer mortality or the risk of progression to advanced cancer. Further studies may show which approaches work best to reduce breast cancer deaths, the report said.

In this instance, ACOG agreed with USPSTF: “Based on the lack of data, ACOG does not recommend routine use of alternative or adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.”

Women with dense breasts should still be encouraged to receive regular screening mammography, even if the results they get may not be as accurate as those for women with less dense breasts, said Diana L. Miglioretti, PhD, of the University of California, Davis, who worked on a report for the USPSTF guidelines.

What’s Next?

Despite ongoing debate and uncertainties surrounding some breast screening guidance, support for ending copay requirements for follow-up tests after a positive mammogram finding is widespread.

[….]

When the USPSTF finalizes its breast screening guidelines, the recommendations will be woven into discussions between primary care physicians and patients about breast cancer screening.

To read the entire article, click here.

NCHR Comments on USPSTF Draft Recommendation on Breast Cancer Screening

Breast Cancer, Legislation, Policy, Uncategorized,

June 6, 2023

We are pleased to have the opportunity to express our views regarding the U.S. Preventive Services Task Force Draft Recommendation Statement regarding breast cancer screening.

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.

While we support the task’s draft recommendation that women who are at average risk of breast cancer should undergo a screening every other year rather than annually, we are concerned that the task force’s recommendation of lowering the age of screening mammography from 50 years old to 40 years old is broadly applied to all women, rather than directed at groups most at risk. The guidelines are only supposed to be regarding women of average risk of breast cancer, and information is widely available to indicate some women are at higher risk because of genetic predispositions, smoking, obesity, family history, and other factors.  Dense breasts are also a risk factor, but unfortunately breast density also makes mammography less accurate[1] and tends to be especially high for women under the age of 50[2].

It is especially important to note that the most recent research, which may post-date the writing of these draft recommendations, had findings that suggested that Black females should start screening approximately 8 years earlier than White women, and that Hispanic and Asian and Pacific Islander females could start even later[3]. For that reason, we urge the USPSTF to consider whether the recommendation to start at age 40 should only apply to Black women and to other women who also have higher than average risk of breast cancer at a younger age, whereas starting at age 50 or even later is scientifically supported for other racial/ethnic groups that have been studied.

We agree with the USPSTF that there is not enough evidence to recommend screening mammography for women 75 years old or older.

We also agree that biennial mammogram screening has benefits that outweigh the risks for most women between the ages of 50-74 and for women at high risk between the ages of 40-50, there is currently insufficient evidence that using additional screening tools, such as using an MRI following a screening mammogram, is beneficial even for women with dense breasts, unless a diagnosis is needed when abnormalities are shown during the mammogram.

We understand that the USPSTF may be reluctant to suggest different screening schedules for Black women or for any specific group of women, but we urge the Task Force to focus on the scientific data. In this case, that includes different recommendations based on race and ethnicity data. Women are capable of understanding why the age to start mammography screening may be different for women with different risk factors. What is confusing is when some physician groups recommend annual mammograms for all women starting at age 40, even though the data do not support that recommendation. USPSTF should not compromise its standards to be more similar to those recommendations.

NCHR is grateful for the opportunity to comment on this USPSTF draft recommendation. The National Center for Health Research can be reached at info@center4research.org or (202) 223-4000.

 

REFERENCES

1) Kolb TM, Lichy J, Newhouse JH. Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology. 2002 Oct;225(1):165-75. doi: 10.1148/radiol.2251011667. PMID: 12355001.

2) Barrette, Lori, Breast Density: What Women Should Know” University of Rochester Medical Center. 15 October 2015. <https://www.urmc.rochester.edu/news/publications/health-matters/breast-density-what-women-should-know>

3) Chen T, Kharazmi E, Fallah M. Race and Ethnicity–Adjusted Age Recommendation for Initiating Breast Cancer Screening. JAMA Netw Open. 2023;6(4):e238893. doi:10.1001/jamanetworkopen.2023.8893

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

Uncategorized, We're In the News

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?

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

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

Policy, Testimony & Briefings, Uncategorized

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

    Uncategorized

    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

    Uncategorized

    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

    Uncategorized

    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

    Testimony & Briefings, Uncategorized

    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.