Category Archives: We’re In the News

Lilly battling rivals for breast-cancer patients

In the News, We're In the News

John Russell, Indianapolis Business Journal, June 9, 2023

Eli Lilly and Co. is pushing hard to gain a sales edge against two other drugmakers in the war against metastatic breast cancer. It is spending hundreds of millions of dollars to win over patients with an extensive advertising campaign.

The Indianapolis-based company, maker of cancer drug Verzenio, is blanketing airwaves with commercials that tout its drug’s track record in helping afflicted women live a little longer.

Metastatic breast cancer—also known as MBC or stage 4 breast cancer—is a tough, crippling disease without a cure that claims about 40,000 lives a year. The disease is the most severe form of breast cancer. Nearly three-quarters of all women diagnosed with the disease die within five years.

Last year alone, Lilly spent $111.8 million advertising Verzenio, according to ad-tracking specialist iSpot.tv, as reported by Fierce Pharma Marketing, an industry newsletter. That made Verzenio the 10th-most advertised drug in the U.S. by spending, up 60% from $70.1 million in 2021.

No other cancer drugs broke the top 10 list for advertising spending. (Lilly has two other drugs on the top 10 list—diabetes drug Jardiance, fifth-highest; and diabetes drug Trulicity, seventh-highest.)

Lilly declined to say how much it is spending on its Verzenio campaign, or to confirm the outside estimates. But it defended the use of the direct-to-consumer marketing effort.

[….]

The drugmaker has produced about 10 TV spots for Verzenio since 2018, and two of them are currently running as part of a “Future Photos” campaign for women with metastatic breast cancer. It is also running two spots highlighting use of Verzenio for treatment of early breast cancer as part of its “Make Your Way” campaign.

Lilly shows no sign of slowing its advertising push for Verzenio as it competes against Pfizer’s Ibrance and Novartis’ Kisqali in the war against metastatic breast cancer.

All three medicines belong to a class of drugs called CDK inhibitors, which work by blocking overactive enzymes that would otherwise allow cancer cells to proliferate.

[….]

The drugs are not cheap. List price for Verzenio or Ibrance is about $14,500 a month. For Kisqali, the price ranges from $6,000 to $15,000 a month, depending on the dosage. The actual price for all three drugs varies, depending on health plans and pharmacies.

Three-way fight

Some experts say the three-way advertising war is likely to confuse patients, as they try to figure out, with their doctors, which medicines are likely to help and what to expect from the side effects.

Common side effects for Verzenio, for example, are diarrhea, low white-blood-cell counts, anemia, nausea, headaches and tiredness.

“Competition can be good if it keeps prices down, but otherwise it can be confusing, because they all have different risks,” said Diana Zuckerman, an epidemiologist and president of the National Center for Health Research, a nonpartisan health think tank in Washington, D.C. “It’s rather impossible for the average person to make sense of the list of risks even if they read them.”

[….]

Last month, Lilly launched its latest commercial for Verzenio, an upbeat, 60-second spot that encourages patients to look ahead, not just back. The commercial opens with a 60-something, gray-haired woman sitting on a couch, flipping through a photo album.

“Living with metastatic breast cancer means I cherish my memories,” she says in a voiceover. “But I don’t just look back on them. I look forward to the chance to make new ones every day with Verzenio.”

The camera zooms in to show a new section of the album, titled “Future Memories.” The pages scroll by, showing pictures of the woman at an alumni reunion, a backyard cookout, a New Year’s Eve party and other celebrations, with everyone wearing big smiles.

“Verzenio is proven to help you live significantly longer when taken with fulvestrant,” the announcer says. How much longer? According to small type at the bottom, women who take Verzenio and fulvestrant (an older drug for breast cancer) lived for a median of 46.7 months, versus 37.3 months on fulvestrant alone.

Some experts raised an eyebrow when asked about the “significantly longer” claim, given that the additional survival benefit of Verzenio is about nine months, compared to taking an older drug alone.

“When people hear ‘significant,’ they probably think an extra year or two of life, at least,” Zuckerman said. “For cancer drugs, living nine months longer is considered a meaningful benefit, unless the side effects—nausea, vomiting, diarrhea, exhaustion, etc.—make a person’s life miserable. Wouldn’t you rather have 37 enjoyable months instead of 46 miserable months?”

Indeed, the announcer spends nearly half of the 60-second Verzenio spot listing common side effects and warning patients to see their doctors immediately. (“Blood clots that can lead to death have occurred.”)

Lilly said its direct-to consumer marketing campaign has been successful “at raising awareness and helping patients feel more prepared for discussions about Verzenio with their physicians.”

Two national patient-advocacy groups, Breast Cancer Action and the National Breast Cancer Coalition, declined to comment about the competition among the three drugmakers or the effectiveness of the drugs. Nor did they comment about whether direct-to-consumer marketing was helpful.

Some breast cancer patients who are taking Verzenio acknowledge that the drug has powerful side effects, including diarrhea, but they take it on the advice of their oncologist.

[….]

The ads run only in the United States, one of the few countries to allow direct-to-consumer drug advertising. IBJ asked a few patients who live overseas to look at the ads on the website iSpot.tv for their reaction.

Debbie Donnison, 61, of Worcester, England, who was diagnosed in 2022 with stage 4 breast cancer, said she has read the package insert sheets carefully but was alarmed when listening to the announcer rattling through them in the TV spot.

“They sound terrifying without context,” she said. “…They say them as fast as possible whilst your brain is saying, ‘Hey, hang on a minute.’ I realize they don’t want to focus on them, though, and time is short.”

To read the entire article, click here. 

For Canadian Patients, Therapeutic Psychedelics Beset by Red Tape

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Jonathan Moens, Undark, March 8, 2023

IN JANUARY OF 2022, Janis Hughes was told she had two years to live. After two prior bouts of cancer, she was now told she had stage 4 breast cancer, which had already spread to her sternum, ribs, and right lung. The news devastated her, making her feel “a great weight” pressing on her chest, robbing her of any joy. One day, she came across a documentary about how psilocybin mushrooms, commonly known as magic mushrooms, combined with therapy could help people with terminal cancers get relief from their existential dread. Hughes, now 66, was not one for taking what she considered “hard drugs,” but she was intrigued.

“I had nothing to lose at this point, and it just resonated with me — oh, that’s what I need,” she said.

Getting access to these drugs, however, was not going to be easy. In Canada, where Hughes lives, it is generally illegal to use psychedelics outside of a research setting. But since 2020, the government has allowed a small number of patients to seek medical exemptions. More recently, in January 2022, Canada reversed a regulatory restriction that had prohibited patients from accessing restricted drugs, including psychedelics, through its Special Access Program. The SAP, which is overseen by Health Canada, the nation’s public health agency, allows patients with serious or life-threatening conditions to obtain emergency access to unapproved medications when conventional therapies have failed or are otherwise unsuitable.

Canada’s recent policy change makes it among the few countries in the world to explicitly offer psychedelics on a compassionate or emergency use basis.

Hughes applied through the SAP, but soon ran into a hurdle: She had to find a doctor willing to fill out an eight-page form; administer psilocybin, the psychoactive compound in magic mushrooms; and oversee the entire process. The doctor would also have to take responsibility in case anything went wrong. She asked two oncologists at her cancer center and her family physician, but all of them declined. One oncologist had never heard of psilocybin-assisted therapy for terminal cancer patients, Hughes said, and the other told her that she preferred not to get involved because of the amount of paperwork. Her family physician was open to helping with her application, she said, but didn’t want to be responsible for overseeing her use. When Hughes finally found a willing doctor, she would have to travel more than 1,000 miles across Canada to an unfamiliar city to be treated. She decided against it.

[….]

“This SAP process is really a horrible process for getting patients access to experimental drugs like psilocybin,” said Spencer Hawkswell, CEO of TheraPsil, a nonprofit psychedelic advocacy group based in British Columbia that currently works on assisting patients in applying through the SAP. “It just doesn’t work.”

Not everyone sees the SAP so bleakly. While the program may be slow, some medical ethicists and physicians say the application form asks perfectly legitimate questions and should help ensure that the drugs are prescribed safely and effectively. Psychedelics hold a lot of promise, they argue, but the evidence surrounding their use is still preliminary, so safeguarding against misuse is critical.

These experts also say that the best way to get access to these drugs is through a clinical trial, a type of study that tests how well a treatment works in humans. Such trials guarantee a certain level of safety and help health regulators compile data to rigorously identify the benefits of the drugs. “Then all patients could ideally have access to them without going through these pathways,” said Holly Fernandez Lynch, an assistant professor of medical ethics and health policy at the University of Pennsylvania.

Clinical trials specific to these patients are rare, however, and conducting one is costly. And according to the SAP’s critics, patients are often left with few legal options.

THE FIRST STUDIES specifically looking at how psychedelics could help patients with existential distress took place in the late 1960s in the United States. While the studies mostly focused on drugs other than psilocybin, they generally seemed to suggest that psychedelics could help terminal cancer patients relieve deep-seated feelings of anxiety. But those studies came to a halt in 1970, when the country’s Controlled Substances Act banned psychedelics and classified these and other drugs as “Schedule I,” meaning they were now considered to have “no currently accepted medical use” and “a high potential for abuse” by federal law.

It was only about 30 years later that scientists picked up where they had left off. Of particular importance were two seminal studies published in 2016 by researchers at Johns Hopkins University and New York University, respectively, showing that terminally ill patients experiencing distress exhibited significant improvements in mood, anxiety, quality of life, and depressive symptoms after a single high dose of psilocybin. The studies had notable limitations: The sample sizes were relatively small, about 90 percent of participants were White, and about half had post-graduate education. But, for most of the NYU study participants, the drugs had quick and positive effects that lasted at least four and a half years.

End-of-life anxiety is not an official clinical diagnosis, however, so there was no pathway to approval by the U.S. Food and Drug Administration. Scientists soon pivoted to other conditions, including treatment-resistant depression. One of the latest studies on these patients found that psilocybin alleviated depressive symptoms as well as escitalopram, an often-used antidepressant. Last November, the biggest study on this group of patients to date, with more than 200 participants, showed that a high dose of psilocybin significantly reduced depression scores.

[….] And questions about how the drug actually works in the brain still remain. Scientists are just starting to map the specific receptors, pathways, and brain regions that seem to be altered when patients are on psychedelic drugs; there is currently no consensus on what biological mechanisms might explain the drugs’ anxiety-relieving or mood-boosting effects.

“The really quick answer,” said Albert Garcia-Romeu, an assistant professor and researcher in the psychedelics research center at Johns Hopkins: “We don’t know.”

[….]

SEVERAL HEALTH EXPERTS who do not have direct ties to Health Canada or to psychedelic advocacy groups reviewed the SAP application form for Undark and said they do see merit in the questions. Among other things, the form asks for patient and drug manufacturer information, the rationale for prescribing the drug, and treatments the patients have tried already.

“None of those things strike me as an outrageous ask,” said Fernandez Lynch, the University of Pennsylvania professor.

Quite the contrary, these questions are a necessary vetting tool to ensure the safe distribution of unapproved drugs, said James Downar, the head of palliative care at the University of Ottawa.

Hawkswell acknowledged that many of the questions posed are legitimate but said that much of the wasted time comes from physicians having to answer “absurd” follow-up questions by Health Canada, like asking doctors why symptoms like suicidal ideation, severe depression, and hopelessness are unacceptable.

In one example, Health Canada asked a medical professional to provide reasons why two of his patients, who were applying to use psilocybin through the SAP, couldn’t seek other legal treatments, including electroconvulsive therapy.

While ECT is approved for treatment of severe depression, mania, and schizophrenia in Canada, the therapy is controversial and, in some cases, can lead to serious adverse effects, including memory loss. Eventually, after some discussions with the health agency and pressure from the media, the SAP approved psilocybin for all four of his patients.

The controversy highlights what critics see as the heart of the issue: Unlike physicians, SAP health officials are trained to “check boxes” that follow internal guidelines and not to carefully evaluate what treatment is best for patients, Masuda said. Requests passing through the U.S. equivalent of the SAP, known as expanded access, are also vetted by health officials within the FDA, but the final say rests squarely with the medical professional, said Diana Zuckerman, president of the National Center for Health Research, who was involved in finding ways to improve the U.S. program. In fact, she said, the FDA approves expanded access requests in virtually all instances and the relevant forms are designed to be easy to complete and take about 20 minutes.

The SAP could follow a similar model. It might also benefit from creating a standardized form with pre-written answers that physicians could check off and determine whether their patients are eligible for psychedelic drugs, said Garcia-Romeu, the Johns Hopkins researcher. That way, the process would be streamlined, there would be fewer ambiguities, and drugs would likely be more fairly distributed.

[….]

To read the entire article, click here.

Many pediatric drug study results were never posted to a U.S. government database

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Ed Silverman, Stat News, January 24, 2023

Amid ongoing controversy over clinical trial transparency, a new analysis found that results of 43 studies involving thousands of children were never reported to a U.S. government database or published in the scientific literature.

In some cases, medicines being studied were for such life-threatening conditions as congenital heart disease and Duchenne muscular dystrophy. One study explored the use of a particular painkiller for reducing the amount of opioids needed to treat pain following heart surgery. Another tested a drug for lowering aggression among children diagnosed with attention deficit hyperactivity disorder, or ADHD.

In each instance, the researchers scoured ClinicalTrials.gov, the federal database, and medical journals, but were unable to find results. More than 3,600 children participated across the 43 studies. There was partial information posted to the database or published in journals for another 22 studies, although the researchers noted that medical journal findings can be unreliable or omit relevant outcome data.

“When any adult or child participates in a clinical trial, they are taking a risk for the greater good, but if the results are not made public, those studies are of no help to anyone,” said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank that was one of three organizations that conducted the analysis. “Our next step is to work with Congress to fix this situation.”

The study has not yet been published in a scientific journal, but was made available on medRxiv, a preprint server. These platforms have become an increasingly popular destination for many studies before they have been peer-reviewed by medical journals.

In one instance, Astria Therapeutics failed to post results for an open label extension study of a drug to combat Duchenne muscular dystrophy. The study enrolled 130 boys. But after the Phase 3 trial failed, research into the drug was abandoned and the study was terminated. The company made the Phase 3 results available 110 days later than required by law.

But results for the extension study have still not been posted to ClinicalTrials.gov and are more than a year overdue. TranspariMED, another of the organizations that conducted the analysis, wrote that it was unable to locate final results from the extension study in scientific The company did not provide an explanation. We asked the company for an explanation and will update you accordingly.

In another instance, Phoenix Children’s Hospital ran a trial to determine whether a painkiller, ketorolac, could reduce opiates needed to treat pain in children after heart surgery. The hospital sought to enroll 166 infants and children aged between 3 months and 4 years. The primary completion date was December 2020, but results were never posted and the hospital did not respond to TranspariMED. We asked the hospital for comment and will pass along any reply.

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To read the entire article, click here.

Lawmakers, advocates press for diversity in clinical trials

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Erin Durkin, National Journal, February 15, 2023

Congress in December enacted new requirements that require drug- and device-makers to ensure there is sufficient diversity in their clinical trials. Yet lawmakers and advocates don’t want to stop there.

Among them is Democratic Rep. Robin Kelly, who plans to reintroduce a bill this month that would require sponsors of research funded by the National Institutes of Health to lay out recruitment goals that reflect the race, ethnicity, age, and sex of patients who have the condition being studied or that reflect the general population of the United States. Republican Rep. Brian Fitzpatrick cosponsored the measure. Republican Sen. Susan Collins and Democratic Sen. Bob Menendez sponsored a companion bill in the Senate.

“Racial and ethnic minorities are not properly represented in clinical research. That’s the bottom line,” Kelly told National Journal.

The proposal aligns with a measure enacted as part of the massive government-funding bill passed at the end of December. That provision requires drug and device sponsors to submit diversity action plans to the Food and Drug Administration. The agency is also required to develop new guidelines or update already existing guidance for these plans.

Kelly said her focus on NIH clinical trials can complement the FDA measures because there are “things that NIH will capture that FDA won’t capture.”

[….]

Eyes are now on the implementation of the new requirements for the FDA. Diana Zuckerman, president of the National Center for Health Research, said she is concerned that the new provisions lack teeth but that it is “potentially helpful” that Congress “reminds the agencies that they’re not happy with the lack of diversity.”

Ricki Fairley, cofounder and CEO of Touch, The Black Breast Cancer Alliance, said Kelly’s bill focusing on the NIH is a start, and that “we need more of this.” She said participation in a clinical trial should reflect “the burden of disease.”

“Who is getting this disease, who’s dying from it … that’s who should be in the trials. … Until we get that level of care and support, it’s not going to change,” said Fairley, who works on the campaign When We Tri(al), which aims to get more Black women to enroll in clinical trials for breast-cancer treatments.

“I know I can’t change the mind-set of a health care professional with illicit bias—I can’t change that,” she said. “What I can change—I can talk to Black women, educate Black women, and … teach them how to advocate for themselves.”

Kelly said her bill won’t fully solve the issue of diversity in clinical trials but that “it will take care of some things.” Along with submitting recruitment plans for clinical trials, the measure would require NIH and FDA to conduct a national awareness and educational campaign around the need for diverse clinical trials. She pointed to the use of “trusted messengers” during the COVID-19 pandemic to get people vaccinated.

To read the entire article, click here.

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.

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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.

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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.

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

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

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

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

Toxic Chemicals in Artificial Turf and Infill Materials

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

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

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

Evidence of Harm vs. Evidence of Safety

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

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

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

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

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

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

Bottom Line

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

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

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

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

Letter to the Editor: Asphalt playgrounds are bad for kids. So is artificial grass

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Los Angeles Times and Yahoo News, September 7, 2022

To the editor: It’s frightening that L.A. schoolchildren are playing on sizzling asphalt, but the commentary and reporting on it miss an important part of the story.

Years of research show that the school playground surfaces that are even hotter than pavement are made from artificial turf or colorful rubber. On a warm, sunny day, when grass fields are about 90 degrees, artificial turf fields are often 150 degrees or hotter; my organization has measured temperatures up to 180 degrees. Rubber playground surfaces are similarly hot.

Artificial turf is sometimes installed in an effort to save water, but unfortunately, artificial turf must be watered to prevent it from getting so hard that it can cause injuries when children fall.

Scientists have clearly documented the dangers of artificial turf, including heat and PFAS and other chemical exposures, but their concerns are regularly ignored by school boards and other community decision makers. The Times can contribute to the health and safety of children across the country by examining what these dangers are and why they are being ignored.

Diana Zuckerman, Washington

The writer is president of the National Center for Health Research.

This letter originally appeared in Los Angeles Times.

Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust

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

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

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

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

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

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

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

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

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

Building Resiliency

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

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

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

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

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Fighting Misinformation

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

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

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

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

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

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

To read the entire article, click here.

FDA official bolting to Big Tobacco shines a light on the agency’s revolving-door problem

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Dan Vergano, Grid News, August 3, 2022

The departure of the head of the Food and Drug Administration’s tobacco science office for a job in the tobacco industry shines a new spotlight on a long-running problem: the “revolving door” between government regulators and the industries they police.

Matt Holman, whose work at the FDA influenced decisions around the safety of products such as e-cigarettes, left the agency Tuesday for a job with Philip Morris International, whose products — sold overseas — include Marlboro cigarettes and the electronic tobacco-delivery system IQOS.

Agency watchdogs say where there is smoke, there’s an ethics fire. They’ve warned of revolving-door concerns — only well-documented for high-level positions and for the Defense Department — for decades. But there is little hard data on just how big the problem is. A Grid analysis of LinkedIn profile data suggests that at least 2,700 ex-FDA employees now work for the pharmaceutical industry. Another 1,100 current FDA employees have moved the other way, from industry to the agency, according to the profile information.

Former FDA employees are found throughout many other industries regulated by the agency as well: Around 1,200 now work in the biotechnology industry, and more than 600 work in the medical devices industry. Some of the most high-profile examples include Trump FDA chief Scott Gottlieb, on the board of directors of Pfizer weeks after he left the job, as well as the current commissioner, Robert Califf, who went from heading FDA during the Obama administration to Alphabet Inc.’s health subsidiaries, and then back to heading the agency this year. Califf pledged not to work for a pharmaceutical or medical device firm for four years after leaving his current post to win the Senate votes he needed for his confirmation.

In a July 26 memo announcing Holman’s departure, newly installed FDA Center for Tobacco Products Director Brian King said that Holman had recused himself from tobacco-related regulatory decision-making and been on leave before July. “I’m grateful to Matt for his contributions to the Center and unwavering commitment to you all over the years,” said King.

The numbers are both interesting and not surprising, said Michael Carome of Public Citizen, a public health watchdog group based in Washington, D.C. The count likely underestimates the number of agency employees who have jumped to the industries they once regulated, he added, and obviously doesn’t include industry figures who have moved to the agency, where they briefly stay before returning to their home industry, another area of concern for ethics experts.

“Unfortunately, when you see somebody go from a regulating agency to the regulated industry, the public is naturally going to react like it’s a betrayal, because it does call into question your commitment to the mission of protecting the public,” said government ethics expert Walter Shaub of the Project on Government Oversight. While regulated companies may honestly want the expertise of the people charged with regulating them, said Shaub, “the other thing is that they want to know the inside workings of the FDA.”

“They want to, or one might suspect they want to, create an atmosphere in which employees at FDA know that there’s a lucrative job waiting for them, potentially, as long as they don’t really upset the regulated industry, right? I just think that’s human nature,” he added.

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Regarding Holman, Philip Morris International said the former FDA official “is committed to helping existing adult smokers access scientifically substantiated smoke-free alternatives while protecting youth,” in a statement sent to Grid.

Holman is barred from communicating with the FDA about Philip Morris for a year, under ethics rules, and about any matter he was personally involved with at the agency for life. In comments to the New York Times, Holman defended his move, noting that he consulted with agency ethics lawyers and viewed Philip Morris International as moving away from cigarettes to less harmful tobacco products, saying he could have jumped to the industry much earlier after 20 years at the FDA if that had been his goal. (He has not yet responded to a request for comment from Grid.)

However, numerous regulatory affairs or drug development employees at FDA-regulated pharmaceutical companies, including Merck, Abbott and Johnson & Johnson, worked at the FDA for more than a decade prior to moving to the industry, according to the LinkedIn data. “The idea that they recuse themselves is really BS, because they are telling the companies how to manipulate the system behind the scenes,” said Diana Zuckerman, president of the National Center for Health Research, herself a former Department of Health and Human Services employee.

Holman’s departure comes as the Biden administration has turned up the heat on the tobacco industry, planning to require slashing nicotine in cigarettes to minimally addictive levels, and moving to prohibit menthol cigarettes. A 2016 law has led to a crackdown on e-cigarettes, threatening small vaping shops and leading to a lawsuit with Juul after the agency last month ordered the e-cigarette maker to halt sales, despite allowing tobacco giant RJR to sell its own e-cigarettes. The agency’s tobacco and food safety programs are now under external review after the recent infant formula shortage and a surge in teens vaping nicotine since 2017.

“There have been a lot of strange decisions coming out of that office,” said Stanton Glantz, founding director of the UCSF Center for Tobacco Control Research and Education, a longtime tobacco industry critic, referring to the Center for Tobacco Products.

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To read the entire article, click here.