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FDA Warns Allergan Over Breast Implant Studies

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Sasha Chavkin, International Consortium of Investigative Journalists: May 19, 2020

United States health authorities issued a warning letter to leading global breast implant manufacturer Allergan for failing to properly carry out post-market safety studies.

The U.S. Food and Drug Administration found that Allergan did not meet its standards for recruiting and following up with participants in studies that included several styles of implants withdrawn from sale worldwide last year due to cancer risks.

Another company, Ideal Implant Incorporated, was rebuked for failing to properly track complaints by customers or take adequate corrective actions for problems identified during a site inspection.

“The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations,” Dr. Binita Ashar of the FDA’s Center for Devices and Radiological Health said in an agency statement announcing the warning letters.

In November 2018, the International Consortium of Investigative Journalists revealed that thousands of women around the world were suffering from serious illnesses after receiving breast implants, a finding that was part of its global Implant Files investigation.

In the months after the Implant Files’ publication, regulators around the world took action to better protect patients. Authorities in France, Canada, and the United States announced bans on Allergan Biocell implants, which were associated with increased risk of a rare form of cancer.

The moves prompted Allergan to announce a global recall of Biocell products last July. (Earlier this month, Allergan was acquired by global pharmaceutical giant AbbVie.)

The recalled implants are among the ones that Allergan was failing to properly study, the FDA found. The agency noted that the studies were crucial to identifying the risks for patients already implanted with Biocells.

“Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market,” Ashar said in the FDA’s statement.

The agency touted the warning letters as a part of its “ongoing efforts” to better protect breast implant patients, also citing its Medical Device Safety Action Plan and the development of a National Breast Implant Registry to collect data on breast implant safety.

But Dr. Diana Zuckerman, the director of the National Center for Health Research, a health policy think tank, said the agency must also be willing to take tough measures against companies that fail to follow its rules.

Zuckerman noted that breast implant makers have a history of poor compliance with safety studies mandated by the FDA, which approved silicone breast implants for the U.S. market in 2006 despite scant data on their long-term safety.

Instead, the agency allowed manufacturers Allergan and Mentor to conduct long-term safety studies after their products were already on the market. Within three years, Allergan and Mentor lost touch with 40% and 80% of the patients, respectively, in key sections of these post-approval studies, torpedoing the FDA’s demand that they collect reliable long-term data.

Nonetheless, the agency permitted the implants to remain on the market.

Zuckerman was skeptical that the warning letters would have much effect unless the FDA showed it was willing to take products that violated its rules for safety studies off the market.

“It absolutely should be possible to take off the ones that aren’t studied properly,” Zuckerman said. “I guarantee if they did that the ones that are still on the market would finish their studies.”

Read the full article here. 

How MLB is navigating the coronavirus pandemic to play ball

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ESPN staff, ESPN: May 19, 2020

MAJOR LEAGUE BASEBALL’S plan to start the season by July 4 relies on a dizzying array of moving parts, including the cooperation of 27 U.S. cities and a foreign country, the availability of more than 200,000 reliable coronavirus tests and a promise not to interfere with the nationwide fight to contain the pandemic.

ESPN examined the challenges facing MLB as it struggles to get back on the field. What emerges is like nothing that has been attempted in the history of American sport, less a baseball season than a military-style operation in which any number of variables could derail the plan, or, worse, contribute to the spread of the deadly disease.

[…]

WHEN MLB ABANDONED the idea to play the season under a bubble-like quarantine, it eased the restrictions that players would face but also created a riskier and more complicated scenario, according to health experts.

Even if teams are limited to regions — reducing travel, as the plan anticipates — players and other personnel will still travel between cities where people are living under different health orders and the virus may be spreading at different rates. Some states have reopened more than others and are projected to see a spike in cases, while others remain all but closed. Georgia, for example, partially ended its stay-at-home order on April 24, lifting restrictions on gyms, bowling alleys, hair salons and other businesses. In Cobb County, where the Braves play, new cases have been averaging about 50 a day. Some models and experts predict Georgia will soon see an increase in deaths because of the reopening.

“I wouldn’t want to put players in Atlanta’s ballpark,” said Beth Blauer, the executive director of the Johns Hopkins Center for Civic Impact, which specializes in the use of data to advise governments and nonprofits on best practices. “You have to determine where to play based on that modeling. You can’t bring players into hot spots. … You’ll know between mid-May and June how devastating the decisions are and where the new hot spots are, potentially.”

Alex Fairly, CEO of Fairly Group, an Amarillo, Texas-based risk management firm whose clients include MLB and the NFL, served as chairman of Lt. Gov. Dan Patrick’s Back to Work Task Force on Sports and Entertainment, which included representatives of the Astros and Houston Texans. The challenge of figuring how sports will be staged safely “fried my brain,” said Fairly, adding that the process caused him to lose sleep. “There are 8,000 issues. No one knows exactly what to do because this has never happened. It’s a true black swan moment.”

Baseball’s plan designates about 100 essential employees per team — players and other on-field personnel and “a limited number of essential staff who come in close proximity to the players.” These “Tier 1” and “Tier 2” individuals will be tested multiple times per week, though the plan doesn’t specify how many times that would be. The plan says nothing about regular testing for 150 “Tier 3” individuals who are involved in “essential event services” but will be separated from the others. If those people come into contact with someone who has the virus, they will be tested.

Beyond their families, teammates, managers and other baseball personnel, players still will be exposed to a broad range of people — from hotel staff to security personnel; from bus drivers to flight attendants. All will be traveling in their own circles when not working; MLB’s plan does not say anything about testing those workers. That creates added potential for an outbreak, experts said.

“One of the things I try to explain to people is that whatever other people are doing who live anywhere near you, is gonna affect you,” said Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C., a nonprofit independent think tank. “Just because you’re not going to get a tattoo when you’re in Georgia when your team is playing the Braves, if the person serving you at the restaurant is married to a person who got a tattoo or married to the person who is the tattoo artist, then you as a customer at that restaurant or even picking up carryout has the potential for being contaminated by those people who are doing those things.”

Keeping stadiums and other areas sterile will be a perpetual ordeal. It will involve perimeter security to keep fans away, both at the ballpark and hotels, where autograph seekers often congregate.

[…]

IN INTERVIEWS WITH dozens of health care experts — doctors, epidemiologists, immunologists, policy specialists, government authorities — there was consensus that the main component to keeping baseball safe will be diagnostic testing. That’s the same issue that has bedeviled the national effort to combat the coronavirus.

The goal of testing is to weed out and isolate those who test positive and prevent outbreaks. The risks of insufficient testing are incalculable. Clusters of the coronavirus have erupted in group and travel environments. In early March, more than 100 people became infected at a Boston leadership conference of Biogen, turning the drug company into an unwitting spreader of the disease to other states.

With that nightmare scenario for baseball in mind, and players and staff traveling in and out of their communities, it’s imperative for MLB to ferret out positive cases before they spread, the experts said. MLB’s plan calls for testing players and personnel “multiple times” per week, but not daily, as some experts suggest.

“If you were doing daily testing, you’d have the ability to pick up very low numbers on the virus, pick it up as soon as somebody has the ability to transmit,” said Dr. Melissa Nolan, an infectious disease expert at the University of South Carolina.

Nolan described MLB’s testing plan as a B-minus — compared to an A-plus if you were testing daily — but said she believed it could be effective, particularly if players are diligent about social distancing and limit their exposure away from the ballpark.

Trout told ESPN: “I don’t see us playing without testing every day.”

Dr. Howard Forman, a Yale professor of health policy who has offered guidance to some sports leagues and teams, said he believes baseball’s plan should work. He noted that data suggest the prevalence of the virus among top-level athletes is likely to be extremely low, plus it will be easier to limit exposure without fans and other workers at the ballparks. Forman wouldn’t say which leagues he had spoken with.

Under MLB’s plan, only the person who tests positive will be quarantined. That policy conflicts with current Centers for Disease Control and Prevention guidelines, which call for anyone who has had close contact with a confirmed case to quarantine for 14 days. “Our experts are advising us that we don’t need a 14-day quarantine [in such cases],” Manfred told CNN. The plan says baseball is following rules established by “health care institutions and governmental entities” but does not specify which entities.

Baseball is in a difficult position: Quarantining players who come in contact with infected individuals could force MLB to shut down entire teams.

Most health experts interviewed by ESPN said they believe MLB would be increasing the risk of an outbreak by not quarantining more extensively, if only for a few days.

“CDC guidelines are pretty clear that anybody who makes substantial contact with somebody who has the virus needs to be quarantined,” Dr. Ashish Jha, director of the Harvard Health Institute, told ESPN. “I think baseball has to ask themselves on what basis are they going against the CDC guidelines. How confident are they gonna be that another player on another team didn’t have substantial contact with that player? It just strikes me as risky. My feeling is it just depends on how lucky you feel.”

Zuckerman, who runs the nonprofit think tank in D.C., said, “I could understand not quarantining for 14 days, because potentially you’d end up never being able to play. But not quarantining at all seems dangerous.” But Humble, the former Arizona health director, said MLB developed “a reasonable plan. The idea of the CDC guidance is to minimize risk, so if you find another way, that’s OK. Guidance shouldn’t be one-size-fits-all. This may even be better, because of the frequency of testing, which is robust.”

After a positive test, clubs are required to work with local health officials to trace those who came in contact with the infected individual. Those people will receive an expedited test and, if negative, will be allowed to remain active — raising the possibility that people exposed to the virus could return to baseball within minutes. Baseball’s plan calls for additional testing of those individuals every day for one week, with results returned within 24 hours. “That’s time someone could be infecting other players, staff, their families,” one union source said.

Experts told ESPN that it can take several days for someone to test positive after contracting the virus.

[…]

Read the full article here. 

‘They killed her’: Why are breast implants still putting millions of women at risk?

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Maria Aspan, Fortune: May 18, 2020

Thirty-three years before her death, Paulette Parr visited her doctor for a popular and relatively routine procedure. It was 1986, and Parr was 35, working in human resources at the local hospital in Sikeston, a 16,000-person Missouri enclave midway between St. Louis and Memphis. A married mother of two young boys, she was interested in what plastic surgeons still call a “mommy makeover,” a catchall for the various procedures that nip, tuck, and lift women back to a pre-childbirth shape. For Parr, that meant getting her first set of breast implants.

For the next 15 years, through losing her first husband and remarrying and getting promoted to her hospital’s purchasing department, Parr was mostly happy with her implants, and with how they made her look and feel. But they were silicone-based, a type the U.S. Food and Drug Administration banned in 1992 over concerns that they were causing autoimmune and safety problems, and Parr eventually started to worry about them. So by 2002, when she learned that one of her implants had ruptured and was leaking silicone into her body, Parr’s surgeon replaced them with saline-filled versions. Her new Biocell implants were covered in a roughly textured silicone shell, designed to reduce movement of the device.

That’s when Parr’s implant-related health problems really began, according to a lawsuit her husband has filed against pharmaceutical company Allergan, the maker of Biocell products and one of three major manufacturers of American breast implants. In 2010, after one of her saline implants started leaking, her plastic surgeon replaced them with yet another set of Biocell textured implants, this time filled with silicone, which the FDA had allowed back onto the market in 2006.

“They were gorgeous, and they were put in by a reputable doctor,” says Paulette’s widower, Calvin Parr, months after her death. “We never gave it a second thought.”

Breast implants have long been a punch line, mocked as frivolous markers of female vanity. But that dismissive attitude overlooks a business with a serious and sometimes deadly impact on the health of its overwhelmingly female customer base. More than 8 million American women have undergone breast-related plastic surgeries since 2000; in 2018 alone, more than 400,000 women chose one for either cosmetic or reconstructive reasons. Breast augmentation is the most popular cosmetic procedure tracked by the American Society of Plastic Surgeons.

Many women, especially those affected by breast cancer, say they are grateful to have implants as an option. “It’s a decision that’s personal,” says Lynn Jeffers, the society’s current president, a plastic surgeon, and a cancer survivor who’s getting post-mastectomy reconstruction. “With the data that I have now, I’m comfortable having implants.”

And pharmaceutical companies have been very comfortable selling them, despite a long history of government recalls and product-liability lawsuits. Allergan, which was acquired by AbbVie in May, sold $399.5 million worth of implants in 2017, before regulators around the globe started banning some of its products. Its main rival, Johnson & Johnson, doesn’t break out results for its Mentor Worldwide breast implant business. Smaller specialist Sientra reported annual “breast products” revenues of $46.4 million in 2019.

Those numbers pale in comparison to blockbusters like Allergan bestseller Botox, which raked in $3.8 billion last year. But like Botox, breast implants can have attractive recurring revenue built in for manufacturers and the doctors who use their products. Even under ideal circumstances, breast implants “are not lifetime devices,” the FDA warns, and will likely need to be replaced every 10 to 15 years, for a cost of up to $12,000 per cosmetic procedure.

Yet as doctors, patients, lawyers, and public health experts tell Fortune, breast implants have remained on the market despite decades of inadequate testing and study, recurrent safety concerns, and poor regulatory oversight. Those problems plague many medical devices, which range from machines used outside the body to artificial parts implanted within it. But breast implants are unique in their affiliation with female sexuality and physical appearance, their intersecting roles as elective beauty products and clinical tools that can help cancer survivors feel more like themselves—and the degree to which patients’ mounting concerns about them have been dismissed for decades. Now, that accumulated failure of oversight has created sweeping, sometimes tragic crises for potentially millions of women.

“There are a lot of women who are really suffering,” says Diana Zuckerman, president of the National Center for Health Research. “You have these products that are widely, widely sold, and every few years we learn something new about the problems they cause.”

Breast implant makers walk a particularly fine line when it comes to creating a product that is both safe and “realistic.” Today’s implants are either filled with saline (more likely to break) or silicone (more natural looking and feeling but plagued by a history of safety concerns). Their exteriors can be either smooth or made of a “textured” silicone shell. Smooth implants are more popular in the U.S., but surgeons working with mastectomy patients sometimes prefer textured versions, because the products’ rougher surface enables tissue to grow onto the implant more easily.

All of these variations are prone to malfunctions or side effects, which can include ruptured implants; a buildup of scar tissue that can cause pain and tissue hardening; a large collection of symptoms often known as “breast implant illness,” which can include joint pain, migraines, and chronic fatigue; and, increasingly, a sometimes fatal cancer of the immune system known as ­BIA-ALCL, for “breast implant–­associated anaplastic large cell lymphoma.”

“The breast implants that are on the market right now all have issues,” says Madris Tomes, a former FDA manager who tracks reported medical device failures at her Device Events firm. “I wouldn’t recommend them to anyone that I care about.”

The causes of the various problems with breast implants are still poorly understood, which public health experts blame on a lack of testing or objective, long-term studies that do not rely on manufacturer-provided data or funding. Device makers also have yet to fully report the data the FDA required as a condition of allowing silicone implants back on the market in 2006.

[…]

Read the full article here. 

You Can’t Travel, but You Can Vacation at Home

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Hilary Nangle, AARP, May 12, 2020

In a pre-Covid-19 world, the freedom to be at home without obligations would have seemed like a vacation. But isolating for the coronavirus has changed that perspective. The American belief in productivity may make some feel guilty for taking a vacation day at home, but experts say that it’s no less important to do so now than it was before the pandemic.

“It’s important because it seems like something that we shouldn’t do, because with no place to go, it feels like a waste of time,” says Andrea Bonior, a clinical psychologist in Bethesda, Maryland, and author of Detox Your Thoughts. “We have this big blurring between working and home, and taking a day off is a way to reclaim that boundary.”

Home should be a place for pausing, resting and healing, Bonior says, and she recommends doing something creative, social or nourishing with an “off” day at home — even watching TV without guilt. It may seem silly, because you may be working at home anyway, but it’s important to reclaim some space emotionally, and time off — without commitment or obligation — is key to helping lower overall stress levels.

Over the past few years, it has become “harder to distinguish vacation days from other ones,” says Diana Zuckerman, a psychologist and epidemiologist and president of the National Center for Health Research in Washington, D.C. But, “it’s important to have at least a day or two when you don’t work.”

How to plan a ‘home-cation’

But how does one vacation, literally, in the home? Bonior recommends starting by thinking about where, if you could travel, you would go. “That’s a clue to your values right now. If you would choose to spend time with other people, maybe spend time connecting digitally with others.” You might play a game, host a watch party for a movie, or start a book group online.

If you’re thinking about nature, you’re probably craving fresh air and sunshine. Depending upon your circumstances, maybe find a safe place to take a long walk. Or, if you have a backyard, sit outside and read or enjoy a garden. “Don’t dismiss the importance of sunshine, even through a window,” Bonior says. Pair that with watching nature documentaries or travel shows or simply looking at pictures of trees. “There’s research literature on how even looking at pictures of trees makes people feel better,” Zuckerman says. “For a lot of people, nature really does make a difference. Looking at the natural world can be uplifting.”

Some “home-cation” ideas require a bit of advance planning, others can be as easy as allowing yourself to make popcorn and watch movies. Speaking of movies, why not create a daylong film festival? Pick a genre, location or actor and queue up related movies. Or, create a music or dance festival.

Whether you’re pining for France, coastal Maine, a spa escape, or a camping getaway, you can recreate a semblance of your dream trip by using your senses to help evoke the experience. Think about typical food and drink, not only the flavors but also the aromas and textures; think about what you’d see and hear; and think about what you would do. Now set about recreating that at home. Here, a few examples to get you started.

Vacation in France without leaving home

If France is calling to you, spend a day there. Let technology aid your imagination and help you travel faster than the old Concorde. First, listen to Edith Piaf or other typical French music to set the mood. Then get ready for some virtual tours. Go up into the Parisian signature Eiffel Tower, built for the 1889 World’s Fair; descend into the Lascaux Caves in southwestern France to see the prehistoric cave paintings; discover the Mona Lisa without a hint of crowds at the Louvre or browse the paintings in Museé d’Orsay.

You may not be able to stroll the incredible Champs d’Elysses, but you might tantalize your taste buds with the flavors of France you would find along that avenue; perhaps a green salad with bread and a cheese and charcuterie plate. Or maybe make a delicious croque monsieur (a fancy-pants broiled ham and cheese).

Read the full article here. 

Tests for COVID-19: Has the FDA said yes too many times?

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By Robert M. Kaplan and Diana Zuckerman, The Hill Opinion Contributors, May 6, 2020

There are many controversies about the coronavirus, but there is one point of consensus: We need testing, testing, and then more testing. But yesterday, in response to criticisms from chairs of two House health subcommittees, the FDA tightened their standards for antibody tests intended to identify people who were previously exposed to the coronavirus. Why?

Typically, the FDA approves tests based on evidence of accuracy. But, under the urgency of the pandemic, the FDA temporarily lifted the requirement that tests be validated before they are marketed. Until the new policy was announced, it was not clear when or if the FDA would review the accuracy of each test.

The FDA website shows that, to date, the FDA has temporarily approved coronavirus testing for 84 different labs and companies. There were 14 new approvals in the last week alone and more than 400 more applications are waiting for FDA’s review. Unfortunately, none of the tests currently available – not the 84 and not the other 400 — have a record of proven accuracy that can be independently verified.

[….]

What happens when hundreds of unvalidated tests flood the market? Monitoring a pandemic requires accurate, consistent information. With so many tests, we can’t know when cases are peaking, stabilizing, or decreasing in different communities — and therefore, when it is possible to loosen restrictions on social distancing.

Read the article here https://thehill.com/opinion/healthcare/496403-tests-for-covid-19-has-the-fda-said-yes-too-many-times

 

Coronavirus Relief Act Gives Drug Makers New Sway Over FDA

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By David S. Hilzenrath, Project on Government Oversight:

Last year, based on growing concerns about the safety of certain sunscreens, the Food and Drug Administration (FDA) published a plan of action.

It proposed concluding that, for two sunscreen ingredients, the risks outweigh the benefits, and it proposed declaring that there was insufficient data to support the safety of a dozen others—for example, one that has shown up in blood plasma, amniotic fluid, urine, and breast milk.

It proposed restricting properties of spray sunscreens to reduce the risk of inhaling them and suffering lung disease, and it proposed requiring that many sunscreens meet a stricter standard for protection against ultraviolet radiation.

It said it wanted to eliminate “potential confusion permitted by the current labeling regime,” under which a product labeled with a higher sun protection factor or SPF can provide “inferior protection” than one with a lower SPF because it filters a narrower spectrum of ultraviolet radiation.

The FDA’s proposal was apparently derailed by the coronavirus.

More specifically, by part of Congress’s response to the pandemic: the economic relief legislation known as the CARES Act, passed in late March.

While Americans were focused on a deadly plague and its devastating fallout, Congress fundamentally altered FDA oversight of thousands of drugstore items.

Little-noticed provisions of the CARES Act gave manufacturers new sway over the consumer protection agency and streamlined the process by which the FDA makes decisions about so-called over-the-counter or OTC drugs—products marketed for personal health and sold without a prescription.

[…]

“User Fees”

[…]

While the CARES Act requires the FDA to negotiate with industry, it requires the agency to “consult” with others, such as “representatives of patient and consumer advocacy groups.” In the realm of prescription drugs, the so-called patient advocacy groups the FDA consulted the last time user fees came up for renewal generally had ties to the pharmaceutical industry, POGO’s 2016 “Drug Money” investigation found.

The FDA and manufacturers have for years been laying the groundwork for adoption of user fees for over-the-counter products. In 2016 and 2017, they held a series of meetings on the subject. Industry participants included Procter & Gamble, Bayer, Sanofi, Johnson & Johnson, and a trade association, the Consumer Healthcare Products Association.

The plan the FDA and industry developed set out “performance goals” for the agency to meet under an anticipated user fee regime, including what the document describes as “substantially shortened timeframes” for the FDA to act on requests from manufacturers of over-the-counter drugs.

“This goals document represents the product of FDA’s discussions with the regulated Industry, and consideration of input by public stakeholders,” the document, called a “commitment letter,” says.

The performance goals “are important for facilitating timely access to safe and effective medicines,” the document says.

The plan the FDA and industry developed was contingent on action by Congress. Now that Congress has acted, the FDA plans to follow the performance goals in that document, FDA spokesman Charlie Kohler said in an email to POGO.

Diana Zuckerman, president of the National Center for Health Research, said the commitment letter “does not seem appropriate.”

“Performance goals should include at least as much attention regarding evidence of safety or effectiveness as it does to the issues that industry cares the most about,” Zuckerman said by email.

Historically, industries have embraced user fees as a means of reducing regulatory delays. For Congress, getting companies to pay for regulators’ salaries has been an easier pill to swallow than spending taxpayer dollars or adding to federal budget deficits.

The new user fees will enable the FDA to increase its budget and staffing for overseeing nonprescription drugs.

In the 2016 slide presentation, the FDA said it was spending just $8.2 million a year and had the equivalent of only about 30 full-time employees to oversee “hundreds of thousands of products consumed – in many cases, on a daily basis – by millions of Americans.”

The FDA compared the $8.2 million to what it said was the $8 million cost of producing “the ‘Blackwater’ episode of the hit TV series Game of Thrones.”

According to the industry’s Consumer Healthcare Products Association, over a five-year period, the user fee program will generate more than $130 million in fee revenue for the FDA.

 

[…]

Read the full article here. 

NCHR Comments on Public Access to Federally Funded Research

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National Center for Health Research, May 6, 2020

National Center for Health Research Public Comments on
OSTP’s Request for Information: Public Access to Peer-Reviewed Scholarly
Publications, Data and Code Resulting From Federally Funded Research

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

Our research center has long advocated for making federally funded research publicly available. As a think tank focused on research and data related to human health, we have supported data sharing and other efforts to make research results more freely available, particularly for research that was funded by federal agencies or submitted to federal agencies as part of application materials to the FDA and other federal agencies. Research data and results that are partially or fully funded by or conducted by the federal government should be freely available to the public.

In this comment, we will focus on two issues: 1) Access to peer-reviewed scholarly publications and 2) Access to data for analysis.

Despite efforts to make articles in scholarly publications freely available to the public, most are not. All journal articles based on research funded by the federal government should be freely available to the public, and that should not require the authors to pay thousands of dollars for each article to be available through open access. We understand the financial needs of scholarly publications, but U.S. taxpayers should not be required to pay to read an article based on research that they also paid for. Since journals depend on high quality data to succeed, the government should require that journals have an open access policy for federally funded research results; authors either should not be required to pay anything, or should be offered a greatly discounted rate that the federal government requires the researcher to pay using the research funding that supported the work.

Unfortunately, ClinicalTrials.gov has not fulfilled its goal of making research results publicly available in a transparent and timely fashion. Despite Congressional pressure, too often study results are not reported on the ClinicalTrials.gov website or are greatly delayed, and neither FDA nor NIH has enforced the requirements or penalized those who failed to comply. In addition, results reported on ClinicalTrials.gov are often subjective summaries rather than objective charts and graphs that present the aggregate data. The information most often provided is insufficient for other researchers or medical providers to scrutinize.

In addition, research conducted partially or entirely with federal funds is not always published in a timely manner, or at all. In some cases, the authors have submitted manuscripts that have been rejected by journals; in some cases, there are competing pressures that make it difficult for the researchers to finish writing and submitting manuscripts, and in other cases, the only journals willing to publish a specific article charge thousands of dollars for publication that the authors can’t afford. We strongly urge that PIs of federally funded studies be required to make the raw data available to other U.S. researchers if it hasn’t been published within 3 years of completion of the initial study. Such data sharing between researchers is essential for ensuring that federal agencies have not wasted taxpayers’ money on research that never becomes available to potentially benefit the public.

Even when federally funded research results are published, the results may be biased or inaccurate. Sharing of raw data after publication is an invaluable tool for confirming the accuracy of reported research findings and enabling other researchers to replicate results and understand any conflicting findings.

U.S. taxpayers deserve to have the government maximize the usefulness of the funds they’ve invested in research by making that research publically available. Efforts to improve public access to federally funded research will benefit the scientific community, the medical community, public health, and the public.

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

NCHR’s Public Comments on FDA’s Proposed Inclusion of Older Adults in Cancer Clinical Trials

Policy, Testimony & Briefings, ,

May 4, 2020

National Center for Health Research’s Public Comments on FDA’s Proposed Inclusion of Older Adults in Cancer Clinical Trials Guidance for Industry

[FDA-2019-D-5572-0002]

We are writing to express our views on the FDA Draft Guidance on Older Adults in Cancer Clinical Trials. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We have long urged the FDA to require older adults in clinical trials of drugs for the treatment of cancer and other diseases that are likely to be used by people over 65. When our Center’s president served on CMS’ Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), she pointed out at every meeting that there were few if any patients over 65 who had been tested in clinical trials for the drugs and devices that were seeking to be covered by Medicare. As a result, it was impossible for the MEDCAC members to determine if the likely benefits outweighed the risks of any of those products, including cancer diagnostic tests and treatments.

We strongly support FDA’s efforts to improve the diversity of clinical trials and analyses of demographic subgroups, but have been disappointed that these efforts have not been enforced in a meaningful way. Subgroup analyses of safety and efficacy are essential for new drugs and devices so that patients and clinicians can make informed treatment decisions. New medical products should only be approved for populations for which there has been sufficient testing to determine that the benefits outweigh the risks. This is of particular importance for older adults in cancer trials. Moreover, if the FDA refused to approve cancer drugs for patients over 65 or over 70 when those age groups were not adequately studied, it would provide a substantial incentive for sponsors to be more vigilant about recruiting and studying patients in older age groups.

As stated in the guidance, it is not sufficient to only study the safety and efficacy of treatments among younger adults and assume that the results would be the same for older adults as well. We also strongly support the recommendation to evaluate smaller, discrete age groups (such as ages 65-74 and 75 and up), as well as the recommendation to collect additional safety measures for older adults, such as cognitive functioning. However, there are additional aspects of subgroup analysis that must be taken into consideration.

Subgroup analysis must determine the unique benefit to risk ratio for each subgroup, rather than determine whether the benefits of a treatment differ between younger and older patients. Older adults are more likely to have comorbidities that can affect how drugs are absorbed, metabolized, or eliminated, which may impact the safety and efficacy of a particular treatment. Therefore, there must be an assessment of the unique risks and benefits for older adults. It is not important to know that a medical product is more or less safe or effective for older patients compared to younger patients; what matters to older patients is whether the benefits outweigh the risks for patients in their age group.

In addition, it is not necessary that the proportion of older patients studied is consistent with the proportion of older patients with the particular type of cancer. What matters is that there be sufficient numbers of older adults so that subgroup analyses can be conducted to assess the benefits and risks of treatment for patients in several older age groups. Subgroup analyses are not meaningful if the numbers of older patients in the trials are small.

Since older adults are likely to be more frail and to have other serious comorbidities, it is imperative to determine the adverse effects and the efficacy of new drugs for older adults prior to FDA approval. All too frequently, post-market research, even if required, is delayed, follow-up is inadequate, or for other reasons the results are not as informative as had been expected.

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

 

NCHR Comments on CPSC Priorities for FY2021/2022

Policy, Testimony & Briefings, , , , , , , , ,

National Center for Health Research, April 2020

Diana Zuckerman, Ph.D., President of the National Center for Health Research

Comments on the U.S. Consumer Product Safety Commission
Agenda and Priorities for FY2021/2022

April 2020

The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and public health experts who analyze and review research on a range of health issues. Thank you for the opportunity to share our views concerning the Consumer Product Safety Commission’s (CPSC) priorities for fiscal years 2021 and 2022. We greatly respect the essential role of the CPSC, as well as the challenges you face in selecting the most important priorities.

We want to start by emphasizing two issues involving chemicals in products that affect our and our children’s health, (1) artificial turf and playground surfaces and equipment, and (2) organohalogen flame retardants. We will also briefly discuss sport and recreational helmets, sleep-related products for infants, furniture stability, home elevators, and liquid nicotine packaging. All these issues should be CPSC priorities.

Artificial Turf and Playgrounds: Risky Chemicals and Lead

We expressed our concerns about artificial turf and playgrounds last year. Our concerns are even greater this year because of increasing evidence of lead exposure from these products, as well as from playground equipment.

Requiring testing for artificial turf, playground surfaces, and the paint used for playground equipment needs to be a priority, because children are exposed to these synthetic rubber and plastic fields and playground surfaces as well as playground equipment – and the lead and harmful chemicals they contain – day after day, year after year.

A new issue that arose in the last year is research indicating that the paint used on outdoor playground equipment contains lead. Professor Alexander Wooten from Morgan State conducted studies in Maryland that indicate that paint with lead is widely used on playground equipment, such as climbing structures, in some cases at very dangerous levels.1 We have learned that there are no federal restrictions on lead used in outdoor paint, even for products used exclusively by young children. CPSC should investigate this issue immediately.

The rubber and plastic that make up turf and playground surfaces contain chemicals with known health risks, which are released into the air and get onto skin and clothing. Crumb rubber – whether from recycled tires or “virgin rubber”– includes endocrine disruptors such as phthalates, heavy metals such as lead and zinc, as well as other carcinogens and skin irritants such as some polycyclic aromatic hydrocarbons (PAHs) and volatile organic compounds (VOCs).2,3,4,5,6 Other plastic or rubber surfaces used in playgrounds also contain many of these chemicals.7 Moreover, the plastic grass in artificial turf also has dangerous levels of lead, PFAS, and other toxic chemicals as well. PFAS are of particular concern because they are “forever chemicals” that get into the human body and are not metabolized, accumulating over the years. Replacing tire waste with silica, zeolite, and other materials also has substantial risks.

Tire crumb is widely used as infill for artificial turf fields and also used for colorful rubber playground surfaces. In addition to the chemicals noted above, these playground surfaces contain lead and create lead dust on the surface that is invisible to the eye but that children are breathing in when they play.8

The CPSC is well aware that no level of lead exposure is safe for children, because lead can cause cognitive damage even at low levels. Some children are even more vulnerable than others, and this vulnerability can be difficult or even impossible to predict. Since lead has been found in tire crumb as well as new synthetic rubber, it is not surprising that numerous artificial turf fields and playgrounds made with either tire crumb or “virgin” rubber have been found to contain lead. However, the Centers for Disease Control and Prevention (CDC) also warns that the “plastic grass” made with nylon or other materials also contain lead. Whether from infill or from plastic grass, the lead doesn’t just stay on the surface – it can get into clothes, on the skin, or into the air that children breathe.

While one-time or sporadic exposures are unlikely to cause long-term harm, children’s repeated exposures, especially during critical developmental periods, raise the likelihood of serious harm. There are few activities that children engage in for as many hours in their early years as those on playgrounds and playing fields.

We appreciate the CPSC’s ongoing efforts to investigate the safety of crumb rubber on playgrounds and playing fields. As your study using focus groups to examine children’s use of playgrounds and exposure to playground surfaces has shown, children who use playgrounds with artificial surfaces could be exposed to the chemicals in these surfaces.9 It is unfortunate that the EPA report on artificial turf (which did not include playground surfaces or playground materials) did not provide the scientific evidence needed to support their assumptions that the likely levels of exposure to dangerous chemicals was low enough that it was not likely to harm children. The EPA did not study the actual impact of the exposure to endocrine disrupting chemicals on children and did not study lead exposure from synthetic playground surfaces, leaded paint used on playground equipment, or artificial turf.10

Meanwhile, we have repeatedly heard the companies that make these products and those that install them make erroneous claims at the state and local government levels, falsely stating that CPSC and other federal agencies have concluded that these materials are proven safe. As we all know, that is not correct.

We encourage you to closely evaluate the research that has been done, focusing on independently funded research of short-term and long-term safety issues. We need information that can protect our children from harm. In addition, we strongly urge you to convene a Chronic Hazard Advisory Panel (CHAP) to examine the short-term and long-term risks of different types of artificial turf used in playing fields and children’s playgrounds, including surfaces and lead paint used on climbing equipment and other materials.

In addition to the risks of lead and the long-term risks of cancer and other health problems caused by hormone disruption, these fields can cause short-term harms. Artificial turf generates dust which may exacerbate children’s asthma.11,12 Fields heat up to temperatures far higher than ambient temperature, reaching temperatures that are more than 70 degrees warmer than nearby grass; for example, 180 degrees when the temperature is in the high 90’s and 150-170 degrees on a sunny day when the air temperature is only in the 70’s.13,14 We have measured the temperatures ourselves and been shocked by the results. These temperatures can cause heat stress and burns.

Fields made of crumb rubber have been marketed as reducing injuries compared to grass. However, research has shown that this is not the case. We have spoken to students terribly harmed by turf burn, and studies have indicated increased risk for some types of injuries, including joint, foot, and brain injuries.15,16,17 That is the reason that only two Major League Baseball parks use artificial turf and why the men’s soccer World Cup is now always played on grass.  In response to the demands of women soccer players, the Women’s World Cup will require grass in 2023.

Organohalogen Flame Retardants

The National Academies of Sciences, Engineering, and Medicine issued their scoping plan to assess the hazards of organohalogen flame retardants (OFRs) last year.18 The report concluded that OFRs can be divided into subclasses on the basis of chemical structure, physicochemical properties, and predicted biologic activity. As noted in their summary of the report:

“The committee identified 14 subclasses that can be used to conduct a class-based hazard assessment and concluded that the best approach is to define subclasses as broadly as is feasible for the analysis; defining subclasses too narrowly could defeat the purpose of a class approach to hazard assessment.”

We encourage you to convene a CHAP to use this scoping plan to evaluate OFRs and to develop regulations to address OFRs in children’s products, upholstered residential furniture, mattresses/mattress pads, and the plastic casing of electronic devices. In addition, it is essential to consider current flammability standards to determine if there are changes that would improve their safety from chemical exposures as well as exposures during a fire.

OFRs are not bound to products to which they are added, so they migrate out of products and into dust. This allows them to get onto our skin and food and into the air. Because of their widespread use and the long-lasting nature of OFRs, consumers are continuously exposed to OFRs19 and many bioaccumulate in our food supply.20,21 As a result, OFRs are present in nearly all people in the U.S.22,23 For these reasons, CPSC should focus on the potential for hormone disruption, altered brain development, reduced ability to get and stay pregnant, and the timing of puberty.24,25 While not all OFRs have been adequately studied to determine whether all are unsafe, those that have been sufficiently studied have proved to be harmful to health.

We share the Commission’s concerns about fire hazards as well, but there is evidence that these flame retardants may not be effective at preventing deaths in real world situations.26,27 When the chemicals burn during a fire, the inhaled smoke is more toxic to humans, and exposures could result in serious harms, including death.

Helmets for Sport and Recreational Activities

There are up to 3.8 million concussions reported each year related to sport or recreational activities, with most reported for children and adolescents.28 This number is likely an underestimate.29 We urge the CPSC to focus greater attention on the need to ensure the effectiveness of helmets intended to protect against brain injuries during athletic activities. Currently, CPSC only provides guidelines for bicycle helmets, even though many organized sports and recreational activities use helmets to reduce the risk for severe head injuries, including baseball, football, snow sports, skiing/snowboarding, and climbing. Unfortunately, these helmets are not necessarily designed to prevent mild concussions.30 We encourage CPSC to consider how design changes could improve the ability of helmets to prevent severe head injuries as well as mild concussions, and to develop guidelines for helmets that reduce these risks without interfering with vision or hearing or other safety concerns.

Baby Products and Products Posing Risks to Young Children

The CPSC is the major safeguard to protect infants and young children from unsafe products that are widely sold and inadequately studied. Crib bumpers and infant sleepers are two examples that have received CPSC attention but CPSC has not adequately protected families from the tragedies of infant deaths caused by these products.

There is nothing more tragic than when an infant or young child dies due to a product in the home that families or loved ones purchased because they erroneously assumed they were tested and found to be safe. The standard for these products should not be based on the number of deaths per year, but rather the 1) risk to benefit ratio of the product and 2) whether regulations or restrictions would make the product safer. In the case of crib bumpers, they have no benefit. In the case of inclined infant sleepers, products were sold that were promoted as superior to other available products but in fact had no comparative benefits and were less safe.

Furniture that tips over and home elevators are two other examples of products that have resulted in deaths of young children. In both cases, CPSC should do more to prevent the sale of products that can be redesigned or modified to make them safe.

Liquid Nicotine Packaging

We agree with other public health and consumer organizations that have urged CPSC to immediately remove from the market dangerous liquid nicotine products lacking the child-resistant packaging and flow restrictors required under the Child Nicotine Poisoning Prevention Act of 2015. The law requires the CPSC to enforce a mandatory child-resistant packaging standard for liquid nicotine containers, including the use of flow restrictors.

Liquid nicotine is a highly toxic product that can seriously harm or kill children. Since liquid nicotine can be quickly absorbed through the skin, flow restrictors are an essential safeguard to reduce the risk of nicotine poisoning in children.

Effective CPSC enforcement measures to remove noncompliant products from the market are long overdue, and that enforcement should be an immediate priority.

Final Thoughts

CPSC is the only federal agency whose mission is to protect children and adults from harmful products used in their daily life. Flame retardants and lead and many different chemicals in artificial turf and playground surfaces and equipment get into the air and dust and thus into our bodies. These chemicals tend to have greater risks for fetuses and children. There are large gaps in our knowledge about the chemicals in the products on the market, because the companies do not provide that information to the public. Ideally, the potential health impact of all of these chemicals would be evaluated in the final product before it was sold. If that doesn’t happen, CPSC must do more to identify the health risks as soon as possible after children and adults have been exposed.

Too often, the lack of independently funded and publicly available research has been used to mislead the public. Claims that “there is no evidence of harm” are misunderstood to mean “there is no harm.”

While reducing exposures to dangerous products is key, there will always be some potential for harm. Whether those harms are from the intended use of a consumer product or an unintended but foreseeable use, CPSC has a very important role to play in reducing harm. Improving the timeliness and targeting of information campaigns to warn parents and children about harmful products is also a key task of the CPSC.

References

  1. Wooten, Alexander, Lead and Playgrounds, Presentation at the Takoma community forum in Washington, DC, July 29, 2019.
  2. California Office of Environmental Health Hazard Assessment (OEHHA). Evaluation of Health Effects of Recycled Waste Wires in Playground and Track Products. Prepared for the California Integrated Waste Management Board. 2007. https://www2.calrecycle.ca.gov/Publications/Details/1206
  3. Llompart M, Sanchez-Prado L, Lamas JP, et al. Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 2013;90(2):423-431. https://www.ncbi.nlm.nih.gov/pubmed/22921644/
  4. Marsili L, Coppola D, Bianchi N, et al. Release of polycyclic aromatic hydrocarbons and heavy metals from rubber crumb in synthetic turf fields: Preliminary hazard assessment for athletes. Journal of Environmental and Analytical Toxicology. 2014;5(2):1133-1149. https://www.hilarispublisher.com/open-access/release-of-polycyclic-aromatic-hydrocarbons-and-heavy-metals-from-rubber-crumb-in-synthetic-turf-fields-2161-0525.1000265.pdf
  5. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water, Air, & Soil Pollution. 2018;229:64. https://link.springer.com/article/10.1007/s11270-018-3711-7
  6. Perkins AN, Inayat-Hussain SH, Deziel NC, et al. Evaluation of potential carcinogenicity of organic chemicals in synthetic turf crumb rubber. Environmental Research. 2018;169:163–172. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396308/
  7. KimS, Yang JY, Kim HH, et al. Health risk assessment of lead ingestion exposure by particle sizes in crumb rubber on artificial turf considering bioavailability. Environmental Health and Toxicology. 2012;27:e2012005. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278598/
  8. Baca, N. Parents demand answers on playground lead in DC. wusa9.com. October 2, 2019. https://www.wusa9.com/article/news/local/dc/parent-forum-lead-playgrounds/65-45401b01-3371-436a-8f55-a364be0c07d3
  9. Consumer Product Safety Commission. Summary of Playground Surfacing Focus Groups. 2018. https://www.cpsc.gov/s3fs-public/Playground_Surfacing_Focus_Group_Report_2018.pdf
  10. National Center for Health Research. Children and Athletes at Play on Toxic Turf and Playgrounds. Center4research.org. http://www.center4research.org/children-athletes-play-toxic-turf-playgrounds/
  11. Shalat, SL. An Evaluation of Potential Exposures to Lead and Other Metals as the Result of Aerosolized Particulate Matter from Artificial Turf Playing Fields. Submitted to the New Jersey Department of Environmental Protection. 2011. http://www.nj.gov/dep/dsr/publications/artificial-turf-report.pdf
  12. Mount Sinai Children’s Environmental Health Center. Artificial Turf: A Health-Based Consumer Guide. 2017. http://icahn.mssm.edu/files/ISMMS/Assets/Departments/Environmental%20Medicine%20and%20Public%20Health/CEHC%20Consumer%20Guide%20to%20Artificial%20Turf%20May%202017.pdf
  13. Serensits TJ, McNitt AS, Petrunak DM. Human health issues on synthetic turf in the USA. Proceedings of the Institution of Mechanical Engineers, Part P: Journal of Sports Engineering and Technology. 2011;225(3):139-146. https://plantscience.psu.edu/research/centers/ssrc/documents/human-health-issues-on-synthetic-turf-in-the-usa.pdf
  14. Penn State’s Center for Sports Surface Research. Synthetic Turf Heat Evaluation- Progress Report. 2012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  15. Theobald P, Whitelegg L, Nokes LD, et al. The predicted risk of head injury from fall-related impacts on to third-generation artificial turf and grass soccer surfaces: A comparative biomechanical analysis. Sports Biomechanics. 2010;9(1):29-37. https://www.ncbi.nlm.nih.gov/pubmed/20446637
  16. Balazs GC, Pavey GJ, Brelin AM, et al. Risk of anterior cruciate ligament injury in athletes on synthetic playing surfaces: A systematic review. American Journal of Sports Medicine. 2015;43(7):1798-804. https://www.ncbi.nlm.nih.gov/pubmed/25164575
  17. Mack CD, Hershman EB, Anderson RB, et al. Higher rates of lower extremity injury on synthetic turf compared with natural turf among national football league athletes: Epidemiologic confirmation of a biomechanical hypothesis. American Journal of Sports Medicine. 2019;47(1):189-196. https://www.ncbi.nlm.nih.gov/pubmed/30452873
  18. National Academies of Sciences, Engineering, and Medicine; Division on Earth and Life Studies; Board on Environmental Studies and Toxicology; Committee to Develop a Scoping Plan to Assess the Hazards of Organohalogen Flame Retardants. A Class Approach to Hazard Assessment of Organohalogen Flame Retardants. Washington (DC): National Academies Press (US). 2019. https://www.ncbi.nlm.nih.gov/books/NBK545458/
  19. Allgood JM, Vahid KS, Jeeva K, et al. Spatiotemporal analysis of human exposure to halogenated flame retardant chemicals. Science of the Total Environment. 2017;609:272-276. https://www.ncbi.nlm.nih.gov/pubmed/28750230
  20. Lupton SJ, Hakk H. Polybrominated diphenyl ethers (PBDEs) in US meat and poultry: 2012-13 levels, trends and estimated consumer exposures. Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment. 2017;34(9):1584-1595. https://www.ncbi.nlm.nih.gov/pubmed/28604253
  21. Schecter A, Colacino J, Patel K, et al. Polybrominated diphenyl ether levels in foodstuffs collected from three locations from the United States. Toxicology and Applied Pharmacology. 2010;243(2):217-224. https://www.ncbi.nlm.nih.gov/pubmed/19835901
  22. Centers for Disease Control and Prevention. Fourth National Report on Human Exposure to Environmental Chemicals, Updated Tables. 2019. http://www.cdc.gov/exposurereport/
  23. Ospina M, Jayatilaka N, Wong LY, et al. Exposure to organophosphate flame retardant chemicals in the U.S. general population: Data from the 2013-2014 National Health and Nutrition Examination Survey. Environment International. 2017;110:32–41. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6261284/
  24. Dishaw L, Macaulay L, Roberts SC, et al. Exposures, mechanisms, and impacts of endocrine-active flame retardants. Current Opinion in Pharmacology. 2014;19:125-133. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4252719/
  25. Kim YR, Harden FA, Toms LM, et al. Health consequences of exposure to brominated flame retardants: A systematic review. Chemosphere. 2014;106:1-19. https://www.ncbi.nlm.nih.gov/pubmed/24529398
  26. Shaw SD, Blum A, Weber R, et al. Halogenated flame retardants: Do the fire safety benefits justify the risks? Reviews on Environmental Health. 2010;25:261-305. https://www.ncbi.nlm.nih.gov/pubmed/21268442
  27. McKenna S, Birtles R, Dickens K, et al. Flame retardants in UK furniture increase smoke toxicity more than they reduce fire growth rate. Chemosphere. 2018;196:429-439. https://www.ncbi.nlm.nih.gov/pubmed/29324384
  28. Halstead ME, Walter KD, Moffatt K, et al. Sport-related concussion in children and adolescents. Pediatrics. 2018;142(6):e20183074. https://pediatrics.aappublications.org/content/142/6/e20183074
  29. Baldwin GT, Breiding MJ, Dawn Comstock R. Epidemiology of sports concussion in the United States. Handbook of Clinical Neurology. 2018;158:163-74. https://www.ncbi.nlm.nih.gov/pubmed/30482376
  30. Consumer Product Safety Commission. Which helmet for which activity? https://www.cpsc.gov/safety-education/safety-guides/sports-fitness-and-recreation-bicycles/which-helmet-which-activity
  31. Perry, C. Why Inclined Baby Sleepers Are So Dangerous. Parents.com. November 8, 2019. https://www.parents.com/baby/sleep/basics/why-inclined-baby-sleepers-are-so-dangerous/

Dietary Supplements Before and During Chemotherapy

Diet, Habits, & Other Behaviors, General Treatment Issues, Treatment & Management, ,

Meg Seymour, PhD, National Center for Health Research

Many Americans, including those with cancer, take dietary supplements. People take supplements because they believe it will help them stay healthy and give them vitamins and minerals they may not get from their diet. Chemotherapy patients often take supplements because their nausea makes it difficult to eat, and they want to be sure to get enough nutrients. 

People think of dietary supplements as a no-risk insurance policy to improve nutrition, but a study published in 2020 shows that supplements can have risks if you are undergoing chemotherapy. More than 1,000 breast cancer patients were asked whether or not they took any supplements either before or during their chemotherapy.[1] The researchers then continued to evaluate any subsequent cancer or death for up to 15 years (almost all of the women were followed for at least 5 years).

  Results showed that patients who took vitamin B12 before and during their chemotherapy were more likely to die or have their cancer return. They were also more likely to die from any cause, not just from cancer. This increase in cancer recurrence or death was only for people who took the B12 supplements both before and during their chemotherapy. Patients who only took the B12 supplements before chemotherapy or only took supplements during chemotherapy were not more likely to have a recurrence of their cancer or die. Patients who took Iron supplements both before and during chemotherapy were also more likely to have their cancer return or to die of any cause. However, the same was also true for people who only took iron supplements during their chemotherapy.

The researchers also looked at antioxidant supplements, which include vitamins A, C, and E. They found that most patients did not take these supplements both before and during chemotherapy, but those who did were more likely to have cancer return after treatment. However, this finding was not “statistically significant,” which means that more research is needed to determine whether these worse outcomes occurred by chance.  In addition, the 44% of the patients in the study who were taking multivitamins did not have better or worse outcomes than people who were not taking them.

This is what scientists call an observational study rather than a clinical trial. In a clinical trial, some patients would be randomly assigned to take supplements and others would be assigned to take a placebo (with no active ingredients). In an observational study, people make their own decisions about what treatment (in this case supplements) to take. Those who chose to take supplements might have different health issues or health habits than those who did not. For example, it is possible that the people who were more likely to take supplements both before and during their chemotherapy were less healthy to begin with. For example, they could have been taking B12 or Iron supplements because they had anemia, and anemia may have increased the possibility of cancer recurrence or death. Also, because patients were asked whether or not they took supplements (instead of being given the supplements by researchers), it is impossible to know whether what patients said about supplements was completely accurate. For example, some patients could have said that they were regularly taking a supplement, but really they only took it occasionally.   

Dr. Christine Ambrosone, the lead researcher of the study, said in an interview that this is only one observational study, and doctors should not necessarily base their recommendations on this single study. Doctors need to consider the specific needs of each patient. For example, someone with anemia might need a dietary supplement, and the benefits of those supplements might outweigh the potential risks. 

If you are considering taking a dietary supplement, it is important to keep in mind that the Food and Drug Administration does not regulate dietary supplements for purity and quality. There is no guarantee that a supplement will work or even that it contains exactly what the bottle says it contains.[2] It is always important to talk with your doctor to help you decide if the benefits of any dietary supplement you are considering outweigh the potential risks. 

 

  1. Ambrosone, C. B., Zirpoli, G. R., Hutson, A. D., McCann, W. E., McCann, S. E., Barlow, W. E., … & Unger, J. M. (2019). Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221). Journal of Clinical Oncology, JCO-19.
  2. Brooks, J, Mitchell, J., Nagelin-Anderson, E. , & Zuckerman, D. National Center for Health Research. How Safe are Natural Supplements? Center4research.org. http://www.center4research.org/examining-safety-natural-supplements/. 2019.