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NCHR Written Statement for North Salem Central School District Board of Education

Policy, , , , , , ,

May 12, 2021

Dear Dr. Freeston and the North Salem Central School District Board of Education:

As president of the National Center for Health Research, I want to share the information we have provided to Members of Congress, state and federal agencies, state and local legislators, parents, and others who want to ensure that our children are not exposed to dangerous chemicals or other substances when they play on artificial turf or playgrounds. Our nonprofit think tank is located in Washington, D.C. Our scientists, physicians, and health experts conduct studies and scrutinize research conducted by other experts in the field. Our goal is to explain scientific and medical information that can be used to improve public health.

Our organization has been testifying and writing about the dangers of synthetic turf and playground surfaces for several years.  Our scientific staff has reviewed all publicly available scientific studies pertaining to the health impact of the lead and chemicals that are in artificial turf and playground surfaces, compared to natural surfaces such as grass and engineered wood fiber.

In the last year, scientists have reported finding potentially dangerous levels of lead in artificial turf fields and playground surfaces.  In addition, plastic grass and synthetic rubber are made with different types of hormone-disrupting chemicals, some of which are known to be particularly harmful to growing children.  Scientists at the National Institute of Environmental Health Sciences, which is an institute of NIH, have concluded that these chemicals can be threats to health even at low levels.

Manufacturers and advocates for synthetic turf often state that artificial turf has been declared safe by federal authorities.  That is completely untrue.  It is essential to understand that there are no federal requirements for safety testing of these synthetic turf products before they are sold. The EPA and the federal Consumer Product Safety Commission are jointly studying the chemicals used in these products, but they have not yet released any data on studies of children exposed to these fields and playgrounds day after day and week after week.

There is a dangerous trend of replacing natural fields and playground surfaces with materials that are dangerous to our children’s health, potentially dangerous to adult fertility and health, and bad for our environment.  In the last year, we’ve learned new information about lead and PFAS in artificial turf, as well as the risks of some of the newer infill materials that turf companies are using to replace tire crumb.

The “plastic grass” itself has dangerous levels of lead, PFAS, and other toxic chemicals.  PFAS are of particular concern because they are “forever chemicals” that get into the human body and are not metabolized, accumulating over the years. As I mentioned in an NPR interview this week1, new research published in the prestigious Journal of the National Cancer Institute found that people with greater exposure to PFAS are significantly more likely to be diagnosed with kidney cancer.2  Previous research suggests that testicular cancer is also associated with PFAS.

Lead

The American Academy of Pediatrics states 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 that can be difficult or even impossible to predict. You may have been told that lead is only a problem for artificial turf made with tire crumb infill, but that’s not correct. The Centers for Disease Control and Prevention (CDC) warns that the “plastic grass” made with nylon or some other materials also contain lead.  The lead doesn’t just stay on the surface.  With wear, the turf materials turn to dust that is invisible to the eye but that children are inhaling when they play.

Why are Chemicals that are Banned from Children’s Toys Allowed in Artificial Turf and Rubber Playground Surfaces?

There are numerous studies indicating that endocrine-disrupting chemicals found in plastic cause serious health problems. As noted above, scientists at the National Institute of Environmental Health Sciences have concluded that unlike most other chemicals, these hormone-disrupting chemicals can be dangerous at very low levels, and the exposures can also be dangerous when they combine with other exposures in our environment.

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

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

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

Envirofill and Other Alternative Infills

Replacing tire waste with silica, zeolite, and other materials also has substantial risks because the dust from these materials can be inhaled.

Summers in New York can get hot.  Even when the temperature is a pleasant 80 degrees Fahrenheit, artificial turf and playground surfaces can reach 150 degrees or higher.  Obviously, turf and playground surfaces are likely to be even hotter than 150 degrees on a sunny 90 degree day.  That can cause “heat poisoning” as well as burns.

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

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

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

Despite claims to the contrary, no independent studies have demonstrated that artificial turf is safe.  Although the Trump Administration’s EPA stated that there was no conclusive evidence that the levels of chemicals in artificial turf was harmful to children, they made it clear that their research was based on assumptions about likely exposures rather than scientific research on children.

Scientific Evidence of Cancer and Other Serious Harm

It is essential to distinguish between evidence of harm and evidence of safety. Like the Trump Administration’s EPA, 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 is no clear evidence that an artificial turf field has caused specific children to develop cancer. However, that statement is misleading because it is virtually impossible to prove any chemical exposure causes one specific individual to develop cancer. As an epidemiologist, I can also tell you that for decades there was no evidence that smoking or Agent Orange caused cancer.  It took many years to develop that evidence, and the same will be true for artificial turf.

I have testified about the risks of these materials at hearings of the U.S. Consumer Product Safety Commission and state and local agencies.  At these hearings, I am sorry to say that I have repeatedly seen and heard scientists paid by the turf industry and other turf industry lobbyists say things that are absolutely false, most recently at a hearing in a Connecticut community. They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true).

On the contrary, we know that the materials being used in artificial turf contain carcinogens, and when children are exposed to those carcinogens day after day, week after week, and year after year, they increase the chances of our children developing cancer, either in the next few years or later as adults.  That should be adequate reason not to install them in your community.  That’s why I have spoken out about the risks of artificial turf in my community and on a national level.  The question must be asked: if they had all the facts, would families choose to spend millions of taxpayer dollars on fields that are unhealthy and unsafe rather than well-designed natural grass fields?

Dangerously Hard Fields and Injuries From Turf

Artificial turf fields get hard over time, and this can cause brain injuries and other injuries.  Turf companies recommend annual tests at 10 locations on each turf field, using something called a Gmax scores.  A Gmax score over 200 is considered extremely dangerous and is considered by industry to pose a death risk.  However, the synthetic turf industry and ASTM (American Society for Testing and Materials), suggest scores should be even lower — below 165 to ensure safety comparable to a grass field.  Do you want to pay to have those tests conducted annually on artificial turf fields, and replace a relatively new field that fails the test?

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

Any child who plays on artificial turf knows about “turf burns” that can be very painful and can get infected, but other injuries are even more serious. A study of more than 2,000 young female soccer players from 109 teams over the course of a season found that ankle sprains were almost twice as likely on turf compared to natural grass.4 Knee injuries are also much more likely on artificial turf.  A 10-year study of 5 different types of knee injuries on grass compared to artificial turf was conducted across all 3 divisions of NCAA football. They found that posterior cruciate ligament (PCL) tears occurred almost 3 times as often on turf than on grass.5 Athletes playing at lower levels experienced anterior cruciate ligament (ACL) tears 1.6 times more often on turf than they did on the grass.  This issue persists at the professional level as well, which is why the National Football League’s Player Association demanded artificial turf fields be replaced with natural grass, citing the league’s official report regarding increases in injuries on artificial turf surfaces. The report showed non-contact knee injuries happened 32% more often on turf.6

Environmental Issues

In addition to the health risks to school children and athletes, approximately three tons of infill materials migrate off of each synthetic turf field into the community environment each year.  About 2-5 metric tons of infill must be replaced every year for each field, meaning that tons of the infill have migrated off the field into grass, water, and our homes.  The fields also continuously shed microplastics as the plastic blades break down.7,8 These materials may contain additives such as PAHs, flame retardants, UV inhibitors, etc., which can be toxic to marine and aquatic life; and microplastics are known to migrate into the oceans, food chain, and drinking water and can absorb and concentrate other toxins from the environment.9,10,11

Synthetic surfaces also create heat islands.12,13  In contrast, organically managed natural grass saves energy by dissipating heat, cooling the air, and reducing energy to cool nearby buildings.  Natural grass and soil protect groundwater quality, biodegrade polluting chemicals and bacteria, reduce surface water runoff, and abate noise and reduce glare.14

Conclusions

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

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

I am not paid to write this statement.  I am one of the many parents and scientists who are very concerned about the impact of artificial fields on our children.  I’m sure you agree that it is important that decisions are based on scientific evidence, not on sales pitches by individuals with conflicts of interest.

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

 

Sincerely,

Diana Zuckerman, Ph.D.

President

 

References

  1. Vega, T., & Zuckerman, D. (May 10, 2021). The Role of Environmental Regulations in the Fight Against Cancer. The Takeaway. New York City, New York; WNYC.
  2. Shearer, JJ et al, Serum Concentrations of Per- and Polyfluoroalkyl Substances and Risk of Renal Cell Carcinoma. 2021; JNCI: Journal of the National Cancer Institute, Volume 113, Issue 5, , Pages 580-587, https://doi.org/10.1093/jnci/djaa143
  3. Anderson SE and Meade BJ. Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals. Environmental Health Insights. 2014; 8(Suppl 1):51–62. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/
  4. Steffen, K., Andersen, T. E., & Bahr, R. Risk of injury on artificial turf and natural grass in young female football players. British Journal of Sports Medicine. 2007; 41 Suppl 1(Suppl 1), i33–i37. https://doi.org/10.1136/bjsm.2007.036665
  5. Loughran, G. J., Vulpis, C. T., Murphy, J. P., Weiner, D. A., Svoboda, S. J., Hinton, R. Y., & Milzman, D. P. Incidence of Knee Injuries on Artificial Turf Versus Natural Grass in National Collegiate Athletic Association American Football: 2004-2005 Through 2013-2014 Seasons. The American journal of sports medicine.2019;47(6), 1294–1301. https://doi.org/10.1177/0363546519833925
  6. Dulik, Brian. NFLPA asking teams to change all fields to natural grass. AP News. September 20, 2020. https://apnews.com/article/nfl-football-archive-9b34d4402f2f82ae60708605f65aa560
  7. Magnusson K, Eliasson K, Fråne A, et al. Swedish sources and pathways for microplastics to the marine environment, a review of existing data. Stockholm: IVL- Swedish Environmental Research Institute. 2016. https://www.naturvardsverket.se/upload/miljoarbete-i-samhallet/miljoarbete-i-sverige/regeringsuppdrag/utslapp-mikroplaster-havet/RU-mikroplaster-english-5-april-2017.pdf
  8. Kole PJ, Löhr AJ, Van Belleghem FGAJ, Ragas AMJ. Wear and tear of tyres: A stealthy source of microplastics in the environment. International Journal of Environmental Research Public Health. 2017;14(10):pii: E1265. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
  9. Kosuth M, Mason SA, Wattenberg EV. Anthropogenic contamination of tap water, beer, and sea salt. PLoS One. 2018,13(4): e0194970. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895013/
  10. Oehlmann J, Schulte-Oehlmann U, Kloas W et al. A critical analysis of the biological impacts of plasticizers on wildlife. Philosophical Transactions of the Royal Society B. 2009;364:2047–2062. http://rstb.royalsocietypublishing.org/content/364/1526/2047
  11. Thompson RC, Moore CJ, vom Saal FS, Swan SH. Plastics, the environment and human health: Current consensus and future trends. Philosophical Transactions of the Royal Society B. 2009;364:2153–2166. https://royalsocietypublishing.org/doi/full/10.1098/rstb.2009.0053
  12. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 2014;72:895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
  13. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  14. Stier JC, Steinke K, Ervin EH, Higginson FR, McMaugh PE. Turfgrass benefits and issues. Turfgrass: Biology, Use, and Management, Agronomy Monograph 56. American Society of Agronomy, Crop Science Society of America, Soil Science Society of America. 2013;105–145. https://dl.sciencesocieties.org/publications/books/tocs/agronomymonogra/turfgrassbiolog

The Role of Environmental Regulations in the Fight Against Cancer

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NYC NPR, May 10, 2021

Last month, President Biden announced he wanted to boost funding for research on cancer and other diseases. But experts say that the fight against cancer will be tough to win if there isn’t also a focus on preventing the disease by regulating carcinogens. The Environmental Protection Agency has historically been slow to act on known carcinogens and much more research is needed to find out exactly which toxins are making us sick.

Diana Zuckerman, president of the National Center for Health Research, joined The Takeaway to discuss what it would take to win the war on cancer.

To listen, click on the play button on https://www.wnycstudios.org/podcasts/takeaway/segments/role-environmental-regulations-fight-against-cancer

Biden’s ‘end cancer’ pledge begs for environmental oversight

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

Ariel Wittenberg, E&E News: May 4, 2021

President Biden pledged last week to “end cancer as we know it,” a bold promise focused on boosting funding to the National Institutes of Health for a special Advanced Research Projects Agency-Health.

ARPA-H would be similar to the Department of Energy’s Advanced Research Projects Agency-Energy, or ARPA-E, acting as a technology incubator by funding high-potential, high-impact projects that are too early for private-sector investment, but with the “singular purpose to develop breakthroughs to prevent, detect and treat” diseases.

“I can think of no more worthy investment. I know of nothing that is more bipartisan,” Biden told Congress last week. “So let’s end cancer as we know it. It’s within our power. It’s within our power to do it.”

But public health experts who have spent their careers examining environmental causes of cancer say it may not be possible to truly stop cancer without EPA stepping in.

The agency has been infamously slow to stop the use of known carcinogens for decades. Those include benzene, arsenic and asbestos, which is responsible for 40,000 deaths per year alone.

“We know that several chemicals are known to cause cancer in humans and others are highly suspect,” said Bob Sussman, an attorney and former EPA official now representing multiple groups in asbestos litigation against the agency. “There are many causes of cancer, but if we don’t address chemicals, we won’t get the job done.”

EPA could help Biden on his mission if it were faster to regulate not just asbestos but also PFOA, phthalates and bisphenol A, said Linda Birnbaum, who formerly led the National Institute of Environmental Health Sciences.

Listening to Biden’s address to Congress, she said, she was happy to hear the president “talking about major changes in how society functions.”

“But the focus was on treatment and cures,” she said. “I’m not opposed to treatment and cures, but I think it’s better to prevent if you can.”

Diana Zuckerman, president of the National Center for Health Research, agreed that the nation needs a “two-pronged attack” to end cancer.

“You can’t talk about even reducing cancer without talking about environmental toxins,” she said.

She noted that while Biden did mention a need to research cancer “prevention” during his speech, the medical community often refers to cancer screenings as prevention.

“Screening isn’t prevention; it’s early detection. You’ve already got the cancer; we just found it early,” she said. “If you want to prevent it, you have to deal with what causes it in the environment.”

Asked whether EPA sees a role in Biden’s quest to “end cancer as we know it,” the agency responded only, “EPA is fully on board with President Biden’s agenda.”

It’s not exactly clear what that means. Biden did not mention a role for the agency during the cancer portion of his speech to Congress. But the president’s quest to end cancer is famously motivated by his late son, Beau Biden, who died of glioblastoma in 2015.

[….]

Margaret Kripke, a professor of immunology at the University of Texas’ MD Anderson Cancer Center who has been studying the environmental causes of cancer for years, served on the President’s Cancer Panel in the early 2000s. The culmination of her work on the panel was a report on environmental causes of cancer that said “the true burden of environmentally-induced cancer has been grossly underestimated.”

The paper also took aim at EPA, complaining that “ubiquitous chemicals,” like bisphenol A, were still found in many consumer goods despite growing evidence of links to cancer.

“Not a whole lot has changed since then,” Kripke told E&E News last week, “except that we do know more about cancer and how it works, and how chemical exposures work.”

Unfortunately, she and Birnbaum concur, not everyone agrees about what type of evidence is needed to prove a given chemical causes cancer.

[….]

Kripke said EPA might be empowered to regulate more carcinogens if there were more research, either in the lab or in epidemiological studies.

“I do think it’s on the regulatory agencies, because there are a lot of things that are clearly carcinogenic that are regulated in other countries that are not regulated here,” she said. “But at the end of the day, the agencies can only act on the basis of information, and that information ultimately comes from the research efforts.”

That’s where she hopes Biden’s new mission can help. She said cancer funding is often determined by panels of researchers, who themselves can be biased toward funding research similar to their own. If the purpose of an ARPA-H organization is to fund research that would have difficulty obtaining funding otherwise, she said, studies on the health impacts of chemicals could fit that bill.

“If they are going to have a little broader thinking about what is appropriate for funding than traditional panels made up of people doing current cancer research, then maybe there might be a better opportunity to propose studies on cancer-causing agents or chemicals,” she said.

The Department of Health and Human Services did not respond to a request for comment on whether, if approved by Congress, a new ARPA-H would emphasize environmental causes of cancer.

But Zuckerman said she is skeptical that an ARPA-H would mean more funding for research on environmental carcinogens. While ARPA-E, at the Department of Energy, does fund applied and demonstration research for new technologies — the kinds of work private companies don’t find economical — Zuckerman noted that the research is often then picked up and used by companies looking to make money.

“You may get a huge infusion of cash, and yay for that, but it is still within a system where, at the end, there are people who want to earn money off this research,” she said. “You can earn a lot more money off a cancer treatment than you can off reducing pollution.”

You can read the entire article here https://www.eenews.net/stories/1063731675

NCHR Statement at FDA Advisory Committee Meeting on Keytruda and Tecentriq for Advanced Urothelial Carcinoma

Policy, Testimony & Briefings

April 28, 2021

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  I am trained in statistics, clinical trial design, epidemiology, and public health and was a faculty member and researcher at Yale and Harvard and a Fellow in Bioethics at Penn.  I’ve also worked at HHS. 

The details differ but in both cases our statistical and research analyses support the FDA findings that the data do not confirm the indication.

That’s especially important because both Tecentriq and Keytruda cause substantial adverse events and an alternative treatment has shown clear benefit!

FDA grants accelerated approval with requirements for post-market RCTs to evaluate overall survival to ensure clinically meaningful benefit.  But the randomized clinical trials conducted did NOT show benefit. How could FDA continue to offer accelerated approval for any drugs in the future if post-market RCTs results are ignored?

Most of you are clinicians and you’re used to trying different types of treatment in hopes that something will work. But the rules for FDA approval are different.  Shouldn’t cancer patients be eligible for free treatments in clinical trials instead of paying for treatment that isn’t proven to work – and that has risks?

Can other studies be used to confirm the indication?  FDA explained the problems very clearly.

  • Not appropriate to use studies with data based on patients that aren’t for the same indication:

      #1) PD-L1 high and

      #2) not eligible for cisplatin or other options.

To Stay: Two More Cancer Indications With ‘Dangling Approvals’

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Kerry Dooley Young, Medscape News: April 29, 2021

Two more cancer indications that had been granted accelerated approval by the US Food and Drug Administration (FDA) are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27–29) and follows a similar verdict from day one.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immunotherapy checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the 3-day FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck & Co (the manufacturer of pembrolizumab), told ODAC members during a discussion.

[….]

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet been proven to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

[….]

To read the entire article, see https://www.medscape.com/viewarticle/950165

NCHR Statement Regarding Cancer Drugs that Failed to Confirm Efficacy after Accelerated Approval

Policy, Testimony & Briefings, , ,

April 29, 2021

I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  Today I’m speaking from my perspective as a scientist who left Harvard more than 30 years ago to come to Washington D.C. to work in the House of Representatives. I worked as a Congressional investigator for the Subcommittee that conducted oversight over all of HHS, and that’s when I first learned about the laws and regulations governing the FDA.  I was responsible for several oversight hearings that attracted enormous media attention, because we found that patients had been harmed when the FDA was not following the law pertaining to FDA approval.

The law is very clear:  Drugs and biologics must be proven safe and effective, and that’s defined as having benefits that outweigh the risks for most patients.  FDA’s memoranda that were provided to this Committee for this meeting and for each of these indications over these last 3 days have made it clear that the data do not support that.  This Advisory Committee has looked at the data, seen reasons for optimism when looking at nonsignificant trends, and recommended that the FDA keep drugs on the market that don’t meet the standard specified by law.  That’s your right to do that, since you are advising the FDA based on your perspectives, experiences, and interpretations of the data.

I want to thank the FDA scientists who carefully analyzed the data and presented their findings.  You did a great job.  I’m here to urge the FDA to follow in your footsteps and follow the law and rescind approval for these indications until the companies complete randomized clinical trials that prove that the benefits outweigh the risks. I especially want to thank Dr. Pazdur for explaining how the FDA’s Expanded Access program can fill in the gaps for patients who need access to these drugs.  The companies agreed to complete confirmatory trials as part of the accelerated approval of their drugs, and I strongly urge the FDA to hold them to it.

All of these companies are leaders in their field and absolutely capable of conducting the research needed to prove whether or not their drugs have benefits that outweigh the risks for the exact specific indications they were previously approved for.  The companies also have the ability to make expanded access quick and easy.  Let’s face it, if they don’t have the expertise and resources to do the studies and help with expanded access, who does?  If the data don’t confirm the initial accelerated approval, the companies should work with the FDA to design trials to narrow the indication to figure out which are the patients most likely to be helped and which are the ones most likely to be harmed.

FDA Scrutinizes Pricey Cancer Drugs

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Politico Pulse: April 28, 2021

What should be done about expensive cancer drugs on the market that might not work? That could be the first thorny question to confront Woodcock, who is acting FDA commissioner while Biden weighs whether to nominate her for the full-time role.

The FDA is convening an expert panel this week to discuss whether the agency should revoke approved uses of three therapies that, despite positive signs from early research, failed to help patients with certain cancers live longer. All three medicines were approved under Woodcock’s tenure as drug chief and after increasingly speedy reviews.

Drug regulators “wanted to get these drugs to market as quickly as possible,” said Diana Zuckerman, a drug safety expert and president of the National Center for Health Research, who is presenting several times at this week’s meeting. “That was clearly their goal and they succeeded in doing it. But now there is a reckoning.”

What the companies say: Genentech, Merck and Bristol-Myers Squibb, the companies at the center of the debate, say their drugs still have value against the cancers in question, they just need to do more research. And Genentech on Tuesday applauded the advisory panel’s vote to keep its drug on the market for triple-negative breast cancer, one of the approvals in question.

To see the entire Politico Pulse, read https://www.politico.com/politicopulse/.

Can California’s public universities mandate COVID-19 vaccines?

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Robert M. Kaplan and Diana Zuckerman, Ph.D., Monterey Herald: April 26, 2021

Last week, the University of California and the California State University system proposed mandating COVID-19 vaccines for faculty, staff, and students beginning in the fall.  Only those with medical conditions aggravated by vaccination or those with legitimate religious objections would be excused.  The policy is consequential: Public university students, faculty and staff include nearly 1,000,000 Californians. But is the mandate feasible? And, should the California universities dive headfirst into what promises to be a complicated controversy?

With waning competition for shots, public health officials now worry about vaccine hesitancy. Lower vaccination rates give more opportunities for variants to develop and could make the pandemic last longer. We all benefit when more people are vaccinated.  Yet, national polls by Stanford and YouGov show that about 20% of Americans will refuse to be vaccinated, and one in three estimate their likelihood of getting vaccinated is below 50%. Only 20% strongly agree that vaccines should be mandated and 45% report that vaccinations should be strictly voluntary.

Requiring vaccinations may be legal. Since 1905, courts have consistently upheld vaccination mandates, but with some exemptions.  Although 50 states and Washington D.C. can require vaccines for primary schools, all states allow medical exemptions.  Further, 45 states permit religious exemptions and 15 recognize philosophical objections.  Only 16 states allow post-secondary institutions to require vaccinations for influenza or hepatitis B.

Despite these precedents, the UC/CSU proposal could be derailed because current CDC policy only allows mandates for vaccines approved by the Food and Drug Administration. Technically, no COVID vaccine is currently approved. Instead, the three vaccines have been authorized under a different vetting mechanism called Emergency Use Authorization.  Unlike FDA approval, EUA is a temporary agreement that allows medical products to be used in emergency situations based on FDA’s determination that the benefits “may” outweigh the risks.  That requires a less rigorous standard of evidence than FDA approval. Before the pandemic, EUAs were only used to speed emergency treatments to a relatively small number of people threatened by Ebola, Zika, and anthrax.

To be fair, each of the three authorized (but unapproved) COVID vaccines underwent rigorous testing in large studies. However, the FDA had announced that full approval of these vaccines would require following study participants for “at least one to two years.”  For the EUA’s,  FDA permitted just two months of follow-up and stated that while two months was the minimum to determine safety, it wasn’t sufficient to determine how long the vaccines would be effective.

With the EUAs in hand and bolstered by promising early results and extremely high demand for vaccines, companies had no incentive to continue the trials. Despite advice by scientists to continue studies with the inclusion of a control group, all three companies provided the vaccine to participants who had received a placebo. The ethical reasons for this are obvious; however, the consequence is that a rigorous evaluation of the long-term benefits and side effects is no longer possible in the absence of a placebo control group.

What do we know about safety?  137 million Americans have had at least one dose of the vaccine.  Although at least half have experienced bothersome reactions, very few have reported serious side effects that resulted in permanent damage or death. The FDA and CDC have two systems to track real-world reactions. V-SAFE is an app that regularly asks vaccinated individuals to report any health problems. Unfortunately, very few individuals use it.  The other system, the Vaccine Adverse Event Reporting System (VAERS) is designed for health care providers to report bad reactions to vaccines.   As with V-SAFE, reporting is not enforced and therefore reactions are under-reported.  The current systems are limited because they were not designed to accurately determine how many people experience adverse events.

UC/CSU should be commended for proposing a bold strategy to address a serious problem.  A mandate to vaccinate university communities could turn the campuses into COVID safe zones. However, it is likely to encounter serious legal challenges if none of the vaccines are FDA approved before the mandate is implemented. Instead of waiting for the FDA to deny approval for insufficient evidence, the UC and CSU systems could use their exceptional creativity and research capability to produce better evidence that would inform the FDA about the long-term scientific safety and effectiveness of the vaccines.

Robert M. Kaplan is a faculty member at Stanford University’s Clinical Excellence Research Center and a former Associate Director of the National Institutes of Health. Diana M. Zuckerman is the President of the Washington DC-based National Center for Health Research. She is an expert on the safety and effectiveness of medical products. You can view the original article here. 

Conflicts Galore: Upcoming Accelerated Approval Cancer Panel May Be Tainted By Industry Relationships

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Sarah Karlin-Smith, Pink Sheet: April 21, 2021

Six members of the FDA Oncologic Drugs Advisory Committee received conflict of interest waivers to participate in the agency’s upcoming three-day meeting to review the accelerated approval of six checkpoint inhibitor indications after the three cancer immunotherapies at issue failed to confirm clinical benefit in post-market trials raising questions about whether industry influence may heavily factor in the committee’s decision making.

The high number of waivers could mean that a majority or close to a majority of the panelists will have conflicts based on the typical number of advisors on FDA panels. The agency used to be subject to waiver limits but the 2012 FDA Safety and Innovation Act removed these restrictions.

ODAC’s 27-29 April meeting, part of the agency’s broader industry-wide effort to evaluate accelerated approvals for oncology drugs, is unprecedented in the number of drugs and indications up for accelerated approval withdrawal. The committee will discuss two indications for Tecentriq (atezolizumab); three for Keytruda (pembrolizumab); and one for Opdivo (nivolumab).

[….]

Vinay Prasad, a hematologist-oncologist at the University of California San Francisco acknowledged that it may not always be easy to find unconflicted experts but, he said they do exist. He also argued that in this case you might be able to look at other professionals like internists who study research methods and FDA approvals, for example for panel members.

[….]

Diana Zuckerman, president of the National Center for Health Research said that while FDA needs some people with clinical expertise who understand the illness and issues with the treatment, it doesn’t need an entire panel of these people. She said that one way FDA can find more qualified experts is by looking at schools of public health where academics rarely get money from industry and they have expertise in understanding clinical trials as well as biostatics.

Even if the academic’s salary isn’t directly funded by their work with industry, there are multiple reasons to be concerned that work on industry trials with the same drugs creates conflicts.

“There’s research showing that researchers feel more positively about drugs that they’ve studied. That’s normal human behavior. You feel proprietary towards something that you’ve studied. You also have a relationship with the company,” said Adrian Fugh-Berman a professor Pharmacology and Physiology at Georgetown where she directs PharmedOut, a project that focuses on evidence-based prescribing and studying industry marketing practices.

The person may also be thinking about how their behavior on the committee may impact other research opportunities the university or they in particular have with the company, she explained.

“Are you going to get more research grants for the company if you kill their drug?” Fugh-Berman said.

[….]

Over the past 12 months ODAC has had two other committee meetings where four waivers were granted but that is far from typical. Most agency advisory committees don’t have any waivers or at most have one or two, per data from FDA from 2018 onward.

FDA is supposed to publish an annual report to Congress on advisory committees that include information on waivers but the latest report available online was from fiscal year 2016. FDA did respond to questions about whether more updated data exists and where it can be found.

​To read the entire article, see https://pink.pharmaintelligence.informa.com/PS144196/Conflicts-Galore-Upcoming-Accelerated-Approval-Cancer-Panel-Includes-Many-Industry-Relationships

4 in 10 Adults Over 50 Consult Online Reviews When Picking a Doctor

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Steven Reinberg, HealthDay: April 14, 2021

Finding a new doctor can be a daunting task. For help, many older adults turn to online reviews, a new study finds.

In fact, many people rate online reviews as highly as they would a recommendation from friends and family when picking a doctor, the new research found.

“Doctors and policymakers should know that many older adults are viewing and valuing online ratings and reviews when choosing physicians,” said researcher Dr. Jeffrey Kullgren. He’s an associate professor of internal medicine at the University of Michigan in Ann Arbor.

[….]

Diana Zuckerman is president of the National Center for Health Research, a nonprofit think tank that conducts research on a range of health issues. She said that choosing a doctor is a complex undertaking.

“The trouble with these ratings is they’re not based on how good the physician is,” said Zuckerman, who wasn’t involved in the new study. “They’re usually based on convenience issues, like how long do you have to wait in the waiting room, how nice is the doctor, and does the doctor listen to you. These are all nice things, but they’re not really the important things.”

[….]

In all, the survey found that 40% of adults aged 50 to 80 have used online doctor rating sites and trust them almost as much as recommendations from family or friends for choosing a doctor. Also, online ratings were seen as more important than where a doctor went to medical school or trained.

[….]

Women, people with more education and those with chronic conditions were the most likely to turn to online rating sites, the investigators found.

[….]

Zuckerman said that most people don’t have the expertise to rate a doctor in ways that are meaningful in terms of how good a physician is or how good the medical care that they’re going to get is.

Often, online ratings should be taken with a grain of salt, she said, because you don’t know exactly what the ratings are based on.

The recommendation of friends or family members can be helpful, but in the end, it’s going to be how your experience with a doctor measures up to your needs and expectations that are important. And you shouldn’t be afraid to change doctors if you’re dissatisfied with your care, she adonvised.

Zuckerman agreed with the researchers that it’s up to policymakers and clinicians to set standards and criteria for online reviews. Patients, too, need to understand the pros and cons of online ratings.

You can read the entire article here.