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Beleaguered FDA in talks for drug-company funding

Eleanor Laise, Marketwatch: July 13, 2021


Amid a firestorm over its approval of a new Alzheimer’s treatment, the Food and Drug Administration is holding closed-door meetings with companies it regulates — talks that critics say allow drug and device makers to exert outsize influence over the agency’s operations, threatening to erode public trust in the agency at a critical moment.

The talks focus on “user fees” that pharmaceutical and medical-device companies pay to the FDA annually and when applying for approval of new products. The FDA in recent years has become increasingly reliant on such payments, which funded nearly half of the agency’s total spending in fiscal year 2020. In exchange for the fees, the FDA agrees to certain deadlines for reviewing new-product applications, the type and frequency of meetings with companies submitting applications, and other commitments. The medical-product user-fee agreements are generally renegotiated every five years — a process that’s happening now, in advance of the current agreements’ expiration next year — and submitted to Congress for authorization.

Although the FDA is required by law to consult with patient and consumer advocacy groups on the discussions and make minutes of its industry meetings public, the meat of the talks often remains hidden, observers say. Since September of last year, the FDA has held more than 150 meetings with industry to discuss fee agreements for brand-name prescription drugs, generics, medical devices and biosimilars (products similar to branded biologic drugs), which together are expected to generate nearly $2 billion for the agency this fiscal year. Yet consumer advocates and other outside groups attempting to track the discussions say they remain in the dark about most of the details. FDA summaries of some recent meetings have been posted months after the fact or sum up a discussion in a single sentence. Medical-product safety experts say they’ve repeatedly asked for more access and details on the negotiations, to no avail.

“We simply can’t get a view into this process, and the lack of transparency is deliberate,” says Madris Kinard, a former public health analyst at the FDA and CEO of Device Events, which tracks medical-device adverse-event reports.

Details about the negotiations that have trickled out raise alarms among some medical-product safety experts, academic researchers and consumer advocates that the industry’s leverage in these talks ultimately puts patients at risk. User fees are speeding more products to market without a corresponding increase in resources to track the safety of those products, critics say. Yet in the current round of negotiations, FDA efforts to allocate more user fees toward monitoring the safety of medical products already on the market have met industry resistance.

[….]

The main idea behind the user-fee programs was to speed up FDA review of medical-product marketing applications — and they’ve delivered on that front. The median time to approval for standard new-drug applications was 10 months in fiscal 2018. In the years before user fees were first enacted, the median FDA application review time was nearly three years, according to a study by Kesselheim and colleagues at Harvard and Brigham and Women’s Hospital.

[….]

But user-fee deadlines can have serious side effects, some experts say. As the opioid crisis was exploding, “there was a question of ‘Why does the FDA keep approving the opioids?’ ” says a former FDA official. “One reason was that they had applications and had user-fee obligations to review the applications.” So long as an application met the standard requirements, “it would be approved,” he says. “That’s an example of the mindset” created by the deadlines.

Several studies have linked faster drug-approval timelines to safety issues. A 2014 study in Health Affairs found that drugs approved after user fees were enacted were more likely to get new black-box warnings or be withdrawn from the market than drugs approved in the pre-user-fee era. Other studies have found that, compared with drugs approved at other times, drugs given the green light shortly before their user-fee deadlines were more likely to have subsequent safety issues.

[….]

In the current round of medical-device user-fee negotiations, one of the FDA’s goals is to improve device safety, including through increased funding for surveillance of devices already on the market, the agency says. That proposal met stiff resistance from the industry, according to outside groups that have received FDA briefings on the talks. At an April 7 negotiation meeting, the industry expressed the view that fees “should be solely for the premarket review process,” according to a summary posted by FDA. Medical-device trade group AdvaMed didn’t respond to requests for comment.

At the start of the prescription-drug user-fee negotiations, the FDA also emphasized its hope of improving the Sentinel Initiative, a system for assessing the safety of approved medical products. But a related proposal advanced by the FDA during the negotiations was shot down by the industry, a December meeting summary notes.  

[….]

Revolving doors

“There’s not a lot of friction between the industry and the agency” in prescription-drug user-fee negotiations, says a former FDA official. “The industry knows it’s getting good value.”

A sign of the amicable relations: One FDA official leading the current round of prescription-drug user-fee negotiations left the agency in April of this year, according to her LinkedIn profile, to become vice president of science and regulatory affairs at BIO — one of the industry groups she’d just been negotiating with. The former FDA official, Khushboo Sharma, participated in a user-fee negotiation meeting with BIO and other industry representatives as recently as Feb. 12, according to meeting summaries posted by the agency. “That is obviously an outrageous situation and clearly undermines the integrity” of the process, says Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank.

Asked for comment, the FDA sent a link to its post-employment restrictions, which say in part that current employees who have begun seeking employment outside the federal government must immediately recuse from certain matters that affect “the discrete industry, economic sector, or other defined class of organizations in which the prospective employer operates.” BIO didn’t respond to a request for comment. Sharma says that she worked with FDA ethics officials “to ensure I was recusing myself from all appropriate activities. I started seeking post-employment opportunities after negotiations had concluded.”

When the agency’s position does conflict with an industry’s, the FDA “is not going to come out on top,” says Lisa McGiffert, a patient-safety advocate at the nonprofit Patient Safety Action Network. Given the industry’s track record of snagging many items on its wish list, some observers are concerned that the current round of negotiations could chip away at FDA standards for approving new drugs. One issue: the use of “real-world data,” which can come from insurance claims, medical records, disease registries and other sources beyond the bounds of clinical trials. In an August 2020 letter to the FDA about user-fee reauthorization, PhRMA said that real-world data and evidence “may, in some circumstances, be adequate on their own to satisfy the substantial evidence criteria for demonstrating effectiveness” of drugs.

[….]

To read the entire article, click here.

My breast implants are making me sick — and I’m not alone

Pamela Appea, Salon: June 20, 2021


In November 2016, a few weeks after I had breast implant surgery, I came down with an unexpected case of thrush (an unappealing fungal infection characterized by a thick white coating on my tongue). As a Black married mother of two, even though I was still sick, I tried — but failed — to power through and take care of my kids. With intense flu-like aches, pain, and fever, it hurt to eat, drink, swallow, or even open my mouth. I couldn’t properly brush my teeth for several days.

Unfortunately, my primary care physician was on vacation. Panicked, I called the Manhattan oncologist whom I had seen a few weeks earlier. He’d been very kind to me following my DCIS breast cancer diagnosis, unilateral mastectomy and post-surgical treatment. The officer’s medical team could barely understand me when I tried to make the appointment on the phone.

“I don’t think you have thrush — didn’t I just see you a few weeks ago?” he said, trying to put me at ease as I stared at his cheerful neon tie. (I think he prided himself on his fun ties.)

It was torture opening my mouth so the doctor could diagnose me.

“Okay, that’s the worst case of thrush I’ve seen in some time,” the seasoned specialist said. He said he was putting me on antibiotics stat. I asked — or rather, wrote on a notepad, since I couldn’t speak clearly — if there could be any connection between the my immune system and the very new breast implant that was now in my body. The oncologist emphatically dismissed the notion as impossible.

Once he got the results of my lab work back, my physician said there was no evidence of anything wrong; I should bounce back in a few days. “These things sometimes happen,” he told me, smiling as he ushered me out.

While the antibiotics eventually cleared up the thrush, unfortunately I have never fully bounced back. In subsequent years since my breast implants were put in, it became even more clear that something was going on with my immune system. But none of my doctors really listened.

Although it was not formerly recognized by the medical community until recently, Breast Implant Illness (BII) has, in the past few years, finally received attention from both media and researchers. Nicole Daruda founded a Facebook’s support group, called Breast Implant Illness Healing by Nicole, in 2013; now, it boasts over 145,000 members. Daruda tentatively estimates that 50,000 women in the US have BII, although precise research-backed numbers are not readily available

“We are overwhelmed by women trying to join the Facebook group to be educated about Breast Implant Illness,” Daruda said. She estimates that 3,000 to 5,000 women message the group’s moderators every month. To try to meet the demand, Daruda later founded a nonprofit, Healing Breast Implant Illness Society of North America.

Research is just barely starting to emerge on BII. One study, published in Annals of Plastic Surgery in 2020, followed 750 women suffering from Breast Implant Illness over a multi-year time period. Once these women surgically removed their breast implants, the vast majority reported the majority of their symptoms had significantly improved or disappeared entirely.

Awareness appears to be growing, too. A wave of celebrities are talking more openly about breast implants and their health and wellness — including Victoria Beckham, Ayesha Curry, Ashley Tisdale, Chrissy Teigen and others.

A documentary that touches on the subject of BII, “Explant,” is screening right now at the Tribeca Film Festival. The film follows Michelle Visage, one of the celebrity judges on “RuPaul’s Drag Race.” Visage, a media personality, singer, DJ and actor who was well known for her signature Double-D breasts, found that doctors didn’t take her seriously when she told the specialists her immune system was out of whack. Visage experienced chronic health issues, including Hashimoto’s disease, that she now attributes to her breast implants.

Awareness of BII is crucial given the popularity of breast implants. Since 1998, the number of breast augmentation procedures in the US has increased threefold; now, they are one of the most sought-out cosmetic procedures.

The desire for breast augmentation seems so powerful regardless of what else is going on in the world,” said Dr. Diana Zuckerman, founder of the National Center for Health Research. “What most concerns me is how reluctant most plastic surgeons have been to make sure their patients know the risks before making a decision.”

Because breast implant technology has existed for decades, many women erroneously believe they are safe.

[….]

In the years after my implant, some of my symptoms mirrored women on support groups I found online, which is how I figured out I had Breast Implant Illness. While symptoms sometimes waxed and waned, I got used to experiencing a host of autoimmune and other symptoms like insomnia, brain fog, extreme breathlessness, cuts that took weeks to heal, rashes, frequent colds and much more.

But BII is no longer regarded as a myth. Many or even most doctors, including plastic surgeon Dr. Anthony Youn, believe Breast Implant Illness is real. Dr. Youn acknowledges it is a controversial topic among many of his fellow American plastic surgeons.

“If you’re happy with your breast implants and you don’t believe they are adversely affecting your health, then there is no need for treatment. If you are sick and believe your implants may be the cause, speak with your primary care physician and a board-certified plastic surgeon about whether explantation may be a possible solution for you,” Dr Youn said. “There are many causes of the symptoms of Breast Implant Illness (BII) that don’t involve breast implants, so it’s often best to rule those out first,” he continued.

In his 17 years of practice in the metro Detroit region, Dr. Youn, a member of the American Society of Plastic Surgeons and The Aesthetic Society, has performed surgery on thousands of women who elected to get breast implants. Anecdotally, he estimates the number patients who later returned to his practice stating they had Breast Implant Illness symptoms is an extremely small percentage.

[….]

Though not all women with breast implants go on to develop Breast Implant Illness, all women deserve education, informed consent, insurance coverage and most important information about potential risks. If, in 2015, there had been an FDA Breast Implant Black Box Warning (which was officially unveiled in late 2020), I honestly never would have gotten breast implants in the first place.

To read the entire article, click here.

Emergency Use Authorization vs. Full Approval: What are the Implications?

Laurie Saloman, Contagion Live: June 20, 2021


Emergency use authorizations, or EUAs, have gotten a lot of attention during the COVID-19 pandemic. The concept of the U.S. Food and Drug Association (FDA) authorizing a product or treatment quickly and without going through a full and complete review process was first introduced in 2005. At that time, the FDA issued an EUA for an anthrax vaccine available to military personnel due to a spate of anthrax-laced letters that killed or sickened nearly 2 dozen people.

Over the following years, EUAs were issued for a variety of experimental therapies for diseases such as H1N1 (swine flu), Middle East Respiratory Syndrome (MERS), Ebola, and Zika, which often arose quickly and threatened to become bona fide pandemics. Since last year, numerous EUAs have been issued for COVID-19-related products, including diagnostic and antibody tests, clinical treatments, and vaccines.

But what does it actually mean when a product is given an EUA, and why don’t companies automatically seek full FDA approval? According to Diana Zuckerman, PhD, president of the National Center for Health Research, there are several reasons why a company might not pursue approval for a product.

“One [reason] is that it’s found to not work, and so no effort is made to get it approved, and the other is that the company doesn’t necessarily have the incentive to do the research that they would need to do in order to get it approved, because the standards for an EUA are always lower than the standards would be for FDA approval,” she said. “If FDA approval would require a bigger, longer-term study with more patients, that just may not be worth it.” She offered the example of EUAs for various therapies for the Ebola virus, which does not currently present a threat to the US.

Even if a company wants to receive full approval for a product, it can run into problems if it can’t find enough of a patient population to participate in large-scale trials, added Susan Wood, PhD, professor of Health Policy and of Environmental and Occupational Health at the George Washington University Milken Institute School of Public Health and the former Assistant Commissioner for Women’s Health at the FDA.

Zuckerman and Wood agreed that, ideally, companies producing therapies that receive EUAs would go on to pursue approval for these therapies, especially as approved therapies can sometimes be repurposed to work for conditions other than those for which they were initially intended. “The reason why we were able to move…quickly with Covid was because of the work that had been done with other coronaviruses previously, and that really set the stage,” Zuckerman said. “Whether it’s for a rare disease or a future pandemic that we can’t predict, yes, having more information now can help us later.”

For companies, having full approval provides a measure of control. The FDA can withdraw an EUA at any time, preventing a company from selling or dispensing their product; in contrast, it can take several years for the agency to rescind an approval. Insurance typically doesn’t pay for products under an EUA, although in the case of Covid-19 vaccines the government is footing the bill, possibly making financial motives less of a factor for pharmaceutical companies.

But while EUAs are designed to help people get immediate assistance, it’s not uncommon for tests or therapies granted EUAs to end up being ineffective. In the case of COVID-19 tests and treatments, the FDA issued EUAs it later revoked. For example, in March of 2020, companies were permitted to sell antibody tests—which purported to tell users whether or not they had COVID-19 in the past—without submitting EUA applications. In May of 2020, companies were allowed to sell COVID-19 diagnostic tests for 15 business days before they had to submit EUA applications. During that month, the FDA issued 84 EUAs for various labs and companies, and there were an additional 400 applications pending review.

But by February of 2021, enough data on testing had been collected for the FDA to reject 225 different antibody tests. Similarly, although the FDA had granted EUA status to the drug hydroxychloroquine in March of 2020, by June of 2020 it was clear from studies that the drug not only had no discernible benefit but might even be harmful to Covid-19 patients, and the EUA was withdrawn in June 2020.

The lack of full approval by the FDA has been cited as a factor in the reluctance of some people to get the Covid-19 vaccine and has emerged as a flashpoint in the fight over vaccine mandates. Typically, mandates come after years of experience with a vaccine. “Normally…the testing is slower, the back and forth between the FDA and companies is slower, the review process is slower, and it comes on the market in a graduated fashion,” Wood said. At that point, there’s much more acceptance by the general population. “Now, everything’s been compressed, including EUA, and we’re moving straight into mandates by businesses.”

Read the original article here.

NCHR’s Statement to FDA Advisory Committee Meeting on Neurological Devices

June 3, 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 trained in epidemiology and public health 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 regulation of medical devices.

The law states that devices must be reasonably safe and effective.  It’s not exactly clear what reasonably safe or reasonably effective means, and often the FDA states that if they have reason to believe that similar devices are reasonably safe and reasonably effective, that’s good enough.  The special controls for Class II devices that the FDA has suggested for devices you’re reviewing today and tomorrow provide some evidence that the devices will work as intended and will be reasonably safe, but the general controls for Class I devices do not.

Neurological devices are important, and some of these devices are somewhat complex.  Obviously something called a “barf band” is not a complicated device, and it is an example of an acupressure device that costs only about $10, but if the goal is to prevent nausea and vomiting, and the company wants to sell it in the U.S., shouldn’t it be proven to work, like any other neurological device?  And some of those devices cost $20 or $30 or even over $200.   Just because the risks are small should not make it OK for FDA to let companies sell devices that are not effective if used as directed.  The standards for medical devices should be higher than the “let the buyer beware” standards of dietary supplements – which are basically nonexistent standards.

I was reassured that there are randomized controlled trials on many of the devices you’ll be reviewing today and tomorrow, but there are many different companies making many different versions of these devices, so the fact that some are shown to work doesn’t mean that they all work!  For example, when  chemotherapy patients want to reduce nausea and vomiting, they want to know if one of these acupressure devices is more effective than others.  And even when some devices are shown to work in a randomized controlled trial, that definitely doesn’t tell us that a new, similar device made by these same companies or any other companies will be safe and will be effective.  

The FDA has a reputation as the gold standard for safe and effective medical products, but that standard has been tarnished when patients are shown to be harmed in recent documentaries and in TV programs on during prime time this week.

I respectfully urge you to urge the FDA to up their game, by regulating all these neurological devices as Class II, and requiring the kind of meaningful evidence for new devices that we would want for any device that we use as health professionals, as patients, or as consumers.

Thank you for the opportunity to speak today.  I appreciate your service on this panel and look forward to hearing your discussion of these devices.

Racial Differences in Prostate Cancer

Meg Seymour, PhD: National Center for Health Research


About 13% of men will develop prostate cancer during their lifetime, and about 2-3% of men will die from it.[1] After lung cancer, prostate cancer is the leading cause of cancer deaths in men[2], and older men are more likely to get prostate cancer then younger men.[1]

There are known racial differences as well: Black men are 1.5 times more likely to get prostate cancer than White or Latino men, and 3 times more likely to get prostate cancer than Asians and Pacific Islanders.[3,4] On average, Black men get prostate cancer a younger ages than other men, and their cancer is often more aggressive and more advanced when it is discovered.[1] Black men are also more than twice as likely to die from prostate cancer than men from other races.[1] 

This article will discuss the known racial differences in the screening, treatment, and outcomes of prostate cancer in the United States, as well as why these differences may exist. Note that many of the differences that have been studied compare Black and White men, and data about men from other races and ethnicities are more limited.

Differences in Screening

One of the main methods of screening for prostate cancer is a blood test that measures levels of prostate-specific antigen (PSA). PSA tests alone cannot tell if someone has cancer, but high levels of PSA might lead to further testing, like a biopsy. Another method of testing is the digital rectal exam, in which a doctor inserts a (gloved and lubricated) finger into a patient’s rectum to feel the prostate for bumps or hard areas, which might be cancer. 

As of 2018, the United States Preventive Services Task Force does not recommend prostate cancer screening for men ages 70 and over.[5] For men ages 55 to 69, they recommend that PSA screening should be an individual choice, based on factors such as family history or patient preference. For more information about prostate cancer screening and the recommendations for it, you can read this article.

If the results of a PSA test or digital rectal exam leads a doctor to suspect cancer, it can lead to a biopsy. A biopsy is when a small sample of tissue is removed and examined under a microscope for cancer cells.[6]

A 2017 article in a medical journal found that overall, non-Hispanic White men were slightly more likely to undergo PSA screening than Black men. This was a trend for the United States overall, but analysis by individual states showed that screening rates were actually higher for Black men in some states.[7] More recently, a 2020 study showed that between 2014 and 2018, Black men underwent prostate cancer screening at either a slightly lower rate than White men or at the same rate.[8] The study authors note that Black men need to be more intensively screened because they are more likely to get prostate cancer.  

A study presented at the 2021 meeting of the American Society of Clinical Oncology included over 4,000 Black men ages 40-55 who had been diagnosed with prostate cancer.[9] The study found that men who had an average of 3 PSA tests prior to their diagnosis were less likely to have metastatic disease than men who had an average of 0.5 PSA tests at the time of their diagnosis. Only 1.4% of the men who had been screened an average of 3 times had metastatic disease, compared with 4.2% of the men who had the least screening. Higher rates of PSA screening prior to diagnosis was also associated with a 25% reduction in the risk of dying from prostate cancer. The study suggests that more frequent PSA screening is associated with better outcomes among younger Black men.

Accuracy of screening also varied by race. A 2018 study found that although Black men were slightly more likely to have a false positive from their PSA screening, they were less likely to have a false positive from a digital rectal exam. Further, Black men were more likely than White men to have aggressive tumors and cancer that has metastasized, which means that it has spread to other body parts.[10] 

Differences in Treatment

There are numerous treatment options for prostate cancer, such as surgery, radiation, hormone therapy, and what are called watchful waiting and active surveillance. These treatment choices also vary by race.  

Active surveillance means that no specific treatment like surgery or a drug is used. Instead, a doctor closely monitors the cancer to see if it grows, using regular PSA tests, digital rectal exams, and biopsies. This option may be used if a man’s cancer is small, localized, or expected to grow slowly, so that he is not immediately treated with aggressive treatments that may have side effects.[11] Active surveillance is used for as many as 33% of men diagnosed with prostate cancer,[12] but it is not equally used among all men in the United States. A 2020 study found that although Black and White men receive active monitoring at the same rate, Hispanic men were less likely to receive it.[12] The researchers could not identify why this ethnic difference exists, but they noted that it could have to do with factors such as patient preferences or how often the option is offered by doctors.

Watchful waiting (also called observation) is slightly different from active surveillance. It involves less intensive follow-up, such as fewer tests. Instead, the patient’s doctor decides to wait and see if symptoms change. For many men, prostate cancer grows so slowly that a man might die of other causes before he would die of the cancer, so aggressive treatment is not needed. Treatments for prostate cancer can cause undesired side effects, such as incontinence and impotence, so many men may choose active surveillance or watchful waiting, if their cancer is considered low-risk enough.  

Definitive therapy refers to radiation treatment or surgical removal of the prostate. Both procedures can have side effects such as erectile dysfunction and impotence.[13] A 2017 study looked at over 300,000 men who were diagnosed with localized prostate cancer and compared which men received definitive treatments, such as surgery, to which men received no treatment, such as men undergoing active surveillance. The study found that although White and Asian men received definitive treatment at about the same rate, Hispanic and Black men were less likely to receive it than White men were.[14] In the study, Black men with high risk prostate cancer were actually less likely to receive definitive therapy than White men with lower risk disease. Although Black men were likely to be on active surveillance, Black men on active surveillance are actually monitored less than White men on active surveillance. The researchers argue that Black men might be more likely than White men to benefit from definitive therapy, so they are concerned by the result that they are less likely to receive it. 

A 2016 study looked at surgical treatments for localized prostate cancer in men insured by Medicare. The researchers found that, on average, Black patients experienced a longer delay between diagnosis and treatment, and had more postoperative complications than White patients.[15] Research on men with metastatic prostate cancer has also found that Black men treated with the drugs docetaxel, abiraterone acetate, or enzalutamide have similar or even better outcomes to other men.[16] Researchers question why Black men have overall higher mortality rates from prostate cancer than other men. For example, is the higher death rate among Black men because they often have more advanced cancer when it is discovered, because their cancer is more aggressive, or because there is unequal access to treatments?

Why Do These Differences Exist?

Some people have suggested that racial differences in prostate cancer outcomes are because White men are, on average, of higher socioeconomic status than Black men. However, research has found that comparing men of the same socioeconomic status level, cancer screening was still more common among White men and detection of cancer was also earlier for White men.[17]

Researchers have suggested that differences in survival by race may be because Black men are more likely to be diagnosed at advanced stages of their cancer, when treatment options are more limited and can be less effective.[17] They are also more likely to have comorbid illnesses, such as diabetes and hypertension, which could affect survival rates.

A 2016 study found that, among men with localized prostate cancer, when researchers adjust for differences like at what stage a man’s cancer was diagnosed and what treatment he received, survival rates are equal across all races of men.[15] It is possible that the differences in cancer survival between races are due to racial differences in access to care.

There is an ongoing need for research into the causes of racial disparities in prostate cancer outcomes. 

The Bottom Line

Prostate cancer is a common form of cancer in men, and although it does not always need to be actively treated, it is one of the leading cancer killers. Black men are disproportionately affected. They are often diagnosed at younger ages, with more advanced stages of cancer, with more aggressive cancers, and they may be more likely to need screening. Further research is needed to understand the causes in racial differences in prostate cancer, but at least some of the differences in rates of survival between Black and White men may be due to differences in access to medical care.

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

The National Center for Health Research is a nonprofit, nonpartisan research, education and advocacy organization that analyzes and explains the latest medical research and speaks out on policies and programs. We do not accept funding from pharmaceutical companies or medical device manufacturers. Find out how you can support us here.

References 

  1.     Centers for Disease Control and Prevention. Who Is at Risk for Prostate Cancer?. Cdc.gov. https://www.cdc.gov/cancer/prostate/basic_info/risk_factors.htm. Updated August 2020. 
  2.     Siegel DA, O’Neil ME, Richards TB, Dowling NF, Weir HK. Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity — United States, 2001–2017. MMWR Morbidity and Mortality Weekly Report. 2020;69:1473–1480. 
  3.     Borno H, George DJ, Schnipper LE, Cavalli F, Cerny T, Gillessen S. All men are created equal: addressing disparities in prostate cancer care. American Society of Clinical Oncology Educational Book. 2019 May 17;39:302-8.
  4.     Dobbs RW, Malhotra NR, Abern MR, Moreira DM. Prostate cancer disparities in Hispanics by country of origin: a nationwide population-based analysis. Prostate Cancer and Prostatic Diseases. 2019 Mar;22(1):159-67.
  5.     Fenton JJ, Weyrich MS, Durbin S, Liu Y, Bang H, Melnikow J. Prostate-specific antigen–based screening for prostate cancer: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018 May 8;319(18):1914-31.
  6.     American Cancer Society. Tests to Diagnose and Stage Prostate Cancer. Cancer.org. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/how-diagnosed.html. Updated December 2020. 
  7.     Jindal T, Kachroo N, Sammon J, Dalela D, Sood A, Vetterlein MW, Karabon P, Jeong W, Menon M, Trinh QD, Abdollah F. Racial differences in prostate-specific antigen–based prostate cancer screening: state-by-state and region-by-region analyses. Urologic Oncology: Seminars and Original Investigations. 2017; 35(7):460-e9. 
  8.     Kearns JT, Adeyemi O, Anderson WE, Hetherington TC, Taylor YJ, Zhu J, Burgess EF, Gaston KE. Contemporary racial disparities in PSA screening in a large, integrated health care system. 2020; 38(6): 308-308. 
  9.   Bassett M. Vaccination, Screening Succeeds in Cervical and Prostate Cancers. MedPageToday. https://www.medpagetoday.com/meetingcoverage/asco/92688. May 19, 2021. 
  10.     Miller EA, Pinsky PF, Black A, Andriole GL, PierreVictor D. Secondary prostate cancer screening outcomes by race in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Screening Trial. The Prostate. 2018; 78(11):830-8.
  11. American Cancer Society. Observation or Active Surveillance for Prostate Cancer. Cancer.org. https://www.cancer.org/cancer/prostate-cancer/treating/watchful-waiting.html. Updated August 2019. 
  12. Washington SL, Jeong CW, Lonergan PE, Herlemann A, Gomez SL, Carroll PR, Cooperberg MR. Regional Variation in Active Surveillance for Low-Risk Prostate Cancer in the US. JAMA Network Open. 2020; 3(12):e2031349-.
  13. Tracy CR. Prostate Cancer Treatment & Management. Emedicine.medscape.com,. https://emedicine.medscape.com/article/1967731-treatment. Updated February 2, 2021. 
  14. Moses KA, Orom H, Brasel A, Gaddy J, Underwood III W. Racial/ethnic disparity in treatment for prostate cancer: does cancer severity matter?. Urology. 2017;99:76-83.
  15. Schmid M, Meyer CP, Reznor G, Choueiri TK, Hanske J, Sammon JD, Abdollah F, Chun FK, Kibel AS, Tucker-Seeley RD, Kantoff PW. Racial differences in the surgical care of Medicare beneficiaries with localized prostate cancer. JAMA Oncology. 2016;2(1):85-93.
  16. Hahn AW, Bilen MA, Agarwal N. Successful Recruitment of Black Men to Prostate Cancer Clinical Trials—A Lesson in Achievement. JAMA Network Open. 2021;4(1):e2034652-.)
  17. Di Pietro G, Chornokur G, Kumar NB, Davis C, Park JY. Racial differences in the diagnosis and treatment of prostate cancer. International Neurourology Journal. 2016;20(Suppl 2):S112.

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

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

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

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

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.

Merck is not a start-up company – they should conduct well-designed studies. If less appropriate studies are accepted as alternatives, does this create disincentives for all companies to do the well-designed studies they agreed to do?

Our analysis agrees with FDA that neither progression-free survival not overall survival were clinically meaningful or statistically significant. What is the justification for keeping the indication for years while awaiting data that might or might not support approval?

FDA also points out that Real World data must meet scientific standards to confirm meaningful benefit.

Patients deserve treatments that provide meaningful benefits that outweigh meaningful risks and they need to be able to trust that FDA approval confirms that.

As a cancer survivor myself, I know that patients want hope.

What are the ethics of your decision today?  FDA approval has always meant rigorous evidence – it isn’t supposed to be based on wishful thinking or speculation about cross-over data or post hoc manipulation of data.  I respectfully urge you to listen to what the FDA scientists told us repeatedly in their memo — the evidence DOES NOT support continued approval and using other studies can’t provide the data needed. 

In conclusion, patients have suffered from taking cancer drugs that aren’t proven to work.  Other treatment options are proven to work.  Physicians can still choose whatever treatments are on the market, but treatment decisions shouldn’t be based on the mistaken belief that these drugs are proven effective for advanced urothelial carcinoma.

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

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