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NCHR’s Testimony to FDA on TOOKAD to Treat Low-Risk Prostate Cancer

Prostate Cancer, Testimony & Briefings, ,

Diana Zuckerman, National Center for Health Research, February 26, 2020

Thank you for the opportunity to speak today.  I am Dr. Diana Zuckerman, president of the National Center for Health Research. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.

Although active surveillance is recommended for many patients with low-risk prostate cancer, some patients prefer treatment and that can be a reasonable choice as long as the treatment has a meaningful benefit and does not increase patients’ harms. However, the clinical data for TOOKAD that we are discussing today do not clearly demonstrate that its benefits outweigh its risks – efficacy is uncertain, particularly for U.S. patients, and the drug has the well-known very negative side effects typical of prostate cancer treatments.  

There are 5 major problems with the data, and the FDA did an excellent job of expressing their concerns:

#1.  There was only 1 clinical trial. Replication is the key to science, and effective treatments are available for prostate cancer, so the FDA should not approve a new treatment based on just one study.

#2.  This one trial took place in Europe, and 99.8% of participants were white.  Five patients – not 5% but only 5 men — were not white. Given the higher percentage of African American men who die of prostate cancer, this lack of diversity should not be considered acceptable, unless the FDA is considering approving this product for white men only.

#3. The accuracy of detecting cancer is one major problem. The data showed a high false negative rate. 13.5% of those in the active surveillance arm had a negative biopsy after 2 years. Since it is unlikely that the cancer would spontaneously disappear, this probably reflects false positives in the original diagnosis or false negatives in the post-test. This high false negative rate raises major concerns about the accuracy of biopsies in the treatment arm and at baseline. 

#4. Further, there was a large amount of missing data regarding biopsies at 24 months. Unfortunately, 18.4% of the patients in the treatment arm and 41.5% of those in the active surveillance arm were missing these crucial pieces of information regarding efficacy.  That makes it impossible to draw conclusions based on this one study. 

 #5. The trial was open-label, meaning patients as well as those collecting the data knew whether a particular patient was receiving the treatment or active surveillance. The decision to pursue definitive therapy  — such as surgery — was a subjective decision. Wouldn’t active surveillance patients be more likely to choose treatments later. Also, when biopsy results were uncertain, pathologists may have been biased by their knowledge of whether or not a patient was assigned to the treatment group. 

The FDA held a workshop in September 2018 to discuss issues related to clinical trials of novel treatments for localized prostate cancer.  They concluded that treatment endpoints might be clinically meaningful only if 1) the patients using the new therapy were less likely to undergo subsequent treatment (such as surgery), 2) there was an overall reduction in adverse events, and 3) there was no reduction in long-term cancer control.  However, in this trial, these criteria were not met. 95% of those treated with TOOKAD had adverse event in the weeks after treatment compared to 55% of the men on active surveillance. For many men these problems continued 2 years after treatment, when 34% continued to have urinary problems compared to 16% with active surveillance. Two years after treatment, 38% of patients treated with TOOKAD had erectile dysfunction, compared with 12% of those assigned to active surveillance. In other words, erectile dysfunction was 3x as prevalent among those treated with TOOKAD.

The long-term complications of the treatment that are unclear.  In addition to the urinary problems and ED that might be worse for those who are subsequently treated with surgery, it may be more difficult to obtain accurate biopsies. 

The American Urological Association recommends active surveillance as the best available treatment for low-risk prostate cancer patients, and the data clearly support that recommendation.  We understand that the fear of cancer can persuade men to seek treatment, but if so they should not be bamboozled by ads to choose a product that may have no benefits for them but that does have clear risks of erectile dysfunction and urinary problems. If the FDA thinks this product might have a useful benefit, they should require at least one double-blind study – preferably two – since the treatment does not involved surgery and is therefore easier to blind.  The studies should also include a patient population that represents the diversity of men with prostate cancer. There is no need to rush to approve this particular treatment based on a single, open label trial with endpoints of questionable clinical relevance and problems with inaccurate diagnoses. Better research needs to be completed before approval because the sponsor did not comply with FDA’s recommendations for the study and was even less likely to do so after the product is approved.   

The Oncologic Drugs Advisory Committee voted 13 to 2 against approval of TOOKAD to treat low-risk prostate cancer.

NCHR’s Comments on FDA’s Notice on the Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks

Policy, , , , ,

National Center for Health Research, February 24, 2020

National Center for Health Research’s Public Comments on FDA’s Notice on the Modified Risk Tobacco Product Applications  for IQOS System With Marlboro Heatsticks

Thank you for the opportunity to comment on the FDA Notice on the Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks submitted by Philip Morris International.

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

We strongly oppose the approval of this modified risk application by Philip Morris International. According to the FDA, a modified risk tobacco product needs to demonstrate that it (1) significantly reduces harm to smokers and (2) promotes public health. However, there is insufficient evidence to support the claim that these products significantly reduce harm for smokers. Further, there are potential risks to public health because these products may be appealing to non-smokers, particularly adolescents.The products do contain nicotine, which is addictive.

The applicant claims that “switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.” They also claim that it delivers tobacco taste and nicotine satisfaction, which could promote IQOS use as an alternative to smoking cigarettes. However, there is not sufficient data that cigarette smokers would switch to complete IQOS use instead of continuing to smoke traditional cigarettes and thus engage in dual use. The study designs, for example, do not show that consumers’ actual use of the product would significantly reduce the use of traditional cigarettes or result in them switching completely from cigarette use. Without that scientific evidence, there is no proof to support the applicant’s claim that this product leads to a substantial reduction in toxicity.

Nearly 90% of smokers smoked their first cigarette before the age of 18,1 yet adolescents were not included in any of the studies provided by the applicant. The vaping epidemic among adolescents illustrates why we should be concerned about lack of data on teenagers. Research has shown that over half of 12th graders who vape reported that they do so “in order to “see what it’s like,” and one-third report that they vape “because it tastes good.”2 The interest that adolescents show in vaping suggest that adolescents who previously did not consume tobacco products may be interested in trying a novel form of smoking, particularly one with a flavor, such as menthol. Since the applicant has failed to provide any research on the likely impact on adolescents, we can’t assume that adolescents would not be enticed to try the product.

The main reason why we oppose a risk mitigation claim for these products is that they have not been proven to reduce risk. In addition, previous studies have demonstrated that adolescents are likely to perceive products with risk-mitigation claims as less harmful, and Philip Morris International has failed to demonstrate that this would not be the case for their IQOS system. To add to the public health concerns, the effects of the risk mitigation claims in advertising and marketing were not tested, despite the fact that some tobacco advertisements can increase use among youth. The increase in vaping among youth has demonstrated that adolescents are swayed by advertising, and that once they begin a habit such as vaping or smoking, they are unlikely to stop.

In summary, the data provided do not adequately support the claim that the IQOS systems 1) significantly reduce harm for smokers and 2) promote public health. A modified risk statement may encourage people, particularly adolescents, who do not smoke to begin using this tobacco product. At the same time, such a statement could lead to more dual usage among current smokers thinking that this is a safe alternative.

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

References

  1. Youth and Tobacco Use. CDC.gov. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/. Updated December 10, 2019.
  2. National Institute on Drug Abuse. Monitoring the Future Survey: High School and Youth Trends 2019. National Institute on Drug Abuse; National Institutes of Health; U.S. Department of Health and Human Services; 2019. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/drugfacts-mtf.pdf

National Center for Health Research Written Statement to Greenwich Board of Education

Testimony & Briefings, ,

National Center for Health Research, February 19, 2020

Written Statement to Greenwich Board of Education

Diana Zuckerman, PhD, National Center for Health Research

February 19, 2020

Dear Chairman Bernstein and Members of the Greenwich Board of Education:

I am disappointed that I was unable to be there in person for your meeting on February 20, but I wanted to update you on the latest research about the health risks of artificial turf for children and adults.

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 metals 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. Our goal is to explain scientific and medical information that can be used to improve policies, programs, services, and products.

We commend you for considering the possible risks of replacing grass fields with artificial turf. 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. Tire crumb has well-known risks, containing chemicals that have the potential to increase obesity; contribute to early puberty; cause attention problems such as ADHD; exacerbate asthma; and eventually cause cancer. However, the plastic grass itself has dangerous levels of lead, PFAS, and other toxic chemicals as well.  PFAS are of particular concern because they are “forever chemicals” that get into the human body and are not metabolized, accumulating over the years. Replacing tire waste with silica, zeolite, and other materials also has substantial risks.

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products. Despite claims to the contrary, none have concluded 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 rather than scientific research on children.

Lead

As you know, the American Academy of Pediatrics states that no level of lead exposure should be considered safe for children, because lead can cause cognitive damage even at low levels. Some children are more vulnerable than others, and that can be difficult or even impossible to predict. Since lead has been found in tire crumb as well as new synthetic rubber, it is not surprising that numerous artificial turf fields and playgrounds made with either tire crumb or “virgin” rubber have been found to contain lead. However, the Centers for Disease Control and Prevention (CDC) also warns that the “plastic grass” made with nylon or some other materials also contain lead. Whether from infill or from plastic grass, 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 breathing in when they play.

Why are chemicals that are banned from children’s toys allowed in artificial turf and rubber playground surfaces?

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals (also called EDCs). There is very good evidence regarding these chemicals in tire crumb, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment (OEHHA).[1]

A 2018 report by Yale scientists detected 92 chemicals in samples from 6 different artificial turf companies, including unused bags of tire crumb. Unfortunately, the health risks of most of these chemicals had never been studied. However, 20% of the chemicals that had been tested are classified as probable carcinogens and 40% are irritants that can cause asthma or other breathing problems, or can irritate skin or eyes.[2]

There are numerous studies indicating that endocrine-disrupting chemicals found in rubber and plastic cause serious health problems. Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, 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 Consumer Product Safety Commission has banned numerous endocrine-disrupting chemicals from toys and products used by children. The products involved, such as pacifiers and teething toys, 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 rubber and other 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 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.

Scientific Evidence of Cancer and Other Systemic 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 no clear evidence that an artificial turf field has caused specific children to develop cancer. However, the statement is misleading because it is virtually impossible to prove any chemical exposure causes one specific individual to develop cancer.

As an epidemiologist, I can 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 the U.S. Consumer Product Safety Commission as well as state legislatures and city councils. 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. They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true). 

However, we know that the materials being used in artificial turf and rubber playground surfaces 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 Greenwich or any other community choose to spend millions of dollars on fields that are less safe than well-designed natural grass fields?

Dangerously Hot and Hard Fields

I lived in Connecticut for several years while on the faculty at Yale and Vassar, and I know the climate well. When the weather is warm and/or sunny, it is usually quite pleasant to be outside – as long as you aren’t on artificial turf or an outdoor rubber surface. Even when the temperature above the grass is 80 degrees Fahrenheit, artificial turf can reach 150 degrees or higher. Obviously, a 90 degree day is likely to be even hotter than 150 degrees on turf. That can cause “heat poisoning” as well as burns.

Artificial turf fields get hard as well. 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. Is Greenwich paying to have these tests conducted on all your public artificial turf fields?

The hardness of natural grass fields is substantially influenced by rain and other weather; if the field gets hard, rain or watering 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 that is the way safety is determined.

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 greater 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.[4] The fields also continuously shed microplastics as the plastic blades break down.[5,6] 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.[7,8,9]

Synthetic surfaces also create heat islands.10,11 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.[12]

Envirofill and Alternative Infills

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. 

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. Last year, I told members of the BET that their decision about artificial turf can save lives and improve the health of children in Greenwich.  You owe it to your community to make sure you know the risks of artificial turf and do all you can to protect Greenwich children from the known risks and also the suspected risks.  Because of Greenwich’s reputation as a well-educated and affluent community, your decisions about artificial turf in Greenwich will be cited by other communities, making it even more important that your decision is 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

The PDF of this letter can be found here.

References

  1. State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007. http://www.calrecycle.ca.gov/publications/Documents/Tires%5C62206013.pdf 
  2. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water, Air, & Soil Pollution. 2018;229:64. https://doi.org/10.1007/s11270-018-3711-7 
  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. York T. Greener grass awaits: Environmental & fiscal responsibility team up in synthetic turf. Recreation Management. February 2012. http://recmanagement.com/feature_print.php?fid=201202fe02
  5. 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
  6. 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/
  7. 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/
  8. 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
  9. 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
  10. 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
  11. 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
  12. 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

NCHR Testimony on Low Nicotine Cigarette Claim

Testimony & Briefings, , ,

Nina Zeldes, National Center for Health Research, February 14, 2020

Thank you for the opportunity to speak here today. My name is Dr. Nina Zeldes and I am here as a senior fellow speaking on behalf of the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from drug and medical device companies or tobacco companies, so I have no conflicts of interest.

We strongly oppose the approval of this modified risk application by the 22nd Century Group for their low-nicotine combusted filtered cigarette tobacco products. According to the FDA, a modified risk tobacco product needs to demonstrate that it (1) significantly reduces harm to smokers and (2) promotes public health. Unfortunately, evidence is lacking to support the claim that this product significantly reduces harm for smokers. At the same time, it is likely to entice people who have never smoked, especially adolescents, to start smoking.

As the applicant has pointed out, this low nicotine cigarette poses similar risks of tobacco-related disease as conventional cigarettes. Its only advantage is that it contains much less nicotine, and could therefore be less addictive. However, the claims of reduced harm seem to be based entirely on the assumption that people would smoke less often – an assumption that was not adequately supported by the applicant’s data. For example, this product was rated as less satisfying than smokers’ usual brand of cigarettes and less likely to be used again compared to nicotine gum, raising questions about whether smokers would switch completely to this product and ultimately quit smoking.

The FDA briefing document points out that nicotine is often perceived as causing smoking-related health risks. That means that a claim of a product having “95% less nicotine” will be misunderstood as being less likely to cause cancer, when in fact it just means potentially less addictive. Although the applicant provided a voluntary warning that “less nicotine does NOT mean safer”, study participants who were shown this warning still perceived this product as safer than conventional cigarettes. Additionally, the applicant only tested the claims on packaging and not how they would be used in ads and social media. We’ve all learned that the context and imagery in these ads can vastly alter how these claims are interpreted. Tobacco companies have learned how to make very persuasive ads that go beyond the specific claims that they make.

And as we all know, smoking is a habit that is very difficult to break, and addiction to nicotine is only one of the reasons that quitting is so difficult.

Most smokers start smoking as children and adolescents, and yet adolescents were not included in any of the studies provided by the applicant. Previous studies have demonstrated that this group is likely to perceive products with a risk-mitigation claim as less harmful, but that is not proven in this case.

In conclusion, while the claim that this product contains 95% less nicotine may be factually correct, the company’s claims of health benefits are based on the implied assumption that this product would help smokers quit. If that is supposed to be the benefit, their product should have sought to market this product as a cessation aid. Moreover, the packaging does not explain how to achieve this health benefit. Because of such claims, smokers interested in reducing smoking-related health risks might start using this product, instead of quitting or using available FDA-approved cessation products. Meanwhile, non-smokers, particularly adolescents, might start using this product, thinking it is a safe alternative to other tobacco products.

If we’ve learned anything from the vaping epidemic, it is that adolescents are easy to influence, and once they start a habit like smoking or vaping, they are unlikely to stop. We encourage you to let the FDA know that you do not believe that would be an acceptable outcome.

Thank you.

FDA considers black box warning for all breast implants

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

Mariel Carbone, WCPO Cincinnati: February 09, 2020

Although many other survivors choose implants after their mastectomies, [Lily McBreen is] adamant that she won’t. Having almost lost her life once, she’s worried the side effects of receiving breast implants could endanger it again.

[…]

“I wanted to avoid the rheumatological symptoms that have been out in the news for so many decades,” she said. “There has been so many accounts of women complaining of problems with them.”

Those symptoms, which women are calling “breast implant illness,” are among the many reasons the United States Food and Drug Administration could soon take extreme measures when it comes to educating the public about implants.

[…]

Currently, the black box warning exists only as a draft while the FDA continues to consider its implementation.

The draft warning outlines three main concerns.

First, “breast implants are not considered life time devices” and women may require more surgery if complications occur.

It also states that implants have been associated with BIA-ALCL.

[…]

Finally, it describes how some patients have reported a variety of symptoms, including “joint paint, muscle aches, confusion, chronic fatigue, autoimmune disease and others.”

The FDA is also proposing a patient decision checklist, which would include situations in which the device should not be used, considerations for a successful breast implant candidate, risks of surgery, the importance of using an appropriate physician, the risk of BIA-ALCL and other symptoms and discussion of other options.

Still, some have said these proposals don’t go far enough, including Diana Zuckerman who is President of the National Center for Health Research. The center initiated the Breast Implant Working Group, which is made up of six experts including patient advocates and plastic surgeons.

“The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients,” the working group said in a statement. “The FDA draft Black Box states that ‘breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’ Association implies correlation rather than causation. In fact, the evidence is clear that breast implants can cause BIA-ALCL.”

Read the original story here.

Coalition Letter Urging Support for the Reversing the Youth Tobacco Epidemic Act

Policy, Testimony & Briefings

February 4, 2020

See PDF: Coalition Letter Urging Support for HR 2339 2.4.20

U.S. House of Representatives
Washington, DC 20515

Dear Representative:

We are writing to express our strong support for H.R. 2339, the Reversing the Youth Tobacco Epidemic Act of 2019. This legislation will address the current youth e-cigarette epidemic that is undermining the progress made in reducing youth tobacco use.

Use of e-cigarettes by youth has escalated rapidly in recent years, placing a new generation at risk of nicotine addiction and tobacco use. Between 2017 and 2019, e-cigarette use more than doubled among high school students (from 11.7% to 27.5%) and tripled among middle school students (from 3.3% to 10.5%). More than 5.3 million middle and high school students used e-cigarettes in 2019, an alarming increase of more than 3 million in two years. Use of other tobacco products, including cigarettes, cigars and hookah, is also a serious problem. Tobacco use remains the leading preventable cause of death in the United States and is responsible for approximately $170 billion in health care costs each year.

The Reversing the Youth Tobacco Epidemic Act provides a much-needed response to this serious public health problem. Its prohibition on flavored tobacco products, including flavored e-cigarettes, flavored cigars, and menthol cigarettes, is needed to stop tobacco companies from targeting and addicting kids with enticing flavors, such as gummy bear and cotton candy. Flavors mask the harsh taste of tobacco and make it easier for kids to start to use a tobacco product and to become addicted.

The bill’s prohibition on flavored e-cigarettes is all the more important because the Administration’s recently released policy on flavored e-cigarettes will leave thousands of flavored e-liquids and devices on the market. Flavors are a key reason for widespread youth use of e-cigarettes. Ninety-seven percent of current youth e-cigarette users have used a flavored e-cigarette in the past month, and seven out of ten said they used e-cigarettes “because they come in flavors I like.”

The bill’s prohibition on menthol cigarettes, flavored cigars, and other flavored tobacco products will also help protect kids and public health. More than half of youth smokers – and seven in ten African American youth smokers – smoke menthol cigarettes. As a result of decades of pervasive tobacco industry marketing, 85 percent of African-American smokers smoke menthol cigarettes, and menthol is a likely contributor to the higher rates of tobacco-caused death and disease experienced by African Americans. A 2013 Food and Drug Administration (FDA) analysis concluded that menthol cigarettes increase youth initiation, increase nicotine addiction, and make it harder for smokers to quit. Cigars are also available in a wide variety of flavors that make them more attractive to kids. More than one million high school students smoke cigars.

In addition to its prohibition on flavored tobacco products, the Reversing the Youth Tobacco Epidemic Act includes a number of other provisions that will help to reduce youth use of e-cigarettes and use of other tobacco products, including prohibiting online sales of most tobacco products, addressing inappropriate marketing and advertising, and ensuring that FDA will promptly implement the graphic health warnings on cigarette packs and advertising that are required under the 2009 Tobacco Control Act.

Youth use of e-cigarettes and other tobacco products is a problem that will not resolve itself. It will require action by Congress. The Reversing the Youth Tobacco Epidemic Act provides the comprehensive response that is needed. We urge you to support this important legislation when it comes to the House floor.

Sincerely,

AASA, The School Superintendents Association
Academy of General Dentistry
Action on Smoking & Health
African American Tobacco Control Leadership Council
American Academy of Oral and Maxillofacial Pathology
American Academy of Oral and Maxillofacial Radiology
American Academy of Otolaryngology-Head and Neck Surgery
American Academy of Pediatrics
American Association for Cancer Research
American Association for Dental Research
American Association for Respiratory Care
American Cancer Society Cancer Action Network
American College Health Association
American College of Cardiology
American College of Occupational and Environmental Medicine
American Dental Association
American Federation of School Administrators
American Federation of Teachers
American Heart Association
American Lung Association
American Medical Association
American Public Health Association
American School Counselor Association
American School Health Association (ASHA)
American Society of Addiction Medicine
American Thoracic Society
Americans for Nonsmokers’ Rights
Association of Educational Service Agencies
Association of Maternal & Child Health Programs
Association of School Business Officials International
Association of Schools and Programs of Public Health
Association of State and Territorial Health Officials (ASTHO)
Association of Women’s Health, Obstetric and Neonatal Nurses
Asthma and Allergy Foundation of America
Big Cities Health Coalition
Campaign for Tobacco-Free Kids
Catholic Health Association of the United States
Children’s Wisconsin
ClearWay Minnesota
Common Sense Media
Community Anti-Drug Coalitions of America’s (CADCA)
Eta Sigma Gamma – National Health Education Honorary
First Focus Campaign for Children
International Association for the Study of Lung Cancer
March of Dimes
Mesothelioma Applied Research Foundation
NAACP
National African American Tobacco Prevention Network
National Association of County and City Health Officials
National Association of Elementary School Principals
National Association of Pediatric Nurse Practitioners
National Association of School Nurses
National Association of Secondary School Principals
National Association of Social Workers
National Black Nurses Association
National Center for Health Research
National Coalition for Cancer Survivorship
National Education Association
National Hispanic Medical Association
National Medical Association
National Network of Public Health Institutes
National Rural Education Advocacy Collaborative
National Rural Education Association
Oncology Nursing Society
Parents Against Vaping e-cigarettes (PAVe)
Prevent Cancer Foundation
Public Health Solutions
SHAPE America
Society for Cardiovascular Angiography and Interventions
Society for Public Health Education
Students Against Destructive Decisions
The Society of State Leaders of Health and Physical Education
The Society of Thoracic Surgeons
Trinity Health
Trust for America’s Health
U.S. PIRG

 

Artificial Intelligence Is Rushing Into Patient Care – And Could Raise Risks

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

Liz Szabo, Kaiser Health News,

Health products powered by artificial intelligence, or AI, are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots.

IBM boasted that its AI could “outthink cancer.” Others say computer systems that read X-rays will make radiologists obsolete.

“There’s nothing that I’ve seen in my 30-plus years studying medicine that could be as impactful and transformative” as AI, said Eric Topol, a cardiologist and executive vice president of Scripps Research in La Jolla, Calif. AI can help doctors interpret MRIs of the heart, CT scans of the head and photographs of the back of the eye, and could potentially take over many mundane medical chores, freeing doctors to spend more time talking to patients, Topol said.

Even the U.S. Food and Drug Administration—which has approved more than 40 AI products in the past five years—says “the potential of digital health is nothing short of revolutionary.”

Yet many health industry experts fear AI-based products won’t be able to match the hype. Many doctors and consumer advocates fear that the tech industry, which lives by the mantra “fail fast and fix it later,” is putting patients at risk—and that regulators aren’t doing enough to keep consumers safe.

[…]

Relaxed AI Standards At The FDA

The FDA has come under fire in recent years for allowing the sale of dangerous medical devices, which have been linked by the International Consortium of Investigative Journalists to 80,000 deaths and 1.7 million injuries over the past decade.

Many of these devices were cleared for use through a controversial process called the 510(k) pathway, which allows companies to market “moderate-risk” products with no clinical testing as long as they’re deemed similar to existing devices.
In 2011, a committee of the National Academy of Medicine concluded the 510(k) process is so fundamentally flawed that the FDA should throw it out and start over.

Instead, the FDA is using the process to greenlight AI devices.

Of the 14 AI products authorized by the FDA in 2017 and 2018, 11 were cleared through the 510(k) process, according to a November article in JAMA. None of these appear to have had new clinical testing, the study said. The FDA cleared an AI device designed to help diagnose liver and lung cancer in 2018 based on its similarity to imaging software approved 20 years earlier. That software had itself been cleared because it was deemed “substantially equivalent” to products marketed before 1976.

AI products cleared by the FDA today are largely “locked,” so that their calculations and results will not change after they enter the market, said Bakul Patel, director for digital health at the FDA’s Center for Devices and Radiological Health. The FDA has not yet authorized “unlocked” AI devices, whose results could vary from month to month in ways that developers cannot predict.

To deal with the flood of AI products, the FDA is testing a radically different approach to digital device regulation, focusing on evaluating companies, not products.

The FDA’s pilot “pre-certification” program, launched in 2017, is designed to “reduce the time and cost of market entry for software developers,” imposing the “least burdensome” system possible. FDA officials say they want to keep pace with AI software developers, who update their products much more frequently than makers of traditional devices, such as X-ray machines.

Scott Gottlieb said in 2017 while he was FDA commissioner that government regulators need to make sure its approach to innovative products “is efficient and that it fosters, not impedes, innovation.”

Under the plan, the FDA would pre-certify companies that “demonstrate a culture of quality and organizational excellence,” which would allow them to provide less upfront data about devices.

Pre-certified companies could then release devices with a “streamlined” review—or no FDA review at all. Once products are on the market, companies will be responsible for monitoring their own products’ safety and reporting back to the FDA. Nine companies have been selected for the pilot: Apple, FitBit, Samsung, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool and Verily Life Sciences.

High-risk products, such as software used in pacemakers, will still get a comprehensive FDA evaluation. “We definitely don’t want patients to be hurt,” said Patel, who noted that devices cleared through pre-certification can be recalled if needed. “There are a lot of guardrails still in place.”

But research shows that even low- and moderate-risk devices have been recalled due to serious risks to patients, said Diana Zuckerman, president of the National Center for Health Research. “People could be harmed because something wasn’t required to be proven accurate or safe before it is widely used.”

Johnson & Johnson, for example, has recalled hip implants and surgical mesh.

In a series of letters to the FDA, the American Medical Association and others have questioned the wisdom of allowing companies to monitor their own performance and product safety.

“The honor system is not a regulatory regime,” said Jesse Ehrenfeld, who chairs the physician group’s board of trustees. In an October letter to the FDA, Sens. Elizabeth Warren (D-Mass.), Tina Smith (D-Minn.) and Patty Murray (D-Wash.) questioned the agency’s ability to ensure company safety reports are “accurate, timely and based on all available information.”

[…]

Read original story here.

NCHR Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut

Policy, Testimony & Briefings, , , ,

National Center for Health Research, January 21, 2020

National Center for Health Research’s Public Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen® Snuff Fine Cut

Thank you for the opportunity to comment on the FDA Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut.

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

We strongly oppose the approval of this modified risk application for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer” for the following reasons:

  • This safety claim could result in a higher number of dual users, and there is not sufficient evidence to suggest that dual use would reduce the risk of lung cancer. 
  • Even if an individual’s complete switch from combustible tobacco products to this product reduces a user’s risk of lung cancer, we agree with the FDA’s own website, which indicates that the use of smokeless tobacco products increases the risks of other types of cancers, such as oral, esophageal, and pancreatic cancer, as well as other diseases.
  • Because snuff has risks, data are needed to ensure that the marketing of this product as a modified risk product would not increase the number of non-smokers who would start using tobacco products. Increased use is likely, especially among teens and young adults, because, as with vaping, when people hear claims that a product is “safer,” they often misinterpret that to mean the product is “safe.”
  • Research has already shown that individuals who start using smokeless tobacco products, such as this product, are more likely to start using combustible tobacco products.
  • The modified risk statement could be interpreted as suggesting that Copenhagen Snuff Fine Cut can be used as a smoking cessation strategy. However, the sponsor has not provided scientific evidence that using this product helps people stop smoking. 
  • Although smoking and lung cancer deaths have both gone down in Sweden and Norway, the company has not provided evidence that these “favorable public health outcomes” are due to smokeless tobacco products. In addition, there is no evidence that additional reductions would occur in the U.S. market if this modified risk reduction application is approved, because the healthcare system, tobacco reduction campaigns, popular products and cultural influences are different than they are in Sweden and Norway.

In summary, a modified risk statement may encourage people who do not smoke to begin using this tobacco product and could lead to more dual usage, therefore, this product would not reduce the health risks for lung cancer.

For questions or more information, please contact Nina Zeldes, PhD at the National Center for Health Research at nz@center4research.org or at (202) 223-4000.

References

  1. US Food and Drug Administration. Executive Summary of USSTC MRTP Application for Copenhagen® Snuff Fine Cut. Silver Spring, MD: US Food and Drug Administration; 2020. https://digitalmedia.hhs.gov/tobacco/static/mrtpa/Copenhagen/2.3-executive%20summary%20_Redacted.pdf

No Shortage of Controversies for New FDA Commissioner

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Thomas M. Burton, The Wall Street Journal: January 29, 2020

New Food and Drug Administration commissioner Stephen M. Hahn rises at 4 a.m. each day for an hour of intensive strength and stamina training. On stressful days, he fits a second workout in during the late afternoon.

Dr. Hahn, 60, takes over an FDA under fire for failing to adequately respond to the health threat from growing use of e-cigarettes and vaping products. This spring, he and the agency will face applications from e-cigarette companies and have to decide what e-cigarette products can qualify to stay on the market.

[…]

Dr. Hahn also faces thorny decisions on stem-cell research and use of cannabidiol, or CBD, that will likely put him in the hot seat between rival advocacy groups.

The man taking on these challenges comes to the FDA with a sterling reputation in medicine and management, but with no previous government experience, unlike his predecessor Scott Gottlieb. That has some concerned about his ability to tackle the issues ahead.

“Always we have concerns when someone comes in who doesn’t know the FDA, which is a complex organization,” said Diana Zuckerman, president of the public-interest research group National Center for Health Research in Washington.  “I never think it’s a good idea.”

What’s more, Dr. Hahn may not have long to make his mark if Mr. Trump fails to win re-election Nov. 3. “It’s a hard thing to come in with so little time [in the president’s term] and so little government experience,” said a former FDA commissioner, Robert Califf, who served under President Obama. “It’s so difficult to change policy with so little time.”

Dr. Hahn didn’t immediately comment for this article.

[…]

Read the original story here.

Everything is designed for men, even drugs

In the News, We're In the News, ,

Producers Kim Mas and Ranjani Chakraborty, Vox: January 16, 2020

This short video explains why designing medicine around the “average man” is so dangerous. Most things in society are built for, and designed around, a specific “reference man.” This “standard human” is usually a white male in his 30s who weighs around 155 pounds. When we design everything from cars, to air-conditioned offices, to city streets, reference man is the default user. And when it comes to healthcare, that can mean deadly effects for women.  Watch the video above to find out how dosages are determined with “reference man” in mind. After dozens of women got into car accidents under the influence of sleeping pills they’d taken the night before, the FDA had to tell women to cut their dose in half; it turned out, women metabolize Ambien’s active ingredient twice as slowly as men. What was supposed to be a “gender-neutral” dose was anything but. Diana Zuckerman, president of the National Center for Health Research, explains why we need more inclusivity in clinical trials — for women, for people over 65, and for people of color.

https://www.youtube.com/watch?v=CVdn-2KE2bs