All posts by CPTFadmin

Hospitals Push Women to get 3D Mammograms, Despite No Evidence they Save More Lives

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

Megan Henney, Fox Business, also posted in Yahoo Finance: October 20, 2019

Hospitals and doctors are aggressively promoting high-tech breast cancer screenings, spending millions of dollars to market 3D mammograms to patients — despite no evidence that they save more lives than traditional mammograms.

According to a Kaiser Health News investigation, over the past six years manufacturers of 3D equipment have paid doctors and teaching hospitals more than $240 million, including $9.2 million related to 3D mammograms. Almost half of that money went to related research, while some paid for speaking fees, consulting, travel meals or drinks.

The report found that influential journal articles, some cited hundreds of times by other researchers, were written by doctors with financial ties to the 3D industry.

Currently, Medicare and most insurance companies cover the cost of an annual screening mammogram for women over the age of 40. But 3D screenings add about $50 to the cost of a typical mammogram. Kaiser reported that Medicare, which began paying for 3D exams in 2015, spent an additional $230 million on breast cancer screenings within the first three years of coverage. By 2017, nearly half the mammograms paid for by the federal program were 3D.

Overall, 3D screenings may slightly increase the cancer-detection rate, finding about one extra breast tumor for every 1,000 women screened in the U.S., according to a 2018 analysis in the Journal of the National Cancer Institute. It can also prove more effective for women with dense breast tissue.

But new technology isn’t always better, said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund at the National Center for Health Research.

“Hospitals love new gadgets, and 3D mammography has been promoted as the latest, greatest best thing,” Zuckerman told FOX Business. “It’s expensive, and then they’re going to pass those prices onto patients.”

When the Food and Drug Administration approves new technology, the agency is not required to prove that it’s better — only that it’s as good as what already exists, she said. Despite that, the new equipment is generally more expensive, sometimes ten times as much; in order to pay for it, hospitals tend to charge “quite a lot of money” to the patient, Zuckerman said, as well as use them on patients who don’t necessarily need to be tested.

“I personally find it problematic, and I can only say that if I have trouble sometimes determining how much is hype and how much is fact, I can only imagine people who don’t do this for a living have trouble figuring it out,” she said.

Read the original story here or here.

Breast implants, heavy metals & autoimmune disorders: What should be in FDA warnings?

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

Kris Pickel, AZ Family: October 18, 2019

As the Food and Drug Administration considers issuing stronger warnings for breast implants, there is a debate brewing over the content of those warnings.

The FDA is looking at several options.

• A checklist of possible risks. Doctors would be required to go over the checklist with patients who are considering breast implants.

• Listing the ingredients in breast implants.

• A box warning, also known as a black box warning. It’s the strongest warning the FDA issues signifying there is a risk of serious or even life-threatening adverse effects.

The FDA recently updated its website, acknowledging what has become known as breast implant illness.

“Some breast implant patients report a variety of systemic symptoms, such as chronic fatigue, brain fog, joint and muscle pain, which may not meet the diagnostic criteria to be categorized as a disease. Patients refer to these symptoms collectively as ‘breast implant illness (BII).’ In some cases, patients report that removal of their breast implants without replacement appears to reverse their symptoms.”

The regulatory agency is reacting to pressure from a growing movement by tens of thousands of women who believe breast implants made them sick. They describe many more symptoms than what the FDA recognized.

BII is not a new problem

Women have expressed concerns about breast implants for decades. Many women say doctors discount any connection the implants and the issues they experience, often making them feel their illness and symptoms are psychosomatic.

Nicole Daruda is one of the key figures behind the growing number of women demanding stronger warnings.

With recent attention on symptoms and illnesses potentially caused by breast implants, hundreds of women are requesting to join her Facebook group, Breast Implant Illness and Healing by Nicole, every day.

Five years after getting implants, Daruda was too sick to work.

She says at that time, there was almost no information available on a possible link between breast implants and the often-debilitating symptoms that plague some women.

“I put the words together, ‘breast implant illness,’ because I didn’t know what else to call it,” Daruda said.

n March, the FDA held public meetings on the safety of breast implants.

Women showed up from across the country, demanding stronger warnings that list the chemicals and heavy metals contained in breast implants. And they don’t just want the cautions to come from the FDA. They believe the caveats should come from breast implant manufacturers, too.

When Daruda had her implants removed, she described them as “sticky,” with silicone coming through the shell. It’s a condition known as “gel bleed.”

While the FDA acknowledges that gel bleed happens, it does not list it as a known risk or complication of breast implants.

“I lost over a decade of my life and health to breast implants,” Daruda said. “After my explant, it took me four years to recover the better part of my health. I still have permanent damage to my kidney from heavy metal.”

[…]

An estimated 35 million women have breast implants. Many of them never reported negative health effects.

Cohen Tervaert says certain factors can increase a woman’s risk of having an adverse reaction to implants. Those factors include allergies (any type from hay fever to metal allergies), an autoimmune disease, and a family history of autoimmune diseases.

Large-scale studies need to be done, according to Cohen Tervaert, but how they are done needs to change.

After his presentation to the FDA, the agency asked registries that collect data on patients and the safety and performance of breast implants to start tracking information on autoimmune diseases.

While many health professionals and implant manufacturers are quick to note that the safety of breast implants has been studied extensively, Dr. Diana Zuckerman, president of the nonprofit National Center for Health Research and an expert on national health policy, says women cannot make informed decisions based on those studies.

The former senior policy advisor to the White House was vital in helping women with breast implant illness to organize and work with the FDA to secure the public meetings on breast implant safety.

“There are hundreds of studies of breast implants published in the last few decades, but almost all are so biased that they are fatally flawed,” she explained. “Almost all were paid for by the companies that make breast implants or the doctors whose salaries depend on those surgeries. The researchers asked the wrong questions and studied implants in ways that didn’t make sense. For example, they studied too few women, studied women with implants for a short period of time, and didn’t study the debilitating symptoms that women said they were experiencing. They also tended to study women with any kind of breast implants, instead of studying whether some breast implants were safer than others. And because of who was paying for the studies, even when the researchers found that implants caused medical problems, those findings were often misrepresented or completely covered up.”

When it comes to proving cause and effect between breast implants and illnesses, Cohen Tervaert believes the evidence is there.

Citing laboratory studies, he says mice prone to autoimmune diseases like lupus or arthritis developed the conditions after the implants were introduced. At the same time, mice that showed no prior sensitivity to autoimmune diseases did not develop health problems with the implants.

Another finding is that more protracted illness appears to result in more difficult recoveries.

“Proof that we have is, that if you remove the breast implant, breast implant illness can be reversible, especially if the period between implementation and explantation is very short,” Cohen Tervaert said. “You see, quite often, complete recovery of the symptoms.”

“If it’s, however, longer, than there is only partial recovery,” he continued. “And if you have developed an autoimmune disease, those autoimmune diseases can be difficult to treat until you remove the breast implants.”

A 2017 study found silicone from breast implants can migrate throughout a woman’s body — even if the implant was not ruptured — because silicone can “bleed” through the shell.

Silicone has been found not just in the tissue around the implants, but also in various organs throughout the body, including the central nervous system and brain.

Women studied had symptoms ranging from fatigue and cognitive impairment to headaches and body pain. The study found 60% to 80% of patients showed health improvements after their implants were removed.

The FDA has not decided if it will impose stricter guidelines on breast implant studies.

The agency issued warning letters to implant makers Mentor and Sientra in March, citing “low recruitment, poor data, and low follow-up rates in their required post-approval studies.”

The FDA gave the manufacturers a two-week deadline to fix the issues. Seven months later, no action has been taken against the manufacturers.

An FDA spokesperson tells CBS 5 Investigates they will not speculate on possible punitive actions.

Also in March, the FDA announced that it would hold future meetings to discusses material used in medical devices, including breast implants. They say they will focus on why some people have adverse reactions while others do not.

“The vast majority of patients implanted with medical devices have no adverse reactions,” the FDA said. “The device works and performs as expected to treat medical conditions or help patients better manage their health. However, a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes, causing pain and other symptoms that may interfere with their quality of life.”

A date for the meeting has not been set.

Read the original story here.

Massive Marketing Muscle Pushes 3D Mammograms, Despite No Evidence They Save More Lives, Investigation Shows

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

Liz Szabo, USA Today: October 18th, 2019.

When Dr. Worta McCaskill-Stevens made an appointment for a mammogram last year, she expected a simple breast cancer screening – not a heavy-handed sales pitch.

A receptionist asked if she wanted a free upgrade to a “3D mammogram,” or tomosynthesis.

“She said there’s a new approach and it’s much better, and it finds all cancer,” said McCaskill-Stevens, who declined the offer.

A short time later, a technician asked again: Was the patient sure she didn’t want 3D?

Upselling customers on high-tech breast cancer screenings is just one way the 3D mammography industry aggressively promotes its product.

A KHN investigation found that manufacturers, hospitals, doctors and some patient advocates have put their marketing muscle – and millions of dollars – behind 3D mammograms. The juggernaut has left many women feeling pressured to undergo screenings, which, according to the U.S. Preventive Services Task Force, haven’t been shown to be more effective than traditional mammograms.

[…]

The American Cancer Society, Susan G. Komen and the U.S. Preventive Services Task Force also say there isn’t yet enough evidence to advise women on 3D mammograms.

When the Food and Drug Administration approved the first 3D mammography system, made by Hologic, the agency required the technology to be safe and effective at finding breast cancer – not at improving survival.

“The companies do the minimal research needed to get FDA approval, and that usually means no meaningful evidence of how it helps patients,” said Diana Zuckerman, president of the National Center for Health Research.

Valenti said Hologic presented strong evidence to the FDA. “The data was overwhelming that 3D was a superior mammogram,” Valenti said.

Describing a breast exam as 3D may conjure up images of holograms or virtual reality. In fact, tomosynthesis is closer to a mini-CT scan.

Although all mammograms use X-rays, conventional 2D screenings provide two views of each breast, one from top to bottom and one from the side. 3D screenings take pictures from multiple angles, producing dozens or hundreds of images, and take only a few seconds longer.

Yet some studies suggest that 3D mammograms are less accurate than 2D.

A 2016 study in The Lancet Oncology found that women screened with 3D mammograms had more false alarms. A randomized trial of 29,000 women published in The Lancet in June showed that 3D detected no more breast tumors than 2D mammograms did.

And, like all mammograms, the 3D version carries risks. Older 3D systems expose women to twice as much radiation as a 2D mammogram, although those levels are still considered safe, said Diana Miglioretti, a biostatistics professor at the University of California-Davis School of Medicine.

Valenti said the newest 3D systems provide about the same radiation dose as 2D.

Diagnosing more cancers doesn’t necessarily help women, Brawley said. That’s because not all breast tumors are life-threatening; some grow so slowly that women would live just as long if they ignored them – or never even knew they were there. Finding these tumors often leads women to undergo treatments they don’t need.

A 2017 study estimated 1 in 3 women with breast cancer detected by a mammogram are treated unnecessarily. It’s possible 3D mammograms make that problem worse, by finding even more small, slow-growing breast tumors than 2D, said Dr. Alex Krist, vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. By steering women toward 3D mammograms before all the evidence is in, “we could potentially hurt women,” Krist said.

Some experts worry that patients, who tend to overestimate their risk of dying from breast cancer, are acting out of fear when they choose treatment.

“If there was ever an audience susceptible to direct-to-consumer advertising, it’s women afraid of breast cancer,” Zuckerman said.

Some proponents of 3D mammograms imply that women who opt for 2D are taking a risk.

The first question many women have about 3D mammograms is: Are they less painful?

In ads, Hologic claims its 3D device was less painful for 93% of women. But that claim comes from a company-funded study that hasn’t been formally reviewed by outside experts, Zuckerman noted. Given the limited data provided in the study, it’s possible the findings were the result of chance, said Zuckerman, who called the ads “very misleading.”

Valenti said peer review is important in studies about cancer detection or false alarms. But when it relates to “general patient satisfaction or patient preference, those are data that we get in other ways,” he said. “Plenty of [doctors] have the [3D] system now and you can get feedback from them. “

While screenings may not generate a lot of income, they can attract patients who need other, more profitable hospital procedures.

“Anytime you diagnose more tumors, you can treat more tumors,” said Amitabh Chandra, director of health policy research at Harvard University’s John F. Kennedy School of Government.

Click here to read the full article.

NCHR Letter to Mayor Cohn and Members of the Rye City Council Concerning Artificial Turf and Playgrounds

Environmental Exposures, Policy, Testimony & Briefings, ,

National Center for Health Research, October 16th, 2019

Dear Mayor Cohn and Members of the Rye City Council:

I am writing on behalf of the National Center for Health Research.  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 have been contacted by families in Rye who are concerned about the risks of artificial turf and playgrounds. We are impressed with their knowledge and agree with them that converting grass fields to artificial turf poses unnecessary dangers to children in your community.

As a scientist who has worked on health policy issues for more than 30 years, I don’t shock easily.  However, it is shocking and disturbing that artificial turf athletic fields and playgrounds are exposing children on a daily basis to chemicals and materials that are known to have the potential to increase obesity; contribute to early puberty; cause attention problems such as ADHD; harbor deadly bacteria; exacerbate asthma; and eventually cause cancer.

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products. A recently released EPA report found toxic chemicals in artificial turf, but did not evaluate whether or not the level of exposure would harm children.  Despite claims to the contrary, no federal agency has concluded that artificial turf is safe.

Scientific Evidence of Cancer and Other Systemic Harm

First, it is important to distinguish between evidence of harm and evidence of safety.  Companies that sell and install artificial turf often claim there is “no evidence that 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.

The artificial turf industry will tell you there is no clear evidence that their fields caused any child to develop cancer.  That is true, but 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).

Most research has focused on the risks of infill made from recycled tire waste. However, recent research has indicated the presence of dangerous levels of chemicals in the plastic blades of grass as well as in the tire waste. So, even if the infill is replaced with a safer materials, the plastic grass carpet itself is dangerous.

We know that the materials being used 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 Rye or any other community choose to spend millions of dollars on fields that are less safe than well-designed natural grass fields?

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals as well as carcinogens.  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 2015 report by Yale scientists detected 96 chemicals in samples from 5 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 on the impact of hormone-disrupting chemicals (also called endocrine disrupting chemicals or EDCs), and the evidence is clear that these 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, have been banned for more than a decade, even though they would result in very short-term exposures compared to artificial turf.

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.

Envirofill and Alternative Infills

Artificial turf fields are often 50-70 degrees hotter (or more) compared to grass fields, and this can be dangerous for children on a warm day.  Envirofill artificial turf fields is advertised as “cooler” and safer than tire crumb, 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 rock, corn husks, and Corkonut) have raised concerns and none are proven to be as safe or effective as well-designed grass fields.  And as noted above, the plastic grass itself is made from dangerous chemicals.

Dangerously Hard Fields, Turf Burns, and Hot Fields

I want to briefly mention safety issues pertaining to Gmax scores.  A Gmax score measures how hard a field is, specifically regarding brain injuries.  A score over 200 is considered extremely dangerous and is considered by the synthetic turf 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.

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, and 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.

In addition to hard fields, artificial turf is more likely to cause “turf burns” which can be very painful and can get infected.  There is a good reason why almost all professional baseball parks use grass rather than artificial turf, and why professional football and soccer teams also prefer natural grass.

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]

As noted above, artificial turf gets much hotter than grass, and so does the air above it.  Synthetic surfaces 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]

Conclusions

There are currently no safety tests required prior to sale that prove that any artificial turf products are safe.  In many cases, the materials used are not made public, 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 I can attest to the fact 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 or 202 223-4000).

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.  Your decision about artificial turf can save lives and improve the health of children in Rye and will serve as a model to other communities.

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 potentially harmful. The only question is how harmful and how much exposure is likely to be harmful?  We should not be willing to take such a risk. Our children deserve better.

Sincerely,

Diana Zuckerman, PhD
President

 

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. Yale Study Reveals Carcinogens and Skin Irritants in Synthetic Turf. http://wtnh.com/2015/09/03/new-yale-study-reveals-carcinogens-and-skin-irritants-in-synthetic-turf/
  3. Anderson SE and Meade BJ, Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals, Environ Health Insights. 2014; 8(Suppl 1): pgs 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. Int J Environ Res 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. Phil Trans R Soc 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. Philos Trans R Soc Lond B. 2009. 364: 2153–2166.
  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

Some textured implants have a cancer risk. Here’s why women are told not to remove them

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

Joce Sterman and Alex Brauer, WJLA: September 16, 2019.

WASHINGTON (SBG) – We’ve all heard of recalls on cars and dangerous toys, but a global recall of a device that’s surgically implanted inside your body has thousands of women on alert. The recall of Allergan’s textured BIOCELL breast implants was prompted by a government analysis that showed an increased risk of cancer. Still, women who have them are generally being told not to have them removed from their chests.

For the last two months, Raylene Hollrah’s email and phone have been blowing up, with hundreds of women contacting her non-profit, dedicated to raising awareness about the emerging cancer. It’s called Breast implant-associated anaplastic large cell lymphoma, also known as BIA-ALCL.

The fear women are dealing with comes following the August global recall of Allergan’s BIOCELL textured implants due to the increased the risk of lymphoma, a cancer of the immune system that Raylene now knows all too well.

When she was diagnosed with BIA-ALCL in 2013, it was a brutal double whammy. Hollrah had survived breast cancer and a mastectomy. During reconstructive surgery in 2008, she got the textured implants that eventually gave her cancer a second time, making her just the 25th documented case of BIA-ALCL in the United States at that time. Her treatment and the research that preceded it came courtesy of Dr. Mark Clemens, who is a pioneer when it comes to researching the disease at MD Anderson Cancer Center in Texas.

In 2017, our Sinclair station in Washington, WJLA/ABC7 was one of the first in the country to tell Raylene’s story and highlight the link between textured breast implants and lymphoma. In that report, reporter Kimberly Suiters pointed out the Food and Drug Administration was aware of 258 confirmed cases of BIA-ALCL. But she said the warnings were not making it to women who might be at risk.

When she was diagnosed with BIA-ALCL in 2013, it was a brutal double whammy. Hollrah had survived breast cancer and a mastectomy. During reconstructive surgery in 2008, she got the textured implants that eventually gave her cancer a second time, making her just the 25th documented case of BIA-ALCL in the United States at that time. Her treatment and the research that preceded it came courtesy of Dr. Mark Clemens, who is a pioneer when it comes to researching the disease at MD Anderson Cancer Center in Texas.

In 2017, our Sinclair station in Washington, WJLA/ABC7 was one of the first in the country to tell Raylene’s story and highlight the link between textured breast implants and lymphoma. In that report, reporter Kimberly Suiters pointed out the Food and Drug Administration was aware of 258 confirmed cases of BIA-ALCL. But she said the warnings were not making it to women who might be at risk.

Allergan voluntarily pulled the implants as well as its related tissue expanders from the market, but they remain in thousands of women, many of them breast cancer survivors. And while a letter obtained by Spotlight on America shows the company is offering free replacement implants, it won’t pay for revision surgery.

The letter explains the decision not to cover surgical fees is in line with an FDA recommendation that textured implants not be removed in patients who have shown no symptoms of BIA-ALCL. The FDA is telling doctors to stop using the implants but has told women they can keep the implants if they’re not symptomatic.

Diana Zuckerman with the National Center for Health Research says, “Some of the women are going to say I don’t care what the FDA says, I’m getting them out.”

Zuckerman explained the FDA’s advice to keep the implants balances the risks of surgery with the chances of getting this type of lymphoma, which is rare. BIA-ALCL is also highly treatable and Zuckerman says removing the implants before a woman is diagnosed with BIA-ALCL is not a 100% guarantee that she won’t develop the disease.

And there’s another big question following the recall: exactly who has these implants? Zuckerman says many women don’t know and may struggle to find out as doctors don’t have to keep these records permanently.

That’s a big deal considering it could take years for this kind of cancer to develop. For Raylene Hollrah, her BIA-ALCL diagnosis came five years after she had her implants placed. After cancer a second time, she had them removed permanently. Now Hollrah has become an advocate for women in this same situation, making sure they know about BIA-ALCL.

So far no one has firmly pinpointed why these implants are a cancer risk, although many theories exist. And while the recall right now is only for Allergan’s BIOCELL textured implants, the FDA said it, “will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted.”

[…]

Read the full article here.

What Does Vaping Do To Your Lungs? Here’s What We Know

In the News, We're In the News

Yvonne Kim, Elite Daily: September 11, 2019.

In recent months, the national uptick in teen vaping has become less of a viral trend and more of a burgeoning public health emergency. Although e-cigarettes are nothing new, they are coming under increased scrutiny as otherwise healthy, young smokers experience a sudden rise in lung problems — and, now, even deaths. With investigations ongoing, it remains unclear exactly what vaping does to your lungs, but here’s what we know so far.

[…]

As of Sept. 6, the CDC has cited about 450 cases across 33 states of common symptoms — including chest pain, shortness of breath, and vomiting — among people with histories of vaping. While lung scan results appear similar to pneumonia, tests show there are no infections, according to The New York Times. There is yet no specific substance or product that links all the cases, but the CDC plans to continue identifying a cause through interviews and investigation. It launched an official investigation on Aug. 1, 2019, according to the press release.

“We are committed to finding out what is making people sick,” CDC Director Robert Redfield said in another press release. “All available information is being carefully analyzed, and these initial findings are helping us narrow the focus of our investigation and get us closer to the answers needed to save lives.”

How Safe Are Breast Implants, Really?

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

Rebecca Nelson, Elemental by Medium: September 3, 2019.

When Jamee Cook got breast implants at 21, she hoped to feel more confident about her body. Instead, the implants nearly ruined her life.

Just three years after her surgery, Cook, who is now 42, started having a slew of medical problems: fatigue, fevers, sinus infections, memory problems, and trouble concentrating. She felt like she constantly had the flu and could barely muster the energy to take care of her three kids. Because of her health problems, she had to quit her job as a paramedic. Four years ago, she finally saved up enough money to get her implants removed due to the complications and discovered her symptoms subsided. “I felt like I did a turnaround,” she says. She had finally gotten her life back.

Cook is not an outlier among women with breast implants. The safety of breast implants has long been a topic of debate in the medical community. After a safety scare in the 1990s, silicone implants were banned for more than a decade before the U.S. Food and Drug Administration (FDA) allowed them back on the market in 2006. But a growing body of evidence suggests that these newer breast implants aren’t as safe as this generation of women has been led to believe. The FDA requested in July that the implant manufacturer Allergan recall their textured implants, citing a link to a rare cancer called breast implant-associated anaplastic large cell lymphoma. And an online movement of thousands of women who say their implants have made them sick is calling more attention to other long-term complications.

Breast implants first came on the market in the U.S. in the 1960s. They are classified as medical devices by the FDA and an estimated 10 million women around the world have them currently. While the vast majority of those women don’t have issues, there’s increasing evidence that implants are associated with serious risks. But the available data on their safety is of poor quality, and doctors, researchers, and patients disagree about what some of the risks actually are — making it all the more difficult for women to determine them before making a decision.

The medical community has long downplayed the potential complications of implants, says Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C., who has studied implants. “There are many, many plastic surgeons whose entire livelihood depends on doing breast augmentation surgery. If they were to tell every patient what all the risks are, they’d have fewer patients.”

Here’s what’s known for sure: Nearly 600 cases of breast implant-related anaplastic large cell lymphoma, a cancer of the immune system, have been reported to the FDA. As of July, 33 people died from it. Textured implants made by Allergan were linked to the cancer, and recalled globally that month. While the FDA says there’s generally a low risk of people with breast implants developing cancer from them, the agency said in a statement at the time that “we believe all individuals who are considering a breast implant of any type be informed of the risk.”

“Of the millions of women with breast implants, we know that complications occur in at least 1% of patients,” says FDA spokeswoman Stephanie Caccomo. “We believe, though, that all women should be aware of the potential risks and complications of breast implants, which are not lifetime devices.”

People who consider implants may be unaware that they are viewed as temporary devices to be removed or replaced at a later date. According to the FDA, the longer people have the implants, the higher their risk for complications. “The life of breast implants varies by person and can’t be predicted,” reads a FAQ about breast implants on the agency’s website. “That means everyone with breast implants will face additional surgeries — but no one can tell them when. And while a few people may keep their original implants for 20 to 30 years, that is not the common experience.”

[…]

Read the full story here.

Teens Are Being Hospitalized After Vaping: Here’s What We Know So Far

Uncategorized

Parents, Yahoo! Lifestyle: August 27, 2019.

Last month, a 17-year-old from Texas named Tryston Zohfeld‘s lungs suddenly failed. He was rushed to Cook Children’s Hospital in Fort Worth, Texas and put into a medically-induced coma while the situation only worsened. X-rays found that the teen had a total blockage of his lungs. Ruling out diseases like pneumonia, doctors finally concluded that the lung inflammation and inability to exchange oxygen and carbon dioxide Zohfeld was experiencing had been brought on by chemicals the teen had been inhaling from his vape pen, which he had been regularly using since 8th grade.

While Zohfeld was grateful to be released from the hospital after an 18-day stay, his story is just one of several cautionary tales related to vaping and e-cigarettes that are making headlines nationwide. A 20-year-old from Utah named Alexander Mitchell was recently “on death’s door” after his lungs failed. The young man had been using e-cigarettes. Also this summer, 18-year-old Chance Ammirata’s lung collapsed. The Miami student admitted to vaping about one Juul pod every two days (roughly the equivalent of 10 cigarettes-worth of nicotine a day) for a year.

Now, the U.S. Centers for Disease Control and Prevention (CDC) is conducting an ongoing investigation into cases like these. Here’s what you need to know.

[…]

The Dangers of Vaping for Teens

With hope, the ongoing CDC and FDA investigations will offer parents more answers about the link between e-cigarette use and lung disease, but in the meantime, experts are noting that teens are an especially vulnerable group.

Diana Zuckerman, PhD, president of the National Center for Health Research told CBS News, “It seems some kids are having very measurable damage in a very short period of time than what we’ve seen from [cigarette] smoke.” She explained that a young person’s size might be a factor in how they experience the effects of the chemicals, noting, “The same amount of vaping for a child that weighs, say, 100 pounds, is a bigger issue than for somebody who weighs 200 pounds.”

At the same time, e-cigarettes that include nicotine put teens at risk of addiction, which amplifies their risk of illness. Teens who use nicotine can become addicted in just days. Yale Medicine pediatrician Deepa Camenga, M.D., says that nicotine affects teens differently than adults because “teens are just more vulnerable than adults are to developing an addiction to nicotine. As a result, it may be harder for teens to stop because their brain is still growing and developing.”

Potential Lung Damage Symptoms from Vaping

The CDC notes that “in many cases, patients reported a gradual start of symptoms” including:

  • breathing difficulty
  • shortness of breath
  • and/or chest pain before hospitalization
  • in some cases, mild to moderate gastrointestinal illness including vomiting and diarrhea and fatigue

People who experience illnesses after vaping are encouraged to report the incident to the FDA here.

 

Read the original article here.

Sample Vaping Letter

Uncategorized

If you’re concerned about the epidemic of e-cigarettes and vaping, contact your two U.S. Senators to let them know how you feel!  A sample letter is below.  Here is a link to find the names and contact info for your senators.

Dear Senator_____:

I am very concerned about the dangers of e-cigarettes and I am writing to ask you to require that Congress address this serious epidemic.  Action is urgently needed since the Centers for Disease Control and Prevention (CDC) is investigating reports that more than 250 people, including many teenagers and young adults, have suffered harm and in some cases, hospitalization because of lung injuries from vaping.

One man in Illinois has died and vaping is strongly suspected as the cause of his fatal illness.

Scientists are studying whether certain brands of e-cigarettes are most likely to be harmful, and whether the lung damage is caused by the chemicals, contamination or other causes.  Meanwhile a range of vaping products are widely sold and teens and adults are being seriously harmed.

In 2016, the Food and Drug Administration’s (FDA’s) Center for Tobacco Products (CTP) issued regulations aimed at restricting access to e-cigarettes and requiring studies of their risk.  The regulations were supposed to go into effect in 2018, but were delayed.  Meanwhile, the FDA has failed to require the companies to prove that their products are safe.

The industry and the scientists they have hired claim that vaping helps people to quit smoking, but that has not been proven.  Meanwhile, we now know that vaping can cause serious lung damage in just a year or two.  That’s faster than cigarettes, which generally take decades to cause serious harm.

After initially delaying the regulation of e-cigarettes for 4 years, the former FDA Commissioner, Dr. Scott Gottlieb, modified his views, calling vaping an epidemic, and vowed that the agency would take appropriate action.

Please become a co-sponsor of the SAFE Kids Act (S. 655), which would ban most flavoring from e-cigarettes.  These flavors are a major reason why children like to vape.  In addition, please contact the FDA and urge the agency to immediately restrict the marketing of e-cigarettes and require that these devices be drastically restricted until the companies submit conclusive safety data through the PMTA process.  The current delay is harming unknown numbers of teens and adults.

  Sincerely,

E-cigarettes affect a person’s blood vessels after just one use, study finds

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

Caitlin O’Kane, CBS News: August 22, 2019.

Vaping, even temporarily, can affect the blood vessels in healthy people — even if the vape pod does not contain nicotine, according to a new study published in the journal Radiology this week.

Researchers from the University of Pennsylvania School of Medicine studied 31 volunteers, all of whom were healthy, non-smoking adults with an average age of about 24 years old.

The participants were monitored as they each took 16 three-second inhalations from a disposable e-cigarette. The researchers used an ePuffer with flavored e-cigarette liquid but no nicotine in it. A research coordinator made sure sure the participants did not cough or swallow the vapor.

The researchers then conducted MRI scans on the participants and found a reduction in blood flow in the femoral artery in their legs. This change occurred after just one vaping experience.The findings suggest vaping impaired function of the endothelium, or inner lining of blood vessels, a press release on the study explained.

“These products are advertised as not harmful, and many e-cigarette users are convinced that they are just inhaling water vapor,” Alessandra Caporale, Ph.D., a post-doctoral researcher and lead author of the study, said in a statement. “But the solvents, flavorings and additives in the liquid base, after vaporization, expose users to multiple insults to the respiratory tract and blood vessels.”

[…]

“Lung damage is what we’re most focused on right now, but there’s so much more going on,” Dr. Diana Zuckerman, president of the National Center for Health Research, recently told CBS News. “There are chemicals in Juul and e-cigs and we’re not exactly sure what the impact is going to be because we haven’t seen it before.”

A study published in the journal Pediatrics last year found a number of different toxic chemicals in e-cigarettes, including one linked to several types of cancer. Some of the chemicals turned up even when teens used non-nicotine products like fruit-flavored vapes.

Read the original story here.