Category Archives: news-you-can-use

No Shortage of Controversies for New FDA Commissioner

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.

Is Vaping Safer than Smoking Cigarettes?

Laura Gottschalk, PhD, John-Anthony Fraga, Jared Hirschfield, Diana Zuckerman, PhD, National Center for Health Research


Electronic cigarettes, or e-cigarettes, are being marketed as the “safe” new alternative to conventional cigarettes. By February 2020, reports of 68 deaths and more than 2,800 vaping-related hospitalizations due to lung illnesses have made it clear that vaping can be even more dangerous than smoking.23, 24 Many of the patients report vaping marijuana products or marijuana and nicotine products, but others only vaped nicotine products. Based on what they know so far, doctors believe that the cause is chemical, not bacterial. But until these reports of hospitalized teens and adults are scrutinized in greater depth, we won’t know what types of vaping are most dangerous and under what circumstances.

E-cigarettes come in a variety of forms and include vape mods, Juuls, and vape pens. There are brand name products (Juul is the most widely used) and “home-made” versions.  Some contain high levels of nicotine, while others contain marijuana or just contain flavoring.  The focus of this article is on e-cigarettes because most of the research that exists has been done on them, but much of the information below is relevant to these other products as well.

The big questions are: Are they safe?  Will they reverse the decline in smoking—giving new life to an old habit—or can they help people quit smoking?  Here is what you need to know.

What are E-cigarettes?

E-cigarettes are battery-operated devices that were initially shaped like cigarettes, but now include vape mods, Juuls, and vape pens. The brand-name products contain nicotine, an addictive drug that stimulates, relaxes, and is naturally found in tobacco. It is the nicotine in cigarettes that makes smoking so addictive, and the same is true for most vaping and juuling. These electronic products allow nicotine to be inhaled, and they work by heating a liquid cartridge containing nicotine, flavors, and other chemicals into a vapor. Because e-cigarettes heat a liquid instead of tobacco, what is released is considered smokeless.1

Is Vaping Safer than Smoking Traditional Cigarettes?

The key difference between traditional cigarettes and e-cigarettes and related products is that the latter don’t contain tobacco.  But, it isn’t just the tobacco in cigarettes that causes cancer and other serious diseases. Traditional cigarettes contain a laundry list of chemicals that are proven harmful, and e-cigarettes have some of these same chemicals.

While smoking can cause lung cancer, breast cancer, emphysema, heart disease, and other serious diseases, those diseases usually develop after decades of smoking.  In contrast, in 2019 it became clear that vaping could cause seizures and serious lung damage after just a year, possibly less, based on CDC reports of almost 200 patients hospitalized for lung damage apparently caused by vaping.2,3   While there have been warnings about the possible risk of e-cigarettes for a decade, it was not expected that they could cause such severe damage in such a short period of time.

Since 2009, FDA has pointed out that e-cigarettes contain “detectable levels of known carcinogens and toxic chemicals to which users could be exposed.” For example, in e-cigarette cartridges marketed as “tobacco-free,” the FDA detected a toxic compound found in antifreeze, tobacco-specific compounds that have been shown to cause cancer in humans, and other toxic tobacco-specific impurities.4 Another study looked at 42 of these liquid cartridges and determined that they contained formaldehyde,  a chemical known to cause cancer in humans.5 Formaldehyde was found in several of the cartridges at levels much higher than the maximum EPA recommends for humans. In 2017, a study published in the Public Library of Science Journal showed that significant levels of benzene, a well-known carcinogen, were found in the vapor produced by several popular brands of e-cigarettes. 6

The body’s reaction to many of the chemicals in traditional cigarette smoke causes long-lasting inflammation, which in turn leads to chronic diseases like bronchitis, emphysema, and heart disease.7 Since e-cigarettes also contain many of the same toxic chemicals, there is no reason to believe that they will significantly reduce the risks for these diseases.

In fact, a preliminary study presented at the 2018 annual meeting of the American Chemical Society found that vaping could damage DNA.8 The study examined the saliva of 5 adults before and after a 15-minute vaping session. The saliva had an increase in potentially dangerous chemicals, such as formaldehyde and acrolein. Acrolein has been proven to be associated with DNA damage, for example, and DNA damage can eventually cause cancer. 9

A study of mice funded by the National Institutes of Health found that e-cigarette smoke could cause mutations in DNA that could increase the risk of cancer. These specific mutations have been shown to potentially contribute to the development of lung and bladder cancer in mice exposed to electronic cigarette smoke. The researchers claim that these chemicals could also induce mutations leading to cancer in humans.  It has not been reported how many of those harmed had used juul devices. While many of those harmed had vaped marijuana, many also used nicotine e-cigarettes,10 so the risks of “juuling” need to be carefully and immediately studied.

Because they are smokeless, many incorrectly assume that e-cigarettes are safer for non-smokers and the environment than traditional cigarettes. However, a study published in the International Journal of Hygiene and Environmental Health found that the use of e-cigarettes results in increased concentrations of volatile organic compounds (VOCs) and airborne particles, both of which are potentially harmful when inhaled.11 Although e-cigarette vapor may not result in the obvious smell and visible smoke of traditional cigarettes, it still has a negative impact on air quality, especially when vaping indoors.

There are no long-term studies to back up claims that the vapor from e-cigarettes is less harmful than conventional smoke. Cancer takes years to develop, and e-cigarettes were only very recently introduced to the United States. It is almost impossible to determine if a product increases a person’s risk of cancer or not until the product has been around for at least 15-20 years. Despite positive reviews from e-cigarette users who enjoy being able to smoke them where regular cigarettes are prohibited, very little is known about their safety and long-term health effects.

There is also danger from e-cigarettes exploding in the user’s mouth or face.  Last year, the British Medical Journal used data from several agencies to estimate that there were roughly 2,035 e-cigarette explosion and burn injuries in the U.S. just in a three-year period from 2015 to 2017.  One of the authors of the study stated that the number was likely higher as such incidents were not well tracked.  The report also said that e-cigarettes, commonly powered by a lithium-ion battery, could overheat to the point of catching fire or exploding, a phenomenon known as “thermal runway”.12

Can Vaping Help to Cut Down or Quit Smoking Regular Cigarettes?

If a company makes a claim that its product can be used to treat a disease or addiction, like nicotine addiction, it must provide studies to the FDA showing that its product is safe and effective for that use. On the basis of those studies, the FDA approves or doesn’t approve the product. So far, there are no large, high-quality studies looking at whether e-cigarettes can be used to cut down or quit smoking long-term. Most of the studies have been either very short term (6 months or less) or the participants were not randomly assigned to different methods to quit smoking, including e-cigarettes. Many of the studies are based on self-reported use of e-cigarettes. For example, a study done in four countries found that e-cigarette users were no more likely to quit than regular smokers even though 85% of them said they were using them to quit.13 Other year-long studies, conducted in the U.S., had similar findings.  A study published in a prestigious medical journal in 2014 found that although smokers may believe they are vaping e-cigarettes to help them quit,  6-12 months after being first interviewed, nearly all of them are still smoking regular cigarettes.14 Similarly, a year-long study published in 2018 compared smokers who used e-cigarettes to traditional cigarette smokers, and concluded that e-cigarette users were more likely to say they were trying to quit but no more likely to successfully kick the smoking habit, with 90% of e-cigarette users still smoking regular cigarettes at the end of the study.  Until there are results from well-conducted studies, the FDA has not approved e-cigarettes for use in quitting smoking.15

Teenagers, Children, and Vaping

The percentage of teenagers who have tried e-cigarettes has more than quadrupled in recent years, with 25% of seniors and 20% of sophomores vaping in just the last month.26 Three million U.S. students in middle school and high school tried e-cigarettes in 2015, according to the National Youth Tobacco Survey. And, 1 in 5 middle schoolers who said they had tried e-cigarettes also said they had never smoked conventional cigarettes.16

E-cigarette and juul use by young people is worrisome for a number of reasons:

  1. The younger people are when they begin smoking, the more likely it is they will develop the habit: nearly 9 out of 10 smokers started before they were 18.17
  2. Nicotine and other chemicals found in e-cigarettes, juuls, etc.  might harm brain development in younger people.18
  3. Vaping may introduce many more young people to smoking who might otherwise never have tried it, and once they are addicted to nicotine, some may decide to get their “fix” from regular cigarettes. Whether vaping or juuling is a “gateway” to regular cigarettes or not, young people who use them risk becoming addicted to nicotine and exposing their lungs to harmful chemicals.

The sharp rise in vaping among youth highlights the need to stop manufacturers from targeting teenagers with candy-like flavors and advertising campaigns.

Even children who are too young to smoke have been harmed by e-cigarettes and related products. The liquid is highly concentrated, so absorbing it through the skin or swallowing it is far more likely to require an emergency room visit than eating or swallowing regular cigarettes. In 2012, less than 50 kids under the age of six were reported to poison control hotlines per month because of e-cigarettes. In 2015, that number had skyrocketed to about 200 children a month, almost half of which were under the age of two!19

For more information about juuls, check out our article here.

How are these products regulated?

The FDA was given the power to regulate the manufacturing, labeling, distribution and marketing of all tobacco products in 2009 when President Obama signed into law the Family Smoking Prevention and Tobacco Control Act and in 2010 a court ruled that the FDA could regulate e-cigarettes as tobacco products.20

E-Cigarette Ad

It wasn’t until 2016 that the FDA finalized a rule to regulate e-cigarettes, which would ban the sale of e-cigarettes to anyone under the age of 18 and would require all e-cigarettes that hit shelves after February 15, 2007 to go through a “premarket review,” the process that the FDA uses to determine whether potentially risky products are safe.21 Companies were to be given from 18 months to two years to comply with this rule and prepare their applications. However, in 2017, the Trump administration appointed a new FDA Commissioner, Dr. Scott Gottlieb, who defended the safety of e-cigarettes and delayed implementing the rules until 2022.8 Nevertheless, as the epidemic of e-cigarette use among youth became obvious, in 2018, Commissioner Gottlieb threatened to crack down on the advertising of e-cigarettes to children under 18.22 Critics have questioned whether sales and ads can be effectively restricted. Moreover, Commissioner Gottlieb resigned in 2019, and it is unclear how the agency will respond to the growing evidence that vaping can cause serious harm.

In the meantime, individual states have always had the power to pass laws restricting the sale and use of e-cigarettes. Current laws pertaining to e-cigarettes are available on the Public Health Law Center website: https://www.publichealthlawcenter.org/resources/us-e-cigarette-regulations-50-state-review

The Bottom Line

E-cigarettes, juuls, and other similar products have not been around long enough to determine the harm they cause in the long run. Unfortunately, many people, including teenagers, are under the impression that e-cigarettes are safe or that they are effective in helping people quit smoking regular cigarettes. Studies by the FDA show that e-cigarettes contain some of the same toxic chemicals as regular cigarettes, even though they don’t have tobacco. There is evidence that some of these toxic chemicals can cause DNA damage that can cause cancer. More important, the reports of teens and adults who died or were hospitalized due to vaping are proof that vaping can be extremely dangerous even after just a few weeks, months, or years.

The big three tobacco companies—Lorillard, Reynolds American, and Altria Group—all have their own e-cigarette brands, so it’s not surprising that e-cigarettes are being marketed and advertised much the way regular cigarettes used to be. Here are the 7 Ways E-Cigarette Companies Are Copying Big Tobacco’s Playbook.

Although there are clearly serious dangers from vaping, more research is needed to confirm the impact of vaping on DNA damage, especially in children. Meanwhile, claims that e-cigarettes are an effective strategy to quit smoking are not supported by the evidence thus far. In addition, more toxicological studies and epidemiological studies are needed to understand the hundreds of reports of permanent lung damage and deaths from vaping.  It is essential to find out whether some types of vaping are more dangerous than others in the short-term and the long-term.  To understand the risks for everyone who vapes, research is needed to compare the risks of specific brands of e-cigarettes with tobacco products, as well as to neither smoking nor vaping.

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

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

  1. O’Connor RJ. Non-cigarette tobacco products: What have we learned and where are we headed? Tobacco Control. 2012;21(2): 181–190. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3716250/
  2. Hauck G.  CDC reports 153 possible cases of vaping-related illnesses, many involving THC. USA TODAY. August 22, 2019. https://news.yahoo.com/cdc-reports-153-possible-cases-180325194.html
  3. Sum LH. He went from hiking enthusiast to ‘on death’s door’ within days. Doctors blamed vaping. Washington Post. August 24, 2019. https://www.washingtonpost.com/health/one-mans-near-death-experience-with-vaping-related-lung-failure/2019/08/24/ca8ce42c-c5b4-11e9-9986-1fb3e4397be4_story.html 
  4. Food and Drug Administration. Summary of Results: Laboratory analysis of electronic cigarettes conducted By FDA. FDA News & Events. July 22 2009.
  5. Varlet V,  Farsalinos K, Augsburger M, et al. Toxicity of refill liquids for electronic cigarettes. International Journal for Environmental Research and Public Health. 2015;12:4796-4815. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4454939/
  6. Pankow JF, Kim K, McWhirter KJ, et al. Benzene formation in electronic cigarettes. PLOS ONE. 2017;12(3),e0173055. https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/28273096/
  7. Centers for Disease Control and Prevention. Overviews of Diseases/Conditions. February 2019.  https://www.cdc.gov/tobacco/campaign/tips/diseases/index.html
  8. McGinley, L. FDA sued for delaying e-cigarette, cigar regulations. Washington Post. March 27 2018.  https://www.washingtonpost.com/news/to-your-health/wp/2018/03/27/fda-sued-for-delaying-e-cigarette-cigar-regulations/?utm_term=.f92695720619.
  9. Lee HW, Park SH, Weng MW, et al. E-cigarette smoke damages DNA and reduces repair activity in mouse lung, heart, and bladder as well as in human lung and bladder cells. Proceedings of the National Academy of Sciences of the United States of America. 2018;115(7), E1569. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5816191/
  10. Kaisar MA, Prasad S, Liles T, et al. A decade of e-cigarettes: Limited research & unresolved safety concerns. Toxicology. 2016;365: 67–75. http://doi.org/10.1016/j.tox.2016.07.020
  11. Robert Langreth. More Evidence Links Vaping Lung Injuries to Vitamin E Acetate. December 20, 2019.
    https://www.bloomberg.com/news/articles/2019-12-20/more-evidence-links-vaping-lung-injuries-to-vitamin-e-acetate  
  12. Kaplan S. E-Cigarette exploded in a teenager’s mouth, damaging his jaw.  The New York Times. June 19 2019.  https://www.nytimes.com/2019/06/19/health/ecigarettes-explosion.html
  13. Adkison SE, O’Connor RJ, Bansal-Travers M, et al. Electronic nicotine delivery systems: International tobacco control four-country survey. American Journal of Preventive Medicine. 2013;44(3):207-215. https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23415116/
  14. Grana RA, Popova L, Ling PM. A longitudinal analysis of electronic cigarette use and smoking cessation. JAMA Internal Medicine. 2014;174(5):812–813. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4122246/
  15. Food and Drug Administration. Electronic Cigarettes. FDA News & Events. 25 July 2013.
  16. Singh T, Arrazola RA, Corey CG, et al. Tobacco use among middle and high school students – United States, 2011-2015. CDC Morbidity and Mortality Weekly Report. 2016. 65(14);361-367. https://dx.doi.org/10.15585/mmwr.mm6514a1
  17. Centers for Disease Control and Prevention. Fact sheets: Youth and tobacco use. Updated 2019. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/
  18. Centers for Disease Control and Prevention. Preventing tobacco use among youth and young adults. 2012. http://www.cdc.gov/tobacco/data_statistics/sgr/2012/index.htm
  19. Kamboj A, Spiller HA, Casavant MJ, et al. Pediatric exposure to e-cigarettes, nicotine, and tobacco products in the United States. Pediatrics. 2016;137(6). pii: e20160041. https://pediatrics.aappublications.org/content/137/6/e20160041.long
  20. Food and Drug Administration. Regulation of E-Cigarettes and Other Tobacco Products. FDA News & Events. April 25, 2011.
  21. Food and Drug Administration. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. 21 CFR Parts 1100, 1140, and 1143. 2016;81(90):28973-29106. https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10685.pdf 
  22. Saltzman J, Freyer F. The FDA issues a warning: Teen vaping is ‘an epidemic.’ Boston Globe. September 13 2018. https://www.bostonglobe.com/metro/2018/09/12/fda-cracks-down-vaping-orders-makers-address-sales-minors/JaiqQYzZAl4CINLufnkKlL/story.html.
  23. Knowles H, Sun LH. What we know about the mysterious vaping-linked illness and deaths. Washington Post. January 10, 2020. https://www.washingtonpost.com/health/2019/09/07/what-we-know-about-mysterious-vaping-linked-illnesses-deaths/  
  24. Centers for Disease Control and Prevention. Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products. Updated 2020. https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html
  25. Vaping Could Up Risks for Asthma, COPD and Other Lung Diseases. Dec 16, 2019. (HealthDay) Newshttps://consumer.healthday.com/cancer-information-5/electronic-cigarettes-970/vaping-could-up-risks-for-asthma-copd-and-other-lung-diseases-753003.html 
  26. NIDA Press Office. Researchers sound alarm on potential health effects of vaping. September 18, 2019. https://www.drugabuse.gov/news-events/news-releases/2019/09/teen-e-cigarette-use-doubles-2017

What Health Care Coverage Under the Affordable Care Act Means to You

What Health Care Coverage Under the Affordable Care Act Means to You

If you are thinking about enrolling for health care coverage for 2019, you have from November 1-December 15, 2018 to apply through Open Enrollment.  Here’s what you need to know about what it will pay for:

  •  Doctor’s visits—Doctor’s visits and outpatient surgery or procedures that do not take place in a hospital;
  • Trips to the emergency room—the average cost can be more than an average month’s rent;
  • Treatment in the hospital for inpatient care.  If not insured, an average three-day stay can cost $30,000;
  • Care before and after a baby is born— prenatal care, labor and delivery costs tens of thousands of dollars.  A C-section alone can cost $50,000;
  • Mental health and substance use disorder serviceswhich include treatment, counseling, and psychotherapy;
  • Your prescription drugs—almost half of all Americans took at least one prescription drug in the last 30 days;
  • Services and devices to help you recover from injury or to help with disabilities or chronic conditions. This includes physical and occupational therapy, speech therapy, and psychiatric rehabilitation;
  • Lab tests, whether complicated or simple blood tests;
  • Preventive services can include counseling, cancer screenings, and vaccines to keep you healthy; and
  • Pediatric services including dental care and vision care for children.

 

For more information about how to sign up for health insurance through Open Enrollment under the ACA, see our article here.

The Dangers of Juuling

John-Anthony Fraga, National Center for Health Research


What is Juuling? Is it safer than smoking?

A new type of e-cigarette called “juul” has become so popular that it is now about 68% of the $2 billion e-cigarette market. The “juul” is especially popular among children and young adults due to its sleek and discreet design, its ability to be recharged on a laptop or wall charger within one hour, and its liquid-filled cartridges that come in popular flavors like cool mint, creme brulee, and fruit medley.

As of February, 68 deaths and more than 2,800 cases of serious lung illness related to e-cigarettes have been reported to the CDC. [9] It was not initially known whether those harmed had used juul devices. However, the most recent reports state that all types of e-cigarettes were used by the teens and adults who were harmed by vaping, so the risks of “juuling” need to be carefully and immediately studied. [10]

Juuling has become very common at teenage hangouts and even at school. Medical professionals are very concerned because juul delivers higher concentrations of nicotine than other e-cigarettes. Not only is nicotine highly addictive, but it is also toxic to fetuses and is known to impair brain and lung development if used during adolescence.[1] It is not replacing cigarette smoking but rather encouraging it: A 2017 study found that non-smoking adults were four times more likely to start smoking traditional cigarettes after only 18 months of vaping, which includes “juuling.”[7] For more information about e-cigarettes in general, check out our article here.

How does the Juul Work?

According to Juul Labs, the company that owns and sells the juul e-cigarette, the device uses an internal, regulated heating mechanism that creates an easily inhaled aerosol. This mechanism prevents the batteries in the juul from overheating and exploding, which has been a problem for other brands of e-cigarettes. Juul is easy to use because there are no settings to adjust or control. All that is required is a non-refillable juul pod cartridge that clicks into the top of the juul and contains a nicotine e-liquid formula. This e-liquid is heated and converted into vapors that are inhaled by the user. One of the reasons it is so popular among youth is that it is so easy to use – no prior experience or knowledge required. All they have to do to intake nicotine is to put a juul to their mouth and inhale.

What makes Juuls different from other e-cigarettes?

The increased harm of juuls compared to other e-cigarettes is due to the concentration and contents of its juul pods. The e-liquid is 5% nicotine by volume, which is more than twice the concentration of nicotine in similar devices like the Blu e-cig cartridge (2.4% nicotine). This increases the risk of addiction; in fact, a study done by the UK’s Royal College of Psychiatrists showed that nicotine is about as addictive as cocaine and even more addictive than alcohol and barbiturates (anti-anxiety drugs).[2]

The impact on the developing brain is also of great concern. Brain imaging studies of adolescents who began smoking at a young age had markedly reduced activity in the prefrontal cortex of the brain, an area critical for a person’s cognitive behavior and decision making, leading to increased sensitivity to other drugs and greater impulsivity.[3] The amount of nicotine in one juul pod is equivalent to a pack of cigarettes. Since teens often use multiple pods in one sitting, they can unknowingly become exposed to unsafe levels of nicotine that can have immediate and long-term health consequences. In 2016, the Food and Drug Administration (FDA) was given the authority to regulate e-cigarettes such as juul but has allowed e-cigarette manufacturers to postpone their applications for FDA approval until August 2022. Meanwhile, these harmful devices can remain on the market and continue influencing adolescents to become addicted to nicotine.[8]

Another reason why the juul is a unique threat to teens is its patented formula of nicotine. While other brands use a chemically modified form called “freebase nicotine,” juuls use “nicotine salts” that more closely resemble the natural structure of nicotine found in tobacco leaves. This makes the nicotine more readily absorbed into the bloodstream and makes the vapor less harsh so that it is easier to inhale more nicotine for longer periods of time.

In addition to this patented formula, juul pods contain a greater amount of benzoic acid, 44.8 mg/mL, compared to other e-cigarette brands, which are in the range of 0.2 to 2 mg/mL. According to the Center for Disease Control and Prevention (CDC), benzoic acid is known to cause coughs, sore throat, abdominal pain, nausea, and vomiting if exposure is constant, which is the case when using a juul.[4] This is due to how juuls utilize the properties of benzoic acid to increase the potency of the nicotine salts in its e-liquid.

What makes Juuls popular among children and teens?

Since juuls are small, discreet, and closely resemble a USB drive, they can be easily hidden and used in a wide variety of settings, such as the classroom. Teachers and school administrators across the nation are finding students juuling when their backs are turned: Students can take a hit, blow the small, odorless puff of smoke into their jacket or backpack, and continue their school work in a matter of seconds. Compared to other forms of teenage rebellion, juuling is especially dangerous as middle and high school students are unknowingly becoming addicted to nicotine at an alarming rate.

Because a person must be at least 21 to purchase a juul or juul pod, a juul black market is the source for many teens, through eBay or Craigslist. In response, the FDA contacted eBay to raise concerns about listings of juul products on its website, resulting in the removal of the listings and the creation of measures to prevent new listings from being posted.[5]

In April 2018, FDA Commissioner Scott Gottlieb announced that he was creating a Youth Tobacco Prevention Plan aimed at stopping the dramatic rise in the use of e-cigarette and tobacco products among youth. The FDA specifically asked Juul Labs for documents related to product marketing and research on the health, toxicological, behavioral, or physiological effects of their products in order to understand why youth are so attracted to them.[6] Additionally, Juul Labs is currently facing lawsuits in several states claiming that its products were deceptively marketed to youth under the legal smoking age. The FDA now plans to create enforcement policies for e-cigarette manufacturers, including juul, that are marketing their products to children and teenagers.

The Bottom Line:

The popularity of juuls among adolescents exposes them to large amounts of nicotine that can have adverse health risks for their physical and emotional development. While juuls are called e-cigarettes, they look nothing like them, making it easy for children and teens to secretly use them without a parent, guardian, or teacher noticing. This may be just a temporary trend, but if the FDA does not quickly do more to restrict flavors that appeal to adolescents and to educate the public about the risks, it is likely to create an enormous increase in young people addicted to nicotine.

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

References:

  1. England, L., Bunnell, R., F. Pechacek, T., Tong, V., & A. McAfee, T. (2015). Nicotine and the Developing Human (Vol. 49).
  2. Nutt, D., King, L. A., Saulsbury, W., & Blakemore, C. (2007). Development of a rational scale to assess the harm of drugs of potential misuse. The Lancet, 369(9566), 1047-1053. doi:https://doi.org/10.1016/S0140-6736(07)60464-4
  3. Musso, F., Bettermann, F., Vucurevic, G., Stoeter, P., Konrad, A., & Winterer, G. (2007). Smoking impacts on prefrontal attentional network function in young adult brains. Psychopharmacology, 191(1), 159-169. doi:10.1007/s00213-006-0499-8
  4. Centers for Disease Control and Prevention. Safety Material Data Sheet: Benzoic Acid. Accessed July 30, 2018. Available at: https://www.cdc.gov/niosh/ipcsneng/neng0103.html
  5. “Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop the youth use of, and access to, JUUL and other e-cigarettes. ” FDA News & Event. FDA, April 24, 2018. Accessed: July 30, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605432.htm
  6. “Official Request of Information for JUUL Labs.” FDA Rules and Regulations, FDA. April 24, 2018. Accessed: July 30, 2018. https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM605490.pdf
  7. Primack, B. A., Shensa, A., Sidani, J. E., Hoffman, B. L., Soneji, S., Sargent, J. D., . . . Fine, M. J. (2018). Initiation of Traditional Cigarette Smoking after Electronic Cigarette Use Among Tobacco-Naïve US Young Adults. The American Journal of Medicine, 131(4), 443.e441-443.e449. doi:10.1016/j.amjmed.2017.11.005
  8. “FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation” FDA Newsroom, FDA. August 6, 2018. Accessed: August 8, 2018. https://www.fda.gov/TobaccoProducts/NewsEvents/ucm568425.htm
  9. Centers for Disease Control and Prevention. Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products. Updated 2020. https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html
  10. Johnson CK.  What we know so far about the US vaping illness outbreak.  AP: The Washington Post.  September 10, 2019.  washingtonpost.com/national/health-science/what-we-know-so-far-about-the-us-vaping-illness-outbreak/2019/09/10/146e4fbe-d40a-11e9-8924-1db7dac797fb_story.html

Heart Disease and Breast Cancer

Diana Zuckerman PhD, Cancer Prevention and Treatment Fund

In a first-of-its-kind scientific statement, the American Heart Association reminds women that heart disease is the #1 killer of women and that frequently used breast cancer treatments can increase a woman’s chances of developing heart disease.1 These treatments include radiation, hormone therapy, chemotherapy, and targeted therapy.

Facts that will Help you Decide your Treatment Options

Fact:  Heart disease affects almost 50 million U.S. women, and 1 in 3 deaths in women in the U.S. are due to heart disease. Breast cancer affects about 3.3 million U.S. women, and 1 in 32 deaths in women are due to breast cancer. That means that women are about 10 times more likely to die of heart disease than to die of breast cancer.

 Fact: Women with a history of breast cancer are more likely to die from heart disease than women without a history of breast cancer. That is because some health habits cause both heart disease and breast cancer, and because some breast cancer treatments can also increase your chances of dying of heart disease.

Fact: There are many things you can do to decrease your risks of developing both breast cancer and heart disease:  not smoking, eating a healthy diet, losing weight (if you are overweight or obese) and being physically active

Which Breast Cancer Treatments Harm the Heart?

Radiation therapy:

Radiation therapy is often recommended for women who have a lumpectomy, so it is important to know that it can cause inflammation that can damage heart muscles and blood vessels. Studies on animals show that it can also cause clots to form in the coronary arteries. The risks are higher for radiation that is directed at the left side of the chest. The effects are not immediate, but radiation can increase the chances of heart disease at any time between 5-30 years after radiation therapy.

Hormonal therapy:

Tamoxifen is a hormone therapy that is often prescribed for breast cancers that are sensitive to the hormone estrogen. Studies show that tamoxifen lowers bad cholesterol, but there is no evidence this decreased their chances of developing heart disease or dying from it. Perhaps that is because tamoxifen also increases the chances of forming blood clots, which can be dangerous if they are in the lungs, heart, or brain.

Aromatase inhibitors are a type of hormone therapy that is often prescribed for postmenopausal women with breast cancers that are sensitive to the hormone estrogen. Aromatase inhibitors increased the chances of developing heart disease by less than 1%, but the risks may be higher (about 7%) in women who already have heart disease. The U.S. Food and Drug Administration issued a warning about this for one aromatase inhibitor, anastrazole (brand name arimidex).

Chemotherapy:

Doxorubicin, a type of anthracycline-based chemotherapy, can have harmful effects on the heart, which can be permanent and irreversible. Doxorubicin can damage heart cells and cause inflammation that can weaken the heart muscles, which can lead to heart failure. Heart failure means the heart isn’t pumping well, which can cause the body to become swollen and the lungs to fill with fluid.  This can cause you to feel short of breath, tired, or weak.

5-Fluorouracil (5-FU), is a type of antimetabolite chemotherapy used for metastatic breast cancer and other cancers. Some women who take 5-FU develop chest pain caused by a blood clot or tightening in the blood vessels that feed the heart (coronary arteries). In very rare cases, the heart does not get enough blood, which can cause a heart attack.

Targeted Drugs:

Trastuzumab or pertuzumab are targeted drugs that work against breast cancer cells that make the protein HER2. These medications can cause heart failure that is reversible. Because of the risks, women should only take these medications for 1 year.  Women who are over age 50 with diagnosed heart disease, high blood pressure, reduced heart function, or prior use of doxorubicin are most likely to be harmed by this drug.

Prevention

Studies show that there are things you can change to help prevent breast cancer and heart disease.

  1. Stop smoking
  • For heart health – Smoking increases the chances of having a heart attack or stroke.
  • For breast health – Women who start smoking at a younger age, and smoke for many years, are more likely to develop breast cancer. Smoking causes about 4 in 1000 breast cancers. Quitting decreases the chances of developing breast cancer, but it may take about 20 years to see the full benefits.2
  1. Maintain a healthy weight
  • For heart health – Being overweight or obese (a BMI of 25 or above) increases the chances of developing heart disease.
  • For breast health – Every extra 10 pounds over “normal” weight (BMI below 25) increases the chance of developing breast cancer by about 10%.
  1. Be physically active
  • For heart health – Sitting, watching TV, lying in bed, or driving for 10 hours or more a day while you are awake instead of 5 hours or less per day increases the chances of developing heart disease by about 18%. The AHA recommends exercising for 30 minutes or more a day 5 days each week.
  • For breast health – Those same sedentary activities for 12 hours or more a day compared to 5.5 hours or less increase the chance of developing breast cancer by about 80%. To prevent breast cancer, exercise for 30 minutes or more a day 5 days each week.
  1. Eat a healthy diet
  • For heart health – Eating a diet rich in fresh vegetables, Fresh fruit, fish, poultry, and whole grains reduces your chance of dying from heart disease by about 28% compared to eating a typical U.S. diet with many fast foods, red meats/processed meats, and packaged or processed foods.
  • For breast health – The typical U.S. diet is associated with a greater chance of developing breast cancer, but the clearest evidence is for eating at least 15 oz of red meat or processed meat each week compared to less than 9 oz. of red meat or processed meat.

Heart Health for Breast Cancer Patients and Survivors

High blood pressure, diabetes and high cholesterol increase the chances of having a heart attack or dying from one. The AHA recommends controlling blood pressure, blood sugar, and blood cholesterol with diet, exercise, and medications when needed. Exercise is good for the heart and it also fights off cancer. Studies show that exercising 30 minutes a day for 5 days out of the week decrease the chances of breast cancer returning and from dying from breast cancer.

The Bottom Line

Heart disease is a major cause of deaths in women, and remains a number one cause of death in breast cancer survivors. Women who are at a higher risk of heart disease should talk with their doctors about the risks and benefits of commonly used cancer treatments.

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

References:

1Laxmi S. Mehta. et al. Cardiovascular Disease and Breast Cancer: Where These Entities Intersect: A Scientific Statement From the American Heart Association. Circulation. 2018, originally published February 1, 2018. https://doi.org/10.1161/CIR.0000000000000556

2Jones ME. et al. Smoking and risk of breast cancer in the Generations Study cohort. Breast Cancer Research. 2017;19:118. https://doi.org/10.1186/s13058-017-0908-4

Alcohol and Cancer

Danielle Shapiro, MD, MPH, Cancer Prevention and Treatment Fund

The link between and alcohol and cancer may surprise you. A 2017 statement by the American Society of Clinical Oncology (ASCO) reports that drinking alcohol increases the risk of cancer of the mouth and throat, vocal cords, esophagus, liver, breast, and colon. The risks are greatest in those with heavy and long-term alcohol use. Even so, moderate drinking can add up over a lifetime, which could be harmful.[1]

What is Moderate Drinking? Heavy Drinking?

According to the National institute of Alcohol Abuse and Alcoholism (NIAAA), “moderate” drinking is 1 drink per day for women and 2 drinks per day for men, but not all “drinks” are equal. A drink is defined as approximately 14g of alcohol, which equals: 1.5 ounces of distilled spirits (e.g., vodka, gin, tequila, etc), 5 ounces of wine, 12 ounces of beer, and 8 ounces of malt liquor.[1,2] (Click here to see the CDC’s fact sheet.)

Heavy drinking is defined as 8 or more drinks per week OR 3 or more drinks per day for women and 15 or more drinks per week OR 4 or more drink per day for men. Most adults who engage in high-risk drinking started as teens.[1] (Click here to see our article on teen drinking.)

Drinking Amount and Cancer Risk

According to the International Agency for Research on Cancer (IARC), a branch of the World Health Organization (WHO), alcohol is a “group 1 carcinogen.” That means it can cause cancer in humans. Group 1 carcinogens include cigarette smoke, UV solar radiation, radon, and asbestos, for example.[3] Alcohol is known to cause six types of cancer, including cancer of the mouth and throat, vocal cords, esophagus (squamous cell), liver, female breast, and colon/rectum. Alcohol may also be tied to cancer of the pancreas, stomach, and lung, but more research is needed to find out for certain.[4] (Click here to see the National Cancer Institute’s Fact Sheet.)

Some of these cancers, such as mouth and throat cancer, are rare (about 1% lifetime risk), while colon cancer and breast cancer are much more common. [7] Depending on the amount a person drinks, he or she can increase the risk for even rare cancers. For example, moderate drinkers can almost double their lifetime risk of mouth and throat cancer to almost 2%, while heavy drinkers have a 500% increased risk of having mouth or throat cancer, from 1% to 5%.

Scientists believe that when alcohol comes into direct contact with tissue through drinking and swallowing, it causes more damage. For example, in the heaviest drinkers, alcohol raises the lifetime risk of esophagus cancer from about 0.5% to about 2.5%.[1,7]

Women need to be more cautious when drinking any amount of alcohol. The World Cancer Research Fund estimates that for every additional average drink per day, breast cancer risk goes up by 5% pre-menopause and up by 9% after menopause. Alcohol affects the amounts of certain sex hormones circulating in the body. For women who have had hormone receptor-positive breast cancer, 7 or more weekly drinks increased the chances of having a new cancer diagnosed in the other breast from about 5% to about 10%.[1]

How Alcohol Causes Cancer

Scientists believe that alcohol causes cancer in several ways:[1, 4]

  • Alcohol (ethanol) is broken down into a toxic substance called acetaldehyde. Acetaldehyde is directly toxic to the body’s cells.
  • Alcohol causes damage to cells through a process called free-radical oxidation.
  • Alcohol causes the body to absorb less folate (an important B vitamin) and other nutrients (antioxidant vitamins A, C, and E), which naturally repair damage and fight off cancers.
  • Alcohol increases the body’s level of estrogen (a sex hormone associated with breast cancer).

Does Quitting Change Your Chances of Developing Cancer or Cancer Recurrence?

Yes, drinking less alcohol on a regular basis reduces cancer risk, even in people who were already diagnosed with cancer. Research has shown that heavy or moderate drinkers who substantially reduce their alcohol consumption will slowly reduce their risk of developing mouth, throat, vocal cord, and esophagus cancer, but it would take 20 years of abstention to reduce the chances of developing those cancers to the lower chances of someone who never drank so frequently.  It is not clear whether reducing or giving up drinking after years of moderate or heavy drinking will have much impact for other alcohol-related cancers.[1]

In those who survived an esophagus cancer, drinkers tripled their risk for a new primary cancer diagnosis. On average, the risk of a new cancer diagnosis after esophagus cancer is removed is 8 % to 27%, and continuing heavy drinking will triple that risk.[5]

Among all cancer survivors, heavy drinking caused an 8% increased risk in dying and a 17% increased risk of cancer recurrence. Patients with cancer who abuse alcohol do worse because alcohol causes poorer nutrition, a suppressed immune system, and a weaker heart.[1]

What You Can Do to Lower Cancer Risk for You and Your Family

  1. . If you drink alcohol, limit drinks to an average of 1 a day for women and 2 a day for men.
  2. Recognize heavy drinking in a loved one, because the more a person drinks, the greater his or her chances of developing cancer. The “CAGE” questionnaire can help spot heavy drinking. Has the person tried to Cut back? Has the person been Annoyed when asked about drinking? Has the person felt bad or Guilty? Has the person needed a drink first thing in the morning (Eye opener)? Each “yes” counts as 1 point. A score of 2 or more suggests problem drinking.[6]
  3. Talk with your doctor about your risk. Doctors can refer or offer counseling and treatment services to patients with risky drinking habits.
  4. Seek help early. Problem drinking can’t be wished away. There are many resources to access information and help. The Substance Abuse and Mental Health Services Administration (SAMHSA), which is part of the U.S. Department of Health and Human Services (HHS) has a toll free hot-line and website. Call 1-800-662-HELP (4357) or visit https://findtreatment.samhsa.gov/  today.
  5. Practice healthy habits. Eating a diet rich in cancer-fighting nutrients (i.e., fruits and vegetables), exercising, maintaining a healthy weight, reducing stress, and getting restful sleep can all help to lower cancer risk. Don’t smoke, and quit if you do. Drinking and smoking increases cancer risk more than either one alone.

The Bottom Line

To prevent cancer, try to limit your drinking by sticking to a maximum average of 1 a day if you’re a woman and 2 a day if you’re a man.

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

Footnotes:

  1. LoConte, NK. et al. Alcohol and Cancer: A Statement of the American Society of Clinical Oncology. Journal of Clinical Oncology. published online before print November 7, 2017. DOI: 10.1200/JCO.2017.76.1155. Available online: http://ascopubs.org/doi/full/10.1200/JCO.2017.76.1155
  2. Centers for Disease Control and Prevention. Alcohol and Public Health. Fact Sheets- Moderate Drinking. Accessed November 16, 2017. Available online: https://www.cdc.gov/alcohol/fact-sheets/moderate-drinking.htm

 

Can Aspirin Prevent Cancer?

Renee Barlev, MD and Diana Zuckerman, PhD: Cancer Prevention and Treatment Fund

Many Americans take low-dose aspirin, also called baby aspirin, to prevent cancer and heart disease.  However, by 2019, the latest research suggested that aspirin is not as helpful as many patients believe.

In 2016, the U.S. Preventive Service Task Force (USPSTF), an independent group of medical experts, recommended low-dose aspirin “for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC) in adults aged 50 to 59 years who have a 10% or greater 10-year CVD risk [risk of developing cardiovascular disease], are not at increased risk for bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years”.1   They did not recommend aspirin to prevent all types of cancer, only colorectal cancer.

Primary prevention means preventing a disease that a person has not yet developed. As you can see above, there were quite a few caveats on who might benefit from “baby” low dose aspirin (typically 81mg).  For example, patients with an increased risk of bleeding due to certain medications, or with a history of other medical conditions such as stomach or intestinal ulcers, kidney disease, or severe liver disease.1

Recommended Guidelines in 2019 from the American College of Cardiology (ACC) and the American Heart Association were not as enthusiastic about aspirin for primary prevention of heart disease, saying that “low-dose aspirin might be considered” for certain patients.2  They did not comment on aspirin to prevent cancer.

Studies  published almost a decade ago had mixed results for cancer prevention. One study suggested that a daily dose of at least 75mg aspirin taken for several years could reduce the risk of developing colorectal cancer or dying from it.3 Other studies suggested that aspirin may reduce mortality from other cancers, as well as reducing the chances of cancer spreading.4,5 However, a 2019 meta-analysis that combined results from several studies found aspirin did not significantly affect cancer mortality.6  One clinical trial known as ASPREE (Aspirin in Reducing Events in the Elderly) found that individuals who took aspirin were more likely to die from cancer.

In conclusion, more research is needed to conclusively determine whether daily baby aspirin can help to prevent cancer.

BottomlineDo I Need Aspirin?

Some patients think they may as well take aspirin, because it might help and won’t harm.  That’s not an accurate assumption.  Aspirin can have risks even at low doses. You should discuss aspirin therapy with your doctor and let him or her know:

  • Your medical history and the medicines you are currently using, whether they are prescription or over-the-counter
  • Any allergies or sensitivities you may have to aspirin
  • Any vitamins or dietary supplements you are currently taking

Other Ways to Prevent Heart Disease and Cancer

To reduce your risk of colorectal cancer, don’t smoke, don’t drink alcohol in excess, have a healthy diet, stay physically active, and maintain a healthy weight.  Being older, and having a family history of colon cancer, Crohn’s disease, or ulcerative colitis are the risk factors you can’t control.7

To reduce your risk of heart disease, don’t smoke, keep your cholesterol and blood pressure under control, and do what you need to do to prevent diabetes.  Being a man and older are risk factors you can’t control.8

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

References:

  1. Final recommendation statement: Aspirin use to prevent cardiovascular disease and colorectal cancer: Preventive Mmedication. U.S. Preventive Services Task Force. 2017.
    https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/aspirin-to-prevent-cardiovascular-disease-and-cancer
  2. Donna K. ArnettRoger S. Blumenthal,  Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease. Journal of the American College of Cardiology. 2019;17:CIR0000000000000678.   http://www.onlinejacc.org/content/early/2019/03/07/j.jacc.2019.03.010?_ga=2.223365151.502443893.1555427130-1631669420.1554414836
  3. Rothwell PM, Wilson M, Elwin CE, et al.  Long-term effect of aspirin on colorectal cancer incidence and mortality: 20-year follow-up of five randomised trials. Lancet. 2010;376(9754): 1741-50. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61543-7/fulltext
  4. Rothwell PM, Folkes FG, Belch JF, et al.  Effect of daily aspirin on long-term risk of death due to cancer: Analysis of individual patient data from randomised trials. Lancet. 2011;377(9759): 31-41. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)62110-1/fulltext
  5. Rothwell PM, Wilson M, Price JF, et al. Effect of daily aspirin on risk of cancer metastasis: A study of incident cancers during randomised controlled trials. Lancet. 2012;379(9826): 1591-1601.   https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60209-8/fulltext
  6. Zheng SL, Roddick AJ.  Association of aspirin use for primary prevention with cardiovascular events and bleeding events: A systematic review and meta-analysis. JAMA. 2019;321(3):277-287. https://www.ncbi.nlm.nih.gov/pubmed/30667501
  7. Colorectal Cancer Risk Factors. American Cancer Society. https://www.cancer.org/cancer/colon-rectal-cancer/causes-risks-prevention/risk-factors.html
  8. How to Prevent Heart Disease. Medline Plus.  Last reviewed 2015.   https://medlineplus.gov/howtopreventheartdisease.html

Libertarians Score Big Victory In ‘Right-To-Try’ Drug Bill

Sarah Karlin-Smith, Politico: August 3, 2017

The Senate unanimously approved a bill Thursday that would allow people facing life-threatening diseases access to unapproved experimental drugs, providing a victory for libertarian advocates who see government regulators thwarting patients’ rights.

The bill, S. 204 (115), passed swiftly and easily in a Senate bitterly divided over health care. The powerful pharmaceutical lobby, which had quietly opposed an earlier version, kept an unusually low profile. The industry has been focused on fighting off any efforts to go after drug pricing, which President Donald Trump has said he would tackle. […]

The legislation would allow patients with serious diseases — anything from a late-stage cancer to multiple sclerosis — to request access to experimental drugs directly from drug companies without having to go through the FDA, which has its own compassionate use program that approves 99 percent of requests.

But the right-to-try bill doesn’t require drugmakers to make the experimental treatments available. In the 37 states that have similar laws on the books, Goldwater can point to only one doctor who says he has utilized a state right-to-try law for a patient — and that medicine was being made available to certain patients by the FDA anyway.

That’s led some critics to call it “right-to-ask” — and it may give desperately ill people false hopes. […]

And if the experimental drugs do become widely used outside the standard clinical trial system, it could undermine some of the rigorous science needed to know whether medicines are safe and effective. Many drugs that start the clinical trial process flop. Some are harmful.

“You have a situation where patients think they want to take a risk and don’t necessarily understand what risk they are taking,” said Diana Zuckerman, president of the National Center for Health Research, which lobbied against the bill.

And while the revised bill would require annual reports on whether the drugs used by these patients helped — or potentially harmed — them, patient safety experts are concerned it may not be enough. […]

 

Read the original article here.

A Shocking Diagnosis: Breast Implants “Gave Me Cancer”

Denise Grady, The New York Times: May 14, 2017

Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.

In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest.

“My whole world came crumbling down again,” said Ms. Hollrah, now 43, who owns an insurance agency in Hermann, Mo. “I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer. I thought, ‘I’m not going to see my kids grow up.’”

Her disease — breast implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer. If detected early, the lymphoma is often curable.

The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling. But the added warnings are deeply embedded in a dense list of complications, and no implants have been recalled. The F.D.A. advises women only “to follow their doctor’s recommended actions for monitoring their breast implants,” a spokeswoman said in an email this month.

 Until recently, many doctors had never heard of the disease, and little was known about the women who suddenly received the shocking diagnosis of cancer brought on by implants.

An F.D.A. update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the F.D.A.’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease.

Women who have had the lymphoma say that the attention is long overdue, that too few women have been informed of the risk and that those with symptoms often face delays and mistakes in diagnosis, and difficulties in receiving proper care. Some have become severely ill.

Implants have become increasingly popular. From 2000 to 2016, the number of breast augmentations in the United States rose 37 percent, and reconstructions after mastectomy rose 39 percent. Annually, nearly 400,000 women in the United States get breast implants, about 300,000 for cosmetic enlargement and about 100,000 for reconstruction after cancer, according to the American Society of Plastic Surgeons. Allergan and Mentor are the major manufacturers. Worldwide, an estimated 1.4 million women got implants in 2015.

As late as 2015, only about 30 percent of plastic surgeons were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston.

“I’d like to think that since then we’ve made progress on that,” Dr. Clemens said.

Late last year, an alliance of cancer centers, the National Comprehensive Cancer Network, issued treatment guidelines. Experts agree that the essential first step is to remove the implant and the entire capsule of scar tissue around it. Otherwise, the disease is likely to recur, and the prognosis to worsen.

Not all women have been able to get the recommended treatment. Kimra Rogers, 50, a nursing assistant in Caldwell, Idaho, learned last May that she had lymphoma, from textured implants she had for more than 10 years. But instead of removing the implants and capsules immediately, her doctor prescribed six rounds of chemotherapy and 25 rounds of radiation. A year later, she still has the implants.

“Unfortunately, my doctor didn’t know the first line of defense,” Ms. Rogers said.

She learned about the importance of having the implants removed only from other women in a Facebook group for those with the disease.

Her health insurer, Blue Cross Blue Shield of Montana, covered the chemotherapy and radiation but has refused to pay for removal of the implants, and told her that her appeal rights were “exhausted.” In a statement sent to The New York Times, a spokesman said, “Cosmetic breast implants are a contract exclusion, as are any services related to complications of the cosmetic breast implants, including implant removal and reconstruction.”

Physicians dispute that reasoning, saying the surgery is needed to treat cancer. Her lawyer, Graham Newman, from Columbia, S.C., said he was planning a lawsuit against the implant makers, and had about 20 other clients with breast-implant lymphoma from Australia, Canada, England and the United States.

Ms. Rogers has been unable to work for a year. If she has to pay to have the implants removed, it will mean taking out a $12,000 loan.

“But it’s worth my life,” she said.

Insurers generally cover implants after a mastectomy, but not for cosmetic enlargement, which costs $7,500 or more. Repeat operations for complications are also common, and usually cost more than the original surgery.

Diagnosis and Treatment

Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants.

Most implants in the United States are smooth. But for some, including those with teardrop shapes that would look odd if they rotated, texturing is preferable, because tissue can grow into the rough surface and help anchor the implant.

Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy.

What’s inside the implant — silicone or saline — seems to make no difference: Case numbers have been similar for the two types. The reason for the implants — cosmetic breast enlargement or reconstruction after a mastectomy — makes no difference, either.

Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit.

To make a diagnosis, doctors drain fluid from the breast and test it for a substance called CD30, which indicates lymphoma.

The disease is usually treatable and not often fatal. Removing the implant and the entire capsule of scar tissue around it often eliminates the lymphoma. But if the cancer has spread, women need chemotherapy and sometimes radiation.

“In the cases where we have seen bad outcomes, it was usually because they were not treated or there was a major delay in treatment, on the level of years,” Dr. Clemens said. Doctors at MD Anderson have treated 38 cases and have a laboratory dedicated to studying the disease.

About 85 percent of cases can be cured with surgery alone, he said. But he added that in the past, before doctors understood how well surgery worked, many women were given chemotherapy that they probably did not need.

Case reports on the F.D.A. website vary from sketchy to somewhat detailed and rarely include long-term follow-up. Some describe initial diagnoses that were apparently mistaken, including infection and other types of cancer. In some cases, symptoms lasted or recurred for years before the right diagnosis was made.

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted.

“It could also just be the immune system response to some component of the texturing,” Dr. Clemens said. The rough surface may be irritating or abrasive. Allergan implants seem to be associated with more cases than other types, possibly because they are more deeply textured and have more surface area for bacteria to stick to, he said. Allergan uses a “lost-salt” method that involves rolling an implant in salt to create texture and then washing the salt away. Other makers use a sponge to imprint texturing onto the implant surface.

Allergan is studying bacterial biofilms, and immune and inflammatory responses to breast implants, a spokesman said in an email. He said the company took the disease seriously and was working with professional societies to distribute educational materials about it.

Another possible cause is that some women have a genetic trait that somehow, in the presence of implants, predisposes them to lymphoma. Dr. Clemens said researchers were genetically sequencing 50 patients to look for mutations that might contribute to the disease.

Dr. Clemens was a paid consultant for Allergan from 2013 to 2015, but not for breast implants, and no longer consults for any company, he said.

A spokeswoman for Mentor said the company was monitoring reports about the lymphoma, and stood behind the safety of its implants.

[…]

Read the full article here.

What If Ryan Gets His Wish and Trumpcare Becomes Law

Shannon Firth, Washington Correspondent, MedPage Today: March 14, 2017

WASHINGTON — The Republican’s repeal and replace bill, American Health Care Act, cleared two congressional committees and the Congressional Budget Office released its scoring report, Speaker of the House Paul Ryan (R-Wisc) says passing the GOP plan is a make or break issue Congress.

So it is time to ask the pundits: what will happen if this bill becomes law?

MedPage Today asked policy experts on both sides of the great healthcare divide to answer that question and this is what they told us.

From the Pro Repeal and Replace Camp:

Douglas Holtz-Eakin, PhD, president of the American Action Forum touted the bill because it allows people to make their own choice. He predicts that eliminating the individual mandate will mean 5 million fewer uninsured in 2018.

“The bill basically says we respect your decision to not purchase insurance. There’s a public policy decision about how much we respect people’s decisions and clearly we know where the bill comes down on that,” he said. […]

And Now the Loyal Opposition:

Under the Affordable Care Act, the reason everyone pays for all of the various benefits was because doing so lowered costs, explained, Diana Zuckerman, PhD of the National Center for Health Research.

In the same way that car insurance lowers the cost of having an accident when everyone buys it, under this philosophy healthcare also protects everyone who buys it, Zuckerman said.

“Under [the AHCA] it’s a different view. It’s not that view of ‘We’re all in this together,’ and if we all share the cost, we’ll all get good insurance. Instead the view of this plan is every person for themselves. Everybody should get what seems best for them, even though that could result in 24 million not getting any insurance.” […]

Read the full article here.