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Dietary Supplements Before and During Chemotherapy

Meg Seymour, PhD, National Center for Health Research


Many Americans, including those with cancer, take dietary supplements. People take supplements because they believe it will help them stay healthy and give them vitamins and minerals they may not get from their diet. Chemotherapy patients often take supplements because their nausea makes it difficult to eat, and they want to be sure to get enough nutrients. 

People think of dietary supplements as a no-risk insurance policy to improve nutrition, but a study published in 2020 shows that supplements can have risks if you are undergoing chemotherapy. More than 1,000 breast cancer patients were asked whether or not they took any supplements either before or during their chemotherapy.[1] The researchers then continued to evaluate any subsequent cancer or death for up to 15 years (almost all of the women were followed for at least 5 years).

Results showed that patients who took vitamin B12 both before and during their chemotherapy were more likely to develop cancer again in the 5-15 years after treatment and were more likely to die as a result. They were also more likely to die from any cause, not just from cancer. This increase in subsequent cancer or death was only for people who took the supplements both before and during their chemotherapy. Patients who only took the supplements before chemotherapy or only took supplements during chemotherapy were not more likely to develop cancer again or to die from cancer or other causes in the years after treatment. Patients who took iron supplements both before and during chemotherapy were also more likely to develop cancer again after treatment or to die of cancer or any cause. However, the same was also true for people who only took iron supplements during their chemotherapy.  

Results showed that patients who took vitamin B12 before and during their chemotherapy were more likely to die or have their cancer return. They were also more likely to die from any cause, not just from cancer. This increase in cancer recurrence or death was only for people who took the B12 supplements both before and during their chemotherapy. Patients who only took the B12 supplements before chemotherapy or only took supplements during chemotherapy were not more likely to have a recurrence of their cancer or die. Patients who took Iron supplements both before and during chemotherapy were also more likely to have their cancer return or to die of any cause. However, the same was also true for people who only took Iron supplements during their chemotherapy.

The researchers also looked at antioxidant supplements, which include vitamins A, C, and E. They found that patients taking these supplements both before and during chemotherapy had a 41% higher chance of cancer returning after treatment. However, this finding was not “statistically significant,” which means that more research is needed to determine whether these worse outcomes occurred by chance. The 44% of the patients in the study who were taking multivitamins did not have better or worse outcomes than people who were not taking them. 

This is what scientists call an observational study rather than a clinical trial. In a clinical trial, some patients would be randomly assigned to take supplements and others would be assigned to take a placebo (with no active ingredients). In an observational study, people make their own decisions about what treatment (in this case supplements) to take. Those who chose to take supplements might have different health issues or health habits than those who did not. For example, it is possible that the people who were more likely to take supplements both before and during their chemotherapy were less healthy to begin with. For example, they could have been taking B12 or Iron supplements because they had anemia, and anemia may have increased the possibility of cancer recurrence or death. Also, because patients were asked whether or not they took supplements (instead of being given the supplements by researchers), it is impossible to know whether what patients said about supplements was completely accurate. For example, some patients could have said that they were regularly taking a supplement, but really they only took it occasionally.   

Dr. Christine Ambrosone, the lead researcher of the study, said in an interview that this is only one observational study, and doctors should not necessarily base their recommendations on this single study. Doctors need to consider the specific needs of each patient. For example, someone with anemia might need a dietary supplement, and the benefits of those supplements might outweigh the potential risks. 

If you are considering taking a dietary supplement, it is important to keep in mind that the Food and Drug Administration does not regulate dietary supplements for purity and quality. There is no guarantee that a supplement will work or even that it contains exactly what the bottle says it contains.[2] It is always important to talk with your doctor to help you decide if the benefits of any dietary supplement you are considering outweigh the potential risks. 

 

  1. Ambrosone, C. B., Zirpoli, G. R., Hutson, A. D., McCann, W. E., McCann, S. E., Barlow, W. E., … & Unger, J. M. (2019). Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221). Journal of Clinical Oncology, JCO-19.
  2. Brooks, J, Mitchell, J., Nagelin-Anderson, E. , & Zuckerman, D. National Center for Health Research. How Safe are Natural Supplements? Center4research.org. http://www.center4research.org/examining-safety-natural-supplements/. 2019.

What People With Cancer Need to Know about Coronavirus (COVID-19)

Cancer Prevention and Treatment Fund: April 1, 2020


The coronavirus can infect anyone, young or old, healthy or frail. People with cancer and other serious health conditions, and their loved ones, need to be especially careful. Here’s what you need to know.

Some cancer treatments, such as chemotherapy, targeted therapies, immunotherapy, and radiation, can weaken the immune system and possibly cause lung problems. People who have weakened immune systems or lung problems are more likely to have serious symptoms if they become infected with this virus. Anyone with cancer in the lungs (whether lung cancer or cancer that has spread to the lungs) is especially at risk if they develop COVID-19.

If you had scheduled surgery, screening, or other procedures that were considered not urgent or not immediately life-threatening, those might have been postponed. This is for everyone’s protection. Many hospital staff,  including doctors, nurses, receptionists, and cleaning staff, have been exposed to the virus and don’t know whether they can infect others.  If you are battling cancer or doing follow-up after successful treatment, you don’t want to be exposed to the coronavirus when you go in for surgery or testing procedures.  And, you don’t want your medical center to be less able to fight the coronavirus at a time when it is spreading throughout your community.

The coronavirus is spreading in all 50 states, in urban, suburban, and rural areas, so it is important to listen to health experts (and governors or mayors) who tell you to stay home, limit contact with others, and keep a distance of 6 feet away when you or your family members or caregivers go grocery shopping or other essential activities.

What is coronavirus?

Coronaviruses are a large group of viruses that can cause respiratory illness. The new (novel) coronavirus is called SARS-CoV-2 and the illness it causes is called coronavirus disease 2019, which is why it’s abbreviated as COVID-19.  Since it is new, nobody has immunity from it.

How does COVID-19 spread between people?

The virus usually spreads through close contact with other people, especially through droplets when a person coughs or sneezes – or even when they breathe normally. These droplets can travel through the air and can be inhaled or get into the noses, mouths, or eyes of people nearby.

It is most contagious when the person has symptoms, but it is possible to catch the virus from infected people who have no symptoms at all. In addition, these droplets (as well as fecal matter containing the virus) can end up on surfaces where it can survive for hours or even days. When you touch these surfaces and then touch your face, you can be exposed to the virus. That’s why it’s important to wash your hands regularly.  If you don’t have antiseptic wipes, you can wipe down surfaces in your bathroom, kitchen, and other rooms with bleach of rubbing alcohol to help prevent exposure.  However, most of the time the virus is spreading through close contact with people who have it.

What about food or food packaging?  The risk of catching the virus from packaging is very low, but since the virus can survive for up to 24 hours on cardboard and up to 3 days on plastic and stainless steel, it’s a good idea to wash your hands for at least 20 seconds after handling mail, takeout containers, and packaging from groceries. You can also disinfect food packages using a cleaning product that kills viruses, but don’t use disinfectants on food.

What are the symptoms of COVID-19?

Symptoms tend to start between 2 and 14 days after coming into contact with the virus.  Although some people have compared the symptoms to a cold or flu, there are some differences.

The most common symptoms are:

  • Fever (this can come and go)
  • dry cough
  • tiredness

Other symptoms include:

  • shortness of breath
  • aches and pains
  • sore throat
  • trouble breathing
  • chest pain or pressure
  • pink eye (conjunctivitis)
  • loss of sense of smell (and sense of taste)

These symptoms are less common but can be signs of COVID-19:

  • runny nose
  • diarrhea
  • nausea or vomiting
  • abdominal discomfort

Most people who are infected with this coronavirus have mild symptoms and can recover at home in about 2 weeks. However, symptoms can become severe.  These are the ones that require immediate medical attention:

  • difficulty breathing or shortness of breath
  • persistent chest pain or pressure
  • confusion or inability to awaken
  • blueish color in the lips or face

People who are older than 60, and people who have existing serious health conditions, such as heart disease, lung disease, and diabetes, are more likely to develop severe illness and complications from COVID-19. This includes people who are receiving cancer treatments that can weaken the immune system.  The most serious complications include pneumonia, organ failure, and death.

How can I protect myself and others?

The best way for anyone to protect themselves is to avoid being exposed to it. There are no proven medications or vaccines, so don’t be fooled by false claims (especially those made by telemarketers).

“Social distancing” or “physical distancing” refers to staying away from other people because it is impossible to know who has the virus.  The safest people in your life are the ones you are living with who are not exposed to others who might have the virus (in other words, they are not going to work or spending time close to other people). Staying at home and not seeing your loved ones is not fun, but it is essential for your own safety and for everyone else’s.  If everyone does that now, the spread of this virus will be reduced sooner, and some of these restrictions will no longer be necessary in a few weeks.

  • stay at home
  • avoid public spaces
  • avoid public transportation and unnecessary travel
  • avoid social gatherings
  • work from home
  • stay at least 6 feet away from people when out in public
  • avoid physical contact in social situations, such as shaking hands, hugging or kissing

AND

  • wash your hands using soap and water for at least 20 seconds, especially after being out in public
  • use alcohol-based hand sanitizer when soap and water aren’t available (or wash your hands as soon as you get home)
  • avoid touching your face when your hands aren’t clean or you are out in public
  • avoid contact with people you don’t know very well
  • clean and disinfect surfaces you touch daily, including things you might not think of like doorknobs, light switches, faucet handles, and phones. Make sure you use a cleaning agent that is effective for killing viruses.

What about a face mask?  Experts say that you only need to wear a face mask if you have the virus, to avoid infecting other people you must come in contact with.  It is not clear that it protects you unless you are in close contact with someone with the virus.  If you want to be extra cautious, since the masks that doctors and nurses use are in short supply, you can use homemade masks or scarves to cover your face when you are out in public.  But you should NOT be out in public except when absolutely essential.

If you are undergoing cancer treatment that can weaken your immune system or cause lung problems, here are extra steps to protect yourself:

  • Make a plan with your doctor to monitor for symptoms
  • Avoid friends and family except those you live with or depend on for essentials.  Otherwise, rely on your phone to maintain contact.
  • Have a plan with your loved ones or caregiver if you or they get sick
  • Have the medications you rely on and order any you need in advance (to be delivered, if possible)
  • Ask a friend or family member to shop for groceries for you
  • Wash your hands (20 seconds with soap and water) even more often if you are exposed to others

What should I do if I develop symptoms?

If you develop a fever, cough, or shortness of breath, call your doctor. If you are currently receiving chemo, a fever is a medical emergency.  Other severe symptoms, such as difficulty breathing, persistent chest pain or pressure, confusion or inability to awaken, or blueish color in the lips or face, means you need to call 911. Tell the 911 operator that you think you have COVID-19 so the responders can take the necessary precautions to protect themselves.

People who experience mild symptoms can usually stay home and will recover in about 2 weeks. But, if you are receiving treatment for cancer, be sure to tell your doctor.  Do not just show up at the doctor’s office with symptoms:  Call them first so you have tell them about your symptoms and they can help decide what to do.  If you do become sick, you can take the following steps to protect others:

  • Stay home, unless you need essential medical care
  • Wear a facemask when you are near others.  (People caring for you should also wear a facemask).
  • Stay away from others in your home as much as possible
  • Cover your mouth and nose when you cough or sneeze, properly dispose of tissues, and wash your hands
  • Monitor your symptoms and temperature

If you were not tested for COVID-19, you should follow those steps until at least one week has passed since you first noticed symptoms or your fever goes away for 3 full days without fever-reducing medicine.  If you have been diagnosed with COVID-19 based on test results, you should follow these steps until you have 2 negative test results taken 24-hours apart, your fever goes away without fever-reducing medicine, and your symptoms improve.

What if my cancer treatment is delayed?

When a person is diagnosed with cancer, they are likely to want treatment as soon as possible.  Treatment or testing may seem more urgent than it really is, especially with cancers that often grow slowly, such as prostate cancer or breast cancer. And, if you don’t have COVID-19, you don’t want to be exposed to it during cancer surgery, testing, or follow-up appointments.  Talk to your doctor about what is the best strategy to get the treatment you need when it is safe to do so.

Questions?

We are here to help by answering your questions.  We do not provide medical care.  If you have questions contact info@stopcancerfund.org and we’ll get back to you as soon as possible.

‘Bad advice from the president’: Trump touts unproven coronavirus drugs

Sarah Owermohle, Politico: March 20, 2020.


President Donald Trump said he will “slash red tape like nobody has even done it before” in a bid to get unapproved coronavirus treatments to patients faster and identify effective drugs.

The president said Thursday he directed the Food and Drug Administration to “eliminate out-of-date rules and bureaucracy so this can go forward fast” — but he did not offer any details. Instead, Trump and top health officials highlighted steps the government has taken in recent weeks to launch clinical trials of potential coronavirus treatments.

Trump’s remarks came one day after he teased that an “exciting FDA announcement” was on the way — news that reportedly caught some in the health agency by surprise as they scrambled to finalize details, said three HHS officials.

Food and Drug Administration Commissioner Stephen Hahn appeared to downplay the president’s optimism about speeding up access to three drugs in particular. “What’s important is not to provide falsehood but provide hope,” Hahn said.

“We need to make sure the sea of new treatments will get the right drug to the right patients, at the right dosage, at the right time,” he added. “That’s why it is important we have our professionals looking at these therapeutics in development.”

Trump suggested certainprograms that the administration could use to get experimental drugs to people quickly outside of clinical trials. One such route, known as “Right to Try,” was established by a 2018 law that Trump and Vice President Mike Pence supported to help people who are seriously ill and have no other treatment options.

“What we’re talking about today is beyond Right to Try,” Trump said, adding that the law “has been a tremendous success.”

But outside researchers were quick to sound the alarm.

“Wow, that is bad advice from President Trump,” said Diana Zuckerman, a drug safety expert at the National Center for Health Research. “Lives can be saved if red tape is cut in terms of making tests, respirators, and hospital beds more available. Making untested antivirals available is not a good strategy.”

The Right to Try program allows patients to appeal directly to drugmakers to use medicines that are still being developed and tested. Bioethicists and drug policy experts argue there are other ways to help people access experimental medicine — like the FDA’s compassionate use route, also name checked by the president — and that Right to Try fuels false hope, while making it difficult to collect data on how well the drugs work.

[…]

Read the full the article here

Do Vitamin D Supplements Prevent Cancer and Heart Disease? What the Research Says

Meg Seymour, PhD


Approximately 40% of Americans are low in vitamin D.[1] Low vitamin D has been linked to a number of health problems, including cancer, heart disease, and heart attack.[2, 3] 

Sunshine on your skin (without sunscreen) is a great way to get vitamin D (15 minutes between 10 a.m. and 3 p.m is key)[4], but many Americans don’t get that much sun, especially during colder months. Popular foods that provide vitamin D include fish and fortified milks or cereals.[5]  Scientists have studied whether taking vitamin D supplements could decrease the risk of developing health problems for people who do not get enough vitamin D from these natural sources. 

Do Vitamin D Supplements Help Prevent Cancer?

Researchers have conducted several long-term clinical trials to determine whether vitamin D supplements can decrease the risk of developing cancer. Randomized, controlled clinical trials are the “gold standard” of research. In these trials, some participants were assigned to take vitamin D supplements, and others were assigned to take a placebo (sugar pill). Then, the researchers measured whether or not the people given the supplements were less likely to develop cancer over time. 

A 2018 study found that vitamin D supplements did not prevent cancer. Researchers assigned 5,000 people, ages 50-84, to either take 100,000 IU of vitamin D or placebo once a month for 3 years. After 3 years, they found that monthly supplements of high doses of vitamin D did not decrease the percentage of people developing cancer.[6] An even larger study from 2019, of almost 26,000 patients over the age of 50, also found no benefit. The researchers assigned participants to take either 2000 IU of vitamin D or a placebo every day for over 5 years. People taking vitamin D every day were just as likely to develop cancer as the people taking the placebo.[7] 

A meta-analysis published in 2019 also looked at the impact of vitamin D supplements on cancer. A meta-analysis is a type of combination study that combines the results of many smaller studies. The study found that although vitamin D supplements did not prevent cancer, people who took daily vitamin D supplements were less likely to die from cancer.[8] The researchers suggested that even though vitamin D supplements do not prevent cancer, perhaps they affect the way that tumors grow. However, a bigger meta-analysis (combining more than 30 studies totaling 18,000 participants) found no difference in deaths from cancer for those who did or did not take the supplements.[9] The two meta-analyses had different methods and looked at different studies, so further research is needed in order to determine whether or not vitamin D supplements actually can prevent deaths from cancer. 

Most people taking vitamin D are taking it combined with calcium. For that reason, it is important to look at research that examines the effect of taking them both. A 2017 study looked at more than 2,300 women ages 55 and up. Half were assigned to take 2,000 IU of vitamin D and 1,500 mg of calcium per day, and the other half were assigned to take a placebo every day. The researchers followed them for 4 years and found no difference between the two groups in the chances of getting cancer.[10]

Why is it that people with low vitamin D are more likely to develop cancer, but vitamin D supplements do not prevent cancer? One possibility is that people low on vitamin D might be different from people with enough vitamin D in ways that are related to an increased risk of cancer. For example, people might be low in vitamin D because they do not go outside and exercise regularly, and people who exercise regularly are less likely to develop cancer [11]. Obese people are more likely to develop cancer, and obese people tend to have lower levels of vitamin D.[12]

Are Vitamin D Supplements Good for Your Heart?

People who do not have enough vitamin D are more likely to develop heart disease and have heart attacks.[13,14] Researchers have conducted clinical trials to find out if vitamin D supplements can help prevent heart disease. The same large study from 2019 that measured vitamin D supplements and cancer also looked at whether or not people taking the supplements had fewer heart attacks. The study found no benefit: there was no difference in the number of heart attacks between those taking vitamin D and those taking placebos.[7] 

Since people taking vitamin D supplements often take calcium supplements as well, researchers want to understand if taking both of these supplements affects heart health. The results of these studies are not consistent, with some showing an increase in strokes,[15] and others finding no impact on heart health.[13] More clinical trials on the combination of vitamin D and calcium are needed to draw any conclusions about whether these supplements are helpful or harmful to heart health. 

Potential Risks of Supplements 

Some older research found that taking a combination of vitamin D and calcium increased the risk of kidney stones.[16] However, more recent research has found that there is no increased risk of kidney stones in people taking the combination of vitamin D and calcium.[10] A large clinical study conducted in 2019 found that taking vitamin D supplements alone did not increase the chances of developing kidney stones, upset stomach, or hypercalcemia (too much calcium in the blood).[7] 

The Bottom Line

There is not enough evidence to conclude whether taking vitamin D prevents cancer or heart problems. The United States Preventive Services Task Force, a federally funded group that analyzes scientific research, has concluded that there is not enough evidence to say that the benefits of taking supplements, including vitamin D and calcium, to try to prevent heart disease and cancer outweigh the risks.[17]

If you are worried that you are not getting enough vitamin D, talk with your doctor about getting your vitamin D levels tested. If you choose to take a supplement, be sure to talk with your doctor about the amount of vitamin D you are taking. Unless you have a medical need and your doctor recommends it, it is not recommended to take more than 4,000 IU of vitamin D per day. It is better to try to get your vitamins from food or the sun.[18] The Food and Drug Administration requires that food packaging in the United States say what percentage of your daily vitamin D needs are included in a serving of packaged food. Read the labels on your food if you are concerned about getting enough vitamin D in your diet. For more information about vitamin D, what it does for the body, and getting vitamin D from food and the sun, click here

 

  1. Forrest, K. Y., & Stuhldreher, W. L. (2011). Prevalence and correlates of vitamin D deficiency in US adults. Nutrition Research, 31(1), 48-54.
  2. Hossain, S., Beydoun, M. A., Beydoun, H. A., Chen, X., Zonderman, A. B., & Wood, R. J. (2019). Vitamin D and breast cancer: A systematic review and meta-analysis of observational studies. Clinical Nutrition ESPEN, 30, 170-184.
  3. Garland, C. F., Garland, F. C., Gorham, E. D., Lipkin, M., Newmark, H., Mohr, S. B., & Holick, M. F. (2006). The role of vitamin D in cancer prevention. American Journal of Public Health, 96(2), 252-261. 
  4. U.S. News and World Report. How Much Time in the Sun Do You Need for Vitamin D? Health.usnews.com. Updated July 2018.  https://health.usnews.com/wellness/articles/2018-07-18/how-much-time-in-the-sun-do-you-need-for-vitamin-d
  5. Dietary Guidelines 2015-2020. Vitamin D: Food Sources Ranked by Amounts of Vitamin D and Energy per Standard Food Portions and per 100 Grams of Foods. Health.gov https://health.gov/our-work/food-nutrition/2015-2020-dietary-guidelines/guidelines/appendix-12/
  6. Scragg, R., Khaw, K. T., Toop, L., Sluyter, J., Lawes, C. M., Waayer, D., … & Camargo, C. A. (2018). Monthly high-dose vitamin D supplementation and cancer risk: a post hoc analysis of the vitamin D assessment randomized clinical trial. JAMA Oncology, 4(11), e182178-e182178.
  7. Manson, J. E., Cook, N. R., Lee, I. M., Christen, W., Bassuk, S. S., Mora, S., … & Friedenberg, G. (2019). Vitamin D supplements and prevention of cancer and cardiovascular disease. New England Journal of Medicine, 380(1), 33-44.
  8. Keum, N., Lee, D. H., Greenwood, D. C., Manson, J. E., & Giovannucci, E. (2019). Vitamin D supplementation and total cancer incidence and mortality: a meta-analysis of randomized controlled trials. Annals of Oncology, 30(5), 733-743.
  9. Goulão, B., Stewart, F., Ford, J. A., MacLennan, G., & Avenell, A. (2018). Cancer and vitamin D supplementation: a systematic review and meta-analysis. The American Journal of Clinical Nutrition, 107(4), 652-663.
  10. Lappe, J., Watson, P., Travers-Gustafson, D., Recker, R., Garland, C., Gorham, E., … & McDonnell, S. L. (2017). Effect of vitamin D and calcium supplementation on cancer incidence in older women: a randomized clinical trial. JAMA, 317(12), 1234-1243.
  11. Willer, A. (2005). Cancer risk reduction by physical exercise. World Review of Nutrition and Dietetics, 94(R), 176.
  12. Nair, R., & Maseeh, A. (2012). Vitamin D: The “sunshine” vitamin. Journal of Pharmacology & Pharmacotherapeutics, 3(2), 118.
  13. Chin, K., Appel, L. J., & Michos, E. D. (2017). Vitamin D, calcium, and cardiovascular disease: a “D” vantageous or “D” etrimental? An era of uncertainty. Current Atherosclerosis Reports, 19(1), 5.
  14. Vanga, S. R., Good, M., Howard, P. A., & Vacek, J. L. (2010). Role of vitamin D in cardiovascular health. The American Journal of Cardiology, 106(6), 798-805.
  15. Khan, S. U., Khan, M. U., Riaz, H., Valavoor, S., Zhao, D., Vaughan, L., … & Murad, M. H. (2019). Effects of nutritional supplements and dietary interventions on cardiovascular outcomes: an umbrella review and evidence map. Annals of Internal Medicine, 171(3), 190-198.
  16. Jackson, R. D., LaCroix, A. Z., Gass, M., Wallace, R. B., Robbins, J., Lewis, C. E., … & Bonds, D. E. (2006). Calcium plus vitamin D supplementation and the risk of fractures. New England Journal of Medicine, 354(7), 669-683.
  17. Moyer, V. A. (2014). Vitamin, mineral, and multivitamin supplements for the primary prevention of cardiovascular disease and cancer: US Preventive Services Task Force recommendation statement. Annals of Internal Medicine, 160(8), 558-564.
  18. Harvard Health Publishing. Harvard Medical School. Taking too much vitamin D can cloud its benefits and create health risks. health.harvard.edu. https://www.health.harvard.edu/staying-healthy/taking-too-much-vitamin-d-can-cloud-its-benefits-and-create-health-risks. Published November 2017. Updated December 2019. 

 

Celebrities Are Getting Coronavirus Tests Faster Than Everyone Else

Shira Feder and Julia Naftulin, Insider: March 13, 2020


When news broke that Tom Hanks and his wife Rita Wilson had become the first celebrities diagnosed with the coronavirus, it was a moment that struck fans — particularly in countries that have yet to feel the brunt of the virus — just how far and fast it is spreading.

But amid the praise for how Hanks and Wilson are handling the situation, many people have also called into question how quickly the couple were tested and diagnosed, while most of the general public in the US and many European countries struggle to even find out where to get a test.

[…]

It was a dramatic moment when medical officials raced onto the Chesapeake Energy Arena basketball court in Oklahoma City on Wednesday night to prematurely shut down the game the Jazz and Oklahoma City Thunder teams were playing. They’d received a tip that Rudy Gobert, a basketball player for Utah Jazz, had tested positive for the new coronavirus.

Up until that point, testing had been sluggish. On Tuesday, 2,728 people were tested across the US — just over 50 people for each state. On Wednesday night, 58 tests were performed on athletes and team staff.

That day, the same day the World Health Organisation declared COVID-19 a pandemic, new stats emerged showing the US had done a total of five tests for every one million people, compared to with almost 4,000 tests per million people in South Korea.

“Other countries are testing much more broadly than we are,” William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine, previously told Business Insider. “We are trotting along while they’re racing along.”

The only other people who were tested nearly as quickly appeared to be political officials, like Ted Cruz, Paul Gosar, and Matt Gaetz, who were exposed at conservative conference CPAC.

According to Diana Zuckerman, the president of the National Center for Health Research in Washington, DC, it makes sense that high-profile celebrities and athletes have more access to COVID-19 testing than the general public.

“I think there’s a lot of benefit for a physician to have celebrity patients, and that means that those physicians are going to do their very best to please their patients in ways that they might not work quite so hard for in a non-celebrity patient,” Zuckerman told Insider. “When something is available but limited, and there’s limited access but it exists, people with more fame are and more money are more likely to get it.”

America is lagging behind every other country when it comes to coronavirus testing

Without testing widely, it is impossible for public health officials to measure exactly how dangerous this outbreak is. As of Friday, CDC criteria states that anyone who had close contact with a confirmed COVID-19 patient within the past 14 days should get tested, as should people who traveled from a high-risk area within the past 14 days.

But many people who may have coronavirus do not fit this criteria.

The US has fallen far behind other countries when it comes to testing, plagued by delays, errors, and limited testing supplies. Finally, on Thursday, the FDA approved Roche’s test to be rolled out free. There are now also testing drive-thrus in Colorado and California. To speed things up, private labs like Quest Diagnostics have begun offering their own coronavirus tests for people with the money or insurance to pay for it.

“We’re certainly in a situation where there’s such a limit to the number of tests available. We hope the situation will change soon, but currently it’s a big problem,” Zuckerman said.

Regardless, she hopes there will be less favorable treatment.

“It’s a little bit hard to make the case that celebrities deserve to be tested before people who actually have symptoms,” said Zuckerman. “It isn’t just the celebrities, it’s also the people taking the subway to work.” 

There’s another problem: tests are free for Americans, but ambulances and treatment are not

Those that have sought treatment for the coronavirus have faced another conundrum: some have gotten stuck with hefty bills.

The Miami Herald reported that one man was charged $3,270 for a test at the hospital. The New York Times reported that one man left a mandatory quarantine and received a bill for thousands. Another uninsured person was issued a $1,295 bill out-of-pocket.

“Anybody that wants a test can get a test,” Trump announced to reporters on March 6. But testing supplies are limited and to-test-or-not-to-test is a decision that has been left up to individual clinicians and healthcare provider’s judgments.

Trump also announced that insurers will pay for coronavirus treatments. The next day vice president Mike Pence clarified that insurers have waived copays for the coronavirus tests — not the coronavirus treatment, which may require respirators and hospital stays and can quickly get expensive.

Read the full article here

CPTF Statement Supporting Maryland House Bill to Ban State Funds for Artificial Turf and Playgrounds

Diana Zuckerman, PhD, National Center for Health Research, March 5, 2020


CPTF Statement Supporting Maryland House Bill 1098
To Ban State Funds for Artificial Turf and Playgrounds
March 5, 2020

Diana Zuckerman, PhD, President

Thank you for the opportunity to express our strong support for of HB 1098, to restrict the funding of additional artificial turf fields and playground surfaces in Maryland.

As a long-time resident of Montgomery County and president of the National Center for Health Research (NCHR), I am hoping that this bill will finally get the support it deserves.  NCHR is a non-profit public health organization which analyzes and explains scientific and medical information that can be used to improve policies, programs, services, and products.

Our organization has been testifying and writing about the dangers of synthetic turf and playground surfaces for several years, and we’ve testified before state, local and federal legislative bodies and regulatory agencies.  Our scientific staff has reviewed all publicly available scientific studies pertaining to the health impact of the lead and toxic chemicals that are in artificial turf and playground surfaces, compared to natural surfaces such as grass and engineered wood fiber.

In the last year, scientists have reported finding potentially dangerous levels of lead in artificial turf fields and playground surfaces.  In addition, plastic and synthetic rubber are made with different types of hormone-disrupting chemicals, some of which are known to be particularly harmful to growing children.  Scientists at the National Institute of Environmental Health Sciences, which is an institute of NIH, have concluded that these chemicals can be threats to health even at low levels.  According to research at Yale University, 20% of the 96 chemicals they found in samples at five different synthetic turf companies were classified as probable carcinogens.[1]

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

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

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

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products.  Despite claims to the contrary, none have demonstrated that artificial turf is safe.  Although the Trump Administration’s EPA stated that there was no conclusive evidence that the levels of chemicals in artificial turf was harmful to children, they made it clear that their research was based on assumptions rather than scientific research on children.

Lead

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

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

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals (also called EDCs) and other toxins.  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).

The California OEHHA conducted three laboratory studies to investigate the potential health risks to children from playground surfaces made from tire waste.1 The researchers created a chemical solution that mimicked the conditions of a child’s stomach and placed 10 grams of tire shreds in it for 21 hours at a temperature of 37°C.  One study mimicked a child touching the tire shreds and then touching her mouth by wiping recycled tire playground surfaces and measuring chemical levels on the wipes.  To evaluate skin contact alone, the researchers tested guinea pigs to see if rubber tire playground samples caused any health problems.  Results of the OEHHA studies showed that five chemicals, including four PAHs, were found on wipe samples.  One of the PAHs, “chrysene,” was higher than the risk level established by the OEHHA, and therefore, could possibly increase the chances of a child developing cancer.

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

There are numerous studies indicating that endocrine-disrupting chemicals found in rubber and plastic cause serious health problems. Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, hormone-disrupting chemicals can be dangerous at very low levels, and the exposures can also be dangerous when they combine with other exposures in our environment.

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

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

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

Scientific Evidence of Cancer and Other Serious Harm

It is essential to distinguish between evidence of harm and evidence of safety. Like the Trump Administration’s EPA, companies that sell and install artificial turf often claim there is “no evidence children are harmed” or “no evidence that the fields cause cancer.” This is often misunderstood as meaning the products are safe or are proven to not cause harm. Neither is true.

It is true that there no clear evidence that an artificial turf field has caused specific children to develop cancer. However, the statement is misleading because it is virtually impossible to prove any chemical exposure causes one specific individual to develop cancer.

As an epidemiologist, I can also tell you that for decades there was no evidence that smoking or Agent Orange caused cancer.  It took many years to develop that evidence, and the same will be true for artificial turf.

I have testified about the risks of these materials at the U.S. Consumer Product Safety Commission, as well as previous Maryland hearings.  I am sorry to say that I have repeatedly seen and heard scientists paid by the turf industry and other turf industry lobbyists say things that are absolutely false.  They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true).

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

Dangerously Hot and Hard Fields

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

Artificial turf fields get hard as well.  Turf companies recommend annual tests at 10 locations on each turf field, using something called a Gmax scores.  A Gmax score over 200 is considered extremely dangerous and is considered by industry to pose a death risk.  However, the synthetic turf industry and ASTM (American Society for Testing and Materials), suggest scores should be even lower — below 165 to ensure safety comparable to a grass field.  Are Maryland communities paying to have these tests conducted on all public artificial turf fields?

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

Environmental Issues

In addition to the health risks to school children and athletes, approximately three tons of infill materials migrate off of each synthetic turf field into the greater environment each year.  About 2-5 metric tons of infill must be replaced every year for each field, meaning that tons of the infill have migrated off the field into grass, water, and our homes.  The fields also continuously shed microplastics as the plastic blades break down.[4,5] 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.[6,7,8]

Synthetic surfaces also create heat islands.[9,10]  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.[11]

Envirofill and Alternative Infills

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

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

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

Conclusions

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

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

I am not paid to write this statement.  I am one of the many parents and scientists who are very concerned about the impact of artificial fields on our children.  Your decisions about artificial turf and playground materials will directly and indirectly help educate parents throughout the state, making it even more important that your decision is based on scientific evidence, not on sales pitches by individuals with conflicts of interest.

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

Please pass HB 1098 and thank you for addressing this critical public health issue.

 

References

  1. State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007. http://www.calrecycle.ca.gov/publications/Documents/Tires%5C62206013.pdf
  2. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water, Air, & Soil Pollution. 2018;229:64. https://doi.org/10.1007/s11270-018-3711-7
  3. Anderson SE and Meade BJ. Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals. Environmental Health Insights. 2014; 8(Suppl 1):51–62. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/
  4. 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
  5. Kole PJ, Löhr AJ, Van Belleghem FGAJ, Ragas AMJ. Wear and tear of tyres: A stealthy source of microplastics in the environment. International Journal of Environmental Research Public Health. 2017;14(10):pii: E1265. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
  6. 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/
  7. Oehlmann J, Schulte-Oehlmann U, Kloas W et al.  A critical analysis of the biological impacts of plasticizers on wildlife. Philosophical Transactions of the Royal Society B. 2009;364:2047–2062. http://rstb.royalsocietypublishing.org/content/364/1526/2047
  8. Thompson RC, Moore CJ, vom Saal FS, Swan SH. Plastics, the environment and human health: Current consensus and future trends. Philosophical Transactions of the Royal Society B. 2009;364:2153–2166. https://royalsocietypublishing.org/doi/full/10.1098/rstb.2009.0053
  9. 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
  10. 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
  11. 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

CPTF’s Comments on Cyramza for Metastatic Lung Cancer at FDA Oncologic Drugs Advisory Committee Meeting

Cancer Prevention and Treatment Fund: February 26, 2020


Cancer Prevention and Treatment Fund’s Public Comments on Cyramza for Metastatic Lung Cancer at FDA Oncologic Drugs Advisory Committee Meeting

Thank you for the opportunity to share our views today. The Cancer Prevention and Treatment Fund understands the need for effective new treatments for metastatic lung cancer. However, the data provided by the sponsor does not provide evidence that Cyramza improves survival, and it may worsen quality of life.

Although there are not yet enough long-term data to determine how Cyramza affects patients’ survival, the data that are available are not promising. Survival rates are almost identical with the drug or placebo (HR 0.92). It is important to note that the survival rates were never significantly different, but the difference was smaller as longer-term data were analyzed. We agree with the FDA that based on the confidence intervals, the drug could potentially worsen survival by about 30% — or could possibly improve survival by 30%. That risk of shortening overall survival is especially important because of the other risks of the treatment.

Let’s look at the number of deaths that occurred within 30 days of treatment in the RELAY trial. Of the 221 patients taking Cyramza, 6 died from adverse events, compared to none in the placebo arm. FDA specified that one of these was caused by drug treatment, while a second may have been caused by the drug. Although the FDA agrees with Lilly’s assessment that the other deaths are not caused by the drug or drug combination, those data aren’t made available so we can’t draw conclusions. But even if it is only 2 deaths, that’s almost 1% of the patients – not an irrelevant number! Since this shows that Cyramza can be fatal for these patients, and there is no currently no evidence that it significantly increases overall survival on average for lung cancer patients, the FDA expressed a great deal of concern about this indication. If Cyramza benefits any specific types of patients in terms of overall survival, there is no evidence of who those patients are likely to be.

Patients treated with Cyramza had a 7 month improvement in progression-free survival. This may be meaningful to patients if it is also associated with an improvement in quality of life. However, the data from the RELAY trial do not support this.  The sponsor spins these results to conclude that the quality of life of life is not worse in patients taking Cyramza, but in fact, patients in the placebo group had fewer symptoms, such as shortness of breath, pain, and daily activity level, as measured by the Lung Cancer Symptom Scale. Our Center has worked with many seriously ill patients over the years, and we’ve found that
patients care about two outcomes: 1) will they live longer and 2) what will their quality of life be in the days, weeks, months, or years they have left. The only patients that care about progression free survival are the ones that don’t understand what it means. When patients are told a drug is promising based on progression free survival, it is confusing and frankly misleading to most patients. They think it means they will live longer.

The results of the research are also worrisome regarding the FDA’s measures of specific adverse events. 72% of patients treated with Cyramza experienced a grade 3 or higher adverse events compared to only 54% of patients treated with placebo.

  • 29% of patients treated with Cyramza experienced a serious adverse event compared to 21% of placebo-treated patients.
  • Bleeding and hemorrhage occurred twice as often in patients treated with Cyramza,
    compared with placebo.
  • Grade 3 hypertension was roughly 5x more common among those treated with Cyramza compared with placebo. Overall hypertension was roughly 4x as prevalent among the Cyramza group.  I disagree with the sponsor’s assertion that hypertension is no big deal. In fact, heart disease is the #1 killer of men and women in the U.S. and hypertension is called “the silent killer.” Yes, there are medications for it, but they also have side effects that can be debilitating.

Overall, the study’s results suggest that when Cyramza is combined with erlotinib and compared with placebo plus erlotinib, the potential benefits of Cyramza do not outweigh the known risks. Given the data provided, there is no justification for rushing to approve this particular treatment.

We respectfully request that you advise FDA to not approve this indication for Cyramza without evidence that it improves overall survival enough to outweigh the risk for adverse events and reduced quality of life.

After FDA’s Cancer Director Dr. Richard Pazdur instructed the Advisory Committee at length that progression free survival was acceptable evidence for approval even if there was no evidence of overall survival, and even if more effective treatments were already available, the Advisory Committee voted 6 in favor of approval and 5 opposed.

The Cancer Prevention and Treatment Fund can be reached at info@stopcancerfund.org or at (202) 223-4000.

Drugs to Quit Smoking Can Affect Mental and Physical Health: the Truth About Chantix and Zyban


Everyone knows that smoking harms health and that the habit is difficult to quit. Unfortunately, some products that help people stop smoking can also be harmful – perhaps too harmful to consider using.

In June 2011, the U.S. Food and Drug Administration (FDA) announced new concerns about the safety of Chantix. Their announcement came in the months after two reports by independent researchers that there were more reports of deaths and violence from taking Chantix than any other drug.[1]

These reports added to concerns about two stop-smoking drugs, Chantix and Zyban. In July 2009, the FDA had already announced “black box” warning labels on both drugs. A “black box” warning is the FDA’s most serious caution and indicates that a drug carries significant health risks.  The black box warnings for Chantix and Zyban warn of the mental health risks associated with their use, which can include changes in behavior, depressed mood, hostility, and suicidal thoughts.[2]

These warnings were recommended as the result of information gathered from clinical trials, as well as a series of reports to the FDA’s Adverse Event Reporting System. Zheng-Xiong Xi, MD, PhD, a researcher at the National Institute on Drug Abuse, found that Chantix was associated with incredibly dangerous side effects in many individuals, including suicide attempts and seizures, as well as psychosis, depression, and serious injuries resulting from dizziness, loss of consciousness, movement disorders, and visual disturbances.These problems have been noted among individuals with a history of mental illness but also have occurred among individuals with no prior history of mental illness.[3]

Analysis from reports to the FDA’s Adverse Event Reporting System similarly shows that some people who used Chantix and Zyban began experiencing changes in behavior, depressed mood, and suicidal thoughts shortly after starting the medication. The symptoms usually ended shortly after the medication was stopped, but some people still reported symptoms after stopping the medications, while still others did not even begin developing the symptoms until after they stopped taking the drug.

Neither Chantix nor Zyban contains nicotine, unlike other smoking cessation aids such as chewing gum and the patch. Nicotine withdrawal can also cause mental health problems similar to those caused by Chantix and Zyban, such as depression, anxiety, irritability, restlessness, and sleep disturbance. However, the mental health risks of these two drugs far exceed the symptoms suffered by people with nicotine withdrawal.

Zyban is another name for Wellbutrin, an anti-depressant. Its marketing as a smoking-cessation drug came about after researchers noticed that smokers who took Wellbutrin for depression had less desire to smoke. GlaxoSmithKline carried out additional research in order to get approval to sell Wellbutrin under a different name as a medication to quit smoking. However, like most anti-depressants, the pills–whether they are called Wellbutrin or Zyban–can cause an increase in suicidal thoughts.  Antidepressants have carried black box warnings about suicide risks since 2004.

Chantix: News about increased risk of suicide, violent behavior, and other mental health problems

From the approval of Chantix in May 2006 until July 2009, the drug was linked to reports of approximately 100 suicides, 200 suicide attempts, and almost 5,000 serious psychiatric events. Doctors are not required to report deaths or serious complications to the companies that make the medication or the FDA, although drug companies are required to do so.  Because most doctors don’t report, it is assumed that the numbers are much higher and that those problems have continued since 2009.  In fact, in May 2011, the Institute for Safe Medication Practices (ISMP) revealed that hundreds of cases of suicides, psychotic reactions, hostility, aggression and other serious problems tied to Chantix had not been properly reported to the FDA by Pfizer, the drug’s manufacturer. Among the 589 delayed reports of severe problems, there were more than 150 suicides-almost doubling those previously known.  Thomas J. Moore, the ISMP senior scientist who analyzed the data, stated that, based on the FDA’s adverse event reports, Chantix is the riskiest of all drugs sold in the U.S. In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities recorded as any other drug.[1]

The discovered reports coincide with a study by Moore released in December 2010 examining all of the most serious adverse drug events reported to the FDA since 1968. Chantix had the largest number of reported cases of violence (408).[1]

A large 2011 study found that Chantix was 8.4 times more likely to lead to suicide or self-injury compared to nicotine replacement products like nicotine gum or patches. There were 1,818 reported cases of suicidal thoughts or behavior for Chantix and only 50 for nicotine replacement products.[4]

Increased risk of heart attack for patients with cardiovascular disease

Research has shown that these stop-smoking drugs affect not only mental health, but can also jeopardize physical health. In June 2011, the FDA warned that Chantix may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. After reviewing a randomized clinical trial of 700 smokers with stable cardiovascular disease, the FDA found that certain events, including heart attacks, were reported more frequently in patients treated with Chantix than in patients treated with placebo (2.0% vs. 0.9%).[5]

Do the risks outweigh the benefits? NCHR says YES

Quitting smoking is usually a step towards improving one’s health, but doing so at the risk of mental or heart health is not a good compromise.  Instead, there are other, safer ways to quit smoking.

The unreported deaths and serious injuries for people taking Chantix raises questions about whether other information is being withheld. Since most doctors don’t report adverse reactions to the FDA, it is likely that Chantix has caused many more deaths and injuries than reported. For that reason, we believe that Chantix is not a safe choice. At the very least, the mental health of anyone taking Chantix or Zyban should be closely monitored by a healthcare professional. Additionally, if you have a history of cardiovascular disease, consult your doctor before taking Chantix, and if you experience new or worsening symptoms of cardiovascular disease, contact your doctor immediately.

If you or someone you know is trying to quit smoking, be aware of the symptoms associated with quitting, and if symptoms develop, a healthcare professional should be consulted.

Controversy Over Black Box Warning

In 2014, the makers of Chantix lobbied the FDA to remove the black box warning on the drug, citing a meta-analysis, an observational study of hospital records, and reported adverse events to argue that dangerous side-effects were not as common as previously believed. However, we question the results of the meta-analysis, since many studies on Chantix were excluded.

Meta-analysis is a valuable tool, but its accuracy depends on the quality of each study and whether they fit together. The five studies included in the meta-analysis consisted of one study of schizophrenics, one study of depressed patients, and 3 studies of mentally healthy patients. It is important to study schizophrenics and depressed patients, but those data should not be analyzed together with 3 studies that exclude such patients.

To consider the implications of studies that claim to show that Chantix does not have serious psychiatric side effects, it is important to realize that most people with acute psychiatric side effect from medication do not end up in hospitals or the ER. Psychiatric side effects are often not reported in medical records. Because psychiatric commitment laws depend on acts of violence, not threats of violence, many people with dramatic psychiatric symptoms end up in jail, not in hospitals. In fact, some studies show that there are more mentally ill individuals in the criminal justice system than in psychiatric facilities.

Removal of Black Box Warning

After hearing the testimony about these shortcomings from NCHR President Diana Zuckerman and numerous other experts, the FDA decided to keep the black box warning on Chantix in 2015. However, in response to industry pressure, the FDA removed the black box in 2016[6], and the warnings that were in the black box are now part of the label under a heading of “Warnings and Precautions” for both Chantix and Zyban.[7, 8] Thus, although the official black box warning for Chantix has been removed, there are still warnings on their labels about the psychiatric risks of Chantix and Zyban. In addition to the label, which most patients do not read, the Medication Guide listed on the Chantix manufacturer’s website warns of the potential side effects of “New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions.”[9] These warnings are also on the home page of Chantix.com. Zyban has a black box warning about suicidal thoughts, and warnings similar to Chantix on the label and medication guide.

Below are the current “Warnings and Precautions” listed for Chantix and Zyban:

Neuropsychiatric Adverse Events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with CHANTIX for the occurrence of such symptoms and instruct them to discontinue CHANTIX and contact a healthcare provider if they experience such adverse events.

Neuropsychiatric adverse events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with ZYBAN for the occurrence of such symptoms and instruct them to discontinue ZYBAN and contact a healthcare provider if they experience such adverse events

Below are the previous black box warnings for both Zyban and Chantix:

ZYBAN:

Serious neuropsychiatric reactions have occurred in patients taking ZYBAN for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking ZYBAN who continued to smoke.

CHANTIX:

Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment or after stopping CHANTIX. If you, your family or caregiver notice agitation, hostility, depression or changes in behavior, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia or confusion, stop taking CHANTIX and call your doctor right away. Also tell your doctor about any history of depression or other mental health problems before taking CHANTIX, as these symptoms may worsen while taking CHANTIX.

Additional Resources:
Chantix Citizen Petition
Statement of Diana Zuckerman, PhD at FDA Joint Public Advisory Committee Meeting on Chantix
Quitting smoking: women and men may do it differently

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

  1. Moore TJ, Glenmullen J, Furberg CD (2010) Prescription Drugs Associated with Reports of Violence Towards Others. PLoS ONE 5(12): e15337. Retrieved 27 May 2011 at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0015337
  2. U.S. Food and Drug Administration. “Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban.” Press release. FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban. 1 July 2009.
  3. Xi ZX. Preclinical Pharmacology, Efficacy and Safety of Varenicline in Smoking Cessation and Clinical Utility in High Risk Patients. Drug, Healthcare and Patient Safety. 2010;2:39-48. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/21278851
  4. Moore TJ, Furberg CD, Glenmullen J, Maltsberger JT, Singh S. (2011) Suicidal behavior and depression in smoking cessation treatments. PLoS ONE 6: e27016.
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NCHR’s Testimony to FDA on TOOKAD to Treat Low-Risk Prostate Cancer

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


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

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

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

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

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

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

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

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

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

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

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

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