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

General Treatment Issues, Uncategorized, ,

Diana Zuckerman, Ph.D., Cancer Prevention and Treatment Fund: updated February 10, 2021.

The coronavirus can infect anyone, young or old, healthy or frail.  But, people diagnosed with cancer during the last year are at higher risk of dying from COVID-19 if they are infected. Here’s what you need to know.

People who are over 60 or who have cancer and other serious health conditions, and their loved ones, need to be especially careful to avoid getting infected.  A study published in December 2020 of more than 2 million cancer patients, found that people diagnosed with cancer during the previous year are much more likely to die of COVID compared to other COVID patients.  All cancer patients were at higher risk, but the ones in most danger had been diagnosed with leukemia, non-Hodgkin’s lymphoma, or lung cancer. The CDC has also updated their list of other health problems that put people at greatest risk, and they include many common health conditions: Anyone who is obese (BMI of 30 or higher) or has a serious heart condition, Type 2 diabetes, a weakened immune system (from cancer or an organ transplant), chronic kidney disease, COPD, or sickle cell disease is especially at risk if they are exposed to the coronavirus.  Smoking also increases the risk of being seriously harmed by the virus, as do many other medical conditions, including high blood pressure, pregnancy, HIV, and liver disease.

If you had scheduled medical appointments, surgery, screening, or other procedures in the past year that were considered not urgent or not immediately life-threatening, those were probably postponed. This was for everyone’s protection.  Many hospital staff, including doctors, nurses, receptionists, and cleaning staff, have been vaccinated against COVID but their facilities may be limiting procedures that are not essential because the doctors are vaccinating others or are treating COVID patients. You don’t want to be exposed to the coronavirus when you go in for surgery or testing procedures for other medical conditions.  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.

Will the COVID vaccines make it safer to have medical procedures or doctor’s appointments? To visit friends and family members?

Many healthcare workers have been vaccinated, but some nurses and aides have refused the vaccine so far.  You should ask about that when you make an appointment. Pregnant healthcare workers and those with serious allergies may choose not to be vaccinated. Pregnant healthcare workers and those with serious allergies may choose not to be vaccinated.  More important, the vaccines do not prevent infection, even though they usually prevent people from getting obviously sick.  If your healthcare worker is vaccinated, he or she could have asymptomatic COVID without knowing it, and could possibly infect others.  For that reason, healthcare workers and patients need to continue to wear masks and keep their distance.

The coronavirus is still spreading in all 50 states, in urban, suburban, and rural areas, so it is important to listen to health experts who tell you to stay home, limit contact with others, wear a mask, and keep a distance of 6 feet away when you or your family members or caregivers go grocery shopping or other essential activities. It will be months before most people are vaccinated.  Unfortunately, some governors, mayors, and state legislators have reopened businesses for political reasons, even in states where the virus is spiking.  Even if you are staying at home as much as possible, the fact that others in your community are going to bars, parties, restaurants, stores, and hair salons will put you at greater risk when you make essential visits to the supermarket, to work, to the doctor, or spend time outdoors, because you may come into contact with people who are infected because they aren’t being as careful as you are.

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.

How does COVID-19 spread between people?

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

The virus is thought to be most contagious in the days just before and just after a person develops symptoms, but it is possible to catch the virus from infected people who have no symptoms at all.  Experts still don’t know how contagious the virus is when a person has it but never develops symptoms.  This is crucial information that scientists are trying to find out, especially since experts believe that many young children never develop symptoms, while other children get very sick and some have died from the coronavirus.

What about children?  Unlike the flu, which is riskiest for the youngest children and oldest adults, infants and young children are much less likely to get sick from the coronavirus than adults.  Preliminary studies suggest that children over 10 are as contagious as adults, but that younger children are much less infectious. For example, there are few known examples of the virus spreading in daycare centers that follow coronavirus safety standards. Nevertheless, almost half a million children have been diagnosed with the virus in the U.S. (almost 10% of all cases) and 70,000 children were newly diagnosed in late August, which was 17% more than the weekly number of new cases two weeks earlier.  Fortunately, few children become so sick that they are hospitalized (estimates range from less than 1% to 8.5%), and less than half of 1% of children diagnosed with coronavirus in the U.S. have died.

The tiny droplets from coughing, sneezing, singing, talking, or breathing (as well as fecal matter containing the virus) can result in the virus 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. However, there are no documented cases of anyone catching COVID from a surface.  Nevertheless, it’s important to wash your hands regularly.  If you’re concerned about exposure at home, you can wipe down surfaces in your bathroom, kitchen, and other rooms with bleach or rubbing alcohol to help prevent exposure.

What about food or food packaging?  The risk of catching the virus from packaging is extremely low, but it’s a good idea to wash your hands for at least 20 seconds after handling mail, takeout containers, and packaging from groceries. You don’t need to disinfect food packages using a cleaning product that kills viruses, and NEVER use bleach or disinfectants on fruit, vegetables, or any other food.

What about the vaccines?

If you are eligible to be vaccinated with either the Pfizer or Moderna vaccine, that is the best protection available for most people.  Keep in mind, however, that the vaccines were not studied on nursing home patients and not studied on many people with COVID who were ages 65 or older, so it might be less effective for older people.  (Flu vaccines are often less effective for older people, because their immune systems are weaker).  The vaccines were found to be as safe for adults of all ages and races. The vaccines were  studied on few people under 18, pregnant women, people with compromised immune systems, or those with serious allergies, so it will be a while before we have information about safety or effectiveness data for them.

Both of the vaccines have frequent side effects such as fatigue and chills, especially after the second dose.  These are not considered dangerous, but it is important that anyone getting vaccinated is told about those risks, since they could be frightening to patients who don’t understand that those symptoms are not thought to be reason for concern.

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, not everyone with COVID-19 has those types of symptoms.  In fact, some people (especially children, teens, and younger adults) have very mild symptoms or none at all, which is why getting tested is so important before you spend time with others. The CDC says that people with these symptoms or combination of symptoms may have COVID-19:

  • Cough
  • Shortness of breath or difficulty breathing

Or at least two of these symptoms:

  • Fever
  • Repeated shaking with chills
  • Muscle pain
  • Headache
  • Sore throat
  • New loss of taste or smell
  • Congestion or runny nose
  • Nausea or vomiting
  • Diarrhea

Those are the most common symptoms.  However, children or adults can have other symptoms as well, including heart problems and “covid toes” that look like a minor case of frostbite.

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

As described above, people who are older than 60 or with other medical conditions are more likely to develop severe illness and complications from COVID-19. The most serious complications include pneumonia, stroke, blood clots, organ failure, and death.

How else can I protect myself and others?

If you are not yet eligible to be vaccinated, the best way to protect yourself is to avoid being exposed to the virus. There are no proven cures, so don’t be fooled by claims, regardless of the source.  Two types of medications have been found to help people who are seriously ill, but are not a cure.  Remdesivir has been found to help very ill patients by reducing the number of days of hospitalization in one study, but was not effective in a WHO study published in October.  It has not been proven to save lives. Two inexpensive steroids, dexamethasone and hydrocortisone, have been found to reduce the chances of dying among COVID-19 patients on ventilators or those requiring oxygen, but not other patients. Regeneron, the experimental antibody drug that President Trump took when he was diagnosed, is not generally available but has been used with good results by some friends of the President.  However, it was found to have a potential safety concern and as of October 30 is no longer being administered experimentally to hospitalized patients receiving mechanical ventilation of intense oxygen.  It is still being studied on less seriously ill COVID-19 patients.

Experts now agree that hydroxychloroquine with or without azithromycin is not a good treatment for COVID-19 because it has been found to increase heart problems and has not been shown to prevent or treat COVID-19.  Another possible treatment is blood plasma from people who recovered from COVID-19.  Research has shown these transfusions are usually safe, but there is no clear evidence that they are beneficial.

Research is continuing to find out which of these treatments are safe and effective and for which patients.

“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 friends and 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.

Spending time with friends, family, or people at work

In general, the more people you interact with, the more closely you interact with them, and the longer that interaction, the greater your chances of becoming infected or infecting others. That’s why there have been so many cases after Thanksgiving, and why hospitals are full all over the country. So, think about:

  • How many people will you interact with?  (The fewer the better)
  • Can you keep 6 feet of space between you and others?
  • Will you be outdoors or indoors? (Outdoors is somewhat safer. It can be heated but not if it has walls all around and a ceiling.)
  • What’s the length of time that you will be interacting with people? (Shorter is better)

Research conclusively shows that face masks that cover your mouth and nose help to prevent the spread of the coronavirus.  Some masks are more effective than others:  stretchy “gators” may actually do more harm than good, and bandanas and scarves are too loose to be very helpful.  The paper surgical masks worn in hospitals are effective and so are cloth masks you can make for yourself or buy, if they are made of cotton and at least two layers thick. Masks are important to prevent people from spreading the virus and also to help helps prevent infection or serious symptoms for the person wearing the masks. Experts suggest wearing two masks at the same time for extra protection.

Bottom line: Since most of us haven’t been vaccinated and can’t get coronavirus tests every day, it’s especially important to wear masks whenever you are out in public or with people you don’t live with.  But you should NOT be out in public or with people you don’t live with except when it’s essential.  Depending on your age, health, and who you spend time with, it may not be safe for you to go to all the places that are open.  Especially avoid indoor areas where you are likely to be close to others for more than a very short period of time (15 minutes) or whose workers are close to many other people, such as a tattoo parlor, hair or nail salon, restaurant, concert, party or movie theater.  If you must go to a store, try to go to one that makes appointments with customers or limits the number of customers, and spend less than one hour indoors to reduce exposure to any coronavirus that is in the air.

In summary:

  • Stay at home or go outside in your yard or neighborhood where you can keep at least 6 feet away from others
  • Avoid public spaces where there are other people, especially indoors
  • Avoid public transportation when possible and unnecessary travel
  • Avoid all social gatherings that are indoors or where people are close together
  • Work from home if possible
  • Stay at least 6 feet away from people when out in public (indoors or outdoors). Further away is even better, especially if people are singing or talking, or if there isn’t good air filtration.
  • 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
  • Put the toilet seat down before flushing in a shared or public bathroom
  • A lower priority would be to clean and disinfect surfaces, and only those in your home or workplace that could expose you frequently to the virus, including doorknobs, light switches, faucet handles, and phones. An antibacterial cleaning agent won’t kill a virus, so try to find one that is effective for killing viruses.

If you have a weakened immune system or other serious health 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 or computer 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 more than one of the symptoms listed above, call your doctor.  If you have severe symptoms, such as difficulty breathing, persistent chest pain or pressure, confusion or inability to awaken, or blueish color in the lips or face, 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. Do not just show up at the doctor’s office with symptoms:  Call them first so you have tell them about your symptoms and any other health problems so that 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 or two weeks have passed since you first noticed symptoms or your fever or other symptoms go  away for 3 full days without medicine.  If you have been diagnosed with COVID-19 based on test results, you should follow those same steps until you have 2 negative test results taken 24-hours apart, and your symptoms improve.

What if my other scheduled medical treatment is delayed?

When a person is diagnosed with a serious disease, they are likely to want treatment as soon as possible. If you don’t have COVID-19, you don’t want to be exposed to it during surgery, testing, or follow-up appointments. Treatment or testing may seem more urgent than it really is, but it is definitely more important than going to a restaurant, store, or party.  Some medical centers are overwhelmed with Covid-19 patients, and others are not. 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@center4research.org and we’ll get back to you as soon as possible.

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

We're In the News, ,

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

Diet, Habits, & Other Behaviors, ,

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. 

Vitamin D and COVID-19

Research has shown that Vitamin D supplements can help protect against acute respiratory infections like the flu[16]. That is why in 2020, research is underway to determine if vitamin D supplements can help protect against COVID-19. Thus far, the research has found that people low in vitamin D are more likely to have tested positive for the coronavirus than people who are not low in vitamin D.[17] This research is based on studies of people who tested positive at a time when testing in the U.S. was relatively rare and many of the people who were tested did so because they had respiratory symptoms such as coughs or flu-like symptoms. Since these were not clinical trials, it is not clear whether being low in vitamin D makes someone more susceptible to COVID-19 symptoms, or whether old age or other traits increases the chances of having low vitamin D levels and also increases the chances of developing COVID-19. Research is being conducted to determine if vitamin D can help prevent serious symptoms or help patients recover.

Potential Risks of Supplements 

Some older research found that taking a combination of vitamin D and calcium increased the risk of kidney stones.[18] 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.[19]

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.[20] 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. Martineau AR, Jolliffe DA, Hooper RL, Greenberg L, Aloia JF, Bergman P, Dubnov-Raz G, Esposito S, Ganmaa D, Ginde AA, Goodall EC. Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data. BMJ. 2017; 356.
  17. The Scientist. Trials Seek to Answer if Vitamin D Could Help in COVID-19. https://www.the-scientist.com/news-opinion/trials-seek-to-answer-if-vitamin-d-could-help-in-covid-19-67817. August 2020. 
  18. 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.
  19. 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.
  20. 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

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

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

Policy, Testimony & Briefings, , ,

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

Uncategorized, , ,

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

Uncategorized,

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.
  5. U.S. Food and Drug Administration. FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease. 6 June 2011. Retrieved 6 July 2011 at http://www.fda.gov/Drugs/DrugSafety/ucm259161.htm
  6. FDA. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. FDA.gov. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-revises-description-mental-health-side-effects-stop-smoking. December 16, 2016. Updated March 8, 2018.
  7. Chantix. [Package Insert]. New London, CT: PF PRISM CV; 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf
  8. ZYBAN. [Package Insert]. Brentford, United Kingdom: GLAXOSMITHKLINE; 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020711s048lbl.pdf
  9. Chantix. [Medication Guide]. New York, NY: Pfizer; 2019. http://labeling.pfizer.com/ShowLabeling.aspx?id=557&section=MedGuide

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

Prostate Cancer, Testimony & Briefings, ,

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Policy, , , , ,

National Center for Health Research, February 24, 2020

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

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

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

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

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

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

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

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

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

References

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