Category Archives: Other Cancers

Phthalates Q&A

Environmental Exposures, Other Cancers
By Paul Brown & Stephanie Fox-Rawlings, PhD
Updated 2016

Phthalates are synthetic chemicals found in everyday plastic products, including toys, children’s care products, medical tubes and saline or blood bags, and food packaging. They are used to make plastic flexible.  They are also used in many personal care products that smell good, such as shampoo and creams, as well as air fresheners. The use of some phthalates is being restricted in some products; however, they are still very common. Phthalates can leach out of the plastic to cause health problems, especially for young children.

Q: Animals exposed to phthalates are more likely to develop serious diseases and health problems, such as liver cancer, kidney cancer, and male reproductive organ damage1, but have any studies shown that phthalates cause health problems in humans?

A: Yes, studies by Harvard researchers have shown that phthalates may damage human sperm DNA, reduce sperm numbers, and reduce its mobility2, and another study from several major medical centers has found that phthalates may cause genital changes for boys.3 Mount Sinai researchers found that girls exposed to more phthalates were more likely to be overweight.[end Wolff MS. (2012, January).Associations between phthalate metabolite urinary concentrations and body size measures in New York City children. Environmental Research 112:186-193] Other studies have shown that being exposed to phthalates increases the chance of developing asthma, allergies and bronchial obstruction.4

Q: Can phthalate exposure affect a child’s behavior?

A: Yes, prenatal exposure to phthalates and/or as a young child increases the chances of cognitive and behavior problems.5 Higher levels of phthalates have been associated with attention and memory problems, increased aggression and law-breaking behaviors, as well as poor social skills.

Q: Have scientists representing the European Union concluded that phthalates are safe?

A: No, in 2006, the European Union banned the use of 6 phthalates in toys that may be placed in the mouth by children younger than 3.6 The banned phthalates are DINP, DEHP, DBP, DIDP, DNOP, and BBzP. More recently the European Union banned the use of DEHP, BBP, DBP and BiBP in electronic equipment starting in 2019. The chemicals cause environmental and health hazards during recycling or disposal.7

Q: How are phthalates regulated in the US?

A: As of February 2009, U.S. law bans children’s toys and child care products related to sleep or feeding that contain the phthalates BBP, DBP, or DEHP. Toys or items that can be placed in a child’s mouth cannot contain DIDP, DINP, or DnOP.8 In 2014, the Chronic Hazard Advisory Panel recommended banning DIBP, DPENP, DHEXP, DCHP, and DIOP.9 The Consumer Protection and Safety Commission (CPSC) followed with a proposed a rule to ban DIBP, DPENP, DHEXP, and DCHP in children’s toys and care products.10 However a final rule (and thus the ban) has not been published. The Environmental Protection Agency (EPA) has planned to assess seven phthalates under the Toxic Substances Control Act, which could limit their use in all kinds of products.11 These are DBP, DIBP, BBP, DEHP, DnOP, DINP, and DIDP. However, it is unclear when assessment will occur.

Q: If phthalates are banned, will the toy industry start using unsafe alternatives?

A:  No, federal legislation requires that alternatives to the banned phthalates are not hazardous under the Federal Hazardous Substance Act.8 Manufactures are also required to sufficiently test their product to insure it will not cause injury through normal use or predictable misuse.

Q: Should the Consumer Product Safety Commission (CPSC) establish federal regulations for phthalates that preempt state laws?

A: That would be a bad idea because some States have better laws than the federal government. The CPSC is a small agency that has a hard time keeping up with reports of unsafe products that are sold in the U.S. In 2015, CPSC recalled more than 600 distinct products, including 52 for children and babies.11 The states of California and Washington have passed strong laws to protect adults and children from unsafe products, and it would be inappropriate for federal laws to interfere. California has listed six phthalates (DBP, DEHP, BBP, DINP, DIDP, and DNHP) on their Prop 65 lists of chemicals known to cause cancer, birth defects or reproductive harm.12 In Washington state, the definition of “children’s product” is broader that that used by the CPSC. Therefore, there are some children’s products that cannot be sold in the state of Washington but are not banned by the CPSC. Examples include children’s cosmetics or clothing that are not packaged as toys.13

For more information, contact Dr. Diana Zuckerman or Paul Brown at (202) 223-4000 or by e-mail at dz@center4research.org and pb@center4research.org

Agent Orange and Serious Diseases including Multiple Myeloma

Environmental Exposures, Other Cancers
Nicholas J. Jury, PhD and Diana Zuckerman, PhD
2015

It has taken many years to determine how Agent Orange exposure during the Vietnam War has harmed the health of those who were exposed. One of the reasons is that it can take decades for cancer to develop after a dangerous exposure.  Agent Orange was used extensively by the United States military during the Vietnam War to clear vegetation to make it easier to see enemy soldiers. Agent Orange was contaminated with dioxin, making it more dangerous to humans. Nearly 1.5 million veterans were exposed to Agent Orange during the war 14  when approximately, 20 million gallons of Agent Orange were sprayed over Vietnam during Operation Ranch Hand. 15,16

Although more research is still needed to learn more about the risks of Agent Orange, by 2012, the Institute of Medicine had concluded that individuals exposed to Agent Orange are more likely to develop these types of cancers and serious diseases 17:

Cancers:

  • Chronic B-cell leukemia
  • Chronic lymphocytic leukemia
  • Hodgkin disease
  • Non-Hodgkin lymphoma
  • Prostate cancer
  • Respiratory cancers (bronchus, larynx, lung, and trachea)
  • Soft tissue sarcoma

Serious diseases:

  • Early-onset peripheral neuropathy
  • High blood pressure
  • Ischemic heart disease
  • Parkinson disease
  • Stroke
  • Type 2 diabetes

The report also stated that some of the children being born to those exposed had spinal cord birth defects. 18

New research indicates Agent Orange also increases the chances of developing a type of cancer of the bone marrow called multiple myeloma.

Veterans who have been exposed to Agent Orange or other herbicides during military service are eligible to receive Veterans Administration health care benefits and compensation for respiratory cancers without having to prove the connection between their disease and exposure.  19

Does Agent Orange cause Multiple Myeloma?

Bone marrow is crucial for making new blood cells. Multiple myeloma causes blood cells to accumulate in the bone marrow and interfere with the process of making new blood cells. 20  Patients who develop multiple myeloma are usually diagnosed first with a condition called monoclonal gammopathy of undetermined significance (MGUS). 21, 22  Patients who have MGUS tend to develop multiple myeloma, and this risk increases over time. 23  More than 26,000 people are expected to be diagnosed with multiple myeloma this year, and less than half are predicted to survive. 24

In its 2012 report, the Institute of Medicine stated that there was insufficient evidence to conclude that exposure to Agent Orange can cause multiple myeloma. 25  However, a study published in a cancer journal in 2015 reported that veterans who were exposed to Agent Orange were 2.4 times more likely to develop MGUS than the veterans who were not exposed to it. 26  The study was based on 958 veterans who served in the United States Air Force during Operation Ranch Hand. This study provides compelling evidence that Agent Orange exposure can increase the risk of multiple myeloma.

Morcellation devices: a surgical tool that can spread cancer? What you need to know

In the News, Medical Treatments with Cancer Risks, Other Cancers
By Anna E. Mazzucco, Ph.D.
2014

If you have uterine fibroids and are considering treatment or if you’ve heard about uterine morcellation in the news, this article will help you understand the issue.

What are power morcellation devices?

A power morcellation device is a small surgical tool which cut tissue into smaller pieces.  This allows organs or other tissues to be removed through smaller incisions, making surgery shorter and leaving smaller scars behind.  The front end of a power morcellator has a spinning blade that cuts the tissue into tiny pieces (pulverizes it), and the back end is connected to a tube which sucks the tissue through the device (see image below).

morcellator

Power morcellation devices were originally designed for removal of the uterus (or the womb), but are currently used for many different types of surgical procedures because they make it easier for a physician to perform surgery using smaller incisions.

What is the controversy about morcellation devices?

In 2012, two Harvard doctors had their lives tragically affected by these devices.  Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, which is affiliated with Harvard Medical School, had surgery in the fall of 2013 to remove her uterus due to fibroids.  After the surgery she was diagnosed with advanced (stage IV) uterine cancer, spread by the use of power morcellation during her surgery.  The morcellation left behind tiny pieces of tumor throughout her pelvic cavity, which allowed the cancer to spread.  While morcellation devices are sometimes used with a bag to contain the fibroid or tissue so that it won’t spread, the bags can be difficult to use so not all surgeons use them.   Dr. Reed was never told that morcellation would be performed during her surgery, or about the potential risks.

As a result of this surgical procedure with morcellation, a small cancer that could have been easily and completely removed through surgery has been spread and is now considered fatal.

Dr. Reed, who is now undergoing aggressive treatment for her metastasized uterine cancer, and her husband, Dr. Hooman Noorchashm, who was a surgeon at nearby Brigham and Women’s Hospital (also affiliated with Harvard), began a campaign to raise awareness of this issue and prevent other patients from being harmed.  As a result, Brigham and Women’s Hospital has since changed its policies on use of morcellation.  Since their story came out, other similar stories have surfaced, confirming that cancer has been spread by these devices, that it is not a rare event, and that it can have fatal results.  Moreover, many of these patients had not been told about these potential risks before their surgeries, and in some cases weren’t even told that morcellation would be used.  In May 2015, the Wall Street Journalreported that the FBI is investigating whether information about the risks of morcellation was not reported by hospitals, doctors, and device makers, as required by law.

What are uterine fibroids?

Uterine fibroids are non-cancerous (benign) growths on the uterus.  They are very common among women, especially during and after the reproductive years.  In many women, they do not cause any noticeable symptoms or problems.  But in some women, uterine fibroids can cause pain, discomfort during sex, and heavy bleeding.  To read more about fibroids and treatment options for them, read our in-depth article here.

What are the risks and benefits of using power morcellators?

Morcellation can allow surgeons to do shorter, less invasive surgeries.  This can reduce the chances of excessive blood loss and infection, and can reduce the amount of time spent in the hospital and result in an easier recovery afterwards.  However, in the case of fibroids, there is no way to rule out the chance of hidden cancer which could be spread by morcellation.  The Food and Drug Administration (FDA) estimates that 1 in 350 women receiving surgery for uterine fibroids has a hidden cancer that could be spread by morcellation. This is why the FDA released a warning in April 2014 recommending against morcellation for uterine fibroids.

On July 10-11, 2014, the FDA held a public meeting to discuss the risks and benefits of these devices.  Our testimony before the FDA panel on uterine morcellation, is here.

On November 24, 2014 the FDA announced that they were issuing an immediate change in the label for power morcellation devices, which will now include a black box warning as follows:

“Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”

These tragic events involving power morcellation devices raise questions about how medical devices are approved and monitored, and how a tragedy like this can be prevented in the future.  If larger studies had been done before the FDA allowed these devices to be used, and if cases of cancer being spread by morcellation had been reported to the FDA by doctors and companies, the FDA could have warned doctors and patients much earlier and prevented women from being exposed to these risks.

What do patients need to know?

If you are considering surgical treatment for uterine fibroids, be sure to discuss morcellation with your surgeon and make your wishes clearly known.  Depending on your particular situation, there are alternative surgical procedures, such as vaginal hysterectomy, which can be done without morcellation.  For any surgical procedure, make sure you have a clear and thorough discussion with your doctor about exactly how the procedure will be done, what choices you have, and what the risks and benefits of different options are.   If you feel that you are not getting enough information from your doctor, consider getting a second opinion.  Be sure to ask your doctor how often they perform the procedure you will have, because patients usually have a better outcome from surgery if the doctor performs the exact same surgery frequently.  If the physician does not have many years of frequent experience with the surgery, seek out a doctor who does.  For more tips on how to make smart decisions about medical treatments, especially use of medical devices, read our article here.

Endometrial cancer: what you need to know

Other Cancers, Prevention,
By Laurén Doamekpor, M.P.H.

What is endometrial cancer?

Endometrial cancer—also called uterine cancer—is the most common cancer affecting a woman’s reproductive system. It is diagnosed when tumors start growing in the lining of the uterus, which is called the endometrium. Studies show that endometrial cancer is much more likely to occur in women who have already reached menopause, and most endometrial cancer is diagnosed around age 70.27 When physicians and medical experts talk about endometrial cancer, they often refer to it as type I or type II. Type I endometrial cancer is more common, and is influenced by levels of the female hormone estrogen in a woman’s body.28 Anything that affects a woman’s estrogen levels can potentially raise or lower a woman’s risk of developing type I endometrial cancer.29 Type II is less common and does not seem to be related to estrogen.30

In 2013, 49,560 new cases of endometrial cancer were diagnosed in the U.S., and about 8,000 women are expected to die from it this year.31

What are common symptoms of endometrial cancer?

Abnormal vaginal bleeding or discharge are frequently reported symptoms, as is pain in the pelvic area, and pain during intercourse.32  However, a woman can have endometrial cancer without having any of these symptoms, and women can have these symptoms without having cancer. You know your body best, so it is important to see your doctor if you experience any symptoms that seem out of the ordinary.

Who is at risk?

Some of the factors that increase a woman’s chances of getting endometrial cancer are out of her control, but she can reduce her risks.  These factors increase a woman’s risks of endometrial cancer:

  • Had her first menstrual period before age 126
  • Has a family history of endometrial cancer6
  • Has or had trouble getting pregnant6
  • Has used or is using tamoxifen, a drug used to treat or prevent some types of breast cancer. Tamoxifen blocks estrogen to the breast, starving cancer cells that like to feed off of estrogen, but it acts like estrogen on the uterus.6
  • Had menopause after age 5533
  • Is obese – Studies suggest that obesity may be the largest risk factor for endometrial cancer.4

The more menstrual cycles a woman has in her life, the greater her risk.  That is why either early menstruation or late menopause (or both) can increase a woman’s risk of getting endometrial cancer.  And that is why taking birth control pills lowers a woman’s risk of endometrial cancer. Oral contraceptives eliminate “real” menstruation, replacing it with “withdrawal bleeding.”34

Screening and diagnosis

For women without symptoms, there are no accepted guidelines for a routine screening test.  That is why it is important to see your doctor if you experience any symptoms.  Most cases (80%) are diagnosed at an early stage because of symptoms, and as a result survival rates are high9. Most women with symptoms that are consistent with endometrial cancer will receive one or more of the following tests, in addition to a physical exam and blood tests:

  • Pelvic exam: A pelvic exam will allow your doctor to check your vagina and uterus for any unusual changes in size or shape.
  • Transvaginal ultrasound: This type of ultrasound (sound waves) makes a picture of the uterus, and can be used to detect small masses.
  • Biopsy: A biopsy involves the removal of tissue from the uterus to test whether cancer cells are present. 35

However, screening all women instead of only screening women with symptoms will often result in unnecessary biopsies because of false-positive transvaginal ultrasound results. for that reason, screening should be limited to symptomatic women to minimize anxiety and complications from biopsies.9

What are the treatment options?

If you have been diagnosed with endometrial cancer, treatment depends on the type of uterine cancer you have and how far it has spread, your age, and how fast the tumor is likely to grow.36 Treatment usually includes:

  • Surgery to remove the tumors
  • Chemotherapy
  • Radiation therapy
  • Hormone therapy to block hormones and keep them from feeding cancer cells 10
  • Immunotherapy12-15

The effectiveness of treatments can vary. For example, a 2023 study found that adding radiation to chemotherapy treatment did not increase how long endometrial cancer patients lived12 However, immunotherapy in addition to chemotherapy, has been shown to significantly improve outcomes according to the results of two different randomized clinical trials.13,14 Experts have predicted that these studies will convince doctors and patients to incorporate immunotherapy into the treatment of all patients with endometrial cancer,

How can you lower your risk of endometrial cancer?

Did you know that being overweight or obese increases your risk of many types of cancer, including endometrial cancer?  Keeping your weight down is the number one way you can reduce your risk, so limit the number of calories you eat and drink and stay (or get) active.  You can read more about the link between excess weight and cancer here. Scientists have proposed a few different explanations for this link, but one of them is that fat tissues secrete hormones, including estrogen. Abnormal amounts of estrogen circulating in the body increase a woman’s chances of developing type I endometrial cancer.

Dropping pounds (or at least not gaining weight) offers many health benefits in addition to lowering your risk of endometrial cancer. Shedding pounds can be a challenge. One of the easier ways is to cut down on sodas and other sweetened drinks that are high in calories with zero nutritional value.  A 2013 study found that women who drank a lot of sugar-sweetened beverages, such as Coke, Pepsi, and other carbonated beverages (such as 7-Up, Sprite), or non-carbonated drinks such as lemonade or Hawaiian Punch, were more likely to develop type I endometrial cancer than women who didn’t drink them, regardless of their body mass index (BMI), how physically active they were, or whether they had a history of diabetes or smoking. The study was based on postmenopausal, mostly white women who participated in the Iowa Women’s Health Study.  We don’t know if the results would be identical for younger women, or women of color, but we do know that these types of sugary beverages are generally harmful because they cause weight gain and do not provide nutrition.37 (Although the drinks are called “sugary,” most are made with corn syrup, not sugar.)

Physical activity is another way to control or reduce your weight and is one of the NRC’s seven recommended ways to maximize your health. Everyone can benefit from regular exercise, because it reduces the risk of heart disease and diabetes and can help you sleep better and improve your mood.38 Simple changes to your daily routine can make a difference. Read here to learn how to begin an exercise routine that works for your schedule.

The bottom line

If you’re having any pain in the pelvic area or experiencing unusual bleeding or discharge, be sure to tell your doctor.  Many of the factors that increase your risk of endometrial cancer are out of your control. What you can control is what you eat and drink. You can lower your chances of endometrial cancer and many other cancers by keeping your weight down and staying active.

 

  1. Amant F, Moerman P, Neven P, Timmerman D, Van Limbergen E, & Vergote I. Endometrial cancer. The Lancet. 2005;366(9484):491-505.  ▲
  2. Setiawan, VW, Yang HP, Pike MC, McCann SE, Yu H, Xiang Y, Wolk A et al. Type I and II Endometrial Cancers: Have They Different Risk Factors? Journal of Clinical Oncology. 2013;31(20): 2607-2620.  ▲
  3. Doll A, Abal M, Rigau M, Monge M, Gonzalez M, Demajo S, et al. Novel molecular profiles of endometrial cancer-new light through old windows. J Steroid Biochem Mol Biol. 2008;108(3–5):221–229.  ▲
  4. Felix AS, Weissfeld JL, Stone RA, Bowser R, Chivukula M, Edwards RP, Linkov F. Factors associated with Type I and Type II endometrial cancer. Cancer Causes & Control. 2010;21(11):1851-1856.  ▲
  5. National Cancer Institute SEER Cancer Statistics Factsheets: Endometrial Cancer. National Cancer Institute. Available at: http://seer.cancer.gov/statfacts/html/corp.html. Accessed November 26, 2013.  ▲
  6. National Cancer Institute. What you need to know about cancer of the uterus. Risk Factors. Available at: http://www.cancer.gov/cancertopics/wyntk/uterus/page4. Accessed November 26, 2013.  ▲
  7. Setiawan VW, Pike MC, Kolonel LN, Nomura AM, Goodman MT, Henderson BE. Racial/ethnic differences in endometrial cancer risk: the multiethnic cohort study. Am J Epidemiol. 2007;165(3):262-270.  ▲
  8. Combination oral contraceptive use and the risk of endometrial cancer. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development. JAMA. 1987;257(6):796-800.  ▲
  9. Trojano, G., Olivieri, C., Tinelli, R., Damiani, G. R., Pellegrino, A., & Cicinelli, E. (2019). Conservative treatment in early stage endometrial cancer: a review. Acta bio-medica : Atenei Parmensis, 90(4), 405–410. https://doi.org/10.23750/abm.v90i4.7800
  10. National Cancer Institute. What You Need To Know About Cancer of the Uterus- Diagnosis. 2010. Available at:http://www.cancer.gov/cancertopics/wyntk/uterus/page6. Accessed November 25, 2013.  ▲
  11. National Cancer Institute. What You Need To Know About Cancer of the Uterus- Treatment. 2010. Available at:http://www.cancer.gov/cancertopics/wyntk/uterus/page8. Accessed November 26, 2013.  ▲
  12. Nelson, R. (2023).No Survival Benefit to Radiation Add-on in Endometrial Cancer. Medscape. https://www.medscape.com/viewarticle/990236?ecd=WNL_confwrap_230405_MSCPEDIT&uac=140425SY&impID=5307712#vp_1
  13. Eskander, R., Sill, M., Beffa, L., et al. (2023).Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer. NEJM. https://www.nejm.org/doi/full/10.1056/NEJMoa2302312
  14. Mirza, M., Chase, D., Slomovitz, B., et al. (2023).Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. NEJM. https://www.nejm.org/doi/full/10.1056/NEJMoa2216334
  15. Nelson, R. (2023)’Home Run’: Immunotherapy Add-on for Advanced Endometrial Cancer. Medscape. https://www.medscape.com/viewarticle/990179?ecd=WNL_confwrap_230405_MSCPEDIT&uac=140425SY&impID=5307712
  16. Inoue-Choi M, Robien K, Mariani A, Cerhan JR, Anderson KE. Sugar-Sweetened Beverage Intake and the Risk of Type I and Type II Endometrial Cancer among Postmenopausal Women.Cancer Epidemiol Biomarkers Prev. 2013. doi:10.1158/1055-9965.EPI-13-0636  ▲
  17. Centers for Disease Control and Prevention. Physical Activity and Health. Available at:http://www.cdc.gov/physicalactivity/everyone/health/. Accessed December 2, 2013.  ▲

Flaxseed: What is it and Can it Keep you Healthy?

Breast Cancer, Diet, Habits, & Other Behaviors, Other Cancers, Ovarian Cancer
Carla Bozzolo, Cancer Prevention and Treatment Fund

1024px-Brown_Flax_SeedsSuddenly, everyone is talking about adding flaxseed to your diet.  What is flaxseed and how can eating it make you healthier?

What is Flaxseed?

Flaxseed is the seed of the flax plant and can be eaten as whole seeds, ground into a powder (flaxseed meal), or the oil can be taken in liquid or pill form.[1] There is evidence that it is a great way to incorporate dietary fiber, antioxidants, and omega-3 fatty acids into your diet.

Flaxseed has been shown to lower cholesterol in some people and it may even reduce the risk of breast cancer. People take flaxseed to help with many digestive conditions, including chronic constipation, diarrhea, diverticulitis (inflammation of the lining of the large intestine), irritable bowel syndrome (IBS), ulcerative colitis (sores in the lining of the large intestine), gastritis (inflammation of the lining of the stomach), and enteritis (inflammation of the small intestine). According to the National Institutes of Health (NIH), more study is needed to prove that flaxseed benefits people who have these conditions.[2]

What’s in This Miracle Seed?

Omega-3 essential fatty acids

Flaxseed is the richest source of omega-3 fatty acids,3 which is good for our hearts, brains, and normal growth and development.4 Omega-3 fatty acid can also be found in fish, plants, nuts, and oils made from nuts. No matter how you consume flaxseed—whole, ground or the oil—you will increase your intake of omega-3 fatty acids.

Lignans

Lignans are a type of plant estrogen that may help slow down certain cancers—cancers that depend on hormones to grow. Lignans also work as an antioxidant, which means they protect cells from the damage that comes with aging. Antioxidants—found in berries and many other foods—may help fight certain cancers. Lignans are concentrated in the coat of the seed so when flaxseed is expressed into oil, the anti-cancer and antioxidant benefits of the lignans are lost.

Dietary fiber

Dietary fiber helps regulate the digestive system and can lower bad cholesterol. Dietary fiber in flaxseed is only found in whole and ground flaxseeds, not in flax oil.

Flaxseed and Breast Cancer

For women who have gone through menopause, a small daily serving of flaxseed (just over half a teaspoon) was enough to lower breast cancer risk. While more research is needed, some studies suggest that for younger women who have not yet gone through menopause flaxseed reduces the risk of breast cancer and slows down the progress of certain breast cancers and other cancers that need estrogen to grow. A study published in 2013 found that eating flaxseed decreased a woman’s chance of getting breast cancer by 82%.

Flaxseed and Cholesterol

Flaxseed (but not flax oil) seems to decrease bad cholesterol among people who have relatively high cholesterol. Once again, women who already went through menopause seemed to benefit most: their “bad” cholesterol dropped more than the bad cholesterol of men or younger women. This is important for older women, because bad cholesterol tends to increase after menopause, as estrogen levels decline.

Who Benefits the Most?

Flaxseed has the potential to benefit everyone as a great source of dietary fiber with almost no side effects.  People with high levels of bad cholesterol and women who are post-menopausal benefit the most.

Different Ways to Eat It

Flaxseed is sold as whole seeds, ground seeds (flaxseed meal), liquid oil, and oil in a pill form. It can easily be added to cereal, baked goods, salad, yogurt, and many other types of food.  Since whole seeds tend to go through the body undigested, ground seeds are considered to be more beneficial.  Flaxseed oil delivers essential fatty acids but it doesn’t have fiber or lignans. If you want to get all the benefits of flaxseed—omega-3 fatty acids, fiber, anti-oxidant and cancer-fighting properties—choose ground flaxseed.  

Cautions

Few side effects have been reported from flaxseed. When taken to reduce constipation, it should be taken with plenty of water.

The fiber in the flaxseed may also lower the body’s ability to absorb medications that are taken by mouth, so it should not be taken at the same time of day that you take pills or dietary supplements.

The Bottom Line

Flaxseeds are a great source of dietary fiber and omega-3 essential fatty acids for men and women of all ages. They don’t have any known serious side effects, and ground flaxseeds are easy to include in the foods you eat every day.

References:

  1. National Institutes of Health. National Center for Complimentary Medicine. Herbs At A Glance: Flaxseed and Flaxseed Oil. April 2012: http://nccam.nih.gov/health/flaxseed/ataglance.htm
  2. National Institutes of Health. National Library of Medicine. Flaxseed: MedlinePlus Supplements. August 2011. http://www.nlm.nih.gov/medlineplus/druginfo/natural/991.html
  3. National Institutes of Health. National Cancer Institute. Antioxidants and Cancer Prevention: Fact Sheet. July 2004. href=”http://www.cancer.gov/cancertopics/factsheet/prevention/antioxidants”>http://www.cancer.gov/cancertopics/factsheet/prevention/antioxidants  ▲
  4. Brown L, Rosner B, Willett W, and Sacks F. Cholesterol-lowering effects of dietary fiber: a meta-analysis. American Journal of Clinical Nutrition. 1999; 69:30-42.  ▲
  5. Cotterchio M, Boucher BA, Kreiger N, Mills CA, & Thompson LU. Dietary phytoestrogen intake–lignans and isoflavones–and breast cancer risk (Canada). Cancer Causes Control.2008; 19:259–272  ▲
  6. Buck K, Zaineddin AK, Vrieling A, Linseisen J, & Chang-Claude J. Meta-analyses of lignans and enterolignans in relation to breast cancer risk. American Journal of Clinical Nutrition. 2010; 92:141–15  ▲
  7. Velentzis LS, Cantwell MM, Cardwell C, Keshtgar MR, Leathem AJ, & Woodside JV.Lignans and breast cancer risk in pre and post-menopausal women: meta-analyses of observational studies. British Journal of Cancer. 2009; 100:1492–1498  ▲
  8. Lowcock E, Cotterchio M, & Boucher B. Consumption of flaxseed, a rich source of lignans, is associated with reduced breast cancer risk. Cancer Causes Control. 2013. E-publicaton ahead of print. Retrieved from href=”http://www.ncbi.nlm.nih.gov/pubmed/23354422″>http://www.ncbi.nlm.nih.gov/pubmed/23354422.  ▲
  9. Pan A, Yu D, Demark-Wahnefried W, Franco O, and Lin X. Meta-analysis of the effects of flaxseed interventions on blood lipids. American Journal of Clinical Nutrition. 2009; 90:288-297.  ▲
  10. Fukami K, Koike K, Hirota K, Yoshikawa H, and Miyake A. Perimenopausal changes in serum lipids and lipoproteins: a 7-year longitudinal study. Maturitas. 1995; 22:193-197.  ▲

 

Testimony of Dr. Jennifer Yttri at FDA Advisory Committee on Tivozanib

Other Cancers, Other Cancers, Policy, Testimony & Briefings
May 2013

I am Dr. Jennifer Yttri and I am speaking on behalf of the Cancer Prevention and Treatment Fund of the National Research Center for Women & Families. Our non-profit research center scrutinizes medical data, evaluating scientific evidence of benefits and risks for patients.  We analyze and review research and provide objective and understandable health information to patients, health care providers, and policy makers.  Our organization does not accept funding from pharmaceutical companies and therefore I have no conflict of interest.

Today’s fundamental question is whether the one completed Phase 3 clinical trial is enough to approve the new drug tivozanib as a treatment for patients with renal cell carcinoma.

FDA guidelines recommend two trials that support efficacy of a drug. In some cases, FDA will approve a new drug based on only one trial if that trial shows a significant improvement over existing therapy. In the FDA’s own words: “A conclusion based on two persuasive studies will always be more secure than a conclusion based on a single, comparably persuasive study. Reliance on only a single study will generally be limited to situations in which a trial has demonstrated a clinically meaningful effect on mortality, irreversible morbidity… and [when] confirmation of the result in a second trial would be practically or ethically impossible.”

The NDA submitted for tivozanib relies on one phase 3 study comparing tivozanib to sorafenib. While tivozanib was shown to increase progression free survival by 3 months in patients with renal cell carcinoma, it did not improve overall survival. In fact, there was a non-significant lower overall survival for tivozanib, suggesting the drug may actually harm patients more than it helps them. This one study alone is not enough to meet the FDA’s guidelines for drug approval.

In addition, the study results have inconsistencies that raise red flags about the research and about the drug itself.

1.       Patients receiving tivozanib had increased progression free survival, so why were they more likely to die in the first 30 days due to disease progression, compared to sorafenib. This does not make sense. The deaths in the first 30 days could be due to chance, but the disease free survival could also be due to chance.  More research is needed to clarify the risks as well as the long-term benefits.

2.       FDA noted that 70% of sorafenib patients stopped taking the drug at least temporarily and 44% ended up with a reduced dose. This is much higher than other studies – for example one study highlighted by the FDA had only 14% interruption and 10% reduction.  There is no logical explanation for this, but these unusual problems could make sorafenib seem inferior to tivozanib, when in fact it might be superior.

These inconsistencies may be due to chance or to irregularities in how the studies were conducted in other countries.  Standard of care and assessment of disease varies in the US and other countries, and fewer than 10% of patients enrolled in the trial were in the US.  We agree with the FDA reviewer that it is preferable to enroll US patients, so that the study reflects the disease burden and treatment in the US and can provide better insight into treatment outcomes for US patients.

Regardless of the reason for the inconsistencies in the study, a second, independent, phase 3 study would help determine the safety and efficacy of this drug for treatment of renal cancer.

We urge you to recommend that the FDA require the sponsor to complete a second trial to confirm the positive effect of tivozanib on PFS; address the concern over lower OS; and provide better information on how generalizable the results are in the US population. Based on the data provided, there are no ethical concerns with requiring another trial. With the additional information, the FDA can make an informed decision as to whether tivozanib meets their standards of safety and efficacy.  That is not possible based on this one study with such inconsistent results.

Physician Groups Make Recommendations to Reduce Healthcare Costs

Breast Cancer, Cervical Cancer & HPV, Other Cancers, Prostate Cancer
Nyedra W. Booker, PharmD, MPH, Cancer Prevention and Treatment Fund
  • Does an 18-year-old girl need a pap smear?
  • Should a patient with a mild sinus infection be given antibiotics?

You might be surprised that the answer to both questions is NO according to leading physicians.

In an effort to improve medical care in the U.S. and save healthcare dollars at the same time, each of nine U.S. medical groups recently proposed a list of Five Things Physicians and Patients Should Question. This is a bold move by medical groups who collectively represent almost 375,000 physicians.  Currently, doctors are paid more for ordering more tests and diagnostic procedures, so these recommendations  are not financially beneficial to the physicians involved, but have the potential for reducing the cost of medical care for patients, health insurance companies, and government health programs such as Medicare, Medicaid, and Veterans healthcare.

The medical groups represent a wide range of medical care.  The nine groups include the American Academy of Allergy, Asthma & Immunology; American Academy of Family Physicians; American College of Cardiology; American College of Physicians; American College of Radiology; American Gastroenterological Association; American Society of Clinical Oncology; American Society of Nephrology and the American Society of Nuclear Cardiology.

Recommendations

Here are just a few of the groups’ recommendations:

Hives – Routine diagnostic testing (such as immunoglobulin E (IgE), a skin prick or blood test for allergies) is not recommended for patients with chronic hives, because such testing is usually ineffective at identifying the cause. [American Academy of Allergy, Asthma & Immunology]

Pap Smears – Routine pap smears to screen for cervical cancer are not recommended for women under the age of 21. [American Academy of Family Physicians]

Cardiac Stress Test – Cardiac stress test imaging (a procedure where dye is inserted into the blood stream and images show how well the blood is flowing through the heart) is not recommended for cardiac patients at their annual check-ups unless symptoms are present. [American College of Cardiology]

X-Rays and MRIs for Back Pain – Imaging (X-rays, MRIs) is not recommended for a patient with lower back pain unless a specific cause has been identified. [American College of Physicians]

MRIs and CCTs of the Brain – Imaging of the brain, including MRIs and CCTs (cranial computed tomography), is not recommended for a patient with a headache unless specific risk factors have been identified. [American College of Radiology]

Colorectal Cancer Screening– Colorectal cancer screening by any method (including flexible sigmoidoscopy, computed tomography colonography, double-contrast barium enema test) should be repeated every 10 years in low to average-risk patients who received a normal result at their last colonoscopy screening.  This is less frequently than previous recommendations.  It is recommended that people get their first colonoscopy at age 50. [American Gastroenterological Association]

Breast Cancer Testing – Imaging (PET, CT and radionuclide bone scans) is not recommended for patients with early-stage breast cancer at low risk for metastasis (cancer spreading to other parts of the body). [American Society of Clinical Oncology]

Cancer Screening – Routine cancer screenings (including colonoscopy, mammography and pap smears) are not recommended for patients on dialysis who have a short life expectancy, unless specific signs and symptoms are present. [American Society of Nephrology]

Chest Pains – Routine cardiac imaging including a stress echocardiogram (which  uses ultrasound to show how well the heart is pumping blood) is not recommended for a patient with chest pains who is at low risk for a heart attack or cardiac-related death, is able to exercise, and has a normal electrocardiogram (EKG).[American Society of Nuclear Cardiology][1]

A complete list of all 45 recommendations is available at: http://choosingwisely.org

How Will This Help?

Healthcare spending in the United States reached almost $2.6 trillion in 2010 and is expected to rise to around $4.6 trillion by 2020 unless major changes are made to eliminate unnecessary procedures, according to the Centers for Medicare & Medicaid Services.[2] An increase in the number of people living with chronic illnesses, rising prescription drug prices, and the high administrative costs of managing healthcare programs will contribute to increasing costs. While many continue to debate the exact reasons why healthcare spending is out of control, most agree that something needs to be done immediately.

In 2011, the American Board of Internal Medicine Foundation (ABIM) announced the Choosing Wisely campaign, and the National Physicians Alliance helped develop a multi-year initiative that would promote discussion among physicians, patients and consumer groups, aimed at decreasing healthcare costs by reducing unnecessary tests and procedures. Each participating group of physicians was asked to develop a list of five recommendations based on evidence from research findings. These recommendations were specific to their respective medical fields.

While many doctors and health experts understand that more medical care, and more expensive medical care, is not necessarily better medical care, studies show that the American public is wary of health care guidelines, even when they’re based on strong evidence. Patients and consumers tend to assume that running more tests and relying on newer, more costly technologies translate into health improvements (see Is Newer and More Expensive Care Better?).  As for doctors, the need to pay for expensive new imaging devices by charging for their use, the desire to give patients a clear diagnosis, and concerns about harming a patient by missing a diagnosis can all contribute to ordering unnecessary imaging and other tests.

Given this divide, it’s not surprising that Choosing Wisely has generated praise and concern. While many are praising the initiative as a step in the right direction to reduce the staggering cost of healthcare in the U.S., others question whether these cost-cutting strategies will come at the expense of good patient care.

Next Steps

The American Board of Internal Medicine Foundation and the National Physicians Alliance will continue to work with the nine medical specialty groups and several partnering organizations, including Consumer Reports and the American Association of Retired Persons (AARP), to develop tools and resources to help physicians discuss healthcare decisions with their patients. There will also be at least eight additional medical specialty groups joining the initiative and releasing their recommendations in the fall of 2012.

References:

  1. Choosing Wisely: An Initiative of the ABIM Foundation. Accessed April 04, 2012. http://choosingwisely.org/?page_id=13.
  2. Centers for Medicare & Medicaid Services. “National Health Expenditure Projections 2010-2020.” Accessed April 09, 2012. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/proj2010.pdf

 

Radiation and Thyroid Cancer

Medical Treatments with Cancer Risks, Other Cancers
Sonia Nagda, MD, MPH, Cancer Prevention and Treatment Fund

Recent media reports have raised fears that radiation from dental x-rays and mammograms increase the risk of thyroid cancer.  Thyroid cancer rates have been increasing over the past 30 years, and this cancer affects women three times as often as men.[1] Is it true that dental x-rays and mammograms are to blame for the increase in thyroid cancer?  Can a simple thyroid shield (an optional extension of the lead apron that blocks x-rays from reaching the neck) reduce the risk and put fears to rest?

Radiation in many forms-including x-rays, CT scans, sunlight, nuclear fallout (from atomic warfare or nuclear accidents such as Chernobyl) and even the radiation therapy that is used to treat cancer-can harm the DNA in the body and cause cancer. For more on this, see:  Everything You Ever Wanted to Know About Radiation and Cancer but Were Afraid to Ask.

The thyroid gland is one of the organs most sensitive to the risk of radiation. Located in the neck directly over the trachea (the tube that brings air from the nose and mouth into the lungs)¸the thyroid gland makes two different hormones, known as T3 and T4, which are responsible for regulating energy and the body’s metabolism.

Background Radiation vs. X-Rays

We are all exposed to small amounts of radiation all the time. This is called “background” radiation. People who live in areas where radon gas is common or at high altitude have higher levels of background radiation.

For radiation to affect your thyroid and cause cancer, it has to reach your thyroid gland in sufficiently high doses-either from a big one-time dose (as from a nuclear disaster) or through many smaller doses. The closer the area being x-rayed is to the thyroid, the greater the amount of scattered rays that will reach it.  Since the mouth is closer to the thyroid than the breasts, it makes sense that dental x-rays are more likely to affect the thyroid gland than mammograms, which are x-rays of the breast. On the other hand, dental x-rays expose patients to much less radiation than a mammogram: 0.005 millisieverts (mSv) for a dental x-ray, which is comparable to one day of natural background radiation, as compared with 0.4 mSv for a mammogram, which is comparable to 7 weeks of background radiation.[2]

Besides the dose, the age of the person being x-rayed or scanned is important. The thyroid gland is particularly sensitive to radiation during childhood and adolescence-when the gland is most active and a person’s body grows the most. As we age, the thyroid gland doesn’t work as hard, and the amount of radiation that it takes in becomes much smaller.

Dental X-Rays: a Risk for Thyroid Cancer or Not?

A study by Sara Schonfield and colleagues at the National Cancer Institute, published in 2011, compared the number of dental x-rays received by a group of thyroid cancer patients prior to their diagnosis with the number received by a group of similar individuals without thyroid cancer. Overall, those who had dental x-rays were twice as likely to develop thyroid cancer.  More than 75% of the thyroid cancer patients were diagnosed before the age of 44. The more dental x-rays that a patient received, the more likely he or she was to develop thyroid cancer: the patients who received more than 10 x-rays had more than 5 times the risk of developing cancer than someone who had not had any dental x-rays.[1]

Mammograms: a Risk for Thyroid Cancer or Not?

The radiation that scatters from the breast to the thyroid gland is so negligible that the risk of developing thyroid cancer in a 40-year-old woman getting a mammogram is 6 in a billion.[3] This is similar to the amount of radiation your thyroid would get by standing outside for 30 minutes. Even if you got mammograms every year from the ages of 40 to 80, your risk of developing thyroid cancer would still only be 1 in 17.8 million, so there’s really no need to use a thyroid shield. In fact, using a thyroid shield during a mammogram makes the image blurry and more difficult for the radiologist to read. And, the thyroid shield can slip out of place and get in the way of the x-ray image, making a repeat exam (potentially exposing you to more radiation!) necessary.[4]

So, if mammograms don’t increase the risk of thyroid cancer, why are women three times as likely as men to be diagnosed with this cancer? Unfortunately, researchers have not yet found the answer to this question. Some believe that it could be related to better detection, and others think it could be a combination of diet, genetics, and the environment.[5]

Other Forms of Imaging

While CT scans of the head and neck are not as common as mammograms or dental x-rays, these can produce a lot of scattered radiation that can be absorbed by the thyroid. Studies have shown that wearing a thyroid shield during CT scans of the head and neck significantly limits radiation exposure to the thyroid gland.[6,7]

What You Need to Know to Keep You and Your Family Safe

  • Wear a thyroid guard during dental x-rays and CT scans.
  • You do not need to wear a thyroid guard during your mammogram. Continue regular mammography as recommended based on your breast cancer risk and age. Click here to learn about the latest mammography guidelines.
  • Try to keep x-rays of all kinds to a minimum, especially in children. Make sure that a scan (x-ray, CT, etc.) is being done only when needed, and that repeat exams are not done more frequently than absolutely necessary. Request that medical records and images be sent to all of the doctors treating you so that they don’t ask you to undergo scans that have already been done.

References:

  1. Schonfeld SJ. Lee C. Berrington de Gonzalez A. “Medical Exposure to Radiation and Thyroid Cancer.” Clinical Oncology 2011; 23:244-250.
  2. “Patient Safety: Radiation Exposure in X-ray and CT Examinations.” RadiologyInfo.org. Accessed April 23, 2012. Available at: http://www.radiologyinfo.org/en/pdf/sfty_xray.pdf.
  3. Sechopoulos I, Hendrick RE. “Mammography and the Risk of Thyroid Cancer.” AJR 2012; 198:705-707.
  4. Kopans DB. “Mammograms and thyroid cancer: The facts about breast-cancer screening” Accessed April 20, 2012. Found at: http://www.massgeneral.org/imaging/about/newsarticle.aspx?id=2720.
  5. Chen AY, Jemal A, Ward EM. “Increasing Incidence of Differentiated Thyroid Cancer in the United States, 1988-2005.” Cancer 2009; 115(16): 3801-3807.
  6. Williams L, Adams C. “Computed tomography of the head: An experimental study to investigate the effectiveness of lead shielding during three scanning protocols.” Radiography 2006; 12: 143-152.
  7. Lee YH, Park E, Cho PK, et.al. “Comparative Analysis of Radiation Dose and Image Quality Between Thyroid Shielding and Unshielding During CT Examination of the Neck.” AJR 2011; 196:611-615.

Arsenic and Lead in our Juice (and You Thought Poisoned Apples Were only in Fairy Tales!)

Diet, Habits, & Other Behaviors, Other Cancers, Skin Cancer
Langan Denhard and Brandel France de Bravo, MPH, Cancer Prevention and Treatment Fund

Arsenic—it’s a scary word with dangerous connotations.Recent studies show that arsenic is present in many everyday beverages and food.In response, Congressman Frank Pallone and Congresswoman Rosa DeLauro introduced a bill named Arsenic Prevention and Protection from Lead Exposure in Juice (APPLE) in early February 2012. If it becomes law, it would require the FDA to set limits within the next two years on the amount of arsenic and lead allowed in fruit juices and other foods.[1]

What are the Dangers of Chronic Arsenic Exposure?

There are two types of arsenic: organic and inorganic.Organic arsenic is usually non-toxic and harmless when consumed.However, the FDA has identified two strains of organic arsenic that can cause cancer: dimethyl arsenic acid (DMA) and monomethyl arsenic acid (MMA).Recent testing by the FDA found small amounts of these strains in apple juice. Inorganic arsenic has been linked to increases in bladder, skin, and lung cancers when consumed in high quantities.It also increases the risk of cardiovascular disease and type 2 diabetes, and weakens the body’s immune system, making it harder to fight respiratory infections and flu. Exposure to high levels of arsenic can cause diarrhea, fatigue, nausea, skin discoloration, and in rare instances, death. Very little research has examined what happens to children exposed to low levels of inorganic arsenic over a long period.A 2004 study led by Columbia University’s Joseph Graziano, PhD, suggests that children who consumed water with arsenic levels above 5 parts per billion (ppb) showed evidence of lowered IQ.[2]

What are the Current Laws in Place Concerning the Levels of Arsenic in Food and Drink?

 

There is surprisingly little regulation on the levels of arsenic allowed in food and drink.According to Michael Taylor, deputy commissioner of the FDA, 23 ppb is the “level of concern” for arsenic concentration in fruit juices but there is no legal limit. Information on the FDA site states, “[The] FDA is collecting all relevant information to evaluate and determine if setting guidance or other level for inorganic arsenic in apple juice is appropriate.”[3] The FDA and the EPA revised the federal limit for arsenic allowable in public water and bottled water to 10 ppb in 2006, noting that the safest level would be 0 ppb.[4] States have the authority to mandate limits below 10 ppb, and New Jersey has the strictest limits, with a maximum level of 5 ppb. State officials caution against consuming or cooking with water at any higher concentration.[5]

Do my Family Members Consume Arsenic?

In November 2011, Consumer Reports completed a study of 88 samples of apple and grape juice that found that 10% had arsenic levels surpassing the drinking-water standards.Of this, most of the arsenic found was inorganic.A sample Walgreen’s grape juice was found to have an arsenic concentration of 24.7 ppb—more than double than the legal limit for drinking water—and most of it (82.9%) was inorganic.Of the two harmful types of organic arsenic, MMA was found in higher concentrations in apple juice whereas DMA was more likely to be found in grape juice.Consumer Reports also found that 35% of children younger than 5 drink more juice than is recommended by pediatricians.[2]

On February 2012, another study, led by a research group from Dartmouth College, presented troubling new findings.In an effort to cut down on the use of high fructose corn syrup as a sweetener, some manufacturers have been making the transition to organic brown rice syrup (OBRS).Because arsenic-based pesticides were once used in rice production, and rice plants are extremely effective in taking in the leftover arsenic from the soil, using syrup made from organic brown rice has resulted in arsenic in infant formula and other commonly used products.[6]

Currently, the only formula brand using OBRS is Nature’s One, which produces Baby’s Only Organic Dairy Toddler Formula and Baby’s Only Organic Soy Toddler Formula.These products were tested against 15 formulas that did not contain OBRS, and it was found that Nature’s One’s products had more than 20 times as much arsenic as the other brands.In a statement published on its web site, the company says, “An independent, third party testing laboratory completed testing on organic brown rice syrup used in formulas produced in 2011. The testing proved there are no safety concerns using the organic brown rice syrup ingredient.”The company has not released test results to the public, “to protect against inaccurate interpretations.”[7]

Cereal bars and “energy shots” are other possible daily sources of arsenic. A little less than half of all cereal bars contain organic brown rice syrup, and when tested, those with OBRS listed in the top five ingredients had the highest concentration of arsenic. At least half of the arsenic tested was inorganic and any organic arsenic was classified as DMA, one of the two harmful forms of organic arsenic.[6]

The Bottom Line

The drinking water limit on arsenic was set at a low level because water is frequently consumed on a daily basis throughout one’s life.For that reason, higher arsenic levels in foods consumed less often are of less concern.Fortunately, arsenic is usually excreted within 2-3 days of consumption.Nevertheless, some experts believe that the arsenic level allowed in water may be too lax, and additional sources of arsenic can add to those risks, especially for children and pregnant women.We need more research to know whether or not it is safe to consume low-levels of arsenic every day.

Meanwhile, the two things you can do are:

  1. make sure your drinking water meets the federal limit of 10 ppb of arsenic, especially if you have a private well or live in a rural area, and
  2. protect your children, whose bodies are smaller and still developing, from unnecessary exposure to arsenic.

It is especially important to protect infants from arsenic exposure until further research is conducted, so avoid formulas and baby foods containing rice products as a main ingredient.Most pediatricians advise against giving your children juice regularly because even when it has no added sugar, it delivers a lot of calories with little nutrition.The presence of arsenic is another reason to ration the juice!

If you are worried about your water supply, call your local health department for a list of labs certified to test for arsenic.The cost of testing ranges from $20-$35[8] NSF International provides extensive information on how to treat your home water.

References:

  1. Congresswoman Rosa L DeLauro. US House of Representatives. Congressman Frank Pallone (D-NJ) and Congresswoman Rosa DeLauro (D-CT) Fight to Protect Children from Arsenic in Apple Juice.Congresswoman Rosa L DeLauro: Representing the Third District of Connecticut. 8 Feb. 2012. Web. 28 Feb. 2012.
  2. “Arsenic in Your Juice:How Much Is Too Much? Federal Limits Don’t Exist.”ConsumerReports.org. Consumers Union, Jan. 2012. Web. 28 Feb. 2012.
  3. “Questions & Answers: Apple Juice and Arsenic.” FDA: US Food and Drug Administration. US Department of Health and Human Services, 16 Dec. 2011. Web. 21 Feb. 2012. <http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm271595.htm>.
  4. “Basic Information about Arsenic in Drinking Water.” EPA: US Environmental Protection Agency. EPA, 26 Jan. 2012. Web. 01 Mar. 2012. <http://water.epa.gov/drink/contaminants/basicinformation/arsenic.cfm>.
  5. Buchanan, Gary A. “NJDEP New Jersey Department of Environmental Protection.” The Official Web Site for The State of New Jersey. 1 Nov. 2010. Web. 01 Mar. 2012. <http://www.state.nj.us/dep/dsr/arsenic/guide.htm>.
  6. Jackson, Brian P., Vivien F. Taylor, Margaret R. Karagas, and Kathryn L. Cottingham. “Arsenic, Organic Foods, and Brown Rice Syrup.” Environmental Health Perspectives (2012). Web. 21 Feb. 20
  7. “ORGANIC BROWN RICE SYRUP CONCERNS.” Nature’s One . Nature’s One, Inc. Web. 21 Feb. 2012. <http://www.naturesone.com/brown-rice/>.
  8. “Arsenic in Private Drinking-Water Wells.” Division of Toxicology and Environmental Medicine. ATSDR, 6 Aug. 2008. Web. 01 Mar. 2012. <http://www.atsdr.cdc.gov/arsenic/>.

Can Sleeping Pills Cause Cancer?

Colon Cancer, Diet, Habits, & Other Behaviors, Lung Cancer, Medical Treatments with Cancer Risks, Other Cancers, Prostate Cancer
Brandel France de Bravo, MPH, Kousha Mohseni, MS, Cancer Prevention and Treatment Fund

When we hear “sleeping pills,” most of us think of prescription drugs such as Ambien (generic name zolpidem), Restoril (temazepam), and Lunesta (eszopiclone).  While prescription sleep medications are big business — more than $41 billion/year in the U.S. many people with trouble sleeping turn to over-the-counter antihistamines such as Tylenol PM and Benadryl.[1]  However, the use of these drugs may take a nosedive in light of the findings of a study published in the prestigious British Medical Journal. Led by researchers at the Scripps Clinic Viterbi Family Sleep Center in California, the study shows that people who take these drugs are significantly more likely to be diagnosed with cancer or to die within the next two and a half years than people who don’t take them. Author Dr. Daniel Kripke estimates that these popular sleep medications could cause 320,000 to 507,000 deaths in just one year.

The researchers looked at 10,529 primary care patients who were prescribed sleeping pills between 2002 and 2007 and compared the health of each of them to at least two very similar patients without such prescriptions who were the same sex, ethnicity, marital status, smoking status, and had similar health conditions, alcohol use and BMI (which measures if a person is overweight). The patients were followed for 2.5 years on average, and were from a Pennsylvania clinic that serves a mainly low-income population.

Sleeping Pills, Death, and Cancer

Patients who were prescribed sleeping pills were at least three to five times more likely to have died during the study than were the patients not prescribed sleeping pills. Even the patients who were prescribed fewer than 18 pills per year were at higher risk of dying: 3.6 times higher. Patients who were prescribed more than 132 pills a year were more than five times as likely to die.

The researchers were careful to exclude from the study patients who were diagnosed with cancer before the study or very early in the study. Heavy users of sleeping pills (over 132 pills prescribed per year) had a 35% greater risk than those with fewer pills prescribed.  Among those with prescriptions for sleeping pills, the increased risk of their developing lymphoma, lung cancer, colon and prostate cancer was greater than the risk from being a current smoker.

Before this study, there were at least 18 other studies showing an increased risk of death for people taking sleeping pills, and several also showed an increased risk of cancer.  However, this study is especially well-designed and the only one that includes the newer, short-acting class of popular sleeping pills known as nonbenzodiazepines. These were generally believed to be safer than previous generations of sleeping pills because they wear off more quickly. In fact, before this study it was believed that the worst side effect was weight gain due to night time raids on the refrigerator while sleep walking.

Among study participants, the most commonly prescribed sleeping pill was zolpidem (sold as Ambien, Edluar, or Zolpimist), followed by temazepam (a benzodiazepine sold as Restoril). However, prescriptions for the use of any sleep aid was associated with a significant increase in the risk of death, including eszopiclone (”Lunesta”), zaleplon (”Sonata”), barbiturates, as well as antihistamines such as diphenhydramine (the active ingredient in Benadryl), which is also used in many over-the-counter sleep aids. The average age of patients was 54, but the study found harm associated with sleeping pill use in every age group.[2]

All the sleeping pills showed a similar increased risk of death except Lunesta, which showed a more than 500% increased risk compared to any of the other sleeping pills.  However, Lunesta was a relatively new drug at the time of the study, and relatively few people took it. For that reason, it is not possible to say whether the risk of Lunesta is really that high.  Also important to note: This study did not evaluate cancer among patients taking Belsomra, a newer sleeping aid with numerous side effects.[3]

One shortcoming of the study is that getting a prescription for a sleeping pill is not the same as taking sleeping pills.  It is possible that some of the people with prescriptions, especially for small numbers of pills, never took any of them. It is also possible that people who did not have prescriptions for sleeping pills took Benadryl or other over-the-counter antihistamines to help them fall asleep, instead of the prescription version of the same pills.  However, those shortcomings would tend to underestimate the risk of sleeping pills, rather than overestimate the risks.

In addition to the major study cited above, there is other evidence linking sleeping pills to cancer.  For example, a study of Taiwanese patients published in 2012 found that Ambien promoted viral infections, which reflects a weakening of a person’s ability to fight off infections and diseases.[4]  That could explain the increased risk of cancer.

Also, a study published in the Korean Journal of Family Medicine in 2018 found that sleeping pills were strongly associated with esophageal, kidney, prostate, liver, stomach and pancreatic cancers. Of all the sleeping pills in the study, Ambien most strongly predicted a diagnosis of cancer.[5]

But Why?

What could possibly explain these increased risks?  Are people who are prescribed sleeping pills more anxious or stressed out? There is evidence that they are more likely to have car accidents or to fall down, probably because of the residual effects of the drugs during the day.  Other studies show an increase in infections among people taking sleeping pills, and that can also increase the risk of cancer and death from other causes. These other studies all suggest that sleeping pills really do increase the risk of dying and there are no logical explanations to explain away the substantial increased risks found in this study, especially the increased risk of cancer.

While the researchers can’t say for sure that the sleeping pills caused death or cancer, many people who used to take these medications should think about these new research findings and consider other, safer ways to fall asleep.  The sleep specialists who conducted the research suggest that since these sleeping pills have limited benefits, old-fashioned sleep aids like warm milk, as well as cognitive-behavioral approaches that can be taught and used for the rest of your life, would be excellent alternatives.  If you decide to toss your sleeping pills, be sure to see our article Drugs in the Drinking Water for tips on safe medicine disposal.

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

References:

  1. Consumer Reports. Why Americans Can’t Sleep. ConsumerReports.org. https://www.consumerreports.org/sleep/why-americans-cant-sleep. Updated January 14, 2016. Accessed October 15, 2018.
  2. Kripke DF, Langer RD, Kline LE. Hypnotics’ association with mortality or cancer: a matched cohort study. British Medical Journal. Open 2012;2:e000850 doi:10.1136/bmjopen-2012-000850
  3. Kripke, D. F. (2015). Is suvorexant a better choice than alternative hypnotics? F1000Research, 4, 456. http://doi.org/10.12688/f1000research.6845.1
  4. Kao, C.-H., Sun, L.-M., Liang, J.-A., Chang, S.-N., Sung, F.-C., & Muo, C.-H. (2012). Relationship of Zolpidem and Cancer Risk: A Taiwanese Population-Based Cohort Study. Mayo Clinic Proceedings, 87(5), 430–436. http://doi.org/10.1016/j.mayocp.2012.02.012
  5. Kim, D.-H., Kim, H.-B., Kim, Y.-H., & Kim, J.-Y. (2018). Use of Hypnotics and Risk of Cancer: A Meta-Analysis of Observational Studies. Korean Journal of Family Medicine, 39(4), 211–218. http://doi.org/10.4082/kjfm.17.0025