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Can a handful of nuts a day keep cancer away?

Breast Cancer, Colon Cancer, Diet, Habits, & Other Behaviors, Ovarian Cancer, Pancreatic Cancer, Prevention, , ,
By Krista Kleczewski, Claire Karlsson, and Edyth Dwyer

Evidence is growing about the many ways in which eating nuts, seeds, and legumes can improve your health. Eating walnuts or legumes like peanuts, beans, or lentils have been linked to healthier hearts and a lower risk of diabetes, but now studies show they may also cut your risk of getting cancer! Here’s what we know and don’t know.

In addition to erroneously thinking that peanuts are nuts, many people think almonds, cashews, and pecans as nuts, but they are actually types of seeds. The difference is based on the plant they grow on, where peanuts grow underground below the plant roots, nuts and seeds grow inside or outside the plant’s fruit. Although this article uses the term “nuts,” the studies we describe include many combinations of nuts, seeds, and legumes. It’s also important to note that each study has different methods, and they need to be interpreted differently. Some studies looked at fewer than 100 people and closely tracked their diet and health, while others were meta-analyses that collected results from many studies of thousands of people and summarized their findings. 

What are some health benefits of nuts?

 In 2015, a Dutch study of 120,000 men and women between the ages of 55-69 found that those who ate about half a handful of nuts or peanuts each day were less likely to die from respiratory disease, neurodegenerative diseases, diabetes, cardiovascular diseases, or cancer than those who consumed no nuts or seeds.[1] The same benefit was not seen for peanut butter, however, which suggests that the salt, vegetable oils, and trans fatty acids in peanut butter may counterbalance the benefits of the peanuts. A serving of nuts is about the size of 30 almonds, and a study found that eating several servings a week had health benefits. A 5-year study conducted in Spain of 7,000 men and women aged 55 to 80 years old found that eating at least three servings of nuts per week reduced the risk of cardiovascular and cancer death.[2] Another study similarly found eating nuts – especially walnuts — reduces the risk of developing cancers, diabetes and heart disease when eaten as a part of the Mediterranean Diet, which also emphasizes fruits, vegetables, whole grains, and legumes.[3] Walnuts were highlighted by the study as reducing inflammation associated with certain cancers and other conditions like diabetes and heart disease. More evidence is needed, however, to determine the specific impact of walnuts on cancer risk.

Breast Cancer

Eating large amounts of peanuts, walnuts, or almonds can reduce the risk of developing breast cancer, according to a 2015 study of 97 breast cancer patients.[4] The researchers compared the lifetime consumption of peanuts, walnuts and almonds among breast cancer patients with the consumption of those without breast cancer, finding that women who ate large quantities were half to one-third as likely to develop breast cancer. No difference was found between people who ate a small amount of nuts, legumes and seeds and those who ate none at all, suggesting that a person needs to consume a substantial amount of these over their lifetime to reduce their chances of developing breast cancer.

Another study looked at the risk of breast cancer for people who ate nuts and peanuts compared to people who did not. Some types of breast cancers respond to the body’s natural hormone estrogen, growing faster when exposed to estrogen. These are called Estrogen Receptor (ER) positive cancers. ER negative cancers are not influenced by exposure to estrogen. In a study of over 4,000 women in the Netherlands, those who ate 10 grams (a large handful) of nuts per day had a 45% lower risk of developing ER negative breast cancer when compared to those who ate no nuts, but it did not significantly affect ER positive breast cancer.[5,6] Since ER negative breast cancer occurs in only a third of the 12% of women who are diagnosed with breast cancer, the risk to the average person decreased overall by about half of 1% when their diet included that many nuts. 

Girls who regularly eat nuts in their diet may be less likely to develop breast cancer as adults. A 2020 study of more than 9,000 girls between the ages of 9-15, and found that girls who regularly ate peanut butter or any kind of nuts were 36% less likely than girls who did not to have developed benign breast conditions when followed up with 10 years later. Although not dangerous, benign breast conditions (such as breast cysts or hyperplasia) increase a woman’s chances of eventually getting breast cancer. [7]

Can eating nuts, legumes and seeds reduce colorectal cancer risk?

To find out whether snacking on foods with peanuts lowers your chances of getting colorectal cancer (also called colon cancer), researchers studied more than 23,000 adults in Taiwan, ages 30 and older.[8] The researchers reported in 2006 that women who ate meals with peanut products at least twice each week were less likely to develop colorectal cancer. More research is needed to see if this benefit is actually from the peanuts.

A 2021 meta-analysis collected results from over 40 studies, and it examined whether eating more nuts would have an impact on colon cancer risk. Researchers found that eating 5 grams of nuts per day could decrease the risk of colon cancer by 25%.[9] Since the lifetime risk of colon cancer is about 4%, a 25% reduction would mean a decrease from 4% to 3% of the overall risk of colon cancer for people regularly eating nuts. Five grams is about 5-6 almonds, and this study found that the benefits of eating nuts started for people averaging just 2 grams per day and continued to decrease for people eating up to 9 grams per day.  After that, the effects leveled off, so eating more than 9 grams was not more beneficial than eating 9 grams. A meta-analysis combines results from many studies, so the 2-9 grams per day were average amounts, whether the person eats them all in one day or spread out over the course of a week. 

In one of the largest studies of diet and cancer, which was conducted in 10 European countries, researchers discovered that eating nuts and seeds reduced women’s chances of developing colon cancer, but did not lower the risk for men.[10] Women who ate a modest daily amount of nuts and seeds (about 16 peanuts or a small handful of nuts or seeds) every day were less likely to develop colon cancer, and women who ate the largest quantities of these foods were the least likely to develop colon cancer. Again, more research is needed to understand these findings.

Researchers have also investigated whether a diet containing nuts and peanuts can improve patient chances of survival for those who have already been diagnosed with colon cancer. In a study of over 800 patients with advanced (stage III) colon cancer, patients who ate more nuts were more likely to survive after treatment, without being re-diagnosed with colon cancer.[11] This study measured a serving of nuts to be one ounce, or about 15 cashews. When compared to those who ate no nuts, those who ate 2 or more servings of nuts per week had 46% lower risk of re-diagnosis of their cancer, as well as a 53% lower risk of dying from the cancer. This study has several important limitations to keep in mind. Not only was it a relatively small study, but it only examined Stage III colon cancer patients, comparing cancer patients who ate nuts to those who did not eat nuts. This means that the results cannot be generalized to the average American’s risk of colon cancer. 

Pancreatic Cancer

Eating nuts also seems to lower the risk of developing diabetes, which may then lower the risk of developing pancreatic cancer.[12] In addition, a large study of women found that frequently eating nuts was associated with less chance of developing pancreatic cancer,13 one of the most deadly cancers.

A 2021 meta-analysis that examined results from over 30 studies, found that the chances of developing pancreatic cancer risk decreased for those who ate more nuts. The average lifetime risk of developing pancreatic cancer is about 1.5%. Because the results show a 6% lower risk for those eating nuts, this means the overall risk of pancreatic cancer may lower from 1.5% to 1.4% for people who regularly eat nuts.[9]

Ovarian cancer

A 2010 study examined the possible link between ovarian cancer and foods high in phytoestrogens and/or fiber, including nuts, beans, and soy.[15] They found that these foods seemed to help prevent “borderline ovarian cancer”—slow-growing tumors that are less dangerous and more likely to affect younger women. However, these foods did not seem to protect against the more aggressive types of ovarian cancer.

What makes nuts good for your health?

There is still some debate about why nuts might be so beneficial. Omega-3 fatty acids are found in peanuts, walnuts, and some seeds, and researchers think their health benefits may help to prevent cancer.[16] The omega-3 acids can help protect cell structures and walls, and since they are anti-inflammatory; that might reduce the risk of cancer for people who regularly eat peanuts, walnuts, and seeds. [17]

Some research has shown that walnuts can also improve your gut biome, meaning it helps you grow healthy bacteria in your gut.[18]  To test this, an experiment was done on 18 people, where some were assigned to eat walnuts and others ate no nuts. Blood and fecal samples were tested, and researchers were able to see changes in the bacteria, and lower levels of “secondary bile” which suggests the nuts decreased inflammation in their intestines. This experiment studied a very small group of people, so more research is needed to understand why these nuts, seeds, and legumes improve the risk of cancer over a lifetime. 

 

The Bottom Line

There is growing evidence that nuts, legumes, and seeds reduce the risk for several types of cancer, as well as having other health benefits. Researchers are still investigating whether the health benefits of nuts are because people who eat nuts have a healthier overall diet, but tree nuts seem to have some health benefits on their own. Peanuts and peanut butter may also have benefits, but the higher levels of fat and sodium could explain why these legume products show fewer health benefits. Peanuts, walnuts, almonds, and other nuts are high in calories, so don’t overdo it. It seems safe to assume that adding these foods to your diet, in small quantities several times a week, is a good idea, especially if you use them to replace less healthy snacks.

 

 

 

  1. Brandt, P., & Schouten, L. Relationship of tree nut, peanut and peanut butter intake with total and cause-specific mortality: A cohort study and meta-analysis. (2015). International Journal of Epidemiology, 44(3), 1038-1049. doi:10.1093/ije/dyv039  
  2. Guasch-Ferré, M., Bulló, M., Martínez-González, M.A., Ros, E., Corella, D., et al. Frequency of nut consumption and mortality risk in the PREDIMED nutrition intervention trial. (2013). BMC Med; 11: 164. doi: 10.1186/1741-7015-11-164  
  3. Toner, CD., Communicating clinical research to reduce cancer risk through diet: Walnuts as a case example (2014). Nutr Res Pract. 8(4): 347–351. doi: 10.4162/nrp.2014.8.4.347  
  4. Soriano-Hernandez, A.D., Madrigal-Perez D.G., Galvan-Salazar H.R., Arreola-Cruz A., Briseño-Gomez L., Guzmán-Esquivel J., Dobrovinskaya O., Lara-Esqueda A., Rodríguez-Sanchez I.P., Baltazar-Rodriguez L.M., Espinoza-Gomez F., Martinez-Fierro M.L., de-Leon-Zaragoza L., Olmedo-Buenrostro B.A., Delgado-Enciso I. (2015). The Protective Effect of Peanut, Walnut, and Almond Consumption on the Development of Breast Cancer. 2015;80(2):89-92. doi: 10.1159/000369997.  
  5. van den Brandt P.A., Nieuwenhuis L. Tree nut, peanut, and peanut butter intake and risk of postmenopausal breast cancer: The Netherlands Cohort Study. Cancer Causes Control, (2018). 29(1):63–75.
  6. Putti T.C., El-Rehim D.M.A., Rakha E.A., Paish C.E., Lee A.H.S., Pinder S.E., et al. Estrogen receptor-negative breast carcinomas: a review of morphology and immunophenotypical analysis. (2005). Mod Pathol, 18(1):26–35.
  7. Berkey C.S., Tamimi R.M., Willett W.C., Rosner B., Hickey M., Toriola A.T., et al. Adolescent alcohol, nuts, and fiber: combined effects on benign breast disease risk in young women. (2020). NPJ Breast Cancer;6(1):61.
  8. Yeh, C. C., You, S. L., Chen, C. J., & Sung, F. C. Peanut consumption and reduced risk of colorectal cancer in women: a prospective study in Taiwan. (2006). World Journal of Gastroenterology, 12(2), 222.  
  9. Naghshi, S., Sadeghian, M., Nasiri, M., Mobarak, S., Asadi, M., Sadeghi, O. Association of total nut, tree nut, peanut, and peanut butter consumption with cancer incidence and mortality: A comprehensive systematic review and dose-response meta-analysis of observational studies. (2021). Adv Nutr, 12(3):793–808.
  10. Jenab, M., Ferrari, P., Slimani, N., Norat, T., Casagrande, C., Overad, K., Riboli, E. et al. Association of nut and seed intake with colorectal cancer risk in the European Prospective Investigation into Cancer and Nutrition. (2004). Cancer Epidemiology Biomarkers & Prevention, 13(10), 1595-1603.  
  11. Fadelu T., Zhang S., Niedzwiecki D., Ye X., Saltz L.B., Mayer R.J., et al. Nut consumption and survival in patients with stage III colon cancer: Results from CALGB 89803 (alliance). (2018). J Clin Oncol,36(11):1112–20.
  12. Jenkins, D. J., Kendall, C. W., Banach, M. S., Srichaikul, K., Vidgen, E., Mitchell, S., Josse, R. G., et al. Nuts as a replacement for carbohydrates in the diabetic diet. (2011). Diabetes care, 34(8), 1706-1711.  
  13. Bao, Y., Hu, F. B., Giovannucci, E. L., Wolpin, B. M., Stampfer, M. J., Willett, W. C., & Fuchs, C. S. Nut consumption and risk of pancreatic cancer in women. (2013). British journal of cancer.  
  14. Lee J.T., Lai G.Y., Liao L.M., Subar A.F., Bertazzi P.A., Pesatori A.C., et al. Nut consumption and lung cancer risk: Results from two large observational studies. (2017). Cancer Epidemiol Biomarkers Prev,26(6):826–36.
  15. Hedelin, M., Löf, M., Andersson, T. M. L., Adlercreutz, H., & Weiderpass, E. Dietary phytoestrogens and the risk of ovarian cancer in the women’s lifestyle and health cohort study. (2011). Cancer Epidemiology Biomarkers & Prevention, 20(2), 308-317.  
  16. Fabian C.J., Kimler BF, Hursting S.D.. Omega-3 fatty acids for breast cancer prevention and survivorship. (2015) Breast Cancer Res;17(1):62. https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-015-0571-6
  17. Freitas R.D.S., Campos M.M.. Protective effects of omega-3 fatty acids in cancer-related complications. (2019). Nutrients;11(5):945. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6566772/#:~:text=Omega%2D3%20polyunsaturated%20fatty%20acids,structure%20and%20fluidity%20of%20membranes
  18. Holscher H.D., Guetterman H.M., Swanson K.S., An R., Matthan N.R., Lichtenstein A.H., et al. Walnut consumption alters the gastrointestinal Microbiota, microbially derived secondary bile acids, and health markers in healthy adults: A randomized controlled trial. (2018). J Nutr;148(6):861–7.

What would impact of 21st Century Cures Act be on cancer and your healthcare costs?

In the News, Legislation, New Cancer Research, Policy
 NOVEMBER 23, 2015

This summary of an analysis published online in the prestigious medical journal BMJ on November 23, 2015, shows that using preliminary research to approve new medical treatments has high costs for patients’ lives and healthcare dollars.  These three very promising medications did not work, and one of them caused skin cancer and also made Alzheimer’s symptoms worse.

21ST CENTURY CURES ACT AND SIMILAR POLICY EFFORTS: AT WHAT COST?

BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h6122 (Published 23 November 2015) Cite as: BMJ 2015;351:h6122

By Diana M Zuckerman, Nicholas J Jury, and Christina E Silcox

A controversial proposed law in the United States, the 21st Century Cures Act, is described by supporters as an innovative attempt to jump start the process of finding new cures for the thousands of diseases that currently lack effective treatments. But would this bill promote new cures, or increase the availability of new medical products that do not necessarily work? Alzheimer’s disease is often cited as an example of a devastating disease with enormous costs and no cure in sight. We examine the potential harms and costs that would have been incurred by three Alzheimer’s drugs that were rejected under current Food and Drug Administration approval standards but could have been approved under the standards promoted by 21st Century Cures and similar legislation.

We selected for analysis all the Alzheimer’s drugs reviewed by the FDA within the past five years for which a determination was made, to determine the likely impact of the proposed changes on their approval.

All three drugs had impressive results in preliminary clinical trials.  Two of the drugs showed great improvement based on the well-established biomarker of beta amyloid plaques on the brain, and the third based on tests of memory and cognition.  When larger, better designed clinical trials were conducted, however, two of the Alzheimer’s drugs were found to be ineffective, and the third drug caused an increase in memory problems and an increase in skin cancer.

Cost estimates

More than five million patients in the US have Alzheimer’s disease, about 1.3 million of whom are being treated with an Alzheimer’s drug. To conservatively estimate market share, we looked at the cholesterol lowering drug atorvastatin (Lipitor), which garnered 18% of market share during its first year on the US market based on biomarker data. If one of these drugs had gained a similar market share it would translate to 234,000 patients a year taking a drug that put them at risk of a greater loss of cognitive skills than if they had taken a drug already on the market, or perhaps no treatment at all. If semagacestat was the drug approved, almost 19,000 more patients would have developed skin cancer, based on the phase III results.

Most current Alzheimer’s drugs are available as generics, which has reduced their price. Donepezil has most of the US market share. The brand name version (Aricept) costs about $7500 a year at Walgreens, the largest pharmacy chain in the US. The brand name versions of memantine, galantamine, rivastigmine, and memantine-donepezil each cost over $5000 a year at Walgreens.

New drugs are priced based on the current market price of competing drugs, not on research and development costs. A conservative estimate is that a promising new Alzheimer’s drug would be priced similarly to Aricept ($7,500 a year). This is 87% more than generic donepezil, almost doubling the cost for any patient who switched to the new drug.

Assuming 18% of the market share before postmarket studies  are completed, we estimate the cost of treating 234,000 patients at $1.76 billion a year, or $7 billion over four years until postmarket studies were completed.  Given the modest benefit of current Alzheimer’s drugs, and the impact of current direct-to-consumer advertising practices in the US, a promising new drug would be expected to garner higher prices and more prescriptions, so the cost could easily double.

Since the cognitive abilities of patients with Alzheimer’s disease tend to worsen over time regardless of treatment, it would be virtually impossible for physicians to realize that semagacestat was causing cognitive decline or that the other drugs were ineffective. Physicians would also have been unlikely to notice that semagacestat increased patients’ risk of skin cancer. It would not have been until post-market phase III studies of cognitive and health outcomes were completed years later that physicians and families would have realized that the drugs were ineffective and possibly harmful.

Under pressure from Congress and industry, FDA standards have loosened in recent years, and the agency often approves products based on biomarkers that have good but inconclusive evidence of clinical benefit. For example, cancer drugs are often approved based on tumor shrinkage or progression-free survival and studies conducted after the drugs are in widespread use have shown that many do not help patients live longer. Osteoporosis drugs have been approved based on bone mineral density or microscopic bone fractures, rather than hip fractures that harm health. The proposed law and several other Congressional proposals would weaken current FDA standards further. As our examples show, this could to lead to patients taking ineffective and potentially harmful drugs and waste billions of healthcare dollars.

Read the whole article here.

The 21st Century Cures Act could be a harmful step backward

In the News, News Stories & Editorials
Susan F. Wood and Diana Zuckerman, The Washington Post
November 19, 2015

Precision medicine is the next big thing in health care, and it’s also one of the few health goals that Congress and the White House agree on. But while we await treatments targeting the precise genetic makeups of individuals and diseases, medical researchers still are not paying enough attention to the most important kinds of differences among patients: those of sex, age and race.

A clear example of this disconnect is the 21st Century Cures Act, which was passed overwhelmingly by the House of Representatives and is being scrutinized by the Senate. The stated goal of the bill is wonderful: to stimulate the development of new cures for a range of diseases. Many medical schools and patient organizations are supporters, since the proposal would provide almost $9 billion more for the National Institutes of Health — including a boost for precision medicine. The 360-page bill offers other potential benefits as well. But an immediate impact would be to ignore how differences between men and women and younger and older patients influence the safety and effectiveness of many medical products.

Throughout the 20th century, most medical research was conducted on relatively young, healthy men. In recent years, researchers have realized that treatments often affect women and older patients differently than men or younger patients. These differences can affect safety and effectiveness. The sleeping pill Ambien, for example, makes women drowsier for longer periods than it does men, putting them at risk if they drive the next morning. Since most medications are taken by people older than 65 and women of all ages, it makes sense to analyze the effects of age and sex on the drugs’ safety and effectiveness before they can be sold.

But the 21st Century Cures Act is based on the assumption that there will be more cures if drugs and devices are studied more quickly by testing them on fewer patients — in some cases, on just a handful. Unfortunately, such studies would be too small to allow safety and effectiveness findings to be broken down for subgroups such as men, women, young adults and seniors.

This embrace of smaller, more preliminary studies could drastically lower scientific standards. When fewer people are studied, it is more likely that a drug will seem safe and effective even if it has dangerous side effects for many patients — who may not have been included in those small studies.

In addition to allowing smaller studies, the House bill would encourage the Food and Drug Administration to determine a drug or device’s effectiveness based on “clinical experience,” which the bill defines to include the experience of one or more doctors or patients. Scientists call these anecdotes and note that just because one doctor has had success treating a few patients with a particular drug does not prove it is either safe or effective. Worse, the bill specifies that after studying only small groups of patients, drug manufacturers could sell a new treatment to anyone, even if the patient was not among the types studied. In fact, hospitals would be paid extra to make it financially feasible to prescribe more expensive new drugs to Medicare patients, even if the drugs were never studied on patients older than 65 (the age of most Medicare patients).

Similarly, lifesaving medical devices, such as heart valves, could be approved based on case histories, which are written descriptions of the experiences of just one or two patients. They are unlikely to be good predictors of how a treatment helps or harms most patients.

The recalls of drugs such as Vioxx and devices such as metal-on-metal hips in recent years have made clear that inadequate testing can produce ineffective and harmful products. And since new drugs tend to be much more expensive than older ones, the costs of widely used, unproven medical products can be enormous in both human and economic terms.

These sections in the 21st Century Cures Act go in the opposite direction of the push for precision medicine and what we’ve learned about differences between male and female and older and younger patients. The General Accountability Office has concluded that the NIH needs to make a priority of analyzing data related to sex differences. Just three years ago, the House and Senate overwhelmingly passed legislation that directed the FDA to ensure that men and women, old and young, are studied, with results analyzed to see which treatments are safest and most effective for whom. Why is Congress undermining that law?

Congress should surely increase funding for research to find 21st-century cures, but the price should not be returning to early-20th-century standards, when unproven medical products were widely available and often put all Americans at risk.

See the article here.

Children and Cell Phones: Is Phone Radiation Risky for Kids?

Brain Cancer, Environmental Exposures, Prevention, , , , ,
Hannah Kalvin

Children use cell phones to watch TV, play games, make phone calls, and send text
messages.  Many older kids and teens have their own cell phones, which they are attached to kid texting24/7. But are there risks to such frequent use by children, and if so is that different than the risks for adults?

Cell phones emit a type of radiation that is known as Radio Frequency-Electromagnetic Radiation (RF-EMR), also referred to as microwave radiation. There have been concerns from the scientific community about whether or not cell phones are safe. Cancer is a particular concern, but since cancers take 10-20 years to develop and children’s frequent cell phone use is a relatively recent development, there are more questions than answers.  To read more about whether we should be worried about cell phone radiation in general, read our article here.

There are several studies of the impact of cell phone radiation on children. Here are some of the conclusions so far:

  • A 2010 study of cell phone radiation noted that, “in general and on average, children suffer a higher exposure of their brain regions than adults.”  This is because children have proportionally smaller heads and brains, yet receive the same levels of cell phone radiation as adults.1 The American Academy of Pediatrics agrees, saying that “when used by children, the average RF energy deposition is two times higher in the brain and 10 times higher in the bone marrow of the skull, compared with mobile phone use by adults.”2
  • Another study found that people who begin using cell phones (and cordless landline phones) before the age of 20 are at an even higher risk of developing brain tumors than people who begin using these wireless phones as adults.3,4 This is because of the closer proximity of the source of radiation to the brain of kids (they have thinner tissues and bones than adults).
  • Research also suggests that cell phone exposure could affect children’s behavior.5 The children in the study who were hyperactive or had emotional or behavioral problems, including trouble getting along with other kids, were much more likely to have mothers who used cell phones during pregnancy. After accounting for other factors that could affect behavior, the children of these mothers were 80% more likely to have behavioral problems than children whose mothers rarely or didn’t use cell phones. However, this is difficult to study because mothers who use cell phones frequently during pregnancy or after the baby is born, may pay less attention to their children, resulting in the children’s bad behavior. More research is needed to understand the link between mother’s cell phone use and children’s behavior.
  • Children that used cell phones more were more likely to have ADHD. Although the link to ADHD was only for children who also had high levels of lead in their blood, when researchers adjusted for blood lead level, they still found that ADHD was more likely for children who made more phone calls and spent a longer amount of time on the phone.6 This study was conducted in Korea, so it would be important to do similar research on children living in other countries.
  • A 2014 article reviewing studies on children and their cell phone use found that the younger the child, the greater the risk of brain cancer and brain tumors. The same article also points to studies concluding that cell phones are associated with an increased risk of breast cancer (due to adolescents putting cell phones in their bras), parotid (salivary) gland tumors, and sperm damage for adolescents and adults.7

Reactions To Research About Cell Phone Radiation

In 2012, the American Academy of Pediatrics wrote a letter to the Federal Communications Commission, which sets the standards for cell phone radiation in the United States, and recommended that they reevaluate these standards since this had not been done since 1996. Their reasoning is that “children, however, are not little adults and are disproportionately impacted by all environmental exposures, including cell phone radiation.”2 But, as of 2015, the FCC still says that there is no evidence between wireless device use and health problems and continues to uphold the regulations from 1996.8 Other countries have taken a different approach. As of 2014, Turkey, Belgium, Australia, and France have warned about the dangers of children’s cell phone usage.7

 

Conclusions

Scientists disagree on whether cell phone radiation can cause cancer or other health problems.  Since so many children and adults use cell phones so frequently, that makes it difficult to do a study comparing high and low cell phone usage.  And since brain tumors and other cancers usually do not develop until several decades after the initial exposure, it could be years before we know how risky cell phones are and under what circumstances.7

By the time we find out, many people will have been harmed if cell phones are found to be dangerous. Here are some precautionary tips on how to protect your children from the health issues that could be connected to cell phone radiation.9

  1. Turn airplane mode on when giving a child a technology device or when a cell phone is near a pregnant abdomen, to prevent exposure to radiation.
  2. Turn off wireless networks and devices to decrease your family’s radiation exposure whenever you aren’t actively using them. As an easy first step, turn your Wi-Fi router off at bedtime.
  3. Decrease use of phones or wifi where wireless coverage is difficult, in order to avoid an increase in radiation exposure.
    The warning about RF exposure found on an iPhone 5s.
    The warning about RF exposure found on an iPhone 5s.
  4. Use the speaker phone or a plug in earpiece when you use a cell phone. To protect children from radiation, they should not use cell phones except in emergency and should use the speaker phone.
  5. Increase the distance between you and your cell phone whenever it is on, to reduce your exposure to radiation emitted. For example, do not use a cell phone while a child is on your lap, and do not carry your cell phone in your baby carrier, crib, or pockets. When the phone is on, tell your kids to put it in a backpack as far from their body as possible (such as an outside pocket) or on the desk or other furniture at home, instead of holding it or carrying it in a pocket.
  6. Read the fine print: All device manufacturers advise that cell phones should be at least 5 millimeters, or about ¼ of an inch away from your body or brain. With the iPhone 6 and the iPhone 6s, the company advises users to keep the cell phone at least 10 millimeters, or about half an inch, away from your body or brain. See the safe distance for your phone. For iPhone 5 and iPhone 6, this is located under: Settings -> General -> About -> Legal -> RF Exposure.
  7. Share this info with your friends, family, and schools so that they can make these simple changes as well.

 

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

Testimony of Dr. Anna Mazzucco before the FDA on “Framework for Regulatory Oversight of Laboratory Developed Tests”

Policy, Testimony & Briefings
By Dr. Anna Mazzucco
January 8, 2015

Thank you for the opportunity to speak today at this very important meeting.  My name is Dr. Anna Mazzucco, and I am speaking on behalf of the National Center for Health Research.   I received my Ph.D. in cell biology from Harvard Medical School, and I conducted post-doctoral research here at NIH. Our nonprofit organization conducts research, scrutinizes data in the research literature, and then explains the evidence of risks and benefits to patients and providers.  [Our organization does not accept funding from companies that sell medical products, and therefore I have no conflicts of interest.]

I am speaking as a scientist who appreciates the power of data and who also wants patients and physicians to have the best information possible before they make potentially life and death decisions.  The FDA released new guidance on laboratory-developed tests because of evidence that patients are harmed by faulty tests.

We applaud the FDA for their plan to improve oversight of lab tests and the NIH for their commitment to medical care. We have a few key points:

  • Many of these tests are used to diagnose a disease or determine a course of treatment.  If the test doesn’t work correctly, the patient may be exposed to risks from a treatment they didn’t need, OR not receive treatment that would help them.
  • When the FDA started regulating devices almost 40 years ago, these tests were very different.  They are now widespread and are the basis of high-risk decisions.
  • Under CLIA, test makers do not have to demonstrate “clinical validity”.  At FDA, approval standards include safety and effectiveness.  FDA review will improve transparency and data quality.
  • Current policies do not require adverse event reporting or manufacturing safeguards.  FDA approval does.  Patients using high-risk diagnostics deserve those protections.

Our Center has frequently urged the FDA to improve their oversight of medical devices. Despite past criticisms, we believe it is essential that FDA have the authority to regulate laboratory-developed tests in order to stimulate even better science, and help ensure that patients receive the full benefit of our growing scientific knowledge.

To paraphrase Dr. Josh Sharfstein’s JAMA article:

Patients travel in ambulances that are regulated, to hospitals that are regulated, for care using medicines that are regulated, administered by nurses and physicians, who are regulated. That same patient’s life or death should NOT depend on whether an unregulated diagnostic test result is accurate.

Thank you for the opportunity to speak today.

Senate counterpart to 21st Century Cures bill is struggling

In the News, News Stories & Editorials
BRETT NORMAN, POLITICO
OCTOBER 25, 2015

 

The Senate’s companion effort to the House-passed 21st Century Cures is struggling to navigate a dramatically different political reality than the one that helped rocket the medical innovation bill through the lower chamber over the summer.

The HELP Committee is aiming to release its draft of the Innovations for Healthier Americans Act next month, but it missed earlier targets in September and October. If it’s not out soon, it won’t be possible to gather feedback and mark it up by the end of the year – the goal Chairman Lamar Alexander (R-Tenn.) has set.

It will make fewer changes to how FDA reviews medical treatments – and will likely be less expensive – than the Cures bill the House overwhelmingly passed in July.

Since the summer, the debate over high prescription drug costs has intensified and complaints from public safety groups about Cures’ FDA reforms have grown louder. That’s drawn added scrutiny from Democrats to provisions viewed as pharma-friendly, as well as pressure to address drug prices, a highly partisan topic on the Hill.

[…]

“You have a House bill that has many negative aspects from a public health point of view and has one big positive aspect – a lot of additional money for NIH,” said Diana Zuckerman, president of the National Center of Health Research, and a critic of the House Cures bill. “You have a Senate that cannot create that same big pay-for. You can see why it’s not moving that quickly.”

[…]

The Senate is a very different place. The bill moved so quickly through the House that “by the time the criticism started coming out, it had already passed,” Zuckerman said.

Read the full article here.

 

Approved but not proven: what’s up with FDA, cancer drugs?

In the News, News Stories & Editorials
Nick Mulcahy, Medscape Medical News
October 22, 2015

In approving new cancer drugs, the US Food and Drug Administration (FDA) is now heavily relying on surrogate markers of effectiveness, such as tumor shrinkage, instead of proof that an agent improves survival, according to a new analysis.

The investigators conclude that this might be having a deleterious effect on patients, public health, and healthcare costs.

“Our results suggest that the FDA may be approving many costly, toxic drugs that do not improve overall survival,” write Chul Kim, MD, MPH, from the National Cancer Institute (NCI), and Vinay Prasad, MD, MPH, from the Knight Cancer Center at the Oregon Health and Sciences University in Portland.

[…]

Lack of follow-up is part of the problem here.

Postmarketing studies with results are missing for about one-third of the drugs approved with surrogates. This means that the survival effect of 13 of the 36 drugs approved on the basis of surrogate markers is still untested or without reported results.

Enforcement of postmarketing studies is of “critical importance,” Drs Kim and Prasad write.

Their study is timely, given Congressional debate on how the FDA approves drugs and medical devices. In July, the House passed the 21st Century Cures Act, which encourages the use of surrogate markers as one way to speed new drugs to market. Opponents of the legislation, however, say that its lax standards would permit unsafe and ineffective products to reach the marketplace. The Senate is deliberating its own version of the House bill.

Surrogate markers, especially tumor response rate, should not be used to approve cancer drugs, according to a critic of the approval process for cancer drugs in the United States.”It’s outrageous that tumor shrinkage is a basis of approval,” said Diana Zuckerman, PhD, from the National Center for Health Research in Washington, DC, who was asked for comment.”Cancer drugs are good at killing cancer cells,” Dr. Zuckerman told Medscape Medical News. Thus, tumors respond to the toxic agents and die or shrink, which is typically captured by radiographic imaging and is reported as an overall rate in clinical trials. But the problem is that they also kill healthy cells, and overall survival might not improve.

“It’s important to know if the patient will live longer,” she said.

In their study, half the drugs (18 of 36) approved on the basis of surrogate markers were eventually found to not improve survival, Drs Kim and Prasad report.

Pharmaceutical companies have “no incentives” to speed up the survival discovery process, unless early signs of survival improvement are obvious, said Dr. Zuckerman, whose nonprofit think tank receives funding from individuals and foundations and focuses on the safety, efficacy, and quality of healthcare in the United States.

But the FDA has incentives to approve drugs on standards less stringent than improved survival, she noted.

“The FDA is trying so hard to please Congress and industry that they are approving drugs on the basis of flimsy evidence, and patients are being harmed,” she said.

Agency budget is one of the motivators for the FDA to loosen its standards, Dr. Zuckerman explained.

The use of surrogates in cancer drug approval seems to be here to stay, she said, citing a personal conversation she had with an ex-FDA official. There is no real debate about using progression-free instead of overall survival. “That ship has sailed,” she said, repeating her source’s comments.

The NCI has also transitioned to emphasizing progression-free survival as a primary outcome in its funded studies, she observed.

However, some of the drugs approved using surrogates during the study period have been hailed as practice-changing and have led to dramatic improvements. For example, vismodegib (Erivedge), which was approved in 2012 for locally advanced or metastatic basal cell carcinoma on the basis of treatment response rate, was called “the greatest advance in therapy yet” in an editorial published that year in the New England Journal of Medicine (2012;366:2225-2226).

Dr. Zuckerman was not swayed. “Some patients have been helped by approvals using surrogates, but the vast majority have not,” she opined. As Drs Kim and Prasad report, half of the drugs did not improve survival despite approval, and only five of 36 have been proven to improve survival, she added.

Read the full article here.

Comments of Members of the Patient, Consumer, and Public Health Coalition on “Testicular Toxicity: Evaluation During Drug Development – Guidance for Industry”

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Comments of Members of the Patient, Consumer, and Public Health Coalition on “Testicular Toxicity: Evaluation During Drug Development – Guidance for Industry” [Docket No. FDA-2015-D-2306-0001]

We appreciate the opportunity to provide feedback to the FDA on the evaluation of testicular toxicity during drug development. The recommendations in the draft guidance are very important and we support the FDA’s effort to better characterize drug-induced testicular toxicity.

The Cancer Prevention and Treatment Fund is a charity that helps children and adults learn how to reduce their risk of cancer, and assists them in choosing the safest and most effective treatments. The Fund is a program of the National Center for Health Research. We are dedicated to enhancing the ability of the Food and Drug Administration (FDA) to promote and protect the health of adults and children through enforcement of the Food, Drug and Cosmetics Act.

As recognized by the FDA, the effects of many medications on male infertility are either unknown or inconclusive. Testicular toxicity (TT) is a sporadic and challenging issue in pharmaceutical drug development. Although the incidence of TT in pharmaceutical development is typically lower than the incidence of hepatic and renal toxicity, TT presents a challenging issue due to the lack of accurate and precise screening methods. The standards proposed in the Draft Guidance will advance the FDA’s ability to protect the public from drugs with the potential to cause testicular toxicity.

In an effort to strengthen the proposed safeguards, we suggest the following changes to the Draft Guidance:

Section III: Nonclinical Evaluation

The Draft Guidance recommends repeat-dose toxicology studies with at least 4 weeks of drug exposure in two species. We suggest a study duration of at least 3 months based on evidence reported in the literature. For example, a recent survey found that, while TT was generally identified in studies of short duration (less than or equal to 4 weeks), two sponsors indicated that TT had been identified only in studies of greater than or equal to 3 months duration: one detected TT in a 3-month rat study and the other saw TT in a 6-month rat study and in a dog study of more than 6 months in duration.[1]

We also recommend that sponsors be required to submit all data from all species tested for testicular toxicity, and that discordant results from different species be transparent. Furthermore, if rodent studies are concerning but studies in large animal species do not raise the same level of concern, the sponsor should be expected to provide additional studies to help clarify the toxicity profile if the discrepancy cannot be explained. Sasaki et al. noted that it is frequently the case that testicular findings attributable to toxicity are recognized in only one of the two species used for preclinical toxicity testing. And, importantly, experience has shown it is usually not possible to dismiss findings in rodents based solely on the absence of similar observations in the large animal species.[2] Despite this fact, about half of the sponsors in the study would dismiss worrisome rodent findings, if the toxicity was not corroborated in the second species tested.[3]

While the Draft Guidance recommends demonstration of the reversibility of an adverse finding after cessation of dosing, we recommend the sponsor be required to explain the rationale for the timing and length of the recovery period. The justification should include consideration of the drug’s half-life and time required to achieve off-drug pharmacokinetic and pharmacodynamic steady state. Data provided in the survey by Sasaki et al. note the importance of a suitable duration of recovery. One sponsor reported worsening of testicular changes during the 28-day recovery period following a 28-day rat study. Another sponsor noted that, for one project, TT was only conclusively identified in a 3-month dog study after similar findings in the 1-month dog study had been dismissed as background lesions. The findings in the 3-month dog study suggested that mature germinal cells were affected, which may be why the lesion appeared to significantly worsen after 1 month.[4] Because a drug may have lingering effects on upregulation or downregulation of receptors and other biochemical processes, the recovery period parameters (timing, length, etc.) must be transparently explained in the context of the drug’s biochemical effects.

Section IV. Monitoring of the Testes During Clinical Trials

The Draft Guidance recommends semen analyses be completed at baseline and at 13 weeks (one spermatogenic cycle) after initiation of the investigational drug. If adverse effects are seen during the first 13-week period, another 13-week evaluation, at one spermatogenic cycle (13 weeks) after final exposure to the investigational drug, is recommended to assess for recovery of changes in semen parameters. We recommend specifying that the first 13-week analysis must occur after the drug reaches steady-state concentrations, or at least 3 half-lives after initiation of the investigational drug. Likewise, if an analysis is completed after the final exposure, the Guidance should specify that it occur at least 3 half-lives after the end of dosing. This recommendation would be particularly critical for drugs with long half-lives, where the drug would not have reached its steady-state concentration at the end of only 13 weeks. For example, amiodarone, with a half-life of 58 days, would not be expected to reach steady state concentrations until about 25 weeks after its initiation.

In fact, the Final Guidance should require all preclinical and clinical analyses to occur on a timeline that can be justified based on the particular investigational drug’s unique pharmacokinetic and pharmacodynamic parameters.

Section V. Design of a Clinical Trial to Evaluate the Effect of a Drug on the Testes

The primary endpoint suggested in the Draft Guidance is a 50% decline in sperm concentration from baseline. A 50% decrease is a very large decrease and, at this time, no standard percent decline that predicts testicular toxicity has been identified. A smaller change may be relevant on a clinical and population level. We recommend substantially reducing the minimum decrease required as a primary endpoint or providing solid documentation to justify the use of such a large change in sperm concentration as a primary endpoint.

If you have any questions, please contact Tracy Rupp, PharmD, MPH, RD at tr@center4research.org or 202-223-4000.

Cancer and Military Service

In the News
Nicholas J. Jury, PhD and Diana Zuckerman, PhD
2015

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Cancer has many causes.  The main ones that experts can identify are linked to heredity and environment.  Members of the military and their family members have the same risks from heredity as others do, but are sometimes at higher risk of certain cancers because of exposures in their environment.

Can Military Service in Afghanistan and Iraq Increase Cancer Risk?

Are Gulf War veterans more likely to get brain cancer or lung cancer than other veterans? Are troops returning from Iraq and Afghanistan likely to become ill from chemicals spewing from open air pits where garbage was burned on military bases? Since the garbage includes tires and other products made of materials that can be toxic when burned, the Cancer Prevention and Treatment Fund is urging safety measures to prevent toxic exposures on military bases and studies of the health risks. This is a situation where common sense should prevail: open air pits that burn toxic materials are dangerous to the health of those nearby.

Camp Lejeune and Contaminated Drinking Water

Contaminated drinking water at the Marine Corps Base Camp Lejeune in Jacksonville, North Carolina put military families and civilians who lived or worked there from the 1950’s through the 1980’s at risk for cancer and other serious diseases.

  • Men living or working on the base from the mid-1950s until 1987 have been much more likely to develop breast cancer than other men.  Breast cancer is rare among men, and men often do not recognize the symptoms and so delay treatment.
  • Pregnant women who were exposed to more contaminated drinking water at Camp Lejeune were 4 times as likely to give birth to children with serious birth defects compared to women who were less exposed.  Their children were also slightly more likely to develop childhood cancers such as leukemia.

We have been strongly urging U.S. officials to continue investigating how contaminants at Camp Lejeune have harmed children and adults in letters to Congress and in public statements.

Agent Orange and Vietnam War Veterans

Agent Orange was used by the U.S. military during the Vietnam War to clear vegetation to make it easier to see enemy soldiers. Agent Orange was contaminated with dioxin, making it much more dangerous.  Nearly 1.5 million veterans were exposed when 20 million gallons were sprayed over Vietnam.

  • New research indicates Agent Orange may increase the chance of developing a cancer of the bone marrow called multiple myeloma.
  • The Institute of Medicine has concluded that people exposed to Agent Orange are more likely to develop chronic B-cell leukemia, chronic lymphocytic leukemia, Hodgkin disease, Non-Hodgkin disease, prostate cancer, respiratory cancers, and soft tissue sarcoma. They are also more likely to develop Type 2 diabetes, high blood pressure, stroke, Parkinson disease, heart disease, and peripheral neuropathy.

For more information, see Agent Orange and Serious Diseases including Multiple Myeloma.

Would Washington’s FDA fix cure the patients or the drug industry?

In the News, News Stories & Editorials
Alec MacGillis, ProPublica
October 20, 2015

This might seem to be a rough political patch for the pharmaceutical and medical device industries. The exponential price increases of several drugs have brought scrutiny to the overall rise in drug costs and have prompted several 2016 candidates, most notably Hillary Clinton, to vow action to rein in the industry. Meanwhile, thousands of complaints are pouring into the Food and Drug Administration about a contraceptive implant made by Bayer.

In Congress, however, things are looking better for the manufacturers. Legislation is advancing that would speed up the FDA’s approval process for medications and medical devices, offering a rare example of how major initiatives can get traction even in today’s gridlocked Washington.

The industry has mounted a major lobbying and public relations push for the 21st Century Cures Act. The bill, in turn, has garnered an unusually broad range of support, ranging from Republican lawmakers and conservative think tanks to the White House, patient advocacy groups, Democrats and nonprofit organizations that are typically leery of deregulatory efforts by industry. One reason: Lawmakers softened up the usual opponents of looser rules with a big carrot — billions of dollars in new federal medical research funding for the National Institutes of Health. After years of austerity, that money is awfully difficult to turn down.

But the enthusiasts have left a small band of critics warning that bipartisan consensus does not necessarily affirm the bill’s worth. Far from showing that Washington can still get big things done, they say, it shows how a lobby can blow past skeptics if the pot of resources is sweet enough. They maintain that the bill, which easily passed the House in July and has a counterpart soon to be introduced in the Senate, hasn’t received the scrutiny that such sweeping legislation deserves.

[…]

The promised NIH money also brought on board major universities, which carry out about $15 billion of all NIH-funded research. “It was the investment in NIH that led everyone to get behind it,” said Atul Grover, chief public policy officer at the Association of American Medical Colleges. “As soon as we talked about innovation, people said, look, you can try to grease the skids on the approval process, but if we’re not investing as a nation in research, then this other stuff is not going to make much difference. You have to invest in cures to get them.”

The list of entities lobbying on the bill now runs to about 1,800 quarterly entries in the Senate’s lobbying database, with more than 1,100 lobbyists registered as working on it, which is staggering even by the standards of Washington. And what has been so beneficial for the legislation is that the vast majority of those entities are not companies or trade associations, which are motivated by bottom-line demands, but patient groups and universities, which have a far more neutral sheen.

“Members of Congress who wouldn’t be responsive to pharma’s lobbying did respond to universities’ lobbying or to patients’ lobbying,” said Diana Zuckerman, president of the National Center for Health Research, an advocacy group that has spoken out against the legislation. “It was a perfect storm of lobbying.”

Read the full article here.