All posts by CPTFeditor

House overwhelmingly passes bill to speed FDA drug approvals

In the News, Uncategorized
By Carolyn Johnson, The Washington Post
July 10, 2015

 

A bipartisan bill that would make significant changes to the process for developing new drugs and medical devices overwhelmingly passed the House in a 344-77 vote Friday morning.

The bill, called 21st Century Cures, was cheered by rare across-the-aisle support from politicians, with 230 co-sponsors nearly evenly split between Democrats and Republicans. The pharmaceutical industry, patient advocacy groups, and medical organizations also support the bill, which calls for an additional $8.75 billion for the National Institutes of Health.

The bill tries to address the impatience that stems from a major societal problem: despite billions of dollars of research into diseases that range from common cancers to the rarest genetic diseases, we still lack treatments for thousands of conditions. Many of its provisions seek to make the drug approval process less burdensome.

But its laundry list of provisions that tweak the process for approving new drugs or devices have raised significant concern from industry watchdogs and physicians who say the legislation is aimed more at helping drug and device companies than patients. Critics say the bill’s regulatory alterations do not address the real problem with the development of new therapies and could lead to the approval of treatments that don’t work and could even harm vulnerable sick people.

“The bill unfortunately offers a horse trade,” said Vijay Das, a healthcare policy advocate at Public Citizen, a patient advocacy organization. “It increases funding for the world-renowned NIH in exchange for providing perks for the pharmaceutical and medical device industries.” […]

“We share Congress’ desire to increase funding for NIH, but there are dangerous parts of this bill that many members of Congress did not fully understand,” Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank, said in a statement. “As often happens, well-funded pharma lobbying was more effective than experts’ concerns about patient safety.”

Read the full story here.

21st Century Cures drug bill triggers a DC dust-up over relaxed development regs

In the News
By John Carroll, Fierce Biotech
July 10, 2015

 

Lawmakers in the House easily passed the 21st Century Cures Act today, a big step toward once again shaking up the legal framework built to guide drug development in the U.S. while significantly boosting the amount of funding that flows to the NIH.

As for the $9 billion being earmarked for the NIH–which comes along with more funding for the FDA–after years of research budget stagnation, there’s virtually no debate. The bill’s authors have found a way to pay for that by reining in some spending to Medicare prescription drug plans and selling off some of the crude oil in the country’s stockpile, and Democrats are being won over by the notion of increased federal spending for more precise medicines. Research groups in the industry and academia are pushing this hard, and finding open arms in the capitol.

The political trip wire in the bill centers on changes to the way drugs and devices are developed and approved. Among the provisions in the bill, regulators would be given the authority to approve new antibiotics based on preclinical testing combined with small human trials. Biomarkers and other so-called surrogate endpoints could be used more easily to approve new drugs, offering developers a shorter clinical path to developing a drug. And the bill strips away some requirements for reporting physician payments from pharma companies, if they’re associated with education–a very broad categorization. […]

Consumer advocates, though, see the new development regulations as a recipe for unleashing drugs and devices that would later prove dangerous and unhelpful.

“The irony is calling this 21st Century Cures, when they’re talking about standards that were left behind in the 20th century, because they were found to not be good,” Diana Zuckerman, president of the National Center for Health Research, tells the Washington Post.

But there’s also been notable opposition from some well-known experts in the field who aren’t in the least bit happy about a switch in rules that would devalue the current gold standard for clinical development, which relies on randomized, well-controlled drug studies. Harvard’s Jerry Avorn, for example, has a problem with “shorter or smaller clinical trials” for devices as well as new criteria for relying on “evidence from clinical experience,” including “observational studies, registries, and therapeutic use” that could be used to allow for new uses of approved drugs. “Although such data can provide important information about drug utilization and safety once a medication is in use, there is considerable evidence that these approaches are not as rigorous or valid as randomized trials in assessing efficacy,” Avorn writes.

“In our rush to find new effective treatments, we should not harm our patients with ineffective toxic ones,” writes JAMA editor Rita Redberg. That’s the line that marks the boundary between supporters and opponents of the bill.

Read the full story here.

Running and skin cancer prevention

5K, Events, Prevention, Skin Cancer
By Danielle Pavliv
2015

Exercise reduces your risk of cancer and many other diseases, but running outdoors can increase your risk of skin cancer if you don’t follow a few simple rules.

Running is one of the most popular forms of exercise. It can be done anywhere, doesn’t require a gym or any special equipment (although some people prefer to use a treadmill)-just a good pair of shoes and comfortable clothing. Running outside — whether on a track, in the woods, or on a path by the river — can be a wonderful and restorative way to exercise. Nature and exercise are both great ways to improve your mood.

Running regularly can lower the risk of many health problems including heart disease, stroke, osteoporosis and bone fracture, diabetes, and obesity.[end Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: The evidence. Canadian Medical Journal. 2006; 174(6):801-809.] In addition, it can improve mental health and blood pressure.[end Paluska SA, Schwenk TL. Physical activity and mental health: Current concepts. Sports Medicine. 2000;29(3):167-180.] However, many people don’t take proper precautions when they decide to go running outside, and the results can be deadly.

Imagine this: it’s a nice day outside, so you decide to go for a jog, wearing running shorts and a t-shirt. You probably don’t spend too much time thinking about what to wear — you simply notice what the temperature is, put on something comfortable, and go. Sunscreen seems like a hassle, and you think you’ll probably sweat it off anyway. It’s not like you will be laying out at the pool or playing golf all day, so how much harm can a 30-minute run cause anyway?

While many of us try to protect our skin when spending time outside, data show that just over half of all American adults usually take at least one of these three precautions:  seeking shade, using sunscreen, or wearing sun-protective clothing.[end Sun-Protective Behavior Rates. Skin Cancer. Centers for Disease Control and Prevention. August 2011. Available at: http://www.cdc.gov/cancer/skin/statistics/behavior.htm.] People who don’t do any of these are at much higher risk for skin cancer.

Skin cancer

Skin cancer is the most common of all cancers. In the U.S., accounting for almost half of all cancers and affecting over 2 million people each year. One in 5 Americans will develop skin cancer during their lifetime.[end Robinson JK. Sun exposure, sun protection, and vitamin D. Journal of the American Medical Association. 2005;294(12):1541-1543.] There are three types of skin cancer: basal cell, squamous cell, and melanoma. Basal cell carcinomas are the most common type of skin cancer. They rarely spread to other areas of the body, and are very treatable. Squamous cell carcinomas, on the other hand, can spread to organs and other areas in the body and can be fatal if they are not caught early. The third type of skin cancer, melanomas, are the least common but most dangerous — they kill more than 8,600 Americans every year.[end Skin Cancer Statistics. Centers for Disease Control and Prevention. April 2012. Available at: http://www.cdc.gov/cancer/skin/statistics/.] If found early, however, melanomas can be treated. Melanomas are most often caused by ultraviolet radiation from the sun or tanning beds. They usually resemble moles and are often black or brown. Most change over time, including an increase in size.[end National Cancer Institute. Signs and symptoms of melanoma. U.S. National Institutes of Health. January 11, 2011. Available at: http://www.cancer.gov/cancertopics/wyntk/skin/page8.] In recent years, incidence of melanoma has increased significantly, especially in those with fair skin. While melanoma is more prevalent in men than women, rates of diagnoses and death are increasing for both men and women.

Is exercising outside more risky than just relaxing outside?

In 2006, Dr. Christina Ambros-Rudolph and colleagues at the Medical University of Graz in Austria conducted a study to see if marathon runners are at higher risk of melanoma than people who don’t run as regularly.[end Ambros-Rudolph CM, Hofmann-Wellenhof R, Richtig E, Müller-Fürstner M, Soyer HP, Kerl H, Dermatol A. Malignant Melanoma in Marathon Runners. Archives of Dermatology. 2006;142(11):1471-1474.] They examined over 200 runners and found that they are at increased risk for skin cancer. In fact, runners who trained the most intensively had the highest rates of skin lesions. Almost all of the athletes wore shirts and shorts that did not totally cover their arms, back and legs, and only 56% wore sunscreen. Although there was a clear link between sun exposure and skin lesions, the researchers found another reason the athletes who had more intense workouts were more prone to skin cancer. Endurance exercise such as long-distance running suppresses immune function in the body, which is why extreme athletes are often more susceptible to infections than others. This can release a type of protein called cytokines, limiting the ability of the body’s immune system to fight off potential cancers. In addition, sweating a lot while outside is linked to skin cancer. The wetter your skin, the more UV rays are absorbed, which means that exercising on sunny days can be much more dangerous for your skin than just sitting or laying down in the sun.

How to stay safe outside

You don’t have to give up running outside — there are plenty of ways to protect yourself outside for exercise or any other activity. Try to do as many of these as possible each time you go out in order to lower your risk for melanoma or other types of skin cancer:

  • Use a generous amount of sunscreen with a sun protection factor (SPF) of 30 or higher, even on cloudy days — cloud cover only blocks out one type of UV rays. Reapply often, especially if you are sweating or in the water. Use a water-resistant sunscreen that will stay on when you swim or sweat.
  • Avoid the sun between 10 a.m. and 4 p.m., when UV rays are the strongest. If you want to go for a run outside, try to do it early in the morning or right before sunset.
  • Put on some sunglasses with high UV absorption to protect your eyes, and a hat to protect your face.
  • Wear clothes made of tightly woven fabrics that you cannot see through. Try to avoid regularly exposing areas of your body such as your shoulders, neck and chest. To prevent overheating, wear light-colored clothing that reflects the sun’s rays.
  • Look for shade: try to do your stretches and other exercises in a shaded area.

Choosing a sunscreen

The American Academy of Dermatology recommends that everyone wears a water-resistant sunscreen of at least 30 SPF daily.[end American Academy of Dermatology Sunscreen Website. Stats and Facts. Prevention and Care. Sunscreens. 2012. Available at: http://www.aad.org/media-resources/stats-and-facts/prevention-and-care/sunscreens.] Further, they recommend using a broad-spectrum sunscreen that protects against both types of UV rays (UVA and UVB). You can use the Environmental Working Group’s website to find out which sunscreen really work and don’t contain a lot of harmful and even cancer-causing ingredients. The Food and Drug Administration (FDA) didn’t regulate sunscreen until June 2012. Prior to that date, there was no guarantee that the sunscreen you were slathering on your body actually protected you or did what the label claimed. Now, manufacturers are required to label their products accurately and are held to safety and effectiveness standards.[end FDA sheds light on sunscreens. U.S. Food and Drug Administration. June 2012. Available at: http://www.fda.gov/forconsumers/consumerupdates/ucm258416.htm.] When choosing a product, remember that a sunscreen with twice the SPF does not mean you can stay outside in the sun twice as long before you get a sunburn. The intensity of UV radiation matters just as much as how long you are in the sun, which is why it’s so important that you limit your exposure from 10 a.m. to 4 p.m.[end Jou PC, Feldman RJ, Tomecki KJ. UV protection and sunscreens: What to tell patients. Cleveland Clinic Journal of Medicine. June 2012;79(6):427-436.]

Make sure to regularly check your body for any new moles or scaly patches. If they change size, form or color, visit a dermatologist. If you have skin cancer in your family, you will likely want to get your moles checked regularly.

Sun damage is permanent and irreversible, so it’s important to take good care of your skin throughout your life. Remember — a tan is a sign of skin damage. There’s no such thing as a “healthy” tan!

For more information about the most dangerous type of skin cancer, see http://dev.stopcancerfund.org/t-skin-cancer/treating-skin-cancer-melanoma/

The Benefits of Exercise After Getting Cancer

Breast Cancer, Colon Cancer, Diet, Habits, & Other Behaviors, General Treatment Issues, Prevention, Quality Of LIfe, Treatment & Management

Farmin Shahabuddin, MPH, Morgan Wharton and Annika Schmid, Cancer Prevention and Treatment Fund

You may have heard that regular exercise can reduce your risk of developing cancer, but did you know it’s also good for cancer patients who are undergoing or have completed treatment?

Is Exercise Good for Everyone with Cancer?

Exercise has proven benefits for cancer patients, ranging from improved fitness and higher quality of life to reduced rates of recurrence and a longer life. What we know about exercise and cancer mostly comes from studying patients with breast or colon cancer, but there is now evidence that there are benefits of exercise for men and women suffering from almost all types of cancer, even cancer as advanced as Stage III. [1, 2]

The best news of all: It doesn’t matter if you were fit before you got diagnosed.[1, 3, 4] A 2026 study found the following finding: lung and rectal cancer survivors who were inactive before their diagnosis but became active enough to meet physical activity guidelines afterward were still 42% and 49% less likely to die from their cancer, respectively, compared to those who remained inactive both before and after diagnosis.[5] So, it’s never too late to start exercising to fight cancer. If you’re coping with cancer or its aftermath, now is the time.

How Does Exercise Help Cancer Patients?

Many studies have shown that exercise is beneficial to cancer patients, but no one is sure exactly why. Earlier studies suggested that exercise may help women avoid breast cancer or a recurrence of it by decreasing female hormones that feed cancer in the breast [6,7] or by lowering inflammation in the body [8] , a suspected contributor to many diseases.

Physical Benefits of Exercise for Cancer Patients

Studies have shown that in cancer patients, exercise during or after treatment reduces fat and improves body mass index (BMI). [9, 10] Exercise lowers blood pressure, boosts the immune system, and increases bone mineral density. [10, 11] Denser bones mean fewer fractures.

Not surprisingly, cancer patients who exercise regularly during and after treatment reported increases in strength, walking ability, aerobic capacity, and flexibility. [9, 10]

Cancer patients who had completed treatment reported fewer negative side effects from treatment once they began to exercise regularly.[2] Patients who exercised during treatment reported less nausea and less difficulty sleeping.[10] The most reported improvement was reduced fatigue. [4, 10, 11]

A study published in 2021 indicates that exercise may also help relieve “chemo brain” (also known as chemo fog), which is a common side effect for cancer patients undergoing chemotherapy.[12] Common symptoms of chemo brain are having trouble with learning new tasks, remembering names, paying attention, and concentrating. The study found that patients who did either 2.5–5 hours of moderate intensity exercise (like brisk walking) per week or who did 1.5–2.5 hours of high intensity exercise (such as running) per week in the week before starting chemotherapy, within 1 month of completing chemotherapy, and 6 months after completing chemotherapy were less likely to report “chemo brain” symptoms than patients who did not exercise. Chemo brain can be upsetting and debilitating, affecting more than 75% of breast cancer patients undergoing chemotherapy, for example.

Mental and Emotional Benefits

In addition to the physical health benefits of exercise, cancer patients who exercised also reported improved mental and emotional well-being.[9] Patients who exercised during treatment and those who began to exercise afterwards frequently reported an increase in quality of life, less anxiety, and a renewed “fighting spirit.”[10] Cancer patients over the age of 80 who exercised regularly during their weeks or months of treatment reported less loss of memory.[13]

Long-Term Survival and Reducing Cancer Recurrence

Because exercise improves the immune system, cancer patients who exercise regularly lower their risk of the cancer returning. [1, 9, 11, 14] Patients who exercise are less likely to die from cancer and are more likely to live longer than patients who don’t exercise.

A large 2026 study combining data from six major long-term research projects followed more than 17,000 cancer survivors for an average of nearly 11 years after diagnosis to examine the survival benefits of moderate to vigorous physical activity. The activities included brisk walking, cycling, or swimming, and the patients had been diagnosed with bladder, endometrial, lung, oral cavity, ovarian, or rectal cancer. Current guidelines suggest that people with a history of cancer should aim for 150 to 300 minutes of moderate intensity or 75 to 150 minutes of vigorous intensity aerobic physical activity per week.[5]

The study found that even less than the standard recommended guidelines of physical activity seemed beneficial. For example, bladder cancer survivors who exercised were 33% less likely to die from their cancer, endometrial cancer survivors were 38% less likely, and lung cancer survivors were 44% less likely, compared to those who did no physical activity. Oral and rectal cancer survivors who doubled the amount of activity that was in the recommended guidelines were 61% less likely to die of oral cancer and 43% less likely to die of rectal cancer.[5]

A 2022 study found that cancer survivors who exercise and do not sit 8 or more hours a day live longer than less active cancer survivors.[15] The study followed over 1,500 cancer survivors ages 40 and over for an average of 4.5 years. The researchers found that those who exercised at least 150 minutes per week were less likely to die (of cancer or anything else) than people who did not report exercising. Survivors who reported sitting for more than 8 hours a day were also more likely to die than those who reported sitting less than 4 hours per day, and survivors who reported both a lack of exercise and sitting more than 8 hours per day were the most likely to die of all the survivors studied.

A 2020 study of 8,002 Black and white adults aged 45 and older in the U.S. examined whether sitting for long periods of time increases the chances of dying from cancer.[16] Each participant wore a hip-mounted device, like a fitness tracker, for 7 consecutive days to measure how much time they spent sitting versus being physically active. Over an average follow-up of about 5 years, 268 participants died of cancer. People who spent the most time sitting were more likely to die from cancer compared to those who sat the least. People who replaced just 30 minutes of sitting per day with moderate to vigorous physical activity had a 31% lower chance of cancer death. In fact, people who swapped that sitting time for light activity like standing or gentle walking were 8% less likely to die. This shows that the total amount of time spent sitting matters in addition to the time spent exercising, so cancer survivors should try to sit less and move more throughout the day.

What Kind of Exercise Should I Do?

Aerobic activity of light to moderate intensity was the most common type of exercise in the studies of cancer patients. [1, 9] Combining aerobic exercise with walking and resistance training (such as weightlifting or using resistance bands) led to greater health benefits than aerobic activity alone. [9, 11]

Walking can improve the health of cancer patients. Studies estimate that the greatest benefit from walking is seen in patients who walk at an average speed (a 20-minute mile) for 3–5 hours weekly.[2] Patients who walked just 1 hour per week, regardless of walking speed, showed improvements over the group of patients who reported no physical activity in a week.

To get the most out of exercise, you need to make it a habit—something you commit to for the long-term. That’s why it is better to start small, with easily achievable changes like using the stairs regularly instead of the elevator or walking each evening after dinner. Remember to set realistic goals, because it is better to start small and keep it up than to try to do too much and give up. Don’t miss the chance to get at least some benefit from this easy, free strategy to fight cancer.

The Bottom Line

Exercise helps individuals who are undergoing cancer treatment and those who have completed cancer treatment. Cancer patients who exercise regularly during and after treatment can expect fewer side effects from treatment, including less fatigue, fewer problems with concentration and memory, and better overall fitness and health. Patients who exercise are less likely to experience a return of cancer in the future and are more likely to live longer, healthier lives.

You should try to walk at least 3 to 5 hours a week at an average pace (about 1 mile per 20 minutes). Even minimum exercise, like walking one hour per week, can improve the health of cancer patients who have completed treatment, compared to cancer patients who do not exercise at all. The benefits from exercise can be seen in all cancer patients regardless of whether they exercised regularly before they were diagnosed with cancer. It’s never too late to begin to exercise and improve your health!

References

  1. Jeffrey A. Meyerhardt, D.H., Donna Niedzwiecki, Donna Hollis, Leonard B. Satz, Robert J. Mayer, James Thomas, Heidi Nelson, Renaud Whittom, Alexander Hantel, Richard L. Schilsky, and Charles S. Fuchs, Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: Findings from CALGB 89803. Journal of Clinical Oncology, 2006. 24(22): p. 3635-3541.
  2. Michelle D. Holmes, W.Y.C., Diane Fesknich, Candyce H. Kroenke, Graham A. Colditz, Physical activity and survival after breast cancer diagnosis. Journal of the American Medical Association, 2005. 293(20): p. 2479-2486.
  3. Jeffrey A. Meyerhardt, E.L.G., Michelle D. Holmes, Andrew T. Chan, Jennifer A. Chan, Graham A. Colditz, and Charles S. Fuchs, Physical activity and survival after colorectal cancer diagnosis. Journal of Clinical Oncology, 2006. 24(22): p. 3527-3534.
  4. Margaret L. McNeely, K.L.C., Brian H. Rowe, Terry P. Klassen, John R. Mackey, Kerry S. Courneya, Effects of exercise on breast cancer patients and survivors: A systematic review and meta analysis. Canadian Medical Association Journal, 2006. 175(1): p. 34-41.
  5. Rees-Punia E, Teras LR, Newton CC, et al. Leisure-Time Physical Activity and Cancer Mortality Among Cancer Survivors. JAMA Netw Open. 2026;9(2):e2556971. doi:10.1001/jamanetworkopen.2025.56971
  6. Key T, Appleby P, Barnes I, Reeves G. Endogenous sex hormones and breast cancer in postmenopausal women: reanalysis of nine prospective studies. J Natl Cancer Inst. Apr 17 2002;94(8):606-616.
  7. McTiernan A, Tworoger SS, Ulrich CM, et al. Effect of exercise on serum estrogens in postmenopausal women: a 12-month randomized clinical trial. Cancer Res. Apr 15 2004;64(8):2923-2928.
  8. Friedenreich CM, Neilson HK, Woolcott CG, et al. Inflammatory Marker Changes in a Yearlong Randomized Exercise Intervention Trial among Postmenopausal Women. Cancer Prevention Research. January 1, 2012 2012;5(1):98-108.
  9. Daniel Y T Fong, J.W.C.H., Bryant P H Hui, Antoinette M Lee, Duncan J Macfarlane, Sharron S K Leung, Ester Cerin, Wynnie Y Y Chan, Ivy P F Leung, Sharon H S Lam, Aliki J Taylor, Kar-keung Cheng, Physical activity for cancer survivors: Meta analysis of randomised controlled trials. British Medical Journal, 2012. 344(70).
  10. Ruud Knols, N.K.A., Daniel Uebelhart, Jaap Fransen, and Geert Aufdemkampe, Physical exercise in cancer patients during and after medical treatment: A systematic review of randomized and controlled clinical trials. Journal of Clinical Oncology, 2005. 23(16): p. 3830-3842.
  11. Rosalind R. Spence, K.C.H., Wendy J. Brown, Exercise and cancer rehabilitation: A systematic review. Cancer Treatment Reviews, 2009. 36: p. 185-194.
  12. Elizabeth A. Salerno, Eva Culakova, Amber S. Kleckner, Charles E. Heckler, Po-Ju Lin, Charles E Matthews, Alison Conlin, Lora Weiselberg, Jerry Mitchell, Karen M. Mustian, Michelle C. Janelsins. Physical Activity Patterns and Relationships With Cognitive Function in Patients With Breast Cancer Before, During, and After Chemotherapy in a Prospective, Nationwide Study. Journal of Clinical Oncology. 2021. https://ascopubs.org/doi/full/10.1200/JCO.20.03514.
  13. LK Sprod, S.M., W Demark-Wahnefried, MC Janelsins, LJ Peppone, GR Morrow, R Lord, H Gross, KM Mustian, Exercise and cancer treatment symptoms in 408 newly diagnosed older cancer patients. Journal of Geriatric Oncology, 2012. 3(2): p. 90-97.
  14. Barbara Sternfeld, E.W., Charles P. Quesenberry, Jr., Adrienne L. Castillo, Marilyn Kwan, Martha L. Slattery, and Bette J. Caan, Physical activity and risk of recurrence and mortality in breast cancer survivors: Findings from the LACE study. Cancer Epidemiology, Biomarkers & Prevention, 2009. 18(1): p. 87-95.
  15. Cao, C, Friedenreich, CM and Yang L. Association of Daily Sitting Time and Leisure-Time Physical Activity With Survival Among US Cancer Survivors. JAMA Oncology, January 6, 2022 online, https://jamanetwork.com/journals/jamaoncology/article-abstract/2787951.
  16. Gilchrist SC, Howard VJ, Akinyemiju T, Judd SE, Cushman M, Hooker SP, Diaz KM. Association of Sedentary Behavior With Cancer Mortality in Middle-aged and Older US Adults. JAMA Oncology. 2020;6(8):1210–1217.

House overwhelmingly passes 21st Century Cures Act

In the News
By Steven Ross, Modern Healthcare
July 10, 2015

 

In a rare act of bipartisanship, House members voted 344-77 on Friday in favor of the 21st Century Cures Act, which supporters say will speed the development and regulatory approval of medical breakthroughs. Critics say that speed would come at the expense of patients’ safety. 

The legislation would provide an additional $9.3 billion in mandatory funding over the next five years to fund the National Institutes of Health and establish a Cures Innovation Fund to support work toward breakthroughs in biomedical research. It also provides $550 million in added funding to the Food and Drug Administration over the same period.

Supporters of the legislation say it will remove regulatory roadblocks in the FDA review process for medications and medical devices. 

It has received strong support from both the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association. The industry groups argue that the bill would make the review process more efficient and less cumbersome, reducing the costs of bringing a product to market and ultimately lowering the cost of those therapies for patients. […]

The bill also has its critics, who say it would loosen FDA review standards and allow therapies to be sold before enough clinical data is gathered to determine whether they are safe and effective.

“What they’re doing is that they’re replacing the burden of proof for drug companies and device companies with a burden of uninformed decision-making for patients and doctors,” said Diana Zuckerman, president of the National Center for Health Research, a Washington D.C.-based not-for-profit patient-advocacy organization. “You’re replacing the burden of proving that your product works with the burden of having expensive products on the market that may or may not work.”

Read the full story here.

Antioxidants and cancer risk: the good, the bad, and the unknown

Diet, Habits, & Other Behaviors
By Nyedra W. Booker, PharmD, MPH and Diana Zuckerman, PhD
Updated 2015

Do you take vitamin pills or dietary supplements? If so, you are not alone! Most adults in the U.S. take at least one dietary supplement,1 and products with claims of cancer and other disease-fighting benefits are increasingly popular. Vitamins A, C, E, beta carotene and selenium are all considered “antioxidants,” and people take them hoping to prevent disease and improve overall health.  You have probably heard that antioxidants fight cancer, but the latest research suggests that any benefits they have in preventing cancer may be reversed for people who already have cancer (including those who have cancer but haven’t been diagnosed yet).

What are antioxidants?

Antioxidants prevent a chemical process known as “oxidation,” which is a natural part of living and aging. Oxidation damages cells and can lead to the development of disease, including Alzheimer’s, heart disease, and cancer. Antioxidants are found in fruits, vegetables, nuts, beans, grain cereals, and other foods. Even dark chocolate is rich in antioxidants.

The antioxidants made by our body play an important role in finding and repairing damaged cells, as well as boosting our immune system. But do antioxidants in dietary supplements provide the same health benefits as the antioxidants we make on our own? Supplements are often produced using man-made products or by extracting the antioxidants from certain foods. Unfortunately much of the health benefits may be lost during these manufacturing processes.2

The good, the bad and the unknown

A landmark study from the late 1980s was among the first to look at the effect of antioxidants on cancer risk. The study involved almost 30,000 Chinese men and women at high risk for cancer who took daily vitamin and mineral supplements for 5 years. Patients were assigned to receive one of the following combinations of supplements:  (a) retinol and zinc, (b) riboflavin and niacin, (c) vitamin C and molybdenum, or (d) beta carotene, vitamin E and selenium. Men and women taking the antioxidant combination of beta carotene, vitamin E and selenium had significantly lower death rates and a reduced risk for cancer after 1-2 years of taking the supplements.3

However, excitement about antioxidants to prevent cancer was short-lived. In 1994, the New England Journal of Medicine (NEJM) published findings from an 8-year study on antioxidant use to prevent lung cancer in men who smoke. Almost 30,000 male smokers age 50-69 were randomly assigned to one of the following: (a) vitamin E, (b) vitamin E + beta carotene, (c) beta carotene or (d) placebo (a sugar pill).  But rather than reduce the risk for lung cancer, the men taking beta carotene (either alone or in combination with vitamin E) were more likely to develop lung cancer after only 18 months of daily beta carotene use, and the number of lung cancer cases continued to increase disproportionately for the duration of the study.4

In 1996, a study of more than 18,000 men and women at high-risk for lung cancer looked at whether antioxidants could reduce the risk of lung cancer in high-risk patients. Study participants included current smokers, former smokers, and workers with prior exposure to asbestos, who were randomized to receive beta carotene, vitamin A or placebo.  The study was stopped early when preliminary results showed a 17% higher death rate in the antioxidant groups.5

These two lung cancer studies caused great concern about antioxidants.  Beta carotene was discontinued two years into a study involving 540 patients with head and neck cancer taking a combination of vitamin E + beta carotene supplements to prevent a second cancer. But the researchers found a significant increase in the risk of a second cancer in the patients who continued to take vitamin E. Once this supplement was discontinued, the cancer risk decreased to that of patients taking the placebo.6

A 2012 review of almost 80 randomized clinical studies of antioxidant use (vitamin A, C, E, beta-carotene and selenium) again showed cause for concerns. Together the studies included a total of almost 300,000 men and women (described as both “healthy” and with diseases in a “stable phase”). Men and women were more likely to die if they were taking Vitamin E, beta-carotene or doses of vitamin A that exceed the Recommended Dietary Allowance (700µg for women and 900µg for men). The authors concluded that the use of antioxidant supplements could be dangerous for the general population and those diagnosed with various diseases.7

What could explain the possible increased cancer risk?

Starting around 2008, there was growing evidence that antioxidants could be dangerous for anyone who already had cancer, and that could explain some of the contradictory results of previous studies. In one study, large doses of vitamin C supplements reduced the effectiveness of several anti-cancer drugs including Methotrexate, Doxorubicin and Imatinib, resulting in 30-70% fewer cancer cells killed. The authors concluded that vitamin C may actually be helping cancer cells survive by protecting the cells’ power source.8 In another study, the antioxidants vitamin C and N-acetyl cysteine (often sold under the name “NAC”) significantly reduced the effectiveness of anti-cancer drugs Vinblastine and Cisplatin.9

As more recent studies continue to suggest antioxidants could actually help cancer cells grow, research by Zachary Schafer shows that cancer cells’ survival can be aided by antioxidants that protect these cells from free radicals.10 Free radicals harm cells, and getting rid of free radicals therefore can help cancer cells. “If you are a person who is healthy, meaning no tumors of any kind, antioxidants are probably going to protect against cancer,” Schafer says. But he points out that if a person has cancer cells, antioxidants can help those cancer cells survive.

The bottom line

Dietary supplements are intended to be used when your body is not receiving certain nutrients in the right amounts, but like drugs, they can have unintended side effects so they should only be taken as recommended.

If a person definitely doesn’t have cancer, antioxidants can help them.  However, if they have cancer, even if they have early cancer that hasn’t been diagnosed yet (which is certainly a risk for heavy smokers or former smokers, for example), antioxidants could be harmful.

It may be tempting to go out and buy nutritional products that claim to be all-natural and will make you feel great and stay healthy. Remember, however, that a product labeled as being “natural” or “organic” is not necessarily safe. The Food and Drug Administration (FDA) does not test the safety and effectiveness of nutritional supplements before they are placed on the shelf the way they do for prescription and over-the-counter medications.  Consequently, you may be purchasing a product that is neither safe nor effective!

So what are some proven strategies that can help reduce your risk of cancer?

  • Maintain a healthy weight by limiting the high-calorie foods you eat and getting regular physical activity
  • Eat plenty of fruits and vegetables every day (fruits and vegetables should cover half of your plate. For more tips, see My Plate: A New Alternative to the Food Pyramid)
  • Limit the amount of red meat and processed meat (hot dogs, sausages, bologna, etc.) that you eat
  • Eat foods made of whole grains

Weight and cancer: What you need to know

Diet, Habits, & Other Behaviors
Brandel France de Bravo, MPH, Noy Birger, Shahmir Ali ABD, and Ealena Callender, MD, MPH,  Cancer Prevention and Treatment Fund

There are many reasons why being overweight is bad for our health, but most people
don’t realize that cancer is one of them.  Of course, excess body weight can contribute
to serious medical conditions such as heart disease and type II diabetes. Still, more
recent research shows that excess body fat also increases the risk of developing certain
types of cancer.

Researchers estimate that more than 481,000 of newly-diagnosed cancer cases
worldwide in 2012 were due to overweight or obesity. [1] An estimated 111,000 cancer
cases in North America are caused by being overweight or obese. This represents 23%
of total global cancer cases – the highest of any region. In addition, three cancers
accounted for 73% of all obesity-related cancers among women globally: endometrial
cancer, postmenopausal breast cancer, and colon cancer. For men, kidney and colon
cancers accounted for 66% of all obesity-related cancers. Other cancers associated
with overweight and obesity include prostate cancer, several gastrointestinal cancers,
and non-Hodgkin’s lymphoma.

In 2018, American Cancer Society researchers concluded that each year from 2011 to
2015, approximately 37,700 cancer cases in men in the U.S. and 74,700 cancer cases
in women aged 30 years or older were attributable to excess body weight. [2] Among men,
the excess cancers ranged from 3.9% in Montana to 6.0% in Texas. In women, the
excess risk of cancer was almost twice as high as for men, ranging from 7.1% in Hawaii
to 11.4% in Washington, DC. The highest number of weight-related cancers were
primarily found in southern and midwestern states, as well as Alaska and Washington,
D.C. Overall, cancers attributable to excess body weight account for at least 1 in 17 of
all cancers in each state.

The good news is that a large 2014 study showed that with a healthy diet and regular
exercise, postmenopausal women may significantly reduce their cancer risk. [3]  In the
study, researchers defined a healthy diet as one that limits red meat and processed
meat, emphasizes whole grains over refined grains, and includes two and a half cups of
vegetables and fruits daily. In addition, regular exercise involves at least 150 minutes of
moderate-intensity physical activity or 75 minutes of vigorous-intensity physical activity
every week. Those with the healthiest diets and most active lifestyles saw their chance
of getting breast cancer drop by 22%, their likelihood of colon cancer drop by 52%, and
their overall chance of dying during the 12-year study drop by 27%. While all the women
who ate better and exercised more lowered their chances of developing cancer, non-
white women seemed to benefit the most.

A 2020 study of more than 8,000 Black and White men and women also found that
exercise helps lower the likelihood of dying from cancer. The study found that inactive
people (whether couch potatoes or sitting at a desk all day) were more likely to die from
cancer. At the same time, those who engaged in light to moderate physical activity were
less likely to die from cancer. [4]

In 2022, a study of adults aged 59 to 82 found that those who were as physically active
as was recommended by the Physical Activity Guidelines for Americans were less likely
to die of cancer than those who were less active. [5] All men and women in the study
who were at least moderately active were less likely to die from cancer or
cardiovascular disease than those who were not active at all. In addition, when
researchers evaluated the type and intensity of activity, the activity that seemed most
likely to reduce the chance of dying from cancer was running, followed by other aerobic
exercise, swimming, and cycling.

How does obesity increase the risk of developing cancer?

Excess body weight results in extra body fat – which has unique features that can make
it more likely for an obese person to get cancer. [6] Body fat, also known as adipose
tissue, contains an abundance of cells that cause chronic inflammation and make it
easier for tumors to grow.

Chronic inflammation in individuals with excess body fat may also contribute to insulin
resistance. [7]  Insulin is a hormone that helps our cells use glucose – a type of sugar
found in the foods we eat – to make energy. Insulin resistance means our bodies can’t
respond properly to insulin, and the glucose we need for energy stays in our blood,
where it can’t be used. Too much glucose in our blood – also referred to as high blood
sugar levels or hyperglycemia – increases the likelihood of getting and dying from
cancer. [8] Elevated blood sugar levels lead to an increase in insulin and similar hormones
that cause tumors to grow. The higher the insulin level of a breast cancer patient, the
greater the chance of death. [9] For example, one study of non-diabetic women with early-
stage breast cancer found that women with the highest fasting insulin levels had three
times the risk of recurrence and death compared with women with the lowest insulin
levels. High insulin levels may also interfere with the way certain cancer drugs work,
making treatments less effective. [10]

Researchers think the danger of excess weight is partly due to hormones secreted by
fat tissues, such as estrogen. In women, estrogen comes from a different source before
and after menopause. Before menopause, a woman’s ovaries secrete estrogen. After
menopause, estrogen comes from other tissues in the body. For obese postmenopausal
women, most estrogen comes from body fat, which can encourage the growth of cancer
cells. [11,12] Increased estrogen and increased body fat increase the likelihood of
developing postmenopausal breast cancer and endometrial cancer (also called cancer
of the uterus) in women. [11,12]

The location of body fat also may be important. Fat tissue deep inside your body
wrapped around your organs may increase the risk of developing cancer. For example,
one study followed 3,086 men and women for up to seven years and used medical
imaging scans and physical exams to assess the location of excess fat deposits. [13] After
statistically controlling for the effects of age, exercise habits, BMI, and eating habits,
researchers concluded that those with more fat deep inside the body, compared to
those with fat mostly just beneath the skin, were more likely to develop heart disease
and cancer.

How new is this news?

Researchers have documented the link between obesity and cancer
for many years. In 2003, based on a study of more than 900,000 adults, researchers
estimated that 90,000 cancer deaths could be avoided if adults maintained a normal
body weight. [14] Of all deaths from cancer in Americans over age 50, as many as 14% in
men and 20% in women may be attributable to overweight and obesity. [15]

Every additional study helps to explain how it is that fat fuels tumor growth. Renehan et
al.’s 2012 study, which seemed to be groundbreaking at the time, is based in part on an
earlier meta-analysis (a type of statistical analysis that combines many studies) in which
many of the same authors analyzed more than 200 comparable data gathered from
different countries around the world. [16] The meta-analysis found that excess weight in
men was most strongly associated with cancer of the esophagus, thyroid, colon, and
kidneys. According to the meta-analysis, being overweight did not appear to increase a
man’s risk of prostate cancer. On the other hand, one U.S. study found that an
overweight man with prostate cancer is more likely to die of it than a man with prostate
cancer who is not overweight. [17]

According to the meta-analysis, excess weight in women increases the chances of
developing endometrial cancer, cancer of the gallbladder, esophagus, and kidneys. A
few other cancers were also associated with being overweight for both men and
women, including leukemia, multiple myeloma, and non-Hodgkin’s lymphoma, but the
link was weaker. In men, rectal cancer and malignant melanoma also seemed related to
weight. In women, those with a higher BMI were slightly more likely to be diagnosed
with post-menopausal breast cancer, cancers of the pancreas and thyroid, and colon
cancer.

Additional studies have come to similar conclusions. For example, the American
Institute for Cancer Research (AICR) estimated that excess body fat is responsible for
49% of endometrial cancers; 35% of esophageal cancers; 28% of pancreatic cancers;
24% of kidney cancers; 21% of gallbladder cancers; 17% of breast cancers; and 9% of
colon cancers. [18]  In addition, AICR estimates that over 100,000 new cases of cancer
each year are due to excess body fat, which is similar to estimates from the 2018
American Cancer Society study.

Neuhouser’s study, conducted at 40 U.S. clinical centers, of women ages 50 to 79
followed for about 13 years, showed that women who gained more than 5% of their
baseline weight during the study’s follow-up period had a modest increase in their
chance of getting breast cancer. [19] The risk was most significant for women with a body
mass index (BMI) over 35 — they were 60% more likely to develop breast cancer than
women of normal weight. Keep in mind that a BMI of 30 or higher is considered obese.

A 2016 study found that the link between obesity and cancer is more robust in some
countries than others. [20] Middle Eastern countries have the highest proportion of
overweight and obesity in the world and a high proportion of obesity-related cancer. [20] In contrast, countries in sub-Saharan Africa and Asia have only seen a limited increase in
BMI over the last 30 years. Likewise, North America and Europe have a large proportion
of obesity-related cancers, while countries in sub-Saharan Africa and Asia have a
smaller proportion of obesity-related cancer.

Several studies show that high dietary fat intake increases the risk of post-menopausal
breast cancer, [21]  prostate cancer, [22]  and pancreatic cancer. [23] Researchers have also
found that high-fat diets may increase the likelihood of death from cancer, while low-fat
diets reduce the chances of cancer recurrence. [24] It is unclear whether weight or diet is a
stronger predictor of increased cancer risk, although red meat and processed meat
have been found to increase the risk of some cancers. For more information, see our
articles entitled “Red Meat: The News is Not Good” and “Are Processed Meats More
Dangerous Than Other Red Meats?”

Does losing weight reduce your risk of cancer?

Can losing weight help prevent you from getting cancer? The evidence is clear for some
cancers but not for others. For example, postmenopausal women who lose weight may
reduce their chance of getting breast cancer. [25] Also, weight loss may reduce the
likelihood of gastroesophageal reflux – which may be linked to esophageal cancer. In
addition, some studies have found an association between weight loss and decreased
chance of getting prostate cancer.

Men and women who experience significant weight loss after bariatric surgery may
decrease their likelihood of getting cancer. Bariatric surgery, also called weight-loss
surgery, is generally associated with a decrease in body weight of 20% to 35%. [26] A
2022 study of 30,318 men and women compared the incidence of cancer and cancer-
related death between obese patients who had bariatric surgery and those who did not.
The incidence of most types of cancer and cancer-related death was lower in the
surgical weight loss group. This difference was most significant for endometrial cancer –
the cancer most strongly associated with obesity.

Other studies of obese patients who intentionally lost weight found a decrease in certain
factors in the blood that encourage tumor growth. Called tumor growth factors, these
markers represent chronic inflammation and create a setting that makes it easier for cancer cells to grow. [27,28]  Estrogen – a hormone associated with postmenopausal breast cancer and endometrial cancer – also decreased in women who intentionally lost weight. [27] The study found that women who experienced just a 10% weight loss saw their blood estrogen levels decrease by at least 33%. Overall, researchers have not reached a conclusion about the association between weight loss and postmenopausal breast cancer. Although one study showed a decreased likelihood when the weight loss occurs after age 30 but before menopause, [28] other studies have found no impact at all. [29]

What we know and don’t know

Decreasing the likelihood of getting cancer is one of the many benefits of achieving and
maintaining a healthy body weight. However, we still do not fully understand how a
person’s weight, diet, level of physical activity, and genes all work together to determine
one’s cancer risk.

Bottom Line

After giving up tobacco, watching your weight and staying active are your best forms of
health insurance. For guidelines and tips on living a healthy lifestyle, read Eating Habits
That Improve Health and Help with Weight Loss and BMI. [30]

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

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

References:

  1.  Arnold M, Pandeya N, Byrnes G, et al. Global burden of cancer attributable to high
    body-mass index in 2012: a population-based study. The Lancet Oncology.
    2015;16(1):36-46. doi:10.1016/S1470-2045(14)71123-4
  2.  Islami F, Goding Sauer A, Gapstur SM, Jemal A. Proportion of Cancer Cases
    Attributable to Excess Body Weight by US State, 2011-2015. JAMA Oncology.
    2019;5(3):384-392. doi:10.1001/jamaoncol.2018.5639
  3. Thomson CA, McCullough ML, Wertheim BC, et al. Nutrition and Physical Activity
    Cancer Prevention Guidelines, Cancer Risk, and Mortality in the Women’s Health
    Initiative. Cancer Prevention Research. 2014;7(1):42-53. doi:10.1158/1940-
    6207.CAPR-13-0258
  4. Gilchrist SC, Howard VJ, Akinyemiju T, et al. Association of Sedentary Behavior
    With Cancer Mortality in Middle-aged and Older US Adults. JAMA Oncol.
    2020;6(8):1210. doi:10.1001/jamaoncol.2020.2045
  5.  Watts EL, Matthews CE, Freeman JR, et al. Association of Leisure Time Physical
    Activity Types and Risks of All-Cause, Cardiovascular, and Cancer Mortality Among
    Older Adults. JAMA Network Open. 2022;5(8):e2228510.
    doi:10.1001/jamanetworkopen.2022.28510
  6. Khanna D, Khanna S, Khanna P, Kahar P, Patel BM. Obesity: A Chronic Low-Grade
    Inflammation and Its Markers. Cureus. Published online February 28, 2022.
    doi:10.7759/cureus.22711
  7. Gutierrez DA, Puglisi MJ, Hasty AH. Impact of increased adipose tissue mass on
    inflammation, insulin resistance, and dyslipidemia. Curr Diab Rep. 2009;9(1):26-32.
    doi:10.1007/s11892-009-0006-9
  8. Stocks T, Rapp K, Bjørge T, et al. Blood Glucose and Risk of Incident and Fatal
    Cancer in the Metabolic Syndrome and Cancer Project (Me-Can): Analysis of Six
    Prospective Cohorts. Wareham NJ, ed. PLoS Med. 2009;6(12):e1000201.
    doi:10.1371/journal.pmed.1000201
  9.  Hede K. Doctors Seek To Prevent Breast Cancer Recurrence by Lowering Insulin
    Levels. JNCI Journal of the National Cancer Institute. 2008;100(8):530-532.
    doi:10.1093/jnci/djn119
  10. Boyd DB. Insulin and Cancer. Integr Cancer Ther. 2003;2(4):315-329.
    doi:10.1177/1534735403259152
  11. Cleary MP, Grossmann ME. Obesity and Breast Cancer: The Estrogen Connection.
    Endocrinology. 2009;150(6):2537-2542. doi:10.1210/en.2009-0070
  12. Kaaks R, Lukanova A, Kurzer MS. Obesity, Endogenous Hormones, and
    Endometrial Cancer Risk: A Synthetic Review1. Cancer Epidemiology, Biomarkers
    & Prevention. 2002;11(12):1531-1543. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4142485/
  13. Britton KA, Massaro JM, Murabito JM, Kreger BE, Hoffmann U, Fox CS. Body Fat
    Distribution, Incident Cardiovascular Disease, Cancer, and All-Cause Mortality.
    Journal of the American College of Cardiology. 2013;62(10):921-925.
    doi:10.1016/j.jacc.2013.06.027
  14. Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, Obesity, and
    Mortality from Cancer in a Prospectively Studied Cohort of U.S. Adults. N Engl J
    Med. 2003;348(17):1625-1638. doi:10.1056/NEJMoa021423
  15. NCI. Home | Cancer Trends Progress Report. Published March 2020. Accessed
    January 10, 2023. https://progressreport.cancer.gov/
  16. Renehan AG, Tyson M, Egger M, Heller RF, Zwahlen M. Body-mass index and
    incidence of cancer: a systematic review and meta-analysis of prospective
    observational studies. The Lancet. 2008;371(9612):569-578. doi:10.1016/S0140-
    6736(08)60269-X
  17. Wright ME, Chang SC, Schatzkin A, et al. Prospective study of adiposity and weight
    change in relation to prostate cancer incidence and mortality. Cancer.
    2007;109(4):675-684. doi:10.1002/cncr.22443
  18. Nelson M. Large study finds (again) obesity links to many cancers. American
    Institute for Cancer Research. Published March 1, 2017. Accessed January 10,
    2023. https://www.aicr.org/resources/blog/large-study-finds-again-obesity-links-to-
    many-cancers/
  19.  Neuhouser ML, Aragaki AK, Prentice RL, et al. Overweight, Obesity, and
    Postmenopausal Invasive Breast Cancer Risk: A Secondary Analysis of the
    Women’s Health Initiative Randomized Clinical Trials. JAMA Oncol. 2015;1(5):611.
    doi:10.1001/jamaoncol.2015.1546
  20. Arnold M, Leitzmann M, Freisling H, et al. Obesity and cancer: An update of the
    global impact. Cancer Epidemiology. 2016;41:8-15.
    doi:10.1016/j.canep.2016.01.003
  21. Wynder EL, Cohen LA, Muscat JE, Winters B, Dwyer JT, Blackburn G. Breast
    Cancer: Weighing the Evidence for a Promoting Role of Dietary Fat. JNCI Journal of
    the National Cancer Institute. 1997;89(11):766-775. doi:10.1093/jnci/89.11.766
  22. Giovannucci E, Rimm EB, Colditz GA, et al. A Prospective Study of Dietary Fat and
    Risk of Prostate Cancer. JNCI Journal of the National Cancer Institute.
    1993;85(19):1571-1579. doi:10.1093/jnci/85.19.1571
  23. Thiébaut ACM, Jiao L, Silverman DT, et al. Dietary Fatty Acids and Pancreatic
    Cancer in the NIH-AARP Diet and Health Study. JNCI: Journal of the National
    Cancer Institute. 2009;101(14):1001-1011. doi:10.1093/jnci/djp168
  24. Chlebowski R. Lifestyle Change Including Dietary Fat Reduction and Breast Cancer
    Outcome. The Journal of Nutrition. 2007;137(1):233S-235S.
    doi:10.1093/jn/137.1.233S
  25. Wolin KY, Colditz GA. Can weight loss prevent cancer? Br J Cancer.
    2008;99(7):995-999. doi:10.1038/sj.bjc.6604623
  26. Aminian A, Wilson R, Al-Kurd A, et al. Association of Bariatric Surgery With Cancer
    Risk and Mortality in Adults With Obesity. JAMA. 2022;327(24):2423.
    doi:10.1001/jama.2022.9009
  27. Byers T, Sedjo RL. Does intentional weight loss reduce cancer risk? Diabetes,
    Obesity and Metabolism. 2011;13(12):1063-1072. doi:10.1111/j.1463-
    1326.2011.01464.x
  28. Harvie M, Howell A, Vierkant RA, et al. Association of Gain and Loss of Weight
    before and after Menopause with Risk of Postmenopausal Breast Cancer in theIowa Women’s Health Study. Cancer Epidemiology, Biomarkers & Prevention.
    2005;14(3):656-661. doi:10.1158/1055-9965.EPI-04-0001
  29. Teras LR, Goodman M, Patel AV, Ryan Diver W, Dana Flanders W, Feigelson HS. Weight loss and postmenopausal breast cancer in a prospective cohort of overweight and obese US women. Cancer Causes Control. 2011;22(4):573-579. doi:10.1007/s10552-011-9730-y
  30. Dudley S, Pederson S, Kennedy C, Rosseau N. Eating Habits That Improve Health and Help with Weight Loss and BMI. National Center for Health Research. Published March 29, 2010. Accessed January 10, 2023. https://www.center4research.org/eating-habits-improve-health-help-weight-loss-bmi/

 

Walking with a hope of a cure for cancer

Events
May 2015

On Saturday, April 25th, Sherina Garner walked her own 5K fundraiser in memory of her mother, Valerie Veney, who died from lung cancer. Fourteen people donated $453 to her cause, which Sherina then matched, raising a total of $906 for the National Center for Health Research and its main program, Cancer Prevention and Treatment Fund. We would like to thank Sherina Garner for her hard work and dedication, and most importantly, for taking action to help children and adults reduce their risks of cancer.

Sherina writes about her mother, Valerie Renee Veney: “She was a loving, kind woman with a beautiful smile. She passed away from lung cancer at the young age of 59, leaving behind her two children (Sherina and Tycho, Jr.) and husband of 43 years who loved her so much that a year later, he passed away, too.”

“She was a phenomenal woman who worked hard every day and cared for her family, even when cancer was growing in her body. From her 23 years of work as a Youth Correction Officer in the Youth Service Administration of the District of Columbia Government, it was clear that she was dedicated to helping people, especially children. She raised her grandson and assisted numerous young people, both in her community and at work.”

“When she found out she was sick with lung cancer, it was already stage 4. It was a surprise to her family that she had end-stage lung cancer. She was strong even up until her death. She was able to communicate with her family what she wanted at the end of her battle, and the Lord took her home peacefully. Before passing, she said: Let people know those cigarettes are killing your lungs slowly. Lung cancer is an awful pain to have.”

She was a mother, wife, sister, cousin, friend that was gone too soon.”

Sherina-Garner-5K

Hope for children’s rare drug approval process

News Stories & Editorials
By Lisa Gillespie, USA Today (Kaiser Health News)
June 7, 2015

Advocates for children with rare diseases are watching closely a congressional effort to streamline the nation’s drug approval process because the bill includes a provision that would extend a federal program that rewards companies making remedies for these young patients.

The reward program, the advocates say, offers hope to families that often have very few options. Approximately 15 million children are diagnosed with rare diseases, and 35% of deaths in the first year of life are caused by them.

“Treatments aren’t getting to kids, and kids deserve more than the leftovers,” said Nancy Goodman, the founder and executive director of the advocacy group Kids v Cancer. Goodman’s 10-year-old son died from brain cancer. She helped push for the original reward program in the hope that children like her son would have access to a wider range of treatments.

The extension of that program is part of the bipartisan 21st Century Cures bill, which seeks to rewrite the rules for drug development to make innovative treatments available faster. The overall bill has generated support on Capitol Hill, but some critics contend that it has the potential to undermine drug safety and to profit drugmakers.

Children’s advocates say there is a shortage of good therapies for rare and often deadly pediatric diseases that can include a wide variety of conditions including cancer, skull deformities or enzyme deficiencies. Pharmaceutical companies have historically been hesitant to test drugs for children because of concerns about potential negative outcomes, children’s ability to consent to treatment and the perception that the market for these drugs was limited. So doctors have often been left to try adult-tested drugs on sick children but without the studies that show pediatric safety or effectiveness. But drugs used on adults don’t always work on children in the same way because of differences in metabolism and maturation of organs.

The advocates say more research needs to be conducted with children. But that testing is a sensitive process. It can be very costly and it requires extra care because there are more stringent ethical protocols to protect these minors, who can’t often give informed consent. Bad results — either injuries or deaths — can set back research efforts and have financial consequences for the company.

With that in mind, Congress in 2011 set up a program to help promote more pediatric drug research. It gives creators of medicine for rare pediatric diseases a voucher that they can use to have another one of their drugs approved quicker than usual — six months vs. a process that can run a year or often more.

Drugmakers can also sell that voucher, which can be a big windfall for a small drug company trying to recoup research and development costs. There have been four vouchers given out since 2014, and one was sold for $67.5 million and a second for $125 million.

The voucher program, which advocates say holds big potential, expires next year. The cures bill seeks to extend it another three years.

“A lot of companies are reluctant to get into pediatric drug development because it’s very difficult if something goes really wrong,” said Alexander Gaffney of the Regulatory Affairs Professionals Society, an association for people involved in overseeing health care or the quality of health care products.

Drugs that are approved for cancer in adults are commonly not approved in kids. “Children are not simply small adults, they metabolize drugs very differently,” Gaffney said.

Critics say that however well-intentioned the voucher program is, it could have some unintended consequences. For example, a company could get a drug approved by theFood and Drug Administration but never bring it to market, if the maker decides it would not generate enough money. Yet the company would still pocket the priority review voucher.

Because of the speed sought by the program, vouchers could be given out without some of the safeguards that come in more traditional testing. For example, the research might not uncover that the drug could be fatal to a child after a few months or years.

Diana Zuckerman, president of the National Center for Health Research, a non-profit group that seeks to represent children and families on health research policy issues, says the rush in moving drugs through the system can obscure problems. Drugmakers “shouldn’t be able to sell it [or use it] unless it works,” she said.

She noted that in some studies as few as 10 kids are included because the disease is so rare. With such a small population size, the company is not likely looking at big profits.

“When you’re doing a study of rare disease, it’s a small sample size and it’s easy to manipulate the data to make it look better than it is,” said. “You don’t want an incentive to represent the company wrongly in the short term,” to get the voucher for another larger drug.

Julia Jenkins, executive director of the EveryLife Foundation for Rare Diseases, an advocacy group pushing for drug companies to spend more on drug development, wants the pediatric drug voucher program extended. She notes that the program is still too new for officials to evaluate whether it is effective.

One problematic part of the current House version, she said, is that it only extends the program for three years, and drug companies generally need 10 years to scratch up investors and research a new drug. The potential reward of expedited drug review might not be enough to allow a company to make a financial plan for a drug based on the program.

The expanded bill covers more than 60 health issues, including a $10 billion boost in funding for the National Institutes of Health and $550 million in extra money for the FDA over the next five years. Other provisions include creating a database of genomic information from a million U.S. patient volunteers and allowing the FDA to approve drugs without the gold-standard clinical trial, instead using smaller observational studies or clinical experiences.

The bill passed the House Energy and Commerce Committee unanimously in May and is expected to come up for a vote in the full House. Senators are in the early stages of working on a similar bill.

See original article here.

Speeding up drug-approval process could have downside

In the News, News Stories & Editorials
By Ed Silverman

Excerpted from The Wall Street Journal, May 30, 2015.

Would a congressional bill designed to jump-start medical innovation end up lowering standards for approving new uses of existing medicines?

Consumer advocates are raising this concern about the 21st Century Cures legislation, which passed the House Energy and Commerce Committee unanimously last week and, in part, is designed to reform the approval process for drugs. Supporters say the bill is a long overdue move that, among other things, will give the FDA the tools to ensure treatments reach patients faster.

But critics say that a section of the bill devoted to drug development is problematic. Specifically, they point to language that would allow the FDA to approve additional uses for drugs without having to rely on randomized controlled trials. These are considered to be the gold standard for determining whether a medicine offers a benefit, and they help gauge the extent to which there are risky side effects.

The bill, however, pushes aside evidence in favor of something called “clinical experience,” which is defined as a mix of observational studies, patient registries and therapeutic use. None of these, however, are viewed as scientifically rigorous for establishing whether a drug may be effective. Instead, critics say the language in the bill is sufficiently, perhaps deliberately, vague.

“Clinical experience is something that should be considered as additional information, but absolutely never take the place of scientific data,” says Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank. “By urging FDA to get away from randomized clinical trials, drug makers may have more power to urge the FDA to consider data that is favorable to their product.”

To read the entire article, including similar concerns expressed by Dr. Steven Goodman from Stanford, see http://www.wsj.com/articles/speeding-up-drug-approval-process-could-have-downside-1432857506