Tag Archives: cancer

What Genentech is doing to fix biotech’s diversity problem

Fortune Editors, Fortune: April 7, 2021

There’s a big problem with clinical trials: a lack of diversity. And that issue is ultimately detrimental to countless people’s lives and health.

Take, for example, breast cancer research. For a long time, the thinking in the health care world was that Black women didn’t develop breast cancer as often as white women, but when they did, they were more likely to die because of it.

“There was this assumption that it was an issue of access to care, the quality of care,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank that analyzes the latest research and helps consumers and organizations put that information to work. But “if you looked at the research, you saw that the original major studies of breast cancer treatment were done on white women.”

That meant the research featured fewer women with triple-negative breast cancer, which Black women develop more often than white women. “Because [women with triple-negative breast cancer] weren’t studied,” Zuckerman continues, “[the researchers] didn’t realize that the treatments that they were studying would not work on those types of cancer.”

Zuckerman talks with Fortune’s Ellen McGirt on this week’s episode of Leadership Next, a podcast about the changing rules of business leadership. Also on the episode with McGirt and cohost Alan Murray is Alexander Hardy, who became CEO of biotech company Genentech two years ago.

Hardy has made it clear that he’s committed to boosting diversity within the biotech world and in clinical trials, and he was already doing so before the pandemic. But COVID-19 crystallized some of the issues in the U.S.


During the show, Hardy also discusses the ways the COVID-19 pandemic has changed the biotech industry, and how those changes could spill over into research on diseases such as Alzheimer’s, ALS, and cancer.

To read the entire article and listen to the podcast, click here.

Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors

Nicholas Florko, STAT News: March 1, 2021

In 2000, the Food and Drug Administration approved just three cancer drugs. Last year, even with the agency laser-focused on the coronavirus pandemic, much of its staff teleworking, the agency still approved a record-breaking 17 different cancer therapies — more than in any other category. That’s the legacy of FDA drug center chief Janet Woodcock. Woodcock, a 36-year veteran of the agency, is infamous for pushing the FDA to loosen its standards for drugs for rare conditions like Duchenne muscular dystrophy. But Woodcock’s most lasting impact at the FDA is her transformation of the way the agency approaches cancer drug approvals….. Now the nation’s top cancer doctors are emerging as Woodcock’s most vocal backers in her campaign to become President Biden’s FDA commissioner.

Critics say Woodcock’s cancer crusade has come at a cost. With the speed has come an erosion of the agency’s high standards and an increasing willingness to greenlight drugs that haven’t actually been proven to extend a patient’s life. … Their complaint mostly revolves around Woodcock’s willingness to accept studies testing drugs based on so-called surrogate endpoints, measures like the shrinkage of a tumor, rather testing a drug based on how long it keeps a patient alive. ….It’s a view that even some former FDA officials hold; one described Woodcock as pushing “flexibility even at the expense of science.”


“For many cancers there is an improvement in survival, the question is which drugs are responsible for that and which ones aren’t, that’s the big unknown and that’s what’s so frustrating,” said Diana Zuckerman, the president of the National Center for Health Research. The end result of this confusion, critics argue, is that doctors and patients are left guessing whether a drug is truly effective, or worth the money.


Read the full article here.

We can’t ever go to the doctor with our guard down’: Why Black women are 40% more likely to die of breast cancer

Maria Aspan: Fortune Magazine June 30, 2020

Racism kills Black Americans, and has long before COVID-19. But its toxic combination with sexism has particularly vast and disastrous consequences for the health of Black women.

While Black people in the U.S. are dying from the COVID-19 pandemic at a disproportionately high rate, this national health crisis underlines an even grimmer status quo: Black Americans are also much more likely to die from far more common and longstanding health problems every day. Black women are at particularly high risk of heart disease and strokes, and are at least three times as likely to die as a result of childbirth as white women, contributing to the overall alarmingly high maternal mortality rate in the United States.

Then there are the shocking statistics around breast cancer, which affects one in every eight women and is the most common non-skin cancer affecting women. Black women are less likely to develop it—but 40% more likely to die from it than white women, according to the U.S. Centers for Disease Control and Prevention.

The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it. Now the disproportionately high toll of COVID-19 on the Black population in the U.S. and the simultaneous national reckoning over racism are drawing new attention to the racial inequities hurting Black women—and amplifying the voices of doctors, scientists, and public health experts who have long sounded the alarm.


Women of all races could be legally omitted from government-funded clinical trials before 1993, and are still often under-represented in most research studies of conditions that affect them. Pregnancy and menstrual cycles are thought to “complicate” the results of trials that are mostly conducted on white men, who are seen as the “norm.”

This can obviously backfire. In 2013, the U.S. Food and Drug Administration sharply cut its recommended dosages of Ambien for women, after years of complaints about grogginess and falling asleep while driving, when followup tests showed that women metabolized the active ingredient in sleeping aids much more slowly than men.

When it comes to clinical trials funded by pharmaceutical companies, “the FDA encourages but does not require diversity in clinical trials,” says Diana Zuckerman, a scientist and president of the National Center for Health Research. “Worse, the agency frequently approves drugs and devices for all adults, even if they were primarily studied on white adults.”

One treatment that the FDA approved in April, for the “triple-negative” type of breast cancer that disproportionately affects Black women, was approved after being tested on 108 patients. Eight of them, or 7%, were Black. Another breast-cancer treatment was approved last year after being tested on 234 patients; seven of them, or 3%, were Black.


Read the full article here

Dietary Supplements Before and During Chemotherapy

Meg Seymour, PhD, National Center for Health Research

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

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

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

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

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

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

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

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


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

Can Belly Fat Cause Cancer?

Ammu Dinesh and Claire Viscione, National Center for Health Research

Belly fat is common among men and women. However, when a person’s body shape looks more like an apple than a pear, that could increase their likelihood of developing cancer. 

More than two-thirds of adult Americans are overweight or obese.1 Most people know that obesity increases the risk of diabetes, heart disease, and high blood pressure. But did you know that being overweight increases your chances of developing cancer, and that having an “apple” body shape due to belly fat can increase your chances of developing cancer even if you are not overweight?

Why is belly fat dangerous?

Whether your body fat is located at your waist (giving you an apple shape) or hips (giving you a pear shape) makes a difference to your health. Women tend to gain more belly fat as they get older. Regardless of their weight, white, black, and Latina women with a waistline measurement of 35 inches or more have higher health risks. This is also true for Asian women with a waistline of 31 inches or more. Although it is important to get rid of excess fat in general, belly fat is the most threatening to your health.

Physicians use often use body mass index (BMI) to estimate whether you are overweight or obese. However, determining your waist circumference is just as important. Even if you are not overweight or obese, if you have a lot of belly fat, you are more likely to develop cancer.

Unlike the fat that sits just beneath the skin, the fat that sits around internal organs is called visceral fat.2 This fat is the most dangerous, and it is typically what shows up as belly fat. If you measure your waistline, you can get a good idea of whether you have a dangerous amount of belly fat. 

Women Men
Low health risk 31.5 inches or less 37 inches or less
Intermediate health risk 31.6 – 34.9 inches 37.1 – 39.9 inches
High health risk 35 inches or more 40 inches or more

Table 1. What does your waistline measurement mean? 2

Several studies have looked at the relationship between belly fat and cancer. One study followed over 150,000 post-menopausal women ages 50-79 for about 20 years.3 This study found that women who have extra belly fat are at higher risk of death regardless of their weight. Causes of death in the study included cardiovascular disease and cancer. The women of normal weight who had extra belly fat tended to be older, nonwhite, and with less education and income. They were also less likely to use menopausal hormones and to exercise. 

To figure out your BMI for the chart below, enter your height and weight into this calculator.

Apple Shape (Extra Belly Fat) Not “Apple Shape”
Not Overweight (BMI below 25) 20% more likely to die from cancer within 20 years
Overweight (BMI of 25-29.9) 19% more likely to die from cancer within 20 years 4% less likely to die from cancer within 20 years
Obese (BMI of 30 or higher) 26% more likely to die from cancer within 20 years 4% less likely to die from cancer within 20 years

Table 2. Likelihood of death due to cancer in women based on BMI.3

Women who were not overweight or obese but had extra belly fat were just as likely to die from cancer as overweight women with extra belly fat.

A different study followed over 3,000 men and women for 7 years.4 They used CT scans and physical exams to look at the fat throughout the body. Over the course of the study, the men and women developed 141 cases of cancer, 90 heart-related incidents, and 71 deaths from various causes. The study found that people with more belly fat, specifically visceral fat, were about 44% more likely to develop cancer and heart disease, even when adjusting for waist circumference. 

What can you do?

As you can see, belly fat can be very dangerous, especially for women, even if they are not overweight. Losing weight or preventing weight gain can lower health risks. By exercising regularly, you can get rid of unhealthy belly fat. It is also important to change your diet to eat foods that are high in nutrients and essential vitamins. You can do this by eating more fresh vegetables, nuts, and whole-grain breads instead of processed meat, red meat, candy, pasta, and white bread. These few changes can help you lose belly fat and improve the quality and length of your life.

Local bans on unhealthy food and drinks may also be effective in reducing belly fat. A 2019 study shows that a ban on the sale of sugar-sweetened beverages at a large college campus substantially decreased consumption and led to significantly less belly fat.5 Students who stopped drinking the beverages had improved insulin resistance and lower cholesterol. The combination of the ban and a brief motivational talk was even more effective than the ban by itself.

Learn more about how extra body fat can increase your risk for developing cancer, and how you can make a commitment to your health and reduce risky belly fat:


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



  1. Center for Disease Control and Prevention. FastStats- Overweight Prevalence. CDC.gov. https://www.cdc.gov/nchs/fastats/obesity-overweight.htm. Updated June 13, 2016.
  2. Harvard Health Publishing. Abdominal obesity and your health. Health.Harvard.edu. https://www.health.harvard.edu/staying-healthy/abdominal-obesity-and-your-health. September 2005. Updated January 20, 2017.
  3. Sun Y, Liu B, Snetselaar LG, Wallace RB, Caan BJ, Rohan TE, et al. Association of Normal-Weight Central Obesity With All-Cause and Cause-Specific Mortality Among Postmenopausal Women. JAMA Network Open. 2019;2(7):e197337. https://www.ncbi.nlm.nih.gov/pubmed/31339542.
  4. 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. http://www.onlinejacc.org/content/62/10/921.
  5. Epel ES, Hartman A, Jacobs LM, Leung C, Cohn MA, Jensen L, et al. Association of a Workplace Sales Ban on Sugar-Sweetened Beverages With Employee Consumption of Sugar-Sweetened Beverages and Health. JAMA Network Open. 2019. doi:https://doi.org/10.1001/jamainternmed.2019.4434

Good news for coffee drinkers: the health benefits outweigh the risks for most people

By Morgan Wharton and Jessica Cote

latte-249102_640Most Americans drink coffee every day.1 The caffeine in coffee helps us stay alert but also may cause jitteriness and interfere with sleeping. A few studies suggest that decaffeinated coffee also has health benefits, perhaps because of antioxidants or acids in the coffee bean.2

What Are The Health Benefits Of Drinking Coffee?

For years medical experts advised people to drink less coffee, mostly because of research suggesting coffee might increase the risk of heart disease. However, numerous studies conducted recently have discovered coffee’s unexpected health benefits. Like all well-designed research, most of these studies considered the impact of age, sex, body mass index (BMI), physical activity, tobacco use, and whether family members had developed cancer. By controlling for those factors, researchers made sure they could separate coffee’s impact on health from the effects of people’s lifestyle, family history, and previous health problems.

Colorectal Cancer

Meta-analyses are a kind of statistics that combine data from several comparable studies to make one very large study. These results are usually more accurate than any one study can be. Taken together, three meta-analyses suggest that drinking about four or more cups of coffee per day may reduce the chances of getting colorectal cancer by 11-24%.345

Endometrial (uterine) Cancer

Using data from 67,470 women who participated in the Nurses’ Health Study, researchers found that women who drank four or more cups of coffee per day were 25% less likely to develop endometrial cancer than women who drank only one cup of coffee per day. Compared to women who did not drink any coffee, those who drank four cups or more per day were 30% less likely to develop endometrial cancer. Decaffeinated coffee was just as effective as caffeinated coffee, but caffeinated tea did not lower the risk of endometrial cancer.6

Liver Cancer And Cirrhosis (Scarring of the Liver/Chronic Liver Disease)

One study found people who drank one or two cups of coffee per day had a slightly lower risk of getting the most common type of liver cancer compared to non-drinkers, but people who drank three or four cups of coffee were about half as likely as non-drinkers to get this kind of liver cancer. Meanwhile, people who drank five or more cups per day had an even lower risk than that (about one-third the risk of non-drinkers).7

Similarly, a study in Japan found a 76% decrease in the risk of that type of liver cancer in people who drank at least five cups of coffee per day compared to those who did not drink coffee. The strongest benefit was seen in individuals with hepatitis C, a disease which increases a person’s risk of developing liver cancer, although the researchers were not sure why.8

A study of 120,000 Americans over an 8-year period found a 22% decrease in the chances of developing cirrhosis for each daily cup of coffee. In Norway, a 17-year study of 51,000 citizens found that those who drank two or more cups of coffee per day were 40% less likely to develop cirrhosis compared to those who did not consume coffee.9

Skin Cancer

Using data from two enormous studies, the Nurses’ Health Study and the Health Professionals Follow-up Study, researchers found that men and women who drank more than three cups of caffeinated coffee per month were 17% less likely to develop basal cell carcinoma compared to people who drank less than one cup per month. Basal cell carcinoma is the most common and least dangerous type of skin cancer. Drinking decaffeinated coffee did not affect basal cell carcinoma.10

A 2014 study in the Journal of the National Cancer Institute found that the more coffee participants drank, the less likely they were to develop malignant melanoma over a 10 year period. Melanoma is the most dangerous form of skin cancer. Almost 450,000 whites, aged 50-71, participated in the study. Researchers found that drinking four or more cups of coffee per day was linked to a 20% lower risk of getting malignant melanoma. Once again, drinkers of decaffeinated coffee lost out. Their risk of getting melanoma was no different from that of non-coffee drinkers. Coffee drinking, however, did not affect the least dangerous form of melanoma, called melanoma in situ.

Remember that no matter how much coffee with caffeine you drink, the best way to prevent skin cancer is still to limit your time exposed to the sun and ultraviolet light! 11

Type 2 Diabetes

People in Finland consume more coffee than almost any other nation, and a study of 14,000 people over 12 years  found that men who drank 10 or more cups of coffee daily had a 55% lower risk of developing type 2 diabetes than men who drank 2 cups of coffee a day or fewer.  Even more dramatic, women who drank 10 or more cups per day had a 79% lower risk of developing type 2 diabetes than those who drank fewer than 2 cups daily.12

A different Finnish study of 5,000 sets of identical twins found that individuals who drank more than seven cups of coffee per day had a 35% lower risk of type 2 diabetes than their twins who drank two cups or fewer per day.13 Because identical twins are so biologically similar, the difference in disease risk is very likely caused by coffee consumption levels. Studies of fewer people in other countries have found less dramatic but similarly positive results.

Parkinson’s Disease

A study of more than 8,000 Japanese-American men found that men who did not drink coffee at all were three to five times more likely to develop Parkinson’s disease within 30 years than men who drank four and a half cups or more of coffee per day.14


Because suicide may be related to alcohol intake, medications, and stress levels, suicide studies took those factors into account.  A 10-year study of 128,000 people in California found that the risk of suicide decreased by 13% for every additional cup of coffee consumed per day. Even one cup of coffee per day seemed to reduce the risk of suicide. A different 10-year study of 86,000 women found a 50% lower risk of suicide for those who drank two or more cups of coffee per day compared to women who did not drink coffee.15

Brain Power and Aging

A study of 676 healthy men born between 1900 and 1920 suggested that coffee helped with information processing and slowed the cognitive decline typical of aging. Cognitive functioning was measured by the Mini-Mental State Examination, a 30 point scale. Men who regularly consumed coffee experienced an average decline of 1.2 points over 10 years, while men who did not drink coffee saw a decline of 2.6 points over 10 years. Men who drank three cups of coffee per day declined only 0.6 points over 10 years.16

Even old mice are sharper with caffeine: a study using a mouse model of Alzheimer’s disease showed that coffee actually reversed the cognitive decline and slow-down in processing that occurred with age. Mice given caffeine in their water showed signs of recovering their memory during testing.17

What about the risks?


Two separate studies found that 300 mg of caffeine (two to three cups of coffee) decreased a woman’s chances of getting pregnant by more than a third. This same amount of coffee also increased the chances of women having low birth-weight babies by 50%. These studies took into account potentially influential  factors such as contraception used in the past and infertility history.18

Hip Fracture

According to data from the Nurses’ Health Study, women aged 65 and over who drank more than four cups of coffee per day had almost 3 times as many hip fractures over the next six years as women who did not drink coffee. Researchers took important factors into consideration such as how much calcium the women consumed each day.19

Parkinson’s Disease among post-menopausal women taking estrogen-only hormone therapy

Other researchers used data from the Nurses’ Health Study to evaluate the risk of Parkinson’s disease among women who drank coffee while using estrogen medication after menopause. For women who were NOT using estrogen therapy, those who drank four or more cups of coffee per day were about half as likely to develop Parkinson’s disease as women who did not drink coffee. For women who did use post-menopausal estrogen, however, those who drank four or more cups of coffee were about twice as likely as those who didn’t drink coffee to develop Parkinson’s.20

Heart Disease

Two different meta-analyses found that people who drank five or more cups of coffee per day were 40-60% more likely to develop heart disease compared to those who did not drink coffee at all. Other studies have also shown that high coffee use (five to ten cups per day) increases the risk of heart disease, while moderate consumption (three to four cups daily) was not associated with a higher risk. Only coffee drinkers who consumed more than nine cups a day had a greater risk of dying from heart disease.21 It is important to consider that people drinking close to 10 cups of coffee a day are likely to have other health problems, such as stress or sleep deprivation, and this could contribute to higher risk of heart disease and death regardless of coffee use.

Bottom line

For most people, drinking coffee seems to improve health more than harm it. Many of coffee’s health benefits increase with the number of cups per day, but even one cup a day lowers the risk of several diseases. However, women who want to get pregnant or already are pregnant and women over 65 should probably limit their coffee intake because, in their case, the risks may outweigh the health benefits.

Even though many studies show coffee has benefits, it’s still not clear why. How can one popular beverage help metabolism (for example, lowering the risk of type 2 diabetes) and also protect against a range of cancers? Until further research can solve that puzzle, most adults should continue to enjoy their cup (or two, or three) of Joe. Finally, remember that nearly all studies on coffee and health have been done on adults. Coffee may affect children and teens differently.

The worst new drug of 2014

DIANA ZUCKERMAN, PHD, PRESIDENT OF The Cancer Prevention & Treatment Fund 

It’s only February, so it may seem early to be talking about one of the Food and Drug Administration’s (FDA’s) worst decisions of 2014. Yes, the year just started, but the FDA has already made a decision that could potentially harm thousands of patients.

The agency just approved a new diabetes medication that doesn’t noticeably improve health but may in fact cause cancer.

It’s called Farxiga (Dapagliflozin) and it will be available—and probably widely advertised—very soon. The good news is that the drug lowers blood sugar, which is a major symptom of type 2 diabetes. However, lowering blood sugar is not necessarily a way to improve health. The new drug is meant to reduce medical problems such as heart disease or kidney damage. Unfortunately, there is no evidence that it actually improves health—in fact, quite the opposite.

The FDA reports that the most common side effects of Farxiga are genital fungal infections and urinary tract infections. Not fun, but those aren’t its most serious side effects. If a patient has moderate or severe kidney damage (as many diabetics do), the drug is not beneficial and could cause further damage, possibly even renal failure.

But the more frightening news is that patients taking Farxiga in studies done for the FDA were more than five times more likely to contract bladder cancer than the patients who took an older diabetes drug. Based on the findings of the companies making and selling Farxiga, FDA scientists concluded that the drug might stimulate bladder cancer in patients already at risk. The fear is that patients take diabetes drugs for years, and the longer someone takes this drug, the greater their risk of cancer.

Bladder cancer can be fatal, and is especially dangerous in people who have diabetes.

The companies’ studies also found that patients taking the drug were more than twice as likely to get breast cancer as diabetics not taking the drug, but they say this could have happened by chance.

It’s important to mention that only a small number of African Americans were studied. Because African Americans are more likely to have diabetes than Caucasians, these studies should have included greater numbers of them to find out if the drug is safe or effective for them.

With so many other diabetes drugs already on the market, why would anyone want to take this drug, and why would FDA approve it?  Here’s the scorecard, based on information provided by FDA scientists and available on the FDA website:

  1. Is the drug new? Yes.
  2. Does it reduce the medical problems caused by type 2 diabetes, such as blindness, heart disease, kidney damage, or amputations? No.
  3. Can it cause kidney damage or make it worse? Yes.
  4. Does research show that patients taking it are more likely to get bladder cancer. Probably.
  5. Does research show that patients taking it are more likely to develop breast cancer? Maybe.
  6. Does research show it is more effective than most diabetes drugs on the market? No.
  7. Will it cost more than most other diabetes drugs on the market? No information on cost yet, but new drugs usually do cost more.

The FDA is requiring that the label for the drug warn patients with bladder cancer that they shouldn’t take Farxiga because it might make their cancer worse. Ya think? And, the agency is requiring the companies to study 17,000 diabetes patients for at least four years to determine whether and how often patients taking Farxiga are diagnosed with cancer, liver problems, or heart disease when the drug is taken for a longer period of time.

The FDA rejected this drug two years ago because of these cancer concerns and questions about how well the drug prevents the major risks of diabetes. But the FDA has been beaten up by many complaining congressmen since then, and by some patient groups, pushing it to approve more new drugs quickly rather than waiting for safety studies to be completed. Also, the pharmaceutical companies don’t like to take no for an answer, they spend lots of money on lobbying, and they are very effective at pushing FDA to reconsider rejections. Because of that, the FDA selected an advisory committee to review the data in December, and those doctors and scientists also expressed concerns about risks and benefits. I was at the meeting and pointed out that there were too many serious unanswered questions.

Despite my concerns, the concerns of FDA scientists and other experts, and the concerns of the advisory committee members themselves, the committee recommended that if the companies continued to study the drug after it was approved, in order to figure out what the actual risks are, the company could sell it now.

It’s too early to say whether this will be the worst decision the FDA makes in 2014. Maybe the diabetes patients who take it will be lucky and not be harmed by the drug. Or maybe only a few patients will develop cancer or kidney failure as a result of taking it. Or the FDA scientists who expressed their concerns could be wrong, and I could have made a mistake when I agreed with them. But regardless of what happens with this drug, it still would be a bad decision to allow the sale of a drug with such serious (potentially fatal) unanswered questions.

Given the epidemic of diabetes in this country, the risks are huge. For that reason, this drug worries me even more than some of FDA’s similarly mind-boggling decisions of 2013, such as:

  • drug for hot flashes that has no meaningful benefits but can increase the risk of suicide among women who weren’t depressed
  • An antibiotic for pneumonia that seems to kill more patients than other antibiotics

I’ve always respected the scientists at the FDA for working so hard to try to keep all of us safe. I still do. But decisions are being made at the agency that seem to ignore scientists and science, and that is dangerous for all of us. Whether we have diabetes, hot flashes, pneumonia, cancer, or any other disease, we deserve better.


A version of this post appeared in The Huffington Post, Maria’s Farm Country Kitchen

 In 2018, the U.S. Food and Drug Administration (FDA) announced a new warning on Farxiga and other SGLT2 inhibitors because they can cause a rare but life-threatening infection of the genitals and area around the genitals. The infection is called necrotizing fasciitis of the perineum or Fournier’s gangrene.  

Comments of the Cancer Prevention and Treatment Fund on FDA draft guidance to industry on Acrylamide in foods

January 14, 2014

The Cancer Prevention and Treatment Fund strongly supports the Food and Drug Administration in its efforts to advise industry on reduction of acrylamide in food products.  The Grocery Manufacturers Association estimates that acrylamide is present in approximately 40% of the total caloric intake in a typical American diet.22 Given this near-ubiquity, and the fact that the chemical reaction which produces acrylamide also produces commercially desirable color, taste and texture characteristics, reduction of acrylamide represents a challenge.  However, the evidence of possible human harm necessitates its treatment as a significant public health issue. While this report represents an important step in FDA regulation of acrylamide and suggests many possible acrylamide reduction methods, we are concerned that this guidance is not specific enough in providing clear and concrete recommendations that can be implemented.  Although FDA guidance does not have the force of law or regulation, the addition of terms such as “when feasible” implies that the FDA is not serious in its efforts to persuade companies to substantially reduce acrylamide.  FDA monitoring of acrylamide in 2002 indicated wide variation even among products from the same food category –as much as 5 or 10 fold differences in several categories.  This is clear evidence that significant acrylamide reduction can be accomplished without losing desirable product qualities. Thus, although there is clearly much room for improvement, this report contains few immediately implementable guidelines for industry. Since 2002, it has been known that acrylamide is created in food products as the result of a reaction between carbohydrates and the amino acid asparagine at high temperatures during browning (i.e., the Maillard reaction).23  In addition to its known neurotoxic properties, both animal toxicology and human epidemiological studies suggest that acrylamide may be cancer-promoting, which has led to its carcinogen classifications by EPA, NTP and IARC.24,25,26,27 Higher dietary acrylamide consumption has been associated with increased risk of endometrial, ovarian, pancreatic, renal and possibly breast cancer.28,29,30,31.  Acrylamide is already regulated in drinking water and was classified by EPA as “likely to be a carcinogen to humans” and was classified by the National Toxicology Program as “reasonably anticipated to be a human carcinogen,” both more than a decade ago.  The European Food Safety Authority has been overseeing acrylamide monitoring within the European Union since 2007, and the European Commission has set recommended indicative values for acrylamide in food products, providing a quantitative framework for both assessment of reduction efforts and investigative action.  This is a very important health issue and we strongly urge the FDA to intensify its efforts and assert leadership of both the national and international efforts to regulate acrylamide and ensure public safety. Our areas of specific concern are the following:

  • While encouraging manufacturers to conduct their own testing, FDA should update and expand its own monitoring efforts.  Monitoring of acrylamide in food products over time is needed for any reduction efforts to be assessed and successfully implemented.  The current FDA monitoring strategy tested only several hundred foods in four geographic regions annually between 2002 and 2006, and the last publicly available information is from 2006.32  Given the wide range of acrylamide levels even within a single food category, more extensive and up-to-date monitoring is needed to adequately evaluate acrylamide levels and the success of reduction methods.
  • While this report encourages manufacturers to monitor acrylamide levels, it does not give any specific values which should prompt corrective efforts.  Without such guideposts, monitoring alone is unlikely to result in significant reductions.  Recommended target values or action levels, together with active monitoring, will allow FDA and manufacturers to directly access efficacy of reduction efforts and trigger investigation when needed.  The European Commission has set indicative values for acrylamide in food products, including separate values for products intended for infants and young children, and these values are intended to be gradually reduced.33  Indeed, these indicative values have been broadened to include more specific categories and some have already been lowered since their release in 2011, and the European Food Safety Authority is currently conducting a risk assessment at the request of the European Commission to determine if current recommendations are sufficiently protective.  Such a system provides a quantitative framework for reduction efforts and allows increased surveillance of items of special health importance.  Values at least as low as the 2013 European Commission indicative values should be adopted, with the shared intent of gradual lowering of these values as reduction efforts improve.
  • Without accurate and affordable detection techniques, manufacturers are unlikely to measure acrylamide in their products, especially when participation is voluntary.  This guidance encourages manufacturers to be aware of acrylamide levels in their food products.  This is a crucial step towards evaluating reduction efforts.  However, this vital imperative is followed by a discussion of both the technical limitations and expense associated with current methods of acrylamide detection.  While FDA has committed to improving these techniques, they remain costly and fraught with technical limitations, making widespread voluntary use, especially by small manufacturers, unlikely.  FDA should continue to investigate means to improve acrylamide detection and make specific recommendations to industry regarding best possible techniques in order to facilitate participation in monitoring.  As an example, the European Commission has recently set measurement uncertainty (MU) values and tasked the European Committee for Standardisation (CEN) with analytical standardization of LC-MS and GC-MS for acrylamide detection.  Such efforts, in addition to adoption of standard references, will increase consistency and improve confidence in acrylamide detection efforts.
  • In this guidance, the FDA specifically states that it does not intend to recommend one method over another.  This is unfortunate because it leaves both guesswork and legwork to industry.  FDA states that “this guidance is intended to suggest a range of possible approaches to acrylamide reduction and not to identify specific recommended approaches.”  The role of federal agencies should include evaluating reduction approaches to determine which are more efficacious and feasible than others, and providing that potentially useful information to industry, even if only to help identify and encourage prioritization of those approaches first, in addition to continuing research in this area.  Clear communication of superior and cost-effective approaches to acrylamide reduction may result in higher industry participation and more successful reduction efforts.
  • FDA monitoring since 2002 has shown that many foods contain higher levels of acrylamide than the level considered safe by the EPA for drinking water.  Some of the highest acrylamide levels are found in potato and cereal products which are common in the American diet.  These surveys also show that a healthy diet which includes whole grains can have significant acrylamide levels, potentially even higher than a diet which includes less healthful choices such as potato chips and French fries.  The FDA has maintained its message to consumers that a balanced, healthy diet is a way to manage concern over acrylamide consumption, when the evidence shows that this advice is not accurate. 
  • The effects of acrylamide reduction on overall product nutrition should be considered in the context of all health risks and benefits.  For example, lower temperature frying reduces acrylamide, but also requires longer cooking time, resulting in higher fat content in fried foods.  While we commend thorough consideration of all possible health implications of acrylamide reduction methods, FDA should also consider which outcomes can be more easily mitigated by other dietary or lifestyle interventions in order to fully assess risks and benefits.

Lastly, as acrylamide accumulates in food as a result of the handling and cooking process, rather than in the raw food itself, and is a serious human health concern, it could be viewed as source of food adulteration and regulated as such under Section 402(a) of the Federal Food, Drug and Cosmetic Act with action levels.  We ask that FDA consider these improvements to this draft guidance, and use its full authority to ensure that the public is sufficiently protected.

The Cancer Prevention and Treatment Fund

 For additional information, contact Anna Mazzucco at am@center4research.org or (202) 223-4000.

Public Comments on NIOSH Draft Intelligence on Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace

By Anna E. Mazzucco
December 16, 2013

Thank you for the opportunity to speak today.  My name is Dr. Anna Mazzucco, and I speak on behalf of the National Research Center for Women & Families, and our Cancer Prevention and Treatment Fund.  After completing my Ph.D. in cell and developmental biology at Harvard Medical School, I conducted research at the National Cancer Institute.  I speak today as a cancer biologist gravely concerned that these regulations lag behind the state of the science, and fall far short of protecting Americans from occupational causes of cancer.

In 2013, more than half a million Americans will die from cancer.  A 2003 joint report from the National Cancer Institute and the National Institute for Environmental Health Sciences stated that “exposure to a wide variety of natural and man-made substances in the environment accounts for at least two-thirds of all the cases of cancer in the United States.” Yet after reviewing the current state of regulatory policy and research efforts, the President’s Cancer Panel reported in 2010 that “environmental health, including cancer risk, has been largely excluded from overall national policy on protecting and improving the health of Americans.”   When notorious and decades-known carcinogens such as asbestos and radon are still present at unsafe or unknown levels in American workplaces, how can the public have confidence that our regulations can handle new and complex occupational hazards arising every day?  Only a few hundred out of more than 80,000 chemicals in use in the United States have been tested for safety.  We should be concerned.

The National Institutes of Health estimated the total cost of cancer in 2008 at $201.5 billion in both direct health care costs and the indirect cost of lost productivity due to premature deaths.   Another recent study estimated that cancer is responsible for 20 percent of all health care spending.  Disability days alone cost $7.5 billion in lost productivity each year.  And these numbers cannot attempt to capture the human value of lives lost.

Unfortunately, the NIOSH draft report represents a continuation of the status quo.  It reinforces a reactive rather than proactive approach to regulation.  It maintains historical policy positions which are no longer appropriate.  It  places burdens on workers rather than on industry.  And, it overlooks glaring gaps in regulation. This report does not provide sufficient information on proposed new policies that would add to redundancy between agencies, rather than eliminating redundancy.  Even more troubling, these new policies could allow a more permissive stance towards carcinogens in the workplace despite more stringent regulation of the very same agents by other federal agencies.

We have 5 Areas of concern that we want to emphasize:

  1. Safe exposure limits must be based on actual, not theoretical, workplace exposures. Real-life workplace chemical use involves multiple agents and complex exposures.  This report does not give any concrete statements on how to address the true chemical milieu to which workers are exposed.  There is no scientific reason to limit our safety analyses to single agents.  If the goal is to prevent chemical hazard exposure in the workplace, then we must start with the workplace, and not a theoretical framework which likely applies to very few real-life situations.
  2. Acceptable occupational risk assessments should be based on up-to-date, circumspect and truly representative information.  NIOSH uses a lifetime cancer risk increase of 1 in 1,000 as the acceptable regulatory threshold, while stating that “controlling exposure to lower concentrations is always warranted.” NIOSH admits that “an excess risk of 1 in 1,000 is one or more orders of magnitude higher than what the United States permits for the general public.” NIOSH justifies this questionable threshold with two arguments:  The first is the historic “benzene decision” made by the U.S. Supreme Court in 1980, where a 1 in 1,000 risk was used in a seemingly rhetorical example.  The second justification is that workers are a very small subset of the general population, and higher exposures for small numbers of people may be considered acceptable if they are comparable to the overall risks of employment itself.  We disagree with these nonscientific justifications.  There is increasing evidence that occupational carcinogens spread into the greater environment.  For example, trichloroethylene (TCE), an industrial solvent, is now present in approximately one-third of the U.S. water supply.   The maximum risk threshold acceptable to the EPA is 10-fold less than the NIOSH threshold – and given the overlapping exposures, that does not make sense.  The EPA considers 1 in 1,000,000 to be the target threshold for as many people as possible, but that is 1000 times lower than the NIOSH threshold. The bottom line is that there is no scientific basis for these differential safety standards, and we now know that occupational and environmental exposures frequently become indistinguishable.  For that reason, the workforce should be afforded the same level of protection as the general public.
  3. Safety determinations will only be as effective as the quality of the science they are based on.  This report outlines the use of linear modeling to extrapolate low-dose effects of carcinogens.  But linear modeling isn’t appropriate for chemicals with non-monotonic dose-response curves, such as endocrine disruptors.  In addition, bioaccumulation and multigenerational effects must be considered — otherwise, limits will be simplistic and inaccurate. When NTP/EPA/IARC classifications disagree, NIOSH says they will “adopt the classification determined to be most relevant to occupational exposures“.  This policy would allow for “down-classifying” of carcinogens based on workplace considerations.  Given the technical difficulty in distinguishing between occupational and greater environmental exposures, the public needs detailed information about this decision-making process, so that we can ensure that any down-classifications are justified by scientific evidence.  NIOSH should also consider making full use of the NTP Executive Committee before investing their own time and resources in classifying agents, in order to focus their efforts on the stated goal of reducing risks.
  4. A safe exposure level based on technical feasibility rather than safety places workers at risk. NIOSH plans to set the recommended exposure limit (REL) to the higher, detectable dose (the reliable quantitation limit).   This would directly place workers in potentially unsafe conditions, while rendering them powerless to detect or remove the agent to ensure safe levels.  If we want to instead guarantee safety to workers in this situation, NIOSH needs to ban these chemicals until more sensitive detection methods are developed.  That policy would protect workers while creating an incentive for industry to develop more sensitive diagnostic capabilities or find safer alternatives.
  5. Sensitive subpopulations require protections too.  Birth defects, childhood cancer, and adult cancers can all caused by in utero exposures.  The NIOSH draft report does not provide details on how sensitive subpopulations will be protected.  Just as NIOSH sets risk thresholds for all workers, it must have regulations which sufficiently protect everyone in that group.

We urge you to consider these changes, and use every resource at your disposal to ensure that our national policies regarding occupational carcinogens meet their goal of protecting Americans at work.  This will ensure a healthy society, thriving economy, and also safeguard our environment for generations to come.

For more information, contact Anna Mazzucco at (202) 223-4000 or am@center4research.org


Do lemons prevent cancer?

By Caroline Novas

A widely circulating e-mail claiming to be from the Institute of Health Sciences (or the Health Sciences Institute) in Baltimore states that lemons are a “proven remedy against cancers of all types” and that lemons are 10,000 times stronger than chemotherapy.  The e-mail also says that pharmaceutical companies have kept the truth from us because lemons are much less expensive than the less effective synthetic versions that companies can sell for a large profit.

Although there is an “Institute of Health Sciences” in Baltimore that is “dedicated to uncovering and researching most urgent advances in modern underground medicine,” the Institute’s web site has no article about the cancer-fighting properties of lemons. It does, however, contain numerous articles promoting unproven alternative medicines and treatments. Most certainly, is not a credible scientific or medical source.

Regardless of the source, the claims the e-mail makes are NOT correct. Lemons are not a “proven remedy against cancers of all types,” and no studies have ever been done that would compare the effectiveness of a lemon to chemotherapy.

A few studies indicate that lemons and other citrus fruits have naturally occurring substances that may have cancer fighting properties, namely modified citrus pectin and limonoids.  These properties have not been tested in humans.

Modified citrus pectin (MCP)

Modified citrus pectin is a carbohydrate found in the peels of citrus fruits modified to be absorbed into the intestinal tract for easier human consumption. In its natural state, pectin is an indigestible dietary fiber.  Animal studies have found that MCP can inhibit the spread of prostate, breast, and skin cancer to other organs. MCP makes it difficult for cancer cells to break off and spread, although it has no impact on the initial tumor.

However, there is almost no information about whether MCP is effective in humans.  One study that measured prostate cancer in humans treated with MCP after standard treatment failed, showed a slowing in the progression of the disease, as measured by doubling time for prostate specific antigen (PSA). The longer the doubling time for PSA in patients with prostate cancer, the better their prognosis is expected to be. Patients taking MCP for 12 months showed a statistically significant increase in prostate specific antigen doubling time (PSADT), when compared to the 12 month period before they began taking MCP.  Unfortunately, the study used no control group (men that did not take MCP after standard treatment failed) and therefore could not compare the survival rates of men who took MCP after standard treatment failed, with those who did not.


Limonoids are chemicals found in citrus peels that are responsible for lemons’ bitter taste. Research has found that at very high levels, limonoids are capable of slowing cancer cell growth and inducing apoptosis (cell death). However, studies have focused on animals and in vitro human breast cancer cultures (breast cancer cells removed from the human body and studied in a laboratory). As a result, there is little information about limonoids’ effectiveness in preventing or combating cancer in humans.

The bottom line

Although lemons have health benefits, the claims that “lemons are a proven remedy against cancer of all types” and “lemons are 10,000 times stronger than chemotherapy” are certainly false.  Furthermore, while a few studies have looked into the anti-carcinogenic properties of modified citrus pectin and limonoids and found some promising results, not enough research has been done to prove its effects on humans. It’s possible that in the future, after more research, a medicine will be developed to prevent or fight cancer using these ingredients; if so, it will probably be in much higher concentrations than found in nature

MCP and limonoids are not unique to lemons; they are found in all citrus fruits, which have many known health benefits and should be part of any healthy diet.


The Health Sciences Institute. http://hsionline.com/

Glinksy Vladislav and Avraham Raz. (2009). Modified citrus pectin anti-metastatic properties: one bullet, multiple targets. Carbohydrates Research. 28;344(14):1788-91

BW Guess et. al (2003). Modified citrus pectin (MCP) increases the prostate-specific antigen doubling time in men with prostate cancer: phase ll pilot study. Prostate Cancer and Prostatic Diseases. 6, 301-304

Polouse SM, Harries ED, and Patil BS. (2005) Citrus limonoids induce apoptosis in human neuroblastoma cells and have radical scavenging activity.  Journal of Nutrition. 135(4): 870-7