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4 Things You Should Know About Clinical Trials

Illustration: Mark Allen Miller

When Mary Elizabeth Williams was diagnosed with stage 4 melanoma, her prognosis was grim. But she came across a clinical trial for immunotherapy—which uses the body’s natural defenses to fight cancer—and was declared cancer-free just three months later. Some may be reluctant to take part in a clinical trial due to some well-known myths. Here, she sets the record straight:

Myth: “If I get into a clinical trial, I’ll be stuck in a placebo group and won’t be treated.”

Fact: “Only a small number of trials employ placebos as a means of measuring a treatment’s effectiveness,” says Williams. “They are much less common in studies like mine, involving people with serious health conditions such as cancer. In my trial, every patient received the same medication. And when control groups are part of a study, patients in those groups typically still receive treatment (which may be the usual standard of care) throughout the trial.”

Myth: “Clinical trials are a last ditch.”

Fact: “While many trials are open only to patients who are late-stage, or for whom other forms of treatment have been unsuccessful, others are available to patients of varying condition,” Williams explains. “Increasingly, doctors are learning to work with patients to tailor a treatment plan that is best for the individual—including exploring trials.”

Myth: “I’ll be locked in even if it doesn’t work or I don’t like the trial.”

Fact: “Both the doctor and the patient can reassess throughout, according to how the patient is feeling and her ability to withstand treatment,” says Williams. “It’s just an option—it’s not jail.”

Myth: “Forget it; there’s nothing going on in research in my small town.”

Fact: “Concerned that trials are available only to people close to big-name hospitals? Research craves variety, and trials are often conducted in cooperation with several facilities at a time,” says Williams. “Mine ultimately involved more than 100 facilities around the world. You can search for recruiting studies based on your condition and location at clinicaltrials.gov.”

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9 Awesome Must-Try Nut Butters

Nut butter: It’s one of those miracle foods that tastes fabulous and also can be really healthy. Of course, along with all the great brands and flavors out there, the shelves are also full of jars laden with sugar, hydrogenated oils and other undesirable ingredients. Here’s a collection of some of our faves that are delicious and nutritious, too.

MaraNatha Organic No-Stir Peanut Butter ($7 for 16 oz., amazon)

These days, you can pretty much get any kind of nut and seed butter, and that’s great—but sometimes all you want is a nice PB&J, nothing fancy. For those moments, and when you want a good basic peanut butter to add to recipes, look no further than MaraNatha. This no-nonsense peanut butter is organic and contains just peanuts, (ethically sourced) palm oil, a touch of unrefined cane sugar and sea salt. It’s super-creamy, not too sweet and full of roasted peanut flavor.

Barney Butter Smooth Almond Butter ($18 for 10 oz., amazon)

Almond butter tastes great, but if there’s one drawback to it, it’s often kind of gritty. Not so with Barney Butter, which is silky smooth and free of bitterness, thanks to the blanched almonds (that is, the skins are removed). You can feel good about this nut butter in other ways, too: The palm oil is ethically sourced and the ingredients are non-GMO certified, so the butters are good for the planet as well as for you.

Nuttzo Crunchy Seven Nut & Seed Butter ($16.35 for 16 oz., amazon)

Organic cashews, Brazil nuts, almonds, chia, flax, pumpkin seeds—the ingredient label on this crunchy spread reads like a who’s who of the healthy nut and seed world. Why choose among all those little nutrient-rich crunch bombs when you can have ’em all in one jar? If you like your spreads smooth, move along; this one is all crunch, all the time. Its rich flavor makes it fantastic for sandwiches, spread onto apple or banana slices or just licked right off a spoon (not that we would ever do that…).

Sun Butter ($15 for 16 oz., amazon)

For kids (or adults) with a peanut and/or tree nut allergy, welcome to your new favorite spread. Made in a nut-free facility from roasted sunflower seeds, it’s loaded with vitamin E, an antioxidant that boosts immunity and fights inflammation. Use it anywhere you would a nut butter (even in cookies).

Nutiva Organic Coconut Manna ($14 for 15 oz., amazon)

Coconut is certainly having a moment, so it’s no wonder that coconut butter made our list. It isn’t as smooth and spreadable as other nut butters; the texture is grainier, and the oil separates and rises to the top. (It’s easily re-incorporated though; simply warm the whole jar in a small pan of hot water and stir.) But it is rich, slightly sweet, luscious and so satisfying. Use it in desserts, spread it on toast or fruit, or add it to oatmeal or smoothies. (And here are some more ideas for how to incorporate it.)

Soom Tahini ($14 for 2 11-oz. jars, amazon)

If you think of tahini as simply an ingredient in hummus, you’re in for a treat. Try this sesame seed butter just about anywhere you would use peanut or almond butter and watch it take on a whole new life. Spread it on sandwiches or apple slices, whisk it into dressings, even bake it into cookies or cakes. And it’s nut free, so good for people with allergies. We like this particular brand for its smooth texture and pure sesame flavor, free of the bitterness present in some tahinis. (FYI, Soom also makes a chocolate flavor.)

Rawmio Chocolate Hazelnut Spread ($14 for 6 oz., amazon)

Yes, this is pricier than another, more well-known brand of chocolate-hazelnut spread (which will remain nameless here), but worth it when you consider that it’s organic, has far cleaner ingredients (only three, and no emulsifiers or artificial flavors) and 8g sugar per 2 Tbsp. serving compared with 21g in the other brand. Needless to say, it’s also super-delicious and loaded with rich chocolate flavor.

Justin’s Vanilla Almond Butter ($16 for 16 oz., amazon)

Nut butter that tastes like vanilla frosting? Yes, please! This jar has all the goodness (few and all recognizable ingredients, vegan, light on the sugar), but it’s the indulgent flavor that will knock you out. The secret? Along with vanilla, it’s made with organic cocoa butter, the fat that makes chocolate so luscious (but don’t worry, it’s also heart healthy and anti-inflammatory).

Peanut Butter & Co. The Heat Is On ($8.50 for 1 lb., amazon)

With chili powder, cayenne and crushed red pepper, this spicy peanut butter is no joke. It’s awesome on bread, of course, but it really shines in sauces and dressings. Plus, it’s made with super-clean, non-GMO-certified ingredients and has 8g protein but only 1g sugar.

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Cancer History May Affect Survival After Organ Transplant

FRIDAY, April 22, 2016 (HealthDay News) — Organ transplant patients who previously had cancer may be at increased risk for new cancer and early death compared to organ recipients with no cancer history, new research suggests.

The findings indicate that transplant patients with a history of cancer may need closer monitoring to detect recurrent and new cancers early, the study’s senior author, Dr. Nancy Baxter, said in a news release from St. Michael’s Hospital in Toronto. Baxter is chief of the hospital’s General Surgery Department.

She and her colleagues reviewed 33 studies that included a total of nearly 400,000 patients in 12 countries. They found that organ recipients with previous cancer were 1.5 times more likely to die prematurely from any cause than those with no previous cancer.

Moreover, those with previous cancer were nearly twice as likely to develop a new cancer and had three times higher risk of dying from cancer, the study found.

The increased risk of new cancer and death did not vary according to the type of organ transplanted, according to the paper published April 22 in the journal Transplantation.

Previous research has found that cancer survivors are at increased risk of cancer recurrence after an organ transplant. But, findings regarding the risk of new cancer and death were inconsistent, according to the authors of the new study.

The new paper did not examine whether the increased risk of new cancer and early death was related to characteristics of organ donors or factors such as the type of immunosuppressant drug taken, said lead author Dr. Sergio Acuna. He is a physician and doctoral student in clinical epidemiology at St. Michael’s.

Previous studies have found that transplant recipients with previous cancers are more likely to receive organs from so-called “expanded criteria donors” — older donors who might have had a history of high blood pressure, stroke or dialysis. These factors are associated with deaths from heart attack or stroke, and organ rejection, Acuna said.

The researchers excluded studies about patients who received a transplant to treat cancer, such as liver cancer patients who receive a new liver.

More information

The United Network for Organ Sharing has more about organ transplantation.

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Heavy Pot Use in Teen Years Linked to Shortened Life

FRIDAY, April 22, 2016 (HealthDay News) — Men who were heavy pot smokers in their teens may not live as long as those who did not use marijuana when they were young, a new study suggests.

Researchers examined data from more than 45,000 men in Sweden who did compulsory military training in 1969-1970 and were followed until 2011.

About 4,000 of the men died during the 42-year study period. Those who were heavy marijuana users in their late teens were 40 percent more likely to die by age 60 than those who never used the drug, the investigators found.

But the study did not prove that early and heavy marijuana use led to an early death. The findings were published online April 22 in the American Journal of Psychiatry.

A previous study of the same group of men showed no link between marijuana use and death. But because this new study covered a longer period (42 years), the men had reached ages when the harmful effects of previous marijuana use — such as cancer, lung and heart disease — were more likely to have developed, the researchers said.

Interestingly, the risk of death from either accidental injury or suicide among the men rose in accordance with their level of marijuana use as teens, researcher Dr. Edison Manrique-Garcia, from the Karolinska Institute in Stockholm, said in a journal news release.

More information

The U.S. National Institute on Drug Abuse has more on marijuana.

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Celebrity Cases May Help Spur Rise in Double Mastectomies

By Kathleen Doheny
HealthDay Reporter

FRIDAY, April 22, 2016 (HealthDay News) — Media coverage of celebrities who battle breast cancer is not always balanced or thorough, and this skewed view may be one factor in the growing popularity of double mastectomies, a new study suggests.

“Celebrities do have a significant impact on medical decision-making, but in this case it might be a negative effect,” said study author Dr. Michael Sabel. He is chief of surgical oncology at the University of Michigan Comprehensive Cancer Center.

“The media coverage represents a kind of bias that makes people think this [double mastectomy] is the [best] treatment for breast cancer,” Sabel said.

Still, the study didn’t prove that media coverage actually caused the increase in double mastectomies seen in the past decade.

In the study, Sabel and his team gathered information on 17 celebrities who publicly disclosed their breast cancer diagnosis between 2000 and 2012. Among them were Christina Applegate, Sheryl Crow, Melissa Etheridge, Joan Lunden, Cynthia Nixon, Suzanne Somers and Wanda Sykes.

Four celebrities underwent a double mastectomy, and 45 percent of the media coverage about their diagnoses mentioned the surgery, the study found. In a double mastectomy, both breasts are removed.

Meanwhile, only 26 percent of media coverage mentioned surgery when reporting on 10 celebrities who had a single mastectomy or breast-conserving therapy, the findings showed.

During that time, the rate of double mastectomies at the University of Michigan’s cancer center rose about fivefold — from 4 percent of women in 2000 to 19 percent of women in 2011, the researchers said.

In some cases, the surgery is warranted, Sabel said. For instance, it could be recommended for a woman with breast cancer who has a strong family history and carries the genetic BRCA mutations that dramatically raise cancer risk, he explained.

“But we are seeing a tremendous rise [of double mastectomies] in those who don’t have high risk,” Sabel added. Many women come in with their minds made up, and instead of asking about options, they state their wish, he said.

Sabel wondered if media coverage might be playing a role, so his team analyzed more than 700 articles from major U.S. print publications, such as the Chicago Tribune, Los Angeles Times, USA Today and others.

The researchers looked only at celebrities who had breast cancer, not those, like actress Angelina Jolie, who have the genetic mutation that raises risk but who did not have a breast cancer diagnosis.

The researchers did highlight the case of actress Christina Applegate, who got a double mastectomy in 2008 after being diagnosed with breast cancer at the age of 36. But only a small part of the media coverage explained that she had BRCA mutations and a family history that raised her risk of a recurrence, the study authors noted.

What women take away from that kind of skewed coverage, Sabel suggested, is that every early breast cancer patient should have a double mastectomy.

Besides the skewed coverage, he said, other factors are driving the increase in the number of women choosing the aggressive procedure. Among them are more information about genetic risks and improvements in breast reconstruction methods.

The bottom line? Surgeons should work to educate the media about choices, Sabel said, to dispel the notion that double mastectomy is always best. Women should go to their surgeon with an open mind, asking about each option, and the pros and cons of each, he said.

The study was published online recently in the Annals of Surgical Oncology.

Dr. Courtney Vito, an assistant clinical professor of surgical oncology at the City of Hope National Medical Center, in Duarte, Calif., said the study findings reflect the questions she often gets in her practice. Celebrity coverage can give women the wrong impression, she agreed.

“Some patients view a bilateral [double] mastectomy as a benchmark of quality, even when it is sometimes medically inappropriate,” Vito said.

For instance, a woman with early stage breast cancer but many other medical problems, such as obesity or high blood pressure, may be at less overall risk if she chooses breast-conserving therapy.

“Many women who have had bilateral mastectomy said they feel empowered,” Vito said. Yet it does not improve their survival odds, she added.

“Because breast cancer treatment is tailored to personal history, family history, tumor biology and personal wishes, you must choose a physician with whom you can have a collaborative relationship,” Vito said.

More information

To learn more about mastectomy, visit the American Cancer Society.

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U.S. Suicide Rate Up 24 Percent Since 1999: CDC

By Steven Reinberg
HealthDay Reporter

FRIDAY, April 22, 2016 (HealthDay News) — Suicide rates in the United States rose 24 percent between 1999 and 2014, with young girls and middle-aged men accounting for the largest increases, federal health officials reported Friday.

By 2014, the total suicide rate reached 13 per 100,000 people, said researchers from the U.S. Centers for Disease Control and Prevention’s National Center for Health Statistics. The greatest annual increases occurred after 2006, the agency said.

“This increase is puzzling and troubling,” said Deborah Stone, a CDC behavioral scientist who was not involved with the study. “Despite increased suicide prevention efforts, rates are rising.”

While no single cause is apparent, Stone said the Great Recession and rising rates of mental health problems, drug abuse and gun availability may account for some of the climb.

The economic downturn that began in 2008 is “probably just one factor,” Stone said.

According to the report:

Suicide rates climbed by 1 percent a year from 1999 through 2006, and by 2 percent annually since then.
Men aged 45 to 64 saw a 43 percent increase in suicide rates over 15 years.
Girls aged 10 to 14 years accounted for 150 suicides in 2014, which represented an increase of 200 percent during the study period.
Three times as many men took their lives in 2014 as women (just under 21 per 100,000 versus nearly 6 per 100,000, respectively).
Overall, suicide rates remained highest among men 75 and older.
For men, guns were used in most suicide deaths (about 55 percent in 2014), while poisoning — including overdoses — was used most often by women (34 percent in 2014).
Suicide by suffocation — including hanging — increased among both sexes, accounting for about one in four suicides in 2014.

Although suicides have increased among whites, suicides among American Indians have risen even more, said lead author Sally Curtin, a statistician from the National Center for Health Statistics (NCHS). And notably, suicide rates for black males dropped 8 percent over the 15-year period, she said.

One expert believes more accurate reporting accounts for some of the uptick that the researchers captured.

“Because more attention has been paid to suicide over the last 10 years, the stigma associated with reporting suicide has decreased, so we are getting a much more accurate count,” said Dr. Morton Silverman. He is a senior advisor to the Suicide Prevention Resource Center of the U.S. Substance Abuse and Mental Health Services Administration.

Stone, however, believes the increases are real. “Suicides are actually under-reported,” she said. “There is no research that the reporting has changed.”

The study findings are consistent with what has been seen over the last decade, said Daniel Reidenberg, managing director of the National Council for Suicide Prevention.

“One thing that the findings don’t tell us is how many lives we are saving from suicide every day or every year through suicide prevention efforts,” Reidenberg said.

Also, the findings do not address the effect that suicide has on loved ones, he added.

This matters, Reidenberg said, because research has shown that those who lose a loved one to suicide experience more mental and physical health problems, and an increased risk of suicide themselves.

Stone called suicide an important public health problem that demands attention. “It takes a community-wide effort to prevent suicides, so we can’t expect one thing is going to solve everything,” she said.

However, awareness of the likelihood of suicide is one major step, experts suggest.

According to the American Association of Suicidology, warning signs of an impending suicide include thinking or talking about killing oneself; increased abuse of alcohol or drugs; a sense of purposelessness or hopelessness; or withdrawal from friends, family or other social contacts.

Additional red flags are uncontrolled anger, recklessness or significant mood changes.

The new report is published in the April issue of the CDC’s NCHS Data Brief.

More information

For more about suicide, visit the U.S. National Institute of Mental Health.

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U.S. Suicide Rate Up 24 Percent Since 1999: CDC

By Steven Reinberg
HealthDay Reporter

While no single cause is apparent, Stone said the Great Recession and rising rates of mental health problems, drug abuse and gun availability may account for some of the climb.

The economic downturn that began in 2008 is “probably just one factor,” Stone said.

According to the report:

Suicide rates climbed by 1 percent a year from 1999 through 2006, and by 2 percent annually since then.
Men aged 45 to 64 saw a 43 percent increase in suicide rates over 15 years.
Girls aged 10 to 14 years accounted for 150 suicides in 2014, which represented an increase of 200 percent during the study period.
Three times as many men took their lives in 2014 as women (just under 21 per 100,000 versus nearly 6 per 100,000, respectively).
Overall, suicide rates remained highest among men 75 and older.
For men, guns were used in most suicide deaths (about 55 percent in 2014), while poisoning — including overdoses — was used most often by women (34 percent in 2014).
Suicide by suffocation — including hanging — increased among both sexes, accounting for about one in four suicides in 2014.