Will FDA obey Trump, take step backward?

Researcher warns of using under-tested drugs, cites futile treatment on his father 

Dr. Cary Gross

Can some cancer treatments do more harm than good?

Absolutely, indicates Cary Gross, professor of medicine and cancer researcher at the Yale University School of Medicine, in a recent article in The Washington Post.

Gross cites the case of his own 80-year-old father, who'd been treated for Hodgkin's disease and couldn't walk because of weakness when his oncologist suggested a new, expensive, risky drug that was covered by insurance.

The oncologist was afraid chemo might do more harm than good but believed the "targeted therapy" treatment that used antibodies to kill only cancer cells would work.

Although the tumors shrunk at first, and Gross' father regained some strength, he experienced mild pain in his feet after a few months, followed by more severe shooting pains through his legs. Those side effects, Gross wrote in his article, again prevented him from walking and kept him bed-bound.

He subsequently died.

"The Food and Drug Administration had approved the treatment based only on a small study of about 100 patients, one-third of whom demonstrated complete remission," Gross reported.

"Although side effects were rare, the average age of patients in the study was 31. This is typical of cancer-treatment studies, which most often test new drugs in younger and healthier people — not older people with lots of medical conditions."

Gross expresses fear that "unfortunately, our government's commitment to evaluating new drugs is about to take a step backward. At a recent meeting with pharmaceutical company executives, President Trump announced he would be cutting regulations 'at a level nobody's ever seen before.'"

The FDA, he contends, "shouldn't shy away from requiring thorough evaluation of new drugs. The same level of enthusiasm and funding that goes into developing new treatments should be invested in testing whether they are safe and effective in patients outside of the initial small trials. Under-tested drugs with unclear safety profiles and efficacy should not be given to broad swaths of the population."

Other illustrations of clinic trials and their aftermath can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

64 percent more likely to succumb to disease

Being socially isolated may markedly raise risk of women with early breast cancer dying

Is being isolated socially a killer?

Very possibly.

An article by Liz Szabo of Kaiser Health News cites a recent study that "patients with early breast cancer who are socially isolated have a higher risk of dying from their disease."

According to the story, women with fewer social ties "were 43 percent more likely to see their breast cancer return, 64 percent more likely to die from breast cancer."

The study, funded by the National Cancer Institute and published in the journal Cancer, considered ties of friends, family and community and religious groups.

As well as spouses or romantic partners.

Dr. Wendy Chen

The study's co-author, Wendy Chen, a breast cancer medical oncologist at Boston's Dana-Farber Cancer Institute, clearly stated, however, that the findings do not prove "strong social support actually prolongs life."

Still, she said, they should be a reminder to physicians to evaluate more than their patients' physical health.

Szabo's story postulates that patients with stronger social ties not only receive moral support but encouragement to check out symptoms, to exercise, to eat healthier and to take meds.

Those patients also receive practical assistance, it adds, like picking up prescriptions, cooking meals and providing transportation to doctors' appointments.

The study looked at 9,267 women in the After Breast Cancer Pooling Project, which combined four studies of women from five U.S. states and China. Doctors, the Kaiser Health News story indicated, "followed women for a median of 10 years."

Isolated women, researchers found, also "were heavier, more likely to smoke, less likely to exercise and less likely to undergo chemotherapy, even if this treatment would have been appropriate for them."

Just under 250,000 American women are predicted to be diagnosed with breast cancer annually, with more than 40,000 expected to die from it.

A closer look at the ups and downs of the disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

Similar to females in poor developing nations

Racial gap widening in cervical cancer deaths — to the detriment of black women

A widening racial gap has been found in regard to cervical cancer deaths.

With black women being on the short end of the stick.

Over all, according to an article in The New York Times by Jan Hoffman late last month, a study published in the journal Cancer has determined that "the death rate…is considerably higher than previously estimated."

Hoffman's story says researchers have reported that "the rate which black American women are dying from the disease is comparable to that of women in many poor developing nations" in Latin America, Asia and Africa.

The article notes that "what makes the findings especially disturbing…is that when screening guidelines and follow-up monitoring are pursued, cervical cancer is largely preventable."

Some experts say the expected repeal of the Affordable Care Act, which covers screening, is likely to make matters worse.

The new study, which looked at data from 2000 to 2012, showed the mortality rate for blacks was 10.1 per 100,000, compared to 4.7 for white women.

Anne F. Rositch, Ph.D.

Anne F. Rositch, Ph.D., lead author and an assistant epidemiology prof at Johns Hopkins Bloomberg School of Public Health, explained that women who'd had hysterectomies — which almost always remove cervixes — were excluded from the study.

The racial disparity, it was speculated, reflected "unequal access to screening, ability to pursue early-warning test results, and insurance coverage."

"Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at caregivers touches on studies that show other racial disparities.

Women warned of post-mastectomy risks

Reconstructive surgery can numb breasts, cause pain and become potentially perilous

Reconstruction, according to The New York Times, can lead to complete numbness in the breasts.

An article by Roni Caryn Rabin yesterday contends that doctors often fail to warn patients that although reconstructive surgery following breast cancer might save their nipples and keep their breasts natural-looking, they afterwards may be unable to "sense the slightest touch of [their] breasts, perceive warmth or cold, feel an itch if [they have a rash or pain if they bang into a door]."

And nipples may "lack any feeling."

In addition, sexual arousal may not be restored.

Rabin's story indicates that "plastic surgeons performed more than 106,000 breast reconstructions in 2015, up 35 percent from 2000."

Most often, they use a woman's belly fat to create a new breast.

The lack of sensation "is potentially dangerous," the story charges. "Women who have had mastectomies and reconstructive surgery have sustained severe burns on the breasts from heating pads, hair dryers, curling irons, sunbathing and overly hot showers."

Dr. Andrea L. Pusic

And although the surface of the skin may become numb, pain underneath still may radiate everywhere: 

The Times piece notes that some women have tingling sensations after the surgery, others have "debilitating pain."

The "post-mastectomy pain syndrome," the story maintains, "is fairly common, affecting anywhere from 25 percent to 60 percent of mastectomy patients, according to published studies."

The Times article quotes Dr. Andrea L. Pusic, a plastic surgeon at Memorial Sloan Kettering Cancer Center who specializes in reconstruction and studies patients' post-surgery quality of life, as admitting that "our focus has been on what women look like. What it felt like to the woman has been a kind of blind spot in breast surgery. That's the next frontier."

Reconstruction and other post-surgery treatments are dealt with in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

Need for caregivers growing while supply shrinks

Volunteer U.S. caregiving force of 40 million is in grave danger, doctor asserts in N.Y. Times

The American reliance on a volunteer caregiving force may be unsustainable.

Why?

Because the demand for caregivers is growing — due to longer life expectancies and more complex medical care, according to a story in The New York Times by Dr. Dhruv Khullar, resident physician at Massachusetts General Hospital in Boston — while the supply is shrinking, "a result of declining marriage rates, smaller family sizes and greater geographic separation."

That, Khullar indicates, is what members of the National Academies of Sciences, Engineering and Medicine think.

His piece notes that "some 40 million Americans…help a parent, grandparent, relative or neighbor [every day] with basic needs: dressing, bathing, cooking, medications or transportation."

Dr. Dhruv Khullar

And it suggests the AARP and National Alliance for Caregiving believe "the typical family caregiver is a 49-year-old woman caring for an older relative — but nearly a quarter of caregivers are now millennials and are equally likely to be male or female."

A third of them apparently provide more than 21 hours of care weekly.

Mostly, they're unpaid, "but the economic value of their care is estimated at $470 billion a year — roughly the annual American spending on Medicaid."

About a third of the total also have full-time job, and a quarter work part-time.

The strain on caregivers is evident, however.

Especially when it comes to finances.

Sixty percent of those caring for older family members, the Times story says, end up cutting their work hours, taking a leave of absence or making other career changes.

In addition, "family caregivers are more likely to experience negative health effects like anxiety, depression and chronic disease."

One study Khullar cited found that those caring for a disabled spouse and experiencing mental or emotional distress "were 63 percent more likely to die within four years than noncaregivers."

His article says one way of helping caregivers is to bolster counseling and support services available to them. Another way would be to develop "respite programs to temporarily relieve them of their responsibilities."  

Details about overcoming such stresses and distresses can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at caregiving.

2,014 women with mastectomies studied

Radiation after some breast reconstructions can cause extra complications, report says 

Radiation might dramatically affect the results of breast reconstruction.

According to a recent report on Breastcancer.org, new research "suggests that radiation after implant reconstruction seems to cause more complications than radiation given after autologous reconstruction [rebuilding the breast with tissue from your own body]."

The study, presented at the annual San Antonio Breast Cancer Symposium, "looked at medical data and collected patient reports on reconstruction outcomes from 2,014 women who had mastectomy and breast reconstruction."

Two years after radiation was completed, 39% of women who'd undergone implant reconstruction had at least one complication — compared to 26% for those who'd had autologous reconstruction.

Worse yet, the study showed radiation was "linked to more than doubling the risk of complications" after the implants but was "not associated with a higher risk of complications" in women who'd undergone the other treatment.

Complications included "infection at the surgery site, hematoma (collection of blood outside blood vessels), capsular contraction, and other problems."

Those with implants who'd been treated with radiation also were less satisfied with their results than those who didn't get radiation, the study indicated.

Dr. Reshma Jagsi

Dr. Reshma Jagsi, lead author of the study and deputy chair of radiation oncology at the University of Michigan, contended that women who planned to receive post-mastectomy radiation therapy needed to be informed of the "significant impact" the study found regarding radiation and implant reconstruction. 

And conversely, she said, "those who plan to pursue autologous reconstruction…may derive some reassurance" from the statistics.

Dr. Marisa Weiss, Breastcancer.org founder, added that "one thing I recommend as a breast radiation oncologist who deals with this issue all the time is to make sure the implant you get is fairly close to your original size." The problem with a bigger size, she noted, is that the skin has already "lost a lot of its blood supply with mastectomy, it's been stretched, it's maybe been subjected to chemo, it's not the happiest camper on the block."

After mastectomies, radiation normally is recommended if the cancer is about two inches long, if it's spread to four or more lymph nodes, if it's spread to the skin, or if cancer cells are found in the rim of tissue around the disease (the margins).

Post-surgery feelings of patients are addressed in detail in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

No need found for an added diagnostic tool

In diagnosing male breast cancer, ultrasound isn't better than mammography, study says

Ultrasound imaging apparently doesn't provide any more information than mammography when it comes to men's breast cancer.

A new study's conclusion, according to an article on the Breastcancer.org website, is "that mammography should continue to be the main diagnostic tool for detecting breast cancer in men with symptoms."

It originally had been thought ultrasound might offer additional benefits.

The study, whose findings were reported at the recent annual meeting of the Radiological Society of North America, had looked at the records of 360 men above the age of 25 who'd had symptoms that included "feeling a lump, pain, and nipple discharge."

Dr. Eric Blaschke

Dr. Eric Blaschke, one of the study's authors, was quoted as saying, "We didn't find that use of ultrasound in male breast cancer was useful in detecting new cancers."

Some 2,470 men are expected to be diagnosed with breast cancer in 2017, the story noted. "For men, the lifetime risk," according to the website, "is about 1 in 1,000."

Risk factors for men, the site indicates, include growing older (the average age of those diagnosed is about 68), having high estrogen levels, having Klinefelter syndrome (which means having more than one X chromosome), having a strong family history of breast cancer or genetic mutations, and having been treated with radiation to the chest. 

Details about breast cancer, for women and men, can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

Breast cancer patients 45% more impaired

Largest study to date of the condition validates women's 'chemo-brain' discomfort 

Women who've had read cancer know about the dread and discomfort of 'chemo-brain' first-hand.

But now, the largest study of it conducted so far proves that the condition — which includes impairments in memory, paying attention and processing information — can be a major problem for up to six months after chemotherapy.

Michelle C. Janelsins, Ph.D.

According to investigators at the University of Rochester's Wilmot Cancer Institute, led by Michelle C. Janelsins, Ph.D., 581 breast cancer patients treated at sites across the United States were compared to 384 healthy patients.

The women with breast cancer exhibited 45 percent more impairment, ScienceDaily reported this week.

Is chemotherapy the only cause of the condition?

No. 

The story indicates some impact may have stemmed from heightened anxiety and depressive symptoms from the onset (diagnosis and pre-chemo), being of a younger age and being a member of the black race.

Regardless, the LiveBetterWithCancer website has suggested a much longer influence for chemotherapy. 

Last fall it published a piece saying a study of mice had indicated that the animals' cognitive impairment could equate to 10 years in humans and "have a long lasting impact on the quality of life of cancer survivors."

The site noted that 'chemo brain' might translate into confusion, difficulty multi-tasking, finishing sentences, finding the right words or learning new skills. 

Personal details of my wife's chemo-brain can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.