Thousands of rectal cancer patients might be spared the brutal effects of radiation, study says

Tens of thousands of patients annually might be able to rely not on radiation but only surgery and chemotherapy to treat their rectal cancer. 

According to a recent story by Gina Kolata in The New York Times that cites a large clinical trial initially reported in the New England Journal of Medicine, more than 10,000 people each year may therefore avoid potentially serious side effects.

Dr. Eric Winer

Dr. Eric Winer, president of the American Society of Clinical Oncology, the organization to which the results of the test were revealed, was quoted as indicating that the study is part of a new direction for cancer researchers.

"Now that cancer treatments have  improved," Kolata reports him saying, "researchers are starting to ask different questions. Instead of asking how cancer therapy can be intensified, they are asking if there are elements of successful treatments that can be eliminated to provide patients with a better quality of life." 

Winer, who wasn't directly involved in the study, was asked to comment because of his expertise.

Rectal cancer annual affects 47,500 U.S. residents.

The study determined that radiation treatment didn't improve outcomes, despite the fact that, the Times piece indicates, for decades "it was typical to use pelvic radiation, [which] puts women into immediate menopause and damages sexual function in men and women. It also can  injure the bowel, causing issues like chronic diarrhea. Patients risk pelvic fractures, and the radiation can cause additional cancers." 

More information about less being better can be found in Rollercoaster: How a man can survive his partner's breast cancer, a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Saving sperm can overcome infertility in men who get testicular cancer, Mayo Clinic doc says

Should men diagnosed with testicular cancer worry about having children in the future? Yes, says a doctor at the Mayo Clinic in Rochester, Minnesota.

Dr. Bradley C. Leibovich

Bradley C. Leibovich, MD, a urologic oncologist there and the medical director of the Center for Digital Health, notes that "the first thing we do with men that are interested in preserving fertility is talk about sperm banking."

One side effect of chemotherapy, radiation and other cancer treatments can definitely be infertility, Leibovich told Jason Howland of the Mayo Clinic News Network online a while back, so saving the sperm should be a priority before starting treatment.

Another concern is "lower levels of testosterone, a hormone produced primarily in the testicles," the News Network story says.

The article also quotes Leibovich as saying, "Most men have normal testosterone levels with just one testicle. For men that do wind up with a lower level of testosterone, it's really easy to replace." 

The piece then says that under the "guidance of a healthcare professional, testosterone replacement therapy, in the form of injections, pills, patches or gels, can restore normal testosterone levels in men."

In an earlier story in the News Network also written by Howland, it's noted that "the disease is not common. Just 1 in 250 men will develop testicular cancer at some point in their lifetime, according to the American Caner Society. Most of those cases are in young and middle-aged men."

Leibovich explains that "we like men to do monthly testicular self-examinations. Because if you find that testicular cancer early, the amount of treatment people need to get that cure is significantly less." 

More information about dealing with side effects of treatments can be found in Rollercoaster: How a man can survive his partner's breast cancer, a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Cancer vaccines are new type of immunotherapy that might help in fight against breast cancer

Virtually everyone's talking about vaccines, pro and con, regarding Covid-19 but other vaccines merit major attention as well.

According to an article by Cynthia Weiss of the Mayo Clinic News Network in today's daily Marin Independent Journal, cancer vaccines are "another type of immunotherapy that is being developed and tested for breast cancer."

Weiss' story goes on to say that such vaccines can "help train the immune system to see and 'memorize' antigens, or proteins, found on the surface of cancer cells, so that the immune system can fight these antigens if encountered in the future."

The vaccines, the piece adds, "are being studied in different breast cancer settings: treatment of current cancer; prevention of cancer recurrence; or to decrease the risk of cancer spreading to another part of the body, or metastasis."

Dr. Pooja Advani

Weiss' piece is a question-and-answer format with facts supplied by Dr. Pooja Advani, a Mayo Clinic oncologist and hematologist in Jacksonville, Florida.

Immunotherapy, not incidentally, is a comparatively new treatment for breast cancer that's also been used in treating lung and kidney cancers as well as melanomas. 

It "harnesses the body's immune system to help fight cancer," the Mayo Clinic information indicates.

Currently, Advani's information states, "immunotherapy is approved primarily for patients with metastatic or locally advanced triple-negative breast cancer, which is an aggressive subtype of breast cancer, representing 10%-15% of breast cancer, with limited treatment options other than chemotherapy."

Immunotherapy is not immune to side effects, however. Typical ones, according to the story, "can include fatigue, chills, body aches, injection site pain, infusion-related reaction, headache, flu-like symptoms and gastrointestinal symptoms."

And that's not all. Weiss' Q&A piece asserts that immunotherapy "also can affect live function tests; cause respiratory symptoms, such as shortness of breath, cough and fever; cause symptoms of overactive or underachieve thyroid glad, or adrenal gland; and rash."

But most of those symptoms, it should be noted, "are mild to moderate and reversible, if detected early and treated in a timely manner."  

More information about recent treatments can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Home remedies can work but beware side effects

Breast cancer prescription might lessen pain for those without the disease, Mayo Clinic suggests

Tamoxifen, a prescription drug used for breast cancer treatment and prevention, can also lessen breast tenderness for those without the disease.

The problem, of course, is that there are potential "side effects that may be more bothersome than the breast pain itself."

That information is part of a laundry list of pain remedies suggested by the Mayo Clinic News Network.

Home remedies on the list may be effective, the network says, despite their being little research about their efficacy.

Furthermore, a network story indicates, for "many women, breast pain solves on its own over time" so a sufferer "may not need any treatment" at all.

But methods worth trying, according to the non-bylined network article, include: putting hot and cold compresses on the tender breast; wearing a firm support bra, or a sorts bra during exercise; experimenting with relaxation therapy; limiting or cutting out caffeine; following a low-fat diet; and using over-the-counter meds such as Tylenol (acetaminophen) or Advil or Motrin (or virtually any other brand of ibuprofen).

The article also lists alternative medicines such as vitamins (Vitamin e) and dietary supplements (evening primrose oil).

Checking with your physician before attempting any of the above remedies is highly recommended — in regard to risks and whether the self-care treatments are appropriate for you, as well as for approved dosages.

According to the article, treatments by doctors might include topical non-steroidal anti-inflammatories, an adjustment of birth control pills, a reduction of menopausal hormone therapies, or a prescription medication (the aforementioned Tamoxifen or Danazol).

More information on treating pain and disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

2 experimental drugs might extend patients' lives

Renewed hope is possible for women with aggressive breast cancer, new study indicates

Two experimental drugs might help women with an aggressive form of breast cancer, results of a new study show.

According to a recent Associated Press story by Marilynn Marchione that cites reports in the New England Journal of Medicine and at a San Antonio Breast Cancer Symposium that the cancers "had spread widely and and resisted many previous treatments," one drug "showed particular ability to reach tumors in the brain, which are notoriously tough to treat."

The other combines "a sort of homing device for cancer cells with a payload of chemotherapy that's released when it reaches its target."

Dr. Ian Krop in his office.

Marchione's article quotes the study's leader, Dr. Ian Krop of the Dana-Farber Cancer Institute in Boston, to the effect that infusions of T-DXd, the second drug, become "a guided missile…able to bring the chemotherapy directly to the cancer cell."

That study — focusing on often-fatal HER2-positive cancers, which have a protein on their cell surfaces driven by an overactive gene that promotes tumor growth — tested TDXd on 253 women. 

Most of the them, who had, on average, tried six other treatments before the experimental drug, saw their tumors shrink — and 6 percent of them found zero signs of cancer in at least two followup scans.

The positive response rate, the AP story again quotes Krop, "is three to four times better than what's usually seen in this situation." 

To see results showing a median time of 16 months until cancer worsened "is exciting," he added.

All involved, however, noted that side effects — including lung inflammation, low blood counts, nausea, anemia or fatigue — were substantial.

But anti-inflammatory meds can alleviate some of those issues, it's believed.

The study was sponsored by the drug's developers, Daiichi Sankyo Inc. and AstraZeneca, who are seeking approval in the United States, Europe and Japan.

Study of the other drug — tucatinib, from Seattle Genetics — was done on 612 patients. Its side effects included diarrhea, fatigue, nausea and some liver issues, but 45 percent of those on the drug were alive two years after being given it (along with the usual treatments, Herceptin and the chemo drug Xeloda) as opposed to 27 percent who weren't.

More information on experimental drugs can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Bills can be as bad for patients as side effects

Lack of money may adversely impact health of cancer patients, says AARP article

Surviving cancer may depend on what's in your savings account.

At least that's the conclusion of an article by Peter Moore in an edition of "AARP: The Magazine" a while back.

The piece suggests that average costs for the disease "run in the $150,000 range."

Why so much?

Moore postulates that "containing the cancer and killing [the] abnormal cells without damaging nearby healthy cells often requires a range of treatments, over an extended period of time — lengthy radiation, complicated surgeries, costly chemotherapy, plus other strong medications to supercharge your immunity."

Although new treatments emerge with regularity, he writes, "with new hope comes even more cost: 11 or the 12 cancer drugs that the Food and Drug Administration approved in [a recent year] were priced at more than $100,000 [annually.]"

Even with a good insurance policy, "a patient is probably looking at a bill of more than $4,000 in deductibles and co-pays."

Patients, of course, must often cope as well with "loss of income during months of treatment and recovery," not to mention travel and lodging expenses "at a cancer-centric health facility."

Plus the costs of myriad follow-up tests.

Moore notes that "not only are cancer patients two and a half times as likely to declare bankruptcy as healthy people, but those patients who go bankrupt are 80 percent more likely to die from the disease than other cancer patients, according to studies from the Fred Hutchinson Cancer Research Center in Seattle."

Dr. Gary Lyman

The AARP story also quotes Dr. Gary Lyman of that center: "For many patients, when they get the bills, it can be as bad as some of the side effects of the disease or the treatment."

Moore entertains the idea that many patients don't discuss their financial fears with their doctors, fearing such action could "compromise their treatment."

The result of that silence and fears, or from a patient lying because he or she couldn't afford to follow a prescribed regimen?

"Doctors [don't] know that their patients might take their pills less often than prescribed [and/or] avoid follow-up therapies or tests."

More details about what else impacts cancer patients psychologically 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.

FDA approves 31 new therapies in one year

New screenings and treatments are helping to boost the number of cancer survivors in the U.S.

By 2026, some 20.3 million cancer survivors will be living in the United States — up from 15.5 million a decade earlier.

That, according to a recent article in Parade magazine by Sheryl Kraft, is because innovations in screening and treatment are helping patients beat the odds.

"In just one year," the piece reports, "31 new therapies to treat more than 16 types of cancers were approved by the U.S. Food and Drug Administration."

Dr. Otis Brawley, chief medical and scientific officer for the American Cancer Society, believes that screening can save lives. "Some estimates say that we can decrease the number of colorectal deaths by 12,000 to 20,000 if screening guidelines were followed."

Dr. Jame Abraham

And Dr. Jame Abraham, director of Cleveland Clinic's Breast Oncology Program, notes that hormone therapy might be all that's necessary to treat 70 percent of women with the most common form of breast cancer. 

"That means a large number of patients can safely avoid chemotherapy," the Parade story quotes her as saying. "We can individualize treatment and make sure we are prescribing the right treatment for the right purpose."

It was tough previously to identify which women with early-stage breast cancer were at risk for recurrence, so many had received unnecessary chemo, radiation and hormonal therapy. But a groundbreaking study known as the TAILORx trial found that many women could be saved from "unnecessary side effects like fatigue, hair loss, nausea, vomiting and anemia," the quote continues.

Another new treatment, immunotherapy, which "works by reprogramming a patient's own immune cells to find and attack those cancer cells through the body," also is being held out as innovative — and the American Society of Clinical Oncology's "advance of the year."

Immunotherapy now is being heralded as "extremely promising for treating triple-negative breast cancer, one of the most difficult-to-treat breast cancers," after having already been shown to have "significant results in young patients with a form of leukemia and adults with multiple myeloma (a type of blood cancer) and lymphoma (a type of cancer involving cells of the immune system)."

Yet another new testing method, CancerSEEK — according to the Parade piece, "a simple blood test, which in its research phase was performed on people already diagnosed with cancer," can identify markers for for tumors containing mutated DNA in the bloodstream. 

These markers are associated with eight common cancer types: breast, lung, colorectal, ovarian, liver, stomach, pancreatic and esophageal.

Lastly, the story cites a less invasive and faster lung-cancer technique called microcoil localization, "which can pinpoint and remove small bits of affected tissue using a needle inserted through the chest wall to remove the cancer at its earliest stage."

Minimally invasive surgery — instead of the currently popular "lobectomy, which removes a portion of the lung by opening up the chest, followed by radiation and chemotherapy."

More details on new techniques and treatments can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

New drugs can lead to 'varied, bizarre' problems

Cancer-killing immunotherapies can cause major side effects in otherwise healthy organs

New immunotherapies can eliminate cancers but may also cause big problems with healthy body organs. 

According to a recent story by Laurie McKinley in The Washington Post, the perplexing side effects can range from inconsequential to severely dangerous, even life-threatening.

The article cites the case of a 55-year-old patient whose therapy "knocked back her cancer [but] also gave her 'almost every 'itis' you can get'… arthritis-like joint pain, lung inflammation called pneumonitis and liver inflammation that bordered on hepatitis."

The woman, McKinley's piece continues, warns "that highly touted immunotherapy treatments have downsides as well as benefits and to watch for complications, because 'not all doctors know all the side effects.'"

The upside is clear, however.

Checkpoint inhibitors, the new therapies, "offer a tantalizing chance for survival for patients with advanced melanoma and hard-to-treat cancers of the bladder, kidney and lung," the story says.

The downside? 

"The treatments, designed to unleash the immune system to attack malignancies, also can spur an assault on healthy organs, causing varied and bizarre side effects ranging from minor rashes and fevers to diabetes and deadly heart problems."

Dr. Drew Pardoll

Some of the symptoms, unfortunately, can fool doctors because they "can mimic those of the flu, infections or even food poisoning. That lack of awareness [by physicians] can be dangerous, given that quick intervention is the key to preventing serious damage."

The Post article quotes Dr. Drew Pardoll, director of the Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University, as noting that immunotherapy "has a completely different side-effect profile than chemotherapy, and that has caught some physicians off guard."

Doctors, including emergency-room physicians, dermatologists and gastroenterologists, Pardoll insists, "need to go back to school" to earn about immunotherapy.

The side effects, McKinley writes, "occur in 15 to 70 percent of immunotherapy patients, depending on which drug is used and whether the medications are used individually or combined with one another or conventional cancer treatments."'

Are the cancer treatments worth using despite the side effects?

According to Kevan Herald, an immunologist and endocrinologist at Yale University, they absolutely are. "If it's a choice between staying alive and developing diabetes versus not, I'd always pick taking the drug and managing the diabetes."

Jeffrey Bluestone, an immunologist at the University of California, San Francisco, is also quoted in the Post piece. "The last thing you want to do is scare people away from lifesaving treatments," he maintains.

Questions about new treatments, drugs and research on life-threatening diseases are addressed in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

$373,000 per regimen for new treatment

FDA gives its okay to a second gene therapy that can send blood cancer into remission

The FDA has approved a new gene therapy for adults with aggressive non-Hodgkin's lymphoma.

According to a recent story by Denise Grady in The New York Times, Yescarta was okayed for patients who've undergone two regimens of chemotherapy that failed.

The Times article notes that the therapy "is part of the rapidly growing field of immunotherapy, which uses drugs or genetic tinkering to turbocharge the immune system to fight disease. In some cases the treatments have led to long remissions."

The therapy, which turns cells into "living drugs," is made by Kite Pharma.

Approval by the Federal Drug Administration was its "second in a radically new class of treatments that genetically reboot a patient's own immune cells to kill cancer."

The first was Kymriah, made by Novartis. It was okayed in August "for children and young adults with an aggressive type of acute leukemia."

That one costs $475,000 per dose, although the company has said "it will not charge patients who do not respond within the first month after treatment."

Yescarta isn't quite as expensive — $373,000 per treatment.

Dr. Frederick L. Locke

Dr. Frederick L. Locke, a leader of a study of Yescarta (and a specialist at the Moffitt Cancer Center in Tampa in blood cancers), is quoted as saying, "We're excited. We think there are many patients who may need this therapy."

Grady's story says "about 3,500 people a year in the United States may be candidates for Yescarta," which is intended "to be given once, infused into a vein, and must be manufactured individually for each patient."

Side effects, as with many therapies, can be daunting.

Life-threatening issues that stem from the Yescarta treatment can include "high fevers, crashing blood pressure, lung congestion and neurological problems," the story indicates.

According to Grady, two patients in the study that led to the drug's approval, "died from side effects," although doctors — through training and experience — apparently "have learned to manage them better."

The study, which was conducted at the Dana-Farber Cancer institute and Brigham and Women's Cancer Center in Boston, involved 111 patients at 22 hospitals.

"Initially," Grady's piece delineates, "54 percent [of the 101 who received Yescarta] had complete remissions…Another 28 percent had partial remissions [and] after six months, 80 percent…were still alive. With a median follow-up of 8.7 months, 39 percent of the 101 were still in complete remission — a much higher rate that achieved with earlier treatments — and 5 percent still had partial remissions."

Dr. Caron A. Jacobson

Says Dr. Caron A. Jacobson, who helped do the study: "You're really seeing people get their life back. After a couple weeks in the hospital and a couple weeks at home, they go back to work. On its face, it's quite remarkable and revolutionary."

The treatment, the Times explains, "was originally developed at the National Cancer Institute, by a team Dr. Steven Rosenberg led. The institute entered an agreement with Kite in 2012, in which the company helped pay for research and received rights to commercialize the results."

The drug giant Gilead reportedly bought Kite two months ago for $11.9 billion.

"In just several decades, said Dr. Scott Gottlieb, the FDA commissioner, "gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer."

A look at many treatments and clinical trials can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at caregivers.

How high-risk men's lives may be extended 37%

UK clinical trial shows that two prostate cancer therapies can be much better than one

Can combining two existing therapies extend the life of men with advanced, high-risk prostate cancer by 37%?

A new study seems to answer that question with a "yes."

Nicholas James

"These are the most powerful results I've seen from a prostate cancer trial," reported Nicholas James, professor of clinical oncology at Queen Elizabeth Hospital in Birmingham, United Kingdom, lead author of an abstract presented to the American Society of Clinical Oncology, in a recent story by Jessica Glenza in The Guardian. 

It's a "once in a career feeling," he noted. "This is one of the biggest reductions in death I've seen in any clinical trial for adult cancers."

Researchers, the Glenza story indicated, "combined standard hormone therapy with a drug called abiraterone, which is typically used only for cancer patients whose disease has stopped responding to standard hormone therapy."

Patients who received both medications did have "slightly stronger side effects," however — "especially cardiovascular and liver problems."

The study, which looked at a group of 2,000 men, was done as part of an ongoing randomized trial conducted in the United Kingdom and Switzerland.

James also was quoted as saying that "abiraterone not only prolonged life, but also lowered the chance of relapse by 70% and reduced the chance of serious bone complications by 50%."

More than 27,000 men in the United States, and 11,000 men in the UK, die of prostate cancer each year.

Details about many clinical studies on cancer 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.

Gene-changing leukemia therapy nears approval

Feds open door to okaying cancer-fighting treatment that genetically alters patient's cells

An FDA panel has given a unanimous vote of confidence to a gene-altering leukemia therapy.

According to a story by Denise Grady in The New York Times today, the Food and Drug Administration panel has unanimously recommended, following successful clinical trials, that "the agency approve the first-ever treatment that genetically alters a patient's own cells to fight [lethal] leukemia, transforming them into what scientists call 'a living drug' that powerfully bolsters the immune system to shut down the disease."

The agency is likely to accept the recommendation, Grady's story indicates, an action that would make Novartis' experimental treatment the first gene therapy to reach the market — ending in September a decades-long competition by researchers and drug companies.

"To use the treatment," the article continues, "a separate treatment must be created for each patient" — at enormous cost: between $300,000 and $600,000 for the requisite single infusion, according to analysts.

The CAR T-cell technique has multiple steps: Cells removed from the patient must be frozen, thawed and processed at a plant run by the manufacturer, frozen again and shipped back to the treatment center.

Severe side effects — including "fever, crashing blood pressure, lung congestion" — can potentially be life-threatening, but scores of patients have experienced long remissions and, in some cases, possible cures, the Times story maintained.

On the other hand, "re-engineering cells for treatment sometimes take four months," it noted, leaving some patients "so sick that they died before their cells came back."

Dr. Carl H. June

Dr. Carl H. June, an immunology professor and leader of the University of Pennsylvania research team that developed the treatment and licensed it to Novartis, has labeled the altered cells "serial killers."

One cell purportedly can destroy up to 100,000 cancer cells.

The panel's recommendation specifically dealt with leukemia "that has resisted treatment, or relapsed, in children and young adults ages 3 to 25" — for patients who typically had a bleak prognosis.

The clinical trials, according to a story by Laurie McKinley in The Washington Post yesterday, took place "in almost a dozen countries," with results of 83 percent of patients going into remission.

That story also indicated that "researchers are exploring CAR T-cell therapy's use for multiple myeloma and chronic lymphocytic leukemia [and] are also tackling a far more difficult challenge — using the therapy for solid tumors in the lungs or brain."

Meanwhile, Dr. Stephen Schuster, a Penn oncologist and leader of a lymphoma study, is quoted by the Post as saying, "We're saving patients who three or four years ago we were at our wit's end trying to keep alive."

Details on a variety of cancer therapies 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.

TV star has 'no idea how to react' to good news

Remission! Two-year battle with breast cancer being won by actress Shannen Doherty

Actress Shannen Doherty's breast cancer apparently has gone into remission.

After a two-year public battle with the disease.

According to an article by Umberto Gonzales in The Wrap over the weekend, Doherty wrote on Instagram that she has "no idea how to react," and added that "for now, I'm going to just breathe."

Shannen Doherty

But the "Beverly Hills, 90210" television star is realistic.

She noted that "as every single one of my fellow cancer family knows, the next five years is crucial. Recurrences happen all the time."

Meanwhile, she said, "Decisions. Reconstruction, which is several surgeries. Decision on taking a pill for the next five years comes with its own set of problems and side effects."

Her over-all feeling, however, was that "I am blessed."

Her battle became public when, according to Gonzales, "she sued her former management firm after her health insurances lapsed," which led to a delay in having her breast cancer diagnosed.

The star has undergone chemotherapy and a mastectomy.

Details about the disease, reconstruction, side effects and follow-up treatments 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.

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.