Promising pancreatic cancer pill can be taken while it's under regulatory review, FDA says

The Federal Drug Administration (FDA) has expanded access to a promising new drug for pancreatic cancer.

According to a recent story in The Washington Post by Christopher Rowland, "more patients will be able to take the pill while it is under regulatory review. The agency said it recognizes the dire need for a drug to fight one of the most lethal cancers."

The experimental drug was approved two days after the FDA received an access application from the drug's manufacturer, Revolution Medicines.

Dr. Marty Makary

The ultra-quick approval of daraxonrasib "reflects the FDA's strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer," the story quotes former FDA Commissioner Marty Makary as saying. 

In trials, the drug "has doubled average survival time for pancreatic cancer patients who have already received conventional treatment," the article continues. "The expanded access program, also known as 'compassionate use,' will be limited to that set of patients as well."

Makary's piece also indicates that the "company said it will provide the drug at no cost to patients in the program. Insurance typically does not cover expanded access drugs before they have been approved."

In one clinical trial, "patients had a median survival of 13.2 months compared with 6.7 months for those people receiving chemotherapy," the story adds.

More information on clinical trials can be found in Rollercoaster: How a man can survive his partner's breast cancer, aVitalityPress book that I, Woody Weingarten aimed at male caregivers. My other books are MysteryDates — How to keep the sizzle in your relationship; The Roving I, a compilation of 70 of my newspaper columns; and Grampy and His Fairyzona Playmates, a whimsical fantasy intended for 6- to 10-year-olds that I co-authored with my then 8-year-old granddaughter. Check out my website at https://woodyweingarten.com for details.

FDA, citing cancer link in rats, bans red dye in food, beverages, and drugs — but not until 2027

The Federal Drug Administration has banned Red Dye No. 3 in food, beverages, and drugs after linking the chemical to cancer in rats.

According to a subhead in a recent edition of The New York Times online, consumer and food safety groups "have long urged the agency to revoke the use of this dye and others."

Why it's being banned is still a bit of a mystery since the FDA has also claimed that studies show the dye causes cancer in rats but not humans, says the Times story by Andrew Jacobs and Teddy Rosenbluth. Under federal rules, the FDA "is prohibited from approving food additives that cause cancer in humors or animals."

The FDA action calls for companies to begin removing the dye from their products in 2027, the article notes, "more than three decades after the synthetic coloring was first found to cause cancer in male laboratory rats." In 1990, the agency banned the chemical for use in cosmetics and topical drugs.

The petroleum-based additive has been used to give candy, soda and other products "their vibrant cherry red hue," the Jacobs-Rosenbluth piece explains.

Jim Jones

Jim Jones, the FDA's deputy commissioner for human foods, declares in a statement that claims Red Dye No. 3 "puts people at risk are not supported by the available scientific information."

Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest, says "the agency's failure to act sooner was partly the result of industry opposition to a ban, but also reflected chronic underfunding of food safety at the FDA," the Times article reports. And he's quoted as adding, "The FDA has a track record of allowing unsafe chemicals to linger in our food supply long after evidence of harm emerges. And part of the reason for that is that the agency lacks a robust system for reevaluating the safety of chemicals that have already been approved."

According to Jacobs and Rosenbluth, "a big chunk of the blame also falls on Congress for failing to provide the authority and the resources the FDA needs to do its job to protect public health."

Artificial dyes and food additives have been a target for Robert F. Kennedy Jr., who was nominated big President Trump to be health secretary.

More information about disease-causing agents 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.

Three other books of mine are MysteryDates®, a look at how you can keep the sizzle in your relationship; The Roving I, an anthology of 70 newspaper columns I wrote; and Grampy and His Fairyzona Playmates, a whimsical children's fantasy about a sorcerer and two fairies that I co-authored with my then 8-year-old granddaughter. Details can be found at https://woodyweingarten.com/.

Patients already using new experimental blood tests to detect cancer, Washington Post reports

Some patients may be using blood tests to detect cancer that haven't been cleared by the FDA.

A story by Marlene Simons in today's editions of The Washington Post reports that Galleri, a new multi-cancer detection test, is but one of 20 tests in various stages of development that analyze substances in the blood that might indicate cancer. 

Those tests, the article says, "may be especially useful finding 'silent' cancers — such as pancreatic or ovarian cancer — which often don't cause symptoms until the disease is advanced and more difficult to treat."

On the flip side, Simons' piece indicates, "while these findings are promising, experts warned of drawbacks. So far, there's no evidence that finding cancer via a blood test translates to longer survival and fewer deaths, or even a cure, experts said."

Dr. Lori Minasian

The WashPost story also quotes Dr. Lori Minasian, deputy director of the National Cancer Institute's division of cancer prevention, as warning that "people want to believe there is one test that can pick up all the different kinds of cancers, and if it's negative, they can go on their way. But it's not that simple.

Several experts, the piece continues, "pointed out that multi-cancer detection tests don't find every cancer at its earliest stage, in part because certain cancers spread quickly."

These tests, which aren't covered by Medicare or other insurance, have yet to be cleared by the Food and Drug Administration for final approval — but are available as "lab-based" tests under federal guidelines that "permit their use in certain settings."

Caveats include many unanswered questions, the story says, "such as whether use of the tests should be based on age, risk factors, or family history." Along with the notion of how frequently people should take the blood tests, the remaining issues make it almost certain that they "probably are several years away from widespread use."

More information on research into various diseases 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.

FDA gives providers 18 months to implement new standards on mammograms and dense breasts

The Federal Drug Administration has established national mammogram standards to protect women with dense breasts.

According to the headline on a recent story by David Ovalle in The Washington Post, "almost half of women over 40 have dense breast tissue, which is tied to a higher risk of breast cancer — and also makes it harder to detect cancer."

The article notes that the new FDA standards require mammogram providers "to inform women with dense breast tissue that their cancer screenings may be difficult to interpret and suggest that they consult with their doctors about the need for additional tests" — such as MRIs or ultrasound.

Providers must implement the new regulations, which are expected to save lives by helping women detect cancer earlier, within 18 months.

The new standards are a minimum, but states can still require more severe language.

Breast cancer, Ovalle's story says, "is the most common cancer among women, after skin cancer, and the second leading cause of cancer deaths among women overall."

The American Cancer Society estimates, the piece continues, that in 2023 almost 300,000 women will be diagnosed with invasive breast cancer, and almost 44,000 will die from it.

Dr. Hilary Marston

Dr. Hilary Marston, the FDA's chief medical officer, claims in a statement that the "action represents the agency's broader commitment to support innovation to prevent, detect, and treat cancer," the Post article reports,

Currently, according to JoAnn Pushkin, executive director of the New York-based Dense Breast-info, a resource website that aims to teach patients and health-care professionals about dense breasts, some states tell women only that they have dense breasts, "really not enough to raise a red flag."

Pushkin in 2005 had a mammogram that showed no cancer, but an ultrasound shortly thereafter did. Because her breast cancer wasn't detected years earlier, she had to undergo eight surgeries, eight rounds of chemotherapy, and 30 rounds of radiation.

"Someone should have told me," the Post story quotes her saying about the greater difficulty detecting cancer in  people with dense breasts. "When I'm denied this information, I have effectively been denied an opportunity for early-stage diagnosis."

JoAnn Pushkin

The National Cancer Institute cautions that women with dense breast have a higher risk getting breast cancer.

Additional information on mammograms and dense breasts 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.

Docs wary about study showing cancer drug might cut Covid deaths for patients in hospitals

A new study found that an experimental cancer drug reduces death in hospitalized Covid patients by 55 percent.

According to a story this week by Carl Zimmer in The New York Times, however, some experts are cautious about over-interpreting the results of the study.

Veru, the Miami company that developed the drug, sabizbulin, has applied to the federal Food and Drug Administration (FDA) for emergency authorization to use it.

Dr. Ilan Schartz

The story quotes Dr. Ilan Schwartz, infectious disease expert at the University of Alberta who wasn't involved in the study, as saying, "This looks super-impressive. We have a small number of treatments for patients with a severe disease that improve mortality, but another treatment that can further reduce deaths would be very welcome."

He cautioned, though, that the clinical trial was relatively small — only 134 patients receiving the drug while 70 got a placebo over a course of 60 days — and said he'd "welcome large and independent confirmatory studies."

Researchers hypothesize, among other things, that the drug, which is taken in pill form, helps Covid patients fight potentially life-threatening lung inflammation.

Dr. David Boulware, an infectious disease expert at the University of Minnesota, also cautioned about the impact of the study. He suggested the large 45 percent mortality rate in the placebo control group might be a sign the study was too small to draw firm conclusions. The death rate, he was quoted as saying, "jumps out at me as rather high."

In addition, he observed, "trials which are stopped early routinely overestimate the effect." He predicted a similar fate as what happened with the drug molnupiravir, which initially appeared to reduce the risk of hospitalization from Covid by 50 percent but settled for a more realistic figure of 30 percent in the final analysis.

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

FDA finds bodies are absorbing chemicals

Stop your worrying — a new study indicates you can keep smearing on sunscreens to prevent skin cancer 

Worries about skin cancer should supersede concerns about absorbing sunscreen into the bloodstream.

Dr. Aaron E. Carroll

At least that's the conclusion of a new study reported online today by Dr. Aaron E. Carroll in The New York Times.

Skin cancer, the article says, "is the most common malignancy in the United States, affecting more than three million people each year."

But sunscreens, it asserts, "are a key component of preventing skin damage that can lead to skin cancer." 

Carroll, a professor of pediatrics at Indiana University School of Medicine who notes that recommendations against UV exposure "apply to everyone," suggests some folks who want to be extra safe switch to sunscreens that contain zinc oxide and titanium dioxide — inorganic compounds that aren't absorbed into the body but sit on the skin reflecting or absorbing the sun's harmful rays.

But even using sunscreens without those two components are unlikely to put you in peril.

The Federal Drug Administration (FDA) study, published in JAMA, tested  24 healthy people. It found that continued use of sunscreens did lead to an accumulation of potentially dangerous chemicals in the body — avobenzone, oxybenzone, octocrlene and ecamsule.

More information about scientific research into consumer products 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.

Feds ignore complaints, fears of many women

FDA declines to ban breast implant that's linked to cancer but intends to increase information about risks

The FDA has decided not to ban a type of breast implant linked to a rare cancer — at least for now.

According to a story by Laurie McKinley in last week's editions of The Washington Post, the decision, which came a month after a dramatic hearing in which many women expressed fears, complained about the implants and called on the Food and Drug Administration to execute such a ban, the agency plans instead to "increase efforts to collect and disseminate information about risks involving the device."

A joint statement by Amy Abernethy, FDA principal deputy commissioner, and Jeff Shuren, director of the agency's Center for Devices and Radiological Health, maintains that the FDA doesn't believe the textured implant "meets the legal standard for being banned at this time, based on available data and information."

Other countries have either banned or restricted sales of similar products "because of concerns about what's called breast implant-associated anapestic large cell lymphoma, or BIA-ALCL," McKinley's story contends.

The FDA also notes that "while textured implants make up as much as 80 percent of the market share in some other countries, they represent only 10 percent or less of the implants sold in this country," the Post article continues.

Federal officials also say they don't have "definitive evidence" demonstrating that the implants cause  "'breast implant illness,' a constellation of auto-immune problems that includes joint and muscle pain and allergies and fatigue — a topic that was repeatedly raised at the March hearing." But they do add, according to McKinley's piece, that evidence supports "that some women experience systemic symptoms that may resolve when their breast implants are removed."

Diana Zukerman, PhD

That admission has led Diana Zukerman, a PhD and president of the National Center for Health Research, to claim it's "the closest the FDA has come to acknowledging breast implant illness," which, she insists, is "definitely progress."

Historically, the agency tends to be reluctant to ban devices — having done so only twice, with powdered surgeons' gloves and prosthetic hair fibers.

The FDA has, however, "said it is considering requiring implants to carry what's called a boxed warning — the agency's strongest safety warning. And it may require doctors and patients to sign checklists of risks to make sure women have the necessary information to make an informed decision."

McKinley's story states that "bout 400,000 women a year get implants in the United States — 75 percent for cosmetic reasons and most of the rest for breast reconstruction about cancer surgery."

For more information on implants and reconstruction, check out "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

FDA charged with not protecting patients

Women challenge risks of breast cancer implants at FDA meeting, but no changes are expected

Women linked to breast implants challenged plastic surgeons, regulators and implant-makers last week but apparently came away disappointed because no U.S. changes are in the offing.

Other countries, however, have taken steps to halt sales of the implants.

According to The New York Times, as cited in the Kaiser Health News Morning Briefing online, the women attended "an emotionally charged" federal Food and Drug Administration advisory panel meeting and called for a ban on at implants associated with a rare form of lymphoma.

In addition, they "asked implant-makers to disclose the materials used in the devices and also called for a 'black box' warning — a label that the FDA can require, noting heightened problems with a drug or device."

The Washington Post noted, as reported on KHN, that they told "searing stories about broken health, disrupted families and lost careers," and said they wanted the panel "to recommend more long-term research, bans or restrictions on certain products…and a beefed-up informed consent process so that women have a clear understanding of theorists and benefits of the devices before they opt for surgery."

Jamee Cook

Jamee Cook, a Texas paramedic who leads a group called Breast Implant Victim Advocacy, said "experienced chronic fatigue, numbness and migraines — symptoms that were resolved" when she had the implants removed, a story in The Wall Street Journal reported, according to KHN.

She charged that the FDA has not fulfilled its responsibility to protect patients."

The Journal also noted that nearly "three decades after the FDA first pulled silicone [gel] breast implants of the U.S. market [because of fear they might cause breast cancer or lupus] and then allowed some back on, women continue to report debilitating conditions to the agency. The FDA is revisiting the issue again this year and is grappling with efforts to study which issues are proven and which not proven."

By quoting the Associated Press, the KHN summary then showed what results evolved — and what didn't — from the meetings. It said that government medical advisers claimed "it's too soon" for any ban because "more information is needed to understand the problem."

The FDA panel, a day after reviewing the research presented, recommended no immediate restrictions on breast implants.

The bans imposed by other countries, however, came within days of the FDA's rejection of the idea of sales limitations.

In the United States, some 400,000 women get implants each year, 100,000 of them after cancer surgery.

According to a story by Marie McCullough last week in The Philadelphia Inquirer, health authorities in Canada and the Netherlands — "just days after France became the first country to ban sales of numerous brands of textured and polyurethane-coated implants" — announced plans to suspend sales.

That article notes that "since the first report of implant lymphoma in 1997, almost 700 cases and 17 deaths have been tallied worldwide, including 270 cases and nine deaths in the United States, according to the latest count from the American Society of Plastic Surgeons."

More data about implants, and reconstruction, 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.

Valsartan, larsartan, irbesartan risks cited

Finding cancer-causing contaminants causes FDA to recall blood-pressure drugs 

Millions of bottles of generic blood-pressure meds have been recalled after a contaminant that causes cancer was found.

According to a recent story on the Tech2.org website, the Federal Drug Administration (FDA) ordered the recall after determining that folks who've taken certain hypertension meds over the past four years may have been exposed to small amounts of impurities following a change in the way companies manufacture the active ingredient.

The carcinogens, the article continues, "are a chemical byproduct of the process used to synthesize the active ingredients in medicines, which includes valsartan, losartan and irbesartan."

Agency leaders, the story says, have estimated that "between 1 and 2 million people may have taken the drugs with the impurities."

The recalled products, a USA Today story says, "are part of a large class of drugs called angiotensin II receptor blockers, or ARBs, which relax blood vessels. Many of these commonly prescribed drugs are not part of the recall."

But, overall, "the risk to individual patients remains very small, although this doesn't diminish the significance of this episode or our concerns," read a joint statement from FDA Commissioner Scott Gottlieb and FDA Director Janet Woodcock.

David Light

David Light, founder and chief exec officer of Valisure, an online pharmacy that chemically validates the drugs before shipping them to consumers, said "companies may not be cleaning the active ingredients as a cost-saving measure," noting, too, that "it would not have been unexpected that the synthesis process would cause pollutants."

Details on risks of drugs that might worsen medical conditions can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a book that I, Woody Weingarten, aimed at male caregivers.

'Precision medicine' altering treatment focus

FDA clears pricey oncology therapy drug for multiple cancers with a shared mutation

The federal Food and Drug Administration has approved a drug, Vitrakvi, for a wide range of cancers based on a shared mutation.

According to a recent Washington Post story by Laurie Mcginley that was reprinted in newspapers across the country, the decision shifts treatment focus away from tumor location, apparently "an advance for the sometimes controversial field of 'precision medicine.'"

The FDA action on Vitrakvi (aka larotrectinib) marks the second treatment to receive the agency's "clearance based on a common biomarker found in an array of cancers."

The approval was given simultaneously for adults and children, contrary to the more typical FDA action regarding oncology drugs whereby kids are not considered until much later than adults.

Vitrakvi is intended, Mcginley's story says, "for patients with advanced solid tumors containing what's called an NTRK gene fusion, a hybrid of two genes that can promote uncontrolled cell growth. Cancers of the thyroid, lung and head and neck, among others, can be caused by the defect."

Dr. Scott Gottlieb

According to a story in the online magazine Healio, Dr. Scott Gottlieb, a FDA commissioner, notes that approval of the new site-agnostic oncology therapy "marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body."

The breakthrough drug (that was tested in three clinical trials), the Washington Post piece adds, "is for patients whose cancer has spread or who would experience severe complications by undergoing surgery and have no satisfactory alternatives."

Precision medicine has spawned both enthusiasm and skepticism, partially because both the drugs and the tests can be quite expensive.

The drug's manufacturer, Loxo Oncology, Inc., and its partner, Bayer, announced that "the wholesale acquisition cost will be $32,800 for a 30-day supply of capsules for adults. The cost for the liquid formulation for children…will start at $11,000 per month."

Patient affordability "is one of the big barriers to precision medicine right now," McKinley quotes Carolyn Presley, a geriatric oncologist at Ohio State University Comprehensive Cancer Center, as saying. "Show me the money — how are you going to pay for it?"

Elizabeth Jaffee, Johns Hopkins oncologist, nevertheless predicted that precision medicine "is going to be the way to treat cancer in the future," the Washington Post story reports.

More information on research into cancer 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.

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.

Can electric fields tweak genes in immune cells?

Cancer treatment revolution possible via new gene-editing technique, new report says

A new rapid gene-editing method potentially could revolutionize treatments for cancer.

According to a story by Gina Kolata in recent editions of The New York Times, researchers have reported in a new scientific paper that they've found a way to tweak genes in the body's immune cells by using electrical fields.

What could happen, Kolata reports, is that genes could be removed from white blood cells and beneficial replacements inserted — "all in far less time than it normally takes to edit genes."

In addition to cancer, the method apparently could profoundly impact "infections such as HIV and autoimmune conditions like lupus and humanoid arthritis."

The journal Nature first published details of the paper, but "because the technique is so new, no patients have yet been treated with white blood cells engineered with it," the Times story indicates.

Currently, Kolata notes, "scientists attempting to edit the genome often must rely on modified viruses to slice open DNA in a cell and to deliver new genes into the cell. The method is time-consuming and difficult, limiting its use."

Fred Ramsdell, Ph.D.

The use of electrical fields rather than viruses, a process that's vastly speedier, means that "in theory a treatment could be available to patients with almost any type of cancer," her story continues. And the Times writer then quotes Fred Ramsdell, Ph.D. and vice president of research at the Parker Institute for Cancer Immunotherapy in San Francisco, as saying, "I think it's going to be a huge breakthrough."

The institute, she writes, "is working with the authors of the new paper, led by Dr. Alexander Marson, scientific director of biomedicine at the Innovative Genomics Institute — a partnership between University of California, San Francisco and the University of California, Berkeley — to make engineered cells to treat a variety of cancers."

The scientists already are conferring with Food and Drug Administration employees about using the new method to attack both solid and blood cancers.

"Our intent," says Ramsdell, "is to try to apply this as quickly as possible."

Information about other cancer research 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.

$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.

Prediction: Price of drug therapies will skyrocket

New FDA-approved cancer gene therapy to cost $475,000 for a single course, reports say

Are pharmaceutical companies gouging the public?

Very possibly, as evidenced by a new gene therapy for childhood leukemia that will cost almost half a million dollars for a single course.

Reports yesterday about Federal Drug Administration approval for Novartis' Kymriah, which is the first gene therapy for cancer that it's okayed, say it will cost at least $475,000.

Although some oncologists have described the CAR-T drug as revolutionary, critics fear the price tag could pave the way for future drug costs to skyrocket.

According to a story by Catherine Ho in the San Francisco Chronicle, the way the treatment works is this: A patient's cells are extracted from his or her blood, then sent to a site where they'll be genetically modified. The altered cells are then re-infused into the patient's body.

The FDA this week approved Kymriah as a treatment for childhood B-cell acute lymphoblastic leukemia, a cancer of the blood and bone marrow that's the most common childhood cancer.

The National Cancer Institute has estimated 3,100 patients up to 20 years old are diagnosed with the disease annually. Although the survival rate is 90 percent, that figure drops to as low as 10 percent for those who relapse after a bone marrow transplant. It is that subset of patients who are eligible for cell therapy, whose rate of success is said to be between 70 and 80 percent.

Only a few hundred children and young adults are expected to be treated with Kymriah each year.

Bruno Strigini

A Guardian story, supplemented by Associated Press reporting, said that Bruno Strigini, Novartis' head of oncology, has explained that the high cost of the treatment is an attempt to balance patient access to the drug with ensuring a return on the company's investment.

The Guardian piece also cited a Novartis statement to the effect that the company "was collaborating with Medicare on a plan in which the government would only pay for the treatment if patients responded to them by the end of the first month."

Side effects of the drug include high fevers, diarrhea, vomiting, delirium, loss of balance, and difficulty speaking and understanding.

More information about the exorbitant costs of cancer treatments can be found in  "Rollercoaster: How a man 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.

Rare malignancies of immune system studied

Implants may bring a new disease to cancer patients with mastectomies, N.Y. Times says 

Can breast cancer implants give a woman who's had a mastectomy another cancer?

According to a recent article by Denise Grady in The New York Times, the answer is a definite yes.

The new cancer, it indicates, may not be breast cancer "but a rare malignancy of the immune system —  caused by the implants used to rebuild her chest."

The disease, anaplastic large-cell lymphoma, is a cancer that's "been linked to implants with a textured or slightly roughened surface, rather than a smooth covering," the piece says.

Although the federal Food and Drug Administration first reported a link between implants and the disease in 2011, an FDA update in March linked nine deaths to the implants and helped raise awareness, Grady's article notes.  

The FDA has also received 359 voluntary reports of implant-associated lymphoma from doctors or patients around the world.

That number, the story says, "is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease."

As of now, however, no implants have been recalled — and "what's inside the implant, silicone or saline, seems to make no difference."

Between 2000 and 2016, the number of U.S. breast augmentations rose 37 percent — "and reconstruction after mastectomy rose 39 percent," Grady writes.

"Annually, nearly 400,000 women in the United States get breast implants, about 300,000 for cosmetic enlargement and about 100,000 for reconstruction after cancer, according to the American Society of Plastic Surgeons," the story adds.

Lymphoma, if detected early, is often treatable and rarely fatal — although its symptoms "usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit."

Dr. Mark W. Clemens II

In cases with bad outcomes, the Times quotes Dr. Mark W. Clemens II, a plastic surgeon and expert on the disease at the University of Texas MD Anderson Cancer Center in Houston, "it was usually because they were not treated or there was a major delay in treatment, on the level of years."

Clemens believes that as late as 2015, "only about 30 percent of plastic surgeons were routinely discussing the cancer with patients," the Times piece says.

The newspaper also notes that what causes the disease isn't known. "One theory," Grady's story postures, "is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma."

Clemens noted that researchers are also looking for mutations that might contribute to the disease.

More information about women's difficulties after reconstruction 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.

Does cancer cure take back seat to bottom line?

Extending cancer patients' lives more profitable than preventing disease, says N.Y. Times scribe

Heidi Williams, MacArthur "genius" grantee

Want to know why preventing cancer isn't the chief priority in development of drugs?

Answer: It's not profitable enough.

According to The New York Times, "economic incentives encourage researchers to focus on treatment rather than prevention."

A recent piece written by Austin Frakt and distributed in an online Times' newsletter, "The Upshot," charges that the sitution stems from the "way the patent system interacts with the Food and Drug Administration's drug approval process" — an interaction that "skews what kinds of cancer clinical trials are run."

Austin Frakt

Frakt contends there's "more money to be made investing in drugs that extend cancer patients' lives by a few months than in drugs that would prevent cancer in the first place."

Those findings are based on the work of Heidi Williams, a MIT economics prof and MacArthur "genius" grant winner, and two other experts.

After patenting a drug, pharmaceutical companies "race the clock to show that their product is safe and effective" — so they can obtain FDA approval, Frakt notes. "The more quickly they can complete those studies, the longer they have until the patent runs out, which is the period of time during which profit margins are highest."

Drug companies have found developing meds "to treat late-stage disease is usually much faster than developing drugs to treat early-stage disease or prevention, because late-stage disease is aggressive and progresses rapidly."

That, in turn, "allows companies to see results in clinical trials more quickly, even if those results are only small improvements in survival."

Between 1973 and 2011, Frakt writes, "there were over 17,000 trials of patients with the lowest chance of survival…but only 500 for cancer prevention, which confer the longest survival gains."

Williams' study estimated that current incentives "led to 890,000 lost life-years among American patients found to have cancer" in one year alone.

The best way to address the problem, Frakt suggests, is to have the FDA more routinely give approvals based on "indications of improved health that can be measured more quickly than survival — so-called surrogate endpoints." 

Another remedy might be to extend the period of a drug's market exclusivity to compensate for what's called the "commercialization lag."

Details on research and clinical trials regarding cancer in general and breast cancer in particular can be found my the book I, Woody Weingarten, aimed at male caregivers, "Rollercoaster: How a man can survive his partner's breast cancer."

Do nail salons breed cancers, other health woes?

Chemicals in nail products threaten manicurists, clients with cancers and miscarriages

Can manicures be hazardous to your health?

Possibly.

According to The New York Times, new medical research shows links "between the chemicals that make nail and beauty products useful…and serious health problems."

The problems are not so distinct for customers, but they're apparently clear for "manicurists who handle the chemicals and breathe their fumes for hour on end, day after day."

In a May 8 article by Sarah Maslin Nir, the Times claimed "stories and tragedy abound at nail salons across the country, of children born slow or 'special,' of miscarriages and cancers, of coughs that will not go away and painful skin afflictions."

Older manicurists, it said, "warn women of child-bearing age away from the business, with its potent brew of polishes, solvents, hardeners and glues that nail workers handle daily."

The federal law that regulates cosmetics safety doesn't require companies to share data with the Food and Drug Administration.

Warnings basically have been ignored by manufacturers of the risky products, and the industry has vigorously fought regulation.

As a follow-up to the Times piece, New York Gov. Andrew M. Cuomo ordered emergency measures initiated to help quash the health hazards, educate workers of their rights, and fight apparent wage theft. He called for a task force to conduct probes and close salons that don't meet the new standards.

Among the changes he demanded are the mandatory wearing of gloves and masks, proper ventilation for the salons, and requiring bonds to ensure payments to workers.

Cancer in all its forms, of course, is the scourge of our time. Once contracted, it is likely to turn into an ordeal of ups and downs — such as I, Woody Weingarten, chronicled in my VitalityPress book, "Rollercoaster: How a man can survive his partner's breast cancer" — which focuses on a male caregiver's journey through surgery, chemotherapy, radiation and the aftermath of all those treatments.

My book also provides up-to-date coverage of breast cancer research and meds — as well as a guide to where help can be obtained.