When are drug costs and side effects too much?

Study shows new hope for some breast cancer patients through immunotherapy drugs

Breast cancer for a long time was in effect immune from immunotherapy. That apparently is no longer the case.

According to an Associated Press story by Marilynn Marchione this week, one of the new immunotherapy drugs "has shown promise against breast cancer in a large study that combined it with chemotherapy to treat an aggressive form of the disease."

For the first time.

There's a big caveat lurking in the researchers' labs, however: "The benefit for most women was small."

And that, according to Marchione's story, raised questions "about whether the treatment is worth its high cost and side effects."

Results of the new study — which tested a drug from Roche called Tecentriq — were discussed at a cancer conference in Munich and published by the New England Journal of Medicine.

The type of drugs in question, called checkpoint inhibitors, have previously been found helpful in treatments of many other cancers "by removing a chemical brake that keeps the immune system from killing tumor cells."

Their discovery, in fact, recently earned scientists a Nobel Prize.

Dr. Michael Hassett

Side effects of the chemo and Tecentriq, which costs $12,500 a month, included nausea and low blood cell counts, similar to other treatments.

The story quoted Dr. Michael Hassett of the Dana-Farber Cancer Institute in Boston, who didn't take part in the study, as saying "he felt 'cautious excitement' that immunotherapy may prove helpful for certain breast cancer patients."

Details about other research on and treatments for the 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.

Fighting the virus that spreads through sex

Federal regulators boost their OK on use of cervical cancer vaccine from age 26 to age 45

U.S. regulators have expanded the use of Merck's cervical cancer vaccine, Gardasil 9, to adults up to age 45.

The vaccine, according to a recent story by Linda A. Johnson of the Associated Press, was previously approved only for preteens and young adults through 26.

Johnson's article notes that the vaccine protects against the human papilloma virus, or HPV, which can cause cervical cancer, certain other cancers and genital warts — and that the virus is "very common and is spread through sex."

HPV, it goes on to say, "doesn't cause any problems, but some infections persist and eventually lead to cancer."

Johnson also writes that the Centers for Disease Control and Prevention estimated about 14 million people become newly infected with HPV each year, mostly teens and young adults" — and adds that 33,700 are diagnosed annually with a cancer caused by an HPV infection.

The latest version of the pharmaceutical giant's vaccine protects "against nine strains of HPV, four more than the original" did in 2006, the story indicates.

Details about other new vaccines and drug, and other Federal Drug Administration action, 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.

'Fundamental change' in treating tumor cells

Nobel Prize goes to American, Japanese working separately on cancer immunotherapies

Two researchers who worked on game-changing therapies that unleash brakes against cancer have won 2018's Nobel Prize for medicine.

James P. Allison (left) and Tasuko Honjo

The pair — Dr. James P. Allison of the MC Anderson Cancer Center in Houston and Dr. Tasuko Honjo of Kyoto University in Japan — found "checkpoint inhibitor" therapies that "greatly increased survival of cancer patients and may produce even greater results when combined with traditional therapies," according to an online story this week by Tina Hesman Saey in ScienceNews, the nonprofit magazine of the Society for Science & the Public.

The article indicates that "all previous types of cancer therapy were directed at the tumor cell, but Allison's and Honjo's approach was to remove brakes that keep the immune system in check."

The two, who were working separately, will equally share the prize of just over $1 million.

An earlier piece by Saey and Aimee Cunningham in ScienceNews noted that they had identified proteins that act as brakes on tumor-fighting T cells.

A Reuters story said the "scientists' work in the 1990s has since swiftly led to new and dramatically improved therapies for cancers such as melanoma and lung cancer, which had previously been extremely difficult to treat."

Treatments known as immune checkpoint blockade that resulted from their work, the piece added, "'have fundamentally changed the outcome' for some advanced cancer patients," the Nobel institute said."

The discoveries consequently spawned a multi-billion dollar market for new cancer medicines.

Reuters quoted a professor at the Institute of Cancer Research in London, Kevin Harrington, as contending the two scientists' work had revolutionized cancer treatment:

"We've gone from being in a situation where patients were effectively untreatable to having a range of therapy options that, when they work, work very well indeed," he said in a statement. "For some patients we see their tumors shrink or completely disappear and are effectively cured."

More information on 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.

New insights, treatments, tests in disease 'war'

Medical community is starting to believe less is more when it comes to cancer treatments 

More and more doctors and patients apparently are using less aggressive weapons to fight cancer these days.

Dr. Justin Bekelman

A story by Laurie McKinley in yesterday's Washington Post quotes Dr. Justin Bekelman, a radiation oncologist at the University of Pennsylvania, about the medical community's focus on the "war on cancer."

Historically, he says, that phrase "implied that more is better and decimation is desired."

McKinley's story contends, however, that the idea is "falling out of favor," not only because it "subtly blames patients" who die "but also because it doesn't capture a world of new biological insights, improved treatments and molecular tests that are transforming how cancer is treated."

According to Bekelman, "Knowing when not to treat" can be "great medicine" — because, the story charges, oncologists equipped with new tools and evidence can cut back on toxic and costly approaches likely do more harm than good.

Cancer, nevertheless, is not monolithic, the story indicates.

Rather, some cancers "need to be bludgeoned, but others can be treated with more tailored therapies or simply watched."

Although the latest mindset of "doing less in the face of danger" can be "emotionally difficult" for both patients and physicians, the article notes, proof that less is more has been frequently popping up lately, including a landmark clinical trial published in June that found more than "two-thirds of women with early-stage breast cancer can safely avoid chemotherapy." 

Not to mention the fact, according to the piece, that "men with early-stage, low-risk prostate cancer are rapidly embracing 'active surveillance' over surgery — and avoiding possible complications such as incontinence and sexual dysfunction," and that throat cancer caused by human papilloma virus, because it varies from other types of the disease, allows a cutback "in a brutal treatment regimen and [reduces] the risk of potentially devastating disfigurement."

The Post story also mentions the emergence of immunotherapy, usually less toxic than chemo, "as a first-line treatment for many patients," and cites a recent study showing that "people with advanced kidney cancer can skip surgery to have their kidneys removed and instead go right to drug treatment."

De-escalation isn't happening universally, however. 

McKinley contends that the "most common form of thyroid cancer, which poses little risk, is often still treated with unnecessary surgery, experts say. And some malignancies, such as pancreatic cancer, are so lethal that doctors are racing to find ways to ramp up treatment."

Details on trends and clinical trials in treatment 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.

TV star joins disease-awareness initiative

Julia Louis-Dreyfus happily returns to  Emmy-winning 'Veep' role after breast cancer

Instagram selfie with 'Veep' crew.  

TV stalwart Julia Louis-Dreyfus, who'll undoubtedly remember her breast cancer diagnosis and treatments for the rest of her life, is happily back at work at HBO's satirical "Veep."

And she's also involved in her first cancer-awareness initiative.

According to an Associated Press story by Leanne Italie today, the 57-year-old star says it feels "fantastic" to be acting again.

Louis-Dreyfus disclosed her cancer diagnosis last September, shortly after having garnered her sixth consecutive Emmy Award for her Selina Meyer role.

According to the AP, the seventh and last season of "Veep," which will air in the spring, evoked this from the former "Seinfeld" co-star: "I feel good. I feel strong. I've got energy and, yeah, back o my old tricks. It feels like I never left."

Her wading into the cancer-awareness waters, the piece continues, comes through her "helping Carolina Herrera designer Wes Gordon design a flower-adorned T-shirt as part of Saks Fifth Avenue's 20th year raising money through its Key to the Cure program."

Over two decades, the program has donated almost $40 million to cancer research and treatment organizations.

All proceeds from the shirt that will sell for $35 during October, which for decades has served as Cancer Awareness Month, reportedly will go to the AiRS Foundation, which the AP describes as "a nonprofit Louis-Dreyfus supports for its work in helping women with the costs of breast reconstruction after mastectomy."

The shirt features three poppies (in red and pine tones) and a slogan: "We are fighters & we are fighting for a cure."

Noted the actor about the design process, "It was a super-fun endeavor," elaborating that she "wanted it to have a sort of femininity and a powerful message at the same time because I believe the two can go hand in hand. I liked the idea of talking about fighting."

Regarding reconstruction, she'd noted that "up to 70 percent of breast cancer survivors who have had a mastectomy are really unsure or unaware of their reconstruction options, and many of those women who desire to have surgery don't have sufficient insurance or other resources to cover it."

Regarding her participation in the awareness program, she said that while she now was "putting my whole self into Key to the Cure," she'd previously been "very careful about managing my time and conserving my energy. You can't spread yourself too thin."

After going under the knife for breast cancer, Louis-Dreyfus had been perhaps a bit less eloquent and a bit more dramatic. She'd written on Instagram, "Hoorah! Great doctors, great results, feeling happy and ready to rock after surgery. Hey cancer, f**k you!"

More details about both reconstruction and awareness 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.

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.

Jury in landmark case rules against Monsanto

Court verdict awards man who claims that Roundup caused his terminal cancer $289 million

Monsanto plans to appeal a verdict that awarded $289 million to a dying man who blamed its herbicide Roundup for his cancer.

Attorneys for the 46-year-old former school groundskeeper, Dewayne Johnson, said the decision will bolster thousands of pending cases and open the door for countless people who blame their suffering on the weed killer, according to an Associated Press story by Paul Elias today.

"I'm glad to be here to be able to help in a cause that's way bigger than me," the plaintiff reportedly said about yesterday's verdict. 

The California Superior Court jury in San Francisco unanimously agreed that Johnson's heavy contact with Roundup contributed to his non-Hodgkin's lymphoma and that, the story said, "Monsanto should have provided a label warning of the potential health hazard."

The $289 million was broken down into $39 million in compensatory damages and $250 in punitive damages. Johnson's lawyers had sought a total of $373 million.

Robert F. Kennedy Jr.

Robert F. Kennedy Jr., an attorney for Johnson and the son of the late U.S. senator, declared on Twitter that the punitive damages were for "acting with malice and oppression."

He predicted that the verdict "is going to trigger a cascade of new cases."

An online Common Dreams story quoted Ronnie Cummins, international director of the Organic Consumers Association, an advocacy group and longtime Monsanto critic, to the effect that the verdict proves "there is no confusion" when "ordinary citizens, in this case a jury of 12, hear the facts about Monsanto's products, and the lengths to which this company has gone to buy off scientists, deceive the public and influence government regulatory agencies."

Robert Cummins

And, to twist the knife, he added: "This is a company that has always put profits ahead of public safety…We hope that this is just the first of many defeats for Monsanto, and that the U.S. Environmental Protection Agency will pull this product off the market."

The case was the first filed by a cancer patient against the agribusiness giant to reach trial. It was fast-tracked because of the severity of Johnson's cancer.

Elias' story quoted Brent Wisner, Johnson's lead trial lawyer, as saying that the jury has told Monsanto, a unit of Bayer AG following a $62.5 billion acquisition by the German conglomerate"
"Enough. You did something wrong and now you have to pay…There's 4,000 other cases filed around the United States and there are countless thousands of people out there who are suffering from cancer because Monsanto didn't give them a choice…We now have a way forward."

Monsanto, one of the companies that produced for use by U.S. forces in Vietnam the defoliant Agent Orange, which has been linked to cancer and other diseases, has long denied any link between glyphosate, the active ingredient in Roundup, and cancer.

It has cited hundreds of studies that glyphosate contending is safe.

Scott Partridge, a spokesman for the agribusiness giant, said the corporation will appeal "and vigorously defend this product, which has a 40-year history of safe use and continues to be a vital, effective, and safe tool for farmers and others."

Johnson had used Roundup — and a similar product, Ranger Pro — as a pest control manager at a San Francisco Bay Area school district in Benicia, spraying from a 50-gallon tank attached to a truck. During gusty winds, Wisner said, the product would cover his face — and once, when a hose broke, the weed killer soaked his entire body.

He allegedly had applied Roundup up to 30 times a year.

When Johnson contacted the company after developing a rash, the attorney added, he was never warned it could cause cancer.

His non-Hodgkin's lymphoma was diagnosed in 2014. His landmark case was filed two years later.

George Lombardi, another Monsanto attorney, said that disease takes years to develop, so Johnson's cancer must have started well before he started working at the district, the AP story notes.

"The simple fact is," Wisner told the jury (which deliberated for three days at the end of the eight-week trial) in his opening statement in July, "he is going to die. It's just a matter of time."

His doctors have indicated that that's likely to happen within two years. Whether he dies before the appeal is adjudicated is anyone's guess.

The EPA, which is the past has often favored big business and now is being gutted by the Trump administration, has said glyphosate is safe for folks using it in accordance with label directions. But the French-based International Agency for Research on Cancer, part of the World Health Organization, classified it in 2015 as a "probable human carcinogen" — and California added it to its list of chemicals known to cause cancer.

More details on disease risks can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPresss book I, Woody Weingarten, aimed at male caregivers.

Appeal expected on ruling on breakfast foods

Los Angeles court says industry doesn't need to put cancer warning labels on cereals 

There's a cereal war going on these days.

Between advocates of breakfast foods such as Grape-Nut flakes and Cheerios that contain whole grains and researchers who insist those cereals contain a chemical — acrylamide — that's a potential cause of cancer.

The latest shot in the skirmish, according to a story by Bob Egelko in the San Francisco Chronicle, came when a California court ruled recently that the breakfast cereals don't need cancer warnings.

The 3-0 ruling by the Second District Court of Appeal in Los Angeles said the cereals, produced by Post, General Mills and Kellogg, needn't heed Proposition 65, a right-to-know law state voters passed in 1986 that "requires businesses to notify the public when their products, or any substances they release into the environment, contain ingredients that have been shown to cause cancer or birth defects" because such labels might discourage consumers from buying healthy food.

A huge win for the cereal industry, the decision was based on 2003 and 2006 letters from the U.S. Food and Drug Administration to state health officials claiming that warning labels "would mislead consumers and lead to health detriments."

Requiring warnings on all foods containing the chemical at levels that pose any risk of cancer, the court indicated, might harm the value of "peanut butter, rye and whole wheat bread, sunflower seeds, and prune juice," according to the Chronicle piece.

Justice Chaney

Another story, by Eric Schroeder on the Food Business News website, reports that Associate Justice Victoria Gerrard Chaney had said no Prop. 65 warning "should be placed on foods, including breakfast cereals, unless and until the science supports such a warning."

The court decision observed "that when the state sought to require Prop 65 warnings on canned tuna because it may contain harmful levels of mercury, an appeals court said California law was preempted because federal health officials were already advising consumers of tuna's benefits and possible risks."

The state Supreme Court, Egelko's story continued, "followed officials' directions in 2004 by refusing to allow Prop. 65 warnings on anti-smoking patches containing nicotine, which can cause fetal damage."

An appeal of the court ruling — in which a dismissal of a suit by Richard Sowinski, a retired Walnut Creek physician who'd sought to require Prop. 65 warnings on 59 cereals — was expected.

The ruling, not incidentally, means the court has rejected arguments that Prop. 65 warnings would encourage the companies to make safer cereals.

Federal agencies have listed acrylamide as a carcinogen, and it was placed on the Prop. 65 list in 1990.

In 2002, researchers learned the chemical was "a byproduct of baking, roasting or frying carbohydrate-rich foods such as potato chips and French fries — both of which now carry Prop. 65 warning labels — and cereals," the Chronicle story stated.

Acrylamide has also been the recent focus of whether warning labels are necessary on coffee packaging.

Details on other cancer risks 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.