Monday, April 15, 2019

Medicare coverage of costly drug being debated

Will Trump administration drop the restrictions on new type of blood cancer treatment? Stay tuned!

Will insurance companies be able to block expanded Medicare coverage of cancer care?

The answer is a positive maybe.

According to a story last week by by Robert Pear in The New York Times, insurers are pushing to keep existing restrictions against an expensive new type of treatment, CAR-T cell therapy. 

"Cancer patients, doctors and drug companies are urging the Trump administration to remove the restrictions," the story says.

The restrictions are intended to hold down costs of the treatment, which Pear explains "is manufactured specifically for each patient." 

Many more "such 'personalized medicines' are in the pipeline," he adds.

Medicare's final decision is expected in the next few weeks. 

According to the Times, the federal "Food and Drug Administration has approved two CAR-T products to treat certain blood cancers: Kymriah, made by Novartis, with a list price of $375,000 or $475,000, depending on the type of cancer, and Yescarta, made by Gilead Sciences, with a list price of $373,000."

Although CAR-T treatments "generate high costs up front…the benefits could last for years," Pear contends.

The treatments, he notes, "have been remarkably effective in some patients who had a dismal prognosis after exhausting other options."

Dr. Francis S. Collins
Pear's story quotes Dr. Francis S. Collins, director of the Centers for Medicare and Medicaid Services, as saying that "harnessing the power of a patient's immune system in this way was a 'marvel of modern medicine."

And Pear attributes to Kirsten A. Sloan, vice president of the American Cancer Society Cancer Action Network, the notion of favoring people having access to the treatment and letting "the doctor decide which patients should be eligible."

In CAR-T therapy, immune- or T-cells are removed from a patient's blood, sent to a lab to be "genetically engineered  to recognize and attack cancer cells, and then sent back to the hospital for infusion into the patient."

The problem is the over-all cost: The infusion, doctors' fees and hospital stays can add up to $750,000 or more.

A statement from one of the nation's largest insurers, UnitedHealth Group, expresses concern that CAR-T therapies could create significant financial risks for both the government and private Medicare Advantage plans.

More information about controversies over new treatments or drugs 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.

Monday, April 8, 2019

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.

Friday, March 29, 2019

Agribusiness 'negligent' about herbicide risks

Monsanto loses second consecutive case that finds Roundup causes cancer, this time for $80 million 

A federal jury in San Francisco slapped an $80 million judgment against Monsanto this week for causing a Sonoma man's cancer through Roundup.

The six-person jury deliberated only one day. 

Its verdict, that Monsanto had been "negligent by not using reasonable care" to warn of the risks of the herbicide, was unanimous. 

Edwin Hardeman
The award against Monsanto, now owned by Bayer AG, which intends to appeal, included $75 million in punitive damages, $5 million in compensation and $200,000 for medical expenses for 70-year-old Edwin Hardeman, a retiree who'd contracted non-Hodgkin's lymphoma, a blood cancer, after more than two decades of using Roundup to kill weeds on his 56-acre property.

According to an online story by Amanda Bronstad in's The Record, Hardeman's attorneys, Aimee Wagstaff and Jennifer Moore, issued a statement after the verdict asserting that "it is clear from Monsanto's actions that it does not care whether Roundup causes cancer, focusing instead on manipulating public opinion and undermining anyone who raises genuine and legitimate concerns about Roundup."

The lawyers noted that "it speaks volumes that not one Monsanto employee, past or present, came live to trial to defend Roundup's safety or Monsanto's actions," the article continues.

Bayer, through a statement, claimed that "over four decades of extensive science and the conclusions of regulators worldwide…support the safety of our glyphosate-band herbicides," which the company continues to insist "are not carcinogenic."

The World Health Organization's cancer arm, however, has certified that glyphosate is "probably carcinogenic to humans."

The federal verdict, which may be as bellwether for 800 other lawsuits against Monsanto, follows a case in a San Francisco Superior Court in which jurors awarded $289 million, which was cut to $78 million by the judge.

Another case against the agribusiness was scheduled to start today in Alameda County Superior Court. Plaintiffs are Alva and Alberta Pilliod, both of whom contracted non-Hodgkin's lymphoma after decades of using Roundup.

Information on other verdicts against major corporations 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.

Thursday, March 21, 2019

2nd major ruling against Monsanto weedkiller

Unanimous U.S. court verdict labels Roundup as major factor in Sonoma man's non-Hodgkin's lymphoma 

In what might be a bellwether case, a six-person federal jury in San Francisco unanimously found this week that Roundup, Monsanto's weedkiller, was a substantial factor in a Santa Rosa man's cancer.

Or at least one active chemical ingredient in it — glyphosate — was.

The case could affect hundreds of others: Monsanto faces 9,000 similar lawsuits in the United States alone.

According to a story by Sam T. Levin in The Guardian, the 70-year-old plaintiff, Edwin Hardeman, said he'd used the herbicide for nearly three decades, had at least once gotten it on his skin, and "alleged that his exposure to [it] caused him to develop non-Hodgkin's lymphoma [NHL], cancer that affects the immune system."

In a second phase, the jury still must weigh liability and damage.

Hardeman, who was diagnosed with non-Hodgkin's lymphoma in 2015, has used Roundup to control weeds and poison ivy on his properties since the '80s.

A BuzzFeed News story notes that "Jennifer Moore, an attorney for the Sonoma County man, said Hardeman used Roundup regularly, spraying approximately 6,000 gallons of the herbicide over the course of 26 years."

The so-called bellwether trial, which means the verdict could possibly affect future litigation, followed a California state court verdict last August that Roundup caused the terminal cancer of Dewayne Johnson, a former school groundskeeper.

That jury, Levin's piece asserts, "said Monsanto failed to warn Johnson of Roundup's health hazards and 'acted with malice or oppression.'"

It awarded Johnson $289 million in damages, although that was later slashed to $78 million.

Monsanto, predictably, has appealed.

The Guardian story notes, however, that "Hardeman's trial has been more limited in scope. While Johnson's attorneys argued that Monsanto had 'bullied' scientists and fought to suppress negative studies about its product, the federal judge barred Hardeman's lawyers  from discussing Monsanto's alleged influence on research and regulations during the hearings."

Judge Vince Chhabria
Judge Vince Chhabria did, on the other hand, verbally flog the company on a procedural order during the trial by saying, "Although the evidence that Roundup causes cancer is quite equivocal, there is strong evidence from which a jury could conclude that Monsanto does not particularly care whether its product is in fact giving people cancer, focusing instead on manipulating public opinion and undermining anyone who raises genuine and legitimate concerns about the issue."

Despite the latest verdict, Monsanto, which has been bought by Bayer for $63 billion, continues "to argue that Roundup is safe to use and does not cause NHL."

The Hardeman trial is in effect a test case for almost 800 others nationwide that were consolidated. At least six more trials, according to MarketWatch, are expected to start this year in federal and state courts.

Details on other court cases about products that cause 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.

Sunday, March 10, 2019

Stop sugary drinks and lessen your risks 46%

Yale study finds daily diet soda might lower risk of colon cancer recurrence — and death

Drinking diet soda every day can be particularly beneficial for those who've beaten colon cancer.

A new study by Yale University researchers, according to a story by Nyssa Kruse of The Hartford Courant a while ago, found that patients who drank it "were less likely to see a recurrence and less likely to die than those who didn't drink diet soda."

The study analyzed 1,018 patients, determining that "those who drank one or more 12-ounce artificially sweetened drink a day saw a 46 percent improvement in risk."
Dr. Charles S. Fuchs
Kruse's story quotes Dr. Charles S. Fuchs, director of the Yale Cancer Center, as calling the findings "exciting" — after noting that "artificially sweetened drinks have a checkered reputation in the public because of purported health risks that have never really been documented." 

The researchers attributed half the benefit of diet drinks "to patients substituting diet sodas for drinks full of sugar," the Times story indicated.

In a separate cancer study, unrelated to soda, Yale researchers found cancer patients who used complementary treatments (such as yoga, acupuncture and homeopathy) alongside traditional treatments such as chemotherapy "were more likely to die than those only using traditional treatments" — because they'd be likely to refuse a component of traditional treatment.

Details on other cancer research 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.

Saturday, March 2, 2019

Did patients get risky cancer pain drugs?

Documents given to N.Y. Times describe federal failure to block restricted opioid prescriptions

When risky cancer pain drugs were prescribed for patients of other diseases who couldn't tolerate them, the federal government did little or nothing to stop the practice.

That, at least, is the conclusion of  a recent story by Emily Baumgaertner in The New York Times.

Baumgaertner's piece maintains that although the fast-acting class of fentanyl drugs had  been approved only for cancer patients with high opioid tolerance, it was "prescribed frequently to patients with back pain and migraines, putting them at high risk of accidental overdose and death, according to documents collected by the Food and Drug Administration."

The FDA had established "a distribution oversight program in 2011 to curb inappropriate use of the dangerous medication, but entrusted enforcement to a group of pharmaceutical companies that make and sell the drugs," the article asserts.

The Times also notes that "some of the companies have been sued for illegally promoting other uses for the medications and in one case even bribing doctors to prescribe higher doses."

Some 5,000 page of documents were provided the Times after being "obtained by researchers at the Johns Hopkins Bloomberg School of Public Health through the Freedom of Information Act."

The story about the so-called offline prescribing quotes Dr. Andrew Kolodny, an opioid policy researcher at Brandeis University who wasn't involved in the investigation, as saying, "They had the fox guarding the heinous, people were getting hurt — and the FDA sat by and watched this happen."

FDA officials counter that stance by claiming they had only piecemeal data, which "made it difficult for the agency to measure potential harm to patients."

Dr. Janet Woodcock
One official — Dr. Janet Woodcock, the director of the Center for Drug Evaluation and Research at the FDA, was specifically quoted as believing a stricter oversight program "would be 'extremely onerous.'"

She contends, furthermore, that "all drugs have risks and cause harm."

The class of  drugs in question "contain a narcotic up to 50 times stronger than heroin and up to 100 times stronger than morphine," the Times story indicates.

The drugs are expensive. One prescription for a month's worth, Baumgaertner's story says, "can cost more than $30,000."

Details on investigations into other drugs 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.

Monday, February 18, 2019

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 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.

Tuesday, February 12, 2019

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.