Tuesday, August 9, 2022

Bans on abortion are complicating access to drugs for cancer, arthritis, ulcers, other diseases

Some chronically ill women, because of legal bans on abortion, are facing questions about critical medications that could be used to end a pregnancy.

That conclusion is drawn in a story by Katie Shepherd and Frances Stead Sellers in yesterday's editions of The Washington Post.

"The sudden imposition of anti-abortion laws [after the reversal of Roe v. Wade] has left patients, doctors and pharmacists wading through a minefield of treatments and legal and ethical dilemmas related to women's health care — even in situations…that have nothing to do with pregnancy," Shepherd and Sellers write.

Medicines that treat conditions from cancer to autoimmune disease to ulcers, the piece notes, "can also end a pregnancy or cause birth defects and, as a result, "doctors and pharmacists in more than a dozen states with strict abortion restrictions must suddenly navigate whether and when to order such drugs because they could be held criminally liable and lose their licenses for prescribing some of them to pregnant women."

Even if they could show their patients suffer from conditions such as rheumatoid arthritis, the Post story goes on, "some doctors worry they could be prosecuted for prescribing such drugs to a patient with an unintended pregnancy."

Such patients, Shepherd and Sellers continue, "are also at greater risk because they can no longer seek abortions in their home states should they accidentally become pregnant while taking such drugs — no matter how grievous the injuries to the developing fetus."

Dr. Traci Poole
The article quotes Dr. Traci Poole, faculty member at Belmont University College of Pharmacy in Nashville and a practicing pharmacist, as asking, "If you are of childbearing age, are you going to be denied medications that could potentially interfere with a pregnancy?"

The story also says that physicians and pharmacists acknowledge "being blindsided by the speed of changes to state laws," and say they're making change to their practices to protect themselves against liability.

CVS and Walgreens and other major drugstore chains are instructing employees to delay filling prescriptions until they can validate their use to ensure they'll not be used to terminate pregnancies.

The Shepherd-Sellers article also quotes Jack Resneck Jr., president of the American Medical Association, who told federal lawmakers last month that doctors "have been placed in an impossible situation — trying to meet their ethical duties to place patient health and well-being first, while attempting to comply with vague, restrictive, complex, and conflicting state laws that interfere in the practice of medicine and jeopardize the health of patients."

More information about laws and their unintended consequences is available in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Tuesday, July 26, 2022

Women with cancer diagnoses — and docs — face tough choices because top court discarded Roe

Following the U.S. Supreme Court's eliminating abortion rights validated half a century ago in the Roe v Wade decision, pregnant women with cancer diagnoses may face wrenching choices.

Doctors as well are now facing difficult decisions.

That's the conclusion of a recent story by Gina Kolata in The New York Times, which headlines the piece with: "Urgent questions arise about how care of pregnant women with cancer will change in states where women are unable to terminate pregnancies."

Kolata's piece notes that "if the life of a fetus is paramount, a pregnancy can mean a woman cannot get effective treatment of her cancer. One in a thousand women who get pregnant each year is diagnosed with cancer, meaning thousands of women are facing a serious and possibly fatal disease while they are expecting a baby."

Dr. Clifford Hudis
The article quotes Dr. Clifford Hudis, chief executive officer at the American Society of Clinical Oncology, to the effect that "if a doctor can't give a drug without fear of damaging a fetus, is that going to compromise outcomes? It's a whole new world."

The Times story explains that cancer drugs are dangerous for fetuses in the first trimester, and while older chemotherapy drugs are safe in the second and third trimesters, "the safety of the newer and more effective drugs is unknown and doctors are reluctant to give them to pregnant women."

Some 40 percent of women who are pregnant and have cancer have breast cancer, but many other cancers occur in pregnant women: blood cancers, cervical and ovarian cancer, gastrointestinal cancer, melanoma, brain cancer, thyroid cancer and pancreatic cancer.

Moreover, the story says, "women with some types of cancer, like acute leukemia, often can't continue with a pregnancy if the cancer is diagnosed in the first trimester. They need to be treated immediately, within days, and the necessary drugs are toxic to a fetus."

Dr. Eric Winer, director of the Yale Cancer Center, is also quoted: "In my view, the only medically accepted option is termination of the pregnancy so that lifesaving treatment can be administered to the mother."

Some oncologists, Kolata's story continues, "say they are not sure what is allowed if a women lives in a state like Michigan, which has a law that criminalized most abortions but permits them to save the life of a mother."

Dr. N. Lynn Henry
In that regard, still another physician, N. Lynn Henry, an oncologist at the University of Michigan, says that "we can't prove that the drugs caused a problem for the baby, and we can't prove that withholding the drugs would have a negative outcome."

In other words, the story goes on to attribute to unnamed doctors, "complications from pregnancy — a miscarriage, a premature birth, birth defects or death — can occur whether or not a woman with cancer takes the drugs. If she is not treated and her cancer gallops into a malignancy that kills her, that too might have happened even if she had been given he cancer drugs."

A law professor and bioethicist at Harvard, I. Glenn Cohen, projects — according to the story— that "we are putting physicians in a terrible position. I don't think signing up to be a physician should mean signing up to do jail time."

Additional information about chemotherapy 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.

Tuesday, July 19, 2022

New study confirms that breast and brain cancer cells easily migrate to body's 'sweet spots'

Cancer cells do extremely well in body's so-called sweet spots, new research shows.

According to a recent story by Lee Bullen of Zenger News in Newsweek magazine, a group of researchers led by the University of Minnesota Twin Cities have "shed new light on how cancer thrives."

Previous studies, the article says, showed that cancer cells — which can "sense the stiffness of the environment they are in, from hard bone and tough muscle to soft, fatty tissue" — have a sweet spot "of stiffness…where they can move faster."

The latest study, published in the scientific journal "Nature Materials," indicates that the sweet spot is "a just-right Goldilocks spot somewhere in the middle."

David Odds, PhD
Bullen's story quotes David Odde, PhD and professor at the university's Department of Bio-medical Engineering, as saying that "this discovery challenges the current thinking in the field, which is that cells only move toward stiffer environments. I think that this finding will change how people think about this phenomenon."

He added, "We're basically decoding how cancer cells invade tissue, they don't just move randomly. They actually have particular ways in which they like to move, and if we can understand the, we may be better able to trip them up."

The researchers had analyzed both breast and brain cancer.

More research information is available in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Tuesday, July 12, 2022

U.S. judge OKs refunds for customers in suit that says Monsanto masked Roundup's cancer risks

A federal judge has tentatively approved small refunds for customers in a lawsuit accusing Roundup's manufacturer of hiding cancer risks.

According to a recent story by Bob Egelko in The San Francisco Chronicle, buyers of the weed killer in recent years would be eligible for 20% refunds. 

The amount would be minuscule, however — between 50 cents and $33, depending upon the amounts of 19 versions of the herbicide purchased "during a period determined by the statute of limitations in their state."

Gillian Wade
As an example, the story cites California, the state in which the ruling jurist, U.S. District Judge Vince Chhabria of San Francisco, resides. 

There, Egelko's article quotes Gillian Wade, a lawyer for the plaintiffs, as saying, the judgment would mean a refund based on "one product per year for the last five years if they no longer have a receipt or other proof of purchase, and more products if they have such documentation."

The proposed settlement calls for Bayer, the parent company of Monsanto, the giant agribusiness that makes Roundup, to pay between $23 million and $45 million, depending on the claims. Of that amount, the Chronicle story says, "up to 25% would go to attorneys for legal fees and costs, and the rest to customer refunds."

Despite Chhabria's ruling, which seemingly validates the nationwide settlement of the lawsuit accusing Monsanto of false advertising, the company continues to describe the product "as perfectly safe."

Egelko's story notes that Monsanto still cites the weed killer's "approval since 1991 by the U.S, Environmental Protection Agency. But the International Agency for Research on Cancer, an arm of the World Health Organization, classified the herbicide's main ingredient, glyphosate, as a probable cause of human cancer in 2015. And the EPA has now offered to allow California to place cancer warning labels on Roundup sold in the state."

The settlement is separate from the tens of thousands of suits filed against Monsanto and Bayer by people diagnosed with cancer after spraying Roundup, the world's most popular weed killer, on their crops. San Francisco Bay Area juries alone already have awarded damages of $133 million in three of those cases, and just recently the U.S. Supreme Court denied review of Monsanto's appeal of the award to one of the plaintiffs, Edwin Hardeman, a former school groundskeeper in Benicia who was diagnosed with non-Hodgkin's disease in 2015.

Chhabria's ruling, the judge emphasized, doesn't hinder any customer's right to sue for any illness or other harm caused by the weed killer.

He is scheduled to finalize his approval of the refunds in January.

Information on other lawsuits related to 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.

Thursday, July 7, 2022

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.

Tuesday, June 21, 2022

Top U.S. court rejects Roundup maker's appeal of decision that the weed killer causes cancer

The U.S. Supreme Court has let a $25 million verdict against Bayer, parent company of Monsanto, manufacturer of the popular weed killer Roundup, stand. 

The original jury found that Monsanto, the giant agribusiness that manufactures the pesticide, had failed to warn about cancer risks to those using the product.

The top court's decision not to intervene means not only that the decision in the suit brought by Edwin Hardeman, who was diagnosed in 2015 with non-Hodgkin's lymphoma, can remain intact but the way is cleared for thousands of similar lawsuits against Bayer. 

A story by Ann E. Marimow in an edition of The Washington Post this week notes that the "Biden administration had urged the court to deny the company's [stance], a departure from the Trump administration's position."

Hardeman's suit alleged that his use of Roundup for more than two decades caused his cancer and that Monsanto, which Bayer purchased in 2018, failed to warn about the risks associated with the active ingredient, glyphosate.

After an international research group in 2015 classified glyphosate as "probably carcinogenic to humans," the state of California demanded a warning label on Roundup, the nation's most widely used weed killer — in opposition to the Environmental Protection Agency's repeatedly concluding that "glyphosate is unlikely to cause cancer in humans."

Two years ago, according to the story, "Bayer agreed to pay more than $10 billion to settle tens of thousands of potential U.S. claims" but it admitted no wrongdoing. It also said it was moving toward alternate ingredients to "manage litigation risk in the U.S. and not because of safety concerns."

Judge Michelle Friedland
Just days before the Supreme Court ruling about the Hardeman suit, "a separate ruling from the 9th Circuit ordered the EPA to reconsider its finding in 2020 that glyphosate did not pose 'any unreasonable risk to man or the environment,'" Marimow's article reports. As a part of the unanimous decision, Judge Michelle Friedland writes that the Trump-era opinion "was not supported by substantial evidence" and didn't meet the agency's "legal obligations for reviewing environmental impact."

More information on court battles over carcinogenics 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, June 19, 2022

Small study shows that experimental drug makes rectal cancers vanish in 100 percent of the cases

A small rectal cancer clinical trial has had an unexpected result — remission in every patient.

According to a story by Gina Kolata in recent editions of The New York Times, the cancer vanished in each of the 18 patients, "undetectable by physical exam, endoscopy, PET scans or MRI scans." 

Dr. Luis A. Diaz Jr.
Dr. Luis A. Diaz Jr. of Memorial Sloan Kettering Cancer Center, who published a paper on the trial in the New England Journal of Medicine, is quoted as saying he knew of no other study in which a treatment completely obliterated a cancer in every patient. "I believe this is the first time this has happened in the history of cancer" he says.

That view is confirmed by Dr. Alan P. Venice, a colorectal cancer specialist at the University of California, San Francisco, was wasn't involved in the study. That kind of record, he says, is "unheard of."

The patients entered the study with the expectation that they might face chemotherapy, radiation and, most likely surgery that cold result in bowel, urinary and sexual dysfunction — and require colostomy bags. All 18 were pleasantly surprised to find that no such treatments were necessary.

Dr. Andrea Cercek
"There were lots of happy tears," Dr. Andrea Cercek, an oncologist at Memorial Sloan Kettering and a co-author of the paper, is quoted.

The immunotherapy drug the patients were given every three weeks for six months — dostarlimab, a checkpoint inhibitor produced by GlaxoSmithKline, which sponsored the clinical trial — costs about $11,000 per dose. "It unmasks cancer cells, allowing the immune system to identify and destroy them," the story says.

The study's authors indicate that although the earliest patient to complete the trial is more than two years post-treatment, many have only been involved for six months, and all patients will be monitored for at least five years.

Dr. Julie Gralow
A follow-up story by Kim Bellware and Lenny Bernstein in The Washington Post notes that the study's results marked "the first time immunotherapy alone eliminated the need for chemotherapy, radiation or surgery."

The Post story quotes Dr. Julie Gralow, chief medical officer and executive vice president of the American Society of Clinical Oncology, as commenting that "I'm excited when you see such a dramatic response. It gives me hope we can find such a dramatic [treatment] for other cancers, too." 

More information about clinical trials 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.

Monday, June 6, 2022

U.S. government cracking down on false Medicare claims by major health-care outfits

The Justice Department is continuing to investigate false Medicare claims that have apparently padded the pockets of major health-care organizations.

According to a story by Christopher Rowland in yesterday's editions of The Washington Post, the U.S. government maintains those organizations have likely been mining "patient records for outdated, irrelevant conditions to increase profits."

A major culprit, Sutter Health systems, which runs 24 hospitals in Northern California, settled a civil whistleblower lawsuit last year for $90 million that alleged it had submitted false risk codes to get higher Medicare Advantage payment. It did not, however, admit any wrongdoing or liability.

Sutter's aim, the Post story contends, "translated into millions of dollars in inflated bills to the federal Medicare Advantage insurance program." 

Dr. David Terry
Rowland's article quotes Dr. David Terry, a recently retired psychiatrist who worked with in large health organizations in Kansas that aren't part of the lawsuits, as saying that what's been done is "not ethical coding, it's how to code for more money. That pressure is there." 

A whistleblower, Kathy Ormsby, had testified that her work auditing medical case files uncovered the alleged scheme to defraud the government. Sutter supposedly paid her to scour health histories of thousands of elderly Medicare patients and then pressured physicians "to add false diagnoses it found [including cancer and stroke] to their current medical records."

According to Rowland's article, the action, aimed at making patients appear sicker than they were, was often done "without the knowledge of the patients themselves."

Ormsby, the piece continued, "discovered 90 percent of diagnoses for cancer were invalid, as were 96 percent for stroke and 66 percent for fractures."

The government suit against Sutter was filed in U.S. District Court in California as part of a broader government crackdown on abusive billing practices. Sutter is the parent company of Ormsby's former employer, the Palo Alto Medical Foundation, which has 1,600 doctors.

The government still has a similar case against Kaiser Permanente pending — and, the article says, "lawsuits also are playing out in federal arts against UnitedHealth Group, Cigna and Anthem. The government's Office of Inspector General has audited Human and found it overfilled the government."

Kaiser and United Healthcare have denied any improper conduct; the others haven't commented.

Rowland's story talks about byproducts of the abuse. "Patients' medical records, padded with false diagnoses, are inaccurate. That could unnecessarily stigmatize patients who were improperly deemed obese, or malnourished, or mentally ill. It introduces potential phantom influences on treatment decisions, critics say."

More information on abuses in the medical system 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."