Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts

Friday, September 4, 2026

'Magic mushrooms' may prevent nerve damage caused by chemotherapy, research on mice finds

Although the latest research on psilocybin was conducted in mice, clinical trials on humans are scheduled to begin this month.

That's a big deal — because the preliminary study found that the hallucinogenic compound known as "magic mushrooms' may prevent nerve damage caused by chemotherapy.

A story by Andrew Jacobs in yesterday's editions of The New York Times says "a study published…in the journal Science makes a compelling case that administering psilocybin shortly before cancer treatments might prevent chemotherapy-induced peripheral neuropathy, a condition that affects about two-thirds of patients who receive chemo."

If the trials are successful, the story claims, "the treatment could revolutionize cancer therapy and improve the quality of life for millions."

Peripheral neuropathy, for which there are currently no effective treatments, "causes pain, tingling and numbness in the hands and feet, and can force patients to scale back or halt chemotherapy when the discomfort becomes too much to bear," he article explains.

For some patients, the pain and discomfort never goes away.

Patrick Dougherty
"The good news," the story quotes Patrick Dougherty a pain medicine researcher at Texas MD Anderson Cancer Center and an author of the study, is that after getting chemo treatments "you're cured of your cancer. The bad news is your hands and feet are going to feel like they're burning the rest of your life. This is not what people want."

Psilocybin, which remains illegal at the federal level, has already shown increasing promise for treating depression, anxiety, end-of-life distress and other mental health challenges," the Times article proclaims.

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.

 

Thursday, August 27, 2026

FDA okays pill that can help pancreatic cancer patients live twice as long as having chemo

The FDA yesterday approved Daraxonrasib, which in a clinical trail had shown that advanced pancreatic cancer patients could live twice as long as those who got chemotherapy.

The drug is poised to transform care for the disease, according to a story by Gina  Kolata, Rebecca Robbins, and Carolyn Y. Johnson in today's editions of The New York Times. Daraxonrasib, the article says, "is not a cure, but it is the first treatment to substantially extend the lives of patients with pancreatic cancer."

The breakthrough drug, which will be sold under the brand name Rasonque, was approved for patients with metastatic pancreatic cancer who already tried chemo.

Dr. Anna Berkenblit
"We've never seen a benefit like this," the story quotes Dr. Anna Berkenblit, chief scientific and medical officer at the Pancreatic Cancer Action Network, an advocacy group for research and patients.

The costly drug, which is taken twice a day, will have "a sticker price of $39,800 a month, or about $478,000 when patients take it for a full year," the Times piece reports. The vast majority of the cost  is expected to be covered through insurance.

Pancreatic cancer kills more than 50,000 people in the United States annually.

The researcher who led the key study, Dr. Brian Wolpin of the Dana-Farber Cancer Institute in Boston, the article notes, "said in an interview that he was stunned by the trial results..."I have not seen anything like [them] before in trials we have run...I just kept repeating, 'Wow.'" 

But Daraxonrasib, the story continues, "often causes side effects like rash, diarrhea, fatigue, and nausea. Several patients who took the drug in clinical trials said the side effects could be harsh."

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.

Saturday, June 13, 2026

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.


Friday, April 24, 2026

Two pancreatic cancer treatments show promise in clinical trials, New York Times maintains

Two experimental drugs are bringing hope to patients with deadly pancreatic cancer.

According to a recent story by Gina Kolata and Rebecca Robbins in The New York Times, clinical trials show promise for daraxonrasib and a personalized vaccine that employs mRNA technology, best known for its use in Covid-19 vaccines.

 

Researchers presented data supporting this conclusion at a San Diego cancer conference, but neither drug has yet been approved for use. Nor has the data “been published in a medical journal or reviewed by regulators,” the article reveals.

 

Pancreatic cancer kills more than 50,000 Americans each year. “Many patients die within a year of diagnosis, and only 13% of people live for five years after being diagnosed,” the piece says.

Dr. Robert Vonderheide
 Kolata and Robbins quote Dr. Robert Vonderheide, director of the Abramson Cancer Center of the University of Pennsylvania, as saying “the statistic that caught everyone’s eye was a doubling of overall survival…To see that effect with a side-effect profile that is manageable unleashed a lot of excitement  in the field.”


Vonderheide wasn’t involved in the new research but is president-elect of the American Association for Cancer Research, the group of oncologists and scientists that hosted the California meeting.

 

Initial findings of the clinical trials were that daraxonrasib gave patients “over 13 months, compared to less than seven months for those who received chemotherapy.”

 

Pancreatic cancer, the story notes, “is different from many other cancers,” Kolata and Robbins maintain. “It is often caught very late, when the disease has already spread widely, because it often presents no early symptoms.…And treatment approaches like immunotherapy that have transformed the outlook for other cancers have not worked for that of the pancreas.”

 

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

 

Friday, December 29, 2023

Small clinical trial shows promise in pancreatic cancer vaccine, story in New York Times reports

Using a vaccine aimed at each patient's tumor may have delayed the return of pancreatic cancer in half of those who received it in a small clinical trial.

According to a story by Benjamin Mueller in editions of The New York Times from a while ago that I just came acrossa study in Nature, "was a landmark in the…movement to make cancer vaccines tailored to the tumors of individual patients."

Dr. Anirban Maitra
Dr. Anirban Maitra, specialist in the disease at the University of Texas MD Anderson Cancer Center, who was not involved in the study, is quoted as saying, "This is the first demonstrable success — and I will call it a success despite the preliminary nature of the study — of an mRNA vaccine in pancreatic cancer. By that standard, it's a milestone."

The study only dealt with 16 White patients who were given the vaccine as part of a treatment that also "included chemotherapy and a drug intended to keep tumors from evading people's immune responses," Mueller's story indicated.

Five years ago, when researchers at Memorial Sloan Kettering Center in New York extracted tumors and shipped samples of them to Germany, the study started. In that country, scientists at BioNTech, the company that made a Covid vaccine with Pfizer, analyzed the genetic makeup of certain proteins on the surface of the cancer cells. BioNTech scientists then produced personalized vaccines "designed to teach each patient's immune system to attack the tumors," the Times story reported.

The piece also quoted Dr. Ira Mellman, vice president of cancer immunology at Genentech, which developed the pancreatic cancer vaccine with BioNTech, as saying, "Just establishing the proof of concept that vaccines in cancer can actually do something after, I don't know, 30 years of failure is probably not a bad thing. We'll start with that."

More information about medical 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, June 17, 2023

Author/N.Y. Times essayist points to possibility of lengthy extended life for cancer patients

A revolution in cancer treatment — involving multiple drugs — may be within the grasp of modern medicine. 

That's what's posited in a guest essay in The New York Times this week by Kate Pickert, author of Radical: The Science, Culture, and History of Breast Cancer in America.  

The author starts off by citing as an example a woman who's been kept alive, despite having metastatic cancer, for nine years by taking "a series of eight drug regimens…including three as part of clinical trials." The patient in question, she reports, "switches from one medication to another when it becomes clear that a treatment doesn't work or has stopped working because her cancer has figured out how to resist its efforts."

This approach, the writer says, "is increasingly becoming a standard of care for patients facing diagnoses that were once death sentences." For those patients, she adds, "cancer is more like a chronic disease than a one-time catastrophic event."

What's happening now is in no way proclaiming that a cure for cancer is imminent, but acknowledging instead that "the landscape for many cancer patients has changed tremendously in just the past five years," her Times essay declares.

Dr. Jedd Wolchok
The article quotes Dr. Jedd Wolchok, oncologist and director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine: "The pace of progress is most certainly accelerating. There are so many things converging."

At the end of her piece, Pickert talks about her own situation (she's had chemotherapy, drug treatment, and radiation for breast cancer) and notes that if her cancer returns, "which is unlikely at this point, I will benefit from a wide array of drugs — many of which were approved in the past five years."

Within 24 hours of the Times column, a story by Katherine Ellison appeared in The Washington Post that totally supports the idea of cancer becoming a chronic, treatable disease. 

That concept alone can lower anxiety, and that relief is crucial for cancer patients who are all too aware that more than 600,000 Americans are expected to die of the disease this year.

Despite that statistic, the Post story proclaims, "even some of the most fearful cancers today are increasingly survivable — provided they're addressed with care and vigilance that may span months to years to a lifetime."

That notion's addressed by positive numbers, the article proffers, explaining that of the 18 million U.S. residents with a history of the disease, "for many of them, cancer has become less an imminent threat than a chronic illness, serious but not necessarily deadly."

More good news? The death rate from all cancers, according to an American Cancer Society report released in January, is down almost a third since 1991.

Ellison's story quotes Lidia Chapira, breast-cancer expert and medical professor at Stanford University: "We're not quite there yet, but we're moving closer to the situation we have with HIV patients, in that today even people with incurable cancers may be living for decades. I'm still treating patients who were diagnosed decades ago, while my colleagues are seeing people in their 50s and 60s who had cancer as children."

Information on newer drugs 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 caregivers. 

Wednesday, November 30, 2022

Clinical trial of new drug for metastatic breast cancer patient shows 'unheard of' survival rates

A new clinical breast cancer drug trial has resulted in "unheard of" survival rates.

According to a recent story by Gina Kolata in The New York Times, for some patients with metastatic tumors that were not significantly affected by other forms of chemotherapy, the treatment halted their cancer's growth.

The findings of a new study, published in the New England Journal of Medicine, might "change how medicine [is] practiced," the article indicates.

Dr. Eric Winer, who was not involved in the study but who is director of the Yale Cancer Center and head of the American Society of Clinical Oncology, is quoted as saying that "this is a new standard of care. It affects a huge number of patients."

The Times piece notes that the new treatment, using an experimental drug (trastuzumab deruxtecan, sold as Enhehru) "that targeted cancer cells with laser like precision" was "stunningly successful, slowing tumor growth and extending life to an extent rarely seen with advanced cancers."

The trial, which focused on a mutant protein known as HER2, involved 557 patients. Tumors in those who took the experimental drug stopped growing for about 10 months, twice the length of those who took only standard chemotherapy. Those patients survived for almost two years, compared to less than a year and a half for those who received standard chemo.

Dr. Halle Moore
"It is unheard of for chemotherapy trials in metastatic breast cancer to improve survival in patients by six months," the story quotes Dr. Halle Moore, director of breast cancer oncology at the Cleveland Clinic, as saying.

Dr. Susan Domchek, a breast cancer specialist at the University of Pennsylvania's Abramson Cancer Center, also is quoted to the effect that she plans to see — even before the Food and Drug Administration approves the drug, which has a wholesale price of about $14,000 every three weeks — if the data from the study will be sufficient to convince insurers to approve it.

More information about successful 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.

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.

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.

Wednesday, April 1, 2020

Doctors cite value of immunotherapy

Lung cancer patients are heavily benefitting from new treatments, Parade magazine reports


A lot of good news has been developing in the past several years about finding and treating lung cancer, according to Parade magazine.

A recent article by Marygrace Taylor suggests that, despite the disease growing for both never-smokers and women, "there's reason to be optimistic."

How so?

"There's been a huge jump in how long people are living with lung cancer," the piece quotes Dr. Nathan Pennell, Cleveland Clinic oncologist, as saying. "It's an extraordinary change."
Dr. Nathan Pennell


The Parade story then goes on to cite the value of such treatments as immunotherapy, which "helps the immune system better recognize and remove cancer cells without necessarily impacting normal cells," according to Dr. Jacob Sands, an American Lung Association spokesman. 

More than 1,000 clinical trials are currently studying how patients "can benefit from checkpoint inhibitors, immunotherapy drugs that block proteins that cancer cells use to stave off attacks from the immune system," Taylor writes.

Pennell adds that "we now know that if you add a checkpoint inhibitor to chemo, people live substantially longer" — and most likely with fewer side effects.

Dr. Jacob Sands
Sands also points to the efficacy of an advanced screening tool like low-dose CT scans, which "catch cancers at earlier stages when they're more likely to be cured."

Another new weapon in the war against lung cancer is stereotactic ablative radiotherapy (SABR), a specialized form of highly targeted radiation "often used to treat patients with early-stage lung cancer when surgery isn't an option."

One recent trial, the article reports, found the treatment "could double survival time without progression of [the] disease."

Finally, advanced bronchoscopy, which uses a lighted tube to examine abnormal parts of the lung just as traditional bronchoscopy does but also utilizes "smaller, more powerful tools" to create 3D maps of patients' lungs and helps doctors access areas that the traditional method can't reach.

More information about innovations in cancer 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 caregivers.

Sunday, November 3, 2019

Help possible for some breast, prostate diseases

Common dietary supplement might be the remedy for a rare genetic mutation that can lead to cancer


Although a rare genetic mutation leads to cancer, a fix may already be available.

According to a recent story by Gina Kolata in The New York Times, "a common dietary supplement may help overcome mutations in the Pten gene."

The real question, the Times asks, is, "Should patients take it?"

And the paper's answer, based on medical personnel that were interviewed, is a qualified yes.

Kolata's article says that the mutation "markedly raises the risk for several cancers, including prostate and breast cancer…as well as autism and schizophrenia in some individuals."

The lifetime risk in carriers, it indicates, is an astoundingly high 85 percent.

In theory, those at risk could help themselves by eating brussels sprouts, broccoli or other cruciferous veggies. The problem is, Kolata reports, to get enough to be of real use, "they'd have to eat a lot: six pounds of brussels sprouts a day — raw."

Instead, a healing compound "is widely available as a dietary supplement" found in local drugstores.

Experts, Kolata adds, "are debating whether to embark on a clinical trial with it."

The Times specifically cites a study published in the journal Science in which "researchers found evidence that a compound called indole-3-cabinol (i3c) blocks an enzyme that inhibits the activity of Pten. With the gene more active, patients with the mutation may be better protected against cancer."

The study, Kolata notes, "was done only in mice and in human cancer cells grown  in petrie dishes."

She explains, further, that although the findings do apply to Pten gene activity, "there is little evidence for most of the other wild claims made for i3c by supplement makers."

Although inherited Pten mutations are rare, striking one in 200,000, the gene also spontaneously mutates in many tumors. "When that happens," the Times piece maintains, "the patient's prognosis is poor."

Dr. Mustafa Sahin
The article quotes Dr. Mustafa Sahin, an expert on the gene at Boston Children's Hospital (who wasn't involved in the work at Beth Israel Deaconess Medical Center in Boston that was the basis for the Journal report), called the research a "tour de force study" whose result was "a paradigm shift in the field [that is] very exciting in terms of its therapeutic implications."

The Times also quotes Dr. Pier Paolo Pandolfi, director of the center who's been trying to find a way to restore Pten activity for years and is the senior author of the paper, as saying about the findings: "We got lucky — or smart."

More information about mutations, especially the BRCA1 and BRCA2 gene, 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, January 26, 2019

'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.

Tuesday, February 28, 2017

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.

Sunday, December 25, 2016

Blacks, Hispanics, Asians lose 'huge advantages'

Minorities underrepresented in drugmaker-sponsored clinical trials on immunotherapy


Cancer patients who are people of color apparently are disproportionately being left out of experimental trials on immunotherapy.

According to a piece by Denise Grady last week in The New York Times, researchers are aware folks getting the treatments "have been overwhelmingly white."

But scientists claim they're trying to remedy the situation.

Some cancer centers are attempting to bring the trials to black, Hispanic and Asian patients instead of making those potential clinical trial participants come to them.

Immunotherapy, which the article calls "the hottest area in cancer research and treatment," involves drugs that help immune systems fight cancer.

The Times piece focuses on two major 2015 studies of "nivolumab, a type of checkpoint inhibitor, one of the most promising drug classes for cancer," and says that "patients taking it [in both tests] lived significantly longer than those given chemotherapy."

In the first case, 92 percent of the patients were white; 88 percent were in the second. Census figures for 2015 show Caucasians make up only 77 percent of the U.S. population.

According to the Times piece, researchers say studies of nivolumab may omit minority patients "because it can take longer to find and enroll them," an obstacle disliked by drug makers such as Bristol-Myers Squibb, which financed the lung and kidney studies of that particular med.

Testers, the Times article notes, claim that one major cause of the problem is that "people in minority groups tend to have lower incomes and less education, and therefore less awareness of medical studies and how to find them."

Another reason may be that many live in areas that don't have easy access to a prime cancer center.

Dr. Julie R. Brahmer
Moreover, the piece goes on to quote Dr. Julie R. Brahmer of the Johns Hopkins Kimmel Cancer Center as saying, "minority patients with cancer are more likely to have other, poorly controlled chronic diseases like diabetes, that make them ineligible for studies."

In addition, some financial hurdles may be impossible to surmount — "frequent trips to the hospital, requiring time off work and expenses for travel, parking and child care. Some doctors simply assume that lower-income, minority patients could not afford it."

The irony, the Times indicates, is that clinical trials, which usually provide expensive drugs and treatments without charge, "can be a lifeline" that offer "huge advantages" such as "new treatments that may otherwise be unavailable."

Information about 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.

Monday, December 5, 2016

Hallucinogen aids 80 percent, two studies signal

Clinical tests of shrooms show psilocybin can ease depression and anxiety in cancer patients


The salient ingredient of "magic mushrooms," it's just been discovered, can ease depression and anxiety in cancer patients.

In a story by Jan Hoffman in last week's editions of The New York Times, two studies of psilocybin are cited.

The hallucinogen, it said, significantly reduced both psychological disorders in about 80 percent of the 80 cancer patients studied.

With minimal side effects.

The response, according to the story, was "sustained some seven months after the single dose."

In both clinical trials, the Times piece indicated, "the intensity of the mystical experience described by patients correlated with the degree to which their depression and anxiety decreased."

The studies, published in the Journal of Psychopharmacology, took place at New York and Johns Hopkins universities.

Psilocybin's been illegal in the United States for more than four decades. But trials of the substance — "for alcoholism, tobacco addiction and treatment-resistant depression" — are underway in both the United States and Europe.

Trials of other illegal drugs are also underway.

Just this week, the Times said, "the Food and Drug Administration approved a large-scale trial investigating MDMA, the illegal party drug better known as Ecstasy, for post-traumatic stress disorder."

Cancer-related psychological distress, "which afflicts up to 40 percent of patients, the story went on, "can be resistant to conventional therapy."

Hoffman's article also stated that "in the 1940s and 1950s, hallucinogens were studied in hundreds of trials. But by 1970, when those drugs were placed in the most restricted regulatory category, research ground to a near halt."

However, "since about 2000, investigators have begun studying them [again], mostly with private funding."
Dr. Stephen Ross
Dr. Stephen Ross, the lead investigator and chief of addiction psychiatry at NYU, was quoted as saying, "Cancer patients with anxiety and depression need help immediately, especially if you consider that they are at elevated risk for completed suicide."

According to the Associated Press, Dr. Roland Griffiths of Johns Hopkins said "it's not clear whether psilocybin would work outside of cancer patients, although he suspects it might work in people facing other terminal conditions."

But Dr. George Greer, co-founder of the Heffter Research Institute, which funded the two studies, apparently doesn't see a commercial use for psilocybin, which is also called shrooms, purple passion or little smoke, "because these patients needed only one dose."

Instead, according to The Times, "he envisions a nonprofit manufacturer, with distribution restricted to specialized clinics."

Details of other cancer-related research can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, have aimed at male caregivers.

Monday, October 24, 2016

Clinical trial on lymphoma is suspended

Cancer researcher's work put into question by his failure to file timely report on deaths


It's no secret that new research can frequently contradict old — even when the latter has only been public for a few days or weeks.

But now comes a new wrinkle: Researchers may be invalidating their work by failing to file appropriate reports.

Or, at best, bringing their tests into question.

Case in point: An early-stage clinical trial sponsored by the National Cancer Institute on an experimental drug, ibrutinib, that involved lymphoma of the central nervous system, a blood cancer that to date had no effective treatment and was often deadly.

According to a story this week by Laurie McGinley in The Washington Post, the lead researcher failed to tell authorities in a timely manner that "two patients had died of fungal infections that might have been caused by the experimental treatment."

That failure, which led to the researcher being suspended "until he undergoes additional training," meant the trial was suspended — despite what McGinley's story called its "impressive results" in which eight of the 18 patients enrolled in the study "continue to be in complete remission, including six whose disease had not responded to previous treatment — a situation that usually causes death within a matter of months."

Dr. Francis Collins
The reporting lapses were reported by Dr. Francis Collins, National Institutes of Health director; Dr. Doug Lowe, NCI director; and other officials.

The study, which was begun in 2013, centered on ibrutinib being used in conjunction "with a cocktail of chemotherapy medications. In addition, steroids were used to reduce swelling in the patients' brains."

The principal investigator, Kieron Dunleavy, had reported concerns — after the second fatality — and "ordered CT scans in other patients in the trial to try to catch fungal infections early, before they became deadly," but he allegedly delayed filing "an official 'unanticipated problem' report" for months.

That kind of report is supposed to be filed within 24 hours of suspecting a problem caused by the treatment.

When the Federal Drug Administration — which regulates trails — learned of the problem, it "conducted a review that concluded there also were several other adverse events that weren't promptly reported," McGinley's story indicated.

Collins said "that it appeared that the combination of ibrutinib and steroids 'seemed to place patients, many of whom have compromised immune systems, at an enhanced risk of infection,'" the article said.

Information on research, and how it often flip-flops, can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a book I, Woody Weingarten, aimed at male caregivers.

Wednesday, December 30, 2015

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."