Health

One Dose, Then Surgery: A New Way to Test Brain Tumor Drugs

Published

11 years ago

January 23, 2015

In this Oct. 24, 2014 photo, Dr. Nader Sanai operates on cancer patient Lori Simons at Phoenix’s Barrow Neurological Institute. The surgery was part of one the most unusual cancer experiments in the nation, testing medicines very early in development and never tried on brain tumors before. (AP Photo/Brian Skoloff)

MARILYNN MARCHIONE, AP Chief Medical Writer

Lori Simons took the bright orange pill at 3 a.m. Eight hours later, doctors sliced into her brain, looking for signs that the drug was working.

She is taking part in one of the most unusual cancer experiments in the nation. With special permission from the Food and Drug Administration and multiple drug companies, an Arizona hospital is testing medicines very early in development and never tried on brain tumors before.

Within a day of getting a single dose of one of these drugs, patients have their tumors removed and checked to see if the medicine had any effect. If it did, they can stay on an experimental drug that otherwise would not be available to them. If it did not, they can try something else, months sooner than they normally would find out that a drug had failed to help.

“They don’t lose any time,” said Dr. Nader Sanai, the doctor leading the study at Phoenix’s Barrow Neurological Institute.

Time is everything for people with glioblastoma, the most common and deadly type of brain tumor, the kind that killed Massachusetts Sen. Edward M. Kennedy in 2009. Even when surgeons think they got it all, the cancer usually grows back and proves fatal. The few drugs to treat these tumors have little effect — median survival is about 14 months.

“We’ve had an endless string of failures” to find better ones, Sanai said.

His study is for people whose cancer came back. Doctors use a stored sample from the original tumor to see if its growth is driven by any genes or pathways targeted by one of the experimental drugs in development. If so, they give that single dose of the new drug before surgery to remove the new tumor.

Then, the tumor tissue is examined under a microscope to see if the drug had its intended effect on the genes or pathways.

So far, the study has tested one drug from AstraZeneca PLC in four patients. Another drug, from Novartis, will be added soon.

“We’re trying to develop a portfolio of these” so there are many possible drugs available for new patients under a single “umbrella” study, Sanai said.

It is called a “phase zero” clinical trial because it comes before the usual three-phase experiments to determine a drug’s safety, ideal dose and effectiveness.

“We view this as a great thing, as something that will produce better drugs that have greater chance of working,” said Dr. Richard Pazdur, cancer drug chief at the FDA.

“Cost potentially will go down and certainly time will go down” for companies testing new drugs this way and patients seeking something that will help, he said.

Finding treatments for brain tumors is “a huge unmet medical need” that justifies trying a new approach, Pazdur said.

Dr. James Doroshow was involved in the only previous studies like this, done at the National Cancer Institute.

In the past, “if you had a new drug, you’d give it to a patient, you’d measure the blood levels, but very rarely would you have a way to know whether the presumed method of action was working in the patient,” he said.

The Arizona study gives a way to check that, because the tumor is removed right after the first dose is given. And if the drug does not work in any or few of the people who get it, the study could spare others a futile treatment, and limit the time and money a drug company invests.

“If you’re going to fail, you want to fail early and fail fast before you put thousands of patients into randomized trials,” Doroshow said.

The experimental drug did not appear to help Simons, a 55-year-old former pharmacist from Gold Canyon, an hour’s drive east of Phoenix. Doctors decided to try an older drug, Temodar, after her surgery in late October.

“The real interest in these kind of trials is not necessarily putting patients on these drugs but keeping them off drugs that aren’t going to work,” said Sanai, who treated Simons.

The patient said she had no regrets about participating.

“It’s a revolutionary trial. I think it will open up a pathway for many other drugs to be studied in this manner,” Simons said. “I go into this with no motive for me. It’s just for the future, people who have cancer like I do, and see what kind of treatments they can have.”

___

Online:

Treatment options for brain cancer: http://1.usa.gov/ZqXBlz

American Cancer Society info: http://bit.ly/UJMhZG

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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Rep. Kamlager-Dove Introduces Bill to Protect Women in Custody After Reports Detailing Miscarriages and Neglect

The Pregnant Women in Custody Act would expand safeguards beyond the federal prison system to include women detained by U.S. Immigration and Customs Enforcement, U.S. Customs and Border Protection and the Office of Refugee Resettlement. The proposal follows reports of pregnant women being shackled, denied medical care and suffering miscarriages while in immigration detention.

Published

4 days ago

May 17, 2026

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By Bo Tefu, California Black Media

Congresswoman Sydney Kamlager-Dove (D-CA-37) on May 7, reintroduced updated legislation aimed at strengthening protections and healthcare standards for pregnant and postpartum women held in federal custody, including in immigration detention facilities.

The Pregnant Women in Custody Act would expand safeguards beyond the federal prison system to include women detained by U.S. Immigration and Customs Enforcement, U.S. Customs and Border Protection and the Office of Refugee Resettlement. The proposal follows reports of pregnant women being shackled, denied medical care and suffering miscarriages while in immigration detention.

The legislation builds on a bipartisan version previously passed by the House during the 117th Congress. The updated bill includes new standards for healthcare access, mental health and substance use treatment, high-risk pregnancy care, family unity protections and increased federal oversight.

“Proper pregnancy care is a human right, regardless of your immigration or incarceration status,” Kamlager-Dove said in a statement. “It’s unacceptable that there are virtually no legal safeguards for pregnant women in federal custody.”

The bill would also limit the use of restraints and restrictive housing for pregnant women, improve data collection on maternal health in custody and require additional staff training and enforcement measures.

Supporters of the measure said the legislation is intended to address long-standing concerns about maternal healthcare and safety in detention settings, particularly for Black women and low-income women who are disproportionately impacted by incarceration and health disparities.

“Pregnant women in custody should never be subjected to dangerous and inhumane treatment that threatens their health, dignity, or the well-being of their babies,” said Patrice Willoughby, chief of policy and legislative affairs for the NAACP and a longtime public policy and government affairs strategist, in a statement.

A 2021 report estimated there are about 58,000 admissions of pregnant women into U.S. jails and prisons each year. Kamlager’s statement also cited a recent investigation by NBC News and Bloomberg Law that identified allegations of severe mistreatment or medical neglect involving at least 54 pregnant women or families in county jails between 2017 and 2024.

Federal policy under the Department of Homeland Security restricts the detention of pregnant, postpartum and nursing immigrants except in extreme cases. However, the agency reported that ICE deported 363 pregnant, postpartum or nursing women between January 2025 and February 2026, including 16 recorded miscarriages during that period.

The bill is cosponsored by several House Democrats and backed by organizations including the NAACP and the Vera Institute of Justice.

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How Is AI Affecting California? The State Wants You to Share Your Story

The program marks the first time the state has opened the platform to all Californians. State officials said the effort is designed to give residents a direct role in discussions about how AI should be regulated and used as the technology rapidly expands across industries.

Published

4 days ago

May 17, 2026

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By Bo Tefu, California Black Media

Gov. Gavin Newsom announced May 7 that California is expanding its Engaged California digital democracy initiative statewide, inviting residents to help shape future state policies on artificial intelligence (AI) and its impact on jobs and the economy.

“We’ve got to be clear-eyed about this moment: AI is moving fast, bringing enormous opportunity, but also real risks,” Newsom said in a statement. “Californians deserve a seat at the table as we shape what’s to come.”

The initiative will roll out in two phases. Beginning immediately, Californians can sign up online to share how AI is affecting their work and communities and provide ideas for possible government action. Later this summer, a smaller group reflecting the state’s workforce demographics will participate in live discussions focused on developing policy recommendations.

State officials said the goal is to identify areas of agreement among Californians and provide policymakers with public feedback as the state develops future AI regulations and workforce strategies.

Engaged California is modeled after digital democracy programs used in Taiwan and is intended to encourage structured public discussion rather than social media-style debate. Officials described the effort as a form of “deliberative democracy” aimed at helping residents engage directly in state decision-making.

“The more Californians are engaged in the democratic process, the better able we’ll be to confront the challenges we face together,” said Nick Maduros, California Secretary of Government Operations, in a statement.

The statewide launch builds on two earlier pilot programs. One pilot gathered public input following the Los Angeles firestorms to help guide recovery efforts, while another collected ideas from state employees about improving government operations.

California has positioned itself as a national leader in AI policy and development. Since 2023, the Newsom administration has introduced initiatives focused on responsible AI use in government, cybersecurity protections, workforce training and regulations targeting risks such as deepfakes and AI-generated robocalls.

The state has also partnered with companies in Silicon Valley — including NVIDIA, Google, Adobe, IBM and Microsoft — to expand AI education and workforce training programs across California schools and universities.

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California Launches Free Diaper Program for Newborns Statewide

The initiative, called Golden State Start, will provide 400 free diapers to every newborn delivered at participating California hospitals beginning this summer. The state is partnering with Baby2Baby, a California-based nonprofit that distributes essential items to children in need nationwide.

Published

5 days ago

May 17, 2026

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By Bo Tefu, California Black Media

Gov. Gavin Newsom announced Friday that California will launch a first-in-the-nation program providing free diapers to families with newborns, part of a broader effort to lower costs for parents and improve infant health outcomes.

The initiative, called Golden State Start, will provide 400 free diapers to every newborn delivered at participating California hospitals beginning this summer. The state is partnering with Baby2Baby, a California-based nonprofit that distributes essential items to children in need nationwide.

State officials said hospitals participating in the program will give families the diapers when they are discharged after birth, helping parents leave with an immediate supply of newborn essentials.

“Every baby born in California deserves a healthy start in life,” Newsom said in a statement. He said the program is part of California’s broader affordability efforts, which also include free school meals, universal preschool for four-year-olds and expanded after-school programs.

The announcement comes ahead of Mother’s Day and is tied to the administration’s broader CalRx initiative, which aims to reduce costs for essential products and medications. State officials said California is also exploring ways to lower diaper prices by challenging high costs from major brands.

The first year of the program will prioritize hospitals serving large numbers of Medi-Cal patients, with plans to expand to additional hospitals and birthing centers over time. Officials said the effort is intended to reduce financial pressure on low-income families and improve infant and maternal health by ensuring parents have access to clean diapers.

“California families deserve to feel supported during one of life’s more exciting, yet vulnerable transitions,” First Partner Jennifer Siebel Newsom said in a statement. She said the program would allow parents to focus on caring for their newborns instead of worrying about basic supplies.

According to Baby2Baby, one in two families in the United States struggles to afford diapers. The organization has distributed more than half a billion items to children over the past 15 years through partnerships with shelters, hospitals, foster care programs and schools.

State officials said Baby2Baby will oversee diaper purchasing, warehousing and distribution through its existing hospital and community partnerships across California.