Please ensure Javascript is enabled for purposes of website accessibility
US Aims to Help More Cancer Patients Try Experimental Drugs
gvw_ap_news
By Associated Press
Published 5 years ago on
June 3, 2019

Share

CHICAGO — Sally Atwater’s doctor spent two months on calls, messages and paperwork to get her an experimental drug he thinks can fight the lung cancer that has spread to her brain and spine.

“We are here to help. We are not here to make a drug company give a specific drug to a patient. We don’t have that authority.” — Dr. Richard Pazdur, Food and Drug Administration
Nancy Goodman begged eight companies to let her young son try experimental medicines for a brain tumor that ultimately killed him, and “only three of the companies even gave me a reason why they declined,” she said.
Thousands of gravely ill cancer patients each year seek “compassionate use” access to treatments that are not yet on the market but have shown some promise in early testing and aren’t available to them through a study.
Now the government wants to make this easier and give more heft to the requests. On Monday at a cancer conference in Chicago, the Food and Drug Administration announced a project to have the agency become the middleman.
Instead of making doctors plead their case first to companies and then to the FDA if the company agrees to provide the drug, the FDA will become the initial step and will assign a staffer to quickly do the paperwork. That way, when a company gets a request, it knows the FDA already considers it appropriate.
“We are here to help. We are not here to make a drug company give a specific drug to a patient. We don’t have that authority,” said Dr. Richard Pazdur, the FDA official leading the effort. But the agency gets little information now on how many requests are turned down and why.
The current system also is cumbersome and sometimes unfair, he said. Patients in rural or inner city areas or at community hospitals that lack staff to work on special requests may be disadvantaged. Social media campaigns can add to the inequity.

Advocate Says FDA Has Not Been the Problem

“We do not want to have the situation where somebody who screams loudest gets the drug” and other worthy candidates don’t, Pazdur said.
The project only involves drugs for cancer, not other diseases. It has nothing to do with the federal Right to Try law passed last year, which many have called “right to ask” because it only allows patients to request a drug from a company under certain circumstances and does not mandate that it be provided.
The new FDA project is “absolutely going to change things” and push more companies to say yes, Goodman said. She founded an advocacy group, Kids v Cancer, after her son Jacob Froman died in 2009 at age 10.
The FDA has not been the problem, she said. It keeps a website with links to companies’ policies and contact information for patients, and has quickly approved the vast majority of these requests whenever a company has granted access.
That’s what happened when Dr. Chul Kim, a lung specialist at Georgetown Lombardi Comprehensive Cancer Center, made his first attempt to get compassionate use for a patient, in this case to help Atwater, whose cancer was spreading despite usual treatments.
“I felt there was an urgent need to switch therapy,” and early results suggested the experimental drug could get into the brain, which many therapies can’t do, and fight the cancer there, Kim said.
He started the process in early February and ultimately got Atwater the drug in late March.

‘Giving Me Space’ in Life with Cancer

“I have other patients and I needed to carve out time for this,” and was fortunate to have staff that had been working with the company on a study who could help, Kim said. Once the company agreed, it took the FDA only a day to do the same.

“It requires quite a bit of work [usually at least 24 hours over several weeks]. A lot of people have to drop what they’re doing to get all that done.” Dr. Ajai Chari, Mount Sinai’s Tisch Cancer Institute
“It requires quite a bit of work,” usually at least 24 hours over several weeks, said Dr. Ajai Chari at Mount Sinai’s Tisch Cancer Institute in New York where dozens of patients have gotten compassionate use access over the last decade. “A lot of people have to drop what they’re doing to get all that done.”
Chari just did it for Michael Walsh, a 58-year-old musician from New York City, who has had myeloma since 2011.
“He’s exhausted all approved FDA therapies,” including 13 types of chemotherapy, Chari said. Within a few weeks of starting on the experimental drug, Walsh had a dramatic reduction in his cancer.
“I’m working, doing things,” Walsh said. “It is giving me some space to have the cancer be under control.”
Atwater, the 68-year-old Washington woman treated at Georgetown, is hoping for the same from her experimental drug. She said she asked her sister who had breast cancer how she might be able to tell if the treatment was working.
“She said, ‘You’re still here, aren’t you?'” Atwater said. “I think it’s worth the risk. At least I hope it is.”

DON'T MISS

CA Home Prices Near $1 Million Average. What do Central Valley Homes Cost?

DON'T MISS

American Airlines Retreats After Blaming a 9-Year-Old for Not Seeing a Hidden Camera in a Lavatory

DON'T MISS

Explorers Find What They Believe Is World War II Ace Richard Bong’s Downed Plane in South Pacific

DON'T MISS

Giants Rally From a Big Deficit Again and Spoil a Solid Start by Paul Skenes in 7-6 Win Over Pirates

DON'T MISS

This Sweet Tradition Is Sure to Bring Out the Crowds at Fresno State’s Farm Market

DON'T MISS

Long-Term Mortgage Rates Ease for Third Straight Week, Dipping to Just Below 7%

DON'T MISS

General Sherman Passes Health Check but World’s Largest Trees Face Growing Climate Threats

DON'T MISS

Sheriff’s Memorial for Fallen Officers: In Valor There Is Hope

DON'T MISS

Charlie Colin, Founding Member of Train, Dies at 58 After Slipping in Shower

DON'T MISS

Cavaliers Fire Coach J.B. Bickerstaff Despite Making Second Round of Playoffs

UP NEXT

Portland Nurse Returns Home After Treating Gaza Burn Victims

UP NEXT

RNC HQ Evacuated: Blood Vials Addressed to Trump Prompt Security Alert

UP NEXT

Ex-Employee Kills 2, Injures 3 in Suburban Philadelphia Linen Company Shooting

UP NEXT

Search and Rescue Ongoing After Iowa Tornado; 1 Dead

UP NEXT

How the Beatles Empowered a Research Genius to Save Millions of Lives

UP NEXT

Petrochemical Company Fined $30M for 2019 Houston Explosions

UP NEXT

Biden Releases 1 Million Barrels from Northeast Reserve to Lower Gas Prices

UP NEXT

UN Security Council Rejects Russia-Backed Resolution on Banning Weapons in Space

UP NEXT

Why US Catholics Are Planning Pilgrimages in Communities Across the Nation

UP NEXT

Extremists Reign in Israel After Decades of Unchecked Violence

Giants Rally From a Big Deficit Again and Spoil a Solid Start by Paul Skenes in 7-6 Win Over Pirates

2 hours ago

This Sweet Tradition Is Sure to Bring Out the Crowds at Fresno State’s Farm Market

2 hours ago

Long-Term Mortgage Rates Ease for Third Straight Week, Dipping to Just Below 7%

2 hours ago

General Sherman Passes Health Check but World’s Largest Trees Face Growing Climate Threats

2 hours ago

Sheriff’s Memorial for Fallen Officers: In Valor There Is Hope

3 hours ago

Charlie Colin, Founding Member of Train, Dies at 58 After Slipping in Shower

4 hours ago

Cavaliers Fire Coach J.B. Bickerstaff Despite Making Second Round of Playoffs

5 hours ago

Carr Brothers Donate $250K to Valley Children’s Hospital

5 hours ago

Cal Chamber’s Job Killer List Shrinks, but Does Its Influence?

5 hours ago

Supreme Court Finds No Bias Against Black Voters in a South Carolina Congressional District

6 hours ago

CA Home Prices Near $1 Million Average. What do Central Valley Homes Cost?

Even in the face of high interest rates, buyers are still going after homes and statewide prices have reached record numbers. In April, the ...

23 mins ago

23 mins ago

CA Home Prices Near $1 Million Average. What do Central Valley Homes Cost?

60 mins ago

American Airlines Retreats After Blaming a 9-Year-Old for Not Seeing a Hidden Camera in a Lavatory

1 hour ago

Explorers Find What They Believe Is World War II Ace Richard Bong’s Downed Plane in South Pacific

2 hours ago

Giants Rally From a Big Deficit Again and Spoil a Solid Start by Paul Skenes in 7-6 Win Over Pirates

2 hours ago

This Sweet Tradition Is Sure to Bring Out the Crowds at Fresno State’s Farm Market

2 hours ago

Long-Term Mortgage Rates Ease for Third Straight Week, Dipping to Just Below 7%

2 hours ago

General Sherman Passes Health Check but World’s Largest Trees Face Growing Climate Threats

3 hours ago

Sheriff’s Memorial for Fallen Officers: In Valor There Is Hope

MENU

CONNECT WITH US

Search

Send this to a friend