Image source: (Bloomberg/Baltimore Sun)


BYJENNIFER MECKLES

 

You're watching multisource health news analysis from Newsy.



Breast-cancer patients and doctors hoped Avastin would be a miracle treatment.

But since its debut on the market three years ago -- the FDA has been skeptical.

This week, a panel voted unanimously to revoke approval of the drug -- here’s ABC:

“Avastin is the best selling cancer drug in the world. The FDA panel ruling, which came down in the last hour clear away for the government to remove its endorsement of the drug. The panel claims the drug is ineffective in fighting breast cancer. However, doctors, patients, and the drug’s maker says it improves patients’ quality of life.”

The chemotherapy drug - created by Genentech -- is still approved to treat many other cancers -- including colon, lung, kidney and brain. NBC’s Brian Williams explains what the panel’s ruling means for metastatic breast cancer patients:

“The side effects can be unsafe for breast cancer patients. Avastin is still approved treat other forms of cancer, but this means now insurers wont pay for it as a breast cancer treatment.”

Stealing the headlines in this story -- patient reaction. Cancer patients and their families protested before the hearing and gave emotional testimony during it. At the heart of the debate? CNN reports -- money.

“The debate is highly charged. Some patients have accused the FDA of letting Avastin’s high cost – as much as $88,000 for a year – cloud its judgment. By regulation, the agency is not permitted to consider cost when it evaluates the safety and effectiveness of any treatment.”

CBS spoke to a woman who will be forced to make huge sacrifices to afford treatment:

“As far as future treatment goes - if the insurance companies decide they’re not going to cover Avastin, my husband tells me we’re going to have to sell our house. But I don’t really want to do that if I don’t I have to.”

Avastin was first introduced in 2008, and earned a fast track approval by the FDA for its seemingly successful results. Not until later did the agency deem it unfit to treat cancer.

The FDA says Avastin doesn’t extend life-- but doctors argue it does provide better quality of life. Both parties agree the side effects are serious enough for consideration. (Video: WPTY)

Cure Today says -- fast approval, then a quick revoke -- is evidence the process of testing new cancer agents is changing:

“It is now necessary to define predictive factors at the same time a drug is initially being developed. Not only is FDA approval in jeopardy, but drug companies can no longer afford the cost of huge trials to show a tiny difference in outcomes.”

Avastin is still approved for use overseas by the European Commission. And Reuters reports -- a spokesperson for Medicaid says that insurer will continue to cover the drug. FDA Commissioner Margaret Hamburg will make the final decision about Avastin -- that’s expected in late July.

 

'Like' Newsy on Facebook for updates in your news feed

Get more multisource video news analysis from Newsy

Transcript by Newsy

Sci/Health News: FDA Revokes Avastin

FDA Panel Doesn't Back Popular Cancer Drug

June 30, 2011
(2:49)
A Federal Drug Administration panel has cleared the way for the government to remove its endorsement of the drug Avastin.
   
TRANSCRIPT

To leave a comment, please log in with Facebook Connect or your Newsy account. Register here to create one.
MOST RECENT|MOST POPULAR|MOST COMMENTED|HIGHEST RATED

Video from Google's Project Glass Released
Google released the first video from its Project Glass reality headset.
(1:15)
May 26, 2012
Top News Headlines: At Least 90 Dead in Syrian Attacks
More headlines: Drone strike kills suspected militants; Shooting spree in Finland; Pope's butler arrested.
(1:21)
May 26, 2012
Facebook Looking to Build Own Browser?
The social media giant may be interested in acquiring Opera Software, and grabbing their own browser in the process.
(1:29)
May 26, 2012
Nearly One Third Of Olympic Tickets Remain Unsold
Nearly a third of the London 2012 Olympic event tickets remain unsold.
(1:29)
May 26, 2012
Skydiver Survives Jump Without Parachute
A video of Gary Connery skydiving from 2,400 feet in the air without a parachute has gone viral.
(2:40)
May 26, 2012
15-Year-Old Boy Invents New Way to Detect Cancer
A 15-year-old Maryland boy won a $75,000 prize for inventing a dipstick sensor that can detect pancreatic cancer.
(1:53)
May 26, 2012
Prehistoric Flutes Date Back 40,000 Years
When scientists reanalyzed prehistoric artifacts from Germany, they discovered modern humans may have been in Europe earlier than previously thought.
(1:43)
May 26, 2012
Private Spacecraft Docks with International Space Station
SpaceX successfully docked its Dragon capsule into the International Space Station.
(2:40)
May 25, 2012
Bankia Suspends Shares; Multibillion Euro Bailout in Future?
The Spanish bank halts trading of its shares in advance of a board meeting. Bankia is expected to request a major bailout from the government.
(2:10)
May 25, 2012
Top News Headlines: Police Find Mother of Kids Left in Shed
More headlines: FBI identifies man in Miami plane incident; Hurricane Bud headed toward Mexico; Wall Street analysts look at Facebook's flop.
(1:24)
May 25, 2012
Exonerated Former Football Star Asks for Second Chance
After Brian Banks' rape conviction from 2002 was dismissed, he's asking NFL coaches for a chance to prove himself on the field.
(1:20)
May 25, 2012
Ukrainian Lawmakers Brawl Over Language Bill
A Ukrainian Parliament session erupted into a boxing match over the proposal to make Russian the official language of the eastern region.
(1:13)
May 25, 2012
Average Salary for CEO: $9.6 Million
According to an analysis from The Associated Press, the average salary for the head of a public company was $9.6 million in 2011.
(2:28)
May 25, 2012
Egyptian Election Pacing Toward Secular-Religious Showdown
Muslim Brotherhood candidate Mohamed Morsi and former air force chief Ahmed Shafiq poised to face off in second round.
(2:02)
May 25, 2012

Newsy

www2