FDA Musn't Restrict Freedom to Use Avastin to Fight Breast Cancer

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Simply stating that Avastin "works" and leaving it at that hardly addresses the issue. Any drug must be evaluated by its "therapeutic index," which is to say, its efficacy (how well it works) relative to its safety (its side effects). Clearly, in all its approved indications, not only breast cancer, Avastin has major side effects (even compared to other cancer drugs) because it's an anti-angiogenic agent. It's no secret.
So the FDA's role is upholding a certain standard for what counts as an approvable drug. The agency does not simply approve an agent because "it works" - rather, an agent is approved because 1) it works relatively safely AND 2) that efficacy translates at least into an improved quality of life if not also an increased overall survival.
Unfortunately, patients are desperate to live - (a serious psychological problem that has nothing to do with cancer or any other disease) - and in their desperation they put faith into doctors and medicines. FDA is very right (note my value judgment here) to temper that desperation by saying to patients, in effect, "don't let your desperation cloud your better judgment." It's paternalism sure, but it's for the common good (yes, just like seat-belt laws).
Mr. Dick Turpin

Mr. Dick Turpin of CA 9:27AM June 30, 2011

Avastin cost $80k a year and its manufacturer can not show it works. They only wanted to keep it on the market milking patient dry while they try to test it again, after failing repeatedly. Wrong!
Happy to report the FDA rejected Avestin as a breast cancer treatment. This is the second time they rejected it and it was an unanimous decision. no doubt at all.
http://www.latimes.com/health/la-na-avastin-20110630,0,1645062.story

Ron of IL 11:06PM June 29, 2011

Funny how European regulators looked at the same clinical trial results and had a very different opinion. Things that make you go, hmmm.

steve of CA 8:58PM June 29, 2011

"He’s right. People should be free to choose the medicines they want"
They should also be free to pay for it. I do not want to pay higher insurance premiums to my insurance company so that they can pay for a drug that does not work.
That a drug works for a tiny percentage of patients is unimpressive as an argument. Placebo also works for a tiny percentage of breast cancer patients. In fact, it works just as well as Avastin.
People have the right to pay for and use their Avastin. That right has not been taken away today, and will never be taken away in the case of Avastin. FDA has protected my right to not waste my money. FDA has also protected the right of every single American taxpayer to finance a therapy that does not work through Medicare.
There is nothing wrong with the cost of Avastin. Our payments for Avastin finance the research of new and improved drugs these breast cancer patients hope to live long enough to take. These payments also reward successful scientists and businessmen and provide an incentive to use their time in drug development rather than investment banking.
There is no such thing as "free" treatment. If you want your wife to take Avastin on the off chance that she will survive even though all the data suggest that all benefit she will derive is consistent with taking a sugar pill, by all means pay for it. Do not, however, ask me to do the same.

tsauhr of MA 6:23PM June 29, 2011

The FDA absolutely has the right to review the impacts of drugs after they have been approved. Avastin was initially approved for non small cell lung cancer and pancreatic cancers, and then expanded to other metastatic cancers, renal, brain and breast. With the knowledge that the risks are greater than the benefits, FDA needs to act.
Yes, I understand the devastation that current Avastin users must be feeling. I currently take Avastin for stage IV lung cancer and count on this drug for suppression of cancer growth. But if it meant that I would likely have fatal side effects I would expect FDA to reverse their approval decision.
If traditional chemo works just as well with fewer side effects, why are breast cancer patients willing to take the risk of fatal side effects of Avastin?

A Baker of IL 8:12AM June 29, 2011

Avastin has been proving to be worthless and the FDA need to do the responsible thing to protect citizens from getting ripped off by big pharma swindles.
This drug is failing in the test of free markets, it doesn't work. So all the kings men and all the kings PR slush funds can't put humpty-dumpty back together again. Apparently drug companies can buy advocacy hacks and trolls to promote their schemes, but we need to FDA to stand up for us, not for the pharma industry profits. Funny how some conservatives who profess capitalism are always trying to use government to pick winners because they get paid to bulldog for some company.
Big drug companies are bankrupting our healthcare system with overcharging for bogus drugs, all while we are showering drug companies with enormous subsidies like Medicare Part D. Time to stop the madness and this likes like a good place to draw the line.
If these complainers were so concerned about breast cancer then fight Republican efforts to kill womens clinics that are major providers of breast exams.

Ron of IL 9:37PM June 28, 2011

You write “The FDA has urged Roche to find a way to identify women who will benefit from the treatment. Allowing the drug to become a mainstream treatment for breast cancer, knowing that many will die from the treatment itself, is a terrible disservice to the patients.” Of course FDA wants company to “identify women who will benefit from the treatment and not be killed by treatment.” That’s in the perfect world. Company wants that.There is not perfect world for many with terminal cancer. Patients facing Imminent death listen to best alternatives to save their life from their Doctor and decide what choices they wish to make.
I have no idea if FDA will outlaw the drug. I kind of doubt it. AZT in a similar situation was approved. All the safeguards of warning the patients were observed. Warning that some will die from drug. Persons with AIDS DEMADED drugs and did not want to wait for better choices on who should receive the drug. Death was at the door.
I suspect FDA will look at the record. Was life prolonged ? Did benefit for terminal ill patients out weigh those who died of drug. Is possible stronger statements must be given to patients. Updated known statistics. MAYBE the record will show 1 in a 100 will die earlier than expected. As opposed to X number will live longer by Y perid of time. Decision is much more complicated than as you say, “ knowing that many will die from the treatment itself, is a terrible disservice to the patients.” Drugs are suspended when change from the believed results occur. I don’t know that data. You have not shown me that data. FDA will evaluate the data and make their decision. Your comment certainly does not persuade me. My late cousin would be begging for Avastin. Knowing drug could kill her. Knowing there is no other chance to prolong her life.

Bill Hedges of MO 3:12PM June 27, 2011

The trials showed clearly that about 1 in each hundred women treated with Avastin for breast cancer will die from the Avastin. And there's no clear benefit from the Avastin treatment. This week's hearing will air testimonials from survivors who think they've been helped. The question is whether anecdotes will trump data.
This editorial is horribly uninformed. For the facts, here is the FDA's report from last summer:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM237171.pdf
And this is the transcript from the FDA's meeting with Roche last summer:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM221998.pdf
The FDA has urged Roche to find a way to identify women who will benefit from the treatment. Allowing the drug to become a mainstream treatment for breast cancer, knowing that many will die from the treatment itself, is a terrible disservice to the patients.

T. Jefferson of PA 1:38PM June 27, 2011

Drugs go through different phases in clinical trials to get approval for use. Cost can be $$$250,000,000 - 750, 000,000 or More. With no assurance it will ever meet the standard to pass.
I would not hazard a guess the amount of R & D that Amgen has spent on "lepid." They have worked on it before 1985. Well pass $$$ 1 billion am sure...

Bill Hedges of MO 9:44AM June 27, 2011

Put on your critical thinking caps folks and read the lines.
1.)
PETER ROFF FDA Musn't Restrict Freedom to Use
Avastin to Fight Breast Cancer because the value of Avastin stock will go down.
2.)
It was refreshing to read Mr Roff's
Avastin commercial and not have to read about all the nasty side effects in small print. I hope US News will bring us more commercials like this that pose as journalism.

Sam Seederly of CT 4:17AM June 27, 2011