FDA Declares Cancer Drug, Avastin, Unsafe




Unprecedented FDA vote declares Avastin, the world’s best-selling cancer drug, UNSAFE
Last updated at 3:27 AM on 30th June 2011

Comments (0)
Add to My Stories

Unsafe? The FDA has held a shock vote against Avastin, the blockbuster cancer drug

A shock vote has seen a panel of cancer experts rule that Avastin, the best-selling cancer drug in the world, should no longer be used in breast cancer patients.

The unprecedented vote by the Food and Drug Administration (FDA) clears the way for the government to remove its endorsement from the drug.

The advisory panel’s comes less than a year after the same panel reached the same conclusion.

The six members of the FDA oncology drug panel voted unanimously that Avastin is ineffective, unsafe and should have its approval for breast cancer withdrawn.

‘I think we all wanted Avastin to succeed but the reality is that these studies did not bear out that hope,’ said Natalie Compagni-Portis, the lone patient representative on the panel.

The vote is not binding and FDA Commissioner Margaret Hamburg will make the final decision sometime after July 28.

The drug is approved for multiple cancers and will still be available for breast cancer, though insurers are expected to drop coverage if it loses FDA approval.

The FDA began steps to remove Avastin’s breast cancer approval in December, but Roche took the rare step of appealing that decision and lobbied the agency and Congress for a second hearing.


If you scroll down on the left side, there is an article and you can click on it. BUT, there is no direct link. ?]

So, anyway, here is the article:

not dated, but appears to be July 1, 2011

YESTERDAY by ■ Michael Krebs - comments

Op-Ed: An FDA Avastin rejection is a window on Obamacare redistribution

The FDA’s pending rejection of the late-stage breast cancer drug Avastin offers a window on an Obamacare wealth redistribution, effectively putting less value on sick American women than on people in foreign nations receiving US monetary or military aid.
According to a Reuters report on Wednesday, the cumulative cost of the wars in Iraq, Afghanistan and Pakistan to the American taxpayer is estimated at $3.7 trillion and climbing. These wars are effectively investments by the US government in the future security of these nations, and similar investments are being made in Libya and Yemen currently.

Similarly, according to Vaughn’s Summaries, the United States continues to commit monetarily to foreign governments, with Israel and Egypt consistently receiving billions. In 2011, the US government has pledged fresh financial support for Tunisia, Egypt, Pakistan, and Libya.

Additionally, the US military operates large non-combat bases in Japan, South Korea, Germany, Eastern Europe, and the Middle East.

These foreign investments exist, and have existed, throughout the financial crisis that has decimated the US economy over the past few years, a period of time known as The Great Recession. The US national debt is broadly seen as unsustainable, and US politicians in both political parties are now openly discussing the demise of many entitlement programs common to American citizens.

Social Security and Medicare are on the chopping block, but foreign monetary and military aid is not.

And now the prospect of health care rationing under President Obama’s health care legislation has just this week presented itself.

Avastin is a late-stage chemotherapy drug for women in the final throes of breast cancer. It is a drug that represents experimentation and innovation in medicine and that offers a frontier understanding of what is possible in modern biochemistry.
However, according to the Washington Post, Avastin costs roughly $88,000 per year per patient to administer.

It has been argued by the US Food and Drug Administration panel of “experts” that Avastin poses more of a danger than it does a benefit. Yet, The American Spectator notes that Europe’s similar governmental body of health experts, the European Medicines Agency, came to a remarkably different conclusion, recommending that Avastin treatment be expanded.

The FDA and EMA recommendations on Avastin represent very divergent conclusions. European women hold more value to Europe’s government agency than American women hold to the US federal government.

Great societies are judged to be great by the manner in which they treat their women and children.

The Avastin rejection is a health care rationing issue, and it is a decision made on financial grounds. This is Obamacare’s ugly underbelly, and it is real.
The Avastin rejection is a death sentence for women who need more than hope. The rejection of this drug in the backdrop of US investment elsewhere around the world is an effective way of saying quite loudly that the rest of the world’s citizens matter more than our own women.

An American woman is not worth $88,000 a year, but trillions can be distributed elsewhere.

Read more: digitaljournal.com/article/308614#ixzz1Qzs05aY4

An FDA Panel Is Deciding Life or Death For My Wife
December 16, 2010 will forever be the day that changed my life. I had just received a news flash across my monitor that the FDA had confirmed its advisory panel’s decision to ”de-label” the drug Avastin for breast cancer patients. The practical implication of this was that my wife Arlene was now at mortal risk.
My wife has stage IV or metastatic breast cancer. This is an incurable disease that claims the life of a woman every 14 minutes. A reported 17,500 women take Avastin for metastatic breast cancer and my wife is one of them. As Avastin is a unique drug that works by cutting off blood flow to tumors, we believe that the drug is saving my wife’s life and taking Avastin away is tantamount to a death sentence.
I picked up the phone to call my wife and tell her the news. When she answered, I was too choked-up to speak. The next five minutes were some of the worst moments of my life as I told my wife that bureaucrats in Washington were deciding to take away a drug that was keeping her alive.
I read a mountain of reports about the FDA’s Avastin decision and it become clear that it was corrupted with procedural problems (the Wall St. Journal referred to it as “rigged”), rendered almost meaningless by poor science and tainted by the bad faith of the FDA, which had moved the goalposts for approval of Avastin, almost after the game had been played.
(read the rest of this heart-rending story at the link)

In the US, Medicare and Medicaid are likely to continue coverage of Avastin, although private insurance may choose otherwise.

The FDA decision, when it comes, does not affect CMS," Don McLeod, a spokesman for the Centers for Medicare and Medicaid (CMS), told Reuters. “The drug will still be on the market, doctors will still be prescribing it, and we will continue to pay for it.”

Will private insurers follow CMS’ lead? A WellPoint Inc. spokeswoman said it would not drop support for patients already taking Avastin and is unlikely to disrupt coverage for new patients, according to Reuters.

Avastin is prohibitively expensive, costing about $8,000 a month, the Los Angeles Times reported.


Avastin will still be available in the US, and will likely be covered by private insurance for many cancers. However, if the FDA approval for breast cancer is withdrawn, private insurers may not pay for that use of the drug.

Outside advisers to the Food and Drug Administration voted 6-0 against Avastin’s use in breast cancer at a first-of-its-kind hearing in Silver Spring, Md. Their recommendations will be sent to FDA Commissioner Margaret Hamburg, who will make the final ruling on an unspecified date. Avastin will remain on the market because it’s approved for four other types of tumors.

The decision capped two days of testimony from patients urging the panel to continue access while FDA scientists argued the drug is too dangerous. A final ruling is at least weeks away while the agency takes comments from the public through July 28. Doctors can prescribe Avastin “off label” in breast cancer even if approval is withdrawn, though insurers may no longer pay the $8,100-a-month price tag.


Anybody interested in whether the FDA was correct in de-labeling Avastin, you facts and stuff? Or just “heart-rending stories”?

from Wikipedia:

Adverse effects

Bevacizumab inhibits the growth of blood vessels, which is part of the body’s normal healing and maintenance. The body grows new blood vessels in wound healing, and as collateral circulation around blocked or atherosclerotic blood vessels. One concern is that bevacizumab will interfere with these normal processes, and worsen conditions like coronary artery disease or peripheral artery disease.[28]
The main side effects are hypertension and heightened risk of bleeding. Bowel perforation has been reported. In advanced lung cancer, less than half of patients qualify for treatment.[29] Posterior reversible encephalopathy syndrome,[30]nasal septum perforation, and renal thrombotic microangiopathy have been reported.[31] In December 2010, the FDA warned of the risk of developing perforations in the body, including in the nose, stomach, and intestines.
These effects are largely avoided in ophthalmological use since the drug is introduced directly into the eye thus minimizing any effects on the rest of the body.
edit] Costs

Bevacizumab is one of the most expensive drugs widely marketed. In 2008, sales of Avastin generated nearly $2.7 billion for Genentech.[32] Both physicians and the media have criticized the high cost of a drug that doesn’t cure cancer*citation needed] but only prolongs lifecitation needed*]. In the U.S., many insurance companies have refused to pay for all or part of the costs of bevacizumab. In countries with national health care systems (such as the UK and Canada), many of those national health services have restricted its use because of its extraordinarily lop-sided cost-benefit ratio; in the U.K., for example, the National Institute for Health and Clinical Excellence has taken the public position that bevacizumab should be taken off the market because it costs nearly £21,000 per patient but has only limited usage in cancer treatment because it merely extends life rather than providing a cure.[33]


Consider the recent avalanche of news stories about the FDA’s two-day hearing on Avastin for breast cancer. Nearly every story included respectful, uncritical and often fawning coverage of the patients who spoke at the hearing and who demonstrated outside the hearing. They all said the same things: Avastin saved my life. I wouldn’t be here without Avastin. I demand the right to choose Avastin.

If it were scientists making these claims the reporters (or at least the good ones) might ask them some hard questions: what is the evidence for your claim? How do you know the drug saved your life? They might even point out that for every person standing there being interviewed there might be many more unable to give interviews because they were dead. They might point out (and educate their readers along the way) that anecdotes are not evidence.

Now I have no idea whether Avastin is the greatest thing since ice cream or maybe it should never been approved in the first place.
But these trashy articles certainly don’t provide any enlightenment.

I do suspect that a drug that keeps patients alive w/o curing them at $100K/yr has to be every drug company CEO’s dream. No doubt the first shot is free.

If Avastin is so easy to make that it creates huge profits, then it should be pretty easy to come up with a substitute that is cheaper.

Any geniuses out there to take on the challenge?

Here is a starting point: Avastin works by cutting off the blood supply / supply of nutrients to tumors. That process … of cutting off the blood supply … is called “antiangiogenesis”.

So, you can look up antiangiogenesis and start from there.

I will give you a second clue: a lecture by an M.D. named Judah Folkman

In fact, here is the lecture:


Dr. Folkman showed us a door to the future of medicine.

Now, it is up to the next generation to continue his work.

DISCLAIMER: The views and opinions expressed in these forums do not necessarily reflect those of Catholic Answers. For official apologetics resources please visit www.catholic.com.