Cancer patients, beware of this brutal drug
Desperate measure
When a drug is given fast-track approval, the FDA is signaling that the treatment is so promising it needs to be rushed to market. For desperate patients with advanced cancers, that sounds like a miracle–a “wonder drug” that arrives just in time to answer their prayers.
That’s why some patients thought the FDA was just being cruel when officials recently decided to retract the approval of Avastin for metastatic breast cancer.
Brace yourself–you won’t hear me say this often: This is one case where the FDA got it right.
Many patients who pin their last-ditch hopes on Avastin are being taken for a very expensive, dangerous, and pointless ride.
A little too fast
Last summer, an FDA panel voted 12-to-1 in favor of retracting the agency’s 2008 fast-track approval of Avastin for advanced breast cancer. Now, five months later, FDA officials have agreed that the drug is potentially more dangerous than useful.
And with that, the floodgates of Avastin love opened wide.
Congressmen made impassioned pleas to keep the drug available to breast cancer patients. Thousands of signatures were collected in an online petition to save the drug. And a young man made an emotional appeal in a YouTube video.
But before anyone writes Avastin’s obit, keep in mind that the drug will remain available to treat cancers of the brain, lung, kidney, and colon. So even if the FDA does succeed in the tangled bureaucratic process of retracting the drug’s breast cancer approval, any oncologist will still be able to prescribe the treatment off-label for breast cancer patients.
No problem. Until the bill arrives. When used off-label, Avastin won’t be covered by insurance.
Which brings us to one of Avastin’s biggest drawbacks: The price is obscene. It costs about $88,000 per year. But if your income is less than $100,000 per year, you get a sweet break on the cost: only $57,000 for the year!
That’s one reason Avastin is the world’s best selling cancer drug. In 2009, sales totaled around $6 billion.
Despite the outrageous cost, many oncologists prescribe the drug to about half of all women diagnosed with metastatic breast cancer. So why would the FDA take it away?
In a press release, the agency cited no less than FOUR Avastin trials. Their conclusion: The drug didn’t “prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.”
Which brings us to Avastin’s other huge drawback: side effects.
Check “important safety information” on the Avastin website and here are some of the hideous items you’ll find:
- Gastrointestinal perforation–sometimes fatal (The FDA release notes that perforations may occur in the nose,stomach, and intestines)
- Incomplete wound healing–sometimes fatal
- Serious bleeding in the stomach or brain–sometimes fatal
- Severe high blood pressure that may cause stroke or heart problems–sometimes fatal
- Kidney problems–sometimes fatal
- Vision disturbances–including blindness
And then there’s this bizarre side effect: “The formation of an abnormal passage from parts of the body to another part, sometimes fatal.”
What the…?
So let’s review:
1) Avastin is staggeringly expensive,
2) it comes with a snake pit of nightmarish side effects that are sometimes fatal, and
3) for metastatic breast cancer, the Avastin website states this: “There are no data demonstrating an improvement in disease-related symptoms or increased survival with Avastin.”
In case you missed that, their own website tells you that you shouldn’t expect ANY improvement using Avastin against breast cancer. What else could anyone possibly need to hear?
Sources:
“FDA begins process to remove breast cancer indication from Avastin label” FDA News Release, 12/16/10, fda.gov
“F.D.A. Rejects Use of Drug in Cases of Breast Cancer” Andrew Pollack, New York Times, 12/16/10, nytimes.com
