Genentech Tries New Tack on Shelved Breast Cancer Drug Avastin

This is an article from the San Francisco Chronicle about "a new kind of study" Genentech is going to try with it's discredited drug, Avastin. They will be looking for a DNA profile of patients who have responded to the drug. I bring this to my readers attention because it is an example of the sort of departure from the scientific method we're seeing in medicine. Their evidence from this study would clearly be anecdotal, but since they have deep pockets, they may be able to find something useful there. But it also shows how individual patients who were successfully treated are recruited and interviewed by these companies to make the case for the drugs. We have to remember that these are anecdotal results from these individuals. If a patient had a positive result from homeopathy or laetrile, and stood before congress to plea for insurance coverage for that treatment, they would be laughed out of the theater. Controlled studies are in place for a reason, and we have to willing to accept their results for better or worse even though we're surprised or skeptical as with PSA testing, or antibiotics.
I wrote about Avastin here. Info on my practice here.

Online study of Avastin breast cancer patients

Victoria Colliver

Saturday, April 14, 2012

South San Francisco's Genentech has teamed up with personal genetics company 23andMe for a new kind of study - one that doesn't require patients to find a clinical trial center or make frequent visits to a doctor's office.

The Bay Area companies are initiating an online effort to recruit 1,000 patients with metastatic breast cancer who have taken Genentech's Avastin, a drug that had its approval for breast cancer revoked last year over safety and efficacy concerns.

Genentech officials hope to find genetic markers in those patients that could identify who might respond better to the drug than others. They say the study is not necessarily designed to get the drug back on the market for breast cancer, but to figure out if Avastin helps certain types of breast cancer patients. Such research could ultimately lead to its reapproval...
Critics say the online study appears to be biased toward women who have done well on Avastin, but its sponsors say they're simply trying to find common factors in a large group of patients that could be tested in more traditional clinical trials...

The U.S. Food and Drug Administration revoked its approval of Avastin for breast cancer after studies showed the drug caused life-threatening side effects such as bleeding and heart failure. Studies also found it failed to help patients with metastatic breast cancer live longer...

Please click on the title if you'd like to read the whole article.

Approval for Avastin for Breast Cancer Revoked by FDA

I've been putting off posting about this latest article about Avastin for breast cancer. I find the way that these very loaded controversies are settled very depressing. In the case of Avastin, it looks like in the best case scenario it extends life for 5-6 months at a cost of $88,000 per year. Recent studies show that the life span extension is more like 1-2 months. It also comes with many nasty and dangerous side effects. To lobby against the FDA ruling, Genentech and Roche mount a defense including the impassioned pleas of patients themselves. I get queasy even writing about this. Medicine needs to have studies to evaluate treatments, not anecdotes from desperate patients. It brings up the horrors of cancer and how we want to do anything in reason to help fight it. But we have to balance the evidence with the emotion and it's so incredibly difficult. If patients have been harmed, and their lives shortened, those voices should be out there also or should they? Should we really be deciding drug efficacy issues in the court of public opinion? We have always needed to studies to weed out anecdotal results. It is a sad day when questions in medicine are decided much as in politics, that those with the money have an outsized voice. Science is getting sidelined because money speaks loudest. But those heart breaking voices of cancer patients are so compelling, we all get that...
November 18, 2011

F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug
By ANDREW POLLACK

The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling on an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials. The commissioner, Dr. Margaret A. Hamburg, said that clinical trials had shown that the drug was not helping breast cancer
patients to live longer or to meaningfully control their tumors, but did expose them to potentially serious side effects like severe high blood pressure and hemorrhaging.

“Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing,” Dr. Hamburg told reporters Friday. “This is the case with Avastin when used for the treatment of metastatic breast cancer.”

Avastin will remain on the market as a treatment for other types of cancers, so doctors can use it off-label for breast cancer. But insurers might no longer pay for the drug, which would put it out of reach of many women because it costs about 88,000 a year...

Please go to the link to read the whole article.
Information on my practice here.