FREEDOM OF ACCESS TO MEDICINES NEWSLETTER #10
June 28, 2011
FDA Avastin Hearing Begins Today!
FAMEDS will be following the Protest, Hearing and media session on Capitol Hill every step of the way, starting at 7am EST Tuesday & Wednesday! Please continuously check our Twitter account, Facebook page and Website for News as it happens!
AVASTIN IN THE MEDIA
Hearing May Be End of Road for Breast Cancer Drug
via ABC News
Hearing on Avastin for breast cancer may be final twist in saga of much-debated drug
Reputation and Precedent in the Bevacizumab Decision
via New England Journal of Medicine
FAMEDS IN THE MEDIA
Battleline with Alan Nathan
- Radio Interview on Monday, June 27th
FDA wrong to revoke drug approval
- OpEd by Terry Kalley via The Oakland Press
MLB's Tampa Bay Rays Baseball Player Adam Russell Blogs: He is supporting FAMEDS & the Fight For Avastin to Save Patients including his Sister, who has Metastatic Breast Cancer and is on Avastin! View the Entry Here: www.raysindex.com/adam-russell-needs-our-help
THE FDA'S SCIENCE ON AVASTIN IS PURE ALCHEMY
On the 28th and 29th of June, the FDA will hear an appeal by the drug manufacturer Genentech, which is fighting a prior decision by the FDA to take off label Avastin the anti-cancer drug for patients with incurable metastatic breast cancer. 40,000 women per year die of metastatic breast cancer and an estimated 17,500 currently rely on Avastin for their survival.
In the interim, senior personnel from the FDA appear to be unusually sensitive to criticism of their decision. They keep publically justifying their decision to take Avastin off-label as being driven by science. Nothing could be further than the truth.
After the first trials on Avastin, the FDA granted Avastin accelerated approval and then asked for follow up trails. These follow-up trials exactly met the FDA requirements for permanent approval. The FDA then went out of its way to disown its own mandates. Worse, it started to misrepresent the results of these trials.
For example, the FDA presented as toxicities of Avastin those that pertained to the underlying chemotherapies tested with Avastin, not Avastin itself. The FDA hyped Avastin's toxicities when in fact these were unaltered from when the FDA granted accelerated approval for Avastin for metastatic breast cancer.
The gold standard of all trials is to obtain a large increase in overall survival. Critics of Avastin have pointed to this lack of OS data as proof that the drug does not work or is not worth the cost. Yet the way that the trials were designed by the FDA make it clear that meaningful OS data could not be expected nor did the FDA request (and presumably anticipate) it in its follow-up trials.
We can be sure of this because in designing the follow-up trials, the FDA allowed for patients on all arms of the trials to change medications once progression free survival ended. By definition, once a patient's cancer progressed, then the data on PFS would be captured. Furthermore and importantly, the FDA stated that those patients with progression would be allowed to continue on whatever protocol they wished. At their death, from whatever cause and after taking whatever drugs, the OS data could then be collected on these patients.
Let's follow two hypothetical patients in their trials: Patient A on Avastin and chemotherapy X and Patient B just on chemotherapy X, who will be the control arm of the study. Let's further assume that at some point both showed progression of their cancer. At the stage of progression their PFS data was captured. A rational patient and her doctor will conclude at this point of progression that she is not responding well and she will change her drug regimen.
Patient A may choose to move on to chemotherapy Y plus Avastin. Patient B may choose to add Avastin to chemotherapy X. Depending on the subsequent progression of their disease both patients might then change medications yet again, possibly multiple times in an effort to stay alive. Subsequent treatments might include other chemotherapies and combinations including or excluding Avastin. Upon their deaths, their OS data was collected and added to the information from each arm of the trial.
To gather meaningful data on overall survival, one would need a trial where Patient A remained only on a regimen of Avastin and chemotherapy X and Patient B remained only on chemotherapy X until their respective deaths. If all other factors of variation were controlled for in these trials, then one could claim data with statistical significance.
In the Avastin trails, Patient A did not show a statistically significant overall survival versus Patient B. But this is exactly what one would expect because both arms followed different drug regimens after their cancer had started to progress. Being rational patients trying to prolong their own lives, they departed this controlled environment and took whatever drugs might prolong their lives. This rendered the OS results completely void of statistical meaning because the control had ceased.
Yet it is precisely this meaningless OS data that the FDA and its supporter claim is scientific proof that justifies the FDA taking Avastin off label. Congress must investigate this charlatanism masquerading as science before many innocent women lose their lives prematurely.