FREEDOM OF ACCESS TO MEDICINES NEWSLETTER #9
June 27, 2011
The FDA Avastin Hearing Begins Tomorrow!
Last Chance to sign the petitions being submitted and presented tomorrow! To clarify, there are currently 2 petitions and both will be submitted! Please sign BOTH!
Sign the FAMEDS Petition
Sign the Care2 Petition
The peaceful protest will be a rally of patients, family members, friends & supporters, taking place outside of the FDA White Oak Campus located at 10903 New Hampshire Avenue, Silver Spring, MD 20993. Beginning at 7am EST and lasting until the start of the Hearing. Please join us if you are in the DC / Maryland area!
The Hearing is taking place in the Building 31 Great Room. FAMEDS' Founder Terry Kalley has requested to speak at the Hearing and been granted a short time to testify on behalf of his wife. Register to view the webcast
Following the FDA Hearing, Mr. Kalley will make its way to Capitol Hill for congressional meetings, and wrap up the day with media availability in 2103 Rayburn House Office Building.
AVASTIN IN THE MEDIA
FAMEDS IN THE MEDIA
THE FDA'S JUNK SCIENCE ON AVASTIN WILL KILL PATIENTS
The FDA is about to send an estimated 17,500 women to their premature deaths all in the name of science. Yet it is the FDA that has the science wrong and is doing all it can to justify a terrible decision.
A little history is needed to understand this situation. In 2008 the FDA granted the anti-cancer drug Avastin accelerated approval for use by women with metastatic breast cancer based on a trail, E2100. Metastatic breast cancer, is an incurable disease that kills about 40,000 women a year in the U.S. Avastin is unique in that it starves tumors of blood flow, thereby inhibiting their ability to grow.
The FDA also required the drug's manufacturer, Genentech to run two more trials. This they did in the form of the AVADO and RIBBON1 trials.
In granting accelerated approval, the FDA agreed that the data showed robust delay in tumor progression known as progression free survival (PFS). This was evidenced by a PFS of 5.5 months, which was obtained from the E2100 trial.
||CHEMOTHERAPY USED WITH AVASTIN
||MEDIAN PFS BENEFIT OF AVASTIN VERSUS NON-AVASTIN (MONTHS)
||Taxane or Anthracycline
For Avastin to receive a full FDA approval, the AVADO and RIBBON 1 trials had to show confirmation of a PFS benefit. All the trials confirmed that PFS benefit. Yet the FDA reneged on its own written agreement for Avastin to receive approval based on these successful trails and the FDA will instead pull the indication for metastatic breast cancer from the Avastin label, subject to a final hearing at its headquarters on June 28 and 29, 2011.
To complicate matters further, the Director of the Office of Oncologic Products at the FDA, Richard Pazdur, tried to cover up for this flip-flop by claiming later that the reason that the FDA went negative on Avastin's PFS data was because the magnitude of the PFS data of the subsequent trails did not equal those of the first E2100 trial. The problem with this spin is that equaling the magnitude of the original PFS was not stated anywhere as the objective of the follow-up trials. The FDA literally made this up after the fact – moving the goal posts after the match.
Furthermore, the FDA already had the final PFS data from the AVADO trial when it granted accelerated approval to Avastin. The PFS from AVADO was 0.9 months, the lowest PFS data from all trials and well below the original PFS of 5.5 months from the E2100 trial. Clearly, the FDA already knew that the magnitude of PFS data from subsequent trails would be less than 5.5 months but still granted the accelerated approval. To withdraw the approval for Avastin based on PFS below 5.5 months is irreconcilable with its prior decision granting accelerated approval.
But the FDA is the gift that keeps on giving. At the upcoming hearing, the FDA will argue that the PFS data for the first trial is an outlier - in essence a statistical fluke - and that the data for this trial should be dropped. The FDA has no basis to make this claim. The FDA is trying to perform a hatchet job on a successful trial. Applying its logic, the drug's manufacturer should try to have the lowest PFS of 0.9 months dropped instead, which would be equally absurd.
Based on the results of just three trials, it is impossible to draw a conclusion to drop one of the trials as an outlier, as the FDA is attempting. For a statistically significant sample to occur, many more trials would need to be conducted and only then would one be able to determine if one or more of the trials really were outliers.
The FDA also granted accelerated approval to Avastin based on certain data on overall survival and the known health risks of the drug. No new data of any significance was derived from the follow-up trials. This has no stopped the FDA from a full attack on Avastin based on its lack of overall survival data and it supposed excessive health risks. Results deemed acceptable for an accelerated approval are now judged by a different standard for full approval.
The FDA is making up the science as it goes along. If it confirms its decision after the appeal hearing, this will be a death sentence to women reacting well to Avastin. The FDA is clearly in need of reform. The sooner the better before more innocent Americans lose their lives.
HAVE YOU FRIENDED US?