FAMEDs Newsletter #9.5
June 23, 2011

Freedom of Access to Medicines Fight for Avastin at the FDA Hearing June 28-29: Viral Video: Avastin Fight Song

Hello,

Please view the attached urgent Press Release and talking points document for Freedom of Access to Medicines (FAMEDS). The only non-profit leading the effort against the FDA from pulling the drug Avastin off-label at the Hearing June 28-29th, which is helping 17,500 women survive with Metastatic Breast Cancer. This is an issue that affects all Americans and both political parties. Please consider featuring the topic to bring awareness to the cause. Feel free to contact me via email or phone at any time to answer any questions or to schedule an interview with FAMEDS' Founder Terry Kalley.

Thank you,

Rachel Partain
Freedom of Access to Medicines
(O) 248.275.1222
(C) 248.404.0722
fameds.org
twitter.com/FAMEDS
facebook.com/FAMEDS

VIRAL VIDEO LAUNCHED FOR AQABA TECH NON-PROFIT CLIENT FAMEDS

STERLING HEIGHTS, MICH., June 20, 2011 – "Dangerous Medical Decisions Should be Left to Patients and Physicians, and NOT a Politician, Who May be out Fishing!" declares the Internet Video that is picking up momentum and going viral for Freedom of Access to Medicines (FAMEDS), based in Troy, Michigan.

FAMEDS, who is the only non-profit organization advocating the fight against the U.S. FDA from disproving the drug Avastin for use by Metastatic Breast Cancer patients, has just launched the "Avastin Fight Song" Video, as part of their online campaign, on their Website and on YouTube. Several other news outlets have now posted the video on their own Websites. The video creatively states the Mission of FAMEDS, which is to save an estimated 17,500 women with the incurable illness, who currently rely on Avastin to stay alive and are performing well with the medicine. The catchy four minute video points out a long list of facts why Avastin should not be pulled off-label at the FDA Hearing, which takes place at the FDA Headquarters in Silver Springs, Maryland on June 28-29, 2011. The American made drug has been approved for use in Europe and many other countries. No appeal is allowed to be made after this decision is reached.

The Avastin Fight Song video can be viewed on FAMEDS' Homepage: www.fameds.org and on YouTube at: http://youtu.be/MHjyqaWbCdE. FAMEDS was established to ensure that women with Metastatic Breast Cancer have continued access to Avastin should they and their doctors determine that it is the right medical choice for them. Furthermore, it is dedicated to ensuring that current patients continue to receive their private insurance and Medicare coverage for Avastin. FAMEDS was founded by Terry Kalley, the husband of an Avastin super-responder. FAMEDS is continually trying to gain Signatures by the FDA Avastin Hearing date on their Petition: fameds.org/petition.

THE AVASTIN STORY - 17,500 WOMAN NEED THIS DRUG TO STAY ALIVE STOP THE FDA FROM MAKING A FATAL MISTAKE

FACTS AND HISTORY
  • 40,000 American women die each year from metastatic breast cancer (MBC), an incurable disease
  • An estimated 17,500 women are currently taking Avastin for MBC in the U.S.
  • Avastin is a unique drug, the only antiangiogenic on the market. It works by cutting off the blood flow to tumors, thereby limiting their ability to grow
  • The FDA granted Avastin accelerated approval in early 2008 subject to running further follow-up trials
  • The follow-up trials were run according to the FDA requirements
  • The Oncologic Drug Advisory Committee, a panel that reviews trial data for the FDA, was presented data by the FDA and voted in the summer of 2010 to take Avastin off-label based on their assessment that on average Avastin did not provide sufficient benefit versus the risks
  • The FDA confirmed the ODAC decision in December 2010.
  • Genentech, the manufacturer of Avastin will appeal the FDA's decision at a hearing on June 28th & 29th, 2011 at FDA headquarters in Silver Spring, Maryland
PROBLEMS WITH THE DECISION – PRACTICAL
  • If Avastin is pulled off-label, the great likelihood is that patients will lose their private medical coverage as well as their Medicare coverage.
  • Without private medical or Medicare coverage the drug is unaffordable to all except the wealthiest
  • This means that the wealthiest will obtain Avastin and the remainder will not have this opportunity
  • Without Avastin, countless American women will die needlessly
WHAT CAN THE FDA DO?
  • Unless the FDA reverses its decision, any other grandfathering it might attempt with current patients will be meaningless because the FDA has no way to compel insurance companies to keep their current coverage in place.
THE FDA'S APPROACH TO AVASTIN IS SCIENTIFICALLY & MEDICALLY FLAWED
  • There are countless stories about "super-responders" including some who have been successfully taking Avastin for several years with extraordinary results.
  • These super responders almost certainly belong to one or more subgroup of patients, for whom Avastin works extremely well.
  • The FDA uses a rigid statistical approach, which relies solely on averages and medians to make decisions.
  • The FDA's approach misses and ignores the existence of one or more subgroups of patients who are responding well (that is, well above average) to a drug because these subgroups are lost in the averages.
  • It is highly likely that the disease we label "metastatic breast cancer" consists of multiple variations of cancer, each susceptible to its own discrete or targeted treatment.
  • The FDA's approach to Avastin is medically unsound because the FDA's procedures discourage progress in medical research
  • The future advances in medical research and cancer treatment lie in identifying patient subgroups and understanding their genetic predisposition to targeted therapies.
  • This will enable matching cancer treatment to the genetic profile of the patient based on that patient belonging to one or more identified subgroups.
  • We currently have no idea why Avastin is working so well for certain patients but clearly one or more subgroups respond very well to Avastin
  • The logical next step is for the FDA to allow and indeed demand of Genentech that they continue research to identify the biomarkers of patients who might respond to Avastin.
  • While this research is underway, Avastin should stay on label so that existing patients can continue their treatments.
  • Instead of studying these super-responders, the FDA at times denies their existence, sometimes hints that they may exist, but regardless has made no accommodation for them in its plans to remove the MBC indication for Avastin.
  • The FDA is saying in essence that they know some women may respond well to the drug but until there is a way to predetermine them, Avastin needs to go.
  • For current patients, this is equivalent to throwing the baby out with the bathwater or in essence disconnecting the feeding tubes or oxygen from a patient.
  • Some of the patients have failed to respond to many other drugs and for them Avastin may well be their only, last hope
  • Removing a patient with a serious disease from a medication when she is doing well is unethical, unwise and extraordinarily dangerous
  • Breast cancer oncologists want to keep Avastin as an option because it gives them an extra and unique weapon in their battles against an incurable disease
THE PROCESS THAT THE FDA FOLLOWED WAS RIGGED AGAINST AVASTIN
  • The FDA has rigged the process by using a different set of standards to judge the outcome of the trials than it had mandated at the start of these trials
  • The FDA has not adhered to the basic tenets of administrative procedure in its evaluation of Avastin.
  • The FDA has deliberately overemphasized the risks of Avastin while understating its benefits.
  • The FDA has departed from past regulatory practices in that the FDA has approved other cancer drugs with worse toxic profiles than Avastin and approved other cancer drugs with equal or lesser benefits than Avastin.
  • The FDA's reasons for rejected Avastin are misleading, contradictory to their earlier statements or intellectually unsustainable.
  • The FDA has failed to investigate allegations of wrongdoing by its own panel members. For example, costs were not supposed to be part of the decision-making process yet one panel member, Jean Grem of the University of Nebraska, explained her anti-Avastin vote by observing, "We aren't supposed to talk about cost, but that's another issue."
  • The FDA lacked specificity in describing the prerequisites for Avastin's approval. Regulated entities such as drug manufacturers cannot operate in an environment where they do not know what is required of them by regulators. This represents a broken regulatory environment.
  • The FDA has created a regulatory environment where the regulated are scared to challenge the regulated for fear of retaliation and retribution.
  • Without clear standards, the risks associated with drug approvals will rise, thereby further decreasing the number of manufacturers willing to risk undertaking costly trails in an uncertain regulatory environment.
  • This sclerotic and less than honest process is retarding advances in medical science.
  • This is evidenced by the declining number of drugs in the FDA approval pipeline, as well as the declining number of applications for conducting trials.
PROBLEMS WITH THE FDA DECISION – THE FDA CHANGED THE END-POINTS IN THE TRIALS
  • The FDA clearly established certain endpoints for the follow up trials. These were improvements in progression free survival (PFS) and overall response rate (ORR). Overall survival was not supposed to decrease. Avastin met all its endpoints.
  • At the ODAC hearing in 2010, the FDA staff reviewers framed the debate such that the main topic of discussion was the overall survival, even though this exhibited similar results to the initial trial and was not the primary endpoint of the trial.
  • The FDA did not establish the magnitudes of the PFS end-point for the follow-up trials when they designed the trial.
  • Only after the trials were run did the FDA state that the magnitude of the benefit needed to equal the results of the original trial. Clear the FDA moved the goalposts after the game has been played.
  • The FDA then rejected the results based on "insufficient" benefit, substituting its subjective opinion for what should have been a scientific decision.
  • The FDA staff reviewers also focused on the health risks of Avastin, even though these were dealt with in the initial trails and no new data of any materiality were discovered in the follow-up trials.
PROBLEMS WITH THE FDA DECISION - THE ODAC HEARING WAS FLAWED
  • The Oncologic Drugs Advisory panel is supposed to be independent of the FDA's Director of the Office of Oncology Drug Products. In practice, he chooses its members by direct and indirect influence.
  • The FDA's staff reviewers overinflated the health risks of Avastin by inter alia, presenting risks as being caused by Avastin when they were in fact risks well-known to be associated with the chemotherapies with which Avastin was tested.
  • The FDA over-emphasized the side effects by over-emphasizing rare side effects and not presenting them in context.
  • Patients know the risks of Avastin before they begin their treatments and almost all consider the greatest risk to their lives to be not taking Avastin.
  • ODAC only had two practicing oncologists out of 13 members. Had they been familiar with using Avastin, they would have known that most side effects are well tolerated by patients.
  • The effect of the FDA overinflating the side effects while using the incorrect end-points for the benefits was to alter the risk / reward calculation in the minds of the ODAC panel.
THE FDA HAS MADE A DECISION AT ODDS WITH OTHER MEDICAL AUTHORITIES
  • The same day that the FDA ruled against Avastin (December 16, 2010), its counterpart in Europe, the European Medicines agency reached the opposite conclusion from the FDA based on the same data and approved Avastin for use with Taxol.
  • On April 15th, 2011, the European Medicines Agency reversed an earlier opinion and recommended expanding Avastin's approval to include Xeloda, another chemotherapy.
  • This creates a perverse situation where Europeans gain unfettered access to a drug invented in San Francisco while American women don't.
  • Avastin also remains available in Australia, Mexico, South Africa, etc.
  • In October, 2010 the U.S. National Comprehensive Cancer Network, a consortium of 21 leading U.S. cancer centers that issues evidence-based medical guidelines, reaffirmed its position that Avastin is valuable in some cases. The NCCN includes such major institutions as Memorial Sloan-Kettering in New York, Dana-Farber in Boston and MD Anderson in Houston.
FLAWS WITH THE UPCOMING AVASTIN HEARING ON JUNE 28TH & 29TH
  • Incredibly, the same ODAC panel that created a need for an appeal will itself hear the appeal.
  • The FDA and Genentech cannot agree on much related to the hearing resulting in delays of document submission for the hearing.
  • The FDA is stacking the panel with ad hoc members whose prior voting record is known
  • This has all the drama of a murder trial, with knowingly innocent women about to be sentenced. The big difference is that when the verdict is rendered, these women will, not have endless appeals, unlike the usually less innocent on death row. This verdict will be final.
CONCLUSION
  • The FDA changed the rules of the game for the approval of Avastin.
  • It is hard to understand how the health care of American women with metastatic breast cancer is better off with fewer choices and not more in this battle. We are also creating a situation where we are reducing the number of options for treatment for a disease that has no cure. We have increased the length of time that women survive metastatic breast cancer without finding a cure. We have achieved this by offering treating oncologists and their patients a portfolio of options, none of which is a cure but each of which can offer some benefit to some patients. To start reducing those options by removing Avastin, a unique drug, makes no sense.
  • Avastin is keeping American woman alive and improving their quality of life.
  • Removing Avastin will result in needless, premature deaths.
  • The FDA evaluation process is unscientifically unsound & retards advances in medical science.
  • The FDA evaluation process of Avastin has been rigged.
  • Basic tenets of administrative procedure were abused by the FDA in its evaluation of Avastin.
  • The bottom line is this. Even if one thinks that Avastin should be pulled off the market in the future, it is unconscionable to remove the drug from current patients against their will and against the advice of their doctors.
WHY SHOULD ANYONE CARE ABOUT THIS AVASTIN SITUATION?
  • The premature ending of 17,500 lives should greatly concern any civilized society.
  • The issues affecting the Avastin women today, could apply equally to another drug that you or a loved one will need tomorrow.
  • The failure of the FDA to approve safe drugs in the most effective and efficient manner means that drugs are getting to market later than they should, thereby depriving seriously ill patients of critically needed options. Often, these patients die before they are able to receive promising drugs.
  • These delays due to the FDA's hyper-cautious approach to trials and due to the FDA's inefficiencies lengthen the time and cost to market of drugs, thereby increasing the nation's health care costs.
WHAT SHOULD CONGRESS BE DOING?
  • Holding hearings to shed light on the FDA abuses of process that have created this crisis for the Avastin women
  • Demanding answers from the FDA
  • Informing the American public of the scandalous treatment of these Avastin women
  • Exercising oversight over an Agency that seems to be without any. The relevant committees need to stop being afraid to ask tough questions of the FDA, just because the FDA are the "experts".
  • Ascertain through its oversight obligations whether the FDA's mantra that it is "just following the science" is true or not.
 
 
Avastin Fight Song


Composer and performer, Andrew Katz, NYC

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