2500+ supporters and growing. Communication to FDA attached.
Truly remarkable! In less than one week, today we passed 2500 supporters, a number that is growing by the hour. With your continued involvement, this collective voice will grow even stronger. Please keep your foot on the gas pedal, sharing and posting in all ways that you can.
Below we are sharing a condensed / synopsis version of a letter sent, just yesterday, to Mr. Ben Fisher at the FDA. There is no question Mr. Fisher has been placed in the challenging role of balancing voices from all sides on a complicated issue made even more complex by the infusion of politics and misinformation. But in the end, it is critical that physicians, societies, and all other stakeholders stay vigilant and not allow science and ethics to be compromised. The path forward: allow the scientific process to proceed as originally agreed upon by all stakeholders, allow a fair and objective assessment that centers on what is best for present and future patients, and don't allow politics and social media to steer the future of these or other important areas of women's health. During this critical phase, we are depending upon strong and balanced leadership from Mr. Fisher, and Mr. Shuren, to work with all stakeholders to achieve these very reasonable aims, and to restore confidence that this FDA process sets politics aside and is driven by science and what is best for patient care.
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Letter to Mr. Ben Fisher
Concerns relating to regulatory process are heating up rather quickly within our field. The FDA description of the process has left no clearer understanding of the key question at hand: that is, what could possibly be the rationale and motivations on the FDA end in changing the criteria from 1-year rather than 3-year outcomes, suddenly and unexpectedly without any safety concerns. Your advising this week that it was perfectly fine for surgeons to still implant Uphold devices remaining on their operating room shelves, reinforced in powerful terms that there are no safety concerns embedded in this recent decision.
This decision unnecessarily and unfairly halted safe and planned scientific inquiry, relating to procedures that many surgeons believe represented core advances in pelvic organ prolapse surgery. There is strong and quickly growing sentiment that outside influences must have successfully pressured the agency to ordain a conclusion before the science was ready for fair and clinically meaningful assessment, which is inherently unacceptable and intolerable to our professional community.
A few days ago we forwarded notification of the petition that is circulating nationwide, which has now reached over 2,300 supporters in just a few days. This petition is not a referendum on mesh, but rather, it is a referendum on fair, scientifically valid, and unbiased handling of this issue by the FDA. This group of physicians is growing by the hour, and is attracting the attention of media.
We fully understand and acknowledge the historically difficult circumstances that you and your team at the FDA has had to navigate. And before last week, physicians believed there was alignment on a scientifically valid and ethical process. This level of trust changed drastically with last week’s FDA action, and there is widespread consensus that shifting the core terms of the --522 trial timeframe and analysis is scientifically invalid, unfair to stakeholders including present and future patients, and ethically problematic with respect to enrolled research subjects.
The focus and request here is straightforward: we need an expeditious revisiting of this issue, and clarification of a practical and realistic path forward so the research framework that had been previously laid out is carried to its planned completion, and then interpreted along with other relevant quality studies with a common goal of doing what is best for women’s healthcare. Thank you very much for your ongoing dedication to navigating this issue and to ensuring a fair process which, in the end, all stakeholders will be proud of.