FDA Commissioner: Who Would You Choose?

Today—approximately one year after COVID-19 changed all Americans’ daily lives—the need for strong, ethical FDA leadership that makes decisions based on science—is increasingly in the news. Patient safety advocates have long known the impact FDA leadership has when reviewing and approving drugs and medical devices. But more Americans are starting to understand this powerful agency that oversees COVID-19 treatments and vaccines makes critical decisions that impact us all.

In 2020 we became a 501(c)(3) Non Profit!

December hearings on the Covid-19 Vaccines:

Board members Kim Witczak, Dru West, and Marie Garlock all spoke at the FDA hearings on behalf of the USA Patient Network about Covid vaccines, voicing our concerns that studies on the vaccines need to continue and that those who are vaccinated need to be followed longer than 2 months and given clear instructions on how to report adverse reactions.  Links to the videos of our public comments:

December 10 Hearing on Pfizer Vaccine

Kim Witczak speaking:  https://youtu.be/-fj5k-RgNKw

Dru West speaking: https://youtu.be/SsKyzuTUMMk

Dec 17 Hearing on Moderna Vaccine

Marie Garlock speaking: https://youtu.be/BunVNPtA3x4

Tess Schulman - ASHES Nonprofit and Medical Device Problems Co-Chair says:

I would tell any new advocates that the two keys to success are collaboration and persistence! Team up with experienced advocacy groups and other non-profits like NCHR, even if they are tangentially relevant to your specific advocacy goals. We have strength in numbers, and that's how we get things done! You must be willing to go the distance, too, and realize it will be slow going, which is why you have to be persistent. It does get tiring, but that's why we collaborate, to share the load when some of us become overwhelmed. If I'm not knocking on the FDA's door or attending a public hearing like the one on immune reactions to metals in implants, I have a whole network of other advocates who can. We are the constant water, slowly wearing away the rock.

Last month we featured John James and his recently published research article, "Informed consent, shared-decision making and a reasonable patient’s wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario," published in the BMJ.  This month we want to show how this research can be applied in practical ways for advocacy and patient care.
 

You can also read more about John's advocacy work in this issue of our newsletter.

Summer is ending, but our advocacy work continues.

This issue we'd like to honor Jamee Cook, a wife and mom from Texas. She worked as a paramedic in the state of Texas for 11 years but now spends most of her time volunteering as a patient advocate.  Read more about her advocacy for women who received breast implants in the August newsletter. 

Here's a summary of our recent activities, a salute to a valiant patient safety activist, and more information on what we're doing to insure that medical treatments involving drugs or devices are safe, effective, and affordable.

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This summer, we'd like to give a salute to a valiant patient safety activist, and more information on medical devices. The spotlight is on a Linda Radach, a true warrior in many areas, but particularly on medical device safety.