IL-14: Ted Gradel’s Testimony Before the FDA

Ted Gradel

On September 13, 2016, Ted Gradel testified before the Food & Drug Administration (FDA) as a participant in a hearing to draft guidances relating to the regulation of human cells, tissues, or celluar or tissue-based products.

The two days of hearings were held at the National Institute of Health in Bethesda, MD.

Gradel testified as an individual participant and shared his experience as a recipient of stem cell injections.

The full context of Gradel’s testimony is being presented as a prelude to the analysis of his candidacy for the 14th district Republican nomination in 2020:

“Hello and thank you for the opportunity to speak today. My health issues are relatively modest compared with so many of the fine presenters today so I will gloss over those rather quickly.

“I was diagnosed with moderate osteoarthritis in both knees four years ago [2012] at age 48 and told I had no other options other than to endure the pain and eventually have knee replacement surgery.

“I sought out the alternative, stem cell therapy and the results have been fantastic. When you deal with chronic pain, even though mine was modest, on a regular basis, it’s quite liberating to wake up pain free every day.

“Now, four years later, I have been diagnosed with moderate to severe osteo in my left hip and two different orthopedic surgeons have told me I have no options other than endure the pain and eventually get hip replacement surgery. I am very thankful that I know about the procedure I already had. I am very thankful that I have the option of stem cell therapy right now and I plan to schedule a procedure soon.

“A couple of things I am having a hard time understanding, and I do have a different perspective than that last speaker and I respect her opinion.

“I respect how difficult this is to process but I am having a hard time understanding and talking about just the autologous stem cells, my own stem cells. How is this being considered regulated as a drug? When I look at that little vial, the little sliver of SVF, stromal vascular fraction that is sitting at the bottom of that test tube, those came out of my body and those are my cells.

“I am having a hard time understanding how — I don’t really care if the lab technician added an enzyme or if they have been manipulated either minimally or maximally, I feel like I should have the right to have those cells injected back into my own body, without having to deal with government regulations and extensive testing or anything like that.

“That decision should rest between me and my physician. If you surveyed the average U.S. citizen and asked whether they should be allowed access to their own blood, tissue or cells or whether they would prefer the FDA restrict that access, I have a very strong opinion that the vast majority would say that decision should be theirs and their physician’s.

“The other thing I am confused on is it just seems that there are so many people who are again, very smart, educated, experienced people, PhDs, Mds, that are so violently opposed to what is going on and it’s almost like they take any success stories, which we have heard so many of today and they are awesome stories. Julie and Georgianna and Shelley — all the people that have talked about how they have benefited, it just seems like so many people want to downplay those and say: ‘Well that’s just anecdotal evidence and they didn’t have proper testing.’

“Whereas you take a couple of adverse, negative adverse events and these critics want to blow those up, highlight them conspicuously and hold them up as a reason to disallow these procedures for everyone. It doesn’t make sense to me as an average, non-medical, layperson.

“I ask that you — there will be negative outcomes and those are extremely unfortunate when they happen, absolutely but we must learn from those rather than running from those. I ask that you consider how many thousands of U.S. citizens will be negatively impacted if these procedures are restricted in big ways.

“People suffering from chronic debilitating conditions — as mentioned by so many speakers, the demand is there and other countries have approved these procedures.

“If we force thousands of patients to look overseas, it will likely be more costly and less safe.

“Many thousands more won’t be able to afford those procedures in traveling and so they’ll be forced to live with debilitating conditions when they might otherwise have had an option.

“I truly believe that these stem cell therapies have the ability to positively impact so many lives and I ask that you keep that decision making ability where it belongs, in the hands of the individual patient and their physicians.

“Thank you.”

Ted Gradel, 9/13/16 testifying before the FDA on Stem Cell Therapy
From the transcript available online from the FDA

Gradel raises multiple, significant concerns on a variety of topics including government preventing people from receiving the treatment needed to chronic conditions, the opiod crisis, people’s own bodies being regulated as a drug, among other topics.

And these can and should be discussed within the context of a congressional campaign, especially when the incumbent Democratic congresswoman is a licensed registered nurse.

Later this week, McHenry County Blog will assess Gradel’s candidacy for Congress in depth.

And we will be reviewing the facts around Gradel’s involvement with a stem cell clinic in detail, based on over 2 months of research and the cooperation of Ted Gradel’s campaign.

Please limit comments to the testimony from 2016, and all of the facts will be shared during the series on Gradel’s candidacy about events taking place after his testimony.

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