Texas Stem Cell Legislation 2017 – Action Alert

TXCap UPDATE June 2017 THANK YOU to everyone who wrote and called the Texas Legislature! HB810 Charlie’s Law was signed by Gov. Greg Abbott. The Texas Board of Health will define rules starting in Oct. 2017. Here is a news report as of Sept. 25, 2017 The future of stem cell therapy in Texas
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May 13th, 2017 – There are currently bills before the Texas Legislature that would allow access to adult stem cell therapy in the State of Texas, rather than by travelling outside of the U.S.

This week advocacy members of Patients For Stem Cells testified before the Texas House of Representatives in support of these bills, and we are happy to report House Bill 810 by Rep. Tan Parker, passed the Texas House with 150 yes votes and zero no votes.

An emotional speech by Rep. Drew Springer, R-Muenster, about his wife’s need for a medical cure from stem-cell research, brought together this unanimous, bi-partisan vote.

Now the Texas Senate needs to hear from their Texas constituents! The next step is the Senate vote, and we have advocates at the Capitol who will deliver your testimony.

If you live in Texas, please send the following information:

1. Your full name, city, state & zip code

2. Why you think adult stem cell therapy should be allowed in Texas. Maybe you or a loved one has a terminal or chronic condition that could be treated by stem cells. Or you just want to support medical freedom.

Send your email to: PatientsForStemCells@gmail.com

Deadline before Senate vote: Tues, May 16th, 2017

Please click here to find your Senator and also call to express your support for the HB 810 stem cell bill.

For everyone who doesn’t live in Texas, rest assured that this legislation may well start a trend for other States to follow. We will keep you informed as this movement expands, and look forward to your participation!

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♦ FDA wants to Stop Stem Cell Therapy AND Breast Reconstruction -Make Comments by Sept. 27th 2016

fdahearingUPDATE: Congratulations everyone! We submitted 6,952 comments! Click HERE to read the comments.

Sept. 24th, 2016 – Cellular therapy is a disruptive medical innovation which is revealing a surprising truth: our own bodies are the best source of medicine ever discovered. This is challenging many of the conventional therapies, such as drugs and surgery. The FDA’s regulatory approach starting in 1993 has been inhibitory to the wider adoption of this therapy. The current proposals, which seek to classify certain stem cell procedures as a prescription drug, which will only insure that more patients are forced to pursue medical tourism.

If you you think you or a loved one might ever need to use their own stem cells, for example to avoid a knee replacement, then please take a few moments to make comments to the FDA by Sept. 27th. Instructions provided below.

The FDA has presented 4 draft guidances, with the goal of shutting down stem cell clinics in the U.S. Readers of the PFSC blog helped start the citizen feedback process earlier this year when over 600 registrations for the FDA Part 15 hearing overwhelmed the agency. The hearing had to be postponed until Sept 12-13th 2016 and expanded to 2 days, which only allowed 5 minutes each for the 100 people who registered to speak. These presentations from scientists, cellular therapy providers and patients were mostly in opposition to the guidances. The legal and scientific details are available below in links to the testimony and articles.

FDA PROPOSED BAN ON BREAST RECONSTRUCTION TECHNIQUE
The FDA was roundly criticized for proposing that not only your stem cells, but also your fat, should be classified as a drug, requiring a decade of trials. Rick Jaffe, a lawyer with 3 decades of healthcare legal experience, raises the alarm in this passionate piece.

THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures – Richard Jaffe, Esq. The huffington Post, 09/18/2016

HOW TO MAKE COMMENTS TO THE FDA BY SEPTEMBER 27, 2016

Click HERE to submit your comments o FDA.

Tell your own story if you have had stem cell therapy, or think you want it in the future.
In your own words (or FDA will reject it) make the following points, if you support continued access to your cells:

1. Withdraw the four HCT/P guidance documents, and work with the experts on solutions
2. Stop trying to regulate a person’s use of their own body parts
3. Continue access to responsible stem cell therapy that uses the patients’ own tissue

A great deal of media attention has arisen, so you may want to save your comment, and also post it as a comment on the articles we’ve included below.

Click HERE to read comments submitted by others.

UPDATE: An amazing 6,952 comments were submitted by the deadline of Sept. 27th. FDA has never received more than 20 comments on previous guidances.

Click HERE to review the speaker agenda for the two day hearing.
Click HERE to view Day 1 of the hearing.

1:48:00 Mary Ann Chirba (Boston College)
1:53:00 and 2:58:40 Arnold Caplan (Case Western Reserve)
1:59:10 and 2:53:00 Keith March (Indiana University)

These three presenters are leaders in the field. Caplan was the first to discover the healing abilities of adult stem cells. In FDA Draft Stem Cell Guidance Documents Exposed as Improper Rulemaking, Bad Science and Heartless Public Policy Richard Jaffe comments “…these presenters and especially March and Caplan showed that the FDA’s view was biologically unsound.”

Alexey Bersenev (Yale University) posted an objective scientific review of the hearing, also noting the import of March and Caplan’s input,
Historic FDA public hearing on regulation of cell therapy in US

Click HERE to view Day 2 of the hearing.
Click HERE for a patient presentation provided by SammyJo Wilkinson.

In the last presentation at the hearing, SammyJo explains how her own stem cells put long-term multiple sclerosis into remission and recovery since 2014. She also echoed the proposals for solutions presented, such as the conditional approval plan and patient registry proposed by Arnold Caplan, Janet Marchbroda (BPC) Day 1 4:16:00, and Leslie Miller (AACT) Day 1 3:23:58.

Editorial – Improving the regulatory framework for cell therapy does not equate to deregulation
Caplan A. I., Ricordi C., CellR4 2016; 4 (4): e2109

Many moving presentations were made by patients on Day 2, about lives restored by cellular therapy from illnesses that had no effective treatment options. In our next post we will explore how the media has covered the FDA regulatory story, and how the patient experience is finally being included.

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♦ Only 4 Adverse Events Reported Against 570 Stem Cell Clinics

A Freedom Of Information Act (FOIA) request to the FDA has revealed only 4 reports of adverse events against a list of 570 U.S. stem cell clinics.

This low number of FOIA reports demonstrate that:

  • There is clearly not an established pattern of harm.
  • There is no significant trend of harm, just fear of harm.
  • Fear of harm is not a basis for crafting health policy. Proof of harm is as essential as proof of safety.

Pervasive hype, both overly positive and overly negative hurts us all. Dr. Feel Good and Chicken Little have no place at the table of social or health policy of such gravity to our lives and the lives of those we love.

Here is the response to the request, followed by links to the 4 reports.

Cc: “ORAHQ ACRA ESS FOI-DISCLOSURE STAFF”
Sent: Monday, August 22, 2016 2:45:07 PM
Subject: FOI Request 2016-6466

8/22/2016

Dear Requestor,
The attached records are being provided by the Office of Regulatory Affairs (ORA)Information Disclosure in response to your request #2016-6466 dated 08/08/16 for records from the Food and Drug Administration pursuant to the Freedom of Information Act regarding:

ADVERSE EVENTS RE CELLULAR THERAPIES

Your request is granted in part.

After a thorough review of the responsive records, we have determined that portions of the documents are exempt from disclosure under FOIA exemptions (b)(4) and (b)(6) of the FOIA 5 U.S.C. § 552, as amended and delineated below:

Exemption (b)(4) permits the withholding of “trade secrets” (TS) and “commercial confidential information” (CCI). Disclosure of this information would impair the government’s ability to obtain necessary information in the future and cause substantial harm to the competitive position of the person from whom the information was obtained. Under the balancing test of this exemption, we are withholding all proprietary information identified as TS and CCI.

Exemption (b)(6) permits the withholding of information which, if released, would constitute a clearly unwarranted invasion of personal privacy. In this case, it was determined that there is no countervailing public interest qualifying under the standard set forth, under exemption (b)(6), to release the personal identifying information of certain third parties.
ORA considers your request closed. If you have any questions about this response, you may contact Anna Postell at 301-796-6488.

Sincerely,
Anna Postell
Program Analyst

These are the adverse event reports:
APPLIED_Consumer Complaint 127882_Redacted.pdf
APPLIED_Consumer Complaint 131004_Redacted.pdf
APPLIED_Consumer Complaint 141021_Redacted.pdf
APPLIED_Consumer Complaint 144501_Redacted.pdf

Note: The request was granted in part, This doesn’t mean there are more than 4 records and the FDA is withholding them. It means the privileged types of information (b)(4) and (b)(6) are not provided, which you can see have been redacted in all of the 4 records.



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