Tag Archives: stem cells

♦ 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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♦ Adult Stem Cells Restore Sight To The Blind

March 13th, 2016 – Stem cell patients are making news! PFSC brings together all the reports on Doug Oliver and Vanna Belton, both of whom have regained vision thanks to a pioneering trial led by Dr. Jeffrey Weiss.

First, THANK YOU! to all PFSC subscribers for responding to the FDA Part 15 Hearing registration drive. As hoped, the overwhelming response caused the FDA to postpone the April 13th hearing, and there will be a collaborative workshop w/ stake holders. We look forward to open dialog with the FDA. More info forthcoming as soon as we learn of it.

Now the leaders in the Senate are looking at ways to advance cellular therapy. Patients will be listened to as constituents. At the end of this post, look for information on how you can support this legislation, which is being introduced on March 15th, 2016. [Update: delayed until March 16th, so we have another day to email our Senators.]

Doug Oliver

Doug Oliver

To help readers understand what this legislation could do for the health of Americans, PFSC will run a series of posts highlighting the positive outcomes from clinical trials, and patient stories. For conditions ranging from orthopedics, to stroke and autoimmune diseases. Starting with this story on vision recovery previously thought to be impossible.

Doug Oliver’s vision has been deteriorating since he was 30 due to a form of macular degeneration called Autosomal Dominant Drusen. By his early 50’s, Doug was legally blind, and could no longer drive or see faces.

Doug’s story was covered by Nashville Fox Affiliate WZTV, in a year-long series of reports by Mikayla Lewis which tracked his recovery from legally blind to regaining his driver’s license. His vision changes are documented in his medical records from exams at Vanderbilt University Eye Institute; he has released these records to the public as part of his effort to spread awareness of this treatment.

Highlighted facts of Doug’s case:

  • May 2015, the time of his first television interview with FOX, (before treatment), his vision was 20/400 in the right eye and 20/2000 in the left.
  • Oct 2015, at the follow-up interview (after treatment in Aug 2015), his vision had improved to 20/40 and 20/40 visual acuity range, which is legal for driving.
  • Dec 2015, Doug received his driver’s license.
  • Mar 2016, his vision is 20/30 in his right eye and 20/40 in the left.
  • Mar 11th, 2016 Mikayla Lewis returns to see Doug taking his wife for a drive “Stem Cell Therapy Helps Blind Man See“.

In his latest interview, Doug addresses a common confusion. When people hear “stem cells” they think of therapies that utilize embryos. The reporter includes an explanation by former Senator Bill Frist, MD that research on use of embryonic cells is fading. Adult stem cells from one’s own tissues are proving to be the safer and more effective method.

Vanna Belton

Vanna Belton

Vanna Belton’s vision was 20/3000 in both eyes, after she lost her sight in a matter of weeks in 2009 due to a severe onset of optic neuritis, leaving her completely blind. Vanna is still considered legally blind, but following stem cell therapy in the SCOTS trial in 2014, she can now see enough to no longer need a white cane. Vanna’s case presentation has been published in Neural Regeneration Research Journal, and is currently being submitted for follow up peer-reviewed publication.

The reports on Vanna’s case span the range from positive, factual, to a little histrionic. Patients considering such an investment in experimental therapy that has not yet reached publication or approval need to have all the information available.

The Baltimore Sun report by Meredith Cohn, an experienced health journalist, falls into the balanced journalism category, exploring the pros and cons. The next two reports are from science blogs, recapping Meredith’s story. Science Alert echoes the balanced tone, while the negative terms like “renegade” indicate the Inverse blog is using sensational terms to attract viewers. Yet the author hedges her bets at the end with “Weiss’ work is important because it’s pushing the frontiers of science well beyond what we even think is possible.”

Is this press release the Principal investigator, Dr. Jeffrey Weiss, a board certified retinal surgeon and ophthalmologist, explains the Florida-based Stem Cell Ophthalmology Treatment Study (SCOTS). It is registered with the National Institutes of Health with identifier NCT01920867. It lists the conditions treated by SCOTS, as well as study contacts. The study uses the patient’s own stem cells obtained under anesthesia from the bone marrow. These cells are injected around and potentially in the eye.

In the above media reports Dr. Weiss states 278 patients have been treated, and 60 percent of his 278 patients with macular degeneration, glaucoma and other diseases have regained some sight.

Like many of the cellular therapies offered in the U.S. the SCOTS trial is a patient-funded clinical trial; in this case treatments cost $21,000, which insurance does not cover because the procedure is investigational. Doug raised the funds for the treatment from his local community and through a GoFundMe campaign. Vanna spent her wedding budget to pay for treatment and got married at the courthouse instead.

The SCOTS trial is tracking patient results and submitting early initial case reports like Doug and Vanna’s to peer-reviewed publications. This is the first step in the process leading to publishing the results on all of the patients to determine safety and efficacy. If results warrant it, the therapy could be approved. Multiple trials and many years are usually required for approval, but the new legislation being introduced to the Senate HELP Committee could speed this approval process.

MARCH 2016 CELLULAR THERAPY LEGISLATION INTRODUCED

Senators Mark Kirk and Susan Collins are poised to introduce this legislation, because they recognize the hardship placed on patients with difficult to treat diseases, who are left with no option but to raise funds for cellular therapy, and many have to travel outside the U.S. to received treatment.

Mar 16, 2016: The Kirk/Collins bill will be introduced to the Senate HELP Committee.
Apr 06, 2016: The bill is scheduled for markup (approximate date).

YOU CAN HELP PASS STEM CELL LEGISLATION

Click TAKE ACTION for step by step instructions and draft letters you can email your Senators today. Your story can make it clear why this bill will help patients, whether you are a patient, or know someone who needs stem cells. If you are in a state that has a Senator on the HELP Committee, we urge you to schedule an in person meeting during recess March 27th-April 4th.

Patient For Stem Cells will be monitoring this legislative process and reporting developments as they happen. This may finally bring together all the stake holders, the regulators, legislators, researchers, physicians and patients, so that cellular therapy finally gets the high priority that a breakthrough therapy deserves.

Please use the share buttons below spread this post far and wide so our Senators get plenty of emails!

If you have a stem cell story you’d like us to cover, or wish to report on your interaction with your Senator, please Contact PFSC.

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