Gives patients a voice – Stem Cell Showdown: Celltex vs. the FDA

businessweek
Balanced Journalism Category: ARTICLES THAT INCLUDE OPPOSING VIEWPOINTS
Media item: Stem Cell Showdown: Celltex vs. the FDA
Published by: Bloomberg BusinessWeek
Author: Susan Berfield on January 03, 2013

Jan 11, 2012 the following letter was sent to Susan Berfield, who replied with the response we invited, which is posted below our comments. This is the type of exchange we were hoping for with the media.

Dear Susan,
Thank you for your article “Stem Cell Showdown: Celltex vs. the FDA”. Several members of our group, Patients For Stem Cells, were interviewed in your article.
Our group represents patients who have been denied access to our own stem cells because the FDA has regulated our cells as drugs. We oppose this decision and believe it is a violation of our basic rights.

We feel this is a very balanced article that exposes the challenges the industry is undergoing, and finally gives patients a voice too. Real patients discussing real concerns balanced against academics with theoretical concerns.

Part of our mission is to expose the severe financial biases of academics who are frequently tapped as experts in stem cell stories. For example, you quoted as an expert George Daley, who holds the following embryonic stem cell & IPS patents:

-2008 President-George Daley-Children’s Hospital-
-Creating Embryonic Stem Cells for Mass production-PCT/US2007/019935
-Method for Enhancing Proliferation of Stem Cells-PCT/US03/29185
-Proprietary Kit to see if an iPS Cell is Correctly Manufactured-PCT/US09/57849
-Method to Create iPSC’s (artificial stem cells)-PCT/US08/12532

Any of these multi-million dollar patents would be rendered worthless if doctors routinely use autologous stem cells in the practice of medicine.

Again, great work and congratulations for giving patients a voice!

Sincerely,
SammyJo Wilkinson, a member of Patients For Stem Cells
www.patientsforstemcells.org

AUTHOR’S RESPONSE

Thank you for your help with my story and for the close reading of it now. I understand your concerns about the competing financial interests of many of those involved in stem cell research and I’m glad you are reminding us all of that. Everyone I spoke with–scientists, executives, and patients alike–has something at stake. I believe George Daley was speaking out of concern for patients generally, not only those seeking treatment with autologous stem cells.
I appreciate the opportunity to respond.

Regards, Susan

5 comments
Stem Cell Treatment
Stem Cell Treatment

There are lot of research done in Medical Industry. These all are the mile stones in the medical industry. 



Zchick1836
Zchick1836

Finally a journalist who gave patients a voice! Thank you Susan Berfield, and thank you PFSC for having a place to post these articles! Over the past few years, as an MS patient and a stem cell recipient, I have a growing suspicion that something in the MS community is just not right. Something isn't adding up. Conflict of interests between doctors, FDA, and drug companies are over the top. We keep asking ourselves "why are so many MS patients seeking overseas/alternative treatments?" I had confirmation that MS patients are at the top of the list of "disease communities" seeking stem cell treatment abroad. There has to be more to this than meets the eye. The claims the drug companies, the FDA, and many scientists are making, are in direct opposition to what MS patients are actually experiencing. As of late in the media, our suspicions are being confirmed. The MS drugs are being proven ineffective and very dangerous. Efficacy rates in the drug studies are being called into question. We hope to dispel the idea that the majority of MS patients are being marketed to by foreign/domestic stem cell clinics. In reality, our experience is, that patients share their successes and failures with each other in regard to AdMSC treatments and clinics. We then make informed decisions in becoming a medical tourist. The successes we are seeing/hearing from other patients, far exceed any FDA approved treatment available to us in the USA to date. You could then form a hypothesis about other "disease communities" like ALS, Alzheimer's, Parkinson's etc, seeking overseas treatment for exactly the same reasons. There is a GIANT breakdown somewhere in our current system, and the huge popularity of medical tourism is a direct reflection of this gaping black hole.

marierhodesrn
marierhodesrn

Todd McAllister summarized the conflicts of everybody here: https://www.box.com/s/waxwfciz1eqxsbinvmxu. The readers digest: short version: doctors have a bias in the direction of treatment, academics in pulling down endless grants to fund their labs, "industry" in creating barriers to entry, consultants in generating consulting fees, and regulators in expanding regulatory turf. The only people who don't have a conflict are the very sick patients with few options who are now forced overseas. The only group that has tried to set up uniform standards and provide some oversight is ICMS. Now some others are trying, it's difficult to say which organization will succeed in the end.

marierhodesrn
marierhodesrn

COmpeteing financial interests are not just a theoretical construct either.  It is more than just the patients noticing it.  In an article titled "Autologous cell therapies: challengesin US FDA regulation" published in Future Medicine by McAllister, Audley and L'Heureaux stem cell scientists from a company called CytoGraft

 

Quote"On one end of the spectrum is the academic community. Through societies such as the International Society for StemCell Research, this community tends to echo the FDA’s conservative stance,and encourages continued bench-top and animal research. While justifiedin many cases, we cannot ignore the potential financial self-interest served by this message. That is, the NIH funded academic community is well served by a regulatory policy thatpromotes a longer and basic research intensive developmental path. Indeed it is no surprise to see the International Society for Stem Cell Research closely linked to the war on stem cell clinics"

 

It's obvious that if you are a stem cell researcher it suits your career best if autologous cell therapies are not available for a long time-if ever.  The more pent up demand that there is for a therapy the better it is for their products when they come out.  That just basic business and to pretend t hat somehow that doesn't matter to scientists when today's scientist holds patents and their commercialization can not only secure long term royalties but also tenure and academic security is plain naive.

 

It is patients who care about their health above all others including stem cell scientists who claim thie concern is all for the patient when they insist we can't have our own cells...  Marie Rhodes.

SammyJoW
SammyJoW moderator

You can now post comments on the articles at http://PatientsForStemCells.org, use your social lgoin ID and post it to Twitter, Facebook or LinkedIn in one fell swoop. We would like to hear from other patients who are interested in stem cells, also reporters, scientists and doctors. Do you think patients should have access to their own adult stem cells now?