Much More than Minimally Manipulative

These next few blogs will get back to Doug Sipp’s carelessness accuracy and why any reporter who attempts to use Sipp’s blog as a source for anything others than giggles has a serious ethics problem (which Sipp himself can’t help with as the ex-trucking supervisor’s manual is mum on bioethics).  One of Doug Sipp’s recurrent whipping boys appears to be the ICMS, a physician professional organization. I must admit that when I first read these Sipp posts, his attacks on ICMS made little sense. After all, Sipp espouses oversight over stem cell use and the only professional group trying to place guidelines around and restrictions on stem cell use was ICMS. 

So why attack the ICMS? Money. The iPS cells being hawked by Doug’s bosses at RIKEN are late to the proverbial stem cell soirée. An entire professional organisation founded to treat patients responsibly using their own stem cells is an incredible threat to the patent interests of Sipp’s paymasters, who must delay the use of any stem cells until they have had a chance to cash in.

First, what is the ICMS? From their web-site, it’s clear that they are a physician professional organisation.  Unlike the rouge clinics Sipp loves to point to, ICMS has actually established written guidelines for a right and wrong way to use stem cells in patients in accordance with the Declaration of Helsinki (oops, Sipp never took that course…) They have also required accredited clinics to collect data on patients in a registry. So what’s wrong with ICMS? They represent a massive threat to Sipp’s puppet masters.

To get a better sense of the who, what, where, and why for these ICMS related posts I actually did something that our ex-trucker turned pretend science policy guru never did; I made sure Sipp’s supporting links actually supported his vitriol and I e-mailed the people involved to check accuracy. Low and behold, Sipp’s precision is like a pub drunk walking the bobby line at closing time.

Sipp first sets the scene of the his ICMS “freak show” by claiming that it's headquarters are nowhere . To do this, he uses a Google street view off the ICMS Facebook page which shows what appears to be an empty lot and claims that’s where the world headquarters of ICMS are located. Could a physician professional organisation actually receive its mail in an empty lot? Well, turns out Sipp didn’t look too hard. The address on the Facebook page he quotes does indeed show this scene, but it doesn't take an advanced science to degree to figure out something is amiss. Turns out that Facebook's geolocation software can't handle a PO box, as it's not an actual physical address, so it has picked a random road in Salem, Oregon. What happens if you…I don’t know, actually see if there’s an address on the official web-site (www.cellmedicinesociety.org)  rather than trusting Facebook as a source for narcissistic mirror peering journalistic integrity? Well if you did that, you’d get a different “picture”. When one looks up where PO Box 4432’s physical address is located on the Black Book service it’s actually:

The Real Location of the ICMS PO Box...

VISTA POST OFFICE
3624 COMMERCIAL ST SE
SALEM, OR 97302

It didn't take a degree in rocket science or bioethics to find the actual physical place where ICMS has it’s PO Box.

After setting the falsified place where his orgy of inaccuracy will begin (an abandoned lot a US Post Office), Sipp then libels digs his teeth into the individuals who founded ICMS. Let’s take these one by one:

Michael Freeman, M.P.H., Ph.D.-Freeman legitimately holds a Ph.D. in Epidemiology and a Master of Public Health degree. No pretend bioethicist 4 year English major here. Freeman is an professor at Oregon Health and Science University and has a CV 14 pages long that makes Doug’s lack of education “life experience” look really bad (Freeman states he has total 130 publications on his OHSU site ).  Let’s compare the real professor versus the fake bioethicist. A search of the American National Library of Medicine lists 41 publications for Freeman, most actual research studies. Doug Sipp has 16 publications, pretty much all of them marketing ads for RIKEN opinion pieces about the horrors of stem cell tourism.  So why is our ex-trucker who his falsifying credentials as a researcher calling out a real university professor?

Sipp loves to dig up dirt from people’s distant past and claim it has some bearing on their current credibility and Freeman is no different. Here Sipp cites a 1990's insurance dispute between then chiropractor Freeman (before his M.P.H. and Ph.D.) and the state of Oregon quasi-governmental insurance program. Sipp hyperlinks a court case as proof positive that Freeman is a Charlatan. However the link doesn’t actually point to a case where Freeman was found to be doing anything wrong, it’s actually a link to the verdict exonerating Freeman! So what Sipp would have the reader believe is proof positive of Freeman’s guilt, is actually the opposite. I guess understanding legal documents is also not in the ex-trucking supervisor's handbook. 

Christopher Centeno, M.D.- Centeno is a physician founder of ICMS. Centeno is a double boarded M.D. who was actually also awarded a graduate degree, unlike our ex-trucker. He also has far more publications than Sipp, again most focused on actual clinical research rather than sales jobs editorials. His attack of Centeno focuses on his court case against FDA. While Sipp claims that this is some sort of attempt at “deregulation”, what he hasn’t yet told his readers is that two former FDA commissions have agreed with Centeno’s position on stem cell regulations and published their thoughts in the Wall Street Journal (see ex-commissioner 1 and ex-commissioner 2). In particular this group of ex-FDA employees contains an M.D./ Ph.D, an M.D., and attorney. So far no ex-trucking supervisor editorials have been accepted by the Wall Street Journal, but I'm sure this science policy chief marketing manager is trying hard.

Sipp then goes onto attack Centeno based on the written testimony of an expert hired by FDA to support it's position that the orthopaedic stem cell therapy used by Centeno and colleagues represents a new drug. Here Sipp uses an old trick, only showing the side of this story that supports the smear campaign to colour his attack argument. In this case he points out the testimony of George Muschler, who himself is like a ticking time bomb about to explode all over Sipp's parade. Why? For this I will rely on a statement by Centeno given to me and a post by Centeno on Sipp's site.

[Centeno]-"Muschler was commenting on our early case study research and comparing that to an FDA drug trial. There is no way to compare a physician trying different IRB approved remedies on individual patients with a massive FDA drug trial. Eventually, this early research led to two large papers, one n=227 and n=339, both better research than Muschler himself ever published on his own competitive device. Turns out Muschler was quite the hypocrite..."

Dr. Muschler's Trojan Horse/Competitive Device-Can you say "conflict of interest"?

What does that mean? What competitive device? For this I will use Centeno's comments on Sipp's blog:

"Dr. Muschler established his own standard for what constitutes effective research. Unlike our procedure, where we went through two years of an IRB where we didn’t charge patients, Dr. Muchler’s competitive procedure that spawned his “Cellect Device” was used by surgeons solely based on a study in dogs (i.e. without any human use or IRB oversight). This is despite the fact that under current FDA rules, the device more than minimally manipulates a bone graft sample by allowing stem cells to attach to the sample, as its stated goal is to alter the biologic characteristics of that bone graft. After that, it was used in thousands of patients before a single human trial was performed. When that study was finally published, it wasn’t an RCT with a placebo; instead it was a comparison trial similar to the one we published on our procedure (see http://www.box.com/s/vzlh0sqt3v987m33vnfj)."

Centeno also pointed me to a Sipp source for this blog post, "Dr." Amy Price, a woman who turned out to be quite bonkers. 

Amy Price in University Garb after not Actually Graduating from any University with anything similar to a PhD

Meet Amy Price, "PhD". Amy was a patient volunteer for the Spinal Injury Foundation (SIF), a non-profit meant to educate patients about spinal injuries that was begun by Centeno and Freeman. Over a several year period, Centeno donated several hundred thousand dollars to the organisation and took no salary nor did he benefit in any way from the organisation. The organisation had a web-site that was ultimately taken over by Amy Price, "Ph.D". While Doug Sipp's posts point to the archived versions of the site, mine points to the contemporary version, where Amy Price's smiling face greets us (see above).

The way to understand this former patient volunteer for the non-profit is to use court documents where she sued both SIF and ICMS (can you say, "Axe to grind?"). For example, Amy holds herself out as a PhD, which she trumpets on her Linkedin business page. With that in mind, reviewing her deposition in this case says it all:

Q [SIF Attorney] Okay. Could you tell me your educational history and what degrees you hold?
A [Amy Price] I can't recall.
Q Okay. Do you have a Ph.D. from Oxford?
A No.
Q Okay. Do you have a Ph.D. from any  university?
A I have a Ph.D.
Q Okay. From what university do you have a Ph.D.?
A I'm -- at this point, I don't recall. It's 14 many years ago.
Q Okay. Isn't it true, in 2011, you received the Ph.D. from -- in psychology from -- an Oakland University?
A No.
Q Okay. Did you have a Ph.D. from Oakland University?
A No.
Q Do you have a Ph.D. from King's College?
A I don't recall the names of all the colleges and things. I'm sorry.
Q Okay. Where did you have a Ph.D. from?
A I don't recall.

Doug Sipp's star source, for "breaking open" the ICMS "Freak Show" is quite a freak herself. She claims to have a Ph.D. (even more brashly than our ex-trucking supervisor), but can't seem to remember where she got that degree (a cereal box top?). So you spend a large chunk of your life pushing your Ph.D. thesis rock uphill and you can't remember where that happened? If you can't remember where you got your Ph.D. can anything that you say possibly be accurate? Is this the definition of "knackered"? 

So what did the judge have to say about the "case" she brought against SIF about the same time she leaked all of the unreliable "reliable" information to Sipp? The judge found against her for abuse of process and made her pay all costs and allows SIF to pursue punitive damages.

In conclusion, rather than delving even deeper to Doug Sipp's ICMS rubbish, it's likely best for Sipp just to end it here. It's also a good idea to end with a statement from the Pew Center's Project for Excellence in Journalism:

"Journalists rely on a professional discipline for verifying information. When the concept of objectivity originally evolved, it did not imply that journalists are free of bias. It called, rather, for a consistent method of testing information--a transparent approach to evidence--precisely so that personal and cultural biases would not undermine the accuracy of their work. The method is objective, not the journalist. Seeking out multiple witnesses, disclosing as much as possible about sources, or asking various sides for comment, all signal such standards. This discipline of verification is what separates journalism from other modes of communication, such as propaganda, fiction or entertainment. But the need for professional method is not always fully recognized or refined. While journalism has developed various techniques for determining facts, for instance, it has done less to develop a system for testing the reliability of journalistic interpretation."

Huh...looks like the ex-trucker's manual is also mum on source verification, but the Pew Research Center sure isn't...

More than minimally manipulated

More than minimally manipulated is an FDA term that means that cells are processed beyond a certain point. 

While the Celltex controversy was unfolding down in Texas, the International Cellular Medicine Society (ICMS), a group dedicated to applying stringent guidelines, announced the appointment of plastic surgeon Ricardo Rodriguez as its new president. will be the third leader of this organization, which has shown a frankly astonishing ability to project its patient centric messages (and those of its previous leaders, sports medicine doctor Christopher J. Centeno, and chiropractor/epidemiologist Michael D. Freeman) in major media and across the internet. 


But what exactly is the ICMS about, how did it burst so suddenly onto the stem cell scene, who are its leaders, and what motivates them? The tale is long, so I'm afraid I'm going to need to ask a bit more of your time than usual to explain.

ICMS gets it's mail at a PO Box, like many small organizations. Also like many small non-profits without funding, it's true presence is on the internet. 

The Salem P.O. box is a convenient place for ICMS executive director, Salem-based David Audley, to pick up the mail, and just one hour by car from Oregon Health Sciences University in Portland, where former ICMS president, Michael D. Freeman (2009-2012), teaches forensic epidemiology. Freeman, originally a chiropractor, More recently, he seems to be putting this knowledge to frequent use as an expert witness in various cases, including testifying for the defense in the Casey Anthony trial, and giving lectures on "Exposing, defusing and debunking junk science" in Los Angeles this January.

I don't know what led Freeman out of chiropractic and into the arms of epidemiology, expert testimony, and his longtime partnership with Chris Centeno, owner of Regenerative Sciences (of Regenexx™ and USA v Regenerative Sciences fame), but PubMed shows their first co-authored publication to be from 2004 ("Waddell's signs revisited?"). This co-authored comment in Spine  and their next six papers have nothing to do with stem cells, but rather various forms of spinal injury, with a focus on spine trauma. For the past few years I thought this was anomalous, and not particularly worth commenting on.

But then last month I stumbled across some real expert testimony, by Dr. Muschler and Freeman, in the FDA vs Regenerative Sciences case. But for anyone interested in seeing what a barn burner of back and forth between these two experts only need to look as far as Centeno's response to this article:

Dr. Muschler established his own standard for what constitutes effective research. Unlike our procedure, where we went through two years of an IRB where we didn’t charge patients, Dr. Muchler’s competitive procedure that spawned his “Cellect Device” was used by surgeons solely based on a study in dogs (i.e. without any human use or IRB oversight). This is despite the fact that under current FDA rules, the device more than minimally manipulates a bone graft sample by allowing stem cells to attach to the sample, as its stated goal is to alter the biologic characteristics of that bone graft. After that, it was used in thousands of patients before a single human trial was performed. When that study was finally published, it wasn’t an RCT with a placebo; instead it was a comparison trial similar to the one we published on our procedure (see http://www.box.com/s/vzlh0sqt3v987m33vnfj).

Centeno and Freeman were also leaders of a separate, now-defunct organization (Spinal Injury Foundation) prior to becoming the first and second president of the ICMS, and said organization was tasked with, among other things, providing the institutional review of a body of research behind Centeno's Regenexx™ Freeman responded to the FDA's expert declarations here, and Regenerative Sciences posted a chronology here.

Freeman and Centeno: the early years

At this point in the story, I have to give credit to an anonymous friend of the blog who pointed out that the Spinal Injury Foundation itself evolved from a different website, Whiplash 101. Centeno also founded an (also now-defunct) online Journal of Whiplash and Related Disorders, for which he and Freeman, served as co-editors-in-chief.

http://web.archive.org/web/20050210122622/http://whiplash101.com/

Centeno and Freeman's Spinal Injury Foundation ran awareness days and other fundraisers including, in 2007, a chance to drive a Lamborghini, Ferrari, Bentley, or other speedmobile around a race track in the Rockies. The promotional page for the event included the cautionary text: "If you can't find a car you like, consider psychiatric help or high-dose antidepressants."

Snap your neck for whiplash!

It was in around 2005 that Centeno showed visible symptoms of the stem cell itch (his first stem cell paper was published the following year). We know this because 2005 was the year he sold the Colorado professional corporation known as "Christopher J. Centeno, M.D., P.C."  to Florida-based company PainCare Holdings for $3,250,000 in cash and 1,132,931 PainCare shares valued at $3,750,000. The PainCare deal turned rancid after that company was accused of overstating its revenues, and became subject to multiple class action suits. Centeno was able to regain his assets.

Not long after this settlement, Centeno and Freeman started the first version of the ICMS, known as the American Stem Cell Therapy Association (ASCTA) at www.stemcelldocs.org. This group, whose founding members included Freeman, Centeno, and Centeno's partner John Schultz, espoused the same basic set of values that characterizes the ICMS, including an emphasis on the use of autologous stem cells as teh practice of medicine.

Whatever the case, the ICMS' general strategy seems to me to have consisted from Day One of: 1) the promotion of the use of stem cells as the practice of medicine.

In a remarkably short time, the ICMS became a credible organization, complete with various guidelines, an Offshore Clinics Report another patient portal (Stem Cell Watch), a newsletter, a Treatment Registry, which is at 750 registered patients and counting, and a Clinic Accreditation Program for clinics. The organization also recently announced a deal with an insurance company to provide malpractice insurance for their members. This, in my view, may prove to be one of the most valuable member service ICMS has introduced to date.

The accreditation program allows clinics to certify taht they are following guidelines. The first outfit accredited by the ICMS is the Regenerative Medicine Institute of Tijuana, Mexico. The ICMS process, took less than a year (the RMI application for accreditation was announced on March 15, 2011, and the ICMS approval announced on February 24, 2012). In the more recent release, ICMS executive director David Audley praised the clinic, saying, "The safety profile has been excellent. We have tracked patients over at least two follow ups and a minimum of six months and not seen a single cell-related adverse event." 

ICMS has also investigated clinics when adverse events were reported. This occurred when the organization announced investigation of the death of a patient treated at the same clinic, and then CNN later announced that the clinic's stem cell treatment didn't cause the death of the  two patients. The group's website issued a release noting:

The investigation of the deaths was led by ICMS Board President Dr. Michael Freeman, forensic epidemiologist and Affiliate Professor of Epidemiology at Oregon Health & Science University School of Medicine and Adjunct Associate Professor of Forensic Medicine at Aarhus University. The investigation involved extensive interviews and review of documents, as well as consultation with experts in clinical applications of stem cells, including Dr. Keith March, Professor of Medicine and Director of the Vascular and Cardiac Center for Adult Stem Cell Therapy at the Indiana University School of Medicine. As a result of findings uncovered during the investigation into the patients’ deaths, the ICMS initiated an on-site evaluation of ethical and clinical practices of RNL Bio, conducted by Dr. Glenn McGee, John B. Francis Endowed Chair of Bioethics at the Center for Practical Bioethics.

The ICMS has made the following findings:

• The death of patient JJJ, which occurred nearly 2 months after his last stem cell infusion, was unlikely to have been caused by either the stem cells or the procedures used to administer the stem cells. The specific cause of Mr. Jun’s death is currently unknown as no documentation has been released with this information.
• The death of patient LSK, which occurred on the same day as the stem cell procedure, was likely to have been caused or triggered by the stem cell procedure. The cause of death was due to a pre-existing blood clot that traveled to the lungs, and may have been precipitated by the procedure used to infuse the stem cells, or less probably, from a clot formed by the cells.
• No evidence was found to suggest that inaccurate information caused either patient to give consent to medical procedures that they otherwise would not have given. A review of all relevant forms, chart notes, correspondence, and interviews suggests that both patients were provided sufficient information to give appropriate informed consent, and both did give consent.

The ICMS has accepted other applications as well. Take World Stem Cells, LLC, for instance. Located in Cancun, Mexico, this clinic flies the ICMS badge right on the top page of its website, and applied for accreditation last May. 

http://worldstemcells.com/stem-cell-therapy-conditions.html

Chris Centeno has been keeping busy after being replaced by Freeman as head of the ICMS and is now locked in a legal fight over an injunction the FDA sought against his company Regenexx. He has licensed to partners in Argentina and China, and set up a stem cell treatment subsidiary in the Cayman Islands. He is also a planning committee member and speaker for this year's one-day ICMS-sponsored session in Hollywood, FL, held in conjunction with the annual meeting of the Age Management Medicine Group, alongside other such luminaries as Jeffry S. Life. 

Yes, that Jeffry S. Life.

It is too soon to say what will happen under new leadership, and best of luck to Dr. Rodriguez and the latest generation of ICMS leaders in setting the group on a course to science-based medicine. 

ICMS Audited by FDA to Ensure Compliance with Guidelines

ICMS Audited by FDA to Ensure Compliance with  Guidelines

The International Cellular Medicine Society reports that the FDA has audited its institutional review board (IRB), which the ICMS states has been asked to review "nearly two dozen study applications over the last 3 years from nearly a half dozen countries."

The group has run an HHS registered IRB for several years and it's press release states that it will be completely transparent with FDA. The agency commonly audits IRB's for compliance with HHS OHRP guidelines.