Who is the real Doug Sipp?

Doug Sipp's blog has viciously attacked any physician using stem cells. While a few of his attacks have been against real bad actors, many have also been against physicians trying to do legitimate work. He's also attacked groups of sick patients who want access to this care. Why?

To understand Sipp and his blog, we need to digress back into his history. Doug is an American who has lived in Japan since the early 1990s. When Doug first arrived in Japan after college, he worked on "patient simulation software". He then worked as a freelance translator at the Nature Network. It's interesting that neither job was academic in any way, nor did either qualify him as being an expert bioethics or policy issues on stem cells.

He has commented on his tenure as a science translator. In one 2005 article, he boasts that translating science articles can be lucrative:

"Pay Translation can be a lucrative business or sideline in Japan, which offers some of the best per-word rates in the world. Fees for technical translations from Japanese into English range from ¥3000 to ¥6000 per page (US$23 to $46); English to Japanese translations pay a little less. An experienced translator working with familiar subject matter can earn in excess of ¥10,000 (US$77) per hour, but few people are able to maintain that pace for a full 8-hour workday."

That's more than 140K USD a year! (or 88,500 pounds)! So we know Doug had a smattering of first jobs after a four year college degree and was making some serious cash translating science articles.

He states in his profile on the Nature Network that he now manages communications for a research institution in Kobe Japan. What is that research institution? The Riken Centre is a large and often entrepreneurial group of different labs scattered across Japan. 

While Riken seems like a credible place that does legitimate science, it has also done some nutso things in recent years. They have recently been in the news for trying to clone woolly mammoths. This is despite Japan's neighbour south Korea being infamous for serious ethical issues cloning dogs and cats. In fact, a science daily news site reported that Riken had taken "one giant leap for mankind" by reviving...wait for it...a dead rat!

The Riken Zombie Rat...

So is Riken merely a government research institution with no financial incentives? Not really. This on-line page explains how centers like Riken can cash in on bio-tech. Nature has described how Riken works with pharma companies to license their valuable patents. This page at the Riken Centre web-site explains more about how Doug's bosses in the life sciences area monetise their science. While their work is supposedly funded by the government, as one example, if you use Riken's cell clones to find something that leads to a patent, like the Yakuza, the center wants it's cut! In fact RIKEN filed a total of 998 patents in fiscal year 2008-2009. RIKEN has even set up a program it calls a "Baton Zone" that it explains as:


"Integrated Collaborative Research Program with Industry
Projects on topics proposed by private industry are undertaken at RIKEN to integrate the two parties’ expertise. An ad hoc collaborative research team, headed by an expert sent from the company, is formed to construct a technology platform and to realize prompt commercialization of research outcomes."

Riken-We want our "Vig"...

What's interesting is that Sipp's bosses at Riken have created an entire centre to commercialise patients (read turn them into cold hard cash). The tag line says it all, "Managing technology to create value". 

The web-site claims that "The RIKEN Venture system enables researchers to put their own world-class scientific achievements to commercial use". Read, "big pay day for scientists"... Heck, RIKEN will even give you office space in their buildings! How many companies have taken advantage of this program? 24 and counting... 

That company list is interesting in that the most prolific area of university-private payola is...you guessed it-Biology! 

Now is this characterisation of the Riken center and Doug's bosses fair and balanced? Maybe not, yet Doug has never been fair and balanced. What is fascinating, is that despite friendly news organisations noting that Doug's work is nasty...

CE: Well, now that you mention “rhetorical license,” let me ask you something else.  You don’t exactly mince words on the blog.  

...Doug's employers seem to turn a blind eye. In fact, there's every indication that his employers love his hate speech. While he started out as a communications director, after he began viciously and often unfairly attacking stem cell clinics and sick patients that were competitive to the interests of the his bosses patents on iPS cells, he got a promotion to the director of bioethics and policy for that unit. Funny thing, he knows nothing about bioethics! He has a four year degree and did not major in bioethics. He holds no masters degree nor doctorate in the field. Frankly, it's unlikely that he would qualify as a graduate student in bioethics, let alone a director of bioethics!

More on Doug's Bosses and why they would support his hate speech...

[I want to thank an anonymous reader of the blog for some of this information]. As discussed, Sipp works at a research center that uses competitive technologies to the adult stem cell clinics he bashes. In fact, the Riken Center is involved in the MEXT iPS cell research network which focuses on the distribution of iPS cells as well as patenting and licensing of intellectual property (iPS cells). 

iPS cells are a very popular topic in Wall Street biotech plays as unlike adult stem cells; they can be patented like a drug chemical (as they don’t exist in nature) and mass produced in bioreactors for mass distribution like a drug. If iPS cells become a clinical reality, these Riken patents would be worth a fortune to the bio-pharma industry and this centre. So what could possibly threaten the commercialisation of the science breakthrough known as iPS cells? Safer adult autologous stem cells being used by physicians as transplant surgeries instead of drugs. After all, why would a doctor use very expensive iPS cells provided by a pharma company through a Riken license if cheaper stem cells from the patient's own body would work as well?

While Sip has done a great job concealing his true intentions from the press, this talk that he gave in London in 2010 really says it all:

"Appearing: Congress Day 3 Thursday 13 May 2010 - AFTERNOON PLENARY SESSION 4:20 PM

Overcoming the threat to legitimate business: medical tourism and the stem cell industry"

Who are the “legitimate” business interests? Doug's bosses of course! If the Riken centre has no financial skin in that game, why is it filing for about 1,000 patents a year and licensing them to private industry? (see US 2010/0167398 A1 and US 2011/0091869 A1). If its interests are the pure pursuit of knowledge, why file for a patent at all? 

We can even drill the cells for profit scam right down to the scientists in Doug's unit. For example, why is the director of the group where Mr. Sipp works on the scientific advisory board for iPS Academia Japan, Inc?

What is iPS Academia Japan? It’s a for profit business entity devoted to cashing in on the discovery of iPS cells. This is from their web-site:

"Our main task is to manage the patents and other intellectual property relating to iPS cell technology, and grant the license to entities under such patents and intellectual property to use the technology in healthcare and pharmaceutical research as well as in drug discovery and to commercialize the iPS cell-related business."

In summary, who is Doug Sipp? I live in the UK and in this part of the world we have an ancient custom of "sin eaters". The general idea is that some poor bloke is hired at a funeral to "eat" (read internalise) the sins of the dead so that the deceased can more easily make it to heaven. This concept has now also been generalised to mean someone who does the nastiness to keep others pure.

I view Doug as a "sin eater"The recent movie, "The Borne Legacy" explains it well. After just being given and carrying out an order to do something heinous and horrible against civilians, the main character, a military operative/assassin, gets a pep talk from his boss:

“We are the sin eaters. It means that we take the moral excrement that we find in this equation and we bury it down deep inside of us so that the rest of our cause can stay pure. That is the job. We are morally indefensible and absolutely necessary. You understand?”

Doug and his bosses consider Doug to be morally indefensible and absolutely necessary and he is assigned the dirty work so that their cause can appear to be scientifically pure, even if what they are actually doing is harming patients by limiting choices and access. 

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. 

Chinese company smartly invests in stem cell anti-aging

Chinese company smartly invests in stem cell anti-aging

Late last year, a Hong Kong-based Caymans-incorporated company, Zmay Holdings, caught the stem cell fever, plunking down around $40 million (a total of 330 mil HKD) in bonds and equity in a deal for a technology that involves growing various types of human stem cells from ordinary somatic cells by treating them with Chinese herbs. This makes sense, as any chemical may induce differentiation in cells.

Zmay, bought the tech from inventor Xiongbin Lin.

Forty mil is big money by any measure. And the new licensees have lost no time in seeking to capitalize on their investment. The Institute of Aging Institute of Anti-Aging Medical Research on Stem Cells (Hong Kong) Limited, which was acquired from Lin as part of the deal, has recently changed its name to 159 Anti-Aging Center (H.K.) Ltd., registered a web domain, and is on a hiring spree.