July 29, 2010

Volume 2, Issue 7

In This Issue

· The Truth About ISSCR and Its One and Only Mission

Don Margolis

Bangkok, Thailand

It is very easy to get emotional when discussing stem cell therapy. Recent media attacks that have gone so far as to call stem cell therapy snake oil are increasing at a perplexing rate. One reason for this is that the ISSCR has declared war on offshore clinics, dubbing them predators of desperately ill patients. The ISSCR, led by Dr. Irv Weissman, maintains an enormous budget for PR and it shows. Rather than RSCI just hurl a few insults back or simply accuse anyone of having hidden agendas, it is time to put facts on the table.

This special issue of the RSCI newsletter is dedicated to all the patients and caregivers out there that must be given the opportunity to make their own decisions about stem cell therapy without the influence of special interest groups.

It is our sincere hope that patients will use the information provided in this newsletter when confronted with negativity and misrepresentations. Patients must fight back or face the reality that stem cell therapy may no longer be a choice at all. We believe the power is in the patients. Make your voice heard whenever and wherever possible.

The billionaires who are in total control of ISSCR and, indeed, western medicine, are using lies and hundreds of millions in P.R. to destroy your right of medical choice in order to increase their current bottom line profits of $15 million PER HOUR. (1) Are you going to let it happen?

Barbara Hanson Don Margolis

Stem Cell Pioneers Repair Stem Cell Institute

THE TRUTH ABOUT ISSCR AND ITS ONE AND ONLY MISSION:

TO KEEP STEM CELLS AWAY FROM SUFFERING PATIENTS

A Closer Look at Stem Cell "Irv"

The media has been ablaze recently with stories and blog posts about ISSCR (International Society for Stem Cell Research) and Stanford University researcher, Irving Weissman, its current president. The group is systematically attacking off-shore stem clinics with a vengeance. The Google news search shown here tells the story well, showing a dramatic spike in news stories about the organization this past two months. The media usually refers to "Irv" (as he prefers to be called) as a threadbare academic, toiling in his Stanford lab working for the good of mankind, but is this picture of an unbiased academic consistent with what's been published about Irv? Similarly, ISSCR has been positioned by the media as a champion and protector of the common man, a group of academics trying to protect the public from evil stem cell scams. Is this true, or is there a deeper story below the surface?

Academic or Conflicted Businessman?

Every academic or physician who might influence the public or colleagues must report his or her, "conflicts of interests". Stanford is no different and has such a policy (see http://rph.stanford.edu/4-4.html). Irv's Wikipedia page, clearly lays out multiple such conflicts:

Disclosures and Conflicts of Interest

Dr. Weissman has been cited in several articles for numerous financial conflicts of interest as an academic.^[3], ^[4], ^[5]. . Weissman himself has made tens of millions from stem cell related ventures with financial interests in many stem cell based companies including SyStemix, StemCells Inc, Cytotherapeutics, OVP Venture Partners, Cellerant, Amgen, DNAX, and T-Cell Sciences.

So Irv has multiple conflicts, so what? Don't most academics? These surely don't influence his decisions or public statements, do they?

Weismann's Public Statements vs. Business Interests

If you follow stem cell developments and news, Irv is the Joe Biden of Stem Cell Research, someone who constantly seems to be making statements that make no sense and aren't in keeping with his academic credentials and standing or are so out of touch as to be absurd. Take for example this statement made at the American Association for the Advancement of Science annual conference:

Umbilical cords contain blood-forming stem cells at a level that would maintain the blood-forming capacity of a very young child ...They don’t make brain, they don’t make blood, they don’t make heart, they don’t make skeletal muscle, despite what various people claim ... [The banks] do the therapies, then they let the patients go on their own, short of maybe 50-150,000 dollars for a therapy that has no chance ─taken away from a family that needs them when they have an incurable disease. It is wrong.

As discussed in the Newsweek article above, this statement wasn't consistent with the measured language from the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics. In addition, this certainly wasn't consistent with the thousands of published animal studies and pre-clinical work performed by Irv's colleagues (ISSCR members) who worked with cord blood cells and saw great promise. Since the cord blood industry had already performed some 14,000 safe transplants and Irv was counter to his own organization, ISSCR issued a statement distancing itself from Irv's rant. Irv has made other statements counter to the academic community's consensus in stem cells, the most prevalent of which have been about adult stem cells (aka the competition to embryonic stem cells-Irv's area of expertise). How about this piece from science writer, David Fumento:

While ASC researchers like Black or Losordo may get calls from reporters if they’ve just published an exciting new discovery, those same reporters (to "add balance") make sure they give a counter-quote from ESC advocates like Harvard’s Melton, or Stanford’s Irving Weissman. Those men will often say things that are, simply, ludicrous-and they get away with it.

In a recent Washington Monthly piece by Chris Mooney, for example, Weissman claimed there is "no independently verified evidence today" that a non-embryonic stem cell of one type "can turn into another [type of] tissue at all." Sure, that claim is contradicted by countless published, peer-reviewed papers to the contrary, all available at the push of a few keys at the free Internet database PubMed. (One was even co-authored by Weissman.) But reporters feel a quote from a prominent credentialed ESC booster gets them off the hook from having to do that simple search.

"Whether there’s any evidence to the contrary or not, reporters don’t bother to check," says the FRC’s Prentice.

Yet it’s even worse than that. If Melton or Weissman thought reporters would do additional research, they wouldn’t make such comments. They count on journalists’ ignorance and laziness – and they get it.

Why would Irv want to Misrepresent the Science?

Weissman himself holds more than 30 patents (see http://tinyurl.com/36jpgys). While it may seem strange for an academic to hold patents, this disturbing trend has proliferated of late as cash strapped universities encourage professors to patent their discoveries for a cut of the licensing action. Patents=licensing fees, meaning that for a company to develop a certain type of stem cell as a Pharma drug, if Irv holds the patent, they must license his patents to develop the drug. In addition, Irv's current company, Stem Cells Inc lists this as its mission:

StemCells, Inc. is engaged in the research, development, and commercialization of stem cell therapeutics and enabling technologies for use in stem cell-based research and drug discovery.

So Stem Cells Inc is not a purely academic endeavor, but one with its own business interests to protect. The March 10th, 2010 10K SEC filing of the company lists Weissman as a member of the board of directors since 1997. For his consulting to this company, Weissman was to receive 500,000 shares of common stock valued today at about $400,000 plus an undisclosed amount of ongoing cash compensation. Based on the American Association of University Professors estimate of Stanford's annual salary for professors, with that one contract, just in stock alone, Irv received about 2 1/2 times his annual salary as a signing bonus.

Irv and the ISSCR?

Irv and the ISSCR seem to be developing a very specific lexicon of words used in their press releases and repeated by the media. As examples, Google searches as of July 2010 under the following search terms with "ISSCR and stem cell" reveal the following results:

"Rouge Clinics"-14,900 pages
"Predator"-1,310 pages
"Clinic Scam"-20,000 pages

Are all of these words being independently used by journalists and bloggers to describe off-shore stem cell clinics? No, similar language appears in ISSCR's own press releases and the statements of its leadership:

See http://news.sciencemag.org/scienceinsider/2010/06/stopping-stem-cell-snake-oil.html-"At the society's annual meeting here last week, ISSCR President Irving Weissman, a stem-cell scientist at Stanford University, said that such clinics prey on vulnerable—often terminally ill—patients, taking their savings as well as precious time from their family and loved ones."
See http://media-newswire.com/release_1122621.html -"Many people are going into the hands of predators,” said Irving Weissman, MD, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine and immediate past president of the International Society for Stem Cell Research, or ISSCR."

Why this specific language? Who's coordinating the messaging?

Why the Outright Attack on Investigational Care?

Investigational care means care that has yet to be accepted as standard of care in the medical community or care that lacks strong evidence (what's called level 1 evidence) to support its use. The kind of evidence we're discussing here is a very high bar to jump, so by some estimates as much as a third to a half of all medical care practiced today is in this investigational category. For example, every time a surgeon tries a variation of a tried and true surgical technique, it's investigational. Every time a doctor uses a drug for a different disease than the one that is FDA approved or alters the dose beyond the recommended amount, it's investigational. In essence, we're surrounded by investigational care every day and just about everyone who has interfaced with the medical care system has likely received some form of medical care that doesn't have high levels of evidence to support its use, so it's considered investigational. Investigational care also includes alternative therapies, nutraceuticals, and other new therapies. What are other common types of investigational care?

An innovative ultrasound treatment to kill prostate tumors without more invasive surgery
Platelet Rich Plasma to help heal orthopedic injuries
Many compounded drugs used by doctors everyday and made by prescription

However, while each therapy has its distracters, no-one is launching a coordinated high dollar attack on these therapies. Why then the full frontal assault on stem cell clinics offering investigational care?

The Money Lost by Pharma by new Stem Cell Therapies will be Epic

What is a society that represents the interests of stem cell researchers doing spending huge dollars on a high dollar public relations firm? Who's footing that bill? The ISSCR web-site lists the following corporate sponsors: Geron, StemCells Inc, Pfizer, Tengion, Cellerant, Sanofi-aventis, Reneuron, F. Hoffman-La Roche LTD, just to name a few. ISSCR's conferences list many more as sponsors.

To understand how much big Pharma stands to lose to these new stem cell based treatments, you must first understand that for many diseases in medicine, doctors simply manage symptoms or try to hold back the dam, they don't cure anything. How much do the traditional Pharma companies stand to lose if stem cells "cure" various diseases? Let's take angina, or heart pains caused by heart disease. The market size is estimated by CV Therapeutics Market Report as (see http://media.corporate-ir.net/media_files/NSD/CVTX/reports/ar96.pdf):

Approximately 6.7 million people in the United States suffer from angina, accounting for $3.0 billion in annual sales of anti-anginal drugs.

So in this one diagnosis, Pharma will lose 3.0 billion a year if stem cells are capable of curing heart disease. If one takes that 3 billion and divides it by 6.7 million patients, that's $437 a year per patient. Assuming those patients will live on average 35 years when they start the therapy, that's $15,295 lost lifetime revenue per patient. If Pharma is to make that lost revenue up, they must control the pipeline of stem cell therapies and get a big premium from insurance companies for their stem cell therapy. Using this methodology, a reasonable price for a stem cell therapy to cure heart disease may be in the $30-40,000 range, especially if you account for the decreased cost of doctor visits, hospitalizations, surgeries, etc...

However, what if stem cell clinics in the U.S. or off-shore are offering effective stem cell therapies at $5,000 per treatment? It will be very hard to argue to insurance companies that your Pharma stem cells are worth $30-40K.

What if the results of simple stem cells obtained from the patient, cord blood, or other sources are as good as the patented Pharma stem cell treatment? The “blockbuster" Pharma stem cell product may slip into oblivion as the competition from physician clinics eats up the market. What if insurance companies get wind that a doctor using a simple stem cell re-implant from the patient or a transplant from a donor can cure heart disease for $5,000? Good bye Pharma stem cell market.

ISSCR's Purge

ISSCR recently announced a purge of members associated with off shore stem cell clinics. These members will be sent notices and "loyalty oaths" where they pledge never to be involved with a stem cell clinic that is practicing outside a Pharma sponsored trial or outside the parameters of US FDA's regulations. This last part is left a bit vague by ISSCR, as many countries where these off-shore stem cell clinics exist obviously don't have US style drug laws in place, laws bought and paid for by your overpriced prescriptions.

Perhaps just as interesting is that one of the key members involved in ISSCR's attack on stem cell clinics is Doug Sipp, a manager for the Riken Center for Developmental Biology in Japan. One of Sipp's recent lecture titles is telling, entitled Overcoming the threat to legitimate business: medical tourism and the stem cell industry. If ISSCR is concerned about patients, why is a key player involved in the attack on off-shore stem cell clinics giving lectures about threats to business interests?

ISSCR's takes the Attack to Medical Journals

One of ISSCR's key members, Andreas Nagy recently brought the ISSCR attack to the medical journals, with an editorial entitled, Stem Cell Therapy for the Kidney: A Cautionary Tale (http://www.ncbi.nlm.nih.gov/pubmed/20558540). Nagy et al were commenting on a case report by Thirabanjasak et al. entitled, “Angiomyeloproliferative Lesions Following Autologous

Stem Cell Therapy” in which the authors described the death of a patient with End Stage Renal Disease who received stem cells. The patient had the stem cells injected blindly into the abdominal cavity, presumably targeting the kidneys (not a recommended medical practice). The injections were unhelpful and the patient began dialysis within a few months (which is common for patients with End Stage Renal Disease). After six months the patient presented with abdominal pain at the site of stem cell injection, and imaging revealed a suspected cancer. At 11 months after the stem cell treatment the left kidney was removed. The authors concluded that while strange looking lesions appeared at the injection sites in the kidney and elsewhere, there was no cancer. The patient ultimately died of a severe infection unrelated to the stem cell therapy. Although the paper was interesting, Nagy took the opportunity to speculate that the stem cell treatment caused the patient’s death, despite the fact that Thirabanjasak et al. did not reach the same conclusion. Why the overreaching?

Nagy is a key player in the induced pluripotent stem cell (IPS) movement . IPS is the lab practice of taking a normal cell such as a skin cell and transforming into an embryonic like stem cell. Why go through all the trouble of turning a normal cell into a stem cell if adult stem cells already live in all of us? In a word, Patents. An adult stem cell taken from a patient and used to cure his or her disease may not be able to be patented, based on the results of recent court cases questioning gene and stem cell patents.

(See http://badgerherald.com/news/2010/05/04/stem_cell_research_p.php and http://scienceblogs.com/geneticfuture/2010/03/jaw-dropping_verdict_against_m.php).

A patent is necessary to protect a Pharma company from competitors if it spends the money to jump through the regulatory hoops to get a stem cell line approved as a drug. Nagy's attack on the use of the patient's own stem cells and Weissman like hyperbole appears to be rooted in both a personal business conflict of interest (nobody will use IPS cells if their own adult stem cells are effective) and the institutional attacks being launched by ISSCR, an organization where he remains a key player.

Conclusions

Weissman and ISSCR have presented themselves to the media as unbiased academics trying to help sick patients avoid stem cell scams and doctor predators. If their message were just one of education about what might be credible or might not be credible therapy, their points would be more consistent with other professional organizations seeking to help patients make difficult choices in the era of internet information overload. However, unlike other organizations, ISSCR's message is very different. ISSCR is trying to wipe from the face of the earth, all investigational care involving stem cells-the good and the bad (aka the competition). This behavior appears to come from the top, as Weissman has done the same through the years, often bashing other promising therapies in the media that were in competition with his business interests.

Since countless patients will perish before US FDA gets around to approving stem cell therapy for many diseases, one has to question ISSCR's motives. These patients obviously deserve the right to access whatever investigational care they wish. In addition, the contention that ISSCR is unbiased doesn't fit with multiple demonstrated conflicts of interests. When ISSCR's leader has already made 8 figures selling stem cell companies and signs 6-7 figure consulting agreements, Irv can't be characterized as a monkish academic simply trying to protect the public, but is simply another businessman with a financial dog in the fight. In addition, as an organization, ISSCR also has key business conflicts with the stem cell clinics it is seeking to shutter.

(1) https://en.wikipedia.org/wiki/List_of_pharmaceutical_companies

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RSCI EPILOGUE:

Thank you for reading the Repair Stem Cell Institute’s Newsletter! We want to bring you up to date on the new improved stem cell treatments that are available now.

In 2009, the Repair Stem Cell Institute helped thousands to learn about the safe and effective stem cell treatments available to them. Many chose stem cell treatments that the Institute recommended, and perhaps two-thirds of them are well on their way to an improved quality of life.

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WHO WE ARE/WHAT WE DO

Repair Stem Cell Institute

RSCI is a worldwide public service organization providing access to high-quality stem cell treatment care through education, empowerment and advocacy. RSCI offers individual patient guidance to individuals needing expert and reliable stem cell treatments for chronic and disabling diseases at no cost to the patient. Treatment information, diseases treated, featured articles…and for the beginner, STEM CELLS 101 is a must!

The Stem Cell Blog

The STEM CELL BLOG was created by RSCI Director of Communications and Editor of the Newsletter, David Granovsky, to increase awareness of the exciting world of stem cells. With over 800 articles, The STEM CELL BLOG is a good place to get started on all things stem cells; science, news, celebrities, religion, politics and treatments. Email don@repairstemcells.com for assistance. The STEM CELL BLOG receives about two dozen emails per day from people asking where to get treated, what is the current status of treatment for their disease, etc.

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Don Margolis’ Blog

Don Margolis started the first stem cell treatment company in the world for no-option heart patients in 2003, a company which treated its first commercial patients in 2005.

In 2008 he started the only stem cell blog in the world dedicated to “Stem Cell Victories.” Hundreds of patients took their health and life into their own hands and were rewarded with life extensions and better quality of life. The donrmargolis.com blog is focused on the individual patients who have been helped by Repair Stem Cell therapy. Hundreds of featured patients with Parkinson's, Diabetes, Spinal Cord Injuries, Multiple Sclerosis, Heart Disease etc. have experienced significant improvements in their condition and quality of life. Articles are searchable by disease or category.

And then Don founded the Repair Stem Cell Institute…

RSCI Defined

RSCI helps patients with so-called "untreatable" medical conditions make educated choices and connect with the world’s finest, most advanced stem cell doctors.

Stem Cell Patient Advocacy:

RSCI is the world’s only Stem Cell Patient Advocacy company and the only public service organization in the world whose mission is to empower "untreatable" patients and educate them as to how stem cells may (or may not) help them. RSCI helps patients NOW, not 10-30 years in the future. We offer individual patient guidance at no cost to those whom desire access to expert and reliable stem cell treatments for chronic and disabling disease. RSCI does not treat patients; rather, we guide patients toward a better quality of life.

Stem Cells are Safe, Effective & Beneficial!

Have you been told Repair Stem Cells are untested, unsafe, ineffective and even detrimental? In fact, the safety and efficacy of Repair Stem Cells ARE proven in over 1000 clinical trials in the US and around the world! The October RSCI Newsletters specifically detail how safe and effective stem cell treatments are. They contain everything you'll need to empower yourself to make life-improving decisions: October 2009 Edition and October 2009 Special Edition

RSCI Standards:

As of now there are about 500 stem cell "treatment centers" around the world. RSCI selects only the top treatment centers in the world in order to help patients completely avoid both the incompetent treatment centers and the shell companies that will take your money and vanish. RSCI-Standards

RSCI 2010 Decision Guide:

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EMAIL: heather@repairstemcells.com

THE FUTURE OF TREATMENT HERE TODAY!

· Heart Disease Data Surpasses All Others!

Cellular therapies for heart disease are available with statistical data on patient’s improvements now available that surpass all other treatment result statistics.

· Parkinson’s Disease Treatments address Blood Brain Barrier!

Cellular therapies for Parkinson’s disease are available now with new improved treatments coming soon that address the Blood Brain Barrier!

To find out more on treatments for HEART DISEASE, HEARING or PARKINSON’S, email heather@repairstemcells.com with the word “HEART DISEASE” or “PARKINSON’S” in the subject line. Please include your name and your country in all messages.