Tuesday, 28 August 2012

Doug Sipp's Blog and Accuracy on "The CellTex Affair"-Part 1

My focus for the next several blogs will be to use what's publicly available on the Internet to check the accuracy of Doug Sipp's blog. My goal will be to pretend that I'm a reporter doing research. Basically, like a good reporter, I need to do my homework and confirm my sources. I won't make any judgements on the subject matter (like CellTex or RNL).

Doug and several other blokes have been agitating against CellTex Therapeutics, a company in the U.S./Texas whose claim to fame was treating Governor Rick Perry's low back with stem cells. While none of these bloggers knew much about what CellTex was doing, many focused on RNL Bio, a South Korean company that licensed it's stem cell technology to CellTex. Doug had previously made it his personal quixotic quest to take down RNL (see posts on 12/1/10, 11/16/10, 7/1/10, and 6/6/10) . So in this "affair" RNL became a proxy for attacks on CellTex.

So let's ask a question any good reporter should ask:

Was the RNL technology licensed to CellTex dangerous?
RNL Bio reported that it banked stem cells for about 8,000 patients who were later treated. The process was to take adipose stem cells from the patients, grow them in culture to greater numbers, and then to re-inject them locally at the site in need of tissue repair as well as intravenous. Of those patients, the families of two eventually testified against the company. Both believed that the injections were responsible for the death of their loved ones. So we have two suspected deaths in about 8,000 patients.
  • Were the 2 deaths related to the treatment? There is only one group that commented on this issue in any detail, the ICMS. From this press release they state:
    1. The two patients were not part of their registry, but they felt the need to investigate because they were patients treated with a common technique to patients in their registry.
    2. The investigation of the deaths was led by 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 Centre for Adult Stem Cell Therapy at the Indiana University School of Medicine.
    3. The death of patient 1, 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. 
    4. The death of patient 2, 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 travelled 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.
    5. So in conclusion, after an expert panel of university physicians investigated the deaths, one was related to the stem cell treatment.
What were Sipp's comments?  

"The ICMS promptly launched an "investigation" which unsurprisingly has found that the company was effectively blameless because they had patients sign informed consent forms prior to undergoing the procedures that appear to have killed at least two of them." 

What? Maybe this post was before the ICMS announced their findings? No, Sipp's post is dated 12/16/10 and the ICMS post discusses that they will discuss the findings at the Korean National Press Club (future tense) on 12/14/10. So Doug falsified the ICMS findings to suit his story line. If he had been a reporter for any news agency he would have been immediately sacked.

So just how dangerous is 1 death in 8,000 treated patients? Let's compare this to other drugs used by some of the same patients. RNL had treated patients with multiple sclerosis. One of increasingly popular FDA approved drugs that MS patients can use is called Tysabri (natalizumab). MS patients who use this drug have approximately a 1 in 800 chance of contracting a rare and serious brain infection called PML (progressive multifocal leukoencephalopathy), which is almost a certain death sentence. So there would have to be ten times the reported deaths for RNL's stem cell treatment just for it to match the leathality of a rising star MS drug! So why the Sipp alarm? 

To end this instalment on the accuracy of Doug Sipp (or lack thereof), Doug misrepresented the information coming out of ICMS on RNL so it would fit his story. Journalists are bound by an ethical code. The society of professionalism journalists has the following in their professional code:
"Journalists should:
— Test the accuracy of information from all sources and exercise care to avoid inadvertent error. Deliberate distortion is never permissible."
 As I will show over the next several posts, Sipp often distorts information or flat out misrepresents it altogether. He's on a bender of inaccuracy. So any journalist relying on Sipp's wonky information and taking it as gospel has a problem.