Beware of Clinical trials as the Gold standard

[FayeForCure]

There has been a lot of talk about Medical Tourism and "experimental", unorthodox/unconventional ( not approved by american medical establishment) stem cell treatments.

Dr Young is in the midst of setting up a clinical trial network for spinal cord injury in China, while dissing all the programs people travel to overseas for being untested by "american medical standards."

(He will not be using embryonic stem cells,... which many erroneously think he went to China for...., but umbilical cord blood stem cells instead.)

How interesting to note, that he himself conducted a clinical trial in 1990 which gave the green light to a treatment for acute spinal cord injury, but which subsequently through various follow-up studies proved to be a farce.

Results of clinical trials by pharmaceutical companies have also frequently been doctored. So beware of of the stamp of approval given by "scientific" clinical trials, as outcomes can easily be manipulated to show positive results even in an official "FDA approved" setting.

[FayeForCure]

Even the fact that a reputable scientific Journal chooses to publish the results of such as "FDA approved" clinical trial is no guarantee of its legitimacy. Here is a sample quote from one of the other follow-up studies on Dr Young's methyklprednisolone clinical trial for the treatment of acute spinal cord injury:

Summary: NASCIS III. All primary outcome measures of NASCIS III were negative. Post-hoc analyses proved interesting only when the data were arbitrarily restricted to patients treated within 3 to 8 hours of injury, excluding almost 70% of the original study population, and when
bilateral light touch sensation, bilateral pinprick sensation, bilateral deep pain, bilateral pressure, left-sided and bi- lateral motor scores, and right-sided ASIA motor scores were ignored. Even then, the potential treatment effect was lost at 1 year. Analysis of compliance is specially invalid in this protocol because all groups received active medications. Reexamination of the “interesting” raw data....

http://www.thejns-net.org/spine/issues/ ... 930001.pdf

It's unfortunate that so much trust is given to scientists and that their peer review often is lacking or severely delayed.

Another example of poor peer review famously came to light in the Korean Dr. Hwang case, where the claimed cloned embryonic stem cell lines proved non-existent.

[FayeForCure]

A review of 46 published references on the topic of methylprednisolone in the treatment of patients with acute spinal cord injury yielded the following statement in a write-up on recommendations for acute sci:

evidence suggesting harmful side effects ( of using Methylprednisolone) is more consistent than any suggestion of clinical benefit

http://www.spineuniverse.com/pdf/traumaguide/9.pdf

[FayeForCure]

http://www.sciam.com/article.cfm?chanID ... =3&catID=4

"Where all of this gets really risky," Caltech's Anderson adds, "is when clinicians start to move forward with trials that are based on experimental results that may not be solid."

Transdifferentiation studies spawned a number of clinical trials, including several in which heart attack patients received an injection of blood-forming stem cells in their hearts in hopes of replacing dead cardiac muscle. The results came in last year and were not encouraging: In two shorter trials, heart function improved by a few percentage points or not at all, and one longer study found a slight but temporary benefit.

Weissman says that most clinical studies of stem cells fail to meet what he sees as key criteria: They should be based on clear, peer-reviewed demonstrations of tissue regeneration, replicated by a large number of independent groups that provide rapid, long-lasting benefits.

Chien agrees that basic stem cell biology has not kept pace with clinical studies, but he says there is a compelling need for new treatments. "I can understand why people are motivated to try to do something" by conducting trials, he says. "They're going to go on and we will learn something from them," he notes, although he adds that treatments currently in the clinic are unlikely to enter the mainstream

My comment: there are more clinical trials than the basic biology warrant,......it's become sort of a status symbol to proceed to clinical trials.