Posted by matthew r on April 25, 1998 at 14:27:25:
In Reply to: Re: Santa Barbara Diabetes Project posted by Al Gordon on April 25, 1998 at 14:07:47:
I nearly paid these people $20,000 a few years ago and I am glad I didnt. I learned about them from a diabetes forum and called them up. I think the bad guys were Loran not Sansum but Sansum were doing the injections and running the patients.
Now I only trust the quiet researchers and scientists not the publicity seeking ones.
I have had this clipping for a long time. By the way Diabetes Interview is a great newspaper.
FDA CRACKS DOWN ON LORAN MEDICAL CONTROVERSIAL INJECTIONS STOP
In response to a warning from the FDA, Loran Medical Systems has
suspended its controversial trials which involve injecting people with
diabetes with fetal and rabbit pancreatic cells. The warning, issued
January 4th, states that Loran violated regulations that govern the
importing of biological products and the conducting of clinical trials.
Critics have called the company's procedure, which costs $20,000,
unproven and ineffective.
In September of 1995, Diabetes Interview published the first
comprehensive story on Loran's practices. Loran's history includes
high-pressure sales tactics, and distributing a sales kit which touts
unpublished studies that had conflicting interpretations. The Wall
Street Journal followed up on the story, quoting the publisher of
Diabetes Interview, who said, "I think people need to be warned."
The FDA issued an initial advisory to Loran in April of 1995, but
desspite the cautionary request, Loran went ahead to inject 32 patients
with the human fetal and newborn rabit pancreatic cells at a cost of
$20,000 for each patient-a grand total of $640,000.
The FDA claims the Russian-exported pancreatic cells fall under
category of a drug and therefore must be regulated by the agency.
Because Loran does not biologically alter the pancreatic cells, the
company maintains that the substance does not fall within FDA
jurisdiction.
"They do not understand what we are doing," James Stevens, a
spokesperson for Loran, told theWall Street Journal, . Stevens
acknowledged that he has no medical background. Loran had
scheduled 18 new patients for March of this year but has now cancelled
the injections. The company does not plan on proceeding until it has
addressed the FDA's concerns.
Dr. Darrell Wilson, a Stanford diabetes specialist who has studied the
post-operatoin data of the patients treated by Loran, told Ralph King
Jr. of the Wall Street Journal, "The data, even at face value, are not
very impressive and the study design is so poor as to make them
interpretable." Wilson advises people with diabetes to avoid the
treatment.
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