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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 HEALTH 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 Loran's history includes high-pressure sales tactics, and distributing a sales kit which touts unpublished studies that had conflicting interpretations.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 HEALTH, Scott King, who said, "I think people need to be warned."
The FDA issued an initial advisory to Loran in April of 1995, but despite the cautionary request, Loran went ahead to inject 32 patients with the human fetal and newborn rabbit 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 the 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 the Wall 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-operation 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 uninterpretable." Wilson advises people with diabetes to avoid the treatment.
0 comments - Apr 1, 1996
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