FDA never approved the medical device
2:00 a.m. February 19, 2009
FEDERAL COURT — A federal jury has convicted a San Diego man of selling an unapproved medical device that he claimed could treat a wide range of conditions and diseases with electrical currents.
James Folsom, 68, faces a possible sentence of more than 140 years in prison and $500,000 in fines for 26 felony counts. He is being jailed while awaiting sentencing on May 11.
Between 1997 and last year, Folsom sold more than 9,000 devices with names such as NatureTronics, AstroPulse, BioSolutions, Energy Wellness and Global Wellness. He distributed them to wholesalers and retail consumers.
The business generated more than $8 million in revenue over that time, according to the office of U.S. Attorney Karen Hewitt in San Diego.
Assistant U.S. Attorney Melanie Pierson said the case was the largest involving illegal medical devices that she has seen in 20 years working as a prosecutor in San Diego County.
During Folsom’s trial, which ended Tuesday in U.S. District Court, officials for the Food and Drug Administration testified that his device was never submitted to the agency for review.
Folsom is a former business associate of Kimberly Bailey, a Fallbrook woman who sold similar devices until she was sentenced to life in prison in 2002 for plotting the kidnapping, torture and murder of her business partner and lover.
Folsom’s device is made up of a small black box with dials, a digital screen and wires leading to a pair of stainless steel cylinders or metal plates. The box is plugged into an electrical socket, and a patient holds the cylinders or stands on the plates.
Marketing material found on several Web sites said the device uses electrical frequencies to destroy diseased cells in the body. It also said the device was inspired by the work of San Diego inventor Royal Raymond Rife, who in the 1930s theorized that cells could be destroyed by directing precise radio frequencies at them.
Rife believed cancers, viruses and other illnesses could be treated with the technology. He could never prove his ideas, and the medical community widely discredited his work.
Or did he? In 1934, Dr. Rife opened a clinic, which successfully cured 16 of 16 cases within 120 days. Working with some of the most respected researchers in America along with leading doctors from Southern California, he electronically destroyed the cancer virus in patients, allowing their own immune systems to restore health. A Special Research Committee of the University of Southern California oversaw the laboratory research and the experimental treatments until the end of the 1930s. Follow-up clinics conducted in 1935, 1936 and 1937 by the head of the U.S.C. Medical Committee verified the results of the 1934 clinic. In his 1953 book, Dr. Rife wrote about the cancer clinics:
“The first clinical work on cancer was completed under the supervision of Milbank Johnson, M.D. which was set up under a Special Medical Research Committee of the University of Southern California. 16 cases were treated at the clinic for many types of malignancy. After 3 months, 14 of these so-called hopeless cases were signed off as clinically cured by the staff of five medical doctors and Dr. Alvin G. Ford, M.D. Pathologist for the group.
Prosecutors said Folsom conducted business under false names to avoid detection by the FDA. He also marketed the device “for investigative purposes,” giving potential buyers a false impression that the equipment was being considered for FDA approval.
Medical devices must be reasonably safe and effective for the FDA to approve them, said Bob Gatling, head of the FDA office that maintains records on device evaluations and a witness at the trial.
The FDA’s process for assessing medical devices has come under increasing fire. Some scientists say the agency watered down its standards while President George W. Bush was in office, according to a January story by The New York Times. Congress launched an investigation into the matter in November.
-Okay now i must rant a little bit. I do not know James Folsom and or what devices he is selling, but i must tell you that Royal Raymond Rife was a scientific genius and what this reporter probably didn’t know was that Rife’s work was not just theory in fact the same newspaper San Diego Evening Tribune that wrote this story actually covered Rife’s brillant work. From the 1930’s-50’s he was in a ton of newspapers. His work made the front page several times.
Peace and Good health!