Dr. Stanley Jacob, a nationally known advocate of DMSO, pleaded innocent before a U.S. magistrate in Baltimore yesterday on charges he gave checks totaling $48,200 to the Food and Drug Administration medical officer responsible for regulating the controversial drug.
Jacob, 57, an associate professor of surgery at the University of Oregon, was released on his own recognizance after entering pleas on four counts of conspiracy and giving a gratuity. His trial is set for the week of Feb. 22 in U.S. District Court in Baltimore.
Jacob was among the first to discover medical uses for DMSO, a solvent traditionally used as an industrial degreaser and an animal liniment. He has promoted the drug as a pain-reliever through congressional testimony and has treated a wide range of celebrities, including Olympic athletes, New York City Ballet stars and former Alabama Gov. George Wallace. He was featured prominently in an upbeat "60 Minutes" segment on the drug, aired twice on CBS last year.
Dr. K.C. Pani, 63, the FDA medical officer, is charged with accepting 24 separate payments from Jacob described in the orginal indictment as totaling more than $30,000 but adding up to $48,200. Pani is scheduled to be arraigned tomorrow.
The indictment against Pani is the first in the agency's history, although another FDA medical officer, Henry Welch, was allowed to resign in 1963 after the U.S. Senate found he received $287,000 in "honorariums" from the drug industry he was supposed to be regulating. Last year, one FDA official was fired and another resigned after Congress discovered they were entertained frequently by officers of a contact-lens solution firm they were responsible for monitoring.
The FDA, acting on Pani's recommendation, approved the use of DMSO for bladder inflammation in 1978.A Salt Lake City firm in which Jacob holds stock provided one of the two studies supporting that decision.
Questions about the quality of those studies prompted the FDA to conduct an internal investigation in 1979. At a Senate hearing in July 1980, then-FDA Commissioner Jere Goyan said he found the DMSO studies "disturbing" because the sponsors, including Jacob, had not reported some side effects of eye damage to his agency.
Specifically, a 1977 study done for Jacob and the Utah firm by Dr. Arthur Scherbel, of the Cleveland Clinic, found eye problems in four of 11 patients. This study was not given to Pani, as required, and he learned of it through his superiors three years later.
In a recent book on DMSO, Jacob says he is willing to testify under oath that he has never concealed evidence that shows DMSO is unsafe.
An FDA spokesman said the agency "re-reviewed" Pani's limited approval of DMSO this fall and found insufficient reason to stop marketing the drug. However, the Utah firm -- Research Industries Corp. -- was ordered to conduct more studies, "and we're investigating the researchers who did the original studies," said Wayne Pines, of the FDA.