A federal grand jury today indicted a Food and Drug Administration medical officer for allegedly accepting more than $30,000 from a leading advocate of DMSO, a controversial drug the official was charged with monitoring.
In what a spokesman said was the first indictment of an FDA official in the agency's history, Dr. Kaniambakam Chakra Pani, a medical officer in the FDA's Division of Anti-Infective Drug Products, was accused of having deposited 24 checks written by Dr. Stanley Jacob, ranging from $200 to $3,000, in his personal bank and credit union accounts.
Jacob at the time was a major stockholder and director in a firm whose tests of DMSO were used by the federal government in deciding to allow the drug's limited use in cases of bladder inflammation. The drug, also known as dimethyl sulfoxide, also has been used, without approval, for the treatment of arthritis and in some cases, cancer.
According to the indictments, which culminated a year-long investigation by the U.S. attorney's office, the checks were written between Dec. 1, 1975 and Jan. 6, 1979, three of the 10 years when Pani was solely responsible for monitoring experimental tests of DMSO for the U.S. government. As medical officer, Pani was responsible for reviewing all new drug applications by firms seeking to market DMSO for humans.
Pani, 63, is charged with conspiracy and receiving a gratuity. Jacob, 57, an associate professor of surgery at the University of Oregon, was charged with conspiracy and giving a gratuity.
After learning of the indictments, FDA Commissioner Arthur Hull Hayes Jr. placed Pani on "administrative leave," which means he is not to report for work, but will continue to receive his $50,112 salary, the government's top civil service salary.
Reached at his office, Pani termed the charges "the usual bureaucratic way of life" and vowed to fight them. Describing his relationship with Jacob, he said, "We are friends, we are scientists. We belong to the same church ..."
Jacob's Baltimore attorney, Jervis S. Finney, said his client "emphatically denies each of the charges made against him."
In a prepared statement, Jacob said: "I have done no wrong. There is no doubt this will result in my complete vindication. This FDA-inspired action will only temporarily lessen my effectiveness in trying to make DMSO available to the sick and the needy."
In 1978 the FDA approved the use of DMSO only for a specific type of bladder inflammation. It based its decision on the results of two tests, one of them performed by Research Industries Corporation, a Salt Lake City firm in which Jacob holds 150,000 shares of stock. Jacob also was the government-approved monitor of the clinical testing for the study and is the author of a recently published book, "DMSO: The True Story of a Remarkable Pain Killing Drug."
Thousands of Americans use DMSO for unapproved purposes such as relief of arthritis pain, and the FDA has been criticized for nearly two decades for its delay in determining whether the drug is safe. Many people using the drug buy an industrial version of DMSO, which is a chemical solvent used by veterinarians and in industry as a degreaser.
Federal prosecutors began their criminal investigation of the agency's experience with DMSO following complaints by some FDA officials that the two tests upon which limited approval was granted contained grave flaws. During a Senate hearing on DMSO in July 1980, FDA medical officer Michael Hensley testified that bureau managers "prohibited" him from taking to federal officials evidence that the studies were deficient. The reason Hensley gave was that DMSO is "politically sensitive" and Jacob had "political clout."
In May 1979 an FDA internal investigation regarding the quality of the DMSO tests and the relationship of the two doctors caused responsibility for the drug to be taken from Pani according to an FDA spokesman, and sent to another medical officer in a different division.
The grand jury found in 1979 Pani "intentionally misstated" the true nature of his relationship with Jacob.