PORTLAND, Ore. -- Food and Drug Administration officials, looking for irregularities in research programs, have examined the records of Dr. Stanley W. Jacob, a co-discoverer of the controversial drug DMSO who treated Former Alabama Gov. George Wallace.
FDA investigators, accompanied by federal marshals, secured an administrative search warrant from a U.S. magistrate before examining Jacob's records Thursday on dimethyl sulfoxide.
The drug, a byproduct of the paper-making process, is reputed to have unusual body-penetrating, pain-killing and healing properties. Wallace, who was crippled in a 1972 assassination attempt, recently came to Jacob at the University of Oregon Health Science Center for treatment.
Jacob and Robert Herschler, a Crown-Zellerbach Corp. chemist, first disclosed DMSO's unusual properties 18 years ago. It has been used to treat animals for several years, but the FDA has allowed its regular use for the treatment of only one human ailment _ interstitial cystitis, a bladder inflamation.
It has allowed limited, experimental use of the drug in certain research programs.
The FDA alleged in its affidavit for the warrant that unapproved variations of the drug have been transported across state lines, and that some of the variations have been used in human studies.
The affidavits also alleged that findings by a Cleveland scientist of eye damage in patients using the drug have been withheld.
Dr. Arthur Scherbel, of the Cleveland (Ohio) Clinic is named as the source of the new eye findings. He was conducting research under an investigational new drug permit from the FDA on patients who suffer from scleroderma, a fatal and debilitating bone and tissue disease for which there is no other treatment.
The exact nature of the eye problems associated with DMSO use were not revealed in the court documents filed in Portland.
In an affidavit that led to the search warrant, Dr. Michael J. Hensley, an FDA investigator, stated that he had determined that Dr. Scherbel had administered DMSO to his scleroderma patients orally, intravenously and to specific body locations, even though the only use provided under the investigational new drug permit was specific local application.
'I further learned that many of Dr. Scherbel's DMSO patients had experienced ocular (eye) problems during the course of their long-term treatment with DMSO and that such problems might have been drug-related,' Dr. Hensley said.
The FDA went to federal court for the warrant late Wednesday, charging that Jacob was resisting showing his records.
The FDA investigators said they wanted to examine the records to search for 'irregularities in research programs.'
The warrant was granted by U.S. Magistrate Edward Leavy. FDA officials sought and received permission to have federal marshal accompany them on their search.
Jacob, an associate professor of surgery at the University of Oregon Health Sciences Center, was unavailable for comment Thursday.
