FDA Consumer

Researcher disqualified – Dr. Jerome Weiss

Researcher disqualified – Dr. Jerome Weiss

Researcher Disqualified

A visit to a doctor can involve manythings: a physical examination, a prescription, or instructions on diet or special exercises. But most patients don’t expect an FDA investigator to subsequently appear on the doorstep asking for details of their visit to the doctor. That, however, is exactly what happened to half a dozen patients who had the misfortune to visit New York physician Dr. Jerome Weiss for gastrointestinal ailments.

In the 1970s and 1980s, Dr. Weisshad agreed to do studies of two new drugs for Smith Kline & French Laboratories, a Philadelphia drug company. One drug, Darbid, had already been found effective for treating stomach ulcers, but SKF wanted data to prove it was also effective in treating irritable bowel syndrome. The other drug, Combid, was approved for treating some gastrointestinal disorders, but the drug company wanted it to be specifically approved for acute gastroenteritis.

FDA investigators reviewing the studiesnoticed certain irregularities in data sent by Dr. Weiss to SKF in 1982. In the Darbid study, the results for the control group (patients taking an inert placebo instead of the real drug) were not what would be expected. Also, diaries that should have been completed by the patients had obviously been filled out by the doctor.

Investigators from FDA’s New Yorkoffice visited the doctor’s office. They compared 30 of the doctor’s patient charts with the case report forms submitted to Smith Kline & French Laboratories, and found a number of significant deviations: The dates differed for diagnostic procedures such as barium enemas (required by the study protocol as a base-line measurement); all of the case report forms listed at least one more patient visit than the patient charts; four of the patient charts indicated the patients were taking other medications that would have interfered with the study; and all the patient charts had been modified, apparently to make them agree with the case report forms.

The most damning evidence camefrom the patients that supposedly had been in the studies. As FDA investigators visited one after another, it became all too apparent that Dr. Weiss had never even given the investigational drug to the patients he claimed were in his “studies.’ Of 11 patients visited, nine were sure they had not been in a drug study and that they had not received the investigational drug; two simply couldn’t remember. Six remembered clearly that they had not had barium enemas or a sigmoidoscopy (as listed on the records) and that they had not made as many visits to Dr. Weiss as were listed in the records. Apparently, Dr. Weiss had submitted their names as participants in the study, but had treated them just like all his other patients.

The New York office then sent a letterto Dr. Weiss in August 1984, explaining that numerous irregularities had been found in the data submitted by him to Smith Kline & French and that because of this he might be disqualified as a clinical investigator. The letter offered him an opportunity to explain his behavior at an informal hearing. Instead, in November of that year, Dr. Weiss signed an agreement with FDA declaring himself ineligible to receive investigational drugs.

But he still had to explain his violationof the law. In February 1985, FDA’s New York office met with Dr. Weiss’ legal counsel, who responded to the charges against his client, offering reasons why Dr. Weiss should not be prosecuted –one of which was that the doctor was 65 and due to retire soon. FDA found none of the reasons particularly convincing and brought criminal charges against the doctor, saying “the vital process of approving drugs to ensure their safety and effectiveness can work only if clinical investigators who test the drugs accurately report their study results.’

Dr. Weiss was charged with falsifyingpatient case report forms and patient consent forms in two separate studies with the intent to mislead Smith Kline & French and, therefore, FDA. On Dec. 4, 1986, the physician pleaded guilty to one count of falsifying clinical study data and records with intent to defraud and mislead. On Feb. 27, 1987, he was sentenced to 200 hours of community service and fined $10,000.

COPYRIGHT 1987 U.S. Government Printing Office

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