Tests of Cass Associates Rejected by Government

An eight-hour pain-reliever, originally approved by a Cambridge drug-testing firm, has been taken off the market by the Food and Drug Administration. The FDA said the original tests were "irregular," and the manufacturer has been unable to prove the drug effective without those tests.

The FDA rejected the data of Cass Associates, Inc., headed by Leo J. Cass '33, director of the Las School Health Services. FDA notified the manufacturer, cheesebrough-Ponds, that without Cass' studies, which were now void, there was not enough evidence that the drug was effective.

The Kafauyer-Harris Drug Amendments of 1962 require a "demonstration of effectiveness" for all new drugs. The Food and Drug Act of 1938 required only a "demonstration of safety."

Cheesebrough-Ponds was told to submit new data for the drug, Measurin, which it did. The FDA rejected the material, none of which was done by Cass Associates, because it "just didn't supply the necessary data," Dr. Robert J. Robinson, acting head of FDA's Bureau of Medicine, said yesterday.

Dr. James L. Goddard, head of FDA, said last night that this was the first case he knows of where a drug was removed from the market because of faulty testing.

All eighty of the drugs tested by Cass have been under re-examination by the FDA, since they accused the private drug-testing firm this spring of "untrue statements of material fact" in 1963 tests of Norgesic, another pain-killer. The FDA charged that among those tested were a number of people who were dead at the time they were supposed to have taken Norgesic.

"We will not accept any research done by Cass for any firm." Goddard said last night. In addition, the FDA has urged all drug manufacturers who have relied on Cass to submit new data from other drug-testing firms.

Dr. Dana Farnsworth, director of University Health Services, said last night that what happens to Cass Associates has "no connection with the University in any way," and that Cass's job with UHS is not in danger.

Officials of FDA would not say how many of the tests Cass Associates has done may have irregularities in them. Gifford D. Hampshire, of FDA's Information and Education Commission, said yesterday that there was no direct relationship between FDA's handling of the Norgesic case and the Measurin case, except that "once certain studies were suspect, we began to look into other drugs of Cass."

The Norgesic case is still subject to a hearing. Until the hearing, Norgesic is still being sold retail, according to God-dard, but Riker Laboratories, the manufacturer, has been ordered to stop shipping.

Rep. L. H. Fountain, (D-N.C.), chairman of the Intergovernmental Relations Subcommittee of the House Committee of Government Operations, which held a hearing on Measurin in May, said last week that during the months when the effectiveness of Measurin was being re-examined, the drug continued to carry advertising claims validated by Cass Associates.

Although Dr. Robert F. McCleery, director of FDA's Medical Advertising division, recommended that all claims based on Cass research be removed from labels--including the drug's chief selling point: "eight-hour pain relief"--this was not done, according to Fountain. Instead, the company was told to simply delete Cass's name from its claims. As a result, Fountain said, "promotional labeling and advertising continued to contain claims based on Cass work."