Showdown Set Tuesday on Heart-Drug Study By Morien Mintz Washington Post Staff Winer Even a couple of years azo it would have been a sure thing. Philanthropist Mary Lasker’s “citizen witnesses" usually scientists from the Medical research establish- ment—would go 10 Capitol Hill to testify that the cause was good and the need great. The chairmen of the health appropriations subcommittees. pre-sold admirers and believ- ers both. would agree. And the money would be routinely ap- propriated, because in these maiters. what Rep. John E. Fo- garty (D-R.1) and Sen. Lister Hill (D-Ala.) wanted; they got, Only traces of the benign certainty of the old days will be evident tomorrow when, tentatively, House and Senate conferees will meet to ap- prove, dilute or reject one of the last great efforts of the llasker forces—-a proposed $5- million item for massive tests, 1974, Dr. Shannon said, there of Atromid-S, a patented pre-| wil) be “a definitive answer to scription drug, to see if it is the question of the critical useful in preventing heart dis-! ease. ' Sen. Hill will be leading the fight for the appropriation, a “starter” on a study that ulti- mately mated $50 million. The battle will be one of his last, because he is retiring from the Senate at year's end. But John Fogarty, his long- time ally, is dead. Now, in the House subcommittee he headed, skeptical voices are heard, especially that of Rep. Neal Smith (D-lowa). And, ma new development Saturday, Smith released a letter oppos- ing the Atromid-S project from Dr. James A. Shannon, who until a few days ago was director of the prestigious Na- tional Institutes of Health. Replying on Aug. 5 to ques- tions from Smith, Dr. Shannon said that he and the National Heart Institute consider a sep- arate Atromid-S = study “not ... high priority.” He said that Atromid-S al- ready is among four cholester- ol-lowering drugs being stud- ied in the Heart Institute's Coronary Drug Project. When this study is completed in would cost an estl- effectiveness of these drugs” in reducing the incidence of heart attack and death in men who have had one or more at- tacks, To date, none of the four drugs has shown any “signifi- cant superiority” over the oth- ers, Dr. Shannon said. Smith asked if the taxpayers should finance a study for Atromid-S alone which, by Shannon's estimate, would re- quire 20,000 persons—2 times aS many as will be in the Coronary Drug Project when enrollment is completed by next July. These would be women as well as men wha— unlike the men in the drug project—never have had a heart attack. “It would be prudent to await the results (of the Coro- nary Drug Project) before committing thousands of nor- mal subjects to any drug treat- ment regimen in the hope of preventing coronary heart dis- ease without better knowledge of the attendant risks,” he said. Dr. Shannon told Smith that “there has been a group of side effects and possible toxic effects (with Atromid-S) which warrants continued close mon- itoring of this drug before it can be recommended for un- qualified long-term usage.” The views of Dr. Shannon and the Heart Institute were not sought hy Hill. Instead, the Senator took testimony only from advocates of an -\tromid-S study. One was Dr. Louis R. Krasno, clinical = research director in San Francisco for United Airlines. Sinee April, 1965. he has tried Atromid-S in 700 men, comparing them with 700 un- treated controls (last October, another 1000 men were added). These Limited trials were sin- sle-blind, that is, the investiga- tors—but not the patients— knew whether the participants were receiving a drug or a dummy pill. Single-blind tests do not eliminate the possibil- ity of bias, as do double-blind trials in which neither patient nor physician knows if the pill is drug or placebo. The Coro- nary Drug Project is double- blind. Last July, Sen, Hill said that the Krasno tests showed “an enormous drop in the death rate...” Dr. Shannon, how- ever, told Rep. Smith that the results, which he called “en- couraging,” “cannot be consid- ered evidence of effectiveness in preventing coronary heart disease.” Last spring, a publicity blitz based on the Krasno study WaS mounted by tne Lasker forces. The theme was that Atromid-S may prevent heart attacks. In June, however, the theme was repudiated by the manufacturer, Ayerst Labora- tories, In a “corrective letter” sent at the insistence of the Food and Drug Administration, Ay- erst apologized to the medical profession for an advertise- ment implying that Atromid-S is beneficial in heart disease. The firm also acknowledged to doctors that the ad failed to call attention “to a number of the more serious side effects..." A year earlier, John M. Weiner of the Univer- sity of Southern California testified before Hill that Atromid-S was “free of serious side effects.” After failing last year. the “starter” appropriation was re- vived this spring. Although it was spurned in the House, the Senate approved it after Hill, in an unusual example of leg- islative geographics, assigned it—in the Department of Health, Education, and Wel- fare money Dill—not to the Heart Institute, but to “Re- gional Medical Programs.” His Senate Appropriations Committee report said, “if large-scale studies were done the results of the limited (Krasno) tests might well be substantiated. If so, the drug in general use would save hundreds of thousands of peo- ple from heart attacks and death every year.”