PRESIDENT AND STRIKE: AVOIDS RESPONSIBILITY See Editorial Page .:YI [ 4 AOF gAt43U Pai4b SUNNY High-80 Low-58 Fair and warmer Seventy-Six Years of Editorial Freedom VOL. LXXVI, No. 62S ANN ARBOR, MICHIGAN, THURSDAY, AUGUST 4,.1966 SEVEN CENTS Drug Research Produces Need for Code o] FOUR PAG Ethick By WALLACE IMMEN Second of two parts What characterizes ethical be- b havior in medical experimenta- tion? Should a doctor have the privilege of subjecting his patients to tests of experimental cures without consulting them? How may the development and efficacy of drugs best be controlled? In spite of this country's ad- vanced medical technology, these crucial questions have remained unanswered for years. Because there is no consensus as to what defines proper conduct in experi- ments on people, until now legal rulings have been avoided and solutions left to the discretion of the individual researcher. Con- trols were slipshod and temporary. A tremendous increase in the volume of experiments involving new drugs and procedures has burdened the country's control agencies and a lack of volunteers has led many doctors to conduct tests on patients who are not in- formed that their therapy is any- thing more than routine or that any danger is involved. But often, much danger is involved, prompt- ing demands from citizens and officials for quick action when, all too frequently, tragic results stem from such practices. Doctors, who are chastised as a group for the actions of a few of their colleagues, are now especially aware of the need for reform of control procedures and a uniform and adequate code of medical re- search ethics.,They are also con- cerned of possible side effects which could result in prescribing drugs which doctors, eager to get their names in medical'journals and receive marketing approval, took shortcuts in ;testing. Seeking quick action not only on a code, but also on methods of making drug experimentation safe and reliable, most activity is being focused at federal and organiza- tional agencies as the most effec- tive means to reach all levels of research work. Several groups are working on the same problems, but there is little cooperation between them and their overlapping of in- terests has caused some resent- m;ent. A look at what is being done, however, shows that all feel it is vitally important to attain accord in medical research pro- cedures. Major re-evaluation of both the methods of approval and in juris- diction has begun with the Food and Drug Administration, as the, highest federal authority chargedl with the control of development and marketing of medicines. The FDA is simplifying procedures to promote safety and minimize the need for high-speed testing, the main cause of questionable prac- tices in drug experimentation. The department recently has been bog- ged down and has begun a pro- gram aimed at speeding the ap- proval of new drugs while at the same time assuring more safety in the durgs which are already on the market. The changes are being directed by the FDA's new commissioner, James Goddard. His concern, he simply states, is "to boost FDA and medicine in general onto a higher scientific plane." Since taking office last January, he has adopted the belief, "once you've got all the facts, there's no point in waiting." He has revamped the organization and 'reduced the backlog of work from more than a year in some cases to a few weeks. This has been accomplished by reorganizing the drug supervision procedures to enable one team of scientists to follow a pending drug through all stages to approval, avoiding much red tape.. Goddard has established "risk versus benefit" as the most ra- tional criterion for evaluating the safety and efficacy of a drug in the belief that the "risk" involved in most drugs is small in com- parison to their potential contri- bution to medicine. It is a new approach for the FDA and will most likely result in the approval of some prescription drugs which are potentially more dangerous than drugs available today, but much more beneficial in the long run. In order to make sure this will work, he has called for an en- largement of the FDA's clinical staffs and has established links with universities and the Public Health Service for help in assuring a reputation of scientific excel- lence for the agency. Goddard's fight is also for ex- cellence in the laboratory. It is his hope that new speed and pre- cision attained by the FDA will put an end to the need for sloppy drug trials and prevent the dan- gers resulting from haste. Unfortunately, all the FDA's work on safety will still come to little avail if it is bypassed as a control agency. In this respect, the doctor is not always to blame as marketing companies are fre- quently discovered "neglecting" certain aspects of drug tests which may mean a possible re-evaluation of one of their products by the FDA. Paul Lowinger of Wayne State University Medical School recently related an incident in which he was inyolved in a drug toxicity experiment for a pharmaceutical house. In submitting his findings, he requested that the FDA be sent a copy even though the drug had already received approval. ,3{e later learned that his, and many more reports which contained informa- tion which may have changed the statis of some drugs distributed by the house were never seen by the FDA. He and others have advocat- ed a strong new drug law which requires, among other things, a duplicate of all drug studies be sent to the FDA. An ethics code, however, would not be in the form of a rigid law for this would make the medical clinic a police state. When such guidelines are established, the problem of abiding by them v rest directly on the integrity individual doctors. The precepts a code would be drafted and e forced by the American Medic Association as the highest autho ity in the medical profession. Independence for researche has been. the call from AMA lea ers and in the face of FDA e pansion, they have asked the go ernment to limit the latitude its control powers. Outgoing AM President James Appel highlighl this belief in his farewell addr before the House of Delegates cc vention held in June in Chicag Appel believes "the FDA unde estimates the compentency of mo physicians in drug evaluation a use." This belief was echoed incoming president Charles Hu son who called upon governme See CONTROVERSY, Page 3 Court Rules To Dismiss 'Oath' Case Colorado U Regents Test Constitutionality Of State Loyalty Oath By CAROLE KAPLAN A case instituted by the regents of the University of Colorado to test the constitutionality of the Colorado loyalty oath was dismiss- ed in the Boulder District Court last Thursday. The Colorado regents are cur- rently required by law to admin- ister the oath to all faculty mem- bers, and several professors have refused to teach at the school because they did not care to take the oath. The loyalty oath requires that, all teachers in the state swear al- legiance to the United States and * Colorado Constitutions and laws. and that they promise to teach respect for the country and flag "by example and precept" in their classrooms. A similar oath was recently de- clared unconstitutional in Wash- ington. According to Frank Bell, news editor of the Colorado Daily, the case was dismissed because the Colorado regents made no claim for which relief could be granted. Although there has been no viola- tion of the law, the regents thought it might be declared un- X constitutional, in which case they would no longer be required to administer it. The defendant in the case is Boulder District Attorney Rex Scott, since he would be the pros-, ecutor if a violation of the law occurred. The regents and Scott, both em- ployes of the state government, are both represented in court cases by the Colorado attorney general. The attorney general's office has ap- pointed two lawyers to handle the opposing parties' cases. Bell said yesterday that the next step, if the regents wish to pursue the case, is the Colorado Supreme Court. He said there is some feel- ing that the district court's deci- sion to dismiss the case would be upheld, in which case the regents would be forced to drop it. If the decision is reversed, the district court will decide on the constitutionality of the loyalty oath. The Colorado regents will de- cide on future action at their next meeting, Aug. 27, Bell said. NEWS WIRE Late World News By The Associated Press PARIS-PRESIDENT Charles de Gaulle sent a telegram yes- terday to Premier Alexei N. Kosygin of the Soviet Union, con- gratulating him on his re-election and saying it is a "favorable element" in cooperation between Paris and Moscow. SAIGON-COMMUNIST dispatches yesterday claimed mem- bers of the International Control Commission were among those strafed by American and South Vietnamese planes in alleged attacks on a Cambodian frontier village. The commission-composed of Poland, India and Canada- reportedly was investigating charges of earlier strikes at the village of Anlong Trach when one raid took place Tuesday, the Soviet news agency Tass said. The ICC was formed in 1954 to supervise the truce estab- lished by the Geneva Conference that year. * * * * SAIGON-U.S. B52s STRUCK for a third time yesterday at the demilitarized zone that separates North and South Viet Nam and also bombed suspected Viet Cong positions 30 miles north- west of Saigon. The U.S. Command announced the eight-jet bombers from Guam hit North Vietnamese infiltration routes and suspected gun positions in the six-mile wide buffer zone that divides the two Viet Nams at the 17th Parallel. WASHINGTON - PRESIDENT Johnson, speaking at the swearing-in of a new foreign aid director, said yesterday that despite its critics "foreign aid has been an important force for good in the world." "It has helped build the foundations for peace and stability," he said. Disputing critics who say that foreign aid is endless and in some cases futile, Johnson said: "We remember that in 1949 some of our leading news analysts were calling American aid to Japan a $2 billion failure. One major magazine declared that, 'The American taxpayer must prepare himself for an indefinite period of vast appropriations'" DETROIT - THE NEW CAR market showed surprising strength last month as sales were the second highest of any July and ran well ahead of expectations. Preliminary sales reports from the four U.S. auto companies reported 635,633 cars sold. This was topped only by last year's July in which 710,821 cars were sold. The July just ended had 25 selling days, one less than the 26 of 1965. The auto industry, which entered July with an inventory of about 1.7 million new cars, had set its sights on sales of 615,000 cars in July to help with an orderly reduction of the huge stock- pile. * * * * PARTLY BECAUSE THE LEGISLATURE delayed in ap- proving the budget for higher education, and partly because of late information about appointments and changes, a number of University employes were not paid on schedule last Friday. Most of the delayed paychecks were for academic employes. -Associated Press KOSYGIN SPEAKS SOVIET PREMIER ALEXEI KOSYGIN speaking to the Joint Union Council and Nationalities Council in Moscow yesterday. Kosy- gin pledged that the Soviet Union will "do everything in its pow 8r to help the Vietnamese people expel the Americans." '66 Election May Prove Good for 'U Voters Oust Thorne, FlaVin--Newcomers May Be Less Critical By MARK LEVIN Special To The Daily DETROIT - Michigan vote turned 12 state legislators out office in Tuesday's primary ele tion,. and Lansing sources indic that two of these defeats may hc promise for improved Universit Legislature relations. Reps. Harry Thorne (D-Detroi and Raymond Flavin (D-Flin were both defeated by challenge from within the Democratic par Both were members of the pow ful Ways and Means Committi which acts as the appropriatio committee, f o r t h e Miehig~ House. Thorne, a member of the Joi Capital Outlay Subcommittee, b been one of the outspoken criti of the University for its failure comply with P.A. 124. Under t provisions of this act, the Jo Capital Outlay Subcommittee h the power of dispensing planni money for higher education c struction. Leaves Vacancy ;, Thorne, a Lansing obser commented yesterday, was "intE upon the assertion of legislat power in the field of higher ed cation." His defeat leaves a 1 cancy on this important subco mittee, which could be filled b3 House member more favorable the University. Flavin, a freshman legislat sided with the State Board Education in favor of an in pendent Flint college in place the present Flint branch of I University. He was also a strong advocate state support for the propo Osteopathic College, which n with criticism from some univ sity observers. Dzendzel Wins Another Democrat, R a y m 0: Dzendzel, majority leader of I Senate, narrowly escaped def from a strong challenge by JC Lama, a Wayne 'State Univer speech instructor. Dzendzel si ported the Communist speal ban at state universities, and opponent was strongly backed the Wayne State University Yot Democrats and other liberal e ments in Dzendzel's district. The AFL-CIO, however, g their endorsement to Dzend which helped him in the r Dzendzel, who also introduced* stop-and-frisk bill into the S ate, had strong backing f1 homeowners' groups and ot conservative groups within district. Jack Faxon (D-Detrot), cha man of the Subcommittee Higher Education Appropratic received the largest number votes of any state legislator in I troit. He had four primaryi ponents. Faxon, considered the , c critic of University tuition creases, has accused the Univ sity of taking insufficient intem in student welfare. He cond te recent inquiry into tuition rai In a local race for the Repl can nomination to U.S. Congr as well as three Republican st congressional contests, moder Republicans defeated their 'c servative opponents. They EDUCATION: More Power, Responsibilities Lead To Rapid Expansion of SE Staff By PATRICIA O'DONOHUE The State Department of Edu- cation (SDE) is in an "unpreced- ented period of growth," accord- ing to Marvin Tableman, special assistant to Ira Polley, Superin- tendent of Public Instruction. As a result it is rapidly expanding the size of its staff. Tableman explained that this expansion is necessary because un- der the new constitution "this of- fice has received new and broader powers" and as a result, more re- sponsibility. He added that the new federal programs enacted during the last and present ses- sions of Congress and the Execu- tive Organization Act have neces- sitated a re-organization of the department. Tableman said that the SDE was also responsible for the regu- lation of state school programs and supervision of the new scho- larships awarded to the tuition grants for private colleges. He added that the SDE has in- creased the size of its staff by 33 per cent in the last year. He indi- cated that this figure would be doubled within the next three years. Demand Consultants He explained that present'-serv- ices of SDE, such as the Vocational Rehabilitation Program, the ele- mentary and secondary school re- ports, and the Report on Higher Education demand many consul- tants and professionals in the field of education. He said that 'Phantom' Drop-Outs Missing from Records; "the competition with the profes- sions" hindered these acquisitions but that they were gradually in- creasing the staff to the number which they feel is needed. At the present time SDE is in the process of developing the re- port on higher education. Dr. Har- old Smith of Upjohn in Kalama- zoo is currently heading the com- mittee preparing that report. Tableman said that the report. will establish guidelines for the planning and coordination of higher education in the future and will include planning, pro- gramming, budgeting and facili- ties planning for state' institutions of higher education. He said the report should establish prelimin- ary guidelines within 8-10 months. Charles E. Morton, a member of the State Board of Education, said that the aim of the report on planning coordination between the institutions of higher education is to tie these schools into a state- wide 'system. He Added that this would not interfere with existing programs. Lack of Funds Morton cited the lack of funds as a big problem in providing the kind of staff the SDE needs. He added that the low pay and civil service classification prevented the department from obtaining many nationally prominent people who are earning more in other states. Morton said that the plight of Flunk-Out Percentage Higher Than Estimates By MEREDITH EIKER Students withdrawing from the University during the academic year can often not be identified by University records. According to Robert Cope, Grad, University records can only be used to ident- ify "students who voluntarily left and went through the normal withdrawal procedures and stu- dents who were asked to leave be- cause of disciplinary action or aca- demic failure." counted for by the record system. Cope explained that the main purpose of the research being done as part of the Michigan Student Survey is "to gain a more thorough understanding of why students leave the college they first enter as freshmen and to assess the nature and extent of undergradu- ate problems in a large university." Students not enrolled at the University in the fall semester of 1965 who were originally enrolled Data on the entering freshmen of those two years was obtained from normal University records in the Office of Admissions and from the extensive collection of data gathered in the .Michigan Student Study. 2207 students were admit- ted to the literary college in the fall of 1962 and 2161 students in the fall of 1963. Of the total 4368 students en- tering the University's literary college in those years, 1387 stu- dents appeared on the compara- Questionnaires revealed that the most common reason for with- drawing from the University was "academic failure." Dean William Haber of the literary college ear- lier this summer noted that only about five per cent of the students in the college are asked to leave for academic reasons. Edward G. Groesbeck, University registrar, said that the overall flunk-out rate at the University is about eight per cent. ,,_ V% _ -h - aV1" fail t at.e - demic failure because the Univer- sity only identifies those whom it actually asks to withdraw as hav- ing flunked out. Students who withdraw because they feel they have failed academically are not included among University failure percentages. Groesbeck commented that the University has not wanted to go to the expense of keeping detailed student withdrawal data. Studies by individual offices such as the one the Michigan Student Study withdrawal such as needing higher grades in order to be admitted to graduate school and wanting to major in a field not offered at the University. Cope said further that many students who leave the Uni- versity go directly into medical schools or other professional schools and cannot be considered drop-outs from higher education. Data Cope is collecting also in- dicates that female withdrawal is somewhat greater than male. This he attributes to marriage and