JANNUARY 6,1963 THE MICHIGAN DAILY PAGE THREE -..,'.-, JANUARY 6,1963 TIlE MICHIGAN DAILY PAGE THREE lbricht o Get Support 11 .... 11 By PRESTON GROVER Associated Press News Analyst MOSCOW - Diplomatic sources suggested yesterday that Soviet' Premier Nikita S. Khrushchev's visit to the East German party congress Jan. 15 is to build up Communist leader Walter Ulbricht and not knock him out. Top - level Soviet delegations have been sent to every congress meeting in the East European bloc this fall and winter. But Khrush- chev himself will handle the par- ty representation in the most trou- bled area in the bloc, East Ger- many. East Germany's economy has been going from bad to worse for the past few years. Building the wall through Berlin in August, 1961, was expected to give it a lift by stopping the flight of top level workmen to the West. In- stead, the situation in East Ger- many has been getting worse. Ulbricht's End? There was wide speculation that the steady deterioration might mean the end of Ulbricht. But that is'-not the case either in Moscow or in certain quarters in Western Europe. The announcement of Khrush- chev's visit came as a considerable surprise and led to surmises here that East Germany is in a worse situation, economically and polit- ically, than was earlier suspected. Stalinists The presence of Khrushchev was looked upon here as likely to see the developments of an intensified East German campaign against party dissidents, all of whom now are generally labeled Stalinists. More talk, but no definite com- mitments, may arise about settling the Berlin situation by separate treaty with East Germany. Restricted offers of aid might be given within the limits of the Soviet Union's own strained pro- duction system. Heated Exchange Another, perhaps more heated exchange, may occur between the Chinese and Soviet leaders over the political and doctrinal leader- ship in the Communist camp. Western diplomats feel certain the Chinese will send a high-level delegation to East Berlin. At party congresses in Bulgaria, Hungary and Czechoslovakia, and at the congress in Italy, Chinese delegates attacked the Russian program of "no-war-with-Amer- World News Round By The Associated Press NEW DELHI - Prime Minister Jawaharlal Nehru has informed Communist China that India is willing to refer their Himalayan border dispute to the Internation- al Court of Justice after Peking accepts New Delhi's basic truce demand. * * * ca." Soviet spokesmen have since fought back. Food, Money The things most needed by the hungry East German economy are food and money. Approaches have been made to West Germany for a loan. Help is unlikely to come in great quantity from the Soviet Union, where food is already show- ing spotty shortages, and money is so scarce that little added capital can be spent to build up agricul- ture. More likely Khrushchev's pres- ence is intended to warn unwilling industrial and party workers in Germany that Ulbricht is still Khrushchev's man. Besides that, nobody here can point to a really promising replacement for U1- bricht. Khrushchev and other Soviet spokesmen have talked recently about the need of a Berlin settle- ment, but the line has been soft, and no deadlines have been set.! I 1I Il I j . i r J1 I PARTY CONGRESS-Soviet Premier Nikita S. Khrushchev (left) will travel to the East German party congress, informed sources predict, to give support to East German Communist leader Walter Ulbricht. DRUG INSPECTION: FDA To Use New Authority NOW TN PROGR1ES By W. JOYNES MacFARLAN Associated Press News Analyst WASHINGTON-Starting Feb.j 7, the Federal Food and Drug Ad- ministration will begin checking on new drugs, with power to bar those believed either unsafe or in- effective. New regulations announced yes-+ terday greatly widen the FDA's authority to exercise a watchdog role over experimental use of new drugs on human beings, before the medicines are marketed generally. The added controls over experi- mental use are the most signifi- cant of new powers given the agency under law revisions, voted by Congress last year. Most revo- lutionary is the right to terminate testing when a drug appears to be unsafe or ineffective. Thalidomide Much of the impetus which brought the law changes and the resultant new regulations came from the, international furor creat- ed by the drug Thalidomide. "The purpose of these regula- tions is to eliminate all unneces- sary risks to the public that may attend drug development and to impose only necessary restrictions on the conduct of investigational drug research." Welfare Department spokesmen said, however, that the modifica- tions in the proposed regulations are not believed to have weakened them. Necessary Controls FDA Commissioner George P. Larrick said the new rules "pro- vide strong and necessary controls over the investigational use of new drugs." The regulations require that pa- tient consent to use of investiga- tional drugs be obtained by investi- gators, unless this is not feasible or is contrary to the patient's best interest. They will require that the FDA be put on notice and given full details about the distribution of drugs for investigational use. Clinical investigations be based on adequate animal studies to as- sure safety. Properly Planned The clinical investigations them- selves be properly planned and executed by qualified investigators, and that these investigators and the FDA be kept fully informed during the progress of the inves- tigations. "If an investigation finds that the drug is not safe or is ineffec- tive, the FDA will require discon- tinuance," the announcement said. Previously the regulations did not require either initial notice to FDA of a clinical trial of a new drug or subsequent reports on such use. Radioactive new drugs were ex- empted from the regulations pro- vided that they are shipped in ac- cordance with Atomic Energy Commission regulations. FDA said the following were five principal objections to the regu- lations as originally proposed and the changes made in response to them : 1) The proposals were said to be too inflexible in the planning of the investigation of the safety and effectiveness of a new drug. Animal Study "The regulations have been re- vised more adequately to describe the different phases of the clini- cal investigation, which may be- gin only after adequate studies on animals ..., 2) The proposed regulations were said to require excessive and unnecessary record keeping. "As revised, the regulations call for 'adequate' records and provide that only the necessary records need be kept ...' Inspection 3) They were said to impinge upon the physician-patient rela- tionship, by calling for inspection of the clinical records. "The provisions for inspection of the patient's records have.been modified, making it clear that the investigator may withhold the names of volunteers or patients unless the records of a particular volunteer or patient require a more detailed study of drug effects, or unless there is reason to believe that the records do not represent actual results obtained ..." 4) Sections of the proposed reg- ulations dealing with publication of findings of investigators were construed as restricting free flow of scientific information. Promotional Material "These sections were clarified to state that the sponsor or per- sons acting for or on his behalf shall not disseminate any promo- tional material representing the drug to be safe or effective. (but) . . .this is not intended to bar factual news reporting to sci- entists or the public." 5) The proposed regulations were said to deny extremely im- portant new drugs ... to patients who might need them urgently as a life-saving measure. "The increased flexibility . will allow the sponsor of a new drug investigation to add new in- vestigators after the program is started. There is no bar in the regulations to giving the necessary instructions to and obtaining the necessary commitments from a new investigator by telephone in case this is needed to save a life." A spokesman for the Pharma- ceutical Manufacturers Association said it is oLvious that the FDA has tried to meet the basic ob- jections to the original regulations. But he added: "The burden of paperwork im- posed by the new regulations is enormous. "The success of the department in meeting its stated goals will, of course, depend in large part on the wisdom of the administration of these regulations..." UNIVERSITY SHOP C LOTHING and FURNISHINGS also WOMEN'S WASHINGTON - Undersecre- tary of State George W. Ball will fly to Paris Wednesday to open far-ranging talks with NATO on formation of an Allied nuclear force for Europe. NEW YORK-Secretary of La- bor W. Willard Wirtz said yester- day the future of collective bar- gaining is at stake in the 14-day longshore strike and declined com- ment on reports that the Kennedy administration might seek some legislation making union and management submit disputes to compulsory arbitration. * * * LONDON-Labor party leader Hugh Gaitskell was reported show- ing improvement yesterday, suf- fering from pleurisy and pericar- ditis-inflammation of membranes around the lungs and heart. * * * WASNIN&TON - The relay communications satellite gave evi- dence yesterday that its power supply has revived, making two successful intercontinental test transmissions, one of them lasting more than an hour. WITH A of FALL and WINTER STOCK Buy Now and Save on,. . 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