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posted on 26 Aug 2012 01:43 by ordernexiumpa
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ant, or conclusive, evidence. "We mean that, Order Nexium where a reasonable number of clinicians have conducted tests which show that a drug has the claimed effects, FDA should permit the drug to be marketed even though Order Nexium other tests by other clinicians do not show the same effects. This is a case of difference of medical opinions, which, as Dr. Hussey had said, should not be resolved by the fiat of any authoritarian body but by each physician in his own practice. "Senator Kefauver. All right. "Then we seem to be pretty well agreed all the way around, sir." Id., at p. 2012. Only at a few points in the hearings was there focus upon "controlled" investi- gations. When Dr. Charles May, Professor of Pediatrics at New York University, testified, the concept of a controlled examination was used to distinguish the facilities available to the individual physician. See Hearings before the Subcom- mittee on Antitrust and Monopoly, July 18, 1961, p. 204. The same distinction was emphasized by the testimony of Dr. Louis Goodman, Professor of Pharmacology at the University of Utah. See Id., at pp. 217, 243. The one witness before the Senate hearings who stated that he had "often testified to the importance of double-blind controlled trials in clinical research" insisted that his statements did not constitute a demand for such trials on all new drugs. The witness, Dr. Louis Lasagna, asserted that : "The emphasis should be on scientifically acceptable evidence, of whatever quality and quantity required to give a reliable answer to the questions posed concerning the drug's effects." Hearings before the Senate Subcommittee on Antitrust and Monopoly, July 19, 1961, pp. 282-283. In di.scussing the subject of phraseology. Dr. Lasagna concisely stated a view which permeated the hearings : "I would hope that if such a bill were passed, that there would be every opportunity for a flexibility of interpretation." /er treatment of many common diseases. Rheumatoid arthritis is such a condition. There are highly qualified physicians who favor the use of cortico- steroid drugs. There are others who feel that the employment of the cortico- steroids Order Nexium does more harm than good and that the only meritorious drug is aspirin. Still others are proponents of, resixctively, Butazolidin, gold salts, and anti- malarial drugs such as quinacrine, chloroquine, and hydroxychloroquine. The use of pyramidon. or large doses of vitamin D, still has adherents, and particu- larly among clinicians in foreign countries. The reaction of experts to any new drug offered for the treatment of rheumatoid arthritis will inevitably be condi- tioned by the school of thought to which they happen to adhere. By whose advice is FDA to be guidwi in the evaluation of a new drug for this condition?" [Dr. Klumpp then considered similar problems Order Nexium with drugs for epilepsy, mucous Order Nexium colitis, and the common cold.] The above specific illustrations are only a few of the many that can be cited to show that (a)' The determination of the effectiveness of a drug is always diflScult and sometimes cannot be achieved except by the test of time and widespread use. (b) Therapeutic representations are essentially matters of opinion. (c) Differing schools of thought frequently exist concerning therapeutic issues, and the school which favors one theory as to the nature and treatment of disease tends to be skeptical of the drugs advocated in opposing schools. More- over, medical opinions as to effectiveness of a particular drug can differ widely among equally qualified physicians because of basic differences in opinion relating almost entirely to questions of diagnosis and preferred method of treatment, as well as differences as to the comparative eflScacy of one member of a class of drugs in relation t-o others or Order Nexium the mode of action of a particular drug in the complex body mechanism. Hearings at pages 232-235. Conclusions The legislative history of the 1962 amendments establishes quite clearly that Congress did Order Nexium not intend "substantial evidence" to mean a preponderance of evi- dence. Nor did Congress expect the medical profession to arrive at single con- clusions about drugs and treatments. Rather than enacting standards which would require exact Order Nexium proof and which could leave no room for minority opinions. Congress explicitly favored concepts of flexibility which could accommodate the range of responsible professional opinions. Had Congress disagreed with Secretary Ribicoff's view that the amendments would not change the estahlished pattern of testing drugs, there would have been more discussion on the subject of the methodology of drug testing. But Congress did not take issue with the Secretary's assessment of the law, and the legislative history shows that Congress intended to maintain flexibility in the area of drug
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