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Biomedical subjects

L Lasagna

Publications and source records attributed to L Lasagna.

At least 55 records · Page 3Linked to original sources
PubMed1988

Anorectic drugs: drug policy making at the state level.

This study outlines the attempts of four states (Louisiana, Kansas, Wisconsin, and Michigan) to restrict anorectic prescriptions. The actions in these four states exemplify the various mechanisms used in regulating anorectics, ranging from educational efforts to legislative enactments. We examine the evidence used in promulgating these policies and review some of the current literature on the safety and efficacy of anorectics. Despite the existence of evidence demonstrating the safety and efficacy of anorectics, the states seem to be moving toward more severe restrictions, in contrast to the federal regulatory agencies.

Appetite Depressants↗
PubMed1987

Trends in drug development: the 1985-86 new drug approvals.

New drug approvals in 1985 and 1986 were analyzed to determine whether any new trends have emerged in the US drug development process. Fifty-three new drugs (including three biologic products) were approved during this period; 46 met the Center for the Study of Drug Development's definition of a new chemical entity (NCE). More than 70% of the 46 approvals were granted in the fourth quarter, 50% in December alone. Four were FDA classified as 1A (important therapeutic gain), 24 as 1B (modest gain), and 16 as 1C (little or no gain); two biologics were not classified. Nine drugs were given orphan status. For the 37 non-orphan drugs, the duration of the "development phase" (IND filing to NDA submission) was 5.6 years; the "review phase" (NDA submission to approval) was 2.6 years; and the "total time" (IND filing to NDA approval) was 8.2 years. Review phase for the four 1A drugs was 2.4 years; for the 24 1B drugs, 2.6 years; for the 16 1C drugs, 2.8 years; and for the nine orphan drugs, 2.7 years. Of the 46 drugs, 33 (71.7%) were available in foreign markets prior to US approval with a mean of 5.5 years of prior marketing. Although the total of 46 NCE approvals in 1985 and 1986 represents a two-year high, there has been a dramatic shift towards fourth quarter approvals. Lengths of the development and FDA review phases are in keeping with those values for previous years.

Humans↗
PubMed1987

Benefit-risk ratio of agonist-antagonist analgesics.

Many agonist-antagonist analgesic substitutes for morphine have been synthesized and their safety and efficacy evaluated in animals, humans or both. Several drugs in this class have achieved regulatory approval and have reached the marketplace. Agonist-antagonist analgesics have proved clinically acceptable and are in some respects superior to the standard narcotic analgesics, most markedly in their diminished addiction liability. In other respects, however, agonist-antagonist analgesics are inferior to morphine; they probably have lower analgesic ceiling efficacy, are more likely to produce psychotomimetic effects, and can precipitate abstinence in patients physically dependent on opioids.

Analgesics, Opioid↗
PubMed1987

New indications for already-approved drugs: time trends for the new drug application review phase.

For 55 individual drugs, the time required for approval of the original new drug application (NDA) was compared with the time required for approval of supplemental NDAs. The mean time required for the original NDAs was 22.2 +/- 18.1 months; the mean for review of all 46 follow-on indications was similar (19.1 +/- 17.9 months). Since subsequent applications do not ordinarily require new assessment of clinical safety or animal toxicity studies, one would expect the subsequent applications to be processed more expeditiously. Such is not the case. The negative implications of these facts are discussed.

Drug Evaluation↗
PubMed1987

Drug regulation in the United States and the United Kingdom: the Depo-Provera story.

In 1984, both the United Kingdom and the United States received recommendations from panels of experts specifically convened to consider the merits of Depo-Provera (depot medroxyprogesterone acetate [DMPA]) as a long-term contraceptive agent. This study compares the final reports written by these panels. We explore why, despite access to essentially the same data, the U.K. panel recommended marketing approval but the U.S. Public Board of Inquiry did not. We conclude that differing national policies helped shape the interpretation of the data and thus the divergent outcomes.

Animals↗
PubMed1987

The desire to regulate: the wish to discover.

In considering post-registration research, the paper deals with the motivation of the interested parties for such research, new uses for established drugs, ways of filling information gaps and concludes with a number of fundamental principles on which post-registration research should be based.

Data Collection↗
PubMed1986

Graphical analysis of multivariate pain data in analgesic trials.

In order to compare analgesic treatments effectively one must measure pain over time. In a single-dose clinical analgesic trial one typically obtains repeated pain measurements from each patient during a relatively short period (4-6 hours). Such measurements constitute multivariate data, which are usually reduced by simple addition to a single derived pain measure for analysis of between-treatment differences. In this article we consider graphical procedures for the display of multivariate, clinical analgesic data. The first of these are the traditional time-effect curves, with added "standard error bars." We also examine a multivariate display, the biplot, which is based on principal component analysis. This technique provides a representation of the raw pain scores at each time of measurement by a vector originating from the origin of a two-dimensional graph. The multivariate pain scores of individual patients are summarized by points on the graph. Differences in pain scores over time (or between treatment groups) may be examined by relating points (or ellipses representing treatment groups) to different vectors. Using actual data from a postsurgical analgesic trial, we compare the two approaches and show that the multivariate approach is a useful addition to the standard technique for display of such data.

Analgesics↗
PubMed1986

Clinical testing of products prepared by biotechnology.

In summary, new therapeutic products derived from biotechnology will have to satisfy all the usual demands of regulatory agencies, plus some new requirements generated by their special nature. The chemical identity and purity of rDNA compounds will have to be assured, animal toxicity testing will be required, and sufficient data on clinical safety and efficacy will have to be gathered to justify FDA approval. In this process, empiricism will be the key word. NDAs will be approved on the basis of facts, and not theory, and that is as it should be. How costly will this process be? Part of the process is more or less under the control of the sponsor, i.e., the part leading up to the filing of the NDA. Trials can be organized and carried out efficiently or inefficiently; the difference will be measured in years and millions of dollars. The same generality can be applied to the preparation of the inevitably voluminous NDA. Two final worries: Litigation and damage awards are threatening the stability of much of our society. The trend toward holding pharmaceutical manufacturers responsible for strict product liability, not negligence, is fearsome, since it is not possible to protect oneself against harm which cannot be predicted or prevented. Unforeseen serious adverse effects with an rDNA product involving thousands of patients could spell bankruptcy for a biotechnology company. The last issue is what I will term the "biotechnology Chernobyl disaster".(ABSTRACT TRUNCATED AT 250 WORDS)

Biotechnology↗