Government Regulations and the Use of Drugs

I have tried to trace the new drug development pattern from 1766, when Withering obtained his medical degree, to the present.The role of governmental authority as defined by the 1962 Kefauver-Harris amendments to the 1906 law and the subsequently issued regulations has been summarized. Four phases of testing in man have been detailed.Something of the scientific or research capability of the pharmaceutical industry has been presented.It is concluded that in the period of over two hundred years of medical education in the United States, the university hospital has become more and more the focus of medical research, teaching and practice in the community. The safety and effectiveness in the use of drugs in the future will depend upon the liaison and rapport of the industry physicians, government officials and the university hospital teacher-clinical investigators (phase 1 and 2) in designing the most critical studies of the safety and effectiveness of new drugs.Whether the medical profession as we know it will participate more in the future than has been possible since 1962 in mass clinical trial (phase 3) before new drug approval by governmental authority remains to be seen.The final approbation or disapproval of a drug after NDA approval (phase 4) will continue to be in the hands of the participating physician as long as he can establish scientifically that the drug is the best possible agent for him to use in healing the sick and comforting the dying.     

From Racism to Genocide: Anthropology in the Third Reich

From Racism to Genocide: Anthropology in the Third Reich . Gretchen E. Schafft. Urbana: University of Illinois Press, 2004. 297 pp.     

Affordable ART and the Third World: difficulties to overcome

⁶ Present address: 80 Grove Road, Millhouses, Sheffield S7 2GZ, UK⁷ Correspondence address. Tel: +44 (0) 114 262 0718; E-mail: I.d.cooke{at}sheffield.ac.uk A coherent strategy is required, donors to cover the costs ofa business plan and personnel to provide advice and trainingand the country must be chosen. An urban environment is preferredwith a local link, ideally a University Department with an existingART programme and a willingness to be involved. Premises, aclinician and an embryologist must be identified, appropriatetraining arranged and excellent communication systems put inplace. Apart from arranging equipment and servicing supplies,management systems and transparent data collection processesmust be established. The protocol and local variations haveto be agreed. The clinic needs to be related to the local healthsystem, referral patterns must be created and screening processesset up to develop a waiting list of suitable patients. The natureof prior treatments must be defined. At some point, there needsto be a visit of an agreed scientific adviser with or withouta donor representative. The number of patients treated in aninitial cohort and review details should be determined. A longerterm programme, the creation of a local professional networkand clear relations with the state health system need to beexplored. Any of these stages may constitute difficulties tobe overcome.     

Criteria of the sensitivity of Zajdela and Morris hepatoma cells to glucocorticoids

Glucocorticoids induce tyrosine aminotransferase synthesis in 7777 Morris hepatoma but fail to do so in Zajdela hepatoma. This internal property indicates the resistance to the hormone. However, both hepatoma cell lines do respond to the triamcinolone acetonide in a similar way, as judged by some other criteria, e. g. interaction with the immobilized hormone on the inert carrier, adhesion to glass and kinetic parameters of alkaline phosphodiesterase I activity. Moreover, both cell types respond to glucocorticoids by modification of synthesis of some proteins, as revealed previously by two-dimensional electrophoresis. The results show that in case of tumour cells which retain their specific receptor apparatus but do not respond to glucocorticoids by usual criteria, the conclusion whether tumour cells are hormone-sensitive or not has to be drawn from the analysis of their multiple response judging by several assays.     

Ghosts and Shadows: Construction of Identity and Community in an African Diaspora.

Ghosts and Shadows: Construction of Identity and Community in an African Diaspora. 2nd edition. Atsuko Matsuoka and John Sorenson. Toronto: University of Toronto Press, 2001. 261 pp.     

Disclosure of individual genetic data to research participants: the debate reconsidered

Despite extensive debate, there is no consensus on whether individual genetic data should be disclosed to research participants. The emergence of whole-genome sequencing methods is increasingly generating unequalled amounts of genetic data, making the need for a clear feedback policy even more urgent. In this debate two positions can be broadly discerned: a restrictive disclosure policy ('no feedback except life-saving data') and an intermediate policy of qualified disclosure ('feedback if the results meet certain conditions'). We explain both positions and present the principal underlying arguments. We suggest that the debate should no longer address whether genetic research results should be returned, but instead how best to make an appropriate selection and how to strike a balance between the possible benefits of disclosure and the harms of unduly hindering biomedical research.     

Drawing Shadows to Stone: The Photography of the Jesup North Pacific Expedition, 1897-1902

Drawing Shadows to Stone: The Photography of the Jesup North Pacific Expedition, 1897-1902. Laurel Kendall. Barbara Mathé. and Thomas Ross Miller. with Stanley A. Freed. Ruth S. Freed. and Laila Williamson. New York, 1997. American Museum of Natural History, New York, and the University of Washington Press, Seattle and London. 112 pp., 97 illustrations.     

Disclosure of genetic information to relatives in Israel: between privacy and familial responsibility

This article presents findings from a large quantitative-based study conducted in Israel in eight genetic clinics across the country regarding patients’ attitudes to disclosure of genetic information to relatives. The study examines the similarities and differences between the two largest groups who visit genetic clinics in Israel – for prenatal screening and for carrier testing for cancer. It was found that the overall rate of intention to inform relatives was high. It was also found that respondents in the cancer group expressed a more familial-based approach than those in the prenatal screening group. In addition, a relatively high rate of non-disclosure was found in the prenatal screening group as compared to the cancer group. These findings are significant in light of a widespread wish in Israeli society to give birth to a child without a disease or disability. A reconsideration of current practices and guidelines in this area is therefore required.     

In the Shadows of Medicine and Modernity: Medical Integration and Secular Histories of Religious Healing in Turkey

Building upon the World Health Organization's recent publication WHO Strategy for Traditional Medicine (WHO 2002), this paper examines the historical position of "traditional medicines" at their intersection with the development and modernization of a biomedically based health care system in Turkey. This paper considers how the historical development of Turkey's health care system, as a prominent site for the articulation of the state's broader modernization project, sustained particular formulations of subjectivity and citizenship that were defined in opposition to a set of cultural practices and modes of religious-political authority represented by "traditional medicines." Consequently, projects and policies seeking to formally integrate "complementary" or "alternative" therapies directly confront this past and the various ways in which it is reenacted in constituting the present.     

Microsomal monooxygenase system in Morris hepatoma: purification and characterization of cytochromes P-450 from Morris hepatoma 5123D of 3-methylcholanthrene-treated rats

Two forms of cytochrome P-450 (hepatoma P-450MCI and P-450MCII) were purified from hepatoma 5123D microsomes of tumor-bearing rats treated with 3-methylcholanthrene. Hepatoma P-450MCI had a specific content of 18.4 nmol/mg protein and showed a main protein band with a minimum molecular weight of 56,000 on sodium dodecyl sulfate-polyacrylamide gel. Hepatoma P-450MCII had a specific content of 7.38 nmol/mg protein and a minimum molecular weight of 50,000. The carbon monoxide-reduced difference spectral peak of hepatoma P-450MCI was at 446.5 nm, whereas the peak of hepatoma P-450MCII was at 451 nm. In the reconstituted system, hepatoma P-450MCI catalyzed 3-hydroxylation of benzo[a]pyrene and O-deethylation of 7-ethoxycoumarin, but showed low activities for N-demethylation of benzphetamine and aminopyrine, O-demethylation of p-nitroanisole, and p-hydroxylation of aniline. On the other hand, hepatoma P-450MCII did not catalyze hydroxylation of any of the substrates tested. By Ouchterlony double-diffusion analysis, hepatoma P-450MCI was immunologically indistinguishable from rat liver cytochrome P-450c, but hepatoma P-450MCII was distinct from hepatoma P-450MCI and rat liver cytochrome P-450c. Peptide maps of hepatoma P-450MCI and rat liver cytochrome P-450c after proteolysis with Staphylococcus aureus V8 protease demonstrated the similarity of the two cytochromes P-450.