RESUMO
We consider here some of the legal and political background behind today's laetrile controversy. First, we provide a brief historical review of our present food and drug legislation and discuss details of these laws with respect to attempts by laetrile's backers to use the courts in the legalization of this compound. We analyze one case, Rutherford v. United States, that was won in the lower courts by the advocates of laetrile and conclude that the courts may have allowed emotionalism to interfere with the process of rational decision-making. On a larger scale, this emotionalism manifests itself as political pressure that may bring about changes in our food and drug legislation. These changes could loosen restrictions on the effectiveness requirement and result in the sacrifice of consumer protection in favor of making available more drugs, some of them ineffective, from which the patient may choose for treatment.
Assuntos
Amigdalina , Governo Federal , Regulamentação Governamental , Legislação de Medicamentos , Amigdalina/história , Amigdalina/normas , Pesquisa Biomédica , Avaliação Pré-Clínica de Medicamentos , Liberdade , História do Século XIX , História do Século XX , Direitos Humanos , Humanos , Jurisprudência , Legislação de Medicamentos/história , Autonomia Pessoal , Preparações Farmacêuticas/normas , Estados Unidos , United States Food and Drug AdministrationRESUMO
The National Cancer Institute (NCI) recently acquired a large supply of formulated products of amygdalin manufactured by Cyto Pharma of Mexico, for possible use in a clinical trial in the US. Tablets for oral administration and ampules of the injectable produce were obtained. Both forms were extensively analyzed and evaluated by several analytic and pharmaceutical laboratories under contract with the NCI. Analytic test procedures were developed to determine the chemical integrity and quantitative composition of the formulated products. Routine physical and biologic tests were also performed to evaluate the manufacturing quality of both dosage forms. The results indicate that both the oral and injectable forms of amygdalin were substandard by US criteria for manufactured pharmaceutical products. All samples were determined to be chemically subpotent, mislabeled, and of poor manufacturing quality. More than 20 samples of the ampules were found by visual inspection to contain microbial contamination. Other samples were found to be pyrogenic. Based on the results of the testing performed, both tablet and ampule forms of amygdalin manufactured by Cyto Pharma of Mexico are considered unfit for use in man.