A time for restraint.

The debate on the use of human embryos for research will be one of the more important issues of the 21st century. Unlike recombinant DNA technology, embryonic stem cell research most probably will result in the destruction of living embryos. Many people consider this research immoral, illegal, and unnecessary. Therefore, it is imperative to proceed cautiously. Federal funding of research using human embryos or pluripotent cells derived from them would be inappropriate until further resolution of the ethical issues has been achieved.

Ethical and financial considerations in third-party support of investigational cancer therapies.

The appropriate use of and compensation for investigational cancer therapies raises a number of ethical, policy-related, and financial considerations. Ethical considerations include the use of therapeutic regimens for individuals versus controlled clinical trials, the extent of information necessary to indicate that a therapy may be safe and effective, and the informed consent of the patient. Financial concerns include the status of the therapy in the evaluation phase within the Food and Drug Administration, the policy of third-party payers, and the current state of medical knowledge. The policy-related considerations are those regarding the use of and payment for investigational therapies.

Aerosolized pentamidine. Approved for HIV-infected individuals at high risk for Pneumocystis carinii pneumonia.

Aerosolized pentamidine isethionate (NebuPent, LyphoMed Inc, Rosemont, Ill) was recently approved by the US Food and Drug Administration for use in prophylaxis against Pneumocystis carinii pneumonia in individuals infected with the human immunodeficiency virus who are at high risk for this infection. The recommended dose is 300 mg of aerosolized pentamidine isethionate administered every 4 weeks via the Respirgard II nebulizer (Marquest Medical Products Inc, Englewood, Colo). The drug is indicated for individuals infected with the human immunodeficiency virus who have a history of P carinii pneumonia or individuals with a CD4 (T4) lymphocyte count less than or equal to 0.2 x 10(9)/L with no history of P carinii pneumonia. We present information about the drug and its use, including safety information and use of the nebulizer.

An interview with FDA Commissioner Frank Young. Interview by Carmella Bocchino.

The Food and Drug Administration (FDA) has recently been the target of congressional investigations and has seen recent changes in its approval procedures. In this interview, FDA Commissioner Frank Young responds to harsh congressional criticisms and details the FDA approval process.

Contemporary issues: diseases with a food vector.

Foodborne disease has become a contemporary issue. Several large, well-publicized outbreaks of foodborne disease have heightened public awareness that harmful microorganisms may be present in food and that chronic as well as acute disease may be caused by foodborne microbes. The field of food microbiology has likewise experienced a resurgence of interest. New tools, such as recombinant deoxyribonucleic acid technology and monoclonal antibody production, used to elucidate microbial virulence factors have facilitated identification of disease-causing microbes once thought to be harmless and demonstrated the complexity of individual virulence mechanisms previously considered to be well understood. Foodborne pathogens are also causing disease via some surprising food vectors, such as chopped, bottled garlic and sauteed onions. In addition to acute gastrointestinal disturbances, certain microorganisms may, through complex interactions with the human immune response, cause chronic diseases that affect several major organ systems. These microbes are serving as models in studies of molecular mimicry and genetic interrelatedness of procaryotes and eucaryotes. Other recently recognized attributes of foodborne microorganisms, such as the heat shock phenomenon and the possible nonculturability of some bacteria, may affect their ability to cause disease in humans. Because foodborne disease is a major cause of morbidity and mortality, the study of these diseases and their causative microorganisms presents a unique challenge to many professionals in the subdisciplines of microbiology, epidemiology, and clinical medicine.