Search PubMed⌕ Search

Biomedical subjects

F E Young

Publications and source records attributed to F E Young.

At least 19 recordsLinked to original sources

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.

Bioethics↗

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.

Clinical Trials as Topic↗

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.

Acquired Immunodeficiency Syndrome↗

The FDA's new procedures for the use of investigational drugs in treatment.

The Food and Drug Administration has established new procedures to make promising investigational drugs available for treatment of patients with immediately life-threatening or serious diseases as early in the drug development process as possible and well before general marketing begins. The purpose of this article is to inform the medical community about these new procedures and to facilitate their implementation. Examples of immediately life-threatening and serious diseases are given and the procedures that physicians should use to obtain a drug under the new regulations are described. The treatment use of zidovudine (Retrovir), while still in the investigational phase, is described as a case study. The article also summarizes the Food and Drug Administration's new procedures under which drug sponsors can charge for investigational drugs.

Acquired Immunodeficiency Syndrome↗