Faculty Bibliography

The FDA requirements were outlined in a letter dated to the manufacturer of Accutane, Roche Laboratories, a division of Hoffmann-La Roche Inc. of Nutley, N.J. The company released the letter Thursday and said it would comply. Accutane, which has the generic name isotretinoin, was approved by the FDA in 1982. It is known to cause severe birth defects in about 25 percent of the babies exposed to it before birth. These defects include facial malformations, typically missing or misplaced ears, severe mental retardation and serious heart defects. In an interview Thursday, Carolyn R. Glynn, a spokeswoman for Roche Laboratories, said that in addition to the measures called for by the FDA, the company would also prepare a test for doctors to administer to women to make certain they understand the hazards involved in taking Accutane

The recommendations to prescribing physicians specify that Accutane only be given to women whose severe disfiguring acne cannot be controlled with any other treatment, who are ''reliable in understanding and carrying out instructions,'' and ''capable of complying with the mandatory contraceptive measures.'' It also said Accutane should be prescribed ''only by physicians who have special competence in the diagnosis and treatment of severe, recalcitrant cystic acne.'' Warning labels given to the patient with a newly designed blister package must state that there is at least one chance in four that Accutane use in pregnancy will result in a deformed infant. A package must include a photograph of ''an infant with the characteristic visible external deformities incurred due to exposure to Accutane,'' the letter said. ''What's needed is a departure into restricting who can prescribe the drug and under what conditions, with criminal penalties,'' Dr. [Sidney Wolfe] said. ''Some people in the general counsel's office of the F.D.A. believe they have the authority to do it.''

Accutane, which has the generic name isotretinoin, was approved by the FDA in 1982 for the 'treatment of severe, recalcitrant, cystic acne unresponsive to conventional therapy.' Accutane is known to cause severe birth defects in about 25 percent of the babies exposed to it before birth. These defects include facial malformations, typically missing or misplaced ears, severe mental retardation and serious heart defects. In an interview Thursday, Carolyn R. Glynn, a spokeswoman for Roche Laboratories, said that in addition to the measures called for by the FDA, the company also would prepare a test for doctors to administer to women to make certain they understand the hazards involved in taking Accutane

Noting the poor experience with artificial hearts so far, Dr. Claude Lenfant, director of the National Heart, Lung and Blood Institute, said federal efforts would focus instead on developing a partial artificial heart known as a left ventricular assist device (LVAD). One device made by Novacor, of Oakland, Calif., worked continuously in a laboratory for a year without major problems under simulated circulatory conditions. It also met other rigorous tests of reliability, Lenfant said. The device for permanent use is nearing the stage where it will be tested in humans, subject to approval from the Food and Drug Administration, Lenfant said. Lenfant views the research on an improved ventricular assist device as a possibly speedier route to an artificial heart because it can more quickly resolve some medical problems potentially associated with all these devices. By testing permanent ventricular assist devices, he said, 'we will know in three to four years whether we have with that simple device the same problems that exist with the Jarvik heart.'

While mannitol injections produced apparently dramatic results, the authors of the report, from the Marshall Islands and the University of Hawaii, warned that the study was small and not scientifically controlled. Nevertheless, the team, headed by Dr. Neal A. Palafox, said it was important to convey the results because mannitol is inexpensive and readily available around the world, particularly in remote areas where the nonbacterial food poisoning is most common. Problem Is On Rise Ciguatera poisoning, which results from a toxin produced by a form of algae, was originally described by Spanish explorers and its name is derived from the Spanish word for a poisonous snail. The incidence of the poisoning appears to be rising in Florida, the Caribbean and the Pacific, health officials say. The true incidence is not known. The poisoning can produce a wide variety of symptoms, which usually develop within 12 hours of eating contaminated fish. In the overwhelming majority of cases they are mild. Among the symptoms are a burning pain when drinking or touching water; teeth may feel numb; fingertips tingle and feel numb; arms and legs feel weak; dizziness; nausea, vomiting, abdominal cramping and diarrhea. Muscle and joint pains, often felt in the thighs, calf, knees and ankles, are likened to muscle cramps after jogging and in severe cases, people cannot walk because of the pain

Dr. [Alan R. Hinman] said that although the Swedish study ''did not give us all the information that we might like,'' American public health officials view the research as very important. In part, this is because it was the first thorough assessment of acellular pertussis vaccines in infants less than 1 year old. Disease Surging in Sweden ''The matter is much more complicated than scientists had thought,'' Dr. [Kallings] said. ''Our study did not give a clear answer and not much will happen until we perform another, larger one.'' The pertussis study showed that development of ''bacterial vaccines is more complicated than expected,'' Dr. Kallings said.

''The only reason he's back in the game is because of the device,'' Dr. [Frazier] said. ''I say that with absolute certainty.'' He said the pump was removed after two days and the patient was recovering well. Dr. Frazier said he expressed skepticism about the potential success of the pump when he first saw it two years ago and Dr. [Richard K. Wampler] asked for his cooperation. ''For most devices I have some optimism, but for this one I didn't think it would work,'' Dr. Frazier said. Dr. Frazier said he had expected that the pump would work like a blender to break up the red cells in the blood or cause clots. But, he went on, Dr. Wampler ''prevailed on me to do the studies'' that showed the pump did not have such adverse effects in experiments on animals and in the first two cases. 'A Real Coup'

It works on a principle similar to that of the Archimedes screw, named after the Greek scientist who invented it about 300 B.C. as a means of raising water from ditches or wells for irrigation. The Archimedes screw traps liquid in its spiral vanes as it turns inside a close-fitting tube. Rotation forces the fluid to rise with the spiraling grooves of the device. The heart continues to beat in its normal rhythm while the Nimbus pump is working. The device pumps up to four liters of blood a minute, more than enough to meet the body's basic demands, [O. H. Frazier] and [Richard Wampler] said. The heart of a healthy person pumps about five liters a minute. Frazier and Wampler both speculated that, if the promise holds and no negative side effects are discovered, the pump might be used temporarily in perhaps 150,000 patients a year, including heart attack victims who suffer from such complications as acute heart failure and a sharp drop in blood pressure resulting from shock

Through an ad in a local newspaper, Cannell urged prospective patients who refuse to give up smoking to seek care from some other doctor. He said he did not want them as patients. He pledged to treat any patient for an emergency (and did so recently for a smoker who was about to suffocate). He also promised to continue caring for those already in his practice who ignored his warnings about smoking. Cannell, in turn, defends his unusual stance by citing the tradition of allowing doctors and patients to choose each other. Putting a novel twist on the ethical obligations of physicians to treat patients, he also cites Hippocrates, who warned physicians that their primary duty was to do no harm. Cannell argues that by treating smokers for tobacco-related problems he is, in effect, encouraging them in their deadly habit. On this logic, Cannell has received support from an expert in ethics. Cannell 'is not going against any kind of ethical practice I know of,' said Dr. John H. Burkhart, who heads the American Medical Association's council on ethics and judicial affairs. Burkhart said he admired Cannell for 'not wanting to be a co-conspirator' with smoking patients