Faculty Bibliography

Detecting adverse drug reactions after the drugs are marketed is a radically different task from recognizing them during the premarketing experimental testing phase. Before a drug is marketed, extensive laboratory tests are made on from 500 to 3,000 individuals. But those numbers, while statistically adequate to determine a drug's efficacy and its safety in ordinary use, may be too few to detect the less common but still serious adverse reactions. If Zomax has really killed 11 or 12 Americans and no more, it will be hard to imagine a test on any reasonable number of people that would reveal such a peril in advance. Whereas reporting of premarketing data to the Food and Drug Administration is mandatory, most of the figures for adverse reactions to drugs already marketed comes from a voluntary reporting system. Some physicians and hospitals have little zeal for filling out yet another form for the F.D.A. Some doctors also - or instead - report adverse reactions to drug companies. In fact, about 80 percent of the adverse reaction reports that the drug agency receives come from drug companies, Dr. [Judith K. Jones] said. Although the voluntary system seems to be a fairly sensitive means of detecting deaths and severe adverse reactions, the less serious reactions seem to be underreported, for many reasons. One frequently cited reason is the physician's fear of exposing himself or herself to potential malpractice suits by acknowledging that a drug injured a patient. However, Dr. Jones of the F.D.A. said there was no such danger because the agency kept confidential the names of those who report adverse reactions

For example, one serious kidney disorder is glomerulonephritis, in which inflammation affects the glomerular filtering cells. Although all forms of glomerulonephritis destroy some kidney cells, only some types destroy enough cells to cause end-stage kidney disease and to require dialysis or organ transplants. Now, Dr

Excreting nitrogen and other wastes in the urine is the kidneys' main task. But that is only part of the kidneys' larger role - to keep nearly constant the body's internal environment. This environment consists chiefly of the fluids and chemicals that are found in different amounts and proportions inside and outside the body's billions of cells. In many cases, too much or too little of one chemical or another in this environment makes the body decide to stop living. Keeping the body's juices suitably balanced would be hard work for a chemical engineer; the kidney makes it look easy, most of the time. ''Kidney damage caused by diabetes mellitus looms as the most prevalent, costly, and debilitating cause of kidney failure in the United States,'' said Dr. [Eli A. Friedman], a kidney expert at Downstate Medical Center in Brooklyn. Moreover, increasingly careful control of blood sugar levels in diabetics, according to Dr. Friedman, ''holds the promise of preventing kidney damage'' in the 5.5 million Americans who have diabetes

Dr. [Barney B. Clark]'s prognosis depends in part on how quickly the pneumonia responds to therapy, and for that reason the doctors have adopted a ''wait-and-see'' attitude, Dr. [Chase N. Peterson] said. Responding to Treatment ''He seems to be responding rather quickly,'' Dr. Peterson said. Nevertheless, Dr. Clark's doctors have said that infection poses one of the biggest hazards in his long-term care. The pneumonia is the first serious one that he has suffered since the artificial heart was implanted 93 days ago. At a news conference earlier this week, Dr. William C. DeVries, the surgeon who implanted the artificial heart on Dec. 2, said that Dr. Clark's chronic lung problem was the 62-year-old retired dentist's greatest medical problem. ''Many people with lung disease as severe as his will die from nothing else except that disease,'' Dr. DeVries said

In the interview with the surgeon, Dr. William C. DeVries, Dr. [Barney B. Clark] was asked whether the plastic heart had been uncomfortable. ''Not at all,'' he responded. ''It's comfortable. It's a thing you get used to.'' It ''doesn't bother me at all,'' he continued, adding, ''Yes, it has been hard, but the heart itself has pumped right all along and I think it is doing well.'' '' ''All in all,'' he added, ''it has been a pleasure to be able to help people.'' The 62-year-old retired dentist also said he was worried about the state of his lungs. ''Lack of air'' and ''shortness of breath,'' caused by a chronic lung problem that predated the implant operation, bothers him the most, he said. But Dr. Clark said his symptoms were ''getting a little better.'' Dr. Claudia Berenson, a psychiatrist who evaluated Dr. Clark before the artificial heart was implanted on Dec. 2 and who has seen him almost every day since then, said he had ''totally resolved'' a mental condition that she diagnosed as ''acute brain syndrome.''

''There is no doubt that it is a major advance in the management of kidney stones,'' the medical journal The Lancet said in a recent editorial. This procedure usually takes no more than 90 minutes, often less than an hour, and patients' hospital stays have averaged only four days. ''Pain and suffering is minimal, and the patient usually can return to work within one week of the time of the procedure with no physical restrictions,'' Dr. [Lynwood H. Smith] said. Then from 500 to 1,500 shocks are given to destroy the stone. ''A report like a pistol shot rings through the laboratory with each spark discharge and staff and patient have to wear earplugs,'' according to the report in The Lancet

For example, one serious kidney disorder is glomerulonephritis, in which inflammation affects the glomerular filtering cells. Although all forms of glomerulonephritis destroy some kidney cells, only some types destroy enough cells to cause end-stage kidney disease and to require dialysis or organ transplants. Now, Dr. [Ira Greifer] said, the results from biopsies and immunological tests are allowing doctors to better determine which types of glomerulonephritis are benign and which might progress to end-stage kidney disease. Classification Is Difficult The therapy involves the risk of peritonitis, which is potentially fatal. Nevertheless, the children have a ''wearable artificial kidney.'' Moreover, by relaxing the strict dietary restrictions, the therapy has been of psychological and nutritional benefit, according to Dr. Richard N. Fine of the University of California at Los Angeles Center for Health Sciences. New Aids for Transplants In another development that is still in its early stages, researchers have adapted the tools of molecular biology to stop some rejection crises that threaten the success of a transplanted kidney. Dr. Charles B. Carpenter of the Brigham and Women's Hospital in Boston, representing a team from his hospital and from the Dana-Farber Cancer Institute in Boston, reported that it had made monoclonal antibodies against a type of lymphocyte called T-12 cells, which are involved in the process in which a body rejects transplanted tissue. The antibodies, derived from mice, were injected into 14 patients. An evaluation was possible in only 10, Dr. Carpenter said, and of these, the 10-day course of anti-T-12 treatment helped seven, seemingly on a long-term basis

The issue arose in Dr. [Barney B. Clark]'s case earlier, too, when doctors at the hospital were describing his persistent state of confusion for many days after he suffered a number of seizures. After being asked repeatedly about that confusion, Dr. Chase N

''Stand up here,'' he told the reporter, ''let us take off your clothes, make you unable to speak very well, put needles and tubes into you, have night indistinguishable from day over a several-week period, and then I'll ask if by any chance you are frustrated and confused.'' The reality is that the 62-year-old retired dentist's experience was not so different in many respects from that of others in intensive care units for long periods. Indeed, life in intensive care can be so unsettling for many people that doctors often diagnose what they call ''intensive care unit psychosis.'' Dr. [Fitzhugh Mullan] described his experience in ''Vital Signs,'' published earlier this month by Farrar, Straus and Giroux: ''I was stripped bare, placed on a rolling stretcher, covered with a thin sheet, and wheeled through the halls of the hospital to the surgical suite.'' Dr. Mullan's glasses had been left at his bedside, so everything appeared fuzzy. ''The thought of riding in a public elevator stark naked, protected only by a drafty sheet, made me anxious. It epitomized my vulnerability.''