The role of data audits in detecting scientific misconduct: results of the FDA program

Article Abstract:

Scientific misconduct occurs during a significant number of investigative drug trials based on analysis of Food and Drug Administration (FDA) audits of the investigators. Before October 1985, serious deficiencies were found in 12 percent of audits, but in only seven percent since that date. Some investigators who had grossly violated rules of drug research were able to resume their participation in drug trials. If drug trials are continued, successful regulation of misconduct, which ranges from negligence to fraud, requires additional measures. Potential investigators could have to meet certification standards and peer-review, or their level of participation in the tests could be limited. The FDA could insist on competitive applications for participation in authorized drug trials, and could suspend investigators if a hearing is required. Manufacturers who fail to detect their researchers' misconduct could be penalized.

Case studies, Drugs, Laws, regulations and rules, Investigations, Testing, Clinical trials, Medical research, Fraud in science, Science fraud, United States. Food and Drug Administration

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Experience and outcomes in AIDS

Article Abstract:

The quality of care at different hospitals may vary depending on a variety of factors. One factor may be the amount of experience the hospital has in performing certain surgical or medical procedures. Another factor may be the amount of experience the hospital has in treating certain conditions such as AIDS. A research study found that fewer patients died from Pneumocystis carinii infection, an infection common among AIDS patients, at hospitals with more experience treating AIDS patients than at those with less experience. Health professionals with less experience may not recognize complications as early, and they may not be aware of the most advanced drug therapies. A possible solution may be to restrict treatment of AIDS patients to the most experienced hospitals. Another solution is to increase education on the care of AIDS patients for health care professionals in less experienced hospitals.

Editorial, Evaluation, Hospitalization, Hospital care

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Residents' experiences in, and attitudes toward, the care of persons with AIDS in Canada, France, and the United States

Article Abstract:

Medical residents in the US may be more reluctant to care for AIDS patients than residents in Canada and France. A total of 542 Canadian residents, 1,745 US residents and 361 French residents were surveyed about their attitudes toward AIDS patients. All were in their last year of a family medicine or internal medicine residency. Most of the residents in each country felt that they had received little training in caring for AIDS patients. Most thought it would be unethical to deny treatment to AIDS patients, but many would not treat them if given the choice. More US residents would choose not to treat AIDS patients than French or Canadian residents. More US residents were also reluctant to treat those at risk of AIDS than their French or Canadian colleagues. These differences could be a result of different cultural values in the US, France and Canada.

Care and treatment, Beliefs, opinions and attitudes, Residents (Medicine)

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