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Several states have laws mandating disclosure of payments made to physicians by pharmaceutical companies, and an investigation was made to determine the accessibility and quality of the available data, to describe the prevalence and magnitude of disclosed payments. Payments of $100 or more were made to physicians by pharmaceutical companies, but the laws did not provide easy access to public, and the quality of data accessed was not satisfactory.

The financial conflict disclosures at drug-related meetings is characterized to assess the relationship between conflicts and voting behavior at meetings that considered specific products. Disclosures of conflicts of interest at drug advisory committee meetings are common, often of considerable monetary value, and rarely result in recusal of advisory committee members.

Some HMOs that have low quality-of-care scores do not reveal this information to the public. In a study of HMOs between 1997 and 1999, between one-fourth and one-half of HMOs withdrew their quality-of-care data from public databases, depending on the year. HMOs that had low quality-of-care scores were three times more likely to withdraw the data than those with high scores.

Many newly introduced drugs must be used for several years before any serious side effects become apparent. In a study of 548 new drugs approved between 1975 and 1999, 10% acquired a black box warning in the Physicians' Desk Reference (PDR) or were withdrawn from the market because of serious side effects. Half of the black box warnings occurred within seven years and half of the withdrawals occurred within two years., Context: Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs. Objective: To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market. Design and Setting: Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black box warning). Main Outcome Measures: Frequency of and time to a new black box warning or drug withdrawal. Results: A total of 548 new chemical entities were approved in 1975-1999; 56(10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%. Eighty-one major changes to drug labeling in the Physicians' Desk Reference occurred including the addition of 1 or more black box warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years. Conclusions: Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.

The number of physicians who are disciplined for sex-related offenses against patients is increasing and many of the physicians continue to practice. Data from the Public Citizen's Health Research Group reveal that the percentage of physicians disciplined for sexual offenses against patients doubled from 2% of all disciplinary actions in 1989 to 4.4% in 1996. A total of 761 physicians were disciplined for sex offenses between 1981 and 1996. Although many lost their licenses, 40% were allowed to practice in the same community.

Medical researchers must follow the same ethical guidelines when conducting clinical trials in developing countries as they would have to do in the US. In 1994, the AIDS Clinical Trials Group (ACTG) 076 study found that zidovudine given to pregnant women significantly reduced the rate of transmission of the virus to the baby. However, in 15 studies proposed since then of HIV-infected pregnant women in developing countries, some or all of the women will not be given zidovudine. This results in a double standard since these studies would be considered unethical in the US.

Obstetrical care in the United States is burdened by soaring costs and a paradoxical inability to bring rates of infant mortality in line with those of other developed countries. A […]