Ethics and eplerenone.

The use of a placebo arm in clinical trials is unethical if there is an active comparator that is acceptably safe and effective. We argue that reasonable evidence of effectiveness and safety of an inexpensive alternative to an expensive therapy is sufficient to require that the inexpensive therapy be included as a comparator when the expensive therapy is tested, and that use of an inactive placebo comparator only is not ethical. For example, studies of the expensive drug eplerenone for congestive heart failure have not included a spironolactone arm, although there is reasonable evidence that spironolactone would be safe and effective, and spironolactone is inexpensive. The requirement to study inexpensive therapies is based on avoidance of unnecessary cost in medical care as an example of non-maleficence. Several ethical actors in the design, conduct, and publication of clinical trials and their results bear responsibility for the appropriate conduct of clinical trials. That responsibility includes protecting study subjects from being asked to participate in clinical trials that serve primarily to promote the use of new and expensive therapies.

The haunting of medical journals: how ghostwriting sold "HRT".

Adriane Fugh-Berman examines documents unsealed in recent litigation to investigate how pharmaceutical companies promoted hormone therapy drugs, including the use of medical writing companies to produce ghostwritten manuscripts and place them into medical journals.

Why lunch matters: assessing physicians' perceptions about industry relationships.

Many studies have shown that pharmaceutical marketing affects prescribing choices. Studies that have assessed the effects of educational interventions on perceptions of pharmaceutical promotion have found mixed results. This study assesses the short-term effects of an educational intervention about marketing tactics on the attitudes and fund of knowledge of residents, medical students, and attending physicians. A 1-hour slide show that covered detailing, prescription tracking, drug samples, medical meetings, and journals was developed by PharmedOut and presented at a total of 14 grand rounds and seminars at departments of family medicine, internal medicine, pediatrics, psychiatry, cardiology, and neurology. Pre- and posttests included attitudinal and fact questions addressing the influence of drug reps, gifts, pharmaceutical advertising and drug samples on prescribing behavior. The posttest asked whether attendees intended to change their prescribing behavior. The Mann-Whitney U test was used for Likert-scale questions and the Fisher exact test was used to compare the number of pre- and posttest correct answers for the multiple choice and true/false questions. Three hundred seventy-three participants completed pre- and posttests. Significant attitudinal shifts were seen overall, particularly in questions addressing influence of salespeople on physicians in general and on the respondent individually. Some participants commented that they intended to stop seeing drug reps or stop attending industry-funded meals. A new educational presentation can substantially shift attitudes toward perceived susceptibility to pharmaceutical marketing activities. Further research is needed to see if attitude change persists.