Whistleblowing without names is hearsay.

Peter Gøtzsche's proposal to provide anonymity to certain people reporting bad practices within the pharmaceutical industry, regulatory apparatus or health systems is superficially appealing but likely to generate more problems in the longer run than it might solve in the short term. We need to analyse what features of our systems generate problems and correct those, rather than rely on insiders to report on the resulting problems, as all these reports do is offer a false sense of security that things are safer now that one problem has been identified.

The crisis in Cochrane: Evidence Debased Medicine.

The mission of the Cochrane Collaboration, established in 1993, was to systematically review medical evidence with a view to producing the best quality and trustworthy evidence. Twenty-five years later, it is in a crisis that centres on the dismissal one of its founders and the question of access to clinical trial data. The original mission aimed at improving health. In the face of stalling life expectancies, the stakes in the current crisis could not be higher. This essay looks at the crisis in the context of the disastrous effects of medication for paediatric depression on children as a consequence of the suppression of adverse findings from clinical trials.

The shipwreck of the singular.

In 1962, Louis Lasagna was one of the central figures in the creation of our current drug regulation systems. His influence on the practice of modern medicine, through a series of unanticipated consequences of these systems, has been profound. In the 1960s, he was one of the most progressive thinkers in medicine. By the 1980s, he had apparently become one of the most reactionary. This article attempts to delineate the dilemmas he believed he was dealing with, dilemmas that stemmed from a system he had helped create, that produced this apparent change in orientation. The problems with which he grappled are ones that remain unresolved and indeed, have become more acute. The example of how he attempted to remedy what had gone wrong may provide pointers as to how to solve or how not to solve current difficulties.

Epidemiological evidence in forensic pharmacovigilance.

Until recently epidemiological evidence was not regarded as helpful in determining cause and effect. It generated associations that then had to be explained in terms of bio-mechanisms and applied to individual patients. A series of legal cases surrounding possible birth defects triggered by doxylamine (Bendectin) and connective tissue disorders linked to breast implants made it clear that in some instances epidemiological evidence might have a more important role, but the pendulum swung too far so that epidemiological evidence has in recent decades been given an unwarranted primacy, partly perhaps because it suits the interests of certain stakeholders. Older and more recent epidemiological studies on doxylamine and other antihistamines are reviewed to bring out the ambiguities and pitfalls of an undue reliance on epidemiological studies.

Science, rhetoric and the causality of adverse events.

This paper outlines aspects of the interface between law and science in the domain of treatment induced injury, using examples drawn from litigation on SSRIs. In the face of claims that randomized controlled trials provide uniquely appropriate evidence and that there should be a statistically significant doubling of the risks on treatment, the examples used demonstrate that the methods of assessing the possibility of causal links between treatment and injuries must necessarily be tailored to both the injury and the treatment.

The engineers of human souls & academia.

AIMS: There has been recent concern about interactions between academia and the pharmaceutical industry. This article seeks to explore the basis for the current sense of crisis. METHODS: The approach taken is a historical one, outlining the origins of the crisis. RESULTS: The analysis outlines the roles that brands, patents, and the control of the scientific literature play in the current marketing of psychotropic drugs, and describes the processes of guideline capture and brand fascism. CONCLUSIONS: The analysis makes it difficult to see current interactions between industry and academia as anything but bad for academia. One option that might restore some balance would be to restrict scientific meetings and journals to communications that made all relevant scientific data available, excluding exercises that restrict access to data.

EuroSCORE: useful in directing preoperative intra-aortic balloon pump placement in cardiac surgery?

BACKGROUND: The placement of preoperative intra-aortic balloon pumps (IABP) in high-risk patients has been described, although controversy remains regarding the appropriate selection of these patients. The EuroSCORE is a proven predictor of operative mortality for coronary artery bypass surgery (CABG). Our objective was to assess whether patients with a preoperative IABP had a 30-day mortality consistent with their predicted mortality. METHODS: Sixty-sis patients who had had an IABP sited while undergoing CABG were retrospectively identified. The additive EuroSCORE was calculated with omission of the IABP preoperative placement score of 3 points. Patients with a EuroSCORE <5 were considered low risk, and those > or = m5 as high risk. RESULTS: High-risk patients with preoperative IABP placement had a significantly lower mortality (1/16, 6.25%) than predicted. The predicted versus actual mortality was 12.6% versus 6.25%. CONCLUSION: Correct identification of appropriate patients who would benefit from pre-emptive placement of IABP could potentially be performed using the EuroSCORE.

Reliability and validity of an objective assessment instrument of laparoscopic skill.

A novel objective assessment method in reproductive endoscopic surgery could advance surgical education.