Jeanne Lenzer

Alteplase for stroke: money and optimistic claims buttress the “brain attack” campaign

# Alteplase for stroke: money and optimistic claims buttress the “brain attack” campaign {#article-title-2} Both doctors and the public are becoming more alert to potential conflicts of interest, and an increasing number of journals now require competing interest statements from their authors and reviewers. In this article Jeanne Lenzer uses the example of guidelines produced by the American Heart Association to discuss some of the questions that can arise when interests conflict As doctors and the public become more aware of conflicts of interest involving study bias,1 publication bias,2 and industry gift giving3 they turn to credible non-profit organisations for sound medical recommendations. Unfortunately, many groups (and their individual panellists) that serve as arbiters of inconclusive data may also suffer from conflicts of interest. 4 5 One such conflict is self referencing bias. An example of this is in specialty guidelines for colon cancer screening, where radiologists recommend barium enemas while gastroenterologists recommend colonoscopy. A more important conflict arises when corporations with a financial stake in the recommendations issued by a non-profit making organisation provide financial support for that organisation. In this paper I examine an example of such a conflict, in which a treatment recommendation that could cost more lives than the disease itself was supported by statistics from only one randomised controlled study. Additionally, poor outcomes and dissenting opinion appear to have been obscured. This recommendation may have been made in a true spirit of unbiased scientific inquiry, but the appearance of dispassionate analysis was eroded by large donations from a drug company to the organisation making the recommendation and payments for research and lecture fees to its individual expert panellists. #### Summary points The American Heart Association rated the thrombolytic agent alteplase (tPA) as a class I (definitely recommended) intervention for stroke despite controversy about its safety and efficacy Most of the associations stroke experts have ties to the manufacturers of … Correspondence to: Dr Starkman

Why we can’t trust clinical guidelines

Despite repeated calls to prohibit or limit conflicts of interests among authors and sponsors of clinical guidelines, the problem persists. Jeanne Lenzer investigates

Ensuring the integrity of clinical practice guidelines: a tool for protecting patients

Jeanne Lenzer, Jerome Hoffman, Curt Furberg, and John Ioannidis pull together a large expert working group to offer a manifesto for clinical guidelines

Why cancer screening has never been shown to "save lives"--and what we can do about it.

The claim that cancer screening saves lives is based on fewer deaths due to the target cancer. Vinay Prasad and colleagues argue that reductions in overall mortality should be the benchmark and call for higher standards of evidence for cancer screening

Is widespread screening for hepatitis C justified

Several organisations have recommended greatly expanded screening for hepatitis C infection. Ronald Koretz and colleagues are concerned that no study has tested whether this will lead to net clinical benefit or harm in screened populations

Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers

The chairman and one of two additional co-chairs of the working panel that wrote the controversial cholesterol guidelines on reducing cardiovascular risk, released last week,1 2 had ties to the drug industry at the time they were asked to lead the panel. And, in all, eight of the 15 panelists had industry ties. The chairman, Neil J Stone, professor of medicine at the Feinberg School of Medicine, Northwestern University, Chicago, told the BMJ , “When I was asked by NHLBI [the National Heart, Lung and Blood Institute] to chair the [cholesterol] panel, I immediately severed ties with all industry connections prior to assuming my role as chair.” He severed those ties in May 2008. Later he had to complete a disclosure statement regarding financial ties to industry, and in response to the question regarding his ties from 2008 to 2012 he wrote “None.” David Newman, a physician researcher at the Icahn School of Medicine at Mt Sinai in New York City, told the BMJ that dropping industry ties on taking up such roles without declaring these previous ties was against the spirit of competing interests declarations. Stone acknowledged to the BMJ that before being empanelled he had financial ties to Abbott, AstraZeneca, Merck, Pfizer, Sanofi-Aventis, and Schering-Plough, and he had served as a consultant to Abbott, AstraZeneca, Merck, Pfizer, Reliant, Schering-Plough, and Sonaste. All six corporations to which Stone had financial ties make drugs to treat hyperlipidemia. Stone said that he …

Unnecessary care: are doctors in denial and is profit driven healthcare to blame?

A newly launched movement led by prominent doctors is challenging the basic assumption in US healthcare that more is better. Jeanne Lenzer reports

FDA committee votes to withdraw bevacizumab for breast cancer

An advisory committee to the US Food and Drug Administration voted unanimously to withdraw approval of a top selling drug for the treatment of metastatic breast cancer. The six member panel concluded on 29 June that bevacizumab (marketed by Genentech as Avastin) had not been shown to be either effective or safe for the treatment of breast cancer. The FDA is inviting public comment on the decision for one month before issuing a final ruling. This unusual action comes after several surprising developments in the approval process of bevacizumab. In February 2008 Genentech was granted “accelerated approval” to use bevacizumab to treat breast cancer. The approval relied on a key study, known as E2100, that tested paclitaxel (marketed as Taxol) alone versus bevacizumab together with paclitaxel. The decision was seen as highly unusual, because the study used a controversial primary end point of “progression-free survival.” Ralph D’Agostino, professor of …

Why the FDA can't protect the public

Medical device makers often fail to properly conduct safety studies and the US Food and Drug Administration provides scant oversight. Jeanne Lenzer and Shannon Brownlee look at some of the problems with post approval surveillance of novel devices

An untold story

This week’s headline story about antidepressants highlights the ongoing problem of how study results are often distorted by a failure to access full datasets. Jeanne Lenzer and Shannon Brownlee report