2007 trial vioxx

The retrial of the case began in January The trial then moved into its second phase, in which the jury heard evidence specifically relating to Mr. Following the completion of that second phase, the jury concluded that Vioxx use by Mr. That verdict was significant because Mr. Humeston took Vioxx for only 2 months prior to suffering his heart attack.

After a third and final phase, the jury heard arguments and evidence and rendered its verdict awarding punitive damages to the Humestons. Independent data and safety monitoring boards should be mandated and their governance should not be under the control of the company. Industry should not be allowed to select who serves on these boards or allowed to compensate members after their service.

In considering articles for publications, journals should understand that studies with immense financial implications require a higher level of scrutiny than others, especially when the study is conducted by the company with the financial stake. Journals should be prepared to go beyond the usual high quality review, paying particular attention to the possibility of bias. Articles should be accompanied by editorials by people without financial conflicts of interest. Even the best oversight cannot always detect mistakes.

When journals discover that information has been withheld or that results are incorrect, they need to rapidly disseminate that information and ensure that any web search that identifies the errant manuscript also identifies the correction. Authors should sign agreements that they will notify journals if such information becomes available or face being blacklisted by the journal.

Our system depends on putting patients' interests first. Collaborations between academics, practising doctors, industry, and journals are essential in advancing knowledge and improving the care of patients. Trust is a necessary element of this partnership, but the recent events have made it necessary to institute proper systems that protect the interests of patients. A renewed commitment by all those involved and the institution of these systems are the only way to extract something positive from this unfortunate affair.

Merck had influence over all aspects, including data analysis, safety monitoring, and reporting. Academic medicine, industry, medical journals, and government agencies need to define a set of principles to restore trust in collaborations on drug development.

Contributors and sources: HMK's research is focused on determining optimal clinical strategies and identifying opportunities for improvement in the prevention, treatment, and outcome of cardiovascular disease with emphasis on older populations. He was responsible for the concept and writing of this article and is its guarantor.

JSR has studied and reported on conflict of interest in medicine. He participated in the concept and design of this article and revised it for critical content. AHP has research interests in the history of public health and law, including pharmaceutical research and marketing. He consults on this topic at the request of plaintiffs in the Vioxx litigation. He contributed document research and interpretation to this article and participated in its revision. DSE has studied and reported corporate corruption of science.

He contributed to the development of this article and revised the work for critical content. This article arose from access to Merck documents as a result of tort litigation.

All authors have been consultants at the request of plaintiffs for recent suits against Merck related to rofecoxib. References w1-w37 are on bmj. National Center for Biotechnology Information , U. Journal List BMJ v. Author information Copyright and License information Disclaimer. Correspondence to: H M Krumholz ude. This article has been cited by other articles in PMC. Associated Data Supplementary Materials [extra: References].

Early suspicion of cardiovascular risk Since the early development of rofecoxib, some scientists at Merck were concerned that the drug might adversely affect the cardiovascular system by altering the ratio of prostacyclin to thromboxane, which act in opposition, balancing blood flow and clotting. Obscuring the risk Despite the concern articulated by Dr Scolnick, the published VIGOR study obscured the cardiovascular risk associated with rofecoxib in several ways. Short and long term use For several years, Merck continued to investigate other indications for rofecoxib and conducted additional trials.

Promoting constructive collaboration The rofecoxib case is bad news for industry, academics, journals, and the public. Supplementary Material [extra: References] Click here to view. Notes Contributors and sources: HMK's research is focused on determining optimal clinical strategies and identifying opportunities for improvement in the prevention, treatment, and outcome of cardiovascular disease with emphasis on older populations. References 1. United States Securities and Exchange Commission.

Vioxx rofecoxib : frequently asked questions. Morrison BW. Letter to Ken Lasseter; manuscript draft for protocol HFD, medical officer review. Food and Drug Administration.

Washington, DC: Jarrell said about 4, other lawsuits were dismissed before trial and that juries have favored the company. Two other trials ended with hung juries. Topics Lawsuits Virginia. Thank you! Please tell us what you liked about it.

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