Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Increased Scrutiny of Pharmaceutical Company Clinical Trials: The Defense Perspective
In recent large-scale pharmaceutical litigation, plaintiffs' counsel have concentrated significant resources seeking the details of how individual patients in pre- and post-marketing company clinical trials were assessed, characterized, and reported to the Food and Drug Administration ('FDA'). The reason is clear: They are seeking to develop (in the author's opinion unfairly) a story that the pharmaceutical company hid risks and overstated benefits. The efficacy and safety data generated by industry-sponsored studies, and the manner in which the data are analyzed and reported, have therefore become the focus of large-scale pharmaceutical litigation.
Recent events in the Vioxx' litigation show that plaintiffs' counsel are now expanding this approach to industry-sponsored studies submitted to medical journals, with apparent success. The editors of the New England Journal of Medicine ('NEJM') claim that they recently obtained information revealing inaccuracies in the data reported in the VIGOR (Vioxx Gastrointestinal Outcomes Research) study that calls into question some of the study's conclusions. (Curfman GD, Drazen JM, Morissey S. Expression of concern: Bombardier et al., Comparison of upper gastrointestinal toxicity of rofexicib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520-8. N Engl J Med 2005; 353: 2813-14.) Although the VIGOR study was designed to compare gastrointestinal events in patients with rheumatoid arthritis treated with either rofecoxib (Vioxx) or naproxen (Naprosyn'), data on cardiovascular events were also monitored. According to the editors, three myocardial infarctions (heart attacks) in Vioxx patients were incorrectly omitted from the data submitted to the NEJM. The editors concluded that the omission of the three additional heart attacks ' which raised the total number of heart attacks in Vioxx patients from 17 to 20, as opposed to 4 in Naprosyn patients ' rendered certain calculations and conclusions in the VIGOR article 'incorrect' and 'misleading.'
According to Merck & Co., the manufacturer of Vioxx, the VIGOR article fairly and accurately represents the results of the study. (Tesoriero HW, Tomsho R, Winslow R. Vioxx plaintiffs seek mistrial after allegation on Merck study. The Wall Street Journal. Dec. 10-11, 2005 A1, A9.) Merck contends that the three heart attacks at issue were appropriately excluded from the data presented in the article because the heart attacks occurred after the pre-specified data cutoff point for counting adverse events in the study. As cutoff dates are used in every clinical trial to define the period during which benefits and risks of a treatment are measured, Merck was simply abiding by the pre-specified study protocol. Furthermore, by February 2001, within 3 months after the publication of the article, Merck had provided to the FDA all of the data from the VIGOR study, including the three additional heart attacks.
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?
The Benefits of Blockchain for e-Discovery and Data Preservation
As businesses across various industries increasingly adopt blockchain, it will become a critical source of discoverable electronically stored information. The potential benefits of blockchain for e-discovery and data preservation are substantial, making it an area of growing interest and importance.