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'Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing ever happened.' In this author's opinion, Winston Churchill's keen observation of human nature is an apt description for how the pharmaceutical industry deals with dangers revealed or at least signaled in clinical trials. For years, plaintiffs' lawyers have honed in on clinical trials conducted by pharmaceutical companies when preparing for and trying cases. These studies, often the banner touted by defendants as evidence of their innocence, are a natural place to begin the search for what went wrong when a drug is subsequently pulled from the market despite the supposed 'rigors' of clinical testing. While there is nothing new about plaintiffs' lawyers reviewing clinical trials with a fine-toothed comb, there has been a radical and bold step taken in the world of medical/science academia. Specifically, major publications such as the New England Journal of Medicine ('NEJM') and the Journal of the American Medical Association ('JAMA') are ensuring that industry-sponsored studies do not merely contain partial truths.

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.

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Whatever happened to the title agents licensing bill? At one point, it 'had to happen.' Innumerable meetings were held. Forests were felled to provide the paper to print and distribute various drafts of proposed bills. Lincolnesque letters and articles were written and published. E-mails clogged up thousands of mailboxes. And now silence. There may very well be a bill on the Governor's desk in the near future. This article represents an attempt to explain why the agent-licensing bill is not there yet. The opinions expressed are the author's own, have no official sanctions and do not advocate any particular version of the bill.