April 19, 2007 The Pump Handle 0Comment

By David Michaels

An editorial in the latest issue of Nature takes up a problem that public health advocates have been battling for years: confidentiality orders that keep important scientific data hidden from the public, scientists, and even regulatory agencies.

One recent case of such data being kept secret, which Nature reporter Jim Giles covers in an accompanying article, is Eli Lilly’s schizophrenia drug Zyprexa. David Egilman, a physician who had access to confidential documents about Zyprexa’s dangers, is being threatened with jail time for his role in the release of the papers to, among others, New York Times reporter Alex Berenson. The story Berenson broke was front page news:

Documents provided to The New York Times last month by a lawyer who represents mentally ill patients show that Lilly played down the risks of Zyprexa to doctors as the drug’s sales soared after its introduction in 1996. The internal documents show that in Lilly’s clinical trials, 16 percent of people taking Zyprexa gained more than 66 pounds after a year on the drug, a far higher figure than the company disclosed to doctors.

The documents also show that Lilly marketed the drug as appropriate for patients who did not meet accepted diagnoses of schizophrenia or bipolar disorder, Zyprexa’s only approved uses. By law, drug makers may promote their drugs only for diseases for which the Food and Drug Administration has found the medicines to be safe and effective, though doctors may prescribe drugs in any way they see fit.

In his Nature article, Giles explains that these documents had not been released to the public because defendants’ lawyers obtained them from Eli Lilly during pre-trial negotiations. The cases were settled before they reached court, and experts like Dr. Egilman were bound by confidentiality agreements. Giles goes on to explain why confidentiality restrictions of this sort are hazardous to public health:

This situation is common and has angered public-health experts and some lawyers. Discovery documents often contain evidence that suggests a drug is not as effective or as safe as its manufacturer claims and the information has sometimes not been released to regulators such as the US Food and Drug Administration. Yet lawyers are under no obligation to ask for the confidentiality order to be removed, even if the material suggests that the public is at risk.

Some have argued that without secrecy agreements, defendants might be less willing to settle cases. The agreements probably result in plaintiffs and their attorneys get larger settlements, essentially being paid to keep silent. The cost of this efficiency is high, however: millions of patients and their doctors are left in the dark about serious drug side effects and other health risks.

Dr. Egilman perceived clear danger to public health associated with maintaining secrecy about the content of the documents. He became involved in alerting the public, at potentially large personal risk.

If these documents were so important, why didn’t the court release them? The underlying problem here is that there is no formal oversight process for courts to decide whether sealed documents are sufficiently important that they should be released to the public or given directly to regulatory agencies charged with protecting the public’s health. The lack of process leaves whistleblowers like Dr. Egilman no alternatives, when they perceive public health danger.

The Project on Scientific Knowledge and Public Policy (SKAPP) held a conference entitled “Sequestered Science: The Consequences of Undisclosed Knowledge” to examine the effects of withholding scientific data in court cases and other circumstances. Our papers appeared in the Summer 2006 issue of the journal Law and Contemporary Problems and are available for free downloading through SKAPP’s website.

In their editorial, the Nature editors echo the call made by Dan Givelber and Tony Robbins in their paper “Public Health Versus Court-sponsored Secrecy,” one of the Sequestered Science paper. The editors argue that sealed drug documents should be opened up, and suggest avenues and reasons for doing so:

[A] few states, such as Florida, have introduced anti-secrecy laws. But there are also other reform options. Courts could, for example, be allowed to take previous secrecy orders into consideration when setting damages. Drug companies might think twice about sealing data from clinical trials if they knew they could come out in a future trial and incur greater financial cost.

Scientific bodies have an interest in ensuring that as many public-health data as possible are released into the public domain. The Institute of Medicine and the American Association for the Advancement of Science (which already has a joint committee with the American Bar Association to consider such matters) could help by fostering discussions between the plaintiffs’ lawyers and the drug industry on how to move the issue forward.

The industry’s reputation, as well as the public good, will benefit in the long run from arrangements that get pertinent information about drug safety into the public domain as quickly as possible. Global registers of clinical-trial results are probably the most pressing requirement here. But less court-imposed secrecy around public health would also be a positive step, in part by helping to ensure that companies are fully complying with such registers.

The tension between openness and sequestration in science is not new, although now this conflict feels particularly acute, and the stakes seem particularly high. Secrecy is often the easier road, and transparency is not now, and perhaps never has been, the default position. But the Zyprexa incident underscores the need for an open and transparent process to ensure that documents that could potentially save lives not be hidden for the sake of protecting parties in lawsuits.

David Michaels heads the Project on Scientific Knowledge and Public Policy (SKAPP) and is Professor and Associate Chairman in the Department of Environmental and Occupational Health, the George Washington University School of Public Health and Health Services.

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