Sealed drug documents should be opened up.
In the course of lengthy, expensive litigation over drug safety in the United States, opposing sets of lawyers often form unholy alliances. These cases are frequently settled before reaching court, and the two sides agree to confidentiality orders being placed on any drug-company documents to which they have been granted access. This suits the courts, which want parties to cases under their jurisdiction to gain access to as much information as possible; the drug companies, who want to keep most of the data confidential; and the plaintiffs' lawyers, who want to win a good deal for their clients. But it may not suit the wider public interest.
Every now and then, some of those sealed documents leak out. In a recent trial concerning the schizophrenia drug Zyprexa, for example, documents emerged that suggested to some parties that the manufacturer, Eli Lilly, had sought to play down some known side-effects of the drug (see page 838). But documents considered during pre-trial negotiations usually remain sealed by private agreement between the court and both sets of attorneys — even where there is a public-health interest in releasing some of the information they contain.
Some plaintiffs' attorneys have argued for the creation of ethical guidelines or legislation that would bar lawyers from reaching such agreements. Drug companies have countered that the agreements are helpful to the fair resolution of cases because they allow fairly untrammelled access to information relevant to each case. Without such agreements, defendants would doubtless resist the release of both personal and commercially sensitive information, slowing down cases and reducing their chances of just resolution.
Even 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 public-health data are released into the public domain.”
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.