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A Times Editorial

Don't let drugmaker hide records

Beyond arbitrating private disputes, the courts play a key role in protecting the public interest. A federal magistrate in Orlando is deciding whether to open records of the drug company AstraZeneca or allow the maker of the blockbuster drug Seroquel to hide potentially embarrassing information. This should be an easy call. If the documents would inform the public about risks of the drug, alert the public to a faulty FDA review or warn the public about less-than-forthcoming marketing practices of the drugmaker, they should be opened. Even when handling private lawsuits, the courts should be looking after the public interest.

Thousands of personal injury lawsuits have been filed against AstraZeneca by patients who claim the drug led to weight gain and diabetes. Some 6,000 cases have been consolidated in the U.S. District Court in Orlando for pretrial hearings. The drug, which racked up $4.45 billion in sales last year, has been approved by the FDA for schizophrenia and bipolar disorder but has been prescribed for a wide range of problems such as insomnia and depression.

The company sought to keep a raft of internal documents sealed. But just hours before a hearing before U.S. Magistrate Judge David Baker, the company and plaintiffs' lawyers came to an agreement to open about 100 documents. St. Petersburg Times staff writer Kris Hundley reported that among these docments was a discussion by Seroquel marketing managers on "burying" the results of unfavorable clinical trials and a 2006 voice mail message from the company's "scientific alignment manager" that told sales reps to "neutralize customer objections" when doctors asked about a link between Seroquel, diabetes and weight gain.

This agreement still allows AstraZeneca to keep documents secret that should be disclosed. Fortunately, Judge Baker made clear his role is not just to rubber stamp a deal made between private parties. When an attorney for the drugmaker argued that communications between the FDA and AstraZeneca should be shielded from public view, Baker raised appropriate concerns. He said the public has an interest in learning about the FDA's administrative process and whether it "is running a slipshod operation.''

Exactly right.

The public also has an interest in knowing the results of unpublished clinical studies that AstraZeneca doesn't want to release, and in seeing the notes of its sales reps that indicate how the drug was marketed. AstraZeneca is being sued not just by patients who say the drug caused them medical problems but by four states for the off-label marketing of Seroquel.

If the company believes that the lawsuits are baseless, then it should open its records for all to see. If it continues to refuse, then the court should order the documents unsealed. The public has the right to know if a drug company is putting sales before safety — and if the FDA is acting in the public interest.

Don't let drugmaker hide records 03/02/09 [Last modified: Monday, March 2, 2009 7:23pm]
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