Pfizer’s Headache

After it paid $430 million to settle a 2004 lawsuit over illegal promotion of its anti-seizure drug Neurontin, Pfizer, the world's largest pharmaceutical company, may have thought its legal troubles with that medication were over. Not so fast: A new lawsuit, brought by the same attorney, alleges that the company's misdeeds went much further than originally charged. According to newly unsealed court documents, not only did the company and its subsidiaries push Neurontin for unapproved uses—the practice at the center of the first suit, which Pfizer admitted to as part of its settlement—they did so knowing that the drug was ineffective for several of those conditions (the settlement involved allegations of both criminal and civil violations). Pfizer, according to the documents, engaged in "outright deception of the biomedical community, and suppression of scientific truth"—stalling or stopping the publication of negative study results; manipulating both trial designs and data to make the drug look more effective than it was; and using questionable tactics to enhance the drug's image and increase its sales.

These practices were "highly unethical, harmful to science, wasteful of public resources, and potentially dangerous to the public's health," writes Kay Dickersin, the author of the longest of the documents and the director of the Center for Clinical Trials at Johns Hopkins University.

On Tuesday, Pfizer released a statement saying that it was "committed to the communication of medically or scientifically significant results of all studies, regardless of outcome. Company policy requires that, in all cases, study results are reported by Pfizer in an objective, accurate, balanced, and complete manner with a discussion of the strengths and limitations of the study, and are reported regardless of the outcome of the study."

The lawsuit is in early stages; Boston attorney Thomas Greene (who represented David Franklin, the whistleblower in the first Neurontin case) is seeking permission to bring it as a class-action case. Judge Patti Saris rejected a request to that effect in August, but at the time, says Greene, she had not seen 12 expert reports that now comprise the bulk of the argument against the company. The reports, written by a wide variety of respected academics and submitted to the judge as part of the complaint, cite provocative emails sent by employees of Pfizer and its subsidiaries. They also analyze studies, both published and unpublished, that the company commissioned to test Neurontin's effectiveness at treating four conditions for which it is not approved: nociceptive pain ("think, 'I just hit my finger with a hammer,'" says Greene), bipolar disorder, migraines and headaches, and neuropathic pain, a chronic condition resulting from an injury to the nervous system. A final report concludes that Pfizer encouraged doctors to prescribe Neurontin at higher doses than those approved by the FDA.

In the case of nociceptive pain, the documents suggest a simple pattern of misbehavior: commissioning tests but declining to publish results that showed the drug did not work. The documents list several randomized controlled trials of Neurontin for this acute form of pain. All were commissioned by Pfizer, all turned out negative, and none were ever published in journals.

With bipolar disorder, the documents are not as straightforward. Dickersin's report analyzed all the relevant studies of Neurontin and says they were "marked by extensive spin and misrepresentation of data." Some of the negative ones were published, but only after long delays. Others were published but not cited in marketing literature. According to one of the most comprehensive of the 12 lawsuit reports, by John Abramson, a clinical instructor at Harvard Medical School, Pfizer emphasized studies of low quality that were "not blinded, not randomized, and not controlled." Meanwhile, it says, three double-blind randomized controlled trials—studies performed to the highest possible standard—had shown that Neurontin was in fact no better at treating the condition than a placebo was.