Pfizer manipulated the publication of clinical trials to increase use of its Neurontin epilepsy pill for other illnesses, while suppressing studies that did not validate those uses, according to several experts who reviewed Pfizer documents for plaintiffs in a lawsuit against the drugmaker.
Pfizer’s tactics included delaying publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs’ lawyers, The New York Times writes.
One expert who reviewed the documents, Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that Pfizer documents spell out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings,” according to her report (look here and here for plenty of leisurely reading).
Pfizer issued a statement Tuesday to the paper denying it manipulated Neurontin data, saying “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 or the country in which the study was conducted.”
Just click on each word, folks, to read a report.
The negative studies would have increased doubts about the drug’s value for several unapproved uses - treating bipolar disorder, controlling certain types of pain and preventing migraine headaches, according to the expert opinions. Off-label use helped propel its sales to nearly $3 billion a year before it lost patent protection in 2004, the Times notes. A report submitted by Harvard Medical School's Meredith Rosenthal says that 43 million Neurontin scrips were written due to off-label promotion.
In one example, the experts concluded Pfizer had deliberately delayed release of a study showing the drug had little effect against pain that is a complication of long-term diabetes, even as the outside researcher who was a lead investigator for the study, John Reckless of Bath, England, pushed to publish the unflattering findings on his own, the Times writes, adding that Reckless’s office said Tuesday that he could not be reached for comment.
According to one September 2000 e-mail by a Neurontin team leader at Pfizer, “The main investigator in the UK (Dr. Reckless) is keen to publish but this will have several ramifications.” The team leader later wrote, “I think we can limit the potential downside of the 224 study by delaying publication for as long as possible.”
Pfizer tells the Times thats it submitted the Reckless study to two journals which declined to publish it. The results were not published until 2003 and, according to plaintiffs’ experts, when they did appear they were combined with two other studies and together the findings concluded Neurontin was effective for treating neuropathic pain.
Another series of e-mails had the subject line “Spinning Serpell,” a reference to an investigator on the study, Michael Serpell of Glasgow, Scotland. In the e-mail exchange, a senior marketing manager for Pfizer and a professional medical writer discussed how to cast the results in a more favorable light for a poster presentation at a medical conference, the experts concluded, the Times writes.
“If Pfizer wants to use, present and publish this comparative data analysis in which two of the five studies compared make the overall picture look bad, how do we make it sound better than it looks on the graphs?” the medical writer asked.
In 2002, Angela Crespo, then Neurontin's senior marketing manager, emailed an outside firm that was contracted to write up the study's results: "We are not interested at all in having this paper published because it is negative!!" Pfizer declined to make the three employees in the emails available for interviews, according to The Wall Street Journal.
Pfizer discontinued its marketing program for Neurontin in 2004 after the drug became available as a generic. That same year, the company paid $430 million to settle federal criminal and civil claims that Warner-Lambert, which Pfizer acquired in 2000, promoted Neurontin for unapproved uses during the 1990s.
At the time, the newspaper reminds us, Pfizer said the illegal marketing had occurred before Pfizer acquired the company or drug. On Tuesday, Pfizer repeated that it had instituted procedures when it acquired Warner-Lambert to make sure there was no off-label promotion of Neurontin.
Despite that settlement, separate legal action involving the drug is still pending in Boston, where consumers and third-party payers including insurance companies and trade unions want Pfizer to repay them billions of dollars for Neurontin prescriptions. The plaintiffs accuse Pfizer of fraudulently misrepresenting the drug’s benefits.
Thomas Greene, a lawyer for the plaintiffs, said the documents in the case revealed that even after the Neurontin settlement. “Pfizer continued with the medical marketing firms and planted marketing messages in journal articles that Neurontin was effective while they knew that their own clinical trials had failed to demonstrate it was effective,” he tells the Times.
Johns Hopkins' Dickersin tells the paper that of 21 studies she reviewed, five were positive and 16 negative, meaning they did not prove the drug was effective. Of the five positive studies, four were published in full journal articles, yet only six of the negative studies were published and, of those, two were published in abbreviated form.
Source: The New York Times