Neurontin study more marketing than science: report
NEW YORK (Reuters Health) - A study of the safety and effectiveness of an anti-epilepsy drug mislead doctors and patients about the point of the research, suggests a new report.
Investigators writing in the Archives of Internal Medicine claim that the goal of research on the Pfizer drug Neurontin was really to get doctors recruited for the study to prescribe more of the drug - rather than to test how well it worked.
Led by Dr. Joseph Ross of the Yale University School of Medicine in New Haven, Connecticut, the investigators analyzed published trial results and related company documents, including research reports, marketing analyses and communication among Pfizer employees.
Ross's team was working for the plaintiffs in a lawsuit against Pfizer about the promotion of Neurontin (known generically as gabapentin).
The documents convinced Ross and his colleagues that the company had deceived doctors and patients about the real purpose of the study - telling them that it was intended to make sure the drug worked well in a large variety of patients, after it was already approved by the Food and Drug Administration based on other trials.
That kind of "post-approval" study "serves a really important purpose," said Dr. G. Caleb Alexander, who wrote an editorial accompanying the new study.
"At the time a drug is approved by FDA we know very little about its safety and effectiveness in real-world populations," added Alexander, from the University of Chicago.
Ross and colleagues concluded, however, that the Neurontin trial was not a legitimate post-approval study, but rather a so-called "seeding trial," whose main goal is to get more doctors prescribing the drug.
Alexander said it's hard to know how frequently companies distort post-approval studies for use as a marketing tool, rather than for research purposes.
Seeding trials are "nearly impossible to identify, and that's what makes this such a challenge," agreed Ross.
His team noted that these types of trials have been used for a long time, and in many cases the results may never be published - since the main goal is to increase drug sales.
In this case, a company called Parke-Davis, now part of Pfizer, reached out to more than 700 neurologists and convinced them to give this drug to their patients with epilepsy as part of research on its effectiveness and safety.
But Parke-Davis didn't tell doctors about the real purpose of the study, which was made clear in the company's internal communication, the investigators say.
The company also hid that purpose from review boards whose job is to make sure a study is ethical and doesn't put patients at risk unnecessarily, the investigators add.
Patients involved in the study were fooled as well, Alexander said. "The greatest ethical breach with respect to patients is (that) patients were recruited for a study without the ability for adequate informed consent," since they couldn't know what the study was really about, he told Reuters Health.
These kinds of studies also erode patients' trust, Ross said, since most of them agree to participate in a drug study thinking they're helping researchers gain important information.
Two published studies - both more than 10 years old -- came out of the Neurontin research, Ross and his colleagues explain, and both were "generally supportive" of the drug.
The drug is still marketed by Pfizer to treat seizures as well as damaged nerves that occur as a result of shingles infections. It can cost anywhere from 50 cents to $5 per pill.
"Neurontin is an important FDA-approved medicine that physicians have prescribed to treat millions of patients safely and effectively," a Pfizer spokesperson told Reuters Health via email. "Neurontin has been widely studied for more than two decades and there is an extensive body of publicly available literature on its safety and its use."
Ross and his colleagues point out that while studies like the one they investigated are unethical, they aren't illegal.
He said that the goal of this report was not to "call out" people at the drug company or doctors who were involved in the Neurontin study.
"It's more about, 'how can we use this information to improve practice going forward? How can we all come together and realize that trials for promotion and marketing purposes aren't science?'" Ross told Reuters Health. "We just need to conduct ourselves in a higher ethical standard."
Alexander said that the best way to prevent companies from getting away with drug-promoting studies in the future is for doctors, researchers and policymakers to look very closely at any study they are participating in or evaluating, and to question the rationale behind those studies.
"I think with greater scrutiny, pharmaceutical firms will have a harder time conducting marketing under the guise of science," he said.
SOURCE: http://bit.ly/fO01ME Archives of Internal Medicine, online June 27, 2011.
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