Pfizer accused of manipulating publication of drug info
Reports from an expert panel examining how the pharmaceutical giant, Pfizer, has controlled the flow of research data on the epilepsy drug Neurontin (aka Gabapentin), posit that the company actively and purposefully manipulated the publication of clinical data in a number of ways, including:
“spinning negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results”
Essentially, what Pfizer did, according to the panel of experts, was control how information about the drug Neurontin was released, in order to convince prescribers that the drug was valuable for unapproved or “off-label” use for conditions such as treatment of bipolar disorder, pain control and prevention of migraine headaches. Many drugs are recommended for “off label” uses, which means use for indications not explicitly noted on the label or the monograph.
Neurontin, essentially a drug for adjunct use in the control of seizure disorders, has been prescribed for the treatment of neuopathic pain, migraine headaches and bipolar disorder. These “off-label” uses may have been encouraged through the publication strategy that the expert panel feels the company adopted. The drug’s use as a treatment for bipolar disoder is contrversial at best. Additionally, there are studies, as noted in the article, that provide evidence that Neorontin is not an effective pain relief agent for common types of neuropathic pain. However these findings, it appears that Pfizer may have worked to delay publication of such data.
In the meantime, according to this article, Pfizer managed to accelerate sales of Neurontin to 3 billion USD annually, up until 2004.
Some might say, well, Pfizer has the right to control dissemination of findings as they wish. In this case, some might even go on to say, these studies were not focused on intended use but on “off-label” uses so what harm could result from suppression of negative data regarding something that no one is approved to do anyway?
Those who review clinical studies for ethical soundness usually ask researchers questions about how the results of their research will be disseminated. However there is little attention in the ethical review process to how and when data will be publicized. Many studies that are approved by research ethics boards (REBs) never end up being published in an academic journal, nor publicized in any other way. Alternatively, many studies that are approved end up being publicized beyond the initial expectations or aims of the researcher – as a result of unexpected, compelling or particularly useful findings across a number of contexts. Rarely, if ever, is an REB contacted by a researcher to ask if it is acceptable to wait to publish findings for a few years, or to publish data in a way that the researcher hadn’t indicated during the prospective ethics review.
In the Neurontin case, however, the suppression and manipulation of data, as highlighted by the expert panel, which included the suppression of 8 out of 16 negative studies and the abbreviation of 2 additional negative studies, appears to be less of an incidental occurrence than a marketing strategy to, essentially, ensure continual “off-label” use and thereby increase profits. While Pfizer claims that it presented study results that are “accurate, balanced and complete”, it appears that they may have strategized to hold back negative information that would, for most prescribers, compel them to question the use of Neurontin in a number of clinical situations.
Research ethics boards are constantly examining and renegotiating their jurisdiction. The question that this story leads to is: Should REBs also be involved in decisions about dissemination of data? Surely such an expansion of REB authority would meet significant resistance from researchers, and the mechanisms by which such oversight would operate are far from clear. But the Neurontin/Pfizer case demonstrates why the question is bound to keep arising.