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Remastered Guide to an Evil Empire: Pfizer, part three
“I would not send unpublished Neurontin data to anyone outside Pfizer.”
This is an expansion of the Guide to an Evil Empire: Pfizer Lawsuit article. Due to the sheer size of this article, I will break it into pieces for easy reading. As always, I have attempted to be as accurate as possible, but if there are issues or nuances I have missed, please feel free to leave a comment and I will make a correction. Pfizer has been involved in more lawsuits than I can count, so I attempt to use individual lawsuits as examples of their business practices. The goal of these articles is to make the most extensive and exhaustive account of the long history of Pfizer. Please like, share, comment, and subscribe if you enjoyed this content.
Every so often, well meaning individuals will opine on the state of our value system in the Western world. The usual stance taken commonly revolves around how we prioritize entertainment over science. I am sure most of us have heard permutations of the phrase: “We should pay our scientists like rock stars and our rock stars like scientists”.
What these well meaning individuals often miss is the fact that the collective ‘we’ rarely are the ones paying our scientists. No. It is too often companies like Pfizer. I am not disagreeing with the value proposition, per say. Rather, I am disagreeing with the notion that scientists are inherently more valuable than rock stars. At the very least, rock stars rarely have the potential to do as much damage as scientists.
Frankly, maybe we do need to treat scientists more like rock stars, but payment is not the issue. Until proven otherwise, it might be best to assume that every opinion scientists give is being whispered in their ear by a shady public relations professional that is telling them exactly what to say. After you read this part of the series, you might even agree with me.
The saga of Neurontin
This post is based off these PPT slides. Read them for more details (351 slides).
Neurontin is an anticonvulsant approved in 1995 for the treatment of partial seizures. The product was brought to the market by a subsidiary of Warner-Lambert (a soon to be Pfizer acquisition) – Parke-Davis (hereafter “PD”). From the beginning, PD pursued a hyper-aggressive marketing strategy; however, as the drug was only approved to control partial seizures, the strategy needed to be bold.
PD worked with the marketing firm Cline, Davis & Mann to formulate a marketing strategy that included disseminating information about the drug “as widely as possible” throughout the medical literature. Notably, the goal was to increase off-label use of the drug. The company moved quickly and consistently to contact medical professionals to do papers on off-label uses of the drug. Most extensively, but not exclusively, they targeted pain relief, bipolar disorders, and migraine relief. These medical professionals, such as Dr. Gary Mellick, were paid to write papers for PD.
Of course, PD was only interested in positive results that would reinforce their bottom-line. Despite there being no scientific rationale for many of the uses, they continued to pursue this strategy over the next decade progressively increasing sales and off-label use of the drug. They consistently misinterpreted, misrepresented, and flat out lied about study results. For example, a retrospective analysis of clinical trials claimed that Neurontin may have a potentially beneficial effect on mood disorders and well-being. The FDA came to the opposite conclusion with the same studies.
As early as 1996, the FDA expressed concern to PD about the marketing of drugs for off-label uses. Meanwhile, PD and their marketing consultants continued to develop their marketing strategy, again reiterating that positive results would be published. They pushed for higher doses of Neurontin despite a complete lack of scientific evidence that higher doses were useful. The goal was to “encourage titration of higher doses through peer-to-peer influence”.
“[F]ictionalized case histories could be written based on real situations.”
– PD internal documents
One of the ways in which they promoted the drugs included the use of third party education programs designed to wine and dine medical professionals in order to support product expansion in emerging uses (ie., off-label uses). More deceitful methods included ghostwriting articles and paying people to author those papers, providing the authors with $1000 honorariums in return.
In instances where the conferences they ran led to negative feedback, as was the case with Dr. Vera Bril’s hesitancy over the usefulness of Neurontin, they planted audience members during the Q&A period in order to get her to address some of the “positive” aspects of the drugs. Usually, though, this was not a problem as they screened doctors in order to find the most likely to be enthusiastic about the drug, and excluded ones that were skeptical. If the authors of papers wanted suggestions, PD was happy to help; for example, one paper changed the wording from “probably no more effective than placebo…” to “may be effective in the treatment…” before it made its way to final review. But some authors were more than willing to slip an active placebo into the study to cover up adverse events.
They delayed studies. Ignored studies. Suppressed studies. Suppressed data.
“I would not send unpublished Neurontin data to anyone outside Pfizer.”
– Internal Pfizer documents
Anything to keep the “drumbeat” in the medical literature going. Fake journals sponsored by PD? Why not? A lot of the tactics, in fact, would look similar to most readers today. The key message was safe and effective. The key method was to saturate trade and consumer media with their message. To produce “independent” positive case reports and create “independent” reviews to reinforce global marketing messages (quotations around independent not added by me).
They knew their audience. They knew “a minimal amount of information appropriately delivered” was all they needed to sell the drug. The drug was
only effective. for the last four weeks?
When Dr. David Franklin decided to blow the whistle, Pfizer sent a private detective after him. Manufacturing fear, apparently, is nothing new to Pfizer. Franklin would note that conversations with PD were around his willingness to work in gray areas and claimed the company had made "tens of thousands of payments" for consultations and studies in order to fraudulently push off-label uses of the drugs. And indeed, the facts supported Dr. Franklin. Pfizer ended up paying $430 million dollars to resolve the case. Of course, after $10 billion dollars in sales and 43,415,904 “allegedly” unlawful prescriptions, I bet they do it all again.
This is the end of part three of a multi-part series. Part three covers Neurontin. Pfizer’s lawsuits get progressively more dense as the years go on but this may be due to better records being kept in the latter part of Pfizer’s history.
Please subscribe to stay tuned for part four in this ongoing series.