First Drug Company To Be Accused of Racketeering in US Court Case - What Your GP Doesn't Tell You Podcast
Why this Neurontin case continues to be relevant today
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The episode concerns one of the world’s top selling drugs - Neurontin. And it centres on an extraordinary court case, in which Kaiser Foundation Health Plan and Kaiser Foundation Hospitals, alleged that Pfizer and its subsidiary Warner Lambert had perpetuated racketeering violations under the Racketeer Influenced and Corrupt Organisations Act - legislation that was actually brought in to tackle organised crime.
Kaiser alleged that the pharmaceutical company had encouraged doctors to use Neurontin not just for its approved uses of secondary treatment for epilepsy and nerve pain after shingles, but for several unapproved uses of bipolar disorder, neuropathic pain and migraine. Something that is known as off-label marketing and is illegal in the US. Kaiser also accused Pfizer and its subsidiary of making unsubstantiated claims about the efficacy of Neurontin.
(Neurontin had been developed by the company Parke Davis, which was an operating arm of Warner Lambert. Warner Lambert had been acquired by Pfizer in 2000, so some of the early research was done by Parke Davis, therefore, some of the interview clips include references to Parke Davis and others to Pfizer.)
Dr John Abramson is the guest on this week’s podcast. John is based at the Harvard Medical School, where he lectures on health care policy. He consults as an expert in litigation involving the pharmaceutical industry and was one of the witnesses in the court case. He reveals the forensic work he and his colleagues went through, spending two years examining thousands of documents to uncover the truth.
In this trial, which took place in 2010 at the US District Court in Boston, one of the key points for the plaintiffs would be to establish why there had been increases off-label marketing of Neurontin.
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As John dug through the documents, his detective work revealed how repeatedly evidence had been manipulated and inconvenient facts buried. A classic example of this was when Pfizer and its subsidiary Warner Lambert had presented doctors with a study called the Young study, which purported to show that Neurontin was effective for bipolar disorder, but as John discovered that wasn’t the whole story.
Transparency in medical research is a huge issue, even the regulators don’t get to see all the data for a drug they are asked to approve. They do get a several thousand page clinical report and can ask for further information, but if it is material they are not aware of, they won’t necessarily know what to ask for. And the other major problem is that the data they receive is not the actual patient level data but the tabulated results, so the regulators can’t go back and re-analyse the raw data. For peer reviewers the situation is even worse, they don’t have access to the clinical trial reports and instead have to rely on the manuscripts written by the researchers, often in conjunction with the manufacturers.
So, the only time there is true transparency is during litigation when the plaintiffs have access to drug company data that they would never normally be able to see. That’s why cases like this are so important because they reveal information which would otherwise never be seen.
In this trial as a plaintiff witness, John was able to access the manufacturer’s emails, a number of which revealed the company’s reaction after a clinical study using Neurontin to treat neuropathic pain did not produce any statistically significant results.
After a five week trial, a federal jury found “that Pfizer and its subsidiary Warner Lambert had engaged in a Racketeer Influenced and Corrupt Organisations enterprise that committed mail and wire fraud by fraudulently marketing Neurontin for off-label conditions such as bipolar disorder, neuropathic pain, and migraine, and at doses greater than 1800 mg/day”.
And the judge in her Amended Findings of Fact and Conclusions of Law concluded: “there is little or no scientifically accepted evidence that Neurontin is effective for the treatment of bipolar disorder, neuropathic pain, migraine, or doses greater than 1800 mg/day”.
But the story doesn’t end here, because despite the court’s very clear findings revealing the lack of evidence for the efficacy of Neurontin for these conditions, somehow, this data doesn’t seem to have an impact on licencing decisions in other countries.
For while the FDA, has never licenced Neurontin for anything other than secondary treatment for epilepsy and nerve pain following shingles, remarkably, many places including the UK and other European countries have licenced it for neuropathic pain.
Here in Britain, Neurontin or its generic form gabapentin, is licensed for the treatment of peripheral nerve pain. And the UK's National Institute of Excellence (NICE) recommends gabapentin as a first-line treatment option for adults with all neuropathic pain (except trigeminal neuralgia).
So given the verdict in the court case and the judge’s comments, I wanted to find out from John, just how NICE could come to such a conclusion. What data have they and other regulators been looking at?
Today, Neurontin remains one of the top ten most sold drugs and the majority of its usage is off-label.
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