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Neurontin, an example of off-label marketing

Gabapentin (Neurontin) is a GABA analog. Its list of serious, common side effects is almost as long as its list of off-label uses.  It was originally developed to treat epilepsy it became a mega blockbuster.



Japanese officials: Novartis failed to report side effects of leukemia drug

What started as an inquiry into a clinical trial of its Diovan has morphed into multiple inquiries


May 12, 2014 | By Arlene Weintraub


Novartis ($NVS) is facing yet another investigation in Japan. Little more than a month after a panel of Japanese lawyers uncovered serious misconduct during a trial of its leukemia drug, Tasigna, the Japanese government is probing whether the company broke the law by failing to report side effects of the product.


Sources tell The Japan Times that the country's Health, Labor and Welfare Ministry has opened an investigation into charges that Novartis collected information on 3,000 Japanese patients who were taking the drug last year, and found 30 cases of side effects--10 of which should have been reported to the government but weren't--the paper reports, citing unnamed sources.


Two cases of side effects were also found in connection with the highly scrutinized clinical trial, which took place at the University of Tokyo Hospital. The trial compared the side effects of leukemia treatments, including Tasigna (nilotinib), which is Novartis' follow up [me-too] to its blockbuster Gleevec (imatinib).[1]


In March, hospital officials revealed that Novartis employees had been much more involved in the trial than previously suspected. For example, at least 9 Novartis sales reps collected patient questionnaires during the trial and then faxed them to the hospital, despite the fact that trial protocol requires doctors to return the questionnaires themselves. The independent panel later found that when the misconduct allegations surfaced, some Novartis employees shredded documents and deleted computer files.


Now Novartis is vowing to sign formal contracts with its trial investigators in Japan, according to an editorial in The Japan Times, calling for broad reforms in clinical trial transparency. But the paper points out that Novartis provided much-needed financial support to the University of Tokyo lab that was involved in the leukemia study: ¥8 million over three years ($1.3 million). To foster neutrality in clinical trials, "the government needs to expand its support for researchers so that they don't have to rely on money from the pharmaceutical industry," the paper contends.


Novartis has been under fire in Japan since last summer, when news erupted that employees had been involved in a now-retracted study of its blood pressure drugDiovan. Earlier this year, Japanese regulators filed a criminal complaint against Novartis under its false-advertising law, alleging that the company used misleading data to promote the drug. In April, Novartis ousted its top Japanese executives and replaced them with executives from its British, Canadian and German operations.

Bloomberg news:   

Pfizer Rejected by Top Court on Neurontin Marketing Suits

By Greg Stohr  Dec 9, 2013 4:19 PM PT

The U.S. Supreme Court left intact a $142 million award against Pfizer Inc. (PFE) and let two similar suits go forward with claims that the drugmaker defrauded insurers by illegally marketing its Neurontin epilepsy drug.  The justices without comment today rejected Pfizer’s appeal, letting stand three connected federal appeals court decisions. The cases are part of the fallout from a 2004 guilty plea by Pfizer’s Warner-Lambert unit to charges that it promoted Neurontin for unapproved “off-label’” uses.

The rebuff means a nationwide class-action suit can proceed, seeking damages on behalf of insurers, union funds and employers who paid for ineffective dosages of Neurontin. Pfizer must also defend against a suit byAetna Inc. (AET), which says it paid for more than a million off-label Neurontin prescriptions. In addition, the world’s biggest drugmaker lost its challenge to a $142 million jury award won by the Kaiser Foundation’s health plan and hospitals.

Pfizer “strategically conducted a decade-long, multifaceted fraud to make Neurontin a blockbuster drug,” Kaiser argued in court papers.  Pfizer said in a statement that it “has strong defenses on the merits in the cases that will now proceed in the lower court.”

Unapproved Uses:  At the Supreme Court, Pfizer argued that the Boston-based appeals court improperly relaxed the standards for winning a case under the U.S. Racketeer Influenced and Corrupt Organizations Act, known as RICO. Pfizer said the appeals court should have required proof that the company’s marketing affected the prescriptions issued by individual doctors. The lower court instead said the insurers could rely on aggregate data showing a link between Pfizer’s promotional spending for unapproved uses and the number of off-label prescriptions written. The appeals court decisions “invite an unlimited escalation in RICO and related cases against pharmaceutical companies for off-label promotion using the shortcut of aggregate proof,” the New York-based company argued.

The suing insurers say Pfizer pitched Neurontin as a treatment for bipolar disorders, neuropathic pain and migraines, while suppressing or misrepresenting clinical studies that showed the drug wasn’t effective for those treatments.

‘Snake Oil’:  The insurers point to an internal e-mail describing Neurontin as “the ‘snake oil’ of the twentieth century.” The conduct occurred before Pfizer acquired Warner-Lambert in 2000. In its 2004 plea agreement, Warner-Lambert admitted it promoted Neurontin for off-label uses. Federal law bars drug-makers from promoting uses that haven’t received Food and Drug Administration approval, though doctors are free to prescribe medicines for off-label purposes.  Warner-Lambert’s marketing increased off-label sales from 15 percent of all Neurontin prescriptions in 1994, its first year on the market, to 94 percent of Pfizer’s Neurontin sales in 2002, according to federal government court filings. The drug’s sales hit $2.3 billion in 2002.

The Aetna and class action cases can now go forward in a federal district court in Boston.

The Supreme Court case is Pfizer v. Kaiser Foundation, 13-289.

To contact the reporter on this story: Greg Stohr in Washington at

To contact the editor responsible for this story: Patrick Oster at


The drug companies once given an FDA patent--always for a specific use--can market their drugs for uses never approved based upon marketing (tobacco) science, with the one proviso that they don’t advertise it for those new uses.  Pfizer can educate their sales reps about off label uses, but they can’t tell them to go out and sell it for those uses.  The thought leaders Pfizer hires for journal articles and for continuing educational classes for physicians and Pfizer’s sales reps can under free speech clause of the Constitution “inform” physicians and hospital administrators of these new uses. Based on tobacco science physicians are told of new uses; and then rewarded for increased sales of that drug.  Moreover, Pfizer pays their sales reps based on sales.  Off label uses are found in treatment protocols.  If side effects are included in the calculation, over half of the drugs prescribed are worse than a sugar pill.  In the case of Neurontin, 94% of sales were for off label uses.  This is another case of the 800 pound gorilla having its way with the “regulators”.  The penalties only scratch the trillion dollar surface, are viewed as cost of doing business, and are part of the façade of regulations in the public’s interest. 

One last whack at pharma, the neuroleptic drugs are tested short term (6-9 weeks).  They are downers marketed as fixes for a long list of physical and psychological complaints.  They are marketed as magic bullets effects specific neural transmitters and their receptors such as serotonin[1], GABA, dopamine, etc.   Numerous long-term studies (over a year) have shown them to be worse than a sugar pill for the approved indication.  Emotional conditions in a large population will on an average show improvement.   With or without treatment, some patients will of course get worse but more will improve.  The beauty of downers is that most patients will be in too much of a mental cloud to know which way their condition is going, and lack the resolve to get off their drug.  If they complain to their doctor, they will be given a different downer.  At least half of all patients given downers remain on them for over 10 years.  For more on bad pharma



[1] Many of the new generation downers are SSRI (Selective serotonin re-uptake inhibitors).  Prozac was submitted to the FDA for approval in 1977 but because of minimal benefits and serious side effect it took until 1987 for approval, Germany for example denied approval in 1984. Nevertheless it became a mega blockbuster.  A few of the SSRIs have mixed effects, unlike true downers.  All are marketed as better than the older downers, though with a few exception have not been shown to be better. 


Disclaimer:  The information, facts, and opinions provided here is not a substitute for professional advice.  It only indicates what JK believes, does, or would do.  Always consult your primary care physician for medical advice, diagnosis, and treatment. 

Positive bias averaged 32% (range 11 to 69%) in a NEJM article, 2008.  The study of neuroleptic drugs made a comparison of 74 journal articles to the raw data which was obtained by FOIA (Freedom of Information Act) from the FDA. See, or