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.
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
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).
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.
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
Pfizer Rejected by Top Court on Neurontin Marketing Suits
By Greg Stohr Dec
9, 2013 4:19 PM PT http://www.bloomberg.com/news/2013-12-09/pfizer-rejected-by-top-court-on-neurontin-marketing-suits.html
U.S. Supreme Court left intact a $142 million award against Pfizer Inc. (PFE) and let two similar suits go forward with claims that
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.
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
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
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
‘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
contact the editor responsible for this story: Patrick Oster at firstname.lastname@example.org
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,
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 http://healthfully.org/rc/id1.html
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.
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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 http://healthfully.org/index/id9.html,