- When the body of a 19-year-old student, Traci Johnson,
was found hanging from a shower rod in the laboratories of pharmaceuticals
giant Eli Lilly, US officials were quick to announce that the death could
not be linked to a new anti-depressant drug she was helping to test.
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- During her stay at the hotel-cum-clinic in Indiana known
as the Lilly Lab, Johnson had been taking part in trials for a secret new
formula called Cymbalta, a chemical cousin of Prozac, which the company
hoped would guarantee huge profits for years to come.
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- For the drugs giant, her death on 7 February last year
was an "isolated tragedy" that did not prevent it from pressing
ahead with the Cymbalta trials. It is now on sale in the US and - under
another name - in Europe and the UK.
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- But for the scientific community it was another warning
bell about a class of medicines already under scrutiny for possible ties
to suicide. After all, Johnson was not depressed. Far from it. She enrolled
in the clinical trial as a healthy volunteer in order to earn money to
pay for her college tuition. Anyone with signs of depression was excluded.
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- Now, medical researchers attempting to establish the
truth about Cymbalta are asking why her disturbing and very public suicide
is completely absent from the official record, at least as it is released
to academics and the public. According to an investigation by The Independent
on Sunday, this and at least four other suicides by volunteers have been
hidden by the US regulators, the Food and Drug Administration (FDA).
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- As the FDA admits, even a young woman's death counts
as a commercial secret in the world of pharmaceuticals.
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- Last week, the IoS reported how vital data on prescription
medicines found in millions of British homes has been suppressed by the
US authorities, even though the information could potentially save lives.
As a result, medical specialists say they have been unable to assess the
true risks of big-name products such as painkillers Vioxx (now withdrawn)
and Neurofen.
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- It is hard to overestimate the importance of Cymbalta
to Eli Lilly. Prozac, the popular antidepressant that accounted for a quarter
of the company's $10bn revenues in 2000, went off-patent in August 2001,
causing a bruising financial reaction on Wall Street. In just one day,
the company's stock plunged by almost a third.
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- The replacement was supposed to be Cymbalta, which financial
analysts predicted would bring in a whopping $2bn in sales.
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- Lilly defended its drug, saying that 4,142 depressed
patients had taken Cymbalta and the deaths represent a 0.097% suicide rate.
Besides, it said, it is the underlying depression - not the drug - that
causes sufferers to become suicidal.
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- With so much at stake, the FDA sent experts to Indianapolis
to investigate. When they announced that Cymbalta "couldn't be linked
to her death", her family was outraged. According to the Johnson family
spokesperson, Pastor Joel Barnaby, FDA officials never spoke to them.
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- National headlines following the FDA ruling were unequivocal.
The Associated Press ran an article entitled, "FDA clears Lilly drug
in suicide". And six months after Johnson's death, the FDA approved
the drug for the treatment of depressed patients. Cymbalta, which has the
chemical name duloxetine, is also sold for "stress urinary incontinence"
in Europe and the UK under the trade name Yentreve.
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- Beginning in January, the IoS started filing US Freedom
of Information Act requests for all safety data relating to the drug's
use. The FDA responded with its Adverse Events Reporting System (Aers)
database, which shows 13 suicides reported among patients taking duloxetine
and about 41 deaths. Five suicides are notably absent from the information
supplied by the FDA; that of Johnson and the four patients who committed
suicide while enrolled in clinical trials of Cymbalta.
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- The FDA has a good reason not to release any information
about these five patients: they don't have to. In fact, it's against the
law, according to Dr Robert Temple, its director of medical policy. In
an exclusive interview with the IoS, he said that some of the data filed
by Lilly is considered commercially protected information.
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- When asked whether the FDA would release all the data
from anti-depressant trials analysed by the FDA to a researcher, Dr Temple
said his belief is that "the answer is clearly no". That, he
said, is something "only Congress can change".
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- Dr David Graham, associate safety director at the FDA,
agreed with Dr Temple that it would take action by Congress to make data
available that are currently considered trade secrets. "Most of us
think of trade secrets as a manufacturing process or the names of certain
ingredients, but here, deaths are being considered trade secrets."
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- Following revelations that drug companies were not publishing
negative data, Eli Lilly won praise for its announcement that it would
disclose all clinically relevant trial data on its website. The company
has stated that it will disclose "all medical research results that
are significant to patients, health care providers or payer - whether favourable
or unfavourable to a Lilly product".
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- The company posts clinical trials results on its freely
available clinical trials website (www.lillytrials.com). Data from seven
trials of duloxetine are posted, but these show a total of two deaths associated
with duloxetine, and no reported suicides. Lilly says that it is "on
track" to post all clinical data by 1 July 2005.
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- A spokesman for Eli Lilly, David Shaffer, said some of
the studies are still in progress and that the suicides would be reported
when the studies are completed, the data is reviewed and, if applicable,
they have been published in a peer-reviewed scientific journal. Other suicides
occurred in depression studies "run by another company". Two
cases from a completed study will be posted by 1 July, he said.
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- Dr Jerome Hoffman, professor of medicine and emergency
medicine at the University of California at Los Angeles said, "Like
Dr Temple, I don't know whether this one young woman's death was related
to this drug, nor do I believe that it's possible for anyone to determine
that with certainty."
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- But he said it was "unconscionable" that "the
FDA appears to be prevented by law from carrying out what we all surely
believe is its primary role in this process, which is to safeguard the
interests of the public.
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- "The fact that the law not only does not make this
a requirement - of the drug company itself, no less of the FDA - but that
it actually makes it forbidden, clearly turns the function of this government
agency on its head: from protector of the public health, to protector of
industry."
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- ©2005 Independent News & Media (UK) Ltd.
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- http://news.independent.co.uk/uk/health_medical/story.jsp?story=648010
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