# Eli Lilly's Cymbalta(R) the focus of safety concerns



## M&M (Jan 20, 2002)

Straight from the Co-Cure List:********************************************************[Eli Lilly and Co. claims Cymbalta® provides sustainedpain relief for women with fibromyalgia. Seehttp://listserv.nodak.edu/cgi-bin/wa.exe?A...co-cure&P=R4139 .]http://news.independent.co.uk/low_res/stor...0&host=3&dir=59Was Traci Johnson driven to suicide by anti-depressants? That's a tradesecret, say US officialsResearchers trying to establish the truth about a new drug - now on salein the UK - are being thwarted by a government agency whose job is toprotect the publicBy Jeanne Lenzer and Nicholas Pyke19 June 2005When the body of a 19-year-old student, Traci Johnson, was found hangingfrom a shower rod in the laboratories of pharmaceuticals giant EliLilly, US officials were quick to announce that the death could not belinked to a new anti-depressant drug she was helping to test.During her stay at the hotel-cum-clinic in Indiana known as the LillyLab, Johnson had been taking part in trials for a secret new formulacalled Cymbalta, a chemical cousin of Prozac, which the company hopedwould guarantee huge profits for years to come.For the drugs giant, her death on 7 February last year was an "isolatedtragedy" that did not prevent it from pressing ahead with the Cymbaltatrials. It is now on sale in the US and - under another name - in Europeand the UK.But for the scientific community it was another warning bell about aclass of medicines already under scrutiny for possible ties to suicide.After all, Johnson was not depressed. Far from it. She enrolled in theclinical trial as a healthy volunteer in order to earn money to pay forher college tuition. Anyone with signs of depression was excluded.Now, medical researchers attempting to establish the truth aboutCymbalta are asking why her disturbing and very public suicide iscompletely absent from the official record, at least as it is releasedto academics and the public. According to an investigation by TheIndependent on Sunday, this and at least four other suicides byvolunteers have been hidden by the US regulators, the Food and DrugAdministration (FDA).As the FDA admits, even a young woman's death counts as a commercialsecret in the world of pharmaceuticals.Last week, the IoS reported how vital data on prescription medicinesfound in millions of British homes has been suppressed by the USauthorities, even though the information could potentially save lives.As a result, medical specialists say they have been unable to assess thetrue risks of big-name products such as painkillers Vioxx (nowwithdrawn) and Neurofen.It is hard to overestimate the importance of Cymbalta to Eli Lilly.Prozac, the popular antidepressant that accounted for a quarter of thecompany'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.The replacement was supposed to be Cymbalta, which financial analystspredicted would bring in a whopping $2bn in sales.Lilly defended its drug, saying that 4,142 depressed patients had takenCymbalta and the deaths represent a 0.097% suicide rate. Besides, itsaid, it is the underlying depression - not the drug - that causessufferers to become suicidal.With so much at stake, the FDA sent experts to Indianapolis toinvestigate. When they announced that Cymbalta "couldn't be linked toher death", her family was outraged. According to the Johnson familyspokesperson, Pastor Joel Barnaby, FDA officials never spoke to them.National headlines following the FDA ruling were unequivocal. TheAssociated Press ran an article entitled, "FDA clears Lilly drug insuicide". And six months after Johnson's death, the FDA approved thedrug for the treatment of depressed patients. Cymbalta, which has thechemical name duloxetine, is also sold for "stress urinary incontinence"in Europe and the UK under the trade name Yentreve.Beginning in January, the IoS started filing US Freedom of InformationAct requests for all safety data relating to the drug's use. The FDAresponded with its Adverse Events Reporting System (Aers) database,which shows 13 suicides reported among patients taking duloxetine andabout 41 deaths. Five suicides are notably absent from the informationsupplied by the FDA; that of Johnson and the four patients who committedsuicide while enrolled in clinical trials of Cymbalta.The FDA has a good reason not to release any information about thesefive patients: they don't have to. In fact, it's against the law,according to Dr Robert Temple, its director of medical policy. In anexclusive interview with the IoS, he said that some of the data filed byLilly is considered commercially protected information.When asked whether the FDA would release all the data fromanti-depressant trials analysed by the FDA to a researcher, Dr Templesaid his belief is that "the answer is clearly no". That, he said, issomething "only Congress can change".Dr David Graham, associate safety director at the FDA, agreed with DrTemple that it would take action by Congress to make data available thatare currently considered trade secrets. "Most of us think of tradesecrets as a manufacturing process or the names of certain ingredients,but here, deaths are being considered trade secrets."Following revelations that drug companies were not publishing negativedata, Eli Lilly won praise for its announcement that it would discloseall clinically relevant trial data on its website. The company hasstated that it will disclose "all medical research results that aresignificant to patients, health care providers or payer - whetherfavourable or unfavourable to a Lilly product".The company posts clinical trials results on its freely availableclinical trials website (http://www.lillytrials.com). Data from seven trials ofduloxetine are posted, but these show a total of two deaths associatedwith duloxetine, and no reported suicides. Lilly says that it is "ontrack" to post all clinical data by 1 July 2005.A spokesman for Eli Lilly, David Shaffer, said some of the studies arestill in progress and that the suicides would be reported when thestudies are completed, the data is reviewed and, if applicable, theyhave been published in a peer-reviewed scientific journal. Othersuicides occurred in depression studies "run by another company". Twocases from a completed study will be posted by 1 July, he said.Dr Jerome Hoffman, professor of medicine and emergency medicine at theUniversity of California at Los Angeles said, "Like Dr Temple, I don'tknow whether this one young woman's death was related to this drug, nordo I believe that it's possible for anyone to determine that withcertainty."But he said it was "unconscionable" that "the FDA appears to beprevented by law from carrying out what we all surely believe is itsprimary role in this process, which is to safeguard the interests of thepublic."The fact that the law not only does not make this a requirement - ofthe drug company itself, no less of the FDA - but that it actually makesit forbidden, clearly turns the function of this government agency onits head: from protector of the public health, to protector of industry."


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