Lilly Exaggerates Efficacy of Cymbalta
Lilly has also overplayed the efficacy (effectiveness) of Cymbalta. Seeking to capture a greater segment of the antidepressant market, in 2005, Lilly initiated the direct-to-consumer marketing campaign: “Depression hurts. Cymbalta can help.” Cymbalta advertisements bearing this slogan appeared ubiquitously on television, in print and on the internet. Lilly’s advertising campaign made it appear that Cymbalta not only treated depression but that it also treated physical pain associated with depression.
Scientists reviewing the Cymbalta data have concluded that Lilly’s claims are misleading. For example, in a 2008 article published in Psychotherapy and Psychosomatics, the author concluded that “the marketing of duloxetine as an antidepressant with analgesic properties for people with depression does not appear to be adequately supported.”
The Manipulation of Medical Literature
Lilly has also augmented its misleading advertising campaigns by engaging in selective and biased publication of its clinical trials of Cymbalta. By way of example, Lilly has generally published only favorable studies of its Cymbalta clinical trials and refused to publish any of the negative and unfavorable studies. Such selective publication of clinical trial data gives the impression that the drug is safer and more effective than it actually is.
In a recent study published in the New England Journal of Medicine, researchers obtained clinical trials for antidepressants (including Cymbalta) that had been submitted to the FDA and compared them with studies that had been published. The authors found that there was a “bias towards the publication of positive results” and that, “according to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis shows that 51% were positive.” The authors found that, as a result of such selective publication, the published literature conveyed a misleading impression of Cymbalta’s efficacy resulting in an apparent effect size that was 33% larger than the effect size derived from the full clinical trial data. See Erick H. Turner et al., Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, 358 New Eng. J. Med. 252 (2008).
Lilly’s Cymbalta Profits
Lilly’s misleading direct-to-consumer promotional campaigns, its misleading presentation of Cymbalta’s efficacy and its failure to adequately warn regarding Cymbalta’s withdrawal and dependency side effects, have paid off financially for Lilly. Cymbalta has become a “blockbuster” drug with over $3 billion dollars in annual sales.
In the past few years, Cymbalta has been the second most profitable drug in Lilly’s product line.
Institute for Safe Medication Practices Finds “Serious Breakdown” in Warning Doctors and Consumers about Cymbalta Withdrawal
In October 2012, the Institute for Safe Medication Practices (ISMP), a non-profit healthcare consumer safety watchdog, issued findings from its independent investigation of Cymbalta adverse events found in the FDA Adverse Event Reporting System (FAERS). See QuarterWatch, Monitoring FDA MedWatch Reports, Why Reports of Serious Adverse Drug Events Continue to Grow, Oct. 3, 2012, ISMP.
The ISMP’s investigation uncovered “a signal for serious drug withdrawal symptoms associated with duloxetine (Cymbalta),” and detailed for the public what Lilly already knew: “[W]ithdrawal symptoms were reported in 44-50% of patients abruptly discontinuing duloxetine at the end of clinical studies for depression, and more than half of this total did not resolve within a week or two.”
The ISMP report continued: “[W]e identified a serious breakdown at both the FDA and the manufacturer, Eli Lilly and Company, in providing adequate warnings and instructions about how to manage this common adverse effect.
The ISMP also explained:
Good patient information is essential because abrupt withdrawal effects are likely to affect about 50% of duloxetine patients; they will be severe in at least 10% of that total, and persistent in half. Instead of clear warnings and useful instructions, the duloxetine patient Medication Guide says only:
- “Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.”
This FDA-approved patient guide is materially deficient. It gives no hint of the persistence or severity of the symptoms known to occur. It does not address basic questions:
- What kind of symptoms are most common?
- Should patients taper off the dose, and if so, how slowly?
- What should a patient do if depression or other symptoms recur?
Is there a way to tell whether these are withdrawal symptoms or the previous illness returning?
We could not identify any FDA-approved or company information for patients about how to discontinue duloxetine. We specifically asked Lilly how the company responded if a patient asked for assistance in stopping duloxetine. “If a consumer requests additional information we inform them to consult their physician because they know the patient’s complete medical history,” the company said. Consumers could also obtain the prescribing information intended for physicians.
In conclusion, the report minced no words in its indictment of Lilly’s product information: “A major lapse has occurred in the FDA-approved information for patients about the risks of stopping duloxetine.”