Healthy Skepticism Library item: 15220

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Miller N.
Apology for misleading drug claims
WA Today (Western Australia) 2009 Mar 4
http://www.watoday.com.au/national/apology-for-misleading-drug-claims-20090304-8oii.html

Full text:

A BIG drug company has mailed an apology to all Australian doctors after being caught out making misleading claims about a controversial new anti-depressant.

Duloxetine, sold as Cymbalta, went on the Pharmaceutical Benefits Scheme last July despite official warnings linking it to suicide and liver damage. It has been prescribed more than 82,000 times since, 23,000 in Victoria alone.

A Medicines Australia review has found that Eli Lilly made a “concerted effort” at the time of the PBS listing to spruik “off-label” use of the drug at up to twice the approved dose, as a treatment for physical pain associated with depression.

Companies are not legally allowed to promote drugs for off-label use when there is not enough clinical proof that the treatment works as advertised.

Eli Lilly has a recent track record of off-label promotion.

In January in the US, the company agreed to pay a $US1.42 billion settlement over its marketing of the anti-psychotic drug Zyprexa after pleading guilty to a federal misdemeanour.

The Medicines Australia review found the evidence of a pain relief effect would “enliven a debate in a medical setting”, but did not support the use of Cymbalta as a treatment for physical pain associated with depression. The company was fined $100,000 and ordered to withdraw all promotional material making the claims.

Eli Lilly’s appeal against the decision, saying the material was “educational” rather than promotional, was dismissed.

In a letter to doctors dated February 20, the company apologised for “any unintentional confusion” over the marketing of Cymbalta. It admitted the marketing material might have been misleading, and might have suggested using a higher than appropriate dose of the drug. The Age understands that the letter was prompted by further complaints to the company about its earlier promotion. Eli Lilly was unable to respond to further questions from The Age by deadline yesterday.

Cymbalta has been controversial since it was first approved for use in the US.

The FDA has warned that Cymbalta users “may be more likely to think about killing themselves or actually try to do so, especially when Cymbalta is first started or the dose is changed”.

It also warned that Cymbalta might cause liver damage, and users must not drink alcohol.