Healthy Skepticism Library item: 18544

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: Electronic Source

Silverman E
AstraZeneca On Seroquel Risks: What Diabetes?
Pharmalot 2010 Aug 5
http://www.pharmalot.com/2010/08/astrazeneca-on-seroquel-risks-what-diabetes/

Full text:

Here is an interesting dichotomy: At the same time that AstraZeneca is forking out tens of millions of dollars to settle thousands of product-liability lawsuits claiming the risks of its Seroquel antipsychotic were not properly disclosed (see this), the drugmaker is tagged by the FDA for distributing promotional material that, among other things, fails to mention the risk that promped the lawsuits – a link to diabetes.
A July 29 letter sent by the Division of Drug Marketing and Advertising Communications notes that the efficacy of Seroquel XR was overstated and risk info was omitted in so-called leave-behind sheets. For instance, various studies were cited, but overstated remission rates, the FDA scolded.
“These claims misleadingly suggest that patients will achieve ‘remission’ with Seroquel XR plus antidepressant versus antidepressant alone, when this has not been demonstrated by substantial evidence or substantial clinical experience. The referenced studies are not considered substantial evidence to support claims of ‘remission.’ Remission was not specified as a primary or key secondary measure in these study protocols. Furthermore, six weeks is not a long enough time period to adequately assess ‘remission.’ Moreover, there is no regulatory definition or criteria on how to define ‘remission in MDD,” or major depressive disorder, the FDA writes.
The agency also criticizes a claim that Seroquel XR is “proven effective in MDD as add-on therapy compared to an antidepressant alone” when deciphering the Montgomery-Ã…sberg Depression Rating Scale “as early as week one.” Here’s the hitch: The sheet fails to disclose “that only the 300 mg dosage strength provided a significant improvement in MADRS Total Score at week 1, thus misleadingly implying that the 150 mg dosage strength also achieved this effect,” the FDA writes.
And for those following the Seroquel litigation, this is particularly interesting: The leave-behind sheet also omits “material information” about several risks, such as neuroleptic malignant syndrome, hyperglycemia and diabetes mellitus, and potential for cognitive and motor impairment. Here’s one example: the sheet mentions the risk of tardive dyskinesia, it fails to state that the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.
Either someone at the big drugmaker, which paid $520 million to settle a government probe into improper marketing and agreed to a corporate integrity agreement (see this), is trying to play fast and loose with promotional materials or there is a yawning disconnect when it comes to understanding regulations and the price to pay for failing to fall in line.