AstraZeneca On Seroquel Risks: What Diabetes?
14 CommentsBy Ed Silverman // August 5th, 2010 // 7:19 am
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-Åsberg 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.
MsPiggy
I gather misrepresenting the risk and overstating effectiveness of Seroquel was OK’ed in the fine print of that CIA they signed with the DOJ.
As they say, business as usual.
Stephany
Well, isn’t it quite interesting, that AstraZeneca has sponsored (is the only sponsor) of a contest with NAMI (NAMI also receives funding from AstraZeneca as well as other drug companies)
http://bipolarsoupkitchen-stephany.blogspot.com/2010/07/share-your-experienceyour-voice-your.html
“Share Your Experience.Your Voice. Your Success”-give rights to your story to AstraZeneca & DBSA for DTC, sales “education”
The contest is directed to consumers to tell their story, and the catch is that upon entering AstraZeneca OWNS and has rights to the personal information and story for future use in several marketing media forms.
It will not matter if the patient claims to feel better from depression/bipolar on another pharmaceutical, AZ can use their story, words, poem, image, etc to promote THEIR product, which is ironically–OR NOT–SEROQUEL the antipsychotic turned antidepressant via AZ marketing campaign and attempt to milk the drug for all it is worth to the company before patent expiration.
Bernard Carroll
These are exactly the deceits for which an AZ-sponsored Continuing Medical Education program was nailed last year. Read all about it here.
http://hcrenewal.blogspot.com/2009/10/nemeroff-seroquel-and-accme.html
The pimp was Charles Nemeroff.
Stephany
Bernard Carroll,
Here’s a little walk down CME memory lane with Charles Nemeroff and AstraZeneca and MDD post I just wrote this week about that very topic:
http://bipolarsoupkitchen-stephany.blogspot.com/2010/07/cme-walk-down-memory-lane-charles.html
I reference you in the post.
Bernard Carroll
Stephany,
Right… the gig is ended but the damage lingers on.
epatientgr
Thanks for bringing up this interesting story. Mental Health is not my domain but as I have friends on antidepressant drugs I look around for interesting resources.
I will pass it on to them, but I am afraid that there will be no awareness raised, since these matters are not discussed here. If the doctor is god for other diseases, in mental health he is considered super-god, therefore, no questioning about the necessity of continuing on a drug with a sum of terrible AE, even if FDA also confirms that something is wrong.
Justice in MI
This goes beyond the AZ/Seroquel story, but I wonder if someone can tell me which big pharma companies are currently under CIA agreements, whether resulting from false claims, manufacturing issues, etc..
I don’t mean this sardonically, but if it is shorter to list those companies _not_ under CIAs, that would be equally informative.
Thank you.
Justice in MI
Partly answering my own question, I believe the following are currently under CIAs
Merck/SP
Pfizer (and subsidiaries)
Lilly
AZ
GSK (I think)
Bayer
Others?
Ed Silverman
Hi Justice,
I recall that Cephalon entered into a CIA with the HHS OIG a few years ago. Beyond that, I would have to do something searching.
Cheers,
ed
Justice in MI
Thanks, Ed. Yeah, I haven’t done the requisite googling….I assume Abbott had one following the Lupron bust but don’t know how long these things last.
Justice in MI
Probably something Condor would know, but haven’t seen him flying overhead lately….
harpy
here you go, Justice
http://oig.hhs.gov/fraud/cia/cia_list.asp
there are more than I have time to pick out, but peruse at your leisure…
harpy
and typically the term is 5 years, although that can vary at DoJ’s discretion.
harpy
oops, OIG rather, not DoJ