AstraZeneca Pressured Medical Mgr Over Seroquel
24 CommentsBy Ed Silverman // January 26th, 2010 // 7:12 am
A former UK medical manager claims he was pressured by marketing staff to approve claims about AstraZeneca’s Seroquel antipsychotic that he felt didn’t reflect the medical evidence, the BBC reports. You may recall that lawsuits allege the drugmaker marketed its pill without adequate warnings about possible side effects such as weight gain and diabetes, which AstraZeneca has denied.
But John Blenkinsopp tells the BBC that, “the clinical studies at the time of the launch of Seroquel showed patients developed significant weight gain, significant both statistically and clinically. They (the marketing team) came at me with a number of potential claims all of which were trying to intimate that Seroquel was not associated with weight gain - the data pointed in the opposite direction.
“I understood where they were coming from. I had some robust discussions and exposed them to the data but that didn’t seem to stop them because they were desperate for a differential advantage over one of the competitor products and they didn’t have one,” says Blenkinsopp, who was reportedly speaking publicly for the first time. “”In the end, I was put under quite a significant amount of pressure by the marketeers to sign off claims with regards to the lack of weight gain and I was unwilling to sign that off. The marketeers made it clear it could be career limiting for me.”
In the US, the drug was marketed with claims that it would not cause weight gain. But the BBC notes, in the UK, the pill was marketed without those claims, for one ad that was published in the British Journal of Psychiatry in April 2004.
Lisa Van Syckel
Luv the lead photo
pharmavet
In my first week of my first Pharma job as a medical manager, I was told very explicitly, “Marketing runs the show”. No further explanation necessary.
Jack Friday
http://www.springerlink.com/content/b674622731k4850q/
Get a fork - AZ are DONE!!
In a somewhat similar manner, data regarding weight gain on quetiapine were managed by AstraZeneca.
One internal document, titled “Seroquel Speakers Slide Kit” from March 2001, was apparently utilized to educate physicians regarding the safety and efficacy of the drug (AstraZeneca 2001). One slide makes the claim, in bold, that “Long-term Seroquel has neutral effect on weight,” while another stated
“Seroquel—weight neutral at all doses”.
Several other slides make similar claims. These slides were based on studies examining the drug in the treatment of schizophrenia. Another set of slides, included in a
2003 email, were said to “represent a core detail flow” to “support our current position for Seroquel in the treatment of schizophrenia”. One slide stated
that: “Seroquel, unlike some other antipsychotics, is not associated with meaningful weight gain”(AstraZeneca 2003).
Yet in July 2008, an internal analysis of quetiapine studies in schizophrenia conducted from 1993 to 1999 concluded that “the incidence rate in adult patients with weight gain ≥7% in all trials was 18.2%” and
that in placebo-controlled trials, the relative risk of clinically significant weight gain was 2.5 (Alam and Jeffries 2008). The document noted that “the results of the analysis show that long-term treatment with
quetiapine monotherapy was associated with moderate weight gain in patients with schizophrenia”.
However, a journal publication in 2000, with a lead AstraZeneca author, concluded that based on data from clinical trials with patients with schizophrenia,quetiapine had a neutral effect on weight (Brecher et al. 2000). A physician practicing EBM may have
examined this study and concluded that quetiapine was weight-neutral when the internal data indicated that weight gain was a common side effect of the
drug.1
Despite marketing claims to the contrary, employees at AstraZeneca were concerned about quetiapine induced weight gain as early as 1997. In one email, written regarding an apparently fluke study associating
quetiapine with weight loss, an employee noted that “we must not get too carried away with weight loss when we know the rest of our data appears to point in the other direction” (Hough 1999). In another email, a company
physician who worked with quetiapine noted that trial results consistently found that, over time, weight gain “doesn’t stop…the slope just appears to change” (Arvanitis 1997). A brief synopsis of several relevant
documents on the topic of quetiapine and weight gain is available online (Edwards 2009b).
Justice in MI
Needless to say, consistent with the “smoke and mirrors” documents earlier released. What was also interesting there was that, if AZ did fudge the data, they were more worried about J&J/Respirdal gang blowing their cover than regulators. Exactly because J&J, so the AZ folks emailed to each other, were doing the same thing.
Justice in MI
Vet or others–is there anything that the science folk can do to put the brakes on the cowboys (and gals)? Do in-company regulatory affairs, compliance officers, ethics officers, et. al. provide any useful (realistically) avenues?
Jack Friday
Justice:
Do you have a ref for that?
Justice in MI
Jack–The documents were linked in a WSJ story about Seroquel last year. If you use the Pharmalot search engine to Seroquel or “smoke and mirrors” you’ll probably get a link to the link. Of course, the WSJ requires paid subscription. If you don’t find it, contact me at justiceinmich@gmail.com.
Justice in MI
Alternatively, if you just do a google search with “Seroquel Smoke Mirrors,” you’ll get all kinds of stories, blogs, etc. about the relevant buried studies and internal communications.
harpy
@ JiM - honestly it depends on the company. In the article, it says Seroquel was launched in 1997 and the medical manager left the company in 2000. Compliance programs weren’t mandated by HHS-OIG until 2003 and have only slowly gained influence. I would imagine those companies that have had Corporate Integrity Agreements (or multiple ones) take compliance much more seriously than companies that haven’t been in trouble. So, I think the answer is yes, and many companies do a much better job of it now, but it took a long time to turn the Titanic.
pharmavet
Dear Justice. As a medical reviewer of proposed marketing material it was my job to point out to Marketing what they could and could not say with respect to claims that could not be supported by the clinical trial data, as well as other issues that were likely to tigger a negative response with DDMAC. That was my job, I registered my objections as necessary, and I think that I did my job well, but I did not have veto power. Since FDA did not require preclearance of marketing materials prior to launch, the prevailing thinking among Marketing managers was that we could “get away with” 6-9 months of false and misleading advertising until DDMAC caught up with us, such was the slow pace of FDA response. Marketing managers were considered not to be “pushing the envelope” if they did not “earn” the company at least one NOV/year. They considered an NOV as a badge of courage. In my later years, the companies i worked for voluntarily submitted pre-launch marketing materials to DDMAC for pre-clearance. I haven’t done this for awhile, so that I don’t know whether pre-clearance is required. Just saying how it used to be.
pharmavet
Sorry, one of my sentences got truncated. Should read “In my later years the companies I worked for voluntarily submitted pre-launch marketing materials to DDMAC for pre-clearance”…
SteveM
Re: harpy “it all depends on the company.”
What company exactly? Big Pharma universally continues to explicitly underplay the toxicity of psycho-pharm. All of them.
FDA DDMAC just sent another warning letter dated 7-Jan-10 to Eli-Lilly for misleading advertising related to its rancid drug Cymbalta:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm197224.htm
Plenty more examples to go around. Those voracious, corrupted companies will stop at nothing to move product.
anon
janet woodcock needs to go. She runs the show at the FDA. if they can’t get rid of her, the pharma and the marketing folks will prevail over evidence based medicine.
Former BP
Justice,
Unfortunately, very little. The road is littered with medical & scientific individuals who dared to stand up to the commercial hooligans. If they don’t like what you say, they get rid of you. It happened to me. As a physician, I was concerned about off-label promotion of a drug with dangerous side effects and I was skewered. After that, I was decapitated. I believe this happens in a lot of companies. When you enter, check your ethics at the door. Otherwise, we’ll can you. Then, we’ll black-ball you.
FBP
sp vet
Harpy,
What company follows the rules? I’ve been at 3 and none of them did. All of them pushed off-label, minimized safety issues, used money inappropriately, cuddled up with KOLs, bought favors and laughed at compliance. Not one was honest. The commercial groups are callous, greed-driven jerks.
SP Vet
BMS Guy
Pharmavet,
You are 100% correct. The violations are done with the idea that I’ll sell under false pretences for 6-9 months before DDMAC will catch up. Then, it will likely only happen because a competittor complains. They laugh all the way to the bank!
BMS Guy
pharmavet
Former BP is correct for the reasons stated. Despite it’s apparent size, Pharma is really a very small industry where everybody knows each other. While there are no official lists, anyone in a position to hire knows exactly who is considered “radioactive”. The blacklisted people would be best to consider another line of work. I guess in today’s terms they are called “whistleblowers”. I see lawyers ads all the time looking to pick up ex pharma employees who feel they have been unjustly treated. And I agree that such cases exist. To test my theory I Googled several ex pharma folks that I know have been blacklisted within the past 10 years. While Google is not all-inclusive, not one of the blacklisted folks has ever worked for a drug company again.
Former BP
Pharmavet,
Problem in Big Pharma is that you are “radioactive” if you dare to you raise any question or concern about what the commercial is scheming to do. Ask a question, you’re not a good fit. Raise a concern, you’re a troublemaker. If you’re a performer - we can trash you and change that. Don’t like it - we can fire you at will.
All the ethical person tried to do was the right thing to protect the safety of patients. They have morals and Big pharma doesn’t want them. They don’t stop there, they ruin you! And all you did was ask a question!
Last I heard, a whistleblower was someone who was reporting wrongdoing for profit. Someone inside who is trying to ensure that the company does the right thing should not be called a whistleblower. Apparently, Big Pharma has now decided that they are. The execs are a bunch of greedy crooks.
FBP
Justice in MI
Thanks to all who responded to my question. It is appreciated.
pharmagossip
http://www.bbc.co.uk/podcasts/series/fileon4
Download the programme as a podcast.
Former BP
What’s the difference between a Big Pharma commercial executive and an immoral, unethical, greedy, slimy, disgusting criminal?
The suit!
harpy
lol - just trying to be judicious, folks. having only worked at one company, I’d rather not infer what others may or may not be doing.
anyone out there who thinks their company does a pretty good job of clean sales and marketing?
Former SP
Not me.
pharmavet
Harpy, the answer is yes. Go to CafePharma and click on “Lost Civilizations”.