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Healthy Skepticism Library item: 16611

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

Edwards J
AstraZeneca's Fuzzy Seroquel Math: When 45% Gain Weight, It's 'Weight-Neutral'
BNet 2009 Oct 8
http://industry.bnet.com/pharma/10004691/astrazenecas-fuzzy-seroquel-math-when-45-gain-weight-its-weight-neutral/


Full text:

Even though AstraZeneca executives wrote emails in 1997 saying they believed Seroquel caused weight gain, AZ instructed product managers to promote the drug as having only a “a neutral effect on weight,” according to documents unveiled in litigation in a Florida federal court.

This May 14, 2001, email from Debbie Holdsworth to Seroquel Product Managers states:

Seroquel has a neutral effect on weight during long-term treatment.
Seroquel is not associated with diabetes nor its exacerbation.
However, as BNET noted in March, AZ staff were discussing in 1997 how to handle data that showed it increased patients’ weight:

Aug. 13, 1997, memo from Lisa Arvanitis to her colleagues:
1. Is there a competitive advantage for SEROQUEL re-weight gain which we can articulate in posters/talks/vis aids? We know we have weight gain but is it limited to the short term …? … I was really struck by how consistent the data was.

By 2001, AZ had constructed this brochure, titled, “Distinct advantages of a favorable weight profile.” It is confusing to say the least. It starts by saying:

- Minimal weight gain may reduce the likelihood that treatment with Seroquel will lead to diabetes and other morbidities associated with weight gain.

Read that sentence carefully. It’s meaningless. The brochure then concludes:

As with other antipsychotic agencts, SEROQUEL has been associated with weight gain. However, in a placebo-controlled clinical trial, weight gain ranged from 0.9kg to 2.6kg.

(Translation for Americans: 0.9kg is about 2 pounds, and 2.6kg is nearly 6 pounds.)

Former executive director/development John Patterson had this explanation when confronted with the documents in court that showed 45 percent of patients gained significant weight, per Bloomberg:

If you look at the population as a whole, some are below weight, some are average weight and some are above weight, so that taken together, the effect of Seroquel is weight neutral.

Put another way, Patterson seems to believe that if you gain 5 pounds in weight but I lose 15 pounds, then we have – “taken together” – both lost 10 pounds.

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963