Friday, October 09, 2009

More on the Misleading Promotion of Seroquel

Previous posts (here and here) noted internal documents from AstraZeneca made public during litigation about its blockbuster atypical antipsychotic drug Seroquel (quetiapine) suggesting that the company's marketers manipulated clinical research results to make them appear more favorable to the product, and suppress studies with unfavorable results that could not be easily manipulated.

This week, Bloomberg News reported testimony from one trial about other aspects of Seroquel's marketing. The marketers' claims were at odds with the company's own research results:

AstraZeneca Plc advised its sales force to promote the antipsychotic drug Seroquel as 'weight neutral' four years after company research found 'clinically significant' weight gains in users, internal documents show.

AstraZeneca’s 'global strategy is to demonstrate to consumers that Seroquel has a weight-neutral profile,' Debbie Holdsworth, a marketing official, wrote in a 'dear colleague' letter dated May 14, 2001. The document was produced during a pretrial examination of former executive John Patterson.

'If 45 percent of patients gained significant weight in a year, how could that be weight-neutral?' patient attorney Ed Blizzard asked Patterson, citing a internal 1997 e-mail written by an AstraZeneca doctor, at a hearing in Orlando Oct. 5.
Also, evidence was presented that suggested that company marketers consciously promoted the drug for off-label indications over several years:

Patterson was asked about a 'Seroquel Strategy Summary' issued in December 2000, which described the broadening of Seroquel use 'on and off label' as a sales goal. While doctors are free to prescribe any medicine to treat a given condition, it is illegal for drug companies to promote medicines for uses not approved by the U.S. Food and Drug Administration.

'The company has standards and procedures to ensure its sales representatives do not promote off label,' Patterson testified. Still, the goal of off-label promotion remained in strategy summaries for the years 2001 or 2002, he acknowledged.

Coupled with previous revelations (see posts noted above), it looks like the marketers were employing an integrated strategy combining a variety of deceptions, the sort of broad based stealth marketing approach we have seen employed to promote other health care products.

Such strategies undoubtedly have lead to the prescribing of expensive drugs when other treatments, or no treatment would be better, and have helped support the high prices charged for products that are not necessarily so good for the many patients who have ended up getting them. Of course, the money thus generated has let many executives of the companies that employ such marketing strategies become rich. As Bloomberg reported:

Patterson, who reported directly to AstraZeneca’s chief executive officer, was paid more than $1 million at one point during his tenure at the company. He retired April 1 as executive director of product development, and is the highest- ranking AstraZeneca executive to testify in open court in lawsuits claiming the company withheld information about the risks of Seroquel.

In my humble opinion, if we really want to reform health care in the US (and around the globe), we need to challenge how health care organizations have used their ability to sponsor medical research to manipulate its design, implementation, analysis and dissemination, and when necessary, to suppress its results to favor their vested interests. We also need to challenge systematically deceptive marketing practices designed to make products and services appear more useful than they really are, thus supporting exaggerated prices and prompting overuse. Unless we challenge these and some other causes of excess prices and excess use, attempts to provide universal health insurance and access will bankrupt us all.

(And to preempt anyone in the audience who may recoil from anything that restricts the freedom of action of health care corporations - tell me how manipulation of research, suppression of research, and deceptive marketing is necessary for innovation or for adequate revenues to support good products? I am not arguing for hamstrung companies. I am arguing for honest business practices.)

Hat tip to PharmaGossip.


Anonymous said...

One point that was made to me many decades ago in a class taught by a drug wholesaler's sales manager was that even the smallest change in market size translated into extremely large sales and profit potential. Even then, before the PC, we saw incredible statistical and tracking models.

This point was driven home once again in the Sept. 21, 2009 WSJ article Race for Obesity Drugs Heats Up. This article deals with Arena Pharmaceuticals, Vivus Inc. and Orexigen Therapeutics drive for an obesity drug.

Of note:

" Adam Cutler, analyst at Canaccord Adams, believes there should be room for all three because grabbing just 1% of the overall market will translate to more than $1B a year in sales for any one drug."

With such large financial rewards at stake, and operating in a win at any cost marketing environment with no personal downside for being caught, it is no wonder we see questionable behavior. Behavior that is unfortunately sometimes, but not always, discovered after the fact.

Steve Lucas

insider said...

Thanks Roy