AstraZeneca will discipline more of its US sales team if allegations of illegal marketing tactics are proven to be true, the drug company's chief executive promised. David Brennan's comments came as more confidential training tapes surfaced on the internet, showing how sales reps for the company's cancer drugs are encouraged to talk down rival products.
AstraZeneca has begun an internal investigation into whether the tapes contravene a ban on comparing rival drugs that haven't been tested against each other in a proper scientific study. The company's critics, meanwhile, have passed the allegations to the US department of health and human services, which is monitoring AstraZeneca's sales tactics following earlier ethical lapses.
The new allegations come a fortnight after the company sacked a US marketing manager for comparing the doctor's surgery to "a big bucket of money" and told his salesforce to go and "grab a handful".
In 2003, the company admitted a string of illegal marketing practices, paid $355m (£178m) in fines and compensation to the US government, and promised to abide by a tough five-year "corporate integrity agreement" which promised that there would be no further ethical lapses by its US salesforce. If any of the new allegations are proven and deemed to be a breach of the agreement, the company might be fined again, or even banned from selling drugs to the US government.
The story has been unfolding in slow motion through a number of industry websites and by the efforts of several bloggers, chief among them Peter Rost, a former Pfizer sales executive who has become a thorn in the side of the pharmaceutical industry. Dr Rost has testified to Congress about the dubious marketing practices of the industry, and written the book The Whistleblower: Confessions of a Healthcare Hitman.
Dr Rost has been handed - and published - confidential training tapes used by AstraZeneca sales reps who are trying to encourage doctors to use the company's breast cancer drug Arimidex in preference to a rival product made by Novartis, called Femara. The tapes show reps how to raise doubts over the results of trials of Femara, and then switch back to discussing Arimidex's own positive trial data. Dr Rost said he believed the tapes prove that AstraZeneca is operating illegally. "The only way to make a balanced comparison between two products is to have a well-designed, double-blind, randomised trial with the two drugs in the same trial. But that doesn't seem to bother AstraZeneca; a company for which the lack of comparative trials is a mere nuisance, easily corrected with slick selling.
"AstraZeneca sales, marketing and training have a co-ordinated campaign to sell against Letrozole without any comparative data. Both training examples show exactly how oncology reps can get the doctor to start talking about Letrozole and then compare it to Arimidex without a head-to-head study, and minimise the efficacy of Letrozole by slamming their trial."
An AstraZeneca spokesman said all its marketing presentations aimed to present a "fair and balanced" picture of their drugs.
And David Brennan cautioned against pre-empting investigations into the affair, particularly since the source of the allegations was anonymous website tip-offs. He said that misbehaviour within parts of a drug company's sales organisation was rare and "relatively unpredictable", and the important question was how a company dealt with it.
"There was an issue and we took action; if there is another issue, we will take more action. We have in place a very thorough and well-understood compliance programme in the US and across the entire business, with codes of conduct and operating principles and annual training, and I take all that very seriously.
"As for any particular situation at any particular point of time, I would say that the management responded by doing what they thought they ought to do."
Mike Ward, pharmaceuticals industry analyst at Nomura Code, said that investors should keep an eye on the unfolding allegations. "These things usually result in just a slap on the wrist, but, if Novartis wanted to make a song and dance about it, then AstraZeneca could find itself in trouble."
Source: The Belfast Telegraph
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