Attorneys Allege AstraZeneca Hid Info from Patients

"Oh, please," said Dr. Henry Miller at Stanford University's Hoover Institution in California. Allegations based on selective leaks from plaintiff lawyers?"

Miller has no financial ties to AstraZeneca, but he was an expert consultant to the law firm that defended Merck during litigation over the pain drug Vioxx.

"If the FDA-approved labeling lists all the relevant side effects, what, exactly is the problem?" Miller asked. "What was the company supposed to do -- advertise the known side-effects of the drug in 10, one-minute commercials during the Super Bowl?"

Still other medical professionals had a different reaction.

David Kroll, professor and chairman of the department of pharmaceutical sciences at North Carolina Central University's Biomanufacturing Research Institute and Technology Enterprise, said that given the reports of the case, AstraZeneca's alleged actions would be "unconscionable and unethical" if true.

"This episode is one in a long string of others that have eroded public faith in the pharmaceutical industry and make it difficult for us who try to communicate real-world risks and benefits of drugs," Kroll said.

Dr. John Abramson, clinical instructor at Harvard Medical School in Boston and author of "Overdosed America," believes there should be stiffer penalties for drug companies if they are indeed found to be withholding information.

"As these cases have unfolded, whether it's Vioxx or Neurontin or Bextra, what we've seen is that there have been some sizeable settlements in civil litigation ... as a consequence of alleged fraudulent marketing," Abramson said. "But, to date, these settlements have not been large enough to exceed the costs of not doing business."

Abramson said he is not familiar firsthand with the Seroquel lawsuit, but is serving as a plaintiff's expert witness in other lawsuits involving anti-psychotic drugs.

"One thing that I personally see repeatedly in the litigation work that I do is that safety issues will emerge and there will be a delay in bringing those safety issues forth," he said.

Abramson said the important issue at play is what the company does during this period of delay. He said problems arise when the manufacturer continues to advertise the drug in question in a positive light, even as they are in possession of information that suggests the potential harms of its product.

"The longer this information is delayed and in its place positive information is being supplied, the bigger a hole is dug in terms of coming to an accurate understanding of the risk-benefit ratio of the drug."

Attorneys suing AstraZeneca also revealed another e-mail to the Seroquel global brand team from Hagger Wednesday that compares AstraZeneca's strategies with those at other drug companies. He wrote AstraZeneca needs to make sure publications are "more creative spinning the data, aka Lilly."

The document notes that drug giant Eli Lilly is able to spin the data in many ways and that "negative data usually remains well hidden."

Indianapolis-based Eli Lilly defended itself today against that charge.

"While we have no comment on the memo itself, we will say that at Lilly, we have long maintained a policy of open, transparent disclosure of clinical trial results, regardless of outcome," Eli Lilly spokeswoman Marni Lemons said in a statement today.

Off-label use of Seroquel was also the subject of scrutiny, with one AstraZeneca document explicitly stating a goal of "broader Seroquel use on and off label."

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