Healthy Skepticism Library item: 16519

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Publication type: news

Feeley J, Cronin Fisk M
AstraZeneca Denied Drug’s Diabetes Link Years After Warning
Bloomberg News 2009 Sep 23
http://www.bloomberg.com/apps/news?pid=20601103&sid=aHirLmd7UiF4

Full text:

Sept. 23 (Bloomberg) — An AstraZeneca Plc saleswoman told a U.S. doctor the antipsychotic Seroquel didn’t cause diabetes almost four years after the company warned Japanese physicians about the drug’s links to the disease, internal documents show.

Nancy White, the saleswoman, and a colleague met with an unidentified doctor in July 2006 who reported “getting a lot of flak” from patients about Seroquel’s diabetes links, according to a note unsealed as part of a lawsuit. AstraZeneca wrote in November 2002 to Japanese doctors that it received a dozen reports of diabetes-related cases tied to Seroquel “where causality with the drug could not be ruled out.”

White said in the 2006 note that she told the physician that “there has been no causative effect” found between Seroquel and diabetes. The doctor “said he would not quit writing” prescriptions for Seroquel “due to this at this time,” White reported.

More than 15,000 patients have sued London-based AstraZeneca, claiming the company withheld information about links between diabetes and Seroquel. Many of the suits also claim AstraZeneca promoted Seroquel, approved by the U.S. Food and Drug Administration for schizophrenia and bipolar disorder, for unapproved uses.

Seroquel, which generated sales of $4.45 billion in 2008, is the company’s second-biggest seller after the ulcer treatment Nexium.

‘Unproven Claims’

“The heart of these cases are unproven claims that Seroquel caused diabetes,” Tony Jewell, an AstraZeneca spokesman in Wilmington, Delaware, said in an e-mailed statement. “The evidence does not back up the allegations that Seroquel was responsible for the plaintiffs’ alleged injuries.”

A federal judge in Orlando, Florida, ordered AstraZeneca to unseal the sales-call notes by Sept. 11 after Bloomberg News filed a motion to gain access to company files turned over in Seroquel litigation. The judge allowed AstraZeneca to withhold physicians’ names on privacy grounds.

All federal-court cases over Seroquel, a so-called atypical or second-generation anti-psychotic medicine, have been consolidated in Orlando for pre-trial proceedings.

In his e-mail, Jewell said AstraZeneca “has always provided adequate warnings” about Seroquel’s health risks and has complied with varying regulatory standards around the world in connection with the drug.

‘Adequate Warnings’

“When Seroquel was first approved in 1997, U.S. labeling alerted physicians” that diabetes and weight gain had been observed in some clinical trials, said Jewell, who is based in the company’s U.S. headquarters in Wilmington, Delaware.

Lawyers for ex-Seroquel users say evidence shows the company downplayed the ties between Seroquel-related weight gain and diabetes to protect sales.

In the 2002 letter, AstraZeneca officials warned Japanese doctors not to prescribe the drug for diabetic patients and to push users to monitor their blood-sugar levels. Jewell acknowledged earlier this year AstraZeneca didn’t start warning U.S. doctors to monitor blood-glucose levels until January 2004.

“It’s pretty clear that if a drug poses a diabetes risk in one country, it poses that risk in others,” Dan Carlat, a psychiatrist at Tufts University in Boston who writes a blog about the health-care industry, said in an interview. “I don’t think it’s ethical to warn doctors in Japan about this drug and then downplay or ignore the risk in the U.S.”

Weight Gain

In another note recently unsealed by the company, salesman Eric Payne alerted his supervisors in January 2005 that he had “discussed weight gain associated with atypicals” with another unidentified doctor.

Payne assured the physician there was a low incidence of Seroquel users gaining weight and encouraged the doctor to make the drug his “first line choice,” according to a copy of the note.

Documents unsealed earlier in the Seroquel litigation show AstraZeneca trained its sales force to deflect questions about links between weight gain and the drug.

In a 2005 voice-mail, for example, AstraZeneca manager Christine Ney offered the company’s U.S. salespeople information they could use to “neutralize customer objections to Seroquel’s weight and diabetes profile.”

Eric Garneff, an AstraZeneca salesman, told his bosses in a newly unsealed October 2005 note that he sought to “neutralize any questions associated with” Seroquel and weight.

Paid to Speak

To help market their drugs, companies often pay doctors to speak about their medicines at conferences or other physician gatherings, said Barton Moffatt, a Mississippi State University bioethicist who has written about pharmaceutical industry marketing.

“They are looking for doctors who like the drugs to be good advocates for the products,” Moffatt said in an interview.

AstraZeneca officials offered as much as $1,500 to doctors to speak about Seroquel’s benefits, according to the unsealed sales notes.

“Definitely wants to speak for us,” White, the AstraZeneca saleswoman, told her bosses in a November 2005 note about an unidentified doctor. “Honorarium ranges from $750 to $1,500.”

The company also arranged to have the talks over dinner at upscale restaurants, such as Morton’s Steakhouse or the Capital Grille, the notes show.

The Morton’s chain, opened in downtown Chicago by Arnie Morton and Klaus Fritsch in 1978, operates more than 70 U.S. restaurants, according to the company’s Web site. A three-course dinner for two goes for $99 at the chain’s Houston location.

Darden Restaurant Inc.’s Capital Grille chain features African mahogany paneling and art deco chandeliers at its more than 30 locations, according to its Web site.

‘Top-Flight’ Dinners

“We were always told to do these kinds of dinners in a top-flight manner,” Mike Oldani, a medical anthropologist at the University of Wisconsin-Whitewater and a former Pfizer Inc. sales representative, said in an interview. “We’d often see our script numbers rise after one of these things.”

AstraZeneca also used preceptorships, arrangements in which a drug company pays doctors in return for allowing sales reps to shadow them on patient rounds, and financial grants to help market Seroquel, the notes indicate.

Salesman Rafael Olartecoechea wrote in January 2004 he’d “set up dinner with games and preceptorship” at a psychiatric unit “which has very limited access,” according a copy of the note.

Olartecoechea’s colleague, Deborah Grissett, wrote in July 2004 that an unidentified doctor in Florida was “very excited about the possibility for ‘Ambassador’ grant,” a copy of the note shows.

AstraZeneca’s internal policies forbid payments to doctors “as an inducement” to write more prescriptions for the company’s products, Jewell said in his e-mail.

Physician Perks

As AstraZeneca paid doctors for speaking engagements and picked up dinner tabs, physicians pushed for more such perks and complained if they weren’t forthcoming, the notes show.

One doctor, who was speaking about Seroquel at such programs, was “upset’ at AstraZeneca for “trying to get him to do it for $750,” White wrote in a Sept. 22, 2005, note.

Another doctor was “still angry that he is not a speaker,” Olartecoechea wrote in an April 2005 note. “Says he had all his nursing home patients on Seroquel.”

AstraZeneca salespeople were so focused on raising Seroquel’s prescription numbers in 2005 that they approached physicians outside their offices, the notes show.

Grissett told her bosses in October 2005 she provided “Seroquel reminders” to an unidentified doctor she ran into at a Florida wedding.

The case is In Re Seroquel Products Litigation, 06-MD- 01769, U.S. District Court, Middle District of Florida (Orlando).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.