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On January 26, 2010, a past employee of AstraZeneca told the BBC he was pressured by the firm’s marketers to approve claims that its anti-psychotic Seroquel was not linked with weight gain, despite evidence to the contrary. In the United States, Seroquel has been linked to higher risks of diabetes, other blood sugar disorders, and death. John Blenkinsopp, the company’s former United Kingdom medical manager, told the BBC Radio 4’s File on 4 program that while clinical studies at the time Seroquel’s launch “showed patients developed significant weight gain, significant both statistically and clinically”, the company’s marketing team “came at me with a number of potential claims all of which were trying to intimate that Seroquel was not associated with weight gain”.

According to Blenkinsopp, who was speaking publicly for the first time since leaving AstraZeneca  in 2000, even though data seemed to suggest otherwise the company was “desperate for a differential advantage over one of the competitor products and they didn’t have one”, and so pushed hard for the “neutral weight gain” claim. “In the end I was put under quite a significant amount of pressure by the marketeers to sign off claims with regards to the lack of weight gain and I was unwilling to sign that off,” he told the program, and added that the marketers “made it clear it could be career limiting for me”, reports BBC News Online.

Seroquel was launched in back in 1997 for the treatment of schizophrenia and subsequently had its license extended to include the indication bipolar disorder, and has since become the drug maker’s second-biggest earner generating sales of around $4.45 billion a year.

Across the pond, the drug’s marketing strategy was reportedly heavily centered on the promise of neutral weight effects, and Blenkinsopp’s claims echo accusations made in thousands of current lawsuits against the company in the United States, which allege that AstraZeneca withheld information and failed to adequately warn patients of side effects such as significant weight gain and an increased risk of diabetes.

The accusations have raised fresh talk of a more independent process for evaluating medicines, with Dr Fiona Godlee, editor of the British Medical Journal, telling the BBC that it is time for a “major overhaul” of the approvals process and independent clinical assessments for all new drugs.

A November 12, 2009 Bloomberg.com story discusses how the use of widely prescribed antipsychotic drugs to combat dementia, actually cause more harm than good. British patients with dementia too often get dangerous antipsychotic drugs, causing as many as 1,800 deaths and 1,620 strokes a year, a report commissioned by the U.K. Department of Health uncovered.

The government announced a plan to curb overuse of the medicines, including Eli Lilly & Co.’s Zyprexa, Johnson & Johnson’s Risperdal, Bristol-Myers Squibb Co.’s Abilify, AstraZeneca Plc’s Seroquel and Pfizer Inc.’s Geodon. The drugs, designed to treat schizophrenia, are often inappropriately used a first-line therapy to quell behavioral problems in people with dementia, according to the report by Sube Banerjee, professor of mental health at King’s College London Institute of Psychiatry.

An estimated 180,000 elderly people with dementia in England are given the antipsychotic drugs each year, and just 20% improve because of the treatment, Banerjee said at a press conference in London. As many as two-thirds of the patients don’t derive any benefit from the pills, which boost the risk of early death and carry a range of side effects including sedation, stiff muscles, and trouble thinking and speaking clearly, the report found.

“We need to be sure that only the people who benefit from these drugs get them, and they get them at the lowest possible dose for the shortest period of time,” Banerjee said. “It is clear that these medications are being prescribed to deal with behavior and psychological symptoms in dementia rather than just for psychosis,” he wrote in the report.

Behavioral Therapies

All of the medications, including older, generic drugs such as Haldol and Thorazine, have the same effect, Banerjee said. As a result, doctors can’t switch patients from one medication to another to solve the problem.

Instead, they need to focus on basic techniques, such as trying to determine the cause of a patient’s agitation, and behavioral therapies to improve the situation, he said. In some cases, simple problems such as lack of sleep or hunger can be the culprit, he said.

“It is unacceptable that antipsychotic drugs are routinely prescribed to people with dementia,” said Health Minister Phil Hope. “I know we’re not going to reduce the use of these drugs overnight, but it can be done.”

The government accepted the recommendations from Banerjee and plans to hire a national clinical director for dementia to oversee efforts to improve care and reduce unnecessary drug use, Hope said at the press conference.

‘Chemical Restraints’

“The use of these chemical restraints really should be a last resort,” said Neil Hunt, chief executive officer of the Alzheimer’s Society. “We’ve got a culture and an ingrained pattern of care to shift here.”

In 2005, the FDA required makers of antipsychotics to include in dosage instructions a prominent warning surrounded by a black box about the increased risk of premature death in elderly patients with dementia. An English study released two years later found patients getting the drugs die six months earlier than those who don’t receive them.

On October 29, 2009, pharmaceutical giant AstraZeneca revealed that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel. One of the investigations related to “selected physicians who participated in clinical trials involving Seroquel,” AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the FDA. Doctors are permitted to prescribe any approved drug for off-label uses.

Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.

Tony Jewell, a company spokesman, declined to be more specific about the physicians or clinical trials under investigation. He said the company was in final negotiations to settle the whistle-blower suits and reach a corporate integrity agreement with the Justice Department.

The name of the whistle-blowers and other details of the suits remained sealed in federal court.AstraZeneca, based in Britain, joins a list of drug makers that have paid billions to settle inquiries initiated by complaints from former company insiders.

Earlier this year, Eli Lilly & Company paid $1.4 billion over its marketing of Zyprexa, another antipsychotic drug. And Pfizer announced it would pay $2.3 billion, including a record $1.195 billion criminal fine, mostly over its painkiller Bextra, which has been withdrawn from the market.

AstraZeneca disclosed the settlement in a financial report. Third-quarter revenue rose 10 percent, to $8.2 billion, and operating profit rose 29 percent, to $3.6 billion, at constant exchange rates over the year-earlier quarter.

AstraZeneca also said it had been served with 14,444 civil lawsuits over the drug as of October 9, 2009.