Seroquel Struggle Reaches Congress

Controversy over Seroquel has reached a new peak with both the FDA and the U.S. Congress weighing in on the drug. Seroquel has proven to be wildly popular. In the ten years it's been on the market, manufacturer AstraZeneca estimates that 16 million people have tried it.

Bloomberg.com estimates that global sales of Seroquel increased 24% to a staggering $3.4 billion in 2006. However, its popularity has been accompanied by controversy.

(Seroquel is a second-generation anti-psychotic medication used to treat schizophrenia and manic episodes associated with bipolar disorder.)

In April 2005, the U.S. Food and Drug Administration (FDA) issued a public health advisory about the dangers the drug posed to elderly patients. The FDA's advisory cited 17 studies that compared the use of various second-generation anti-psychotic drugs versus placebos among seniors with dementia. It was determined that taking Seroquel or similar medications increased mortality 1.6-1.7 fold among elderly patients.

On November 16, 2006, the FDA sent a letter to AstraZeneca executives that criticized the marketing of Seroquel. Promotional material about the drug was determined to be "false or misleading because it minimized the risk of hyperglycemia and diabetes mellitus" wrote the FDA.

Critics have long claimed that Seroquel users are prone to diabetes. Studies have indicated that patients who take the drug are 3.34 times more likely to develop diabetes than patients on older anti-psychotic medications. Diabetes mellitus can result in impaired vision and limb amputation.

According to the FDA, AstraZeneca played down such concerns. Company promotional material, for example, stated that, "post-marketing reports of diabetes or diabetes-related events are very rare (<0.01%) with Seroquel."

The FDA pointed out that the reporting of post-marketing adverse events is voluntary. The 0.01% figure only referred to the number of patients who took the time to report diabetes-type problems to their doctors. Patients who developed problems but didn't report them weren't counted.

The FDA has some powerful allies on its side. On March 1, 2007, U.S. Representative Henry A. Waxman (D-California) fired off a letter to the CEO of AstraZeneca, demanding documentation relating to the FDA complaints. Congressman Waxman is chair of the House Oversight and Government Reform Committee, which keeps a close eye on marketing practices by pharmaceutical firms.

In his letter, Representative Waxman requested any relevant company documents given to AstraZeneca staff and promotional material given to physicians concerning the drug.

AstraZeneca has been challenged on a state level as well. In late February 2007, the state of Pennsylvania filed a lawsuit against AstraZeneca and other pharmaceutical companies. The state wants to recover funds spent through Medicaid to purchase Seroquel and similar drugs. Pennsylvania is also demanding money to cover public hospital expenses of people hurt by such pharmaceuticals. The lawsuit accuses AstraZeneca and other companies of encouraging doctors to push off-label use of anti-psychotic drugs.

The company at the centre of this storm doesn't seem too concerned.

While conceding that, "possible side effects can be a concern with any medication," AstraZeneca literature claims "the potential for bothersome side effects is relatively low for people taking Seroquel."

It's a claim that remains debatable, as the FDA, U.S. Congress and state governments grapple with a hugely popular psychiatric drug.

Seroquel Struggle Reaches Congress

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