Tucked in the $520 million settlement agreement between AstraZeneca and the federal government over the drugmaker's alleged improper marketing of its antipsychotic drug Seroquel was the charge that the company paid doctors to study the drug, speak about it, and lend their names to ghostwritten articles.
Those allegations of improper payments to doctors came as researchers from Yale University and Harvard University examined the impact of physicians and researchers financial ties to drugmakers and other companies.
The Yale and Harvard researchers examined 20 major studies on the issue of conflicts of interest in medicine and medical research and found that "patients believe that financial ties influence professional behavior and should be disclosed."
Moreover, the study, published in the current issue of the Archives of Internal Medicine, found that such payments to researchers in medical studies "decrease the quality of research."
The U.S. Attorney's Office for the Eastern District of Pennsylvania in Philadelphia alleged that AstraZeneca made payments to doctors that were intended to get others clinicians to prescribe the drug for uses not approved by the FDA.
"The United States contends that these payments were intended to induce the doctors to promote and/or prescribe Seroquel for unapproved uses in violation of the federal Anti-Kickback Statute," the suit stated. In the settlement, AstraZeneca denied wrongdoing and stated that it entered the agreement "to avoid the delay, uncertainty, inconvenience, and expense of protracted litigation."
The government said the company illegally paid doctors to put their names on studies they did not conduct or write that promoted Seroquel for unapproved uses such as to treat Alzheimer's disease, depression, attention deficit hyperactivity disorder, as well as for anger management and more. Those ghostwritten articles and studies were then used by AstraZeneca to promote the so-called "off label" use of the drug that is also known by its chemical name - quetiapine.
The government alleged that the company's marketing campaign included paying doctors to give speeches about such off-label uses to other clinicians - such as pediatricians and doctors who worked in nursing homes - who would not ordinarily use a drug approved by the FDA for short-term use to treat schizophrenia and bipolar disorder.
In addition to the civil penalty, AstraZeneca entered into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. That agreement requires AstraZeneca to post on its website information about payments it makes to doctors, including money for speeches, other honoraria, travel, and lodging expenses.
"As a result . the names of physicians receiving payments will be disclosed - all leading to better protection for patients," said HHS Inspector General Daniel R. Levinson in a statement.
Click here for the settlement, corporate integrity agreement, and the press release from the U.S. Attorney's Office for the Eastern District of Pennsylvania.
AstraZeneca also faces thousands of personal injury lawsuits from people who took the drug alleging that they were harmed by it. In March, the company won a defense verdict from a New Jersey jury in the first Seroquel case to go to trial.
Tuesday, investors suing Merck & Co. over its handling of the pain medication Vioxx got a boost Tuesday from the U.S. Supreme Court. In a case that hinged on when a two-year statute-of-limitations clock started ticking, the court backed lawyers suing Merck & Co. Inc. in a class-action securities-fraud lawsuit.