Drug Company to Pay Half a Billion Dollar Fine for ILLEGAL Marketing

Posted by Dr. Mercola | May 20 2010 | 11,034 views

Drugmaker AstraZeneca has agreed to pay $520 million to settle federal investigations into marketing practices for its schizophrenia drug Seroquel. This makes AstraZeneca the fourth big drug company in the last three years to admit to federal charges of illegal marketing of antipsychotic drugs.  The company was accused of misleading doctors and patients by spotlighting favorable research while failing to adequately disclose studies showing that Seroquel increases the risk of diabetes.   The New York Times reports that:  “AstraZeneca still faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug’s risks. “

Although this sounds like a lot of money, it’s little more than a symbolic slap on the wrist when you consider how much money they’ve made from the drug already. According to the New York Times, the antipsychotic drug Seroquel pulled in $4.9 BILLION in sales last year!  You see from the company’s perspective it’s merely another cost of doing business.  For every dollar they are fined they are making ten. While not all of their profit was due to their illegal marketing practices, the fine was only a one-time fine, while revenues have poured in over many years and will continue to do so in the future, as a result of these illegal activities.

Puny Fines after Making Massive Illegal Profits Seem to Be the Norm

 

Just last month I discussed the case of Pfizer, the world’s largest pharmaceutical company, that was “punished” with a fine that amounted to three month’s worth of profit for the illegal marketing of the painkiller Bextra.  In 2005, when Bextra was pulled from the market due to its increased risks of heart attack and stroke, about half of its $1.7 billion in profits that year were due to unapproved off-label uses.  There’s no doubt that Seroquel’s blockbuster status and massive sales are in large part due to dangerous off-label uses as well.  Seroquel was approved by the FDA in September 1997 for “the treatment of manifestations of psychotic disorders.”

Three years, later, the FDA actually considered NARROWING its approval to the short term treatment of schizophrenia only. However, by January, 2004, the drug was approved for the short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania), and two years later, they also approved it for bipolar depression.  Schizophrenia and bipolar disorder are serious mental disorders that in many cases may warrant drug treatment, at least short term. However, AstraZeneca also pushed Seroquel for things like anger management, ADHD, Alzheimer’s disease, and even difficulty sleeping!  No federal criminal charges have been filed against the company, but I wonder if that wouldn’t be justified. After all, they’re promoting a potent drug for diseases that they were never formally studied or approved for.Without this important proof of safety and effectiveness, they have put countless human lives at risk for serious side effects, including premature death.

How is this NOT a crime?    But wait, of course no criminal charges will be filed because, just like Wall Street bankers, these companies are “too big to fail”. What a load of horse manure, pardon my language. Nevertheless, that is what happens when your profits are so large you can afford to lobby and payoff the right people in government, to effectively insulate you from any prosecution. Yes these companies are VERY clever.

The Dangerous Side Effects of Seroquel

 

It’s hard to believe that anyone would agree to take such a potent antipsychotic unless they were suffering from a serious mental illness, but the numbers prove that plenty of people do.   This choice can be a devastating one. (And remember, it IS a choice. Your doctor cannot force you to take any drug, and in many cases, people see an ad on TV and voluntarily ask for the drug.)  The potential side effects of taking Seroquel are numerous, and some of them can be fatal.  For example, elderly patients who have lost touch with reality as a result of dementia are at an increased risk of death, which is why Seroquel is not approved for this use.  Seroquel can also increase your risk of suicidal thoughts and actions, especially in children, teens and young adults.   It’s worth noting that the list of serious side effects is far longer – and these reactions are FAR MORE COMMON – than the list of the non-life threatening adverse reactions.  For example, some of the most common side effects of Seroquel include:

·         High triglycerides in 23 percent of patients

·         Weight gain in 23 percent of patients

·         Agitation in 20 percent of patients

·         High cholesterol in 17 percent of patients