GlaxoSmithKline plead guilty to criminal charges relating to the illegal marketing of several drugs and was required to pay $3 billion, the largest fine ever paid by a pharmaceutical company. Specifically, GSK unlawfully marketed the antidepressants Paxil and Wellbutrin for unapproved uses in children and for weight loss/sexual dysfunction, respectively, and failed to disclose safety information for the diabetes drug Avandia. However, critics argue that fines do not deter criminal behavior in large corporations and that wrongful marketing can have serious health consequences given the potent nature of prescription drugs.

1. GlaxoSmithKline: GUILTY in Largest Health Fraud
Settlement in US History
By Dr. Mercola
One of the biggest news stories relating to health right now is the finalization of the biggest
lawsuit yet by the American government against a pharmaceutical company.
On July 2, the British drug maker GlaxoSmithKline plead guilty to three counts of criminal
misdemeanor and other civil liabilities relating to the prescription drugs Paxil, Wellbutrin and
Avandia, and agreed to pay a total of $3 billion in fines–$1 billion to settle criminal charges, and
$2 billion to cover civil liabilities.
The payment is the largest fraud settlement in U.S. history, and the largest fine ever paid by a
drug company.
In 2009, Pfizer paid $2.3 billion to settle similar charges1, and as recently as May, Abbott
Laboratories settled charges over wrongful marketing of the anti-seizure drug Depakote to the
tune of $1.6 billion2. The company had illegally promoted the drug to health care providers for
off-label use in seniors with dementia.
And, according to a July 6 report in the Huffington Post3, a federal investigation into wrongful
marketing by Johnson & Johnson of its antipsychotic drug Risperdal is also wrapping up and
may result in a fine of anywhere between $1.6 to 2 billion.
According to FiercePharma’s recent compilation of the Top 11 marketing settlements by the
drug industry over the past 10 years4, drug makers have agreed to pay more than $11 billion in
fines for their illegal marketing shenanigans over the past decade! But the worst may still lie
ahead: more than 900 whistleblower lawsuits were filed in the last year alone and historically
about 10 percent of whistleblower claims involve drugmakers…
While these fines sound like staggering amounts of money to most people, a fundamental
problem has now become blatantly and painfully apparent, and that is that fines don’t work.
They simply do not curtail criminal behavior when applied to faceless corporations. They’ve
become little more than an expected annoyance that are calculated into the price of doing
business.
Meanwhile, average people are paying for the criminal behavior of these “corporate
personhoods” with their very lives.
Keep in mind that while “wrongful marketing” may not sound like a big deal, we’re not talking
about a toy that you can’t play with in the manner advertised. We’re talking about extremely
potent chemicals that alter brain and biological chemistry. When you consider how shoddy and
fraught with conflicts of interest the approval process is to begin with—as poorly tested drugs are
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2. approved with increasing frequency and must later be withdrawn—it should be frighteningly
obvious how dangerous it can be to market drugs for unapproved uses.
GlaxoSmithKline Guilty of Illegal Marketing and Withholding Hazard Info
When GSK began targeting children, Paxil became a top 10 selling drug with annual sales in
excess of $1.8 billion in 2001 and 2002 alone. This is particularly grievous as, according to the
Justice Department’s complaint5, several clinical studies on Paxil involving children and
adolescents, performed in the mid- to late-90?s, had ALL FAILED to demonstrate efficacy on
this age group! Every single one of them!
According to the US Justice Department6, GlaxoSmithKline:
Unlawfully marketed the antidepressant Paxil to children and adolescents.
The drug is FDA approved for the treatment of depression in adults only.The complaint details
how GSK manipulated the findings of one of these studies to reach the false conclusion that
Paxil was effective against depression in adolescents. A GSK employee also recommended
revising a section of the study relating to side effects, removing the finding that serious side
effects like worsening depression and hostility (suffered by 11 children in the study) were
considered related to the treatment, and replacing it with a statement that headache (suffered
by one participant) was the only side effect considered to be treatment-related.
The complaint calls the study, published in July 2001 in The Journal of American Academy of
Child and Adolescent Psychiatry, “false and misleading.” This fraudulent and misleading study
was subsequently used by GSK to illegally promote Paxil for children and teens…
Unlawfully marketed the antidepressant Wellbutrin for weight loss and sexual dysfunction.
In a recent NPR radio interview7, Carmen Ortiz, U.S. Attorney for the District of Massachusetts,
stated that “GSK hired a public relations firm to create a buzz about getting skinny and how you
could have more sex simply by using this drug…using every imaginable form of high-priced
entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking
tours, to a European pheasant hunt, to tickets for Madonna concerts.”
From 2001 through September 2007, failed to report safety data relating to clinical experience
and other information as required by law to the FDA for the diabetes drug Avandia.
As previously reported, Avandia has been found to be profoundly dangerous—a fact hid by GSK
for over 10 years, as they knew it would adversely affect sales8. This was revealed in a Senate
Finance Committee report, released by Max Baucus and Charles E. Grassley in February 2010.
The report also asked why the FDA allowed a clinical trial of Avandia to continue even after the
agency estimated the drug had caused an estimated 83,000 heart attacks between 1999 and
20079.
Avandia hit the market in 1999 and quickly became a blockbuster drug. By 2006 its annual
revenue was $3.2 billion. A year later, a damning study published in the New England Journal of
Medicine (NEJM) linked it to a 43 percent increased risk of heart attack and a 64 percent higher
risk of cardiovascular death than patients treated with other methods10.
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3. This is a steep price, to say the least, for a disease that does not require drugs to begin with,
and Avandia has become a poster child for the lethal paradigm of faux science.
Why Isn’t Someone Going to Jail??
According to the July 2 press release issued by GSK11, the criminal and civil liabilities resolved
by this final agreement also include inappropriate marketing of six other drugs, and “possible
inappropriate use of the nominal price exception under the Medicaid Rebate Program.”
One aspect that truly worries me is that while the criminal cases we’ve seen in the past several
years are related to drugs, many of these companies, including GSK, also produce VACCINES.
And guess what?
They’re typically not liable for damages from, or harm done by, contaminated or otherwise
dangerous vaccines! We’ve recently seen evidence of “mistakes” in vaccine manufacturing as
well, but vaccine makers are rarely if ever punished for these willful errors and omissions, which
should provide you some further food for thought.
Celebrity Doctors Paid to Illegally Promote Dangerous Drugs
A few days after the US Justice Department reached its agreement with GSK, it was revealed
that TV and radio personality Dr. Drew Pinsky (aka “Dr. Drew,” of sex-advice-giving fame)
allegedly accepted $275,000 to carry out the illegal promotion of GSK’s antidepressant
Wellbutrin. Dr. Pinsky is said to have highlighted the drug’s libido-enhancing side effects on a
number of occasions in 199912, 13.
While Dr. Drew is the one in the news right now, he’s not the only TV and radio doctor who’s
accepted money from drug companies to push their products to an unsuspecting public. For
example, Dr. Marie Savard14, who has appeared on dozens of TV shows such as Good
Morning America, ABC News, and Oprah, is paid by Merck to pitch their HPV vaccine.
According to a July 3 report in the Wall Street Journal15:
“In June 1999, popular radio personality Dr. Drew Pinsky used the airwaves to extol the virtues
of GlaxoSmithKline’s antidepressant Wellbutrin, telling listeners he prescribes it and other
medications to depressed patients because it “may enhance or at least not suppress sexual
arousal” as much as other antidepressants do.
But one thing listeners didn’t know was that, two months before the program aired, Dr.
Pinsky—who gained fame as “Dr. Drew” during years co-hosting a popular radio sex-advice
show “Loveline”—received the second of two payments from Glaxo totaling $275,000 for
“services for Wellbutrin.”
… Doctors are allowed to prescribe drugs as they see fit, but it is illegal for companies to
promote drugs for uses not approved by the FDA, a practice known as “off-label” marketing.
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4. Wellbutrin’s prescribing label doesn’t state that the drug is less inhibiting of sexual libido than
other antidepressants. In an email Tuesday, Glaxo declined to answer questions about its
financial relationship with Dr. Pinsky or other physicians. The company said: “The complaint to
which you refer concerns events in 1999, 13 years ago. It does not reflect what would be
allowed in GSK today.”
I for one do not buy into any of this drivel about how things have changed… If anything, the
evidence tells us that illegal and unethical behavior of corporations like GSK has WORSENED
and solidified into standard modus operandi over the past decade. Case in point: According to a
2010 report by the Public Citizen’s Health Research Group, titled “Rapidly Increasing Criminal
and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010?16:
“Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73
percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in
just the past five years (2006-2010). Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and
Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial
penalties imposed over the past two decades. These leading violators were among the world’s
largest pharmaceutical companies.”
As I’ve reported before, pharmaceutical companies accounted for nearly 20 percent of the top
100 Corporate Criminals in the 1990?s, and there’s NO evidence to indicate that these
shenanigans are in fact on the decline…
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