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September 10, 2006

Glaxo Promotes Mental Disorders - Then Paxil

By Evelyn Pringle

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After gaining FDA approval for Paxil to treat depression in 1992, GlaxoSmithKline spent the next decade launching creative advertising campaigns aimed at promoting not only Paxil but also a myriad of treatable "disorders."

And as a result, Glaxo was able to convince doctors and consumers alike that the drug was appropriate for treating just about every common anxiety of life. In the end Paxil was approved for the following conditions:

Depression
Panic disorder
Social anxiety disorder (SAD)
Obsessive-compulsive disorder (OCD)
Posttraumatic stress disorder (PTSD)
Generalized anxiety disorder (GAD)

Experts say that since the restrictions on advertising were lifted in 1997, drug makers have been using direct-to-consumer marketing as a tool to get people to believe they are mentally ill. According to Marcia Angell, former editor of the NEJM, and author of the best-selling book, "The Truth About the Drug Companies: How They Deceive Us and What to Do About It:"

"If you can define everyone who has the blues as having depression that needs to be treated, you've created a huge market. If you define everyone who is shy as having social anxiety disorder, that enlarges the market. There's probably not a soul alive who hasn't felt shy. If you listen to the pharmaceutical industry, many of the ordinary discontents of life are medical conditions that require drugs."

Other experts are equally appalled over the tactics used in the mass drugging of society. There is nothing more despicable than a physician who knowingly tells normal patients that they are "sick," "ill," or "diseased," for profit, according to neurologist Dr. Fred Baughman, author of, The ADHD Fraud. "Yet this has become standard practice throughout medicine," he says.

Dr. Baughman recently received an email from Barry Turner, a professor of law in the UK, in response to hearing the news about the new, "Intermittent Explosive Disorder," which Mr. Turner called "another outrageous insult to common sense."

"Anger is an emotion and is expressed in different degrees by different people," he wrote, and concluded the message by asking Dr. Baughman: What is the perfect human supposed to look like?

How much attention is normal?
How much activity can be allowed before it is hyperactivity?
How angry are we allowed to be before we are disordered?
How shy can someone be before they are deranged?
Is it possible to be unhappy without being 'depressed'?

Over the years, Big Pharma has learned that selling diseases and drugs to the public at the same time is much easier with the support of heavy hitters. In 2003, as part of the campaign to promote the Paxil-treatable mental disorders, Glaxo hired football icons Terry Bradshaw and Ricky Williams to encourage Americans to "take action if their lives were being impacted by depression or anxiety."

"To kick off National Mental Health Awareness Month," Glaxo wrote in a May 1, 2003 press release, "the football heroes will share their experiences with depression and anxiety at an event in New York City, the first stop on a multi-city tour sponsored by GlaxoSmithKline as part of their ongoing efforts to empower and encourage depression and anxiety sufferers to seek help and treatment."

Glaxo described Terry Bradshaw, as a former quarterback for the Pittsburgh Steelers, four-time Super Bowl winner, member of the Football Hall of Fame and two-time Emmy winner for Outstanding Sports Personality.

The press release quoted Terry as saying: "My hope is that by sharing my story with others, it will help people understand that they don't have to be embarrassed to ask for help."

"Taking that first step towards a diagnosis and treatment," he stated, "was one of the bravest things I've ever had to do."

Ricky Williams was described as a running back for the Miami Dolphins, leading NFL rusher for the 2002 football season, Most Valuable Player of the 2002 Pro Bowl and 1998 Heisman trophy winner.

Ricky was quoted as saying: "Going public with my battle with social anxiety disorder has not only made me a better friend and father, it has had an impact on people I never even met. I am amazed at the response I get from people across the country who tell me that my story has helped them or a loved one get treated."

"At one point," he said, "I would have not been able to get on a plane or talk to a group of three people."

"Now," Ricky added, "I look forward to traveling across the country to speak to large groups about taking the first step towards a better life."

The press release said that, just two years ago, Ricky had dreaded speaking to his teammates, fans or the media due to his condition. However, since "receiving treatment with therapy and Paxil," Glaxo wrote, "Ricky has been able to socialize without anxiety and use his recognition in the public as a football player to help others who may be suffering like he did."

And if Glaxo is to be believed, SAD was an epidemic in the US in 2003. "Ricky is just one of more than 10 million Americans to suffer from social anxiety disorder," the press release reported.

SAD was described as a "condition marked by an intense fear of being scrutinized by other people in social or performance situations and of negative evaluation," and the third most common psychiatric disorder in the US after depression and alcoholism.

The press release even included a link to a web site for readers who wanted to download a list of Terry and Ricky's tips or learn more about their stories. By clicking on the link, people could also learn about National Anxiety Disorders Screening Day and obtain a list of screening sites all across the country.

However, a little over a year after praising Paxil as a cure-all, in July 2004, Ricky did an about face. He announced his early retirement from football, and at the same time relinquished any hope of winning the Paxil "celebrity spokesman" of the year award when he declared during an interview with Dan Le Batard, a reporter for the Miami Herald and ESPN The Magazine, that he had found "marijuana to be 10 times more helpful than Paxil."

It should be noted that the link to the web site no longer provides access to tips or stories about Ricky Williams.

However, at first glance, Paxil seemed to be back on top of its game the following year, when the announcement came that Glaxo had won an award for its achievements in promoting Paxil in 2004, from the Prescription Access Litigation Project.

PAL hosts an annual event known as the "Bitter Pill Awards: Exposing Drug
Industry Manipulation of Consumers," to call attention to the harm caused by runaway drug advertising. For the year 2004, PAL presented "The Cure for the Human Condition Award: For Hawking Pills to Treat the Trials of Everyday Life," to Glaxo stating:

"This past year, the recipient of our award, GlaxoSmithKline, was repeatedly taken to task for practices related to its antidepressant, Paxil. In June, the FDA issued a warning letter to GlaxoSmithKline for its "Hello, My Name is." television ad campaign for Paxil.

"The FDA said that this ad wrongfully "suggests that anyone experiencing anxiety, fear, or self-consciousness in social or work situations is an appropriate candidate for Paxil CR" when these are simply not approved uses of the drug. Despite the warning letter, the harm had already been done as millions of consumers had already seen the ad.

"Marketing campaigns that encourage people to take strong medications like antidepressants for the normal "anxiety, fear or self-consciousness" that we all feel on occasion are deeply irresponsible and show the harms that Direct to Consumer Advertising can cause."

PAL noted that in 2004, Paxil had more than $870 million in sales and Glaxo had the 2nd highest drug company sales of $18.8 billion.

Over the past several years, a steady stream of studies have shown Paxil is associated with serious health problems in infants born to women taking the drug during pregnancy.

In September 2005, the results of studies conducted by Danish and US researcher determined that the use of SSRIs in the first three months of pregnancy was linked to a 40% increased risk of birth defects such as cleft palate and a 60% more likely risk of cardiac defects.

On December 8, 2005, the FDA issued a public safety alert after the results of Paxil studies suggested that the drug increases the risk if heart defects, when women take it during the first three months of pregnancy.

Research published in the February 9, 2006 New England Journal of Medicine found that mothers who took SSRIs, in the second half of their pregnancies were 6 times more likely to give birth to infants with a lung disorder called persistent pulmonary hypertension (PPHN).

The condition occurs when a newborn's circulation system does not adapt to breathing outside the womb and causes high pressure in the blood vessels of the lungs making them unable to get enough oxygen into their bloodstream and can be fatal. Researchers estimate that between 10% and 20% of infants with PPHN will end up dying even after receiving treatment.

Critics say the news about dangerous drugs such as Paxil never reaches consumers because Big Pharma doles out billions of dollars to the media each year and if a negative study is about to come out, a company can just buy a few million bucks worth of ads from each major media outlet to ensure that the story gets minimal coverage, with the unspoken understanding that the ads will be canceled if the story gets too much exposure.

Families seeking justice for infants born with Paxil related birth defects can contact the Baum Hedlund Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/

Evelyn Pringle
evelyn.pringle@sbcglobal.net

Written as part of the Paxil Litigation Monthly Round-Up, Sponsored by Baum Hedlund's Pharmaceutical Antidepressant Litigation Department, www.a-paxil-lawyer-source.com/, www.antidepressantadversereactions.com/, www.paxilbirthdefect.com

Authors Bio:
Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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