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"Yet, in a recent deposition in which I was testifying against gsk in a Paxil suicide case, company lawyers continued to spin their way out of admitting what the company itself had declared in the letter. Meanwhile, the FDA continued to lag behind and to this day the most powerful psychiatric and pharmaceutical interest groups continue to reject the reality of antidepressant-induced violence and suicide." - Peter Breggin, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (Get the book.) "In addition, gsk had already sent out its "Dear Healthcare Professional" letter confirming that Paxil caused increased suicide attempts in all ages of depressed patients. Beyond that, the FDA's own analysis of the data by staffers Marc Stone, MD, and M. Lisa Jones, MD, in late 2006 confirmed that Paxil caused increased suicidality in adults of all ages and in all diagnostic categories. The FDA ignored all of this when it decided to limit the warning to increased suicidality in children and young adults taking the newer antidepressants like Paxil." - Peter Breggin, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (Get the book.) "As the medical expert in Reynaldo's case, I was empowered by the court to examine hundreds of cartons of sealed drug company files concerning Paxil that were contained in GSK's record room. Attorney Farber and I, with the help of my assistant Ian Goddard, spent three days going through the materials that included FDA correspondence and the company's worldwide clinical trials and adverse drug reports for Paxil. Don Farber was new to this complex business of evaluating product negligence documents and part of my duty was to educate him." - Peter Breggin, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (Get the book.) "My evaluation of GSK's internal secret documents confirmed that the company had hidden the true rate of suicidality by failing to report all suicide attempts on Paxil and by artificially inflating the number of suicides for patients taking placebo. Indeed, when the company received many of its suicide reports, it didn't list them as such. Instead, it listed the suicides under the relatively benign category of "emotional lability" (emotional instability). No one on the face of the earth looks for suicide data under the category of emotional lability." - Peter Breggin, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (Get the book.)

"However, gsk only published and disseminated one of these studies, which showed mixed results on efficacy. The lawsuit alleges that the company suppressed the negative results of the other studies, which failed to demonstrate that Paxil is effective and which suggested a possible increased risk of suicidal thinking and acts. gsk is also alleged to have failed to disclose this information in "Medical Information Letters" that it sent to physicians." - Mike Adams, Natural Health Solutions (Get the book.)

"An internal gsk document from 1998 concluded that, in light of the mixed efficacy outcomes from study 329 and the entirely negative results of study 377, GSK's "target" was "t[o] effectively manage the dissemination of these data in order to minimize any potential negative commercial impact." Clearly, Spitzer had the pharmaceutical giant by the "neurotransmitters," and just two months after Spitzer filed the suit GlaxoSmithKline quietly resolved the matter by agreeing to disclose both positive and negative results about safety and efficacy of its drugs. The company further agreed to pay $2." - Kelly Patricia O'Meara, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill (Get the book.)

"At the end of the paper, Nissen declares receiving research support from no fewer than seven pharmaceutical firms, absent gsk. There has followed a heated debate with innuendos of culpability and suppression of data reminiscent of the brouhaha over stents discussed in chapter 2. Experts have weighed in, generally backpedaling on recommending rosiglitazone (Nathan 2007; Psaty and Furberg 2007). It has also provoked reconvening of the relevant fda Advisory Committee with much chest beating as a result (Rosen 2007). For me, there is little to debate." - Nortin M. Hadler MD, Worried Sick: A Prescription for Health in an Overtreated America (Get the book.)

"Two of the three gsk placebo-controlled studies (377 and 701) failed to show that paroxetine was more effective than placebo or that there was any evidence of efficacy for treating MDD in children and adolescents. • Study 377 found that "[n]o clinically or statistically significant differences were detected between paroxetine and placebo in either of the [two] primary efficacy variables," or on any of the secondary measures. • GSK's studies showed the possibility of a link between paroxetine and an increased risk of suicidal thoughts and acts in adolescents." - Kelly Patricia O'Meara, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill (Get the book.)

"The results: "Not only did gsk double the percentage of physicians who perceived them as leaders in GI health, but helped to drive annual sales of Zantac to over $2 billion at peak, 65 percent of which was accounted for by GERD." By 1992, when Mario was named CEO of Glaxo's worldwide holdings company, Zantac made up 44 percent of the company's bottom line. There were, of course, the typical party poopers, inevitable at any pharma victory celebration." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.)

"GlaxoSmithKline (NYSE symbol gsk) CEO: J.P. Gamier $6.5 million in 2005 SEC 10-QFilings, August 2006, for 6 months ending June 30,2006 Marketing and Administration: $3,706,000,000 Research and Development: $1,606,000,000 $2.1 billion more was spent on marketing than research in 6 months! Pfizer (NYSE symbol PFE) CEO: Henry A. McKinnell (announced retirement July 2006) $78 million total from 2001-2005 ($15." - Mike Adams, Natural Health Solutions (Get the book.) "The lawsuit alleges that the company suppressed the negative results of the other studies, which failed to demonstrate that Paxil is effective and which suggested a possible increased risk of suicidal thinking and acts. gsk is also alleged to have failed to disclose this information in "Medical Information Letters" that it sent to physicians. The real cost of prescription drugs If you think that paying sky-high prices for prescription drugs is bad enough, prepare to be shocked: Americans actually pay for drugs three times." - Mike Adams, Natural Health Solutions (Get the book.)

"Study 377 found that "[n]o clinically or statistically significant differences were detected between paroxetine and placebo in either of the [two] primary efficacy variables," or on any of the secondary measures. • GSK's studies showed the possibility of a link between paroxetine and an increased risk of suicidal thoughts and acts in adolescents. Combined, studies 329, 377 and 701 showed that certain possibly suicide-related behaviors were approximately two times more likely in the paroxetine group than in the placebo group." - Kelly Patricia O'Meara, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill (Get the book.)

"In other words, it's fair to say that gsk got a slap on the wrist. And this is from one of the nation's toughest Attorney Generals who dare to stand up against Big Pharma. Imagine how much more easily other states' AGs roll over... Where does all the money go? With the FDA/Big Pharma conspiracy enforcing a monopoly drug market in the United States, and with drug companies further bilking state Medicaid programs out of countless millions through fraudulent billing practices, billions of dollars are disappearing from the pockets of consumers and taxpayers. Where is all the money going?" - Mike Adams, Natural Health Solutions (Get the book.)

"According to Spitzer, "GSK has engaged in repeated and persistent fraud by misrepresenting, concealing and otherwise failing to disclose to physicians information in its control concerning the safety and efficacy of its antidepressant medication paroxetine HCl ("paroxetine") in treating children and adolescents with Major Depressive Disorder ("MDD "). " - Kelly Patricia O'Meara, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill (Get the book.)

"As the public relations industry saw it, gsk specifically hired Cohn & Wolfe to position social anxiety disorder as a severe condition.7 This occurred before Paxil was even approved for the treatment of this condition, in order to give Cohn & Wolfe time to start "cultivating the marketplace."8 The campaign would have two clear objectives. The first was to generate extensive media coverage about social anxiety disorder, always making the link between the condition and the drug." - Ray Moynihan and Alan Cassels, Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All into Patients (Get the book.) "This was the power that gsk harnessed to help sell a little-known disorder to the world. Despite their enormous influence around the globe, public relations firms are largely invisible to those of us whose minds they change. Cohn & Wolfe is actually only a brand name anyway, since it is a subsidiary of the giant WPP Group, a global conglomerate that sells advertising, PR, branding, and other services to many of the world's biggest corporations—including tobacco company Philip Morris—generating revenues of more than $6 billion a year." - Ray Moynihan and Alan Cassels, Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All into Patients (Get the book.) "PMDD, including Pfizer's Zoloft and GSK's Paxil. And as with many new drug approvals these days, they are accompanied by much company-funded "awareness-raising" about the disorder the drugs have been approved to treat. Pfizer's marketing of PMDD even employs some of the words and concepts used by Lilly. Are you giving up days to what you think is PMS? If you are, it could be PMDD. —Zoloft ad It's likely these more recent advertisements have not received the same level of scrutiny from the regulators as the initial Lilly ad received back in 2000." - Ray Moynihan and Alan Cassels, Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All into Patients (Get the book.)

"During the last several years, gsk has also won FDA approval for new uses of Paxil, which help extend and sustain the franchise. Originally approved to treat depression, the drug now has approval for obsessive-compulsive disorder, panic disorder, and post-traumatic stress disorder. After Paxil became the first drug approved to treat a rare and extreme form of shyness, called social anxiety disorder (SAD), in 1999, gsk struck out to raise awareness about SAD, and stories suddenly proliferated in popular media. " - Katharine Greider, The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers (Get the book.) "Whether or not these patents are valid, each of GSK's lawsuits against generics firms triggers a thirty-month stay, blocking generic entry through at least 2003. "With respect to all the pending litigation in the USA relating to Paxil, the Group believes that its patents are valid and that the third party compounds do infringe the Group's patents, and it intends to vigorously litigate its position," gsk told shareholders in a recent annual report." - Katharine Greider, The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers (Get the book.)

"In early 1999 the FDA gave gsk the green light by approving Paxil for this new disorder, pushing the marketing campaign into overdrive. A barrage of direct-to-consumer advertisements, just like those for PMDD, introduced a generation to a psychiatric condition they'd never heard of before. TV commercials that featured disturbing images of people with intense fears of social situations were seen by tens of millions of Americans, including Deborah Olguin, unemployed, watching TV from her trailer park in California." - Ray Moynihan and Alan Cassels, Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All into Patients (Get the book.)

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