Summary

"Paxil is a dangerous and defective drug. That is absolutely the case," said Rob Robinson, the event’s organizer. "The swath of devastation, misery and sometimes death which Paxil has unleashed the world over is simply staggering. Yet GlaxoSmithKline has done everything in its power to keep the sinister truth about Paxil from going public. What’s at stake for the company is a multibillion dollar revenue stream that sales of Paxil have generated for almost ten years."

"GlaxoSmithKline has claimed since 1992," Robinson said, "that Paxil is ‘safe and effective’ after it was approved by the Food and Drug Administration — end of story. But it’s the beginning of the story which GSK conveniently forgets, or rather doesn’t want the world to know about, and that is the fact that Paxil’s FDA approval was based on the company’s submission of fraudulent Phase III clinical trials. As such, GSK’s claim that Paxil is ‘safe and effective’ is specious at best."

"The truth is Paxil represents the greatest fraud ever perpetuated within the pharmaceuticals industry," Robinson said. "But thanks to the unsparing efforts of attorneys representing Paxil victims evidence of this fraud has been uncovered in GlaxoSmithKline’s confidential files. One trial and it all comes out. And that is going to be one huge news story — on the order of Merck’s Vioxx."

A much anticipated Paxil trial set to take place May 2nd of this year was delayed for at least another six months. Robinson says he is not surprised: "GSK has spent hundreds of millions of dollars fighting to keep the truth about Paxil from coming out, but at the end of day I’m confident the company’s efforts will fail."

Approximately 5,000 U.S. citizens have filed suit against GlaxoSmithKline asserting they became addicted to Paxil and then suffered withdrawals when quitting the drug as a consequence of the company failing to warn them of the drug’s dangers. Several thousand more persons have sued GlaxoSmithKline in the UK on the same basis. "Paxil’s reach extends into medicine cabinets the world over, and cuts across all social classes," Robinson said. "Paxil is an equal opportunity destroyer."

Some lawsuits filed against GlaxoSmithKline are on behalf of patients who started Paxil — only to discover they could not stop taking the drug, even with expert medical help. (One patient in Britain was told by her doctors that ‘heroin would have been easier to wean [herself] off and recover from.’)

"Paxil withdrawal symptoms can be so severe and protracted it requires an almost superhuman strength to endure them," Robinson said. "Not surprisingly, some people cannot, and as a consequence commit suicide. Others victims have resumed use of Paxil to escape withdrawal symptoms, but will have to take the drug for the rest of their lives whether they want to or not. In other words, they’ve become lifetime Paxil addicts."

Robinson stated that a review of the medical literature shows that, on average, over one-third of people taking Paxil for any extended period of time experience withdrawal symptoms, and of those, 21% experience severe withdrawal symptoms. In the clinical trials of Paxil, a significant percentage of patients (up to 50% according to some studies) experienced withdrawal.

"There is a huge disconnect between what GSK tells the public about Paxil, and what the truth about Paxil is. That disconnect extends to GlaxoSmithKline’s labeling of the drug throughout the world. GSK is a very big company with an even bigger problem of telling the truth," Robinson said.

In an October 19, 2000 deposition taken of Dr. David Wheadon, Senior Vice President of Regulatory Affairs and Product Professional Services for GlaxoSmithKline, Dr. Wheadon stated "there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been." However, Paxil’s June, 2005 drug labeling states "Paxil has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence."

At the time of Dr. Wheadon’s testimony Paxil’s U.S. drug label claimed: “Paxil is non-habit forming, may cause mild, usually temporary, side effects in some individuals" and further that Paxil “has been studied both in short-term and long-term use and is not associated with dependence or addiction.” "Those claims are now known to be utterly false," said Robinson.

"No discerning member of the public, or the press, will believe that Dr. Wheadon was simply mistaken or ill-informed at the time of his year 2000 deposition," Robinson said. He (Wheadon) knows as much about Paxil as anybody at Glaxo; all one has to do is peruse his sworn testimony to see that’s clearly the case." (Access Dr. Wheadon’s complete testimony at the Paxil Protest web site.)

Dr. Wheadon’s association with Paxil spans two decades; he was part of the original GSK team which presented Paxil’s clinical trials during the FDA’s October 5th, 1992 hearing wherein the company first sought — and later gained — the agency’s approval for the drug.

A Paxil Protest web site, launched on August 8th, 2005, has already received over a quarter of a million ‘hits.’ "The response from the public has been one of exuberance. Which is hardly surprising given the fact that this represents the first time in history a multinational drug company has successfully been targeted using the Internet as a public relations weapon," Robinson said. "The Internet is providing the public the matchless ability to organize and direct participants ‘on the ground’ and to further respond in real time to a highly fluid and dynamic public relations environment. It’s almost like having the equivalent of an AWACS radar plane circling over a public relations battlefield."

The Paxil Protest web site, well organized and easy to navigate, lays out a compelling indictment not only of Paxil, but also of GlaxoSmithKline. "Virtually all of what you’ll see at the Paxil Protest web site was assembled from news stories, medical journals, depositions and the like. It was simply a matter of pulling all the facts together into one big package for the public," Robinson said. "I challenge GlaxoSmithKline to dispute the accuracy and veracity of anything published to the web site."

The Paxil Protest web site also includes important information for Paxil users who might wish to quit the drug. "What I did not want to have happen is to have Paxil users come to the site, panic, and then abruptly quit the drug. The consequences could be disastrous. That’s why an entire web page addresses the issue of how to get off Paxil safely, or as safely as possible."

"I am confident the public as well as the media will discover information that is newsworthy and highly informative on virtually every page of the Paxil Protest web site" Robinson said. "Plenty of story angles to be had," he added.

Robinson, a Paxil survivor himself, said it took several years of intermittent but intensive research to assemble the information presented at the Paxil Protest web site. "My goal was to make it as easy as possible for the public to get to the truth about Paxil — the sinister truth which GlaxosmithKline hides from the world." He describes the Paxil Protest web site as ‘the definitive Paxil Information Clearinghouse.’

As many as 1,000 or more protesters might attend the Paxil Protest. "We simply have no way of forecasting how many people might show up; after all, the call to action is going out the world over," Robinson said.

Victims and survivors of other SSRI drugs such as Prozac, Effexor and Zoloft are also expected to attend in a show of community support.

Original source:
http://www.prleap.com/pr/13734/

Details

• Consumers Join Forces to Protest Against Antidepressant Paxil and Kickoff Boycott of Drug Company GlaxoSmithKline (press release)

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