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The human voice can never reach the distance that is covered
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Suppressed Paxil Suicide Data Released
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Join us in 2006 for the first worldwide GlaxoSmithKline Protest.
Locations and details announced soon.
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THE "NEW" PAXIL PROTEST PETITION
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Paxil survivors please sign both and add your comments.
Coming soon to a theater near you:
Film maker Michael Moore's
"Big Pharma—Healthcare" expose'
If you or someone in your family has been a victim of any GlaxoSmithKline drug — and you are willing to speak to the press — please contact us immediately.
Sunday, May 21st, 2006
Our Link of the Week goes to Dr. Peter Breggin's Op Ed piece wherein he — for the second time this year — unloads on GSK and Paxil. See FDA Warns that Paxil Makes Depressed Adults Suicidal
Thursday, May 18th, 2006
"In the Belly of the Beast": A group portrait of a few individuals who attended the first Paxil Protest outside GSK's Philadelphia U.S. headquarters. That's me in the blue ball cap (looking up at the GSK video crew which filmed us for the three days we were on site.)
Wednesday, May 17th, 2006
A few days ago GlaxoSmithKline (GSK) and FDA notified healthcare professionals via a "Dear Healthcare Professional" letter of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil and Paxil CR. These labeling changes relate to adult patients, particularly those who are younger adults.
In its "Dear Healthcare Professional Letter" GSK states"[the company] continues to believe that the overall risk:benefit of paroxetine in the treatment of adult patients with MDD and other non-depressive psychiatric disorders remains positive."
"Continues to believe ... remains positive." If only the truth could be told.
The DHP letter was almost certainly a strategically delayed response triggered by the stunning publication of a medical expert report (M.E.R.) authored by Dr. Peter Breggin — previously sealed by the court and under confidential and protective order — which documents in precise detail how GlaxoSmithKline systematically hid and manipulated data concerning Paxil-induced suicidality in depressed adults. The number of suicide attempts on the antidepressant Paxil was under-reported and the number of suicide attempts on placebo was inflated. Dr. Breggin said, "The publication of a previously sealed medical expert report is a rare event — (this is) the first in my experience."
What Dr. Breggin is saying in a nice way is that GlaxoSmithKline committed fraud by falsifying allegedly scientific results from its Paxil clinical trials. The result? Untold thousands of people the world over have died unnecessarily because of GSK's willful and malicious (what else can one call it) — fraud concerning Paxil. At least GSK's stockholders divvied up billions in profits along the way. Right?
Sunday, May 14th, 2006
Our Link of the Week goes to GSK Reverses Decade of Denial: Paxil Triggered Suicide in Adults by Vera Hassner Sharav, executive director of the Alliance for Human Research Protection.
Sunday, May 6th, 2006
Our Link of the Week goes to Thich Nhat Hanh. You might also wish to explore Plum Village.
Sunday, April 30th, 2006
Our Link of the Week goes to Drug Trials Outsourced to India. GSK is smack in the middle of this despicable business. For more of the same see GlaxoSmithKline Moves Trials Abroad, India's Clinical Trials and Tribulations and A Nation of Guinea Pigs.
Wednesday, April 26th, 2006
So exactly where does a multinational pharmaceuticals corporation get off thinking it is in a position to dictate to, or demand anything of, its victims. We are in control now....
Drip, Drip, Drip — The Paxil Info Leaks Out
Are you ready for the "new and improved" Paxil? Here it comes. According to this press release NeuroSearch’s development and license partner, GlaxoSmithKline, has planned a Phase II clinical program in patients having major depressive disorder (MDD). Initially, NS2359 will be compared to placebo and a marketed antidepressant. GSK is currently seeking regulatory approvals to initiate the clinical trials in various countries and is identifying the clinical centers involved.
Of course, GlaxoSmithKline will have to try and get one over the FDA again to get this new junk approved ... that shouldn't be too hard. But where's David Wheadon when you need him?
Sunday, April 23rd, 2006
There's a lot going on behind the scenes these days ... which means that now, more than ever, it is absolutely critical for consumer drug activists to remain focused and "keep an eye on the ball."
Our Link of the Week goes to the www.PaxilProtest.com * Ban Paxil * Boycott GlaxoSmithKline airplane banner which circled over Philadelphia during our protest at GlaxoSmithKline's U.S. headquarters in September of 2005. (You might have to scroll the image on your screen to see the whole thing.)
For the upcoming worldwide GlaxoSmithKline protest we'll fly a banner at one of the protest sites — but it'll be a slightly larger one like this "Got Sewage? Royal Carribbean Dumps Daily banner. Maybe ours should read "Got Crappy Drugs? GlaxoSmithKline Dumps Daily". Or something along those lines.
Does anyone wonder why GlaxoSmithKline has not actively sought to derail our extensive Google Adwords campaign which targets the company? Here's a clue.
For its part Google does send us every so often an "your ad has been disapproved" notice, so we just keep loading new ones. We just can't use the word "Paxil" because it violates trademark rights. (Score one for GSK.)
After we began a Google Adwords campaign targeting GlaxoSmithKline's Paxil "Your Life is Waiting" Google Adwords campaign the company pulled its Internet advertising.
When is GlaxoSmithKline going to get its Paxil factory in Puerto Rico cranked back up? (The one the United States marshall's service shut down last year.) For a bit of background check out this April 28th, 2005 letter from the FDA which stipulates the $650 million dollar penal bond GlaxoSmithKline had to post.
Wednesday, April 19th, 2006
GSK's David Wheadon has fled the company, following his unindicted co-conspirator Tadetaka Yamada's lead. Gee, I wonder why?
By the way GlaxoSmithKline ... what's the company's off-the-record body count for the number of kids the world over who committed suicide as a consequence of taking Paxil? (Never mind the adult figures.) We know it runs in the thousands, but is it more likely the case that the figure runs in the tens of thousands? Just thought I'd ask.
Here's a couple of charts to help educate those readers who don't fully grasp the gravity of the situation.
Whatever the ultimate figures are, it's a "paroxetine hydrochloride trail of death" littered with an ungodly number of corpses. (And let's not forget the Advair casualties et al)
Sunday, April 16th, 2006
Our "Link of the Week" goes to" "Hard to Swallow" an article by Thomas J. Moore which first appeared in the Washingtonian Online. From the intro: "Read the ads and you'll think relief from the black cloud of depression is just a pill away. But if you consult the scientific record and look at the medical trials the pills have gone through, you'll see a much scarier story." The article was published in December of 1997....
We keep checking Glaxo's site to see if Jean-Pierre Garnier, GlaxoSmithKline's CEO, has been designated "a hero" (his words) by the company yet. Still no word.
Sunday, April 9th, 2006
Our "Link of the Week" goes to" Antidepressants Facts.
Friday, April 7th, 2006
How about a double shot of GSK's Ole Tyme Golden Snake Oil Formulae to wash that "SSRI imbalance cureall" Paxil pill down with? A squeak of protest from our "corporately handicapped" Food and Drug Adminstration was voiced recently when Dr. Wayne Goodman, Chair of the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee recently said "Biological psychiatrists have looked very closely for a serotonin imbalance or dysfunction in patients with depression or obsessive compulsive disorder and, to date, it has been elusive." He added that although an SSRI may work well in an individual, this "doesn't prove that there is an underlying imbalance, defect or dysfunction in the person's serotonin system."
Goodman was reacting to a recent article (December 2005, PLoS Medicine) about the growing body of medical literature that casts doubt on the "serotonin hypothesis." Co-author Jonathan Leo, associate professor of anatomy at Lake Erie College of Osteopathic Medicine, says the FDA should prohibit SSRI manufacturers from making these claims.
"Elusive" ... "doesn't prove." In other words there's not a single shred of scientific evidence to support the "serotonin imbalance theory." Yet GlaxoSmithKline sold the public on Paxil based on this unscientific and utterly baseless claim.
So where did the idea come from? It was created by GlaxoSmithKline's marketing department ... they dreamed it up. And the public swallowed the whole thing.
If even one of the pending Paxil lawsuits goes to trial — and GSK's internal documents are exposed — the world will have proof positive that Paxil is a colossal fraud.
Commenting on the GSK-propagated SSRI imbalance theory, plaintiffs' expert Dr. David Healy (one of the world's foremost leading authorities on SSRIs, and who has seen GSK's internal documents) said: "The serotonin theory of depression is comparable to the masturbatory theory of insanity. Both have been depletion theories, both have survived in spite of the evidence, both contain an implicit message as to what people ought to do. In the case of these myths, the key question is whose interests are being served by a widespread promulgation of such views rather than how do we test this theory."
And from Dr. Joanna Moncrieff, Senior Lecturer in Psychiatry at University College London: "It is high time that it was stated clearly that the serotonin imbalance theory of depression is not supported by the scientific evidence or by expert opinion. Through misleading publicity the pharmaceutical industry has helped to ensure that most of the general public is unaware of this."
For more background scroll down this page to November 22nd, 2005 and begin reading.
Thursday, April 6th, 2006
April 5th passed with no announcement at GlaxoSmithKline's website trumpeting CEO Jean-Pierre Garnier's Official Day of Enshrinement. That's in reference to the boast Mr. Garnier made to This Is London in an April 5th, 2004 interview: "I'll be a hero in two or three years." It looks like the world will have to hold its collective breath for awhile longer. Until September, perhaps.
Speaking of holding your breath ... check out this new article in Forbes magazine entitled "Trouble Breathing" starring GlaxoSmithKline's blockbuster drug branded as Advair in the United States and Serevent in Europe.
Here's an excerpt: "If we got these drugs off the market, we could prevent 4,000 deaths a year," argues Shelley Salpeter, a clinical professor of medicine at Stanford University who says both Advair and Serevent should be recalled. She pored over the results of 19 previous trials of Serevent-style drugs and found that patients have twice the rate of asthma hospitalizations, twice the rate of life-threatening asthma and four times as many deaths as patients who aren't on those drugs. She believes Advair and Serevent cause four of every five asthma-related deaths each year. "These drugs make asthma worse," she says.
4,000 deaths ... and that's just in the United States alone. Apparently, that ghastly figure represents an entirely acceptable level of carnage — for GlaxoSmithKline.
Financial carnage, that is. The huge class action consumer fraud and wrongful death lawsuits will — when they finally catch up to the company — cost it a paltry 500 million or so dollars. Pocket change when you consider the drug is the fourth-best-selling drug in the world, with $5.6 billion in sales, up 19% in 2005. That's a pretty good deal (if your mind works like J.P. Garnier's.) Then again, the Advair/Serevent saga might morph into a corporate disaster of "Merckian proportions." It couldn't happen to a nicer company if it turns out that way. By the way ... does it even really work?
Forbes closes its article, saying "A recalcitrant company, a suspect drug, young patients dying — and lawyers smelling blood. This could get very ugly."
Now on to those annoying Google ads sponsored by this website ... you can't quite seem to get rid of them, can you Mr. Garnier?
Our latest Google ad (the one replacing the one Mr. Garnier begged Google to pull) is being broadcast throughout every country and territory in the world — including all content sites. How many phone calls and emails does Glaxo's own King of Self Aggrandizement receive from family, friends and business associates on a daily basis asking why he, The Man, is powerless to put an end to them? Probably a lot.
Sunday, April 2nd, 2006
Our "Link of the Week" goes to "Useless and Deadly" courtesy of British Parliament member Paul Flynn. From Mr. Flynn's website: The Seroxat (Paxil) scandal is one of gigantic proportions, which affects millions of people ... The effect of Seroxat (Paxil) is not to free people from the prison of depression, but to create a new prison wall around them; all-encompassing that encloses them in a prison of addiction ... The charge against GlaxoSmithKline could not be graver: it has deliberately suppressed information on the danger of Seroxat and its lack of utility. Two years ago, GlaxoSmithKline wrote me a letter that contains very little that is truthful apart from the date.... For the rest of the Godawful Truth (and a whole lot more) visit the link.
We're just two days away from GlaxoSmithCon CEO Jean-Pierre Garnier's "I'm Going To Be A Hero" day. Can you believe it's almost here?
If April 4th arrives — and Mr. Garnier has not achieved full hero status — he'll still have, according to his backup timeline, an additional twelve months left to make good on the boast. (Of course, Mr. Garnier had no idea when he made that claim there would be this American film maker named Michael Moore who would come along and start poking around in the pharmaceutical underbrush with a long stick to see what he could uncover.)
Wednesday, March 29th, 2006
Eliot Spitzer, Attorney General for New York, announced on March 26th a 14 million dollar multistate settlement with SmithKline Beecham Corporation d/b/a GlaxoSmithKline ("GSK") concerning the drug Paxil.
The settlement resolves claims that GSK delayed generic competition by fraudulently listing and prosecuting litigation concerning paroxetine hydrochloride, a drug that GSK sells as Paxil which is used to treat depressive, anxiety, and obsessive-compulsive disorders.
In August 2004 Attorney General Spitzer reached a separate agreement with GSK under which the company became the first major drug manufacturer to publicly disclose information on clinical studies of its drugs. The settlement followed a lawsuit alleging that the company withheld negative information suggesting a possible increased risk of suicidal thinking and acts in certain individuals taking Paxil.
In April 2005, Attorney General Spitzer reached a second unrelated national settlement with GSK for 10 million dollars. This settlement was designed to resolve state proprietary claims that GSK delayed generic competition by fraudulently listing and prosecuting litigation concerning the drug nabumetone, an anti-inflammatory drug that GSK sells under the trademark Relafen.
According to my estimates, GlaxoSmithKline has (to date) shelled out approximately 500 million dollars to pay company defense attorneys fees and further resolve a veritable tidal wave of Paxil product liability lawsuits. 500 million might sound like a lot of money — and indeed it is — but it's "chicken feed" for a multinational corporate behemoth that has gorged on billions in profits from the fraudulent promotion of its dangerous and defective junk drug: Paxil.
Sunday, March 26th, 2006
Our "Link of the Week" goes to Paxil Suicide Product Liability Class Action Filed.
Baum Hedlund partner, Karen Barth Menzies, stated regarding the lawsuit: “Through our Paxil litigation, we've obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children. That’s about as reprehensible as you can get. Governmental regulators around the world have now analyzed the actual data from the clinical trials, not GSK’s version of it, and have found an increased risk of suicidality. Yet the drug companies and their hired mouthpieces in the medical academic community, including the pediatric arm of the APA [American Psychiatric Association], continue to downplay the Black Box Warning as an “over-reaction” by FDA. They continue to try to hide this risk from parents for the sake of profits. We wanted to make sure the rights of all of these kids are protected by filing this lawsuit.”
I expect a similar class lawsuit to be filed on behalf of the adult population within the next twelve months.
"Sunday Comix": Bush Taking Antidepressants to Control Mood Swings. President George W. Bush is taking anti-depressant drugs to control his erratic behavior, depression and paranoia, Capitol Hill Blue has learned....
Sunday, March 20th, 2006
Our "Link of the Week" goes to an April 5th, 2004 interview by This is London with Jean Pierre Garnier, megalomaniac and CEO of GlaxoSmithCon, who crowed "I'll be a hero in two or three years." We'll see about that in September when Michael Moore's movie "Sicko" comes out. Will Glaxo's board give Garnier the golden boot before this "public relations nuke" blows up in the company's face? (What say you Lord, I mean, Sir, Gent?)
Garnier bag man Tadataka Yamada, current head of GlaxoSmithCon's R&D, sure saw it coming; he'll be gone in May. Too bad the Glaxonian scandal is going to rock the Gates Foundation.
Plans are being finalized for a September, 2006 Paxil Protest. Dates and location to be announced soon.
Wednesday, March 15th, 2006
Relenza: The GSK "dead cat" drug that just won't die. But even J. P. Garnier keeps a stash in his refrigerator now as a talisman to ward off the bird flu.
Sunday, March 12th, 2006
Our "Link of the Week" goes to Dr. Peter Breggin's "Lacuzong" Paxil Product Liability Report. (Your thoughts on this Eliot Spitzer?)
Tuesday, March 7th, 2006
Suppressed Paxil Suicide Data Released: Dr. Peter Breggin (whose website was our "link of the week" this past Sunday) has "officially" joined in the "2006 Public Relations Carpet Bombing" of GlaxoSmithKline.
A medical expert report authored by Dr. Breggin — previously sealed by the court and under confidential and protective order — documents how GlaxoSmithKline systematically hid and manipulated data concerning Paxil-induced suicidality in depressed adults. The number of suicide attempts on the antidepressant Paxil was under-reported and the number of suicide attempts on placebo was inflated. Dr. Breggin said, "The publication of a previously sealed medical expert report is a rare event — (this is) the first in my experience."
I challenge responsible members of the medical professional to carefully review Dr. Breggin's M.E.R. and, thereafter, ever prescribe Paxil again. There is simply no way to spin that report into anything other than what it is: The Godawful Truth.
Dr. Breggin's unsealed report is just one more cap, if you will, being twisted off a pill bottle full of GSK lies, fraud and deceit concerning Paxil — bar none the biggest drug fraud in the history of the pharmaceuticals industry. But the best is yet to come, and before this is all over it is possible racketeering charges could be leveled against GlaxoSmithKline. (In 1999 the U.S. Department of Justice filed a lawsuit under anti-racketeering legislation against major tobacco companies. The case sought $280 billion in penalties on the grounds that the tobacco companies had conspired to deceive the public about the dangers of smoking.)
Dr. Breggin's report further documents how GlaxoSmithKline hid the incidence of Paxil-induced akathisia (agitation with hyperactivity) and stimulation. Akathisia and stimulation are risks factors for suicidality and violence. The product liability report also cites previously unreleased FDA correspondence highly critical of GlaxoSmithKline’s marketing and advertising tactics in regard to Paxil.
Dr. Breggin’s original psychiatric expert report was written for Lacuzong v. Davidson et al, Superior Court of the State of California, County of Santa Clara, Case No.: CV 773623 and signed as an affidavit in California on July 21, 2001. It was based on a three-day examination of GlaxoSmithKline’s sealed files at the company headquarters.
The Lacuzong case was brought by the widow of a man who drowned their two children and himself in a tub after taking Paxil for three days. The attorney was Don Farber of San Rafael, California. The case was “resolved” to the satisfaction of the family and, not surprisingly, the drug company denied all allegations. At GlaxoSmithKline’s insistence, Dr. Breggin’s report remained sealed.
Dr. Breggin stated, “The drug companies settle almost all legal cases brought against them in order to seal incriminating scientific data. This deprives the FDA, medical profession and public of critical information on drug safety and efficacy. The law should be changed to require drug companies to publish all of the safety and efficacy data they generate in regard to their drug products.”
Monday, March 6th, 2006
The mainstream press has picked up on GlaxoSmithKline's PR HyperSpin program dubbed its "Value of Medicine" campaign (which we reported on a few days ago.) In the UK's Independent Online edition reporter Danny Forston published a piece GSK in PR Blitz Ahead of Moore's 'Sicko' Blast at Drug Companies.
Quoted in the article is a GlaxoSmithKline spokeswoman who said "It allows us to finally tell our side of the story." (The godawful truth will work just fine, thank you.) She added that the campaign was not in response to Mr. Moore's documentary. (It's just a coincidence.)
Ken Johnson, senior vice-president of trade group Pharmaceutical Research and Manufacturers of America, 'applauded' GSK's initiative and said "... Michael Moore is not interested in telling both sides of the story. Sensible people will dismiss his work for what it is, a one-sided attack on America's health system." Nice try, Ken. The truth is 'sensible people' are going to see Moore's movie and come to realize just how bad they've been getting screwed by Big Pharma and the corporate interests you represent.
Sunday, March 5th, 2006
Our "Link of the Week" goes to the website of Peter Breggin, M.D.
"Sunday Comix": A movie poster featuring Big Pharma screen idol GSK's Jean-Pierre Garnier starring in, well, you'll just have to click here to see it for yourself....
Wednesday, March 1st, 2006,
February turned out to be this site's "biggest bandwidth" month to date (due, in part, to our "GSK Legal Team" web page being swamped with traffic.)
Tuesday, February 28th, 2006
Today, George W. Bush appointed GlaxoSmithKline velociraptor Tadataka Yamada as a member of the President's Council of Advisors on Science and Technology. Further evidence Yamada is having a "French manicure" applied to the corporate claws he wielded during his days spent roaming GSK's drug abattoir. "Never mind the Paxil fraud, Lotronex et al ad nauseam ... I'm a pretty boy punkin' for the Prez now!" (Gee, I wonder what Bill Gates is going to think about the wisdom of appointing (a poorly vetted) Dr. Yamada to serve as head of his charitable foundation once all of this is paraded across the movie screens of America?)
The question for GlaxoSmithKline now is not "if" but rather "how bad" is the company going to get mauled in Michael Moore's soon-to-be-released movie "Sicko."
Not waiting to find out, GSK is embarking on an all out push to batten down the hatches and install the corporate equivalent of blast proof doors. Of course, it's all for naught: by year's end the public relations topography for Glaxo is going to resemble, say, Dresden after it was firebombed into the stone age during World War II. At least, "that is the hope" (to borrow a line from the sworn testimony of Tachi Yamada, GlaxoSmithKline's Chairman of R&D who is, in three months time, fleeing Glaxo and "getting the hell out of Dodge.")
Turn on your TV these days and you're likely to see a raft of GSK 'warm n' fuzzy' ads running round the clock.
GlaxoSmithKline has also — as we recently wrote about in Breaking News — completely retooled its website and, in the process, ratched up the "feel good" volume from conversational to blaring.
And now, according a February 21st piece that appeared in AdAge "In an unprecedented mission, the $35.4 billion pharmaceutical giant (Glaxo) has quietly anointed its 8,000 U.S. sales representatives as “public relations ambassadors” to lift its image and that of the beleaguered industry with grassroots PR. The initiative, dubbed the ”Value of Medicine,” was created by Michael Pucci, GSK’s VP-external advocacy, to respond to overwhelming criticism and negative perception of the pharmaceutical industry.
“What we’re leveraging here is asking our employees to talk to people, even if they just start with their family members,” he said. Deciding to eschew a traditional corporate branding campaign, Mr. Pucci instead has unofficially “deputized” his sales force to speak on behalf of GSK and the industry....
Armed with salient talking points and answers to tough questions, the sales force is out speaking to Rotarians, Elks, Lions Club members, senior-citizen groups, weekly newspapers, schools and every community group they can think of. And Mr. Pucci said GSK has enough sales reps to cover every county in every state in the country. “Reputation matters,” Mr. Pucci said. “In this industry, it’s so important....
"It's so important."
I hope a GlaxoSmithKline "quietly annointed" drug rep stumbles onto a podium in my city, since I've got a chalise filled to the rim with some really tough questions I'd to publically annoint him or her with...
Dr. Donna Sweet, chair of the Board of Regents for the American College of Physicians said of the Quietly Annointed GlaxoSmithKline Drug Salesperson /Public Relations Ambassador program “It’s not a bad idea if these people are acting as good citizens and telling the truth and not trying to sway people. But I have a hard time believing they’re going to be completely fair and honest in all situations.”
But why would Dr. Sweet have any concerns about Glaxo being "fair and honest in all situations"? After all, as Jean-Pierre Garnier stated in GlaxoSmithKline's 2004 Corporate Responsibility Report: "Corporate responsibility is not just a job for selected people at GSK, it defines the way we do business. Our ten corporate responsibility principles set the standard
for everyone, since responsible business is only a reality if it is practised
by all employees at all times.
Thank goodness GlaxoSmithKline employees have a top shelf role model in their CEO and hero Jean-Pierre Garnier to look up to and emulate. Don't they. Lest anyone doubt it, note that in January 1997, JP was selected by President Chirac of France to receive the Chevalier de la Légion d'Honneur. In 2001, he was named one of 50 "Stars of Europe" by BusinessWeek magazine and presented with the Marco Polo Award for GlaxoSmithKline's commitment to China. In 2005, he was presented with the Global Business Leadership Award from Stanford Business School and honoured by the Children's Health Fund in New York, and awarded the Global Corporate Citizenship Award from AMREF (African Medical and Research Foundation). No doubt about it, ole' JP is a decent, upstanding, ethical and honourable man.
Sunday, February 26th, 2006
Our "Link of the Week" goes to The Truth About Drug Companies by Marcie Angell, M.D. Dr. Angell is the former editor in chief of The New England Journal of Medicine and a physician trained in both internal medicine and pathology. She is also a nationally recognized authority in the field of health care and an outspoken proponent of medical and pharmaceutical reform. Time magazine named her one of the twenty-five most influential people in America. Dr. Angell is also the author of Science on Trial.
If you truly want to know what, as Jean-Pierre Garnier, GSK's CEO put it, "we (Big Pharma) are all about" then read The Truth About Drug Companies wherein Dr. Angell eviserates an amoral and rapacious industry (masquerading as a benevolent force for good.)
"Sunday Comix": "In the words of a very famous person in Washington, GSK is a company with a soul. I love it. I love it.— Jean-Pierre Garnier, CEO of GlaxoSmithKline, waxing rhapsodic on the pseudo-metaphysics of the body corporate.
By the way, Mr. Garnier, that "very famous person in Washington" you spoke of ... it wouldn't happen to be your Big Pharma back slappin, ole' pal George Bush, would it?
Saturday, February 25th, 2006
Jean-Pierre Garnier, CEO of GlaxoSmithKline, recently criticized the movie "The Constant Gardener." Based on John le Carre's novel, it tells the story of a human rights activist murdered after discovering a big pharmaceuticals company was testing experimental drugs on poor Africans.
Mr. Garnier said "The problem with this movie is that the author, at least in the book, attempted to link too much his fiction with reality — a reality that doesn't exist."
"At least in the book."
In commenting on the movie Mr. Garnier was, quite obviously, not thinking of the GlaxoSmithKline-sponsored experiments on the children from Incarnation Children's Center, a care home that specialises in treating HIV sufferers. I guess because the ICC is located in New York and not Africa.
Mr. Garnier continued, saying "It (the movie) is a nice piece of fiction, let's enjoy it. It's entertainment, but it's not what we are all about."
Enjoy what? A thinly disguised version of a GlaxoSmithKline snuff film? If that is indeed what Mr. Garnier classifies as "entertaiment" then the world must wonder what, in his depraved mind, passes for horror....
Sunday, February 19th, 2006
Our "Link of the Week" goes to Dr. Joseph Glenmullen's "The Antidepressant Solution". (Subtitled "A Step-by-Step Guide to Safely Overcoming Antidepressant Withdrawal, Dependence, and 'Addiction'")
Our "GSK Legal Team" web page has been swamped with visitors this month ... surpassing even the usual high traffic load our "Quit Paxil" web page regularly sees.
Saturday, February 18th, 2006
Jim Letten, United States Attorney for the Eastern District of Louisiana, along with James Bernazzani, Special Agent in Charge, Federal Bureau of Investigation, Dan Levinson, Inspector General, United States Department of Health and Human Services, David W. Bourne, Special Agent in Charge, Office of Criminal Investigations, U. S. Food and Drug Administration, and Fred Duhy, Director, Medicaid Fraud Control Unit, Louisiana Attorney General's Office, are "sitting on go" following the August, 2005 indictment by a federal grand jury sitting in New Orleans of Dr. Maria Carmen Palazzo, 53, of New Orleans, Louisiana, for two counts of health care fraud and fifteen counts of fraudulent failure to maintain records of a clinical study.
The indictment (United States v. Palazzo, E.D. La., No. 05266S1) includes charges that Palazzo, as a clinical investigator for SmithKline Beecham, d/b/a GlaxoSmithKline, fraudulently failed to maintain and prepare records required by the FDA for the evaluation of Paxil's safety and effectiveness in children and adolescents.
The indictment followed an earlier investigation conducted by the Department of Health & Human Services which sent Dr. Palazzo this letter on December 3rd, 2003.
SmithKlineBeecham hired the defendant, Dr. Maria Carmen Palazzo, in October 2000 to participate as a clinical investigator in a study involving the drug paroxetine, also known as Paxil, to evaluate the efficacy and safety of the drug in children and adolescents with obsessive-compulsive disorder. Between November 2000 and March 2001, the psychiatrist enrolled 26 study subjects.
The defendant signed FDA Form 1572 agreeing to conduct studies of the drug on human subjects in accordance with the study protocol, to personally conduct or supervise the investigation, and to comply with FDA regulations, according to the indictment. Palazzo also agreed to personally review all case report forms that contain information regarding each study subject. In return, SmithKlineBeecham agreed to pay Palazzo $5,410 for each subject who completed the study.
SmithKlineBeecham later entered into a contract in February 2001 for Palazzo to participate as a clinical investigator in an extension of the Paxil study for a fee of $5,020 per study subject.
Prosecutors charged that Palazzo, "with the intent to defraud and mislead," failed to prepare and maintain records including keeping adequate and accurate case histories on each individual administered the investigational drug or employed as a control in the investigation. Prosecutors listed each failure as a separate count in the indictment.
The counts in the indictment include one that charged Palazzo with omitting from the case report forms material elements from a subject's psychiatric history, such as hyperactivity, attention deficit disorder, and disruptive behavior disorder. Three counts claim that the defendant did not examine the study subjects.
Let's hope the feds will be able to "flip" Dr. Palazzo for a reduced sentence so the public will have an opportunity to see what comes scurrying out from under the GSK rock.
Thursday, February 16th, 2006
We've added a "Countdown to J.P. Garnier Hero's Day" timer at our Welcome page.
Recently we reported on Tadataka Yamada, GSK's Chairman of Research and Development — who is bailing out a year early from his two year contract extension with Glaxo and scurrying for public relations refuge under cover of the Bill and Melinda Gates Foundation. (Not to worry though ... Michael Moore can keep tabs on him.)
Today we learned that Mr. Yamada has been appointed to the Advisory Committee to the Director (ACD) of the National Institutes of Health. According to an NIH press release "The ACD advises the NIH Director on policy matters important to the NIH mission of conducting and supporting biomedical and behavioral research, research training, and translating research results for the public." Don't you feel safer already?
Sunday, February 12th, 2006
Our "Link of the Week" goes to film maker and author Michael Moore's website. (Mr. Moore's site could well turn out to be our "Link of the Year".)
John Caffee, a self proclaimed "resident scholar" at the American Enterprise Institute, has generated a slick piece of Big Pharma propaganda called Striking a Balance: Drug Labeling and the FDA.
Mr. Caffee asserts "Manufacturers of the antidepressant Paxil were charged with failing to warn about it being addictive, again despite an FDA finding to the contrary.
What FDA finding? The fact is there has been not a single FDA study — or for that matter any study conducted by GlaxoSmithKline to examine the issue of Paxil addiction/dependency. (Never mind why.) To wit: Paxil's current drug labeling states: “Paxil has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. While the clinical trials did not reveal any tendency for any drug seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a … (central nervous system) … active drug will be misused, diverted and/or abused once marketed. Consequently, patients should be carefully evaluated for history of drug abuse, and such patients should be observed closely for signs of Paxil misuse or abuse (e.g., development of tolerance, incrementations of dose, drug seeking behavior).”
So there you have it: Mr. Caffee, AEI "resident scholar," can't get even the most basic of facts straight.
Mr. Caffee goes on to say that "As the FDA has explained over and over again, these extra warnings would ward off the very users who stand to benefit the most from using the products." There's no other way to characterize that statement by Mr. Caffee as anything but (let's be frank shall we?) complete bullshit.
You might be wondering what is this "American Enterprise Institute"? Without devoting ten pages of copy to lay it all out for readers, here's a clue: Daniel Troy (whom we've written about recently) is a former partner of the Washington law firm Wiley, Rein & Fielding, a firm which has served the pharmaceutical industry for years is a former member of the industry-backed organization, American Enterprise Institute (AEI) whose officers include Presidents and CEOs of large corporations such as Dow Chemical, Exxon Mobil and pharmaceutical giant Merck. AEI is an organization which lambastes the efforts of those who would litigate against not only pharmaceutical companies, but big tobacco.
Friday, February 10th, 2006
GlaxoSmithKline's website has been completely retooled, with its opening web page now hyping the company's "invest(ment) in the development of a vaccine for the H5N1 strain of flu and the increased production of Relenza through its own manufacturing facilities and through partnerships with other companies." The company also proclaims it has "donated medicines to support humanitarian relief efforts across the globe, including 3.6 million does of antibiotics following the Asian tsunami." And then there's the cute portrait of a little girl capping a link to Glaxo's 2004 "Corporate Responsibility Report."
The new Glaxonian message is clear: "Never mind what Michael Moore says about GSK in his (upcoming) movie 'Sicko' ... we're saving the world from the bird flu pandemic, we give away lots of free medicine to those in need, and we are a responsible corporation — heck, we even have a report to prove it." Hats off to GSK's Spinmeisters: propaganda just doesn't get any better than this.
GlaxoSmithKline is not going to save the world from a bird flu pandemic; instead, what's truly afoot is how best to position the company so it can rake in billions in profits by manipulating world fears. Come a pandemic: there will be no effective GSK influenza vaccine to save you. (Survive the first influenza "wave," and you might see a vaccine after six to 12 months ... assuming enough qualified people are left alive to adequately man any vaccine production lines.) Contract H5N1 and you might as well don a necklace of garlic than take GSK's Relenza — essentially a worthless sugar pill masquerading as a medicine.
And those free medicines Glaxo distributes throughout the world? They're the corporate equivalent of a high flying Wall street stockbroker stooping to toss a few coins in the tin cup of a beggar.
Finally, GSK is not — in spite of its "Corporate Responsibility Report" — a responsible corporate citizen. If anything, GSK is a role model for how not to run a company in an ethical and socially responsible manner.
Thursday, February 9th, 2006
It looks as if the days of doctors putting pregnant women on Paxil are coming to a close.
According to an article just out in WebMD "Babies whose mothers took antidepressant drugs in the second half of pregnancy are six times more likely to have a rare but dangerous lung ailment, a new study suggests. One study isn't proof. But it's strong evidence that taking SSRI antidepressants — such as Prozac, Zoloft, and Paxil — carries an extra risk during pregnancy. The risk is that the babies will have PPHN: persistent pulmonary hypertension of the newborn. Only one or two in a thousand babies get this, but it's very serious. It kills about one in 10 babies who get it. In moderately severe cases, half the survivors suffer hearing loss or brain damage.'We find these results very concerning,' Sandra L. Kweder, MD, deputy director of the FDA's office of new drugs, said in an unusual, hastily called news conference. 'We find the reported association of SSRI antidepressants with this very serious condition to be very worrisome.'"
It was only a few months ago that we reported on the Food and Drug Adminstration's reclassification of Paxil's pregnancy category rating from from "C" to "D" and the addition of new data and recommendations to the Warnings section of Paxil's prescribing information. The FDA had determined that exposure to Paxil in the first trimester of pregnancy may increase the risk for congenital malformations — particularly cardiac malformations.
Has the time come for the FDA to, once again, downgrade Paxil's tetragenicity rating even further from a "Catagory D" to a "Category X" (wherein the risk to the fetus is viewed as clearly outweighing any benefits from Paxil use during pregnancy.) We think so. If it was you in the womb what would your vote be?
Here is a link to the PPHN study as it appeared in the New England Journal of Medicine.
A question we have raised before is "when did GlaxoSmithKline first learn its drug Paxil could harm the unborn?" A careful examination of confidential GSK documents (see our GSK Legal Team page or our Paxil in Babies page) uncovered the following statements:
Two Excerpts From "The Business Plan Guide"
(Paxil) “Allows for rapid washout in the case of … pregnancy.”
GSK attacks competitor Eli Lilly’s product (Prozac), saying “The long half-life of Prozac reduces physician control and can … Increase exposure time to the fetus during pregnancy.”
Two Excerpts From The "PR Firm Memo"
If a patient becomes pregnant one might wish to discontinue therapy as quickly as possible.…
A drug with a short half life (i.e. Paxil), if discontinued immediately after conception, could wash out before the fetal-placental circulation is established.”
Wednesday, February 8th, 2006
It was the same old snake oil pitch from GSK's hooknosed ringmaster Jean-Pierre Garnier today ... the company has a gleaming product pipeline practically bursting at the seams with blockbuster drugs.
Mr. Garnier told a world audience this morning that "Eight major assets are scheduled to enter phase III in 2006 — this will double the number of assets in late-stage development,” and "we (GSK) expect further good news on GSK's late-stage pipeline.” Garnier is, if anything, the consummate con artist.
The truth is investors will be lucky if even one or two of those overhyped "assets" can make the jump from Phase III trials to market. And don't forget what Glaxo's competition is up to.
Garnier also hyped continued strong sales of Advair/Serevent but neglected to remind his audience that the drug will be open to generic competition in late April of 2007. (Never mind the recent added restrictions placed on sale of that drug by the FDA.) And that another big GSK seller, Valtrex, loses exclusivity in August 2006.
The reality is that the merger of SmithKline and Glaxo has created a lumbering corporate elephant that — in spite of Garnier and Yamada's (R & D) attempts to tame the beast — is ready to go rumbling off into open country (and dragging shareholders along with it.) Yamada knows this full well and, according to some insiders, it's one of the reasons he bailed out a year early on his two year contract extension. Garnier is going to be left holding the feed bag.
Tuesday, February 7th, 2006
On Wednesday, February 8, 2006, GlaxoSmithKline will announce its full year results for the year ended December 31st, 2005. The press release is expected to be distributed at approximately 7:00 A.M. Eastern Standard Time (EST).
Following the press release distribution, JP Garnier, Chief Executive Officer; David Stout, President, Pharmaceutical Operations; and Julian Heslop, Chief Financial Officer, will hold a worldwide press conference at The Savoy Hotel - Strand, London.
Unable to attend the press conference? You can listen in on a teleconference that will take place on: Wednesday, February 8, 2006 7:15 A.M. EST The telephone number you will need to call is: 1 866 434 1110.
Callers will be in a "listen only" mode. Should you wish to submit a question, please email your inquiry to firstname.lastname@example.org. Questions will be answered as time allows.
A recording of the press conference will be available from 1:00 P.M. EST on February 8th (until February 15th) and can be accessed by calling:1 866 247 4222 Passcode: 4830550#
A live webcast of the results presentation to analysts with synchronized slides will begin at 9:00 A.M. EST, and can be accessed directly via the GlaxoSmithKline website: http://www.gsk.com/. A replay of this webcast will be available from the corporate website at approximately 3:00 P.M. EST on the same day.
A telephone link for the analyst presentation has also been arranged. This will enable you to listen in to the live presentation and Q&A session. The telephone number you will need to call is: 1 866 434 1110.
A recording of the analysts' teleconference will be available from 1:00 P.M. EST on February 8th (until February 25th) on telephone number: 1 866 247 4222 Passcode: 4056007#
GlaxoSmithKline said Monday that it has found a replacement for Tadataka Yamada, its Philadelphia-based research chief, who is leaving the company to work for the Bill & Melinda Gates Foundation after five years of overseeing research and development for Glaxo. Yamada's sudden departure — which comes one year after a two year extension to his contract — has rattled some who fear his departure might derail GSK’s push to deliver on its pipeline. Not to worry though, right? After all, Dr. Moncef Slaoui, who will replace Yamada, said “GSK has one of the most promising pipelines in the industry. We fully expect to deliver medicines of great value in the coming years.”
Great ... value? If "medicines of great value" includes dangerous and defective GlaxoSmithKline drugs like Lotronex, Raxar, the Trivax vaccine, Pantopaque and Paxil ad nauseam then, on behalf of the public, I say to Glaxo "thanks, but no thanks."
Yamada's move could, like a fox on the run, put him just beyond the snapping jaws of the emerging Paxil scandal, and also provide him partial public relations immunity. It will not, however, save him from the witness stand in a Paxil withdrawal/fraud trial.
If you would like to read excerpts of Mr. Yamada's deposition taken for a Paxil-induced triple homicide/suicide civil suit (which GlaxoSmithKline lost) click on the button in the lefthand column of this page "GSK Yamada".
Andrew Whitty appears to be moving into position as top candidate to replace Jean-Pierre Garnier as CEO of GlaxoSmithKline, although David Stout ( a.k.a. "Pockie" to pharma reps) GSK's chief operating officer is thought to Garnier's preferred choice.
Garnier will officially reach retirement age at the end of 2007.
GSK's board has not yet agreed on a departure date for Mr. Garnier. However, analysts speculated yesterday (Feb 6th) that Sir Christopher Gent, GSK's non-executive chairman, appeared to be keen to resolve the matter early — understandable in light of what could well be lying-in-wait for Glaxo later this year when Michael Moore's new movie "Sicko" hits theaters. (By the way Mr. Gent, how do I obtain one of those "Sir" appellations ... do they sell them on E Bay?) Garnier, for his part, said "I'm not going anywhere soon." We sure hope not ... it'll be far more satisfying to see Mr. Garnier forced out by GlaxoSmithKline's board when his mugshot fills movie screens the world over in the coming months.
Another study is out detailing Paxil withdrawal seen in newborn children whose mothers took Paxil. See Neonatal Abstinence Syndrome After In Utero Exposure to Selective Serotonin Reuptake Inhibitors in Term Infants. That GlaxoSmithKline allowed this to happen to neonates — when it has known all along that Paxil could do this — is monstrous beyond comprehension. But according to Jean-Pierre Garnier, GlaxoSmithKline's CEO who has a central role in the Paxil fraud: "I have no trouble making difficult decisions. I do not agonize too much — just ask around. I sleep well at night." That's o.k. Mr. Garnier, we'll take you at your word — this time.
Monday, February 6th, 2006
Rumors have been swirling about the Internet that I recently "resolved" my lawsuit with GlaxoSmithKline. The fact is I am still on a litigation conveyor belt rumbling towards trial. If I make it that far it will be the fourth time in history that an SSRI-related lawsuit has made it before a jury.
According to Napolean "The whole art of war consists in a well-reasoned and extremely circumspect defensive, followed by rapid and audacious attack." Last week those of you lucky enough to have visited this website witnessed just such an attack on the "GlaxoSmithKline corporate Death Star." The shock waves generated by that cyberspace assault are rippling throughout the entire world.
Michael Moore is hard at work orchestrating a spectacular and asymmetrical cinematic attack on the healthcare industry and "Big Pharma." My bet is GlaxoSmithKline is going serve as the focal point of his assault on the pharmaceuticals industry. (Gosh, does anyone know why that would be?)
If you are a current or former GlaxoSmithKline drug rep, executive or employee and, as Mr. Moore puts it, "you have simply seen too much abuse of your fellow human beings and can't take it any longer — and you would like the truth to be told — please write me at email@example.com. I will protect your privacy and I will tell the world what you are unable to tell. I am looking for a few heroes with a conscience. I know you are out there."
If you haven't made the rounds at "Cafe Pharma" boards yet you're missing out on some choice entertainment. Here's a link to the GlaxoSmithKline board, and here's a sample thread. There are also several threads devoted to Mr. Moore, including this one ... and this one. You go CAPPIE.
Sunday, February 5th, 2006
Our "Link Of The Week" goes to Charles Medawar (Social Audit) and Anita Hardon's book Medicines out of Control?
Medicines out of Control? draws on the SSRI antidepressant case history to describe a system of medicines’ control tainted by secrecy and conflicts of interest, barely accountable to the public, lacking in common sense and losing sight of the meaning of health. Subtitled Antidepressants and the Conspiracy of Goodwill, this book reveals a demonstrably chaotic system of drug evaluation, driven by the almost unquestioned assumption that health is the product of greater ‘disease awareness’ and more new drugs.
These trends reflect the growing dominance of global and market values that now threaten to turn pharmaceutical medicine into something of a polluting enterprise, deeply damaging to the atmosphere of health. Alas, this is no more obvious than global warming to the driver of your average car.
Medicines out of Control? is an attempt to promote a complete rethink about what medicines contribute to health, and the basis of decision-making about drug benefits, risks and harm.
"Sunday comix": "I can't count on people just to trust us as a company to do the right thing, even though they should." said Jean-Pierre Garnier, CEO of GlaxoSmithKline in an October 4th, 2004 article in a Businessweek Online article entitled "It's a 'Perfect Storm' for Drugmakers".
Mr. Garnier, the public should trust you, and your company, about as far as a person can toss a water buffalo with a grand piano strapped to its back....
Wednesday, February 1st, 2006
Sunday, January 29th, 2006
Our "Link Of The Week": Let Them Eat Prozac.
This website, maintained Dr. David Healy (one of the world's foremost authorities on SSRIs), explores threats to public safety and academic freedom surrounding the SSRI group of drugs — Prozac, Zoloft (Lustral), Paxil (Seroxat/Aropax).
It makes available trial transcripts in three major cases involving SSRIs and suicide and homicide.
It also makes available correspondence surrounding issues to do with "ghost writing," efforts to draw attention to the hazards of these drugs and the dramatic changes taking place in academia as an increasing proportion of clinical research is privatized.
"Sunday Comix": The mask of GlaxoSmithKline's CEO Jean-Pierre Garnier. Garnier unmasked.
Thursday, January 26th, 2006
Who needs to worry about terrorists threatening this country when you have the Bush adminstration not only floating — but brazenly arming — a virtual armada of multinational pharmaceutical companies now broadsiding the American public?
A few days ago I wrote about a catastrophic "new rule" in place at the FDA that will, as investigative journalist Stephen Pizzo explains in a recent article, "bar state courts from hearing individual or class-action liability suits against drug companies. The reasoning behind this change was that, because a federal agency— the FDA — approves drugs before they can be marketed to the public, only federal courts should hear cases where someone claims they were injured by those drugs. It's called 'federal preemption.'" For this you can thank Big Pharma's (consumer rabid) attack dog Daniel Troy.
According to Mr. Troy's online resume he "was the first appointee to the FDA made by President George W. Bush."
While at the FDA, Troy, among other things, oversaw the agency’s warning and untitled letters — slashed 80% during his tenure. In 2002, Senator Edward Kennedy responded to this precipitous drop saying ''The FDA is supposed to be a watchdog for patients, not a lapdog for special interests. The precipitous drop in warning letters is an early warning signal that the [Bush] administration may be planning to weaken an agency that is vital to the health of every American family.''
Troy's online resume also states that he "helped raise the agency’s focus on First Amendment issues." The result? Big Pharma's direct-to-consumer (DTC) drug advertising assault on the American public ... 24/7/365 television ads hawking drugs like GlaxoSmithKline's Paxil, Imitrex, Wellbutrin, Flonase, Valtrex ad nauseam.
Troy also "played a principal role in the FDA’s generally successful assertion of preemption in selected product liability cases." A few days ago we told you what Congressman Maurice Hinchey had to say about Troy and his preemption agenda ..."The mission of the Food and Drug Administration is to ensure that the public is protected from unsafe food, drugs and other medical products," said Hinchey. "Daniel Troy is instead making it the agency's mission to protect the drug companies from being held accountable when their products do serious harm."
Stephen Pizzo's piece entitled "Shielding Big Pharma" pulls all of this together for the public in one neat journalistic package. Pizzo points out the similarities between the tobacco and pharmaceutical
Both Big Tobacco and Big Pharma produce and sell products that often cause injury or death when used as directed.
Both industries knew that some of their most profitable products were injuring and killing people, and either hid such evidence, lied about it or both.
Both industries hired their own experts to produce often phony, always misleading non-peer-reviewed, “research” designed solely to
cast doubt on any genuine research by outside experts that came to conclusions that could hurt sales.
Both industries attacked, slandered and punished those within or associated with their industries who broke the company stonewall by trying to sound a warning.
Finally, both industries enjoyed overly cozy relationships with government — relationships that enabled them to maximize profits for a
long as possible, regardless of the harm such products were known to be causing. (In this regard, Big Pharma has gone even further, by compromising the FDA, the very federal regulatory agency that is supposed to protect consumers.)
However, "There is one big difference between the Big Tobacco and Big Pharma stories, though. Big Tobacco faced a hostile FDA under Bill Clinton,
while Big Pharma has a true friend in this FDA, and, for that matter, this
White House. The same administration is now trying its damnedest
to whittle those penalties against Big Tobacco down from $130 billion to
Tuesday, January 24th, 2006
Another junk GSK drug is about to become widely available to the general public. Alli (orlistat), a weight loss drug, was given the green light by a January 23rd Food and Drug Adminstration joint advisory panel vote (11-3) which approved the drug for over-the-counter (OTC) sales.
GSK purchased rights to the drug (previously held by Roche which peddled it as Xenical.)
Safety concerns aside, some in the FDA questioned the drug's efficacy: “There is no evidence presented that a modest, transient weight loss due to orlistat will afford any long-term clinical benefit through either a change in behavior or a reduced risk of serious clinical diseases manifested by being over weight,” an FDA review of studies on the drug finds.
George Quesnelle, president of Glaxo's consumer health-care unit, said an over-the-counter diet drug "would be a significant opportunity for us." Ole' George sure got that right ... Alli is just another Glaxo strategem, an "opportunity," to rip the American drug consumer off for billions of dollars by selling it yet another crappy GlaxoSmithKline drug — one with potentially serious side effects and limited, if any, efficacy.
Dr. Sidney M. Wolfe, director of Public Citizen Health Research Group urged the panel to reject the company’s application, calling it a “desperate attempt to revive this barely effective drug by an OTC switch.” Wolfe also said "This drug doesn't work. There is no evidence that, in the long term, this drug improves morbidity or mortality related to obesity."
Wolfe noted in his testimony before the panel on Monday that the drug can also have serious side effects, especially for people taking the blood thinner Coumadin or the drug cyclosporine, used to prevent organ-transplant rejection. While the prescription version of the drug makes it necessary for doctors to monitor patients who take Xenical, that safeguard wouldn't exist in an over-the-counter setting.
The bottom line, Wolfe said, is that the drug companies are more concerned with profit and saving a struggling drug than with patient safety. The sales of the Xenical have dropped 60 percent, Wolfe said. "They obviously don't like that, so Roche, the maker of the drug, has gotten together with GlaxoSmithKline to push this stuff over the counter."
Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine said "I do not see grave danger in making orlistat available over the counter," Katz said. "But I do see cause for concern, and little reason to expect significant benefit. If the decision were based on the ratio of likely benefit to potential risk, I would be inclined to part company with the FDA, and vote no."
The FDA documents, released Jan. 20, question whether GSK’s proposed six-month treatment submitted under the trade name Alli would be beneficial for a “chronic” condition such as obesity.
FDA reviewers also questioned actual-use data submitted by GSK (sound familiar?) and pointed to potential problems associated with self-selection and label comprehension.
According to current prescribing information, a bevy of potentially distasteful and embarrassing side effects struck about half the participants in trials of the drug. Those side effects — "oily spotting" (26.6%), "flatus with discharge" (23.9%), "fecal urgency" (22.1%), "fatty/oily stool" (20%), "oily evacuation" (11.9%), "increased defecation" (10.8%) and "fecal incontinence" (7.7%) —spotted, soiled, saturated or soaked "the undergarments of trial participants."
"Have you considered placing a warning on the box, 'Don't take this product while wearing your new La Perla underwear?'" FDA panel chairman Dr. Alastair Wood quipped, referring to the Italian brand of lingerie, in one exchange with GlaxoSmithKline company executives.
Perhaps GlaxoSmithKline will provide purchasers of Alli a free supply of adult Depend diapers (or a champaigne cork.)
From an email broadcast issued by Vera Sharav of the Alliance For Human Research Protection (in response to the recent Medtronic scandal):
"This unscrupulous industry has used millions of dollars to seduce the medical profession, its teaching hospitals, professional associations, medical journals, and practice guidelines. Money has corrupted the science, the practice and the armamentarium used to treat patients. It isn't a few rotten apples — it’s the entire orchard that needs to be uprooted to rid medicine of its current culture of insatiable greed."
Here's a few more images of a Paxil withdrawal victim posing with Glaxo's bronze relief outside its Philadelphia, PA headquarters at Three Franklin Plaza:
Freedom From Paxil image #2
Freedom From Paxil image #3
And here's a snapshot of the Paxil Protest information booth and
our plane towing a protest banner overhead.
Sunday, January 22nd, 2006
Our Link of the Week" goes to this powerful potrait of a Paxil victim wielding a sign — in front of a GlaxoSmithKline sculpture — during the fall 2005 Paxil Protest held at GSK's headquarters in Philadelphia, PA. Image may need to be rescaled for full view on your computer. (Michael Moore if you want to embed this image in your upcoming movie feel free.)
I came up with the idea for the image two years earlier after catching a brief glimpse of the sculpture during a Canadian news program that went after Dr. Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline, in a hard hitting interview. (The crux of that interview revolved around the issue of drug labeling for Paxil that varies country by country.)
In the late 1990's, GlaxoSmithKline (then SKB) commissioned Zenos Frudakis to create the piece to celebrate its ungodly success in blasting Paxil revenues past the $1 billion dollar mark. It was christened "Freedom From Depression."
Twenty feet long, 10 feet high, and weighing 7,000 pounds, the piece depicts a human figure in four stages of breaking free from a wall. In designing the sculpture Frudakis explained, “I was conscious that this is a universal desire — the need to be free from some situation, be it an internal struggle or an adversarial circumstance.”
We couldn't agree more, which is why we've decided to rename the sculpture "Freedom From Paxil."
"Sunday Comix": Garnier Wants Stronger FDA.
Jean-Pierre Garnier, chief executive of GlaxoSmithKline, the world's second-biggest pharmaceutical company, has called for stronger powers to be given to America's medical regulator in an effort to tackle mounting public concern about drug safety.
In an interview with The Sunday Telegraph, Garnier said he favoured beefing up the powers of the Food and Drug Administration (FDA), the US medicines regulator. Garnier wants the FDA to be allowed to demand that pharmaceutical companies undertake further tests of medicines that have already received their marketing licence if safety concerns are raised.
Though drugs that have been approved are already constantly monitored by the FDA, at the moment the emphasis is very much on the individual companies to act. Giving the FDA mandatory powers to enforce additional tests would speed up the process, said Garnier.
"Personally, I would favour giving the right to the FDA to mandate `hypothesis-testing' clinical trials to companies, not just at the time of the approval, which they can do, but also during the life of the product ... We have always run trials on our drugs when suggested by the FDA but some companies haven't, so give them [the FDA] the mandatory power [to do so] and then the industry will benefit."
The truth is there is nothing barring GlaxoSmithKline from performing additional drug tests if the company so desired. However, running such tests would, in the case of Paxil, only prove that the drug can cause dependency. And that wouldn't be in the company's best interest.
Friday, January 20th, 2006
Michael Moore's web site announced today that he is in production for his next upcoming movie. Moore has managed to outdo himself with each new movie he has produced, so we look forward with great anticipation to his next tour de force.
Thursday, January 19th, 2006
The American public is now officially screwed. Former Food and Drug Adminstration chief counsel Daniel Troy has finally managed — after leaving the agency — to fulfill a longstanding goal by engineering legislation which immunizes drug companies from claims alleging they failed in their ''duty to warn."
"It's a typical abuse by the Bush Administration — take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry," Senator Ted Kennedy said in a prepared statement.
For a bit more background information on the machinations of Mr. Troy click on this July 13th, 2004 press release issued by Congressman Maurice Hinchey" which reads in part:
"Troy has repeatedly interceded in civil suits on behalf of drug and medical device manufacturers that were accused of harming patients who had used their products. Hinchey provided evidence that Troy worked in cooperation with the manufacturers in taking these actions, that he ignored serious conflicts of interests, and that the FDA sought to mislead Hinchey in his efforts to investigate the matter."
"The mission of the Food and Drug Administration is to ensure that the public is protected from unsafe food, drugs and other medical products," said Hinchey. "Daniel Troy is instead making it the agency's mission to protect the drug companies from being held accountable when their products do serious harm. This is not merely a question of financial compensation for the victims and their families. Civil action is a vital tool in gaining information about medical products and protecting future users of those products. Mr. Troy is trying to take that tool away from the public his agency is supposed to protect."
Hinchey has learned that in at least four separate cases, Troy's Chief Counsel office has submitted briefs arguing the side of the defendant corporation against the families of people who died after using that corporation's product. In three of those cases, Hinchey found evidence of inappropriate collusion or conflict of interest between Troy and the companies the counsel's office stood up for.
Association of Trial Lawyers of America response (excerpt):
The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process,” said Ken Suggs, President of the Association of Trial Lawyers of America (ATLA).
“Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety and an FDA that is beholden to the drug companies it is supposed to regulate,” he continued.
To read the ATLA press release in its entirety click here .
Wednesday, January 18th, 2006
A new page has been added to this site: GlaxoSmithSlime: "The Lighter Side of PaxHell."
Sunday, January 15th, 2006
Our "Link of the Week" goes to Number of US Citizens at Risk to SSRIs.
Contrast that analysis with recent reports in the media of a new study that claims there is no link between adult suicidality and the use of SSRIs.
Dr. Robet Temple, FDA Medical Policy Director of the Center for Drug Evaluation & Research dismisses the findings of the new study (published in the American Journal of Psychiatry and sponsored by the National Institute of Mental Health.) Dr. Temple (in the FDA "Pink Sheet") stated:
"The new study bears only a tangential relationship at best to the previous information…. "the new study doesn't have an untreated group. They have no information at all about what would have happened to those people had they not been treated. It simply sheds no light at all on the particular point raised in the labeling or the analysis of those trials."
"Sunday comix": Who let the dogs out?
Sunday, January 8th, 2006
Our "Link of the Week" goes to The Karasik Conspiracy.
The Los Angeles Times suggested: "think 'True Lies' meets the Physicians Desk Reference." This is the book the industry's trade organization, the Pharmaceutical Research and Manufacturers Association (PhRMA), tried to commission. The book has turned out to be the most revealing portrait of PhRMA's modus operandi and an example of its devious dirty tricks. One of the better links from the site is The Backstory.
"Sunday comix": Following the merger between SmithKline Beecham and Glaxo Wellcome (which created GlaxoSmithKline) SKB's former CEO, Jan Leschly, spoke at an annual convention of the "Institute of Directors" where he told the audience he had given his twenty-something son $2 million to start a new venture in America — a business that "extracts biomolecules from excrement." ("How," Leschly asked the audience, "can we attract talented twenty-eight year olds into the Industry to do what they want to do?") Six months later, Leschly Jr. — having reportedly built the venture into a credible commercial entity according to Leschly Sr. — sold it for $200 million. That averages out to a tidy profit of just over a million dollars a day for 180 days — not a bad ROI. (And if you believe that I've got "a little pink pill" I'd like to sell you....)
Thursday, January 5th, 2006
In Breaking News (August, 2005) I wrote about our efforts to secure a permit for the Paxil Protest from the city of Philadelphia wherein I contacted the American Civil Liberties Union of Philadelphia seeking advice.
On June 27th, ACLU staff attorney Mary Catherine Roper responded via e-mail: Can we schedule a time to talk about your permit process? I am happy to help if the city gives you undue trouble, but we may be able to avoid that with a little advance planning. As for the day of the action, you’ll have to let me know when that is. We may be able to help arrange legal observers and provide information (including defense lawyer contacts) in advance of the action, and I will do what I can to make sure you are able to demonstrate in accordance with your permit. Ms. Roper also volunteered to submit the application (sent to her attention via overnight mail) to the city on our behalf.
A month filled with follow up phone calls and e-mails from me ensued, sans permit. It was later discovered — after contacting the city directly — that the application was never submitted.
Ms. Roper did not respond to subsequent inquiries about the matter, much less offer any explanation.
This month, hot on the trail of some other information, I connected "a couple of SSRI dots": Ms. Roper is a former partner of a law firm representing GlaxoSmithKline in its Paxil product liability — Drinker, Biddle & Reath. (See our GSK Legal Team web page.)
Sunday, January 1st, 2006
Our "Link of the Week" goes to The Corporation. (Now playing on many cable TV outlets.)
THE CORPORATION explores the nature and spectacular rise of the dominant institution of our time. Footage from pop culture, advertising, TV news, and corporate propaganda, illuminates the corporation's grip on our lives. Taking its legal status as a "person" to its logical conclusion, the film puts the corporation on the psychiatrist's couch to ask "What kind of person is it?" Provoking, witty, sweepingly informative, The Corporation includes forty interviews with corporate insiders and critics — including Milton Friedman, Noam Chomsky, Naomi Klein, and Michael Moore — plus true confessions, case studies and strategies for change.
Winner of 24 INTERNATIONAL AWARDS, 10 of them AUDIENCE CHOICE AWARDS including the AUDIENCE AWARD for DOCUMENTARY in WORLD CINEMA at the 2004 SUNDANCE FILM FESTIVAL. The long-awaited DVD, available now in Australia and coming in March to North America, contains over 8 hour of additional footage.
The film is based on the book The Corporation: The Pathological Pursuit of Profit and Power by Joel Bakan.
Saturday, December 31st, 2005
The year 2005 ends, and not one of the Protest Demands (made by us on behalf of, and for, the public welfare) is addressed by GlaxoSmithKline. Until, and unless, there is some sort of unified public outcry it is unlikely GSK will ever address the Paxil disaster in a responsible manner. (Think W.R. Grace and the town of Libby, Montana or Union Carbide and Bhopal.)
This is how it oftentimes works in the corporate world: if a company can get away with it — they'll do just that.
At least we're trying (and we're not about to stop.)
Sunday, December 24th, 2005
Our "Link of the Week" goes to The Emperor's New Drugs.
First published on July 15th, 2002 this meta-analysis of the Food and Drug Administration (FDA) database of controlled trials used in the initial approval for the most popular antidepressants, I. Kirsch, T. J. Moore, A. Scoboria, and S. S. Nicholls (2002) found that antidepressants demonstrated a clinically negligible advantage over inert placebo. These results are surprising, because they come from studies underwritten by the drug manufacturers. This analysis probably overestimates the antidepressant effect because placebo washout strategies, penetration of the blind, reliance on clinician ratings, use of sedative medication, and replacement of nonresponders may penalize the placebo condition or boost the drug condition. These findings do not appear to justify the popularity of antidepressants, which may have been fueled in part by publication bias and outstanding marketing. Psychotherapy may offer an effective alternative with fewer medical risks.
Last week was a bit of a "chessboard victory" for our consumer advocacy efforts. We "sacrificed a pawn" to fashion an opening which GSK's attorneys — as expected — rushed right into. The result? GSK's loss of the public relations equivalent of a bishop. (See Wednesday, December 21st below.) Michael Moore, are you getting all of this?!
Sanofi-Winthrop recently unveiled its marketing campaign for a "controlled release" version of the hypnotic sleep aid "Ambien." (By the way, Paxil was originally trademarked in the United States under "Goods and Services" as a hypnotic. See A Dark History.) In its product information, under "Information For Patients Taking Ambien", Sanofi-Winthrop, to its credit, clearly explains for consumers what drug "dependency" is:
(Sleep) medicines can cause dependence, especially when these medicines are used regularly ... Some people develop a need to continue taking their medicines. This is known as dependence or "addiction."
When people develop dependence they may have difficulty stopping the (sleep) medicine. If the medicine is suddenly stopped, the body is not able to function normally and unpleasant symptoms may occur (see Withdrawal.) They may find that they have to keep taking the medicines either at the prescribed dose or at increasing doses just to avoid withdrawal symptoms.
Ambien and Paxil.
Same addiction — dependency — withdrawal profile.
Wednesday, December 21st, 2005
A couple of GSK's attorneys recently found themselves caught off guard with the publication of our new "GSK Legal Team" web page. Although injunctive relief was sought but not obtained: we did decide (unilaterally) to make "some accomodations."
At the same time one must ask why GSK's attorneys did not, and are not, seeking an injunction to shut this website down (along with the Google AdWord campaign.) "Mr. Robinson, don't send us any more annoying Merry Christmas emails or cards — but that Paxil Protest web site which draws thousands and thousands of visitors each month? ... well, that's o.k. we don't have a problem with that." It speaks volumes.
Sunday, December 18th, 2005
We've added a new web page: GSK Legal Team.
Our "Link of the Week" goes to a lecture by David Healy, M.D., a psychiatrist, historian — and one of the world's leading experts on drugs like Paxil. See Psychopharmacology in Turmoil: an ethical or scientific crisis?
Saturday, December 17th, 2005
We are finishing up a new web page dedicated to and documenting the nexus of law firms and attorneys (United States) serving as counsel for GlaxoSmithKline's Paxil product liability.
On that same page we're also going to tell you about the stupendous legal error made by an attorney representing GSK that led to the release of five highly confidential and damning GlaxoSmithKline documents.
Sunday, December 11th, 2005
Our "Link of the Week" goes to the Government Accountability Project's Fact Squad on Prescription Drugs.
The GAP is is a 28-year-old nonprofit public interest group that promotes government and corporate accountability by advancing occupational free speech, defending whistleblowers, and empowering citizen activists.
According to GAP:
....a October 2005 Harris Poll [reveals] only nine percent of the American public considers the pharmaceutical industry generally honest and trustworthy.
If perception were reality, the prescription drug industry would be in Chapter 11....
Not only do Americans not trust the industry, but there is a crisis of confidence in the FDA as an impartial arbiter of drug safety and effectiveness. The public understands that “He who pays the piper calls the tune.” More than half of the agency’s drug budget comes from industry user fees earmarked for speeding up the approval of drugs. As a result, the FDA, long established as the “gold standard” of consumer protection against industry’s dangerous drugs, now treats the industry as its primary client.
If we, the public, can’t rely on either industry or FDA to tell it to us straight, then where can we turn for independent and reliable information about prescription drugs?
GAP has set out to help fill this void with our own “Fact Squad” of experts, compiled with the guidance of award-winning investigative journalist Jeanne Lenzer. In commending this “Fact Squad” to the public and the news media, we ask that you take note of their backgrounds, education and accomplishments, and give due consideration to their perspectives. The pharmaceutical industry has a story to tell — and a bottomless bank account with which to tell it — but it is a self-interested story. Our “Fact Squad” will help complete the picture by bringing into focus the findings of experts whose first concern is the public interest.
On September 16th of this year we reported that the Therapeutic Goods Administration (Australia) reclassified Paxil (a.k.a. Aropax) from a pregnancy "category C" drug to a "category D" drug, recommending it be avoided in pregnancy.
Three months later and the United States Food and Drug Administration (FDA) has likewise determined that exposure to Paxil in the first trimester of pregnancy may increase the risk for congenital malformations — particularly cardiac malformations. At the FDA’s behest, GlaxoSmithKline has changed Paxil's pregnancy category from C to D and added new data and recommendations to the Warnings section of paroxetine’s prescribing information.
To see the Food and Drug Administration's previous (2003) teratogenicity (the property or capability of producing fetal malformation) ratings of common antidepressants click here. (PDF document)
Sunday, December 4th, 2005
Our "Link of the Week": The Center for Public Integrity. Here's an excellent web site you'll want to spend some serious time exploring if the header "Pushing Prescriptions: How the drug industry sells its agenda at your expense" holds any interest.
Here's the link for the FDA's November 21st regulatory "kiss of death" for the Advair Diskus, GlaxoSmithKline's multibillion dollar asthma drug (affectionately known as the "death inhaler".) Background: In 1996, GlaxoSmithKline put its other asthma medication (Serevent) to the test in a 28-week trial designed to determine its safety and effectiveness (Advair has the same active ingredient as Serevent.) Though the study indicated an increased risk of fatal asthma attacks brought on by the medication, GSK (and the FDA) failed to take immediate action to protect consumers. In fact, it wasn't until August 2003 that an Advair/Serevent "FDA black box warning" was added to the drug's labeling warning consumers about rare, but deadly, risks posed by GlaxoSmithKline's blockbuster medication. This is consistent with GSK's business modus operandi: The acquisition of multibillion dollar profits (and protecting them at all costs) always trumps the obligation to disclose proper drug safety warnings to the public. Always.
In a November 27th interview with The Times Online GSK's CEO Jean-Pierre Garnier claimed he was not concerned about this recent regulatory "setback" even though Advair is GSK's biggest-selling product.
Garnier said Advair (sold as Seretide in Europe) had been prescribed 80 million times and had achieved “a high degree of satisfaction” among patients ... that it was rarely used as the first choice of treatment for asthma, so the restrictions should not be “a huge event.” (Contrary to Mr. Garnier's claims, according to financial analysts, twenty five percent of all Advair prescriptions are written as a front-line treatment for asthma and chronic pulmonary obstructive disorder (COPD). These prescriptions were given despite the black box warning on all Advair products indicating the life-threatening paradoxical effects of this medication.)
If, in Garnier's view, seeing a few billion in GSK's stock value vaporize overnight, and having the company's top-selling drug (four billion in 2004 sales) flagged with additional severe FDA restrictions doesn't qualify as a "huge event" leads one to wonder what, in his mind, does. (His cameo appearance in Michael Moore's new movie, perhaps?)
In that same Times Online article Garnier failed to mention that the "80 million scrips" satisfaction figure he tossed out did not include the hundreds, perhaps thousands, of people who have used Advair — only to be killed by it. (Like huffing a can of Raid bug spray.)
Finally, in that same article Garnier "indicate(d) his growing confidence in the new medicines emerging from Glaxo’s pipeline." The investing public should have about as much confidence in Garnier's "growing confidence" as the confidence one accords a world class con artist. After all, Mr. Garnier is — if anything — a pathological liar. For more on GSK's Fantasy Drug Product Pipeline visit our recently updated "Welcome" page.
Sunday, November 27th, 2005
Our "Link of the Week": The Paxil Petition
According to the petition: We, the individuals listed below, have electronically signed this petition with the goal of stopping SmithKline Beecham (now GlaxoSmithKline), the drug manufacturing company, from falsely marketing, advertising and soliciting the popular SSRI Antidepressant drug Paxil (Seroxat).
SKB falsely advertises, through its Paxil labeling and otherwise, that only drug abusers are at risk of physical and psychological dependence, and withdrawal problems when tapering back or abruptly discontinuing Paxil usage. SKB knows such representations are false, and that all patients, including patients not having a history of drug abuse, are susceptible to withdrawal problems after tapering back or abruptly discontinuing Paxil.
SKB either knows or intentionally does not gather facts showing that massive numbers of Paxil patients are being addicted to Paxil.
SKB boasts to the public in advertising that Paxil's "half life" is good for the patient, that a short half life specifically refines brain chemistry and reduces side effects — but they fail to tell the public that Paxil's half life is bad for the patient in terms of addiction and withdrawal problems.
Tuesday, November 22nd, 2005
Our "cyberspace python" still has GlaxoSmithKline trapped in its coils, in spite of legal maneuverings by GSK to wrestle free. It's safe to say the public relations squeeze is going last for years....
Investors savaged the GlaxoSmithKline share price last week, wiping almost 4% off the drugs group's value as the market reacted to a ruling in the United States on how the company should label its best-selling asthma drug.
The Food and Drug Administration (FDA) recommended late on Friday that Glaxo's Advair asthma treatment — an inhaled steroid that is sold as Seretide in Europe — should be re-labelled to make it clear that the drug should only be prescribed for patients who had not responded to other medication. In short the FDA is saying Advair should be prescribed as a last resort. (We have a narrative on Advair we hope to upload sooner than later.)
Our "Quitting Paxil" page is proving to be this web site's most popular page. Additionally, we seeing a growing number of visitors to that page who have linked to it directly — meaning people are cc'ing a link to it to family, friends and associates.
Last week Fortune magazine published a piece entitled Trouble in Prozac Nation (which was our "link of the week." )
Not to be outdone by Fortune, Time magazine published in its Asia edition a lengthy SSRI-related story entitled Bitter Pills.
Then there was an essay that appeared in the Public Library of Science (PLOS): Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature by Jeffrey R. Lacasse and Jonathan Leo.
In a subsequent New Scientist article entitled Television Adverts for Antidepressants Cause Anxiety Leo quips “Low serotonin levels no more cause depression than low aspirin levels cause headache.”
According to Lacasse and Leo, the mismatch between the scientific literature and the SSRI advertisements is "remarkable, and possibly unparalleled." (The Irish equivalent of the FDA, the Irish Medicines Board, recently banned GlaxoSmithKline from claiming in their patient information leaflets that Paxil corrects a chemical imbalance; the FDA has never taken any similar action on this issue.)
Commenting on Lacasse and Leo's work, Dr. David Healy, said: "The serotonin theory of depression is comparable to the masturbatory theory of insanity. Both have been depletion theories, both have survived in spite of the evidence, both contain an implicit message as to what people ought to do. In the case of these myths, the key question is whose interests are being served by a widespread promulgation of such views rather than how do we test this theory."
Dr. Joanna Moncrieff, Senior Lecturer in Psychiatry at University College London, said: "It is high time that it was stated clearly that the serotonin imbalance theory of depression is not supported by the scientific evidence or by expert opinion. Through misleading publicity the pharmaceutical industry has helped to ensure that most of the general public is unaware of this."
While making the rounds through cyberspace you should also check out the Wall Street Journal article Some Drugs Work To Treat Depression, But It Isn't Clear How. (Hint: it's the placebo effect.)
The House passed the Child Medication Safety Act (HR 1790)
sponsored by Cong John Kline of Minnesota. The purpose of this Act is to
restore parental authority over decisions about their children's health
care: "to protect children and their parents from being coerced into
administering a controlled substance or a psychotropic drug in order to
attend school." The ACT passed by 407 to 12 votes. Dr. Karen Effrem, board member of AHRP, EdWatch and ICSPP led the charge by educating legislators about the harm being done to children who are misdiagnosed as mentally ill, then coerced into taking dangerous, mind-altering controlled substances over their parents' objections. Dr. Effrem presented testimony to Congress
about this issue.
Sunday, November 20th, 2005
Our "Link of the Week" goes to Fortune magazine's Trouble in Prozac Nation. Assiduously researched and written by Fortune's senior writer David Stipp, this article provides a high resolution "3-D" view of the growing SSRI controversy.
Sunday, November 13th, 2005
Our "Link of the Week" goes to Prescription: Suicide?. This film "takes the American public, for the first time, into the actual lives of those who have experienced first hand the use of antidepressants with their children, bringing the audience to the forefront of this currently unfolding live public debate. The film is both witness and catalyst to this moment. What emerges is a loving and fearless testament to family values and the universal struggle to survive as a family. Reluctant at first but wanting to share their personal tragedies so that others could hopefully be spared similar experiences, these six families courageously put aside their personal considerations and allow the audience to take an intimate look at the personal impact of antidepressant drugs on their children."
Prescription: Suicide? can perhaps be viewed as "the opening act" for Michael Moore's 2006 assault on "Big Pharma."
Saturday, November 12th, 2005
Our Paxil cyberspace "total information awareness" campaign (a.k.a "Phase II") continues to be a "bone crushing" success story. Launched on September 11th, 2005, the campaign has (as of today) reached a total of 277,286 individuals, or roughly 4,621 people per day. And this is just the beginning.
Glaxo's attorneys spent last week trying to stop the campaign. Their only "success" was in barring us from using the trademarked word "Paxil" in our efforts. We figured out a novel way to work around that restriction inside of 24 hours.
If all of this is so bad for the company then why, you might wonder, is GSK not suing us (the Paxil Protest.) That is an excellent question. Ask Glaxo.
Sunday, November 6th, 2005
Our "Link of the Week" goes to the Consumers Union web site called "Prescription For Change" which seeks to draw attention back to the urgent need for drug safety reform.
A narrative incorporating the second day of the Paxil Protest is now available.
Friday, November 4th, 2005
It appears we (the public) have reestablished our cyberspace death grip over Glaxo inside of 24 hours — and even managed to tighten our stranglehold. The battle will probably reach a new frenzy by tomorrow morning.
Speaking of "strangleholds": Just wait till Michael Moore's new movie comes out in 2006. It's going to be "Fahrenheit 911" for Big Pharma. And that, of course, includes GlaxoSmithKline.
Thursday, November 3rd, 2005
A new movie called Prescription: Suicide? is set to debut on November 10th. You can view a short trailer by clicking here. (This is an mp4 file and requires Quicktime Media Player.)
GlaxoSmithKline is doing everything in its power to free itself from the coils of the cyberspace "boa constrictor" we recently turned loose on the company. Not surprisingly, Glaxo is fighting back like a cornered (corporate) rat — so we're having to make some subtle, if you will, "adjustments" to maintain our public relations death grip.
It's only a matter of hours, days, or weeks, before the media figures out for itself what we're up to and runs with it....
Wednesday, November 2nd, 2005
In a Today Show interview actress Brooke Shields said that her withdrawal from Paxil, "was devastating when I went off of it, because I went off of it cold turkey, against what my doctors told me."
Are there any more celebrities out there like Brooke willing step forward to tell the world the truth about GlaxoSmithKline's jagged little pill? We'll lay odds that "half of Hollywood" is floating around tinsel town in a Paxil-induced fog and, further, that quite a few of Ms. Shields peers have stumbled onto Paxil's vicious little secret when they tried to quit the drug.
A former pharmaceutical salesman who was fired by GlaxoSmithKline (GSK) has filed a $6 million whistleblower lawsuit against the London-based drug manufacturer.
In the suit, filed Friday in Davidson County (TN) Chancery Court, Scott McRae of Wilson County claims he was dismissed because he refused to lavish gifts on doctors and promote drugs (including Paxil) for non-approved treatments.
Patty Seif, a spokeswoman in GlaxoSmithKline’s U.S. headquarters office in Philadelphia, said the company had not seen the lawsuit and couldn’t comment on it. But she said the company does not engage in the practices described in the suit.
Why, of course not. After all, such practices would directly contradict what GSK Chairman Christopher Gent and GSK CEO Jean-Pierre Garnier said in a joint statement called GSK's 2004 "Corporate Responsibility Report." To wit:
Great (GSK) products, however, are not the whole story — society expects companies to act responsibly in their pursuit of success. If anything, the fact that our business is about human health makes it even more important that we operate to the highest standards.
Monday, October 31st, 2005
The P.R. charade continues ... J.P. Garnier, GSK’s CEO, said that his company would release the patents to the flu "drug" sold under the trade name Relenza.
“This is not about money. We have got to find a way to make more Relenza,” Garnier said.
Not about money. But, of course it isn't. Just like the multibillion dollar Paxil fraud Mr. Garnier helped mastermind was "not about money."
What did Michael Elashoff, biostatistician, and a drug reviewer for the FDA from 1995 to 2000 have to say about Relenza and it's approval by the Agency in this February 19th, 2000 interview with PBS? "Simply stated, Relenza just didn't work in the United States' clinical trials, and really didn't even come close to working. You think the flu can be seven to 10 days, and it maybe knocked half a day or less off the duration. Even that wasn't established statistically. So it was pretty much no different from placebo as far as efficacy, and it had some potential safety concerns, especially in people with underlying lung disease."
Sunday, October 30th, 2005
Our "Link of the Week" is a recent interview with government "whistleblower" Allen Jones. Mr. Jones' lawsuit is set to "rock Big Pharma's world," and possibly that of the Bush Adminstration. See A Lone Wolf Talks on the Drug Leviathan.
Saturday, October 29th, 2005
GlaxoSmithKline's CEO Jean-Pierre Garnier continues to mount his "hey I'm a good guy and we're a great company" P.R. campaign — trying to stay one step ahead the Paxil fraud scandal threatening to blow up in the company's face, and Michael Moore's soon-to-be-released movie "Sicko." We anticipate seeing GlaxoSmithKline, along with Mr. Garnier, crucified, if you will, in Moore's movie — as well they should be.
Mr. Garnier's latest good guy gambit revolves around exploiting bird flu fears. Today, we learned GlaxoSmithKline clinical trials for a vaccine against the H5N1 strain of bird flu will begin soon and should be done by summer.
"We're pulling out all the stops to do everything we can to be ready to help various governments to have their planning in place at the time, and if, there is a catastrophic event," said Glaxo Chief Executive J.P. Garnier.
"Pulling out all the stops." Right. Just like GlaxoSmithKline pulled out all the stops in the past to warn the public about the suicide danger, addiction/dependency and withdrawal problems associated with the use of Paxil. (And that's just one "problematic" GSK drug.)
What Glaxo is doing, in reality, is pulling out all the stops to try and save its own public relations hide.
On the heels of the September, 2005 Paxil Protest: a GSK spokeswoman said they (GSK) did not agree with "the science" of the protestors' "claims."
The subtext of this message was: "Whose science are you going to believe? That of a big and powerful pharmaceutical company, or those protestors?" If there's any issue about science in all of this whole Paxil business, then it concerns the "science of corporate fraud," and that comment was just the opening we've been waiting for. To wit: We are ready to annihilate GlaxoSmithKline's "science firewall" defense using information extracted from the company itself. This approach is consistent with our strategy to, whenever possible, employ GSK's "good" company name, cheery slogans, marketing stratagems, dummied clinical trials, ghost written scientific articles, perjured testimony, vacuous public statements, "Orwellian" propaganda and so on — as P.R. weapons against the company itself.
Friday, October 28th, 2005
GlaxoSmithKline's "Google" Paxil ads are back online today; yesterday we reported they were off. We thought perhaps the disappearance of the ads had something to do with GlaxoSmithKline revising their key word search phrases related to bipolar disorder, but nope — they're still on the list. So the cyberspace battle continues. The good news is we are firmly coiled around, if you will, GSK's "Internet body" — like a boa constrictor in cyberspace — squeezing the company in a public relations death grip that, with each passing minute, hour and day, grows tighter and tighter.
Thursday, October 27th, 2005
"Phase II" of our Paxil "total information awareness" campaign has become a spectacular success inside of 72 hours. Today, GlaxoSmithKline yanked its Paxil and Paxil CR ads off the Internet.
But we've only just begun, and there's a whole lot more to come....
"Phase II" is perhaps the most brilliant (legal) consumer advocacy attack ever unleashed on a corporate hyperpower using the new found power of the Internet. They'll likely write about it one day in textbooks.
Michael Moore are you watching this drama unfold?!
We haven't forgotten about publishing the rest of a narrative for the first Paxil Protest. Please be patient ... we've been extremely busy with more pressing projects consuming our time.
Tuesday, October 25th, 2005
One of our current projects involves documenting and analyzing GlaxoSmithKline's use of the Internet to market its drug Paxil. To do this, we extracted all the Google AdWords from two GSK web sites — www.paxil.com and www.paxilcr.com — and began loading each word or phrase into the Google search engine to see what came up.
Paxil is only approved for a narrow range of conditions; those conditions do not include bipolar disorder. Yet keywords for GSK's www.LifeIsWaiting.com Paxil web site (where they don't say the name of the drug so they don't have to display the suicide Black Box Warning) include 21 phrases specifically related to bipolar disorder. Why? Paxil is approved by the Food and Drug Administration only for treatment of PTSD, GAD, SAD, PD, OCD and MDD. Paxil is not approved to treat bipolar disorder; moreover, we've never heard of physicians prescribing Paxil "off label" to treat bipolar disorder.
Curious to see why, we loaded the GSK's Google AdWord phrase "childhood bipolar disorder" into the Google search engine and expected a "www.LifeIsWaiting.com", "www.Paxil.com" or "www.PaxilCR.com" ad to pop up. No luck. Next, we scrolled the ads on the right side of the Google search results page looking for clues. We clicked on (it had a "GSK smell" to it) the web site ad:
"Suffering From Depression?
Find out how to get a 30 free trial of medication here today."
A web site appeared and asked — not if your child has "childhood bipolar disorder"— but if you (or your child?) have Social Phobia, or Social Anxiety Disorder. We clicked on the "yes" button to see what would happen. Voila! We were redirected to the GSK's Paxil web site LifeIsWaiting.
We find this highly irregular, and so have decided to list for the public, using a matrix style form, every single "Life Is Waiting", Paxil and Paxil CR key word or search phrase GlaxoSmithKline employs — and then show how each word or phrase is used "like a trail of bread crumbs" to lure the unsuspecting public to the doorstep of "Grandma Glaxo's gingerbread Paxil house." It's a marketing nightmare snatched right out of the Black Forest of the Grimm Brothers' fairy tale "Hansel and Gretal."
Sunday, October 23rd, 2005
Our "Link of the Week" goes to Darcy Baston's Internet-based Paxil withdrawal support group and forum called PaxilProgress. If you are struggling to break free from a Paxil addiction — and are seeking support from kindred spirits — then look no further: this is the place to go.
Saturday, October 22nd, 2005
Check out our new page entitled E Mails From The Edge.
We have just learned that GlaxoSmithKline has released a new "blockbuster" drug. "Panexa," co-developed with and distributed by drug company Merd, will be phased in as a replacement for GlaxoSmithKline's dangerous and defective drug Paxil. According to GSK's promotional material for Panexa:
No matter what you do or where you go, you're always going to be yourself. And Panexa knows this. Your lifestyle is one of the biggest factors in choosing how to live. Why trust it to anything less? Panexa is proven to provide more medication to those who take it than any other comparable solution. Panexa is the right choice, the safe choice. The only choice.
For more information visit the GlaxoSmithKline-Merd Panexa web site. By the way, it is satire. If the Panexa web site gives rise to a smile, then check out the Fukitol web site.
Friday, October 21st, 2005
Phase II of our Paxil "total information awareness" campaign is exploding like a thousand super novas in cyberspace. It seems we have gained an extraordinarily powerful ally (or two) in the computer industry who is on to what we are doing, and attempting to help us to the extent they can. You know who you are. ("Do no evil.") Thank you (and thank God.) This effort has been like trying to drive a public relations stake through the heart of a corporate vampire using a "cyber toothpick." We need all the help we can get.
Today we came across at GSK's Netherlands web site the following GSK video: "Do More, Feel Better, Live Longer". (Windows Media Player/RealOne Player/broadband required.)
As we viewed (in horror) this slick piece of corporate propaganda for the first time: all we could think of were the untold hundreds of thousands, perhaps millions, of innocent people maimed or killed by dangerous GSK drugs mixed with deadly corporate deception.
"Do More, Feel Better, Live Longer." Right.
The GSK video is the doppleganger of a (broadband) tribute to the World Trade Center tower attacks and subsequent collapse set to the song "Only Time" by Enya. (Also viewable at this link. Slow loading, but better quality.)
We'd like to see a "GSK drug Holocaust" Enya-style tribute in honor and in memory of the victims of the following GlaxoSmithKline drugs (and corporate deception):
the Trivax vaccine
the LYMErix vaccine
Serevent (narrative being prepared)
Advair (narrative being prepared)
— and God only knows all the other GSK drugs we don't know the truth about.
And let's not forget those orphaned infants and children who have been experimented on like guinea pigs at the NYC Incarnation Children’s Center.
Wednesday, October 19th, 2005
Subsequent to the conclusion of the first Paxil Protest we launched "phase II" of our Paxil "total information awareness" campaign. Once again, the Internet is revealing its awesome power to essentially level the playing field between a corporate hyperpower (i.e. GlaxoSmithKline) and the general public. "Just ask GSK."
Sunday, October 16th, 2005
Our "Link of the Week" goes to the PBS Frontline special "Dangerous Prescription". More than a dozen dangerous drugs have been pulled off the market since 1997. Why were they approved in the first place? An investigation of America's drug safety system.
Over the past year or so we have been tracking down, sifting through and evaluating information needed to construct a detailed narrative and timeline chronicling the fraud behind Paxil. We have almost reached the endpoint of that effort and expect to publish our findings to this site by year's end — if not sooner.
Saturday, October 15th, 2005
Plans for a spring, 2006 Paxil Protest are nearing completion. We anticipate extending the length of the protest from three to five business days. All that remains is choosing the dates, and securing a permit with the city of Philadelphia.
To boost local turnout, a sustained public awareness campaign designed to saturate the Philadelphia region with news of the event is in the works; for this the public can thank a Washington D.C.-based marketing guru who has offered to help with the effort.
Friday, October 14th, 2005
Is this the Big Pharma corporate version of an "axis of evil"?: the Texas Medication Algorithm Project (TMAP), TeenScreen, and President Bush's New Freedom Commission on Mental Health. Possibly. The following interview with "whistleblower" Allen Jones casts a disturbing light into the corners of a very dark room which these programs share. See A Lone Wolf Talks on the Drug Leviathan.
Thursday, October 13th, 2005
Part I of a narrative recounting details of the first Paxil Protest is online.
Given the concern over a potential worldwide "bird flu" pandemic: we mentioned in recent days how Glaxo is working to capitalize on the situation. GSK's pumping up sales of its worthless drug Relenza are part of the strategy. Already we have a full page devoted to exposing the truth about this drug, but to it we add this interview with Michael Elashoff. A biostatistician, Mr. Elashoff was a drug reviewer for the FDA from 1995 to 2000. Elashoff says he found himself marginalized at the FDA after he voiced his concerns about (what was then) a new flu drug called Relenza. In this interview, Elashoff speaks out about the culture of the FDA's drug approval process and why he felt Relenza should not have been put on the market. This interview was conducted on Feb. 19, 2003.
We added a new web page entitled Audiovisual Links.
Wednesday, October 12th, 2005
Mr. Garnier's public relations handlers at GlaxoSmithKline are doing their best to cast their CEO as a kind, caring and considerate man. It's a transparent and predictable effort to get out ahead of the unfolding Paxil scandal and, quite likely, Garnier being marched to the public opinion gallows in Michael Moore's upcoming movie (tentatively called "Sicko.")
In recent days we witnessed Mr. Garnier schmoozing it up with President Bush while discussing the bird flu-vaccines issue. Today, it's a fluff interview in Accountancy Age: "The men who run these huge companies are only too keen to drone on about corporate philanthropy. Usually, they are best ignored, but Garnier is different."
We agree he's "different" alright — but not for the reasons suggested by the story's author.
The interview Paxil victims look forward to is the one wherein Mr. Garnier is questioned by plaintiffs' attorneys in a much delayed 2006 "Paxil withdrawal trial."
Monday, October 10th, 2005
Join us in spring, 2006 for the second Paxil Protest. Location: GSK's U.S. headquarters in Philadelphia, PA. Dates to be announced soon.
We've added a bit of content to our web page Mauled by Myodil, including news of a class action suit filed against GlaxoSmithKline in Australia by survivors of the drug.
Of several Myodil-related news stories we researched is a standout piece entitled "The Spiderman in a Race Against Time" — a must read item for anyone with an interest in this subject matter. Excerpt: In a newspaper report published in England in 1992 one female Arachnoiditis sufferer describing the pain said “I’d rather go through the pain of having 10 babies every day for the rest of my life than have to put up with this pain.” It was also reported in the same paper that such is the intense pain that another victim killed herself by putting her head in a plastic bag and in one final act, donated her spine to research into the condition. Most sufferers said they often contemplated suicide as it had seemed a better option than facing life trapped in what they described as “a living death”.
Several dozen hyperlinks to news stories have been added to our Articles to Browse page in recent weeks.
Yesterday we mentioned a meeting between GlaxoSmithKline's CEO Jean-Pierre Garnier and President Bush. Today we have a follow-up question for the public to mull over: "Why is the president of the United States agreeing to meet with the head of a company that — since March of 1997 — has been ordered by the U.S. Department of Justice to pay more than $562 million dollars in civil fines to resolve allegations that the company had on three separate occasions defrauded the federal Medicare and Medicaid programs? To answer that question the public will likely have to wait until mid 2006 when Michael Moore's new movie focusing on the pharmaceuticals industry is due out.
Sunday, October 9th, 2005
Link of the Week: "How Pharmaceutical Companies Mold
our Perceptions of Mental Illness" (Windows Media Player or RealOne Player required)
This audiovisual presentation of Dr. David Healy lays out the case for bias, faulty data analysis, and manipulated clinical trial finding reports as manifested in the psychiatric literature. In his lecture (Columbia University Medical Center-October 20, 2003), Dr. Healy demonstrated how current clinical practice guidelines that purport to be "evidence-based" are not based on scientifically valid evidence at all.
For those who are unaware of Dr. Healy's contribution to the credibility crisis in psychiatry: his analysis of previously undisclosed company data from SSRI drug trials contradicted the published reports about these trials. His findings of a drug-induced suicide risk challenged the mindset and prescribing practices of the psychiatric establishment in the UK, Canada, Australia, and the US. By bringing the undisclosed hazards to public notice, the debate about the efficacy and safety of SSRIs — and the validity of the process by which they were tested — reached a crescendo.
Families whose children became suicidal after being prescribed an SSRI — some becoming casualties of drug-induced suicide — came to Washington from coast to coast to testify before two FDA advisory committee hearings (in February and September, 2004). Their compelling testimonies, coupled with independent analyses replicating Dr. Healy's, resulted in mandatory Black Box warnings about the drugs posing a twofold risk of suicidal behavior for adolescents.
Corporate profits "apex predator" Jean-Pierre Garnier, CEO of GlaxoSmithKline, is striving to position his company to snap up potentially huge vaccine-related profits resulting from growing world fears of a bird flu pandemic. In a transparent and vacuous public relations ploy ("see...I'm one of the good guys") Mr. Garnier met with President George Bush on October 7th "to review ways in which the industry can support the US Government in its plans to respond to potential global flu pandemic."
Never mind the fact that — according to the Centers for Disease Control and Prevention (U.S.) — currently there is no vaccine to protect humans against the H5N1 virus that is being seen in Asia. Moreover, GSK's track record with producing safe, effective and reliable drug products is a dubious one — including vaccines. See Trounced by Trivax.
In an October 7th press release issued by GlaxoSmithKline Mr. Garnier "commend(s) President Bush for actively planning to protect the American public...." Given Mr. Garnier's complete and utter disregard for the safety of the public (to cite just one example: his role in the Paxil fraud) Garnier's commendation is meaningless.
GSK also seeks to use that same press release as a launchpad to boost potential sales for its worthless drug Relenza into the profits stratosphere: "Relenza is one of several antiviral drugs that could be considered for the treatment of influenza. Currently, pandemic concerns have increased demand for available supplies of Relenza."
Friday, October 7th, 2005
GlaxoSmithKline is this morning facing new allegations that it withheld important safety data on one of its most important drugs.
An American consumer campaign group claims GSK manipulated results of a 26,000-patient study of its asthma treatment Serevent, which is known as Advair when in combination with another drug.
In a letter published in The Lancet, the medical journal, today, Public Citizen says the company "manipulated the data it submitted to the Food & Drug Administration, the US regulator, in an apparent attempt to convince the agency that the drug's risks were smaller".
This development comes to light, coincidentally, as we have been preparing a narrative for Serevent/Advair (which we expect to publish to this site soon.)
Tuesday, October 4th, 2005
We've added a new web page entitled Alternative Mental Health.
Psychiatric drug prescriptions (including Paxil and similar class drugs) for up to 40,000 children in the UK are soon to be phased out according to a September 28th article that appeared in the Guardian Unlimited.
We are encouraged to see the ongoing construction of what is essentially a (UK) firewall protecting children from a pharmaceuticals industry which, increasingly, has focused on how best to penetrate and exploit this highly vulnerable population. Unfortunately, the Food and Drug Adminstration (US) is not following suit.
We added an audiovisual link (AV) division to our Links to Explore page.
Sunday, October 2nd, 2005
Link of the Week: Plaintiffs' attorney Karen Barth-Menzies (Baum Hedlund) explains the Paxil addiction case. (Windows Media Player required.) This hour-long March 17th, 2004 radio interview provides fascinating and riveting insight into a wide variety of issues pertaining to Paxil and GlaxoSmithKline.
Share your support for the Paxil Protest series of demonstrations with the world: Send us a self-addressed, self-stamped envelope and we'll mail you a free Paxil Protest bumper sticker. Send your request to: Paxil Protest, P.O. Box 854, Chattanooga, TN 37401.
Saturday, October 1st, 2005
We note that a long-running commentary — brimming with vile epithets and vicious personal attacks on film maker and social progressive Michael Moore — recently disappeared from CafePharma (which bills itself as "the website for pharmaceutical professionals.")
Mr. Moore is reportedly working on a new movie which focuses on "Big Pharma." The specter of that movie, and what it might contain, is raising the hackles of everyone in the pharmaceuticals industry. As well it should.
Friday, September 30th, 2005
The first Paxil Protest has been completed, and it was a spectacular success. A complete narrative will follow, along with links to all media coverage, including radio, newspaper and television.
We missed posting our Link of the Week last Sunday as we were in Philadelphia. That link goes to the Alliance for Human Research Protection.
Friday, September 23rd, 2005
The Danish biotechnology company Neurosearch, backed by GlaxoSmithKline, has announced Phase III clinical trials of its "depression treatment candidate" NS2359 will begin in 2006.
The company also sees a possible launch of NS2359 in 2009. 'We believe this is a very realistic timetable,' the company's chief financial officer, Flemming Pedersen said. 'Although the project is very important to Neurosearch, it is probably just as important for GlaxoSmithKline PLC as a replacement for Paxil, when the patent expires,' he added.
GlaxoSmithKline is carrying out the final product development.
Neurosearch stands to get about 750 mln dkr from GlaxoSmithKline if NS2359 comes to market and a further 15-20 pct in royalties on sales, giving 3-4 bln dkr a year in license income in less than 10 years.
Founded in April of 1989 by Jorgen Buus Lassen (the "father of Paxil") and several associates, NeuroSearch has yet to progress a clinical program to the Phase III stage. Last month it's fourth lead molecule (NS2330) failed to reach pivotal trials, and upon disclosure of that news 40% of the company's stock value evaporated. In short, Neurosearch has a 100% failure rate spanning 16+ years — with hundreds of millions of investment dollars producing zero returns.
Will the failure of NS2359 be the final nail in the the corporate coffin of Neurosearch? If the company cannot hammer the compound through next year's Phase III clinical trials it could well be.
As such, it is hardly surprising to see Neurosearch spinning NS2359's pending trials as if their success is a foregone conclusion; that it's practically a matter now of handing the drug off to GlaxoSmithKline — so Glaxo can do what it does best — wringing a fast track drug approval out of its U.S. regulatory lap dog the Food and Drug Administration. This bit of Big Pharma black magic will likely be performed by the nefarious Dr. David Wheadon, Vice President Regulatory Affairs and Product Professional Services. ("Ask yourself: What have I done? What is my role in this? What am I willing to do?")
Dr. Wheadon played a pivotal role in past toxic GSK drug approvals, most famously those of Paxil and Lotronex.
Dr. Wheadon was also instrumental in helping Eli Lilly bring Prozac to the marketplace. Then in February of 1992 he was hired by SmithKline Beecham (now GSK) to work on getting Paxil approved.
Thursday, September 22th, 2005
A narrative for GlaxoSmithKline's toxic vaccine LYMErix (pulled from the marketplace) is online now. See LYMErix Lies.
Wednesday, September 21th, 2005
Over the course of the next few days there are not one, but two monster hurricanes set to hit the United States. Out of the Gulf and headed for the heart of Texas it's hurricane Rita. Coming from "everywhere" and set to hit the corporate coastline of GlaxoSmithKline it's hurricane Paxil Protest.
We hear from friends in the UK that Michael Moore's new movie "Sicko," said to be focusing on the nefarious activities of Big Pharma, will showcase GlaxoSmithKline. As such, we invite Mr. Moore to Philadelphia to watch the Paxil Protest make landfall — and in the process capture some absolutely spectacular and unique footage for his film. Likewise, we'll be filming (cinema verite') for a future documentary focusing on GlaxoSmithKline, and the death and destruction spawned by Paxil.
The dark in GlaxoSmithKline seems to lighting up a lot of people these days. For instance, the plot of John Le Carre's book "The Constant Gardener" (now a blockbuster movie) is thought to be influenced, in part, by his research into the activities of GlaxoSmithKline.
Tuesday, September 20th, 2005
GlaxoSmithKline has paid over $150 million to resolve allegations that the company violated the False Claims Act through fraudulent drug pricing and marketing of two anti-emetic drugs, Zofran and Kytril, used primarily in conjunction with oncology and radiation treatment, the Justice Department announced today. The United States alleged in settlement documents that GlaxoSmithKline engaged in a scheme to set and maintain fraudulent and inflated prices for Zofran and Kytril knowing that federal healthcare programs established reimbursement rates based on those prices.
"We believe that our price reporting was lawful and was done in good faith, but we've agreed to this settlement to avoid the delay, expense and uncertainty of litigation," said Mary Anne Rhyne, a company spokeswoman.
But of course.
In 2003, GSK was ordered by the United States Department of Justice to pay $47 million to resolve allegations that the company had defrauded the Medicaid and Public Health Service programs by relabeling products sold to a health maintenance organization at deeply discounted rates and then concealing the discounts to avoid paying rebates, in violation of the Medicaid Rebate program. GlaxoSmithKline paid an additional $40 million to reimburse state Medicaid programs and Public Health Service entities.
Regarding that settlement, GlaxoSmithKline company spokesperson Mary Anne Rhyne said "We believed (the HMO) was acting as a manufacturer and would not be counted toward best price. GSK believes its interpretation of the statute was reasonable and was in good faith."
Well that certainly clears the matter up: GlaxoSmithKline was forced to pay $87 million in civil fines all because of an "unfortunate misunderstanding."
In March of 1997 — as a consequence of yet another unfortunate misunderstanding — SmithKline Beecham Clinical Laboratories Inc. (SBCL) doing business as GlaxoSmithKline was ordered by the United States Department of Justice to pay $325 million for filing of false claims relating to laboratory tests paid for in whole or in part by the federal government. SmithKline Beecham Clinical Laboratories also agreed to adopt a corporate compliance agreement. The multiple scams involved adding on laboratory tests not requested by doctors and which were not medically necessary, billing for lab tests that were not actually performed, giving kickbacks to doctors in order to get their business, and billing Medicare for dialysis testing already paid for by kidney dialysis centers.
GlaxoSmithKline has released a four page (PDF) document to its main web site discussing a link between birth defects and women who take Paxil during pregnancy. As usual, the company seeks to minimize the apparent linkage.
GSK has yet to publish a similar "white paper" responding to the (at least) three Canadian medical research studies that in recent years that have established a compelling link between use of Paxil and delayed onset breast cancer in women. See Paxil and Cancer.
Previously in Breaking news we mentioned a narrative for GlaxoSmithKline drugs Serevent and Advair was being readied. This morning we learned by way of the FDA Advisory Committee's e-mail newsletter that FDA’s Pulmonary-Allergy Drugs Advisory Committee will consider at its July 13, 2006 meeting whether GlaxoSmithKline’s Serevent and Advair (and Novartis’ Foradil) should remain on the market.
In addition to the possibility of withdrawing the drugs, FDA is also presenting options for revised labeling to address the safety issue.
Serevent was included in FDA Office of Drug Safety Associate Director for Science David Graham’s list of marketed drugs with serious outstanding safety concerns, which he presented during a congressional hearing on Merck’s Vioxx.
We have excerpted congressional testimony regarding GlaxoSmithKline's drug Lotronex from that of Dr. David Graham to our web page FDA Lap Dogs. (Dr. Graham's full testimony is also available at our Articles to Browse page.) We also added a memorable comment made by Dr. Robert Temple, M.D., director of the FDA's office of medical policy in a Jan.-Feb., 2002 FDA Consumer magazine article entitled "Why Drugs Get Pulled Off the Market."
We've updated our web page Paxil in Babies to include the information linking use of Paxil in pregnant women to birth defects in babies.
Monday, September 19th, 2005
"The power of the Internet unleashed." Thanks to those of you around the world that are supplying GSK-related information to this site. We've published what we can, while other items remain under careful investigation.
GSK drugs update. We are close to launching a narrative for the LYMErix vaccine. Soon to follow is a narrative for Serevent and Advair. Additionally, we are opening up an investigation into yet another GlaxoSmithKline drug: an experimental vaccine called Fluravix. We ask that the public e-mail us any information it might know of (or have access to) which could assist us in our investigation. We continue to make headway into our investigation of Paxil, a phenylpiperidine, but are not yet ready to publish an interim update.
Everything is now set for the Paxil Protest to take place, and with each passing hour it's looking more and more like this is going to be an extraordinary event ... the likes of which have never been seen. (If you are a member of the media we suggest dispatching a reporter and camera man to the site of the protest for at least one day.) Participants are flying in from all four corners of the United States, and as well crossing over from Canada.
Sunday, September 18th, 2005
The Paxil Protest "Link of the Week" goes to Paxil Lawsuit Filed in California. Anyone with questions about the unconscionable fraud that is Paxil should begin with a careful review of this historic document.
Since this particular lawsuit was filed the amount of evidence that has been amassed against GlaxoSmithKline by plaintiffs' attorneys shows Paxil to be the biggest fraud ever perpetrated within the pharmaceuticals industry. For the time being, that evidence remains confidential and under protective order.
Friday, September 16th, 2005
Earlier this week we initiated an inquiry into GSK's (SKB) LYMErix vaccine. A full narrative devoted to exposing the truth about this dangerous drug — and GSK's sinister deceptions — is being readied for publication.
The public has just learned of some stunning news coming out of Australia: The Therapeutic Goods Administration has reclassified paroxetine (Paxil/Seroxat/Aropax ) from a pregnancy "category C" drug to a "category D" drug, recommending it be avoided in pregnancy.
Details from a preliminary analysis of GlaxoSmithKline data showed a higher incidence of congenital malformations, particularly ventricular septal defects, in babies born to women taking the drug.
Babies of women taking paroxetine in the first trimester of pregnancy were 2.2 times more likely to be born with a congenital malformation and 2.08 times more likely to have a cardiovascular malformation than those born to women taking other antidepressants, the data showed.
A second population-based Danish study found a 60% increase in cardiac abnormalities among babies of mothers taking SSRIs.
Once again the public must ask: What did GlaxoSmithKline know, when did they know it, and did they hide the risks?
To compare the Food and Drug Administration's most current (2003) teratogenicity (the property or capability of producing fetal malformation) ratings of common antidepressants click here. (PDF document)
Thursday, September 15th, 2005
A narrative for the GlaxoSmithKline vaccine Trivax is now available. See Trounced by Trivax.
Previously, in "Breaking News" we alerted the public to GlaxoSmithKline's new Paxil "cyber trap": Life Is Waiting. For untold hundreds of thousands of unwitting victims (including children and newborns) Paxil turns out to be "Hell Is Waiting." (Or "Hell Is Coming.")
To illustrate this on a personal level: Here's an example of the kind of letter we typically receive on a daily basis at the Paxil Protest e-mail box; it came as a response to a suggestion to try and get off Paxil using the P.E.S.T. withdrawal regimen.
I have decided to give in to my Paxil battle — that's right I have lost in a big way. I tried again to come off it for the 5 or 6th time and it drove me to constantly think of throwing myself off my balcony. I got up 3 times in one night just to look at it and try to assess if it would kill me or just break bones. I also wanted to cut my arms. I kept on getting these really gruesome thoughts ... very, very gross it's not like I thought of overdosing or anything (which is more like me I'm a big chicken for pain) it was always very bloody and very painful and disgusting. This is not me. I have never been this way, as a matter-of-fact I never understood why some people did it. I cried constantly. My worry was not worry anymore it was sheer and utter terror it was a nightmare. It was a living hell to say the least. I'm way too scared to go through that again. It is too dark and too much of a scary place for me to venture to. Paxil owns me now and it probably always will. I can see the rest of my life now, I'll probably keep putting on weight till it kills me or the Paxil will first either way there is no way out for me anymore. Very, very, very discouraged.
Scratch the surface of the Internet, and you'll uncover literally thousands of personal vignettes similar to the one above.
Tuesday, September 13th, 2005
We have just learned that GlaxoSmithKline's CEO Jean-Pierre Garnier served as a member of the board of directors for United Technologies — manufacturer of the United States military attack helicopter known as "the Black Hawk." As of February 1st, 2005 Mr. Garnier owned 23,050 shares in the company. The irony, and hypocrisy, is inescapable. More later....
A narrative for GlaxoSmithKline's "dual use" compound called bupropion — which the company markets as the antidepressant Wellbutrin and further as an anti-smoking agent called Zyban — is online now. See Bupropion Blight.
Sunday, September 11th, 2005
Our "Link of the Week" goes to Social Audit's
The Antidepressant Web.
Since September 7th, posts in Cafe Pharma's GlaxoSmithKline forum have cropped up indicating there will be a companywide conference call on September 12th (Monday afternoon) for all GSK managers, followed by a September 13th (Tuesday morning) conference call for all GSK reps. Speculation is it has something to do with Paxil, pregnancy and birth defects.
While in the Philadelphia area: we thought you might be interested in driving by the homes of a few GlaxoSmithKline top executives — all of whom are intimately involved in the Paxil fraud. (Think of it as a creepy version of the "Hollywood guide to the stars" tour.)
These extravagant residences (a palatial house and uptown penthouse apartments) — along with their occupant's trappings of vast wealth — were paid for, in large measure, by profits derived from sales of Paxil.
Directions from GlaxoSmithKline to the residence (349 Pond View Rd., Devon, PA) of Jean-Pierre Garnier, Chief Executive Officer of GlaxoSmithKline.
Directions from GlaxoSmithKline to the residence (220 West Washington Square, Apt. #300, Philadelphia, PA) of Dr. David Wheadon, Senior Vice President Regulatory Affairs and Product Professional Services, GlaxoSmithKline.
Directions from GlaxoSmithKline to the residence (236 South 3rd Street, Philadelphia, PA) of Dr. Tadataka Yamada, GlaxoSmithKline Chairman of Research and Development.
The chances you'll catch a glimpse of one of these elusive corporate chimeras? Well, don't get your hopes up ... these "pathetic cowards" (to use one of Mr. Garnier's own phrases in reference to protestors) won't be anywhere near Philadelphia while the Paxil Protest is going on.
Saturday, September 10th, 2005
More bogus drug claims by GlaxoSmithKline. In this instance it's Flonase. According to this FDA Warning Letter "the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified direct-to-consumer (DTC) advertisements (ads) for Flonase (fluticasone propionate) Nasal Spray that are in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations. Specifically, misleading claims about Flonase Nasal Spray have been broadcast in a 60 second radio ad ("Be Aware") and disseminated in a full-page print ad appearing in daily newspapers, including The Washington Post and USA Today."
Here's a FDA Warning Letter for GlaxoSmithKline's Navelbine: "the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified promotional activities that are in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations. Specifically, GSK made a false or misleading claim regarding the safety of Navelbine in the commercial exhibit hall of the 37th American Society of Clinical Oncology (ASCO) Annual Meeting held in San Francisco, California in May 2001."
One more for the week? How about this FDA Warning Letter for GlaxoSmithKline's Avandia:
Dear Mr. Garnier:
This Warning Letter concerns GlaxoSmithKline's (GSK) promotional activities for the marketing of Avandia (rosiglitazone maleate) tablets. The materials and .activities were reviewed by the Division of Drug Marketing, Advertising and Communications (DDMAC) as part of its routine monitoring and surveillance program. DDMAC has concluded that GSK has promoted Avandia in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations. See 21 U.S.C.§§ 331(a),(b), and 352(a),(n).
Specifically, during the 10th Annual American Association of Clinical Endocrinologists (AACE) Meeting in San Antonio, Texas, on May 2-6, 2001, representatives of GSK made oral representations denying the existence of serious new risks associated with Avandia at GSK's promotional exhibit booth. Additionally, GSK displayed exhibit panels (AV013G) at this meeting that minimized these new risks associated with Avandia.
Your promotional activities that minimize serious new risks are particularly troublesome because we have previously objected, in two untitled letters, to your dissemination of promotional materials for Avandia that failed to present any risk information about Avandia or minimized the hepatic risk associated with Avandia. Despite your assurances that such violative promotion of Avandia had ceased, your violative promotion of Avandia has continued.
Like GlaxoSmithKline spokesperson Mary Anne Rhyne said on August 26th, 2005: "We follow the law, and we follow government guidelines."
In early August of 2005, Jorgen Buus-Lassen, the "father" of Paxil and president of Neurosearch saw his company's stock value plunge 40%.
On the heels of that meltdown, Neurosearch launched an August 31 investor presentation (Powerpoint) dubbed "roadshow" which devotes much screen space to hyping its compound NS2359 (a.k.a. GSK372475) — alleged to be "a highly promising clinical development compound with a new and unique efficacy profile."
NS2359 is being co-developed with GlaxoSmithKline.
Slide #11 of the presentation, titled "The Triple Mode of Action," claims NS2359 "addresses cognitive deficits" and has a "predicted higher efficacy." Further claims that the compound has a "superior safety and kinetic profile" and "no abuse potential" are made.
A Phase II trial for NS2359 is currently underway, but the program is unlikely to yield any news for another year — yet the company carries on as if NS2359 is all but approved.
Given who Buus-Lassen is, and what GSK has done in the past, this is one "pipeline drug" consumer drug advocates should make a point to monitor closely. To this end we recommend setting up a couple of Google News Alerts: one for GSK372475, and one for NS2359.
As well, an effort should made to gain access to the "raw data logs" used to generate NS2359's clinical trial summaries ... provided the compound survives its Phase II trials.
Speaking of survival: The Neurosearch "roadshow" investor presentation also showcases NS2330 — yet fails to disclose the fact that the company's August stock crash resulted because that compound failed to achieve efficacy in two Phase IIb trials for Parkinson's disease and a third Phase IIb trial.
NS2330 is Neurosearch's fourth lead molecule to have failed to reach pivotal trials. Although founded in 1989, NeuroSearch has yet to progress a clinical program to the Phase III stage.
Friday, September 9th, 2005
Interest in the "Paxil Extremely Long Tapering" (P.E.S.T.) method of quitting Paxil seems to be garnering the attention of Paxil addicts the world over. This is an excellent Paxil tapering idea well worth discussing with your prescribing physician; it is "designed" for individuals who suffer severe Paxil withdrawal effects with even a tiny reduction in dosage. For details see Quitting Paxil.
GlaxoSmithKline confidential documents can now be quickly accessed (i.e. downloaded) from this site. You'll need Adobe Acrobat or its equivalent to view them.
Our Mauled by Myodil page has been well received, it appears, by victims of the drug. Today, we received a letter from Peter Groves, President of the Australian Arachnoiditis Sufferers (Queensland Association) which reads:
We fully support your protest against GSK, we in Australia, Australian Arachnoiditis Sufferers (Queensland Association) [who] have suffered from the effects of MYODIL. We will start off with litigation, the bigger picture is to force the federal government to an inquiry into the use and abuse of oil based and water based dyes, a 42 year conspiracy and cover-up involving Federal and State governments, GlaxoSmithKline, Eastman Kodak, and the medical profession. We also will demand a medical research and compensation foundation with an arachnoiditis registry, to be established to look after future sufferers and as this passed onto siblings, it is a scary scenario, what with these large multinationals running amok, must be reined in, this must be the worst medical scandal of the 20th century, gross negligence of a biblical scale. The medical profession must be held accountable also, what with huge kick backs from the drug companies to write prescriptions and not studying the medical journals and information concerning side effects of drugs. We in Australia hopefully in 2006 to commence protests the politicians here do not want anything to do with our cause so it will be an uphill battle, having to get out of our sick beds to be heard, they are gutless and the way we have been so far denied natural justice, THEY HAVE NO CONSCIENCE.
To members of AASQA and all sufferers of iatrogenically induced adhesive arachnoiditis the world over: we hope our efforts to expose the sinister side of GlaxoSmithKline will benefit your cause — and lift your spirits.
Although we do not have plans (as yet) to open up a narrative for GlaxoSmithKline's drug Coreg we thought you might be interested to read the FDA Warning Letter sent to GSK on February 8th, 2005. The reason? Advertising that ....is false or misleading because it omits material risk information and overstates the efficacy of Coreg, and thus misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 USC. 352(a), (n) and 321(n), and FDA implementing regulations. This panel raises serious public health and safety concerns because it fails to include any risk information about Coreg, which is associated with serious risks.
But the company position — articulated by Richard Sykes, Chairman of Glaxo Wellcome June 19th, 2004 — is that "As a knowledge-based industry we understand full well the value of information, and we want to create a climate of openness where the evidence for prescribing our products is clear." Although it's not true (except for the first 13 words), it sure sounds great.
A narrative for GlaxoSmithKline's Advair and Serevent will be uploaded soon.
Thursday, September 8th, 2005
A narrative for GlaxoSmithKline's toxic drug Raxar is now online. See Ravaged by Raxar.
We've also uncovered information about still another useless and deadly GlaxoSmithKline drug: Relenza. See Rooked by Relenza.
More news items about Paxil and pregnancy are pouring into the press. Use of Paxil during pregnancy can cause birth defects. The Therapeutic Goods Administration, Australia's drug watchdog, said preliminary results in a US study of paroxetine — commonly sold as Aropax — showed one in 25 babies born to mothers on the drug had a birth defect. Birth defects normally occur at a rate of about three in 100, with heart defects in one in every 100 to 200 babies. A spokesperson for GlaxoSmithKline, Nikki Capp, said "The main message from the company is paroxetine shouldn't be used in pregnancy, and pregnant women should talk to their doctor." Well, that's one way of getting around having to tell the world about one of Paxil's hidden dangers for babies: Neonatal Withdrawal Syndrome.
Ms. Capp's comments ring hollow given what the public recently learned, and that is what Glaxo apparently knew about its drug Paxil — at least eight years prior. In a 1997/1998 confidential "Business Plan Guide" the company stated one of the sales advantages of Paxil was it “Allows for rapid washout in the case of … pregnancy.” In that same document the company attacked competitor Eli Lilly’s product (Prozac), stating “The long half-life of Prozac reduces physician control and can … Increase exposure time to the fetus during pregnancy.”
And in another confidential GlaxoSmithKline document dated June 5th, 1997 and known as the "PR Firm Memo" GSK communicated If a patient becomes pregnant one might wish to discontinue (Paxil) therapy as quickly as possible.… and A drug with a short half life (i.e. Paxil), if discontinued immediately after conception, could wash out before the fetal-placental circulation is established.”
Before the Paxil saga is over GlaxoSmithKline could face hundreds, perhaps thousands, of additional lawsuits relative to undisclosed risks associated with use of Paxil by pregant women.
For more information on Paxil and babies see our web page Paxil In Babies.
Wednesday, September 7th, 2005
Press coverage of the Paxil Protest has begun. See National Paxil Protest Invites Antidepressant Drugs Victims to Join Public Outcry Against GlaxoSmithKline and Come One Come All — Welcome To The Paxil Protest.
If you are a member of the media seeking a statement from GlaxoSmithKline regarding this web site and the Paxil Protest here are your GSK spokesperson contacts (whose phone numbers are connected to answering machines):
+44 208 047 5502
+44 208 047 5502
+44 208 047 5502
+44 208 047 5502
+1 215 751 7709
Mary Anne Rhyne
+1 919 483 2839
+1 215 751 7709
+1 905 819 3363
"Good luck" on getting any response. After all, what could a silver-tongued spokesperson possibly say in defense of the company? See GSK Counterstrike.
As a last resort you might try calling "The Man" himself: GlaxoSmithKline's CEO, Jean-Pierre Garnier, at his home in Devon, PA: +1 610 254 0937.
Learn the truth about GlaxoSmithKline's toxic drug Myodil. See Mauled by Myodil.
Perhaps Paxil survivors can take some measure of solace in knowing that they are not the first victims of GSK's toxic drugs and toxic deception. Far from it.
So what about it Mr. Garnier? How many millions did GlaxoSmithKline shell out to some slick New York ad agency to come up with the company's slogan "Do More, Feel Better, Live Longer?"
GlaxoSmithKline: "Do Less, Feel Worse, Die Younger"
The AMA (Australia) is today alerting its members of a decision by GlaxoSmithKline to strengthen its warning against the use of Paxil (Aropax in the AU) for the treatment of depression in women contemplating pregnancy or in the first trimester of pregnancy. The identified problem is an increased risk of cardiovascular defects in children born to women who take Paxil.
How timely of GlaxoSmithKline. Any additional PaxHell warnings the company is willing to pass on to the public at this late date? (For example: Paxil spawned addiction/dependency, delayed onset breast cancer, neonatal withdrawal syndrome, potential neurological damage.)
Tuesday, September 6th, 2005
The Paxil Protest web site rolls past the 500,000 hit mark.
We are now featuring a "Link of the Week" embedded in our Breaking News page. This week it's a free newsletter, distributed via e-mail subscription, by Big Pharma's favorite (U.S.) lap dog the Food and Drug Administration. See FDA Advisory Committee.
On May 26th, 2005 the FDA issued a bulletin Adult SSRI Use And Suicidality to Get Committee Review in Next Few Months via the FDA newsletter. A few months has now passed, so the public should expect an announcement sometime very soon. Members of the public who have "a dog in this SSRI fight" should make plans to attend this committee meeting.
The key FDA personnel to keep a very close eye on are Drs. Temple, Katz and Laughren, and to a lesser extent Dr. Janet Woodcock.
SSRI survivors, consumer activists and concerned citizens should begin discussing plans to stage a mini "FDA protest" at the site of this next meeting (which will in all likelihood take place in Bethseda, Maryland.)
Construction of individual narratives for GlaxoSmithKline's toxic drugs Advair, Myodil, Raxar and the Trivax vaccine continues. We are also inching deeper and deeper into "the phenylpiperidine nightmare" data.
Sunday, September 4rd, 2005
Big Pharma, a dangerous and defective drug, faked clinical trials, expendable humans, contract killings and the no-holds-barred pursuit of multibillion dollar profits all collide in Hollywood's screen adaptation of John LeCarre's novel "The Constant Gardener." All in all it's riveting, shocking, disturbing and eye-opening in equal doses. Don't worry though: it's pure fiction....
A new book by Greg Critser entitled Generation Rx: How Prescription Drugs Are Altering American Lives, Minds, and Bodies is due out October 7th. It includes, among other things, exclusive interviews with the strategists, scientists, and current and former heads of GlaxoSmithKline. Perfect timing.
Saturday, September 3rd, 2005
Our new page entitled Glaxo Guinea Pigs provides insight into GlaxoSmithKline's involvement in the testing of its experimental AIDS drug, Epivir, as used in captive populations of orphans and babies — some as young as three months old — at New York's Incarnation Children's Center.
Our new page called Death by Imitrex tells the story of a GlaxoSmithKline drug — with deadly side effects — intended to treat migraines.
We are opening investigatory files on two more dangerous and defective GlaxoSmithKline drugs: Advair and Raxar.
Paxil, it turns out, was just the surface scum on the GlaxoSmithKline witch's brew of toxic GSK drugs.
At the bottom of our web page entitled FDA Lap Dogs we've added a couple of Pulitizer Prize articles concerning the GlaxoSmithKline drug Lotronex.
Our Articles to Browse web page now houses almost 200 links to articles; most deal with the machinations of GlaxoSmithKline.
Friday, September 2nd, 2005
A PR Newswire press release issued yesterday by GlaxoSmithKline announced that the company is expanding its ability to increase vaccines supplies for Americans by acquiring a vaccine research and production facility in Marietta, Pennsylvania. This acquisition adds to the company's growing vaccines presence in the United States, following GSK's recent purchase of Corixa Corporation.
"GlaxoSmithKline can help boost the availability of vaccines for Americans in the future by growing our research and manufacturing capacity in Pennsylvania and the United States today," said Jean-Pierre Garnier, Chief Executive Officer of GlaxoSmithKline. "We are working hand-in-hand with government officials to help meet public health needs by expanding our capabilities as a reliable supplier of vaccines for the US."
Did Mr. Garnier say "reliable"? Reliable as in the Trivax vaccine? Reliable as in GSK's production facilities being shut down in 2005 by federal marshals — with millions of doses of two GSK drugs seized — because Glaxo repeatedly refused to comply with minimum manufacturing standards mandated by the Food and Drug Administration?
Here is the first in a series of warning letters sent to GlaxoSmithKline by the FDA regarding substandard manufacturing practices at its Cidra, Puerto Rico facility where Paxil is made.
After an ongoing review of the virtual mountain of damning evidence piling up against GlaxoSmithKline we have decided to expand the Paxil Protest "invitation" to include the entire general public. Til now we were seeking only Paxil (along with other SSRI/SNRI) victims and survivors. So come one, come all: former GlaxoSmithKline employees ... victims of other GSK drugs (i.e. Myodil, Lotronex, the Trivax vaccine, Imitrex, Raxar, Advair, Epivir ad nauseam) ... members of the general public who are shocked and outraged at GSK's conduct, and anyone else who cares to join in. (Please take a moment now to review the Event Guidelines and the Protest FAQ.)
Thursday, September 1st, 2005
Is GlaxoSmithKline the worst multinational drug company in the world? It's beginning to look more and more like that. Is there any other conclusion the public can arrive at after a review of the GSK record? A review that offers, at best, a fleeting glimpse into GlaxoSmithKline's machinations? The public can only wonder what else GSK has been involved in that has not come to light....
Can GlaxoSmithKline be rescued? Perhaps an employee revolt — staged by the tens of thousands of hard-working and dedicated Glaxo employees essentially held hostage by the unethical and unconscionable business practices of "a few bad apples" (to quote GSK's own CEO — Jean-Pierre Garnier) — would do it. In the case of Mr. Garnier and his minions it's a matter of being "rotten to the core."
Paxil, Myodil, Imitrex, the Trivax vaccine, Lotronex ... to this witch's brew of toxic GlaxoSmithKline drugs, seasoned with a heaping handful of GSK denial and deception, we add yet another: Epivir. Specifically, Epivir as an experimental AIDS drug used in captive populations of orphans and babies — as young as three months old — at New York's Incarnation Children's Center.
Vera Sharav, president of the Alliance for Human Research Protection, said the children had been treated like 'laboratory animals'. 'These are some of the most vulnerable individuals in the country and there appears to be a policy of giving drug firms access to them,' she said. 'Throughout the history of medical research we have seen prisoners abused, the mentally ill abused and now poor kids in a care home.'
All that's missing from this GSK-backed hellscape is the reincarnation of Nazi death camp "doctor" Josef Mengele.
Here's an idea: how about GlaxoSmithKline giving those kids a free T-shirt emblazoned with (what should be) the GlaxoSmithKline logo: "Do Less, Die Younger, Feel Worse."
This web site will document — in crystal clear detail — everything that is known to date about this utterly depraved and morally reprehensible situation spawned, in part, by GlaxoSmithKline.
The silence is deafening. The Paxil Protest web site is launched ... a stunned public begins poring over the site ... a historic protest outside GlaxoSmithKline's U.S. headquarters is set to take place ... a challenge to GSK to dispute the accuracy or validity of anything published to the Paxil Protest web site is issued via a press release — and not a word out of the company.
So what about it GlaxoSmithKline. Mr. Garnier? Dr. Wheadon? Dr. Yamada? Mr. Stout? Dr. Benbow? Dr. Phillips? Mr. Gray? Mr. Viehbacher? Dr. Metz? Mr. Sykes? Don't you have anything to say for yourselves, or your company, which is under a blistering public relations attack? Surely you didn't think Glaxo was going to get away with unleashing the hellscape of Paxil on an unsuspecting public ... that there was not going to be this sort of response. Or did you?
The truth is GlaxoSmithKline's only real option at this point is to initiate an "attack the messenger" campaign. After all, there is no room for GSK to refute the facts.
Wednesday, August 30th, 2005
We are now investigating side effects and disclosure of risk issues for yet another GlaxoSmithKline drug; this time it's the Trivax vaccine. In 2002 GlaxoSmithKline finally admitted that thousands of babies in the UK were inoculated with a batch of toxic whooping cough vaccines in the 1970's.
In 1992, the family of an Irish boy, Kenneth Best, who suffered brain damage from one of these toxic vaccines, was awarded £2.7 million in compensation by the Irish Supreme Court.
Despite a long and fierce battle with GlaxoSmithKline, the boy's family finally won this historic case after his mother Margaret made a startling find when sifting through tens of thousands of Glaxo company documents.
She discovered that the Trivax vaccine used on her son, from a batch numbered 3,741, had been released by Glaxo despite it having failed to pass a critical safety test. Documents revealed that the 60,000 individual doses within this batch were known to be 14 times more potent than normal.
At the time the Irish judge accused GlaxoSmithKline — then known as Glaxo Wellcome — of negligence and attacked the company's poor quality control at its Kent laboratory. Immunology experts condemned Glaxo in court for what one U.S. scientist described as an 'extraordinary event'.
Most of you already know about GlaxoSmithKline repeatedly refusing to comply with minimum drug manufacturing quality control standards mandated by the United States Food and Drug Administration that, in 2005, resulted in two GlaxoSmithKline production facilities being shut down and millions of PaxilCR tablets seized by U.S. Federal Marshals.
We added to the public's Protest Demands an insistence that:
GlaxoSmithKline rush into production Paxil tablets in one-quarter, one-half, one, and five milligram doses so as to give patients addicted to Paxil — and who are trying to taper off the drug — "the tools" necessary optimize their chances of success.
The current and common strategy of Paxil addicts having to shave Paxil pills down using a razor, or the "hold your nose and squirt a (noxious) stream of liquid Paxil down your throat" method of dose reduction is outrageous.
Tuesday, August 31st, 2005
We are now investigating side effects and disclosure of risk issues for two additional GlaxoSmithKline drugs: Myodil and Imitrex.
To view a horrifying video of how individuals injected with GSK's Myodil, a spinal X-ray contrast medium, can sometimes develop a condition called "adhesive arachnoiditis" (a disease which causes severe pain to the sufferer via untreatable and incurable inflammation and nerve atrophy)
click on this link. (Windows Media Player required.)
Glaxo has always maintained that the links between Myodil and adhesive arachnoiditis have not been proven. Sound familiar? But in an out of court settlement in 1995, whilst denying liability Glaxo Laboratories Limited paid out, on average, £16,000 to each of 425 claimants suffering from Myodil Adhesive Arachnoiditis. A further 3,000 claimants had to withdraw because of what many of them felt to be Glaxo's solicitors' bullying tactics. Settling out of court meant that Glaxo effectively closed the door on any further litigation in the UK.
GlaxoSmithKline's company slogan is "Do More, Live Longer, Feel Better." Perhaps that should be changed to "Do Less, Die Younger, Feel Worse."
We have launched a new page dedicated to exposing the truth behind GlaxoSmithKline's 'serotonin-mimicking' migraine drug called Imitrex. See Death by Imitrex. More information will be added as time permits.
A web page dedicated to GSK's Myodil is soon to follow; the public is waiting on more information from one of its top Australian researchers.
If you have not read our expose on still another GlaxoSmithKline drug, called Lotronex, then visit our web site page entitled FDA Lap Dogs.
Saturday, August 27th, 2005
The first Paxil Protest press release is issued.
Friday, August 26th, 2005
California announced it is suing GlaxoSmithKline (along with 38 other drug companies) accusing all of bilking the state of hundreds of millions of dollars by overcharging for medicines. Attorney General Bill Lockyer charged that the drug makers defrauded the state's Medi-Cal system for at least the past decade. Mr. Lockyer said the drug manufacturers charged Medi-Cal as much as 10 times the price for some drugs as they charged others, like private pharmacies and hospitals. Responding to the charges GlaxoSmithKline spokeswoman Mary Anne Rhyne said "We follow the law, and we follow government guidelines." (When, the public must wonder, was this new GlaxoSmithKline company policy enacted. Yesterday?) Perhaps the California attorney general is suing GlaxoSmithKline because he and his office staff are underworked and just plain bored — in other words, it's for "entertainment purposes only."
Thursday, August 25th, 2005
We thought you might be interested in seeing how GlaxoSmithKline's CEO Jean-Pierre Garnier will come across when he's being questioned during the (2006 Paxil withdrawal) trial, so we tracked down some video of him. (Note how Mr. Garnier pronounces "Paxil" as "Paxseel.") As an added bonus we've also included video of two other key GSK executives. A special thanks to our top researcher in the UK for tracking this video down and making it available to us.
2/11/05 video of
Jean-Pierre Garnier, GSK's CEO
6/30/2005 video of
David Stout, GSK President US Pharmaceuticals
7/28/2005 video of
Jean-Pierre Garnier, GSK's CEO
8/16/05 video of
Christopher Viehbacher, GSK President (U.S.)
Tuesday, August 23rd, 2005
We've just wrapped up a big update to the site. As promised, we've added several gems from Alastair Benbow, GSK's European Medical Director (a.k.a. the "Minister of Propaganda") to the "GSK Quotes" page. The "Articles to Browse" page now houses over 150 links — most for stories about GlaxoSmithKline and/or Paxil.
The so-called "Washington protest," organized by Allen Routhier (who wife, Diane, committed suicide after six days on GlaxoSmithKline's Wellbutrin), is set to begin tomorrow.
GlaxoSmithKline is trying to downplay a new study just out linking use of its drug Paxil to adult suicidality. The study is just one more eddy in a colossal riptide of proof that is inexorably dragging GSK out to sea....
The Paxil Protest web site is set to click past 275,000 hits, probably sometime tonight.
Monday, August 22nd, 2005
A new study just published in the journal BMC Medicine has linked use of Paxil (Seroxat) to an increase in suicide attempts among adults. The study, conducted by Dr. Ivar Aursnes and colleagues at the University of Oslo, concludes "the recommendation of restrictions in the use of paroxetine (Seroxat) in children and adolescents ... should include usage in adults."
An unnamed spokesman for GlaxoSmithKline, the makers of Seroxat, who are facing lawsuits in connection with the drug, said: "We take the safety of all our medicines extremely seriously." That self-serving quote could have only come from one GSK lap dog in particular: the notorious Dr. Alastair Benbow.
Articles about the Seroxat suicide study appeared in The Independent and the Guardian Unlimited. Hats off to the British press (as usual) for leaping on this ... the latest installment of the Seroxat saga.
The Paxil Protest website clicks past 250,000 hits. The site is averaging about 25,000 per day. "We've only just begun...."
Saturday, August 20th, 2005
Will film maker and social activist Michael Moore be on hand for the Paxil Protest? One thing we know for sure: in fall of 2004 GlaxoSmithKline sent out "Moore alerts," instructing employees that questions posed by the media or filmmakers should be handled by corporate communications. If Mr. Moore doesn't make it to Philly perhaps it will be because he's trying to catch up with Mr. Garnier (like Roger & Me) at the CEO's palatial chalet in the Alps — the perfect place for Mr. Garnier to hide from the press until the Paxil Protest is over. The first one, that is.
Nancy Pekarek, Vice President of Corporate Media Relations for GlaxoSmithKline, said employees are uneasy about a (Moore) assault. "We've been getting voicemail messages,'' she said. "This is their career, after all, and it's no fun to be targeted. The problem is that Moore's film (isn't likely to) reflect the stringent standards of today.'' Did she really say that ... "The stringent standards of today"? (Here's your link.) Perhaps "central casting" should give Ms. Pekarek a call to see if she would like to star in an "off Broadway" Glaxo tragi-comedy called "Alice in Pharmaland."
We've revised our Articles to Browse listing; we liked the effect of intermingling quotes from GSK executives throughout that page, however, it was growing a bit unwieldy. To remedy that we broke the quotes out and used them to launch a new page. See GSK Quotes. We are pleased with how it turned out and think you will be, too. Most of you, that is.
We know there are quite a few of you "over there in the UK" that are "big fans" of Alastair Benbow, GSK's European "Minister of Propaganda;" we expect you might be a bit disappointed not to see additional quotes from him. All in good time: we'll add more as time permits.
Friday, August 19th, 2005
We've tracked down still more "quotes to remember" from GlaxoSmithKline Vice President David Wheadon — including one excerpted from his testimony given before the FDA's cursory review of Paxil on October 5th, 1992. Jump to this site's "GSK Quotes" and begin a slow scroll. More on the way....
The Paxil Protest web site zooms past 200,000 hits.
Thursday, August 18th, 2005
Please refrain from posting information about the Paxil Protest at the CafePharma "boards." The moderator of that service routinely deletes posts that refer to the Paxil Protest — even comments by drug reps wanting to know what is going on. So much for CafePharma's commitment to free speech.
On Tuesday, August 9th we had added a hyperlink to a CafePharma thread wherein individuals, presumably drug reps, were railing against Jean-Pierre Garnier, GlaxoSmithKline's CEO. That link has since been deleted. Which makes perfect sense, of course, if you read CafePharma's "board posting policies":
....we do not allow posts that constitute personal attacks on identified individuals. We delete such posts when we become aware of them. Personal attacks include references to personal appearance or lifestyle and personal relationships. Allegations of criminal wrongdoing or personal misconduct are also considered personal attacks. Additionally, unsavory names attached to identified individuals are not allowed.
Of course, that policy only applies to people in the industry. For anyone else, take Michael Moore for instance, it's "open season." Scroll through this CafePharma "Moore thread" and you'll see what we mean.
J.P. Garnier is scheduled to speak at the 2006 World Healthcare Congress. That assumes he has not been fired by then, or that he's not cooling his heels on a witness stand in federal court somewhere in regard to his role in the Paxil fraud. See Garnier, Kelly, Sharer and Viehbacher Announced To Speak at 2006 World Health Care Congress.
Ed Silverman of the New Jersey Star-Ledger has written a short piece on the Philly (and Washington) protests called "Protesting Paxil" as follows:
These are the days of anger over antidepressants.
First, consumer activists announced plans to gather for three days next week at the White House to draw attention to the ongoing debate over safety issues and regulatory oversight of the widely used medicines.
Another demonstration is planned next month in front of the Philadelphia offices of GlaxoSmithKline, which sells the Paxil antidepressant. The organizers are demanding the company immediately halt manufacturing and distribution and issue a recall.
The Web site www.paxilprotest.com goes on to demand that if Glaxo refuses to take those steps, the company should issue new product labeling that "unambiguously" states withdrawal reactions are common with Paxil.
One of the controversies over Glaxo's antidepressant is something the company calls "discontinuance syndrome," a term used to describe the difficulties some patients say they have encountered when attempting to discontinue usage."
The Paxil Protest web site rockets past 175,000 hits.
Wednesday, August 17th, 2005
We've installed a "count down timer" to serve as a reminder how much time remains until the protest begins.
The Paxil Protest web site races past 150,000 hits; incredibly, we have not distributed a single press release, or seen a single story in the media about the event as yet.
A new article has been published regarding the spectacular collapse of Neurosearch's stock value. Details provided in this piece offer additional insight into the company's predicament. Morten Larsen, analyst at Standard and Poor's in Stockholm, Sweden, said "History is beginning to count against the company, unfortunately." Unfortunately? This is news to cheer about for Paxil survivors, since the company is run by Jorgen Buus-Lassen — the so-called "father of Paxil" — and financed in part by GSK's millions. Maybe it is true that what comes around goes around....
We've added a new web page entitled Event Guidelines. All persons attending the Paxil Protest should take a few minutes now to review the participation guidelines.
Tuesday, August 16th, 2005
We've added several more books to our recommended reading list.
A few people have asked if this site could be "bought off" by GSK. The answer is a resounding "no" — not for any amount of money. What's at stake here is nothing less than the public good, and putting a stop to the devastation Paxil has wreaked the world over.
Consumer advocates have been posting news of, and a link to, the Paxil Protest web site at "the boards" of Cafe Pharma (which bills itself as "the website for pharmaceutical sales professionals.") Not surprisingly, the site's moderator has been frantically scrubbing Cafe Pharma clean of all things Paxil Protest related, and further blocking the IP address of anyone who "dares" to post comments about the protest.
A powerful, well known and influential consumer drug activist is stepping up to make an assist. Details to follow when the time is right.
Monday, August 15th, 2005
If anyone has a PDF formatted transcript of the October 5th, 1992 FDA meeting (which reviewed the SmithKline Beecham (GSK) application for Paxil) please send it to us; we want to parse the testimony of GSK's Dr. David Wheadon and compare it to other information we have on hand.
The city of Philadelphia issued a "right of assembly" permit for the Paxil Protest on Friday, August 12th. A battle to obtain the permit got underway on July 21st when the application was overnighted to the American Civil Liberties Union of Philadelphia (which had offered to file the permit.) Not only did the ACLU never file the permit ... we were told several times by the person handling the matter that the application had been filed — when in fact it was not. No explanation was ever provided; phone calls and emails were not returned. In the end we submitted the application directly to the city.
Sunday, August 14th, 2005
The Paxil Protest web rockets past the 100,000 hit mark. That web traffic spike came about a result of Paxil Protest visitors cc'ing a link to this site to people they know. Keep it up....
We added a Cyber Memorial page in honor and in memory of families who lost a loved one to a Paxil-induced suicide or homicide. If you do not have a cyber memorial set up just remember we have a home for it here at the Paxil protest web site. That home includes memorials for families who lost a loved one to a psychotropic drug other than Paxil. If you would like to set up a cyber memorial, but don't know how, contact us.
Saturday, August 13th, 2005
A hyperlink to the Southeastern Pennsylvania Transportation Authority's web site (bus, subway, train and trolley service in the Philadelphia area) is added to the Paxil Protest "Philly travel planner." Additional hyperlinks installed throughout the site.
The Paxil Protest web site is hours away from soaring past the 100,000 hit mark.
A phased media push (roll out) is scheduled to begin this next week. "Here we come...."
Friday, August 12th, 2005
Word is coming out of Ireland that Paxil (Seroxat) survivors in that country are excited about organizing a similar protest against Paxil — one synchronized with the U.S. Paxil Protest. Details to follow as they become available....
GlaxoSmithKline positions itself in yet another Paxilian spider's web — this one freshly spun in cyberspace. GSK gets around drug ad regulations (which require the company to disclose drug safety information) by not mentioning Paxil specifically. Have you ever heard the phrase "sinister beauty?" Here's your chance to see a specimen at Life Is Waiting. "Watch where you step."
Thursday, August 11th, 2005
A "how do I get to Philadelphia?" travel information page has been added. See Philly Trip Planner.
The Paxil Protest web site surpasses 75,000+ hits since its launch at 2 p.m. Eastern Time on Tuesday, August 9th, 2005 — and the " public relations drive" for the site has not yet begun. Keep forwarding and posting the Paxil Protest web address to everyone — and every place in cyberspace — you know.
If you have visited this site but have yet to make a contribution, please take a few minutes to do so now. 500 people x $25 = $12,500. Our fundraising goal is $25,000, and this figure would put us halfway there.
Wednesday, August 10th, 2005
A master list of all "close in" hotel facilities proximate to the protest site is now posted in the Protest FAQ. More facilities will be added as time permits.
Word is coming out of Canada that drug consumer advocates in that country are coordinating a protest to be held outside of a GSK facility in that country in support of the stateside Paxil Protest.
Consumer drug advocate Allan Routhier has scheduled a Washington, D.C. protest against GSK (and the FDA) in response to the suicide of his wife, Diane — a woman with no history of mental illness — who took her own life after ingesting the Glaxo drug "Wellbutrin." The ICDFA is lending its support to the event. As well, we encourage the public to support Mr. Routhier's cause. You can view a copy of the wrongful death lawsuit filed against Glaxo for Ms. Routhier's death by clicking here. There is also a BBS board. Mr. Routhier testified before the FDA on two occasions in 2004; you can view his testimony by clicking here. Email Mr. Routhier.
Neurosearch, led by Jorgen Buus-Lassen (the "father" of Paxil) and backed by GSK, saw it's stock value plunge 45% recently.
Tuesday, August 9th, 2005
The Paxil Protest web site logs 45,000+ hits less than 24 hours after the site is launched, and the " public relations drive" for the site has not even begun. Keep forwarding and posting the Paxil Protest web address to everyone — and every place in cyberspace — you know.
The Wyndham hotel at Franklin Plaza is pretty much booked for the Sept. 26th, 27th and 28th; however, rooms may still be available for individual dates if you plan on coming (but not participating every day.) Call and check. Remember, your plans should include arriving a day early if at all possible.
Hyperlink added to this site. See what drug reps are saying about J.P. Garnier, CEO of GlaxoSmithKline in the "Cafe Pharma" forum. A sorry state of affairs at Glaxo.....
This is just getting off the ground folks ... and it's already going gangbusters.
If you are a member of the media and would like to interview Mr. Robinson contact him via e-mail: EventCoordinator@PaxilProtest.com
send Rob Robinson an email