Thursday, November 29, 2007
I wonder if this has anything to do with an email personally handed in today to Gordon Brown by Janice Simmons (See here)
For those of you whom have busy schedules let me condense it into a video for you that runs for just under 4 minutes.
The sudden influx of Australian visitors may also like this video:
Wednesday, November 28, 2007
Has Paxil marketing written all over it - Fid
Source: Fierce Pharma
While GlaxoSmithKline is supplicant at the FDA on one hand, it's getting slapped on the other. The agency warned GSK that its marketing for the breast cancer drug Tykerb is out of hand. E-mail and letters sent to doctors and oncology nurses as part of the drug's launch left out the drug's most serious risks and exaggerated its efficacy, the agency says. That all-important first impression suggested that Tykerb is safer and more effective than it really is, the letter states.
What was left out? First, Tykerb can cause severe diarrhea, which is significant because doctors and nurses might want to order preventive meds or hydration. Second, patients with impaired liver function might require lower doses of Tykerb. And, perhaps most importantly, GSK's marketing materials failed to mention the risk of a particular heart problem known as decreased LVEF, or left ventricular ejection fraction. Patients using Tykerb are supposed to be screened for LVEF problems ahead of treatment and monitored during it to make sure it doesn't decline too precipitously. As for the hype, Glaxo trumpeted a study showing 43 percent decrease in tumor-growth risk and left out the study that showed only 28 percent decrease.
- check out the warning letter from the FDA
- read the report from CNN Money
Are you shocked?
Once again GlaxoSmithKline have failed to mention the severe side effects of one of its drugs.
How many more times are they going to get away with this?
Prime Minister Gordon Brown is to meet a woman from Huntingdon, who has been campaigning for five years to highlight potential problems with anti-depressants.
Janice Simmons set up the Seroxat User Group in 2002 after discovering that her second husband Jon was addicted to the drug.
Since then thousands of people have contacted her website and the group has provided information to people from all over the world.
Mrs Simmons, 58, a grandmother from Great Stukeley, will travel to Downing Street tomorrow (Thursday), accompanied by Huntingdon MP Jonathan Djanogly and Dr Paul Duckett, from Manchester University.
She told The Hunts Post: "I never believed we would get this far. Our MP, Jonathan Djanogly, wrote to Tony Blair in July and we received the invite last week."
Mrs Simmons said there is a long list of demands on their shopping list and her group wants:
* To know why - four years since it started - the investigation into GlaxoSmithKline is still ongoing. The MHRA, (the Medicines and Healthcare Regulatory Agency, the body that regulates medicines), is investigating an allegation that GSK withheld information on Seroxat having a higher suicide risk for under 18s. GSK denies this, saying Seroxat was never licensed for children.
* Why a recommendation from a Health Select Committee report in 2005 - which said that the MHRA should become an independent body - has not been implemented.
* The group wants the MHRA to look at independent information about particular drugs - rather than accept information from drug companies.
* Better enforcement of guidelines from NICE (the National Institute for Health and Clinical Excellence) which state that anti-depressants should not be used as a first-line treatment for mild depression.
* The user group says information from its members indicates that many GPs have not heard of the MHRA or the Yellow Card warning system. This is a yellow card doctors and patients are advised to complete to report the side effects of the drugs.
Mrs Simmons set up the group after seeing the addiction of her husband.
Six years before they met, Jon and his first wife were prescribed anti-depressants when their marriage broke down. Jon's wife committed suicide within three weeks of being put on Prozac while 16 years on, Jon is still dependant on anti-depressants.
The Seroxat User Group will also remind Mr Brown that more support groups and funding are needed to help patients trying to withdraw from anti-depressants.
INFORMATION: Contact The Seroxat User Group on www.seroxatusergroup.org.uk
WAY TO GO JANICE :) :) :)
Word of warning though, when Brown was chancellor he appointed JP Garnier to his International Business Advisory Council - so whatever you may say to him may fall on deaf ears seeing as he is yet another politician who has close ties to GSK
Source: Online News
Some patients who are new users of antidepressants such as Paxil and Prozac and other selective serotonin reuptake inhibitors may run a risk of abnormal bleeding, researchers said.
The following links are for our friends down under. Help spread the word and put pressure on your own medicines regulator to do something about this drug.
Medicines Australia & The TGA Looking In
GSK Australia continue to dupe their public!
Still no reply from...
Delphi Centre, GSK and the TGA
The Delphi Centre & GlaxoSmithKline Advertising
Aropax (Seroxat) - The Bitterest Pill?
Love That Aropax Smile
GSK Advertise Seroxat for Red Nose Day
SSRIs and their Complications down under
GlaxoSmithKline Money Trail Down Under Part 4 - Enter Dr Martin Keller
GlaxoSmithKline Money Trail Down Under Part 3
GlaxoSmithKline Money Trail Down Under Part 2
GlaxoSmithKline Money Trail Down Under Part One
Liebenagate - The excuse! (How GSK duped the New Zealand public)
Another Ian Hudson Scenario?
16 year old directed to the truth.
Video for Australian & New Zealander Visitors to this Blog
Don't forget to trawl through the archives section in the right hand column.
Monday, November 26, 2007
"Patients have nothing to fear when taking Seroxat" - Alistair Benbow, Head of European Clinical Psychiatry for GlaxoSmithKline
To: MHRA Information Centre
Sent: Monday, November 26, 2007 7:29 PM
Subject: FOI Request
1. Has it ever been proven that prolonged use of SSRi's destroys the serotonin receptors?
Saturday, November 24, 2007
Tamiflu and Relenza linked to abnormal behavior in some patients
Source: MSN News
Government health regulators recommended adding label precautions about neurological problems seen in children who have taken flu drugs made by Roche and GlaxoSmithKline.
The Food and Drug Administration on Friday released its safety review of Roche’s Tamiflu and Glaxo’s Relenza. Next week, an outside group of pediatric experts is scheduled to review the safety of several such drugs when used in children.
Thursday, November 22, 2007
Sonic has left a new comment on your post "Seroxat Down Under (Aropax)":
I have been a little down for a while now, i wouldn't call it severe depression at all.
I went to the doctor with mum (i am 16) and mum went on about how she thinks I could be depressed and how the councilors at school think i may be too.
He pretty much heard the word 'depression' and began writing a perscription for aropax. He wouldn't even listen to me. Anxiety? as in? Severe worry? Sure.. i worry, but i don't think its severe. I defintely dont have social problems and am good at making new friends and speaking.
Anyway, I thought he was an idiot, he didnt analyze me at all before he gave me this prescription. He said take half a tablet for 4 days and then after that 1 tablet a day.
And he said "Within the first week you will have suicidal thoughts". I mean gosh, my mum was in there with me and that worried her a lot.
So, after we left I said to mum that I am not taking this drug because I do not suffer from sever anxiety and that guy was an idiot. But mum insisted I should anyway.
Came home, looked it up, found this blog and the wikipedia of it. holly fuck.
There is no bloody way I am going on this stuff. No bloody way. And I can't believe he didnt warn me about all of the side effects and how addictive it is. I asked if it was addictive and he said it wasn't. Fucking idiot. Anyway, just posting to thank you for revealing your story to bring awareness of what this drug can do.
Posted by Sonic to SEROXAT SUFFERERS - STAND UP AND BE COUNTED at 3:26 PM
Wednesday, November 21, 2007
Mylan Inc have been provided patent licenses and the right to market all three strengths of Paroxetine Hydrochloride extended-release tablets beginning no later than Oct. 1, 2008.
This begs the question WHY????
Why on earth would Mylan Inc want patent licenses for a drug that is on its last legs?
Do they not read the papers, the blogs? Have they not witnessed the public outcry?
Do they expect to make a profit from this drug?
Kudo's to the Glaxo Team - it seems they could sell ice to an Eskimo! Though I think you would have been better off using Ebay as there is always some complete nutter wanting to buy serial killer memorabilia!
The coverted Seroxat Sufferers Dumbass award this month must therefore go to Mylan Inc.
You've been had!
Tuesday, November 20, 2007
improve the quality of human life by enabling people to do more, feel better and live longer.
Have GlaxoSmithKline contributed to this physical abuse of my brain by manufacturing and endorsing a pill? Should they be held accountable for what they have done?
There are those that suggest that long term use of Seroxat floods the brain with serotonin, thereby destroying serotonin receptors - if this is the case, why wasn't I told by GlaxoSmithKline when I started taking Seroxat? Why was/is there no mention of this on the patient information leaflet?
GlaxoSmithKline have stood firm stating Seroxat is not addictive, I and countless others beg to differ.
In the courts GlaxoSmithKline have made 'settlements' to claimants regarding the troubles they have had whilst being on Seroxat. What has that achieved?
They are merely papering over the cracks in the hope that their fuck up will go away. Those that have received compensation payouts from GlaxoSmithKline deserve every last penny... or dime as all settlements thus far have been in the States.
Will these settlements fix serotonin receptors left damaged by GlaxoSmithKline's Seroxat?
Money seems to be GlaxoSmithKline's answer to everything. They've used it all along to hide the truth from every man and his dog. Doctors have been paid or wined and dined by GlaxoSmithKline reps, Professors have been hired (Keller) and payments have been made to individuals who have issued writs against GlaxoSmithKline regarding Seroxat. It is also alleged that GlaxoSmithKline paid a huge sum of money to have the Paxil Protest website removed, such was the embarrassment it caused them! Fortunately, Paxil Protest is still accessible, not through the author's doing may I add (PAXIL PROTEST)
What is needed here is a judge with huge balls to say 'NO'
NO - You are not going to gag people by paying them money
NO - You are not going to settle and accept no liability
Custodial sentences are needed for those who have been a part of this cover-up.
GlaxoSmithKline and all those involved in this shameful cover-up need to be told once and for all that they cannot treat human beings with such utter contempt.
The truth will out Glaxo.
Monday, November 19, 2007
Biggest payout: $150,752 to Todd Mahr, a pediatric allergist. Mahr worked on a 2002 clinical trial of GSK's anti-asthma drug, Advair Diskus, and co-authored a 2006 paper that recommended Advair-style inhalers; footnotes in the paper refer readers to GSK's website.
WARNING: Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT®Inhalation Aerosol) or placebo added to usual asthma therapy showed a small but significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,174 patients treated for 28 weeks) versus those on placebo (4 of 13,179).
Subgroup analyses suggest the risk may be greater in African-American patients compared to Caucasians.
They also paid Martin Keller a heap to lie about Paxil
GSK Ordered to pull misleading adverts
The US government has ordered a drug giant to quit running a series of radio and newspaper ads that call the allergy spray Flonase a cost-effective alternative to pricey allergy pills. ...Read more
16th Dec 2003
Glaxo's CEO to scoop 5.7 mln stg a year
Jean-Pierre Garnier, chief executive of GlaxoSmithKline Plc , will earn up to 5.7 million pounds ($9.96 million) a year under a new pay package agreed by the pharmaceuticals group, the Sunday Telegraph reported. ... Read more
11th May 2004
GlaxoSmithKline faces antitrust investigation
A drug manufacturer being investigated for possible antitrust violations because it cut off shipments to Canadian mail-order pharmacies has to turn its records over to the Minnesota attorney general's office, a judge has ruled. ...Read more
19th May 2004
New York sues GlaxoSmithKline
The city of New York has sued drug maker GlaxoSmithKline, claiming that the company engaged in "anticompetitive, fraudulent, and inequitable conduct," when it acquired patents for its anti-depressant Paxil. ... Read more
6th Sep 2004
GSK faces anti-depressant lawsuit
GlaxoSmithKline (GSK) is facing a US lawsuit alleging that it covered up negative research findings on its anti-depressant drug Paxil. ... Read more
22nd Sep 2004
Glaxo drops appeal in Aids drug pricing case
A landmark legal complaint against British drug maker GlaxoSmithKline (GSK) over its Aids drug pricing and policies in South Africa will proceed after GSK dropped its public and repeated vows to appeal a decision allowing the case to go forward, according to AidsHealthcare Foundation (AHF). ... Read more
18th Mar 2005
Glaxo shares dip on factory probe
GlaxoSmithKline shares have fallen almost 2% amid fears a US inquiry into manufacturing quality could be widened and may possibly lead to a big fine. On 4 March the US Food and Drug Administration (FDA) seized batches of two drugs from the Puerto Rico plant. ... Read more
29th Mar 2006
Glaxo agrees US Paxil settlement
GlaxoSmithKline (GSK) has agreed to pay $14m (£8m) to settle US claims that it fraudulently tried to delay competitors to anti-depressant drug Paxil. ... Read more
10th Aug 2006
Glaxo pays $70m to end price row
GlaxoSmithKline has agreed to pay out $70m (£36.9m) to settle numerous civil claims of price-fixing in the US. ... Read more
29th Jan 2007
GSK hid paxil suicide link
Secret emails reveal that the UK's biggest drug company distorted trial results of an anti-depressant, covering up a link with suicide in teenagers. ... Read more
Sunday, November 18, 2007
Your concerns about your grandson are understandable especially in the light of the recent media coverage about Seroxat. .....read
2 Seroxat ban for children
by ROSALIND RYAN, femail.co.uk - 10/06/2003
Depressed children should not be prescribed Seroxat because the controversial drug raises the risk of self-harm and suicidal thoughts in under-18s, according to a new report.....read
3 Man slashed wrists after two weeks on anxiety pill By James Tozer Coroner calls for leading anti-depressant to be withdrawn
A CORONER has called for Britain's biggest-selling antidepressant to be withdrawn after a retired headmaster who was prescribed the drug was found dead with slashed wrists. .....read
4 Agency blamed for promoting Seroxat
The body which regulates medicines is playing Russian Roulette with people's lives over the common antidepressant drug Seroxat, a charity claimed today.....read
5 Seroxat warning to under-18s
Under-18s should not be given the anti-depressant Seroxat as the risk of suicidal thoughts and self harm is up to three times higher among those on the drug, experts said......read
6 Sufferers sue 'happy pill' firm for £30million
By MARTIN DELGADO - 17/11/2007
Pharmaceutical giant Glaxo-SmithKline is facing a £30million damages claim from users of its anti-depressant Seroxat. Lawyers representing patients who insist the drug is addictive have issued the first of 600 High Court writs against the company.....read
7 DoH: 'Seroxat 'link' to suicides'
UK health professionals have raised concerns about possible links between the anti-depressant drug Seroxat and eight cases of suicide, say the Department of Health.....read
8 Shamed Glaxo's u-turn on 'suicide' drug
by BEEZY MARSH and TIM UTTON, Daily Mail - 15/06/2004
Britain's biggest drugs firm has revealed research that shows a leading anti-depressant can cause children to attempt suicide. Glaxo-SmithKline is facing a major lawsuit amid allegations that drug regulators were duped into thinking Seroxat was safe for children.....read
9 Anti-depressant drug linked to increase in suicides
Thousands of patients taking an anti-depressant have been put on alert after the drug was linked to a worrying rise in suicides. Seroxat has been the subject of previous warnings that it may make children more suicidal, but researchers now say that should be extended to adults.....read
10 Drug giant 'covered up safety fear on Seroxat'
A drugs firm covered up vital evidence about thesafety of an anti-depressant linked to a string of suicides, it has been claimed .....read
11 Patients 'hooked on the shy pill'
The makers of a widely prescribed 'anti- shyness pill' face legal action over say it is addictive. Around 900 patients claim they suffered distressing withdrawal symptoms after taking Seroxat.....read
12 Why I resigned over 'happy pill' cover-up
by RICHARD BROOK, Daily Mail - 23/03/2004
The Government knows Seroxat anti-depressants can be dangerous. When one expert was asked to hide the truth, he quit.....read
13 Why you should never trust new wonder drugs
A drug company was last week accused of concealing evidence about the safety of a drug. According to Professor David Healy, this is just the latest case where patients and medical professionals have been misled .....read
14 The 'happy pill' kids
by JENNY HOPE, Daily Mail - 18/11/2004
Soaring numbers of British children are being prescribed anti-depressants and other mind-altering drugs, research reveals today. Some experts fear that drugs are being given too readily to youngsters after the UK saw the biggest rise in the world in prescriptions.....read
15 Medicines watchdog 'failed patients'
The UK medicines watchdog has been accused of failing to protect patients using the anti-depressant drug Seroxat. A programme claims past trials showed that the drug can leave a quarter of users addicted, while rapid increases in its dosage can cause serious side effects.....read
16 Probe into 'addictive' anti-depressant drug
by RACHEL ELLIS, Mail on Sunday - 15/12/2002
After months of pressure, the Government is setting up an investigation into Britain's most widely prescribed anti-depressant, Seroxat. .....read
17 Suicide link = child drugs ban
by PAUL SIMS, Evening Standard - 10/12/2003
GPs have been banned from prescribing children antidepressants after new evidence found the drugs may promote suicidal behaviour. The government says nearly all are risky.....read
18 How can we treat depression naturally?
On a dietary level, it might help your husband to cut back on or eliminate from his diet certain foodstuffs which tend to upset brain chemistry. .....read
19 Anti-depressant 'linked to suicides'
Health professionals in the UK have raised concerns about possible links between the anti-depressant drug Seroxat and eight cases of suicide over the past three years, the Department of Health said......read
20 Record numbers of children prescribed anti-depressants
By DUNCAN ROBERTSON - 23/07/2007
The number of school children prescribed anti-depressants and mind-altering drugs has more than quadrupled in the last decade. New figures show GPs are prescribing pills in record numbers to combat stress, violent behaviour and even tiredness.....read
21 Elderly patients who take anti-depressants run a higher risk of getting osteoporosis
Elderly patients who take anti-depressants run a higher risk of getting osteoporosis, it has emerged. Two studies found that patients who used drugs such as Prozac and Seroxat developed thinner bones.....read
22 A guide to Britain's most popular antidepressant
Below is a guide to the most commonly prescribed anti-depressants in the UK. .....read
23 Doctors hand out a record 31m anti-depressant prescriptions
by DUNCAN ROBERTSON - 14/05/2007
Prescriptions for anti-depressant drugs are at a record high, despite warnings that many people would benefit more from alternative treatments.The use of drugs such as Seroxat and Prozac increased by 10 per cent last year .....read
Remember GSK's recent quotes regarding the recent press release that Lawyers representing patients who insist the bestselling drug is addictive have issued the first of 600 High Court writs against the company?
Let me refresh your memories:
GlaxoSmithKline said: "Seroxat has benefited millions of people worldwide.
"We believe the product is not defective and that there is therefore no merit in this litigation."
It was also posted over at Cafe Pharma where someone has really let loose on the bumbling buffoon, Garnier.
For your amusement I shall add this poster's rant before the Wall Street Journal Story
Come clean on all the other docs you either paid off or threatened on a multitude of drugs, we all can name many under your watch. My personal hope is that someone, somewhere in this company has the guts to come forward and expose all your illegal activities. Maybe some of the reps you just deselected will help out....and to your spokesperson Ms. Pekarek--how can you sleep at night unless you are a sociopath like this French pig. Another disgusting truth about Garnier....the worst should be yet to come, hopefully. He needs to be punished.
Glaxo's Handling of Physician Criticized
By JEANNE WHALEN
November 17, 2007
Over a period of several years, drug maker GlaxoSmithKline PLC was so concerned about a prominent physician's negative views of its diabetes drug that it engaged in a concerted effort to intimidate him and stifle his opinion, a report by the U.S. Senate Finance Committee found.
The report offers a window into the rarely acknowledged practice among drug companies of monitoring and seeking to influence the opinions of leading physicians, who can make or break a drug's sales. The report alleges that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved in the intimidation.
The Senate Finance Committee released the report Thursday, after researching Glaxo's relationship with John Buse, a diabetes expert and professor of medicine at the University of North Carolina in Chapel Hill. In 1999, Dr. Buse began expressing concerns about the cardiovascular risks of Avandia, one of Glaxo's top selling drugs.
FULL STORY HERE
We all know how the story went - basically Buse spoke out about the dangers of Avandia and, in a Hollywood blockbuster movie type way, was 'leaned on' by top officials at GSK including GSK Chief Jean-Pierre Garnier.
GSK are an unholy society laden with excrement whom will stoop at nothing to keep their drugs on the market despite overwhelming evidence that their drugs harm people. Garnier sits in his mansion counting his millions bereft of any conscience.
What was it that turned a young Jean-Pierre into this vile monster he now seems to be? Almost all of the photo's of him circulating the web have him smiling... one of them 'you can't catch me' kinda smiles.
Well JP - Your time is up. Karma is coming to get ya my french friend.
Saturday, November 17, 2007
Source: Daily Mail
Pharmaceutical giant Glaxo-SmithKline is facing a £30million damages claim from users of its anti-depressant Seroxat.
Lawyers representing patients who insist the bestselling drug is addictive have issued the first of 600 High Court writs against the company, each seeking compensation of up to £50,000.
Since first prescribed in Britain in 1990, Seroxat has been linked to at least 50 suicides of adults and children.
GSK, which makes up to £1billion a year from the drug, is already embroiled in lawsuits with American users, and has been accused of failing to act on warnings that it could have serious side-effects, including mood swings and personality changes.
Mark Harvey, of law firm Hugh James, claims Seroxat is "defective" under the 1987 Consumer Protection Act.
He said: "When patients took the drug, not only was there no warning of withdrawal problems, there was also a statement on the data sheet until about 2003 which said you cannot be addicted to Seroxat.
"Unfortunately many people are havingdifficulties as they try to withdraw from the drug, and there are a few who have not been able to stop taking it."
Earlier this year the BBC's Panorama programme alleged that GSK had covered up fears about Seroxat's safety, which the firm strongly denied.
The drug was banned for under-18s in 2003 amid concerns that it contributed to suicide among adolescents with depression, and adult patients have reported that, when they stop taking it, they feel aggressive, reckless and violent towards themselves.
Four years ago a man arrested for armed robbery was cleared after medical experts concluded that his behaviour could have been altered by severe withdrawal symptoms from Seroxat.
GlaxoSmithKline said: "Seroxat has benefited millions of people worldwide.
"We believe the product is not defective and that there is therefore no merit in this litigation."
Due to legal matters I cannot comment on this story but I offer readers of this blog the chance to comment.
I would like to add that many of the people who are part of this litigation may be approached by the press as it is now in the public domain. Pity they haven't been around since myself and many others started voicing our opinions on Seroxat, the MHRA and GSK.
Thursday, November 15, 2007
Source: The Union.com
By Robyn Moormeister, firstname.lastname@example.org
The trial of murder suspect Richard Williams continued in Napa Wednesday, with a psychiatrist testifying for the defense that Williams was unconscious of his acts as he killed his estranged wife with a nail gun.
Dr. Stuart Shipko of Pasadena testified that symptoms from cold turkey withdrawal of the anti-depressant medication Paxil caused an altered state of consciousness while Williams performed the killing, making him legally unconscious, Nevada County District Attorney Cliff Newell said Wednesday.
Under California law, a person who is unconscious is not responsible for criminal acts, and unconsciousness does not necessarily mean a person is passed out, said Stephen Munkelt, Williams' defense lawyer.
When Superior Court Judge Thomas Anderson gave instructions to the jury, he read from a standard document written about the unconsciousness defense, and Munkelt re-read it:
"Unconsciousness does not require that a person be incapable of movement," Munkelt read. "This rule of law applies to persons who are not unconscious, but who perform acts while suffering from a blackout, while sleepwalking, during epileptic seizures, during involuntary intoxication or from the lack of medication," among other possible examples.
"From our perspective, that's a little far-fetched," Newell said, adding that Williams sat on the witness stand Friday and described each step of the killing. "It seems (Williams) knew exactly what he was doing."
Shipko has testified in the Ninth Circuit Court of Appeals concerning Paxil addiction as well as other adverse reactions to certain anti-depressant drugs, according to his Web site, http://www.stuartshipko.com/.
In 2002, he testified in a civil case against pharmaceutical company GlaxoSmithKline, which was claiming in advertisements that Paxil is non-habit forming. Shipko testified the company was misleading consumers into thinking they could stop taking the drug at any time, but that withdrawal symptoms can be severe.
According to the U.S. Food and Drug Administration, possible side-effects of Paxil therapy include changes of mood and suicidal thoughts or actions when the drug is first taken or when the dose is changed. There is no mention in the FDA's patient information sheet on Paxil regarding homicidal thoughts or actions.
Deputy District Attorney Kathryn Francis, with former Assistant District Attorney Ron Wolfson assisting her in court, called on psychiatrist Dr. Eric Raimo of San Diego to refute Shipko's testimony.
Raimo is an expert in alcohol and drug use disorders, according to his resume and medical studies posted on the Internet.
Closing arguments in the case are slated to begin Thursday or Friday, Newell said, after which the jury will deliberate.
Source: Class Action Defence Blog
Plaintiffs filed a securities fraud class action against Glaxosmithkline based on statements made about diabetes drug Avandia that failed to disclose the increased risk of heart attack. Borochoff v. Glaxosmithkline PLC, ___ F.Supp.2d ___, 2007 WL 2907812, *1 (S.D.N.Y. October 5, 2007). Eventually, three separate motions were filed seeking appointment as lead plaintiff in the class action, including one by a “German Institutional Investor Group” that had lost more than $28 million - more than any other putative member of the class action. Id. As the class action was governed by the Private Securities Litigation Reform Act (PSLRA), the district court examined which movant was the “most adequate plaintiff” within the meaning of the PSRLA and concluded that the German group failed to so qualify because of uncertainty in the manner in which a judgment from an American court will be enforced, if at all, in Germany.
In class action litigation governed by the PSLRA, the “most adequate plaintiff” is, inter alia, that “person or group” with “the largest financial interest in the relief sought by the class.” 15 U.S.C. § 78u-4(a)(3)(B)(iii). The presumption under the PSLRA that a particular class action plaintiff is the most adequate representative may be rebutted if the proposed lead plaintiff “is subject to unique defenses that render such plaintiff incapable of adequately representing the class.” 15 U.S.C. § 78u-4(a)(3)(B)(iii)(II)(bb). In this case, the German Institutional Investor Group was entitled to a presumption that it was the most adequate plaintiff for the class action because it had “suffered a loss of over $28 million” and “has the largest financial interest in the relief sought by the class.” Borochoff, at *1. However, competing movants argued that “all those who purchased in Germany may have to be excluded from the class, because any judgment in this [class] action (whether favoring plaintiffs or defendants) may be refused enforcement by a German court. Id.
Based on the district court’s analysis, there is considerable uncertainty “as to whether a judgment in a U.S. class action would be recognized” by a German court. Borochoff, at *2 (quoting In re Vivendi Universal, S.A., 242 F.R.D. 76, 104 (S.D.N.Y. 2007). At least one court refused to appoint a foreign corporation as lead plaintiff in a class action because of the risk that “[f]oreign courts might not recognize or enforce such a decision from an American court, which would allow foreign plaintiffs in the class to file suit against the defendant again in those foreign courts.” Id., at *3 (quoting In re Royal Ahold N.V. Securities & ERISA Litig., 219 F.R.D. 343, 352-53). The district court in the Borochoff class action found it unnecessary to determine at this stage of the proceeding whether the German group would be excluded from the class, but it concluded that “prudence cautions that the arguments for its exclusion are substantial, and in light of that risk it would be improvident to appoint the German Institutional Investor Group as lead plaintiff at this point.” Id. (footnote omitted).
Download PDF file of Borochoff v. Glaxosmithkline
GSK Agrees to "Black Box" Warning for Avandia Heart Attack Risk
Today, the U.S. Food and Drug Administration announced - GlaxoSmithKline (GSK), manufacturer of the popular type 2 diabetes drug, Avandia, has agreed to add new warning information to the existing boxed warning about the potential risk for heart attacks
People who suffer from type 2 diabetes that have heart disease or who are at high risk of heart attack should talk with their medical doctor about the revised warnings. The FDA advises health care providers to closely monitor patients that take Avandia for cardiovascular risks.
On August 14, 2007, certain diabetes medications in the same class of drugs as Avandia, upgraded their warnings to emphasize that these types of drugs may increase the risk of heart failure in some patients.
Today's action follows recommendations made at the July 2007 joint meeting of FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.
Will be interesting to see just how they word the new labelling eh?
Wednesday, November 14, 2007
Why GSK sucks....
When asked whether Avandia could return to its former level of profitability even with a second so-called black-box warning, Glaxo CEO Jean-Pierre Garnier said in a phone interview: "Absolutely. It all depends on what the language is."
The U.S. Food and Drug Administration is expected to decide any day on a labeling revision for Avandia, Glaxo's second-biggest product sales of which have plummeted since a report in May linking it to increased heart attack risk. "It's not the black box that matters or the lack of black box, that's not important to me; it's what is it saying?" Garnier told the Reuters Health Summit in New York.
HOW ABOUT WHAT IT IS DOING -YOU SOCIOPATH. DEATH AS A SIDE EFFECT IS PRETTY IMPORTANT NO MATTER HOW "IT IS SAID". GARNIER SINGLEHANDEDLY TOOK THIS COMPANY TO WHERE IT IS TODAY. IS HE GOING TO BE PUNISHED FOR HIS CRIMES ? NO OF COURSE NOT. HE WILL WALK AWAY WITH MILLIONS AND RETIRE IN FRANCE, WHILE AT THE SAME TIME THIS COMPANY STILL BOTTOMS OUT FROM HIS LIES AND CRIMES. THE FEDS NEED TO LOOK AT HIS STATEMENTS BEFORE HE IS OUTA HERE AND SEND HIM WHERE HE REALLY BELONGS.. IN A 6X8 CELL SOMEWHERE IN THE U.S. HE HAS NO CONSCIENCE, THAT IS OBVIOUS.
Have to say I echo the sentiments of the poster here.
Tuesday, November 13, 2007
To view the post click here
Here it is:
GSK Children litigation - Canada vs Other Countries
GSK has met with, and settled with many children who suffered side effects from paxil. The legal system in Canada stinks, and the lawyers won’t go up against the pharmaceuticals here. I know, I phoned every firm.
I obtained a high profile US lawyer. He is a wonderful man, one who is aware of the extent of suffering the children go through.
Last November (2006) was a very difficult month for my daughter. She had to meet with a GSK lawyer and discuss what she went through due to paxil. Before meeting with their lawyer we had a coffee with our US lawyer. My daughter does not like to discuss her paxil experience with anyone. She spoke with him openly, because she ‘knew’ he truly understood. She spoke about waking up each morning, her first thought being wanting to die. She would take a pin, something sharp and tear her skin. She rode her bicycle down stairs to harm herself. I won’t go on, you all get the picture…
Anyhow, at the end of the meeting I was asked what it would cost for private schooling to get her caught up-to-date. We discussed financial amounts. The GSK lawyer then turned to my daughter and said “we’re sorry this happened to you, but know it wasn’t done deliberately”. Ok, so that is where I spoke up. “Excuse me, don’t lie to her, GSK was very aware, the facts were hidden from the public, that’s why we’re here today”
GSK is aware I post on paxilprogress, but I was then asked if I personally knew Laurie Yorke, Rob Robertson, and Lisa Vansickle, as well as a few others I didn’t know of. “Hell yes!! Laurie is my adopted sister”, were family, as for Rob Robinson, sorry I could not afford the trip to the paxil protest.”
Interesting… what the hell does Laurie Yorke or Rob Robinson have to with my daughters suffering anyways? I shouldn’t have to lay out who I talk to, what we talk about, if it was via telephone, or in person. Anyway, we left the meeting and returned home. Since then, Skye researched schools she wished to attend when she received her settlement from GSK. She talks of going to New Jersey to meet Ryan, the desire to meet another child face to face that understands the suffering she went through.
A year has passed, Skye has received not a dime. Does anyone know why? Not because she hasn’t suffered or doesn’t deserve a settlement like the other children. But in paying her, they may have to pay other Canadian children. Once again it is all about the almighty dollar! They do not give a damn that they withheld information that ended up causing my child so much grief.
The following paragraph is for GSK, everyone that is in litigation with them have their posts from paxilprogress printed off. So by posting this here, I know they’ll get my message.
GSK, the pain and suffering a child suffers on paxil is the same, no matter the location. Place of birth should not matter. Saying that, my daughter’s father was born on US soil, because she resides with her mother in Canada should not make a difference.
I will continue doing what I am, I will provide for my childs needs. In the mean time, you paid her nothing. I am free to speak openly about GSK litigations. Why the hell would you meet with my child and make her rehash a horrific experience when you have no intention of doing anything about it? Was her experience not enough the first time around? How dare you play with my child’s emotions like that!!
Stay tuned, I need some closure to enable me to move on from this. A new website is in progress, one that will be getting media coverage, and will also be linked to every website available to me.
Monday, November 12, 2007
Well, I did!
Did you ever hear a dream talking?
Well, I did!
Glaxo CEO: Avandia can make a comeback
NEW YORK (Reuters) - A possible tighter U.S. label on GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research) troubled Avandia drug may not be a disaster for the diabetes treatment, the company's chief executive said on Monday.
When asked whether Avandia could return to its former level of profitability even with a second so-called black-box warning, Glaxo CEO Jean-Pierre Garnier said in a phone interview: "Absolutely. It all depends on what the language is."
FULL LAUGHABLE STORY HERE
29. 12 November 11:21 GlaxoSmithKline, London, London, City of, United Kingdom
30. 12 November 11:23 GlaxoSmithKline, London, London, City of, United Kingdom
31. 12 November 11:33 GlaxoSmithKline, London, London, City of, United Kingdom
32. 12 November 11:38 GlaxoSmithKline, London, London, City of, United Kingdom
38. 12 November 14:04 GlaxoSmithKline, London, London, City of, United Kingdom
39. 12 November 14:06 GlaxoSmithKline, London, London, City of, United Kingdom
41. 12 November 14:48 GlaxoSmithKline, Philadelphia, Pennsylvania, United States
42. 12 November 14:48 GlaxoSmithKline, Philadelphia, Pennsylvania, United States
43. 12 November 15:00 GlaxoSmithKline, Philadelphia, Pennsylvania, United States
So what part of Seroxat Sufferers y'all been reading? You got a conscience yet?
Friday, November 09, 2007
Isn't it about time the MHRA got their priorities in order?
Wait! How could they possibly bust the very same companies that fund them?
Easy to bust an online pharmacy though as these are, in the main, some collective group of individuals who spotted a lucrative gap in the market, same goes for Viagra and anti-baldness pills.
Who are losing out to these online pharmacies? The MHRA? Nah
The Pharmaceutical Companies Ladies and Gents. The MHRA will bend over backwards to help the hand that feeds them. Get the fake drugs off the shelves because our funders are losing money. Wouldn't surprise me if the MHRA had been given directives to make this a priority.
Meantime, we have the tired, dragged out MHRA investigation into GlaxoSmithKline. Four years and nothing!
So, MHRA - I lay down the gauntlet
SSRi's continue to be prescribed in this country (UK). Your promise to safeguard human health is wearing thin. You are safeguarding pharma profit and that is utterly shameful.
Don't get me wrong - you SHOULD bust these online pharmacies selling fake drugs but you should also get your finger outta your ass and bust GlaxoSmithKline et al for selling fake anti-depressants to the very same people you promised to protect!
Prof. Kent Woods at the helm of the MHRA is incompetent - though no doubt he believes he is the bees knees with the 'major' busts recently of small online pharmacies.
Go for the big guns Kent... or would that leave a vast hole in the MHRA's budget?
We can at least all sleep soundly at night safe in the knowledge that a few wannabe entrepreneurs have been captured by Woods and his crack team of investigators. Well those of us who haven't been left with irregular sleep patterns by Seroxat can!
One can only imagine the pats on the back the MHRA are getting from pharma huh... more like wads in the back pocket I suspect.
The MHRA - Safeguarding Human Health - What a load of bollocks!
Wednesday, November 07, 2007
Thanks to Matthew Holford for the following information:
Oooooh! He's the Director of the Department of Commercial Operations, GSK Espana (or he was in Feb, 2006). Gosh, you do have some important friends, these days, Fidders!
Tuesday, November 06, 2007
Location: United States
I'm an academic with a respectable amount of clinical experience and no drug industry funding. Given my lack of time, don't expect multiple daily updates. Certain things about clinical psychology, the drug industry, psychiatry, and academics drive me nuts, and you'll probably pick up on these pet peeves before long...
Read his rant about Paxil here
Kudos to CL Psych for highlighting this and a dumbass award for the person who wrote in.
More will be revealed if you follow the link
Monday, November 05, 2007
On the right hand side at the top of the page you will see a feedblitz box where you can subscribe to updates of this blog.
About a month or so ago I was checking my subscribers when to my surprise I came across email@example.com - it seems Jose is either updating GSK when anything derogatory is posted about them on here or maybe Jose has a general interest in Paxil/Seroxat related matters?
I mailed him and as far as I know the email address is legit as it didn't bounce back. There was no reply.
Feel free to email him and see if you can see why he takes such an avid interest in the Seroxat Sufferers blog
...and just in case you forgot
Prosecutor picks up nail gun in dramatic opening murder trial
By Robyn Moormeister, firstname.lastname@example.org»
More from Robyn Moormeister 12:01 a.m. PT Nov 3, 2007
The murder of Hendrika Williams was a tragedy as old as time, Deputy District Attorney Kathryn Francis said in court Friday, a classic case of "If I can't have her, no one can."
Francis began opening statements Friday in the murder trial of Richard Williams, accused of killing his estranged wife with a nail gun, then turning the weapon on himself Oct. 22, 2005.
"Rick (Richard) Williams is a jealous, angry, selfish man," Francis said. She referred to Hendrika "Hetty" Williams as a loving mother, a gifted teacher and a devoted wife who wanted a new chance at happiness.
"He took that away from her," Francis said. "She never got a chance for that life."
Francis picked up a large Remington power-driver nail gun identical to the one used in the killing, slightly straining to raise the heavy tool.
"He shot her, reloaded the charge, reloaded another nail, shot her again, reloaded another nail, then shot her again," Francis told the jury. "He shot her once in the temple, once in the back of the head, and once through her heart."
In his opening, Williams' defense attorney, Stephen Munkelt, said the Williams' relationship was "a love story with a tragic ending." Williams was extremely distraught over his wife's relationship with Burns, which she attempted to keep a secret, Munkelt said.
Williams found out about the affair while he eavesdropped on a call between his wife and her friend a month before the killing. The stress of the betrayal combined with side effects from withdrawal of his anti-depressant medication Paxil drove him to kill, he said.
In 1998, GlaxoSmithKline, maker of Paxil, was ordered to pay $6.4 million to surviving family members after Donald Schnell, 60, just 48 hours after taking Paxil, flew into a rage and killed his wife, daughter and granddaughter. (See documents here)
Thursday, November 01, 2007
I've reproduced it here in its entirety.
It seems there will be an awful lot of disgruntled GSK employees 'speaking out' soon which can only be good for the fight.
Here's the post - and the link from the Cafepharma board:
I have had access to executive level discussions regarding the GSK layoffs. I am posting this information from an anonymous "business center" computer location. I won't say anymore, except that my credibility is legitimate.
I understand that rumor, speculation, and misinformation is running rampant right now through out the entire GSK organization. I feel that the lack of communication with our sales force regarding the true intentions of this company is regrettable. I personally know quite a few of the excellent employees of GSK that will be terminated.
I am dismayed that executive level management has so little regard for the employees welfare. Yes, I remember the Zantac Hawaii trips! This is why I am being honest with you.
GSK is planning a second round of layoffs that will occur immediately before second quarter earnings are announced in 2008. Projected sales forecasts for Avandia family over the next six months are dire.
The current layoff scenario has been structured to appease shareholders and Wall Street analysts.
The layoff in 2008 will be attibuted to the new management team. They hope to be given credit by the Street for taking decisive action in the face of declining revenue. This may shore up the stock price at that time.
So you ask, "Why not just lay every one off now?" There is a good answer. The GSK Senior Executives very closely studied the Pfizer layoff from last year. Do Executives from different companies talk with each other? Yes, they do. Pfizer management noted that after the layoff, a significant portion of the sales organization was demoralized. This resulted in many subsequent resignations as Pfizer sales people found new jobs on their own. This resulted in Pfizer not having to pay these people severance packages. The net: Pfizer saved a tremendous amount of money by having a layoff followed by enhanced attrition.
GSK is planning the same situation. This is why the current layoff in not as large as it really needs to be. Two smaller layoffs is more cost effective than one large one.
I have been honest with you. If you survive the current layoff, there is no guarantee you will survive the next one in June 2008. Plan for your future accordingly.
I realize on Cafe Pharma some people will bash this information as false. However, you might be surprised how many people in VERY senior management read this board. They need to know that some managers still care about the employees. The point is, do what is best for you and your family.
I have to admit, it is sad to see what has happened to this once great company. I really hope GSK can recover, but nothing is guaranteed. Best of luck to all of you.