Posts Tagged ‘GSK’

Glaxo To Pay $1Billion To Settle Paxil Birth Defect Cases

Wednesday, July 21st, 2010

Pharmalot
By Ed Silverman
July 21, 2010

In an effort to get its arms around massive litigation, GlaxoSmithKline has agreed to settle yet another wad of product-liability lawsuits involving one of its popular meds. The latest deal involves an agreement to pay more than $1 billion to settle some 800 cases alleging its Paxil antidepressant caused birth defects in children borne to women who took the drug, Bloomberg News writes.

The move comes after a Pennsylvania state court jury last October awarded a woman $2.5 million in damages for failing to properly warn docs and pregnant women about the risks of the antidepressant. This case, which was filed by the family of a three-year-old boy who was born with heart defects his mother blamed on the drug. It was the first of 600 such lawsuits and was seen as a test of Glaxo’s vulnerability (background).

Last week, Glaxo disclosed plans to take a $2.4 billion charge in its second quarter to settle product-liability lawsuits over its Avandia diabetes pill, litigation involving the Paxil antidepressant and a US government investigation into its manufacturing site at Cidra, Puerto Rico.

The Paxil deal, which would provide an average payout of more than $1.2 million to families of the affected children, leaves more than 100 similar cases pending. The birth-defect settlements bring to more than $2 billion the amount Glaxo has agreed to pay to resolve a variety of Paxil-related suits, including claims the pill caused suicides or attempted suicides and addiction problems, Bloomberg writes.

Read the entire article here:  http://www.pharmalot.com/2010/07/glaxo-to-pay-1b-to-settle-paxil-birth-defect-cases/

See all international studies/warnings on Paxil: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

See what doctors, pharmacists, health care providers and others have reported to the US FDA on Paxil side effects (such as birth defects): http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

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GlaxoSmithKline settles case with woman who linked her use of antidepressant Paxil to the death of her infant son

Monday, July 19th, 2010

The Associated Press
By Wayne Ortman
July 19, 2010

SIOUX FALLS, S.D. — A settlement has been reached in a lawsuit filed against a pharmaceutical company by a Watertown woman who linked her prescribed use of Paxil to the death of her infant son, according to court files.

Jennifer Berg of Watertown sued SmithKline Beecham, doing business as GlaxoSmithKline, in October 2007. The complaint said Nathan Berg died in 2004 because of a heart disorder caused by her use of the antidepressant Paxil while she was pregnant.

The federal court lawsuit sought unspecified damages from the company for failing to warn of a link between the two. Letters from her attorneys to the presiding judge indicate there’s a settlement. No settlement documents have been filed in court.

Lawyers at a California firm handling the case for Berg did not immediately return a phone call Monday for comment.

GlaxoSmithKline said last week that it expects to take a $2.36 billion charge against second-quarter earnings for settlements, agreements to settle and other provisions for long-standing legal cases over Paxil, the diabetes drug Avandia and other issues. The company said settlement details would be confidential.

According to the lawsuit, Nathan Berg was born Aug. 20, 2004 at Watertown and was immediately transferred to a Minneapolis hospital where he died 58 days later of Persistent Pulmonary Hypertension of the Newborn (PPHN), a disorder which prevents proper oxygenation of the blood.

“At the time Paxil was prescribed to Ms. Berg, GSK (GlaxoSmithKline) knew or should have known through pre-market studies and post-market studies and reports that Paxil was associated with an increased risk of PPHN in babies whose mothers ingested Paxil during pregnancy,” according to the lawsuit.

Read entire article:  http://www.google.com/hostednews/ap/article/ALeqM5j7UU4otrHhelqaJFcC3ttvwj4bYgD9H29RK00

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Glaxo To Book $2.4 billion To Settle Legal Cases, Including Avandia, Paxil

Thursday, July 15th, 2010

USANewsweek
July 15, 2010

British Pharma giant GlaxoSmithKline is expected to record a legal charge of $2.4 billion for the second quarter of this fiscal year in order to settle legal cases relating to its antidepressant Paxil and controversial diabetes pill Avandia. The British company announced two days ago that the money would be used not only to cover the settlements for Avandia but also other long-standing legal cases. It is learnt that the company would use the money to settle an investigation into its former factory at Cidra in Puerto Rico as well.

The news of the hefty charge, which is around 2.5 percent of the market value of the British drug maker took the edge off an expected rally in the shares after a U.S. panel allowed the company to Avandia in stores but the panel asked Glaxo to include new warnings on heart risks. “Some people might baulk at the size of the charge but probably most will say this is putting it all behind the company, so we can now look to the continuing business and view the stock on a more rational basis,” said Deutsche Bank analyst Mark Clark.

Menwhile, Glaxo did not divulge how much it was setting aside to settle legal issues related to Avandia. The company defended its decision saying that settlement terms were confidential. Earlier, it was reported that Glaxo might have to spend a whopping $6 billion to resolve legal cases related to Avandia but the panel vote allowing the company to keep the drug in market means that the company would be able to settle the claims by paying around $1 billion.

Read entire article:  http://www.usanewsweek.com/news/Glaxo-To-Book-2-4-billion-To-Settle-Legal-Cases–Including-Avandia–Paxil-1279232979/

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GlaxoSmithKline Enters into Confidential Settlement with 200 Families Who Say Paxil Caused Birth Defects

Friday, June 25th, 2010

Fair Warning
By Lea Yu
June 25, 2010

Pharmaceutical giant GlaxoSmithKline has entered into confidential settlements with nearly 200 families who claimed that its antidepressant Paxil caused congenital birth defects.

Most of the claims alleged that babies born to mothers taking Paxil suffered heart defects. Last October, a suit filed on behalf of Lyam Kilker said he was born with three cardiac defects, including a hole between two chambers of his heart that disrupted the aorta.

Kilker’s case is the only one to have gone to trial, and a Philadelphia jury awarded Kilker’s family $2.5 million in compensatory damages. Plaintiffs argued that animal testing revealed potential problems with Paxil, but the company did not follow up with additional tests. A company memo introduced as evidence during the trial also revealed that Glaxo considered covering up any negative test results. “If neg, results can bury,” the 1997 memo said.

In 2005, the Food and Drug Administration warned doctors about a 35,000-person study that found that pregnant women on Paxil were twice as likely to have a child with defects than women taking other antidepressants.

Read entire article:  http://www.fairwarning.org/2010/06/glaxosmithkline-settles-200-birth-defects-cases-linked-to-antidepressant/

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Does anyone else think this is outrageous? “Glaxo Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide Risks”

Friday, May 21st, 2010

BNET
By Jim Edwards
May 21, 2010

It was established years ago that Paxil carries a risk of suicide in children and teens, but GlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.

GSK didn’t immediately respond to a request for comment. A staffer on GSK’s trials hotline confirmed the study was ongoing, however. The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo.

The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.

Read entire article:  http://industry.bnet.com/pharma/10008290/glaxo-is-testing-paxil-on-7-year-olds-despite-well-known-suicide-risks/

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Doctor Who Criticizes Senators For “Attacking” Pharma in Washington Times Article Failed to Mention He’s Served Prison Time for Fraud

Thursday, March 4th, 2010

By Allen Jones
Former Investigator,
Pennsylvania Office of the Inspector General

On March 4, 2010, The Washington Times posted a scathing op-ed by Dr. Gilbert Ross in which Ross slammed Senator Grassley, Senator Baucus and FDA Whistleblower David Graham.   In a rambling tirade Ross accuses the trio of tinkering with the practice of medicine by unfairly criticizing pharmaceutical companies and defends GlaxoSmithKline (GSK) and their discredited drug Avandia.

Ross fails to disclose that he has a personal reason for being angry with the Federal Government. In June of 1993, Ross was found guilty in Federal Court of 13 counts of fraud in a scheme to operate medical clinics for the purpose of obtaining payments directly and indirectly from the Medicaid system. He served 2 years in Federal Prison. http://w3.health.state.ny.us/opmc/factions.nsf/0522fed2dd2160ff852568c0004e894a/85b1e5abf211b2a585256a4a0047eb10/$FILE/ATTH2LGV/lc116347.pdf

Ross is identified as “medical director of the American Council on Science and Health,” but Ross discloses no financial ties to GSK.  The ACSH website however acknowledges that 40% of ACSH’s budget comes from “corporations.”  Does this include Pharma funding? http://www.acsh.org/about/pageID.85/default.asp

It is disgraceful that The Washington Times would post Ross’ criticism of great men and their worthy cause without disclosing very relevant facts relating to Ross’ credibility.

Allen Jones worked as an investigator in the Pennsylvania Office of the Inspector General (OIG), and gained widespread national and international attention as a whistleblower after uncovering pharmaceutical industry payments to government officials for the purpose of implementing a national mental health screening/psychotropic drug treatment plan based on the controversial Texas Medication Algorithm Project (TMAP). In May 2004, the British Medical Journal reported Jones had uncovered evidence major drug companies sought to influence government officials.

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Ghostwriting 101: Pharma hires firms to write glowing reviews of a drug, then pays docs to sign off as authors

Thursday, March 4th, 2010

Scoop Independent News
By Evelyn Pringle
March 4, 2010

A month before the first Paxil birth defect trial against GlaxoSmithKline was set to begin, the Associated Press ran the headline, “Glaxo Used Ghostwriting Program to Promote Paxil,” in reporting on a program called “CASPPER,” which allowed doctors to “take credit for medical journal articles mainly written by company consultants.”

“Drug companies frequently hire outside firms to draft a manuscript touting a company’s drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work,” the Associated Press said on August 19, 2009. “Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.”

Between 2000 and 2002, articles from the CASPPER program appeared in five medical journals. On August 21, 2009, Jim Edwards on BNET, described the CASSPER ghostwriting brochure. The document shows that the intent of CASSPER was to flood the market with ghostwritten information, he said. It stated: “Paxil Product Management has budgeted for 50 articles for 2000.”

The trial in Kilker v Glaxo ended on October 13, 2009, with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The family was award $2.5 million.

Read entire article:  http://www.scoop.co.nz/stories/HL1003/S00045.htm

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Wake Up FDA—Even Drug Giants Are Admitting No Lab Tests Exist To Prove If Antidepressants Work

Friday, February 5th, 2010

By CCHR
February 5, 2010

With drug giant GlaxoSmithKline (GSK) now stating it will abandon future antidepressant research, one can only wonder if the U.S. Food and Drug Administration (FDA) noted GSK’s CEO Andrew Witty’s admission that it is “hard to prove that a depression drug is working” because “patient improvement is measured by subjective mood surveys, and not by the clear-cut blood tests and biological measures used in other diseases.”

To put this in perspective, the head of GSK is pointing out an obvious flaw in the psycho/pharmaceutical cash cow of psychiatric drugs.  There is no way to prove if a drug is working because there are no lab tests to prove anyone has a mental disorder in the first place—unlike medical diseases where blood and lab tests can show the effect of any drug upon the disease.

Given this statement, the next logical question is how did the FDA ever approve any psychiatric drug as safe and effective when the drug makers admit there is no proof of efficacy, only “subjective mood surveys.”

It seems the drug companies are catching on while the FDA is still promoting junk science in order to grant drug approval.

And that’s on top of the Journal of the American Medical Association (JAMA) landmark study published last month that found antidepressants no more effective than placebo. Add to that, 40% of antidepressant clinical trials have not been published because of negative results—they failed to show any significant benefit.  So, even with a “subjective mood survey,” they can’t get the drug to make the mark.  And the studies that did “prove” it did so, as Newsweek put it, for “the same reason why Disney’s Dumbo could initially fly only with a feather clutched in his trunk—believing makes it so.”

The FDA says: “Drugs must undergo a rigorous evaluation of safety, quality, and effectiveness before they can be sold.” Clearly, there is nothing rigorous about testing efficacy in antidepressants.  GSK’s confession is on par with former American Psychiatric Association president, Steven Sharfstein admitting that there is no lab test to confirm a chemical imbalance in the brain.  Reiterating this was his APA cohort Mark Graff, who told CBS Studio 2 that this theory was “probably drug industry derived”—in other words, a marketing ploy in the same vein as antidepressants are “effective.”

John Swann, Ph.D., historian at the FDA, once said: “To establish fraud, the bureau had to show that the manufacturer knew the product was worthless, and this proved difficult in many cases.”[i]

Well, FDA, if a drug company can admit what the FDA has known all along—that the efficacy of an antidepressant or any psychiatric drug is entirely subjective and, therefore, not based on science, how can the FDA continue to approve and condone the use of these drugs as “safe and effective?”

Instead of the potential fraud of a manufacturer, a more pertinent question we should be asking is this:
What if the government agency in charge of approving drugs, the FDA, knew a product was worthless and approved its use anyway? What happens then?


[i] http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/default.htm

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Pharma’s Drug Ads: From Million Dollar TV Ads to $1.7 Billion Internet Marketing Campaign

Monday, November 16th, 2009

November 16, 2009

On November 13th, 2009, Pharmaceutical companies flocked to a two-day FDA hearing into online drug advertising, which could influence their use of social media on the net. 1 Already, the explosive growth in online advertising has intensified public concerns: the pharmaceutical industry spent more than $1 billion on Internet ads last year and is projected to spend $1.7 billion on such marketing efforts in 2012, according to the Direct Marketing Association.2

Both Eli Lilly and Merck have received warning letters this year from the FDA accusing them of misleading online advertisements.3 But while the FDA scrambles to monitor online ads, who monitors the psychiatric-pharmaceutical industry’s use of front groups to indirectly market their products?

A Washington Post article of June 16, 2009 reported that an increasing number of pharmaceutical firms are turning to social media tools, such as Facebook, YouTube, Twitter and MySpace, to market their products.  It cites how a community site sponsored by drugmaker McNeil called “ADHD Allies”—aimed at adults with ADHD—was established and offered an online podcast on financial advice and an “ADHD self-assessment tool.”4

British psychiatrist Joanne Moncrieff explains how this ultimately increases drug sales because only a biomedical approach is promoted: “Drug companies…provide funds for pro drug patient and carer groups and address advertising or disease promotion campaigns to the general public…This influence has helped to create and reinforce a narrow biological approach to the explanation and treatment of mental disorders and has led to the exclusion of alternative” treatments.5

Such websites do not mention company’s product but rather market the “disease.” In advertising, it can be accomplished through a strategy known as “condition branding,” where “mental illness” can be pitched just like cars, beer or laundry detergent.  Witness the brand name “bipolar” and “social anxiety disorder” that drug companies marketed at a fever pitch.

John Read, PhD, Psychology Department, University of Auckland did an analysis of 54 random “advocacy” groups for Post Traumatic Stress Disorder (PTSD) through the Internet. The results, published in the Journal of Trauma & Dissociation this year, found 42% of the websites received drug company funding. The researchers found:

  • “Patients tend to trust these organizations to act in an unbiased manner” but as earlier researchers argued in some cases “patient organizations have become a mouthpiece for the pharmaceutical industry in influencing regulatory authorities.”
  • “Drug company influence within the area of mental health is prevalent and now extends to the Internet. This influence is not always transparent. This study suggests that drug company sponsorship of websites leads to a greater emphasis on pharmacology in the treatment of PTSD,” Dr. Read’s report concludes.6

ADHD Allies/ADHD Moms

In June 2008 Concerta was given an expanded indication by FDA and is now indicated for patients aged 6 to 65.7 In July 2008, McNeill Pediatrics—a subsidiary of Ortho-McNeill Pharmaceuticals—launched what they called an “unbranded group” called “ADHD Moms.” ADHD Moms markets the trademarked name “Mom-bassadors” to get mothers into the Facebook page. 8

  • McNeill spuriously claims “the group is not product-specific, nor are there any advertisements for the company’s ADHD drug Concerta (methylphenidate).” Well not directly, but providing material for the site is a Dr. Quinn, a paid consultant and speaker for McNeil Pediatrics. 9 April White, who also provides content is a paid spokesperson for McNeil Pediatrics.10
  • On April 22 2009, McNeill launched a second ADHD-focused Facebook page called “ADHD Allies,” this time targeting adults.  The “Allies” are board members of another front group Attention Deficit Disorder Association (ADDA), funded by McNeill.11
  • The pharmaceutical company has trademarked “ADHD Allies” and “ADHD Moms.”  ADHD Allies was responsible for a “2008 Harris Interactive survey of 1,000 adults with ADHD.” Not surprisingly, the survey found the condition significantly affects them. 12

Log onto The Bipolar Journey: Living With Bipolar Depression website and while it does show AstraZeneca on the home page, there’s no mention of its blockbuster antipsychotic drug Seroquel, approved by the FDA in 2006 for “bipolar.”  The site looks like a patient information site providing facts about the “disease” and misleadingly saying that it may be caused by a chemical imbalance—for which there is no evidence.

It refers people to the National Alliance for the Mentally Ill (NAMI) that has received $23 million recently from at least 18 drug companies. The site shows that of 17 cites for the exhibit’s showing in 2009, 12 are conferences or events put on by NAMI.

It also links to The Depression and Bipolar Support Alliance, a group that received close to $1 million in pharmaceutical company funding in 2007.

According to an August 27 2009 press announcement, AstraZeneca launched its interactive exhibit, endorsed by New York psychiatrist Janet Taylor. The press release does not mention that Dr. Taylor has financial ties to the company.13

In 2005, global sales for Seroquel reached $2.8 billion.  October 20, 2006, company announced Seroquel was FDA approved for bipolar.14 Within a year, sales reached $3 billion and then soared again in 2008 to $4.66 billion.15

By funding social media front groups that talk only about the “disorder,” drug companies can overcome fears of running afoul of FDA regulations that govern drug advertising and “are embracing social networks to help brand and position their companies in a positive light with consumers and practitioners.”  The top 10 drug companies using social media are: Pfizer, Johnson and Johnson, Novartis, Boehringer Ingelheim, AstraZeneca US, Bayer, GlaxoSmithKline, Sanofi-Aventis, Roche, and Merck.16

This post was written by CCHR International.
Coming next from CCHR Int: Psycho Pharma Front Groups

1 “FDA Addresses Drug Ads in Online Social Media,” Red Orbit, 13 Nov. 2009.

3 “FDA Addresses Drug Ads in Online Social Media,” Red Orbit, 13 Nov. 2009.

5 Joanne Moncrief, in a “Study of the Influence of the Pharmaceutical Industry on Academic and Practical Psychiatry,” http://www.critpsynet.freeuk.com/pharmaceuticalindustry.htm

6 http://www.isst-d.org/jtd/mansell_&_read_ptsd_drug_cos_&_internet%20.pdf; Journal of Trauma & Dissociation, 10:9–23, 2009

12 “Adults ‘Facing’ ADHD: ADHD Allies™ Offers Unique Online Community for Adults with ADHD on New Facebook® Page,” http://multivu.prnewswire.com/mnr/concerta/36533/

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