Posts Tagged ‘GSK’

Glaxo Still Haunted by Faked Paxil Studies in Kids; Crooked psychiatrist expected to plead guilty to criminal charges today

Thursday, August 19th, 2010

“The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.”

BNET
By Jim Edwards
August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

Read entire article here:  http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

Read more about Palazzo here:
http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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GSK & AstraZeneca face corruption investigation—hospitality lavished on those who prescribe drugs could constitute bribery

Monday, August 16th, 2010

Market Watch
By London Bureau
August 14, 2010

U.K. pharmaceutical firms GlaxoSmithKline PLC (GSK 38.15, +0.01, +0.03%) and AstraZeneca PLC (AZN 51.88, +0.49, +0.95%) are facing a corruption investigation in the U.S. over claims that the hospitality lavished on those who prescribe their treatments could constitute bribery, The Independent newspaper in London reported Saturday, without citing sources.

The newspaper said the two firms are among those facing the investigation being carried out by the Department of Justice and Securities and Exchange Commission.

The investigation is thought to center around allegations that drug companies might have contravened the Foreign Corrupt Practices Act, which limits their ability to spend on such things as hospitality, charitable donations and other non-business activities, the newspaper said.

Read entire article here:  http://www.marketwatch.com/story/gsk-astrazeneca-facing-us-probe-report-2010-08-14

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Long Awaited Army Report on Suicides Ignores Role of Suicide-Causing Drugs such as Antidepressants/Antipsychotics

Monday, August 2nd, 2010

OpEdNews
By Martha Rosenberg
August 1, 2010

Why are troops killing themselves?

The long awaited Army report, “Health Promotion, Risk Reduction, Suicide Prevention” considers the economy, the stress of nine years of war, family dislocations, repeated moves, repeated deployments, troops’ risk-taking personalities, waived entrance standards and many aspects of Army culture.

What it barely considers is the suicide-inked antidepressants, antipsychotics and antiseizure drugs whose use exactly parallels the increase in US troop suicides since 2005.

In the report Chief of Staff General Peter W. Chiarelli acknowledges antidepressant risks, saying there’s “fair quality evidence that second generation antidepressants (mostly SSRI) increase suicidal behavior in adults aged 18 to 29 years” but adds that “other research evidence shows the benefit of antidepressant use”.

And nowhere does he acknowledge the suicide potential of antiseizure drugs so widely used for pain and as “mood stabilizers” by troops even though the FDA mandated suicide warnings on Lyrica, Topamaz, Depakote, Lamictal, Tegretol, Depakene, Klonopin and 16 others in 2008.

(Lamictal also has the distinction of wasting more taxpayer money than any other drug according to a July American Enterprise Institute report. Medicaid spent an unnecessary $51 million on Lamictal instead of buying a generic last year, thanks to GSK salesmen. You go, guys,)

When asked by NPR’s Robert Siegel if the high number of medicated troops contributed to suicide, Gen. Chiarelli said, “The good thing about those numbers is…the prescriptions were all made by a doctor.” Asked why troops who had not even deployed were among the suicides, Chiarelli said there were other stressors involved.

In June Marine Times reported 32 deaths on prescription drugs in Warrior Transition Units (WTUs) since 2007 and said an internal review “found the biggest risk factor may be putting a soldier on numerous drugs simultaneously, a practice known as polypharmacy.”

But instead of citing dangerous drugs and drug cocktails for turning troops suicidal (and accident prone and at risk of death from unsafe combinations) the Army report cites troops’ illicit use of them along with street drugs. (The word “illicit” appears 150 times in the Army report and “psychiatrist” appears twice.)

No, it’s not the 8,000 urine samples in 2009 which showed prescription drug traces according to the Army report — it’s the fact that 21 percent of the drugs were “illicit.”

No wonder the revised suicide report form suggested by the Army report doesn’t even have a box to enter “adverse reactions to drug or drug combinations.” Instead, it has a box that asks how long before a suicide a patient was “compliant” with the prescription. Was the medication “taken as prescribed? Skipped?” Taken “In excess of prescription? In different manner (e.g., crushed instead of in capsule)?”

Read entire article here:  http://www.opednews.com/articles/Army-Suicide-Report-Ignore-by-Martha-Rosenberg-100801-596.html?show=votes

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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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