Posts Tagged ‘Glaxo’

Wellbutrin – To Promote or Not Promote… That is the Question

Friday, May 6th, 2011

Seroxat Sufferers – Stand Up and Be Counted
By Bob Fiddaman
May 6, 2011

Did they or didn’t they?

Lauren Stevens, the Glaxo associate general counsel, who is charged with one count of obstructing an official proceeding, one count of falsifying documents before a federal agency and four counts of making false statements to the FDA, has heard evidence given to a jury by James Millar, GSK vice president of strategic pricing, contracting and marketing.

Millar had originally refused to testify but prosecutors persuaded the US District Judge [Roger W. Titus] to order him to give his testimony.

Millar was head of GSK’s marketing for Wellbutrin and remained insistent that GSK’s promotion of its product was as an antidepressant that carried low risk of weight gain and sexual dysfunction.

GSK have claimed that they worked with doctors to stop the promotion of Wellbutrin for off label use.

In 2002, writes Law 360′s Christopher Norton, “GSK became aware that the company’s two top promotional-speaker doctors were using slides in their presentations including information for off-label uses of the drug, but swiftly took steps to bring the pair into compliance with all regulations.”

Those top two doctors were named as Psychiatrist James Hudziak and physician James Pradko, they were both the most highly paid doctors in GSK’s Wellbutrin promotional stable.

It was Millar who, alongside others at GSK, worked with doctors that GSK, claimed, paid to promote the drug in an effort to ensure the physicians removed any mention of off-label uses from their presentations, especially in the wake of new regulations that began to roll out around 2002, he told the jury, writes Christopher Norton for Law360.

It is alleged that Lauren Stevens lied to the FDA when they sought information from GSK about whether or not they promoted Wellbutrin for weight loss. It’s also alleged that Stevens knew GSK had sponsored programs that promoted Wellbutrin as a weight loss drug. Stevens is also alleged to have known that GSK had paid many doctors to promote Wellbutrin to other doctors which included “off-label” use.

Millar claims that he was sent to monitor Psychiatrist James Hudziak after concerns were raised about his potential use of off-label slides, slides he used at presentations. Millar was apparently able to make Hudziak change the presentation and got him to start using a “company approved” slide kit.

Stevens has claimed that she concealed slides from the FDA showing that GSK was promoting Wellbutrin for illegal unapproved use, she has also claimed that she was advised by a company lawyer to do so.

So, we have GSK saying they did everything in their power to stop doctors promoting the illegal, unapproved use of Wellbutrin… yet we have Stevens, as part of her defence, claiming she concealed slides that showed GSK was promoting Wellbutrin for illegal unapproved use. Not only that – she was told to do so by one of GSK’s lawyers!

The mind boggles at how this company operate.

It seems that Stevens, the former Glaxo associate general counsel, is now turning against the very same people she used to work for. You go girl.

The case against Stevens continues.

Her re-indictment can be viewed HERE

Read article here:  http://fiddaman.blogspot.com/2011/05/wellbutrin-to-promote-or-not.html

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Feds Want Glaxo Exec To Testify In Stevens Case

Monday, April 25th, 2011

Pharmalot – April 25, 2011

By Ed Silverman

gavel-flickr4The trial of former GlaxoSmithKline lawyer Lauren Stevens gets under way this week and federal prosecutors hope to force a Glaxo exec to testify, according to documents filed in federal court last week. The feds are trying to compel James Millar, a vp of strategic pricing, contracting and marketing to take the stand in their quest to convict Stevens of obstruction of justice.

Stevens, you may recall, was first indicted last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. More recently, the indictment was tossed, because prosecutors incorrectly portrayed her defense to a grand jury. However, they subsequently issued another indictment earlier this month (back story).

The feds want Millar to be compeled to testify because his testimony “may be necessary to the public interest.” However, prosecutors expect that he would refuse to testify or otherwise provide any info on the basis of his privilege against self-incrimination, according to court documents (read this). As of this morning, the order compelling his testimony has not been filed with the court.

As indicated previously, the trial threatens to evolve into a spectacle where Glaxo execs and Glaxo lawyers – notably, the King & Spalding law firm that frequently represents the drugmaker – turn the courtroom into a finger-pointing match among people who once labored on the same side of the pharmaceutical battlefield (see here).

http://www.pharmalot.com/2011/04/feds-want-glaxo-exec-to-testify-in-stevens-case/

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Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New JerseyDrinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

OklahomaKaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

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Drug Firms Face Bribery Probe from US Department of Justice

Tuesday, October 5th, 2010

Justice Department, SEC Seek Information From Companies on Payments to Overseas Officials

Wall Street Journal, October 5, 2010

by Michael Rothfeld

Federal investigators are looking at ways that drug makers could be paying bribes overseas to boost sales and speed approvals, according to letters sent to the companies and people close to the matter.

Big companies—including Merck & Co., AstraZeneca PLC, Bristol-Myers Squibb Co. and GlaxoSmithKline PLC—in recent months have disclosed they are being investigated for possible violations of a 1977 law that makes it illegal for companies whose stock is traded in the U.S. to bribe government officials in other countries to get business.

[PHARMA]

The companies said they are cooperating with the government, with several adding that the investigation is industry-wide and broader than their companies specifically. Many said they have policies meant to ensure compliance with the Foreign Corrupt Practices Act.

So far, none of the companies has been accused of wrongdoing, and the investigation ultimately may not result in charges.

The Justice Department and the Securities and Exchange Commission requested that companies voluntarily report any violations of the FCPA. Some companies, including SciClone Pharmaceuticals Inc. and Eli Lilly & Co., disclosed receiving subpoenas from the SEC. Baxter International Inc. also has said it is being investigated.

The investigation is targeting transactions in Brazil, China, Germany, Italy, Poland, Russia and Saudi Arabia, people familiar with the matter said.

The Justice Department and the SEC declined to comment.

Such requests from the government typically kick off internal investigations at companies, which generally comply with the requests in order to win leniency from the government if a violation is found.

A lawyer for one drug company said the industry has been vexed because the recent requests were so broad and because the investigations, across operations in several countries, can cost millions of dollars.

“If you don’t have any specifics, a lot of this is just guesswork,” the lawyer said. “Everyone was running around to get in the door to meet with the government so they can better understand what the issues are.”

Letters from the government to one of the companies, which were reviewed by The Wall Street Journal, identified four types of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals.

People familiar with the situation said the other companies received similar letters.

The requests are similar to the government’s actions in an older bribery probe involving medical devices. In that investigation, settlement talks are ongoing with several companies, according to a person familiar with the matter.

Representatives for Merck, AstraZeneca, Bristol-Myers, Glaxo and Baxter declined to comment on the probe beyond saying they were cooperating fully with the government.

A SciClone spokeswoman declined to comment beyond the company’s SEC filings, in which it said it was subpoenaed for documents relating to its practices in China. A Lilly spokesman referred to an SEC filing in which the company said the U.S. government expanded to other countries an investigation of its Polish subsidiaries that began in 2003.

U.S. officials and European regulators have become increasingly aggressive in investigating foreign bribery cases in recent years. U.S. officials recently have threatened to file charges against executives and not just their companies.

The pharmaceutical industry is particularly vulnerable because government plays a bigger role in administering medicine in many foreign countries than it does in the U.S. and drugs are highly regulated, which creates contact with public officials. Doctors and hospital administrators often are government employees overseas.

Some of the alleged bribes could involve payments to doctors to influence drug trials, people familiar with the situation said. Justice Department officials have said publicly that drug companies also could face charges if they bribe government officials in the guise of payment for travel, meals, entertainment or speaking fees.

Read the rest of this article here: http://online.wsj.com/article/SB10001424052748704847104575532091781199092.html

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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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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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Jury recommends major reforms in drug prescribing after investigation of 18-year-old’s suicide under the influence of Paxil

Wednesday, June 30th, 2010

Pharmalot
By Ed Silverman
June 30, 2010

There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.

“If these things had been in place at the time Sara was prescribed Paxil, she would be alive today,” her father, Neil Carlin, said outside court. “We consider this a great victory…We are truly confident that if these are acted upon there will be young lives saved down the road.”

For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18. The teenager hanged herself in her parents’ basement in May 2007. The inquest made numerous recommendations, which you can see if you keep reading…

Of the various recommendations, the one that is garnering the most discussion appears to be the creation of a Drug Safety Board to investigate the side effects and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drugmakers. Drugmakers must also report all adverse events to Health Canada within 30 days.

A Glaxo spokeswoman writes to says the drugmaker “is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.”

1. The Ministry of Health and Long-Term Care (MOHLTC) should develop a Drug Information System. This system would promote:
• Patient safety in the prescribing and dispensing of drugs.
• Collection and compilation of data in a single repository for all drugs dispensed for all Ontarians.
• Research into drug and patient safety.

2. The Drug Information System should track and monitor all drugs dispensed in Ontario regardless of who is paying for the prescription.

3. The Drug Information System should collect, compile and release data upon request to scientists such as those studying population-based health outcomes at the Institute for Clinical Evaluative Sciences.

4. The Ministry of Health and Long-Term Care should commit to developing a province-wide suicide prevention strategy as has occurred in other provinces such as Alberta.

5. The objectives of the province-wide suicide prevention strategy should include:
• Enhanced mental health and well being for Ontarians.
• The education of the public to de-stigmatize mental health disorders, including depression and substance abuse disorders.
• Improving intervention and support for Ontarians affected by depression and substance abuse.
• Improving intervention and treatment for those at risk of suicide.
• Increased efforts to reduce access to lethal means of suicide.
• Increased research activities in Ontario on suicide, suicidal behaviour and suicide prevention.
• Improved suicide and suicidal behaviour-related surveillance systems.
• Inform and educate the media into strategies when reporting deaths due to suicide to prevent ‘copy cat’ suicides from occurring.

6. Strategies in the province-wide suicide prevention strategy should be humane, effective and evidence based, respectful of community and culture-based knowledge, inclusive of research, surveillance, evaluation and reporting and reflective of evolving knowledge and practices.

7. The ministry of Health and Long-Term Care of Ontario and Government of Ontario should commit to supporting the development of a national suicide prevention strategy for all Canadians.

Read entire article:  http://www.pharmalot.com/2010/06/sara-carlin-paxil-and-drug-safety-in-canada/

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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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Paxil Birth Defect Litigation – 600 Cases Pending

Wednesday, February 17th, 2010

Scoop Independent News
By Evelyn Pringle
February 18, 2010

GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in 1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.

Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.

First Trial A Bust for Glaxo

The first trial, in the case of Kilker v Glaxo, ended 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 jury awarded the family $2.5 million in compensatory damages.

After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. “There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further,” he said.

On October 14, 2009, the American Lawyer reported that the plaintiff’s lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. “They said the fact that GSK never adequately studied their own drug was a big deal,” Tracey said. “The animal testing they did showed that they had a potential problem, and they didn’t follow up with adequate studies on animals or humans.”

Read entire article:  http://www.scoop.co.nz/stories/HL1002/S00128.htm

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Glaxo Said to Have Paid $1 Billion in Paxil Suits Including About $390 Million for Suicides/Attempted Suicides Linked to Drug

Monday, December 14th, 2009

Jef Feeley and Margaret Cronin Fisk
Bloomberg.com
December 14, 2009

GlaxoSmithKline Plc has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.

As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid $200 million to settle Paxil addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims, according to the people and court records.

The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst at Matrix Corporate Capital in London. “I don’t think this is within the boundaries of current assumptions for analysts.”

The London-based company hasn’t disclosed the settlement total in company filings. It has made public some accords. Glaxo’s provision for legal and other non-tax disputes as of the end of 2008 was 1.9 billion pounds ($3.09 billion), according to its latest annual report. This included all legal matters, not just Paxil. The company said 112 million pounds of this sum would be “reimbursed by third-party issuers.”

Read entire article: http://www.bloomberg.com/apps/news?pid=20601103&sid=aWNKB4YPWjIY

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