SSRI drug company fined more than $1 billion.

Dr. Weeks’ Comment:   Let’s review – A medical doctor is a doctor of   “medicine”  (just as a juris doctor is a doctor or teacher or law,  and a doctor of philosophy teaches philosophy).   Medical doctors are not trained in aspects of health, nutrition, lifestyle modification or elegant management of  mental or spiritual aspects of life.  I always chuckle when patients complain to me that their medical doctor knows nothing about nutrition. “Why should they?” I inquire, “Nutrition is not part of our training nor is it what is expected of us as medical doctors!”    And when they ask me “Well, you’re a medical doctor. How did you learn all about nutrition and diets and corrective habits of health?” I tell them that when I realized in medication school that using drugs intelligently was only one small aspect of helping patients reattain health and joy, I took it upon myself, extracurricular, to study these other modes of healing, in addition to and not instead of standard medical practice.

As a medical doctor, I constantly study the nature of medicines – both prescription (i.e. man-made, patented and profitable) and naturally occurring (i.e. God- made, not-patentable and practically free for the taking).  Medicines are a powerful and wonderful tool which offer tremendous benefits. However, it is not the core of my practice.  Instead, I use medications only when necessary and only at the minimal dose which is fully effective. The wisdom of healing nutrition, exercise, managing thought processes and self-reliance are the core tenets of Corrective Medicine whereas the use of patented medications, while it often saves lives in the short-run, typically damages, disrupts  or depletes natural biochemical processes and can delay true healing.

When I prescribe a medication, therefore, I consider with my patient, the pros and cons of various drugs and we decide together a therapeutic strategy. Many of my patients come to me for help with psychiatric problems and we typically use some medication to lessen the voices, or calm the inflammed mood, but there is one class of drugs which makes me cringe when patients present on it:  the SSRI drugs.

Many many of my patients love the benefit they receive on these SSRI anti-depressant medications but more than 30% feel that these, more than any other drug class on the market today are “dehumanizing” (I am using their words, the words of patients who, once they detox and taper off these drugs, look back and say “I got lost somewhere along the way. I just disappeared gradually on that SSRI.”

So the news today is that more and more people are agreeing with my patients and their criticism of this SSRI is costing the companies that promote them more than $1 billion.

I hope that my medical colleagues will note the word of caution offered Dr. Don Carlat, psychiatrist at Tufts who wrote: “It would motivate doctors to dig into the literature even more before prescribing these drugs.”

Or maybe we can all try and bear to heart the clarion words of Hippocrates, the father of modern western medicine, when to reminded doctors to “first do no harm”.   That is why I start with God-made unpatented remedies, that is why I teach and practice corrrective medicine and psychiatry, and that is why when I do prescribe patented profitable drugs, the patient and I carefully review the pros and cons of the drug so as to fully inform all parties as to the real risks and benefits.  If you don’t do that or worse, if you hide negative data, it will cost you and those who trust you.    $1 billion is not the true cost for all the suffering.

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From Ann Blake Tracy, Ph.D. see   www.ssristories.com and  www.drugawareness.org
Excellent article! Lots of people would still be alive and many more avoided damage had they listened years ago when I began warning about these drugs, but it is not over there will tragically be many more losses due to their ability to buy the silence this doctor from Tufts says should not be.
The one glaring omission in this article is a case I am very familiar with Tobin vs Glaxo. This is the only murder/suicide case Glaxo was stupid enough to allow to go to court. The jury ruled that the evidence was clear that Paxil was the main cause of this tragic murder/suicide that cost 4 lives in one WY family. They were ordered to pay $6.3 Million – in my opinion a very small amount for four lives! But it will not be the end of these types of cases. They did not figure the losses this company will face from those cases of murder/suicide.
___

The company hasn’t specified in regulatory filings the number of suicide, birth-defect and addiction cases settled.

“It’s important to disclose such settlements because it raises the red flag for both doctors and patients that there might be a problem,” said Dan Carlat, a psychiatrist at Tufts University School of Medicine in Boston who writes and edits a blog and a monthly Psychiatry Report. “It would motivate doctors to dig into the literature even more before prescribing these drugs.”

  • About 450 suicide-related Paxil cases were settled. Only about a dozen haven’t been, the people said. The $1 billion total doesn’t include more than 600 claims that Paxil caused birth defects.
  • A Philadelphia jury on Oct. 13 found the drugmaker should pay $2.5 million to the family of Lyam Kilker, a 3-year-old boy born with a heart defect after his mother took Paxil while pregnant. Based on that outcome, an analyst estimated the company may potentially face additional verdicts in birth-defect cases waiting to be tried in Pennsylvania.
  • 600 More Cases
  • “A liability totaling $1.5 billion is possible,” wrote Savvas Neophytou, a Panmure Gordon analyst in London, in a note to investors the day after the Kilker verdict.
  • In comparison, Pfizer Inc., parent of Wyeth, the maker of diet-drug combination fen-phen, has had to set aside about $21 billion to resolve about 200,000 personal-injury claims over that medicine. Merck & Co. agreed to pay $4.85 billion to resolve more than 48,000 claims over the withdrawn painkiller.
  • Harris Pogust, an attorney for Paxil plaintiffs, couldn’t confirm the total. He said the amounts are confidential.
  • The suicide settlements included a suit over the death of a 14-year-old boy who had been taking Paxil for two months. The parents of Scott Cunningham, of Valparaiso, Indiana, sued after the boy hung himself in 2001. They alleged Glaxo suppressed evidence that Paxil use was linked to the risk of suicide attempts by adolescents. Glaxo denied the allegations, according to court papers.
  • The family settled its suit in May, according to court filings. Family attorney Bijan Esfandiari confirmed the settlement, saying the amount was confidential.
  • About 150 cases over suicides by Paxil users were settled for an average of about $2 million, and about 300 over suicide attempts settled for an average of $300,000, they said. Some of the claims were resolved before suits were filed, according to the people familiar with the matter.
  • Glaxo has settled about 10 birth-defect cases, Sean Tracey, a Houston-based lawyer who represented the family of a child victim, said in court Dec. 2. The settlements averaged about $4 million, the people familiar with the cases said.
  • Glaxo paid an average of about $50,000 per case to resolve about 3,200 claims linking Paxil to addiction problems, the people familiar with the cases said.
  • In its 2008 annual report, company officials noted they had reached a “conditional settlement agreement” in January 2006 with Paxil users who alleged they suffered withdrawal symptoms after taking the drug. The case, filed in Los Angeles federal court, was marked closed in court records in February.
Glaxo Said to Have Paid $1 Billion to Settle Paxil Lawsuits

By Jef Feeley and Margaret Cronin Fisk

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Dec. 14 (Bloomberg) — 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.”

The drugmaker has reduced its insurance coverage to contain costs, “accepting a greater degree of uninsured exposure,” the annual report states. “Recent insurance loss experience, including pharmaceutical product-liability exposures, has increased the cost of, and narrowed the coverage afforded by, insurance for pharmaceutical companies generally,” Glaxo said.

Glaxo Comment

Glaxo declined to confirm the $1 billion figure. “Paxil has been on the market in the U.S. since 1993. Like many other pharmaceutical products, it has been the subject of different kinds of litigation over the years,” said Sarah Alspach, a spokeswoman for Glaxo, in an e-mailed statement. “It would be inappropriate and potentially misleading to aggregate payments in these various types of litigation.”

Chief Executive Officer Andrew Witty has moved to replace revenue lost to generic versions of drugs such as Paxil. Worldwide, Paxil generated about 514 million pounds in sales last year, or 2.1 percent of the total. Glaxo closed up 5 pence to 1,303 pence in London trading Dec. 11, down 8.8 percent from a year ago.

About 450 suicide-related Paxil cases were settled. Only about a dozen haven’t been, the people said. The $1 billion total doesn’t include more than 600 claims that Paxil caused birth defects.

A Philadelphia jury on Oct. 13 found the drugmaker should pay $2.5 million to the family of Lyam Kilker, a 3-year-old boy born with a heart defect after his mother took Paxil while pregnant. Based on that outcome, an analyst estimated the company may potentially face additional verdicts in birth-defect cases waiting to be tried in Pennsylvania.

600 More Cases

“A liability totaling $1.5 billion is possible,” wrote Savvas Neophytou, a Panmure Gordon analyst in London, in a note to investors the day after the Kilker verdict. He still recommended buying Glaxo shares because a likely appeal may reduce the amount paid by the company.

In comparison, Pfizer Inc., parent of Wyeth, the maker of diet-drug combination fen-phen, has had to set aside about $21 billion to resolve about 200,000 personal-injury claims over that medicine. Merck & Co. agreed to pay $4.85 billion to resolve more than 48,000 claims over the withdrawn painkiller.

Harris Pogust, an attorney for Paxil plaintiffs, couldn’t confirm the total. He said the amounts are confidential.

Paxil Is Different

“Paxil’s been different from most drugs,” said Pogust, a lawyer from Conshohocken, Pennsylvania, who is handling suicide and withdrawal cases. “You’ve had three major personal injury litigations over one drug — the suicide, the birth defect and the withdrawal cases. To have three significant problems with one drug is really unusual.”

The company had $11.7 billion in U.S. Paxil sales for nine years starting in 1997, according to documents made public this year in a Pennsylvania trial. In 2002, the year before Paxil faced generic competition in the U.S., sales of the drug there were $2.12 billion. Last year, U.S. sales had fallen to $129 million. Through September of this year, sales were $52 million, down 52 percent from the same period in 2008.

Since at least 2003, Glaxo has faced claims in U.S. courts that some Paxil users were subjected to an undisclosed, higher risk for suicide and birth defects.

A Suicide Settlement

The suicide settlements included a suit over the death of a 14-year-old boy who had been taking Paxil for two months. The parents of Scott Cunningham, of Valparaiso, Indiana, sued after the boy hung himself in 2001. They alleged Glaxo suppressed evidence that Paxil use was linked to the risk of suicide attempts by adolescents. Glaxo denied the allegations, according to court papers.

The family settled its suit in May, according to court filings. Family attorney Bijan Esfandiari confirmed the settlement, saying the amount was confidential.

About 150 cases over suicides by Paxil users were settled for an average of about $2 million, and about 300 over suicide attempts settled for an average of $300,000, they said. Some of the claims were resolved before suits were filed, according to the people familiar with the matter.

Glaxo has settled about 10 birth-defect cases, Sean Tracey, a Houston-based lawyer who represented the family of a child victim, said in court Dec. 2. The settlements averaged about $4 million, the people familiar with the cases said.

Hasn’t Specified

The company hasn’t specified in regulatory filings the number of suicide, birth-defect and addiction cases settled.

“It’s important to disclose such settlements because it raises the red flag for both doctors and patients that there might be a problem,” said Dan Carlat, a psychiatrist at Tufts University School of Medicine in Boston who writes and edits a blog and a monthly Psychiatry Report. “It would motivate doctors to dig into the literature even more before prescribing these drugs.”

Glaxo paid an average of about $50,000 per case to resolve about 3,200 claims linking Paxil to addiction problems, the people familiar with the cases said.

In its 2008 annual report, company officials noted they had reached a “conditional settlement agreement” in January 2006 with Paxil users who alleged they suffered withdrawal symptoms after taking the drug. The case, filed in Los Angeles federal court, was marked closed in court records in February.

“Glaxo did not admit liability” in the addiction settlements, the company’s officials said in a March 2009 filing with the U.S. Securities and Exchange Commission.

The Other $400 Million

In one of eight accords unrelated to individual suicide, addiction or birth-defect claims, Glaxo agreed in 2003 to pay $87.6 million to the U.S. and 49 states over claims it repackaged and privately labeled Paxil and another drug, Flonase, to a health maintenance organization at discounted prices.

Glaxo, denying liability, agreed in 2004 to pay $165 million to settle two antitrust suits over allegations it engaged in sham patent infringement litigation to stall approval of generic versions of the drug, court records show. Of that total, $100 million was for direct purchasers of Paxil, such as drug wholesalers, and $65 million was for indirect buyers, the records show.

In the same year, Glaxo agreed to pay $2.5 million to New York to resolve accusations the company withheld safety data about the antidepressant. The company, calling the claims unfounded, agreed to release safety studies on the medicine’s effect on children.

In 2005, the company added a black-box warning to its Paxil label that the drug increased the risk of suicidal thoughts among adolescents, following a request by the U.S. Food and Drug Administration to do so.

The Philadelphia case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 07-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net and; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

Last Updated: December 14, 2009 00:01 EST

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Dr. Weeks’ Comment:   Let’s review – A medical doctor is a doctor of   “medicine”  (just as a juris doctor is a doctor or teacher or law,  and a doctor of philosophy teaches philosophy).   Medical doctors are not trained in aspects of health, nutrition, lifestyle modification or elegant management of  mental or spiritual aspects of life. …
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