Friday, August 01, 2008

PAL vs Paxil

Boston, MA – Three labor union benefit funds filed a formal objection yesterday to the proposed $40 million nationwide settlement of a class action lawsuit against GlaxoSmithKline (NYSE:GSK). The lawsuit alleged that Glaxo defrauded health plans, union benefit funds and other “third party payors” by failing to disclose the increased risk of suicidal thoughts and behavior among children and adolescents taking the prescription antidepressants Paxil® and Paxil CR®. The $40M settlement is to reimburse third party payors for payments they made to pharmacies for Paxil prescribed to children and adolescents from 1998 to 2004.

The union benefit funds objected to the settlement because the proposed claims process requires information that many health plan and benefit funds don’t have, or could only get through a burdensome, unreasonable process that would be more work than the potential claim was worth. The objectors are Sergeants Benevolent Association Health and Welfare Fund (www.sbanyc.org/benefits), AFSCME District Council 37 Health and Security Plan (www.dc37.net/benefits/health.html) and IUOE Local 4 Health and Welfare Fund (www.local4funds.org). They provide prescription drug coverage for more than 320,000 union members, retirees and their families.

Under the terms of the proposed settlement, TPPs can be reimbursed up to 40% of their costs for Paxil prescribed for Major Depressive Disorder, while all other prescriptions for Paxil for other conditions will only be reimbursed at 15%. This requires TPPs to list a diagnostic code for each and every pediatric prescription for Paxil that they paid for during the seven year period. The objectors challenged this distinction, arguing that almost no one will really get a 40% refund, because almost no TPPs have diagnostic codes for the prescriptions they pay for.

In addition, millions of prescriptions for Paxil were written during the seven years covered by the lawsuit (1998-2004), yet the settlement requires any claim for more than $1,000 in reimbursement to include exhaustive details regarding every individual prescription of Paxil paid for during that seven-year period.

The funds also objected to other requirements, including the way that TPPs are required to calculate the net cost of the payments they made, and to misleading and inaccurate statements in the settlement notice about class members’ rights to object, appear at the hearing, or appeal final approval of the settlement.

“A $40 million settlement may sound very positive, but the devil is very much in the details,” said Gina Alongi, Administrator of IUOE Local 4 Health and Welfare Fund. “The way the settlement is currently structured will prevent many health plans and union benefit funds like ours from getting any real compensation from it.”

The three union funds objecting to the settlement are all members of Prescription Access Litigation (PAL – www.prescriptionaccess.org), a national coalition of more than 130 unions and consumer advocacy groups that works to challenge illegal practices by the pharmaceutical industry.

“TPPs will have to comb through mountains of medical records and bury themselves in paperwork before they ever see a penny from this settlement,” said Alex Sugerman-Brozan. “Class action settlements are only as good as their claims process, and this one fails at a very fundamental level.”

Last year, Prescription Access Litigation objected to an earlier Paxil class action settlement (Hoorman et. al. v. SmithKline Beecham). That $63M settlement was of a class action brought on behalf of consumers who paid for Paxil prescriptions for children and adolescents. As a result of that objection, important changes protecting consumers’ rights were made to the settlement.

A settlement of a class action must be approved by the Court where the case is brought. Because class actions affect the rights of people and entities that aren’t even aware of the lawsuit, the Court reviews settlements to make sure they are “fair, reasonable and adequate.” Members of the class may object to the settlement, and request to speak at a hearing before the Court.

The case is Carpenters and Joiners Welfare Fund et. al. v. SmithKline Beecham Corp. (U.S. District Court for Minnesota, Case #04-CV-3500). The Final Approval hearing in the case is scheduled for September 30, 2008 in the U.S. District Court in Minneapolis, Minnesota. The deadline for third party payors to submit claims for payment from the settlement is December 12, 2008. More information about the settlement, including claims forms, can be found at www.pediatricpaxiltppsettlement.com. A full copy of the funds’ objection to the settlement can be found at www.prescriptionaccess.org/docs/pediatric-paxil-objection.pdf

1 comment:

Anonymous said...

I would like to tell everyone about my experience with taking Paxil. I am doing this so that you may make an informed decision should you decide to take this drug. I was not given that option because certain side effects, though known, have not been disclosed to the FDA, physicians, or consumers.
I was prescribed Paxil by my doctor during an especially stressful time in my life. I had no history of mental illness nor was I diagnosed with an anxiety disorder. I took this medicine, actually a very low dose, from 2001 – 2005. When I decided to stop taking it, I cut my dose back gradually and weaned myself off of it entirely.
I began having gastric distress. This began as I was cutting back on the Paxil and continued long after I quit taking it. I had diarrhea every day for 2-1/2 years. Just about everything I ate went right through me. This lasted all day long, every day. From my research, I have since learned that most of the serotonin in your body is located in your intestines, so it makes sense that if you take something that adjusts that serotonin level, then your intestines would be affected.
I will try to tell you how this has changed my life. It affects everything that I do, from what kind of job I have, where I go, vacations, where and what I can eat. I have had many tests run by specialists and there is no other cause for the diarrhea. I can also tell you that there have been some very embarrassing moments because of this.
About 2 months ago, as an experiment, I started taking the Paxil again. And guess what? The diarrhea stopped almost immediately. I found a blog called Paxil Progress, which is a blog for people who are trying to wean off of Paxil and it seems that my story is not unique at all. This drug causes bowel incontinence, bloating, horrible gas and pain along with the chronic diarrhea.
I wish I had known what this drug would do to me before I started taking it. Please do your homework. The doctors will not tell you about the side effects and withdrawal symptoms, nor will GlaxoSmithKline, the makers of Paxil. Can you guess why they don’t tell you? $$$$$$$$$$$$$$