Paxil Five-Year Litigation History

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Instead, it sent Medical Information Letters only to those physicians who specifically requested information concerning Paxil as a treatment for children and adolescents.

Glaxo also took steps to actively conceal the negative information about Paxil from the American public. In a June 10, 2003 press release in UK, Glaxo disclosed the suicidal thinking or attempts in children, and particularly in adolescents. But the company's American press release on June 19, 2003, stated that "there is no evidence that Paxil is associated with an increased risk of suicidal thinking or acts in adults" and that "not a single person committed suicide."

The American press release also provided no safety or efficacy information about Paxil regarding its use in the treatment of pediatric patients.

The five-year litigation history of Glaxo involves many different types of cases. For instance, in April 2003, Glaxo paid $88 million and signed one in a slew of corporate "integrity agreements," to settle charges that the company overcharged the Medicaid programs for Paxil and the nasal-allergy spray, Flonase, using a complex scheme that involved the re-labeling of products sold to an HMO at deeply discounted prices, to avoid the obligation to pay millions of dollars in rebates to the Medicaid program.

The Medicaid Rebate program requires Glaxo to give Medicaid the same discounts it gives to commercial customers like HMOs, hospitals and drug store chains. Drug companies have to report their lowest discount price for each Medicaid covered drug on a quarterly basis, and then pay a rebate based on that price.

To resolve another shady deal, in a February 6, 2004 press release, Glaxo announced that it had agreed to pay $175 million to settle an antitrust class action lawsuit involving the anti-inflammatory drug Relafen filed on behalf of direct purchasers, including pharmaceutical wholesalers.

This lawsuit alleged that Glaxo used "sham" patent litigation to block generic versions of Relafen from reaching the market. Glaxo filed the patent infringement lawsuits against two generic drug makers in 1997, which triggered an automatic 30-month stay of the FDA's authority to grant approval of the generic drug applications.

However, Glaxo lost the patent litigation when U.S. District Judge ruled after a trial that Glaxo had obtained the Relafen patent through fraudulent misrepresentations to the U.S. Patent and Trademark Office.

The two generic companies, Teva Pharmaceuticals USA and Eon Labs Manufacturing Inc., later filed antitrust suits alleging that Glaxo's patent lawsuits were "sham" litigation filed for the purpose of maintaining a monopoly.

In regard to these lawsuits, Glaxo's Februay 6, 2004 press release said, "Similar actions from other plaintiffs in the Relafen antitrust matter, including claims made by Teva, chain drug stores and Eon Labs have also been settled, resulting in further payments from GSK."

And of course the press release contained the standard claim that Glaxo "continues to believe that its actions were appropriate in obtaining and enforcing its patent for Relafen."

Five months after the announcement of the settlement in the patent case, on June 2, 2004, New York State Attorney General, Eliot Spitzer, issued a press release to report the filing of a lawsuit against Glaxo for concealing information about the safety and efficacy of Paxil in treating children and adolescents.

The complaint alleged that, starting in 1998, Glaxo engaged in a concerted effort to withhold negative information concerning Paxil and misrepresented data concerning the drug's safety and efficacy when prescribed for depression in children and adolescents and pointed out that Paxil "has not been approved for any condition or illness in children or adolescents."

Specifically, it said, Glaxo conducted at least five studies on the use of Paxil in children and only published and disseminated one, which showed mixed results on efficacy.

According to the lawsuit's complaint, because its studies failed to demonstrate efficacy and suggested a possible increased risk of suicidal thinking and acts for these youth:

"GSK sought to limit physicians' access to only the most favorable aspects of the data from these studies. To accomplish this, GSK embarked on a campaign both to suppress and, conceal negative information concerning the drug and to misrepresent the data it did reveal concerning the drug's efficacy and safety."

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