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Bloomberg News reports that the Irish government has taken action to protect the Irish from Seroxat (Paxil in the U.S.) a drug linked to suicidal behavior and to severe withdrawal symptoms. Ireland told GlaxoSmithKine to recall its $2.7 billion drug, because its information leaflet to patients fails to warn about possible suicidal behavior. SSRI antidepressant drugs that were touted as a treatment to reduce suicide have been linked to inducing suicide in some patients.
By contrast, the US government went to court to protect the business interest of pharmaceutical companies. In August, the Department of Justice went to court to the FDA’s right not to restrict false drug advertising —whether a court finds the ads to be true or false. At issue was evidence that linked Paxil to severe withdrawal symptoms—a sign that the drug is addictive: the ads claimed it is not. A judge ordered the ads halted.
One wonders about the US government priorities in setting public health care policy. One wonders also why the FDA has for years kept secret evidence it had, showing that SSRIs were linked to a 68 fold suicide rate in clinical trials! [See analysis of FDA data by Arif Kahn, MD. AHRP Infomail, Sept. 6: http://www.ahrp.org/infomail/0902/06.html ]
In August, a U.S. district judge in California ordered Paxil ads claiming the drug was not habit forming halted to protect the public interest because some people who took the drug became addicted. Thus, the ads claim cannot be said to be true.
On October 13, the British Broadcasting Company (BBC) aired an investigative report about the adverse side effects of Paxil and the other SSRIS, presenting patients who had been affected, doctors and pharmacists. http://news.bbc.co.uk/1/hi/programmes/panorama/2321545.stm
David Healy, MD, an expert on SSRIs, was allowed access to confidential documents in the GlaxoSmithKline archives. He served as an expert witness in a successful U.S. lawsuit against the company last year. “He discovered around one in four of the healthy volunteers suffered this sort of mental turmoil on Seroxat - even when they were on normal doses and even when they’d only been taking it for a few days.” “... they can cause a range of problems, they can make you suicidal, they can throw you into a state of mental turmoil...in some instances they can leave you hooked.”
Dr. Healy’s conclusion was not accepted by the company, but it was accepted by the jury who found GlaxoSmithKline to be negligent and awarded more than $6 million in compensation.
Despite evidence demonstrating some patients’ difficulty withdrawing from the drug, FDA and the US Department of Justice have used their muscle to intervene with the court, defending the drug company—against the public interest. What message do these government agencies send to the American taxpayers when they protect drug companies from being held accountable by the courts?
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.org
Contact: Vera Hassner Sharav 212-595-8974
e-mail: veracare@ahrp.org
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Dublin, Oct. 16 (Bloomberg) — Ireland told GlaxoSmithKline Plc to recall one of its most prescribed drugs because a patient leaflet for the Irish market fails to warn about possible suicidal behavior, the Irish Medicines Board said.
The U.K. pharmaceuticals company has been ordered to recall all stocks of the antidepressant drug Seroxat stored by wholesalers, the board said. The Irish Medicines Board, which controls the sale of medicines in Ireland, asked GlaxoSmithKline to change the leaflets at the end of 2001. Glaxo responded by adding new wording warning patients that suicidal thoughts may increase in the first few weeks of treatment, the board said.
The Brentford, England-based company has now been told to “revise the wording on the license and patient information leaflets to include a reference to suicidal behavior and depression,” the board said in the statement.
Shares in GlaxoSmithKline fell 19 pence, or 1.4 percent, to 1,357p at 3:04 p.m. local time in London. Seroxat, also known as Paxil, is one of GlaxoSmithKline’s most prescribed drugs, with sales of $2.7 billion last year. It’s part of a class of treatments known as selective serotonin re- uptake inhibitors, which the U.S. Food and Drug Administration doesn’t consider habit-forming.
Last year, a jury in federal court in Wyoming said Glaxo should pay $6.4 million to the relatives of a man who went on a shooting rampage, killing his family and then himself after taking Seroxat. At the time, Glaxo said it would appeal. Martin Sutton, a spokesman for GlaxoSmithKline in London, declined to comment, saying the company would issue a statement later today.
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