Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Saturday, May 26, 2007

The need for strict controls on anti-depressant drugs in Ireland

Thanks to the Truthman for alerting me to this article written by Ciaragh O’Neill. The article can be found HERE you will have to scroll down to locate it. I have republished it here for your convenience.

Ciaragh O’Neill writes about the need for strict controls on anti-depressant drugs in Ireland

The chances are that you or someone you know is taking Seroxat. Prescribed for everything from anxiety to depression it has fast become one of the most popular SSRI’s (Selective Serotonin Reuptake Inhibitors) on the market.

Seroxat is Ireland’s most popular anti-depressant, but its popularity here is nothing compared to its popularity in the U.S. In the States Seroxat is known as Paxil and due to loopholes in licensing laws it can be advertised directly to the public. In 2000 GlaxoSmithKline (Seroxat’s
manufacturer) spent approximately $90 million on advertising for the drug, Glaxo reported $2bn in profit from Paxil.

The reason behind Seroxat’s success is licensing. Seroxat has been licensed to treat more conditions than any other drug; it’s even licensed to treat some conditions that haven’t been internationally recognised yet like Generalised Anxiety Disorder.

However these ‘wonder drugs’ have a darker side that revealed itself as prescriptions increased in the ‘90’s. The most common reported symptoms dealing with Seroxat withdrawal include heightened anxiety, dizziness, and loss of balance, electric shock sensations, violent mood swings and vivid nightmares. Dr. Alistair Benbow, head of European Clinical Psychiatry for GlaxoSmithKline says that Seroxat is a “well tolerated medicine that has been used extensively around the world over the last ten years”.

However, this assertion is proved weak when you consider the mounting evidence against Seroxat. In 1998 Toby Tobin decided to sue GlaxoSmithKline after his father-in-law Donald Schell killed himself, his wife, his daughter and his granddaughter in Gillette, Wyoming. Schell
had previously shown no indications of a violent personality; he had been mildly depressed but not suicidal for the previous ten years. Schell had taken just two Seroxat (Paxil) tablets before these tragic events occurred. GlaxoSmithKline were found to be negligent in failing to provide information to Doctors about the possible side affects of Seroxat (Paxil), and were ordered to pay $6 million in compensation. It was revealed during the course of the trial that GlaxoSmithKline had hidden clinical trials, which showed that around one in four healthy volunteers suffered the sort of mental turmoil that Schell suffered.

Since 1991 Seroxat has been licensed to treat depressive illness. In 2003 the Irish Medicines
Board issued a warning that the drug Seroxat should not be used to treat anyone under the age of 18 as it appeared to raise the incidence of suicide and self harm in children and adolescents, and had no benefit in the treatment of depressive illness. A clinical trial was also carried out in which children with depressive illness were prescribed either Seroxat or a placebo. The results of the survey were remarkable; it was found that Seroxat had no greater effect in the treatment of depressive illness than the placebo. The survey also revealed that the risk of suicidal thoughts and behaviour was greater with Seroxat than the placebo. Yet due to loopholes in the drug
licensing laws Seroxat can still be prescribed by Doctors to people under the age of 18 if the Doctors deem it appropriate. The European Agency for the Evaluation of Medicinal Products (EMEA) has also reviewed the drug and determined that patients with a history of suicidal behaviour or thoughts are at a greater risk of suicidal attempts during treatment with Seroxat. Yet still approximately 350 children and adolescents under the age of 18, in Ireland are currently being treated with Seroxat.

Another research group in Sweden ran a similar trial and found that among 916 on the drug
seven-attempted suicide compared to just one in a placebo group.

Why do so many Doctors continue to prescribe the drug in vast quantities, especially to children and adolescents?

GlaxoSmithKline has never had the best reputation for marketing ethics. Glaxo was investigated in 1995 for allegedly bribing health ministry officials. Dr. Reccha, the spokesman for GlaxoSmithKline in Italy responded with the comment “Glaxo is a leader in the world pharmaceutical market. We do not need to do anything here that we do not do in other European countries” Similar investigations are underway in the America where GlaxoSmithKline are charged with bribery and corruption. Allegations include gifts ranging from free holidays abroad to cash payments up to $26,873. Although no formal charges have been
brought officials believe that as many as 3000 Doctors and Sales Rep’s are involved. In Germany 3,500 Doctors are being investigated for alleged undue financial advantages and corruption. The District Attorney’s Office in Munich started to investigate GlaxoSmithKline after a reported increase in their marketing activities. GlaxoSmithKline had invited hospital doctors and their spouses to conferences abroad with 5800 payments of EUR 25, 000 were paid to doctors to cover ‘travel costs’. Other gifts including books, computers and donations were given to Doctors. In one case at the launch of GlaxoSmithKline’s ACE inhibitor drug doctors were invited to travel to the World Cup and to a nearby Formula One race.

One wonders whether GlaxoSmithKline’s aggressive marketing tactics can be linked to the ongoing prescription of their drug Seroxat despite repeated health warnings.


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