Evelyn Pringle: Paxil Birth Defect Litigation - First Trial a Bust for Glaxo

Evelyn Pringle reports on the Paxil/Seroxat suit brought by Andy Vickery on behalf of plaintiffs.

From the page:

A number of birth defect cases are set for trial in 2010. Andy Vickery, who practices at the Houston firm of Vickery, Waldner and Mallia, is handling several cases, with the Novak trial set to start first. The case is unique in that it involves an infant born with heart birth defects to Derek and Laura Novak on April 4, 2002, after Laura was prescribed Paxil during pregnancy for the off-label treatment of migraine headaches.

"Although one might worry that this would cause a jury to blame the prescribing doctor," says Vickery, "in this case, we can show that GSK encouraged this use, by sending out over 1500 "medical information" letters touting the benefits of Paxil for migraine headaches, and by leaving "approved WLF reprint" articles with the prescribing doctors."

...

During opening statements in the first trial on September 15, 2009, Sean Tracey told the jury they were "going to see documents in this case that have never seen the light of day before."

"You will see internal GlaxoSmith documents that the FDA hasn't seen, that the United States Congress hasn't seen, and that no jury has ever laid their eyes on before," he said. "They have been under seal for over three years."

Many of the sealed documents related to the Paxil studies conducted on rats and rabbits. The world-renowned expert from the UK, Dr David Healy, testified on behalf of the plaintiffs.

Paxil was originally owned by a Danish company called Ferrosan, and that company did the preliminary animal studies on rats and rabbits to look at teratogenicity around 1979 and 1980.

Healy explained that a teratogen is an agent that will cause birth defects and "it could be a drug or maybe a virus or maybe an illness."

In addition to birth defects, he said, a teratogen can cause a fetus to be born dead or cause a miscarriage, which is death before birth.

Article here

GSK Head: most drugs work in 30 to 50 per cent of people

'Do we need pharma?
The global market for pharmaceuticals in 2007 was estimated at US $712 bn. The BMJ Clinical Evidence website documents that only 13% of medical treatments examined have been demonstrated to have a beneficial effect, and the largest proportion, 47%, are of unknown effectiveness. But this story is little-told.
The benefits of some of the key earners are far from impressive:
Cancer chemotherapy ($13bn worldwide) 2% impact on 5-year survival
Statins ($30bn) 17% reduction in coronary events, but 25% muscle symptoms if the patient exercises
HAART ($10bn) 4-12 years delay in progression to AIDS in USA and Europe, but 4-12 months in sub-Saharan Africa
So the evidence is there that pharmaceuticals work in some cases—but at a price.
Do we hear the truth?
A 2008 study looked at the effect of pharmaceutical advertising on what journals publish about dietary supplements, and found a powerful influence; in journals with the most of such adverts, 67% of studies had negative (unsafe or ineffective) conclusions, while in those with the fewest adverts the figure was 4%. But negative findings are commonly hyped in the media (which costs money in PR and lobbying) and the positive ones go unheard.
Several years ago Hickey and Roberts wrote about specific ways to design a trial to show the absence of a benefit from these vitamins in heart disease (Hickey S. Roberts H. (2004) Ascorbate: The Science of Vitamin C, Lulu Press). In relation to a recent study critical of nutrients they commented: “We intended our advice to show how NOT to perform a trial of vitamin C and E in heart disease. Perhaps someone should explain that to them”.
Can we afford pharma?
The ecological effect of pharma is considerable. In the UK healthcare represents 8.4% of the GDP (twice that in the USA). That makes healthcare a major player in terms of carbon footprint, pollution and even resource depletion.
Pharmaceuticals contaminate the environment:
- via factory run-offs; a study in India in 2007 found “astronomical” amounts of antibiotics in a major river, coming from manufacturing plants
- via patients’ urine; bioactive levels of contraceptives have been found in urban water systems worldwide
- via disposal of unused medications; Associated Press estimated that as much as 250 million pounds of unused pharmaceuticals may be flushed into US sewers every year by hospitals and care homes.
Incinerators, including hospital incinerators, which are often in urban locations, release quantities of particulates, pesticides and heavy metals that have been shown to cause damage to health, increasing rates of cancer, heart disease and even autism.
What is coming next?
In 2003, GSK’s Vice President for Pharmacogenetics, Dr Allen Roses, said, “the vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people……I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people.”'

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