Editorial: This post by Johanna Ryan notes a significant legal development for anyone taking a generic drug. It’s also a testament to the ability of motivated women to make a difference to the landscape.
We’re posting this interview with Wendy Dolin to draw attention to a victory – a possible break in the terrible legal Catch-22 faced by people in the United States who suffer harm after taking a generic drug.
Wendy will now be able to sue GSK for the suicide of her husband, Stewart Dolin, after six days on generic paroxetine or Paxil (Seroxat in the UK). Under a theory endorsed by the Supreme Court in 2011, she could not sue Mylan, the generic drugmaker. That’s because the law requires them to use the same information label, and the same chemical formula, as GSK developed for Paxil. Yet she also couldn’t sue GSK, which developed the drug and wrote the label, because the six pills her husband swallowed were not made by GSK. In February, however, a federal judge ruled that Wendy Dolin could indeed sue GSK for negligence.
Wendy Dolin has founded MISSD (The Medication-Induced Suicide Education Foundation in Memory of Stewart Dolin) to start a conversation in her community and beyond about the problem that took her husband’s life. The takes on the issue full and squarely of the link between antidepressants and suicide in adults. The risk of suicidal acts in 45-65 year olds from FDA data is the same as that in 18-25 year olds. The mystery is trying to work out what was done to the data to try and hide and the risk to adults. The data Pfizer sent to FDA for adults was totally different to the data they sent regulators in Europe and to the data the company itself published some years later. See Where were the adults?
This interview, first aired May 27th on Chicago’s Channel 5 evening news, is part of that effort. The video is here.
And yesterday, June 4th, the 7th Circuit denied GSK’s writ questioning Judge Zagel’s ruling in this case. GSK had argued that Judge Zagel’s decision was “patently wrong” and he – Judge Zagel – should be ordered to enter judgment in favor of GSK.
Watch this spot. This could be legal history in the making.
BOB FIDDAMAN (@Fiddaman) says
Wendy, I salute you.
David, Johanna, if you could provide me with a logo then I’ll add a ‘sticky’ to my blog’s sidebar for the MISSD website.
Johanna says
Here are the official answers GSK provides in 2014 on its website regarding suicide in adult patients on paroxetine (Paxil):
http://www.gsk.com/media/resource-centre/paroxetine/paroxetine-and-adult-patients.html
The key one is the Medical Information Letter for healthcare professionals. It relies on a trick that David has explained a few times in public lectures. In a table on Page Three, they set out the rates of suicide or suicide attempt on Paxil vs. placebo in six different studies.
Only one study is for major depression. That one shows 8 suicide incidents on Paxil and none on placebo. It’s still less than one percent of the patients – but it’s a stunner. Four other studies for people with other conditions are smaller, and show such tiny numbers of suicide incidents that there’s not much you can say.
Then comes the trick – they insert a study on “intermittent brief depression” where the suicide-incident rates are huge, for both Paxil and placebo. This is a group of patients that I think in the US would usually be diagnosed with Borderline Personality Disorder. They have very unstable emotional lives, and it’s not unknown for one person to make four or five suicide attempts in a year. Mixing in this study allows them to come up with a “total” figure where the suicide rate on Paxil is very, very slightly lower than placebo.
It’s a scam, and GSK knows it. But it allows them to make this point in their letter to Senator Chuck Grassley, their biggest Congressional critic:
“GSK’s 1989 and 1991 analyses of the clinical trial data for Paxil, properly analyzed, revealed no increase in the risk of suicides or suicide attempts for adult patients on Paxil.”
“Properly analyzed,” indeed.