Day 5 – Dolin Vs GSK Paxil Induced Adult Suicide – Chicago.
There was a startling revelation today in the Dolin Vs. GSK trial: Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9. It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting!
Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.
Over the years as GSK’s lies were uncovered and more bodies were buried because of Paxil, GSK later changed the Paxil-induced suicide rate to 6.7. But today the world knows the actual Paxil-induced suicidality figure for adults is 8.9. This number is almost a nine-fold increase in adult Paxil patients experiencing suicidal thoughts, suicidal thinking and completed suicide–thoughts that are created by akathisia and other adverse reactions to Paxil and not by any underlying pre-existing condition.
Today at the trial, expert witness, Dr. David Ross, who worked for the FDA for ten years, testified extensively. While working at the FDA, Dr. Ross was responsible for reviewing new drug applications (NDA’s), i.e., he oversaw the statistics.
His evidence started with 6 points about GSK’s responsibilities (or lack of…)
1. Paxil is associated with an increased risk of suicidal behavior in adults beyond the age of 24.
2. GSK was not upfront about Paxil’s suicidal behavior risk.
3. In 2010, GSK had the ultimate responsibility for the Paxil label. GSK was responsible for ensuring the Paxil label did not contain any false, misleading, or inaccurate information about safety.
4. Federal regulations required GSK to warn doctors that Paxil induces adult suicidal behavior, starting in 1992.
5. GSK could have warned doctors by changing the Paxil label. There is no evidence the FDA would have stopped GSK from issuing a Paxil-specific warning in the non-class labeling sections. In fact, the FDA specifically invited GSK to discuss such changes.
6. GSK did not warn doctors of the true Paxil-induced suicidal behavior risks for adults beyond the age of 24.
Dr. Ross further reiterated to the jury what David Healy previously stated: that the responsibility for accurate drug labeling lies with the product manufacturer and not with the FDA. Dr. Ross added, “…the FDA does not do drug trials, we only know what we are shown.” He added, “You have to rely on the drug company.” He also informed the jury that the FDA’s annual budget is $1.3 billion, most of which comes from drug companies.
Another striking statement Ross shared with the jury was, “The FDA is in charge of enforcing the law, and GSK is in charge of following the law.”
Today’s evidence clearly shows that GSK has not followed the letter of the law enforced by the FDA.
Attorney Brent Wisner from Baum Hedlund asked Dr. Ross if he thought GSK’s label regarding adult suicide was adequate. Dr. Ross answered, “No.” and further added, “It was false and misleading and remains so today.”
Ross also told the jury that if he saw a nearly 9-fold increase in suicide in a drug (any drug) that he “Would not prescribe the drug.” In fact, Ross would categorize a 9-fold increase of any drug as a “frequent adverse event on labeling.”
He also told the jury that the term “Emotional lability” that GSK used instead of suicidality, “conceals what is really going on.”
Remarkably, two GSK employees, along with a third author who received funding and/or similar perks from GSK, published a medical journal paper stating Paxil actually reduced suicide in adults. Ross told the jury that he believed this published paper which contains obvious statistical errors should be retracted. The published article, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo”, by Montgomery, Dunner, and Dunbar was then used by GSK reps to promote the safety of Paxil in adult patients to prescribing doctors, even though GSK knew it was the complete opposite!
Indeed, it was a very bad day for GSK. The standard “Objection!” was lamely shouted out by King & Spalding’s resident Jack-in-the-box, Andrew Bayman, more times than I care to recall. The majority of his objections were overruled by the Honorable Judge Hart.
I’ve long been a critic of both the British and American drug regulators (the MHRA and FDA). Despite ten years of successful blogging, I’m never too old to learn something new, even when the new information is quite tragic: Today I, and the jury learned that drug companies such as GSK hold medical regulators by the balls. Drug companies provide information (to include false data from faulty clinical trials) and medical regulators have to accept drug company information as the truth. GSK should expect ramifications from global regulators after today’s evidence. An almost 9-fold increase in suicidal behavior in adults taking Paxil is appalling, particularly when we know that, for years, GSK continues to claim there is no causal association between suicide and adults taking Paxil.
This lopsided relationship has terrible ramifications for mental health authorities and suicide nonprofits who unconcernedly take drug company hush money. For years both have claimed antidepressants are a safe and effective treatment for a variety of possible ailments (anxiety, OCD, adult depression, e.tc.) A nearly 9-fold increase in suicidality strongly suggests that both mental health and mental health nonprofits have been duped by the pharmaceutical industry, along with prescribing doctors, medical regulators, and an unsuspecting public.
Just think folks: GSK even tried to get a license for Paxil to be prescribed to children after they knew of the Paxil-induced suicide increases in adults!
Nice ethical company, huh?
I’ll leave the last words to today’s witness, David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients. Amid the objections from King & Spalding’s Andrew Bayman, he answered, “No. I don’t believe that it works and I don’t believe that it’s safe.”
Trial continues tomorrow.
For now, it’s time for a Guinness, in honour of Stewart Dolin.
Dolin Vs GSK