Day 7 in Dolin Vs GSK began with the continued cross-examination of former FDA official, Dr. David Ross, by GSK’s King & Spalding attorneys.
GSK is desperately trying to convince the jury that the company repeatedly sought to change the Paxil labeling but, supposedly, the FDA wouldn’t allow it. GSK’s attorney, Andrew Bayman, futilely tried to put words into the mouth of the witness, attempting to trick Dr. Ross into agreeing he said things he has never actually said.
It’s still a head scratcher for me – on the one hand, GSK is claiming that Paxil is safe for adults, on the other they claim they told the FDA there was an increase in suicidality in adults on Paxil. How could both be true?
It appears Glaxo concedes Paxil can increase suicidality in adult consumers but that this suicidality increase does not lead to completing suicide. However, if you die by “suicide” when consuming GSK’s product, Paxil, GSK’s drug didn’t cause it.
Yesterday, former FDA official, Dr. Ross, was asked by Bayman:
“Other than the 6.7 finding with respect to the secondary analysis of definitive suicidal behavior, you’re not aware of anything in GSK’s 2006 adult suicidality analysis that would meet the definition of reasonable evidence of an association between the use of Paxil and suicidality that would warrant a label change, correct?”
Dr. Ross, who remained unphased, replied:
“Well, the answer to that is yes, I am, but more importantly, as I said to your colleague two years ago, that’s a little bit like saying, ‘aside from that, Mrs. Lincoln, how did you enjoy the play?'”
This was a great response considering the excuses GSK regurgitates when faced with claims that Paxil induces adult suicidality, and severe withdrawal effects or birth defects, etc. It is the standard corporate response to repeat, “Paxil has helped millions of people worldwide.”
Why would GSK attempt to place an adult suicide warning on the Paxil label if it is the company’s position that Paxil does not induce suicidality in adult patients?
King & Spalding’s Bayman has been trying to catch Dr. Ross in non-existent contradictions for two days. Dr. Ross, who often quite brilliantly turns the questions back onto Bayman, remains steadfast that the Paxil suicidality data created by GSK is false and misleading.
Thus far GSK has claimed it wasn’t their fault they didn’t warn the public, it was the FDA’s failure. It wasn’t Paxil that precipitated the death of Stewart Dolin; it was his underlying illness. It is GSK’s position that Paxil causes suicidality in adult consumers; it’s also their position that it doesn’t.
Akathisia is the Paxil-induced medical condition that often precipitates suicidal thoughts and suicide itself. GSK continues to point out that there is an FDA class warning for all SSRIs stating the drugs can cause akathisia. However, what GSK attorneys don’t want to mention is that their product, Paxil, is more likely to cause suicidality than other SSRI offenders. Specifically, when the clinical trial data is correctly interpreted, it shows Paxil causes an 8.9 increase in adult suicidality.
All SSRIs can and often do cause akathisia and suicide. Unfortunately, drug companies and the FDA continue, to this day, to inadeqautely define akathisia. This collective failure continues to harm patients and ill-informed prescribers.
Today’s Paxil label describes akathisia simply as “psychomotor restlessness.” Further, it states:
“The use of paroxetine or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. This is most likely to occur within the first few weeks of treatment.”
Once again, there is no mention that akathisia is a precursor to suicide. Of course, GSK’s Andrew Bayman doesn’t tell the jury this fact, either. However, GSK’s BigPharma colleague, former Pfizer Medical Director Dr. Roger Lane, confirmed this fact way back in the 1980’s. Lane wrote two peer-reviewed articles about SSRI-induced akathisia. About akathisia-induced suicide, he stated, “It may be less of a question of patients experiencing fluoxetine-induced suicidal ideation, than patients feeling that ‘death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.”
Lane was referring to fluoxetine, which is the drug, Prozac, just as paroxetine is the drug Paxil. An expert witness for Prozac manufacturers, Eli Lilly and Company, conceded under oath that SSRIs cause akathisia. At the Forsyth v. Eli Lilly and Company murder/suicide trial, Lilly’s expert witness, Dr. Victor Reus testified that both Paxil and Prozac can cause akathisia in patients.
King & Spalding’s Andrew Bayman frequently concedes in the Dolin Vs GSK trial that SSRIs can cause akathisia. Further, Bayman continues to point out that akathisia is listed on the drug class label. However, what Bayman doesn’t want to emphasize is what drug company scientists have known and confirmed for years: As Pfizer’s Dr. Roger Lane stated decades ago: “death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced.”
GSK has downplayed the suicide risk in adults taking Paxil for nearly 25 years. It’s absurd and misleading to claim that calling akathisia “psychomotor restlessness” would ever lead consumers and prescribers to interpret this intentionally vague definition as an increase in suicidality.
GSK and all SSRI manufacturers should be shouting from the rooftops the exact definition of akathisia, as should medicine regulators. Instead, yesterday the Dolin Vs. GSK jury was treated to some loud entertainment by Bayman. He tried to drown out the facts by shouting at the expert witness. It was so unprofessional that the Honorable Judge Hart had to tell Bayman to “stop shouting.”
Further witnesses will be called next week as this case unfolds. Meanwhile, here’s a short video produced by MISSD that helps everyone better understand akathisia.
Dolin Vs GSK