January 29, 2007 — BBC Panorama broadcast " Secrets of the Drug Trials " . In the last of the 4 episodes on paroxetine (Seroxat), Shelley Jofre tells the story of how the facts about this drug were suppressed, even though they had been known to GSK and its predecessor companies from the outset. The episode shows how company officials cynically promoted the drug for young people, knowing that it was neither effective nor safe.
In this episode:
Jofre asks JAACAP Editor Mina Dulcan a question:
"JOFRE: Do you have any regrets about publishing this study?
DULCAN: Oh, I don't have any regrets about publishing at all. It generated all sorts of useful discussion which is the purpose of a scholarly journal."
Dr Healy is quoted as follows:
"We 're in a situation now where people who are ill generally have been deeply betrayed by the whole process, deeply betrayed by the pharmaceutical companies and by all the experts that have been willing to actually lend their names to the process ""If you'd heard the experts talk, they all say the drug was extremely safe and very effective. We were all hoodwinked, misled, duped. They produce these clinical trials which appear to be evidence and they aren't, they're adverts."
May 2, 2007 — The FDA proposes that makers of all antidepressant medications update the existing black box warning on their products ' labeling to include warnings about increased risks of suicidal thinking and behavior (suicidality), in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
June 12, 2007 — FDA Hearing on "Use Of Medication Guides To Distribute Risk Information To Patients" hears that despite the FDA requirement, introduced as part of the required warnings on SSRIs (finalized Feb 3, 2005), medication guides are not being distributed when antidepressant medications are dispensed.
Aug 10, 2007 — Report: In January, a federal judge dismisses the lawsuit O'Neal v SmithKline Beecham, re: the Paxil suicide of 13-yr-old Benjamin Bratt, on the basis of the Bush Administration's new pre-emption policy. The firm of Baum, Hedlund, Aristei & Goldman had been retained as counsel for this suit.
By this time Baum Hedlund is one of the leading law firms dealing with SSRI damage claims. This is because of their groundbreaking role in the early cases of Fentress vs Eli Lilly, Forsyth vs Eli Lilly, Tucker vs GSK, etc. Their primary pharmacology expert in these cases is Dr David Healy. By the mid-2000's, the firm is writing articles on this kind of case, (e.g. the Cure Worse than the Disease). Cindy Hall, at that time a Senior Paralegal at the firm, prepares a comprehensive report for the O'Neal case based on Dr Healy's work. Presumably to have an American expert associated with the report, Baum Hedlund engages Dr Joseph Glenmullen of Harvard to prepare the final draft and put his name on the report. This report is unsealed on January 18, 2008.
In this report, the early evidence on adult safety of Paroxetine is reviewed, including the 1989 data that Dr Brecher reviewed in 1991. The report concludes that most of the suicides that SKB/GSK does not attribute to Paxil, and which are thus omitted from the data, are clearly caused by Paxil. After the data are reclassified and re-analyzed, the conclusion in the report is: "It is my opinion that Paxil increases the risk of suicidality in adults. In addition, GlaxoSmithKline was aware of this risk, but hid it."
Senator Grassley obtains a copy of this report and writes to GSK asking how it is that GSK knew of the dangers of paroxetine in 1989, but the first the public heard of it was the May, 2006 "Dear Health Professional" letter.
Sept 6, 2007 —Senators Charles Grassley (R-IA), the ranking member of the Committee on Finance, and Herb Kohl (D-WI), chairman of the Special Committee on Aging, introduce the Physician Payments Sunshine Act - so named because it aims to " shine a much needed ray of sunlight on a situation that contributes to the exorbitant cost of health care, " according to cosponsor Senator Charles Schumer (D-NY). The bill would require manufacturers of pharmaceuticals and medical devices with annual revenues of more than $100 million to disclose gifts or payments to physicians in any form, whether cash, trips, etc.