The following is a guest post from patient advocate Kim Witczak. I say patient advocate but Kim is much more than that.
Today's guest post is by Kim Witcack. Our paths first crossed back in 2011. Kim was familiar with my advocacy work as I was of hers. Recently we chewed the cud in Chicago at the Dolin Vs GSK Paxil-induced death trial. Though justice doesn't bring back the dead, we are both keen to see justice. We also are intrigued to see how GSK attempts to defend its product and Paxil labeling.
Kim's husband, Woody, died a Zoloft-induced death in 2004. Woody had no history of depression and was prescribed Zoloft, Pfizer's poison pill, for insomnia (rather ironic considering insomnia is one of many listed side effects of Zoloft!). Five weeks later, Woody was hanging from the rafters of their garage. He left no suicide note. Internal Pfizer documents showed its scientists knew akathisia and suicidality was an adverse drug reaction of Zoloft. Apparently, Pfizer forgot to tell Woody and other trusting consumers.
Kim filed a wrongful death suit against Pfizer and has been advocating for drug safety and transparency ever since.
She is a co-organizer at Selling Sickness, an advocacy group dedicated to creating a new partnership model of professionals and advocates to challenge the selling of sickness.
Kim has also been appointed to the voting position of Consumer Representative on FDA Psychopharmacologic Drugs Advisory Committee. The role of the committee is to review and evaluate data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields. The committee also makes recommendations to the Commissioner of Food and Drugs.
Kim has been featured in major news media such as Fortune, Readers Digest, Consumer Reports, Wall Street Journal, New York Times as well as the subject of many local and national television news stories and documentaries. She has testified before the US Senate and FDA regarding FDA-related consumer safety issues. Her website, WoodyMatters, shares her families adverse drug reaction tragedy so that others might live.
Kim has a vast knowledge of SSRIs and insipid industry/government ties. Her knowledge about Dan Troy exceeds mine, and I invited her to write a guest post. Troy seems to have mastered the art of collusion and uses the revolving door between government regulators and the pharmaceutical industry to turn a personal profit.
As ever, it's left to those who mourn the death of their loved ones to carry the light that will, eventually, lead people to the truth. I salute you, Kim.
DEJA VU…The Fox Is Still In The Hen House
As I watch the federal trial regarding the Paxil-induced death of Stewart Dolin, I can’t help but ponder the role Dan Troy is playing behind the scenes. Troy, Glaxo’s General Counsel, has long protected the pharmaceutical industry concerning FDA issues and government regulations. Now he's the top dog in GlaxoSmithKline's global legal department. Having personally witnessed Troy's negative impact on consumers' rights and civil lawsuits, I see his fingerprints all over Dolin v GSK.
Long before President Bush appointed Troy as Chief Counsel for the FDA, Troy assisted drug companies and drug-company supported trade groups such as the Washington Legal Foundation. Under his unofficial FDA leadership, he helped modify the generic-drug application process, oversaw reform to the Hatch-Waxman Act, and was chief architect and author of the original preemption argument used against private citizens in litigation. Troy's efforts served to protect pharmaceutical companies and erode consumers' rights and protections.
Preemption and Congressman Hinchey
In the early 2000s, the FDA started filing amicus curiae “friend of the court” briefs intervening on behalf of the pharmaceutical industry. It seemed whenever drug companies faced civil suits regarding their products' harmful side effects--side effects concealed from prescribing physicians and consumers--Troy worked hard to protect drug makers. These FDA briefs argued that because the products were FDA approved, such lawsuits were “preempted” by federal law and should be dismissed. The briefs suggested that, even if drug manufacturer wanted to warn unsuspecting consumers, the FDA wouldn’t let companies update their warning labels if the FDA didn’t agree. Further, these briefs supported the notion that the FDA is the ultimate authority on product safety and effectiveness and related drug labels. Troy's work at the FDA promoted the view that juries and judges should not second-guess decisions made by FDA scientists and experts.
Many civil lawsuits were tossed out by judges across the country who believed the FDA is the final authority on drug labeling. This effort essentially gave drug companies, such as Pfizer, a free pass when their products caused harm and death. In my husband’s case, Witczak v Pfizer, Minnesota Chief Justice James Rosenbaum overturned FDA-supported pre-emption arguments in their entirety stating, “The FDA has no authority to declare, ipse dixit, that a label is false and misleading.” Judge Rosenbaum went on to state, "It is obvious that state failure-to-warn laws do not pressure manufacturers to include false or invalid warnings. Instead, they give drug manufacturers every incentive to warn of real, known risks as soon as they are discovered -- even before any FDA action."
During a December 15, 2003, presentation titled, “The Case for Preemption,” at the annual Drug and Medical Device Litigation conference for in-house counsel and trial attorneys, Troy asked the audience to contact him if they had a case in which the FDA could help. Clearly Troy's "help" was not meant to assist consumers. Fortunately, my talented attorney clandestinely attended Troy's lunchtime presentation long enough to hear Troy declare, “we have to pick our shots so make it sound like a Hollywood pitch."
Of course, considering the FDA is supposed to serve and protect the public, not drug companies, we took Troy's "Hollywood pitch" speech to New York Congressman Maurice Hinchey. Congressman Hinchey then conducted an investigation of Dan Troy. “For the first time in history,” Hinchey said, “FDA’s Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which FDA can intervene in support of drug and medical device manufacturers.” Hinchey learned that Pfizer was one of Dan Troy’s previous clients at Wiley, Rein, & Fielding and that in the three years before Troy's appointment as FDA Chief Counsel, Pfizer paid the law firm more than $350K for services provided directly by Troy.
Lo and behold, a few years later Malcolm Wheeler, an attorney for Pfizer, called Troy and requested that the FDA get involved in a Zoloft-induced suicide lawsuit filed against them by a private citizen in California. The FDA, through the Department of Justice which represents the FDA in court, filed a brief in support of Pfizer. Together, they stated the plaintiff’s claims were preempted by federal law. This case was then dismissed on preemption. Case in point: money buys influence and power, which is then used against those who have neither.
By 2004 with much damage done, Troy resigned from the FDA and headed straight to the Sidley Austin law firm where he continued working on lucrative pharmaceutical company litigation. Recognizing Troy's long history as a drug company protector, GlaxoSmithKline hired Troy as its top legal General Counsel in 2008. Andrew Witty, GSK’s then chief executive officer, said of hiring Troy, “Dan’s wealth of experience in the regulatory legislative area will be of enormous benefit to us, and ultimately to patients.”
Hmmm...Troy helps patients? Tell that to my friend Wendy Dolin and thousands of other families whose loved ones have suffered or died from Paxil and other SSRIs. Who needs Hollywood movie pitches when the revolving door between pharmaceutical companies and government regulators provides such real-life drama?
With Troy at the helm, it will be interesting to see what arguments GSK has ready to pull out of its back pocket when appealing a verdict for Dolin. Time will tell. But today one thing is certain: The fox continues to guard the hen house.