Guns, Mental Health, and Pills??

When the Music Stops

I wrote a guest post last summer for Rxisk.org series on MARILYN LEMAK. It was the forth and final in the series that asked if an antidepressant like Zoloft could precipitate a murder?

In 1999 Marilyn Lemak of Chicago killed her three children and tried to kill herself.  She has spent over 22 years in jail and late last year had a clemency hearing to present new evidence about the antidepressant Zoloft she was taking. Other posts in the series can be seen here. Trial and Punishment, Then and Now and Clemency Hearing.

---

If you don’t know RxISK, I would suggest you check them out. RxISK is a free, independent website where you can research prescription drugs and report a drug side effect — identifying problems and possible solutions when it might still be possible to intervene and find a solution.

Making medicines safer for all of us

It is run by a group of high-profile medical experts like Dr. David Healy with international reputations in early drug-side-effect detection and risk mitigation, pharmacovigilance, and patient-centered care. A side note: David Healy is one of the world’s renowned experts on antidepressants. I have worked with him closely over the years.

---

When The Music Stops

“I’m glad I didn’t know the way it all would end.  The way it all would go.  Our lives are better left to chance.  I could have missed the pain but I’d have had to miss the dance.”  – Garth Brooks

Every summer around this time in late July, I pause and reflect on how fragile life is and how quickly it can change.  On August 6th, 2003, my life as I knew it came to a screeching halt and, suddenly, I was thrust onto another life path.

19 years ago, I was living life exactly as I imagined it. I was happily married to my husband Woody, traveled the world with a job that I loved, and started to think about a family. We were excited about the next phase of our married life. Woody had just started his dream job with a startup company. Life was good.

Like many entrepreneurs building a business, Woody started having trouble sleeping and sought help. Woody had great respect for the ‘white coat’ and trusted them implicitly. After all they put him back together like Humpty Dumpty from all his sports injuries. Woody’s doctor sent him home with a 3-week sample pack of Zoloft and told it would take the edge off his problem and help him sleep.

I just returned from spending 3 weeks in New Zealand on a BMW Commercial shoot. I was excited to see Woody and was waiting for him to arrive home from work.  Woody walked through the back door, drenched in sweat and his eyes bloodshot from crying.  He dropped his bag and fell into a fetal position on our kitchen floor.  His hands wrapped around his head like a vice, pleading, “Help me. Help me. I don’t know what’s happening to me.  It’s like my head is outside my body looking in. Help me, Kim.” Eventually, we calmed him down and Woody called his doctor about this experience who told him, “You need 4-6 weeks for Zoloft to kick in.”

Every night over the next week, Woody looked for ways to “beat this feeling” in his head. I had never witnessed anything like this before in our 13 years of being together.

Fast forward one week, I kissed Woody goodbye and headed out of town for work. Little did I know this would be the last time I would ever see him alive.  Woody and I talked multiple times a day, so it was odd that I didn’t hear from him for almost 16 hours.  I called my parents and asked if they could go over to our house.

The phone rings and it was my dad.  “It’s bad.”

I will never forget my dad’s tone or words that followed. They are forever etched in my mind and his.

“Woody’s dead.”

“What do you mean, he’s dead? How do you know?”

“Woody is hanging by the rafters in the garage.”

In one phone call, my life was uprooted and never to be the same again.

The coroner asked if Woody was taking any medication. Only Zoloft.  She proceeded to tell me that she needed to take the bottle with her as it might have something to do with his death. Ironically, the same day the front page of our local newspaper had an article about how UK finds link between antidepressants and suicide.

Woody and Zoloft

Woody left no note.  This, in essence, was our note and the first clue in uncovering what happened to my husband.

My journey for the truth took me to the FDA, Congress, the media, and the courts. Ultimately, we helped get FDA Blackbox suicide warnings on antidepressants.

I had a wrongful death, failure to warn lawsuit against Pfizer.  Through the lawsuit we were able to get documents out from under confidentiality seal showing Pfizer and FDA long knew about the risk of suicide.  One document was particularly difficult for me to see in black and white. It was an email exchange between foreign regulators and Pfizer’s Chief Medical Officer about patients complaining of “standing outside their bodies looking in.”

Documents speak volumes and it’s no wonder why drug companies try to do anything to destroy the public’s ability to sue and get internal company documents through the legal discovery process. These internal Pfizer and other company documents were helpful in our lobbying congress which ultimately led to hearings on antidepressants with the exposure of conflicts of interest and the role of industry in academia and FDA.

The games Pfizer played were something I thought only existed in the movies. Clearly, I was a little naive and had no idea the twists and turns to come.  Suing a drug company is not for the faint of heart. Luckily, I had a great law firm Baum Hedlund who not only litigated my case but had a similar mission to expose drug company misconduct and make them accountable for the lives lost.

Fox Guarding Hen House

Pfizer used the FDA to intervene in Baum Hedlund’s civil lawsuits. It was discovered that Pfizer paid industry defense lawyer Dan Troy $300k for some legal work shortly before he was appointed FDA Chief Counsel by President Bush.  In his new role at the FDA, Dan Troy was the mastermind behind the FDA preemption amicus “friend of the court” brief intervening on behalf of pharmaceutical companies in civil lawsuits. The brief argued that because drug was FDA approved, the lawsuits were “preempted” and should be dismissed.

The brief claimed even if a company wanted to warn consumers, the FDA wouldn’t let them update their warning label if the FDA didn’t agree.  Many Zoloft suicide lawsuits were tossed out by judges who believed the FDA was final authority on the drug label. Pfizer even tried arguing the FDA preemption brief in my lawsuit. Not once, but twice. Federal Chief Justice James Rosenbaum disagreed with Pfizer and allowed my lawsuit to proceed.

We worked with NY Representative Maurice Hinchey to help expose the $300k Dan Troy received from Pfizer.  Ultimately Dan Troy resigned his FDA Chief Counsel post but not before damage was done.  He ultimately went back to work for private industry including becoming global Chief Counsel at GlaxoSmithKline, the maker of Paxil, another SSRI.

In the early days soon after filing my lawsuit, Pfizer sent out investigators to snoop around my life. They talked to my next-door neighbors about Woody and even bypassed the legal process and improperly sent my grief counselor a “subpoena” for her case notes on me.  Thankfully, I learned that Pfizer did this and we were able to stop them.

During my 8-hour deposition, Pfizer used a good chunk of their time asking about my advocacy efforts and who knew what in DC.  They wanted to know how I met Senator Grassley and about my work with his office. Or how I got the Minnesota Attorney General Mike Hatch to file an amicus brief on behalf of state of Minnesota in support of my lawsuit. It was clearly used as a fact finding mission.

After almost 4 hours of this line of questioning, with no questions about Woody. I interrupted and said, “Can I ask you a question?”

“No. We are the ones asking the questions”, Pfizer’s attorney from a high profile law firm, Wheeler Trigg, said.

Annoyed, I replied, “I don’t know what this line of questioning has to do with my husband’s death. You have not asked me one question about Woody.  Please continue.”

Eventually Pfizer’s attorney got around to asking questions about Woody including some insulting zingers like if I had an affair or if we had money issues. It was easy to answer their questions when I had truth on my side. The only thing that changed in Woody’s life was Zoloft. He went from having trouble sleeping to head outside body. Five weeks later he is dead.

I learned that the drug companies don’t really care about the individual victim. Woody was just considered acceptable collateral damage. Pfizer cared more about intel gathering and the damage control. They have profits and shareholders to protect.

Same Company.  Same Story.  Different Drug.

While I initially thought these issues were just an isolated issue with antidepressants, I quickly realized it is a huge systemic problem with our overall drug safety system. Before Woody’s death, I never paid much attention to Pfizer or the pharmaceutical industry or the lawsuits involving them. Most of the lawsuits are often centered around illegal marketing and promotion practices while downplaying, manipulating, or hiding side effects and harms.

Here’s a brief glimpse of Pfizer’s track record for safety and ethics. Many were happening during my early drug safety advocacy days and involved similar issues as Zoloft. Unfortunately, this behavior continues today.

• In 1996, Pfizer administered an experimental drug during a clinical trial on 200 children in Nigeria but never told the parents that their children were the subjects of an experiment. Pfizer paid $75 Million to settle in Nigerian court.

• In 2004, Pfizer agreed to plead guilty to two felonies and paid $430 million in penalties for off label promotion of Neurontin for unapproved uses. The New York Times published an article entitled, “Experts Conclude Pfizer Manipulated Studies.” Pfizer delayed the publication of negative studies, spun negative data to place it in a more positive light, and controlled the flow of clinical research data in order to promote Neurontin before going generic.  Unfortunately, I met several people who lost their loved ones to Neurontin suicide.

• In 2009, Pfizer was fined $2.3 billion, the largest healthcare fraud settlement at the time, for fraudulent marketing.  Pfizer pled guilty to misbranding the painkiller BEXTRA with “the intent to defraud or mislead.”

• In 2009, Pfizer paid $750 million to settle 35,000 claims that its drug, Rezulin, was responsible for deaths and liver failures. Eventually, the product was removed from the US market.  Dr. David J. Graham, the senior FDA epidemiologist, who warned about Rezulin, was also involved in identifying issues with antidepressants and suicide.

• In 2010, Pfizer was ordered to pay $142.1 million in damages for violating federal anti-racketeering law by its fraudulent marketing of Neurontin for uses not approved by the FDA.

• In 2010, The New York Times published an article entitled, “Pfizer Gives Details on Payments to Doctors.”  The disclosures were required by an agreement to settle a federal investigation into the illegal promotion of drugs for off-label uses.

• In 2012, Pfizer had paid $1.2 billion to settle claims by nearly 10,000 women that its hormone replacement therapy drug, Prempro, caused breast cancer.

• In 2013, Pfizer agreed to pay $55 million to settle charges of failing to warn patients and doctors about the risks of kidney disease, kidney injury, and kidney failure caused by its popular proton pump inhibitor, Protonix.

• In 2013, Pfizer paid $288 million to settle claims by 2,700 people that its smoking cessation drug, Chantix, caused suicidal thoughts, violence and other severe psychiatric disturbances.  In the legal settlements, Pfizer silenced every victim to never be able to tell their stories in public.  They also required all Chantix safety advocacy websites to be taken down. I believe Pfizer learned from the antidepressant suicide hearings where it was victim after victim telling their powerful story in the open public forum. It’s hard to ignore these real-life experiences. So, Pfizer shut them up.

Eagle Study

Fast forward, after Pfizer settled the Chantix lawsuits Pfizer went to the FDA to ask to have the Blackbox neuropsychiatric warning removed from their drug label. By this time, I was the Consumer Representative on the FDA Psychopharmacologic Drugs Advisory Committee.  We were going to review Pfizer’s new EAGLE study. I was really looking forward to being part of this committee and had many questions to ask about the safety, the lawsuits, the internal company documents discovered and reviewed by experts, and most importantly, the victims. After all, Pfizer just settled the lawsuits for almost $300 million and silenced everyone. One would think the FDA committee would want to have all information including what was discovered in lawsuits involving 2700+ victims before making any decisions to remove the warnings.

A few days before the FDA Advisory Committee, I received an email from the FDA that they wanted to talk with me about the upcoming advisory committee meeting.  Someone (cough Pfizer) brought it to their attention that I had an “intellectual bias” and shouldn’t serve on the committee. The roomful of FDA staffers told me that I was being recused from serving on this meeting.  I told them if they think safety is an intellectual bias (or a point of view), I will always have one.

Much to their surprise, I said I would still like to address the committee and speak during the open public hearing.  I ended up flying out a few days later on my own time and dime to make sure my comments and questions were asked even though they wouldn’t be part of the official public record of this meeting.

Ultimately, in an unprecedented move, the FDA removed this serious Blackbox warning that involved violence, hallucinations, suicide, and other psychiatric side effects. To this day, this story has never really been told by the media. These side effects didn’t suddenly go away. Just the FDA Blackbox warnings.

Zoloft and Marilyn Lemak

Suicide is violence against oneself, and homicide is violence towards others.

Something I don’t often talk about is the nightmares Woody was experiencing while on Zoloft. For as long as I knew Woody, he truly believed he didn’t dream.  So, when he mentioned he was having nightmares after starting Zoloft, I took pause. The nightmares scared him and he wouldn’t repeat them. To this day, I have often wondered if Woody’s nightmares were telling him to do something to me. I will never know.

Prescriptions for antidepressant, anti-anxiety and other psychiatric drugs are at an all-time high. With millions of people taking psychotropic drugs, clearly not everyone will experience violent reactions to taking them. But a certain percentage of the population will, and it is important people are made aware of the potential.

Of the nearly 410 psychiatric drug warnings, 27 warn of violence, aggression, hostility, mania, psychosis or homicidal ideation and 49 warn of self-harm or suicide/suicidal ideation.

Every time there is another mass shooting or high-profile murder/suicide, society keeps asking why and guns are often pinned as the culprit.  It is high time that we seek to try understanding what may be behind these acts of violence in our communities.  Could they be connected to the dangerous side effects associated with psychotropic drugs?

Pfizer and the FDA have long been aware of the association with violence and suicide since the 1991 hearings on Prozac.  Internal Pfizer documents obtained in my lawsuit showed they have known about this risk and kept it from the public.

Why otherwise would Pfizer have created a Zoloft Prosecutor Manual in 1993 to be used in cases where someone claimed a Zoloft defense?

Then there is the 1983 individual case report from a Zoloft clinical trial where a patient withdrew from the study and the  investigator noted:

These went away when he was taken off the study drug.

And what about this email from Franz in South Africa to Roger Lane in Pfizer:

With this reply from Lane who soon after this came to light was no longer working for Pfizer.

SSRI and Violence Cases

There is a long history of high-profile legal cases involving antidepressants and murder/suicides.

• Like the 1998 case of Donald Schell, 60, who murdered his wife, daughter, and granddaughter 48 hours after starting paroxetine.  The jury found GlaxoSmithKline guilty and awarded $8 million to the estate.

• The murder/suicide of Saturday Night Live comedian Phil Hartman and his wife, Bryan.  She murdered Phil and then killed herself leaving their children parentless. The estate sued Pfizer and they quietly settled the case.

• Chris Pittman who at age 12 murdered his grandparents while intoxicated with antidepressants. While Zoloft was put on trial, Chris was ultimately found guilty and sentenced to 30 years.

• Canadian communications executive David Carmichael who murdered his son while on Paxil. He was acquitted and now tells his story and warns about the risks.

In 2017 the BBC did a documentary called, “A Prescription for Murder?” exploring the possibility a pill prescribed by your doctor can turn you into a killer.  They looked at the role antidepressants had in the shooting rampage James Holmes committed at the Aurora, Colorado movie theater in 2012 – The Man who Thinks He is a Monster . and Antidepresssants and Violence.  Holmes had no prior history of violence, and was taking generic form of Zoloft, when he shot and killed twelve people and injuring sixty more .

Many never had a history of violence until they were prescribed a mind-altering drug?  We must continue asking “why?” until there is an investigation into the link between psychiatric drugs and violence.

Marilyn

It has been many years since she took the lives of her children and she lives every day with the consequences. While I don’t know the intimate details of her case, do I think its plausible Zoloft played a role in the murders?  Yes.

Antidepressant induced violence is often not recognized by the courts and this was especially so in the last century. With all the information now available about Zoloft, this drug must be taken into account in Marilyn’s upcoming clemency appeal.