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Today, The Defender and CHD.TV launched a new podcast, “The Defender In-Depth.”
As its host, each week I’ll bring on new guests and, together, we’ll take a deeper dive into one of the past week’s top Defender stories.
This week, I was privileged to have Kim Witczak, a member of the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee, as my guest on the podcast.
She joined us to talk about how her husband’s suicide in 2003, precipitated by the popular antidepressant Zoloft, led her on an “eye-opening” 20-year journey of unearthing corruption in the pharmaceutical, regulatory and academic arenas.
Following last week’s story in The Defender, Witczak shared “the story behind the story” about how she became an “accidental advocate” for drug safety despite her marketing background.
‘My head’s outside my body looking in’
When Witczak’s husband, Woody, started his dream job and began experiencing difficulty sleeping, he didn’t hesitate to see a doctor.
“He had a lot of trust in his doctors,” Witczak said. Woody was given a three-week sample pack of the antidepressant Zoloft and was told it would “help take the edge off and help him sleep.”
Soon though, Woody’s behavior was unusual, telling people “My head’s outside my body looking in.”
Yet, his doctor told him not to worry because Zoloft needed “four to six weeks to kick in.”
It was Aug. 6, 2003, when Witczak, away on a business trip, received a phone call that changed her life: Her husband had committed suicide by hanging himself.
The journey toward becoming an ‘accidental advocate’ for drug safety
An online search shortly after Woody’s death quickly revealed that, in 1991, the FDA held hearings regarding another antidepressant, Prozac, and its link to violent behavior and suicide, Witczak said. Yet, at the time, FDA advisory board members didn’t draw a connection.
For Witczak, this was an introduction to pharmaceutical and regulatory corruption.
Calling it the “Battle for Woody,” Witczak said, “We started going out to Washington, D.C., and doing what we could to make sure that we found out about this link … so that eventually we could make sure no other family had to learn the hard way.”
“I really quickly found out it’s a systemic problem,” she said.
This became apparent to Witczak after a meeting with representatives from the FDA.
“I remember telling Woody’s story and literally being told that ‘oh, this is just an anecdote … we didn’t see it in the double-blinded placebo-controlled studies.’”
“You would think that it would’ve been something that they would’ve been curious about and go on and investigate, but they had no interest,” Witczak said.
“I started to realize the system is really built on promoting benefits, selling and sometimes over-hyping benefits and downplaying or hiding the safety thing,” she said. “It was a really big, eye-opening experience meeting with the FDA.”
Drug safety an ‘afterthought’ during FDA review
Witczak told me that her marketing background led her to the realization that “healthcare is a business.”
“I know those games,” Witczak said. “I look at my business and I can see my business all over this business,” through “sales, promotions, creating the sales tools that we use to get people into the system.”
Witczak said drugs undergoing fast-track review “are not what we used to think as needing two double-blinded placebo-controlled replicated studies.” Instead, “fewer and fewer people” participate in such clinical trials.
For the FDA, drug safety takes a backseat during this process, according to Witczak.
“If we discuss safety, it is kind of an afterthought,” she said, noting that most committee members vote in favor of drug approvals even when they express safety concerns.
‘Well-oiled machine’ marketed COVID vaccines to the public
During the COVID-19 pandemic, Witczak said she “saw a lot of red flags” when the vaccine came out. “It was like a well-oiled machine. Everybody from the media, the government, to celebrities, to the churches were saying it’s ‘completely safe and effective.’ That felt like marketing.”
“Then I started seeing all this usage of sales promotion tools,” including “bring your vax card in for a chance to win a free education” and a “million-dollar lottery,” Witczak added.
“The government had a partnership with McDonald’s. Literally, the shot was on the French fry box, and it was to encourage people [to get vaccinated],” Witczak said. “This is cross-promotion.”
‘Spiderweb’ of corruption implicates Big Pharma, government, academia
Witczak also identified numerous instances of corruption — a “spiderweb,” as she described it, between Big Pharma, drug regulators, scientists and academics.
“I call it the spiderweb because I connected the dots over the years, and in the middle of the spiderweb is the patient-doctor relationship,” Witczak said. “Pharma is behind so many aspects of it, and one of the first things I learned was this idea of ‘ghostwriting.’”
Witczak said she discovered the practice of ghostwriting through her lawsuit against Pfizer — the manufacturer of Zoloft — related to her husband’s death. During the process of discovery, Pfizer documents surfaced showing the drugmaker “already had the articles written” and “already knew what journals [would publish it], when it was going to run,” but the author was listed as “TBD.”
Witczak added that these articles are then published in academic journals and read by “everyday doctors,” who then base “a lot of their recommendations or their philosophy on something based on these articles.”
Medical schools also are implicated in this “spiderweb,” according to Witczak, who described “being shocked” that doctors don’t learn in medical schools how the FDA works in medical schools, adding that this is due to the funding these institutions receive from Big Pharma.
“If you follow the money, you’ll always find the answer,” she said.
Sudden deaths, deaths of children after COVID vaccination ‘normalized’
Despite her efforts and those of other drug safety advocates, Witczak said this spiderweb of corruption persists in part due to an unwillingness to raise certain questions — including those concerning vaccine safety.
Witczak said that when she raised safety concerns regarding the COVID-19 vaccines with the advisory and patient safety groups she worked with, “All of a sudden I realized that with some people … you couldn’t actually question anything because if you started questioning, it was like, ‘you’re selfish and not for the greater good.’”
Instead of being questioned, adverse events and deaths related to the COVID-19 vaccine are being normalized, she said.
“All of a sudden there’s little kids dying. There’s sudden deaths. Where’s the curiosity?” she said.
“Instead, the media and the doctors, everybody’s saying … ‘oh, this is normal, we’ve always had people that died suddenly.'”
Witczak said that despite this, the wave of adverse events and deaths related to COVID-19 vaccination is prompting more people to ask questions and to speak out.
“I feel like the public is waking up, and maybe it’s going to be a whole new generation that’s pushing back and asking these questions,” she said.
“I think the power lies within us to really not be afraid and to push back, because we’re the true change for the future,” she said.
“The Defender In-Depth” airs each Wednesday at 10 a.m. ET on CHD.TV.
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