Paul D Thacker | 24 Oct 2023
Guest essay by Kim Witczak, globally renowned advocate for pharmaceutical drug safety and FDA reform.
Hello readers, today’s essay comes from Kim Witczak, who serves as a consumer representative to a Food and Drug Administration (FDA) advisory committee, and has spent the last two decades advocating for better product safety and a more effective FDA.
Many people now undertand that something went terribly awry among drug safety experts during the COVID pandemic, and Witczak has a unique perspective to explain why.
I will never forget August 6, 2003. The day my life changed forever.
While I was out of town on business, I got a call from my dad who told me my husband Woody had been found hanging—dead at age 37. Woody wasn’t depressed and he hadn’t had a history of depression nor any other mental illness. But he had recently begun a stressful job with a start-up company, and because he was having trouble sleeping, his doctor had prescribed the antidepressant Zoloft to take the edge off and help him relax.
Woody’s death made no sense. Why had he taken his own life? In the following weeks, I started to investigate, to try and understand why my perfectly normal husband had decided to end his life. The only thing that made sense … Zoloft.
Figuring out Zoloft’s dangers completely altered my life’s trajectory, absorbing years of my time, and sending me around the world to learn and speak about drug safety. Today, I sit on one of the Food and Drug Administration (FDA) advisory committees that reviews new drugs coming to market, and while I don’t have a degree in epidemiology or advanced statistics, no physician’s one-hour psychiatry course in medical school provides them my depth of knowledge about antidepressants and how the biomedical industry has replaced physician education with pharma marketing. When physicians began promoting the COVID vaccines—despite the lack of transparency in the clinical trials, despite the lack of a placebo a group—I saw many of the same warning signs I had learned about Zoloft and other drugs. From the pandemic’s beginning, I found a complete lack of focus on safety regarding this novel, rushed to market product. Instead, a message of “safe and effective” was incessantly drilled into everyone’s minds.
My day job is in marketing, and I’ve done publicity for some of the biggest corporations in America. The push for these vaccines smelled exactly like my profession, not like medicine.
Connecting the Dots
If you haven’t heard of Zoloft, you’ve certainly heard of one of its many competitors—Lexapro, Celexa, Prozac—each one a blockbuster product that brought in billions of dollars for drug makers. When I began looking into the history of these medications, I was shocked to learn that the FDA first held hearings on Prozac and the links to violent behavior and suicide in 1991—twelve years before Woody began taking Zoloft. Physicians advising the FDA concluded there was no link between Prozac and suicide, but many of these experts had a financial link to antidepressant drug makers. Nonetheless, the FDA told Eli Lilly, the maker of Prozac, to study the issue of suicidality.
But Eli Lilly never did the studies, and the FDA never followed up. It wasn’t until 2004, the year after Woody took his own life, that the FDA was forced to investigate the suicide issue. And the agency only did this after the UK came out with warnings for children. This was 13 years after the initial FDA hearings in 1991.
I didn’t learn any of this overnight, but when your healthy husband who loves life, kills himself for no reason, your own life gets thrown into disarray and you can’t help but question everything you thought was true. So, I began an investigative journey to understand antidepressants. I attended meetings with the FDA, Congress, and experts across the field of medicine and drug safety. I consumed the ideas of leading critical thinkers who challenged the pharmaceutical industry narrative—books like Let them Eat Prozac, Selling Sickness, Deadly Medicines and Organized Crime, The Truth About Drug Companies, and Overdo$ed America. I also started collaborating with independent patient safety and consumer organizations, attending their conferences to meet experts and learn more: Too Much Medicine, Selling Sickness, Pharmed Out, Preventing Overdiagnosis, ISEPP (International Society of Ethical Psychiatry and Psychology), and Right Care Alliance.
I initially thought that what I was learning about Zoloft was just an isolated issue with antidepressants. But I soon realized it was part of a much bigger, systemic problem with our nation’s drug safety system. The pharmaceutical industry is driven by commercial interests, not public health, and this problem is compounded by a lack of transparency, conflicts of interests, manipulation of clinical trials, and undue corporate influence across the government. Marketing companies ghostwrite pharmaceutical studies for academics who sometimes barely read the papers that get submitted to medical journals, and drug makers then cite these ghostwritten studies as peer-reviewed proof of their products’ safety and efficacy.
The revolving door between Big Pharma and the FDA spins faster than the one between the Pentagon and the defense industry. After Congressman Billy Tauzin wrote a 2003 law that ensured Medicare could not negotiate for lower drug prices, he fled public service to cash in on $2 million salary running PhRMA, the drug industry’s most powerful trade organization. The system is designed and streamlined to hype and sell benefits, while downplaying or hiding harms.
The lawsuit I launched against Pfizer was eye-opening. I wanted Pfizer to pay for what they had done, but I later discovered that lawsuits play a critical role in drug safety by uncovering internal documents showing what was known but withheld from the public. It was a lawsuit that uncovered evidence that GlaxoSmithKline’s famous Paxil Study 329 was riddled with clinical trial reporting errors and other corruption. Documents from another lawsuit against Pfizer showed the company had a marketing schedule for publishing studies and presentations to support their drug. These pages show that Pfizer had already written some studies with an academic author “to be determined” which was denoted on their marketing schedule as “Author TBD.”
I thought the drug approval process was flawed until I learned about the medical device 510K approval process. Some devices are approved based on a “substantially similar” product called a “predicate” that is already on the market. Because a predicate product is already being sold, the FDA doesn’t require companies to do clinical trials to sell the new product.
In my over two decades of advocacy, I have come to understand that healthcare is about business, not health. And pharmaceuticals are about marketing, not medicine. Big Pharma’s influence is everywhere and behind every pill, device, or vaccine, a web of powerful self-interests helps to drive sales and maximize shareholder profits. Ironically, it was my late husband who showed me the path: “Follow the Money.”
But my understanding of the drug industry’s power changed dramatically when the COVID-19 pandemic struck. Global attention seized on vaccines with a novel technology as a “one-size-fits-all” solution to get society back to normal. Because I had spent years studying pharma, I just couldn’t shake the feeling that something wasn’t right.
Fools for Big Pharma
Prior to 2020, vaccines weren’t really on my radar since I don’t have kids, and I hadn’t delved into the subject like I had with drugs and medical devices. However, with the COVID vaccines I observed all the red flags of pharma influence that I’ve come to recognize: lack of transparency, utilizing fast-track regulatory pathways, and accelerating clinical trials: to include unblinding and administering the vaccine to placebo volunteers. Even high school students are taught that science requires a control group, so once pharma gave the vaccine to placebo volunteers, how was this clinical trial “science”?
In the media, I noticed very few stories that delved into safety regarding a medical product that used a novel mRNA technology but was still rushed to market. And while safety was ignored, messages of “safe and effective” were incessantly drilled into everyone’s minds.
Having spent my entire career in advertising and marketing, I’m well-versed in the art of persuasion and the subtleties of manipulation. And in the case of these vaccines, the manipulation was far from subtle. Government agencies, politicians, media outlets, celebrities, sports figures, and the healthcare system all seemed to be synchronized from the beginning in delivering identical messages. It reminded me of a global advertising campaign. Gimmicky sales techniques were deployed to sell the vax like a chance to win a million dollars or free college education.
And while obesity was one of the main risk factors for dying from COVID, the Biden administration marketed the jab in a partnership with McDonald’s—the iconic company of the fast-food industry that got us fat and sick in the first place.
No physician’s one-hour psychiatry course in medical school provides them my depth of knowledge about antidepressants and how the biomedical industry has replaced physician education with pharma marketing.
I was alarmed when I learned that governments granted COVID vaccine manufacturers legal immunity, shielding them from any responsibility for future injuries or fatalities. What incentive would they have to prioritize safety or to investigate and disclose potential safety concerns, instead of hiding them? This was particularly troubling for me, as I was able to hold Pfizer accountable in my husband’s death.
When I expressed valid concerns in various fora with drug safety experts and advocates I had known for many years, I was met with resistance and quickly dismissed. It made me wonder if Big Pharma was using the COVID-19 vaccines as the perfect PR opportunity—a Holy Grail to restore their damaged reputation. When COVID struck, Big Pharma had weathered decades of scandals and was implicated in killing tens of thousands in the opioid pandemic, but physicians were suddenly hailing them as the hero “saving lives” from the SARS virus.
Why experts got hit with amnesia about pharma’s history is unclear, because the industry’s duplicity was staring everyone in face. Weeks before academics began celebrating the Pfizer’s COVID vaccine results in late 2020, Purdue Pharma pleaded guilty to penalties of more than $8 billion for its role in the opioid crisis. The previous record for the largest fraud settlement was held by Pfizer in 2009—that’s the year Pfizer paid $2.3 billion in a case over fraudulent off-label marketing and illegal promotion of a painkiller, an antipsychotic, and other drugs.
Some days after Pfizer was applauded for releasing its initial COVID vaccine results, the New York Times quoted a financial analyst saying Pfizer’s involvement in the pandemic was “as much about public relations as it is a financial return.” The Times also noted that the CEO of Eli Lilly—which produced an antibody treatment for COVID—told investors that the pandemic created “a once-in-a-generation opportunity to reset the reputation of the industry.”
What Cowed the Healthy Skeptics?
When COVID hit, I was shocked at how any healthy skepticism of the pharmaceutical industry suddenly vanished. I quickly realized that vaccines were almost a protected class that couldn’t be questioned.
Where, I wondered, were my fellow critical thinkers and patient safety warriors hiding? Why weren’t they asking the same questions or raising safety concerns like I was? They had long criticized the FDA and the pharmaceutical industry, but somehow the COVID vaccines silenced them. Was it the fear of dying from the “virus” that drove this shift? Or did the Big Pharma’s army of PR operatives overrun their thinking and trigger some vaccine orthodoxy nerve?
Friends and other patient safety advocates explained to me that vaccines were different. I was told by a prominent leader of one nonprofit, “We don’t ask questions about vaccines.” Another well-known advocate who is often quoted in the media, told me, “While I appreciate all your work on antidepressants, you are wrong about the Covid vaccines.”
End of conversation. No further discussion.
I was told by a prominent leader of one nonprofit, “We don’t ask questions about vaccines.”
On an email list for patient safety groups, a few members including a physician, told me that those who choose to not be vaccinated were selfish and didn’t care about the greater good. I even learned that a law firm run by attorneys, who have won national lawsuits against pharmaceutical companies for their corrupt practices, implemented an office policy requiring the COVID shot. Despite knowing better than any FDA official how these companies hide safety data and manipulate clinical trials, these attorneys blindly accepted this novel vaccine.
I have followed Public Citizen for years and have come to rely on their critical appraisals on FDA safety decisions. To my mind, no other nonprofit in America has Public Citizen’s expertise on biomedicine, and they often speak out against controversial products being reviewed at FDA advisory committee meetings.
Yet, to this day, I have not seen them put out one press release on COVID vaccine safety.
Courageously Curious
Whether it’s cognitive dissonance or a disbelief that government, public health officials, and even our own doctors would ever lead us astray, it is time to get curious as to why we have accepted vaccines and must not question them. It’s time to ask serious questions about vaccine safety, how these products come to market, and why vaccine data remains hidden from outside experts. I hope we apply the same critical lens to vaccines as we have with other medical products.
The good news is that people are waking up and challenging their assumptions and beliefs, asking themselves, “Why do I believe this? Where did this belief come from? Is it true? Was it ever true?”
I only wish I had asked the hard questions, twenty years ago, before it was too late, and my husband was gone. And this is why after two decades, I am still advocating for a strong FDA and speaking to groups to hold this industry accountable. I don’t want others to have to experience what our family did.
Kim Witczak is a marketing executive living in Minneapolis and a globally renowned advocate for pharmaceutical drug safety and FDA reform. You can find her story at www.woodymatters.com, read more of her writing on Substack (UN)Acceptable Collateral Damage, or follow her on X @woodymatters.
