How the FDA Buried the Dangers of Antidepressants

I stopped working as a system doctor for several reasons, one of which is that I was horrified at what was being done to patients. From before and since that time, I’ve discovered how many medications have created profound consequences for many I’ve crossed paths with.

When my friend and colleague “A Midwestern Doctor” (AMD) wrote a recent deeply referenced post about how SSRI antidepressants can cause homicidal psychosis, I was shocked. Not so much at the knowledge of the link between the two, something that I had been aware of, but I was stunned to discover just how much evidence there is substantiating that link. 

AMD argues the most important lesson to take from this catastrophe is not the dangers of these drugs, but rather how the FDA was complicit in this disaster. It’s a fact of life that corporations and individuals will always lie for their own benefit, and it is for that reason that we have regulators in place to prevent them from causing too much damage. Regulatory capture describes a state where the regulator has been bought out by the parties it is supposed to police, and we are thus left in a situation where no one remains to protect us from unchecked greed.

We have seen this throughout COVID-19, where, after running a Disinformation campaign against the use of effective repurposed drugs like hydroxychloroquine and ivermectin, a dubious vaccine was approved without most of the necessary data to approve it. Then, as soon as the vaccines entered the market, the captured FDA was deluged with an unprecedented number of reports of severe complications from the drugs, and instead of doing its job pretended those complications did not exist and pushed the vaccine onto the entire population.

What happened with the SSRIs is equally appalling and demonstrates a degree of government malfeasance and regulatory capture I would never have believed was possible had I not seen it happen with my own eyes throughout COVID-19. Exactly how the FDA worked for decades to protect the SSRIs from repeated attempts to restrict their use by citizens, Congressmen, and even its own staff provides pivotal lessons for the enormous task in front of us.

I am proud to host this post, written by A Midwestern Doctor from the Substack “The Forgotten Side of Medicine.”

In the first part of this series (which must be read before this part), I argued that selective serotonin reuptake inhibitors (SSRI antidepressants) provide minimal benefit (only a minority of users benefit from the drugs), and frequently cause significant harm. The side effects vary greatly, and I’ve lost count of just how many people I know who have been severely harmed by these drugs. By the same token, I believe they have seriously damaged the fabric of American society:

Shortly after I published this article, Kim Witczak reached out to me to share a variety of things I did not previously know about these drugs. Witczak, who lost her husband to a tragic SSRI suicide, was one of the leading activists who worked tirelessly through the courts and political process to get warning labels placed on the SSRIs after the heart-wrenching death of her husband. For that reason, I revised the above article after it was originally published to include information she shared with me and realized that this article on the FDA’s malfeasance needed to be updated since there was a great deal I had not mentioned that needed be shared.

.

The medical field’s business model requires the gaslighting of patients it injures so that the public doesn’t stop buying its products—you are always fighting an uphill battle to have an injury recognized. Since a foundational tenet of medical gaslighting is to insist that the patient’s injury arose from a pre-existing medical condition (e.g., all your issues are just from anxiety), if the medical injury causes neurologic damage which in turn creates psychiatric issues, it is often a lost cause to convince the doctor that their treatment created those issues.

In some ways, I believe allopathic (conventional) medicine is extraordinarily advanced, but in other ways, it is very primitive. One of its major problems compared to many other systems that have existed throughout history, is that it fundamentally does not grasp the nature of the human mind, or how the mind affects the body and spirit (conversely, I consider this to be one of the most fascinating subjects in medicine).

I believe that this issue fundamentally arises because so much of medicine is about having a standardized box you can quickly fit patients into, do something for, and then move on to the next one (after all how else could we justify charging so much for such a brief visit). Because the mind is such a dynamic and vibrant organism, doing something simplistic like this metaphorically kills it—but since the entire history of Western medicine has been about controlling nature, it is not surprising how often it also tries to dominate the human mind. Although many severe side effects follow SSRI administration, one of the reactions that most upsets me (due to how common it is) is the degree to which SSRIs dampen the vibrancy of the human mind and spirit—something I am sure many of you can relate to.

Frequently when I talk with people who, to varying degrees, have lost their minds from psychiatric medications, it is both fascinating and horrifying how many different ways that the drugs can damage and alter people’s minds. For example, one common SSRI side effect I’ve heard of (which lasts long after the drugs are discontinued) is brain zaps, where as the name implies, people feel electrical flashes travel through their brains, and quite a few people have told me that these zaps prevented them being able to put together many of the thoughts they had previously had no trouble with.

57% experienced decreased libido
57% experienced delayed orgasm or ejaculation
46% experienced no orgasm or ejaculation
31% experienced erectile dysfunction or decreased vaginal lubrication.

Given that 40% of those on the medications considered this side effect unacceptable, it is a particularly cruel complication as it is almost guaranteed to make you depressed and the stated purpose of these drugs is to treat depression (which more often than not they don’t). While this has not affected the psychiatric profession’s prescribing or promotion of these drugs, it has been indirectly acknowledged as SSRIs are sometimes prescribed for premature ejaculation.

One of the important things to understand about toxins is that their side effects distribute on a bell curve, which means that their most severe effects are much rarer than their moderate or minor effects. Conversely, this means that if you see very worrisome side effects from a pharmaceutical, this indicates that a much broader swath of side effects lies hidden under the surface.

Now, let’s consider the case of the COVID-19 vaccines—they have caused a large number of people to die suddenly, including young athletes, which is such a distinctive and catastrophic event that the general public is beginning to recognize it, and no amount of propaganda can close their eyes. However, the vaccinated dead are not the only victims, and Ed Dowd’s team has done a lot of work to try to quantify the magnitude of the issue our country is facing:

Note: I reviewed Ed Dowd’s report for the next article I am working on, and the saddest part about it is that I believe its estimates of the costs of the vaccine injuries were actually too conservative.

In the case of the SSRI antidepressants (henceforth SNRIs—serotonin and norepinephrine reuptake inhibitors–will also be referred to as SSRIs), they also had an unambiguous, tragic side effect. They would cause people who took them to develop violent and homicidal tendencies, which frequently resulted in suicides, or otherwise normal people committing horrific murders, at times on those closest to them. This was well known by the pharmaceutical companies, as lawsuits had forced them to reveal clinical trial data that showed that these violent tendencies had been observed in the clinical trials.

Many individuals who have committed unspeakable acts have shared similar experiences such as the following:

•Reporting out-of-body experiences where they felt as though they were observing themselves from above and did not have any control over what was happening.

•Hearing voices tell them to kill themselves or others.

•Having an immense writhing irritation within their body (known as akathisia) which they would do anything to make stop.

•Having vivid nightmares.

•Losing track of what was happening around them.

That’s pretty scary and deeply unsetting when you think about it. One of the best accounts I have heard that illustrates how all of this can happen came from a very sweet and loving child who almost became a mass shooter. In his account, he touches on many of the above points:

As you might suspect, we still don’t know why this happens. Consider this correspondence between a clinical investigator for Zoloft, and his contact at Pfizer:

I have often wondered exactly how common these troubling behaviors are. On a population level, there is a consistent association of SSRI usage leading to an increase in Bipolar I (which results in more aggression), which is somehow rationalized by the psychiatric profession as the pre-existing condition being unmasked by the SSRI rather than the SSRI causing it.

On an individual level, I have crossed paths with a few people who have witnessed the grisly deaths that SSRIs can cause, but relatively speaking those are just a fraction of the vaccine deaths I’ve come across. Conversely, many friends who have been on the SSRI drugs have reported some of the effects listed above, and in many cases described these experiences as if there was literally a demon trying to possess them.

The major problem with this dynamic is that while SSRI suicides and homicides are rarer than sudden COVID-19 vaccine deaths, the medical profession is in much greater denial about the SSRI casualties. As a result, when individuals on SSRIs begin exhibiting these psychotic tendencies, the most common response (besides doing nothing) is to raise the dose of their SSRI or change to another SSRI. This often has catastrophic outcomes, as the worst thing you can do with an SSRI is abruptly change the dose or change to another SSRI. Similarly, many critical warning signs are missed by responsible mental health care providers time and time again (including for many mass shooters).

One reader shared a story with me that helps to illustrate how aggressively some psychiatrists will push these drugs, even when there are many signs they are only causing harm. Sadder still, the courts (who lack any understanding of this subject except that the “psychiatrist” is an expert in the area) will typically side with the psychiatrist and forcefully medicate individuals, while their significant others do not want the drugs because they can see the harm being caused to their loved one.

A 1982 study (which could probably never be published in today’s society) examining the effects of blood pressure drugs on a patient’s quality of life cuts to the core of this problem within medicine:

Note: although blood pressure medications can sometimes create significant issues (many observed by relatives are listed within the full study), I consider them relatively benign compared to psychiatric medications. I thus suspect that the magnitude of harm that physicians instead interpret as a benefit is even worse there.

As consumer lawsuits have shown, there were a lot of really concerning data in the clinical trials for the SSRIs. Not surprisingly, the moment the SSRIs hit the market, the FDA was deluged by complaints of severe unprecedented reactions from the drugs (sound familiar?). This should raise some major questions–why on earth was nothing ever done about it at the time, and why are there now more SSRIs on the market than we can count?

Anyone who has studied the economics of the pharmaceutical industry should understand that it primarily depends upon recurring revenue from products that have a large number of customers and high sales margins. My hypothesis is that the more lucrative a drug (or drug class) is, the harder the industry will fight to protect it.

Psychiatric medications are one of the most profitable drug franchises, making approximately 40 billion dollars a year (which also includes the psychiatric medications that “treat” the complications of SSRIs). It is thus, not surprising that very powerful interests will use every tool available to them to protect this franchise, which is particularly problematic, because they provide a significant amount of the funding that the federal regulators and politicians depend upon. This issue sadly extends far beyond the FDA, as how corruption has also been institutionalized within the NIH and within the CDC.

With all this in mind, let’s now examine the sad tale of how SSRIs became one of the most profitable drugs in existence.

Note: One of the best books I have found on this entire subject is Deadly Psychiatry and Organized Denial. The title is aptly named and illustrates the fact that the psychiatric field comes up with an endless list of rationalizations to dismiss the harms of their drugs, aggressively attacks anyone who claims that they exist, and continually gaslights patients who are  harmed by them (often instead arguing that the harm is a sign that they are mentally ill and require the drugs). Like the first part of the series, a significant portion of this article was sourced from that book.

One of the pharmaceutical executives directly involved in obtaining the approval for the original SSRI antidepressant, Prozac, developed a great deal of guilt for what he was complicit in once a large number of SSRI-linked deaths occurred. John Virapen, along with Peter Rost are the only pharmaceutical executives I know of who have become whistleblowers and shared the intimate details of how these companies actually operate. Although the events Virapen alleged seem hard to believe, other whistleblowers have also made similar observations to Virapen (the accounts of the Pfizer whistleblowers can be found in this article and this article).

John Virapen chronicled the events in which he was complicit in “Side Effects: Death—Confessions of a Pharma Insider.” These included outrageous acts of bribery to get his drugs approved, and photographing physicians with prostitutes provided by Eli Lilly so that they could be blackmailed into serving Eli Lilly. For those interested, this is a brief talk that Virapen gave about his experiences. I greatly appreciate the fact he used candid language rather than euphemisms like almost everyone else does:

At the start of the saga, Lilly was in dire financial straits and the company’s survival hinged on the approval of Prozac. Prozac had initially been proposed as a treatment for weight loss (as this side effect of Prozac had been observed in treatment subjects), but Lilly subsequently concluded it would be easier to get approval for treating depression and then get a post-marketing approval for the treatment of weight loss.

As Prozac took off, it became clear that depression was a much better market, and the obesity aspect was forgotten. Lilly then used a common industry tactic and worked tirelessly to expand the definition of depression so that everyone could become eligible for the drug and aggressively marketed this need for happiness to the public, before long, transforming depression from a rare to a common condition. For those wishing to learn more, Peter Gøtzsche has extensively documented how this fraud transpired and both this brief documentary and this article show how depression became popularized in Japan so that treatments for it could be sold.

Unfortunately, while the marketing machine had no difficulties creating a demand for Prozac, the initial data made it abundantly clear that the first SSRI, Prozac, was dangerous and ineffective. Lilly settled on the strategy of obtaining regulatory approval in Sweden, and using this approval as a precedent to obtain approval in other countries. Virapen was assigned to this task and told by his superiors that if he failed, his career was over. Virapen, unfortunately, discovered that whenever he provided Lilly’s clinical trial data to experts, they had trouble believing he was actually seeking regulatory approval, as Prozac’s trial data was just that bad.

Sweden (following their regulatory procedures) elected to allow an outside independent expert to make the final determination on whether Prozac should be approved or not. The identity of this expert witness was concealed, but Virapen was able to determine that it was Anders Forsman, a forensic psychiatrist and member of the legal council on the Swedish National Board of Health. After meeting with Virapen, Forsman proposed an untraceable bribe. Then, upon receiving payment, wrote a glowing letter in support of Prozac, fully reversing his position on Prozac (he had ridiculed it two weeks before) and guided Virapen through re-writing the trial to conceal the 5 attempted (4 of which were successful) SSRI suicides in Lilly’s trial.

Forsman’s expert opinion resulted in Prozac being partially approved and formally priced for reinbursement in Sweden, which was used as a precedent to market it around the world at that same lucrative price. Virapen noted that during this time, German drug regulators who had clearly and unambiguously stated that Prozac was “totally unsuitable for the treatment of depression” suddenly reversed their position, leading Virapen to suspect that similar under-the-table activity must have occurred in Germany. David Healey, a doctor and director of the North Wales School of psychological medicine, likewise concluded that the German approval was due to “unorthodox lobbying methods exercised on independent members of the regulatory authorities.”

Not long after saving Eli Lilly, Virapen was fired. Virapen believes he was fired because he was a man of color in an otherwise Caucasian company (he was told this by his supervisor). Gøtzsche, a leading expert in pharmaceutical research fraud and meta-analyses, on the other hand, attributed this to typical organized crime tactics where Lilly sought to conceal their illegal activity by firing Virapen and his two assistants to bribe Forsman (because immediately afterwards, none of them were permitted to access their offices, and thus could not obtain any of the files that proved that this bribery occurred). Fortunately, as happened with Peter Rost, this unjust firing eventually motivated Virapen to become an invaluable whistleblower.

Both Gøtzsche and Virapen repeatedly emphasized how the trials for Prozac (and subsequent SSRIs) were deliberately designed to conceal their adverse events. Despite this fraud being clearly visible to outside investigators, it was ignored by the drug regulators (with the exception of the Germans who later capitulated to Lilly). It was also often allowed to stand in a court of law, where the purported absence of adverse events in industry trials was used to argue that there was no evidence that the alleged injuries could be linked to the SSRI (the most revolting thing is that the industry even wrote misleading manuals to help prosecutors convict peaceful people on SSRIs who committed these murders).

Over time, however, as the “inexplicable” suicides and grisly murders resulting from the influence of SSRIs mounted, courts ruled against SSRI manufacturers and forced them to reveal concealed industry documents that clearly showed significant adverse events had occurred and the same horrific events the public was witnessing had been detected in the clinical trials for their drugs. It should be noted that while these tactics were pioneered by Lilly, other SSRI manufacturers, including Pfizer, used identical approaches. The key methods were as follows…

Read the full story: How the FDA Buried the Dangers of Antidepressants