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How the FDA Buried the Dangers of Anti-Depressants
In the first part of this series (which must be read before this part), I argued that SSRI antidepressants provide minimal benefit (around 20% of recipients experience a benefit) and frequently cause significant harm. On that basis, it is highly problematic they were ever FDA approved, particularly since they are given out like candy and over 10% of the American population is on them. However, while there are many “bad” drugs on the market, SSRIs (and to a lesser extent a few other psychiatric medications) have a unique side effect that…as much as I am reluctant to use this terminology…can only be described as demonic.
Individuals on SSRIs often report profound disturbances to their grip on sanity, some of whom turn violently psychotic. Most commonly this results in the individual killing themselves, and less commonly killing those around them, frequently in a gruesome fashion, and about once a year a catastrophic mass murder occurs that can clearly be linked to SSRIs. While the more horrific events are rare, SSRI violence is common enough that many of the readers here shared their own experiences with this occurring that mirror what has also happened to people I know in my personal life.
One reader shared a story that highlights many of the common problems with the conventional psychiatric paradigm, and astutely noted that what has happened to her daughter is affecting many in her generation. This issue has gotten much worse since the COVID lockdowns, which have severely damaged the mental health of adolescents, and in most cases, the proposed solution is typically antidepressant medications, which often make things much worse.
The reader’s daughter suffered depression because of the lockdowns and a subsequent separation of her parents (COVID policies have divided many families). Her daughter was admitted to a hospital and given Zoloft, at which point she developed paranoia and hatred towards her mother. While Zoloft failed to address her depression, it did cause her daughter to develop severe rage and begin cutting herself (a common sequela of akathisia) . The mother argued to the father this meant their daughter should stop taking Zoloft, but the father refused this request and instead deferred to the treating psychiatrists who opted to "raise her medication” rather than discontinue it, which led to a further worsening of the daughter’s mental health. Before long, she required residential programs to "rehabilitate" her now severe mental illness.
The mother eventually found a test her daughter took at a young age showing that she had a genetic defect in metabolism that was well known for producing toxic levels of SSRIs in the blood, the results of which the managing psychiatrist agreed justified discontinuing Zoloft. This resulted in an immediate and sustained resolution of the daughter’s mental health issues for 3.5 months. The managing psychiatrist then decided her daughter should be started on an SNRI that was not approved for children. When notified of this, the mother immediately scheduled a call the next week with the psychiatrist to discuss the rationale for this prescription.
The father disagreed with her desire to first consult the psychiatrist, and a few days later he sued the her for medical custody of their daughter, which a judge immediately granted to him and the experimental SNRI was initiated. The daughter immediately suffered severe mental health complications and has resumed cutting. Despite her health issues clearly been linked to the medications with a biological basis for why they are occurring, the father and the managing psychiatrist have insisted they are due to social factors, and despite the mother's best efforts she has been powerless to regain custody of her daughter (you can read her description here to better understand what it is like to be the mother in those types of circumstances).
There are many many things wrong with this story. I felt it was valuable to share, partly because Anita has been trying to bring media attention to her case, and partly because it highlights how some members of the psychiatric profession immensely abuse their power.
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 they exist, and continually gaslights patients who are frequently harmed by them (often instead arguing the harm is a sign 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 (which in turn was partly sourced from Peter Breggin’s pioneering work on this issue).
In most cases when a mass shooting occurs, the shooter is on an SSRI, and often has clear signs the SSRI is creating psychotic tendencies that are entirely ignored by the healthcare professionals they interact with. Each time a mass shooting occurs, the same script is read and a divisive national tragedy emerges with the media arguing anyone who does not want to ban all guns is a murderer.
Typically, school shootings diverge down one of two paths. The first is that someone who happens to be there is armed and neutralizes the killer before they can amass a large body count. While shootings of this type frequently happen, they are rarely publicized in the media. The second is that the police are called, take a while to arrive (90 minutes is one estimate but I was not sure how to accurately calculate this figure), and the killer amasses a large body count prior to their arrival resulting in the annual ritualistic national tragedy repeating itself and being promoted throughout the media.
Sometimes, such as in the recent 2018 Parkland shooting, police officers arrive when the shooting starts, but nonetheless choose not to enter the building, and the shooter succeeds in claiming a large number of victims. While a general consensus by experts has emerged that responding officers should immediately enter the shooting scene, consider that the police chief in Uvalde had attended trainings (as recently as 2 months before the shooting) reflecting the current expert consensus on responding to mass shootings. At this training, each participant was repeatedly told it was critical to immediately enter the shooting location with or without backup and kill the shooter as quickly possible. Instead of immediately stopping the shooting, the police chief ordered his officers at the crime scene to stand down and to instead focus on restraining parents who attempted to enter the building to save their children. After 90 minutes, an off-duty officer from a separate agency (thereby making him free to disobey the police chief) independently ended the shooting on his own.
Regardless of how you dice it, the recent shooting and the decades of mass shootings preceding it suggests that relying upon mental health professionals or police to stop school shootings is unlikely to prevent this annual ritual from occurring. I would argue instead that two very clear solutions emerge.
Evidence Based Policy
Evidence based medicine initially had a very positive effect on the practice of medicine because it forced numerous dangerous and ineffective treatments to be discarded, and it provided the political will to overcome entrenched interests who wish to continue these problematic medical practices. Unfortunately, it soon became clear that evidence could be bought, and as a result much of the evidence base now underlying evidence-based medicine is erroneous evidence that was developed through corruption.
Within politics, a similar movement for “evidence based policy” has also emerged (this was a key component of Andrew Yang’s presidential campaign). Because policy studies are infinitely cheaper to produce than (medical) randomized control trials and are based on mostly publicly available data, the evidence-based policy movement is much less susceptible to corruption. I personally believe evidence based public policy is very important, as you will continually see issues where no real improvement has occurred in for decades, but nonetheless will have opposing members of the political spectrum still be absolutely convinced their approach is the correct one that must happen. An allegiance to evidence is the only effective solution to breaking this deadlock.
With the mass shooting issue, there are two clear evidence-based policies:
•The first is to arm a few faculty members at the school. Despite the fact this is often effective, and no issues have emerged from doing that, when this idea is suggested and it is immediately labeled as a far-right position and met with hatred and derision. Mass shootings prevented in this manner are never reported, and just a few days ago an attempted mass shooting with an illegally obtained AR-15 was stopped by an armed bystander.
•The second is to seriously examine the role psychiatric medications play in school shootings and develop measures to mitigate their potential harm. This suggestion is typically met with even more hatred and derision that the first, to the point it is rarely allowed to even be a topic of discussion. At the same time these practical policies are stonewalled, needing to do “something” to stop these national tragedies is repeatedly chanted from the rooftops, while no viable solution is ever proposed.
One simple step is to be able to recognize who is at risk of turning psychotic from an SSRI, but since a collective denial exists within the psychiatric profession over the side effects from their medications, as numerous past cases show, very few psychiatrists recognize when SSRIs are producing psychosis in their patients (rather they take it as a sign the patient is under treated and requires more medications) and even fewer know how to evaluate for this risk prior to initiating treatment. Currently, I am aware of two metabolic alterations which predispose individuals to turning psychotic from SSRIs, both of which are easy to test for.
The first are individuals have a hereditary weakness of their cytochrome P450 detoxification system. As this is responsible for removing SSRIs from the bloodstream, in these individuals, normal doses of SSRIs will result in them developing elevated blood levels of the SSRI that can often be toxic and produce psychosis. Many forensic investigations, such as those discussed in the first part of this series have confirmed this occurs.
The second requires you to recognize which metabolic type of depression the patient suffers from. William Walsh PhD analyzed the blood of thousands of individuals with depression, and found five common distinct metabolic patterns emerged. One type, characterized by a deficit in methylation does benefit from SSRIs (and goes a long way towards explaining why some people do well on these medications). However, to quote Walsh on another metabolic type: “More than 90% of depressives who experience symptom worsening after antidepressants exhibit a combination of high methyl and low folate levels in blood. Inexpensive lab testing can identify these persons who must avoid SSRI antidepressants. It seems likely that most school shooters had the low folate form of depression and experienced an adverse reaction to antidepressant treatment. These persons respond better to benzodiazepine medications, and also benefit from nutrient therapy to elevate folate levels. This approach is based on biochemical studies of 2,800 persons diagnosed with clinical depression.”
It would also be nice if a conversation began to seriously consider restricting the usage of these medications or withdrawing them from the market. However, as many of us have realized from observing the pandemic response, the profit can be made from pharmaceuticals will trump all other policy considerations.
Psychiatric medications are an especially challenging area to touch because they represent the ideal pharmaceutical product:
•You can diagnose virtually anyone as requiring them.
•It is very easy to emotionally market them (as modern advertising revolves around creating negative emotional states, and all of these drugs are designed “fix“ negative emotional states).
•Once you start them, they are very difficult to ever stop taking (due to their severe withdrawals and the actual causes of depression never being addressed).
•They often serve as a sales funnels for further psychiatric medications to treat their psychiatric side effects (such as antipsychotics for iatrogenic bipolar 1 from SSRIs).
•They allow everyone who is responsible for creating a profoundly mentally unhealthy society to redirect their responsibility to pre-existing biochemical imbalances in the brain.
•New psychiatric medications are very easy to develop which ensures patients will always be on expensive proprietary medications.
(Many of these also apply to the COVID vaccinations)
Like the COVID vaccines lobby, the psychiatric lobby has so much money behind them that they have effectively silenced all debate on this issue. This is why most Americans still have no knowledge of the link between psychiatric medications and psychosis. Similarly, the potential profit for these drugs enabled them to steamroll through the entire regulatory apparatus which before long became captured by industry. As much of what happened behind the scenes was later revealed, the SSRI story provides an invaluable perspective for understanding the present regulatory debacle we are facing.
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. Rost (who did an amazing job messing with Pfizer) along with another Pfizer whistleblower will be the subject of a future article.
John Virapen chronicled the events he was complicit in within “Side Effects: Death—Confessions of a Pharma Insider.” This included outrageous acts of bribery to and targeted blackmail such as photographing physicians with Eli Lilly provided prostitutes so they could be threatened with the release those photos for failing to follow Lilly’s needs. For those interested, this is a brief talk he gave about his experiences. I greatly appreciate the fact he used candid language rather than euphemisms like 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 had been observed in treatment subjects) but Lilly subsequently concluded it would be easier to get approval for the treatment of depression and then get a post marketing approval for the treatment of weight loss. As the marketing took off, it became clean depression was a much better market and the obesity indication was dropped. Lilly used a common industry tactic and worked tirelessly to expand the definition for 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 common condition. For those wishing to learn more, Gøtzsche extensively documents how this fraud occurs.
Unfortunately, while the marketing apparatus had no difficulties creating a demand for Prozac, its data made it abundantly clear the drug was dangerous and ineffective. Lilly settled on the strategy of obtaining regulatory approval in Sweden and using this approval as a precedence 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 determinant on if Prozac should be approved. The identity of this expert witness was concealed, but Virapen was able to determine it was Anders Forsman, a forensic psychiatrist and member of the legal council in the Swedish National Board of Health. After meeting with Virapen, Anders proposed an untraceable bribe, and 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 successful) SSRI suicides in Lilly’s trial.
Forsman’s expert opinion resulted in Prozac being partially approved and formally priced in Sweden, which was used as a precedent to market it around the world at that same price. Virapen noted that during this time, German drug regulators who had clearly and unambiguously stated Prozac was “totally unsuitable for the treatment of depression” suddenly reversed their position, leading Virapen to suspect 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 reached the conclusion 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), while Gøtzsche attributed this to typical organized crime tactics where Lilly sought to conceal their illegal activity by firing Virapen and his two employees who worked with him to bribe Forsman (as immediately afterwards none of them were permitted to access their offices and thus any of the files that proved 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, this fraud was ignored by the drug regulators (with the exceptions of the Germans who later capitulated to Lilly). It was also often allowed to stand in a court of law as the absence of adverse events being detected in industry trials was used to argue there was no evidence the purported injuries could be linked to the SSRI.
Overtime, however, as the adverse events from the SSRIs and the data fraud was so egregious, courts ruled against Lilly and forced them to reveal concealed industry documents that clearly show significant adverse events were occurring from Prozac they intentionally failed to disclose. Many of the tactics used to falsely create an impression of efficacy and conceal harms of the SSRIs are identical to what was done for the COVID vaccines. 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:
•Whenever severe adverse events occurred they were relabeled with benign and innocuous terms. Forsman pioneered this approach in Prozac’s original trial, changing “Five had hallucinations and tried to commit suicide, which four of the test subjects succeeded in doing” to “Five of the other test subjects had miscellaneous effects.”
Private internal documents showed Lilly also wanted to remove all instances of “suicide” from their database, and relabeled suicides reported by investigating doctors as “overdose.” When independent investigators later examined UK regulator data they found many other SSRI manufacturers had copied this terminology for concealing SSRI suicides. Likewise, private memos from Lilly revealed Lilly instructed “suicidal ideation” to be coded as “depression.”
To further illustrate the point, a 1985 in-house analysis of placebo controlled trials for Prozac found 12 suicide attempts on Prozac versus one each on placebo and a tricyclic antidepressant, but after the blind was broken, six of the suicide attempts were removed from the dataset.
This tactic is commonly used in drug trials, and prior to COVID, I was the most familiar with this happening throughout the Gardasil vaccine trials. With the COVID vaccines, the most well-known example of this occurred with a participant in Pfizer’s trial, Maddie de Garay who developed profound permanent neurologic disability from the second vaccine which was then coded as “functional abdominal pain.”
•The design of SSRI trials (which utilize a lead in period) makes it possible deliberately exclude patients from their trials who improve during the placebo’s lead-in period (oftentimes the social support from being part of a trial is sufficient to improve depression) and exclude patients who experience significant side effects from the drugs during the lead-in period. This type of patient filtering is typical for SSRI trials (three-quarters of the SSRI trials have an initial placebo lead-in period of 1-2 weeks).
This is somewhat analogous to individuals with pre-existing autoimmune conditions being excluded from the COVID vaccine trials, which was critical for the vaccine approval as between 1 in 3 to 1 in 5 of these patients appear to develop exacerbations of their autoimmune condition, which would have prevented the vaccines from being “safe” enough to approve. However, while the all of these pharmaceuticals were never tested for safety in the highest risk groups, once they entered the market, they were immediately aggressively marketed to them.
•Suicides that occurred outside the trial period in the placebo group were added to the adverse events experienced in the placebo trials in order to reduce the apparent increase in suicides in the trial period. Released documents show Glaxo-SmithKline, Eli Lilly and Pfizer engaged in this conduct. For example, David Healy noted in 2002 that, based on data he had obtained from the FDA, two suicides and three suicide attempts that were ascribed to the placebo group in a Paxil trial had occurred in the run-in period, before the patients were randomized.
This is somewhat analogous to Pfizer’s vaccine researchers (as detailed in whistleblower reports verified by the British Medical Journal) being unblinded and selectively using PCR testing for placebo subjects (this may also explain why a much larger difference was found in the vaccine “preventing” minor COVID related symptoms than in severe COVID complications, as the former are much easier to fabricate with PCR tests that have a high false positive rate).
•The specific criteria used for determining an improvement in depression was highly subjective, and it was for this reason Germany originally refused to approve Prozac. The subjectivity of what constitutes depression has resulted in a significant discrepancy between the benefit psychiatrists perceive and what their patients experience (doctors commonly think patients benefit more from prescribed pharmaceuticals than their patients do, and much much more than family members of the patient believe the patients benefit). Given that “mental health” is entirely in the mind of the patient, it is insidious that psychiatrists can be the arbiters of the benefits of these drugs.
To this point, Gøtzsche cites an analysis of a prescription database that showed after only two months, 50% the patients had stopped taking their SSRIs, which is irreconcilable with psychiatrists believing SSRIs work in 70-80% of patients. A meta-analysis of 8 SSRI trials for depression likewise found an effect size of 0.25 was reported by observing psychiatrists, whereas no effect (effect size 0.05) was reported by patients. A Cochrane review had similar findings, with effect size of SSRI treatment being 0.29 when evaluated by psychiatrists and 0.06 when reported by patients. All of this is somewhat analogous to the Pfizer vaccine trial, where as detailed by the whistleblower participants were unblinded and vaccine recipients were often not PCR tested once they developed COVID related symptoms.
•The most significant side effects from SSRIs arise from abruptly withdrawing from the medications. As many of the placebo participants in these trials already were on a SSRI, by placing them on a placebo, they experienced severe withdrawal symptoms (thereby making them appear to do worse than the treatment group). Similarly, the trials were timed to only monitor side effects from discontinuation of a SSRI for a very brief amount of time (typically a day), resulting in many withdrawal symptoms occurring when data is no longer collected (SSRIs are known to increase the risk of suicide for weeks).
This is somewhat analogous to each of the COVID vaccine manufacturers terminating their long-term placebo control trials once they got an EUA (each vaccine’s EUA was originally conditional upon long term studies of the vaccine being conducted) but because “the vaccines are so safe and effective,” it was decided it was unethical to not allow participants to receive the vaccine, and the placebo arm of the COVID vaccine trials (which could have revealed all the severe long term complications of the vaccines) was cancelled. In both cases, data on the long term consequences of the drugs can never be collected, and the absence of that evidence is repeatedly utilized to erroneously argued the evidence of absence in court .
•Many of the activating syndromes associated with SSRIs (ie. Bipolar Disorder, Akathisia, Suicide and Hostile Psychosis) could be mitigated with Benzodiazepines (these function as sedating agents). By incorporating benzodiazepines into the experimental design of these drug trials, it was made possible to conceal the adverse events created by the SSRIs (by one estimate 84% of SSRI trials used benzodiazepines as part of the protocol, and 3 of the 4 trials used by the FDA to approve Prozac included a benzodiazepine in the protocol). This is not known by most practicing physicians (who in most case will simply prescribe an even more harmful antipsychotic in cases where these symptoms are recognized and erroneously viewed as under-dosing of the SSRI).
•SSRI suicides are always attributed to “pre-existing” depression, which is then used to argue the suicide meant more SSRIs rather than less SSRIs should be given. In one of the most detailed studies on the subject of depression and suicide, it was found that only 26% of those who commit suicide had been diagnosed with depression prior to the suicide, which makes it quite tenuous to argue all of those deaths could have occurred from untreated depression.
This is analogous to a COVID vaccine injuries initially being blamed on catching COVID (I personally know of numerous cases of fatalities immediately following vaccination in a previously asymptomatic patient that were erroneously coded as COVID-19 deaths), and now being attributed to long hauler syndrome (in fact one of the early ways the vaccine was marketed was to treat long hauler syndrome, which in each case I have observed, the vaccine instead made worse). The screenshot I saw posted today summarizes this issue:
George H.W. Bush
There is a lot of interesting dark history to the Bush Family. The Bush dynasty was founded by Prescott Bush, who built his family fortune by collaborating with the Nazis directly against the wishes of the US government (the Guardian for example confirms it here). His son, George H.W. Bush had the unique accomplishment of being the only CIA chief to later become president, and during his brief tenure was responsible for numerous crimes against humanity in South America. After leaving the CIA once Carter became president, Bush served as a board member for Eli Lilly and then joined the Regan administration as vice president.
After succeeding Regan as president, Bush’s chose Dan Quayle as his vice president. To quote Peter Breggin, a brave psychiatrist who worked in court to expose the anti-depressant industry:
“In Talking Back to Prozac (1994), I pointed out that Prozac was approved under the first Bush administration and that George Bush had been a member of the board of directors of Eli Lilly, the manufacturer of Prozac. I also pointed out that Vice President Dan Quayle was from Indiana, the home state and international headquarters for Eli Lilly. At the time the FDA was approving Prozac, Quayle employed former Eli Lilly personnel on his own staff, and Quayle had considerable leverage over the FDA as the chair of a special committee that was investigating its operations. I questioned whether the FDA might have rejected Prozac and that the entire SSRI onslaught might never have gotten started if the president and vice president of the United States had not been so closely affiliated with Eli Lilly.”
Bush’s son, George W. Bush likewise followed in his father’s footsteps and appointed Eli Lilly executives to senior positions within his administration. He also inserted a provision into the Patriot Act to exempt vaccine manufacturers including Eli Lilly from liability for thimerosal (Mercury) within vaccinations.
In summary, Bush profoundly changed the FDA’s regulatory competency. Consider this example detailed by Virapen that occurred a few years before Bush became president. In 1980 Eli Lilly applied for the approval of Benoxaprofen, and aggressively promoted their new blockbuster medication. Not long after being approved, in 1982, Benoxaprofen was taken off the market after being linked to a small number of deaths and Eli Lilly was subject to a lengthy investigation being conducted by the justice department where it was concluded Lilly intentionally covered up the deaths caused by their drug.
Prozac and the FDA
The FDA’s treatments of SSRIs is the only instance I know of besides the Covid vaccines where the agency has not only ignored but actively tried to conceal a horrific number of adverse events for a pharmaceutical receiving widespread protest from the public. This was most likely heavily influenced by the Bush administration being in bed with Lilly. As such, it is insightful to see how this played out over decades as we ponder how the FDA will handle the COVID vaccines.
First consider the FDA’s behavior when Bush was not yet president as summarized by Gøtzsche and Breggin:
“Initially, the FDA was skeptical and noted serious flaws in Lilly’s trials. An FDA officer wrote in 1984 that patients who didn’t do well after two weeks had their blinding broken, and if they were on placebo, they were switched to fluoxetine (resulting in six weeks of fluoxetine being compared to two weeks on placebo). An FDA review also discovered that 25% of the patients had taken an additional drug, and when the FDA in 1985 removed patients on other drugs from Lilly’s trials, there was no significant effect of fluoxetine. By adding benzodiazepines, Lilly broke the rules for its trials but didn’t inform the FDA, and when the FDA later learned about it, the agency permitted it and thereby broke its own rules. The public and the doctors were never informed about this ruse.”
In 1985 the FDA’s safety reviewer noted under the headline “Catastrophic and Serious Events” that some psychotic episodes had not been reported by Lilly but were detected by the FDA by examining case reports on microfiche. This reviewer also noted that fluoxetine’s profile of adverse effects resembled that of a stimulant drug.
Prozac was ultimately approved in December 1987, and as detailed in the previous section, 3 of the 4 studies this approval was based upon used Benzodiazepines to conceal the psychotic syndromes created by the drugs.
Once Prozac entered the market in 1988 adverse event reports began to accumulate, and by 1991 Prozac had one of the highest rates of adverse events ever reports to FAERS (similar to VAERS but for other pharmaceutical injuries). A hearing was convened where many witnesses had told stories about out-of-character suicides and homicides. The advisory committee members, many of whom had financial ties to pharmaceutical companies producing SSRIs, unanimously rejected this proposal: “There is credible evidence to support a conclusion that antidepressant drugs cause the emergence and/or the intensification of suicidality and/or other violent behaviors.”
For reference, I recently wrote an article documenting the exact same behavior at the FDA and NIH throughout the pandemic.
Lawsuits revealing private internal Lilly documents showed Lilly had repeatedly failed to report adverse events from their SSRIs they were required to report. In 2004, the BMJ received a series of internal documents that showed Lilly had known since 1978 Prozac can trigger a strange, agitated state of mind that can provoke an unstoppable urge to commit suicide or murder. Separate documents showed Lilly initially planned to have a warning for Prozac causing psychosis in the USA package insert, but ultimately only did so in Germany, as their regulators unlike the FDA required Lilly to insert this warning.
Lilly also chose to commit fraud by not reporting 76 of 97 cases of suicidality from Prozac in a post-marketing surveillance study it submitted to the FDA. Cymbalta, a SNRI frequently marketed for treating chronic pain was found by Lilly to cause severe withdrawals once discontinued in half of those who had received it for at least 8 weeks (a sad case from a reader can be found here). Lilly likewise opted to not report this to the FDA (as required to by law). In the first quarter of 2012 more reports were submitted to the FDA on serious drug withdrawal effects for Cymbalta than for any other regularly monitored drug, including two opioids.
In 2003, while examining a clinical trial for giving Paxil to children, the FDA noticed more episodes of “emotional lability” were reported in children on Paxil than those on placebo. The FDA decided to investigate what the actual symptom Paxil’s manufacturer was concealing behind this label, and was informed most cases referred to suicidality. One of the FDA’s safety officers, Andrew Mosholder, a child psychiatrist, further investigated this issue and concluded 22 studies showed that children given antidepressants were nearly twice as likely to become suicidal as those given placebos.
His superiors at the FDA who had recently hidden Paxil’s tendency to cause suicidality in children predictably disputed his report and did not allow it to be released to the public or presented at an advisory meeting. A year later in 2004, the report was leaked, and in a very telling move, the FDA chose to conduct a criminal investigation of the leak rather than address the clear safety concerns it raised.
That year (2004), likely in response to the political pressure resulting from the leaked report, the FDA finally released a black box warning linking SSRIs to increased suicidality in children. Despite knowing about this problem long before the SSRIs came to market, it took over two decades for the FDA to provide this critical black box warning, and only after massive public pressure, countless lawsuits proving these effects were deliberately concealed by the manufactures, congressional hearings, senate hearings and leaked reports publicly shaming the FDA.
By 1990, the public was demanding for the FDA to determine if SSRIs were linked to increased suicidality. As the evidence proving this was clear and unambiguous, the FDA deliberately avoided publishing a report on this topic. Finally, 16 years later, shortly after the FDA was exposed for suppressing the link between suicidality in children and SSRIs the FDA finally published a meta-analysis addressing this question. The 2006 meta-analysis encompassed 372 placebo controlled trials of SSRIs (and related drugs) involving 100,000 patients showed that up to the age of 40 years of age, SSRIs increased suicidal behavior, while in older patients SSRIs decreased this risk.
A common tactic in the pharmaceutical industry is to hyper focus on one specific set of side effects so the other side effects can be covered up. For example, from comparing the incidences of blood clots I hear of to the percentage of people who chose the J&J vaccine, I am relatively certain the mRNA vaccines are more likely to cause blood clots than the J&J vaccine, but whenever this topic is raised, people default to believing only J&J can cause blood clots since it was linked to a few cases of central venous thrombosis and there was a brief period of time where the vaccine was paused by the FDA to assess this risk.
My belief is that the FDA’s long delayed meta-analysis and the black box warning were a direct response to the leaked report proving an indisputable link between SSRIs and adolescent suicidality that was done in order to shield the other side effects from scrutiny. This tactic was ultimately unsuccessful and a year later in 2007 the FDA updated their blackbox warning to apply to adults of all ages (not surprisingly academic psychiatry has vociferously protested these warnings ever since).
The FDA’s meta analysis also almost certainly understated the risk. As detailed throughout this article, the FDA gave the studies they analyzed a free pass on the variety of design flaws that made it easy in conceal the adverse events. In fact, the FDA had reached out to many of the SSRI manufactures and asked the pharmaceutical company to adjudicate possibly suicide-related adverse events in their trials as they saw fit and send those results to the FDA.
When analyzing the 2006 meta-analysis, Gøtzsche found numerous other signs of deliberate fraud by the FDA (keep in mind the goal of this study was most likely to conceal the indisputable link between SSRIs and suicide). For example, in many cases (often due to data revealed from litigation) a single study within the meta-analysis was shown to contain more cases of suicide from a SSRI than the 5 suicides the FDA cited as occurring throughout all 372 of these studies. Numerous post marketing studies have shown similar underreporting occurred. One analysis of prescriptions written in England when SSRIs first came to market found 17 suicides occurred per 10,000 prescriptions for Pfizer’s Zoloft, 24 suicides occurred per 10,000 prescriptions of Prozac and, 27 suicides occurred per 10,000 prescriptions of Paxil.
From extensively reviewing all the data, Peter Gøtzsche an expert in research fraud and meta-analysis reached the overall conclusion was that there are likely to have been 15 times more suicides on antidepressant drugs than reported by the FDA in its 2006 meta-analysis.
In my personal opinion, when your results are off by an order of magnitude, this can only occur through deliberate fraud. This situation is sadly analogous to the profound harm occurring from the COVID vaccines that the regulators and departments of the HSS claim is rare or non-existent.
When you repeatedly see things like the SSRI debacle, it often leads one to believe public health is always secondary to commercial interests for groups tasked with protecting public health. A good argument could be made that much of what we are suffering through with the COVID vaccine campaign is a direct consequence of previous malfeasance within the Department of Health and Human Services (HSS) not being addressed and instead allowed to proliferate. As best as I can tell, the federal government now is significantly more corrupt than it was when Prozac was first approved, and behavior like that detailed within the series has become the norm rather than an exception.
It is very telling that with the SSRIs, the FDA worked hand in hand with industry to do everything possible to prevent revealing any type of adverse effect from these dangerous drugs. It took decades to make some progress on this issue, and that only resulted after numerous court cases, a massive body count, hearings within Congress and the Senate and mainstream media outlets being willing to publish leaked reports that cast the FDA in a bad light. Even with that, functionally nothing has been done (a few warnings were put out), the use of SSRIs has continued to grow, and their growth has only accelerated throughout the pandemic.
In a recent article, I discussed the proven systemic corruption within the HSS makes it function as an arm of the pharmaceutical industry, and in a separate article how unjustified vaccination mandates were engineered to become a political platform of the (previously anti-big Pharma) Democratic Party.
From reviewing the planning documents not foreshadowed everything which has occurred, is abundantly clear parties such as Bill Gates and the WHO intently studied how previous unethical pharmaceutical campaigns fell short of their targets. Many of the factors that allowed the SSRI issue to gradually be brought to light are no longer possible. The media, which previously reported stories critical of the HSS and pharmaceuticals has been bought out and with a few exceptions will never publish these stories.
Many of the stories I have published on this platform 20 years ago would have easily become stories in the nightly news, but now only appear on small independent platforms. For example, as detailed in the previous series on corruption within the NIH, a 2022 investigation by a nonprofit watchdog group that has received no coverage whatsoever was conducted in an identical manner and got identical results to a 2005 investigation conducted by the Associated Press that was widely reported throughout the media.
In spite of continual pleas, there has not yet been a Congressional or Senate hearing on the COVID vaccines. So far, the best we have had were small events hosted by Senator Ron Johnson that were conducted outside those chambers.
However, the biggest problem is the immunity the vaccine manufacturers have from lawsuits. The documents written a decade ago to pave the way for mandatory adult vaccinations emphasized it was critical to get vaccine manufacturer protection through “emergency type situations.” Once that protection is in place, it is not possible to obtain the documents that what otherwise be made available in court through the legal discovery process. This is critical, because those documents are the linchpin that proves fraudulent activity has occurred and can cause the entire house of cards to collapse.
This is not a new issue. Robert F Kennedy for example has repeatedly run into it when attempting to sue vaccine manufacturers such as Merck in order to obtain critical documents showing our children are being severely harmed by vaccinations that should not be on the market. However, prior to COVID there was no existing precedent something so harmful could be mandated on the population with no legal recourse whatsoever against it.
This issue has been building for a long time, and especially given the trans-human direction the pharmaceutical industry is going in, my fear is that even worse pharmaceuticals will be forced through in the future unless this systemic corruption with the FDA, NIH, and CDC is corrected and checks on their powers are put into place. I (and Senator Ron Johnson) are presently hoping a political upset in the 2022 midterms will begin to make this possible.
As we finish, I would like to circle back to the original thesis: SSRIs caused psychotic suicides and homicides. I have sadly only highlighted a small sample of these horrific cases (but enough for ones readers were personally familiar with to be mentioned) and there are many more stomach churning mass killings that have not be mentioned in this series (for those wishing to learn more I would suggest reading Deadly Psychiatry and Organized Denial or Peter Breggin’s work on this subject).
To conclude this series, I would like to cite a peer-reviewed Swedish study that looked at information on over 850,000 patients prescribed SSRIs within a national database of all prescribed medications and compared the rates of violent crimes committed by these individuals when they were and were not taking a SSRI over a 3 year period. This study found SSRIs increased the rate of violent crimes committed by 43% in those between the ages of 15 and 24 receiving the drugs.
How do you reconcile something like that being allowed on the market for decades? This sadly is the same question many of us have had to face as we’ve looked at the entire COVID vaccination program.
I would like to thank each of you for reading this article and sharing it with the parties you find appropriate to share it with.
If you would like to know more on this topic, this article was written by fellow MDs on substack (but still only touch the surface because there is so much to discuss here). Lastly, if you are considering stopping a SSRI or SNRI, do not do so without the guidance of a physician familiar with how to prevent withdrawl symptoms.
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