The Scandalous Truth Behind the Antidepressant Trials
Every now and then, a highly profitable pharmaceutical will come along that everyone also knows is quite dangerous. Remarkably, rather than this stopping the product, it will often be pushed to market and the profits it generates will be used to ensure any objections to its safety get ignored and blown to the wayside.
One of my goals in writing has hence been to review the scandalous history of some of the most dangerous pharmaceuticals on the market. This was done both to help those being harmed by them (e.g., consider the story of the statins and the story of the NSAIDs) and to illustrate that the horrendous malfeasance we’ve observed from the FDA throughout COVID-19 is in fact has been it’s standard operating procedure.
For example, I recently covered the story of Merck’s Vioxx, an unsafe and unneeded painkiller which was kept on the market until outside investigators proved it was causing heart attacks and strokes (estimated to have killed 120,000 people by the time Vioxx was withdrawn), something Merck was fully aware of from the start.
Vioxx resulted in a wave of lawsuits which cost Merck billions of dollars but never resulted in criminal charges against any of the executives responsible for those deaths (rather they got bonuses).
Immediately after the Vioxx lawsuits, Merck brought the HPV vaccine Gardasil to market, fully aware that it had minimal value to those vaccinated (in fact it increased the risk of cancer by 44.6% in those who already had the target HPV-16 or 18 infection — something which like COVID-19 is never tested for prior to vaccination). More importantly, Gardasil had an extraordinarily high rate of adverse reactions.
Note: In its trial, over 50% of the girls were observed to have developed “new medical conditions,” 2.3% of which Merck admitted were autoimmune in nature (although the actual figure was likely much higher).
Once Gardasil hit the market, the CDC and FDA were deluged with a wave of injuries being reported to them. However, rather than listen to these warnings, they doubled down on their claim the vaccine was “safe and effective,” did everything they could to bury those injuries, and ardently worked with Merck to sell the vaccine to as many people as possible.
However, as bad as those stories are, I believe what happened with the Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants is even worse. Since the SSRI saga provides the clearest case study I know of into the gross malfeasance of the FDA, this article will review it in the hope we can better understand the agency’s behavior with the COVID vaccines and just how far it will go to protect the pharmaceutical industry.
Note: Psychiatric medications are one of the most profitable drug franchises, making approximately 40 billion dollars a year — a figure that is expected to significantly increase in the years to come.
The Harms of SSRIs
When integrative physicians are asked to name what they consider to be the five most dangerous mass prescribed drugs in America, SSRIs (and SNRIs) almost always end up on the list, something I believe is due to their mechanism of action (and adverse event profile) having many overlaps with an illegal stimulant like cocaine. In the first and second parts of this series, I attempted to detail those harms which included:
Causing violent psychotic behavior which frequently led to suicide, and less frequently to homicide.
To illustrate: A peer-reviewed Swedish study looked at information on over 850,000 patients prescribed SSRIs within a national database and compared the rates of violent crimes committed by these individuals when they were and were not taking an SSRI over a 3 year period. This study found that SSRIs increased the rate of violent crimes committed by 43% in those between the ages of 15 and 24 receiving the drugs.
Note: I initially focused on psychotic SSRI violence because it is a common but undiscussed thread in mass shootings (and other grisly murders which shocked their community). However, I believe the SSRI suicides (as they are far more common) are an even bigger issue.
Consider for instance that one study found 10% of mentally healthy volunteers on an SSRI became suicidal, while a much larger survey of SSRI users found 39% had experienced suicidal ideation while on the drugs. Additionally, as the previously mentioned Swedish study shows, SSRIs have been repeatedly shown to significantly increase the incidence of hostile (but not yet psychotic) behavior.
Causing 7.7% of the users each year to develop bipolar disorder (ultimately affecting between 20-40% of SSRI users). For many, bipolar disorder is a permanently debilitating disorder which significantly impacts one’s quality of life.
Emotionally anesthetizing 60% of the users. This numbness frequently results in individuals losing the will to leave a toxic relationship or work situation (often for years if not decades), to stop emotionally reacting to things you should react to (e.g., someone being mean to you or violating your boundaries), and to no longer experience the joy or vibrancy of life.
Causing sexual dysfunction in the majority of the users (59% in this study, 62% in this study) which is often extremely impactful to the patient’s life (e.g., 40% in this study found the side effect intolerable).
Note: Keep in mind that sexual dysfunction is one of the fastest ways to make someone depressed.
Increasing the risk of life threatening birth defects by 2-6 times (e.g., taking a single SSRI increases the likelihood of the newborn having a septal defects from 0.5% to 0.9%, while taking two increases it to 2.1%).
Causing severe withdrawal symptoms (e.g., frequent electrical zaps through the brain) in 56% of those who discontinue the drugs, with most (46% of discontinuers) experiencing severe withdrawals. Very few people appreciate just how difficult it can be to get off an SSRI (even after only a brief course of the drugs), or that there is absolutely no support within the conventional medical field for patients wishing to get off the drugs.
This is particularly tragic because many of the SSRI suicides and murders are preceded by someone having their SSRI dose changed (e.g., increased, decreased or changed to a different medication).
Note: Since I was repeatedly asked to do so, I attempted to put together my suggestions on how to withdraw from SSRIs, and I must emphasize it is truly unfair just how addictive these drugs can be.
Sadly in addition to those common side effects, patients also experience a variety of debilitating side effects from the SSRIs such as palpitations, anxiety, and insomnia. Worse still, it is fairly feasible to identify who will have a good or bad response to SSRIs (e.g., from their genetics) but physicians are never taught how to do this as it would understandably reduce SSRI sales if they were only given to those who will benefit from them.
Note: Similarly much (but not all) of the harm which occurs from vaccines (especially in children) could be avoided if doctors were taught to recognize the initial adverse reactions children experience and pause giving those children additional vaccines.
Likewise, if the vaccines were spaced out (rather than all being given together during the critical developmental period of a child) or the most dangerous ones (e.g., Gardasil or COVID-19) were taken off the market, the harm also would significantly decrease.
However none of that has been done since it would be equivalent to an admission vaccines are not “100% safe and effective” and hence significantly reduce vaccine sales. Consider for instance that the government was actually mandated by the 1986 National Childhood Vaccine Injury Act (which gave legal immunity to the vaccine manufacturers) to study the safety of the existing vaccines so that safer ones could be developed, but it has nonetheless refused to do so ever since.
When you read through the previous section, the first thing that should catch your attention is how just high the percentage of adverse reactions were (e.g., many affected approximately half of those taking the drugs). This in turn highlights just how badly the FDA can fail to do its job and “detect” patently obvious side effects which were seen throughout each SSRI’s clinical trials and then throughout America once the drugs entered the market.
To explain this, I put forth the argument that a drug’s approval is not based on its risks versus its benefits, but rather its risks, its benefits, and its potential profitability (e.g., consider how large the potential antidepressant market is). This for example is why fairly safe and effective treatments (e.g., hydroxychloroquine or ivermectin) were relentlessly attacked as unsafe and ineffective by the American medical establishment.
Similarly, it’s why incredibly dangerous and unsafe ones that were also incredibly profitable were pushed on America throughout the pandemic despite widespread public opposition to their adoption and study after study showing the official pandemic policy was causing more harm than good. Likewise, because people are creatures of habit, you can be relatively assured that if something was used in the past which “worked,” you will see it done again and again.
My familiarity in turn with the dirty deeds by used by the pharmaceutical industry with their worst products (e.g., the SSRIs or Gardasil) in turn made me immediately spot those same tactics being used to doctor the COVID vaccine trials, trick the public into buying them, and cover up the deluge of evidence they were harming people.
As you review the SSRI saga, it is important to remember that much of this was only discovered through lawsuits against the manufacturers and Congressional investigations (as the industry has successfully argued their raw data is proprietary information and hence cannot be disclosed to the public — which in turn requires us to “trust” their presentation of it).
Since that time, the pharmaceutical industry has gained much greater control over both the media and government and has legally been granted almost complete immunity from being sued for an unsafe and ineffective vaccine so similar documents are highly unlikely to be revealed through the discovery process.
Note: In an 1989 lawsuit which followed a man shooting eight people dead, wounding another 12 and killed himself one month after he started fluoxetine, Lilly “won” a jury verdict and claimed it was “proven in a court of law … that Prozac is safe and effective.” The trial judge however forced Lilly to admit that it had made a secret settlement with the plaintiffs during the trial and, outraged, the judge changed the verdict in Lilly’s favor to one of “dismissed as settled with prejudice.”
As part of this deal, Lilly illegally regained the incriminating documents it had been forced to disclose, preventing them from being used in other in other lawsuits. Sadly, in addition to burying incriminating documents within the courts, both the FDA and the EMA (Europe’s FDA) have repeatedly managed to “lose” documents in their possession which incriminated the SSRIs.
While we hold randomized controlled trials in high regard, in truth there are a variety of ways they can be doctored to arrive at the results the sponsor wants, regardless of how ineffective or unsafe they are. For example, the public was told over and over that the COVID vaccines were safe, effective, and would end the pandemic despite:
• The Pfizer trial showing that at best you needed to vaccine 119 people to prevent a single minor case of COVID (e.g., a sore throat plus a positive test), 2711 to prevent a major case of COVID (major being undefined), well over 21,720 to prevent a single death and that the vaccine’s ability to prevent transmission had never been tested.
Note: Once the vaccine hit the market, COVID rapidly evolved resistance to the vaccine, so in real life the actual figures were even worse.
• That many of the Pfizer trial participants experienced symptomatic reactions from the vaccine which were as bad or worse than a COVID infection (e.g., 59% experienced fatigue after Pfizer’s vaccine, whereas around 10-15% experience fatigue after a typical influenza vaccine).
• The Pfizer trial 6 month report showing that more people died (and were injured) who got the drug than who got the placebo.
• Numerous whistleblowers coming forward and testifying they suffered a severe reaction to the COVID-19 vaccine which never made it into the final trial report, one of whom directly notified the senior management at the FDA over what was occurring and another, who (being a lawyer) filed a formal governmental inquiry against the lead author of Pfizer’s vaccine trial.
• A manager of a Pfizer trial site providing documented evidence to the FDA that their site was flagrantly violating established research protocols (e.g., not having the trial be blinded, failing to test those who received the vaccine and developed COVID like symptoms for COVID and underreporting vaccine injuries).
Note: The FDA refusing to listen to reports of serious issues with its drug (and in turn denying they even existed) is likewise nothing new (e.g., I recently provided footage of them doing it the 1980s with the now withdrawn DTwP vaccine). Similar, consider Kim Witczak’s experience:
“As the head of FDA division Dr Bob Temple and Dr Tom Laughren told us in a private meeting with them, David Healy and another family, my husband was just an “anecdote” because it didn’t happen in a double blinded placebo controlled trial [even though lawsuits later showed it did].
I kept telling them to go investigate how my husband went from not sleeping (reason for prescription) to head outside body looking in to hanging in 5 weeks with no depression or history of depression or mental health issues.
It was first glimpse that FDA has no desire to investigate and also learned the same people responsible for approving drugs were also responsible for monitoring safety. Obviously, it is out of control with covid vaccines.”
Given all the serious issues which had been detected in their trial, let’s review how Pfizer described their vaccine in their much heralded December 2020 NEJM paper:
“The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines.”
At the time this paper was released, it was greeted with an almost religious jubilation by the medical field, and before long I realized it was an exercise in futility to explain to many of my colleagues why the trial’s conclusion was not at all supported by the data within it. As you all know, that jubilation quickly spread through the country and before long gave rise to the highly unethical vaccination mandates.
However, despite a litany of evidence emerging which showed that Pfizer’s paper had serious shortcomings which should not have passed peer review (e.g., documented fraud by the lead author) NEJM has not issued a retraction or correction. This is identical to what NEJM did with its pivotal Gardasil paper, and what NEJM did with its Vioxx paper until a wave a lawsuits mounted against Vioxx (at which point NEJM issued a “statement of concern”).
Sadly, we were warned in 2004 by NEJM’s editor-in-chief that the medical journals (e.g., the NEJM) are corrupt and cannot be trusted. Had she been listened to, there might have been a bit more skepticism towards Pfizer’s NEJM trial.
Note: For those interested, some of the best resources I’ve come across for the tricks drug companies commonly use to create the illusion a bad drug is “safe and effective” are Doctoring Data (by Malcolm Kendrick), Deadly Medicines and Organized Crime (by Peter Gøtzche), The Truth About Drug Companies (by Marcia Angell) and Bad Pharma (Ben Goldacre).
Of these doctors, Goldacre is the most orthodox one, so I find his book on pharmaceutical corruption, while not as good as the previous, is often more effective for persuading more skeptical parties.
The SSRI Trials
The less concrete a pharmaceutical’s benefit is (e.g., preventing minor flu like symptoms occurring in parallel to selectively applied [and almost always positive] COVID-19 PCR tests), the easier it is to alter the trials parameters to create the illusion that a minor change is actually a big deal (e.g., Pfizer’s 0.8% reduction in the likelihood of having a minor case of COVID).
Since “depression” is a highly subjective metric, a variety of methods were concocted to create the illusion the drugs “helped,” improve depression. This for example was done by using scales which “quantified” the effects of the drugs for anxiety and depression rather than something which directly correlated to either.
To illustrate, in a meta-analysis conducted by GSK, suicide-related events occurred more often (3.86 times) on Paxil than on placebo in children and adolescents, whereas suicide items on rating scales the trials used like Hamilton’s didn’t show this difference.
Likewise, a meta-analysis carried out by the FDA in children and adolescents found suicide items on depression scales “showed” SSRIs decreased the risk of suicide by 8% whereas raw company data showed the risk was increased by 95%.
Note: The subjectivity of what constitutes depression has resulted in a significant discrepancy between the benefits psychiatrists perceive from their medications, and what their patients experience. This 1982 study of the effect of blood pressure medications for instance excellently illustrates the tendency of doctors to overestimate the benefits of their drugs:
Likewise in the SSRI trials, it has frequently been observed that psychiatrists tend to document a much greater improvement for their patients than what the patients themselves reported.
For example in 8 trials, which included 1576 children and adolescents, trial site psychiatrists reported an overall improvement (effect size 0.25), whereas the patients themselves did not (effect size 0.05), results which were also found in a Cochrane review of newer antidepressants in children and adolescents (effect sizes of 0.29 vs. 0.06).
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, and we routinely see countless cases where psychiatrists exercise their power to forcefully medicate patients.
Beyond the fact that many of the common SSRI side effects mentioned previously..