The pharmaceutical enterprise mannequin requires prescribed drugs which are “efficient” sufficient to one way or the other justify pushing them on sufferers however not efficient sufficient to really repair the problem the drug is prescribed for, thus requiring every affected person to take the drug indefinitely. Moreover, the bigger the potential drug market is, the extra aggressively the pharmaceutical trade will push to market it to each out there buyer.

In some instances, resembling for the harmful and ineffective COVID-19 vaccines, this greed is so blatant even most of the people can see it. Conversely, in different instances, it’s sometimes invisible to any in addition to these immediately affected by the medicine and their fast household.

Not too long ago, for instance, I reviewed the statin disaster after Aseem Malhotra on the Joe Rogan present introduced the general public’s consideration to the hazard and ineffectiveness of those medicine and the way the identical reprehensible forces we noticed push the COVID-19 vaccines have been working for many years throughout the ldl cholesterol trade.

Though it is difficult to assert anyone class of medication is the “worst,” case could be made for psychiatric medicines. Along with the medicine being dangerously addictive and most of their “advantages” coming from doctored analysis information, they’ve some disturbing unwanted effects.

Past already tragic problems like deadly coronary heart assaults (which occurred to an in depth good friend of mine), people on these medicine can turn into partially psychotic, and there are various tragic instances of suicides and homicides following their use.

Sadly, due to simply how giant this market is, the trade and the FDA have gone to excessive lengths to cowl up the harms of those medicine for many years, and enterprise as traditional continues within the psychiatric sector.

Be aware: A lot of that is tough to consider, so I chronicled precisely what can now be confirmed occurred with the antidepressants. I did this as a result of what the FDA did again then is likely one of the closest precedents we now have for understanding how the COVID-19 vaccines had been dealt with and what to anticipate will occur sooner or later.

After I revealed an article summarizing the proof for the psychotic, violent, and infrequently lethal behaviors these medicine induced, Kim Witczak reached out to me to share her story. Quickly after Zoloft entered the market, Kim’s husband Woody was unnecessarily placed on the drug and, not lengthy after, immediately killed himself in a fashion attribute of a Zoloft suicide.

Kim determined the very best factor she may do with this tragic state of affairs was to work to forestall it from occurring to anybody else. She had quite a few successes and was instrumental in a black field warning for suicides being positioned on SSRI antidepressants (one thing she believes would have been unattainable to perform in immediately’s far more corrupt political local weather).

On account of her work, Kim turned the buyer consultant on the FDA’s Psychopharmacologic Medication Advisory Committee and is continuously the one dissenting vote on unjustifiable drug approvals.

Be aware: That is analogous to how Ron Paul earned the nickname Dr. No throughout his time in Congress as a result of he was continuously one of many solely dissenting voices towards unconstitutional laws. Kim periodically shares distressing issues she observes with me:

“I’m going to put in writing about it, however I used to be as soon as once more the one no vote. This assembly was about utilizing the antipsychotic Rexulti for an “unmet” want of Alzheimer’s Agitation indication. The information was minimal, and but the demise evaluation was double the antipsychotic price that the FDA calculated from a meta-analysis of different antipsychotics.

Anyway, the committee voted 9-1 to advocate approval for the “unmet” want. The fact is that the federal government has been cracking down on [dangerous and difficult to justify] antipsychotic use in nursing properties.

They’ve seen an increase of [likely fraudulent] schizophrenia diagnoses. So this may assist the trade get their medicine coated [by insurance] and utilized in nursing properties. I informed the FDA they should watch the advertising and marketing and communication round this product to make sure the advantages usually are not overstated, and demise downplayed.

It’s so discouraging, and but I do know there are individuals such as you which are out talking the reality. However hey, a minimum of I received the media to name me out for being the lone dissenting vote on this one!”

Be aware: A way more detailed abstract on absolutely the absurdity of this approval written by Kim could be seen right here. Not too long ago, Kim shared one thing I consider has immense worth for your complete public to know. Nevertheless, to completely recognize it, we should first take a fast detour into Alzheimer’s illness.

Alzheimer’s Analysis?

Alzheimer’s illness presently is likely one of the most devastating ailments in existence, each for the person who experiences it (together with their household) and extra broadly for society, as over 1% of worldwide GDP is spent on caring for dementia (likewise in 2021 Alzheimer’s was estimated to value the USA 355 billion {dollars}), and its value has not stopped growing.

Due to this, Alzheimer’s illness is a “nationwide analysis precedence,” and in 2021, 3.1 billion was allotted for Alzheimer’s and dementia analysis. But regardless of over a century of analysis (amyloid was first recognized as the reason for Alzheimer’s in 1906), cures for Alzheimer’s stay elusive.

The standard view of Alzheimer’s is that amyloid plaques, for some cause, accumulate within the mind and progressively destroy the mind as their focus will increase. Due to how aggressive the amyloid contingent has been, researchers exploring different Alzheimer’s fashions continuously consult with this contingent because the “Amyloid Mafia.”

Sadly, regardless of being studied for a century and infrequently receiving billions of {dollars} in analysis funding every year (final 12 months, 1.6 billion was allotted for amyloid analysis), the amyloid mannequin has introduced us no nearer to treating the illness.

I initially wrote about this subject as a result of an impartial tutorial found that the info in a pivotal 2006 Nature paper (which “proved” the amyloid mannequin and ended the rising dissent towards it throughout the scientific neighborhood) had been fabricated.

Put in another way, this meant that just about 20 years of analysis (together with billions spent funding it) resulted from this fraud (e.g., one among its focuses which by no means acquired analysis assist earlier than 2006, acquired 287 million in analysis grants only for 2021).

Curiously, regardless of this fraud being investigated and confirmed by a premier scientific journal, the paper has not been retracted (there has simply been a discover for the final 12 months that it’s being investigated). The lead creator (Lensé) likewise has not suffered any penalties for his scientific misconduct (regardless of having since been discovered to have a way more intensive file of fraud within the many papers he is revealed that “reconfirmed” his speculation). As an alternative:

“He [Lensé] turned a pacesetter of the College of Minnesota’s neuroscience graduate program in 2020, and in Could 2022, 4 months after Schrag delivered his issues to NIH, Lesné acquired a coveted R01 grant from the company, with as much as 5 years of assist. The NIH program officer for the grant, Austin Yang — a co-author on the 2006 Nature paper — declined to remark.”

Briefly, there’s immense corruption on this subject of analysis. This, I consider, is a results of the pharmaceutical trade eager to bury any analysis that threatens this money cow (the size of Alzhiemer’s makes it one of the doubtlessly worthwhile drug franchises in existence).

The dimensions of this corruption is feasible as a result of Fauci labored for many years to reshape the NIH to operate as a pharmaceutical manufacturing pipeline the place the NIH and its researchers are paid important royalties for questionable prescribed drugs they push by the approval course of.

Within the case of Alzheimer’s, that is notably tragic as a result of quite a few viable therapies exist already for it — nonetheless, since they threaten the Alzheimer’s market, they’ve by no means been allowed to see the sunshine of day.

What Causes Alzheimer’s Illness?

I do know of some strategies which have proven promise in treating Alzheimer’s, but sadly most researchers are unaware of them. All of my colleagues who’ve efficiently handled the situation (or extra generally, slowed its development) have arrived at comparable conclusions on methods to deal with it (their approaches are mentioned in additional element right here):

Restore the blood movement to the mind.

Restore the lymphatic drainage from the mind.

Keep away from pointless toxin publicity (e.g., gasoline anesthesia is a typical offender right here).

Take away toxins from the mind (e.g., heavy metals with EDTA chelation).

Present important vitamins to the mind (e.g., aluminum-free subcutaneous B1 and B12 photographs).

Determine and deal with power infections contributing to dementia (e.g., HHV6 or Lyme).

Of those, the primary two look like crucial and infrequently require bettering the zeta potential of the physique. Moreover, I’ve one colleague who additionally makes use of stem cells in his routine treating the situation, and whereas this does assist, he emphasizes that stem cell remedy is unlikely to learn the affected person if the opposite areas listed above stay unaddressed.

Be aware: Conversely, the spike protein excels at triggering most of the causes of Alzheimer’s illness (e.g., it damages the blood circulation to the mind). One of many saddest problems of the COVID-19 vaccines has been their tendency to induce a speedy cognitive decline within the aged (this, as an illustration, has occurred to the dad and mom of quite a few associates). In every case, that decline is assumed to be a traditional results of ageing.

Likewise, I’ve seen many anecdotal examples of minor cognitive impairment following COVID-19 vaccination and extra important cognitive impairment in COVID-19 vaccine-injured sufferers and watched physicians current information displaying this concern is widespread.

Because the successes of the above approaches utilized to deal with Alzheimer’s are anecdotal, solely utilized by a number of practitioners, and haven’t any medical trials to assist their efficacy, I can perceive why the scientific neighborhood has not embraced and even tried to discover them. Nevertheless, there’s one integrative mannequin for treating Alzheimer’s that has been confirmed to work in medical trials, and but regardless of this being the case, it too has been ghosted by the large Alzheimer’s trade.

change in cognitive performance

Be aware: On this trial, 84% improved, 12% declined, and 4% had no change in cognition from the RE-CODE protocol.

The mind all the time has processes that protect neurons and processes that get rid of them (as that is needed for the mind to adapt to the wants of the atmosphere). Dale Bredesen, MD, in The Finish of Alzheimer’s, in flip, has made a superb case that Alzheimer’s represents the destruction of neurons outpacing their creation and advocates for way of life practices and practical drugs interventions that reverse that stability so your neurons are protected.

The RE-CODE protocol was his try to do that, and in contrast to the roughly 400 failed research which preceded it, this one truly labored.

Lead creator Dr. Kat Toups famous, “I’ve been the Principal Investigator on greater than 20 long-term medical trials for sufferers with MCI and dementia the place the benchmark for achievement was merely a slowing in cognitive decline. This trial is the primary to point out precise enchancment in a number of domains of functioning, in addition to enhancements in MRI mind scans.”

One among probably the most vital factors, Bredesen has made (I agree with) is that amyloid features as a protecting mechanism the mind makes use of towards components that may in any other case injury it. This implies concentrating on amyloid, at finest, is an train in futility and at worse, extremely detrimental to the mind.

Amyloid Medication

Given the scope of this downside and the continuous failure of amyloid medicine (once more, there are lots of of failed medical trials), it’s fairly shocking that Bredesen’s work has been utterly ignored (though sufferers across the nation search out neurologists who Bredesen skilled). Happily, in the end, the present FDA was capable of finding an answer to our lack of ability to deal with the dearth of a viable therapy for Alzheimer’s illness.

On June seventeenth, the FDA granted an accelerated approval for the primary amyloid remedy. To cite their press launch:

“This approval is critical in some ways. Aduhelm is the primary novel remedy permitted for Alzheimer’s illness since 2003. Maybe extra considerably, Aduhelm is the primary therapy directed on the underlying pathophysiology of Alzheimer’s illness, the presence of amyloid beta plaques within the mind.

The medical trials for Aduhelm had been the primary to point out {that a} discount in these plaques — an indicator discovering within the mind of sufferers with Alzheimer’s — is anticipated to result in a discount within the medical decline of this devastating type of dementia.”

Be aware: I couldn’t assist however discover how a lot every of the FDA press releases I learn for this text appeared like promotional materials for the medicine written by the pharmaceutical trade.

The approval of Aduhelm was immensely controversial, to the purpose ten of the eleven members of the FDA panel voted towards approving it (which is one thing not even the atrocious COVID-19 vaccines may obtain).

Three, in flip, resigned following the panel being ignored and Aduhelm nonetheless being permitted, with one stating of their resignation letter that this was “in all probability the worst drug approval choice in current U.S. historical past.” What, then may have accounted for the panel’s unprecedented rejection of a brand new profitable product?

Merely put, Aduhelm failed to point out any enchancment for Alzheimer’s illness, whereas mind swelling or mind bleeding was present in 41% of sufferers enrolled in its research.

Extra importantly, as a result of the drug was priced at $56,000 a 12 months (and subsequently able to bankrupting Medicare), this approval was adopted by quite a few requires this approval to be investigated. Earlier than lengthy, a congressional committee convened for that objective (which is very uncommon; even the COVID-19 vaccines haven’t met the bar for a proper congressional investigation).

Following an 18-month investigation, it discovered that critical irregularities occurred throughout the FDA’s approval course of. For instance, the company sidelined its scientists who raised issues about Aduhelm, and the FDA helped Biogen (Aduhelm’s producer) put together its presentation to the surface committee — one thing that has solely occurred 9 occasions prior to now (all for most cancers medicine).

Briefly, whereas it was extensively recognized that Biogen producers and the FDA labored collectively on Aduhelm, to cite STAT Information: “The back-channel relationship between the 2 began earlier and was much more intensive than disclosed.”

Equally, due to the political backlash towards the approval, the FDA was pressured to conduct its personal investigation, which, whereas much less damaging than the congressional findings, recognized comparable points and admitted the company’s collaboration with Biogen “exceeded the norm in some respects.”

Moreover, one of many extra attention-grabbing gems discovered throughout the congressional investigation was how Biogen deliberate to deal with the actual fact they had been charging an exorbitant sum of money for an ineffective and intensely harmful drug:

“Inside paperwork confirmed the corporate set “an unjustifiably excessive worth” of $56,000 a 12 months for Aduhelm as a result of it needed a history-making “blockbuster” to “set up Aduhelm as one of many prime pharmaceutical launches of all time,” despite the fact that it knew the excessive worth would burden Medicare and sufferers, the report discovered.

The investigation mentioned Biogen was ready to spend as much as a number of billion {dollars} — greater than two-and-a-half occasions what it spent creating the drug — on aggressive advertising and marketing to counter anticipated “pushback” over whether or not Aduhelm was value its worth [consider for a moment its cost, efficacy and safety].

The report mentioned the marketing campaign deliberate to focus on medical doctors, sufferers, advocacy teams, insurers, policymakers and communities of shade, who had been drastically underrepresented in its medical trials of the drug.”

Be aware: Since this time, Biogen has halved the worth for Amgen as lots of its anticipated consumers determined the advantages didn’t justify its value (probably as a result of unhealthy press the drug created).

Then on January 6, 2023, a second amyloid drug (with a barely completely different goal) was permitted by the FDA, additionally produced by Biogen (this time in partnership with Eisai), and once more was accompanied by a glowing press launch from the company.

Leqembi did a bit higher than Amgen; solely 21% skilled mind bleeding and swelling (in comparison with 9% within the placebo group), and 26.4% skilled infusion-related reactions. Conversely, there might have been a tiny profit noticed. When the 898 topics with early-stage dementia who acquired Leqembi had been in comparison with the 897 who acquired a placebo over 18 months, a small delay (27%) in cognitive decline was noticed in these receiving the drug.

Moreover, whereas this variation was deemed to have reached statistical significance, the precise distinction in signs between the therapy and placebo group within the trial was 0.45 factors on an 18-point scale. To cite Medical Xpress:

“Most clinicians within the subject counsel {that a} higher distinction is required to affect sufferers’ lives, for instance 1 to 2 factors.”

Primarily based on how the info was collected, this small distinction was probably an artifact fairly than something significant. Nonetheless, the sphere was overjoyed since, after many years of labor, this was the primary medical trial ever to point out a possible profit for treating Alzheimer’s illness (a slight delay in its development which nonetheless comes at a extreme value).

Responses like these assist as an instance the systemic blindness all through the medical subject on condition that Dale Bredesen already put ahead a less expensive, safer, and most significantly, dramatically simpler medical trial that each one of those researchers (who obtain billions every year) are one way or the other unaware of.

The Revolving Door in Washington

One of the crucial essential factors RFK Jr. shared throughout his presidential marketing campaign pertains to his expertise in spending many years litigating towards federal businesses collaborating with company America in harming the American individuals. His remark was that the federal businesses had been full of fine individuals attempting to do the best factor, however a corrupt management tied their fingers.

This RFK Jr. argued was as a result of our authorities construction favors unethical individuals who should not have America’s pursuits at coronary heart ascending to the highest of the paperwork (e.g., as a result of company America lobbied for his or her promotion), and I totally agree along with his evaluation. Take into account, for instance, that the second official appointed by Trump to move the FDA (and helped pave the best way for Operation Warp Pace), Commissioner Scott Gottlieb, is now on Pfizer’s board.

On the identical time, the commissioner who was in command of the FDA for the entirety of Operation Warp Pace, Stephen Hahn, is now a CEO-partner for the enterprise capital agency that launched (and owns) Moderna.

Sadly, bribing officers by promising them high-paying jobs after they depart workplace shouldn’t be unique to drugs. Our present Secretary of Protection was initially a four-star basic, then employed onto the board of Raytheon (a protection contractor), then appointed to his present place, and since he got here to workplace, probably the most harmful conflict in trendy historical past has damaged out, and Raytheon has made some huge cash.

To additional assist RFK Jr.’s argument, when the COVID-19 aid payments had been handed, they contained a provision for the Authorities Accountability Group (congress’s watchdog and one of many least corrupt businesses within the federal authorities) to analyze how the accountable federal businesses (the NIH, CDC, FDA, and ASPR) dealt with the pandemic.

This investigation (summarized right here) discovered that workers in all 4 businesses noticed political interference occurred, which prevented evidence-based scientific insurance policies from being adopted. Moreover:

“Respondents from CDC and FDA informed us they didn’t report potential political interference in scientific decision-making as a result of:

  • They feared retaliation.
  • Being not sure methods to report points. Respondents from CDC and FDA said they weren’t positive methods to report the potential political interference in scientific decision-making they noticed. For instance, a CDC respondent informed us they weren’t conscious of any present inner procedures that could possibly be used to report potential political interference in scientific decision-making.
  • Believing company leaders had been already conscious. Respondents from CDC, FDA, and NIH said they didn’t report potential political interference in scientific decision-making as a result of they thought management was already conscious of the problem.”

Be aware: That is additionally similar to what members of the CDC have shared when making an attempt to attract consideration to the numerous corruption inside their company.

Moreover, the GAO discovered that a lot of the insurance policies that ought to have been in place to forestall this from occurring (which had been quite simple and widely known as important) weren’t:

“The absence of particular procedures might clarify why the 4 chosen businesses didn’t determine any formally reported inner allegations of potential political interference in scientific decision-making from 2010 by 2021.”

Moreover, the GAO repeatedly noticed officers argue that the dearth of reported points was proof these points didn’t exist, and subsequently meant nothing extra wanted to be finished.

“Officers at CDC and FDA informed us that there was not a selected cause why CDC and FDA lack such procedures and that the businesses didn’t deliberately omit this info [necessary for reporting fraud or violations of scientific integrity] from their present insurance policies and procedures.”

I hope that these examples assist as an instance how a big variety of FDA workers, for good causes, may oppose Aduhelm’s approval — however nonetheless had been overridden by the businesses management.

Be aware: Following the approval of Aduhelm and its successor, Billy Dunn, the Director of the Workplace of Neuroscience, Heart for Drug Analysis and Analysis (which was the division of the FDA chargeable for approving these medicine) left the FDA and have become a board member of a biotech firm creating therapeutics for degenerative neurological circumstances.

JP Morgan’s Healthcare Convention

When Kim contacted me, it was particularly about JP Morgan’s annual healthcare convention, a personal invitation-only occasion described by JP Morgan as “the trade’s greatest gathering.” The forty first convention, from January 9-12, 2013, was the primary one hosted in individual because the pandemic began resumed being in individual (it was hosted in San Francisco). Given this occasion’s affect on the 12 months to come back, Kim made a degree to gleam as a lot as she may from its web site.

Given what she discovered on public show, I can solely think about what was mentioned behind closed doorways. Since behind the scenes footage of the pharmaceutical trade is kind of tough to acquire, we solely have a number of examples as an instance what truly transpires on this tradition:

I now need to share a few of the most essential factors Kim alerted me to. First, if you happen to think about who was chosen to talk there, it says greater than I ever may about the place the priorities of the healthcare trade lie.


What this lineup basically says is that the precedence of your complete trade is how everybody could make as a lot cash as doable and the way interlinked all of that is with the monetary sector. That is not precisely a brand new revelation, however I not often see it said this overtly.

Be aware: Califf turned Biden’s second FDA commissioner on February 15, 2022 (having beforehand served as Obama’s for 11 months from 2016-2017). On the time, there have been critical questions of whether or not his intensive ties to the pharmaceutical trade made it acceptable for him to steer the company. To cite Wikipedia:

“Califf labored very carefully with pharmaceutical corporations on the Duke medical trials middle “convincing them to do giant, costly, and, for Duke, worthwhile medical trials.” He was a paid advisor for Merck Sharp & Dohme, Johnson & Johnson, GlaxoSmithKline, AstraZeneca, and Eli Lilly per ProPublica from 2009 to 2013.

The biggest consulting fee was $87,500 by Johnson & Johnson in 2012, and “most of funds for journey or consulting beneath $5,000”, which has been referred to as “minimal for a doctor of his stature”.

From 2013-2014 he was paid a complete of $52,796; the best quantity being $6,450 from Merck Sharp & Dohme, adopted by Amgen, F. Hoffmann-La Roche AG, Janssen Pharmaceutica, Daiichi Sankyo, Sanofi-Aventis, Bristol-Myers Squibb and AstraZeneca.

He was a director of Portola Prescribed drugs, Inc. from July 2012 to January 26, 2015, an advisor for Proventys, Inc., chairman of the medical advisory board of Regado Biosciences, Inc. and has been a member of that board since June 2, 2009, and a member of the medical advisory board of Corgentech Inc.

Forbes wrote that his shut ties to the drug trade had been why he was not nominated for the FDA Commissioner place in 2009. Califf’s ties to the pharmaceutical trade had been criticized by the journal The American Prospect, and Democratic Senators Bernie Sanders and Joe Manchin, who introduced their intention to vote towards his 2021 renomination [Califf was ultimately confirmed 50-46].”

When Kim despatched me this story, she requested for me to overview this specific presentation:

chris schott

Be aware: I saved the video (linked above) in case it will get pulled. You may additionally need to watch it immediately on their web site (the sound high quality is healthier). The background music they introduced in concurrence with this discuss (if you happen to see by its euphemisms) highlights how these individuals see the world and the way unconcerned the healthcare trade is with the human prices of their enterprise mannequin.

For this text, I transcribed the analyst’s presentation:

“We have seen the pharmaceutical group meaningfully outperform the market in 2022. Now, particularly taking a look at 2023, I am most centered on two new therapeutic areas, and these are weight problems and Alzheimer’s.

Within the weight problems market, we now have new medicine coming to market, so we see sufferers successfully not getting diabetes, decrease charges of coronary heart assaults, and strokes. So it successfully strikes weight problems from an aesthetic market to a medical market. We’re forecasting this could possibly be over a 30 billion greenback annual alternative.”

[Screen flashes to say Obesity — Shifts from an aesthetic market to a medical market $30B+ annual opportunity].

“The opposite market I point out is Alzheimer’s, and this has been by far the biggest unmet want within the healthcare trade. I am inspired this 12 months we’ll see the primary two medicine permitted that may truly modify and decelerate the speed of Alzheimer’s development.”

[Screen flashes to say Alzheimer’s — New Treatment Options $20-25B annual opportunity].

“After I consider a few of the headwinds we may face for this sector in 2023, that might offset a few of these optimistic tendencies that I discussed, one which involves thoughts is actually the sector’s patent cycle, so we’re nonetheless going through quite a few very giant patent expirations as we glance out to the tip of the last decade and I feel the traders are more and more centered on how the trade will handle by these.

What I take into consideration the inflation discount act and what it means for the pharmaceutical sector as a complete, we view the affect as fairly manageable.”

[Screen flashes to say Inflation Reduction Act impacts: Caps out-of-pocket costs at $2,000 for Medicare beneficiaries].

“The invoice mainly caps out-of-pocket prices for seniors in Medicare at 2000 {dollars} [this is something people have been fighting for decades]. The tougher half for the trade is worth negotiation. This would be the first time the US authorities can negotiate drug pricing, and it is on a comparatively restricted variety of medicine, nevertheless it’s one thing we’ll have to observe carefully.

Now going ahead and searching to 2023, the outlook’s nonetheless fairly optimistic in our view. We have core merchandise throughout the sector performing properly, we have got pipelines persevering with to advance and actually broaden out, and the sector shouldn’t be uncovered in any respect to a few of the macroeconomic and provide chain volatility that we’re seeing elsewhere available in the market.”

There are two essential takeaways from this. The primary is that the trade (and the traders who allow it) are involved they could lose a few of their means to cost gouge their clients (once more, nothing new, however uncommon to see so overtly admitted). The second is that medicines for Alzheimer’s illness and weight problems are anticipated to turn into two of the largest franchises within the close to future for an trade determined to develop new drug markets. Kim’s particular cause for sharing all of this was as follows:

“Fascinating to additionally word, FDA Commissioner Califf was keynote speaker on opening day and out of the blue, the FDA granted accelerated approval to the second controversial Biogen Alzheimer drug on Friday [three days before the conference] with out an Advisory Committee. How nice to have the ability to announce to the healthcare biotech trade that one among their new medicine was simply granted accelerated approval.”

I want I had extra to say, however there is not; that, in a nutshell, is the present healthcare trade.

Be aware: Accelerated approvals for “unmet wants” is a typical means the FDA permits pharmaceutical corporations to bypass the standard necessities of proving security and efficacy to ensure that their medicine to be permitted. Kim has witnessed many tragic examples of this throughout her time on the FDA panel.

Defending Recurring Gross sales

Throughout the globe, the over-the-top censorship and stonewalling of any repurposed (off-patent) pharmaceutical drug for the therapy of COVID-19 opened many individuals’s eyes to the fact that the pharmaceutical trade (in lockstep with the federal government) suppresses therapies that threaten the trade’s enterprise mannequin.

Due to the implications of this stonewalling (e.g., lockdowns predicated on there being no solution to deal with COVID-19, harmful hospital protocols as an alternative turning into the usual of care, and disastrous vaccine mandates), it additionally led them to ask if these monopolistic practices went past COVID-19. For instance, I repeatedly heard this said:

“In the event that they went this far for the COVID-19 market does that imply they’ve additionally finished the identical with cures for most cancers?”

The pharmaceutical enterprise mannequin all the time goals to have proprietary merchandise that partially enhance a power situation and should be taken indefinitely (as this ensures the biggest quantity of gross sales). If a product is an off-patent pharmaceutical* (so it’s now not doable to make some huge cash promoting it) or successfully cures a situation (which shortly destroys its market), that’s unacceptable.

Equally, a non-pharmaceutical therapy should be saved off the market if it does this. Essentially the most express admission of this case I’ve seen got here from a monetary report a number of years in the past:

goldman sachs

“The potential to ship ‘one shot cures’ is likely one of the most tasty features of gene remedy, genetically-engineered cell remedy and gene modifying. Nevertheless, such therapies provide a really completely different outlook with regard to recurring income versus power therapies,” analyst Salveen Richter wrote within the word to shoppers Tuesday.

“Whereas this proposition carries super worth for sufferers and society, it may signify a problem for genome drugs builders on the lookout for sustained money movement.

Within the case of infectious ailments resembling hepatitis C, curing present sufferers additionally decreases the variety of carriers capable of transmit the virus to new sufferers, thus the incident pool additionally declines … The place an incident pool stays secure (eg, in most cancers) the potential for a remedy poses much less danger to the sustainability of a franchise.”

In a current collection on emotional well-being and dealing with trauma, I centered on the therapy choices for insomnia as a result of correct sleep is important for psychological well being (and therapeutic many different power circumstances). Presently, whereas People spend over 30 billion {dollars} yearly on sleeping aids (it is fairly a big franchise), most of them do not work very effectively.

For instance, most sleeping capsules sedate you and likewise sedate the mind fairly than placing it to sleep — which is an issue as a result of a sedated mind has problem performing the very important restorative features of sleep.

Oddly sufficient, there’s one sleeping medicine that’s each extremely efficient in placing the recipient to sleep, and that doesn’t suppress the conventional sleep course of.

When it was nonetheless out there, my colleagues discovered it was a significant element of their therapy plans for power sicknesses; sadly, within the Nineteen Nineties, it was taken off the market as a result of the media, in a coordinated style, whipped up hysteria about it getting used for sexual assault, regardless of no proof present to assist this (now disproven) declare.

One type of the drug remains to be doable to acquire (and continuously may be very useful with profound sleeping issues), however it’s difficult to qualify for it. The one means I may interpret these occasions was that due to how giant a market insomnia was, it was unacceptable to have an efficient however off-patent therapy for it available on the market.

Equally, suppose you think about the Alzheimer’s examples above due to how a lot this market is value. In that case, we now have seen billions upon billions be spent to “discover a remedy” for it (e.g., only for 2021, the NIH spent 2.8 billion), whereas on the identical time, confirmed therapies for the illness are ignored by the scientific neighborhood.

As an alternative, we now have two medicine that trigger mind bleeds in 20-40% of the recipients, don’t present any profit for treating the illness, and but are so “revolutionary” the FDA commissioner who helped push them by determined to provide a keynote tackle to your complete trade proper after approving one among them.

One factor that’s usually not appreciated concerning the pharmaceutical trade is that rather more cash is spent on advertising and marketing prescribed drugs than on creating them. It is because the trade found out way back that so long as some case could be made {that a} product “works,” no matter how unsafe or ineffective it’s, it could possibly simply be mass marketed to the inhabitants.

In flip, due to how a lot cash exists in sustaining this mannequin, many different aspects of our society (e.g., medical doctors, the media, medical journals, and the FDA) have been groomed to assist it.

Be aware: After I accomplished an article on the causes and coverings of Alzheimer’s illness, a number of readers knowledgeable me that they’d noticed coconut oil noticeably enhance the dementia of their ailing mother or father. I then regarded this up and came upon there’s additionally scientific proof to assist the observations that had been shared with me (e.g., this examine).

I share this story as a result of along with on a regular basis coconut oil being dramatically cheaper and safer than these “revolutionary” medicine, it additionally seems to be simpler — which is kind of the unhappy synopsis of our present revenue centered healthcare mannequin.

Treating Weight problems

The implicit message of your complete convention (and why Kim in the end despatched it to me) was that within the subsequent 12 months, we’d begin seeing lots of advertising and marketing for treating Alzheimer’s and weight problems since these signify the brand new progress sectors for the trade.

For instance, think about this current article from the Economist, which states that an awesome quantity of knowledge exhibits being chubby impairs your probability of economic success and that “it’s economically rational for bold ladies to attempt as exhausting as doable to be skinny.” That’s then adopted by lamenting how exhausting it’s to reduce weight with the presently out there choices.

This sequence follows the traditional American advertising and marketing method — make the viewer expertise unfavorable feelings after which current the marketer’s product as an answer to these issues, which I not too long ago argued is a root reason for the emotional misery pervasive all through trendy society.

What I discovered notably noteworthy about The Economist’s article was that till not too long ago, stating one thing like this was taboo because it constituted “fats shaming” as a result of it’s understandably hurtful to chubby people and thereby creates quite a lot of harms resembling low shallowness, physique dysmorphia, and anorexia.

Nevertheless, as soon as a worthwhile product exists to “tackle” these unfavorable emotions, all of that goes out the window, and people emotions are as an alternative inspired. So, I can solely think about how far more of this advertising and marketing we are going to see within the close to future.


The identical corruption within the medical subject additionally exists throughout the dietary space. In consequence, the processed meals trade has satisfied a lot of the dietary occupation {that a} processed meals food regimen is suitable for the final inhabitants. Due to this widespread ignorance, People observe an unhealthy way of life, which creates widespread weight problems and plenty of different sicknesses.

As I mentioned right here, this, in flip, has led to an limitless variety of fad diets that do not actually work and torture these attempting to observe them (who then inevitably beat themselves up and blame themselves for his or her failure to reduce weight).

I discover this an actual disgrace as a result of quite a few efficient weight reduction strategies exist (a few of which I totally admit I’ve had to make use of), however like each different competitor to a longtime medical franchise, they’ve by no means been allowed to enter the dialog.

One of the crucial important penalties of our flawed dietary mannequin is the epidemic of diabetes. Most of us know what diabetes is, however until you’re employed in healthcare (the place you’ll most probably see a number of diabetic sufferers every day), it’s fairly difficult to understand the magnitude of this downside or how severely it could possibly have an effect on these with it. Equally, not too long ago the CDC estimated it had value the USA 327 billion {dollars} in a single 12 months.

Whereas virtually everybody acknowledges that food regimen and way of life (e.g., fundamental train) can have a large affect on diabetes, little or no focus is given to those areas. As an alternative, the main focus is simply on giving increasingly more capsules to decrease blood sugar, one thing which the advantages of doing are sometimes overstated.

One of many medical occupation’s hopes for diabetes is {that a} magic tablet will finally emerge that addresses the illness. Whereas I’m severely uncertain that may ever be the case as a result of underlying causes of weight problems, lots of my colleagues have been fairly shocked to see how a lot semaglutide (branded as Ozempic, Wegovy, and Rybelsus) seems to assist diabetics with extra extreme shows of the sickness.

Many of those advantages consequence from it decreasing the will to eat, and never surprisingly, weight reduction is a typical aspect impact of taking the medicine.

Ceaselessly when prescribed drugs are dropped at the market, they’re permitted for very restricted use after which marketed off-label for different makes use of ensuing from the unwanted effects of the drug. Since Ozempic creates that impact, many non-diabetics, in flip, are craving the drug to the purpose we face provide shortages of it.

This example jogs my memory of what occurred with Viagra in 1999 (mentioned in a collection concerning the widespread patterns seen by Pfizer’s whistleblowers). When Viagra was initially developed, it was created to deal with heart problems (because it dilates blood vessels by growing nitric oxide manufacturing — which is commonly superb for you).

Whereas its outcomes had been promising (and arguably superior to any of the usual therapies), throughout its medical trial, Pfizer additionally seen that Viagra handled erectile dysfunction and determined to scrap the initially proposed use of the drug to deal with the a lot bigger sexual enhancement market.

As soon as Viagra hit the market, individuals had been clamoring for the drug (e.g., many urologists informed the Pfizer gross sales rep and later whistleblower that it was the drug they’d been ready their whole profession for).

Pfizer instructed all their gross sales reps to not promote Viagra for something in addition to its restricted FDA approval (erectile dysfunction in older males with pre-existing circulatory impairment). Nonetheless, earlier than lengthy, that was unattainable as a result of everybody needed it (to the purpose that medical doctors continuously needed to fear about working out of their Viagra samples as a result of employees had been stealing it for his or her private use).

Since its approval, quite a few (typically deadly) unwanted effects Pfizer knew about when it introduced the drug to market (e.g., coronary heart assaults, strokes, blindness, listening to loss, or melanoma) have been reported, and quite a few Viagra lawsuits have been filed towards Pfizer.

When Ozempic was first permitted in 2017, it was meant to be an adjunctive remedy (together with food regimen and train) for bettering blood sugar management in adults with sort 2 diabetes. After it was noticed that the drug helped with weight reduction, a brand new formulation was made (Wegovy), and in June of 2021, Wegovy was permitted for weight reduction both chubby adults with a weight-related situation (e.g., diabetes) or these with a BMI of 30 or extra.

Shortly after, in Could of 2022, the same drug (Mounjaro) acquired the same approval to Ozempic’s 2017 one (as an adjunctive remedy for blood sugar management). As soon as individuals realized this drug may assist with weight reduction, like Viagra, everybody else tried to get these medicine, too, together with adults who usually are not chubby and should not have diabetes. Provided that these medicine:

  • Have unwanted effects (e.g., nausea, vomiting, diarrhea, belly ache, and constipation are generally reported — moreover, some proof suggests pancreatic most cancers and different extreme problems are additionally related to this class of medication).
  • The burden loss reverses after stopping the medicine (e.g., one 12 months after stopping semaglutide, individuals regained two-thirds of their prior weight reduction).

They thus might not signify the very best strategy for weight reduction. Nonetheless, I’m positive many normal-weight people will pursue them, and each I and colleagues have noticed that that is fairly detrimental for these regular weight people.

Moreover, not like prior to now, the place the FDA to some extent centered on security, primarily based on Califf’s current actions (and his lengthy monitor file of being in mattress with the pharmaceutical trade), I think that the FDA will do all the things they’ll to permit widespread use of those weight reduction medicine.

Be aware: For example how issues had modified on the FDA, along with pressuring Pfizer to not market Viagra for off-label makes use of when it got here out in 1998, it additionally pulled fen-phen within the Nineteen Nineties as a result of the drug, whereas efficient, created extreme problems for its customers.

What I discover notably noteworthy about fen-phen is that regardless of its risks (and the category motion lawsuits that adopted) being well-known, I periodically heard of instances the place determined healthcare professionals stole it (e.g., from pharmacies) to reduce weight.

Briefly, given the present regulatory atmosphere, I feel it is rather probably JP Morgan’s prediction will maintain, and weight problems medicines will turn into a large drug franchise, particularly given that each one the presently out there ones would require indefinite utilization by the buyer. It is a disgrace as a result of there are a lot safer and infinitely cheaper methods to perform the very same issues these medicine search to do.


In a current article on the Struggle in Ukraine, I mentioned how, like many others, I’ve noticed that again and again, as soon as individuals occupy a sure place of energy within the authorities or companies, a sure diploma of sociopathic thought emerges the place they cease caring concerning the human prices of fulfilling their goals (resembling making extra money). Due to this, I’ve all the time adopted a rule given to me — do not put money into demise.

Mates and family all through their lives have seen numerous instances the place human struggling or demise resulted from traders trying to make a revenue with out pondering of the human penalties of their actions (e.g., funding mercenaries, investing in protection contractors, or investing in meals commodities and thereby making them too costly for the poor to afford).

Whereas there could also be some skepticism to this declare, I, my lecturers, who I belief the judgment of, and well-known figures all through historical past (e.g., Rudolph Steiner) sincerely believed there have been actual religious penalties if a person left their cash with somebody who would use it for evil.

For that reason, I’ve misplaced depend of what number of funding alternatives I’ve seen all through my lifetime (e.g., I mentioned the one Biden created with Raytheon in that current article), I selected to not interact in as a result of the blood that may not directly be on my fingers was not value a better price of return.

I point out this as a result of many encourage traders to deal with investing inside their trade as a result of one will sometimes have a a lot deeper understanding of that market and which issues inside it are presently the very best wager. Provided that the pharmaceutical trade has lengthy been thought of probably the greatest sectors to put money into, and I now know greater than I ever needed to know concerning the trade, I’ve all the time thought it was ironic there have been the one ones I couldn’t put money into.

Sadly because the current JP Morgan convention exhibits, the healthcare trade, and now our regulators as effectively observe a really completely different set of ethics.

The tenure of Califf (who is likely one of the officers most immediately chargeable for the present vaccine catastrophe) is enigmatic of the corruption that has seeped into our democracy; Califf’s ties to the trade in only a few years went from being unacceptable to ample for a number of tenures as the top of the FDA the place Califf could be clearly seen working hand in hand with the pharmaceutical trade.

The perfect metaphor I can consider for this case comes from a scene in one among my favourite (satirical) dystopian films the place a sports activities drink firm purchased out your complete US authorities after which had their product change water all through the USA. We’re at a type of moments in historical past the place everybody must work collectively to reverse the route we’re heading in.

A Be aware From Dr. Mercola In regards to the Creator

A Midwestern Physician (AMD) is a board-certified doctor within the Midwest and a longtime reader of Mercola.com. I recognize his distinctive perception on a variety of subjects and I am grateful to share them. I additionally respect his need to stay nameless as he’s nonetheless on the entrance traces treating sufferers. To seek out extra of AMD’s work, you should definitely try The Forgotten Aspect of Medication on Substack.