Regulatory capture of the FDA

Christopher Cole gives a mini-masterclass on how it is done

The compromised nature of the United States’ health and drug administrations contributes enormously to the burden of ill-health, suffering and death which plagues its population. Everyone knows Washington DC is awash with pharmaceutical and health industry money and lobbyists. Wikipedia has an extensive page on Regulatory Capture: [WP].

Here is a partial transcript of a view from a middle manager inside the Food and Drug Administration www.fda.gov [WP] - describing how this agency has been to a large extent captured by the powerful companies whose products it approves or disallows. He knows it is wrong. He seems to have contemplated blowing the whistle on it, but decided against this to protect his career.

Christopher Cole has worked for the FDA for 11 years. His LinkedIn page states that he is "Executive Officer, Medical Countermeasures Initiative at US Food and Drug Administration".  It seems that he went on dinner dates on 2022-02-03 and 2022-02-09 with a woman who encouraged him to talk about his work.  She was a hidden-video-camera-equipped journalist working for Project Veritas.

Segments of the recordings are here in the Part 1 video:

The Project Veritas page for this is www.projectveritas.com/news/fda-executive-officer-on-hidden-camera-reveals-future-covid-policy-biden/

The drug companies, the food companies, the vaccine companies, they pay us hundreds of millions of dollars a year to hire and keep the reviewers to approve their products.

Biden wants to inoculate as many people as possible. 

This is false terminology - "inoculate" [WP] means to infect an organism or in-vitro sample with a replicating bacteria or virus, which is not how mRNA or adenovirus vector COVID-19 "vaccines" work.

[Apparently referring to a "vaccine for toddlers"] Just from what I've heard, they are not going to not approve it.

You’ll have to get an annual shot [COVID vaccine].  I mean, it hasn't been formally announced yet 'cause they don’t want to, like, rile everyone up.

Some of it has been talked about publicly, but it hasn't been talked about on like CNN or Fox or MSNBC or anything.  I think what's going to happen is it's going to be a gradual thing.  Schools are going to mandate it.

(The protection of the vaccine wanes.)  Eventually there will be an annual vaccine like the flu shot. 

[Journalist asks if this includes "toddlers".]  Well, for everyone.

[Journalist: "Okay. So, the toddlers too, they will have to get it annually?]

Probably.  I mean, that's in the future, we aren't sure.  That might involve more studies.

He was wary of lack of test data to assure parents of the safety of these vaccines for children.

There's always the chance of long, long-term effects, especially with someone younger.

They [two initial vaccination injections] have not been as effective as expected, I agree.

“It’ll be recurring fountain of revenue. It might not be that much initially, but it'll be recurring - if they can - if they can get every person required at an annual vaccine, that is a recurring return of money going into their company.”

There's also a billion dollars a year going into the FDA's budget from the people we regulate.

I have not attempted to transcribe Project Veritas director James O'Keefe talking by phone to Christoper Cole encouraging him to become a whistleblower regarding the corruption he has witnessed and/or been involved in.  This was after Project Veritas contacted the FDA, and got a reply that “the person purportedly in the video does not work on vaccine matters and does not represent the views of the FDA”. This call was 30 minutes before Project Veritas published Part 1, above. Project Veritas has 1.47 million YouTube subscribers.

Part 2 was of most interest to me, since Chris Cole describes how, in his experience, corruption is endemic in the government agencies - because they try to hire people who won’t rock the boat, even if it should be rocked hard to rid it of corruption.

We charge the industry millions of dollars in order to hire more drug reviewers and vaccine reviewers, which will speed up the approval process so they make more money.

Our budget's, like, five and a half billion dollars.  There's also a billion dollars a year going into the FDA from the people we regulated.

They [the FDA] tone down the impact of the user fees on their operations, because they [FDA] know they're dependent on the drug companies and vaccine companies and these other companies for their agency [FDA] to operate.

On the overall impact on approvals . . . I don't think it has an impact on FDA operations.   Obviously there are some people in the agency, which might think more favorably on some drug companies that are in the approval process.

Well the dirty stuff is never really publicized.  There's more pressure to approve something.

Most of them - well, almost all of them - are based on the actual data.
 
So they [the pharmaceutical companies] give you [FDA] more money. Yes. That's great and it increases the chance of approval.

But if the data's not there, it comes back and bites the reviewer in the ass.

Or the [FDA reviewers] all approve it, and then there's adverse reactions, which we'd have to pull it off the market.  It happens. It happens a lot.

And all these like organizations within the FDA, they like started to see all this cash in their eyes.  Its like, Oh, I need to grab some of that.  And I think we've gone too far on that.

They're [FDA] getting a little overzealous in charging the user fees to other non-payroll expenses.

[Journalist: "Why would they do that?"]

Well, why not?  The money gets banked.  It's not spent.  It's multi-year and the money gets banked there - and you want to be able to spend it.
 
[Spend it on?]

On whatever you can, whether its right or wrong.

But then Congress approved it, at a smaller level. They approved it mainly for payroll, but then also its supporting infrastructure and everything, just like this animal out there.

I think it's [charging user fees] probably excessive.

Industry doesn't want to complain about it too much, but I think FDA is probably . . .  I think they are using it to cover other expenses that don't necessarily tie in with the need of the user fees..

I don't think there's enough people saying there [FDA]. "Look, that's fine but that's not right.  So, we're not going to charge those [user fees].”

You don't want to be that person.  You're not going to have a long shelf-life in the agency [FDA] if you are always that person.  Criticizing or suggesting that maybe we shouldn't be doing this.

This is apparently a general problem in government - not just the FDA.

[So if you speak out about it, if you see them . . .?]

You're marked.  You're not going to get to certain levels in government.
 
There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it.

The whistleblower, while it's high profile, whistleblower statutes and everything, that's kind of ridiculous.  There's no protection for someone who speaks up.  There's supposed to be, but there's easy ways to get around that.

Well, you’ll be marked from getting other jobs because another office is not going to want to hire you if you’ve spoken out about something, right or wrong.  They don't look at what you've spoken out about.  They're just not willing to . . . 

Government's [about?] not rocking the boat, and they don't want to . . .
Which is a problem I have with - one of the problems I have with government is like, they don't like people rocking the boat, for right or wrong, at all costs.

They want to hire a safe person, that can do the job, but doesn't necessarily . . ..  is a great hire.

[So, the kind of person that will turn a blind eye, if they see anything?]

That's who they would hire. From what I've heard and they . . . No one's going to hire that person and your like stunned [or some other word?]

It's better just to stay quiet and accept it.

Perhaps it is time for him to start a new career as whistleblower.

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Communism sucks.  Unregulated capitalism sucks.  While it is far from perfect, regulated capitalism, such as here in Australia, is much better than poorly regulated capitalism in the USA - especially with the USA's ruinous so-called health-care arrangements.

However, it is difficult to properly regulate an industry, since people can be influenced by money and the businesses being regulated have a lot of money to splash around as part of their responsibility to their shareholders to maximise their market share and profits.

At least here in Australia we have taxpayer funding for political parties above a certain, relatively small size threshold. Donations to political parties are subject to legal and public scrutiny.

Parties and candidates do not have to motivate people to go to the polling place, since there are fines for not attending. (They can’t force anyone to place a mark on a ballot paper, so this is not “compulsory voting”.) This significantly reduces the costs of running for public office.

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We need to invoke nearly astronomical levels of incompetence and/or corruption, including at the highest levels of government, to explain numerous pandemic decisions - most spectacularly the choice of vaccines to the exclusion of all other treatments and preventives.

How else to explain the Australian government ordering 300,000 courses of molnupiravir [WP], at about USD$700 a course, on 2021-10-05, before any trial results were published and before Merck had even applied for FDA approval, which was on 2021-10-11.  The Australian government also banned most doctors from prescribing ivermectin for COVID-19 prophylaxis or treatment. Molnupiravir is only moderately effective and is unsafe due to its ability to mutate our DNA and to induce viral mutations which may increase virulence and/or transmissibility. Modern Discontent has the lowdown on this lousy treatment:

The Molnupiravir Anthology Series

The prime advantage molnupiravir has over numerous other early treatments - such as rapid 25-hydroxyvitamin D repletion or drugs and other nutrients such as melatonin, magnesium, zinc, ivermectin, quercetin, B vitamins, vitamin C etc. c19early.com - is that it is profitable. It is expensive and patented, so Merck can make millions of dollars from its sale.

By rights, no-one would bother with molnupiravir because it is dangerous, expensive and not very effective. However, because governments have such influence - indeed control - over drug use and purchases, the inferior physical characteristics of molnupiravir are no barrier to its widespread use, as long as its superior profitability drives it through the regulatory process faster than whatever it is competing with. None of the safe, effective®, treatments just mentioned are supported - or in some cases allowed - by governments, for the sole reason that they are not profitable and so lack the impetus to push them through the corrupt regulatory agencies which have been made the gatekeepers for COVID-19 treatments.

There probably are some limits to how useless, harmful and expensive a treatment can be pushed through these regulatory agencies due to their superior profitability. With the disaster of vaccine injury from mRNA and adenovirus vector COVID-19 so-called “vaccines”: nomoresilence.world,

millions of people are finding out the hard way what suffering, harm and death lies within those limits.

Beyond those directly harmed - and their loved ones - there is the suffering, injury and death caused by lack of early treatments, as enforced by inept/corrupt governments which prohibited their use, due to their insistence on vaccines as the sole as the path to safety and health (until profitable patented treatments became available). Beyond all this is the social and economic devastation wreaked on the entire world by this pandemic response man-made disaster. Beyond that is the problem of how the public can ever, justifiably, trust governments and most doctors to really care for them.

The scale and complexity of this disaster is impossible to outline in less than a few hundred sentences.

It didn’t have to be this way. When the full, awful, disgusting, disgraceful truth of the last two years becomes widely recognised, regulatory capture will be a big part of the explanation.

The mechanisms are laid bare in the above videos, by one of the cogs in the machine.

He’s not such a bad bloke - probably. He contemplated being a whistleblower.

Now he is a whistleblower.

I think he should do a proper job of it. His government career has vaporised.

If he accepted James O’Keefe’s invitation, and really threw himself into is new role, he would make the world a much better place. Maybe then he might fall into the arms of a woman who wants to have dinner with him for all the right reasons.

There’s a huge global problem with corruption - and the USA is far from the most corrupt of countries, according to this chart by Visual Capitalist:

Corruption isn’t just paying a bribe so the police or judiciary to go easy on a lawbreaker. It goes beyond paying millions of dollars to legislators and government administrators to enhance a company’s profits.

It includes completely perverting the role of governments, and how they direct doctors to care for their patients and the public, to enhance company profits no matter how much suffering, injury and death results.

This is not necessarily done with great deliberation. The shareholders and management of Pfizer et al. didn’t necessarily set out to kill millions of people and fuck up the entire world - and so their own lives and those of their families - just to get a few tens of billions of dollars in extra profits. They behave like this as a matter of habit. It is their responsibility to maximise their company’s profits. Pfizer’s record of fines for criminal actions (USD$10B since 2000: violationtracker.goodjobsfirst.org/parent/pfizer) shows that corrupt practices are, to some extent at least, standard operating procedure - with the financial and reputational costs being just costs of doing business.

This is evil at work. You can look all around and you won’t find a monstrous figure, with horns, a stench and a menacing soundtrack.

You will just find cogs in the machine like Christoper Cole, and bigger cogs up to the highest levels - including President Biden, the company CEOs and the directors of agencies - who through some egregious mixture of incompetence and/or corruption tolerate and sometimes actively facilitate the growth of this festering pall.

. . .

I have given the lectern a good thumping and the audience is suitably silent and thoughtful. All good.

But how the hell are we going to tackle this dull, common as muck, human tendency to crapify the world? Regulatory capture - at least of the FDA, CDC and similar agencies in other countries - plays a crucial role in most people having only a fraction of the 25-hydroxyvitamin D their immune system needs.