My Take on The Plot to Get RFK Jr

Kennedy’s candidacy threatens investor confidence, regulatory predictability, and the long-term viability of the vaccine business. In where I rant.

Is anyone surprised? The Plot to Get RFK Jr from the Brownstone Institute.

Seriously?

After working 10 yrs regulating Pharma pricing and seeing how “the science” is made, used and abused, I think I have a few insights on this topic.

Investor Confidence

Never forget most of the big Pharma multinationals are publicly traded companies. They owe (supposedly) a fiduciary duty to their stockholders. RFK Jr is going to upset their profitability. If you owned stock wouldn’t you be anxious? A little bit concerned?

In my previous job it was instructive to see how publicly traded pharma companies reacted to pricing issues vs privately held ones. The big multinationals fought over prices that were pennies per pill, met with provinicial premiers and told them their investment in the province would be curtailed and then said something different to the Minister of Health. Privately held companies were more pragmatic, asking how to provide more data, what the options were. Not always, but often.

I always joked Pharma and us, would be better off (in general) if they were privately held companies, and not public (ok Purdue is an exception…)

Regulatory Predictability

This is the BIGGEST CONCERN of Pharma. All this uncertainty in the vaccine market, mRNA vaccines, even drugs must be driving the NUTS. All those spreadsheets of all those Masters of the Universe mapping out profits and losses in each market, and submarket are now shattered.

Pharma ALWAYS asks, how will this be reviewed? Will I need to show X? Can it be classified as Y? Can I use previous data/guidelines for THIS product. On and on. And if you say, well it is a case by case basis, the claws come out. You said X was this and didnt require Y. My drug is just the same. Oh no it is not. On and on.

This is even more acute for the mRNA vaccines. They were approved via EUA. Some tests and analysis was not done at roll out. Then childrens and boosters versions were approved based on incomplete data. The approval is a pyramid scheme.

So if Merck or Sanofi make a new mRNA influenza vaccine, do THEY get the same priviledges? Why or why not? The LNPs were assessed as excipients and they are most certainly not. Can the FDA NOW say, OK the LNPs are being assessed as adjuvants, or as separate pharmacological agents. Can Merck or Sanofi cry foul since they will need to do the studies that were not required for Moderna and Pfizer?

I KNOW this is in the works and that Pharma is worried since they published this WHITE PAPER

Read this carefully

How precedents can be leveraged, regulatory agencies open to scientific rationale…..

The original “error” of assessing the LNPs are excipients for Comirnaty and Spikevax because of the “pandemic” and “regulatory flexibilities” are now being used to perhaps avoid the necessary studies. So yeah. When I see this, I KNOW things are being asked and reviewed internally at the FDA. Good luck FDA.

Multiply this by other tests and studies that were not done.

1. genetoxicity

2. carcinogenicity

3. duration of the modRNA and spike protein

4. etc

Long-Term Viability

This isn’t the FDAs and Pharma’s first rodeo show. Pharma knows how to ride the regulatory landscape. You lose some, you gain some. Ditto for the FDA actually.

But long-term viability?

Aye that is much more serious. That threatens their underlying models, assumptions, spreadsheets, bribes, etc etc

That is when quiet meetings are held with the Ministers, Presidents, Prime Ministers. You know, President X, our industry fuels this state/country. We provide jobs, good high tech research jobs, a tax base that cannot be replaced quickly. We might need to close plants and research facilities. And we will make sure the country and your constituents know why…..

The Plot to Get RFK Jr

James Lyon-Wheiler discussed this on his substack

The Plot to Get RFK Jr.

1. The use of proxys like individual and institutions. Some of which may not realize that they are undermining directly or indirectly the reforms of RFK Jr.

   • I sometimes see on X some very harsh tweets regarding RFK Jr and his methods/approaches by “our side..” Pharma can sometimes use this to their advantage and make individuals/groups unwitting proxies. Just saying it is possible.

   • Neutralize Kennedy without ever addressing the substance of his critique. WATCH OUT FOR THIS. Be not deceived. Call it out. Ignore the emotional messaging and address the substance.

2. Follow the money

   1. NUDGING UNITS, emotional messaging to “inspire and frighten”. Always give anything that hits you very emotionally 24-48 hrs before you respond. Have I told everyone how much I hate nudging? And I should know, because I was TRAINED in using these techniques which sound benign at first, then become more and more coercive (for which I was told, but yeah, the docs NEED to be nudged because they respond emotionally to patients labwork/symptoms/etc….huh?)

   2. as the document states: Why such an aggressive push? Because, as Vaxcyte COO Jim Wassil apparently warned, “investors have stated they are leaving until the next data readout,” citing Kennedy’s “unpredictability” as a systemic disruption to the vaccine capital pipeline. Told ya.

3. Hijacking language

   1. I have spent some time, as has my colleague David Wiseman to analyze the “safe and effective” mantra from a legal and regulatory perspective. What THEY mean is not what WE THINK it means.

   2. St Thomas Aquinas in his philosophical and theological works, often began debates or discussions by carefully defining terms to ensure clarity and precision. We need to make sure we are doing the same and asking Pharma and the FDA what the essence of a thing IS.

   3. Here is my take on the Canadian regulatory definitions of “safe and effective” for the Covid-19 vaccines.

   Here is David Wiseman on Trial Site News for the FDAVersion of “safe and effective” https://rumble.com/v4lrhwl-interview-with-dr-david-wiseman.html

   Start at 39:45

4. Divide and Conquer

   1. use of internal triangulation

   2. these are manipulative tactics that narcissist use. Having a narc mother has given me an acute sense of when these tactics are being used. We must educate ourselves or how this is done, and how to spot this and call it out calmly and accurately.

Fear of Accountability

1. “Novavax, Merck, and Vaxcyte executives appear to express concern over ACIP’s new caution, the FDA’s slow-walking of approvals, and the crumbling of once-reliable regulatory shortcuts.” There we go again. Unpredictability. Semi-control of the agenda, and of the questions that are asked and not asked.

2. “They keep moving the goalposts on vaccines.”

   James is right. The goalposts aren’t moving. It is that this time, the reliable control is gone, the predictability, those who would reliably answer the questions, and who would NOT ask the difficult questions.

I am reminded of Dr R Portnoy who asked one of the most important questions on the mRNA vaccines, and to this day has not been answered. In a meeting on June 15, 2022, Dr. Portnoy, a member of the FDA’s Vaccines and Related Biologics Advisory Committee (VRBAC) asked Dr. W. Gruber from Pfizer what cells produce spike protein, how much do they produce, and for how long? Dr. Gruber dismissed this question as academic.

It is worthwhile watching to see how dismissive Dr Gruber was. And no followup or pushback from the FDA itself (Plus why was Pfizer’s Dr Gruber answering questions in the first place?)

(3h:13m:00s – 3h:15m:46s).

SUMMARY

1. No one should be surprised at the pushback from Pharma

2. No one should be surprised how difficult this will be

3. Hopefully, I showed you some of the techniques that Pharma uses and what the hurdles are and will be.

4. Patience is required, but patience with persistence. This is a long haul and I am confident we will succeed. Do not be discouraged.

5. Do not let emotional language hijack your reasoning skills.

Oh and Happy Canada Day to all the Canadians. Yes, I think the Canada I know and love is slipping away, but I will fight for her until I cannot.

And most of all, cultivate an interior life…..Pray the Rosary.