CONGRESS.
Viral Video. ((PFE (-), BNTX (-)) The sincere questions about the safety and efficacy of mRNA vaccines/boosters as administered – broadly without risk stratification – percolating below the surface bubbled up this week when Project Veritas released some secretly recorded video of one Dr. Jordan Walker, Director of Research & Development, Strategic Operations at Pfizer.
The style of the Veritas Project is not exactly what I look for in a news organization until I remember, they are doing exactly what 60 Minutes used to do back in its salad days when the Vietnam War was raging the United States President was corrupt.
A video Project Veritas secretly recorded between their reporter and Dr. Walker mostly reveals how unserious an organization PFE must be. At one point during a scuffle, Dr. Walker argues he is not a science person but a consultant. (He had previously worked at Boston Consulting)
Well, that is comforting.
The video is a serious problem for PFE because it has now traveled around the world 10 times or more. It is also an issue for the company that, Dr. Walker, once confronted, admits to lying before getting pretty aggressive.
The pharmaceutical industry runs on trust. If a senior executive is willing to lie, regardless of the circumstances, people are probably right not to trust his employer. Maybe PFE just needs a better HR department, but I argue the problems are systemic.
Worse, the altercation has triggered a response from Sen. Ron Johnson, a long-time advocate of vaccine development and administration oversight. Sen. Marco Rubio sent a letter inquiring about the “directed evolution” Dr. Walker boasts about in the Project Veritas video. Perhaps not dispositive but another brick on the load.
You can watch it here and reach your own conclusions.
THE WHITE HOUSE.
Adults at the FDA. After a multi-year internal struggle, the FDA admitted this week it was unable to find an appropriate regulatory pathway for CBD products other than the one already established in the drug channel.
This announcement is not much of a surprise. Since 2018, we have noted the absence of safety data to ensure a route through the dietary supplement pathway. The FDA’s capitulation tells you that first, they have enough other things to do than torture their regulatory mission into a poorly written 2018 Farm Bill.
Second, the industry has been unable to make the case that their products are safe. There isn’t much incentive to do so. It is difficult to compete with an illicit market so time and money for research is not going to be a priority.
The future for a national Cannabis industry, by which I mean CBD in beer or Coca-Cola, is very dim. Without Congressional action, producing CBD-related products that are packaged at scale and distributed across state lines without clear regulatory approval is a near impossibility.
State and local-based operations will persist but with momentum stalled, the illicit market pushing out legal purveyors, and urban crime becoming an election issue, some of the recent permissive attitude may go in reverse.
It is like the 1980s all over again.
Children at the FDA. ((PFE (-), BNTX (-), MRNA (-) NVAX (+)) The Vaccine and Related Biological Products Advisory Committee met on Thursday to decide if the COVID vaccine strains could be harmonized into one shot, perhaps annually.
The meeting had the feeling of people gathered before the death of a loved one. Lots of things to say, none of them mattered anymore. There were calls for more data – these have been a regular and ignored feature since summer 2021 – and concerns about an over-dependence on the mRNA platform.
There was an incremental recognition of potential harms that seemed to refute PFE CEO, Albert Bourla’s breezy dismissal of a stroke risk signal while catching softballs from CNBC at the WEF. Areas of concern remain myo/pericarditis in the young, especially men and stroke risk for people over 65, especially when COVID vaccine is administered with a flu shot.
As we have noted before, immune imprinting is a source of concern from studies of mice but research still needs to develop. Interestingly, PFE itself brought this up as an area of research focus, suggesting their data may be providing a signal beyond what we know now.
Disappointingly, a report on subclinical data on myocarditis that was due on Dec. 31., 2022 has been delayed until June 30, 2022. Since PFE has been managing its regulators by press release since early 2020, a reasonable conclusion is that the data is not positive.
Other Stuff.
British Pivot. ((PFE (-), BNTX (-), MRNA (-)) The UK’s Joint Commission on Vaccination and Immunisation has announced their interim guidance on the COVID vaccines that includes ending vaccination for healthy people age 16-49. Boosters will continue to be available to the elderly and those with compromising health conditions.
Meanwhile the PFE and BNTX are reported to be in talks with PFE and BNTX to modify their contract. Under consideration, apparently is a reduction in doses delivered in exchange for a higher per unit price. We assuming the economic would remain the same. Future contracts, however, seem in doubt.
Recent Events
Venture View with Marcus Whitney: Pitchbook’s 4Q Report, Angel and Seed V. Late Stage + Monogram Health Replay here.
Upcoming Evans
Health Care/Health Policy Black Book, Thursday February 9th @10am.
Have a great weekend.
Emily Evans
Managing Director – Health Policy
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