Countdown 67 Day Election

California 37 days until early voting

TRUMP MAGIC    

The FDA is under intense pressure to OK the coronavirus vaccines with emergency authorization with pressure coming directly from Trump.  Hann’s organization the FDA is responsible for the issuance of the emergency authorization.  Will Hann buckle under pressure? 

The administration has sunk vast resources in the development and manufacture of potential vaccines.   Trump and his cronies and aids are pushing for swift progress and as a result help the president in the November elections.  Trump himself has accused some FDA staff, without any evidence, of holding up treatments “for political reasons.”  [pure projection]  Mark Meadows Trump’s Chief of Staff said the “FDA scientists need to feel the heat.” Trade advisor Alex Azar said that the FDA needs to “get on Trump time.”  With all the pressure the problem becomes one of public trust in the FDA.  Politicization, pressure from the White House and attacks on the medical professionals are not helpful in instilling confidence in the therapies or the ultimate vaccine/s that may become approved. 

Former FDA officials have stated the vaccine will only be effective if it is taken widely by the public.  A former Chief scientist at the FDA Dr. Jesse Goodman said: “We need the American people to have full confidence that medicines and vaccines are safe.”

Part of the problem is confidence in any vaccine that has been rushed through approval.  Operation “Warp Speed” is the name of Trump’s rush at spending monies on unproven vaccines.  New drugs that get approval go through three phases of trials.  Phase I is to determine if there are any possible adverse side effects.  Phase II is used for further assessment of side effects and efficacy, including dosage protocols for things such as age/weight, and any pre-existing condition effects.

Currently the vaccines in trials have rushed through Phase I and Phase II and are started to pursue the Phase III trials.  Phase III includes tens of thousands of volunteers of all ethnicities and age groups either receiving the vaccine or a placebo to determine risks and effects.  Cutting corners makes the results of each of the phases may have potential problems.

There was a report issued in January 2017  prepared before the inauguration listed 22 new drugs that were going through testing and had promise in Phase II trials, had failed in Phase III.  HIV/Aids, common cold, and other corona type viruses vaccine have been worked on unsuccessfully for tens of years.  It would be a monumental feat if a vaccine was effective and safe, however, with the track record of Trump with his unproven and harmful therapeutics does not install confidence.

A prime example of waste on promising therapies is the current $3 billion California project on stem cell started in 2004 known as the California Institute for Regenerative Medicine or CRIM.  The organization will be requesting another $5.5 billion promising Cristopher Reeve to walk and Michael Fox to recover from Parkinson’s.  Hype has not generated any real results yet can be a placebo for hope for these types of infirmities.

The January 2017 report also cautioned against what the FDA termed as a “growing interest in exploring alternatives to requiring Phase III testing before product approval”  The problem with the hype of the virus is that it is coming from the politicians and not the medical professionals and that scares me. 

Trump’s track record with grasping for magic cures such as ingesting chlorine, using uv light internally, Hydroxychloroquine, Oleandrin, and now convalescent therapy does not bestow any confidence in any emergency rush for use of unproven vaccines in September and October this year.   A political decision with potentially dire public health implications.

Trump not to be outdone by Putin that used his powers to order the wide spread inoculations with an unproven vaccine.  No data on the Russian vaccine effectiveness as yet.  If Trump authorizes an unproven drug saying “what could it hurt” with emergency authorization, and if it is deadly will he be using another of his deadly phrases “it is what it is.“

If Trump waits long enough say mid to late October to force the emergency authorization he can claim it is successful without any evidence.  It’s the magical October surprise?