Friday, November 5, 2021

Withdrawing FDA Approved Drugs - A Big Pharma Pastime

Over the past 19 months, we've all been lead to believe that when the Food and Drug Administration (FDA) approves a pharmaceutical, that should be sufficient to prove to all of us that the drug or medical device is safe for human use. This is particularly the case during the COVID-19 pandemic when the mRNA vaccines by Pfizer and Moderna and the adenovirus vaccine by Johnson & Johnson received emergency use authorization with Phase 3 testing being incomplete.  Governments and the mainstream media have done very little to inform the public about Big Pharma's track record when it comes to providing humanity with safe drugs.


A study from 2016 in the International Journal of Health Sciences by Sonali Saluja et al (which also appears on the National Institutes of Health website as shown here) clearly shows that FDA approval means relatively little when it comes to drug safety.  The authors of the study looked at all drugs that were approved by the FDA and which were subsequently withdrawn due to safety concerns between 1993 and 2010.  The authors note that the FDA initiated a series of programs in the 1980s and 1990s which were designed to allow pharmaceutical manufacturers to expedite the process of delivering their products to market.  According to the paper, the authors state that the FDA approves new drugs much faster than their regulatory counterparts in Canada, Japan and the European Union.  Additionally, Canada, Japan and Europe do not allow drug manufacturers to undertake direct-to-consumer advertising which is extremely common in the United States since 1997 when the FDA allowed for more reporting of drugs and less reporting on the risks of those drugs.  This change in legislation resulted in a more than three-foot increase in advertising spending on drug promotion which is very clearly evident on both television and in the print media.


The study reports that there are more than 2 million serious adverse drug reactions annually in the United States which cause an estimated 100,000 deaths.  In the time period between 1993 and 2010, using a sample of data from the National Ambulatory Care Survey, the authors of the study concluded that over this 18 year period, 17 new drugs were approved and later withdrawn after being prescribed at 112 million physical office visits in the United States.  Nine of these drugs were prescribed more than 1 million times before they were withdrawn from use.  They also note that in the first 16 years after drugs are approved, for every 100 newly introduced drug, 27 are either withdrawn from use or receive serious new safety warnings (i.e. Black Box Warnings now known as boxed warnings which identify drugs which may cause serious side effects including death) in the first 16 years after approval with the median time from FDA approval to removal from the market being five years.


In a 2017 study entitled "Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010" by Dr. Nicholas S. Downing et al which appeared on the Journal of the American Medical Association (JAMA) website, the authors noted that among 222 novel therapeutics approved by the FDA between 2001 and 2010, 71 or 32 percent were affected by a postmarket safety event.  Postmarket safety events were most frequent among biologics, therapeutics used to treat psychiatric disorders and therapeutics that received accelerated FDA approval.  These safety events break down as follows:


1.) 3 withdrawals


2.) 61 boxed warnings


3.) 59 safety communications


The median time from approval to first postmarket safety event was 4.2 years with the 30.8 percent of novel therapeutics affected by a postmarket safety event ten years after approval.

Here is a key quote from the article which outlines the problem with my bold:


"The US Food and Drug Administration (FDA) is responsible for ensuring that novel therapeutics are safe and effective. When making approval decisions, the FDA weighs the risks and benefits of novel therapeutics using data gathered in premarket drug testing and clinical trials. The majority of pivotal trials that form the basis for FDA approval enroll fewer than 1000 patients with follow-up of 6 months or less, which may make it challenging to identify uncommon or long-term serious safety risks. These risks may only become evident when novel therapeutics are used in much larger patient populations and for longer durations in the postmarket period."


Doesn't this scenario sound familiar in the era of COVID-19 vaccines?


Let's close with a list of ten dangerous drugs which could cause serious health problems or death which were recalled by the FDA:



As you can see, many of these drugs were on the market for a decade or longer and had been used by millions of patients prior to being recalled because they were dangerous.


Let's close with this thought.  While tens of millions (if not billions) of people, particularly those in the mainstream media, public health and politics, are expressing complete faith in Big Pharma's answer to the COVID-19 pandemic by accepting a novel vaccine that has not yet completed Phase 3 trials, the research outlined in this posting should cause us all to ponder Big Pharma's real agenda.  Here's a hint: 


No comments:

Post a Comment