FDA – Why Are More And More Americans Dying Because Of The FDA?
Because of increasing delays caused by unnecessary FDA costs, caution, and bureaucracy are preventing the introduction of new drugs and antibiotics which would most likely save tens and maybe even hundreds of thousands of American lives every year!!
New and dangerous bacteria are mutating faster, but the FDA is dragging its feet and is approving new antibiotics at a much slower rate than that at which bacteria are mutating!
Tens And Even Hundreds Of Thousands Of Lives?
Antibiotic-resistant bacteria infect two million Americans every year, causing at least 23,000 deaths.
And even more die from complications related to the infections, and the numbers are steadily growing.
The Cause Of The Delays?
Many reasons are being bandied about for the shortage of new drugs and the FDA is not of course the only reason.
Pharmaceutical companies say that because of rising costs that the cost/benefit risks are too high.
Others say that the overuse of antibiotics is causing the potency of the existing ones to diminish too quickly.
But the chief culprit is the FDA.
Why Is The FDA The Real Villain?
The FDA will often quite unpredictably change its rules in the middle of an expensive clinical trial and suddenly tell a company that it must add hundreds and even thousands of new patients to their tests.
And even when trials are successfully completed the FDA is frequently reluctant to give a new drug the green light.
In his book, ‘Antibiotics: The Perfect Storm‘, David M. Shlaes writes,
"Regulatory agencies like the FDA are contributing to the problem with a constant barrage of clinical trial requirements that make it harder, slower and more costly to develop antibiotics".
"The National Institutes of Health was for many years [biased] against funding antibiotic research".
Shlaes spent his professional life as a top drawer researcher, studying antibiotics and has also worked for pharmaceutical companies and had to cope with the FDA.
The FDA’s Dilemma
a) Approve a medication that later proves to have an unintended side effect after which congressional headline-seekers such as Henry Waxman (D-Calif.) will subject FDA officials to a third degree interrogation.
b) Let people die by depriving them of new medicines.
And the FDA for the most part chooses B!
Since the 1940s the miracle of penicillin and later antibiotics have saved tens of millions of lives, by preventing illnesses such as as pneumonia and tuberculosis.
But bacteria become drug-resistant!
For decades pharmaceutical companies, especially in the U.S., routinely came up with new antibiotics that were able to overcome newly mutated bacteria but now the flow of new antibiotics has slowed to a trickle.
The FDA’s play-it-safe attitude is in many ways understandable but its response means that pipeline for new antibiotics is drying up.
Two Dangerous Examples
MRSA and MRSA (CA-MRSA) can still be cured by antibiotics but they are becoming increasingly resistant and resilient to them.
Most MRSA infections occur in people who’ve been in hospitals or other health care settings, such as nursing homes and dialysis centers.
When it occurs in these settings, it’s known as health care-associated MRSA (HA-MRSA).
HA-MRSA infections typically are associated with invasive procedures such as surgeries, intravenous tubing or artificial joints.
Another type of MRSA infection is now occurring in the wider community, amongst otherwise healthy people.
This form, community-associated MRSA (CA-MRSA), often begins as a painful skin boil and is spread by skin-to-skin contact.
Most a risk populations are groups such as child care workers, people who live in crowded conditions and those who engage in close contact sports such as high school wrestling.
NDM-1 Is Spreading
NDM-1 stands for New Delhi metallo-beta-lactamase, which is an enzyme that destroys beta-lactam antibiotics including penicillin, cephalosporins, and carbapenems!
NDM-1 has been reported most commonly from India and Pakistan but is spreading throughout the world as people travel from country to country.
The first three cases of NDM-1 in the United States were reported in June 2010.