Life-Saving" Drug - Only available in the USA!

The dark side of US FDA and Pharmaceutical industry...

Dr. Rakesh Shah 

For those NOT living in the USA - Picture this :

Your family or friend or loved one is sick, and most likely is admitted in the ICU, fighting for his/her life and the doctor taking care of him/her tells you - "there is a medicine recently approved by US FDA and available ONLY in the USA, that we can give to the patient and maybe that can save his/her life, although it is very EXPENSIVE"

What will you do in that situation?

Well, You will do everything in your power and reach to get that medicine because it is the question of the life of your loved one.

And I am NOT saying that you should NOT do it, I am just saying that think TWICE or maybe 100 times before you jump on it. 

Here is why - in my opinion of course.

Let me prepare the ground for you to understand this whole game.

US FDA - the United States and Food and Drug Administration - is a Government agency created to protect people by maintaining quality and safety of food and drugs(medicines) in the USA.

For the most part, it does a pretty good job and I am glad that there is an entity like FDA to protect me - but that is becoming too optimistic now.

Whenever a new drug is approved by US FDA, practically whole world becomes the market for that company - that is the reputation of US FDA. So, from the money standpoint, getting any drug pass US FDA is a major thing for ANY pharmaceutical company.


The path is NOT that easy. It takes forever to fulfill all the requirements of US FDA for the drug to be approved - and that includes many many research trials, clear documentation of its use and side effects and many more things that go with the safety of the drug.

Now comes the kicker - somehow, US FDA created an "Expedited Pathway" to approve drugs fast to make it "least burdensome for pharma companies".

What does that mean?

This means that nowadays, many drugs are approved through this Fast pathways, without undergoing proper safety research - which means, the companies release the drug in the market without knowing for sure that it is safe. And Instead of it taking years, it now takes months to get it done.

How do we know it?

In recent, British Medical Journal article, they found that There were 1710 safety-related label changes over the study interval, with a rate of 0.94 per drug per year among expedited drugs versus 0.68 among standard-pathway drugs. Label changes for expedited drugs were especially high for the most serious category boxed warnings and contraindications.

What does it mean For a common man - A non-medical person?

This LABEL change means that after they sold the medicine for months or in some case for years ( and made millions of $), they found some serious side effects and they were required to mention in the product label. That means many patients were harmed (and many died too).

The irony is - the pharma companies are NOT required to disclose to doctors or patients that the drug went through the "Fast Pathway" and NOT the "Regular One".

The intention of the "Fast Pathway" was good - it was to make the life-saving drug available quickly. This was proved very useful when AIDS medicines were approved through the Fast pathway. There was no other option to treat AIDS at that time, so releasing the drug through the fast pathway made sense and it did work.

But, nowadays - many drugs go through fast pathway - for the diseases where we already have proven other medicines available and are NOT truly life-saving.

The same thing happened with the device called - Vagal Nerve Stimulator - this was supposed to stop seizure/epilepsy

The company knew that it was killing people (It stopped heart instead of epilepsy) and FDA also knew it - but they still released it - although conditionally(Knowing very well that it killed people) - to prove that it is safe. The company never collected and reported data on death after it was sold and installed in thousands of patients. Many patients died.

Another conspiracy is - once the device is FDA approved, you can NOT sue the company (unless there is a manufacturing defect) !!! That is the law

That is how much FDA is controlled by Pharma companies and Medical Device companies.

So, coming back to that life-saving drug...

There is a good chance that the one your doctor asked you to get from the USA, went through the fast pathway and did not have proper trials done to document its use and safety.

Typically those drugs are very expensive - companies want to make most money before the public finds out that the drug does not work or the side effects are too dangerous and life-threatening.

I NEVER prescribe ANY NEW drug which is less than 2 years in the market. There are always other options available for any given disease condition.

It is very rare to be in a situation where the ONLY drug that will work is that NEW, RECENTLY approved EXPENSIVE drug...

So, before you wipe out all your life's saving to get that drug/medicine, think 100 times...think about who controls US FDA...and follow the money... you will find your answer...


                                                                              Dr. Rakesh Shah, MD

                                                                                              Atlanta, GA

                                               Email:                                                                 Contact:  +1-404-697-5625  

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