February 26, 2019 by Dr. Kyle Varner in Solutions

When you last visited the doctor, what was your experience like?

I don’t mean the physical examinations. I’m talking about the environment.

You arrive, check in and sit down in the waiting room…

Given the eternity you usually have to wait, your mind starts scanning the room. Aside from all the sickly looking and elderly people around there’s something else the room is full of –paper.  

More and more clinics today resemble accounting firms than healing centers, and it’s something that’s endemic across the entire healthcare industry.

It’s the same between you and the insurance companies, between them and the doctors, and between the doctors and you.

But it’s also endemic in the pharmaceutical industry. You think they’re spending all their time pumping out drugs to sell and make millions?

Just as doctors spend the majority of their time on paperwork, pharmaceutical companies also spend an insane amount of time ticking boxes instead of saving lives.

Since 1962, the government slammed the breaks on drug development, and pharmaceutical companies spend more time dealing with bureaucracy than developing life-saving drugs.

Read on to discover how the government’s actions from more than half a century ago still affect your life today –and what needs to be done to get us out of this mess…

A tragedy changed the way we deal with drugs

There’s something deeply embedded in our psyche which causes strong reactions when it comes to children.

It’s a primal instinct: They’re going to pass on our genes and allow our species to survive. They’re the closest thing we have to immortality.

So it’s no wonder that the thalidomide disaster was the catalyst for change in how we approach drugs.

Thalidomide was a drug marketed as a mild sleeping pill that was safe even for pregnant women. However, it caused thousands of babies worldwide to be born with malformed limbs.

It was the Germans who first found out, and around 10,000 children were affected in the late 50s and early 60s.

Predictably, there was a huge international backlash. And one of the responses was the Kefauver Harris Amendment.

This was an amendment to the Federal Food, Drug, and Cosmetic Act, which is basically a law that says the government oversees safety regulations in things that can potentially harm us.

This change expanded the scope of the law and forced drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval.

Sounds sensible, right? But every law has unintended consequences, and this one was no exception…

A law to slow drug development

Naturally, when a national tragedy like Thalidomide happens, you want to stop at nothing to make sure it never happens again. One of the most obvious solutions would be to simply shut the whole thing down.

The idea was to make a law that slows down the process for making drugs, so nothing bad gets through and hurts people.

This amendment that was made way back in 1962 informs the scientific safeguards the FDA still uses today. The intent was to protect consumers from unsafe and ineffective medications.

But it’s impossible to sniff out the bad drugs without slowing down every other drug. You don’t know which drug is going to be bad, so every other drug suffers!

All that red tape gets in the way of bringing new drugs to market. It’s not just a safety thing: that red tape causes a financial burden. And let’s not pretend it’s a streamlined procedure either, it’s a heavy-handed, bureaucratic mess.

The statistics back this up too: The number of drugs invented per billion dollars of R&D invested has been cut in half every nine years for half of a century.

And those costs end up being passed on to consumers. The result is that drugs take longer to make, meaning we don’t have access to them sooner, and we have to bear the burden of the FDA’s psychotic need for control through higher prices.

Fear of the FDA

So why hasn’t anything been done about this? It’s because the FDA is a very powerful body with perverse incentives.

Put yourself in the shoes of the average FDA bureaucrat. A company proposes a new drug. If you approve it and it’s good, it doesn’t affect you. If you approve it and it’s bad, you’re now responsible for a lot of damage and even death and best believe your company’s name will be maligned by the press.

But what happens if you don’t approve it? Nothing.

It’s harder to pinpoint the number of people who died because they didn’t get a hypothetical future drug compared to the number of people who were visibly poisoned.

So the FDA has every incentive to put drug companies through the wringer.

Drug companies know this, and they know the FDA has the power to make or break their business if they feel wronged.

But the saddest thing in all of this is the data doesn’t suggest the Kefauver Harris Amendment was effective in keeping us safe.

The rate at which drugs were withdrawn from the market actually rose by 0.8 percent since we introduced that law. That’s drugs the FDA already approved.

What this essentially means is that the amount of bad drugs hasn’t really changed since the law, and people withdrew them when they realized they messed up.

And yet, if we could map out the number of people who’ve died from a lack of drugs, the figures would be staggering. And that’s the power of the unseen. When we look at policies and their effects, we almost never think of these.


The 1962 amendment, like so many government schemes, tells you it’s protecting you in public but hurts you in private. Don’t be fooled by the clever marketing and political rhetoric –the effects are clear. Nowadays, the average cost to create a new drug is $5 billion. That’s a heck of a lot of money even for the White Coat Cartel.

If we simply scrap this law, we could reduce the cost of making drugs, meaning we could afford more and increase innovation (and our life spans!) all at the same time. It’s a pity staying safe doesn’t take into account the poor health we all suffer as a result.

If you’re interested in learning more, read on in Dr. Mary Ruwart’s book Death by Regulation, which tells the shocking truth about drug regulations in the US and the hundreds of thousands of lives that have been lost because of them.

This information is intended to help readers be more informed about their health options when speaking with a professional, but it should not be used alone to diagnose, treat, prevent or cure any disease or condition. Be sure to speak to a qualified doctor before taking any action to make sure that your choices reflect your actual health situation.

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