What’s Wrong with the FDA?

The FDA has a long history of  blocking potentially very effective drugs. One of the big reasons for the problems comes from the drug Thalidomide.

Many of you have heard of Thalidomide. In the late 1950’s and early 1960’s Thalidomide came on the market as a ‘miracle’ cure for morning sickness, insomnia, colds and headaches.

By 1961 it was taken off the market after reports came out that the drug was causing birth defects and peripheral neuritis. Overall the authorities estimated it caused over 10,000 birth defects and 2,000 childhood deaths worldwide.

Other countries approved the drug much sooner than the FDA. Due to the FDA’s slow approval, it probably saved many American baby’s lives. There were only 17 American birth defects reported.

As a result Congress passed the Kefauver-Harris Amendment in 1962. The amendment:

• Required drug manufacturers to prove their drug was “safe and effective”

• Adequately disclose the drug’s side effects

• Allowed the Department of Health and Human Services to deny approval if there is a lack of substantial evidence it will have the effect it purports

‘Substantial evidence’ meant evidence of adequate and well-controlled investigations. “Well-controlled” investigations according to the FDA meant a double-blind, randomized-controlled trial (RCT). RCT’s are challenging both from a cost standpoint and a position where some drugs just don’t work well in these trials.

As a result, approvals for new drugs slowed down dramatically after the amendment became law.

One such drug I am learning more about is DMSO or Dimethyl Sulfoxide. DMSO is a naturally-occurring compound that is found in many fruits and vegetables. A Russian chemist named Alexander Zaytsev first synthesized it in a lab in 1866.

DMSO came onto the market in the 1960’s as another miracle drug. Unlike Thalidomide it didn’t seem to have any significant side effects. About 1 in 2,000 people are allergic to it. However, you can test to see if your allergic by rubbing some on your skin. You will see a reaction on your skin such as hives but no other problems.

The fans of DMSO believe it can help a wide range of problems from baldness to strokes. Many drug companies in the 60’s sought FDA approval. The FDA became overwhelmed and for other reasons as well would not approve it.

One of the big problems with it is that people who use it often notice their breath smelled like garlic after taking it. It also had immediate effects such as easing pain from burns when applied topically.

For these reasons it was very difficult to do a double-blind, placebo-controlled trial. In those experiments the participants are not supposed to be able to tell who has the drug and who has the placebo.

The garlic breath would give it away.

By 1965 over 100,000 people were using it, even without FDA approval. Unfortunately in late 1965, the Wall Street Journal published an article with a headline that ‘went viral’ around the world:

“DMSO May Have Caused Death of Woman Makers of Wonder Drug Warn Doctors”

Turns out the woman was on many other drugs as well. There were no other deaths related to DMSO in this manner. However, for decades after, the FDA continued to reference this one death in their efforts to not approve it.

The drug was still popular in the 1980’s. Here’s a 60 Minutes segment on it. The FDA still would not approve it.

Today you can buy DMSO over the counter from Amazon. I’m looking into the uses of it for some of my assisted living residents. Today the FDA has only approved it for a painful bladder syndrome called interstitial cystitis. Check out the Amazon reviews to see all the other uses there are for DMSO.

Note: I found much of the information for this email in an article from the “Midwestern Doctor”. He writes on Substack.