POST – Why do we need “Clinical Trials” before medications are FDA approved?

1958.  Germany.

You are 26 years old. A new mother to be, and 2 months pregnant. BUT, with severe morning sickness.

You go to the doctor, and you are recommended a new medication, Contergan, to help your morning sickness.  You feel GREAT !!  Your morning sickness is fully controlled.

7 months later, you deliver a beautiful baby — BUT — your brand new baby HAS NO ARMS OR LEGS !!!


In 1956, a German Pharmaceutical company discovered a new compound, thalidomide, which was subsequently launched (under the trade name Contergan) as an effective over-the-counter medication for pregnancy induced morning sickness. This medication was NEVER tested in pregnancy, and not strictly controlled. Very quickly, 14 pharmaceutical companies were marketing thalidomide in 46 countries under 37 different trade names.

Thousands of women took the medication, resulting in approximately 2,000 deaths of children, and over 10,000 children born with serious birth defects.

In 1961, the medication was brought to the US by Big Pharma. BUT, Big Pharma first needed to get FDA approval to market the medication.

At the time, “clinical trials” were self determined and self guided, with no oversight. In other words, Big Pharma can conduct an 8th grade level clinical trial, and the medication would have gotten approved by the FDA. Clinical trials did NOT require FDA review, consent, or approval. They were not subject to any type of medical oversight.

The FDA inspector under John F. Kennedy, Frances Kelsey, demanded safety and effectiveness data before approving thalidomide for release in the US. Since proper safety and effectiveness data was never provided to the FDA, thalidomide was never approved in the US for morning sickness.

Luckily, the US had a president that listened to his advisors, with an FDA inspector that was science minded, and guided by truth and moral conscience.

The FDA refusing to approve thalidomide probably saved the lives of hundreds of thousands of children, not to mention an unfathomable number of physical disabilities.

The tragedy of thalidomide and Kelsey’s refusal to approve the drug motivated and launched profound changes within the FDA. With the passing of the Kefauver-Harris Drug Amendments Act in 1962, legislators tightened restrictions surrounding the monitoring and approval process for medications to be marketed and sold in the U.S., requiring that manufacturers prove they are both safe and effective. Now, drug approval can take between eight and twelve years, involving animal testing and tightly regulated human clinical trials.


2020.  United States.

We are now living thru a pandemic, the likes of which has never been seen in the modern era.

Although we all want a quick treatment or cure for this rapidly spreading viral illness, we also want medications that are not only effective, but also safe.

Safety and efficacy can only be determined by strict clinical trials, and not by hearsay.

Just because “somebody” got better from Covid with Plaquenil, that does not mean it is an effective drug.  Remember, each morning the sun rises, and each morning the rooster crows.  This does not mean that the rooster crowing directly caused the sun to rise.  There is absolutely NO cause-effect relationship between the rooster crowing and sun rising.

Plaquenil has been shown to be totally INEFFECTIVE in Covid patients, while also causing heart damage. It is neither effective nor safe. A sobering thought.

So, please, please, please, DO NOT believe the effectiveness and safety of any medication until proper clinical trials have been performed.

Stay safe.

  • Sudhir S. Athni, MD

 

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