Why All This Paperwork?? 4 Seal Limbs

Last time we heard about the invention of Elixer Sulfanilamide, or the Elixir of Death, as it was called in the newspapers.  Science and business had created a powerful drug that has saved countless lives.  But along with the enormous good that had come from the invention of antibiotics there were some unanticipated consequences. 

As in the original Pure Food and Drug Act, the public outcry caused congress to enact legislation.  The Food and Drug Administration was recreated in its present form.  Companies were required to prove that a new drug was safe before it could be introduced on the market. 

The lack of records at Massengill showing where they had shipped the Elixir of Death prompted the legislators to include documentation requirements in the new law.  It was a milestone event in regulatory history.  Drug makers now had to prove the safety of their products, otherwise they were presumed guilty.

Seal Limbs

In 1957 a European drug company began to market a new drug.  It was alleged to be “An effective tranquilizer and painkiller”; a "wonder drug" for insomnia, coughs, colds and headaches.   It was also said to reduce morning sickness.  So, thousands of pregnant women took the drug to relieve their symptoms.

An American company, Richardson-Merrill Pharmaceuticals, licensed the drug and applied to FDA to market it in America.  The drug was considered to be a straightforward project because it had been sold for years in Europe with no problems.  So the Agency assigned it to their newest reviewer, Dr. Frances Kelsey. 

But when Dr. Kelsey began to analyze the data, she found that all was not as it was alleged to be.  The European company was not reporting the adverse reactions.  A doctor in Europe had begun to report an abnormal number of stillbirths and birth defects among women who had taken the drug. 

The pressure to approve the drug continued unabated, but Dr. Kelsey remained firm.  She withheld approval of the new drug. 

In the meantime the number of reported stillbirths and birth defects reached a level where the safety risk of the drug was undeniable.  In the end at least ten thousand European babies were born with underdeveloped or missing limbs.  Thousands more were stillborn. 

The drug was called Thalidomide.  Fortunately America was largely spared because of Dr. Kelsey's determination.

News reports of the close call in keeping the drug off the U.S. market aroused public support for stronger drug regulation. Congress realized that every drug has side effects and that drugs should only be allowed on the market if the benefits of the drug outweigh the risks.  For the first time drug manufacturers had to prove that drugs were effective before they could be marketed.

We have seen in this account a repeat of the same pattern we have seen before. 

1. Technological innovation
2. Business makes use of the new technology
3. Unanticipated consequences
4. Popular outcry
5. Congress enacts regulations

Note that regulations come at the end of this cycle of events.  They are not isolated actions that occur on their own. They are the outcome of this cycle and cannot simply appear at the whim of a bureaucrat.

This same pattern has replicated itself many times over, resulting in regulations for medical devices, dietary supplements, and many other products.

Here's the problem that consumers have with products like drugs that makes them different from what had been seen before.  Companies use advanced technology to make products whose quality or safety no consumer could ever judge. 

I would invite anyone who takes pills or tablets from time to time to try a little experiment.  The next time you take a pill open the bottle and take one out like you normally would.  Look at it closely, ask yourself a simple question, then take the pill just the way you always do. 

And the question to ask yourself is this, "How do I know this pill is any good?"  And the answer, of course, is that you don't.  You're depending on someone else.