Drug Safety | Suite101.com

New drugs have forever been under attack by people who say there isn't enough data for release. These people (I call them the Pundits of Doom) will scream and present a thousand reasons why a drug is being released prematurely but can never justify the reasons with fact. Most often then just play the famous game of "what if?" What if someone dies while taking the drug? Doesn't that prove the point? Not hardly. I think statistics will show that more people die of aspirin poisoning and its complications than any other drug on the market yet one never hears the hue and cry to take it from the market. It sometimes seems like if it's new, it has to be dangerous. Somewhat like wearing an old shoe. It fits comfortably so why change.

There should be years of testing before a drug is released. What if it doesn't do what it is intended to? This is a valid point to ponder. Just how far would the world be into its research on Aids were the testing requirements held to so strict a standard that drugs weren't released for several years more than they are? How many more lives would be lost? Education seems to have halted the rampant spread of HIV in the more advanced countries, but for those who live in the third world countries, the epidemic continues unchecked. The three drug cocktail used in the US is quite effective in checking the virus and lowering it to undetectable levels. The drugs were released far sooner than normal for the "States" and the market grabbed them up. Individually they helped. In combination the results were remarkable.

Some people died, yes, but many more lived. Should those drugs have been called off the market because some patients died? Probably not.

What if the side effects of a drug are severe? At that point, the time for a definitive action is reached and the drug is recalled. Two cases in point are Thalidomide and Seldane. Once the evidence became conclusive that the drugs in question were far more dangerous than useful in the improvement of quality of life, they were withdrawn from the market. These were fine examples of proper procedure.

But, and this is a big but, how does one explain the removal of combinations that were beneficial to patients yet were removed from the market based on an erroneous investigation? Many years ago there was a product on the market called Ilosone Sulfa. It came in suspension and tablet, and did wonders in controlling many bacterially caused infections. Unfortunately, several children developed reactions to sulfa drugs. Result? Recall and demise of a fine weapon in the arsenal against infection.