The FDA Role in Drug Safety

Although many people and even drug scientists know that drugs can stop working, they don't understand why. Drugs that produce useful effects in our bodies can also produce opposite effects. Everyone knows that drugs can cause serious side effects, but what they don't know is that drugs can also do this by continuing to work the way they're supposed to work. This may sound contradictory, but that's how it is. Drugs activate our cells until our cells stop responding much as the boy who cried wolf too often found that the villagers didn't come when he really needed them. This isn't just a story with a psychological lesson, it is also a physical principle of how drugs work.

Drugs and many other factors change the balance in our bodies. Our bodies react to this change by finding a new balance point. This isn't anything new. We're constantly adjusting to change in our lives. We're just not consciously aware of how we do it. One way we adjust is to ignore the thing that's causing the change. This is also the physical principle that our cells use to prevent being overwhelmed with change - they basically ignore it.

The problem with this is that our cells lose a way to recognize if they should change for something important. They lose a way to recognize an important change, because it can no longer be sensed. That's why the harder they try; the harder it is to produce change. This is true with drugs and the boy crying wolf.

What should be the role of the FDA in all this? Well, the FDA together with the NIH and other academic labs need to do more basic research to understand the action of the drugs that we already have. Today, many of us are a soup of different prescription drugs, nutraceuticals, supplements and over-the-counter medicines with little or no understanding about how they all interact within our bodies. I hope that I'm not trying too hard at a time when many are crying wolf, but the message does need to get out.

Richard Lanzara, Ph.D.

President

Bio Balance, Inc.

Bio Balance ( http://www.bio-balance.com/  ) is an early stage drug development company that has developed the only tested method to prevent drug desensitization at the receptor level. This phenomenon, also known as down-regulation, tolerance or fade, occurs with a large number of very commonly used drugs such as dobutamine for heart failure, isoproterenol for shock or asthma, L-dopa for Parkinson’s Disease, and morphine for pain. Notably, desensitization cannot be remedied by taking larger dosages. With more and more drug, efficacy diminishes and the drug essentially stops working. By using a patented approach, we create new, combination drug candidates that sustain the therapeutic response with a better side-effects profile than the original drugs.