Pharmaceutical companies are a part of the Life Sciences industry. Other components of this industry include drug discovery, development, clinical trials, and other supporting services. A relatively new discipline in Life Sciences is a study known as Economics. Economics, or to most people, money, is playing an ever-greater role in how future healthcare is parceled out. And confidentiality, too, will play heavily into the future of Life Sciences in the U.S. and around the world.

Many of us know of someone who has had a bad reaction to a “safe” medicine. It’s interesting that medications that have survived clinical trials and have been on the market for a number of years have been withdrawn, leaving behind bereaved families, class action lawsuits, large settlements, and yet higher drug costs for everyone. In one particular case some physicians prescribed the medicine incorrectly (counter to the instructions in the package insert), resulting in a number of deaths. Bottom line, a “relatively safe,” efficacious drug was removed from pharmacy shelves. The unfortunate victims’ families seek relief from the pharmaceutical company, not the mis-prescribing physician. Go where the money is.

Let’s move on to biochemistry for a few minutes – when a drug (legal, illegal, oral, inhaled, injected, dermal patch) enters the body, the active ingredient does its intended magic for a while, then is broken down (metabolized) and removed from the body through normal bodily functions. The drug must reach a certain effective concentration in the body in order to perform its intended function. Take the wrong dose (too little or too much) and the result can range from no effect to overdose.

An interesting thing about humans is that we are all different. Some of us are fat, some thin, some never get sick, and so on. By now, most of us know that there are important genetic factors behind these differences. These genetic factors not only affect how we metabolize food but also affect how we metabolize drugs. Turns out that about 10 – 15% of us metabolize certain drugs more slowly than the rest of us. For these select few, the recommended dosage can result in the concentration of the drug in the body ever increasing to the point of potentially serious side effects. The result? A drug, safe for most of us, can be deadly for others. Sometimes these drugs are withdrawn from the market, sometimes not, depending upon the relative merits of the drug and availability of safer alternatives.

A new branch of Life Sciences, called Pharmacogenomics can identify which genetic markers are likely to affect the rate at which certain drugs are metabolized. Pharmaceutical companies are taking advantage of this, particularly when it comes to selecting people to participate in drug trials. Interested in participating in a clinical trial? Have the markers? No thank you.

The result is less risk to Pharmaceutical companies and safer, more effective drugs. The catch, however, is a big one – how do you know if you are one of the 10-15% that probably ought not take these drugs?

There are a lot of details yet to be worked out. As you might guess, genetic testing is expensive – who pays for this testing? The drug company, the insurance company, the patient? Then there are confidentiality issues to consider – if you carry the genetic markers, who will store this information and where will it be stored? Will there be a central database that is accessible to pharmacies to warn them not to fill your doctor’s prescription? What about hospital emergency rooms? Do you carry an identification card? And what about insurance premiums? Will you pay more as a result or is this

a shared risk that we all pay? Do we bring back drugs, taken off of the market, now that we can identify the “at risk” group of users? And how will this work with HIPPA, which guarantees the privacy of our health records. While the answers to these questions are unclear, expect Economics to weigh heavily.

George S. Bernstein, Ph.D.
Double Dragon Consulting Inc. © 2006