Virtual miracles happen with certain biologic drugs like Remicade, which uses engineered versions of naturally occurring proteins to offer powerful relief to sufferers of such ravaging diseases as rheumatoid arthritis and Crohn’s disease. But the price tag on such biotech drugs can be huge–imagine a lifetime of taking drugs, only one of which costs $15,000 a year.
Despite the fact that last year about half of all U.S. prescriptions were for generic drugs, the amount spent for these low-priced products was only 8% of the nation’s total drug bill. Now, generic drug makers are asking Congress to consider a speeded-up approval process for creating less expensive generic versions. They claim they have all the science and technology necessary to do a good job. Not everyone agrees.
If you miss a critical piece or create the new version ever-so-slightly-wrong–which is incredibly easy to do when you’re talking about bio-engineering–you can end up poisoning patients without really understanding where the problem lies. In the case of one anemia drug, it took a company years to figure out that a stabilizing chemical they had added to the “formula” was yielding serious undesirable side effects.
Balancing responsibility with expedience is the name of the bioengineering game. The solution may come down to giving the generic companies permission to duplicate, but then issuing the drugs in “beta” form for the first 5 or 10 years–that is, informing patients, as is done for the expensive process of human clinical trials, that they will use the drugs at their own risk because not all potential side effects are yet known.
When people experience profound relief of pain and suffering, they’re often willing to take whatever risks they must. It only seems fair to give them that chance.