Biotech Advance Could Protect Patients in Drug Trials

I probably don’t say this often enough, but most biotechnological research is entirely ethical and exciting. Case in point: The FDA is poised to approve a test that picks up “biomarkers” that could tell researchers whether a drug is harming a patient’s kidneys during human trials and, I suppose, afterwards. From the story:

Currently, experimental drugs are tested in animals before being taken to human clinical trails. But animals’ reactions aren’t always the best predictor of whether substances will be safe for humans. Drugs harmless to animals can hurt humans, and vice versa. If a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late.

“Using current tests, you have lost about 70 percent of the kidney function before you pick it up,” says William Mattes, director of toxicology at the Critical Path Institute in Tucson.

The new biomarker process has the potential to save a patient’s kidneys.

The ultimate goal of the pharmaceutical industry is to have a range of such marker tests that would signal dangerous side effects like heart failure, liver damage or cancer. Samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.

According to the story, drugs will continue to be tested in animals first. In other words, the biomarkers would be an added protection, not a substitute for other steps in the drug approval process.

It would be nice if the biomarkers could make animal testing superfluous, but that doesn’t seem to be in the cards. After all, the biomarkers will detect damage being caused after the drug is consumed. That means it remains important to attempt to filter out drugs that could be dangerous before being allowed for human use.