Lessons learned

Institutes of higher learning are in a unique position. They have been at the forefront of scientific research for many years and can be credited with developments that have made life better for millions of people.

But sometimes the quest for scientific developments has produced unfortunate casualties. Penn is no stranger to the latter.

In the fall of 1999, the tragic consequences of overzealous research claimed the life of an innocent teenager who volunteered for a study without being fully informed of the potential side effects.

For 18-year-old Jesse Gelsinger, the side effect of the gene therapy experiment he participated in here at Penn was fatal.

This week, the University reached a settlement with the U.S. Attorney's office in the Gelsinger case. And while Penn and the researchers involved "contend that their conduct was at all times lawful and appropriate," the parties are implicitly agreeing that Gelsinger's death was a by-product of their negligence.

Advancing medicine is a noble cause, and gene therapy as a field of study shows great promise for the future. In the 1990s, Penn had emerged as a leader, attracting the top scientists and pursuing ambitious goals.

But somewhere along the way, common sense and best practice became clouded with the desire to come out on top in the race for government funding and international notoriety.

The government alleges that before Gelsinger's treatment for a rare, non-fatal liver condition, warning signs emerged that should have put a halt to the experiment. What is clear now is that those red flags were either not raised or were ignored by the team of doctors led by James Wilson -- who remains a member of the Penn faculty to this day.

Gelsinger and his family were given insufficient information about the risks of the treatment. The researchers at Penn and the Children's National Medical Center in Washington cannot with a clear conscience say that they took every step necessary to ensure patient safety. Whether they understood the risks of the treatment or not, these doctors did not have adequate proof that the treatment was safe.

And the fact that they subverted the University's Internal Review Board, the Food and Drug Administration and the National Institutes of Health further damages their credibility.

When human lives are at stake, recklessness of this nature is never acceptable.

From a legal standpoint, this case has been settled, but the ramifications that it has in the greater science community are still being debated.

As part of the agreement, Wilson will complete a journal article on the lessons learned from this study. All those in some way connected with the study and practice of biomedicine should read it and take to heart its findings.

The University's increased efforts to oversee and clearly define operating procedures for clinical research are a day late but nonetheless worthwhile.

Carrying out research into improving and saving lives is a vital part of what goes on in medical schools such as Penn. The University -- as one of the top research institutions in the country -- has a fundamental obligation to be on the cutting edge. But the lives of patients at all times must come before the advancement of medicine.

To bring closure to this once and for all, the basic human thing to do is offer a sincere apology. It cannot change the tragic outcome, but it can put to rest a very unfortunate chapter in the history of the University.

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