People entrusted to check the safety and efficacy of pharmaceuticals occupy a special place in our society. We put our health and our lives in their hands. When they violate this trust, they deserve severe punishment. The sentence received last week by Mark B. Perkal, the former chief scientific officer and executive vice president of PharmaKinetics Laboratories, does not come close to punishing him for his transgressions.
Perkal supervised the operations of PharmaKinetics, a Baltimore company that tests the effects of newly developed drugs on human subjects. Drug manufacturers used his company to test the efficacy of their products compared to their brand-name equivalents. Several of these generic manufacturers never submitted their own products for tests. Instead, they altered the brand-name drugs and substituted them for their own drugs.
On his own initiative, Perkal found out that Bolar Pharmaceuticals had duped his company when it had asked PharmaKinetics to test its anti-hypertensive drug. He initially refused to cooperate with Bolar executives who insisted on covering up their deception, but relented after consulting with his rabbi. He then lied about his involvement to federal investigators conducting a criminal investigation into generic drug manufacturers.
As a scientist, Perkal should have disclosed this information to the authorities. By the time he uncovered the deception, thousands of people were taking Bolar's drug on the assumption it was effective and not harmful. Once Perkal found out his company had not tested Bolar's drug, he knew members of the public were, in effect, serving as guinea pigs.
Federal prosecutors in Baltimore, who have convicted over 30 drug company executives, eventually indicted Perkal. He pleaded guilty to obstructing justice and making false statements to the U.S. Food and Drug Administration. Prosecutors recommended that he serve between eight and 14 months in prison, as called for in the federal sentencing guidelines.
Arguments that he had made substantial contributions of time ++ and energy to the community along with testimony that he was a pious man who cooperated with prosecutors apparently convinced U.S. District Judge John R. Hargrove to deviate from the sentencing guidelines. Perkal received just four months of home detention. He won't have to wear an electronic bracelet and appears to be free to come and go as he pleases.
It is human nature to fear the gun-toting thug more than the white-collar criminal. However, the generic drug manufacturers who falsified test data are probably equally harmful to society. They deserve stiffer punishment than the lenient sentence handed out by Judge Hargrove last week.