July 5, 2022

Unauthorised tests could land execs in jail

Company did unauthorised tests of bone cement

A Pennsylvania medical-device
company has pleaded guilty over conducting unauthorized tests of its bone
cement on about 200 spinal-surgery patients, three of whom died on the
operating table. Synthes Inc. and its subsidiary,
Norian Corp, have been fined US$23 million and four of their executives could
face jail terms.

The tests were carried out in 2002, 2003
and 2004. The product was approved for use in the arm, but not in the
weight-bearing spine. However, the company trained surgeons to use it
“off-label” so that it could gather data to support its expanded use.
Doctors are allowed to use drugs and medical products for “off-label”
uses, but companies may not promote them that way.

“Often times, those who defend
off-label use are talking about desperate measures for the terminally ill,”
Arthur Caplan, a bioethicist at the University of Pennsylvania, said.
“Using a glue or a stent or [other devices] on an elderly person for a non-approved
purpose is not trying to rescue someone; it’s experimenting on them.”

According to the indictment, the company’s
pilot studies showed that the bone cement could cause blood clots in humans,
while pig research suggested that such clots could move to the lungs. However,
it has not been established that the product actually caused the deaths.

Prosecutors allege that the four executives
realised that the tests were illegal and that a Synthes medical consultant had
warned that the tests amounted to “human experimentation.” They also
allege that the companies were trying to bypass the process of obtaining FDA
approval after long and expensive clinical trials. ~ AP, Nov
30



Michael Cook
clinical trials
informed consent