In May 2004, a Food and Drug Administration investigator triggered a years-long inquiry and trial of Synthes, a multinational medical device manufacturer, uncovering multiple cases of what amounted to human experiments that left five unwitting patients dead. The four business-people found responsible served between five and nine paltry months in prison. The families of the dead were only recently informed that their loved ones had perished on the tables of surgeons using an experimental bone cement. They sued Synthes’ elusive yet “forceful,” “hands-on,” “800-pound gorilla” CEO, Hansjörg Wyss, to no avail.
Clinical Trials Shirked
Between 2002 and 2004, Synthes—based in Switzerland and West Chester, Pennsylvania—tested a revolutionary product they called Norian XR, a cement which turns into bone when injected into the skeleton. The promising product was more effective than acrylic alternatives, but the FDA demanded clinical trials. Wyss and his executives, whom he hand-picked and groomed for company success, knew this would cost time and money.
As it turns out, the FDA’s concerns were well-founded. In the spring of 2002, University of Washington orthopedic surgeon Dr. Jens Chapmen sent an email with the results of an animal study. When Chapman injected Norian XR into a pig’s bloodstream, “the entire pulmonary artery system had clotted off…We were expecting to kill the pig…but not suddenly and with a relatively small dose.”
The following month, executives Michael Huggins and Tom Higgins met with Wyss This was neither the first nor the last meeting in which all parties would agree to proceed with illegal testing of a high-risk device on uninformed patients. Market potential was “considerable” enough to incite “excitement about using Norian for vertebroplasties.”
Whistleblowers and concerned employees like Michael Sharp were at first reassured that the rumors were unfounded and Synthes wouldn’t dare flout the FDA. Then they were terminated for, supposedly, other reasons.
Off-Label Use Norian XR
Synthes sales representatives accompanied orthopedic surgeons, who were paid to use Norian XR on patients uninformed of the experimental nature of their procedure.
Fortune writer Mina Kimes describes orthopedic surgeons as predominantly male and aggressive, the jocks of the medical community prone to temper tantrums and often found performing surgery to loud rock music. Because the FDA’s approval process is notoriously slow, many “orthopods” see the idea of reading labels on medical devices like Norian XR as unnecessary.
Instead, they listen to the sales representatives who often watch over the surgery. Although the act of mixing Norian XR with any other substance—a procedure necessary to inject it into spines—was expressly prohibited by the FDA, many surgeons mixed and injected as instructed by the Synthes representative. Some surgeons ended up with corpses on their table.
One Synthes representative admits, “It’s not uncommon to have a surgeon with a drill in his hand, about to drill a hole, looking over his shoulder at you saying, ‘Is this right?’”
Big Pharma After Money, Not Saving Lives
Dr. Chapman is one of the many surgeons to defend vertebroplasty and even Norian XR. Of course, he was also named to the Hansjörg Wyss chair at UW, to which Wyss gave a $2 million endowment. That Joan Bryant died of cardiovascular collapse on his operating table after he injected Norian XR into her back—after his failed experiment with the pig—has seemingly had no effect on his opinion.
It’s worth noting that in 2009, an article published in the New England Journal of Medicine deemed vertebroplasty ineffective. Meanwhile, in June of this year, Johnson & Johnson—under attack of late for product recalls and marketing Risperdal for unapproved use—splurged and bought Synthes, controversy and all, for $20 billion.