True Horror: Doctors Paid to Inject Experimental Bone Cement in Routine Surgeries, Killing PatientsLisa Garber 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, Hansjrg Wyss, to no avail. Clinical Trials Shirked Between 2002 and 2004, Synthesbased in Switzerland and West Chester, Pennsylvaniatested 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 FDAs 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 pigs bloodstream, the entire pulmonary artery system had clotted offWe were expecting to kill the pigbut 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. 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 FDAs 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 substancea procedure necessary to inject it into spineswas 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, Its 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 Hansjrg 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 backafter his failed experiment with the pighas seemingly had no effect on his opinion. Its 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 Johnsonunder attack of late for product recalls and marketing Risperdal for unapproved usesplurged and bought Synthes, controversy and all, for $20 billion. Explore More: 