Doctors paid to inject experimental 'bone cement' in routine surgeries, killing patients

220 Signs of the Times Health & Wellness
Print Email

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.
Read Full Article


You can contact us at: