The CDC Report on the Infections: Up to 58 Days Hospitalized
All 12 infected patients discovered* by CDC had been treated with Genetech HCT/P cells for complaints including chronic pain, joint or back pain, rheumatoid arthritis or osteoarthritis, and rotator cuff tears.
*In researching this report, we found comments online from other people saying they’d been made ill by these products.
CDC received the first reports from Texas health officials on September 17 and from Florida officials on September 22. CDC then issued a nationwide call for reports of culture-confirmed infections in patients who had received the Genetech/Liveyon products. One additional report has since been received from Arizona. The 12 reports received so far go back to infections as early as last February 21.
Every treatment involved injections into the patient’s knee, shoulder, or spine, or into more than one orthopedic treatment site. One case also involved intravenous infusion. The injections were done at orthopedic, spine, and pain clinics, and an ambulatory surgery center. None was done at a hospital, according to CDC records.
All 12 patients were hospitalized for their infections; the shortest stay was four days, the longest 30, 35, and 58 days. None died. In eight of the 12 cases, the infections were determined to have spread into the patients’ blood streams from injection sites.
In the 58-day hospitalization, the injection site is described in the CDC report as “Intra-articular injection, lumbar spine;” the patient ended up infected with Escherichia coli and Enterococcus faecalis at these sites: “bloodstream, lumbosacral epidural abscess, discitis, and vertebral osteomyelitis.”
The CDC investigators say that in one Texas clinic, the Enterococcus cloacae bacterium was found in all six vials containing the Genetech product. Similar results were found in vials tested at other clinics where injections were given. The source of the infections was apparently the manufacturer, not the clinics, CDC said.
The full “Notes from the Field” report, including the injection sites, pathogens, and subsequent infection sites, is in the December 21 issue of the CDC journal Morbidity and Mortality Weekly Report.
The CDC field report adds, “Health care professionals and consumers should report any adverse events related to treatment with the Genetech/Liveyon products or any unapproved stem cell therapies to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.”
That comment raises this question: Are providers who treated patients with the Genetech/Liveyon products required, legally or ethically, to notify them of the danger?
Liveyon ceased distributing the Genetech products, CDC said. However, it did not shut down its marketing; the company appears to have said in an October 9 announcement (posted under a blog, not confirmed here) that it had a new supplier and was resuming deliveries October 8. Its website seems to indicate that it now calls the product “Liveyon Pure.”
