Did Ethical Standards Slip In Disc Trials?
Researchers Had Financial Interest in the Subject of Their Study
The Food and Drug Administration said last month that it is investigating whether several orthopedic surgeons failed to properly disclose their financial investments in the manufacturer of an artificial spinal disc that the FDA approved in 2006. The surgeons, who were conducting clinical trials that ultimately led to FDA approval of the ProDisc-L lumbar replacement disc, were also investors in a venture capital fund that invested in the development of the product. As investors, the physicians stood to gain financially from the success of the clinical trials. "We are looking at the issue," says Karen Riley, a spokeswoman for the FDA.
Keywords:
Did Ethical Standards Slip In Disc Trials?; Implants Linked to Surgery Site Infections in Breast Surgery; In the Know; AAOS; ASCs; Academy; Administration; American Academy; April; Archives; Association; Back Institute; Balderston; Baltimore. The; Barnes-Jewish Hospital; Breast Surgery Average Infection Increases Cost; CDC; California; Cancer; Charité; Control; Cost; Court; Disc Trials? Researchers Financial Interest; Dr. Balderston; Dr. Rosen; Dr. Rupp; Drug Administration; Epidemiology Mandatory State Licensure; Ethical Standards Slip Disc Trials? Researchers Financial Interest; Ethics; FDA...
show all keywords
Did Ethical Standards Slip In Disc Trials?; Implants Linked to Surgery Site Infections in Breast Surgery; In the Know; AAOS; ASCs; Academy; Administration; American Academy; April; Archives; Association; Back Institute; Balderston; Baltimore. The; Barnes-Jewish Hospital; Breast Surgery Average Infection Increases Cost; CDC; California; Cancer; Charité; Control; Cost; Court; Disc Trials? Researchers Financial Interest; Dr. Balderston; Dr. Rosen; Dr. Rupp; Drug Administration; Epidemiology Mandatory State Licensure; Ethical Standards Slip Disc Trials? Researchers Financial Interest; Ethics; FDA; FDA. As; Financial Interest; Food; Hospital; Hospital Epidemiology Mandatory State Licensure; Implants; Increases Cost; Infection Control; Infection Increases Cost; Infections; Institute; Interest; January; Kennedy; Kent Steinriede; Kent Steinriede In; Licensure; Linked; March/April; Massachusetts; Massachusetts Association; Medicine; Pennsylvania Court; Pennsylvania Hospital; ProDisc; ProDisc-L; Rosen; Rupp; SSIs; School; Site Infections; Slip Disc Trials? Researchers Financial Interest; Standards Slip Disc Trials? Researchers Financial Interest; State Licensure; Steinriede; Steinriede In; Study; Study The Food; Subject; Surgery Average Infection Increases Cost; Surgery Site Infections; Surgery. SSIs; Swiss; Synthes; Texas Back Institute; Texas. Synthes; Trials? Researchers Financial Interest; University; University School; Washington University School; abdominal; added; affidavit; alcohol-based; ambivalent; annual; antibiotics; approval; approved; area; article; artificial; attending; auditing; augmentation; average; bacteria; based; bearing; benefits; bill; billion; blinded; bought; breast; brought; call; capital; caseload; catheters; centers; changing; chief; cited; clinical; collaboration; common; compared; compromised; conducting; confidential; conflict; consultant; contribute; control; court; cover; creating; current; determination-of-need; developed; developer; development; device; disc; disclose; disclosure; disease; dissemination; documents; doubled; due; earned; edition; estimates; ethical; evaluation; executive; expenses; expert; extended; fact; failed; fared; federal; filed; financial; financially; fingernails; fingers; firm; foreign; found; founded; free-care; fund; gain; gels; generally; guidelines; half; hand; handling; hard; higher; hospital-related; hygiene; immediately; immune; implant; improperly; included; includes; including; increases; independent; infection; infectious; influence; interest; introduce; invested; investigating; investment; investors; involved; issue; jumped; lawsuit; led; legislative; length; letter; licensed; long; looked; lower; lumbar; malpractice; manufacturer; mastectomies; mastectomy; medical; meet; meeting; men; month; noted; numbers; orthopedic; paper; part; participated; patient; pay; percent; performed; phone; physicians; plastic; pointed; pool; poor; positive; prescription; prevent; previous; previously; procedures; professor; profited; properly; provided; published; put; rate; reason; received; recommendations; reconstruction; reconstructive; records; reduction; regular; replacement; reports; require; research; researchers; results; return; reviewed; rings; risk; rule; sanitized; seldom; session; settled; settlement; showed; site; skin; sold; specialist; specialized; spinal; spine; spokeswoman; sponsored; staff; state; stood; strict; study; success; successful; sued; suing; suit; surface; surgeon; surgeon-investor; surgeons; surgeries; surgery; sympathetic; system; thresholds; time; treatment; trial; trials; type; ultimately; venture; volumes; woman; women; wrote