[Lessons from a heart valve prosthesis controversy].
Two lessons are to be learnt from the Björk-Shiley heart valve prosthesis tragedy. In the first place pharmacoepidemiologic studies are seriously hampered by recent privacy legislation. Individual patients carrying such a prosthesis cannot be traced and advised as to their health risks any more, because their legal autonomy has to be respected. This is clearly not to their advantage. In the second place the atmosphere of marketing and litigation and the increasing dependency of researchers on money from sources with conflicting interests is not conducive to a well-informed and balanced judgement of the epidemiological evidence of safety and efficacy of medical treatments.
Vandenbroucke
J P
JP
Leids Universitair Medisch Centrum, afd. Klinische Epidemiologie, Leiden.
Grobbee
D E
DE
D016265:Conflict of Interest / Q000331:legislation & jurisprudence*; D017277:Drug Approval; D017007:Duty to Warn; D016021:Epidemiologic Studies; D004869:Equipment Safety; D004992:Ethics, Medical; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006801:Humans; D016365:Liability, Legal; D008297:Male; D009426:Netherlands; D018907:Privacy / Q000331:legislation & jurisprudence*; D011475:Prosthesis Failure; D012106:Research / Q000331:legislation & jurisprudence
Lessen uit een kunsthartklep-controverse.