Description of Event or Problem · 1
REPORTER CONCERNED THAT THIS CO IS MISREPRESENTING THIS PRODUCT IN PRINTED ADVERTISING AND IN THEIR SALES PRESENTATIONS. THE CO CLAIMS IN PRINTED ADVERTISEMENTS THAT THE TUBE ELIMINATES BOTH "HEADSPACE-ASSOCIATED" AND "PARTIAL DRAW" PLATELET ACTIVATION. THEY ALSO CLAIM THAT THE TUBE PERFORMS "EQUIVALENT TO THE LEADING SUPPLIER'S FULL DRAW (5ML) GLASS TUBE." WHEN REPORTER ASKED FOR DATA SUPPORTING THESE CLAIMS GREINER PROVIDED A TWO PAGE DOCUMENT LABELED CONFIDENTIAL THAT CITED WORK DONE IN ANOTHER COUNTRY USING SAMPLES SPIKED WITH HEPARIN, COMPARING A "REGULAR GLASS TUBE" TO THE GREINER TUBE. IN REPORTER'S JUDGEMENT THE STATEMENTS ON THIS DOCUMENT DO NOT SUPPORT (AND PERHAPS CONTRADICT) THE ADVERTISED CLAIMS. (THE DOCUMENT HAS A CONFIDENTIALITY STATEMENT AND WARNS "NOT TO BE DISCLOSED TO A THIRD PARTY".) GREINER ALSO PROVIDED REPORTER WITH DATA REPORTED TO BE FROM AN UNPUBLISHED STUDY PERFORMED AT A HOSP. THE DOCUMENTS ARE TABLES OF DATA THAT ARE LABELED "A COMPARISON BETWEEN 3.2% BD TUBES AND GREINER TUBES". THERE ARE 16 TABLES OF DATA COMPARING PT, APTT, INR AND VARIOUS FACTOR ASSAYS. THE COMPARISON STATISTICS PROVIDED ARE THE MEANS AND THE STANDARD DEVIATION FOR EACH GROUP. THERE IS NEITHER A CORRELATION, NOR T-TEST PERFORMED. TABLE 10 IS OF SPECIAL INTEREST SINCE IT IS HAND-LABELED "HEPERIN" (YES, IT IS MIS-SPELLED ON THE PAPER). THIRTY FOUR SUBJECTS ARE COMPARED, 23 OF WHICH HAVE APTT'S BY THE BD TUBE OF LESS THAN 45 SECONDS. FOURTEEN OF THE PTS HAVE APTT'S OF LESS THAN 35 SECONDS. AS A GROUP, THESE PTS ARE HARDLY HEPARINIZED. OF THE PTS THAT ARE APPARENTLY HEPARINIZED, THE APTT'S PERFORMED ON THE VARIOUS TUBES INDICATE SOME GROSS DISCREPANCIES (EG 156.0 GREINER AND 55.7 BD). THE MEAN APTT USING THE VARIOUS GREINER PRODUCTS VS BD DIFFER BY MORE THAN 10 SECONDS. WHEN REPORTER QUESTIONED THIS TECHNIQUE AND METHOD COMPARISON, THE CO REFERRED REPORTER TO DR. DR ADMITTED THAT THE HEPARIN GROUP DID NOT APPEAR TO CORRELATE AND THAT AS A GROUP THE DATA INDICATED THAT THE PTS WERE NOT ON HEPARIN. DR TOLD REPORTER THAT DR HAD WRITTEN A 2000 WORD REPORT ON STUDY IN WHICH THEY CITED LIMITATIONS. THE BASIS FOR REPORTER'S REPORT IS THAT GREINER IS MAKING CLAIMS IN THEIR MARKETING THAT, IF ACCEPTED ON FACE VALUE, MIGHT BE DANGEROUS TO PTS ON HEPARIN. THE DOCUMENTATION PROVIDED TO REPORTER BY THE CO SEEMS TO INDICATE THE OPPOSITE OF THE ADVERTISED CLAIM. REPORTER DOESN'T SEE HOW THEY CAN CLAIM THAT THEIR PRODUCT ELIMINATES "HEADSPACE-ASSOCIATED" AND "PARTIAL DRAW" PLATELET ACTIVATION. THE CO COULD NOT PROVIDE THEM WITH ANY DATA ON PLATELET FACTOR FOUR (PF4) RELEASE OR ON THE ACTUAL HEPARIN CONCENTRATION. GREINER COULD NOT OR WOULD NOT PROVIDE CORRELATION STATISTICS. THEY OFFERED THAT THE "MEANS" WERE WITHIN TEN SECONDS FOR HEPARINIZED PTS.