scary article --makes you hesitant to believe lab results from studies done outsideUS

[Lani]

Medscape Medical News
Antibiotic Tests Kits Falsely Marketed, Says BMJ

Daniel M. Keller, PhD
Feb 13, 2013


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In its own investigation of problems with antibiotic susceptibility test discs, BMJ reports in an article published online February 13 that a major manufacturer of diagnostic tests used worldwide "has been falsely marketing" these products. Authors Deborah Cohen and Glenn Swift found that British company Oxoid, owned by US diagnostics company Thermo Fisher Scientific Inc, sold antibiotic susceptibility test discs repeatedly over the course of several years that did not contain the advertised amount of antibiotic, and in some cases did not contain any at all.

Their report is based on Oxoid internal reports, emails, and sources, as well as comments by an outside expert consultant whom Oxoid hired to review analytic methods and data. The BMJ quotes Colin Booth, then vice president of science and technology at Oxoid, as admitting in 2003 that tests of the discs were "flawed" and that he did not know how accurate the potency results were. The consultant also expressed suspicion that test methods and results were "too good to be true," according to the authors.

In addition, some discs may have also been cross-contaminated with different antibiotics, and the manufacturer lacked shelf-life stability data.

The BMJ report, based on documentary and other evidence spanning the years 2003 to 2012, alleges that the company at times averaged test data, which could mask products out of compliance; would "cherry pick" or delete data; and misled the UK regulatory authority, the Medicines and Healthcare Products Regulatory Agency.

"At worst, patients may have been prescribed the wrong antibiotic or moved from oral to intravenous treatment unnecessarily. This comes at a time when health agencies around the world are concerned about antibiotic resistance and the shortage of new antimicrobial treatments in the pipeline," the authors write.

In the report, Oxoid denied that it averages results and said it puts all results on the quality certificates for its products.

In reply to the BMJ article, Oxoid issued a statement calling the allegations "unfounded" and not reflecting the "considerable factual information" that it says it provided to the BMJ editor. "We have total confidence in the quality of Oxoid products, and completely disagree with the conclusions in the article," the statement says. Although denying that there were problems in the past, the statement largely refers to the present and says manufacturing standards and "products, processes and practices meet all current legal and regulatory requirements."

In an accompanying editorial, Professor Mark Wilcox, MD, from the microbiology department at the Old Medical School of Leeds General Infirmary in the United Kingdom, writes that it is surprising that to market an in vitro diagnostic device across Europe, a manufacturer has "just to self declare that the product complies" with relevant European laws but has no obligation to submit performance data.

In the United States, the discs are classified as medical devices, and therefore they have to go through the US Food and Drug Administration's 510(k) process, where the companies have to show detailed evidence before a product can be cleared for sale.

Irving Nachamkin, DrPH, professor of pathology and laboratory medicine and director of the Division of Laboratory Medicine at the Perelman School of Medicine of the University of Pennsylvania in Philadelphia, commented to Medscape Medical News, "The most concerning part about the article is that there are no regulatory requirements for analytic data in Europe.... They're just taking it on good faith that the company is making what they say they're making."

If problems exist with a reagent, he wondered whether "procedures [are] in play... in European laboratories to quickly detect a problem with their discs. That's the big question."

Cohen and Swift have disclosed no relevant financial relationships. Dr. Wilcox has reported receiving antimicrobial agent–related consultancies and/or lecture honoraria in the last 3 years from Actelion, Astellas, Astra-Zeneca, Bayer, Cubist, Durata, J&J, Merck, Nabriva, Novacta, Novartis, Optimer, Pfizer, Roche, Sanofi-Pasteur, the Medicines Company, VH Squared, and Viropharma; antimicrobial agent–related research funding in the last 3 years from Actelion, Astellas, bioMérieux, Cerexa, Cubist, Merck, Pfizer, Summit, and the Medicines Company; and in vitro diagnostic medical device–related research grant funding from bioMérieux and the Department of Health/Health Protection Agency. Dr. Nachamkin has disclosed no relevant financial relationships.

BMJ. Published online February 13, 2013. Article full text, Editorial full text