Earthquake-Induced Data Loss – We’re All Shook Up

Adam Marcus and Ivan Oransky are medical journalists who publish the Retraction Watch blog. Their blog’s coverage of error, fraud, plagiarism, and other publishing disasters is often first-rate, and a valuable curative for the belief that peer review publication, as it is now practiced, ensures trustworthiness.

Yesterday, Retraction Watch posted an article on earthquake-induced data loss. Shannon Palus, “Lost your data? Blame an earthquake” (June 25, 2015). A commenter on PubPeer raised concerns about a key figure in a paper[1]. The authors acknowledged a problem, which they traced to their loss of data in an earthquake. The journal retracted the paper.

This is not the first instance of earthquake-induced loss of data.

When John O’Quinn and his colleagues in the litigation industry created the pseudo-science of silicone-induced autoimmunity, they recruited Nir Kossovsky, a pathologist at UCLA Medical Center. Although Kossovsky looked a bit like Pee-Wee Herman, he was a graduate of the University of Chicago Pritzker School of Medicine, and the U.S. Naval War College, and a consultant to the FDA. In his dress whites, Kossovsky helped O’Quinn sell his silicone immunogenicity theories to juries and judges around the country. For a while, the theories sold well.

In testifying and dodging discovery for the underlying data in his silicone studies, Kossovsky was as slick as silicone itself. Ultimately, when defense counsel subpoenaed the underlying data from Kossovsky’s silicone study, Kossovsky shrugged and replied that the Northridge Earthquake destroyed his data. Apparently coffee cups and other containers of questionable fluids spilled on his silicone data in the quake, and Kossovsky’s emergency response was to obtain garbage cans and throw out the data. For the gory details, see Gary Taubes, “Silicone in the System: Has Nir Kossovsky really shown anything about the dangers of breast implants?” Discover Magazine (Dec. 1995).

As Mr. Taubes points out, Kossovsky’s paper was rejected by several journals before being published in the Journal of Applied Biomaterials, of which Kossovsky was a member of the editorial board. The lack of data did not, however, keep Kossovsky from continuing to testify, and from trying to commercialize, along with his wife, Beth Brandegee, and his father, Ram Kossowsky[2], an ELISA-based silicone “antibody” biomarker diagnostic test, Detecsil. Although Rule 702 had been energized by the Daubert decision in 1993, many judges were still not willing to take a hard look at Kossovsky’s study, his test, or to demand the supposedly supporting data. The Food and Drug Administration, however, eventually caught up with Kossovsky, and the Detecsil marketing ceased. Lillian J. Gill, FDA Acting Director, Office of Compliance, Letter to Beth S. Brandegee, President, Structured Biologicals (SBI) Laboratories: Detecsil Silicone Sensitivity Test (July 15, 1994); see Taubes, Discover Magazine.

After defense counsel learned of the FDA’s enforcement action against Kossovsky and his company, the litigation industry lost interest in Kossovsky, and his name dropped off trial witness lists. His name also dropped off the rolls of tenured UCLA faculty, and he apparently left medicine altogether to become a business consultant. Dr. Kossovsky became “an authority on business process risk and reputational value.” Kossovsky is now the CEO and Director of Steel City Re, which specializes in strategies for maintaining and enhancing reputational value. Ironic; eh?

A review of PubMed’s entries for Nir Kossovsky shows that his run in silicone started in 1983, and ended in 1996. He testified for plaintiffs in Hopkins v. Dow Corning Corp., 33 F.3d 1116 (9th Cir.1994) (tried in 1991), and in the infamous case of Johnson v. Bristol-Myers Squibb, CN 91-21770, Tx Dist. Ct., 125th Jud. Dist., Harris Cty., 1992.

A bibliography of Kossovsky silicone oeuvre is listed, below.

[1] Federico S. Rodríguez, Katterine A. Salazar, Nery A. Jara, María A García-Robles, Fernando Pérez, Luciano E. Ferrada, Fernando Martínez, and Francisco J. Nualart, “Superoxide-dependent uptake of vitamin C in human glioma cells,” 127 J. Neurochemistry 793 (2013).

[2] Father and son apparently did not agree on how to spell their last name.

Nir Kossovsky, D. Conway, Ram Kossowsky & D. Petrovich, “Novel anti-silicone surface-associated antigen antibodies (anti-SSAA(x)) may help differentiate symptomatic patients with silicone breast implants from patients with classical rheumatological disease,” 210 Curr. Topics Microbiol. Immunol. 327 (1996)

Nir Kossovsky, et al., “Preservation of surface-dependent properties of viral antigens following immobilization on particulate ceramic delivery vehicles,” 29 J. Biomed. Mater. Res. 561 (1995)

E.A. Mena, Nir Kossovsky, C. Chu, and C. Hu, “Inflammatory intermediates produced by tissues encasing silicone breast prostheses,” 8 J. Invest. Surg. 31 (1995)

Nir Kossovsky, “Can the silicone controversy be resolved with rational certainty?” 7 J. Biomater. Sci. Polymer Ed. 97 (1995)

Nir Kossovsky & C.J. Freiman, “Physicochemical and immunological basis of silicone pathophysiology,” 7 J. Biomater. Sci. Polym. Ed. 101 (1995)

Nir Kossovsky, et al., “Self-reported signs and symptoms in breast implant patients with novel antibodies to silicone surface associated antigens [anti-SSAA(x)],” 6 J. Appl. Biomater. 153 (1995), and “Erratum,” 6 J. Appl. Biomater. 305 (1995)

Nir Kossovsky & J. Stassi, “A pathophysiological examination of the biophysics and bioreactivity of silicone breast implants,” 24s1 Seminars Arthritis & Rheum. 18 (1994)

Nir Kossovsky & C.J. Freiman, “Silicone breast implant pathology. Clinical data and immunologic consequences,” 118 Arch. Pathol. Lab. Med. 686 (1994)

Nir Kossovsky & C.J. Freiman, “Immunology of silicone breast implants,” 8 J. Biomaterials Appl. 237 (1994)

Nir Kossovsky & N. Papasian, “Mammary implants,” 3 J. Appl. Biomater. 239 (1992)

Nir Kossovsky, P. Cole, D.A. Zackson, “Giant cell myocarditis associated with silicone: An unusual case of biomaterials pathology discovered at autopsy using X-ray energy spectroscopic techniques,” 93 Am. J. Clin. Pathol. 148 (1990)

Nir Kossovsky & R.B. Snow RB, “Clinical-pathological analysis of failed central nervous system fluid shunts,” 23 J. Biomed. Mater. Res. 73 (1989)

R.B. Snow & Nir Kossovsky, “Hypersensitivity reaction associated with sterile ventriculoperitoneal shunt malfunction,” 31 Surg. Neurol. 209 (1989)

Nir Kossovsky & Ram Kossowsky, “Medical devices and biomaterials pathology: Primary data for health care technology assessment,” 4 Internat’l J. Technol. Assess. Health Care 319 (1988)

Nir Kossovsky, John P. Heggers, and M.C. Robson, “Experimental demonstration of the immunogenicity of silicone-protein complexes,” 21 J. Biomed. Mater. Res. 1125 (1987)

Nir Kossovsky, John P. Heggers, R.W. Parsons, and M.C. Robson, “Acceleration of capsule formation around silicone implants by infection in a guinea pig model,” 73 Plastic & Reconstr. Surg. 91 (1984)

John Heggers, Nir Kossovsky, et al., “Biocompatibility of silicone implants,” 11 Ann. Plastic Surg. 38 (1983)

Nir Kossovsky, John P. Heggers, et al., “Analysis of the surface morphology of recovered silicone mammary prostheses,” 71 Plast. Reconstr. Surg. 795 (1983)

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