Last spring NIH scientist Charles Natanson published a meta-analysis of studies on hemoglobin-based blood substitutes in the Journal of the American Medical Association (Natanson, C., Kern, S. J., Lurie, P., Banks, S. M. & Wolfe, S. M. J. Am. Med. Assoc. 299, 2304-2312 (2008)). Blood substitutes are . . . well . . . blood substitutes. Like blood, they carry oxygen, but have long shelf lives, don’t need refrigeration, don’t require cross-matching and meet the need for situations where there is a shortage of fresh whole blood. A meta-analysis is a systematic summary, often expressed quantitatively, of existing literature. Data from 16 trials of five different blood substitute products were combined. The bottom line of the Natanson analysis?
Overall, there was a statistically significant increase in the risk of death (164 deaths in the HBBS-treated groups and 123 deaths in the control groups; relative risk [RR], 1.30; 95% confidence interval [CI], 1.05-1.61) and risk of MI (59 MIs in the HBBS-treated groups and 16 MIs in the control groups; RR, 2.71; 95% CI, 1.67-4.40) with these HBBSs. Subgroup analysis of these trials indicated the increased risk was not restricted to a particular HBBS or clinical indication.
Conclusion: Based on the available data, use of HBBSs is associated with a significantly increased risk of death and MI. (Natanson et al., JAMA)
Well, not quite the bottom line. One of the product manufacturers, Biopure (Cambridge, MA) demanded he retract the paper, which he declined to do. So Biopure is suing Natanson for “false and defamatory statements,” citing letters he sent to officials in the UK, Greece and South Africa, but also the JAMA publication itself, claiming the paper was so methodologically flawed it could not support his contention Hemopure was a risky product.
The US is known as a litigious society so you may think that lawsuits like this happen all the time. In fact they practically never happen:
Such lawsuits are highly unusual, says Jann Ingmire, director of media relations at JAMA. In 2000, Immune Response of Carlsbad, California, sued authors of a paper published by the journal that presented data showing that the company’s therapeutic HIV vaccine had failed in clinical trials. Immune Response said the authors refused to include additional data that the company felt was favorable towards the vaccine, but later dropped the lawsuit.
Biopure’s case is unlikely to succeed, says patent litigator Steve Keane in the San Diego office of the international law firm Morrison & Foerster. If a judge were to rule in Biopure’s favour with respect to the JAMA article, Keane says, “it would be an unprecedented restraint on scientific speech.” (Heidi Ledford, Nature)
But succeeding in the lawsuit is probably not the objective. Instead Biopure wants to make it expensive and unpleasant for scientists to publish papers critical of biotech and Big Pharma products, in essence, making them think twice before touching the hot stove. Biopure is the kind of company that gives the industry a bad name.
Not that they care.