Plague on Both Houses? Biopure vs. Natanson

Nature, in its November 13 issue, reported on the lawsuit filed by the firm Biopure against Charles Natanson, an NIH scientist and author of a study published in JAMA that questioned the safety of one of the firm's products.

At issue is the blood substitute Hemopure, a hemoglobin-based blood substitute. Natanson and colleagues looked at clinical trials of five blood substitutes, one of which was Hemopure. They claimed that these products were associated with a 30 percent increase in death, primarily due to heart attack risk. Biopure then sued, claiming that Natanson had made "false and defamatory statements" about Hemopure both in the JAMA article and also in letters he then sent to health officials in the United Kingdom, Greece, and South Africa (countries in which some of the blood substitutes had been approved for sale). Hemopure was initially approved only in South Africa, where the HIV epidemic has seriously restricted the human blood supply; subsequent to the controversy, South Africa withdrew its approval.

In an editorial, Nature attacked Biopure for this attempt to conduct "science by litigation," and noted that however unlikely the suit was to succeed in court, the clear intention was to intimidate scientists from speaking out against commercial products. (As explained in HOOKED, such a suit is sometimes termed a SLAPP suit, designed to have a chilling effect even it it never goes to court at all--in part because of the disparity in financial power between a large firm that can keep a bevy of lawyers on retainer, and the individual scientist who can barely afford legal counsel if named in such a suit.)

And, as the news account in Nature explained, if you want to measure corporate behavior on the Sleaz-o-meter, Biopure wins hands down. Its previous achievements include: the FDA halting a human trial of Hemopure because of safety concerns; three of its executives and the company sued by the US Securities and Exchange Commission for misrepresenting Hemopure's FDA status to investors; and criminal indictment of the company's former head of regulatory affairs for lying about his own health to avoid testifying before the grand jury.

But the main point that I want to make here is that Natanson, very sadly, appears to have invited some of this treatment through his own conflicts of interest. Natanson (who refused requests to be interviewed by the Nature reporter) failed to disclose that he was involved in a provisional patent application for a new technique to make hemoglobin-based blood substitutes safer. He has since amended his conflict-of-interest statement and has withdrawn his name from the final patent application. But one could not blame Biopure if they saw him more as a business competitor and less as a disinterested NIH scientist. Based on the old adage "it takes one to know one," they might well have concluded that Natanson's research methodology in his meta-analysis in JAMA was just as unreliable as their reports of their own research.

So, while I completely concur with Nature's condemnation of Biopure's resorting to a lawsuit to settle what ought to be a scientific question of drug safety, I must also note that scientists need to cleanse themselves of financial conflicts of interest if they wish their findings to be taken seriously.

Ledford H. Company sues researcher over unfavourable review. Nature doi: 10.1038/news.2008.1219

Science by litigation [editorial]. Nature 456:142, 13 November 2008.

Natanson C, Kern SJ, Lurie P, et al. Cell-free hemoglobin-based blood substitutes and risk of myocardial infarction and death: a meta-analysis. JAMA 299:2304-12, May 21, 2008.