Legal Responsibility for Data Integrity … & related concepts

BICO has been in the news lately, not in a good way, with regard to a lawsuit by Redmond, Wash.-based Onconome brought against the university and Dr. Robert H. Getzenberg (now at Johns Hopkins, also being sued). Buyer Beware comments on The Scientist coverage of this incident actually sum up much of my thoughts on the matter: that, although universities own the data generated by faculty, staff, and students, no university can be held accountable for their veracity nor be expected to pay for the costs of replicating or confirming these data. As Buyer Beware notes, in this case (which may or may not involve misconduct), the company should have done so prior to significant investment.

Science offers a bit more coverage:

The company “depended entirely” on Getzenberg to conduct its scientific research through research agreements with Pitt and later JHU, the suit says.

In more than 20 updates to Onconome’s board, the Pitt suit says, Getzenberg reported results for EPCA and biomarkers for other cancers that he described as “amazing”: sensitivities and specificities approaching 100%, which means that the tests identified nearly all cancerous samples and rarely resulted in false positives. Two top medical journals rejected a paper by Getzenberg on a second biomarker called EPCA-2, the suit says. However, he published a paper on EPCA-2 in the April 2007 issue of Urology. It drew widespread media coverage, thanks to a press release from JHU, where Getzenberg had moved in 2005 to take over for Coffey as research director of the James Buchanan Brady Urological Institute.

When Onconome hired its own scientists to develop and market the EPCA tests, they were unable to replicate Getzenberg’s experiments. …

The lawsuit filed in federal court in Pittsburgh and a similar amended complaint filed in circuit court in Baltimore City in July against JHU and Getzenberg include claims of fraud, breach of contract, and “failure to supervise.” Onconome, which says its losses exceed $13 million, asks for damages to be determined at trial and attorney’s fees. …

Thankfully, US taxpayers, who have made a considerably larger investment than $13M, are not suing over federally funded studies that looked so promising at first but did cure cancer or solve world hunger.

Science also notes that Pitt is not conducting an investigation for possible scientific misconduct, while Johns Hopkins did not comment.

Interestingly, two Canadians, Donald Weaver and Christopher Barden, discuss in a letter to Nature the overlooked value in citing patents in the biomedical literature. They examined “all citations in the reviews, articles and letters/reports in Nature (1,773 citations) and Science (1,367)” for the month of December 2008 and found no patent citations. Their rationale for bringing up this issue is that “Patents present novel, rigorously reviewed unpublished work, as well as providing an unmatched resource for detail.” As the BICO case demonstrates, however, a rigorously reviewed novel method will not necessarily generate the anticipated results.

And of course, thinking about companies and universities unable to replicate highly touted methods and their outcomes brings to mind another scientist whose star has fallen, Homme Hellinga, whom, according to recent comments here about an upcoming PNAS paper, we will soon see garnering the sort of headlines Duke would prefer he not (and apparently, per another comment, would prefer to pretend he is not).

11 Comments »

  1. noblesse d'epee said

    Nice post.

    Yes, the relationships between university/PI-held patents, public funding, misconduct, and administrative conflict-of-interest are complex and are therefore difficult to parse from an ethical standpoint. In the case of Duke, I fear that our Med. Center thinks that Hellinga’s patents are worth a great deal of money. He certainly has done a skilled job of convincing administrators that this is true. Of course, these patents have not been challenged or defended in court, so their worth is indeterminate.

    A few years ago, with some fanfare, Hellinga was made a member of the advisory board of Xencor, Inc., a biotech. R&D firm in CA. Specifically, he was asked to assist in the production of PBP-coupled probes for small molecules, such as those he reported in his 2003 Nature paper. He is no longer mentioned on Xencor’s web-site, so I wonder how this partnership worked out for them. Hopefully, they won’t sue Duke.

  2. Their rationale for bringing up this issue is that “Patents present novel, rigorously reviewed unpublished work, as well as providing an unmatched resource for detail.”

    That letter is patently ridiculous, as patents are rigorously reviewed by people who are not scientific peers and according to a set of standards that bears almost no relationship whatsoever to the standards that are applied in peer review of scientific manuscripts.

    • qaz said

      This is a stupid letter. Patents are about ideas not about results. A patent doesn’t have to actually prove that something worked, it only needs to show a plausible statement of how it could work. I would never take a patent as a scientific statement.

      Also, don’t forget that patents are rarely actually written by scientists. At most of the universities that that I know of where patents have been filed, the patents were written by lawyers under the guise of the university technology and patent offices (admittedly with help from the scientists). But what this means is that the patents are often in legalese. Given the patents I recently had to read, I can understand why they’re never cited.

  3. chrislakersome said

    “When Onconome hired its own scientists to develop and market the EPCA tests, they were unable to replicate Getzenberg’s findings………….Losses exceed $13 million”

    Were the $13 millions just the cost of scientific research to validate Getzenberg’s findings?. It does not seem a lot of money considering that the amount is what some NIH funded researchers get for 2 years of their research.

    Why a biotech company should put up with such a rip-off ?. Just because NIH is tolerant when federal funds are misused?.

  4. whimple said

    Thankfully, US taxpayers, who have made a considerably larger investment than $13M, are not suing over federally funded studies that looked so promising at first but did cure cancer or solve world hunger.

    Right, the taxpayers aren’t suing. Instead, taxpayer disenchantment with the inability of NIH/NSF funded science to produce substantive improvements in taxpayer health have “dampened enthusiasm” (as the study sections say) for further taxpayer investments in biomedical research.

    • bikemonkey said

      whimple nails it. There are still costs even if they do not come from a judicial proceeding.

  5. Delenn said

    The title of ‘The Scientist’ article is: “School sued for fake cancer test”
    Hmmm, provocative to say the least, possibly unfair to say the most. Research results that cannot be duplicated can arise from many, many possible scenarios (changes in reagent manufacture, contaminants, antibody avidity and specificity, etc.).

    The coverage to date of the Getzenberg prostate cancer assay remains one-sided, in part, due to the almost complete silence on the part of the involved. Let’s wait and see before labeling cancer tests ‘fake’ for all to see (and media agencies and bloggers to repeat).

  6. Luna Halloween said

    Sometimes people use lawsuits to make money. It would be excellent news for science if it is proven that Dr Getzenberg’s claims are true.

  7. The Scientist is basically the National Enquirer of science. Why else would they put up the disclaimer of “FAKE” cancer test other than to generate headlines and webseach results. Hopefully if Getzenberg is vindicated he could pursue legal action against The Scientist as I do not find much use in that rag. They owe the guy at least an apology for that sensationalizing of the story headline.

  8. Chrislakersome said

    I look for the meaning of FAKE at the dictionary. This is the definition I found

    adjective
    not genuine; counterfeit

    It seems that these are the the claims of the lawsuit according to what has been published on several newspapers.

    There are some other people who need to apologize before The Scientist does, if Dr Getzenberg is proven to be correct.

  9. Interested Party said

    If, in fact, Getzenberg did continually manipulate the data over 6 years to show fantastic results, which was used to recruit investors to fund his continued research, does that not constitute fraud no different than an Enron or a Madoff? In my mind if the claims in the suit are true, investors were cheated.

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