Medical Researchers Want Up To Five Years Exclusivity For Clinical Trial Data Derived From Volunteers
from the papers-before-patients dept
A year ago, we wrote about how TPP's requirement for "data exclusivity" risked undermining one of science's fundamental principles: that facts cannot be owned. Data exclusivity is just the latest attempt by Big Pharma to extend its monopoly over drugs, whether using patents or other means. To a certain extent, you might expect that: after all, companies are designed to maximize profits, and if it means more people suffer or die along the way, well, that's regrettable but sort of beside the point. However, it's surprising to see a group of medical researchers writing in the prestigious New England Journal of Medicine (NEJM) calling for just the same kind of data exclusivity. The post is in response to an earlier NEJM article by the International Committee of Medical Journal Editors (ICMJE), entitled "Sharing Clinical Trial Data":
As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication.
Reasonable enough, you might think. But in the new commentary from the International Consortium of Investigators for Fairness in Trial Data Sharing -- which doesn't seem to have any online presence currently -- a group of "282 investigators in 33 countries" (pdf) beg to differ:
Although we believe there are potential benefits to sharing data (e.g., occasional new discoveries), we believe there are also risks (e.g., misleading or inaccurate analyses and analyses aimed at unfairly discrediting or undermining the original publication) and opportunity costs (e.g., the ICMJE proposal would have enormous direct costs and would probably divert resources, both financial and human, from the actual conduct of trials).
It's rather telling that the new discoveries that arise from research are dismissed as "occasional," while the rather weird concern about "discrediting or undermining the original publication" is put forward as if it were a major problem in the field. The International Consortium of Investigators for Fairness in Trial Data Sharing has a few suggestions for what should be done instead of the ICMJE proposal:
The timeline for providing deidentified individual patient data should allow a minimum of 2 years after the first publication of the results and an additional 6 months for every year required to complete the study, up to a maximum of 5 years.
Five years' data exclusivity takes us into TPP territory. And then there's this:
Persons who were not involved in an investigator-initiated trial but want access to the data should financially compensate the original investigators for their efforts and investments in the trial and the costs of making the data available.
You may have thought research was about winning new knowledge and willingly sharing it with your peers, but in fact it's about money. Actually, what is most shocking about the International Consortium of Investigators for Fairness in Trial Data Sharing's opinion piece is not what it says, but what it doesn't say. The whole thrust of the piece is what a tough life researchers have:
To complete an RCT [randomized, controlled trial], investigators must develop a protocol, obtain funding, overcome regulatory and bureaucratic challenges, recruit and follow participants, undertake analyses, and publish the results. This process takes several years, and for large clinical trials it can sometimes take a decade or longer. Adequate incentives for researchers to invest the substantial time and effort required to conduct RCTs and to publish the results in a timely fashion are important.
But at least it's a noble struggle, you might think, since this is all done for the patients' benefit. Or maybe not:
A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data.
It's all about those career-enhancing publications, apparently. But it's not just the patients who are missing from the International Consortium of Investigators for Fairness in Trial Data Sharing's worldview. They are also ignoring an absolutely indispensable aspect of clinical trials. It's so important that the ICMJE's article begins by acknowledging it in the first sentence:
The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.
This is why the data that results from those clinical trials must be shared as soon as possible: because members of the public who volunteer to take part in them have literally risked their lives in order to benefit others. The idea that this data should be hoarded by the researchers for up to five years just so that they can squeeze out a few more articles that look good on their CV is profoundly insulting to the participants and their unsung selflessness.