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Who Owns the Data?

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Everyday, thousands of altruistic men and women participate in clinical research projects. They carefully fill out questionnaires, give samples of tissue or body fluids, and take drugs or placebos, all in an effort to improve our understanding and/or our treatment of diseases. Terrific advances have resulted from these efforts, such as the use of Herceptin to treat breast cancer or the identification of HPV as the cause of cervical cancer. But there are also many potential advances that have not been made precisely because, unlike preschoolers, many clinical researchers have not learned how to share!

Information and tissue samples are taken from patients with all sorts of diseases, from Alzheimer's and depression to cancer and heart disease. New technologies have made it possible for scientists to combine the molecular data collected from these patients' samples with data from clinical trials, and, almost like a massive jigsaw puzzle, piece together new therapies and figure out who should get which drugs-which is wonderful.

The problem is that this clinical trial data are typically collected by drug companies or academics specifically for their own trials on their own new potential medicines or pet theories. This means the data is often locked away in proprietary silos, where only select scientists get to use it. Drug companies and universities argue that because the data they get from the patients' samples have monetary value they should not have to share it with their competitors. Yet, even when a company changes its business model or is acquired by another company and studies that were underway are halted, they don't start sharing -- they just dispose of or lock up the data and the specimens. And so it goes. As a result, every pharmaceutical and biotech company conducting clinical trials has its own siloed set of puzzle pieces for new therapies that go un-shared -- and oftentimes un-connected.

Meanwhile, the participants whose efforts to contribute to the advancement of science and the health of man and womankind have no idea that their generosity has not been matched by that of the investigators! Surely, the participants in these studies would find it ridiculous that all of this patient data is secret. They would implore us to find a way to share the information -- or at least a part of it. Now, this is finally starting to happen.

A year ago Stephen Friend, the president of the non-profit Sage Bionetworks, which is forming an open source community where computational biologists and medical scientists can share data, and Sharon Terry at Genetic Alliance, a non-profit patient/citizen advocacy group, teamed up to see if they could convince a few drug-making companies to unlock the data in the comparator arms of their clinical trials. (Most drug company clinical trials have two "arms." In one, the patients are dosed receive the "investigational" drug. In the other (the "control" arm), the patients receive either no drug/placebo or the current standard of care. The control arm is also called the "comparator arm.")

Seven companies (GSK, J&J, Pfizer, Merck, Genentech, Lilly, and Medco) pledged to work to contribute at least one comparator arm data set from one of their clinical trials. The result: the launch of the Clinical Trial Comparator Arm Partnership (CTCAP), which Sage Bionetworks will curate and host data for all to use.

Here is where you can help. A year into this project, it is obvious that such data exists and that companies will release it. Paradoxically, these companies (kudos to J&J, Pfizer and GSK for leading the way) are more progressive than many academic researchers, who cite future publications as reasons to not share. As a result, even though these hero companies have achieved a "proof of effort," there will be a huge amount of useful valuable clinical trial comparator arm data that remains unshared.

This will not change unless WE make this issue visible. Here are three ways that WE, the public, can help to get this data released. First, we can ask our elected officials, who value transparency, if there are government policies that could be implemented that could catalyze greater sharing of this data. Second, we can talk to the drug companies at their shareholder meetings and ask them to be a leading examples by sharing data from the comparator arms of their trials. Third, we can open a dialog with the regulatory agencies, like the Food and Drug Administration (FDA), which oversee clinical trials and have access to all of the trial data. Since the FDA's mission is to advance public health by helping to speed the innovations that will make medicines safer and more effective, we can ask the FDA to encourage or even insist that the drug companies share this data.

The research data that pharmaceutical companies and academics have was obtained from altruistic people who wanted to help and be helped. It is wrong to not take advantage of their generous gift! As the founder of Dr. Susan Love Research Foundation's Army of Women initiative, I encourage women to participate in breast cancer research. We've been able to recruit more than 360,000 women willing to volunteer for more than 50 studies. With that said, I also strongly believe that we all need to be willing to participate in research but ONLY if the research will truly benefit everyone. Sharing of the data is an important component of an approach where WE will all benefit!