Mercy Health will be part of gene map project presenting daunting legal issues

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by Cynthia Price
Legal News

The announcement came last week that Muskegon Mercy Health Partners will be engaged in a globally significant project to map the genome of specific cancers, in order to help find treatments and, perhaps, cures.

Mercy Health Partners (MHP) will be collecting tissue samples for use in The Cancer Genome Atlas, an all-encompassing project through the National Institutes of Health (NIH), managed by the National Cancer Institute and the National Human Genome Research Institute.

The cancer-mapping project will be carried out by tiers of organizations, and the International Genomics Consortium (IGC) is one of two national organizations performing the  processing, initial analysis and extraction of DNA and RNA, which the NIH calls being a Biospecimen Core Resource.

It was IGC that chose Mercy Health Partners to be a Tissue Source Site for the project.

MHP was formed from what used to be three Muskegon hospitals (two merged earlier into Mercy General Health Partners and in 2009 MGHP merged with the former Hackley) and is affiliated with the large Trinity Health network out of Novi. However, it is still a fairly small hospital, and it is a great honor to be designated as one of only 14 in the nation to collect tissue, and the only one in Michigan.

Dr. Robert Penny from the IGC explained his organization’s choice: in MHP CEO Roger Spoelman the IGC saw a clear and steady vision with the leadership skills to accomplish that vision. And in the rest of the team, led by Dr. Peter Shireman, the IGC saw the rigorous attention to detail the tissue collection requires.

For his part, Spoelman said that he had dreamed all his adult life of “being a part of finding the cure for cancer,” and is incredibly excited to play a role in what will be the best shot humans have yet taken at a cancer-free future.

The Cancer Genome Atlas, with the clever acronym of TCGA corresponding to the DNA building blocks Thymine, Cytosine, Guanine, and Adenine, will result in an on-line source of detailed DNA sequences found in 20 types of cancer.

And therein lies the legal rub. First, what does this mean for protecting patient confidentiality, as mandated in HIPAA (the Health Insurance Portability and Accountability Act) and other laws? Second, what about Intellectual Property concerns and patenting of the material?

Penny says that, to work through the process for answering these questions, the IGC was awarded an earlier grant from the NIH for a pilot project, called Expression Project for Oncology, or ExPO. The IGC spent “well over a year in meetings with legal patient advocacy groups, IP groups, attorneys ... When we put ExPO out there, that was a great comfort, to see that being successful,” Penny said.

The ultimate responsibility for patient confidentiality rests with the tissue source hospitals themselves. At the point that data come to IGC, patient information has been de-identified by MHP and safely encrypted. Only MHP personnel will have access to the actual identity of patients.

Different health care complexes and different software providers have widely varying methods of protecting patient confidentiality, and part of the process for MHP’s selection involved scrutinizing its patient confidentiality policies to be sure the highest standards were met.

According to Mercy Health Partners, the hospital recognizes that “preservation of the confidentiality, integrity, and availability of information is essential to the success of MHP” and has “extensive policies and procedures that properly safeguard the access and use of information...”

MHP patients must consent in writing, and there will be follow-up a year later, mostly to find out if cancers recur, correlated to treatment methods.

The project requires 500 samples of each of the cancer types. To facilitate exploration of potential differences in treatment responses by ethnicity, the information will be identified in the aggregate by ethnic background of the donors.

Data transferred electronically will be done only by numbers, previously assigned to each patient. The IGC will run a data validation program nightly to catch errors in the data capture.
The ExPO pilot project was limited to five types of cancer, and the “open source” information is currently available on the NIH web site.

For the much broader TGCA project, there will be two levels of access to the website: the general public can see “limited datasets,” and registered researchers may enter a more extensive data collection part of the site.

Regarding patenting the information on the sites, IGC is a non-profit and the NIH has a public welfare goal, so IGC worked with the Boston firm of Ropes & Gray, and came to the same conclusions as the Human Genome Project: “The raw material sequencing alphabetic information was not patentable,” according to Dr. Penny.

This is a policy issue that has been highly controversial over the past decades, but the consensus now seems to be that while the discoveries based on the mapped information are subject to patent, the genes themselves are not. In 1997, the United Nations (UNESCO) Universal Declaration on the Human Genome and Human Rights stated that “[the] human genome in its natural state shall not give rise to financial gains.”

But, as Penny stated, the overarching goal of the project  is to “translate the findings of the Human Genome Project to personal medical care.” It is the discoveries made by those developing treatments for cancer, made possible by the TCGA mapping project, that will be subject to patenting.

The IGC also made sure that the information mounted on the web did not infringe on any other entity’s patented information.

Most of the TCGA’s current funding came from the American Recovery and Reinvestment Act, or stimulus money. It is the expectation that cancer-map-related innovations will be worth billions of dollars, and similar amounts will be saved on future health care.

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