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Friday, 02/16/2007 5:12:16 AM

Friday, February 16, 2007 5:12:16 AM

M2GEN is rolling! Like it or not!> http://www.redorbit.com/news/science/839603/he_holds_the_key_to_cancer_research/index.html?source=r_...

He Holds The Key To Cancer Research
By Carol Gentry, Tampa Tribune, Fla.

Feb. 13--TAMPA -- Every few days, a Federal Express truck pulls into the loading dock at Moffitt Cancer Center & Research Institute with another delivery of tumor tissues, snap-frozen in liquid nitrogen and stored in Ziploc bags.

A white-clad research technician signs for the cooler and takes it to the third floor, where each sample is assigned a bar-code number and stored in a freezer at -80 degrees Celsius until needed for research.

The identity of the donor is fed into a file that becomes part of an encrypted data set accessible to only a trusted few on the team of Tyron Hoover, whom the hospital calls the "honest broker." He holds the key to which patients go with which genes.

"He's the only one who can put the glue together, who can marry the data sets," says Edward Martinez, chief information officer for Moffitt. "It's like a giant jigsaw puzzle."

Hoover, medical director for the tissue bank project, is both a doctor and a lawyer. He briefly worked for plaintiffs suing doctors, until realizing his heart lay in medicine, he said.

As a board-certified pathologist, he's ideally suited to supervising an operation that analyzes, preserves and studies tissue samples. He uses his legal knowledge in dealing with issues of patient consent, research authorizations and compliance with federal privacy laws.

Because of strict federal laws governing medical privacy, all hospitals are paying large sums for security as they transfer information to electronic records. Over the past four years, Martinez said, Moffitt has spent about $30 million for its system from Kansas City, Mo.-based Cerner Corp., of which about $10 million went into security.

"We are as protected as any other hospital in the country -- or any financial institution," he said.

More Than 3,000 Patients Have Given Consent

Moffitt's challenge is especially great as it sets out to build the world's largest cancer tissue databank, which will contain genetic information from patients who received all their treatment elsewhere. The databank, part of Moffitt's Total Cancer Care project, will be developed jointly with Merck & Co. through a for-profit subsidiary called M2Gen.

Discussions over the databank funding continue. Merck has agreed to pay $95 million in cash and in-kind contributions over five years in return for match money that still needs to be approved by various public bodies: up to $28 million in cash and land from Hillsborough County, $15 million from the state, and $2 million in cash and land from the city of Tampa.

Meanwhile, Total Cancer Care is well under way. More than 3,000 cancer patients have given their consent for donation of their tissue to the databank since recruiting began about eight months ago, Hoover said. Moffitt Director William S. Dalton has said he hopes to have donations from 30,000 patients across the state within five years.

Moffitt works with an extensive network of hospitals and physician groups in the state, and so far it has enacted formal agreements on Total Cancer Care with four: Morton Plant Hospital in Clearwater, Sarasota Memorial Health Care, Parrish Medical Center in Titusville, and Center for Cancer & Research in Lakeland, an affiliate of the Watson Clinic. Hoover said negotiations are under way with eight more groups in the state, but declined to identify them.

Under the agreements, Moffitt pays the affiliates so that they can hire additional staff to process the tissues and paperwork for samples that will be sent to Moffitt for inclusion in the databank.

The invitation to cancer patients to donate tissues for the project has to make clear that there is very little chance they will directly benefit, Hoover said. It will be at least a year and probably longer before researchers can match the genetic "fingerprints" from different patients and their individual cancers to treatments that will work.

Or not. One purpose of the databank, Dalton has said, is to spare patients in the future from undergoing risky and painful treatments that will not benefit them.

'We're In A Biomedical Evolution'

Usually the one who invites the patient to participate is the surgeon who performed a biopsy and is about to remove a tumor, said oncologist Fred Schreiber at the Watson Clinic. That site has enrolled about 160 patients in Total Cancer Care so far, he said, with a wide spectrum of cancers.

"We're in a biomedical evolution that's huge," Schreiber said. Using current knowledge of DNA and genetic proteins, by studying the tissue samples, "we'll redefine what cancer really is," he said.

"We'll learn about new technologies, new treatments," he said. "We want to contribute to that effort because overall the goal is to cure cancer."

Schreiber said he's not aware of any patients turning down the request to sign up for Total Cancer Care, but that could change. Until now, the tissue donation entailed no extra time or discomfort, since it was being collected at the time of surgery.

Because it's important to do research on tissues from advanced cancers that are not operable, Schreiber said, patients who are in that group will be asked whether they are willing to go through an extra tissue-collection procedure in order to participate in Total Cancer Care.

Shannon Bouchard, a 41-year-old pancreatic cancer patient from Lakeland who is undergoing both radiation and chemotherapy, says she knows the tissue she donated to Total Cancer Care during surgery in December isn't likely to help her. On the other hand, she said, she has a 16-year-old daughter and 11-year-old son, so she cares about the future.

"If my daughter or grandchild or anyone else has [cancer someday], it will help them, possibly," Bouchard said. "I think it's a great idea."

Just on the off-chance that a discovery comes in time to help her or someone like her, Moffitt has to have a way to reattach the name to the tissue sample. That's where Hoover comes in.

He can pull up the encrypted database that bears the database of patients' names and match it to the one that bears the bar-code numbers for the tissue samples. Then Moffitt can get in touch with the patient -- assuming the patient has given permission for re-contact.

They've tested the system against accidental or purposeful breach of confidentiality and found the risk is "almost zero," Hoover said. "It's not absolutely zero, but it's highly unlikely. We take every precaution to make sure that doesn't happen."

Reporter Carol Gentry can be reached at (813) 259-7624 or cgentry@tampatrib.com.

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Copyright (c) 2007, Tampa Tribune, Fla.