Moffitt-Merck deal seems to help both, with patients the ultimate winners.
By KRIS HUNDLEY
Published February 2, 2007
Dr. Timothy Yeatman, professor of surgery at H. Lee Moffitt Cancer Center and Research Institute in Tampa, has been studying the biological markers of cancerous tumors for about eight years, gathering tissues and doing genetic analyses.
Over that time, the technology has improved dramatically, boosting scientists' ability to analyze more genetic data faster. And through Moffitt's Total Cancer Care program, which Yeatman directs, more than 3,000 patients from around the state have agreed to donate their tumor tissues.
While patients' identities are confidential, the tissue samples are linked to personal clinical information about the progress of the donor's disease and how it has responded to specific therapies. Researchers' goal: Identify the genetic "fingerprints" unique to certain tumors and develop drugs that target those specific markers.
As the opportunities have grown, so too has the cost. Moffitt, which received nearly $54-million in funding last year, has invested about $20-million in the effort. But costs for everything from processing the tissue samples to creating a data warehouse were quickly overwhelming Moffitt's best intentions. Which is why Yeatman, 48, was thrilled with the partnership drugmaker Merck & Co. recently signed with Moffitt.
"They're funding the project with a five-year commitment," he said. "We never could have done this much, this quickly, without Merck."
Merck is reportedly contributing $65-million in cash and $30-million of in-kind services to the arrangement. The county has promised, but not yet approved, up to $28-million for the project. In late January, the state also delayed approval of its $15-million contribution to the incentive package. The city of Tampa has agreed to contribute $800,000 cash and land valued at $1.2-million. The public funds will allow Moffitt to buy an undisclosed site near its current campus adjacent to the University of South Florida and build a facility to house M2Gen, the for-profit Moffitt subsidiary which will operate the tissue bank.
Yeatman said the drugmaker will be paying for personnel as well as contributing information technology and gene processing expertise. In exchange, Merck will share access to the one-of-a-kind database with Moffitt's researchers. It will be the only pharmaceutical company to have such access.
Yeatman said the Merck deal, 18 months in the making, was carefully constructed to avoid conflicts of interest. "We felt that if each party received value in different ways, conflicts would be less apt to happen," he said.
But critics of such ties between pharmaceutical companies and nonprofit research groups warn of possible pitfalls. Merck's handling of early Vioxx trials is cited as a classic example of how financial conflicts of interest can skew scientific research. When a study found that patients on Vioxx were three times more likely to have heart attacks than patients on Naproxen, Merck-funded scientists decided it was because Naproxen prevented heart attacks. It wasn't until four years later that Merck pulled Vioxx off the market because of concerns it increased risk of heart attacks.
Merrill Goozner, with the Center for Science in the Public Interest in Washington, D.C., said researchers' deals with drugmakers often come with strings attached. "And the strings can be debilitating," he said. "These restrictions can become the long arm of the private sector reaching in and acquiring public sector funds for its own purposes."
A Merck spokeswoman said it was a stretch to mention the Vioxx controversy in association with the Moffitt partnership.
"We are a responsible company," said Merck's Janet Skidmore. "This partnership is aimed at delivering ultimately greater knowledge about cancer and developing new medicines to treat people."
Moffitt's Yeatman said safeguards are built into Moffitt's drug trials that eliminate the chance for conflicts due to financial interests. And Merck has agreed to share intellectual property and royalties from any drug discoveries that might emerge from collaborative research.
"That's important because the cancer center is looking for ways to increase funds for research," Yeatman said of future royalties, which would be funneled back to Moffitt through M2Gen.
Merck also waived exclusivity on one key issue. Any drug company may use the database to find patients whose cancers may be particularly responsive to new drugs for clinical trials.
"Now we can find patients with the right profiles on day one," he said. "It's a revolutionary concept."
Yeatman said the matching process will give patients faster access to potentially lifesaving drugs. Drugmakers, meanwhile, will save money by getting their drugs tested on a specially targeted group.
"If clinical trial matching proves as valuable as we think it will, it will create a revenue stream for us," Yeatman said. "And opening up the database for matching purposes was never an issue with Merck."
Kris Hundley can be reached at firstname.lastname@example.org or 727892-2996.
What is it?
Merck & Co. is partnering with H. Lee Moffitt Cancer Center and Research Institute in Tampa to develop a cancer tissue databank that will be run by a for-profit Moffitt subsidiary, M2Gen.
Who gets what?
Moffitt gets a Big Pharma partner that will help speed development of the databank, which will contain genetic profiles of cancerous tumors as well as critical clinical information. Both Moffitt and Merck researchers will have access to the data to develop new drugs, sharing future royalties.
Who pays what?
Merck is contributing $65-million cash and $30-million in-kind services. Public funds include $15-million from the state, up to $28-million from the county and $800,000 cash plus land valued at $1.2-million from the city of Tampa. Neither state nor county officials have yet approved their contributions.
What's the status?
Neither state nor county officials have approved their contributions to the incentive package. The site of M2Gen's new facility also has not yet been disclosed.