Wednesday, June 22, 2011

Drug Industry Buying Up Academic Research Partnerships

Heidi Ledford in Nature--
--describes Pfizer's June 8 announcement that it was spending $100M on a research partnership with eight Boston area academic institutions, and adds that this is only one of a number of recently announced partnerships between drug firms and academic labs. (Yours truly is quoted briefly toward the end of the article.)

The article notes a number of important issues. In recent years, as described in HOOKED, the drug industry has been pulling research support out of the academic medical centers that used to do the lion's share of the late-stage clinical trials of new drugs, electing instead to go with commercial contract research oprganizations (CROs) that can do the job quicker and without academic-administrative red tape, especially if they can outsource the trial to less-developed nations where ethical oversight may be much looser. This more recent trend, however, is to link up even more tightly with academic centers for the earlier, molecule-discovery stages of drug development: "[T]hese relationships are becoming more important as the industry closes its research labs in response to falling profits." The loss of revenue due to the drying-out new drug pipeline (see for instance has crimped the big firms' research budgets, it seems, and sent them looking for more partners in academe.

Now, as I made clear also in HOOKED, it is nothing new for academic labs to discover promising new molecules and drug mechanisms, then to have industry swoop down later and scoop up the findings for commercial development. So why does Pfizer want to put $100M up front instead of just sitting back and letting the scientists in Boston chug along as they always have? Both sides, it seems, have realized that the old system was suboptimal. Ledford quotes Mark Pepys, an investigator in London:

"Yet industry's need for secrecy, and its tendency to change its research focus abruptly, can conflict with the more open and stable academic environment. Pepys experienced this first-hand in the 1990s when the Swiss drug-maker Roche abruptly terminated its collaboration with his team. He faced a long and costly battle to retrieve the intellectual-property rights to a compound developed during the project. A little later, Roche agreed to work on the compound with him again, only to prematurely end the collaboration a second time. Once more, Pepys had to fight to continue his work. 'It was a very expensive and tedious process that has delayed the drug by about ten years,' he says. 'And the clock on the patent is ticking.'

"Nevertheless, Pepys notes that without Roche's help, he would not have been able to develop a compound that, he hopes, will soon be ready for clinical tests in people with Alzheimer's disease. 'Nobody except big pharma can make a medicine effectively,' he says."

From their side, industry has been frustrated with previous, hands-off deals with academe:
"Shiv Krishnan, a senior director at French drug-maker Sanofi's branch in Bridgewater, New Jersey, notes that Hoechst, a German life-sciences company that Sanofi acquired, paid $70 million in the 1980s to fund research at Massachusetts General Hospital. In the end, however, the firm had little to show for it, Krishnan says. 'And why?' he asks. 'Because it wasn't collaborative. It was: I'll send you the cheque and you let me know when you have something.'"

So how do the drug companies propose to fix all this? "Pfizer says it will set up a lab in Boston that will house about 50 researchers — half of them Pfizer employees, the rest Pfizer-funded postdocs from participating academic labs. The team will work on projects selected by an oversight board comprised of academics and Pfizer executives. ... The various deals also aim to smooth over tensions between industry and academia. Duncan Holmes, who heads GSK's Discovery Partnerships with Academia initiative, says that the company will give research partners a year's notice if it chooses to end a collaboration and that, if it that happens, academics would be free to continue with the project. To ease worries about publication restrictions, many agreements stipulate the terms for publication ahead of time."

As we have described at length in previous posts, research funding, per se, seems less corrupting than arrangements that put money directly into the pockets of investigators, like consulting and speakers' fees. Moreover, as Kenneth Kaitlin of the Tufts Center for the Study of Drug Development (heavily funded by industry) adds, the universities now have a stronger bargaining position due Pharma's financial stresses: "Earnings at these companies are falling through the floor and investors are losing confidence."

While I applaud the increased attention to issues that have led to loss of trust in the past, I still agree with Harvard sociologist Eric Campbell: "You should not in any way accept the notion that these giant institutional agreements are without tremendous danger." In general Ledford's piece describes most of the dangers accurately, but one could have used greater emphasis. If university labs start acting more like the drug companies' in-house research labs, we can be pretty sure what will happen to the scientist who's on the verge of discovering a new drug to treat malaria or African sleeping sickness. She'll be told to drop that project and work instead on something that grows hair on bald men, or eliminates wrinkles.

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