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Analysts: Moving Pfizer Antibacterials Unit May Delay Critical Research

Analysts: Moving Pfizer Antibacterials Unit May Delay Critical Research [the Day, New London, Conn.]

From Day, The (New London, CT) (April 8, 2011)

April 08--The World Health Organization, focusing attention on antibiotic-resistant bacteria, issued a policy paper Thursday on World Health Day intended to wake up political leaders about the paucity of antibacterial research. It's unclear, however, whether a change in national policy could come quickly enough to save some Pfizer Inc. jobs in Connecticut.

David Shlaes of Stonington, an industry consultant and former vice president for Wyeth Pharmaceuticals, said in a phone interview that most senior scientists at Pfizer's antibacterials unit in Groton already have found other jobs following the company's announcement that it will move its antibiotic research to China. This could jeopardize a proposal from UCLA infectious-disease expert Brad Spellberg that would move 25 top scientists from Pfizer to a $150 million public-private partnership at New Haven's Yale Science Park. The proposal is intended to spur more research in this field.

Spellberg wouldn't address questions about his proposal to keep top antibiotic researchers working in Connecticut. But he was hopeful about the potential for a public-private partnership geared toward antibiotics research.

"We need to find funding to make all this happen," he said.

In its policy paper, the World Health Organization urged governments worldwide to reduce regulatory bottlenecks and promote antibacterial research aimed at developing more life-saving drugs. Without new drugs, many currently treatable infections will become serious problems again, the health organization said.

Already, about 70,000 people in the United States die each year from drug-resistant bacterial infections. And the number is expected to increase if more antibiotics aren't forthcoming.

"The world is on the brink of losing these miracle cures," said Dr. Margaret Chan, WHO's director-general, in an online video statement. "The arsenal is shrinking."

The arsenal received a shock last month when Pfizer announced that its antibacterials research unit in Groton would be moving to China. Analysts said the move would delay by at least a year or two any serious antibiotic research at Pfizer during a time when the United States desperately needs medicines to fight life-threatening bacteria such as MRSA.

Pfizer did not respond to questions about the future of its antibacterials unit.

At least two pieces of legislation -- aimed at promoting more research on antibiotics -- are moving through Congress. The legislation is endorsed by the Infectious Disease Society of America, which sponsored a webcast Thursday in which a panel of experts spoke of the dire need for more ammunition against drug-resistant bacteria, or so-called "superbugs."

Jim Hughes, president of the infectious-disease society, called anti-microbial resistance an "urgent health crisis." Without more firepower, he said the United States could experience a time similar to the pre-antibiotic era of the 1920s and '30s, before the widespread use of such medicines as penicillin helped control common bacterial infections that killed millions of people worldwide.

"Tried and true antibacterial drugs are losing their value at the same time as the pipeline of new drugs is distressingly void," said Margaret A. Hamburg, commissioner of the U.S. Food and Drug Administration, during the webcast.

Hamburg said the FDA needs to do more to deal with the antibiotic dilemma. Among her concessions were that the agency must be more realistic about the size and length of required clinical trials and more mindful of the cost of such studies.

"At FDA, we will also continue efforts to streamline and modernize our regulatory pathways so that we can expeditiously review applications," she said.

Paul Miller, chief scientific officer at Pfizer's antibacterials unit in Groton, said on the webcast that a more predictable regulatory environment would be helpful. He added his support for legislation such as the Generating Antibiotic Incentives Now Act that offers pharmaceutical companies developing new cures an extra five years of protection from generic-drug competition if their antibacterial research proves fruitful.

"It will put the onus back on the scientists and pharmaceutical companies to discover these drugs, to provide the breakthroughs and to work with academic collaborators to advance the science," Miller said.

Miller added there currently is a disconnect between the value of life-saving antibiotics and what they cost patients.

"There's an expectation that these miracle drugs will always be here and they will be cheap," he said.

But antibiotics are different from other drugs, he said, because they take a while to catch on as medical practitioners use more established drugs until they start to lose effectiveness. Often, he said, antibiotics are still growing in value at the time their patents expire -- unlike other drugs whose sales spike earlier in their life cycles.

Shlaes, the Stonington antibiotics expert, said the United States needs a push-pull mechanism to spur more research. The push would involve federal incentives to conduct late-stage trials of new drugs, while the pull would involve the government guaranteeing markets for breakthrough medicines, he said.

"We have to enter an era of a paradigm shift in how society deals with antibiotics," said Spellberg, the UCLA scientist. "And we have to do so urgently because antibiotic resistance is only going to get worse."

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Posted: April 2011