Infectious disease specialists are concerned that a corporate decision by Pfizer to scale back its R&D spending next year -- plus a transition to China -- will further slow development of new antibiotic drugs.
Pfizer announced this week that it will lay off thousands of research and development personnel, shutter its major research facility in Sandwich, England, and shrink its central lab in Groton, Conn.
The moves, planned for 2012, are designed to preserve the company's profits when its biggest-selling drug, Lipitor (atorvastatin), loses its U.S. patent protection.
Company CEO Ian Read said Tuesday that the firm would spend only $6.5 billion to $7 billion on R&D next year, down from its previously announced budget of $8 billion to $8.5 billion.
His announcement indicated that Pfizer would reduce the number of therapeutic areas in which it would be seeking new products, but did not specify which would be cut.
But word spread to members of the Infectious Diseases Society of America (IDSA) that the company's antibiotic research would be relocated to China, prompting an outcry.
Pfizer confirmed the plan to 番茄社区 in a written statement.
"We will create a new anti-infectives research group in Shanghai, China. This unit will work on a portfolio comprised of candidates currently in progress at our Groton and Sandwich facilities. As we build an anti-infectives research unit in Shanghai, we will continue to run our existing clinical and pre-clinical programs in the U.S. over the next two years," the statement said.
The plan will not sit well with the infectious disease community, said Brad Spellberg, MD, of the University of California Los Angeles, and a member of IDSA's Antimicrobial Availability Task Force.
"It's just a crushing blow," he told 番茄社区 in a phone interview. He said Pfizer had been one of a handful of big companies in the antibiotic field and that the decision would have a crippling effect on antibiotic development.
Although it's possible that Pfizer will attempt to keep up the same level of effort in Shanghai, the results are likely to lag, he argued.
"You can imagine what that means functionally, when you have project teams with specific expertise who live in Groton, Connecticut," he said. "Do you think those people are moving to China? Highly unlikely."
Instead, Spellberg suggested, antibiotic research will be starting essentially from scratch in the new location, and some of the expertise gained in the U.S. and British labs may never be recovered or duplicated.
But Spellberg acknowledged that, to a large extent, Pfizer was facing an untenable situation.
The revenue potential for new antibiotics is far less than for drugs to treat chronic diseases, he pointed out. "You take an antibiotic for seven days and then you stop," Spellberg said, whereas drugs for diabetes or high cholesterol may be taken for life.
Compounding the problem, he said, is an increasingly hostile regulatory environment.
Spellberg said the FDA had fallen under the spell of what he called "radical skeptics" who have demanded that all new drugs -- including antibiotics -- be shown in some rigorous way to be better than placebo. This can be done directly in a placebo-controlled trial, or indirectly with a noninferiority study with a comparator drug that itself has been tested against placebo.
Although it sounds reasonable, neither type of study is possible for antibiotics, according to Spellberg.
The first antibiotics came on the market before clinical testing was mandated, and were accepted essentially on the basis of comparison with historical controls, he explained.
"There has never been a placebo-controlled trial of an antibiotic for life-threatening infections," he said. "It's unethical [and] impossible to do them."
As a result, Spellberg added, there are no drugs that can serve as acceptable comparators either.
The only remedy, he said, was to create a new economic environment for antibiotic drugs that would restore the financial incentives for R&D.
IDSA is backing legislation filed last year by Rep. Phil Gingrey (R-Ga.) called GAIN, for Generating Antibiotic Incentives Now, that would require the FDA to reevaluate its guidelines for antibiotic drug trials, increase the period of market exclusivity for qualified infectious disease products (including diagnostics), and give them priority review.
Lawmakers in Britain are taking another approach. Many in the country were stunned by Pfizer's plan to close the Sandwich lab, which has been a major source of employment and pride since it opened in 1954.
Members of Parliament said they would haul in Pfizer executives for questioning about the decision. They appear to be hoping that pressure from the government in one of the company's most important markets will spark a reconsideration.
Some 2,400 workers are slated to lose their jobs at the Sandwich facility, which is where sildenafil (Viagra), the antifungal drugs fluconazole and voriconazole, and the HIV drug maraviroc were invented.