Stonington - With antibiotic-resistant bacteria killing more Americans every year in U.S. hospitals than died during the decade-long Vietnam War, David M. Shlaes says it's time for federal regulators to rethink policies that have encouraged major companies to abandon antibacterials research.

And the 62-year-old Shlaes, a drug-industry consultant and former vice president for Wyeth Pharmaceuticals, has penned a new book, "Antibiotics - the Perfect Storm," to make his case that the Food and Drug Administration should ease criteria for bringing new bacteria-fighting drugs to market.

"I'm hoping to win over some hearts and minds," said Shlaes during an interview in his hilltop home lined with books and classical music albums. "The FDA has become such a huge roadblock to developing new antibiotics."

Shlaes, whose book published by Springer Science + Business Media came out last month, said the FDA's thinking about antibiotic research changed when concerns over the agency-approved drug Ketek reached a fever pitch after its approval in 2004, fanned by politicians who know little about science or the pharmaceutical business.

Ketek caused liver toxicity in a few patients - no more than 1 in every 100,000 or so, according to Shlaes - but the FDA went overboard in its response by changing the way clinical trials are conducted for experimental antibiotics, he said.

Previously, the FDA approved new antibiotics without drug researchers having to prove they were any more effective than other products on the market; afterward, the agency started requiring stricter measurements of the treatments' effectiveness, including placebo-control trials that Shlaes said are nearly impossible to conduct because patients with infections don't want to take a chance on getting a sugar pill that would delay a sure-fire cure.

One of the problems, Shlaes said, is that the new requirements mean having to enroll more patients in expensive and time-consuming clinical trials. And the greater costs, he said, have forced many major pharmaceutical companies out of the relatively low-profit antibacterials business - one of the few drug sectors, ironically, in which patients emerge with a cure as opposed to a dependency.

"Only five of the 13 largest pharma companies today are in antibiotics," Shlaes said (Pfizer Inc., which has an antibacterials unit based in Groton, is one of the few left). "It used to be that every medium and large pharma company was in antibiotics."

Scarier still, with careers in antibacterials on a downward spiral, academics are starting to abandon the field, Shlaes said, meaning fewer students know how to do advanced antibiotic research.

"In the heyday, we were approving three to four (new antibiotics) a year, and now we're down to one a year, at best," he added. "Three years in the last decade, the FDA approved none."

The repercussions of reduced research commitments are clear, Shlaes said: fewer new antibiotics on the market to fight the so-called superbugs - such as MRSA and gram-negative bacteria - that are proving increasingly resistant to older medicines.

"You use it, you lose it," Shlaes said, reciting his mantra that older antibiotics are sure to lose their effectiveness over time. "If we do not have new antibiotics, bacteria will become resistant."

Statistics back him up.

According to the Centers for Disease Control, as many as 99,000 people die in the nation's hospitals every year from bacterial infections. About 70,000 of these deaths are from drug-resistant bacteria - well above the 58,000 U.S. soldiers who died during the Vietnam War era.

Without more antibiotics to face this growing threat, Shlaes said, the potential health fallout is enormous. Not only are hospital patients likely to be at greater risk of developing drug-resistant infections, he said, but these strains already have started to prey on the community at large.

What's more, Shlaes said, having effective antibiotics is one of the linchpins of modern medicine. Without them, doctors will no longer be able to perform various transplant operations and may be limited in implementing cancer cures and other complex procedures, he said.

"I don't know what it's going to take," said Shlaes, who has been active on various government advisory boards looking at the problem of drug-resistant bacteria, including a 2004 task force that issued a compelling report titled, "Bad Bugs, No Drugs."

"We published many reports, and we got nowhere," he said. "Nothing happened. It's like we didn't exist."

According to a report on the scientific impasse published two months ago in The Chicago Tribune, everyone seems to agree the world needs more antibiotics, but no meeting of the minds has occurred over how to balance the need for clinical trials that test drugs' safety and effectiveness with the necessity of finding new medicines fast. To Shlaes, the question is almost ludicrous. It's more important to have a variety of weapons against bacteria than to make sure every single one of the medicines is fully loaded, he said.

While the United States fiddles with solutions to the clinical-trials issue, Shlaes said, Europe is skipping down a different, more promising path. European governments are considering funding clinical trials to reduce drug companies' upfront risks while providing a guaranteed market for new antibiotics once they are approved.

But Shlaes said other incentives might also help, such as extending marketing exclusivity for firms' best-selling medicines if they develop new antibiotics.

"We're having bigger and bigger problems with resistance," said Shlaes, who regularly opines on his favorite subject in a blog found at http://antibiotics-theperfectstorm.blogspot.com/. "If we don't do something, we're going to be in trouble. I think we're already in trouble."

l.howard@theday.com