'The Drugmakers': Stonington writer's novel shows how the industry works

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Stonington — David Shlaes spent more than three decades in the pharmaceuticals business, but he always had the impression few people really understood how the industry worked. 

"I don't think anyone understands what the pharmaceutical industry really does or what it's like or the pressures it works under," Shlaes said.

So Shlaes, a former industry consultant and vice president for Wyeth now retired in Stonington, set out to write a novel to help outsiders get a peek inside the laboratories, boardrooms and bedrooms of top scientists trying to develop life-altering drugs.

The result is "The Drugmakers," a 300-plus-page book that he is publishing himself following a successful first book, "Antibiotics - the Perfect Storm," published by Springer Science + Business Media in 2010. The first book, a call to action for the U.S. Food and Drug Administration to loosen restrictions on antibiotic developers, sold 12,000 copies, Shlaes reported.

Shlaes, who has a medical degree and a doctorate in microbiology from Case Western Reserve University, had no previous experience in writing fiction and in fact started the book with the intention of penning a memoir. He quickly realized, however, that fiction would give him more latitude to explore the good and bad of the U.S. drug-development system.

"I needed to have more freedom in my writing rather than stick to what had happened," Shlaes said in an interview last month at his home. "By making it a novel, it became easier and more fun to write."

It also was more of a challenge than nonfiction, taking him two years to write compared with the nine months required to finish his first book.

Perhaps unsurprisingly given Shlaes' first book, the FDA starts out as the bad guy in "The Drugmakers," impeding the progress of one promising drug. But the book's main protagonist eventually gets the FDA to back down and change its policies to help drive the drug to market.

"One thing I wanted to get across was how the players sometimes put their personal interests ahead of anything that makes scientific sense," Shlaes said.

Careers are made and lost based on personal connections rather than on sound science, Shlaes said.

The book, based on real-life experiences, spans a 20-year period that roughly correlates to how long it takes to bring some drugs to market. Shlaes said academia, biotechs and large drug firms similar to Pfizer Inc. are profiled in the novel, which traces the paths of several potential treatments, most of which wind up as failures.

"Like any business, it's a mixed bag," he said of the characters who inhabit his novel.

Shlaes said it is often in the interest of the bean counters — those who decide whether a certain line of scientific inquiry is likely to pay off — to block the development of new drugs rather than to take a chance that the treatment will work out. That's because pharmaceuticals is a risk-averse business in which successes are rare and huge failures can lead to the loss of a job.

"With drugs, most of the guesses are completely wrong at the end of the day," Shlaes said. "I think the industry would be better off if it paid less attention to the bean counters, especially early on."

Shlaes said the book explores the human element of drug making, including office affairs and internal politics. It also examines the kind of mindset scientists need to develop knowing that only about 5 percent of the time something they are working on is actually going to lead to a potential new drug.

"If you're a scientist, how do you deal with 95 percent of everything you're doing is going to fail?" Shlaes asks.

Shlaes' book also questions the metrics used to determine success in the industry. One executive in the book, for instance, randomly decides to target getting 10 drugs to the clinic every year hoping that a larger pipeline will mean more drugs succeeding, but Shlaes said this isn't necessarily so.

Similarly, a trend in the industry has been to develop performance ratings with an eye at targeting the bottom few percent of scientists for dismissal. This may work for the first few years, he said, but eventually all the dead weight disappears and people targeted for dismissal become more of an exercise in spotlighting personality clashes with manager than in zeroing in on poor performers.

"I hope people reading this book have a better appreciation for the risks the pharmaceutical industry takes," Shlaes said. "They should also get a better appreciation for the foibles of the industry."


Twitter: @KingstonLeeHow









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