The question put to Rochester author Paul John Scott about his new novel was simple: Can it be this bad in the real world?
Scott, a veteran health and science writer, has written his first novel. Called “Malcharist,” it is a completely made-up story about a potentially dangerous drug being put on the market — with outsourced drug trial research, ghostwritten studies, lack of access to raw drug-trial data, and doctors essentially paid to champion new drugs.
It is fiction, right?
“As far as I know the basic mechanisms depicted in this … are all still humming along,” he said this week in an e-mail exchange. “But the book is indeed a heightened convergence of those practices for sure.”
Scott’s novel is the first published by Samizdat Health Writer’s Cooperative, a Canadian publisher addressing the broad category of health information. This publisher clearly thinks Scott has created a story grounded enough in reality for people to learn a lot about pharma industry practices and our health.
Scott, health correspondent for Forum News Service out of Fargo, has contributed to various publications including the Star Tribune. It wouldn’t be possible to write so clearly about a complex industry without a deep understanding of it, and Scott clearly has that.
Scott described drug company-funded patient-advocacy groups demanding a new drug treatment, a celebrity doctor who doesn’t bother to read the ghostwritten speech he’s being paid well to deliver, slickly packaged PR pitches based on nonsense served up to an ignorant reporter and flat denials of dangerous drug side effects.
“I wanted to get them all in,” Scott said, of industry practices. “I probably left a lot on the table.”
Scott’s novel is actually a thriller, with not-quite-believable villains who need to be exposed. Yet it’s too wonky to be a beach read. There’s even a conversation over the probability concept of p-values.
Scott started work on this seven or eight years ago, having by then spent years as a science and health journalist. When he first got into the field, magazine budgets were bigger and he would be paid to go to academic meetings in health care.
“Eventually, I went through an evolution where I met some people who had been harmed by medications pretty seriously and yet found, like, very little interest in others hearing about their experience,” he explained.
One day he realized people try to block out what he called “unhappy facts” about the prescription medications they take. They don’t want to hear about them.
Scott has created a deeply flawed hero in “Malcharist” to sort out the unhappy facts, a just-getting-by Minneapolis freelance magazine writer. He writes for a second-tier young men’s lifestyle magazine that’s most interested in stories about how to pull off a romantic lobster bake.
Among our hero’s blunders was personally taking a new drug with a dangerous side effect, a very real-world condition called akathisia. The condition is a kind of acute mental restlessness that is a documented side effect of some approved drugs. It wasn’t clear at one point whether he would still be alive on the last page.
This journalist missed a few clues to arrive so late at the realization of potential danger with this new drug, one that its maker hopes turns into a multibillion-dollar franchise.
He had help along the way from a ghostwriter of drug-company studies and speeches and a professor who had turned into a critic of a market-leading antidepressant.
Scott takes his writer into one of those medical meetings he once found so cool, and his book reproduces enough of the numbers — yes, number tables in a thriller — that the reader can see the fictional speaker’s good point that the data really do give up their secrets.
The acts of villainy aren’t what are unsettling about this novel. It’s that so much of the story lies hidden in plain sight.
The drug at the heart of the story was derived from a popular antidepressant and approved as a treatment for stress fractures suffered by runners and triathletes. That’s not much of a business opportunity — unless the maker can get it to catch on as a drug to prevent injuries, too.
It’s not necessarily proper to market a drug “off label,” meaning sold to treat conditions without regulatory approval, but physicians can prescribe a drug for some other condition. For that to be a big business opportunity, though, first somebody has to put that idea into enough doctors’ heads.
And in the story that Scott wrote, the best people to do that are other doctors — what the industry calls key opinion leaders.
Realistic? Well, it has been shown that Purdue Pharma, creator of the OxyContin product that played a big role in what later became known as the opioid crisis, over five years paid about 5,000 physicians, nurses and pharmacists to go through its speaker training.
Have controversies erupted over drug trials? Absolutely, including a 2001 study about a popular antidepressant called Paxil used to treat kids. The trial was formally reevaluated many years later, and these new researchers found the previous conclusions to be flat wrong.
This original Paxil study was a big part of the story when global drugmaker GlaxoSmithKline in 2012 agreed to plead guilty to criminal charges and pay $3 billion to settle criminal and civil liability for, among other things, promoting drugs for unapproved uses.
The action in Scott’s novel takes place years ago, and he said via an e-mail that the industry behaves better now. Yet he continues to have big concerns, including how drug research is done and how underappreciated side effects like akathisia are.
Scott might not have meant to lead the reader to another big conclusion, but it’s going to be hard to think about the global pharmaceutical industry in the same way again.
A drug company is not just a group of scientists in search of more effective treatments for disease. It’s really a group of marketers with a drug compound in diligent search of a bigger market.