Malcharist began life as The Hemingway Effect, and possibly other things before that. For a long time it was The Placebo Suicides before Paul John Scott decided to experiment and see if people would buy a book with a title that didn’t conjure up images they might identify with – other than something vaguely dark and threatening. The book is a page-turner about the corruption of clinical trials told through a medical ghostwriter’s crisis of conscience.
Set in Manhattan in 2010 and laced with dark humor throughout its fast 352 pages, it finds Shivani Patel in its opening chapters in a Town Car with a private driver, “off to recharge the fading hopes of the neurotransmitter era.”
The reader has already met a clinical trial participant experiencing a terrible side effect, a magazine journalist desperate for paying work of any kind, and now the highest-paid ghostwriter for Krøhn-McGill Pharmaceuticals is suiting up to assist the world’s largest drugmaker with marketing a spinoff drug to a room full of Key Opinion Leaders in training.
Patel writes medical journal articles for authors TBD, doing so with data summaries generated by Contract Research Organizations. Hers is work destined to become the evidence base as doctors know it, and the folk who write the guidelines that dictate the treatments we get. She also writes clinical study reports, letters to the editor, review articles, commentaries, published clinical trials and CME – continuing medical education – material for doctors.
Unfortunately, she is “a relic from the weak, pre-industrialized evidence base,” according to her marketing director, “a scientist first, with all the risk that entailed.”
The plot never slows, switching chapters between the viewpoints of an interconnected cast of characters who bring this panoramic tale about the industrialization of medicine in our time to life, including:
- a down-on-his-luck magazine writer who is cajoled into promoting a new pill by a slick PR pitch,
- a telegenic KOL who has parlayed medical ghostwriting to fame, overstaying his welcome with his well-financed masters,
- a trial participant who has developed a terrifying preoccupation with death,
- a pharmaceutical marketing director who needs to make another 7 figures so that he can cash out and move to Florida,
- a widow who is seduced by a strangely well-endowed patient advocacy group, and,
- a regulatory boss who pals around with drug industry goblins on his weekend cycling trips.
Their paths intersect around a new drug that is the subject of a vigorous indication creep. It is a drug that has been rebuilt from an old drug, one itself having been rebuilt from an even older drug, a real-life medication that may have helped take the life of Ernest Hemingway.
We would tell you more but would rather you take the journey yourself.
We can tell you this: it is a work of fiction about subjects that never appear in fiction – akathisia, miscoding, protocol-switching, data-dredging, me-too drugs, CRO’s, KOLs, monoamines, astroturf groups, the illusion of data transparency – all wrapped up in a thriller that will have you turning to the last page. A thriller that will open doors to discussing the shortcomings of SSRIs and other drugs in polite company – something you couldn’t do unless it was ‘fiction’ and the conversation can be diverted to what is concealed under the skirts of key participants. Did she or didn’t she?
Scott has the writing skills to fold this all too real world into dialogue that will leave you in stitches in places, terrified in others, and glad this is not the world you live in – just fiction like The Handmaid’s Tale.
Buy it, read it and review it – we will post your review on Samizdat.org and in an update of Print your own teeshirt, we will give a glossy publication featuring your name – See https://samizdathealth.org/category/malcharist/
susanne says
from – Star Tribune
Rochester author takes scary look at Big Pharma in debut novel
It wouldn’t be possible to write so clearly about a complex industry without a deep understanding of it.
OCTOBER 9, 2020 — 3:42PM
Paul John Scott
by
MORELEE SCHAFER LEE SCHAFER @LEEASCHAFER
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.
lee.schafer@startribune.com 612-673-4302
ANON says
We need to have private investigators who work on behalf of the people, look into how rogue professionals are mistreating innocent people.
https://www.youtube.com/watch?v=P9K27HvhDxA
NO MORE EXCUSES! ~ catch them in their tracks, without the rogue professionals knowing who they are! This is the only way we can STOP a corrupt culture.
As for BIG PHARMA, medicines should only be prescribed if they benefit. If people have too many health issues, there should be MAJOR WARNINGS on patients medical history that clinicians should not prescribe medicines, (especially combining too many medications within a short time frame), like they are handing out smarties. Many medicines KILL especially if one is immunosuppressed and clinicians should err on the side of caution. I hope there are many eyes (benevolent souls), keeping a close eye on those who prescribe and do unnecessary procedures, knowing that the medicines(s) were the problematic cause/angst, right from the onset, prior to many souls passing away.