You’ve said this was the first novel you wrote. What sparked the idea?
My world pivoted in September 2004. Humming with potential but trembling with uncertainty, I found myself encountering much that was new. A new daughter and a new job were the headliners of my life, but the responsibilities that came with both affected me. That Labor Day weekend, while visiting grandparents, I had just read a novel that was not that good. A two star rating would have been generous. I reacted with hubris, if not arrogance. “I could write something better than that,” I thought, never pausing to consider the truth of my statement, much less the work needed to execute it.
Later that month, the FDA yanked Vioxx (Merck’s blockbuster arthritis drug) from the market due to safety concerns. Soon company emails leaked, suggesting that executives had known about the heart troubles with the drug long before the FDA did. I wondered what would happen if the those same emailing executives not only knew about cardiac catastrophe with Vioxx but had actually planned it as a way to drive up profits for other drugs in their warehouse. Thus, the birth of a story. The writing began before the leaves started to fall that autumn.
Your novel is quite detailed on the medical aspects. What sources did you use?
Once I had the kernel of an idea, I began to read about other drugs that had received FDA sanctions. David Willman won a Pulitzer Prize for the Los Angels Times in 2001 for his reporting on events that led to the removal from the market of the once-powerful diabetes drug, Rezulin. That reporting demonstrated turn-of-the-century corruption with pharmaceutical payments to governmental regulators, which created an environment where dangerous side-effects could be ignored. My fictional drug, Anginex, and the history that goes along with it, is based on a set of real medicines called angiogenesis inhibitors. In reading about them, I did learn about their discoverer, kid-genius Judah Folkman, and their unusual side effects in the first generation of these chemicals that caused amyloid deposits.
Speaking of Anginex, you have several fictional drugs in the book. Where did you get the names?
Naming drugs was one of the most enjoyable creative parts of writing Control Group. I spent the first 7 years of my career with weekly interactions at work with pharmaceutical representatives, so I’ve heard many, many different trade names for drugs. It seems that powerful drug names have three syllables and include an “X” or a “Z”. If a drug name is able to get two of those letter in—think Vyoxx—all the better. They also have either an aspirational sound to them or hint at their target organ of interest.
So, “Anginex” met the criteria : three syllables, letter “X”, and “ex-out blood vessel growth,” also known as angiogenesis. When Mackie has that very conversation in the book about the name “sounding like a cardiac drug,” it re-tells a conversation I had with someone as I was wrestling over what to name the drug. I also choose “NuCor” for a cholesterol drug (“new for coronary artery disease” even though it does not obey the other rules), “Hepatazyme” for the ill-fated liver drug that sets the story off (organ of interest), and “Livoxx” for the drug that got the FDA interested in BioloGen in the first place and is revealed in Mackie’s Washington, D.C. Starbucks encounter. Of course, that is almost an anagram of the same drug that got me started with my own story.
The actual flaw in the drug Anginex seems fairly specific. How much if that is true?
In learning about actual drugs like the fictitious drug Anginex, I read up on actual angiogenesis inhibitors (such as the well-known drug, Avastin). I stumbled upon a medical article in the mentioned article from the journal F.E.B.S. that is part of Mackie’s search in the book. That article described, in basic science terms, the theoretical possibility of a biologic soot called amyloid clogging the kidneys and brain. With that tidbit of knowledge in hand, I had my mechanism in place to take a presumably safe drug and make it dangerous if the impurities were not recognized by the machines tasked with safety screening.
What about the NIH’s Computer-based Patient Record, CPR. Is that real?
Like the medicines from BioloGen, the CPR system is a fictitious medical record based on actual principles of early electronic medical records systems. Even in the earliest days of computerized medical records, both physicians and administrators recognized the potential risks of these systems. Not just the risks that inaccurate information being entered into the system; also, the risk that information might be altered to make the electronic record of the patient looked better than the patient herself.
Like the other first-generation electronic medical records, CPR tried to mimic the paper chart with digital tabs for demographics, vitals, exam, and lab tests. Like early generation computer programs, the software was password protected with a simple lock-and-key password. The characters at the NIH who would hijack CPR for the benefits it will bring Big Pharma find ways to bypass these rudimentary systems to suit their own purposes.
How familiar were you with the actual locations of the scenes in Control Group?
I chose the scenes for the novel based on locations where I had lived, worked, and traveled. When I wrote the first draft, I had already lived in Cincinnati, Ohio for 5 years. The trip that BioloGen took to Aruba was inserted during a second draft re-write that coincided with a medical conference I attended in Aruba. And 10 years before tapping out the first draft of the first chapter of Control Group, I lived in Washington, D.C. and worked at a local Starbucks, giving rise to both the scenes in that very store as well as the sidewalk scenes outside the Capitol and the Library of Congress.
The one exception to this general rule for this novel was that I had no direct experience with The National Institutes of Health. For that, I had to call upon both Internet and printed resources about the NIH in general and the Endocrinology department in particular.
Where did you come up with the idea for ADAM, the Automated Device to Acquire Molecules?
I had the great good fortune in 2003, a year before I knew I was ready to write a novel, to go behind the lobby doors of a pharmaceutical company. In that pre-iPhone era, I saw a smaller version of A.D.A.M. in Control Group. I also saw versions of conference rooms and collaboration that is loosely represented in the book. Once I made the decisions to write, many of these previous experiences came tumbling back from the past, ready to be reheated and served up in fictional form. I never had a chance to see a basement with molecular libraries the size of small cars being loaded by E.V.E. in-and-out of a working drug development system. But I wouldn’t have been surprised if it existed then. Even in that building in which I toured.