Writing about my own experiences has proven to be far more challenging than writing about the adventures of Dr. Gwen Maulder in Capitol Reflections or penning two hundred scientific papers. However, when the Huffington Post asks, the only thing to do is try... so here it goes. How does a physician, scientist, inventor, entrepreneur turn into a novelist? First of all, I love reading novels and always wanted to write one. Secondly, it's kind of like the story of the Rabbi who gave out umbrellas instead of bibles to his bar mitzvah students. When asked by a colleague about this unusual practice, he said, "the umbrellas they will at least open someday." If I had written a nonfiction book, I'm not sure we would be here talking. A novel gives one license to illustrate the potential impact of bad policy in a manner that might be labeled alarmist in other genres.
My own path to becoming a writer has been completely unpredictable and, in retrospect, mostly enjoyable. As a medical student, I found myself drawn both to ophthalmology and to public health. I spent the first ten years of my career combining those two interests, first at Johns Hopkins University and then at Georgetown. Much of my research focused on identifying shortcomings in the healthcare system through analysis of Medicare and other insurance data and suggesting at a theoretical level how care could be improved. At a certain point, I began to feel as if I was writing the same paper over and over again and started designing software to improve the process of care. Before I knew it, I was running medical software companies instead of practicing medicine. This ultimately led to stints on the health policy front, first with the Clinton administration and then with the Bush White House.
It was in that latter context that the idea for Capitol Reflections was born. Although I ultimately wound up focusing my efforts on drafting the White House's initiative to computerize medical records, one of the positions that I was asked to interview for was that of FDA Commissioner. Over the years I have been involved with numerous drug development projects for both large and small pharmaceutical companies, so I thought I understood the "D" side of FDA. It was the food side that I knew much less about. I knew enough to know that most of the food inspection in the US is actually done by the Department of Agriculture, which is responsible for ensuring the safety of meat, fish, and poultry. I also knew that FDA was responsible for the rest of the nation's food supply, but I didn't know where the challenges were. I quickly learned that one of the largest challenges facing FDA in protecting the nation's food supply is developing a rational approach to the regulation and labeling of genetically-modified food.
In reality, genetic modification of food, be it plant or animal derived, has been with us since the days of the Bible. Those familiar with the book of Genesis will remember that Jacob and Laban struck a deal that they would divide their flocks by the color of the sheep, with Laban keeping the white sheep and Jacob to colored ones. In a seemingly miraculous manner, all of the new lambs wound up on Jacob's side of the bargain, the first recorded example of genetic modification -- albeit through selective breeding. Similarly, anyone who compares the corn that greeted the Mayflower Pilgrims -- termed "Indian Maize" today -- to the Silver Queen corn that graces our barbecues will realize that we have been genetically modifying crops through breeding for centuries. Moving a gene from one plant to another in a laboratory is not very different from doing so through cycles of breeding -- at least that's the way FDA has always viewed it.
What's new is that we now have the ability to take genes from plants not capable of breeding with one another, or even from animals and bacteria, and inserting them into plants in order to have those plants make a new gene product. The first example of this to reach the market was the "Kanamycin Tomato," a tomato genetically engineered to make low levels of an antibiotic and, thus, be resistant to rot. Our challenge is that Congress never envisioned such possibilities when the original Food Safety laws were passed. The laws say that no approval is needed from FDA before marketing food products for human consumption provided those products are not adulterated and provided they do not contain unapproved additives. The definition of adulteration is spelled out in the law and does not include genetic modification, since that science had not been imagined at the time. Some legal scholars believe a gene inserted into a plant to be a food additive that requires premarket safety approval, but this is far from a universal opinion.
The ins and outs of the issue are not something the average reader wants to sit down and digest in a scholarly article. Yet, the more I learned about the issue, the more I realized that it is one of the major challenges of the 21st century -- one that is likely to have a direct effect on our lives far sooner than global warming. As I thought more about the issue, I began to ask myself "what if." At some point, the question became, "what if the ability to make a genetically-modified food fell into the hands of those with nefarious intent?" That's how Capitol Reflections was born.
It's been amusing and instructive to read some of the early reviews. The plot elements that reviewers have thought the most farfetched are those that have actually happened, albeit to real people with different names. As many reviewers have viewed me as a rabid Democrat with an agenda as have accused me of being on the other side. I guess that means that the book is grabbing people's attention and generating a strong emotional reaction -- hopefully, enough of a reaction that Capitol Reflections will not be the last adventure of Dr. Gwen Maulder to make it onto readers' shelves.