'Bitter Pills: Inside the Hazardous World of Legal Drugs' began as a personal quest for answers after my wife had a severe adverse reaction to one sample pill of a new, heavily-marketed antibiotic. It grew into a magazine article, which triggered an FDA investigation and won the 1993 National Magazine Award for Public Service Journalism. It eventually led to a five-year investigation of the entire pharmaceutical-industrial complex.
The book focuses on issues of international drug safety while exposing the inner workings of the Food & Drug Administration, the pharmaceutical industry, physicians, nurses, pharmacists, consumer advocates and the medical press. Unlike earlier books on these subjects, 'Bitter Pills' weaves a personal narrative through the hardcore investigative reporting, putting a human face on the 'legal drug problem.' Even though most investigative journalism pieces focus on illegal drug use, the truth is that legal drugs kill many more people each year than illicit drugs.
Adverse reactions to prescription and over-the-counter medications are the fourth-leading cause of death in America. 'Bitter Pills' is based on thousands of documents, many obtained from Freedom of Information requests from the FDA and other federal agencies. Others were rescued from discovery materials in lawsuits that were later settled and sealed. It is also based on an exhaustive survey of over 100 books and thousands of papers on various subjects pertaining to drug safety and the legal drug culture.
But 'Bitter Pills' also incorporates hundreds of interviews with government officials, drug company executives, lawyers, physicians, academics, consumer advocates, pharmacists, nurses and patients worldwide - as well as coverage of dozens of conferences in the United States and Europe. I knew nothing about the drug business when I started this project. And I was faced with several problems: how to develop enough expertise on a highly technical field so I could report and write credibly, how to journalistically handle the personal circumstances that got me interested in the subject so I might capture my passion for drug safety without being biased against drug makers, and how to humanize very technical issues.
The drug industry is rife with potential conflicts of interest, but so is the world of investigative journalism. I tried to face those conflicts head-on in my reporting, and I'd advise other investigative reporters to do the same. Because my use of Internet resources was so extensive, I published a guide to the sources in the book, which was updated and expanded for the recently published trade paperback.
There is also a large Web site for the book at www.bitter-pills.com, which allows for pretty extensive research by professionals and lay people. During the research for the book, my assistants and I obtained several electronic databases from IMS, the company that does the 'Neilsen ratings' of drug use. We also obtained adverse reaction reporting databases for different drugs from the FDA, and deposition databases from most investigative journalism various lawsuits.
Much of the material came for free or nominal charges (I'm good at begging, and the FDA will waive its FOI charges if you make the requests properly) but I did have to pay stenographers for some of the depositions. In fact, the FDA is so strapped for cash in its investigative branches that I was asked to donate my copy of a deposition which cost me $500 - to the regulators because they couldn't afford it and couldn't go ahead with their investigation without it.