Managing the Risks of Prescription Drugs
This web site is about my work in drug safety. For three decades I have investigated this fascinating issue that lies at the junction of medicine, science, business, government, and law. I have explored and written about how doctors prescribe drugs; the scientists who discover them; and the extraordinary business organizations that develop, test and sell them. I have investigated in depth how drugs are regulated and the system through which a drug's benefits and risks are weighed. In addition, I have spent many years involved in pharmaceutical litigation that arises from unsafe or improperly marketed drugs.
Drug Safety Research
My consulting and research are conducted under the umbrella of Drug Safety Research, a sole proprietorship with offices in Alexandria, Virginia. I have worked with lawyers, the national news media, and pharmaceutical fraud prosecutors on a wide variety of projects. Legal issues include Medicaid fraud, whistleblower suits against pharmaceutical companies, and the legal cases that may surround the safety withdrawal of a drug.
I'm the author of four books about medicine. Prescription for Disaster examined the entire system through which drugs are discovered, tested, sold, monitored, and regulated. Deadly Medicine told the dramatic story of the nation's worst drug disaster, in which tens of thousands of heart patients were killed. Lifespan: Who Lives Longer and Why examined the results of the modern quest for a longer life. Heart Failure was an anatomy of modern medicine today seen through the lens of coronary care.
Scientific Studies and Articles
After a decade of writing books that increasingly focused on prescription drugs, I discovered that few others had researched the questions I thought were the most interesting or important. As a result, most of my publications since 2000 have appeared in peer-reviewed scientific journals. I am co-author of more than 30 scientific studies focusing on clinical trials, US Food and Drug Administration regulation of therapeutic drugs, adverse event reporting, pharmacovigilance with electronic health records, and the risks of psychoactive therapeutic drugs. For 10 years I was project director for QuarterWatch: An Independent Perspective on Emerging Drug Risks, a drug safety publication of the non-profit Institute for Safe Medication Practices.