Whistleblowing can be bad for your health
In her 2011 book Blood Feud (also published as Blood Medicine), award-winning journalist Kathleen Sharp describes a wrenching example of whistleblowing in the pharmaceutical industry about a drug designed to promote the growth of blood cells.
Beginning in 1992, Mark Duxbury and Dean McClellan became high flying salesmen for Johnson and Johnson, Ortho branch – happily promoting the anemia drug Procrit (or Epogen — erythropoietin). (Yes! that’s the same hormone sometimes abused by high-performance athletes.) Developed by fledgling Amgen, Procrit was licensed to Ortho for specific uses. The two salesmen rejoiced as their careers took off; during 1993, they earned bonuses and their stature rose. Soon however, Duxbury was being encouraged to promote the drug for off-label uses and in high doses—all to enhance sales. He began to realize that the drug was not safe when used in these situations: people were dying because their unnaturally thickened blood resulted in strokes and heart attacks. He was appalled by the fact that the company was giving kickbacks to prescribers who were making false claims to Medicare.
Duxbury raised objections with his employer. For voicing concerns, he was ostracized and then fired in 1998. Along with the stresses of his work, the financial difficulties, and emotional turmoil, Duxbury’s home life collapsed, his marriage fell apart, and he worried about his daughter, Sojurner. He developed multiple health problems, including sleep apnea and dependency on drugs and alcohol.
Duxbury enlisted the help of the famous lawyer Jan Schlichtman featured in the 1995 book, A Civil Action, by Jonathan Harr (also the famous 1998 film starring John Travolta). In 2003, they launched a qui tam lawsuit under the False Claims Act against his former employer. A qui tam case allows an individual to sue on behalf of the government (i.e. the people); if successful, the individual will be entitled to a portion of the proceeds. The process stalled but was revived in 2009. However, Duxbury died suddenly of a heart attack in October 2009 at age 49 with the case still unresolved. The potential value of his qui tam was unknown but was estimated to be 150 million dollars four years later.
Contacted by Duxbury in 2004, author Kathleen Sharp, initially hesitated to take up the project. After the FDA issued increasingly alarming warnings about the dangers of Procrit in 2006-7, she began to take his concerns more seriously. Relying on interviews and many documents from courts and private papers, Sharp reconstructed the events in a narrative that resembles a novel, with direct quotes and even the inner thoughts of the players. Duxbury’s death intestate comes as a shock to the reader, as it may well have been to the author. Reference notes support the unverifiable claims made in her narrative—placing it somewhere in-between “recreative” journalism and fiction.
Since the publication of Blood Feud, the case was referenced in an unsuccessful suit by Duxbury’s daughter Sojourner against her stepmother in 2013 and an appeal of the same year, which gave judgement to the defendant (i.e. not Duxbury). Duxbury v. Ortho Biotech has become an important precedent cited in other qui tam cases into the present.
Blood Feud raises concerns about the behavior of pharmaceutical companies in duping their own salesmen to generate income even at the cost of human life. But it also invites consideration of the too-often-neglected responsibilities of the health care profession and the government. The thorny legal aspects of the pharma industry and its regulation result in multiple lawsuits that contribute to the ever-higher costs of drugs.
Blood Feud: The Man Who Blew the Whistle on One of the Deadliest Prescription Drugs Ever
Kathleen Sharp
Dutton, New York, 2011: 432 pages
Web image by Medhum.org
