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, Sojourner. 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

A child of unconventional, British-born parents, raised in the bucolic countryside of Vancouver Island, British Columbia, her relentless pursuit of science began in a love of animals, carrying her through two Canadian universities to a University of Chicago PhD in pharmacology and tenuous postdoctoral positions investigating the pituitaries of whales and armadillos. The research sent her to sea with grudging whalers and to inhospitable deserts by night. She married fellow pharmacologist Ellis Kelsey, followed him for his work, and became a mother of two daughters. Lack of paid opportunities for a woman scientist sent her commuting to medical school in Chicago where she obtained an MD degree in 1950 at age 36, while her husband kept the home and family together. She was working as a G.P. locum tenens and as an editor for JAMA. After a stint in South Dakota, the family relocated to Washington in 1960 where she began her lengthy career in the FDA, rising through the ranks to positions of prominence. Not long after the move, her stance on thalidomide earned her the Distinguished Federal Service Award of 1962, presented by President J​ohn​​ ​F. Kennedy. It also brought widespread admiration, mountains of fan mail, several other honours, and the resentment of male colleagues. Ellis died suddenly in 1966, but she kept working into her 90s, taking on the public-health challenges of other notorious “remedies” seeking approval. Kelsey’s fame eventually subsided but rose again in 2015 with late honours and her death at 101 years of age.  

Cheryl Krasnick Warsh​,​ who lives and works on Kelsey’s parental home of Vancouver Island, has given us a wonderful biography. With many previous publications in gender history and the history of alcohol and other drugs, Warsh is well placed to handle this vast and ​multifaceted​​ ​topic, sensitive to the misogyny of Kelsey’s century and with expertise on the nature and fortunes of licit and illicit substances.  

In twenty short chapters, Warsh divides this long life into three ​​segments– before​,​ during, and after thalidomide– and identifies her subject in three different ways. She describes “Frankie’s” early years in simple prose, reminiscent perhaps of Gertrude Stein or Emily Carr. Quirks and disputes in the Oldham home become evidence of a high-functioning, dysfunctional family. As a young woman, “Frances Oldham” delved into science studies at what would become University of Victoria and McG​i​ll in Montreal but made the ​trip ​back home every summer. She slipped into the laboratory of distinguished pharmacologist E.M.K. Geiling at the University of Chicago, when he believed the applicant was male. Despite his initial skepticism, Geiling fostered her career and supervised her doctorate. In 1937, she worked on the lethal side-effects of elixir sulfanilamide and determined that the solvent was responsible. At that time, she also became interested in researching harmful effects of pharmaceuticals on pregnancy and explored the legal protections (or lack thereof) for their consumers. With Geiling and Ellis Kelsey, Frances Oldham wrote a pharmacology textbook, one of the first in America, that went into four editions. These experiences, her medical degree and the work with JAMA were excellent preparations for her concerns about thalidomide. Now she was “Dr Kelsey,” one of two in the same home. 

Kelsey first doubted the value of this new drug when the side effect of peripheral nerve damage seemed to have been excluded from the incomplete applications and their inadequate trials. Further delay allowed for the early reports of fetal damage (coming from newspapers rather than manufacturers) to add to the concerns. While she succeeded in blocking the approval of thalidomide, it had managed to make its way into the US anyway, in the form of free samples given to practitioners sloppily engaged as researchers in shoddy “clinical trials.” Warsh carefully tracks the resultant American harm through reports of at least 56 damaged or dead infants documented in a survey of city health officers in 1962—probably merely the tip of an iceberg. She also probed the tragedy’s impact on attitudes to abortion, respect for the disabled, and increasing caution over medications. 

Beyond the thalidomide story, this biography provides a good sense of the evolving field of pharmacology and interesting chapters on the thorny history of several famous drugs–Krebiozen, laetrile, dimethyl sulfoxide (DMSO), artificial sweeteners, and diethylstilbestrol (DES)–and the harmful impact of Xrays on the pregnant belly. Kelsey found support from other women scientists, in particular Barbara Moulton and Helen Taussig​,​ who became her friends. 

Warsh has tapped into a wealth of sources—extending well beyond the numerous publications, FDA documents, and newspaper reports. She interviewed Kelsey, aged 99, in 2014 and spoke with her colleagues, daughters and other family members. She made excellent use of the personal papers, sorted by the pharmacologist herself with the help of FDA historian John Swann; they contain more than 78,000 items and occupy more than 100 feet of shelving in the Library of Congress. Moreover, Warsh follows the court decisions, changing legislation and rules governing not only drug approvals but ​also ​the ordering of female lives in terms of employment and reproductive freedoms. Yet she handles all this information with a deft light touch, accessible language and playful humour.  

A great read about a great scientist and a fascinating era in biomedical science. 

Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide
Warsh, Cheryl Krasnick
Oxford University Press. 
New York, 2024-03-15

Photos of Frances Oldham Kelsey from Wikicommons

Cheryl Krasnick Warsh Interviewed at Library of Congress

We feature four different angles addressing the opioid crisis, mostly as the opioid product OxyContin is involved and as the Appalachian region is affected. Our objective is to show how realms outside Biomedicine—the Humanities, in this case—can provide a range of perspectives suited to preferences, interests, and needs for understanding a particular issue. The four angles we feature are: nonfiction investigative journalism; nonfiction dramatization; narrative nonfiction; and literary fiction. We consider different approaches to selecting the best choice or the best order among available options.

Source Citations:
Macy B. Dopesick. New York; Little, Brown, and Company, 2018
Strong D. Dopesick. John Goldwyn Productions, 2021 (streamed on Hulu)
Keefe PR. Empire of Pain. New York; Doubleday, 2021.
Kingsolver B. Demon Copperhead; Harper, 2022. (Winner of the 2023 Pulitzer Prize for Fiction)

Links:
Russell Teagardens According to the Arts blog pieces mentioned in the podcast: 
Dopesick (nonfiction book – investigative)
Dopesick (TV miniseries)
Empire of Pain (narrative nonfiction)
Demon Copperhead (novel)

Russell Teagarden’s article in The Pharos comparing Dopesick (the book and the TV miniseries) with Demon Copperhead

Recommendations:
De Quincey T. Confessions of an English Opium-Eater. New York; Penguin Classics, 2003. (See Russell Teagarden’s blog piece on this book here.) 
Daudet A. In the Land of Pain. (Translator Julian Barnes) New York; Alfred A. Knopf, 2002. (See Russell Teagarden’s blog piece on this book here.)

The Clinic & The Person is a podcast developed by our editor Russell Teagarden to summon or quicken the attention of health care professionals, their educators, researchers and others to the interests and plights of people with specific health problems aided through knowledge and perspectives the humanities provide.

Feature photo by ANTIPOLYGON