In the early 1980s, drug manufacturers Eli Lilly and Novo Nordisk introduced biosynthetic insulin to wipe out domestic producers and monopolize the world market for insulin products. Unlike animal-sourced insulins, “human” insulin could be mass-produced on a global scale, leading to exponentially greater profits. When thousands began to report serious adverse effects from using biosynthetic insulin, both manufacturers campaigned to silence them. The following are documentary sources related to the controversial introduction of “human” insulin.
Correspondence
Helga Kellner (Mother) and Mark Fleming (Eli Lilly)
Kellner, whose son went into a nocturnal coma while on human insulin, writes to Eli Lilly representative Mark Fleming in May 1998, begging his company not to cease production of animal insulins. Fleming responds by insisting that human insulin is perfectly safe and that Lilly is committed to finding a cure for her son’s disease.
Letters to the Editor
“Hubbard on DNA.” Letter to the Editor. The Harvard Crimson, 28 November 1978.
Ruth Hubbard responds to an article by Daniel Gil on the race between manufacturers Eli Lilly and Novo Nordisk to produce the first synthetic insulin from biotechnology. Hubbard disputes manufactures’ claim that a shortage of animal pancreas glands exists, necessitating synthetic insulin. She also observes that human insulin offers no clinical benefit over existing animal insulins.
“Diabetics need help to get access to insulin.” Letter to the Editor. Daily Press, 28 October 2005.
Andrew Rivard addresses the editor of the Daily Press regarding his 26-year-old girlfriend’s dire need for animal insulins. Explaining how his girlfriend, a mother of two, cannot tolerate human insulin, Rivard urges readers to support the creation of a system to guarantee the safe importation of animal insulins, following Eli Lilly’s planned withdrawal of animal insulins from the market.
News Articles
“Insulin Made by Genetically Engineered Bacteria OK’d.” The Lancaster New Era, 30 October 1982.
News clipping announces the FDA approval of Eli Lilly’s bacteria-engineered Humulin, which the president of the American Diabetes Association describes as “an exciting event in medicine.” The story mentions that an FDA official admitted “Humulin has not been proven clinically superior to animal-produced insulin” and that the new drug will be costly. FDA spokesperson Faye Peterson is quoted on the speedy approval of the drug—the first of its kind.
“Human Insulin Loses its Clean Appeal.” The New Scientist, 15 April 1989.
Frank Lesser reports on the association between synthetic insulin and loss of classic hypoglycemia warning signals. Lesser discusses research suggesting that medical providers’ promotion of newer (human) insulin is the result of pressure from manufacturers, rather than medical need.
“Change From Animal to Human Insulin Raises Questions.” The Indianapolis Star, 19 December, 1989.
Story cites a London biochemist’s remark on the spike in unexplained deaths among seemingly healthy Type 1 diabetics, followed by swift condemnation from insulin manufacturers and large diabetes organizations. Sherman Holvey, President of the ADA, is quoted regarding the lack of scientific studies linking hypoglycemia unawareness to human insulin.
“Change Disastrous for Some Insulin Users.” The Indianapolis Star, 19 December, 1989.
Eli Lilly’s hometown newspaper chronicles the growing reports of harm endured from users of Humulin by narrating stories of three individuals who crashed vehicles and/or nearly died on the drug. On the second page, the president of the American Diabetes Association dismisses as “emotional” those individuals claiming to have trouble transitioning to synthetic insulin.
“High Tech Human Insulin Risky, Swiss Team Claims.” The Edmonton Journal, 9 September 1991.
News item discusses two Swiss studies finding that patients transferring from animal to human insulin are prone to suffer dangerous side effects. The article also cites study authors’ claim that synthetic insulin offers no clinical benefit over animal products (a finding of the FDA—see “Insulin Made” in Lancaster New Era.)
“Diabetics Launch Fight to Keep Drug Available.” Calgary Herald, 14 September 1991.
Two Calgary women discuss their struggles using synthetic insulin, as well as their efforts to secure Canadians’ access to animal insulin.
“Human Insulin: Reality and Myths.” The Observer, 2 April 1995.
In this sponsored ad, the British Diabetes Association (BDA) condemns whistleblower Matthew Kiln, a diabetic physician who called for government action after nearly dying while on human insulin, and others “unnecessarily causing distress” about the dangers of human insulin. (The ad was published after a slew of news stories in the British press questioning the relationship between insulin manufactures and industry-funded patient advocacy organizations.)
“Diabetics Not Told of Insulin Risk.” The Guardian, 9 March 1999.
Paul Brown reports on the British Diabetes Association (BDA)’s suppression of a report finding that as many as ten percent of diabetics may suffer serious side effect on human insulin. The report was based on 3,000 letters sent to the BDA seeking the organization’s support. In the suppressed report, Brown writes, the independent researcher hired to review letters had quoted individuals who had lost their jobs, crashed vehicles, been refused a drivers’ license, divorced spouses, or generally reported that life was “absolutely hell” on human insulin.
“Eli Lilly and Rival Sued.” The Reporter-Times, 7 April 2000.
This news story relates the class action filed by Suzan Kawulok of New Mexico, accusing Eli Lilly and Novo Nordisk of maliciously suppressing evidence of the risks associated with Humulin and Novolin, respectively; withdrawing animal insulins from the market to force users to convert to newer, pricier human insulin; and preventing smaller manufacturers from producing life-saving animal insulins.
“GM Medicine Risks the Lives of Diabetics.” The Guardian, 6 May 2000.
Antony Barnett reports on the class action filed by Suzan Kawulok in the United States, noting the number of British diabetics also struggling to transition to human insulin. Barnett tells the stories of Mervyn Fletcher, who crashed his car and killed his mother-in-law after blacking out from an undetected low blood glucose, and Alasdair Padmore, a diabetic civil servant who stabbed his friend through the heart during a severe hypoglycemia.
“Patients, Doctors at Odds Over Medications.” The Baltimore Sun, 11 August 2006.
This Baltimore Sun story reports on the growing rift between patients and medical providers, as a result of providers’ refusal to take seriously patients experiencing negative outcomes on human insulin.
Peer-reviewed Articles
“Unexplained deaths of type 1 diabetics.” Diabetes Medicine. 1991 Jan 8 (1): 49-58.
Robert Tattersall and Geoff Gill coin the term “dead-in-bed syndrome” to describe the unexplained deaths of 22 patients, aged 12 to 43 years old, who went to bed in apparently good health. The authors conclude that hypoglycaemia or a hypoglycaemia-associated event was responsible for the deaths. While they do not implicate the species of insulin, they write, “all patients were taking human insulin at the time of death, but most had been changed from animal insulin between 6 months and 2 years earlier.”
M. Egger, G.D. Smith, H. Imhoof, and A. Täuscher examine case and control admissions from eight Swiss public hospitals to conclude that transfer of treatment from animal insulin to human insulin was associated with an increased risk of severe hypoglycaemia. Authors advise caution when transferring diabetic patients to human insulin and encourage further studies to explain the reasons for this effect.
Chapters/Books
Insulin: A Voice for Choice by Art Teuscher. Karger, 2007.
Teuscher, a Swiss physician whose patient died after transitioning to synthetic “human” insulin, explains the commercial and regulatory history of human insulin as well as the life-threatening side effects widely reported by patients using it. The author also discusses manufacturers Eli Lilly and Novo Nordisk’s decision to remove animal-sourced products from the market against the wishes of diabetics who could not tolerate synthetic insulin.
Redesigning Life?: The Worldwide Challenge to Genetic Engineering. Ed. Brian Toker. Zed, 2001.
In a section on “Medical Genetics, Science, and Human Rights,” Toker discusses how insulin manufacturers Eli Lilly and Novo Nordisk forced diabetics to transition to synthetic human insulin, resulting in widespread harms. Toker also mentions Natasha Posner’s report, based on 3,000 letters to the British Diabetes Association (BDA), which found that as many as ten percent of diabetics could not tolerate human insulin and that twenty percent preferred animal-source products. The BDA suppressed Posner’s report in 1999, claiming it was “too alarmist.”
Invisible Frontiers: The Race to Synthesize a Gene by Stephen S. Hall. Oxford UP, 2001.
In a chapter entitled “Tell me About Insulin,” Hall discusses the questionable evidence for human insulin, such as the unsubstantiated claim that synthetic insulin produced fewer allergic reactions than animal-sourced insulin. Hall also discusses the FDA’s cursory review of Eli Lilly’s Humulin, which was approved in less than four months based on trials conducted on a small number of participants.
Legal Actions
Suzan Kawulok v. Eli Lilly and Novo Nordisk. U.S. District Court of New Mexico.
The plaintiff, a resident of Bernalillo County, New Mexico, sues manufacturers Eli Lilly and Novo Nordisk for maliciously suppressing evidence of human insulin’s harms, misleading healthcare providers regarding the safety of the synthetic insulin, failing to implement protocols for supervising patients using human insulin, intentionally preventing other companies from manufacturing animal-sourced products, and more.
Organizations
The Insulin-dependent Diabetes Trust
Jenny Hirst, former representative of the British Diabetes Association (BDA), founded the IDDT in 1994 to investigate and respond to widespread reports of harm from patients transitioning from animal to synthetic insulin. The IDDT reported on the sudden deaths of 8-year-old Zoe Burbridge and 16-year-old Selina Trapp, among others. The IDDT also collected global news stories related to the dangers of human insulin and the drug industry’s crusade to protect the reputation of human insulin products.
The Diabetes International Foundation
Floridian David Groves founded the DIF to document adverse reactions to biosynthetic insulin and protect access to animal-sourced products. Before his death, Groves collected news clippings and media from across the world, some of which are still available on the now-outdated site.
Diabetes Inc.’s Colleen Fuller formed this organization in 2001 to unite Canadians and build a strategy to retain natural animal-sourced insulins. Growing to several hundred members across the nation, the SDR worked to inform physicians and people with diabetes about the problems experienced with human insulin. Fuller and others contributed to a widely viewed CBC broadcast on human insulin and testified before the Standing Committee on Health in 2003.
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