Research fraud

Myron Yaster MD, Elliot Krane MD, Mark Schreiner MD, and David Polaner MD

“You are entitled to your opinion. But you are not entitled to your own facts.”

― Daniel Patrick Moynihan

You are probably reading the PAAD because it is simply impossible to keep up with the medical literature, even in a narrowly focused specialty like pediatric anesthesiology. There are too many journals, articles, novel medical breakthroughs, important quality improvement initiatives, editorials, and updated clinical guidelines. Over the past 3 + years we’ve been doing our best to honor the memory of the late Dr. Ron Litman and cull and curate articles from major medical journals, newspapers, and magazines to provide you with the best of what ‘s out there. But what if some of these articles from even the most prestigious journals are FAKE?

Take a moment and just think about this statement: “In the space of a year, the presidents of Harvard and Stanford universities have both been forced to step down amid allegations of research misconduct or plagiarism, and the Dana-Farber Cancer Institute has requested half a dozen retractions and many more corrections.”[1] We’ve discussed scientific fraud and misrepresentation in several previous PAADs and today’s PAAD just rocked me to my core.

The focus of today’s PAAD is an article by reporter Ben Taub published in The New Yorker[2] magazine. Taub’s reporting reveals an (almost) unbelievable tale of research fraud that affects just about everyone reading the PAAD and who has ever taken an anesthesia written Board examination. You know that the metabolism of codeine to morphine by the liver enzyme CYP2D6 is a crucial step for analgesic effects. CYP2D6 polymorphisms significantly impact the extent of demethylation of codeine leading to both poor metabolizers (little to no morphine) and ultra-rapid metabolizers (rapid/extensive metabolism to morphine with risk of toxicity). Much of the pioneering work that produced this insight was performed at the Hospital for Sick Children in Toronto by a pediatric pulmonologist and pharmacologist, Dr. Gideon Koren[3, 4]. He published over 2,000 articles during his academic career. Over the course of my career, I met him on several occasions and attended and listened to many lectures he gave on pediatric and neonatal opioid and sedative pharmacokinetics and genetics. He was awe-inspiring and a legend in pediatric and neonatal pharmacology. Unfortunately, and to my great shock, some (much? most? all?) of his work may be fraudulent. In today’s PAAD, reporter Ben Taub looks at one of Koren’s most important papers in which Koren “found” that a mother who was an unknown ultra-rapid CYP2D6 metabolizer and who was being treated with codeine following childbirth passed on a lethal opioid dose to her infant baby via her breast milk.[5]

It turns out this was junk science, yet few of his work have been formally retracted by the journals in which it was published. In today’s PAAD, I’ve asked Drs. Elliot Krane, Mark Schreiner, and David Polaner, who are on the PAAD’s executive council, and who frequently write on data fraud, to assist. To be honest, I’m still in a state of shock as I write this. Finally, I’d urge all of you to read Taub’s article in its entirety and discuss its implications in your local and national education conferences. Myron Yaster MD

Original article

Taub B: A reporter at large: Did a Celebrated Researcher Obscure a Baby’s Poisoning? After a newborn died of opioid poisoning, a new branch of pediatrics came into being. But the evidence doesn’t add up. The New Yorker; January 28, 2026

https://www.newyorker.com/magazine/2026/02/02/did-a-celebrated-researcher-obscure-a-fatal-poisoning [Note: this article might be behind a paywall for some, particularly outside of the US]

The back story: During a full-term, uncomplicated vaginal delivery, a Canadian mother’s obstetrician performed an episiotomy. Her doctor prescribed Tylenol #3 (300 mg acetaminophen + 30 mg codeine) for pain with the instructions to take 2 tablets in the morning and 2 at night. Because these tablets made her too drowsy, she reduced her intake to one tablet at a time. She breast-fed her baby, who did well for about a week. He then at 12 days of age became progressively somnolent leading to a respiratory arrest. Unfortunately, he could not be resuscitated.

An autopsy was performed and blood samples were sent to the Hospital for Sick Children’s toxicology laboratories for analysis. The Hospital for Sick Children’s pediatric pharmacology and toxicology unit was world-famous and led by one of the world’s leading pediatric and neonatal pharmacologists and toxicologists, Dr. Gideon Koren. The autopsy found an anatomically normal child, but the blood toxicology revealed very high levels of morphine. The blood contained codeine, but in a concentration “more than a hundred times higher” than would be expected from consumption of breast milk. And it also revealed therapeutic levels of acetaminophen, again much higher than would be expected from breastfeeding. Koren and his team interpreted the morphine blood levels as being the result of ingesting breast milk from a mother who was a CYP2D6 ultra-metabolizer, and indeed tested a sample of his mother’s breastmilk, finding morphine present. This was so shocking that professional societies and government regulatory agencies concluded that codeine was potentially unsafe for breastfeeding mothers, and it was essentially removed from the marketplace for that indication.

Seems logical, doesn’t it, that an ultrafast metabolizer would have high morphine levels converted from codeine, and could pass this through breastmilk? Unfortunately, the simple mathematics of the pharmacology and pharmacokinetics made no sense. The amount of morphine in the child’s blood was simply too high, even if the mother were an ultrafast metabolizer, especially if she was taking only 1 tablet every 12 hours as she asserted; codeine and acetaminophen are minimally secreted to breastmilk. So how could codeine and acetaminophen be found in the postmortem blood? And even more alarming was that gastric contents were analyzed and found to contain both codeine and acetaminophen but not morphine, but in Koren’s report he described only morphine in the contents. Asserted by the New Yorker is that Koren’s findings and paper obscured the occurrence of a poisoning of the newborn by ingestion of acetaminophen with codeine, and pharmacologists whom the author consulted in writing this piece support this contention.

Since the paper’s publication, many pharmacologists and colleagues sounded the alarm and asked for outside reviews of the science and findings. Both the journal that published the findings and the Hospital for Sick Children’s leadership prevaricated and did not offer retractions.

Adding to this dispute are the facts that Koren and a colleague published a subsequent case report supporting his theory of codeine toxicity from breast milk, one in which he and his co-author entirely fabricated all the data and the facts. And for years Koren’s pharmacology laboratory at the Hospital for Sick Children performed forensic analyses of opioid in hair samples for law enforcement and Child Protective Services, used in. the prosecution in 8 cases and in decision making by protective services in thousands of cases, resulting in the removal of children from parents’ care. However, his laboratory was later found to have not had any training in forensic pharmacology, did not adhere to the rules of evidence and good standard practice, calling into question convictions. In one case he testified based on his lab’s measurement of cocaine in a child’s hair, resulting in a prison sentence for the mother. Koren’s laboratory was subsequently shut down by the Hospital, and Koren returned to his native Israel, surrendering his Canadian medical license with the promise not to apply for a medical license again in Ontario.

It now appears that the science behind codeine being dangerous for the infants of breast feeding mothers is untrue, possibly published errantly or possibly fraudulently, but in either case untrue. Regretfully, the journals that published the findings have refused to retract the articles for a variety of reasons, largely because of the difficulty adjudicating the veracity of ten-year old papers that are vigorously defended by the head author Koren and his co-authors. Further, many other papers published by this author, who has over 2,000 publications (which by itself seems implausible), are also now under suspicion. There are precedents and guidance for investigating prior publications for fraud. The journals and institutions involved should follow the established advice.[6]

Whether these examples represent out and out fraud, or the use of data and the ignoring of other data to support pre-conceived conclusions and biases, conscious or not, is not the case. The implications are enormous as with the many past and recent cases of scientific fraud that have come to light. Can we trust the papers we read? What is the responsibility of the journals when fraud is suspected? What is the responsibility of academic institutions whose faculty and staff commit fraud? Is there a role for government? Indeed, many fraudulent scientific papers are funded by the federal government. Alexander McCall Smith has speculated that misuse of funds might constitute financial fraud and though an extreme step, could involve the criminal justice system.[6] This also emphasizes the fragile but critical function that reviewers play in the scientific publication process.[7] Had a more careful review been performed, perhaps by better selected experts in the field, might the illogic of the paper’s assertions resulted in rejection, not acceptance, for publication in the first place?

Reporting like Ben Taub’s emphasizes this issue: There is a growing lack of public faith in science and medicine, one example of which is the ongoing epidemic of vaccine denial. If we cannot trust the published scientific literature, how can the public trust us?

Send your thoughts and comments to Myron (myasterster@gmail.com) and he will post in a Friday reader response.

References

1. Marcus A, Oransky I: An epidemic of scientific fakery threatens to overwhelm publishers. In: An epidemic of scientific fakery threatens to overwhelm publishers. The Washington Post; 2024.

2. Taub B: A reporter at large: Did a Celebrated Researcher Obscure a Baby’s Poisoning? After a newborn died of opioid poisoning, a new branch of pediatrics came into being. But the evidence doesn’t add up. In: The New Yorker Magazine. 2026: 28–39.

3. Ciszkowski C, Madadi P, Phillips MS, Lauwers AE, Koren G: Codeine, ultrarapid-metabolism genotype, and postoperative death. The New England journal of medicine 2009, 361(8):827–828.

4. Lam J, Woodall KL, Solbeck P, Ross CJ, Carleton BC, Hayden MR, Koren G, Madadi P: Codeine-related deaths: The role of pharmacogenetics and drug interactions. Forensic science international 2014, 239:50–56.

5. Madadi P, Avard D, Koren G: Pharmacogenetics of opioids for the treatment of acute maternal pain during pregnancy and lactation. Curr Drug Metab 2012, 13(6):721–727.

6. Smith R: Investigating the previous studies of a fraudulent author. BMJ (Clinical research ed) 2005, 331(7511):288–291.

7. Polaner DM, Shafer SL: Falling Dominoes. Anesthesia and analgesia 2019, 128(4):613–614.