Patient advocate calls for retraction of mystery brain disease report from U.S. medical journal

An advocator for New Brunswick patients suffering from antithetic neurological symptoms is calling for the retraction of a caller technological study that recovered nary grounds of a enigma encephalon illness successful the province.

Katherine Lanteigne, the erstwhile enforcement manager of BloodWatch, is alleging probe bias and privateness breaches successful the study published past period successful the Journal of the American Medical Association, oregon JAMA Neurology.

Lanteigne said she has written to the University Health Network's probe morals committee successful Toronto and to the Horizon Health Network and its MIND Clinic successful Moncton. She intends to record ceremonial complaints of probe misconduct arsenic well.

She has asked the University Health Network, oregon UHN, to contented a formal apology for allegedly "flagrantly violating the privateness and dignity of patients."

"This study strips patients of their dignity, it runs roughshod implicit their protected privacy rights and is different illustration arsenic to however and wherefore patients are retraumatized by the aesculapian constitution that they should beryllium capable to trust," Lanteigne wrote successful her May 14 letter, provided to CBC News.

It's the latest improvement successful a statement implicit whether determination is simply a enigma caller illness, as Moncton neurologist Alier Marrero and 3 other physicians flagged arsenic possible nearly 5 years ago, and the quest for answers astir what's making radical sick.

The study, led by neurologist Anthony Lang, a elder idiosyncratic astatine UHN's Krembil Brain Institute, reassessed 25 of 222 patients diagnosed by Marrero arsenic having a "neurological syndrome of chartless cause." Their symptoms ranged from painful muscle spasms and hallucinations to representation nonaccomplishment and behavioural changes.

Study finds explanations for symptoms

The researchers concluded each 25 patients, including 11 who person died, had well-known conditions, specified arsenic Alzheimer's and Parkinson's, functional neurological disorder, traumatic encephalon injury, and metastatic cancer. 

Despite the tiny illustration size, "the chances of immoderate of those different individuals having a enigma illness was little than 1 successful a million," Lang has said, describing the numbers arsenic "very convincing."

The state continues to conduct its ain probe to "further recognize concerns" Marrero raised astir elevated levels of definite biology substances — specified arsenic dense metals and the herbicide glyphosate — in some patients, who helium says present fig much than 500 crossed 7 provinces. Fifty of them person died.

In her missive to the University Health Network, Lanteigne contends 5 of the 13 authors failed to publically disclose they had anterior engagement with the New Brunswick clump of patients, which she describes as "deeply problematic arsenic it demonstrates a probe bias."

WATCH | Woman says her stepdaughter's information was utilized successful JAMA survey without consent:

Lanteigne does not person immoderate technological oregon aesculapian training but said she understands nationalist argumentation and people's rights done her erstwhile advocacy work.

She said has work astir 30,000 pages of documents obtained done accusation requests astir the cases.

According to Langeigne, Sylvia Gautreau of the MIND Clinic, wherever Marrero used to dainty patients, did not uncover she served as researcher for the province's oversight committee during an probe into the archetypal clump of 48 patients successful 2021.

Much similar the JAMA report, that probe concluded the patients did not person a communal illness and offered "potential alternative diagnoses" for 41 of them.

Similarly, Lanteigne said, the documents amusement neurologist Sarmad Al-Shamaa and geriatricians Annette Thebeau and M. Jason MacDonald did not reveal they co-signed a missive with Marrero successful September 2020, alerting the province's main aesculapian serviceman of wellness astir "an unexpected accrued fig of cases of atypical rapidly progressive dementia" implicit the erstwhile 2 years.

This non-disclosure, according to Lanteigne, perpetuates a falsehood it was Marrero unsocial who had raised the alarm.

Meanwhile, she said, neuropathologist Gerard Jansen did not disclose helium contributed to the lawsuit explanation of the "progressive neurological syndrome of chartless etiology" that Public Health sent to doctors, nurses and different health-care professionals successful aboriginal 2021, advising them to beryllium connected the lookout.

"They person to disclose," Lanteigne contends, "because they reason that they're independent."

Researchers successful Canada are expected to disclose immoderate imaginable oregon perceived conflicts of involvement erstwhile they undertake a study.

Patient who declined was included

Lanteigne besides takes contented with consent being waived for a diligent who had declined. 

Stacie Quigley Cormier of Dalhousie Junction said her stepdaughter Gabrielle Cormier is the diligent included against her wishes.

Gabrielle, 23, 1 of Marrero's youngest patients, began exhibiting symptoms successful 2019, and present suffers from utmost fatigue, struggles with attraction and memory, and depends connected a cane oregon wheelchair.

According to Quigley Cormier, UHN called Gabrielle about using her information and she said no. UHN past sent an email, which Gabrielle did not respond to.

Although Gabrielle is not named successful the report, Quigley Cormier said they "could intelligibly see" it was her, which UHN has confirmed successful an email, shared with CBC News.

They "broke her spot and her privacy," said Quigley Cormier, who has besides requested a retraction and apology.

Marerro has 'many questions'

Marrero, successful an emailed statement, said helium has "many questions" astir the study's consent process and entree to patients' files.

"Numerous" patients oregon their families person expressed privateness concerns to him, helium said. Some of the published accusation could pb to patients' recognition due to the fact that it's specified a tiny radical of cases, helium said, calling it "troubling."

In addition, Marrero said he was not informed by the Public Health Agency of Canada's Creutzfeldt-Jakob Disease Surveillance System that immoderate of his patients' autopsy results were going to beryllium published, oregon adjacent that a survey including them was being conducted.

He besides questioned whether immoderate patients not portion of the New Brunswick clump were included, arsenic immoderate of the published pathology accusation does not correspond to immoderate diligent helium reported to the Creutzfeldt-Jakob Disease Surveillance System

"These disturbing facts make further disorder and mistrust." 

Lanteigne is calling connected the Public Health Agency of Canada to motorboat an investigation into the merchandise of diligent information from the surveillance strategy for the study. 

In a abstracted missive to the national agency, she contends the Creutzfeldt-Jakob Dsease Surveillance System unit is the "custodian" of autopsy results, speech from the referring neurologist and a patient's powerfulness of attorney, yet 7 patients whose families did not consent were included successful the report.

She besides wants the wellness agency to notify the 7 families and report what it's doing to guarantee it doesn't happen again.

Study abides by national guidelines, UHN says

CBC News requested interviews with the University Health Network and Lang. Both declined done the manager of outer communications, Ana Fernandes.

"It is not our signifier to remark connected unsubstantiated allegations oregon speculative claims," she said successful an emailed statement.

Asked whether the wellness web volition inquire JAMA to retract the report, Fernandes wrote: "UHN does not find whether a technological nonfiction is published oregon retracted."

But Fernandes stressed UHN is "committed to the highest standards of technological integrity, transparency, and ethical research." All of its objective probe studies acquisition "rigorous" oversight and support by its probe morals board, which operates nether federally regulated guidelines, she said.

"The survey published successful JAMA Neurology followed the established technological process, including third-party adjacent reappraisal by an internationally respected aesculapian journal," Fernandes wrote.

It "contributes caller grounds intended for information and mentation by the broader technological community."

Anyone with concerns should interaction UHN's research integrity office, she added.

JAMA officials did not respond to a petition for comment.

Co-author denies bias

Co-authors Gautreau, Thebeau and MacDonald each declined interviews done Horizon Health Network. Al-Shamaa was unavailable for comment.

Jansen, of Ottawa, declined an interrogation but successful an email said he antecedently had his ineligible squad contented Lanteigne a cease-and-desist missive implicit alleged "smear missive campaigns" against him since 2022.

He did not respond straight to Lanteigne's latest allegation regarding a deficiency of disclosure but said he assisted "very reluctantly" with processing the "cluster criteria" in late-2020 arsenic "no communal symptoms and causes had go apparent" successful his review of the patients' files.

Jansen, portion moving for the Public Health Agency of Canada, had concluded 8 radical thought to person a enigma neurological illness did not dice from thing caller and unknown, and published the autopsy findings online without the national agency's knowledge or approval.

In his email, Jansen denied immoderate bias. "My enactment arsenic [a] doc specializing successful these benignant of classifications require[s] maine to marque an autarkic appraisal of galore patients, earlier drafting immoderate conclusions," helium wrote.

Steps taken to guarantee 'fully independent' study

For the study, pathology accusation was "shared arsenic appropriate" with the University Health Network, Horizon and the Moncton Hospital astatine their request, fixed support by their probe morals boards, Jansen said.

It's mean for institutions to person correspondence copies connected patients they attraction for, helium said. Contact with the Public Health Agency of Canada "would person been unwanted arsenic the survey was to beryllium a afloat autarkic study, avoiding undue power from PHAC."

"The aforesaid is existent for the neurologist who saw these patients and who was besides astatine the cradle of this cluster: his consent oregon collaboration was not sought, not necessary, nor wanted for an autarkic investigation," Jansen said, referring to Marrero.

Informed consent was obtained "where possible," Jansen said. Otherwise, consent was waived by UHN and Horizon/the Moncton Hospital, according to nationalist standards, helium said.

All identifying accusation was removed, "making the accusation that privateness was violated utter nonsense," helium said.

"By accusing america arsenic authors, and sowing unjustified uncertainty connected a scientifically precise beardown and courageous study, Ms. Lanteigne interferes with the patients' imaginable to get a existent diagnosis and imaginable treatment," Jansen alleged.

PHAC says nary grounds privateness policies breached

The Public Health Agency of Canada is alert that immoderate radical person expressed interest regarding the usage of lawsuit accusation successful the survey published successful JAMA Neurology, said spokesperson Anna Maddison.

"PHAC takes concerns raised by patients and families seriously," she said successful an emailed statement.

"There is nary denotation that PHAC's privateness policies were breached successful transportation with this publication, based connected disposable accusation astatine this time."

PHAC was not progressive successful the planning, funding, oregon behaviour of the study, Maddison added.