Thread by @DrNancyOlivieri

"A controversy..which raises uncomfortable questions about the influence of funding from #BigPharma in...Toronto health institutions" - which Dr. Brenda Gallie & I struggled to expose for years

thestar.com/news/investiga…
#Pharma #PatientSafety
👏🙏 @rachelmendleson @TorontoStar
🧵

A long struggle
-2009: @UHN expands use of *unlicensed* drug w/out evidence of #InformedConsent obtained from patients
-2019: UHN conducts a conflicted, internal, confidential 'review' which: "if your aim was to rig the result, is exactly what you would do"
🎯@FearLoathingBTX
/2

How can @UHN claim "appropriate safe care"? During exposure to this *unlicensed* drug over years:
1- Iron levels rose in 50% over the threshold for death
2- 65% patients developed liver injury
3- 17% acquired diabetes
And again, *no informed consent*
thestar.com/news/investiga…
/3

What were patients, many of whom were harmed, and families of patients who died, told?

"The duty to patients arises from the legal doctrine of informed consent, "the constitutionally protected right of self-determination in medical decision-making": ethics.gc.ca/eng/documents/…
/4

When (finally) asked what did a PATIENT tell the @TorontoStar?

"I [was not] comprehensively advised of the risks or that deferiprone wasn’t approved in Canada"

"Patients weren’t adequately informed of the risks or what other patients had gone through on the drug."
Why not?
/5

They knew.
Every relevant @UHN administrator (+ lawyer) were informed in many meetings AND letters.
As was the Chair of UHN's Board of Trustees in a very comprehensive letter (which received no acknowledgement)
Letter available here: inthepatientsinterest.org/the-files/
@JordanMRoberts
/6

Over years, we met w/ @UHN to relay harms & deaths of Barry Sherman's unlicensed drug.
Contemporaneously, Sherman ‘donated’ to UHN, and to MDs prescribing his *unlicensed* drug.
UHN claims that didn’t affect anyone’s judgment.
Others question this:
jme.bmj.com/content/47/8/5…
/7

.@UHN's Mission Statement commits to ensuring patients are "[m]ade aware of existing systemic biases, to support the best health decisions"
Were patients switched from licensed Rx to unlicensed drug made aware of Sherman's funding of research & UHN?
uhn.ca/corporate/Abou…
/8

As for the denials of "significant conflict of interest", every MD/institution taking #Pharma $$ makes the same claim:
"I can't be bought for..."
Genuine Q: if a reviewer is truly unaffected by his #ConflictsofIofnterest, why conceal them?
A review: jme.bmj.com/content/30/1/8
/9

When we first asked, the @UHN Privacy Commissioner claimed administration of Sherman's drug was thru "research"
Then it admitted it "wasn’t research” - that patients received unlicensed deferiprone "thru a compassionate-use" protocol: jme.bmj.com/content/47/8/5…
Sound familiar?
/10

Another institution initially protected a doctor's "compassionate use" treatment, also for yrs
But investigations ruled "compassionate concerns don’t override principles of #PatientSafety or #InformedConsent"
theguardian.com/science/2017/s…
/11

.@UHN characterizes our findings (=harms, deaths, absence of informed consent) as 'a welcome addition to the science.'
But @jameslturk nails it:
"It is outrageous for @UHN & @UofT to obfuscate this as an academic debate."
"It’s not a matter of debate. It’s a matter of harm."
/12

About that "science"
@cochranecollab documented the risks of #deferiprone vs licensed Rx:
-2.6 fold increased risk of joint pain
-8.9 fold increased risk of liver injury
-11.7 fold increased risk of gut problems
cochrane.org/CD004839/CF_th…
No evidence that patients were informed.
/13

UHN: "Olivieri had access to limited information"
A: No. I had access to each page of every chart & provided all data in @PLOSONE (open access)
UHN: "Olivieri didn’t consider all factors used to make treatment decisions"
A: What factors? This 'factor' matters above all others
/14

Finally I recall that, after @rachelmendleson exposed #Motherisk many years ago, #SickKids and @uoftmedicine initially pushed back - defending years of misconduct which, ultimately, they no longer could defend:
thestar.com/news/investiga…
/15

We can’t wait another decade for accountability for @UHN patients.
We need truth.
We need a public inquiry.
/end

Many people asking: how can an *unlicensed* drug be given to 70+ patients via ‘compassionate use’* without a trial protocol/signed consents?
Wish I had the answers.
*🇨🇦 rules: canada.ca/en/health-cana…
About 'compassionate use’ in this scandal: davidhealy.org/wp-content/upl…
More...
🧵

Compassionate use in 🇨🇦 ("Special Access"):

-reserved for "life-threatening conditions where conventional Rx fails/"unavailable via trials"
-"should be exceptional, limited in duration & quantity to meet emergency needs only"

Not what happened here:
thestar.com/news/investiga…
/2

Another MD at another institution claimed The Doc "wasn’t really doing research"; he was just 'caring for patients facing certain death so new treatment could be tried as a last resort': theguardian.com/science/2017/s…

This was not as it turned out, a winning argument…
/3

At long last the chickens came home to roost, and the MD was charged with aggravated assault causing bodily harm.
Shocker: he obtained a suspended sentence.
bbc.com/news/world-eur…
/end