Controversial cancer treatment on children at a top Canadian hospital – The Fifth Estate

[♪♪] -[Pasquale] The 7th
of November, 2016. A big day for Montreal’s
Sainte-Justine hospital. Ministers and dignitaries
celebrate the opening of a brand-new research centre. [Speaking French] -[Pasquale] The bright and
modern building is in the west wing of the
children’s hospital. But, in the east wing,
at the very same time, a crisis is unfolding. For five days, Health Canada’s
inspectors have been seizing files and searching computers
at the Charles Bruneau pavilion, reserved for
children fighting cancer. Health Canada has just received
an anonymous complaint about Dec Gen, A clinical drug trial for
children with terminal cancer. The reputation of one of
Canada’s top pediatric hospitals is in jeopardy. By the time the
inspectors arrive, the study is already in trouble. One child dropped out,
because of side effects. Four others died. And the last of the six children
will die while investigators are working. Within weeks Health Canada
would conclude that the study should be suspended. Was Health Canada
right to close the study? Oh, yes. Absolutely.
-[Pasquale] Why? Jonathan Finlay is the head
of the neuro-oncology department at the largest pediatric
hospital in the United States. There were too many violations
and they were absolutely appropriate in
shutting it down. It would have been
wrong if they hadn’t. -[Pasquale] It wasn’t so long
before that hopes were running high for the study. In 2015, it was billed as the
first of its kind in the world. For the first time,
Sainte-Justine’s oncology experts were to conceive and run
their own clinical study instead of one designed by a large
pharmaceutical company. [♪♪] The Dec Gen study’s goal was to
look at the effects of combining decitabine, an existing
chemotherapy drug, with genistein, a chemical
compound derived from soy, a combination that had never
been tested on children but could give a sliver of hope
to those with no other option, or so researchers said. Mai Pham and Toan Nguyen
are both pharmacists and parents of three children
Liam, Elaine, and Lena, diagnosed with brain
cancer, at the age of 9. [Speaking French] -[Pasquale] That’s when
Sainte-Justine told the family about the Dec Gen study. Lena would be the
first patient to sign on. Deep down, Lena’s parents
knew their daughter would not beat the cancer. Still, they agreed to
take part in the study. -[Pasquale] The miracle
did not materialize. Lena died of cancer 27 days
after her first treatment. -[Pasquale] That was
December 2nd, 2015. Lena’s parents didn’t hear
another word about the Dec Gen study. Shockingly, it was only
much later they learned the chemotherapy drug their daughter
was given had actually expired. The doctor in charge knew it
and still ordered the infusion of medicine to continue. We found proof in
the medical records. Dr Michel Duval runs the
hospital’s haemato-oncology department. He doesn’t see the problem. Lena didn’t suffer any
harmful side effects from the expired medication. Her parents were devastated
but as pharmacists they at least hoped the study would
amount to something. Now they’re not so sure. They’re absolutely right
because it calls into question the validity of any results,
whether they’d be negative results or positive results. -[Pasquale] As they dug deeper,
Health Canada was discovering a disorganized and
incomplete drug trial in a world where precision,
care, and respect of scientific norms are valued above all. You’ve got to follow every
single little step by the book and keep track of everything
because it’s very complicated and if you get anything
wrong it could put in jeopardy the entire study. You have detailed procedures,
you’re following a checklist like a pilot on a plane. And you don’t go wrong
because if you go wrong the plane crashes. -[Pasquale] The research
centre’s own staff was worried about a disaster coming. Eight months
before the inspection, they warned their bosses. [♪♪] -[Pasquale] It was a
high stakes experiment. The combination of decitabine
and genistein had never been tested on children. Although it was tried on mice
and adults without significant results according
to our sources. It was on that tenuous basis
that researchers submitted their protocol for the children’s
study to Health Canada. The protocol is like the
bible of a clinical study. How would you
characterize this protocol? Poorly written. Superficially written and
superficially documented in terms of the background. They could have done
a much better job. -[Pasquale] Doctor Finlay
deplores the lack of clear scientific reasoning
in the protocol. But he does believe the drug
combination was worth trying. Yeah, I thought the rationale
was quite sound for that. The idea of looking at
the two drugs together. It seemed like a cute idea. -[Pasquale] What is the
goal of an experimental cancer trial, what researchers
call a phase one study? You’re testing for toxicity. You’re trying to find out
can we use this medication on a patient population and
how much medication can they take before it
becomes too toxic? The goal is not to
provide therapy. -[Pasquale] Maybe it’s not
but we never really know what doctors say when they’re
trying to enroll patients. Do they know what
they’re getting into? Are they feeling the pressure? This is how the Dec Gen study
was sold to Jenifer’s family. Nervous, likely because Jenifer
knew what was to come. She’d already been through five
rounds of chemotherapy and a bone marrow transplant to treat
two different forms of leukemia. As they do with all important
medical consultations, the family recorded the
doctor’s presentation. It’s much easier
than taking notes. It’s Dr Yvon Samson, one
of the researchers who speaks to the family. He is supposed to present
the study objectively. Remember, the primary goal
is not to cure the patient. It is a phase one study
he says to the family. But he also says
another word, a word everybody remembers. It was the word “remission”. -[Pasquale] Remission?
-Yeah, remission. It was significant
that we heard that word. It was the next important
step in her treatment. Get to remission. Be able to do a transplant. -[Pasquale] Nine times. That’s how many occasions
the researcher says the word “remission” during the meeting. -[Pasquale] He mentions
up to 12 rounds of chemo even though the other
patients can only endure one or two. But Jenifer’s
family didn’t know that. All they could think about was
the possibility of remission. Her brother Michael. It actually meant everything
because if there wasn’t any chance of remission,
I would not have advised her to go that route. There were other treatments,
trials out there and we would have gone with
those other options. -[Pasquale] Bryn Williams Jones
looked over the full transcript of the discussion between the
doctor and Jenifer’s family. Why, he asks, would anyone keep
bringing up the possibility of remission in an
experimental trial? You don’t talk about that in
a phase 1 cancer study with children who are dying because
what you’re doing there is you’re holding out a possibility
that is unrealizable. That’s unfair. -[Pasquale] If you were
wondering how a truly informed consent interview should
look like according to professor Williams Jones,
this is it. We don’t know if it helps and
even if it helps we don’t know if it’s worth the side-effects
that you could potentially have. Nausea, tiredness,
fever, decreased… -[Pasquale] In this PBS cancer
documentary, a researcher lists in detail all of the
side-effects the child involved in the trial
could experience. As you can see,
the list is long. -[Pasquale] The parents’
hope slowly fades. It was an excellent example
of how to do recruitment. The family is crying. They’re sitting
there trying to decide should they participate? And the clinical team
who is recruiting is giving all the information
and they’re making it really clear that the chance of
it succeeding is minimal. This is probably the hardest
decision along the way that you guys have to make. -[Pasquale] When we come back
Jenifer makes her decision and the hospital fights back. [♪♪] [♪♪] -[Pasquale] May 2016. Montreal’s leading
children’s hospital, Sainte-Justine, is enrolling
young patients in a drug trial it’s hoping will make news. 20-year-old Jenifer and
her family have to make a gut-wrenching decision,
whether to take part in the study. That is why the
researcher, Dr. Samson, tells Jenifer to think
about it for a few days. She is relieved. But a few minutes later… You certainly don’t line up the
next step before the person has even consented. -[Pasquale] The operating room?
-Exactly. You just don’t do that. You don’t put people in a
pressured environment where they feel like they have
to decide quickly. That’s unethical. -[Pasquale] Dr Samson
did mention that a cure was improbable. We wanted to ask
him about the tape, but he refused to participate. Instead, the hospital offered
up four people to answer our questions. So, was it fair to raise
the possibility of remission with Jenifer? -[Pasquale] Jenifer
thought about it for three weeks and
finally, she said yes. On May 26th, 2016, she got
her first dose of decitabine. -[Pasquale] But
Jenifer was not okay. She would only receive
one dose of decitabine. She was quickly diagnosed
with a rare fungal infection, “possibly related” to the drug. In her state, Jenifer had a
serious chance of catching a deadly infection, 39% in fact
according to the study protocol. A number that no one in
the family was aware of. So, what did you feel
when she basically died in a little bit
more than a month? It was shock. We were in shock. It was very sudden. It was very sudden. We felt, like, uh, lost. -[Pasquale] Jenifer died
on June 23rd, 2016, from her cancer and respiratory
complications from the fungal infection. Jenifer left behind a legacy. She and her family had
spent years raising money to fight cancer. They believed in
cancer research. They still do. [Speaking French] [Laughter] -[Pasquale] Three months
after Jenifer’s death, five-year-old
Guillaume Daraóche, suffering from leukemia, is
about to become the sixth, and last patient. Like each and every parent,
Guillaume’s mother and father signed the written consent form. It’s supposed to list
clearly the trial’s risks and possible benefits. So far, it’s an incredibly
evasive language. -[Pasquale] Leading cancer
ethicist Jonathan Kimmelman evaluated the 15 page
document for us. He finds it unbelievable
the consent form refers to a possible decline
in the disease. Instead, it should have said… -“If you participate in the
study, the prospects of cure “or the prospects of extending
your survival are very, “very remote. “However, by contributing,
you may be helping to advance “our understanding
of your disease.” -[Pasquale] Nowhere is this
written in the consent form. Guillaume’s parents,
Sylvie and Richard, sign it on September 27th, 2016. -[Pasquale] But on the day
Guillaume was to start the trial, a big problem. Some of his enzyme
levels are too high, higher than the protocol allows. But not enough to
worry the doctor. So, Guillaume is
allowed to begin the trial. A mistake at the hands
of the research team, says our expert. It’s in there as an
on-study requirement, and you have to abide by that. If it says something in there,
we’re not allowed to deviate. -[Pasquale] And what
does that mean? The patient should not have
been allowed on the study. -[Pasquale] Ethicist
Jonathan Kimmelman sees another problem
with the research team. In documents we’ve obtained,
the researchers make claims about the patients’
chance of survival. I don’t know where
they got that number. I’ve never seen
numbers like that. I don’t even know how
you could quantify that because usually survival is not
even measured in a way that’s reliable in phase 1 studies so
that’s certainly not consistent with the numbers that I’ve seen. -[Pasquale] From what you
know, that is untrue? I have no basis for
thinking that’s true. -[Pasquale] Guillaume
died of leukemia and of a terrible infection,
as Jenifer did. The Dec Gen study was suspended
on the day of his death, five weeks after
he’d been admitted. And there was more bad
news for the hospital. In their report,
two months later, Health Canada came
down hard on Sainte-Justine. 76 violations of the
Food and Drugs Act, including 23 critical ones. Violations that presented a
danger to the trial’s subjects or undue risk to their rights,
their health, and their safety. To have Health Canada intervene
in a study and say there’s this shopping list of problems
is extremely damning. Even a couple of errors would
be an alarm bell for a research team but to have a
long list like that? That’s a huge problem in a team. -[Pasquale] The
list is very long. Serious adverse effects
and a death not reported to Health Canada,
incomplete research files, staff that wasn’t
adequately trained, and on at least three
occasions, expired medicine like Lena received. Violations that the
hospital describes as “administrative mistakes.” They don’t seem to
know what they are doing. These are not
administrative errors. These are problems with the
culture of the research team and that research group. -[Pasquale] The same team
that did not tell any of the parents about the
suspension of the study. [Speaking French] In fact, we were
the ones to tell them. [♪♪] -[Pasquale] And something
else was troubling. The hospital’s ethics committee
only learned of the study’s problems on the day
of the suspension. So, who was watching
over Dec Gen? Scientific oversight
would normally be done by an external firm. But hiring one was too
expensive for Sainte-Justine. Who, then, was
monitoring the data? A hospital employee. That’s unacceptable
according to Jonathan Finlay. You need external monitoring. So, the question should be asked
whether an institution that does not have the experience and
expertise conducting a phase 1 trial should be in the business
of doing phase 1 trials. -[Pasquale] The researchers
did not take the suspension very well. Sainte-Justine fought hard to
get Health Canada to reverse the decision. For more than a year the
debate went back and forth. Yeah, it seemed very strange. You know, if this was an
FDA-regulated site visit, they wouldn’t have taken
any of those back answers. They would have just,
“you’re closed down.” -[Pasquale] Health Canada
ultimately determined that the children died of their
cancer and that side effects were in accordance
with the protocol. But they should have
been reported because of their frequency. And in the end, Health Canada
stood by its decision to suspend the study. [♪♪] As for the scientists, they
still believe that the Dec Gen combination merits a
second clinical trial. [♪♪] [♪♪]

54 thoughts on “Controversial cancer treatment on children at a top Canadian hospital – The Fifth Estate

  1. We got a cancer cure, discovered in Alberta, called DCA…. Was used in Ste Justice 60 years ago and now the mexican, in Israel and cuba as a cure also…………… So what's the stall….You can starve the cancer just don't feed the cancer with any sugar of any form…………………..CBD very well knowed also….. Chemo = euthanasia………..

  2. they needed patients and lied to get them sad but not surprising
    9 out of 10 use to tell us to smoke this "brand" of killer product
    marketing is a plague on mankind

  3. Amazing how you hand over your heath and your children's heath to these dumb doctors who know zero about cancer…if you can't take control over your own body..come on…try Ty Bollinger he at least is getting thousands of doctors together who will try to save your life..thousands of veterinarians are curing cancer once they step away from these clueless medical society…!

  4. There have been many microbiologist/scientists that have discovered the cured for cancer. They all mysteriously died…. gee what a coincidence! Guess the pharmaceutical companies don't really want a cure… would put them out of business.

  5. Zero scientific method & zero clinical trial method; shame on the "researchers", shame on the hospital admin and double shame on health Canada for the wrist slap on the bogus trial group. No university hospital in California would have even entertained this research group. Wishing peace of mind and heart to the families

  6. brain cancer? DCA generic drug (essentially vinegar & salt)? lumbrokinase, ubiquinol, soursop, paw paw? sinus cleanse? brain cancer = biofilm?

  7. No accountability whatsoever, our doctors and hospitals are rarely if ever held responsible for their harms, if they were, if they really were, they would conduct themselves differently.

  8. Thank you Fifth Estate for doing this. It makes me, as a person without much knowledge, and who therefore tends to take the words of doctors, especially the so called specialists, as gospel, more aware and therefore more likely to question.

  9. They used live human beings – children – as guinea pigs – this is WRONG! The unreliable 'possibility' of remission was giving people a false sense of hope… – AND – omitting some information about the product used and the RISKS involved – AND – the TRUTH in terms of potential outcome – this was ethically and morally WRONG !

  10. I quit working as an RN after only 5 years. My last hospital job was on oncology floor. The main Dr was in deep with big pharma, falsified "study" numbers & told me he would give chemo on the day he knew a patient would die "to maintain hope". The last time I was told to do CPR on a patient who DID NOT WANT IT, I refused. Calling a code results in extra charges, encourages "practice" for the code team & treats the dying as a lab animal. I could NOT stay in that messed up system, where profit us more important than patient care. Home health was no better, just providing warm bodies to bill the insurance companies, patient outcomes are NOT a big consideration. I'm glad for the education I got, I think ALL humans should learn basic Anatomy & Physiology. The result would be a better educated population, more questions for Drs & better outcomes. No wonder they don't want to teach anyone this, unless you pay for your education. Healthcare across the country has been bought by corporate interests & no longer serves the greater good!

  11. If me or my kids get Cancer.. Chemo is the last option I'm taking.. Seems like 95% who have really bad cancer / stage die faster and because of chemo, just like this drug.

  12. It is our diet. Animals in the wild do not get cancers, heart disease etc. Only domesticated animals such as cats and dogs that share human food get these diseases.

  13. This amazing book give too differents natural cancer treatments That work !!! ($5 ONLY !!!!)


  15. I was diagnosed with stage 4 lung cancer in 2011, and that year we were excited to be celebrating my six year survivor-ship anniversary – a survival that was not remotely contemplated in 2016. Since i diagnosis i have learnt a lot about lung cancer, the first few years were confronting. I had no clue that my LUNG (left) was responsible for these combined symptoms! Fatigue, chest, neck and shoulder pain. My life changed in just one breath when my Doctor diagnosed me with advanced lung cancer that was INOPERABLE, INCURABLE and TERMINAL. I will always remember the pain and tears from my husband’s face as well as my daughters and my close friends. Like many other people this was not the first time that my life was impacted by CANCER. In 2002 my sister was diagnosed with leukemia. Fortunately for us she was diagnosed at an late stage and she pass away. So when my doctor gave the news about me, We all put in mind positive energy to fight against it, Because I was not going to let that put an end to my smile. now i lives a normal healthy and active lifestyle thanks to the “Dr Adebola Herbal Herbs” which my husband doctors prescribed him. SO many good people have lost there life because of greed, The government will preach against herbal herbs because it only one true cure, But will make profit with pills because the money you treat the more money you spent, Thanks to my husband Doctor who told us this. I will want to advice anyone out here going through sorrow with Cancer to reach out to Dr Adebola and I guarantee you that you will be cured. Contact him via: ([email protected]) whatsapp mumber (+19292018600).

  16. There have been many microbiologist/scientists that have discovered the cured for cancer. They all mysteriously died

  17. As a mother who's daughter was diagnosed with leukemia, a blood cancer, I can tell you, you are willing to do whatever is necessary for your child to be in remission. These so called doctors took advantage of that and it's appalling! I trusted everything all 5 Of my daughters doctors told me! To knowingly take that trust, to take their hope away and essentially use it against them is unethical and wrong on so many levels! No parent wants their child to suffer! I put my daughter into 2 clinical trials where extra bone marrow was extracted with every spinal tap. Like I said you do what you believe is best for your child based on the info the doctors give you. This is messed up on so many levels! I would want blood from every doctor who mislead and/or flat out lied to me! I pray for a day when no child has to suffer from cancer ever again!

  18. I wish the Fifth Estate would do a follow-up of a different type of cancer study, done by the US military, using Canadians as public guinea pigs .

  19. fools like this need to be sued..they told the familys that there was a chance where there was none! This was someones child..sick.As a oarent we would fight for them to survive until they cant.
    Time to overhaul the hospital top personnel

  20. And no criminal charges or penalties levied for such clear and present health, safety and protocol negligence?

  21. Unbelievable!!!!😢 My God!!! The drug was expired!!! So the child was on testing drug! Bad bad Dr!
    Poor poor Child!!!
    6 child dies!!!😢
    Hope they get ride of the bad one!
    RIP Dearest Child!

    Thx! For your extreme concern! And thx to the last men during the interview!
    Told himself as he won’t accepting it for his own child!

    Didn’t like some doctors answer during your documentary!

    And why the medication was expired?
    Can’t believe this! 😢

  22. It's very unfortunate that this has happened. The result of this type of scandal makes people not trust what they are told about drug trials and therefore refuse them. Sadly this hurts everyone as volunteers are needed in order to develop new therapies and improve the chances of survival of cancer and many other diseases. I am a nurse who is also a crohn's patient and have participated in several drug trials both phase 1 and phase 2 and 3 studies over the last 25 years. I am fully aware that these trials I have done often were unlikely to benefit me but could help others and also help the researchers and doctors understand the disease and the way it works better. I am very upset to hear of something like this happening at a Canadian hospital. We are known for the quality of our medical treatment and that is a reputation we need to be careful to maintain. Not only will it affect the patient's in the trial but other patients both in Canada and worldwide. If our trials are in question then potentially GOOD results may be overlooked due to the concern over how the trial was conducted and whether or not those conclusions can be trusted. We need to learn from this and make sure it NEVER happens again!!

  23. Gods son Christ Jesus died on the cross for our sins so that by believing in him we can have life…belief in Christ Jesus be a free gift from the father, given to them [ through thee hearing of heth words ] whom he hath chosen for salvation

  24. My dad died in st micheals hospital in toronto after they didn't perform a urine test that would've informed them that his lungs were causing him to drown due to something well beyond a flu. He went into the hospital after having a fall and breaking his neck. They fitted him with a halo, and they tried to give him medication not via IV but instead in some apple sauce that went into his lungs, due to the nature of having a broken neck making swallowing more difficult, and that caused him to die. They said sorry. Late around 3am they suggested we go home to sleep and return the next day, he died around 6am. I remember dad complaining saying there is something very wrong going on and he wanted them to perform tests that they negligently chose not to and went away from protocol.
    Maybe we should've sued them. It would made them not try to skip any of the important items on the checklist. I miss dad. He tried his best to be dad. 🙁
    I still remember that hospital worker looking back down the hallway at us about to walk down the stairs, as she disingenuously peered out from the doorframe of his hospital room, the room she promised to stay in to make sure he was going to be ok.

    Life is too often not what they sell you on the broshure with the lotto they created involving his ability to survive the night. The doctor on staff the next morning made a reference to how many hours he was on duty, and no doubt that would have an effect on his being better able to operate at a professional capacity. 2 well paid hospital employed people acting in concert to avoid doing what they said they would do. That's what happened..

  25. If you want to see chemo at its best, visit a dialysis unit. Chemo blows your kidneys! It’s a serious money maker for these vipers.

  26. Antineoplastins studies were valid and the inventors records were flawless and still seized and he was unjustly taken to court over and over. Even if this was a miracle treatment nothing would have come of it. Antineoplasin therapy worked miracles and is shunned to this day, but thank God the inventor won't give up.

  27. Sad that these doctors families trusted mislead them with false information and hope so that they would have human guinea pigs.

  28. Why doesn't HEALTH CANADA, if they are investing millions of $'s + watching children lose their lives while on clinical trials + also do what the U.S fails to do?
    DR BERZINSKI, an oncologist whose BERZINSKI CLINIC, in Houston, Texas has had patients who had terminal patients come to him, after undergoing the standard chemotherapy +/ or surgery +/ or radiotherapy…..some he treated as young as 4 years old.
    After being treated with Dr Berzynski's patented
    "NEUROPLASTINS" this child is now in his 30's with his own children.
    He has many patients that have had similar results.
    I stead of embracing him + his treatment + making it so ALL patients can receive this amazing treatment the FDA took the Dr to court to try to shut his clinic down- about 7 times.
    His own patients testified as living proof for the success of his treatments.
    Another time they were threatening to imprison Dr Berzynski for 300 years.
    Does this make sense- to stop a Dr, who has a treatment affective at curing cancer, from practicing.
    I ask you to please watch the documentaries on Dr BERZINSKI for yourself- they can be found on YouTube.

  29. doctors need to be screened for personality defects, but they aren't.
    yet when i needed a crappy minimum wage job, i had to submit to a rcmp background check to be able to work in a dusty warehouse
    but because you have a magical piece of paper and walk around with a stethoscope around your neck , you are OK

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