
Chinese hospitals set to sell experimental cell therapies - headalgorithm
https://www.nature.com/articles/d41586-019-01161-2
======
aaavl2821
A company I consulted for was considering licensing a cell therapy from a
large, well regarded US research hospital. When we looked at the manufacturing
data it became apparent that the hospital really had no idea how to
characterize the cells they modified and gave to patients. It was basically
take cells from a patient, purify them and grow them up in culture, add a few
nucleic acids, then readminister. No testing to see if the nucleic acids got
into the cells, how many cells got them, whether the cells changed
unacceptably during culture, haphazard testing to see if they modified the
cell's surface protein levels, no specs as to what level of protein expression
were acceptable, etc. They did do safety testing so it isn't likely that the
cells would be harmful, but its very likely they would have no effect. There
was no malicious intent on the part of the researchers or hospital, they just
didn't know how to do commercial quality QA/QC on cell therapies. At the time,
no one did. Even so there was some stuff they should have known to do but
didnt do

This was ~5 years ago so things QA/QC for cell therapy has advanced since
then, but its still evolving. Would be interested to know how these hospitals
handle this

~~~
chriselles
That’s very interesting to read, thanks for sharing your professional
perspective.

I’m guessing we need to find the sweet spot on the continuum between
dangerously slow regulatory bureaucracy and dangerously regulation free snake
oil?

I would hope that the selling of medical hope includes some control measures
to help shift decision making from the emotional to the logical.

If it’s immediate and transactional, I fear emotion will trump logic based on
human behaviour under stress.

I’m a big supporter of experimental therapies, as long as the process is
robust and logical.

------
devy
What the article title didn't stress is the word "a few selected".

Just to re-iterate what it says in the article, the intent was that this draft
policy change to re-allow (currently banned since 3 years ago) "select elite
hospitals in China to sell experimental therapies would give people with
terminal illnesses faster access to potentially effective treatments."

First, this proposed lifted ban is only for select elite hospitals NOT all
hospitals.

Second, for terminally illness, experimental therapies are indeed used as a
last resort treatment. Just like many other countries. And many anecdotes
we've heard. E.g. Was virus treatment FDA approved? No! Did the doctors have
any other way to save this patient on a life-and-death situation? Not really.
[1]

[1]: [https://www.livescience.com/61963-virus-found-in-lake-
treats...](https://www.livescience.com/61963-virus-found-in-lake-treats-
bacterial-infection.html)

~~~
killjoywashere
Note, a "few selected" == "roughly 1,400 elite hospitals"

From what my friends who do business with, or are physicians from, China tell
me, medicine in China can often be a pretty brutal assembly line, complete
with bribes being passed, literally, under the table.

Having worked in a number of "top" US hospitals, I would be interested in what
the 1400th hospital looks like in this scenario.

~~~
Barrin92
For reference, there's about ~31000 hospitals in China as of 2018, so that'd
be the top 4-5% presumably.

------
thefounder
Cures can't be found without testing and it's clear that some people just
don't have 10-20 years to wait for extensive tests and for investors willing
to pay for risky investments/treatments.

I just hope the patients are monitored/documented well so that the results can
be improved/replicated.

~~~
SmellyGeekBoy
Indeed. My Dad has terminal cancer and all conventional treatments are at best
just (slightly) delaying the inevitable, while having a negative impact on his
quality of life. As a family we're always investigating experimental
treatments and would jump at the chance of something like this.

------
narrator
Way back in 2008 [1] there was a guy on reddit who said he went to China and
got stem cell therapy and went from being a paraplegic to not being one.
Everyone in the thread refused to believe him. They did this recently in an
experimental procedure in America and suddenly, it's reality.

There's something really deep in American culture that says that all medical
breakthroughs must occur in the United States or they're frauds.

[1]
[https://www.reddit.com/r/IAmA/comments/k1hts/i_am_a_28yr_old...](https://www.reddit.com/r/IAmA/comments/k1hts/i_am_a_28yr_old_american_who_went_to_china_to)

~~~
thedailymail
I don't think it's just Americans, and in the case you cite, people were
completely justified in their skepticism. The reddit account was apparently
created for that single AMA post and had no activity before or since. The
company he allegedly went to, Beike Biotech, was notorious at the time for
using various forms of astroturf and deceptive advertising to promote its
unproven stem cell treatments by testimonial, a problem that is rife in stem
cell marketing. The Chinese government ended up cracking down on domestic cell
therapy clinics in 2015 after years of ineffective enfprcement measures, which
would be a very unlikely thing to do if it had faith that local hopsitals had
developed an effective treatment for spinal cord injury.

~~~
narrator
They are still around:

[https://beikebiotech.com](https://beikebiotech.com)

[https://www.bloomberg.com/research/stocks/private/snapshot.a...](https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=54341823)

They've been around since 2005 and have a large network of clinics. You'd
think they would have got shut down by now if they were a scam like Theranos.

Any sources on them being a scam?

------
afarviral
I was interested in the cause of the "toxicity" which resulted in at least one
death as a result of the CAR-T treatment - the article links to:
[https://www.nature.com/news/safety-concerns-blight-
promising...](https://www.nature.com/news/safety-concerns-blight-promising-
cancer-therapy-1.20763)

My take was its hard to find proteins unique to the cancerous target that isnt
also present in healthy tissue. It even mentions a patient being treated where
the target proteins where also present at lower levels in the patients brain.
So I guess the programmed T-cells run amuck typically in the course of
treatment.

I hope that intense competition to control the most effective new cancer
treatments accelerates development. This is once the treatments become
mainstrain, not really addressing the article.

------
z2
Even US-approved CAR T-cell is currently so toxic with a high chance of severe
adverse effects that it should only be used as a last resort treatment. From a
linked article:

    
    
      “Right now it is heroic medicine,” he says — a grueling treatment deployed only in people for whom all else has failed. 
      “Patients are taken sometimes to within an inch of their lives.”
    

I feel like China's health care system is currently in a strange/incapable
position to decide when all else has truly failed, not when plenty of basic
medication is impossible to get, or not covered under any insurance.

------
erlangNewb
I don't agree with this but it seems like a functional method to fund
research. Are we seeing breakthroughs from other countries via the traditional
private funding/patent system?

~~~
mattybrennan
Yes. [https://www.technologyreview.com/s/609999/us-doctors-plan-
to...](https://www.technologyreview.com/s/609999/us-doctors-plan-to-treat-
cancer-patients-using-crispr/)

------
benj111
1\. "But since the ban [on selling untested treatments], hospitals have found
it difficult to recruit participants for clinical trials"

That sounds like a lack of faith in the system, that charging for untested
treatments again isn't going to solve.

2\. How does a self described Communist country ideologically defend charging
for hospital treatment? Not getting in to the rights or wrongs of Communism or
free health care, this just seems contradictory.

------
jimrhods23
What a horrible idea. Clinical trials with no oversight or regulation of
patients that may or may not even know the consequences.

~~~
thefounder
They know the consequences of not trying any risky/experimental treatment:
death.

I know people willing to become guinea pigs for non-life threatening
conditions (i.e back pain).

It's clear that the current approach to develop new treatments/drugs that
requires billions and years or even decades of tests is not fast enough for
many people.

~~~
jimrhods23
With the amount of lawsuits in the US for people that are willingly harming
themselves or abusing drugs: Cigarette companies still getting sued for
smokers dying of cancer..even though it's been known for 50 years that it
causes cancer and Big Pharma getting sued for the Opiod crises means that this
will never happen here until we have major tort reform and an assurance that a
company can't be sued in any court if someone dies as a result of taking
untested treatments.

"It's clear that the current approach to develop new treatments/drugs that
requires billions and years or even decades of tests is not fast enough for
many people"

It takes years of testing because the risk if health or death is too great.
It's foolish to think that allowing anyone to be a human guinea pig for
untested/unfinished treatments will result in any less deaths or suffering
from a terminal illness.

~~~
jimrhods23
It feels weird that I have to argue for safety and the scientific process in a
forum for supposed intelligent people.

It's very anti-intellectual.

~~~
plutonorm
Imagine that you have a 99.99 chance of death. There is treatment that appears
to work in 50% of people, but it's early days, it's only been tried on 10
people. What do you do? Do you want a bear certain probability of death or a
50% chance of a cure? I think it is entirely proper to allow people with the
money to pay for it, to take that gamble. It's their life, not ours. It's
their money, not ours. Sure, we need to be sure that the correct data is
presented to the client, they mustn't be mis-sold. But otherwise I have no
issue with people being free to take a gamble. I would absolutely furious if
this chance for life was withheld from me. And so would you be.

------
flossball
Its OK... Chinese Vampires hop, so we can totally escape them. No big
apocalypse.

~~~
dang
Please don't post unsubstantive comments here.

~~~
flossball
And what would a substantive comment look like for this article? There is
nothing anyone can say other than pure speculation and concerns of caution.

~~~
dang
The standard's not that high; you just need to avoid, say, the bottom quarter
of the barrel. A bunch of comments in this thread are fine.

