
A Dying Scientist and His Rogue Vaccine Trial - denzil_correa
https://www.wired.com/story/infectious-rogue-vaccine-trial
======
patrickg_zill
There surely has to be a middle ground in some cases between the two cases of
$100 million trials and essentially unregulated and unaccountable hotel room
doctors.

Could there be a series of exams that a would be patient would have to write,
to demonstrate that they truly understand the risks, and what protocol is to
be followed?

In investment they have an "accredited investor" category to avoid higher risk
investments from being offered to those who can't afford the risk.

If you have a chronic disease and pass the exam then you become an "accredited
trial patient".

~~~
throwaway84742
Trump wanted to introduce “right to try”, which I think is a great idea. Got
shut down in Congress. Don’t recall why.

~~~
tonysdg
IIRC, part of the argument against is that you're allowing biotech/pharma
companies to test on vulnerable populations. Here's a story on NPR about the
pros and cons: [https://www.npr.org/sections/health-
shots/2017/03/03/5177969...](https://www.npr.org/sections/health-
shots/2017/03/03/517796956/patients-demand-the-right-to-try-experimental-
drugs-but-costs-can-be-steep)

~~~
throwaway84742
Sure, that’s inextricably a part of the deal. Don’t sign on the dotted line if
you’re uneasy about it. As long as nobody is forcing you to do it, I don’t
have a problem. The situation where I can try things (at my discretion) is
strictly better than the one where i unconditionally die.

~~~
lallysingh
The information asymmetry is a real problem.

~~~
throwaway84742
Is it more of a problem than definitely dying, though? That’s the real
question here.

------
reasonattlm
This captures the fundamental issues of incentives in this sort of thing. It
takes a lot of money to run trials, and regardless of what is said about risk
and what participants agree too, anyone suffering an adverse effect has a
strong incentive to resort to the legal system.

The FDA system is the only way to get therapies to large numbers of patients.
But it isn't the only way to get therapies to patients period, and it has
serious flaws. The FDA is risk averse to the point of suppressing progress.
The costs have doubled in the last ten years for no good reason.

There is a desperate need for a less heavy handed, more distributed, faster
system that favors pace of progress - but all attempts to build it will run
into this problem of incentives. The organizations running trials are targets,
and people will respond poorly to being struck by risk no matter what they
sign or are given to understand up front.

Non-profits may work for low-cost treatments, such as repurposed cheap-to-
manufacture compounds from the drug databases (e.g. senolytics), but some
types of therapy genuinely do require an organization with tens of millions in
the bank to sustain development. How do they proceed if not via the FDA?

------
bufferoverflow
My friend just went through an experimental procedure that was supposed to
help her with her MS. She had to travel to a foreign country, where it's not
regulated. And it was quite expensive. Before she went I asked her - if that
treatment has a 10% chance of killing you, would you do it? She said she
would. And she did. She is better now, not fully cured, but can walk and
drive.

One of the younger girls who was with her in the treatment was completely
disabled, bound to a wheelchair, couldn't talk, could barely see, and on day
four after the treatment she got up, could walk and talk. A true freaking
miracle of science. That girl now does mountain biking and mountain climbing,
fully recovered.

~~~
Roritharr
You can't provide such tales without going into more factual detail.

What kind of treatment? What country? Where can I find more about this magical
therapy?

~~~
bufferoverflow
Stem cell transplant (HSCT) with chemo. Russia.

There are small trials in multiple countries, but very hard to get in.

[http://www.bbc.com/news/health-43435868](http://www.bbc.com/news/health-43435868)

~~~
Roritharr
Thank you!

------
anovikov
Phase 1 trials - safety ones - are really cheap. I don't think they make much
more than 1% of total cost of getting a drug into market (while in a total
volume, they might be, because so many drugs fail them). There is no need to
risk killing a lot of people by skipping Phase 1 trials.

After that, i think it's fine to try an untested drug on consenting patient
with a severe chronic, or an acute life-threatening condition.

I understand why it isn't done. Market forces forcing companies to save money
on trials or die, may quickly unwrap this situation to Dr. Mengele-style
'trials' if not kept in check.

------
drewg123
It seems like the key to making medical progress is realizing that not all
treatments are "one size fits all" and figuring out why treatments that are
safe and effective for some people are unsafe for others.

The vaccine from this story seemed to be safe and effective for some
participants, but nearly killed another. How can we differentiate the people
that it will help from the people that it could kill? This is a real problem
in FDA approved medications. Just look at the side effects list for some of
the "biologic" TNF blocking treatments for autoimmune diseases. Yet they are
beneficial for most people.

~~~
djsumdog
Human bodies are vastly different and one of the biggest difficulties is
finding compounds that work the same 99% of the time, with minimal but known
and treatable side effects.

There's a reason this research takes so long. Things might have gotten to
market sooner decades ago, but it all comes down to a trade-off with potential
good vs safety. When political maneuvering gets in the way, you can get things
like the Vioxx disaster. Even with Vioxx, FDA monitoring and procedures did do
what they were suppose to in identifying the problem and pulling it off the
market.

The biggest problem really seems to be money, resources and funding the
research. You might discover something promising, but your company will need
to pay all those people, buy equipment and purchase animals to go forward. If
you get to monkeys and lose a single one, you gotta go back to the beginning.
You might find a side effect in 5% that's really bad/serious and your entire
compound might need to be scrapped.

Companies need to make money off of those investments so the compounds that do
succeeded might become insanely expensive. The entire process is pretty
backwards and I know people who are biochemists in this field who get paid
really shitty despite their important work. A lot of money goes to equipment,
but a lot also goes to management and cronies in the shops that can fund this
stuff.

It's a mess. There needs to be a better, not-for-profit model where a failed
compound doesn't matter as much.

~~~
HarryHirsch
_There needs to be a better, not-for-profit model where a failed compound
doesn 't matter as much_

Phase II/III clinical testing is expensive, and the failure rate (i.e. low
efficacy, compound simply doesn't perform as expected, and certainly no better
than what's already at market) is high. That's what it is, there isn't much
that can be done at that front.

Thankfully a few months ago Goldman Sachs directly addressed the elephant in
the room: pharma yields bad returns, investment in pharma is inadvisable.
There needs to be a different financing model, perhaps from the public purse.

~~~
refurb
_There needs to be a different financing model, perhaps from the public
purse._

How does that solve the issue at hand? As you said, development is expensive
and has a high failure rate. Why would public funding change either one of
those?

~~~
HarryHirsch
New antibiotics are high on the list of things that are needed, but they will
only be used as treatment of last resort, this is where the traditional
investment model fails. Development is too expensive to ever recover the
outlays.

Right now science can't do anything about the high failure rates in Phase II
and Phase III trials. The problem isn't to come up with a compound against
your target of choice, it's that apart from clinical trials we don't have a
way to predict if in real life it will perform better than placebo (Phase II)
or adequately (Phase III).

~~~
Fomite
While commonly used as an example, I'll note this isn't actually even always
true for antibiotics.

The development of Fidaxomicin/Difficid is actually an example of a fairly
inexpensive clinical trial (by clinical trial standards), and Merck didn't buy
Cubist for $9.5 billion for a drug they don't think will recover their outlay.

------
JohnJamesRambo
Reading programmers discuss medicine on HN is as painful as reading doctors
discussing programming.

~~~
Xc43
Except that a good percentage of programmers are not as subject to the know-
it-all symptom that comes from prestige.

Because, our field is not as set as medecine.

~~~
dsfyu404ed
Have you read the comments on non-programming issues in here?

It's hilariously full of "well obviously the solution to X is Y" for things
outside the author's area of expertise.

~~~
Xc43
I assumed wrongly. I guess I thought most programmers were as I am.

------
esaym
> He told them that the vaccine carried risks, as all vaccines do

Oh no, I thought it was taboo to say such a thing!

~~~
hexane360
[https://en.wikipedia.org/wiki/Straw_man](https://en.wikipedia.org/wiki/Straw_man)

Vaccines carry risk, but the risk of disease is orders of magnitude higher.

------
stickfigure
Before rushing to judgement (which is easy to do given just one reporter's
perspective), it's a good idea to read Scott Alexander's experience with
institutional review boards:

[http://slatestarcodex.com/2017/08/29/my-irb-
nightmare/](http://slatestarcodex.com/2017/08/29/my-irb-nightmare/)

~~~
simplicio
Alexander's article was convincing because the downside of ignoring the
regulations in his case was pretty close to zero. Giving a questionnaire to
people probably isn't going to hurt them.

Injecting viruses into desperate people, on the other hand, has some pretty
obvious risks. One can argue whether the current amount of regulation
regarding it is excessive, but its pretty clear there needs to be some
regulation.

Plus, note that the problems here weren't only regarding safety issues. The
study was also poorly designed from the standpoint of getting meaningful data
out of it. So even if one was indifferent to the safety of the study
participants, the whole exercise seems to have been close to worthless, since
the data is unusable.

~~~
tptacek
Read the HN thread on Alexander's article, which includes commentary from
several HN'ers that have dealt with IRBs. Not everyone was convinced; some
people thought he was sort of embarrassing himself.

------
mkirklions
>“If I can help people suffering from herpes, isn’t it my duty to do so?”

Gosh I here that statement echoing in my head about the problems in my life...

Also, this is exactly the kind of problem in healthcare that is completely
government and establishment driven. Physicians keep propping their monopoly
up with literally hundreds of millions of dollars in lobbying/bribery.

Every profession in medical seems to be similar, dumping massive money into
politicians:

[https://www.opensecrets.org/lobby/top.php?indexType=s](https://www.opensecrets.org/lobby/top.php?indexType=s)

Then their 'scientific method' has completely let me down after reading what
these 'experts' consider a study. Lots of hypothesis getting validated by any-
means-necessary. Not to mention their understanding of statistics usually
tosses in the word 'P-value' for extra points, despite their population sample
and study being a terrible representation of outcomes.

Medical is corrupt AF

~~~
techterrier
>“If I can help people suffering from herpes, isn’t it my duty to do so?”

He missed out the 'first do no harm' bit. It's quite important.

~~~
Afforess
"First, do no harm" is not part of the hippocratic oath at all. [1] The actual
line in the hippocratic oath is much more flexible:

> _I will follow that system of regimen which, according to my ability and
> judgment, I consider for the benefit of my patients, and abstain from
> whatever is deleterious and mischievous._

Based on the reported specifics of the rogue vaccine trial, it would seem
Halford did most of this. The article questions his judgement over the
confusion between HSV-1 and HSV-2 strains, but that seems the most notable
lapse. The picture painted is of a scientist trying to cure a disease in spite
of obstacles - not disrupt the system or intentionally cause harm.

[1] [https://www.health.harvard.edu/blog/first-do-no-
harm-2015101...](https://www.health.harvard.edu/blog/first-do-no-
harm-201510138421)

