

Alzheimer’s Drug Sharply Slowed Cognitive Decline - WhitneyLand
http://www.nytimes.com/2015/03/21/business/alzheimers-drug-trial-shows-cognitive-decline-sharply-slowed.html?_r=0

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pcrh
This kind of report is aimed at influencing the stockmarket, not at reporting
success or failure of a particular therapy.

As a Phase I trial, its stated goal is to determine if the treatment is
_harmful_ , not if it is beneficial, and to test if the dose range
_potentially_ affects whatever they are measuring [1].

Thus, the title of this post is misleading, there was _no test to determine
the effect of aducanumab on Alzheimer 's disease_.

Biogen's stock will go up nevertheless... apparently it has by over 9% [2].
There is such a large gap between basic understanding of science and biology
and those who make markets....

[1][https://en.wikipedia.org/wiki/Phases_of_clinical_research](https://en.wikipedia.org/wiki/Phases_of_clinical_research)

[2]
[https://uk.finance.yahoo.com/q?s=BIIB](https://uk.finance.yahoo.com/q?s=BIIB)

~~~
refurb
I see where you're coming from, but I'm going to have to disagree somewhat...

 _This kind of report is aimed at influencing the stockmarket, not at
reporting success or failure of a particular therapy._

It's both. A company is required/expected to publicly release material
information that could influence the stock price. The clinical data also
supports whether or not the molecule "passed" this phase of study.

 _there was no test to determine the effect of aducanumab on Alzheimer 's
disease._

There is no reason why you can't have efficacy endpoints in your phase 1
study. The endpoints tested in this study are indicators of progression of
Alzheimer's disease.

That said (and others here have pointed it out), this is a VERY small study.
There have been numerous other examples of Alzheimer's therapy that have show
promise in early trials and so far, they have all turned out to be duds. I
hope that's not the case here.

~~~
acveilleux
Lack of statistical power. Phase I enrol too few subjects for efficacy. The
reason they do a Phase I is to determine it would be safe to do a larger
trial.

Source: I used to work for the company that is most likely to have done any
MRI analysis for this study. We did Phase I/II/III and they are very different
beasts.

~~~
kirsebaer
A small study will lack statistical power to detect small effect sizes, but a
small study could still detect a large effect.

~~~
pcrh
The point of statistical tests is to assess the accuracy of a prediction.
These trials were not designed to predict/test the efficacy of the drug,
therefore no conclusion regarding efficacy can be drawn.

It is of course possible that there was a real effect, and that this is
reflected in the data gathered, however to determine if that is the case
another trial has to be performed.

------
_ihaque
Better scientific overview of this story from In the Pipeline:
[http://pipeline.corante.com/archives/2015/03/20/biogens_alzh...](http://pipeline.corante.com/archives/2015/03/20/biogens_alzheimers_data.php)

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bluedevil2k
The major side effect was brain swelling and headaches. The company developing
it even said the side effects are scary
([http://mobile.nytimes.com/2015/03/15/your-money/how-many-
mut...](http://mobile.nytimes.com/2015/03/15/your-money/how-many-mutual-funds-
routinely-rout-the-market-zero.html?_r=0&referrer=)).

These "drug X may help Y" are always misleading, usually by the media.

Quote: The most common side-effect was a type of brain swelling. It seemed to
pass once a patient's dose was lowered, Biogen said, but it's a worrying
symptom, and was worst in patients given the highest dose. Inflammation of the
brain has caused companies to dump some earlier experimental Alzheimer's
treatments.

~~~
randyrand
Not sure if linked the right article:

[http://mobile.nytimes.com/2015/03/15/your-money/how-many-
mut...](http://mobile.nytimes.com/2015/03/15/your-money/how-many-mutual-funds-
routinely-rout-the-market-zero.html?_r=0&referrer=)

But I want to comment on that. The article makes it seem like mutual fund
managers provide no benefit whatsoever because they did not beat the market.

Bullshit. They might not help _investors_ make money, but they still provide
benefits. Saying otherwise like saying Apple and Google and Microsoft provide
no benefit because they have not done any better than the tech sector as a
whole. In fact, we can look at the growth of the market _as a measure of how
well mutual fund managers are investing_.

We need to remember, mutual fund managers _compete_ with other mutual fund
managers. They're investments _do_ matter as they dictate where investment
money in our economy goes. They might not make money relative to the market as
a whole, but they still provide important benefits to society.

For example, just because airlines only make .2% profits, their services
benefit society tremendously.

Replacing mutual fund managers with investing in any company whatsoever
(though limiting to public companies changes things) by "flipping a coin" like
the article suggests, would likely have a very bad impact on the economy. It
would have no effect on how well mutual fund managers do relative to the
market, though.

~~~
im2w1l
The more fund managers you have, the more efficient capital allocation you'll
have. The fact that mutual fund managers do not beat the market means that we
have too many fund managers chasing diminishing returns. The increased
efficiency in the markets is too small for their wages.

As the fraction of active fund managers to passive fund managers decreases,
this fact will change. More and more passive investors following in the
footsteps of less and less active investors. This means the tracking error
will increase. At some point the cost of the tracking error will be about the
same as the cost of active management, and that is when we have the right
amount of active management.

I think at least

------
omgitstom
"The drug, called aducanumab, appears to have met or exceeded Wall Street
expectations in terms of how much the highest dose slowed cognitive decline.
However, there was a high incidence of a particular side effect that might
make it difficult to use the highest dose."

There is so much that scares me about this statement.

~~~
randyrand
Personally I think it's promising enough that there is nothing _bad_ about the
increased R&D money they'll have due to higher stock price.

What do you think?

------
bjwbell
TL;DR Phase 1 trial with 166 patients shows promise (many promising phase 1
trials don't pan out in phase 2 or 3 trials).

~~~
WhitneyLand
It's got a ways to go for sure, but the exciting thing is this is the first
drug ever to make it this far, with statistically significant reduction of
plaques and cognitive decline.

~~~
nhstanley
This isn't the first antibody therapy that tries to reduce plaques
(Bapineuzumab, solanezumab, gantenerumab, crenezumab, etc.), but is it the
first one to "work" correctly, but still fail? I don't believe so. I think
bapineuzumab also showed early promise at reducing plaques, though I don't
remember if they did a cognitive analysis that Biogen did here.

Don't get me wrong. I think this is the most promising one we've had, if for
no other reason than the method used to develop it. They took people who lived
into old age without Alzheimer's, and found antibodies from them that targeted
Abeta (so they claim). Really cool stuff, if true, and very promising.

------
mrfusion
It's odd that people with apoe4 had much higher incidence of the swelling side
effect. Why do you suppose that might be?

------
closetnerd
It works on amyloid beta. Curious how this drug compares to magnesium
supplements since there's been research showing that magnesium also effects
the amount of amyloid beta.

~~~
mrfusion
Affects it good or bad?

~~~
closetnerd
Good:
[http://www.ncbi.nlm.nih.gov/pubmed/20413885](http://www.ncbi.nlm.nih.gov/pubmed/20413885)

"Our findings suggest that supplementation of magnesium has a therapeutic
potential for preventing AD."

