
Balaji Srinivasan, who may run the FDA for Trump, hates the FDA - devy
https://www.recode.net/2017/1/14/14276530/balaji-srinivasan-trump-fda-twitter-andreessen-horowitz
======
walterbell
There was a book written near the death of Harvey Wiley, first head of the
FDA, where he was already talking about regulatory capture by industry,
[https://en.wikipedia.org/wiki/Harvey_Washington_Wiley](https://en.wikipedia.org/wiki/Harvey_Washington_Wiley)
&
[https://www.google.com/search?q=the+history+of+a+crime+again...](https://www.google.com/search?q=the+history+of+a+crime+against+the+food+law+wiley)

 _> Wiley soon became a crusader and coalition builder in support of national
food and drug regulation. His work, and that of Alice Lakey, spurred one
million American women to write to the White House in support of the Pure Food
and Drug Act ... Wiley was nicknamed the "Father of the Pure Food and Drugs
Act" when it became law in 1906 ... On March 15, 1912, Dr. Wiley resigned his
leadership of the Chemistry Bureau because, from nearly the beginning, he had
been antagonized in the enforcement of the Pure Food And Drugs Act, and worse,
he had seen the fundamental principles of that act either paralyzed or
discredited ... After his resignation from government work in 1912, Wiley took
over the laboratories of Good Housekeeping Magazine, where he continued his
work on behalf of the consuming public._

The first head of the FDA resigned to work for a private laboratory that
evaluated consumer products. Smartphone spectroscopy ("tricorder") with cloud
analytics is being productized to enable mobile identification of food &
drugs, [http://mashable.com/2017/01/07/smartphone-with-scio-
sensor-c...](http://mashable.com/2017/01/07/smartphone-with-scio-sensor-
changhong-h2/)

Can new regulatory frameworks lower barriers to innovation (in drug discovery
and feedback loops for consumer safety), beyond large incumbents and VC-backed
challengers?

------
anigbrowl
It should be abundantly clear by now that many of the incoming
administration's cabinet/agency picks are aimed at dismantling the federal
administrative structure, regardless of any scientific or practical reasons
for how the structure got to be that way to begin with. Good times for snake
oil salespersons, bad times for anyone else.

~~~
elastic_church
> Good times for snake oil salespersons, bad times for anyone else.

Odd thing to say as it has always been a good time for snake oil. FDA is
riddled with exemptions.

Water, sugar, food color and I'm over here 'preventing' ailments naturally.

------
jefe_
I think the best thing the FDA could do is create a 'Conceal Carry' type of
license which allows you to self prescribe certain types of pharmaceuticals
(all would be great, but start with some). You basically take an 8-12 hour
course and then pass a test, sign a piece of paper waiving the right to sue
over non-compound, non-quality issues, and then get a license which allows you
to purchase certain pharmaceuticals on your own. You could in theory reduce
liability for doctors and pharmacists, opening up some money for something
else like technology. Would boost sales for certain drugs and if done right,
could result in a healthier more productive society.

~~~
JamesBarney
I think this would be great. But I think the course should be per drug. For
instance what you need to know to self prescribe MAOIs is very different from
what you would need to know to self prescribe SSRIs.

It would lead to more people using drugs that are are highly effective but not
prescribed for liability reasons like MAOIs.

------
ozanonay
Anybody who deeply scrutinizes the FDA will find opportunities for reform. For
instance, when the economists Daniel B. Klein and Alex Tabarrok applied their
scrutiny, the result was
[http://www.fdareview.org/](http://www.fdareview.org/)

What is surprising and exciting about the possibility of Balaji's appointment
is not that he has identified opportunities for reform, it is that he may be
appointed despite the fact that reform is his primary motivation!

He has no political motive, no personal motive, he does not "hate" the FDA (he
is not the kind of person to be driven by hate)... he simply sees the FDA's
mandate as an incredibly important one which it could do a better job of
fulfilling. This should inspire optimism.

------
RichardHeart
I like that he's had a successful startup in the field, and is generally smart
as hell: [https://balajis.com/about/](https://balajis.com/about/)

Balaji S. Srinivasan (BSS) is a computer scientist, investor, entrepreneur,
and academic. Dr. Srinivasan holds a BS, MS, and PhD in Electrical Engineering
and an MS in Chemical Engineering from Stanford and taught data mining,
statistics, and computational biology in the Department of Statistics at
Stanford University. He was an NDSEG, NSF, and VIGRE fellow, was named to the
MIT TR35 and Founders Fund F50 lists, and has been published in the New
England Journal of Medicine, Nature Biotechnology, and Nature Reviews
Genetics. He was the CTO and co-founder of Counsyl, a genomics startup that
began in a Stanford dorm room and now tests ~4% of all US births. Counsyl won
the Wall Street Journal’s Innovation Award for Medicine, was named one of
Scientific American’s Top 10 World Changing Ideas, raised more than $65M in
funding from David Drummond, Aydin Senkut, and Founders Fund, and has become
one of the largest clinical genome centers in the world. After ten years in
genomics and five years at Counsyl, he stepped back from an executive role in
November 2012 to work on other areas of technology. He now invests in and
advises startups, teaches a popular MOOC at startup.stanford.edu, runs the
Stanford Bitcoin Group with Professor Vijay Pande of Folding@Home, and writes
at balajis.com.

------
smitherfield
The "Yelp for drugs" pull quote is missing the second part: "with MD star
ratings." i.e. only medical doctors would be able to review/rate. Which IMO is
a reasonable and interesting idea worth exploring.

~~~
amputect
Imagine the little perverse incentives that companies offer to leave a Yelp
rating (rate us and get some free breadsticks! or whatever), but with
pharmaceuticals (leave us a five star rating and get a new car, or a new
medical device, or whatever). That sounds really, really bad, and it would
require a lot of regulation and oversight to make sure ratings weren't being
manipulated. I suspect those two things will be in short supply in the
incoming administration.

~~~
smitherfield
Doctors, like lawyers, accountants, pharmacists and so on have professional
associations with existing and quite strict ethics regulations about this sort
of thing.

~~~
FreakyT
That hasn't stopped "buying expensive stuff for doctors to sway them" from
being a thing, even now!

[http://www.wsj.com/articles/SB100014241278873246951045784145...](http://www.wsj.com/articles/SB10001424127887324695104578414530096553710)

~~~
smitherfield
I didn't say the existing rules were perfect, I'm just noting they exist. You
can also say that a "Yelp for drugs" wouldn't change the existing incentives.

FWIW, the doctors I know take ethics very seriously; they take great pains not
to be seen as accepting gifts, they treat pharma company claims with a great
deal of reasonable skepticism, they always prefer non-drug and OTC treatment
to prescriptions, and generics to branded drugs. A few bad apples do not spoil
the tree.

------
woodruffw
I met someone born with no arms due to exposure to thalidomide [2] as a fetus
several years ago. Governments in Europe had approved its use as a morning-
sickness pill without adequately reviewing its side effects, and thousands of
children paid the price. The FDA, at the time, did not approve thalidomide for
use.

Eliminating the FDA is a far cry from evaluating its performance, the latter
(I think) many people agree is necessary. The former will only result in
public experimentation and, consequently, suffering.

[2]:
[https://en.wikipedia.org/wiki/Thalidomide](https://en.wikipedia.org/wiki/Thalidomide)

~~~
necessity
Far more people die because of drugs the FDA does not approve, when compared
to deaths avoided by it, despite anecdotal evidence of the contrary.

~~~
woodruffw
We hold people and groups accountable for the things that they _do_ , not the
things that they _don 't do_ (except in cases where inaction is a form of
action).

It's wrong to rob someone, but it's _not_ wrong to be afraid of stopping a
robber as a bystander. It's not a good thing that people die because of the
FDA's long approval process, but it's not blameworthy in the same way that
death and suffering caused by hastily approved medicines (like thalidomide)
is.

------
wyoh
But he gave a great talk a few years ago:

Y Combinator: Balaji Srinivasan at Startup School 2013

[https://www.youtube.com/watch?v=cOubCHLXT6A](https://www.youtube.com/watch?v=cOubCHLXT6A)

------
ttam
[https://twitter.com/TonyRomm/status/821105716069023744](https://twitter.com/TonyRomm/status/821105716069023744)

> Scoop: Balaji Srinivasan met w/Trump, but the VC is _not_ up for FDA slot,
> source close to transition tells me.

------
kyledrake
There should be a Yelp for restaurants too, then we wouldn't need food safety
regulations.

~~~
noobermin
What's to stop "innovative drug companies" from buying fake reviews to boost
their numbers? It already happens in places like TrustPilot and others.

~~~
Taek
Right now, not much. The internet and academia both lack a good solution to
information manipulation.

A robust decentralized reputation system would go a very long way in solving a
huge number of problems. I don't think anyone is that close though. I feel
like we are just one major breakthrough away, but that breakthrough is likely
to take a form that nobody is expecting.

~~~
mattnewton
The way to solve it is to have different branches with checks and balances.
The FDA is one such branch that should, in theory, not care about anything
other than consumer safety, the legislative branch limits it's powers so it
doesn't go too far and stop innovation, and the researchers try and beat the
best of FDA's powers with evidence that their drug is safe.

If something is broken there, it's because of leaky incentives (ie, people not
really caring about the consumer on the FDA because of a revolving door with
industry) or because it's imbalanced (the FDA has too much power and it can
shut down drugs with legitimate evidence of safety, for example, or not enough
power, or drug companies don't have enough money anymore to convince the FDA,
etc)

~~~
snrplfth
The leakiest incentive is that the FDA gets in a huge amount of trouble if it
lets through a drug that has unforseen negative side effects, but faces
essentially zero consequences for holding up the approval of a worthwhile drug
indefinitely, and requiring billions of dollars to be spent on its
development.

~~~
daveguy
> but faces essentially zero consequences for holding up the approval of a
> worthwhile drug indefinitely, and requiring billions of dollars to be spent
> on its development.

The FDA does not hold up worthwhile drugs indefinitely. It does take time and
money to scientifically confirm the safety and efficacy of drugs. The whole
point is to make sure drugs are safe and effective -- the FDA does a pretty
good job of that.

Sure the pharma industry would have you believe it's just a bunch of pointless
roadblocks. I would like for you to point out a regulation or requirement of
the FDA that you think should be eliminated.

~~~
snrplfth
The problem is that the pharma industry _wouldn 't_ have you believe it's a
bunch of pointless roadblocks. The pharmaceutical industry, as currently
constituted, generally thinks the FDA's system is great, because it means that
not only are smaller, novel, and foreign competitors easily closed out of the
market, but that they have long-term sole approval for their drugs. The large
drug companies find this an extremely comfortable relationship - it's stable,
predictable, and they are well-practiced at it.

I think that it's not a problem to have an FDA which reviews and approves
drugs, and even one which determines which drugs are qualified for
Medicaid/Medicare payments. But what I would like to see is an "opt-out"
system, where patients could sign a waiver declaring that they are aware that
the drugs they would like have not been approved by the FDA and that they may
be hazardous, to access otherwise-unapproved drugs. I think there are genuine
costs to the current system that are too commonly dismissed:
[http://www.jpands.org/vol15no4/kazman.pdf](http://www.jpands.org/vol15no4/kazman.pdf)

I'm not saying "abolish the FDA", I'm just saying "allow people to bypass its
judgement if they really feel that they have to".

------
RichardHeart
I think the rating FDA's efficacy requires a strong understanding of Bayes'
theorem. You could look at the organization as a test itself. Like many tests
you've got false and true positives, false and true negatives, sensitivity and
specificity.
[https://en.wikipedia.org/wiki/Sensitivity_and_specificity](https://en.wikipedia.org/wiki/Sensitivity_and_specificity)

I find this this topic easy to misunderstand, personally, so I'm wary of
making statements as to whether the FDA should be more lenient, or exactly how
they should improve.

------
TylerE
Wow, this might be Trump's worst pick yet. Dude took $120M in VC money and
just flushed it down the toilet.

~~~
jjawssd
I suppose we should write off the leaders of all the other failed
entrepreneurs in Silicon Valley as well? A place where 9 out of 10 startups
fails.

~~~
extra88
> we should write off the leaders of all the other failed entrepreneurs in
> Silicon Valley as well?

For running government agencies? Yes. Such risk-taking does not belong there.

~~~
Gargoyle
Why not?

~~~
TylerE
A government agency can't declare bankruptcy.

------
tlb
His "replace the FDA with a Yelp for drugs" is obviously an extreme position,
but it's the right direction to explore in. There are many consumers who can
make intelligent tradeoffs about the risks and benefits of not-yet-approved
drugs, and they should be able to do so.

~~~
bazzargh
A counter-example: Thalidomide. Refused approval by the FDA multiple times
(the drug company kept resubmitting it), there were only 17 children born with
Thalidomide-related birth deformities in the USA.

Promoted as a wonder drug for morning sickness, there were 10 _thousand_
children born with birth deformities worldwide.

[https://web.archive.org/web/20090512235601/http://www.fda.go...](https://web.archive.org/web/20090512235601/http://www.fda.gov/fdac/features/2001/201_kelsey.html)

Perhaps memories of this are shorter in the US precisely because the FDA got
this right and there are fewer visible daily reminders why we need drug
regulation.

~~~
tlb
The FDA does excellent work on safety from a first-do-no-harm perspective.
From that perspective, everything is great.

Still, more than 100 million people die every year from diseases. Even with
the best available health care, few live beyond 90. So the very best outcome
imaginable has not been achieved.

The risk with the current FDA is that by minimizing the risk of being harmed
by new drugs, we've locked in the current life expectancy of ~75.

~~~
daveguy
> we've locked in the current life expectancy of ~75.

This is just false. The life expectancy has been rising through modern
history, except a stagnation in 1993 and one this year. You can't point to 1
data point in 50+ years and say we're locked in. Look at the record with the
FDA (data from world Bank)

[https://www.google.com/search?q=us+life+expectancy](https://www.google.com/search?q=us+life+expectancy)

Granted UK and Japan are doing better. They also have healthier lifestyles in
general and strong regulatory agencies.

------
SakiWatanabe
Isn't he the one who spent millions of investor's money only to build a
useless bitcoin computer, which is basically a raspberry pi with a mining chip
which only mines a few satoshis an year?

------
pavlov
I'm not looking forward to people buying experimental cancer drugs from their
local homeopath...

I'm not an expert here, but the notion that dismantling the FDA would unleash
medical innovation seems to ignore that there are already many countries
around the world with much less stringent drug review than the United States.
If that were a significant advantage, wouldn't these countries be showing
measurable gains in life expectancy or some other metric?

~~~
JamesBarney
I'm someone who would look forward to being able to buy drugs without a
prescription. Doctors are expensive and in many cases useless. I have low
testosterone. It was easy to diagnosis via a blood test. It's easy to treat
via simple drugs, and it's easy to follow best practices(every 6 months get a
hematocrit, and testosterone test) But I have to drive across town and spend
$200 every 6 months for some guy to do the same thing.

But you're right there is the issue of it's hard for an individual to consent
without being informed. So I think the manufacturers should be responsible for
putting out a course that teaches and informs the end-user about the drug, and
it's risks. (of course they would be legally responsible for any unreasonable
omissions, or reasonable misunderstandings)

------
snrplfth
Oh no! People might start taking drugs not explicitly approved by the
government after an extremely long, expensive and monopolizing approval
process, like kratom or something crazy.

Can't have that.

------
seertaak
Hey mods: can we reinstate the no politics rule, please? I know I could just
ignore these threads, but for some idiotic reason I can't seem to help myself
from peering into and contributing to these pointless debates where everyone
essentially preaches to the choir and comes out feeling frustrated and angry
at the other side's stupidity/ignorance/dishonesty/corruption.

One of my New Year's resolutions was to mercilessly unfollow anyone on
Facebook whose posts were over 66% political -- no matter whether Republican
or Democrat. Now I'm facebooking like it's 2005, and I gotta say, I'm liking
it. It's so nice looking at happy people on holiday with their families and
kids rather than mulling through all the political hatred and divisiveness. I
never thought I'd say that, but such is the degree of poison afflicting
political discourse that anything to block it out feels like desperately
needed palliative.

You took a courageous decision to ban politics and to my mind it was bliss...
more of the same please!

