
FDA bowed to industry for decades as alarms were sounded over talc - SolaceQuantum
https://www.reuters.com/investigates/special-report/usa-health-fda-talc/
======
davidhyde
So if you are a small cosmetics company the FDA will prevent you from selling
your product without thorough testing but if you are a large cosmetic company
you can simply tell the FDA that everything is OK. This benefits the larger
companies and therefore, monopolies. Strikingly similar to how the FAA seems
to operate with Boeing and look how that turned out.

~~~
chcknsammich
The real root of the problem is probably that the FDA is also a monopoly.

~~~
vkou
Do you _seriously_ think that we'd have fewer of these issues if companies
could shop around for the cheapest & most lax regulator?

If you believe that, please explain to me why the BBB exists, and what
positive social purpose it serves. It is the poster child for a toothless opt-
in 'regulator', and it is worse than useless at dealing with malfeasance by
its members. (But it's pretty good at collecting membership dues.)

~~~
Consultant32452
Imagine if absolutely nothing changed about the BBB except that I forced you
to fund them against your will.

~~~
vkou
Given that the FDA is a product of a democratically elected government that is
ultimately accountable to the people, while the BBB is a 'non-profit'
corporation, accountable to nobody, I think you missed one other important
difference.

If I don't like the FDA, I can vote for someone who will fix it. I happen to
think that they have, overall, done a far better job than most examples of
industry self-regulation.

~~~
Consultant32452
>Given that the FDA is a product of a democratically elected government that
is ultimately accountable to the people

The head of the FDA is appointed by Donald Trump.

>If I don't like the FDA, I can vote for someone who will fix it.

Do you have any evidence to support this claim?

[https://www.usnews.com/opinion/blogs/charles-
wheelan/2014/04...](https://www.usnews.com/opinion/blogs/charles-
wheelan/2014/04/22/study-shows-wealthy-americans-and-businesses-control-
politics-and-policy)

~~~
vkou
Donald Trump is an incredibly shitty person, but is democratically elected.
The head of the BBB is not.

You're letting the perfect be the enemy of the good.

~~~
Consultant32452
The head of the BBB doesn't have a monopoly guaranteed by men with rifles and
cages.

Do you have any evidence to back up your claim that if you dislike the FDA you
can vote someone in who will fix it? I provided pretty compelling evidence
that suggests you cannot.

We're all responding to a story of the FDA allowing a big megacorp give us all
cancer for literally decades. I think we have a very different definition of
the word "good." You can't vote in a better FDA, but you can fire the BBB by
simply ignoring them. No system will be perfect, but a better system is one in
which you can choose to ignore an unreliable source of information and aren't
forced to fund their production of unreliable information.

------
chmaynard
Someday, scholars will write the long, sordid history of how industrial
chemicals have been virtually unregulated for many decades. Thousands of novel
compounds have been introduced into the environment in enormous quantities
without any serious clinical studies of their long-term effects on human
health and the health of the natural world.

~~~
m463
This has been happening for centuries.

I think of the mercury used in gold mining in the 1800's as well as this book
from the 1960's:

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

I also read when the USSR came apart the world started to find out the scope
of hidden environmental problems.

 _" Heavy metal pollution near Norilsk is so severe that it has now become
economically feasible to mine surface soil, as the soil has acquired such high
concentrations of platinum and palladium."_

[https://en.wikipedia.org/wiki/Norilsk#Pollution](https://en.wikipedia.org/wiki/Norilsk#Pollution)

------
costcopizza
And we can't vote these regulators out nor boycott them.

Stories like this erode my faith in...everything.

~~~
cde-v
Don't despair citizen, our corporate benefactors still allow us to Peacefully
Protest™. Peaceful Protest™ solves everything!

~~~
selimthegrim
I would link to that Safely Endangered Pooh meme where fighting fascism with
violent means makes you a fascist but the difference between HN and reddit is
Google and a brain.

------
tolstoshev
"Eleven days later, the company announced that tests by labs it hired had
determined that there was no asbestos–other than some contamination it said
came from an air conditioner – in samples from the one bottle tested by the
FDA and the batch it came from."

Why the hell is there an AC system that is spewing out asbestos particles?

~~~
Roboprog
1970s? Lucky if the ceiling wasn’t coated with the stuff, in fairness.

Quantities / concentrations not specified in the article that I saw at a skim.
Both sides talking past the other, sadly.

------
mikestew
It was over seventy years, after it was decided lead in fuel was a bad idea,
before it was banned in road-going vehicles. [0] Keep that in mind when some
politician or business owner goes on about "bureaucrats". Because
"bureaucrats" to them means "someone who stands between me and more profits".
"Bureaucrats" to _you_ should mean "people that make sure this shit gets
enforced".

[https://en.wikipedia.org/wiki/Tetraethyllead#Controversy_and...](https://en.wikipedia.org/wiki/Tetraethyllead#Controversy_and_phase-
out)

~~~
merpnderp
When these regulators stop "retiring" to cushy jobs in the industry, I'll
believe it's the politicians and not the regulators openly taking bribes in
the form of future "jobs".

An easy fix would be for congress to pass a law preventing regulators from
working in the industry they regulated, but then the politicians wouldn't also
receive those same cushy "jobs".

~~~
openasocket
While I agree with the sentiment, keep in mind it's a little more complicated
than that. People who work on some category of regulations can only find
relevant work in the government or in that sector of industry. Making it
impossible to move from the government to an industry job effectively traps
people for life in their one job unless they change careers.

As a concrete example, my fiance is a lawyer working in environmental policy.
She's worked for the EPA and for various environmental justice groups because
she went with whatever jobs were available in her field, and that wouldn't be
possible with your proposed change.

~~~
markdown
> Making it impossible to move from the government to an industry job
> effectively traps people for life in their one job unless they change
> careers.

And?

~~~
mattkrause
And it’ll be necessary to either a) pay exorbitant salaries for these jobs to
compensate for what is effectively an incredibly broad non-compete or b) hire
idiots that can’t get jobs anywhere else.

------
ppmanik
"J&J, the world’s largest producer of talc powders, said in a statement that
it recalled the 33,000 bottles of Baby Powder out of an “abundance of
caution.” Eleven days later, the company announced that tests by labs it hired
had determined that there was no asbestos–other than some contamination it
said came from an air conditioner – in samples from the one bottle tested by
the FDA and the batch it came from.

Wow just wow

------
jaredandrews
Good interview with a lawyer working on this case:
[https://www.youtube.com/watch?v=FM-4ZoM2rv8](https://www.youtube.com/watch?v=FM-4ZoM2rv8)

------
ksec
So are those Johnson and Johnson Baby powder actually safe?

I remember reading J&J said only a batch in some years contains ultra small
amount of some substance and less than certain % of it is safe.

~~~
gwern
One has to wonder about a lengthy article which refuses to cite any numbers
and instead repeats endlessly that 'no level is known to be safe', which is
irrelevant.

~~~
refurb
I'll probably get down voted to hell, but this seems to be quite overblown.

The FDA has posted their latest analysis of J&J talcum powder.[1] Of the 3
samples, 1 had "none detected" and 2 had 0.00002% or less by TEM (electron
microscope). We're talking close to limit of detection.

The bigger issue is the link to ovarian cancer. The data is all over the
place. This one paper [1] sums up the data nicely - when looking at talc use
there was no correlation with ovarian cancer. Even outside of hygienic use
(condoms, gloves), many women had high talc exposure and no ovarian cancer,
while others had no talc exposure and ovarian cancer.

 _" It may be argued that the overall null findings associated with talc-
dusted diaphragms and condom use is more convincing evidence for a lack of a
carcinogenic effect, especially given the lack of an established correlation
between perineal dusting frequency and ovarian tissue talc concentrations and
the lack of a consistent dose-response relationship with ovarian cancer
risk."_

[1]

~~~
lightedman
"The FDA has posted their latest analysis of J&J talcum powder.[1] Of the 3
samples, 1 had "none detected" and 2 had 0.00002% or less by TEM (electron
microscope). We're talking close to limit of detection."

I do a bunch of mining and know the dangers of talc and its contaminants - it
only takes ONE PARTICLE of tremolite or actinolite to start you on the road to
mesothelioma. You just don't know which specific particle will trigger it.

~~~
refurb
OSHA says....

Permissible Exposure Limit (PEL) for asbestos is 0.1 fiber per cubic
centimeter of air as an eight-hour time-weighted average (TWA), with an
excursion limit (EL) of 1.0 asbestos fibers per cubic centimeter over a
30-minute period. The employer must ensure that no one is exposed above these
limits.

~~~
perl4ever
There's no such thing as 0.1 fiber. A small fiber is still one fiber.

~~~
lightedman
This is correct. A single asbestiform fiber can trigger mesothelioma. There is
NO SAFE EXPOSURE LEVEL.

Perhaps HN readers will understand that once they bother to get a career in
surficial mineralogy.

~~~
perl4ever
A single butterfly can also trigger a hurricane. Therefore we must eliminate
the Karner Blue[1] to save the planet.

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

------
EamonnMR
There's an entire chapter in An Air That Kills on talc.

------
ptah
free market is not always consumer friendly, regulations can save lives

------
dekalbcountyman
so stop putting baby powder on my nuts during the summer? :(

~~~
mikestew
Baby powder is fine, given that I don't know that one can even _buy_ talc
powder anymore. It's all made with corn starch now. Go right ahead and bread
those nuts (verifying that it's non-talc breading, just to be safe).

~~~
rootusrootus
Talc is still very much commonplace. What is actually somewhat hard to find is
pure talc with no fragrance at all. Not everyone wants to smell like baby
powder.

~~~
mikestew
Thanks for a different POV. Here in Redmond, WA I’m either not looking (which
is quite possible), or corn starch dominates the shelves.

~~~
rootusrootus
I've no doubt it varies considerably by store. Maybe by area, as well, though
I'm not all that far from you, so that probably isn't a big factor.

To get actual unscented pure talc I had to find it on Amazon.

------
loceng
To bring a new fight to the attention of more of the public: big pharma is
attempting to have the FDA prevent people from using their own stem cells for
healing via regenerative medicine - either fat or bone marrow derived. They
want to force centralization and also for consumers to buy the stem cell
products they're developing. Their arguments are fear mongering and non-sense,
however they've so far been doing a good job manipulating the FDA.

~~~
ceejayoz
Without citations, this is pegging my woo-meter.

A stem cell treatment provider recently lost a court case where they argued
they're not subject to FDA approval, claiming it's not a medication, drug, or
treatment. That seems like an untenable position to me.

~~~
loceng
Citations would require the doctors that I have had multiple of both fat and
bone marrow derived stem cell treatments from over the last 3 years including
last month.

The FDA has considered your own stem cells as a medication to bring it under
their control - honestly that claim alone is pretty disingenuous, stem cells
and properties of your blood are your body's natural healing mechanisms; with
these treatments they're not changing or manipulating the stem cells, which
you could more reasonably argue should be classified as a medication.

Another claim big pharma is trying to use is that injecting bone marrow into
joints shouldn't be allowed because it's non-homologous - meaning that bone
marrow isn't naturally in the joints, so it shouldn't be allowed to be
injected - the reason they want to prevent it is because injecting stem cells
into joints will clear up the pain caused by osteoarthritis.

~~~
ceejayoz
So, no citations then? Just the say-so from the people selling you expensive
treatments insurance won't cover?

[https://www.nytimes.com/2019/05/13/health/stem-cells-
fda.htm...](https://www.nytimes.com/2019/05/13/health/stem-cells-fda.html)

> There is almost no regulatory oversight of orthopedic procedures using bone-
> marrow extracts or platelets, which are regarded as low risk. While the Food
> and Drug Administration insists that it does have the authority to regulate
> stem cell treatments, it adopted an industry-friendly approach in 2017 by
> giving companies a three-year grace period in which to describe their
> products or treatments so the agency can determine whether they meet the
> criteria of drugs that would require agency approval. So far, few companies
> have submitted any information.

> In the meantime, rogue clinics offering other kinds of procedures have
> flourished, accused of blinding people by injecting cells into their eyes,
> mixing stem cells with smallpox vaccine to treat cancer or causing severe
> infections by administering contaminated blood from umbilical cords into
> patients’ joints or spines. In some of the worst cases, patients had already
> been harmed before the agency took any action, and the patients took legal
> steps themselves, suing the clinics that injured them.

~~~
loceng
What's your point? Not having proper oversight is a different beast than big
pharma trying to gain control.

I've spent nearly $100,000 over the last 3 years on stem cell treatments
because they permanently heal injuries. I researched doctors and clinics
first, felt them out along with their knowledge, and then have done plenty
more than a single treatment with them because they proved to know what they
were doing. Certainly that doesn't negate bad actors who will take advantage
and don't have enough knowledge or proper protocol to maximize outcome,
however once again, you shouldn't be so pessimistically dismissive nor
confounding issues when trying to argue a point.

~~~
ceejayoz
Who do you propose should do the oversight of stem cell treatments, if not the
FDA?

One person's "proven" is an anecdote. Scientific clinical trials are how we
_actually_ demonstrate efficacy (versus the very real placebo effect), safety,
etc. Plus, there's the bonus of _actually_ proven procedures being easier to
get insurance to cover, which should be appealing to someone who's shelled out
six figures.

~~~
loceng
You're still confounding and not understanding what I'm saying.

Whatever organization has oversight of that doctors should have oversight -
that doesn't negate the challenges of regulatory capture that is occurring.

That you're completely dismissing my own personal experience, that I'm willing
to spend $100k of money I'd much rather spend elsewhere, shows just how
dismissive you are. I didn't argue my own experience as part of the data that
does exist relating to stem cell treatments either, like you're seeming to
counter argue with.

You should probably dive into the existing research, and not depend on using
whatever mainstream sources you've used to develop your narrative and
arguments - seems you're falling into the narrative mainstream media wants you
to follow.

~~~
ceejayoz
> That you're completely dismissing my own personal experience, that I'm
> willing to spend $100k of money I'd much rather spend elsewhere, shows just
> how dismissive you are.

Look, people have "personal experience" that prayer cured their cancer, that
essential oils fixed their bipolar disorder, that aliens anally probed them,
etc.

Having invested large amounts of money can make one susceptible to sunk cost
fallacies, too.

"I say it works" is worthless by itself. Sometimes, worse than worthless -
actively harmful. The FDA approval process may not be perfect, but _some_ sort
of scientifically rigorous "does this work and is it safe?" is necessary.

~~~
loceng
I'm not arguing against proper research being done.

You realize that there are, and you can see, before and after imagery -
whether ultrasound, x-ray, or MRI - that is used to see the physical trauma of
the area being treated, treating it, and then seeing the healing that's
occurred with imagery afterward, right? I'm guessing your limited sources
don't actually share that information with you based on your lack of
investigating any of this while being so dismissive, and counter arguing
points I've not been making.

What I was warning of is regulatory capture that I've learned about directly
from the legitimate doctors (not all are I'm sure) that are at the forefront
of regenerative medicine, some who have been doing research on using stem cell
for 18+ years now already.

I understand your skepticism - maybe dive in deeper into different sources and
have just a little bit of curiosity as to the legitimacy of what I'm saying.

~~~
ceejayoz
Lots of aggressive statements about me having "limited sources" and "dive in
deeper into different sources" and... _no sources_.

I asked you for sources at the very top of this thread. Instead I got a bunch
of defensiveness, which is itself illuminating.

Surely this sort of imagery you're talking about is available somewhere, with
clear examples from both the experimental group and the control group,
demonstrating better results in the experimental? These clinics should present
that to the FDA, get the procedures approved, and rake in enormous amounts of
cash from health insurance from their arthritis cures.

