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.
J&J's actions are also very similar to those of the tobacco industry and oil companies- the dangers of their product were well-known within the industry and yet they took steps to obscure the issue and limit regulation rather than address the problem. (In fact I just did a Google search for "hazardous talc" and the first result is an ad: "Johnson & Johnson | Get the Facts About Talc" https://www.factsabouttalc.com)
In the ceramics industry the dangers of talc are well known, in recent years well-known sources of talc have been closed down due to asbestos contamination. In addition talc-silicosis is a very real concern and we never touch raw talc without an OSHA-approved respirator and dust extraction system.
In a different corner of information: pulmonary talcosis is a known danger for intravenous drug users who shoot up pills. We’ve known about that for decades, too
It’s theorised that yes, there is, but I haven’t seen the same papers/case studies that prove it. But: consider that talc dust inhalation is known to cause talcosis, then consider that snorting crushed up tablets with talc in them goes straight into your mucous membranes and lungs, I personally would not be at all surprised.
> 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.
Possibly they're stricter on small companies because if they mess up, you can't fix the issue with a big class-action lawsuit? If Johnson & Johnson mess up, they're big enough to be able to compensate consumers directly.
Not saying it's an ideal solution but if I were a budget-constrained federal agency trying to minimize harm with limited resources I could see myself making a similar call.
Not everything is about money. And moral lapses don't (or shouldn't) disappear just because you pay for them with money. Regulation should protect people from everyone.
The list of untested yet still "approved" chemicals / additives is endless. The ability to pin point the guilt of causing a disease on any one of them is nearly impossible.
Very true. Companies are trusted to perform their own testing which is, at best, only testing for superficial, short-term effects. And substances are tested singly, despite the fact that we know that their effects are often multiplied by orders of magnitude. Look at the "inert ingredients" in pesticides for example.
The real root of the problem is that there are so many products under its purview that the FDA cannot possibly thoroughly vet them all. Doing serious, in-depth, independent analysis of every product would be fantastically expensive. So instead, the FDA and other agencies (like the FAA) establish standards for the processes manufacturers must follow and they primarily audit the processes rather than the products themselves.
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.)
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.
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.
All the work involved in capturing the FDA demonstrates that the FDA is not a "mandatory BBB", if they really had no teeth there would be no need to devote all these resources to dupe/intimidate/capture them.
Of course the FDA has teeth. But the teeth are only sharp enough to hurt the little fish. The big fish keep on swimming while the FDA takes out the little fish, just like the big fish like it. The FDA and the big fish are partners. Notice how nobody in this situation is partners with you and me.
Pretty much true given my knowledge. It is probably time to disband the FDA. That's the easy part. But the FDA serves a vital purpose and a new agency would be required to replace it
> Section 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to conduct inspections of cosmetic firms at reasonable times, in a reasonable manner, and without prior notice in order to assure compliance with the applicable laws and regulations, to determine whether cosmetics are safe and properly labeled, and to identify possible health risks and other violations of the law.
The thing they don't regulate is vitamins, supplements etc. Interestingly those things can be just as potent as "real drugs", but they aren't regulated simply because the seller opted to not say they are drugs, rather on any theory that they're not actually drugs.
Not to worry, those are regulated by the banks, who won't provide financial services to any business selling anything that they think mimics illegal drugs.
The solution to this type of problem is not to weaken or get rid of these cops. We should give them more resources, more power, more independence to resist political pressures, more ethics rules and internal affairs, more respect and leeway to the career professionals to attract the best and the brightest.
This is a frustration to me because neither the left or the right seem to fight for better government, more just, more fair. The right have this childish dream that no government will magically work, which happens to dovetail into what criminal corporations want. The left protect the government unions and allow them to become dysfunctional.
I was with you until you blamed the government unions. That is emphatically not where regulatory happens, even though those unions themselves (in comparison to their beleguared private sector counterparts) are arguably an instance of regulatory capture.
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.
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."
You can absolutely vote out the politicians responsible for for giving authority to these regulators. In fact, it's your duty to vote out crooked politicians. Even when both candidates for an office are crooked, they won't be equally crooked. Figure out which will do the least damage and support that candidate despite their flaws.
And don't give up hope. Crooked interests are absolutely counting on voters' cynicism to allow them to operate.
It's not so simple as good and crooked. How can you even traceback which politician gave which authority to what regulator, and how can you possibly know that the opposing candidate would do a better job? Fringe issues like this are completely out of scope for voters and will not even show up on the politician's platform. If you care deeply about a fringe issue, you need to either hire a lobbyist or become a politician.
I am going to go out on a limb and guess that it is fairly obvious which political party in the United States takes regulatory issues seriously.
I think you might be greatly surprised by how much influence you personally can have on politics on a very practical level by interacting with politicians of said party in your district on a personal level.
> It's not so simple as good and crooked. How can you even traceback which politician gave which authority to what regulator,
It doesn't matter who gave authority to the regulator, what matters is whether or not they are currently responsible for that regulator, and are doing a good job of it.
There's a congressional committee on pretty much every department under the sun. Follow the chain of command.
> and how can you possibly know that the opposing candidate would do a better job?
"Billy really sucks at doing his job, but we can't fire him because we don't know if we hire someone worse" isn't a good reason to keep Billy employed. Keep sacking the ones that are doing a terrible job, until you find one that does a good one.
"Steve is our best salesman but he keeps burning popcorn in the microwave. Joe Janitor just put in his resume: I don't know if he's better with the popcorn but let's fire Steve anyway."
I'm belgian, living in Belgium and I know which american political party take regulation more seriously, which is more obviously corrupt and which is more socially irresponsible...
Just google "climate change republican party" and you will have a good summary about who should get your vote for the sake of your grand children.
You can vote them out, by voting in politicians that care about good governance, as opposed to politicians that actively campaign for no governance (At this point, pretty much the entire Republican party), or politicians that do not actually perform good governance (At this point, this is much, but not all of the Democratic party).
Hint: One of those two parties is fixable, and it can be done through their primaries.
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.
You can peacefully protest all you like, in the designated chain-link cage set aside for you 5 blocks away from the thing you're protesting. Oh, and you do have a permit, right?
It seems there will be constant battles until enough of society is educated enough where they know what they will take a stand for, accept, and what they won't - in part so they are able to elect politicians who are the gatekeepers, on "both sides" - who will eliminate and watch, protect against these efforts or mechanisms of bad actors. The first step is "getting money out of politics" - which is likely an impossible task, why I like Presidential candidate Andrew Yang's Democracy Dollars proposal, giving $100/year for eligible voters to contribute to political candidate of their choice - which will wash out lobbyist money 8:1 - meaning $5 billion from lobbyists will be countered by $30 billion of resources from voters; at minimum it will facilitate not just the narrative that mainstream media and the two-party system has been able to control with establishment politicians.
There certainly could be some of that - however I imagine that behaviour will still be washed out with the overall quantity. It will be interesting to see how it unfolds.
"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?
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".
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".
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.
Hell, you can experience it first hand as a programmer. I could technically work on any programming job, from databases to JavaScript to game engines to machine learning, just like a lawyer could technically be any type of lawyer.
But it is way, way easier for me to get a job doing the exact same type of programming I've been doing for the last decade, in the same environment, and I get paid way, way more to do that, because my specific experience makes me so much more valuable.
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.
There exist tertiary jobs that employ the same skillsets without the danger of pervasive incentives. No one minds if a EPA regulator that does agriculture cases his whole career then take a lawyer job in the fishing or mining industry. It's when that person drops immediately into a legal career at Monsanto that people start seeing a conflict of interests.
Why would anyone in the fishing or mining industry want a lawyer with no knowledge of those industries, only knowledge of agriculture? It's my experience that a lawyer who doesn't have experience in a specific industry is pretty useless as they don't know the topics or the norms. My experience working with lawyers who know the video game industry has been vastly more positive than with those that don't
You can argue this prevents people like FCC's Wheeler, but the current administration has several examples refuting this. Is there no way that you can still work in the field without being able to influence policy?
Wasn’t there talk earlier this year of putting a 10 year delay on retired government officials taking these lobbying jobs? Did anything come from that?
That sounds like it would prevent competent people from regulating.
Better would be to prosecute people who conspire to harm others by intentionally distorting policy. That's how literally all the other legal stuff seems to work.
I like it, but the conspiracy would be almost always impossible to prove. People in these positions don't 'conspire', they say "wouldn't it be nice" to a golfing buddy, who then does what they can to make it happen.
"We've cut budgets such that there aren't enough regulators to keep tabs on things, while J&J bullshits consumers, and your solution is more government?"
Yes, that is exactly my solution. Do you have suggestions?
Likewise, in the '40s, paint manufacturers promised to phase out lead in paint "voluntarily". In 1973 it was finally outlawed, with nothing like a beginning of a phase-out in the interim.
1973 was a low point for trust of fatcat industry, coinciding with revelation of Watergate abuses. It is hard to believe any new such regulation could be enforced today.
>Keep that in mind when some politician or business owner goes on about "bureaucrats". Because "bureaucrats"
You rarely hear even the small government politicians rail against bureaucrats because being able to use their influence withing the bureaucracy for favors (some more ethical than others) is a source of power for them. They may complain about the priorities of the bureaucracy (e.g "we should be funding X not Y") but they don't lament the existence of the administrative arm of government.
"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.
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.
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."
"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.
> it only takes ONE PARTICLE of tremolite or actinolite to start you on the road to mesothelioma.
A completely unhelpful thing to say. Everything starts somewhere, there's nothing special about asbestos. 'It only takes ONE GAMMA RAY PARTICLE to start you on the road to terminal brain cancer' too, but does that mean you shouldn't live in Denver or ever take an airplane flight?
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.
I went through a hysterical moment in my life where i did some grinding on the concrete floor in the basement and the sheeting i put up to keep the dust from going through the home failed. This sent a large plume of fine particulate through my house and i was concerned for the health of my family. Trying to gauge how much of an issue this was turned out to be impossible as the regulatory agencies wouldn’t set some kind of lower limit on exposure.
Then of course you find all manner of skeevy companies leveraging that in scare marketing. Ultimately went with hepa vacuum, big fan to do a few air exchanges with the outside and upgraded furnace filters. Nobody’s died yet.
I wondered that as well. 0 tolerance means our entire planet should be condemned as uninhabitable, then. Clearly there must be some level of parts per 10 to the N that is no more dangerous than a walk on the beach.
300 parts per million is probably bad. 1 part per trillion is probably cleaner than a random meadow.
Some quick googling shows that they did come out with a cornstarch based variety but you have to explicitly look and find that. The J&J website lists the ingredients for Baby Powder as "Talc, Fragrance".
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).
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.
Go right ahead. The link between talc and any kind of harm is limited (and it's asbestos contamination that is the actual culprit, talc itself is fine), and what evidence there is only links to ovarian cancer. Given how many decades people have been powdering their nether regions with talc, I'd find something else to worry about.
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.
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.
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.
> 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.
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.
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.
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.
> 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.
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.
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.
While I'm expecting it will turn out to be bunk, I'm glad you currently have the right to spend your own money on what you want. I'm sure that will soon go away though.
Isn't there a podcast series by Wondery about this? I think it's called Bad Batch, regarding the non-scientifically backed woo that is stem cell treatments?
The source is from doctors I've had stem cell treatments from. The state of California also has had a lot of difficulty - spending $4 billion on stem cell research, only to run into problems with FDA who greatly limit treatments that the science of regenerative medicine shows to be greatly effective.
There aren't many regenerative medicine doctors at the moment and the public isn't educated enough to push back against the regulatory capture that's currently developing. The doctors themselves are adapting to provide certain treatments outside the jurisdiction of the US, otherwise they will continue to provide treatment - knowing that the centralization efforts of big pharma will increase costs to consumers by 2x; people who are in pain of course are arguably the most desperate and whether a treatment that works costs $5,000 or $10,000 - they will pay it.
People mean citations to researchers that don't stand to directly profit from their spurious (i.e., fake) research, like the idiot/murderer that spawned the anti-vaxx movement.
So far you've only cited doctors and clinics that directly benefit from promoting stem-cell research, and no unbiased (i.e., academic) studies showing any sort of statistical benefit.
I don't think you bothered to read the citations you provided. Half of them merely describe what stem cell therapy is, several of them describe what they hope stem cell research will accomplish, and only a handful of them actually consist of research on stem cell therapy itself, almost all of which involve animal trials or laboratory trials on human cells outside of the human body.
One of these articles even noted that stem cell treatment appeared to be more dangerous than chemotherapy with respect to cancer treatment...
So yes, thanks for the cites but you still haven't provided any cites that support the notion that stem cell treatment is either safe or effective in humans.
