I have a serious question - surely if the FDA could roll out a vaccine for the masses (all over the world), you would think that they can surely hurry up with all the medicines (think diabetes, cancer etc) and fixes that have humans waiting…Guess what - the FDA is as much part of the controlling conspiracy and (get paid for holding back research/approvals)…
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Welcome ChrisH to FUDiabetes. It is a very good community of caring and intelligent people.
My response to your post:
All my life I have heard various conspiracies. GM bought off the invented of a carburetor that would deliver super fuel efficiency and great power. That one might have been more believable if it had been Standard Oil or some other oil company.
I won’t say I completely trust the FDA, especially with its current leadership. However, the FDA is a US thing. There are lots of nations with similar departments for determining drug safety and effectiveness.
There are also international researchers working to develop drugs and devices to aid in coping with various diseases.
Yeah that was done in 47 nations with Thalidomide. This resulted in 10 to 20,000 babies born with severe deformities, about 40% of them died at or shortly after birth.It was an FDA reviewer, Dr. Frances Oldham Kelsey who prevented thalidomide being approved in the USA.
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Thank you @CarlosLuis. Remedies/Solutions exist. Most thankful for all the medical advances that have been made over decades. Think the discovery of antibiotics as an example.
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@ChrisH I appreciate your concerns and wish there was sufficient money in the world to address all the medical ills that befall people in it; but i realize there is not, nor are medical issues the sole focus of any government. I, too, wish diabetes would be more treatable, but not at the expense of everyone else and the medical issues they have. While I’m not a fan of our current FDA leadership for certain decisions and actions unsupported by scientific fact or at least an anecdotal preponderance of significance. If evidence exists, even anecdotal, state it and convince me/us, vice making a broad unsupported claims. I agree with @CarlosLuis, the folks here on FUD will listen and consider your statements, but not blindly follow without evidence.
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I would describe the source of our problems not as a conspiracy (but some people term it ‘criminal conspiracy’) and more of a problem with monopoly power and incentives. VERY open ended request for public comment from DOJ & FTC - #20 by mohe0001
Some are suing for ‘criminal conspiracy.’ Those cases take a long time to settle. O'Reilly Automotive sues insulin producers, prescription managers
I actually trust FDA more than a lot of agencies because they have been pretty supportive of diabetics in the past. We have a good relationship with them. They push boundaries on our behalf. They have been helping remove all the illegal patents. That helps free up innovation. The markets are pretty locked up. You can listen to Scott talk about the patent problem here: #1224 Orange Book Chronicles — JUICEBOXPODCAST.com
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I’m not part of the ill-informed quack brigade, but one has to be skeptical of any organization providing information. Even under the best of circumstances, information and guidance will be somewhat imperfect. It is worsened when the administration is captured by industry, partially attributable to the revolving door between pharma and government, as well as by the incentives pharma provides to practitioners that influences and warps expert opinion. Then there is the current administration, filled with individuals having influence and incomes by providing anti-factual and ill-informed opinions.
Even under the best of circumstances, envisioning a hypothetical organization that makes decisions based on solid evidence, without industry influence, and in the interests of the population, broad opinions and decisions will not work for everyone, but for the largest number of people in most situations.
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A separate issue is that I do not think the FDA makes money from withholding solutions, there were allegations of corruption from current and former FDA officials:
Several allegations of corruption have surfaced concerning FDA officials. For example, George Tidmarsh, a top drug regulator, resigned amid claims of soliciting a bribe and misusing his office for a personal vendetta, while another FDA official, Vinay Prasad, resigned after accusations of disclosing trade secret information without authorization and making controversial decisions impacting vaccine approvals.
As far as I know, the above only applies to the current administration. Issues about experts’ non-dsclosure of financial ties is a separate problem
Broader Concerns Regarding FDA Integrity and Influence
Beyond specific allegations against individuals, broader concerns exist regarding the FDA’s funding structure, potential corporate influence, and the “revolving door” phenomenon:
User Fees and Industry Influence: A significant portion of the FDA’s budget comes from user fees paid by the pharmaceutical companies it regulates. This funding model has raised concerns about potential corporate capture and conflicts of interest, with critics arguing it could influence drug approval processes. While the FDA states these fees do not influence product approval decisions, the perception of undue influence persists.
“Revolving Door” Between FDA and Industry: The movement of FDA officials to positions within the pharmaceutical industry after leaving the agency, and vice versa, is a long-standing concern. This “revolving door” phenomenon raises questions about regulatory capture and whether the prospect of private-sector employment could create a bias in regulatory decisions.
Political Interference and Lack of Transparency: Some former FDA officials and experts have expressed concerns about increasing political interference in agency decisions and a lack of transparency in certain programs, such as the “Commissioner’s voucher program.” These concerns suggest a potential erosion of the traditional firewalls between political appointees and scientific review processes.
Ethical Concerns in Drug Review Programs: A House lawmaker has also raised concerns about the FDA’s ultra-fast drug review program, highlighting ethics issues related to financial disclosures of senior
This was the prompt that generated the above Google response to the following:
A separate issue is that I do not think the FDA makes money from withholding solutions, there werre allegations of corruption from a current FDA appointee or official
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I do not trust the FDA, at least completely. It was set up as the Food and Drug Administration, one thing it was set up for is to promote the use of drugs. I’m not saying that drugs aren’t or can’t be a good thing. But a lot of the rules in place weren’t necessarily for the benefit of people. That came over time. But with drawbacks. Like the fact a company could run a 100 tests for a drug and submit the ones they wanted too. This allowed a lot of hidden results, in 1962, 1997 and finally in 2017 rules were put in place to try to have all clinical trials registered that had been done, not just the chosen ones.
Then we come to the things like aspartame, one of the most complained about ingredients. People that reviewed the research at the FDA had recommended it not being approved until further research could be done. People working for the company, then working for the FDA, it getting approved, then back to the company. That is coincidentally when saccharin got in trouble with causing bladder cancer in rats. It turns out the quantity that was fed to rats and the fact that they had a different biology involved in getting bladder cancer that humans didn’t come out until later, after the approval of aspartame. This was thought to have happened because they wanted to push aspartame into approval. There is a huge story in that. I am not saying it might have been approved anyway or whether it is safe, but one of the reasons many have distrust in the FDA. Similar problems with BGH.
So you hope they do their job, but as with any entity, who is in charge at the FDA helm has a lot to say about approvals and processes of anything and that can change tomorrow. But we hope they cover the basics for safety, enough but also without going overboard too and that rules in place do what they are supposed too. Pharmaceutical and chemical manufacturers just have an awful lot of money invested in their product getting out there.
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Just wondering, are you aware of the details about the saccharin studies? The amount of saccharin given to the animals that demonstrated bladder cancer was beyond the deadly dose per pound for an adult? Not exactly scientific.
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I remember Tab was one of the main diet sodas back then. They said the study was equivalent to drinking about 500 cans of Tab per day.
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My understanding with Cancer studies is that there is basically no lower limit for exposure - if you can show cancer at high doses, it is reasonable to expect cancer at much lower doses (perhaps over a longer period of time).
So when they say a compound causes cancer in laboratory animals that’s basically “proof of concept” for that compound being carcinogenic.
Do I have that right?
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That would make water a carcinogen.
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Lets talk about several issues that come when people discuss this topic.
REGULATORY CAPTURE
That is the topic of “regulatory capture.” There is a revolving door, for instance, between people working positions in government regulation and people working in industry.
One example people have recently cited is that the former FDA commissioner now holds a position (making far more money) on the board of directors at United Health Group (one of the country’s largest insurers). https://www.forbes.com/sites/brucejapsen/2025/11/18/unitedhealth-group-taps-former-fda-chief-and-medicare-advisor-to-board/
Does that represent a conflict of interest? One of the practical concerns is that once you know everything about how the government operates, it’s very easy to bring that knowledge to industry. The government moves very slow. Industry moves relatively fast. Therefore, industry has the advantage in out foxing the governments ability to regulate them.
Another example of interest, of late, is Epic (Electronic Health Records company in WI). They have lobbied the government hard so that legislation gets passed that gives them a giant edge in the market and prevents other commercial entities from competing. That is also referred to as, “Regulatory capture,” because the company essentially buys the legislative process through campaign donations.
It’s pretty well accepted that those issues exist for FDA, but that those problems are not exclusive to FDA.
THE DIABETICS & FDA
The diabetic patient community has a bit of a special relationship with FDA through our unique work. Remember back to the early days of building software to control/monitor blood sugar? That stuff was built atop proprietary hardware (insulin pumps). In order to control the delivery of insulin through the pump, the hardware had to be hacked (except for the early Medtronic pumps that lacked encryption and Dexcom devices because Dexcom allowed access to the data openly).
That was legally, a really gray area. Why? Because it involved hacking (which is typically illegal) and it involved class III (high risk) medical devices. If executed poorly, the diabetics might have killed people accidentally. FDA is not a big fan of building medical devices in your garage and distributing those to the public. The FDA will send FDA police to talk to you and they will throw you in jail. Dana Lewis talks about the FDA showing up at conferences where she was talking about DIY pancreas systems. They scared the ■■■■ out of her, but they did not throw her in jail. I’m sure she was very nervous and it took a lot of bravery to speak openly about the work. The FDA was watching diabetics closley.
After some years of that, the FDA brought Ben West (a software developer for Loop APS) in to talk. That meeting is not available on the web anymore, but it is great. They spoke to diabetics from the community in an effort to better understand what was happening. Here’s one record of that from ten years ago: download.
FDA took the time to understand WHY diabetics were doing that work. They determined that the diabetics were not up to anything malicious. They allowed the work to proceed, which was a great act of advocacy. When companies came to them screaming about diabetics hacking their devices and trying to get diabetics in trouble (maybe thrown in jail), the FDA said, “If you don’t want patients hacking your devices, then build secure devices,” and rolled their eyes. They recognized how much work patient advocates were doing and how little work companies were doing. That takes a level of practical, well intentioned insight that isn’t common in government. That makes me feel good about FDA to this day.
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@mohe0001 Typically, yes, work for the government and gain knowledge, and then go to work for the private sector at higher pay. But work in the private sector in a higher pay position, then go to work for the government, then back to the same company. For a fairly short period of time and get an ingredient approved that was having issues, is not.
@bostrav59 I am not sure about the build up of saccharin over time, as it turned out not to be pertinent at all because the route of it causing cancer in rats is not the same in humans. It is handled in the body differently. Thank goodness animal testing is being phased out.
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I have a question for ‘ya, @Marie (and whomever else wants to chime in).
When I write/talk to the government, it’s primarily been about money and markets…and, yeah, I think there’s room for improvement there. There might be a lot of improvement to patient care if patients have more rights or if the medical system functions more in the interest of patient care. I want them to write me insulin prescriptions (and Rx for other vital, life preserving supplies reliably and competently and without me needing to nag them every day for three to six months). I don’t want to be billed for services I am not receiving. Like, if I go to annual appointment and they can’t be bothered to refill an insulin script, that becomes a disaster in my life…or a potential disaster. That happens constantly. It eats up a lot of my time and they are completely unaccountable and incompetent.
But the government hasn’t really even opened the door on discussions about patient care. That’s essentially what all this boils up to. It’s about their negligence. It’s about them fulfilling their basic professional responsibilities, otherwise those responsibilities should be removed.
Let me think about this more…I want to write about how the medical system creates so many more artificial barriers than it resolves, that it has negative value to me and I would rather just have as little contact with it as possible. I want to write about how the primary source of disability, for me personally, is forced participation with the medical system. I think I can document that successfully, at the drop of a hat. But is that an argument that could resonate with anyone else? Would a government employee who is not a diabetic be able to identify with that perspective?
Really what I want out of the medical system is competence, but I’m not sure how to ask for that.
Maybe I just document how incompetent the care I receive is? It’s so expensive and it’s so worthless as to border on medical negligence. I just think about how terrible dealing with that is if you are 20 years old and don’t even really know how your body works and how the insurance system works, etc. It’s no good. I, at least, know how to set my basal rates and what is reasonable hardware performance because I learned all of that the hard way.
Lets face it, 20 year old’s are incompetent (for the most part). They don’t have any money when insurance and the doctor screw them (like they did to me the other week). They can’t fight with the insurers like I can because they don’t know anything about what’s conventional insurance billing and business practice. They don’t know what the laws are. I’m just happy if people survive their 20’s and don’t hurt anybody else through their bad judgement and excessive energy.
But I know better. I have documentation. I can identify medical negligence. Granted, I’m more likely to identify it when it’s associated with a large bill. It makes me mad. But the medical system isn’t gonna actually hurt me through their negligence. I know enough to go buy the insulin over the counter at Walmart. I know how to administer NPH in an emergency. I know how to tell the pharmacist that I am a drug addict in order to access new syringes. I know how to hound the clinic and the insurer to get the prescriptions filled that will sustain life. I know how to evaluate my own insulin dosages. But that doesn’t mean that their behavior is OK.
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The type of studies you describe on saccharin and aspartame are done by toxicologists, whose goal is not study a compound at therapeutic doses, but to determine the LD50 (L=lethal, D=dose, and 50 is % of treated) of a compound. That is different from safety studies that use therapeutic, or usage, doses. The latter are conducted in different species, while the former are conducted in primarily rats and mice.
Drug development do safety studies, which can take years to complete and analyze. Drug development is an extremely complicated process that can take a lot of time to describe. And remember some drugs fail for various reasons, including inability to formulate, unacceptable side effects (risk/benefit), or safety.
Mike
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In a nutshell. No, I do not trust the fda or any other governmental organization to be non-perverted. You point out, accurately, that they don’t have a direct incentive to be disingenuous… but the web is so much more complex than that
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