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Thread: Abolish the FDA

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    Shift Leader thethe's Avatar
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    Quote Originally Posted by zitothebrave View Post
    If only you had a clue. Go on being a cog in the wheel. Keep talking about how great your life will be when you're 60. I'll just keep hanging out with friends and having a good time.
    When I'm 60?

    I'm looking at retirement at 50 the latest but even moreso. I love what I do and I can do it from anywhere.

    Go enjoy playing D&D in your basement when I'm taking family vacations to Hawaii & Japan.

    And don't forget - Not too crispy.
    Natural Immunity Croc

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    Quote Originally Posted by Oklahomahawk View Post
    Is there any department, agency, organization, etc., in this country that doesn't need a good purging? I am against abolishing any of them by the way, at least until after they get a good "Spring Cleaning". I think they potentially serve a purpose for the American people, it's just that corruption, money, and politics have made them lose their way.

    Just my opinion though.
    Absolutely. They all want more power, more money, and more reason to exist. As someone famously said a few years ago, it's a swamp in need of draining.
    Go get him!

    Founding member of the Whiny Little Bitches and Pricks Club

  3. #63
    **NOT ACTUALLY RACIST
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    Quote Originally Posted by zitothebrave View Post
    Again, you don't have the stones. I'm not shocked. Your strategy is to act like tomahawk74 used to act all those years ago. But it's an old and tired thing. Keep on fighting keyboard warrior.

    Tomahawk74, was the man I wonder what happened to him

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    Connoisseur of Minors zitothebrave's Avatar
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    Quote Originally Posted by thethe View Post
    When I'm 60?

    I'm looking at retirement at 50 the latest but even moreso. I love what I do and I can do it from anywhere.

    Go enjoy playing D&D in your basement when I'm taking family vacations to Hawaii & Japan.

    And don't forget - Not too crispy.
    Sure someday you'll have fun. Good old someday.
    Stockholm, more densely populated than NYC - sturg

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    Waiting for Free Agency acesfull86's Avatar
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    https://erictopol.substack.com/p/the...day-at-the-cdc

    The profound data deficiency and lack of any semblance of informativeness by CDC is a topic I covered in a recent Substack post. But yesterday I found out that it takes only 3 people https://newsnodes.com/us, led by Gérard Hoeberigs, to post data promptly every day for each US state — including new cases, tests, % positive tests, hospitalizations, ICUs & deaths—and much of this for the rest of the world. But CDC has an annual budget that exceeds $7.9 billion and cannot do this.



    ^ more stumbling and bumbling from the CDC.

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    https://freebeacon.com/coronavirus/f...f-covid-drugs/

    In New York, racial minorities are automatically eligible for scarce COVID-19 therapeutics, regardless of age or underlying conditions. In Utah, "Latinx ethnicity" counts for more points than "congestive heart failure" in a patient’s "COVID-19 risk score"—the state’s framework for allocating monoclonal antibodies. And in Minnesota, health officials have devised their own "ethical framework" that prioritizes black 18-year-olds over white 64-year-olds—even though the latter are at much higher risk of severe disease.

    These schemes have sparked widespread condemnation of the state governments implementing them. But the idea to use race to determine drug eligibility wasn’t hatched in local health departments; it came directly from the federal Food and Drug Administration.



    ---------

    This nonsense was posted somewhere here a couple days ago...didn't realize it originated at the FDA...

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    https://reason.com/2022/03/08/can-th...y-from-itself/

    Public trust in the U.S Food and Drug Administration (FDA) is at an all-time low, largely due to its bumbled handling of the pandemic. But its failures in tracking, testing, and combating COVID-19 reflect decades of dysfunction at the agency. The incoming commissioner, Robert Califf, has an opportunity to pull the agency out of its fiery tailspin—but only if he is willing to confront an institutional culture of perverse incentives.

    In a better world, the FDA would be single-mindedly focused on protecting public health. The agency's performance would be measured by its effectiveness in achieving that goal, and its employees would seek out the best data to achieve it. Instead, the strongest incentives are to boost the bureaucracy's reputation, budget, and scope of authority—which aren't quite the same as public health gains.

    In his recent book Fixing Food, Richard A. Williams gives us a sobering glimpse at how those incentives undermine the FDA's stated mission. His account is rooted in personal experience: He worked at the FDA for nearly 30 years performing cost-benefit analyses on proposed regulations.

    These analyses were ostensibly meant to help decision makers choose a course of action to maximize the public health benefit at the lowest cost to society. But as he quickly learned, delivering actual benefits to the public is not a high priority among much of the agency's leadership.

    One of Williams' first assignments involved a proposed ban on an ingredient in men's hair dye that was suspected of raising skin cancer risk. After researching the issue, he determined that the ingredient was unlikely to give anyone cancer and that, because there was no alternative ingredient, the costs of banning it would be high. Rather than simply accept this assessment, a higher-up at the Center for Food Safety and Applied Nutrition (CFSAN), where Williams worked, instructed him to redo the analysis because "they haven't decided whether to ban that stuff yet, so they need one that supports a ban and one that doesn't."

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    https://reason.com/2022/03/08/can-th...y-from-itself/

    For example, in the early 1990s, after Williams had risen to the position of chief of CFSAN's economics branch, he was tasked with analyzing the costs and benefits of a proposal that would institute sweeping new requirements on seafood processors with the goal of reducing food-borne illnesses. The most dangerous of these illnesses was contamination from Vibrio vulnificus, a type of flesh-eating bacteria transmitted primarily by eating raw oysters, particularly those from the warm waters of the Gulf of Mexico. But the rule did not actually address the problem of raw oysters. So Williams found that its cost would be devastating for small seafood businesses (though not the large producers who had already voluntarily adopted the standards) and outweighed the benefits.

    But the rule was a priority for the FDA commissioner, who wanted to beat the Department of Agriculture at claiming regulatory jurisdiction over seafood—and the budget that goes with it. So again, Williams was told to change his analysis. In fact, he was given the exact numbers he was to use to calculate the rule's "benefits." According to Williams, he was told to say that "it will prevent about fifty percent of the cases from occurring."

    Again, Williams was told that if he refused to fudge the numbers, he "shouldn't come back to work on Monday."

    Williams was forced to falsify an analysis to produce a result supportive of a predetermined decision made by higher ups. For all of this, Williams was given the highest award the agency offered its employees. Upon receiving that award, he was told that it "isn't for anything you've done, Williams; this is for what you will do!"

    Fourteen years after leaving the FDA, Williams looked into seafood-related illnesses to see how the rule had performed. He found that cases of Vibrio vulnificus had not halved, as the agency had predicted; they had doubled.



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    Quote Originally Posted by acesfull86 View Post
    https://reason.com/2022/03/08/can-th...y-from-itself/

    Public trust in the U.S Food and Drug Administration (FDA) is at an all-time low, largely due to its bumbled handling of the pandemic. But its failures in tracking, testing, and combating COVID-19 reflect decades of dysfunction at the agency. The incoming commissioner, Robert Califf, has an opportunity to pull the agency out of its fiery tailspin—but only if he is willing to confront an institutional culture of perverse incentives.

    In a better world, the FDA would be single-mindedly focused on protecting public health. The agency's performance would be measured by its effectiveness in achieving that goal, and its employees would seek out the best data to achieve it. Instead, the strongest incentives are to boost the bureaucracy's reputation, budget, and scope of authority—which aren't quite the same as public health gains.

    In his recent book Fixing Food, Richard A. Williams gives us a sobering glimpse at how those incentives undermine the FDA's stated mission. His account is rooted in personal experience: He worked at the FDA for nearly 30 years performing cost-benefit analyses on proposed regulations.

    These analyses were ostensibly meant to help decision makers choose a course of action to maximize the public health benefit at the lowest cost to society. But as he quickly learned, delivering actual benefits to the public is not a high priority among much of the agency's leadership.

    One of Williams' first assignments involved a proposed ban on an ingredient in men's hair dye that was suspected of raising skin cancer risk. After researching the issue, he determined that the ingredient was unlikely to give anyone cancer and that, because there was no alternative ingredient, the costs of banning it would be high. Rather than simply accept this assessment, a higher-up at the Center for Food Safety and Applied Nutrition (CFSAN), where Williams worked, instructed him to redo the analysis because "they haven't decided whether to ban that stuff yet, so they need one that supports a ban and one that doesn't."
    This behavior goes on at an unprecedented level in these organizations I'd wager. Burning through tax payer dollars at an insane rate.
    Ivermectin Man

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    Quote Originally Posted by Tapate50 View Post
    This behavior goes on at an unprecedented level in these organizations I'd wager. Burning through tax payer dollars at an insane rate.
    It should infuriate people across he political spectrum…instead, it’s mostly met with a shrug.

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    Quote Originally Posted by acesfull86 View Post
    https://reason.com/2022/03/08/can-th...y-from-itself/

    For example, in the early 1990s, after Williams had risen to the position of chief of CFSAN's economics branch, he was tasked with analyzing the costs and benefits of a proposal that would institute sweeping new requirements on seafood processors with the goal of reducing food-borne illnesses. The most dangerous of these illnesses was contamination from Vibrio vulnificus, a type of flesh-eating bacteria transmitted primarily by eating raw oysters, particularly those from the warm waters of the Gulf of Mexico. But the rule did not actually address the problem of raw oysters. So Williams found that its cost would be devastating for small seafood businesses (though not the large producers who had already voluntarily adopted the standards) and outweighed the benefits.

    But the rule was a priority for the FDA commissioner, who wanted to beat the Department of Agriculture at claiming regulatory jurisdiction over seafood—and the budget that goes with it. So again, Williams was told to change his analysis. In fact, he was given the exact numbers he was to use to calculate the rule's "benefits." According to Williams, he was told to say that "it will prevent about fifty percent of the cases from occurring."

    Again, Williams was told that if he refused to fudge the numbers, he "shouldn't come back to work on Monday."

    Williams was forced to falsify an analysis to produce a result supportive of a predetermined decision made by higher ups. For all of this, Williams was given the highest award the agency offered its employees. Upon receiving that award, he was told that it "isn't for anything you've done, Williams; this is for what you will do!"

    Fourteen years after leaving the FDA, Williams looked into seafood-related illnesses to see how the rule had performed. He found that cases of Vibrio vulnificus had not halved, as the agency had predicted; they had doubled.


    How is this even possible?

    And people want to believe the numbers on COVID deaths - especially the stratification based on vaccination status?
    Natural Immunity Croc

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    Quote Originally Posted by thethe View Post
    How is this even possible?
    Perverse incentive structure coupled with no accountability and a disinterested public

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    Quote Originally Posted by acesfull86 View Post
    https://reason.com/2022/03/08/can-th...y-from-itself/

    For example, in the early 1990s, after Williams had risen to the position of chief of CFSAN's economics branch, he was tasked with analyzing the costs and benefits of a proposal that would institute sweeping new requirements on seafood processors with the goal of reducing food-borne illnesses. The most dangerous of these illnesses was contamination from Vibrio vulnificus, a type of flesh-eating bacteria transmitted primarily by eating raw oysters, particularly those from the warm waters of the Gulf of Mexico. But the rule did not actually address the problem of raw oysters. So Williams found that its cost would be devastating for small seafood businesses (though not the large producers who had already voluntarily adopted the standards) and outweighed the benefits.

    But the rule was a priority for the FDA commissioner, who wanted to beat the Department of Agriculture at claiming regulatory jurisdiction over seafood—and the budget that goes with it. So again, Williams was told to change his analysis. In fact, he was given the exact numbers he was to use to calculate the rule's "benefits." According to Williams, he was told to say that "it will prevent about fifty percent of the cases from occurring."

    Again, Williams was told that if he refused to fudge the numbers, he "shouldn't come back to work on Monday."

    Williams was forced to falsify an analysis to produce a result supportive of a predetermined decision made by higher ups. For all of this, Williams was given the highest award the agency offered its employees. Upon receiving that award, he was told that it "isn't for anything you've done, Williams; this is for what you will do!"

    Fourteen years after leaving the FDA, Williams looked into seafood-related illnesses to see how the rule had performed. He found that cases of Vibrio vulnificus had not halved, as the agency had predicted; they had doubled.



    Just a reminder that the primary function of all government agencies is to get more funding. This just the tip of the iceberg of the corruption in the quest for more funding.
    "Donald Trump will serve a second term as president of the United States.

    It’s over."


    Little Thethe Nov 19, 2020.

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    Quote Originally Posted by cajunrevenge View Post
    Just a reminder that the primary function of all government agencies is to get more funding. This just the tip of the iceberg of the corruption in the quest for more funding.
    Enabled by a public that apparently doesn’t give a damn.

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    https://reason.com/2022/04/13/the-cd...-regain-trust/

    Last week, in an attempt to rebuild its tattered reputation, the Centers for Disease Control and Prevention (CDC) announced via email a forthcoming "revamp" of the agency. The supposed overhaul is at least a year late and more than a dollar short. The proposed overhaul will be based on a one-month review to "kick off an evaluation of CDC's structure, systems, and processes."

    CDC Director Rochelle Walensky has already handpicked a leader: an administrator from another division within the Department of Health and Human Services; three CDC officials will also conduct the review.

    This is a mistake. For an agency that has seen a drop in trust of more than 25 percentage points in less than 2 years, having a bipartisan committee choose the reviewers is necessary and important to establish their credibility. In recent history, Congress has formed bipartisan advisory commissions that, in the wake of crises, direct outside experts to analyze mistakes and figure out how to avoid them in future.



    The list of errors made by the CDC is so lengthy that a one-month process—an entirely arbitrary time period—will all but guarantee that the review is superficial and toothless. CDC guidance is responsible for some of the longest school closures in the world due to myopic policies that were overly focused on cases and transmission. School closures, where students of all ages were instructed to stay home and even avoid the outdoors, led predictably to significant rises in learning loss, mental health issues, obesity, and substance use disorders. The CDC's shockingly unethical and underreported alliance with the American Federation for Teachers, the nation's largest teachers union, also cast doubt on who exactly was steering the CDC ship as they crafted school guidelines.

    The CDC also ignored natural immunity when drafting federal-level vaccine mandates and allowing exemptions to testing, policies that were then duplicated on the state level, resulting in the firing of thousands of healthcare workers and public employees. They oversold the benefits of masking post-vaccination, with no randomized controlled trials (RCTs) conducted to show efficacy, and failed to run any RCTs that might have addressed the weakness of data guiding many of their interventions. They supported useless travel bans that punished countries such as South Africa that were diligently tracking new variants, and were partially responsible, along with slow approval of new tests by the FDA, for the paucity of COVID tests that inexcusably persisted up to and during the omicron surge. This shortage left people lining up for hours outside of testing centers ahead of the December holidays, while Europe and parts of Asia had rapid tests widely available for months, including in vending machines. Other glaring errors include withholding COVID data, providing inaccurate statistics, and relying heavily on other countries' data—like Israel and the U.K.—for disease tracking and efficacy trials of vaccines and boosters.

    CDC mismanagement has left a majority of Americans feeling "confused" by public health recommendations after an endless barrage of unclear messaging and opaque decision making that has left the public viewing CDC guidance as political messaging rather than policy based on scientific evidence. Not surprisingly, America now has one of the lowest vaccination rates among wealthy countries.

    While a thorough bipartisan review of the CDC's approach to the pandemic is necessary and prudent, a full analysis takes time. In the interim, the CDC could take an important first step in restoring trust: admit its mistakes and apologize.


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    https://www.politico.com/interactive...afety-hazards/

    By the time FDA officials figured out it was spinach that was making people sick in 10 states – sending three people into kidney failure – it was too late. It was mid-November 2021 and the packaged salad’s short shelf life had passed. There was no recall. By the time FDA officials got inspectors on the ground, spinach season was over. The fields and the production facilities were empty, which made it impossible to pinpoint the source of contamination.

    Whatever caused the outbreak was likely never fixed.

    This wasn’t supposed to happen. It’s been more than 11 years since Congress passed a sweeping food safety law designed to prevent this type of health risk. In that time, FDA has failed to put in place safety standards for the water used to grow fresh produce, as mandated by that law, despite knowing that water is one of the main ways fresh fruits and vegetables become contaminated with deadly pathogens. Congress has ramped up FDA funding over the past decade, but deadly outbreaks keep happening and it often takes the agency too long to respond.

    Many consumers would be surprised to learn this anemic, slow response is typical for an agency that oversees nearly 80 percent of the American food supply, but slow is what insiders in Washington have come to expect from FDA, regardless of administration.



    This is not your run-of-the-mill slow-churning Washington bureaucracy. FDA’s food division is so slow, it’s practically in its own league. For this story, POLITICO spoke with more than 50 people, including current and former FDA officials, consumer advocates and industry leaders. Some were granted anonymity to speak candidly. There is a remarkable level of consensus that the agency is simply not working. Current and former officials and industry professionals used terms like “ridiculous,” “impossible,” “broken,” “byzantine” and “a joke” to describe the state of food regulation at FDA.


    —————

    Good article for anyone concerned with the FDA’s ability to multitask. For anyone unwilling to read such a long piece, I can confirm that yes, they are able to screw up our COVID response and screw up our food safety oversight at the same time. So no worries there.

    I take issue with the following statement: “Many consumers would be surprised to learn this anemic, slow response is typical.” This consumer isn’t surprised at all. The FDA is a joke.
    Last edited by acesfull86; 04-16-2022 at 03:43 PM.

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    https://www.wired.com/story/the-fda-...d-milk-carton/

    When you drop a box of almond milk into your shopping cart, or order an oat-milk latte, are you being bamboozled? That’s the contention of Big Dairy, which has been pressing its friends in Congress and the US Food and Drug Administration to reserve the name “milk” for fluids extracted from the mammary glands of animals. The FDA, which regulates food labeling, appears poised to grant the industry its wish.



    Back in March, the FDA submitted a draft policy regarding the “labeling of plant-based milk alternatives” to the Office of Management and Budget, which must approve rule changes. While the document has not been made public, the FDA would likely not have filed it without intending to change the status quo. In testimony before the US Senate on April 28, commissioner Robert Califf indicated he agreed with the dairy industry’s line. Consumers aren’t “very equipped to deal with what’s the nutritional value of non-dairy milk alternatives,” he said. Asked about changing the FDA’s policy on affixing the milk label to non-dairy drinks, he said: “We’re moving along quickly and it’s a priority to get this done, so I can assure you it will get done.”

    These answers must have delighted several of the assembled dairy-state senators, including Democrati senator Tammy Baldwin of Wisconsin and Republican senator Mike Crapo of Idaho, cosponsors of the 2021 “Defending Against Imitations and Replacements of Yogurt, milk, and cheese to Promote Regular Intake of Dairy Everyday Act,” which would force the FDA to crack down on plant-based alternative companies that were labeling their products “milk.”

    Others on the Hill are less impressed. In a statement to Mother Jones, Senator Cory Booker, a New Jersey Democrat, expressed surprise that the FDA would place such a priority on tweaking names of popular beverages at a time when the agency has come under scathing criticism for neglecting the food part of its mandate. Booker pointed to a blockbuster April 8 investigation by Politico reporter Helena Bottemiller Evich which found that “regulating food is simply not a high priority at the agency, where drugs and other medical products dominate, both in budget and bandwidth—a dynamic that’s only been exacerbated during the pandemic.” She added: “Over the years, the food side of FDA has been so ignored and grown so dysfunctional that even former FDA commissioners readily acknowledged problems in interviews.”

  20. #78
    I <3 Ron Paul + gilesfan sturg33's Avatar
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    A perfect summation of our country right now


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    Quote Originally Posted by sturg33 View Post
    A perfect summation of our country right now


    Well said

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    https://www.theatlantic.com/technolo...u-asia/661433/

    …the agency’s slow progress on new ingredients doesn’t match the urgency of skin cancer’s threat to public health. In formal statements and position papers, doctors and cancer-prevention advocates express considerable interest in bringing new sunscreen ingredients to the American market, but not a lot of optimism that any will be available soon. The FDA hasn’t added a new active ingredient to its sunscreen monograph—the document that details what is legally allowed in products marketed in the U.S.—in decades. The process for doing this is so onerous that L’Oreal, a French company, chose to go through a separate authorization process to get one of its sunscreen ingredients onto the consumer market in 2006—which meant that only a few specific beauty products containing that ingredient could be marketed legally.

    In 2014, Congress passed a law attempting to speed access to sunscreen ingredients that have been in wide use in other countries for years, but it hasn’t really worked. “The FDA was supposed to be fast-tracking these ingredients for approval, because we have the safety data and safe history of usage from the European Union,” Dobos said. “But it seems to continually be stalled.” According to Courtney Rhodes, a spokesperson for the FDA, manufacturers have submitted eight new active ingredients for consideration. The agency has asked them to provide additional data in support of those applications, but none of them has yet satisfied the agency’s requirements.

    “In the medical community, there is a significant frustration about the lack of availability of some of the sunscreen active ingredients,” Henry Lim, a dermatologist at Henry Ford Health, in Michigan, told me. The more filters are available to formulators, the more they can be mixed and matched in new ways, which stands to improve not just the efficacy of the final product, but how it feels and looks on your skin, and how easy it is to apply. On a very real level, making sunscreen less onerous to use can make it more effective. “The best sunscreen is going to be the one you’re going to use often and according to the directions,” Dobos said. Skin cancer is the most common type of cancer in the United States, and by one estimate, one in five Americans will develop it in their lifetime.

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