4 ms·

If the system is susceptible to anti-vax propaganda thwarting approval of a good vaccine, doesn’t it also follow that the system is susceptible to big pharma l

If the system is susceptible to anti-vax propaganda thwarting approval of a good vaccine, doesn’t it also follow that the system is susceptible to big pharma lobbying for the approval of a bad vaccine? If this wondrously robust multi-layered process buckles in the face of a few hysterical anti-vax groups, you should ask yourself how robust it remains in the face of a billion-dollar pharmaceutical conglomerate with politicians in their pockets.

acdha 5y ago
I think you're confused on several points: the vaccine was approved following extensive safety tests but the lawsuits caused the manufacturer to decide it was not worth manufacturing. The U.S. regulators consistently found no connection between the vaccine and the complaints, so the _scientific_ side worked but the legal / business side let public safety down. Similarly, it's no secret that companies have a vested interest in promoting their products but it's not like Pfizer says “Trust us, we employ doctors!” and the FDA says “Sounds great, no need to check!”. Each step of that process involves peer-reviewed publications, public data releases, and reviews by panels of scientific experts. It is quite valid to say that companies need to be strictly regulated to keep everyone honest but we don't have any indication that this has been happening and anyone who thinks the process is just a large pharma company waving money at doctors to buy silence really needs to learn how cut-throat academic competition is — the career benefits to being the first to report that plot would be huge! Remember also that this happens in many different countries around the world so that hypothetical conspiracy needs to be kept secrete by a multinational group of hundreds or even thousands of people.
- lurquer 5y ago
  In regard to the Lyme disease vaccine issue, you are glossing over a very important component of the story. Due to public pressure, the FDA reconvened to take another look. While the FDA did not change its opinion (except for requesting some additional labeling and studies) the effect was disastrous for marketing. Sales plummeted. And, it was no longer worthwhile to pursue. The ‘official act’ of the FDA reconvening arose solely due to pressure. That’s my point. If anti-vax groups can cause the FDA to “take another look” at a drug that has already passed muster, it is obvious and not fairly deniable that the agency is not immune to political pressure.
  - abakker 5y ago
    makes you wonder how much "public pressure" came from the operators of quack lyme disease message boards and alternative treatment providers...after 4 times having it, I'm happy to say, in Doxycycline I trust. just don't go reading Lyme disease message boards without a tinfoil hat on.
    - inter_netuser 5y ago
      If some dozens lunatics can do this, what can an army of sharp professionals with zero morals and a multi-billion dollar budget can achieve?
      - lurquer 5y ago
        The FDA was created because of the nefarious unethical conduct of doctors/pharma. Yet some HN posters seem to think the organization exists to protect us from skeptics. What a twisted view.
- hitpointdrew 5y ago
  >but it's not like Pfizer says “Trust us, we employ doctors!” and the FDA says “Sounds great, no need to check!” Each step of that process involves peer-reviewed publications, public data releases, and reviews by panels of scientific experts. All these "steps in the process" are completely meaningless when there is a revolving door with big pharma and FDA. This is nothing more than safety/peer-review theater. Example: Scott Gottlieb FDA commissioner 2017-2019, currently sits on the board of directors at Pfizer. Are you really going to put up a stink and fight on an approval if the end goal is cushy job at one of these companies? You can bet if you just "push it through" you will be looked on favorably for one of these jobs, but if you put up resistance and actually want to do due diligence, well then you will never be considered. "It is difficult to get a man to understand something when his salary depends upon his not understanding it." - Upton Sinclair
  - freemint 5y ago
    Except hard evidence is created during the trial. The statistical procedures to evaluate things are standardized.
- holdupnow 5y ago
  Can you please cite these safety tests?
  - acdha 5y ago
    Like all vaccines, they were tested in animals and subsequently by human volunteers _before_ reaching the Phase III clinical trials. Those are double-blind, randomized, placebo-controlled experiments which are generally considered the gold standard for medical testing which test cohorts of people who are exposed to the threat and compare both positive and negative outcomes across those populations without either the recipients or the experimenters knowing which people are in which group until afterwards. https://www.sciencedirect.com/science/article/pii/S0264410X0000520X?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0264410X0... > An adjuvanted recombinant vaccine (LYMErix™) has been approved in the United States for the prevention of Lyme disease in adults, and has demonstrated both safety and efficacy. A clinical trial of over 10 000 adults showed 76% efficacy following the third dose of a 0, 1, 12 schedule. Accelerated schedules demonstrate equivalent levels of protective antibody. Up to 100% of children 2–14 years of age achieve seroprotective levels of antibody. Booster doses induced protective levels of antibody in more than 96% of recipients when administered at months 12 and 24. Only mild or moderate, transient vaccine-associated adverse events have been reported after immunization. The vaccine is a safe and effective method of preventing Lyme disease. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/ > The OspA vaccines proved effective in animal models and safe in human volunteers [18]. Both manufacturers conducted clinical trials in a race to gain the first license for their vaccine [19, 20]. In the LYMErix™ phase III safety and efficacy trial, researchers enrolled 10 906 subjects between 15 and 70 years old who lived in endemic areas and randomized them to receive either the three-dose Lyme vaccine regimen or placebo injections. Vaccinated individuals showed a 76% reduction in Lyme disease in the year following vaccination [20], with no significant side-effects noted. Based on these promising findings, the U.S. Food and Drug Administration (FDA) approved LYMErix™ on 21 December 1998.
  - coolgeek 5y ago
    Apparently, you just created an account to challenge this comment. Do you not understand the FDA approval process? Or do you not understand how to Google that question yourself? Or is it something else? Seriously. What possessed you to create an account to challenge this comment without doing any research at all, yourself?
wildmanx 5y ago
Oh the law firms doing all those class actions are not doing this for free either..

acdha 5y ago

I think you're confused on several points: the vaccine was approved following extensive safety tests but the lawsuits caused the manufacturer to decide it was not worth manufacturing. The U.S. regulators consistently found no connection between the vaccine and the complaints, so the _scientific_ side worked but the legal / business side let public safety down. Similarly, it's no secret that companies have a vested interest in promoting their products but it's not like Pfizer says “Trust us, we employ doctors!” and the FDA says “Sounds great, no need to check!”. Each step of that process involves peer-reviewed publications, public data releases, and reviews by panels of scientific experts. It is quite valid to say that companies need to be strictly regulated to keep everyone honest but we don't have any indication that this has been happening and anyone who thinks the process is just a large pharma company waving money at doctors to buy silence really needs to learn how cut-throat academic competition is — the career benefits to being the first to report that plot would be huge! Remember also that this happens in many different countries around the world so that hypothetical conspiracy needs to be kept secrete by a multinational group of hundreds or even thousands of people.

lurquer 5y ago
In regard to the Lyme disease vaccine issue, you are glossing over a very important component of the story. Due to public pressure, the FDA reconvened to take another look. While the FDA did not change its opinion (except for requesting some additional labeling and studies) the effect was disastrous for marketing. Sales plummeted. And, it was no longer worthwhile to pursue. The ‘official act’ of the FDA reconvening arose solely due to pressure. That’s my point. If anti-vax groups can cause the FDA to “take another look” at a drug that has already passed muster, it is obvious and not fairly deniable that the agency is not immune to political pressure.
- abakker 5y ago
  makes you wonder how much "public pressure" came from the operators of quack lyme disease message boards and alternative treatment providers...after 4 times having it, I'm happy to say, in Doxycycline I trust. just don't go reading Lyme disease message boards without a tinfoil hat on.
  - inter_netuser 5y ago
    If some dozens lunatics can do this, what can an army of sharp professionals with zero morals and a multi-billion dollar budget can achieve?
    - lurquer 5y ago
      The FDA was created because of the nefarious unethical conduct of doctors/pharma. Yet some HN posters seem to think the organization exists to protect us from skeptics. What a twisted view.
hitpointdrew 5y ago
>but it's not like Pfizer says “Trust us, we employ doctors!” and the FDA says “Sounds great, no need to check!” Each step of that process involves peer-reviewed publications, public data releases, and reviews by panels of scientific experts. All these "steps in the process" are completely meaningless when there is a revolving door with big pharma and FDA. This is nothing more than safety/peer-review theater. Example: Scott Gottlieb FDA commissioner 2017-2019, currently sits on the board of directors at Pfizer. Are you really going to put up a stink and fight on an approval if the end goal is cushy job at one of these companies? You can bet if you just "push it through" you will be looked on favorably for one of these jobs, but if you put up resistance and actually want to do due diligence, well then you will never be considered. "It is difficult to get a man to understand something when his salary depends upon his not understanding it." - Upton Sinclair
- freemint 5y ago
  Except hard evidence is created during the trial. The statistical procedures to evaluate things are standardized.
holdupnow 5y ago
Can you please cite these safety tests?
- acdha 5y ago
  Like all vaccines, they were tested in animals and subsequently by human volunteers _before_ reaching the Phase III clinical trials. Those are double-blind, randomized, placebo-controlled experiments which are generally considered the gold standard for medical testing which test cohorts of people who are exposed to the threat and compare both positive and negative outcomes across those populations without either the recipients or the experimenters knowing which people are in which group until afterwards. https://www.sciencedirect.com/science/article/pii/S0264410X0000520X?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0264410X0... > An adjuvanted recombinant vaccine (LYMErix™) has been approved in the United States for the prevention of Lyme disease in adults, and has demonstrated both safety and efficacy. A clinical trial of over 10 000 adults showed 76% efficacy following the third dose of a 0, 1, 12 schedule. Accelerated schedules demonstrate equivalent levels of protective antibody. Up to 100% of children 2–14 years of age achieve seroprotective levels of antibody. Booster doses induced protective levels of antibody in more than 96% of recipients when administered at months 12 and 24. Only mild or moderate, transient vaccine-associated adverse events have been reported after immunization. The vaccine is a safe and effective method of preventing Lyme disease. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/ > The OspA vaccines proved effective in animal models and safe in human volunteers [18]. Both manufacturers conducted clinical trials in a race to gain the first license for their vaccine [19, 20]. In the LYMErix™ phase III safety and efficacy trial, researchers enrolled 10 906 subjects between 15 and 70 years old who lived in endemic areas and randomized them to receive either the three-dose Lyme vaccine regimen or placebo injections. Vaccinated individuals showed a 76% reduction in Lyme disease in the year following vaccination [20], with no significant side-effects noted. Based on these promising findings, the U.S. Food and Drug Administration (FDA) approved LYMErix™ on 21 December 1998.
- coolgeek 5y ago
  Apparently, you just created an account to challenge this comment. Do you not understand the FDA approval process? Or do you not understand how to Google that question yourself? Or is it something else? Seriously. What possessed you to create an account to challenge this comment without doing any research at all, yourself?

wildmanx 5y ago

Oh the law firms doing all those class actions are not doing this for free either..