4 ms·

I am really concerned about the fact that the FDA is trying to fast track stuff. I just want to offer a perspective of why this is dangerous. We are having som

by avgDev 7y ago

I am really concerned about the fact that the FDA is trying to fast track stuff. I just want to offer a perspective of why this is dangerous. We are having some serious issues with flouroquinolone antibiotics. The side-effects of the medication are insane and under-reported. 9 years ago I was given the antibiotic for an infection, my body went into shock, I was released the next day with some odd neurological issues. None of it reported to the FDA, few months later I got tendon pain. I go to mayo clinic, they disagree the antibiotic caused it. Seen 30+ physicians in the span of 2 years, 2 agreed that it is possible. One of them said to wait it out, and refused to actually put it in my chart. The antibiotics carry a 'black label' and clearly state side effects may occur up to 1 year. I reported it to the FDA, then I found groups of people suffering from chronic fatigue, tendon raptures, weird neurological symptoms, some had diagnosis of 'fibromyalgia', some had chronic tendinitis, yet after reviewing their medical information they found they took a flouroquinolone antibiotic but nobody ever even suggested that it could be that. This bring me to Tamiflu fiasco. Governments have spent billions of dollars to purchase Tamiflu to fight the flu. Later reports came out about issues with the studies, the maker picking positive studies and withholding neutral or negative information. It has not proven much better than the drugs we already use to treat the flu. Fast tracking a medication can have terrible results, cost billions of dollars, and cripple hundreds of people. Doing any scientific research with panic in the back of your mind and high pressure from politicians and people is dangerous IMO. Especially, in a profit driven healthcare system.

xyzzyz 7y ago
Fast tracking a medication can have terrible results, cost billions of dollars, and cripple hundreds of people. All of this is true, and yet in our current situation, not fast tracking can have even worse results, cost trillions of dollars and kill millions of people.
- avgDev 7y ago
  It is a difficult situation, but the cure should not be worse than the disease. I just offered my perspective. I am not an expert in medical research, and hope that qualified people can do their jobs and find a safe treatment/vaccine. However, I am scared that people that say 'No' will be silenced or removed, kind of like people in Theranos, who were experts in their fields.
teh_infallible 7y ago
Look up what happened in India with the polio vaccine..
- avgDev 7y ago
  Woah, I just looked it up....I have never heard of this. According to a study 490,000 cases of paralysis were caused by the oral polio vaccine from 2000-2017. Wow.
  - sjg007 7y ago
    Yeah this is a known thing. That's why we don't vaccinate against polio but try to keep it out of the country.
    - IdoRA 7y ago
      The US still vaccinates against polio, but we don’t use the OPV anymore: https://www.cdc.gov/vaccines/vpd/polio/index.html https://www.cdc.gov/vaccines/vpd/polio/index.html The OPV is still used in the few countries where there is polio in the wild because it does have advantages over the IPV.
      - sjg007 7y ago
        Ah yes, thanks for the clarification.
  - hhas01 7y ago
    Where the heck are you getting that 490,000 number from? The oral polio vaccine (aka OPV/Sabin) uses a weakened form of the live virus, which known to revert occasionally to virulent form. Here’s what the WHO site says: “Since 2000, more than 10 billion doses of OPV have been administered to nearly 3 billion children worldwide. As a result, more than 13 million cases of polio have been prevented, and the disease has been reduced by more than 99%. During that time, 24 cVDPV outbreaks occurred in 21 countries, resulting in fewer than 760 VDPV cases.” https://www.who.int/news-room/q-a-detail/what-is-vaccine-derived-polio https://www.who.int/news-room/q-a-detail/what-is-vaccine-der...
sjg007 7y ago
Tendon rupture on and after flouroquinolone use is now a known thing. If you are prescribed them and you feel tendon tenderness then you are supposed to tell your doctor and they will prescribe something else. It doesn't happen to everyone though and some flouroquinolones are better than others (in terms of less side effects). Tamiflu seems to work but reduces symptoms by 1-2 days basically. It may also blunt the overall disease impact in your body as well. There will probably be meta studies on whether fast tracking vs the regular process are equivalent, worse or better than each other.
- kevin_thibedeau 7y ago
  Tamiflu has always been a joke considering the 24h window you have to start using it for such little payoff. It's disturbing how much money is wasted on stockpiling it.
  - sjg007 7y ago
    The 24 hour window isn't necessarily strict. It just takes longer to work after that.
marcosdumay 7y ago
It's worse than that. Because this is a vaccine, it means that everybody will take it, while healthy. That means that the entire population will trade a 0.3% to 4% risk of death (depends on what study you go with, lower numbers seem to be more likely) for the unknown risk of the vaccine. Thus people better be sure there is no severe side effect, even if rare.
- dchyrdvh 7y ago
  Those 4% are 0.04% for some and 40% for others. Now the question is, if you're young and healthy, do you prefer the virus or the untested vaccine?
frank2 7y ago
I don't understand the connection between your experience with a fluoroquinolone and fast tracking. 9 years ago, most of the fluoroquinolone antibiotics had already been on the market for many years.
audiometry 7y ago
Yes. I am not keen on taking the FDA equivalent of the 737-MAX.
dajohnson89 7y ago
thank you for sharing your experience. i hope you feel better
rckoepke 7y ago
Dengue fever vaccine is probably the best example. https://en.wikipedia.org/wiki/Dengvaxia_controversy https://en.wikipedia.org/wiki/Dengvaxia_controversy From https://news.ycombinator.com/item?id=22511832 https://news.ycombinator.com/item?id=22511832 : > "The story of dengue vaccine development is a cautionary tale. The first time you get dengue is usually not too bad, but it can be deadly if you get it again. Part of that is hypothesized to be driven by your own immune system, which, once immunized against one strain, produces antibodies against it in the next infection. However, if it's a slightly different strain of dengue the second time around, the antibodies meant to neutralize the disease are believed to make the disease more virulent instead (antibody-dependent enhancement). The immune system makes it worse. So when a dengue vaccine that didn't fully immunize against all strains was developed (not deliberately, people tried to immunize against all strains but this is a case where less efficacy than expected made things worse), it didn't make things better. It ended up priming people to get dengue."

by avgDev 7y ago

xyzzyz 7y ago

Fast tracking a medication can have terrible results, cost billions of dollars, and cripple hundreds of people. All of this is true, and yet in our current situation, not fast tracking can have even worse results, cost trillions of dollars and kill millions of people.

avgDev 7y ago
It is a difficult situation, but the cure should not be worse than the disease. I just offered my perspective. I am not an expert in medical research, and hope that qualified people can do their jobs and find a safe treatment/vaccine. However, I am scared that people that say 'No' will be silenced or removed, kind of like people in Theranos, who were experts in their fields.

teh_infallible 7y ago

Look up what happened in India with the polio vaccine..

avgDev 7y ago
Woah, I just looked it up....I have never heard of this. According to a study 490,000 cases of paralysis were caused by the oral polio vaccine from 2000-2017. Wow.
- sjg007 7y ago
  Yeah this is a known thing. That's why we don't vaccinate against polio but try to keep it out of the country.
  - IdoRA 7y ago
    The US still vaccinates against polio, but we don’t use the OPV anymore: https://www.cdc.gov/vaccines/vpd/polio/index.html https://www.cdc.gov/vaccines/vpd/polio/index.html The OPV is still used in the few countries where there is polio in the wild because it does have advantages over the IPV.
    - sjg007 7y ago
      Ah yes, thanks for the clarification.
- hhas01 7y ago
  Where the heck are you getting that 490,000 number from? The oral polio vaccine (aka OPV/Sabin) uses a weakened form of the live virus, which known to revert occasionally to virulent form. Here’s what the WHO site says: “Since 2000, more than 10 billion doses of OPV have been administered to nearly 3 billion children worldwide. As a result, more than 13 million cases of polio have been prevented, and the disease has been reduced by more than 99%. During that time, 24 cVDPV outbreaks occurred in 21 countries, resulting in fewer than 760 VDPV cases.” https://www.who.int/news-room/q-a-detail/what-is-vaccine-derived-polio https://www.who.int/news-room/q-a-detail/what-is-vaccine-der...

sjg007 7y ago

Tendon rupture on and after flouroquinolone use is now a known thing. If you are prescribed them and you feel tendon tenderness then you are supposed to tell your doctor and they will prescribe something else. It doesn't happen to everyone though and some flouroquinolones are better than others (in terms of less side effects). Tamiflu seems to work but reduces symptoms by 1-2 days basically. It may also blunt the overall disease impact in your body as well. There will probably be meta studies on whether fast tracking vs the regular process are equivalent, worse or better than each other.

kevin_thibedeau 7y ago
Tamiflu has always been a joke considering the 24h window you have to start using it for such little payoff. It's disturbing how much money is wasted on stockpiling it.
- sjg007 7y ago
  The 24 hour window isn't necessarily strict. It just takes longer to work after that.

marcosdumay 7y ago

It's worse than that. Because this is a vaccine, it means that everybody will take it, while healthy. That means that the entire population will trade a 0.3% to 4% risk of death (depends on what study you go with, lower numbers seem to be more likely) for the unknown risk of the vaccine. Thus people better be sure there is no severe side effect, even if rare.

dchyrdvh 7y ago
Those 4% are 0.04% for some and 40% for others. Now the question is, if you're young and healthy, do you prefer the virus or the untested vaccine?

frank2 7y ago

I don't understand the connection between your experience with a fluoroquinolone and fast tracking. 9 years ago, most of the fluoroquinolone antibiotics had already been on the market for many years.

audiometry 7y ago

Yes. I am not keen on taking the FDA equivalent of the 737-MAX.

dajohnson89 7y ago

thank you for sharing your experience. i hope you feel better

rckoepke 7y ago

Dengue fever vaccine is probably the best example. https://en.wikipedia.org/wiki/Dengvaxia_controversy https://en.wikipedia.org/wiki/Dengvaxia_controversy From https://news.ycombinator.com/item?id=22511832 https://news.ycombinator.com/item?id=22511832 : > "The story of dengue vaccine development is a cautionary tale. The first time you get dengue is usually not too bad, but it can be deadly if you get it again. Part of that is hypothesized to be driven by your own immune system, which, once immunized against one strain, produces antibodies against it in the next infection. However, if it's a slightly different strain of dengue the second time around, the antibodies meant to neutralize the disease are believed to make the disease more virulent instead (antibody-dependent enhancement). The immune system makes it worse. So when a dengue vaccine that didn't fully immunize against all strains was developed (not deliberately, people tried to immunize against all strains but this is a case where less efficacy than expected made things worse), it didn't make things better. It ended up priming people to get dengue."