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I wish the reporter had clarified why Rational Vaccines pursued this unconventional approach. The sentence below seems to imply that this was all they could af

I wish the reporter had clarified why Rational Vaccines pursued this unconventional approach. The sentence below seems to imply that this was all they could afford: After he failed to secure federal funding and an [institutional review board], Halford moved ahead with the trial offshore. But with Peter Thiel as an investor, I assume that money (within reason) wasn't the primary motivator. In general, I'm dismayed by the breathless, sensationalistic tone of this article. The people involved don't seem stupid or malevolent, so I'd like to understand better their rationale for what they're doing.

AndyMcConachie 9y ago
They're doing it because they can. The FDA wouldn't allow it in the USA, so they're infecting people for science in a place where there are fewer protections afforded the citizenry. From an academic standpoint this is ethically questionable. From a purely moral standpoint this is disgusting.
- lardo 9y ago
  Why is giving the vaccine (some form of herpes) to those who are already infected with herpes morally disgusting?
  - Balgair 9y ago
    If many MDs, via the IRB, say that this is a bad idea, but one MD says that it is a good idea and that MD then decides to go overseas to conduct the research, what do you think was actually going on? This is crazy stuff they are doing and many MDs think they should not be doing it at all. The incentives to skew the data they generate are super high and super suspect now.
- tim333 9y ago
  What if it cures the sick without causing problems during the tests. Would that still be disgusting?
  - smcg 9y ago
    "What if the ends justify the means?" I guess we can keep doing it!
  - brainfire 9y ago
    If I play Russian Roulette and don't get shot, does that mean the people who told me it was dangerous were wrong?
    - maxharris 9y ago
      Do you have the final say on what goes into your body or do you not? It is only morally disgusting if the study participants are purposefully _misled_ or _forced_ to submit to the study. This is absolutely NOT the case here.
      - Balgair 9y ago
        You do, however, the MDs do not. And if they are not using MDs, that is insane too. That they are injecting something without IRB approval is nuts as is, that any licensed MD in the US would do so is doubly crazy and I would like to never be practiced on by them. The medical field is a different beast than, say, putting on an aftermarket car-horn or putting super instead of unleaded into the gas tank. The vast majority of people, including nurses and other MDs, have no idea how a specific medicine works or the complexities therein. Docs are required to help them, not to hurt them, we've thought so for thousands of years. Yes, many may say that they are helping the people, but the large majority of other MDs, via the IRB, say that they are hurting them. I'm gonna go with the IRBs here and say this is crazy stuff and sets a very dangerous precedent.
- helloworld 9y ago
  Why wouldn't the FDA allow it? I didn't see anything about that in the article.
Sangermaine 9y ago
I don't believe you actually read the article. The entire article is literally about why they took they approach they did, and why they couldn't do it in the US. The first line of the article is: >Defying U.S. safety protections for human trials Then: >Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks. >...But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns. And as to why not deal with the FDA: >The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations. >“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.” This trial was part of a larger political push to weaken FDA research oversight, as the article clearly and fully explains.

AndyMcConachie 9y ago

They're doing it because they can. The FDA wouldn't allow it in the USA, so they're infecting people for science in a place where there are fewer protections afforded the citizenry. From an academic standpoint this is ethically questionable. From a purely moral standpoint this is disgusting.

lardo 9y ago
Why is giving the vaccine (some form of herpes) to those who are already infected with herpes morally disgusting?
- Balgair 9y ago
  If many MDs, via the IRB, say that this is a bad idea, but one MD says that it is a good idea and that MD then decides to go overseas to conduct the research, what do you think was actually going on? This is crazy stuff they are doing and many MDs think they should not be doing it at all. The incentives to skew the data they generate are super high and super suspect now.
tim333 9y ago
What if it cures the sick without causing problems during the tests. Would that still be disgusting?
- smcg 9y ago
  "What if the ends justify the means?" I guess we can keep doing it!
- brainfire 9y ago
  If I play Russian Roulette and don't get shot, does that mean the people who told me it was dangerous were wrong?
  - maxharris 9y ago
    Do you have the final say on what goes into your body or do you not? It is only morally disgusting if the study participants are purposefully _misled_ or _forced_ to submit to the study. This is absolutely NOT the case here.
    - Balgair 9y ago
      You do, however, the MDs do not. And if they are not using MDs, that is insane too. That they are injecting something without IRB approval is nuts as is, that any licensed MD in the US would do so is doubly crazy and I would like to never be practiced on by them. The medical field is a different beast than, say, putting on an aftermarket car-horn or putting super instead of unleaded into the gas tank. The vast majority of people, including nurses and other MDs, have no idea how a specific medicine works or the complexities therein. Docs are required to help them, not to hurt them, we've thought so for thousands of years. Yes, many may say that they are helping the people, but the large majority of other MDs, via the IRB, say that they are hurting them. I'm gonna go with the IRBs here and say this is crazy stuff and sets a very dangerous precedent.
helloworld 9y ago
Why wouldn't the FDA allow it? I didn't see anything about that in the article.

Sangermaine 9y ago

I don't believe you actually read the article. The entire article is literally about why they took they approach they did, and why they couldn't do it in the US. The first line of the article is: >Defying U.S. safety protections for human trials Then: >Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks. >...But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns. And as to why not deal with the FDA: >The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations. >“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.” This trial was part of a larger political push to weaken FDA research oversight, as the article clearly and fully explains.