Do antivirals and the flu-vaccine even work?(theatlantic.com)
theatlantic.com
Do antivirals and the flu-vaccine even work?
http://www.theatlantic.com/doc/print/200911/brownlee-h1n1
5 comments
The tone of this article is far more shrill than the Atlantic article. Dr. Thomas Jefferson is demanding evidence for assertions - that's "methodolotry"? He's betraying the original ideas of evidence-based medicine by demanding that medicine be based on evidence? For shame.
In this case his evidence base isn't even relevant, because we aren't dealing with seasonal flu but pandemic flu.
Ah, but the epidemiology to back this statement has mostly come from very dubious and biased statistics - specifically, the way that, in Mexico where epidemic originated, the only people they found with the disease were those on the edge of death because of the tendency there to only go to the doctor when you are on the edge of death. Despite the pandemic declaration, we haven't seen death rates above the normal rates of flu season yet (though a slightly different group is dying..). We might see high death rates but ... perhaps ... we should look at evidence before making grand declarations that this like nothing seen before.
Note, the original article is a not screaming endorsement of Jefferson's view, just a summary of debate:
The most vocal—and undoubtedly most vexing—critic of the gospel of flu vaccine is the Cochrane Collaboration’s Jefferson, who’s also an epidemiologist trained at the famed London School of Tropical Hygiene, and who, in Lisa Jackson’s view, makes other skeptics seem “moderate by comparison.” Among his fellow flu researchers, Jefferson’s outspokenness has made him something of a pariah.
In this case his evidence base isn't even relevant, because we aren't dealing with seasonal flu but pandemic flu.
Ah, but the epidemiology to back this statement has mostly come from very dubious and biased statistics - specifically, the way that, in Mexico where epidemic originated, the only people they found with the disease were those on the edge of death because of the tendency there to only go to the doctor when you are on the edge of death. Despite the pandemic declaration, we haven't seen death rates above the normal rates of flu season yet (though a slightly different group is dying..). We might see high death rates but ... perhaps ... we should look at evidence before making grand declarations that this like nothing seen before.
Note, the original article is a not screaming endorsement of Jefferson's view, just a summary of debate:
The most vocal—and undoubtedly most vexing—critic of the gospel of flu vaccine is the Cochrane Collaboration’s Jefferson, who’s also an epidemiologist trained at the famed London School of Tropical Hygiene, and who, in Lisa Jackson’s view, makes other skeptics seem “moderate by comparison.” Among his fellow flu researchers, Jefferson’s outspokenness has made him something of a pariah.
No, he is demanding a specific type of evidence and automatically discounts cohort based research.
Anyway, to prevent another 1918 flu pandemic and 50+ million deaths you need to see if your treatment protects vs cytokine storm http://en.wikipedia.org/wiki/Cytokine_storm not the standard symptoms. (http://en.wikipedia.org/wiki/1918_flu_pandemic) H1N1 is far from this deadly but doing nothing is playing with fire.
PS: You can't compare the results of two studies without looking at their methodology 60% fewer deaths in group A, vs 50% after some adjustments.
Anyway, to prevent another 1918 flu pandemic and 50+ million deaths you need to see if your treatment protects vs cytokine storm http://en.wikipedia.org/wiki/Cytokine_storm not the standard symptoms. (http://en.wikipedia.org/wiki/1918_flu_pandemic) H1N1 is far from this deadly but doing nothing is playing with fire.
PS: You can't compare the results of two studies without looking at their methodology 60% fewer deaths in group A, vs 50% after some adjustments.
I'm surprised how controversial it is to demand placebo trials. The whole thing about ethics is ridiculous as the participants could be told about the uncertainties, about the majority and the minority views.
It shouldn't be hard to find enough educated people to volunteer in the interest of the billions potentially affected by the flu.
It shouldn't be hard to find enough educated people to volunteer in the interest of the billions potentially affected by the flu.
Ethics are not ridiculous. Randomized placebo controlled double-blinded studies have the potential to cause harm to humans.
A fantastic post on the issue can be found here http://www.sciencebasedmedicine.org/?p=467
A fantastic post on the issue can be found here http://www.sciencebasedmedicine.org/?p=467
Well, let's keep things in perspective. We're talking about the ethics of asking some 1000 volunteers _not_ to get a flu jab in one winter. ([edit] not about nazi death camps as the article you posted does)
And I think it is ridiculously un-ethical to vaccinate hundereds of millions of people with a vaccine that has never been tested properly (and I mean the seasonal flu, not the exceptional swine flu situation). These people go out and take risks that may cost them their lives because they have a false sense of safety.
And I think it is ridiculously un-ethical to vaccinate hundereds of millions of people with a vaccine that has never been tested properly (and I mean the seasonal flu, not the exceptional swine flu situation). These people go out and take risks that may cost them their lives because they have a false sense of safety.
Did you read the article? The ethical issue is the fact that you are _not_ preventing a vaccine preventable disease.
What information do you have that the flu vaccine is not tested properly?
edit to your edit: You clearly didn't read the post I linked to above if you think it's about nazi death camps above the ethical considerations of randomized, placebo controlled, double blinded studies.
What information do you have that the flu vaccine is not tested properly?
edit to your edit: You clearly didn't read the post I linked to above if you think it's about nazi death camps above the ethical considerations of randomized, placebo controlled, double blinded studies.
Look, I don't doubt that there are difficult ethical situations. But the flu situation is not one of them. The danger of not getting a flu jab just isn't severe enough to throw Dr. Mengele into the debate.
And to answer your question, I gather that seasonal flu vaccines have never been tested using a controlled, randomized, double-blind study. If that is not the case, then what are we talking about?
And I fail to see how it can be an ethical problem not to use a vaccine of which we don't know whether it prevents anything or not.
And to answer your question, I gather that seasonal flu vaccines have never been tested using a controlled, randomized, double-blind study. If that is not the case, then what are we talking about?
And I fail to see how it can be an ethical problem not to use a vaccine of which we don't know whether it prevents anything or not.
Perhaps an analogy would help:
Most car accidents don't kill people.
Seat belts have been proven as an effective defense against injury and death in automobile accidents.
It would be unethical to perform a study in which you ask humans to undergo a car accident without a seatbelt.
Anyway, that's how I understand it. I guess you could read up on the Tuskegee syphilis experiment, Belemont Report, Declaration of Helsinki and Nuremburg Code to learn more.
Most car accidents don't kill people.
Seat belts have been proven as an effective defense against injury and death in automobile accidents.
It would be unethical to perform a study in which you ask humans to undergo a car accident without a seatbelt.
Anyway, that's how I understand it. I guess you could read up on the Tuskegee syphilis experiment, Belemont Report, Declaration of Helsinki and Nuremburg Code to learn more.
Making people not use something that is proven to prevent death and injury is unethical.
Making people not use something that is _not_ proven to prevent death and injury is _not_ unethical.
None of your examples for unethical procedures have any similarity with that second situation. The syphilis sufferers were not treated with penicillin even though it was proven to be effective. The nazis used prisoners, not well informed volunteers.
And your car accident analogy involves making people have accidents that they would not otherwise have, not using preventive measures proven to work. We're not talking about infecting people with the flu, are we?
Making people not use something that is _not_ proven to prevent death and injury is _not_ unethical.
None of your examples for unethical procedures have any similarity with that second situation. The syphilis sufferers were not treated with penicillin even though it was proven to be effective. The nazis used prisoners, not well informed volunteers.
And your car accident analogy involves making people have accidents that they would not otherwise have, not using preventive measures proven to work. We're not talking about infecting people with the flu, are we?
I wanted to give a more thorough response, I was attending a birthday party earlier.
Remove "making people have an accident" from the car analogy and it is still unethical since seat belts are proven effective. In order to make the study double blinded with a placebo control you'd have to have something of a mock seat belt that fails to restrain the occupant in a crash or an abrupt maneuver.
The flu vaccine has been proven effective as well. The flu kills approximately 36,000 Americans a year. Therefore, a study which involves a placebo flu vaccine to determine who catches the flu and who doesn't is unethical, since those that received a placebo could potentially die or become injured. It doesn't matter if the study infects the participants or if they become infected by general human contact.
You may argue that the participants fully understand their risks and therefore a trial is ethical, but that is only part of the requirement. Again, you can find it outlined in the documents mentioned above.
Remove "making people have an accident" from the car analogy and it is still unethical since seat belts are proven effective. In order to make the study double blinded with a placebo control you'd have to have something of a mock seat belt that fails to restrain the occupant in a crash or an abrupt maneuver.
The flu vaccine has been proven effective as well. The flu kills approximately 36,000 Americans a year. Therefore, a study which involves a placebo flu vaccine to determine who catches the flu and who doesn't is unethical, since those that received a placebo could potentially die or become injured. It doesn't matter if the study infects the participants or if they become infected by general human contact.
You may argue that the participants fully understand their risks and therefore a trial is ethical, but that is only part of the requirement. Again, you can find it outlined in the documents mentioned above.
The flu vaccine has been proven effective as well
The article that started this thread denies that. You need to understand that my rejection of the ethics argument in this case relies on this assumption that the efficacy is not proven. If the flu vaccine were proven to be effective I would agree with all your ethics arguments.
What I find puzzling though is that the proof of efficacy should be prevented by the unproven claim of efficacy. Once a sufficient number of experts is convinced, for whatever reason, that something works, we would be prevented forever from finding out whether that's actually the case. I cannot accept that.
The article that started this thread denies that. You need to understand that my rejection of the ethics argument in this case relies on this assumption that the efficacy is not proven. If the flu vaccine were proven to be effective I would agree with all your ethics arguments.
What I find puzzling though is that the proof of efficacy should be prevented by the unproven claim of efficacy. Once a sufficient number of experts is convinced, for whatever reason, that something works, we would be prevented forever from finding out whether that's actually the case. I cannot accept that.
Jefferson's research doesn't show that the seasonal flu vaccine has no efficacy, just data showing that it has less efficacy for people over 60. He's mostly criticized for dismissing the convergence of independent evidence of efficacy for the vaccine. He has a higher burden to bear if he's to get a review board to approve of a flu vaccine RCT. Oh, and the article comes out just in time for a flu pandemic, promoting fear.
Fear caused by truth is very healthy thing. But who is right or wrong on the subject of flu vaccines itself is an entirely different matter on which I have no opinion.
I got the impression that even researchers who are in favor of the vaccine accepted it was uncertain whether it worked, but at the same time found it unethical to test whether it did actually work.
If that is really the argument and not just a distorted picture presented by incompetent journalists, then I think ethics is either an excuse for some vested interests or just incompetence in field of ethics.
I talked to a philosopher yesterday who specialises in ethics. He confirmed my view that _if_ we didn't know whether the vaccine was effective it cannot be unethical to test it on volunteers.
But I think you are right to move on to the question of whether it is actually uncertain that the vaccine works. However that's a debate that I'm not competent to have.
I got the impression that even researchers who are in favor of the vaccine accepted it was uncertain whether it worked, but at the same time found it unethical to test whether it did actually work.
If that is really the argument and not just a distorted picture presented by incompetent journalists, then I think ethics is either an excuse for some vested interests or just incompetence in field of ethics.
I talked to a philosopher yesterday who specialises in ethics. He confirmed my view that _if_ we didn't know whether the vaccine was effective it cannot be unethical to test it on volunteers.
But I think you are right to move on to the question of whether it is actually uncertain that the vaccine works. However that's a debate that I'm not competent to have.
don't shoot the messenger
[deleted]
If I could give your comment more points, I would.
According to the article, the researcher who "knows the flu-vaccine literature better than anyone else on the planet" calls the vast majority of studies "deeply flawed" and "rubbish." Only four studies were properly designed to pin down the effectiveness of flu vaccine, he says, and two of those showed that it might be effective in certain groups of patients, such as school-age children with no underlying health issues like asthma; the other two showed equivocal results or no benefit.
Yes
I've read some evidence that people who are more likely to die from flu are less likely to get vaccinated for flu thus the vaccinated population 'looks' healthier.
Worst this means that flu vaccines are bogus (not likely, we're quite good at creating vaccines and they work in labs) and best it means they are a HUGE waste of time and money (a bit more likely but you can level that argument at most things we routinely do for health).
However since I am _not_ a virologist or epidemiologist I tend to follow what my doctor says.
Worst this means that flu vaccines are bogus (not likely, we're quite good at creating vaccines and they work in labs) and best it means they are a HUGE waste of time and money (a bit more likely but you can level that argument at most things we routinely do for health).
However since I am _not_ a virologist or epidemiologist I tend to follow what my doctor says.
Uh, what? At worst, that's indicative of nothing, not affirmation of the negative hypothesis.
Think of it this way: if you are healthy, you are more likely to get the flu vaccine and less likely to die of any reason. If you are unhealthy, you are less likely to get the flu vaccine and more likely to die of any reason. Notice that neither of these statements say the following, "Patients who receive the flu vaccine are [more/less] likely to die of the flu then they would have been." Instead, it simply makes the statement that you cannot treat statistics as affirmation of flu effectiveness.
Think of it this way: if you are healthy, you are more likely to get the flu vaccine and less likely to die of any reason. If you are unhealthy, you are less likely to get the flu vaccine and more likely to die of any reason. Notice that neither of these statements say the following, "Patients who receive the flu vaccine are [more/less] likely to die of the flu then they would have been." Instead, it simply makes the statement that you cannot treat statistics as affirmation of flu effectiveness.
I'll let you know. Neither I or my kids are vaccinated.
If you aren't vaccinated, then nothing that happens to you says anything about the effectiveness or the lack thereof of the vaccine.
Dylanz personal experience alone isn't helpful, true, but what happens to the unvaccinated as a group -- the control group compared to the vaccinated -- is absolutely significant to determining the vaccine's effectiveness.
http://scienceblogs.com/effectmeasure/2009/10/journalists_si...