Plos One 可能要撤稿 中国免疫学会现任理事# Biology - 生物学
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孙兵 作为通讯作者的 的猪流感疫苗的二期临床测试结果的论文 2010
理由 临床测试资质单位的混淆 上海巴斯德研究所的羊头 卖的是河南CDC的狗肉
PLoS ONE has issued an expression of concern over a 2010 paper by Chinese
scientists about how the immune system responds to the vaccine against the
swine flu.
The article, “Protection Induced on Day 10 Following Administration of the
2009 A/H1N1 Pandemic Influenza Vaccine,” claimed to study 58 subjects given
the inoculation (more on that below) and that
Recipients could gain sufficient protection as early as 10 days after
vaccine administration. The protection could last at least 60 days.
Individuals with a stronger pre-existing seasonal influenza antibody
response may have a relatively higher potential for developing a stronger
humoral immune response after vaccination with the 2009 A/H1N1 pandemic
influenza vaccine.
Some of the researchers were affiliated with the Hualan Biological Bacterin
Company, maker of the vaccine they tested and one of several sources of
funding for the study — and, it turns out, the reservoir for the patients
in the study. (Can anyone say company town?)
According to the expression of concern (which we reproduce here in full):
Following the publication of the article “Immune Protection Induced on Day
10 Following Administration of the 2009 A/H1N1 Pandemic Influenza Vaccine”,
the Editors of PLoS ONE noticed that the article described findings from a
clinical trial. In line with PLoS ONE’s editorial policies for clinical
trials; the article should have included a trial registration number for the
study and a copy of the trial protocol.
The Editors followed up on this matter with the authors, who indicated that
the trial had not been registered at a public registry. The Editors were
also concerned about the documentation and clarifications provided by the
authors in response to the request for the study protocol and details on
ethical approval for the study. In the light of the concerns raised in
relation to the article, the Editors contacted the Institut Pasteur of
Shanghai to request an institutional investigation into the research
reported in the article.
The Institut Pasteur of Shanghai has now completed their institutional
investigation. While the investigation has not questioned the results
reported in the article, the enquiry has revealed concerns about some
aspects of the study. In the light of the findings of this enquiry, the
Editors issue this expression of concern to make readers aware of the
following concerns in relation to this trial:
@
The article reports that the clinical component of the study was approved by
the Institutional Review Board of Institut Pasteur of Shanghai. However,
the investigation committee has stated that the clinical study was in fact
approved by the Henan CDC Ethics Committee.
@
The Editors feel that the reporting of the clinical trial in the article is
inadequate given that no information is provided regarding the setting for
recruitment of the participants. The investigation committee has reported
that the participants in the study were employees of Hualan Biological
Bacterin Company, China, which is one of the funders of the study, the
manufacturer of the vaccine tested, and the employer of several of the
authors.
@
The article reports that 58 subjects were recruited for the study, however,
the institutional investigation established that approximately 130
volunteers were recruited, while only 58 completed the full protocol.
@
As outlined above, the clinical study was not registered as a clinical trial
. PLoS ONE supports the position of the International Committee of Medical
Journal Editors (ICMJE) on trial registration and follows the WHO definition
of a clinical trial, which constitutes : “…any research study that
prospectively assigns human participants or groups of humans to one or more
health-related interventions to evaluate the effects on health outcomes.”
In this study participants were prospectively recruited, received a vaccine
against the 2009 A/H1N1 influenza virus and their immune response was
evaluated following vaccination. We consider the vaccination to be health-
related intervention and the measurement of the immune response to
constitute a health outcome, and as a result, the Editors consider that the
study fulfills the criteria for a clinical trial and should have been
prospectively registered at a public repository.
The ethical issues here obviously are quite serious, and we’ve seen papers
retracted for similar failings. Indeed, we’ve seen large chunks of a
researcher’s published work go down the drain for IRB-related mishaps —
take Joachim Boldt, for example.
But the bit about study size strikes us, from a scientific standpoint at
least, as potentially far more grave. Assume, for a moment, that the
researchers obtained results from 130 patients but cherry picked data from
only 58, and it’s immediately evident that their entire analysis — one on
which public health decisions very well might rest — is deeply suspect.
After all, if the unreported data show that for 72 people (55 percent of the
study population) the vaccine isn’t effective until 14 days after
administration and lasts only 50 days, Hualan, we have a problem.
We haven’t heard from PLoS ONE about why it felt expressing concern was a
better option than retraction.
We asked Damian Pattinson, executive editor of PLoS ONE, why the journal
didn’t retract the article.
It was indeed an interesting case and we ended up going to COPE about it,
and it was they that suggested the Expression of Concern option.
For what it’s worth, our main consideration was that the concerns were more
to do with potential breaches of our own editorial policies (eg on trial
registration) than actual evidence that the work was unreliable. We left
open the option of a retraction if the instructional report revealed further
issues, but the investigation did not provide clear support for a
retraction.
But we did We also reached William Halford, a herpes research at Southern
Illinois University School of Medicine, who edited the flu manuscript for
the journal — his first gig for the publication as an academic editor.
Since it wasn’t his area of expertise, he asked the advice of two influenza
specalists, both of whom said the paper was worth publishing. However,
Halford said he “leaned hard” on the authors to be more specific in many
places.
You can tell the difference between a paper in which the authors are trying
to be completely transparent and one in which they are deliberately trying
to not paint the clearest picture.
If it hadn’t been for the two expert opinions, I probably would have
rejected the paper because of the lack of detail. At the end of the day, I
remember walking away from the study thinking: It’s my first assignment. I
don’t want to be too much of a hard-ass.
We’re sympathetic. Halford had no way of knowing the problems that would
befall the paper at the time he was editing the manuscript.
But one person who may be wishing that the journal hadn’t let the article
hit the printing press is John Ioannidis, a Stanford researcher who has
become well-known for his work on “why most published research findings are
false.” Ioannidis was the senior author on a meta-analysis, also published
in PLoS ONE, which has so far been the only paper so far to cite the now-
corrected work, according to Thomson Scientific’s Web of Knowledge. We’ve
asked Ioannidis for comment on whether the correction will affect the meta-
analysis, and will update with anything we find out.
Hat tip: Clare Francis
//retractionwatch.wordpress.com/2012/06/15/plos-one-expresses-concern-over-
flu-vaccine-paper/#more-8206
理由 临床测试资质单位的混淆 上海巴斯德研究所的羊头 卖的是河南CDC的狗肉
PLoS ONE has issued an expression of concern over a 2010 paper by Chinese
scientists about how the immune system responds to the vaccine against the
swine flu.
The article, “Protection Induced on Day 10 Following Administration of the
2009 A/H1N1 Pandemic Influenza Vaccine,” claimed to study 58 subjects given
the inoculation (more on that below) and that
Recipients could gain sufficient protection as early as 10 days after
vaccine administration. The protection could last at least 60 days.
Individuals with a stronger pre-existing seasonal influenza antibody
response may have a relatively higher potential for developing a stronger
humoral immune response after vaccination with the 2009 A/H1N1 pandemic
influenza vaccine.
Some of the researchers were affiliated with the Hualan Biological Bacterin
Company, maker of the vaccine they tested and one of several sources of
funding for the study — and, it turns out, the reservoir for the patients
in the study. (Can anyone say company town?)
According to the expression of concern (which we reproduce here in full):
Following the publication of the article “Immune Protection Induced on Day
10 Following Administration of the 2009 A/H1N1 Pandemic Influenza Vaccine”,
the Editors of PLoS ONE noticed that the article described findings from a
clinical trial. In line with PLoS ONE’s editorial policies for clinical
trials; the article should have included a trial registration number for the
study and a copy of the trial protocol.
The Editors followed up on this matter with the authors, who indicated that
the trial had not been registered at a public registry. The Editors were
also concerned about the documentation and clarifications provided by the
authors in response to the request for the study protocol and details on
ethical approval for the study. In the light of the concerns raised in
relation to the article, the Editors contacted the Institut Pasteur of
Shanghai to request an institutional investigation into the research
reported in the article.
The Institut Pasteur of Shanghai has now completed their institutional
investigation. While the investigation has not questioned the results
reported in the article, the enquiry has revealed concerns about some
aspects of the study. In the light of the findings of this enquiry, the
Editors issue this expression of concern to make readers aware of the
following concerns in relation to this trial:
@
The article reports that the clinical component of the study was approved by
the Institutional Review Board of Institut Pasteur of Shanghai. However,
the investigation committee has stated that the clinical study was in fact
approved by the Henan CDC Ethics Committee.
@
The Editors feel that the reporting of the clinical trial in the article is
inadequate given that no information is provided regarding the setting for
recruitment of the participants. The investigation committee has reported
that the participants in the study were employees of Hualan Biological
Bacterin Company, China, which is one of the funders of the study, the
manufacturer of the vaccine tested, and the employer of several of the
authors.
@
The article reports that 58 subjects were recruited for the study, however,
the institutional investigation established that approximately 130
volunteers were recruited, while only 58 completed the full protocol.
@
As outlined above, the clinical study was not registered as a clinical trial
. PLoS ONE supports the position of the International Committee of Medical
Journal Editors (ICMJE) on trial registration and follows the WHO definition
of a clinical trial, which constitutes : “…any research study that
prospectively assigns human participants or groups of humans to one or more
health-related interventions to evaluate the effects on health outcomes.”
In this study participants were prospectively recruited, received a vaccine
against the 2009 A/H1N1 influenza virus and their immune response was
evaluated following vaccination. We consider the vaccination to be health-
related intervention and the measurement of the immune response to
constitute a health outcome, and as a result, the Editors consider that the
study fulfills the criteria for a clinical trial and should have been
prospectively registered at a public repository.
The ethical issues here obviously are quite serious, and we’ve seen papers
retracted for similar failings. Indeed, we’ve seen large chunks of a
researcher’s published work go down the drain for IRB-related mishaps —
take Joachim Boldt, for example.
But the bit about study size strikes us, from a scientific standpoint at
least, as potentially far more grave. Assume, for a moment, that the
researchers obtained results from 130 patients but cherry picked data from
only 58, and it’s immediately evident that their entire analysis — one on
which public health decisions very well might rest — is deeply suspect.
After all, if the unreported data show that for 72 people (55 percent of the
study population) the vaccine isn’t effective until 14 days after
administration and lasts only 50 days, Hualan, we have a problem.
We haven’t heard from PLoS ONE about why it felt expressing concern was a
better option than retraction.
We asked Damian Pattinson, executive editor of PLoS ONE, why the journal
didn’t retract the article.
It was indeed an interesting case and we ended up going to COPE about it,
and it was they that suggested the Expression of Concern option.
For what it’s worth, our main consideration was that the concerns were more
to do with potential breaches of our own editorial policies (eg on trial
registration) than actual evidence that the work was unreliable. We left
open the option of a retraction if the instructional report revealed further
issues, but the investigation did not provide clear support for a
retraction.
But we did We also reached William Halford, a herpes research at Southern
Illinois University School of Medicine, who edited the flu manuscript for
the journal — his first gig for the publication as an academic editor.
Since it wasn’t his area of expertise, he asked the advice of two influenza
specalists, both of whom said the paper was worth publishing. However,
Halford said he “leaned hard” on the authors to be more specific in many
places.
You can tell the difference between a paper in which the authors are trying
to be completely transparent and one in which they are deliberately trying
to not paint the clearest picture.
If it hadn’t been for the two expert opinions, I probably would have
rejected the paper because of the lack of detail. At the end of the day, I
remember walking away from the study thinking: It’s my first assignment. I
don’t want to be too much of a hard-ass.
We’re sympathetic. Halford had no way of knowing the problems that would
befall the paper at the time he was editing the manuscript.
But one person who may be wishing that the journal hadn’t let the article
hit the printing press is John Ioannidis, a Stanford researcher who has
become well-known for his work on “why most published research findings are
false.” Ioannidis was the senior author on a meta-analysis, also published
in PLoS ONE, which has so far been the only paper so far to cite the now-
corrected work, according to Thomson Scientific’s Web of Knowledge. We’ve
asked Ioannidis for comment on whether the correction will affect the meta-
analysis, and will update with anything we find out.
Hat tip: Clare Francis
//retractionwatch.wordpress.com/2012/06/15/plos-one-expresses-concern-over-
flu-vaccine-paper/#more-8206
