Tracking retractions as a window into the scientific process

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FDA has repeatedly hidden evidence of scientific fraud, says author of
new study
with 12 comments
For decades, the U.S. FDA has uncovered misconduct in clinical trials but hidden it from the
public, according to a new paper in JAMA Internal Medicine.
The study, by New York University journalism professor Charles Seife, looked at 78 publications
resulting from trials where the FDA found serious misconduct, including failure to protect the
safety of patients and data fakery. Only three of those publications mentioned the problems
uncovered by the FDA. No retractions or errata were ever issued for any of them.
For example, in one of the three cases:
data from several patients were excluded from the efficacy analysis because site
monitoring raised questions in regard to certain data at 1 study site.65(p431) The FDA documents 64 allege that
none of the individuals enrolled at 1 study site had met the inclusion criteria and that the responsible
researcher had fabricated chest radiographs of participants and committed other forms of misconduct.
(Reference 65 reported results of a trial Ivan wrote about several years ago, in coverage that raised some unrelated
questions.)
The JAMA Internal Medicine article pulls exactly zero punches:

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Conclusions and Relevance When the FDA finds significant departures from good clinical practice, those
findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or
other forms of research misconduct.
Seife also wrote a Slate piece, published concurrently with the paper, which was even more brutal, directly stating that
the FDA actively covers up clinical misconduct:
That misconduct happens isnt shocking. What is: When the FDA finds scientific fraud or misconduct, the
agency doesnt notify the public, the medical establishment, or even the scientific community that the results
of a medical experiment are not to be trustedThe FDA has repeatedly hidden evidence of scientific fraud not
just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or
not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud
regarding a dangerous drug couldnt get forthright answers. For an agency devoted to protecting the public
from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators
of bogus science from the public.
JAMA Internal Medicine wrote an editorial to accompany the paper (behind a paywall). It noted that the FDA is moving
towards more transparency, though their practice of heavily redacting information makes investigative work slow going.
Heres an excerpt:
It is important to note that most FDA inspections are not classified as Official Action Indicated. Seife could
not estimate the actual frequency of serious problems owing to the large number of records that were missing
or unavailable. And he could not determine how often the violations found by the FDA could reasonably be
expected to be acknowledged in an article or how often corrections or retractions were indicated. If the FDA
documents had been more accessible and not heavily redacted, however, it is likely that Seife would have
linked more published clinical trials to apparent research misconduct.

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When the FDA identifies apparent research misconduct, it generally does not make a public announcement or,
in the case of a published clinical trial, notify the journal that published the study. It is in the public interest for
the agency to make available more information about its compliance and enforcement activities, and it has
already begun to do so. In 2009, the FDA announced a transparency initiative; in 2010 and 2011 a task force
issued draft proposals, including those to illuminate the agencys compliance and enforcement activities.
Seife did not contact the journals for reactions, which he normally would have done, he tells us, because this was going
in the peer-reviewed literature rather than the popular press.
(Full disclosure: Ivan and Charles are colleagues at NYU, and some of their mutual students helped gather the data for
the article). We asked Seife about what it was like working with J-school students, and how the process of digging
through the documents went:
One of the wonderful things about having a dozen or so bright students is that you can set them loose on a
many-hands-light-work sort of assignment. Go out and find fraud, my pretties! *cackle* So all I had to do was
point them in the right direction, and data began trickling in.
The tough part was gathering up all the data and validating it. One advantage we had was that we had no
illusions that wed be comprehensive; the redactions were sometimes way too extensive for us to have hope
that wed get everything. That knowledge kept us from spending too much time beating our heads against the
wall trying to crack documents that simply wouldnt be cracked.
Weve reached out to the FDA for comment, but for now heres the one they gave to Reuters. The FDA:
. . . is committed to increasing the transparency of compliance and enforcement activities with the goal of
enhancing the publics understanding of the FDAs decisions, promoting the accountability of the FDA, and
fostering an understanding among regulated industry about the need for consistently safe and high-quality
products.

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Weve also reached out to COPE for some guidance on the ethics of all this, and will update if we hear back [See update
below].

the scientific record; drug

company funding and research

In the Reuters story, Seife agreed with JAMA Internal Medicine that transparency is increasing within the agency.
However, he said,

Suggestion on Refreshing
honesty? Journal asks authors to
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Desdemona on FDA has
repeatedly hidden evidence of
scientific fraud, says author of
new study

Im not sure youll ever get traction until theres some incentive behind it.

TIJSAT on Refreshing honesty?

Journal asks authors to help
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Update 4:30 p.m. EST 2/11/15: COPE Chair Virginia Barbour got back to us about COPEs role in this issue:
I had seen this paper and agree it has implications for the reporting of clinical trials.
I am not sure however, this is an issue just for or even primarily for COPE the responsibility here would
seem to me to lie with the authors, the institutions where the trials were undertaken and the funders of the
studies all of whom will presumably have been aware of the FDA findings in relation to the trials they are
involved with.
My expectation would be that if such information is available the authors should report it in any article arising
from the trial so as to ensure that the information is available to reviewers and editors, and ultimately if it is
published and relevant, to readers. Editors should use this information in assessing the papers as should
reviewers.
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Comments
Political correctness February 9, 2015 at 3:58 pm
Its really sad when the best that a government institution can provide about such serious claims is a
politically correct statement that actually says nothing, reflects no accountability (x78 times), and
shows no immediate desire to address the issue seriously, and transparently. The statement to Reuters
sounds more like the marketing banner of a web-site than a frank statement that should have stated,
instead: We are truly concerned about these allegations and will proceed immediately to release all
documents publicly that will allow further investigations into these 78 publications to progress. The FDA
will do anything and everything in its power to cooperate with the scientific public to ensure that the
literature reflects an accurate portrayal of the scientific basis of those papers. Well, at least thats what
I would say if I were the FDAs spokesperson
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Robet Marcus February 9, 2015 at 4:02 pm

I am concerned about Dr Seifes over-reach in concluding in his specific example the results of a
medical experiment are not to be trusted. It appears the authors, themselves, discovered the
malpractice, and pro-actively removed the fraudulent data from their data set. This, of course, would
reduce the overall statistical power of their analyses, so if they still saw a statistically significant
outcome, it would be even more difficult to obtain, and I dont see why the published data become
necessarily untrustworthy. It also suggests that the authors maintained a reasonable level of scrutiny
over the conduct of the trial.
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Marilyn Mann February 9, 2015 at 7:48 pm

There are two references to JAMA when you mean JAMA Internal Medicine.
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Irene February 9, 2015 at 8:51 pm

From the article: A clinical site in China taking part in a large trial of apixaban, a novel anticoagulant,
had apparently altered patient records. If one were to exclude the data from the patients at that
site, the claim of a statistically significant mortality benefit disappears.179 For this reason, among
others, the FDA wrestled with whether it was appropriate to allow the manufacturer to claim a mortality
benefit. None of this discussion appears in the literature.
Apparently, they didnt wrestle very hard. Heres the relevant labeling (language is identical in the
original and current versions): ELIQUIS treatment resulted in a significantly lower rate of all-cause
death (p = 0.046) than did treatment with warfarin, primarily because of a reduction in cardiovascular
death, particularly stroke deaths.
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Bri February 9, 2015 at 10:36 pm

The FDAs responsibility is to protect the public health not to correct the scientific literature. All of these
incidents can be easily found by searching through the warning letters that FDA sends out to clinical
investigators when evidence of non-compliance or fraud is found. All the warning letters are public
domain and can be found on the FDAs website.
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Michael Kovari February 10, 2015 at 8:19 am

An excellent article by the outstanding journalist and author Charles Seife.
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Desdemona February 13, 2015 at 12:46 am

I am astounded at the near-complete silence from the media on this. Ive been tracking it with Google
News and other than the Slate article, so far I have only found coverage from Reuters, US News, Wired,
and WSJ in terms of mainstream media. A few science pages and other sites I am not familiar with
have picked it up. It never ceases to amaze me the stories the media runs with and generates total
hysteria over and the stories they completely ignore.
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