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JAMA & Yale Find FDA Suppresses


Scientific Fraud in Clinical Trials
By Susanne Posel February 10, 2015

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Susanne Posel ,Chief Editor Occupy Corporatism | The US Independent


February 10, 2015

According to the JAMA Internal Medicine journal, the Food


and Drug Administration (FDA) have critical issues of protocol
with regard to inspecting clinical trial locations where
biomedical research is performed on human subjects.
Shockingly only 2% of the 644 clinical trials involving humans
carried out in 2013 were classified as official action indicated
(OAI) by the FDA and this information was omitted when the
time came for peer-review before authentication and
publication of the data.
The FDA found only 1 out of 57 published clinical trials to
have issues with falsifying data that was submitted.
Four percent of the publications submitted resulted from the
trials where the FDA found significant violations mentioned
the objectionable conditions or practices and 53% involved
violations otherwise characterized.
A shocking 61% of the clinical trials failed to ensure patient
safety with regard to informed consent to procedures while
25% failed to report problems with adverse effects.
The researchers wrote: The FDA does not typically notify
journals when a site participating in a published clinical trial
receives an OAI inspection, nor does it generally make any

announcement intended to alert the public about the research


misconduct that it finds. The documents the agency discloses
tend to be heavily redacted. As a result, it is usually very
difficult, or even impossible, to determine which published
clinical trials are implicated by the FDAs allegations of
research misconduct.
JAMA editors Robert Steinbrook and Rita Redberg called for
the FDA to improve their public reporting of clinical trials.
Last year, researchers from Yale University (YU) School of
Medicine have published a study examining the FDAs
approval ratio and criteria of 448 pivotal trial cases during the
years 2005 2012.
Joseph Ross, co-author of the study, said : The majority of
drugs were studied in high quality clinical trials as we would
expect. A third of new drugs are approved on the basis of a
single trial. It may have been a big trial or it may have been a
very small trial.
The researchers wrote: Many patients and physicians assume
that the safety and effectiveness of newly approved
therapeutic agents is well understood; however, the strength of
the clinical trial evidence supporting approval decisions by the
US Food and Drug Administration (FDA) has not been
evaluated.
Ross continued: Less than half of drugs are compared to an
existing alternative thats available on the market today at the
time of approval.
Shockingly, the research observed that fewer than half the
drugs specified for longterm use are studied for more than six
months.
Ross said: The FDA is doing a good job of maintaining these
flexible approval standards and tailoring each approval
appropriately. So we can have these flexible standards that
allow shorter trials and less certain trials to go forward and be
the basis of an FDA approval so long as were continuing to
study these medications in the post market period.
This proves that a significant portion of the medical treatments
approved by the FDA are not safe nor are they thoroughly
tested.
While some drugs under went severe scrutiny, others were
never compared to existing treatments to judge their
effectiveness.
Indeed, 37% of drugs were allowed to go to consumers with
only having to withstand one clinical trial.
It was shown that:

91% of approvals based on a surrogate endpoint ; meaning


that the drug appeared to work
74% of approvals based on a single trial
77% of approvals based on only 2 trials
50% of approvals based on 3 or more trials
The researchers wrote: Pivotal efficacy trials were classified
according to the following design features: randomization,
blinding, comparator, and trial end point. Surrogate outcomes
were defined as any end point using a biomarker expected to
predict clinical benefit. The number of patients, trial duration,
and trial completion rates were also determined.
Nicholas Downing, co-author of the study remarked: Many
other trials were small, short, and focused on lab values, or
some other surrogate metric of effect, rather than clinical
endpoints like death.
Downing said: Based on our study of the data, we cant be
certain that this expectation is necessarily justified, given the
quantity and quality of the variability we saw in the drug
approval process.
In conclusion, the researchers stated: The quality of clinical
trial evidence used by the FDA as the basis for recent
approvals of novel therapeutic agents varied widely across
indications. This variation has important implications for
patients and physicians as they make decisions about the use
of newly approved therapeutic agents.

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