Busted! Scientists leave out data to produce bogus findings
trials of drugs and other medical therapies are carefully carried out and are
the very gold standard of scientific proof, right? According to an in-depth
review of this question just published in the British Medical Journal (BMJ,) the
answer is no. In fact, the BMJ is sounding the alarm that data reported by
scientists is too often not the truth -- because the researchers leave out
inconvenient evidence. The result of facts-gone-missing could well be
harming patients, spiking up healthcare costs by the selling of medical
treatments based on bogus findings, and threatening the very integrity of
These warnings come from multiple papers released by the BMJ.
The whistle-blowing authors of these articles examined the extent, causes,
consequences of hidden facts, figures, and other data scientists discover as
they do human trials. It turns out this is no "once in a while" kind of problem,
either. The BMJ claims a "large proportion of evidence from human trials is
unreported, and much of what is reported is done so inadequately."
editorial, Dr. Richard Lehman from the University of Oxford and BMJ Clinical
Epidemiology Editor, Dr. Elizabeth Loder, nail the current state of medical
research as a "culture of haphazard publication and incomplete data disclosure."
They call for full access to raw trial data to allow better understanding of the
benefits and harms of many treatments.
Bottom line: when data is left
out, the missing facts distort the scientific record and published results of a
study. This then leads doctors to make potentially dangerous clinical decisions
about what drugs or procedures patients need because the docs are relying on
skewed and even bogus "evidence."
Conveniently missing facts left out of drug trials and more
the current issue of BMJ include a study by Dr. Beth Hart and colleagues, which
document how unpublished data is "conveniently missing" from many published
meta-analyses of drug trials. That's right. Big Pharma's pills and potions are
often pushed based on studies that simply ignore and leave out major data about
what was really discovered about a medication lacking of benefits, potential
dangers, side effects and more. Dr. Hart's team argues that access to full trial
data is necessary to allow drugs to be independently assessed.
additional studies show the requirements for mandatory trial registration and
timely sharing of results are poorly followed, if at all. For example, it turns
out that less than half of US National Institutes of Health funded trials are
published in a peer reviewed journal within 30 months of completion and only 22
percent of trials that are supposed to be subject to mandatory reporting had
results available within one year of completion.
"When the word mandatory
turns out to mandate so little, the need for stronger mechanisms of enforcement
becomes very clear," the researchers report.
And what happens when
ethical, dedicated scientists try to assess true harms vs benefits of Big Pharma
drugs and other interventions? It's not a pretty picture for their careers,
apparently. Additional studies published in the special BMJ issue highlight the
many difficulties these researchers face when they try to buck the
Dr. Lehman and Dr. Loder, however, are bravely speaking out and
directly saying that a concealment of data in clinical trials is anything but
unusual. They label this "a serious ethical breach" and demand that clinical
researchers who fail to disclose data "should be subject to disciplinary action
by professional organizations. These changes have long been called for, and
delay has already caused harm. The evidence we publish shows that the
current situation is a disservice to research participants, patients, health
systems, and the whole endeavor of clinical medicine."