It seems that every few months we read about another
breakthrough cancer cure. We see a picture of a group of solemn people in
lab coats and statements about how their new medicine has delivered astonishing
results "in a laboratory setting" that will take a year or so to
become available to human cancer patients. So why are there so few of these
miracle drugs actually in use? To everyone's surprise, it seems that much of
the research can't be reproduced. How does this happen?
Cancer continues to be a deadly scourge. Many millions of
dollars are invested every year, researching new ways to battle this deadly
disease. Hundreds of research results are published each year, reporting on
laboratory results using mice, rats or monkeys, that could be extended into human research trials. But when
these results (called "pre-clinical research") are used as the basis for human research, the outcomes are rarely
encouraging.
Developing a cancer treatment is expensive, both in terms
of time and money. As a result, the drug companies depend on these lab results
to select the most promising innovations for costly clinical trials. When the
drug companies looked at why their success rates were so low, they took a fresh
look at the pre-clinical research that was used as the basis for their drug development.
In a commentary published in the March 2012 edition of
the magazine Nature, Glenn Begley and Lee Ellis report that when Amgen selected
53 "landmark" pre-clinical studies, they were only able to reproduce
the results of 6. That meant that 89% of these ground-breaking research
projects did not deliver the promised results when the research was performed a
second time. Bayer HealthCare conducted a similar double-check and found that
only 25% of the research they checked could be reproduced.
There is no allegation of improper conduct. No one is
accused of lying or falsifying their results.
However, this inability to reproduce the foundational research certainly
explains why triumphant announcements from the lab rat researchers rarely
translate into drugs administered in the cancer wards. Equally troubling is the
certainty that cancer patients across the country are participating in clinical trials based
on research that does not stand up to re-examination. They cannot expect to be
cured.
So what can be done? Clearly, the bar is set too low for
pre-clinical research results. The rush to publication must be tempered by not
only peer review but independent validation of results. Anything less is a
terrible waste of millions of dollars and false hope for thousands of desperate cancer
patients participating in clinical trials.
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