Quote; "When it comes to disclosing clinical trial data, some drug makers are still keeping secrets, according to a new study.
Thirty-five percent of all trial results for 15 drugs that were
approved in 2012 by the Food and Drug Administration were not publicly
disclosed. And nearly 30 percent of the trials conducted for those drugs
failed to meet legal disclosure requirements.
“This confirms that pharmaceutical companies often fall below legal
and ethical standards,” said Jennifer Miller, an assistant professor in
the Division of Medical Ethics at the NYU School of Medicine and a
co-author of the study, which was published in BMJ. The study examined 318 clinical trials involving almost 100,000 participants.
The findings come amid growing clamor from academics and consumer
groups to press drug and device makers to release trial data. If
research is not published or reported in accessible registries,
physicians and patients are prevented from having a complete picture of
the risks and benefits of medicines.
At issue is the ability for researchers to independently verify study
results and, consequently, improve patient treatments that can lead to
better health and lower costs.
Such concerns have been heightened following various safety scandals
that revealed trial data for some products was never fully published or
disclosed. A few notable examples include the Vioxx painkiller, which
was withdrawn by Merck, and the Paxil antidepressant sold by
GlaxoSmithKline. A recent independent analysis of Paxil trial data reported results that contradicted initial safety claims.
Over the past year, regulators in the US and Europe responded to
concerns by releasing new rules designed to widen access. The World
Health Organization has released a new position statement calling for
companies to publish all research studies.
And several drug makers, in varying degrees, have taken steps to
release trial data. Notably, Glaxo created a web site where data
requests are made to 10 different drug makers. And Johnson & Johnson
is working with Yale University to provide access to data.
Nonetheless, more than 50 physicians and academics sent letters this
week to each of the US presidential candidates asking whether they
support access to clinical trial data held by federal agencies and what
they will do to ensure reporting requirements are met.
And Sense About Science, a UK nonprofit that launched the AllTrials
campaign to widen access to data, is working with 85 asset managers and
pension funds to assess steps taken by drug makers to provide trial
information. A report is expected in coming months.
Despite the grim findings in the BMJ study, Miller noted there are
signs that the industry is gradually adopting what she called ‘best
practices’ toward greater transparency. But to prod drug makers, she
plans to publish an annual scorecard that ranks disclosure of trial
A version of this scorecard, in fact, appears in the BMJ study and
found that Glaxo, J&J and Pfizer released all of the trial data for
the drugs that were approved by the FDA in 2012. “We seek to publish
results of all our clinical trials, regardless of whether the results
might be perceived as positive or negative,” a Glaxo spokeswoman wrote
However, Miller’s scorecard also found that some drug makers fared
poorly. For instance, Gilead Sciences publicly disclosed only 21 percent
of trials for its Stribild HIV drug and Sanofi disclosed just 22
percent of the trials conducted for its Aubagio multiple sclerosis
A Sanofi spokeswoman wrote us that the company registers its clinical
trials on public registries, including clinicaltrials.gov, and study
results included in these registries are published on the company web
site, peer-reviewed medical journals and at medical congresses. A Gilead
spokeswoman declined to comment." Go to: http://pharmalot.com/drug-makers-kept-many-clinical-trial-results-a-secret-study/
Also see; "British
Pharmaceutical Company Glaxo-Smith-Kline Fined $488.8 Million for
"Massive Bribery Network" with Doctors (& more on W.H.O vaccines
controversy)" Go to: http://gkhales.blogspot.co.uk/2015/09/british-pharmaceutical-company-glaxo.html