[Homestead] Honest reporting of clinical trials
tvoivozd at infionline.net
Mon Sep 13 20:55:43 EDT 2004
For decades the corrupt pharmaceutical companies have published the
results of clinical trials that supported their claims, hidden results
of clinical trials that disproved their claims---so they could go right
on selling their ineffective or dangerous snake oil, raking in
fraudulent multi-millions of dollars.
This is about to change.
*Medical journals to require clinical trial registration*
11:18 09 September 04
NewScientist.com news service
Eleven prestigious medical journals around the world have announced a
new strategy intended to force drug companies to disclose more
information about clinical trials.
The International Committee of Medical Journal Editors (ICMJE) plan to
refuse to publish papers on clinical trial results if the trial was not
recorded in a publicly-accessible registry at its outset. The new policy
will be brought into force over the next year. The group of journals
involved includes the /New England Journal of Medicine/, /The Lancet/,
and /The Journal of the American Medical Association/.
These registries would describe the size, design and purpose of each
trial at its beginning. The policy's aim is to prevent companies from
only reporting positive results, or spinning data to suppress
inconclusive or unflattering conclusions about their treatments, says
Catherine De Angelis, editor-in-chief of JAMA.
All the editors had had stories about clinical results being brought
into question "because we knew there were trials out there that were
never being reported", she says. While there are hundreds of other
medical publications that have not publicly endorsed the plan, De
Angelis believes many will. "We already know of several other journals
that are going to sign on."
"This is a really exciting development. This will be a motivator for
companies, no doubt about it," says Kay Dickersin of the Brown
University Center for Clinical Trials and Evidence-based Healthcare in
Providence, Rhode Island. But experts like Dickersin also say greater
steps are needed to guarantee that the public gets the information it needs.
*High profile lawsuit*
For years, medical advocates have been calling with little effect for
biotech and pharmaceutical companies to provide more details about their
clinical results. But recently, the issue has been reinvigorated, partly
due to the high profile lawsuit brought by New York State attorney
general, Eliot Spitzer, against the pharmaceutical giant GlaxoSmithKline.
The suit alleged that the company withheld trial data suggesting that
children taking its antidepressant drug Paxil had more suicidal
tendencies than children receiving placebos. While the company admitted
no wrongdoing, it has agreed to pay a $2.5 million dollar settlement and
to post more comprehensive trial results on its website.
As a result, other industry leaders, such as Eli Lilly and Merck
announced they would also start registering their results online. And
just this week, the Pharmaceutical Research and Manufacturers of
America, an industry trade group to which all three companies belong,
announced the creation of a database in which its member companies would
voluntarily deposit both negative and positive results.
However, an important element of the plan the ICMJE endorses is the
requirement that such registries be run by not-for-profit agencies with
standards for the validity of the data they contain. The editors cite
the database maintained by the US National Library of Medicine -
www.clinicaltrials.gov - as an exemplar.
Volunteer, industry-sponsored substitutes will not work, says De
Angelis. "Why would you put the fox in charge of the hen house?" she
says. "And if they have nothing to hide, why waste money setting up
their own database?"
Another related development this summer came from the American Medical
Association, which began urging Institutional Review Boards at hospitals
and universities to require trials under review to register their
results. All human clinical trials in the US need approval from an IRB
in order to start enrolling patients.
But how many IRBs or journals will stand by these new policies is hard
to guess. "That's why they're insufficient," says Jim Manley, a
spokesperson for US Senator Edward Kennedy who is co-sponsoring a bill
requiring companies to report their results. "Voluntary measures by
companies, while generally laudable, will not produce the comprehensive
information the public needs."
The fate of Edward's bill and similar ones pending is uncertain. The
pharmaceutical industry has great political influence in Washington and
has traditionally resisted new legal restrictions.
"If we knew for certain a law was coming, we wouldn't even bother with
our policy," says De Angelis.
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