[Homestead] Honest reporting of clinical trials

Tvoivozhd 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?"

*Enrolling patients*

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.


Philip Cohen


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