Medical journals get tough on drug companies

[Guest guest]

[This topic was mentioned in yesterday's news, but receives a more

thorough investigation today courtsey of Andre Picard]

 

Medical journals get tough on drug companies

http://www.theglobeandmail.com/servlet/ArticleNews/TPStory/LAC/20040909/TRIALS09\

/TPHealth/

 

By ANDRÉ PICARD

PUBLIC HEALTH REPORTER

Thursday, September 9, 2004 - Page A12

 

Some of the world's leading medical journals say they will no longer

publish results of clinical trials that have not been registered

publicly, a move designed to prevent drug companies from hiding

unfavourable results.

 

" Honest reporting begins with revealing the existence of all clinical

studies, even those that reflect unfavourably on a research sponsor's

product, " the International Committee of Medical Editors wrote in a

commentary that will appear in 11 prestigious journals.

 

" Unfortunately, selective reporting of trials does occur, and it

distorts the body of evidence available for clinical decision-making. "

 

The move is important because physicians rely heavily on articles in

these journals when deciding what drugs to prescribe to patients.

 

The statement from the editors of the New England Journal of Medicine,

Journal of the American Medical Association, the Lancet, and the

Canadian Medical Association Journal, among others, coincides with

hearings in Washington today about a lack of disclosure from trials of

the safety of antidepressants in children and adolescents.

 

The revelation that some antidepressants may actually increase suicidal

thoughts in younger users, information that was withheld by drug makers,

has caused a fury in the international medical research community and

outraged parents of children who were prescribed the drugs.

 

U.S. lawmakers are expected to introduce legislation today that would

require all drug trials involving human subjects to be registered in a

public database before they are allowed to proceed.

 

The Canadian Institutes for Health Research announced last month that it

will no longer fund clinical trials unless they are duly registered, a

policy it said was designed to " support the drive for greater openness

of information. "

 

A clinical trial is a research study using human volunteers designed to

answer a specific health question such as: " Does anastrozole delay the

recurrence of breast cancer in postmenopausal women? "

 

Clinical trials are considered the gold standard of research.

 

But sometimes research produces unclear results or findings that are the

opposite of what the research sponsor expected, and that news could

potentially cost a company millions of dollars in lost sales.

 

In their commentary, the journal editors said researchers and the

companies that sponsor them have an obligation to conduct research

ethically and report it honestly, regardless of the financial fallout.

They said this is particularly true because the research depends on

altruistic volunteers.

 

The editors said that publishing only positive results paints too rosy a

picture and misleads consumers and prescribing physicians about the true

safety and effectiveness of drugs.

 

John Hoey, editor of the Canadian Medical Association Journal, said the

position taken by the editors is an unusual one because it will not

really affect their publications directly, rather, it is more a matter

of principle.

 

" Why should we care about stuff that's unpublished? " he asked rhetorically.

 

" Our feeling is that by doing this we can do some public good. "

 

In addition to its demand that clinical trials be registered before

human subjects are enlisted, the editors laid out a number of criteria

for an " acceptable " registry, including that the goals of the research

be stated clearly, that primary and secondary outcomes be revealed and

that the database be electronically searchable and publicly accessible

at no charge.

 

As part of the new policy, trials must register at or before the onset

of patient enrolment.

 

What this means is that the researchers and their sponsors are making a

commitment to reveal the findings of their trials -- long before the

results are in and regardless of whether they are positive or negative.

 

While various registries have sprung up -- including one announced

earlier this week by the drug manufacturers themselves -- the editors

said only one meets their criteria: http://www.clinicaltrials.gov, which

is sponsored by the U.S. National Library of Medicine.

 

Although only 11 journal editors formulated the statement, other medical

journals are expected to widely adopt the approach.

 

The signatories acknowledge that drug companies could try and sidestep

the registry by getting research published elsewhere, but they argued

that many researchers would be reluctant to sign contracts that might

preclude them from being published in leading journals.