Clinical Trials: Merely the secret record of the sponsor?

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Boycott of secretive drug trials sought

By ED SUSMAN

BOSTON, Dec. 30 (UPI) -- The editor of the prestigious New England

Journal of Medicine called on doctors who engage in clinical trials

to boycott studies sponsored by pharmaceutical companies that do not

fully live up to the spirit of legal requirements to register such

research efforts.

In a study that appears in this week's Journal, researchers from the

National Institutes of Health indicate that many of the registered

trials fail to give critical information -- sometimes not even

including the name of the drug being studied.

For Dr. Drazen, editor of the Boston-based Journal, arguably

the premier medical publication in the world, that type of corporate

evasion is unacceptable.

In a strongly worded editorial Drazen wrote: " In our opinion, it is

unacceptable for a trial sponsor not to register its trial in a

complete, meaningful and timely fashion. We call for all clinical

investigators and patients to participate only in fully registered

trials.

" This call has recently been echoed by the major organization

representing academic medical centers in the United States -- the

Association of American Medical Colleges.

" If a company continues to register trials using meaningless data,

with no respect for the registration process and the patients who

participate in those trials, investigators and patients should refuse

to participate.

" If a company realizes that secrecy and failure to register mean that

it cannot meet its recruitment goals, it will quickly recognize that

the consequence of that secrecy is commercial failure, not

competitive success. We must monitor the companies that are currently

noncompliant to ensure that all live up to the spirit of the law as

reflected in meaningful clinical trial registration. "

Dr. Deborah Zarin, director of ClinicalTrials.gov, the national

database that registers ongoing drug studies, told United Press

International that there appears to be an improvement among the drug

companies in providing key information since May 2005.

In her article, for example, she noted that Lilly did not have a

specific name in the field for " intervention name " -- the drug being

tested -- in 3 of 96 records through May 20. Since that time all 40

of the new studies registered by Lilly have had the name included.

GlaxoKline did not report the name of the drug being studied in

53 of 104 trials, through corrected six of those. " Since May,

GlaxoKline has registered 128 new trials, " Zarin said, " and all

but one of those includes the name of the drug being studied. "

Another key data point in the registry involves naming the " primary

outcome measure " -- in other words, exactly what the trial is going

to try to determine. " I think it would be somewhat difficult to

understand a study if we do not know what the primary outcome measure

it, " Zarin said.

Novartis has registered 239 trials between May 2005 and Oct. 11,

2005, but the nation's No. 6 drug company according to sales listed

the primary outcome measure in just eight of those trials.

In contrast, Pfizer, the nation's leading pharmaceutical company in

sales, listed the primary outcome measure in 99 percent of registered

trials -- 221 out of 224 in the same time frame.

However, Zarin noted that Pfizer still was negligent as far as

including the name of the drug being studied was concerned. Before

May 2005 the drug name was not specifically mentioned in 22 of 75

registered trials; between May and October 2005 Pfizer did not give a

specific name for the drug in 14 of those 224 trials.

Merck, the No. 4 company, had 120 of 132 trials that did not include

the specific drug name through May 2005. However, Zarin said that the

company corrected the records in all but one trial.

In the interim between May and October all 52 of the new Merck

registered trials included the specific drug name. But only 20

percent of those new Merck trials had a primary outcome described.

While the companies are legally required to register the trials, the

wording of the legislation allows the data to be obscured. " Based on

the law as it now stands, I could not say that any of the companies

have broken any laws with their registration filings, " Zarin told UPI

Friday.

ClinicalTrials.gov is part of the National Library of Medicine, which

in turn is a branch of the National Institutes of Health in Bethesda,

Md. The Food and Drug Modernization Act, section 113 mandates the

registration of all public and private trials that test effectiveness

for " serious or life-threatening " conditions submitted to the FDA

under investigational new-drug applications.

Zarin said that her article describing the statistics gathered by

ClinicalTrials.gov should not be viewed as a report card or as a call

for changes in the existing statues. " It's just our report, " she

said, inviting others to interpret it.

Drazen of the New England Journal of Medicine, however, did look at

Zarin's study as a report card and suggested that for some companies

the report would read " improved but could do better. "

He said that since many other drug companies were in full compliance,

it would undercut arguments that being transparent could not be

accomplished in a competitive world.

" We demand complete compliance, because trial registration makes

moral sense, " Drazen said. " When patients put themselves at risk to

participate in clinical trials, they do so with the tacit

understanding that their risk is part of the public record, not

merely the secret record of the sponsor. "

Copyright 2005 by United Press International. .