NIH Proposes Making Clinical Trial Data Free to Public
07 Sep 2004

USA - NIH on Friday proposed a "major policy change" that would make available at
no cost to the public the results of all NIH-funded research six months after the work
is published in a scientific journal, the Washington Post reports.

Scientific journals, some of which sell subscriptions for thousands of dollars,
currently retain control over the published information. The proposal, which NIH has
been considering for more than a year, would require federally funded researchers
to submit their papers to the agency after they have been accepted for publication
and edited by a journal, the Post reports.

The journals would be given six months to "profit from the work," which would then
be made available at no cost on NIH's Internet database, PubMed Central,
according to the Post.

While the scientific publishing industry has said that the proposal would force some
journals to go out of business and cause some scientific societies to declare
bankruptcy, even those opposing the move have said some sort of change in the
current system is "inevitable," the Post reports.

NIH Director Elias Zerhouni, who has held three meetings on the issue with industry
officials and patient advocates over the past six weeks, said, "The status quo is not
an option." According to the Post, the move, which could "trigge[r] a global open-
access revolution," gained "new momentum" recently with report language by the
House Appropriations Committee.

The report stated, "The committee is very concerned that there is insufficient public
access to reports and data resulting from NIH-funded research. This situation ... is
contrary to the best interests of the U.S. taxpayers who paid for this research." The
report advised NIH to create a system that would allow results to be "freely and
continuously available no later than six months after publication," according to the
Post.

Reaction

Roberta Arnold of the Radiological Society of North America said, "If the NIH has to
increase the size of its grants or make other major expenditures to implement a
new, open-access system, taxpayers will end up paying more money for less
research."

However, Zerhouni said that the industry's reaction was "way out of line" with the
actual costs of the proposal. Richard Roberts, a research director at New England
Biolabs and one of 25 Nobel laureates who recently signed a letter in support of
open access, said, "There's lots of free junk and advertisements for snake oil on the
Internet, but people can't get the good research unless they pay for it. That does not
seem right."

Roberts added that scientific journals would continue to attract subscribers because
NIH-funded papers only make up about one-third of the total research published
each year, and several publications feature analysis and commentary, according to
the Post. Alan Leshner, president of the American Association for the Advancement
of Science, which publishes the journal Science, said that the proposal addresses
"some of the concerns" publishers have expressed since the congressional report
was released and "appears to be a reasonable compromise."

Science is one of several journals that provides its articles to the public at no cost
12 months after publication. Sen. Arlen Specter (R-Pa.), who heads the Senate
appropriations subcommittee overseeing NIH, said he generally supports open
access and hopes a reasonable policy resulting from public input will soon emerge.

However, he added that no supportive language on the measure would be included
in the upcoming appropriations bill. The proposal is open to a public comment
period for the next 60 days (Weiss, Washington Post, 9/6).

Merck To Post Clinical Results on NIH Site

In related news, Merck on Friday announced that it plans to post all of its clinical
trial results "well before they are completed" on NIH's Internet registry of
experimental clinical trials in an effort to "expand the purpose and scope" of the
Web site and make it "the standard for the rest of the industry," the New York Times
reports.

According to Merck officials, the company already has posted the protocols for 46 of
its ongoing studies on the site, and it plans to post by the end of this month the
outlines of 50 more trials that are currently under way.

Merck plans to post links to the studies' results as they are published. According to
the Times, Merck "has a history of publishing clinical trials even when the results
reflected poorly on its drugs," while many other companies have "long declined to
make public" negative trial data (Harris, New York Times, 9/6).

GlaxoSmithKline last month agreed to settle a lawsuit filed by New York Attorney
General Eliot Spitzer that will require the company to post all of its clinical trial
results online by the end of 2005. The lawsuit alleged that GSK withheld data from
clinical trials that indicated the antidepressant Paxil is no more effective in
adolescents and children than a placebo and in some cases is more likely than a
placebo to cause suicidal thoughts (Kaiser Daily Health Policy Report, 8/27).

Merck Senior Vice President Peter Honig said, "Merck has long been committed to
publishing the results of all of our trials in a timely manner and now we're
strengthening that commitment." Honig added that more companies should make
their results public because "the perceptions of the pharmaceutical industry as a
whole are not healthy at the moment."

A spokesperson for Sen. Edward Kennedy (D-Mass.) said that despite Merck's
move, legislation on the matter is still needed. The spokesperson said, "A bill is
needed because voluntary measures by companies, while generally laudable, will
not produce the comprehensive information the public needs and deserves to
assess the safety and effectiveness of the medicines they take." Kennedy is
expected to introduce a measure requiring full clinical result disclosures as early as
this week (New York Times, 9/6). Rep. Henry Waxman (D-Calif.) is also working on
a government registry bill.

PhRMA Releases Plan

The Pharmaceutical Research and Manufacturers of America on Tuesday planned
to release its plan for a voluntary online registry that would include summary results
of most of its members' studies, including results not published in medical journals.

According to the Wall Street Journal, PhRMA's database, which would publish
results within a year of their conclusion, "goes well beyond the industry's efforts so
far" but is "certain to draw questions because [it] fall[s] short of what doctors and
other groups are requesting."

The database would feature only summaries of unpublished studies; would exclude
some data, such as early-stage studies and unfinished trials; and would contain
only trials completed after Oct. 1, 2002. PhRMA said most, if not all, of its members
will participate in the program, which would eventually be turned over to an outside
group such as a medical association.

PhRMA Associate Vice President Alan Goldhammer said the registry will "fill the
gap" and "increase the transparency of trial results." He added that the group is
open to expanding the amount of information available on the site, which is set to
launch Oct. 1.

However, PhRMA's proposal "in some ways promises less than what some
individual drug companies," including Merck, have already agreed to make public,
the Journal reports. David Fassler, a Vermont psychiatrist, said a voluntary registry
would not be effective.

"Without an enforcement mechanism, we can't be sure that the data will actually get
submitted and updated on a timely basis," Fassler said. The issue "will to come to a
head Thursday" at a "high-profile" congressional hearing on antidepressant trials
done on children and adolescents, the Journal reports. The American Medical
Association and a group of editors from major medical journals are expected this
week to give more detail on their separate proposals for clinical trial registries
(Wilde Mathews, Wall Street Journal, 9/7).

Kaiser Health
http://www.kaisernetwork.org

SOURCE: Medical News Today, UK
http://www.medicalnewstoday.com/printerfriendlynews.php?newsid=13022

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