On behalf of Consumers Union, the independent,
non-profit publisher of Consumer Reports, we
write in strong support of the comment by the
Center for Science in the Public Interest.

In recent years, there have been repeated exposes
of publication bias, distortions, conflicts of
interest, and falsified data published in the
most prestigious of medical journals. Before
expanding the number of journals where
publication can be accepted in order to qualify
for coverage of the off-label use of drugs, CMS
must make sure that the highest ethical standards
are being met. Equally important, it is essential
that only publicly registered clinical trial
articles be accepted for publication. Only by
registering a clinical trial can researchers
determine whether the end points or length of
time for the trial have been changed in ways that
hide adverse data and exaggerate beneficial data.
The recent example of Paxil’s use among younger
patients is a classic example of how trials
showing that the drug was less useful than a
placebo and caused suicidality among young people
can be hidden.

We appreciate your efforts to ensure the rapid
coverage of drugs which can bring life-saving
help to some of our nation’s most severely ill
patients. To ensure that these drugs are honestly
presented to patients and their doctors—and that
taxpayers do not end up paying for drugs that are
(per the Paxil example) less useful than sugar
pills—we hope that you will insist on

--public registration of the trial in the
ClinicalTrials.gov data base prior to
patient enrollment, and

--public disclosure of any conflict of
interest by the researchers.

The recently reported abuses of medical journals
are so serious that we hope CMS will regularly
review all journals it accepts for off-label
coverage to ensure compliance with the above
minimum criteria.

Thank you for your consideration of these views.