E-drug: ICH guidelines on control groups in clinical trials
---------------------------------------------
E-druggers:
Recently we submitted comments to the U.S. Food and Drug
Administration on an International Conference on Harmonisation (ICH)
document on the choice of control groups in clinical trials. The
document is in significant part an attack on active-controll
http://www.citizen.org/hrg/PUBLICATIONS/1503.htm
We urge those of you in Japan and Europe (the other participants in
ICH), in particular, to bring these comments to the attention of the
appropriate drug regulatory authories in your countries.
Below are excerpts from our letter.
Peter Lurie, MD, MPH
Deputy Director
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, DC 20009
Phone: (202)588-7781
Fax: (202)588-7796
Email: plurie@citizen.org
Web address: http://www.citizen.org
---------
To whom it may concern:
The Draft Guidance on Choice of Control Group in Clinical Trials,
prepared as part of the International Conference on Harmonisation
(ICH), is a clear attempt by the Food and Drug Administration (FDA) to
spread its pro-placebo-controlled trial ideology participated in April of
this year. Dr. Robert Temple, Director of the FDA's Office of Medical
Policy, stated at the meeting, "And people do active control trials in
Europe all the time. Europe is finally getting the idea that they need to
add a placeb employee(2),(3),(4),(5) and would take on added force if
this poorly thought-out Guidance were finalized and adopted by other
ICH countries.
The zeal to expand the use of placebos in clinical trials has resulted in
a document that is so unbalanced that its credibility is undermined.
The structure of the document reflects that bias:
* An entire section (section 1.5) is devoted to attacking
active-controlled trials; there is nothing similar for any of the
other study designs, even clearly weaker designs such as
historical controls.
* This section attacking active-controlled trials actually precedes
the detailed descriptions of the types of controls, so the reader
is poisoned against active-controlled trials before he or she even
learns fully about them.
* The purported weaknesses of active-controlled trials are
mentioned repeatedly, leading to an extremely redundant and
tedious document.
* Ethical considerations are treated as subordinate to supposed
data collection needs; ethics does not even appear in the critical
Table 1, which describes the attributes of the different trial
designs. The question onfronting researchers is not an provide
the most useful data while maximizing the protection of
patients?" When ethical concerns are quite literally out of the
picture, researchers will be led to the first question instead. The
Draft Guidance is a transparent attempt to legitimi
In addition to its attempts to water down the existing ethical codes,
the document places undue emphasis on the supposed needs of
regulators and pharmaceutical companies (who together make up the
ICH) and places these above the needs of patients or phy existing
drug. But the proposed Guidance would drive clinical trials in the
opposite direction. While this may make things easier for regulatory
bodies, which can approve drugs simply on the basis of superiority to
placebo, and to the pharmaceutical in
[snip]
In summary, this Draft Guidance is a remarkably biased description of
the advantages and disadvantages of various clinical trial designs. The
document continues the FDA's longstanding assault on
active-controlled trials and does so at a time where there is less
clinical and ethical justification for such trials than ever. Rather than
challenging investigators to obtain the best possible data using an
ethical design, the Draft Guidance subordinates these ethical concerns
to the reflexive tendency of some researchers to prefer
placebo-controlled studies, to the short-sighted interpretations of drug
regulatory authorities bent on approving any drug as long as it is
somewhat better than nothing, and to the concerns of the
pharmaceutical industry.
Yours sincerely,
Peter Lurie, MD, MPH
Deputy Director
Public Citizen's Health Research Group
Curt Furberg, MD, PhD
Professor
Wake Forest University School of Medicine
Sidney M. Wolfe, MD
Director
Public Citizen's Health Research Group
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.