Health Canada is keeping too many secrets in its drug
regulation process, charge physicians and researchers.
A recent commentary published in the Canadian Medical
Association Journal (CMAJ) has stirred up the debate
once again.
Authors Dr Joel Lexchin, a Toronto
emergency physician and professor of medicine and Barbara
Mintzes, PhD, a postdoctoral fellow in pharmacology
and therapeutics at UBC charge that Health Canada's
Therapeutic Products Directorate (TPD), the federal
authority that regulates pharmaceutical drugs and medical
devices for human use, is failing Canadians by not making
enough information available for health practitioners
and researchers to make informed decisions.
"A company will submit a number
of studies as part of the pre-marketing application,
including animal studies, laboratory studies, and clinical
studies for safety," says Dr Mintzes. "In Canada those
are considered confidential. So unless a company wants
to publish a study, it will stay secret — even
after a drug has been approved."
SUMMARY
OF DATA
In response to criticisms like these — some of
which have come from its own science advisory board
— the TPD has decided to publish more information
in the form of a Summary Basis of Decision (SBD) document.
The new document promises to outline the technical basis
of approval for a given drug, and was developed in collaboration
with over 100 doctors, pharmacists and representatives
from patient groups.
But after assessing two pilot versions
of the SBD, Dr Lexchin and Dr Mintzes maintain Health
Canada is still not going far enough. "[The SBD] does
not provide enough detail to make public the full scientific
evidence for a drug's safety and effectiveness, which
formed the basis for regulatory decisions," says Dr
Mintzes. "The scientific evidence that was used to approve
a drug — or, for instance, if there is new evidence
made available later on — should be made public."
The commentary examined three recent
cases (HRT, COX-2 inhibitors and SSRIs) "in which unpublished
data submitted to drug regulators contained important
clinical information that was either unavailable or
misrepresented within the published literature." Using
data available on the American Food and Drug Administration
(FDA) website, Dr Mintzes and Dr Lexchin were able to
unearth biases within drug reporting that they say would
have remained undetectable using the new SBD templates.
The authors contend that the FDA,
by comparison, makes much of this information available.
(In a response published in the CMAJ, Diane C
Gorman, Assistant Deputy Minister, Health Products &
Food Branch, challenges this claim, writing: "In fact,
the FDA ceased publication of Summary Basis of Approval
documents in 1994, opting instead to publish hundreds
of pages of redacted review information (ie with commercial
confidential information severed).")
But Dr Robert Peterson, director
general of the TPD, says these criticisms are premature.
"My thought to them is: hold that thought. Please wait
until we've begun to publish," he says, adding that
the SBD documents will start to appear early this quarter.
OUT
OF THEIR HANDS?
Dr Peterson maintains that ultimately the source of
any secrecy within the regulatory process goes beyond
the ministry and stems from the Access to Information
Act, a 1985 law that dictates, among other things, how
government will handle third-party information in their
possession.
"Health Canada officials are subject
to the same laws that other people are," he points out.
"In this instance, the Access to Information Act and
the jurisprudence that has been developed around that
through federal court decisions has directed what is
immediately releasable by government and what is subject
to approval by third party."
Changing those regulations at the
federal level would require legislative reform, and
a lot of time. He adds that several pharmaceutical companies
have already indicated their intention to voluntarily
make this data public domain, which he sees as a good
interim solution. "My personal opinion is all of this
should be in the public domain," he says. "The sooner
companies take the steps to simply release their information...
the better we'll be."
But he cautions that creating a
more open environment will bring about an information
overload that could be just as frustrating as the current
dearth. "The reality is we may be talking about 400-800
volumes of material that may have 400 pages per volume.
There is a very, very large amount of material submitted
in support of the application,"
he says. "There are very few individuals who are acting
for full disclosure who are seeking that type of presentation
of the material."
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