What
a difference a year makes. Twelve months ago Health Minister
Ujjal Dosanjh said he would never countenance an independent
drug regulatory agency in Canada. In January he said he
was "not completely opposed" to such a thing. By mid-February
he was "not unalterably opposed." Finally, at the month's
end, he announced a "whole new culture" in drug regulation,
including at the very least an agency to monitor drug
safety in children.
Other options on the table, said
Mr Dosanjh, include new legislation to force drug companies
to divulge research to Health Canada, a mandatory adverse
reaction reporting system, and most daring of all —
a proposal to make drug approvals conditional until
the product proves itself in the real world.
A recent slew of drug safety mishaps,
most notably revelations that rofecoxib may have been
responsible for fatal heart attacks in over 4,000 Canadians,
has finally drawn the government's attention to the
problem. Drug companies aren't revealing everything
they know about their drugs, and Health Canada has no
way of compelling them to do so.
Our
fleeting moment
At the moment, once a drug is on the market, it's almost
untouchable by regulators. Mark Bethiaume, director
of Health Canada's marketed pharmaceuticals division,
told the Globe and Mail that Health Canada can
demand all the data on a drug prior to approval, but
afterwards, "we can ask them to provide us further information
about safety concerns, and if they don't comply with
that, basically our only alternative is to withdraw
the product from the market." They have no legal powers
to enforce the handing over of trial data collected
after a drug's approval.
Last month, the Canadian Medical
Association Journal concluded that Health Canada
"failed miserably" over rofecoxib. Without the power
to enforce the handing over of data, they rely on the
goodwill of pharmaceutical companies who have no interest
in revealing their products' flaws.
Canada is hardly alone in its failure.
The New England Journal of Medicine offered similar
criticism of the FDA, who asked for cardiovascular data
on rofecoxib in 2000, but took "no" for an answer because
they lacked the powers to demand it.
Indeed, governments don't even
know what post-market research is being conducted, because
the manufacturers have no legal obligation to tell them.
Mr Dosanjh says discussions are underway at Health Canada
about ways to register all clinical trials, both pre
and post market approval.
This is a long overdue reform.
The need for a trials registry is underlined not only
by the COX-2 revelations, but also by the SSRI saga,
in which trials showing increased risk of suicidal behaviour
simply went unnoticed by regulators until a researcher
blew the whistle.
The best bet for improving transparency
is probably the embryonic drug trial registry being
put together by the World Health Organisation. Similar
efforts are underway in the United States, but face
a number of political roadblocks.
In the end, only an international
effort can keep tabs on the drug giants, who conduct
research on five continents. And only with American
cooperation can companies be compelled to disclose data.
Mr Dosanjh knows this, and the
first step of his reforming drive will be to meet with
his new US counterpart Mike Leavitt. The Health Minister
likely realizes there are limits to how far Canada can
push the drug companies on its own. Their profits here
are minimal compared to the pharmaceutical El Dorado
that is the United States. If Canadian regulations forced
them to disclose data that might harm their US sales,
it would make commercial sense for them to withdraw
their product from Canada. The only factor that could
change that equation is if the data was bound to be
outed in the States anyway.
In the past, Canada has compensated
for our weak position by relying on the FDA. If a drug
were banned in the US, it would inevitably be banned
here shortly afterwards. This policy may have been driven
by laziness and miserliness, but it worked while the
FDA worked. Now it appears the FDA is not working.
The celecoxib recent debacles have
caused a shake-up south of the border too, and the FDA
is urgently seeking new powers. Earlier this week it
asked Congress for authority to dictate label changes
for drugs, rather than having to negotiate a mutually
acceptable solution with the drug company. If it can
again become an institution capable of protecting American
patients, it will, by default, protect Canadians too.
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