After spending nearly a year mired in bureaucratic red
tape, four Vancouver AIDS patients have been granted access
to experimental drugs TMC 114 and TMC 125. Dr Julio Montaner,
director of the BC Centre for Excellence in HIV/AIDS,
applied to get his patients the phase III meds through
Health Canada's Special Access Program (SAP) because they
were no longer responding to available anti-retrovirals.
Though he's pleased with the final outcome, Dr Montaner
has a bone to pick with Health Canada.
When he began the application process
last year, he had six eligible patients. By the time
the application was approved, one of them had died and
another had been admitted to hospital. Dr Montaner did
everything by the book, filing the initial request with
the SAP in April. They turned him down in August. "They
told me they weren't comfortable with us using the drugs
jointly because they had never been studied toge-ther,"
he says. He made an appeal. But it wasn't until he got
the public support of Health Minister Ujjal Dosanjh
and physician MP Hedy Fry that Health Canada contacted
Dr Montaner with another option — apply to an open
label trial for compassionate use.
He did. "They reviewed my request
within a day," he says.
Dr Montaner's experi—en-ce
with the SAP is rare, says Joanne Garrah, acting manager
of the program. "Ninety percent of requests are looked
after in a 24-hour time frame," she says. "We look at
the urgency of the request."
Ms Garrah explains that the SAP
provides a specific service — getting drugs to
patients who haven't responded to available treatments,
who are allergic to one or more of the ingredients in
conventional drugs or with rare diseases. The drugs
are usually approved for use in other jurisdictions,
like the US. "This is an emergency program," she specifies.
"The request process is initiated by physicians. In
some cases, usually in hospitals, pharmacists and nurses
can help coordinate the application."
"We use their services when we
don't have very good therapies for the condition that
we're treating and we're aware of others that might
work," says Dr Irving Salit, director of the immunodeficiency
clinic at the Toronto General Hospital. "I used the
SAP just the other day for an HIV patient with trichomoniasis."
When the standard treatment wasn't working, he turned
to the SAP for access to an alternative.
Dr Salit says the application process
is generally pretty easy, but it can be slow. "The problem
with the SAP is that you want the drugs immediately,
and you can't always get them." Dr Montaner's disgruntlement
is much more categorical. "It's not working. It's not
getting people access to drugs." His biggest beef is
with the endless bureaucracy; he insists the program
is in dire need of a major overhaul. "We need to have
superior instances of peer review," he suggests. He
would like to see physicians involved in the approval
process — as it stands now, the decision makers
at the SAP are bureaucrats, not doctors. He also believes
that the appeal process needs to change. "It's unacceptable
that the bureaucracy is allowed to work in isolation,"
he says. "I would expect there to be a higher court
[to deal with appeals]."
OTHER
AVENUES
The SAP isn't the only way to get experimental drugs.
Doctors can also enrol patients in open label trials
to appeal for compassionate use, as Dr Montaner ended
up doing. "These trials usually include drugs that are
close to being licensed," explains Alice Tseng, a pharmacist
at the Toronto General who helps get patients access
to these drugs, which are usually in late phase III
trials.
In order to take this route, physicians
need to submit an application to the Therapeutic Products
Directorate (another Health Canada department) and get
permission from the pharmaceutical company. Patients
will also need to sign a consent form. "There's a binder
full of information for each patient and physician to
sort through," says Ms Tseng. She admits that all the
red tape can be a deterrent. "I know of a primary care
clinic that found all the paperwork overwhelming," she
says. "They eventually hired someone to take care of
it for them."
Dr Montaner says though it worked
for his AIDS patients, he found the compassionate access
route a little tricky. "Things can get complicated,"
he explains. "In my case the pharmaceutical company
has given me access but the industry isn't always interested
because it can be a liability. Companies aren't generally
eager to offer compassionate access."
For more information on the
Special Access Program call 613-941-2108. To reach the
Therapeutic Products Directorate call 613-957-1483.
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