UBC Reports | Vol.
50 | No. 11 |
Dec. 2, 2004
Can We Trust the Drug Companies?
The Therapeutics Initiative is working to get reliable data
to doctors and patients
By Hilary Thomson
Imagine you are a 75-year-old woman who has been taking a
daily drug to relieve arthritis pain. You’re shocked
to learn the drug just got pulled off the market worldwide
and you wonder if you can trust your doctor to know what’s
safe.
With the recall in September 2004 of Vioxx®, a top-selling
arthritis pain medication that was found to increase cardiovascular
problems, and a U.S. Congressional hearing into how the drug’s
safety was evaluated, a UBC initiative dedicated to disseminating
evidence about drug therapies couldn’t be more relevant.
Under the direction of Jim Wright, a professor in the departments
of pharmacology & therapeutics, and medicine, the Therapeutics
Initiative (TI) has been providing physicians and pharmacists
with up-to-date evidence on the effectiveness of prescription
drugs for 10 years.
In fact, the current issue of the group’s newsletter,
Therapeutics Letter, (which has a circulation of 10,000) addresses
the storm of uncertainty surrounding the class of drugs called
COX-2s. Used to treat inflammation, the class includes Vioxx®
and Celebrex®.
The newsletter focuses on COX-2’s product monographs
— legal documents written by drug companies to list pertinent
data, including potential benefits and harms. The newsletter
reported that the monographs do not adequately inform of harms
and that they provide insufficient information as to whether
COX-2s increase myocardial infarction or other cardiovascular
events.
“We’ve been looking at this class of drugs for
several years now,” says Wright, a faculty member since
1977. “Our work nearly always surrounds medications,
like these ones, that are widely prescribed but which have
uncertain therapeutic value. Our efforts frequently put us
at odds with drug companies.”
Started in 1994 with a five-year annual grant of $540,000
from B.C.’s Ministry of Health (MOH), the TI is now
operating on a three-year, $1 million per annum grant from
MOH. The group reviews evidence of effectiveness for drugs
prescribed for everything from male pattern baldness to depression
in children and adolescents, and is one of only a handful
of such groups in Canada.
In addition to provincial work, TI members also complete
one-quarter to one-third of the federal government’s
common drug reviews, a year-old process overseen by the Canadian
Coordinating Office for Health Technology Assessment.
“The main challenge in our work is getting to the
truth,” says Wright. “It’s been estimated
that about 90 per cent of the published literature is biased
by economic interests.”
Dr. Warren Bell, a general practitioner in Salmon Arm, B.C.,
says he uses the newsletter “for clarifying and interpreting
the relentless propaganda of the drug industry” and
adds that he has formed a number of prescribing practices
directly out of the pages of the letter.
The largest working group in the TI is the drug assessment
group, headed by Ken Bassett, a faculty member in the department
of family practice and the Centre for Health Services and
Policy Research at UBC.
Some of the 30 assessments completed annually are triggered
by new drug submissions to PharmaCare, the province’s
drug subsidy program. TI researchers review the submissions,
evaluate evidence of the drug’s therapeutic advantage
and report back to government and, in a summarized fashion,
to practitioners via the newsletter. Physicians and pharmacists
also learn of critically appraised evidence through annual
drug therapy courses and numerous interactive seminars.
The TI’s evaluation group measures the impact of these
education efforts on prescribing patterns and assesses how
drugs are being used. It also uses provincial health databases
to learn the impact of drug prescribing patterns on patient
health outcomes.
A challenge for the group is a perception that the TI may
not be independent from the provincial government’s
interest in decreasing costs of PharmaCare. Wright counters
by saying that TI reviews and reports to government don’t
include cost data and are limited to evidence of drug benefits
and harms derived from clinical trials. PharmaCare includes
TI reports as just one of the pieces of information it uses
to make funding decisions, he adds.
Internationally, many TI members are actively involved in
the Cochrane Collaboration. Named for Archie Cochrane, a British
medical researcher, epidemiologist and advocate of rigorous
reviews of health intervention evidence, the collaboration
is an international organization dedicated to making available
reviews of the effects of health-care treatments and therapies.
Wright says it’s currently not possible for groups
like the TI and the Cochrane Collaboration to get complete
data from all clinical trials conducted worldwide. However,
he does have a vision for greater access to reliable and unbiased
data.
“What’s needed is to get more people involved
in Cochrane, better access to data from all clinical trials,
more systematic reviews published and more countries providing
universal free access to the Cochrane resource,” he
says.
Many countries, such as Australia, Finland, Ireland and
England, make the Cochrane Library’s resources available
without charge. In Canada, however, only one province — Saskatchewan
— has paid for the licence. The federal government has balked
at a $500,000 annual fee that would make the library freely
accessible to all Canadians, says Wright.
For more information on the TI, visit www.ti.ubc.ca.
