Legislation is required to force pharmaceutical companies to disclose clinical trial information to Canadians, says Dr. Andreas Laupacis of the Canadian Expert Drug Advisory Committee (CEDAC).
Laupacis, who emphasized that he was speaking as an individual, told attendees at a recent Centre for Health Services and Policy Research conference that he is “enormously frustrated” by how long it is taking to bring more transparency to the system.
Pharmaceutical companies don't make complete information about the original trial protocols and outcomes available, he noted. “We see only a few outcome measures from a trial. Are we getting all the information about harm?”
CEDAC is an independent committee of 11 experts in drug therapy and evaluation who review the effectiveness and cost effectiveness of new prescription drugs. It makes recommendations to Common Drug Review members (including all the provinces and territories except Quebec) about which drugs publicly funded drug plans should list in their formularies, thus making them eligible for reimbursement.
“I lose sleep” over some of CEDAC's recommendations, Laupacis told the conference on national pharmaceutical strategies in February.
One such decision involved whether to list a new, very expensive cancer drug. No good randomized controlled trials had been conducted and the evidence to support the drug was based on some evidence of tumour shrinkage, not on patient outcome, he said. They decided not to list it.
The decision turned out to be correct, given problems with the drug that later became apparent, but the trend toward extremely expensive drugs has “made it much more emotionally difficult to sit on drug reimbursement committees … because one knows that no really means no” since most patients could not afford to pay privately for the drugs.
Laupacis also expressed frustration over the trend to shorter duration of most clinical trials, and the “glacial pace of change” in insisting on head-to-head trials, in which new versions of drugs are compared to already marketed drugs in the same class, instead of to placebos, so that relative benefit can be determined.
“Increasing openness by everyone is a necessary part of legitimate priority setting,” said Laupacis, who is chief executive office of the Institute for Clinical Evaluative Sciences in Toronto. “It is unfathomable to me why we don't insist on the release of all information about clinical trials.”
The need to set priorities and to make well-reasoned decisions about approving and funding drugs was underscored at the conference by representatives of the Canadian, British, Australian and New Zealand health care systems, all of whom are struggling to contain rapidly escalating prescription drug costs while ensuring the public's access to useful and safe drugs.
Expenditures on prescription drugs increased by 115% in British Columbia from 1995/6 to 2004/5; the population grew by only 10% during this same period, the province's deputy minister of health told the conference. Dr. Penny Ballem added that if current trends continue, health care costs will account for over 70% of the province's budget by 2017.
To help in priority setting, Laupacis spoke in favour of including lay members on CEDAC, increasing dialogue with the public about approval and funding of prescription drugs and publishing more “user friendly” documents explaining the committee's recommendations.
Sir Michael Rawlins, chair of the United Kingdom's National Institute for Health and Clinical Excellence, which has a 30-member citizens' council to help with priority setting, echoed the call for more disclosure. “We have to become much more aggressive to have the results of clinical trials available to us,” he told attendees at the conference, which was sponsored by the Centre for Health Services and Policy Research at the University of British Columbia.
Laupacis expressed particular concern about having to make listing decisions based on drug trials that have outcomes based on surrogate markers, rather than clinical outcomes in patients. “How are we to interpret surrogate markers? How valid are they?”
Rawlins told the conference that the surrogate marker issue “must be pursued … we need an international standard.”
Laupacis described drug policy in Canada as “a complicated mix of scientific evidence, judgment, altruism, self interest and politics, superimposed on a complex, semi-rational constantly changing overburdened system.”