The door is now open to add pharmaceutical industry reps to the panel reviewing new drugs for use in B.C. That builds in conflicts of interest, will raise risks to patients and could cost taxpayers more, say the NDP health critic and a drug policy researcher.

But the Campbell government defends its controversial revamping of the drug review process, which used to be under the control of Therapeutics Initiative, an independent agency founded in 1994 at UBC. The time had come, a spokesperson told The Tyee, for a "more integrated" approach.

Alan Cassels, who researches drug policy at the University of Victoria, said integrating pharma industry reps into the decision making process about which drugs are safe and effective could put patients at risk.

"If conflict of interest further infects the system," he told The Tyee, "it's going to be more dangerous to go to the pharmacy in this province. A system that will allow professionals who work for the pharmaceutical industry to weigh in on drug review is just wrong."

Cassels said the drug review process ought to be impartial. Just as the justice system excludes potential jurors who are linked to the judge or prosecutor in a case, the drug review process should stringently exclude those who are linked to the industry.

Conflict rules loosened by task force with industry reps

The concern about conflict of interest standards is prompted by the recommendations of a blue ribbon panel appointed by the Campbell government, the Pharmaceutical Task Force, which critics argued was packed with lobbyists and stakeholders from the pharmaceutical industry.

The task force called on the government to "reform" the provincial regime for reviewing drugs to be used in the B.C. system by eliminating the drug review and education functions of the Therapeutics Initiative.

The Therapeutics Initiative was founded with a mandate, according to its website, to "provide physicians and pharmacists with up-to-date, evidence-based, practical information on prescription drug therapy. To reduce bias as much as possible the TI is an independent organization, separate from government, pharmaceutical industry and other vested interest groups."

The Therapeutics Initiative has been widely credited with saving hundreds of B.C. lives by its cautionary reports on potentially dangerous drugs like Vioxx and Avandia, and with saving the province millions of dollars in unnecessary pharmaceutical purchases.

Its reputation for impartiality and professional neutrality has been buttressed by its stringent conflict of interest rules, which require all potential participants to declare any connection by themselves or their family members with pharmaceutical companies. The Therapeutics Initiative bars anyone with such a conflict from being part of the review process.

But all that will change under the new drug review regime.

Declaring conflict won't insure exclusion

The rules governing the bodies that will replace TI's role in provincial drug review are much more permissive, potentially allowing those involved with the companies that create new drugs to be involved in drug review decisions. The key passage in these looser rules reads: "Individuals who declare possible conflict of interest information are not automatically excluded from participating in the drug review process."

This looks dangerous not only to Cassels but to NDP health critic Adrian Dix, who called the changes in conflict of interest rules the latest move "nine years of attack on the Therapeutic Initiative" by the Campbell government.

"Just look at what they did with the Task Force," Dix said, "putting the province's chief pharmaceutical lobbyists on it. The orders for that had to come from the premier's office."

Industry types dominated task force

One of the pharmaceutical industry lobbyists Dix was referring to, of the five with industry ties who made up the majority of the nine member task force, was Russell Williams, head of the nation's most significant pharmaceutical industry lobby group, Canada's Research-Based Pharmaceutical Companies (Rx&D). Rx&D is a national lobby group based in Ottawa, with members from 50 drug companies. The directors include the presidents, CEOs and other top officials from 14 of the country's biggest drug manufacturers.

Another, the task force chair Don Avison, sits on the board of Lifesciences BC, a lobby group representing dozens of drug firms in the province. From 2005 until 2008, member companies of Avison's group were major donors to the BC Liberals. Last November, Mr. Avison went to work for Pfizer, the world's largest drug manufacturer.

The Tyee asked to speak with Kevin Falcon, B.C.'s health services minister, about criticisms of how his government is changing the drug review regime. He had communications staff at his ministry respond.

BC Liberals defend new review process

In response to questions about the new and looser rules on conflict of interest, the ministry staff said:

"The Drug Benefit Council (Ministry) guidelines were developed to ensure that all individuals involved in the drug review process report any and all potential conflicts of interest prior to being considered for any involvement in the review process. The Drug Resource Review Committee (DRRC) is responsible for administering the guidelines and carries out an objective independent review to determine whether these conflicts should preclude reviewers from participation in the process. This is done on a case by case basis." 

"Eliminating every participant in the review process (whether it be a physician conducting a clinical practice review or patient advocacy group providing input on a proposed drug for example) that has any conflict of interest could eliminate the best resources. In some cases the DRRC may decide that the conflict is not relevant or that there is no expertise available that is free of conflict. In other cases, the reviewer may have a conflict for one assignment and not the next. So, a case by case application is essential."

Asked about the widely held view that the Pharmaceutical Task Force that loosened the conflict of interest guidelines was packed with pro-industry figures, the ministry staff told us:

"The Pharmaceutical Taskforce was made up of government policy makers, academics and pharmaceutical industry members. It was important to take an integrated approach.

"The Task Force heard presentations from a wide range of organizations and stakeholders. They then presented recommendations to government on how to provide the best quality health care for patients, while ensuring the best value for taxpayers."

Ministry staff say 'criticism' motivated changes

Earlier this month, Minister Falcon told a Kamloops radio station that "the academic drug review done by the Therapeutics Initiative would be more economical than an open bidding process," according to ministry communications staff.

That view is shared by the NDP's Dix, who has characterized the new system as both overly cumbersome and overly expensive. Many international experts also have stated their support of the Therapeutics Initiative.

However, the ministry staff said: "The drug review model needed to be changed because the ministry faced criticism for relying exclusively on the Therapeutics Initiative for these types of reviews."

The Tyee contacted Dr. James Wright, the head of the Therapeutics Initiative to ask about the contrast between conflict of interest standards at his organization and those at the Ministry of Health Services. Dr. Wright declined to comment.