Healthy Skepticism Library item: 14703

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Publication type: news

MacLeod A.
Pharma Reps Meet in Secret, Craft New Drug Approval Process
The Tyee 2008 Dec 1
http://thetyee.ca/cms/News/2008/12/01/DrugApproval/

Abstract:

Campbell government hosted closed meetings.

Full text:

The British Columbia Health Ministry hosted a second closed-door meeting on Friday for “stakeholders” — mainly representatives of big pharmaceutical companies — wanting to make changes to the province’s drug approval process.

The meeting at the Sheraton Vancouver Wall Centre was on how to implement the recommendations from the province’s Pharmaceutical Task Force report, written by a panel stacked with representatives of the drug industry, as the Tyee uncovered a year ago.

The task force’s report argued for economic factors to play a bigger role in decision making on what drugs will be available to British Columbians.

Critics feared the panel’s recommendations will be used to increase drug industry influence and gut the role of the Therapeutics Initiative, a group of University of British Columbia researchers who provide drug advice to the government, the Tyee reported in May. The TI reviews the best available science on any given drug to decide whether the evidence supports providing it.

“They’ve taken away the role of the Therapeutics Initiative and they’re replacing it with something else,” said NDP health critic Adrian Dix. Documents discussed at the meeting show no role for the UBC researchers, he said. “There’s no role in this drug review process for an initiative that’s internationally acclaimed.”

The TI has saved money for the government and the lives of patients, said Dix, and yet the BC Liberals appear to have scrapped it, even though UBC’s academic peer review of the TI is not yet available. “It’s very, very disconcerting.”

UBC’s head of orthopedics, Bassam Masri, chaired the review. The other three on the panel were David Henry, the president and CEO of the Institute for Clinical Evaluative Sciences in Toronto, Dalhousie professor emeritus Jean Gray and McMaster Univeristy professor Lisa Dolovich.

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“The review committee met on Oct. 30 and 31, and were expected to have their report ready within a few weeks, though it has not yet been released,” said Dix.

The process appeared biased from the outset, he added. “This was designed to get a result. They seem to have made a commitment to get rid of truly independent reviewing.”

Decisions still to come

A final decision has yet to be made, said Sean Beardow, a Health Ministry spokesperson. “I would say the government is committed to an evidence-based review process, which is what the Therapeutics Initiative is,” he said. “To the best of my knowledge, these are decisions that are still underway.”

Certainly the results of a similar closed-door “multilateral stakeholder session” on “the way forward” held on July 17 were unclear.

While Beardow provided a list of companies and groups represented at the November meeting, as well as an agenda, an earlier request for minutes and other information about the July meeting was not filled. Nor has an FOI request for related records been answered yet.

The Tyee, however, obtained copies of various documents related to the July meeting through other sources.

They include an eight-page draft white paper “for discussion purposes” that was distributed at the meeting, an attendance list, draft conflict of interest guidelines and a drug industry response to the meeting.

Ministry’s white paper

The white paper makes some nods to the people who want drug companies to have more of a say in decisions. “The Deputy Minister will submit to participate in an annual Stakeholder Accountability Session, with the first session to be scheduled for the fall of 2008,” it said. “Additional opportunities for stakeholder participation would also be built into drug review process.”

It outlines a way to reconstitute the current Drug Benefit Committee with a new Drug Benefit Council. The council will have “a minimum of two and up to three public members.”

It said, “When selecting potential candidates for public membership positions, the Ministry would consider individuals that can best represent the public at large. The intent is to provide a public perspective into the drug review process.”

While it might seem odd to put lay people onto a body that should be making decisions based on science and evidence, the government is pressing ahead. On Nov. 24 it put out a press release saying it is seeking three people to sit on the council.

The white paper also said the TI will be disbanded, at least sort of. “A Drug Review Resource Committee would replace the role played by the Therapeutics Initiative,” it said.

According to the documents discussed at the November meeting, the DRRC would be a sub-committee of the Drug Benefit Council, and would work with Drug Review Resource Teams to get expert opinions on new drugs.

Politics vs. academics?

There are clues in the July white paper that politics may play more of a role than academics, however, since the paper said “Members of the committee would be appointed by the health minister.”

Still, the paper argues the government would be broadening the decision making, rather than debasing it. The new committee would include drug economists and a role would be worked out for UBC so there is no shift from evidence-based decisions, it said.

The paper is silent, however, on whether that means continuing to fund and work with the TI, or if it would mean working with more industry-friendly people on the faculty.

The paper also suggests speeding up the time it takes to make decisions on drug approvals. It now takes between nine and 18 months to approve a new drug, it says. New targets would make nine months the standard, with 12 months allowed for “complex” decisions. For “priority” decisions, the targets would be between seven and 10 months.

A four-page briefing note “to update the Rx&D Regional Team” on the July meeting expressed some displeasure with the progress at that point. “The White Paper does not represent substantial changes over the current Drug Review process,” it said. “The timelines for the drug review (9-12 months) offer minimal improvement.”

Nor does the white paper cut UBC and the Therapeutics Initiative out of decision making, the briefing note said. “As the White Paper currently stands, the drug review process and the advisory role of the TI will not be substantially changed from the current process.”

Pharma industry’s ‘next steps’

Also, the industry response said, draft conflict of interest guidelines were too strict and were described as “very restrictive and would only allow for TI-type people to advise the Drug Benefit Council.”

They would, it said, “effectively preclude the participation of most clinical experts and many members of the public.”

Aside from the normal guidelines around financial interests related to decisions the council makes, the draft policy obtained by the Tyee includes this clause: “Personal conflict may arise when a participant or a family member suffer from a condition which could be treated by a drug being considered by the DBC.”

A strict reading of the policy would mean someone whose grandmother has arthritis would be considered to be in a conflict if the council were considering approving a new treatment for the disease.

The industry briefing note also looks at who the leaders within the government will be as changes are made. Interestingly neither of the two co-leaders, David Morel nor Dan Doyle, comes from the Health Ministry.

Morel gets the job with an “economics background with recent experience in the Ministry of Forests and Premiers Office.” Doyle is a former transport deputy minister and “procurement expert credited for his role in ensuring on-time, on-budget construction of 2010 venues.”

Anticipating a final decision on the recommendations by Christmas, the industry note listed “next steps” including “debriefing with” drug industry representatives and doing more research on government decision makers.

The same industry note also raised the possibility of holding “political meetings”.