Life Saving Drug Watchdog May Be Scrapped

A panel stacked with people connected to the drug industry has told the Health Ministry it should get rid of a group of independent researchers whose advice has saved hundreds of British Columbian lives and millions of taxpayer dollars.

Health Minister George Abbott said he accepts the panel's recommendations, and the independent research group the Therapeutics Initiative at the University of British Columbia will at least be altered.

Critics say the minister and the report, which also attacked generic drugs while ignoring many of PharmaCare's biggest expenses, are pandering to the interests of the brand-name drug companies and Liberal party donors who were represented on the task force.

Abbott said it was likely the government would keep the Therapeutics Initiative model, but phase it into another drug review committee with other "stakeholders" represented. Those stakeholders would not include drug company representatives, he said. The panel's report suggested including members of the public on the committee.

"We haven't made a decision yet on that," he said. "I think it's fair to say what we'll see will be a transformation or an evolution of the TI process to make it first of all more transparent and more timely in its decisions, and more inclusive in terms of the number of qualified professionals who might be a part of that process."

NDP health critic Adrian Dix said the report and Abbott's acceptance of the panel's recommendations will one way or another mean the end of independent advice from the Therapeutics Initiative.

Panel stacked

"The pharmaceutical industry has wanted to get rid of the Therapeutics Initiative for an awfully long time," Dix said. "It's breathtaking they had the audacity to do this."

The task force included the industry's top lobbyist Russell Williams, the president of Canada's Research-Based Pharmaceutical Companies (Rx&D) -- a national lobby group based in Ottawa with members from some 50 drug companies and whose directors include the presidents, CEOs and other top officials from 14 of the country's biggest drug manufacturers.

At least five of the task force's nine members had close connections to the industry, as documented by The Tyee in November. The government's announcement listed the chair, Don Avison, as a representative of the University Presidents' Council, while failing to note he also sits on the board of LifeSciences B.C., a lobby group whose members include dozens of drug companies.

"I just think it's sad the pharmaceutical industry got what it wanted and they were on the panel and people who should have been protecting the public interest in that debate were not," Dix said.

"This private deal to get rid of an agency they didn't like. I just think that's wrong," he said. "It's a message to agencies that if you're too tough on industry and if you're too strong in protecting the public interest, that you'll be the target for similar action."

Director optimistic

The managing director of the Therapeutics Initiative, Jim Wright, said the report is contradictory, and once the government takes a closer look, it will realize the value of keeping the group.

At one point, the report says decisions on what drugs PharmaCare pays for should be made by people who have no conflicts of interest, but elsewhere it says "stakeholders" should help make those choices.

"You can't have both. It doesn't really hold together and make sense in terms of those two things."

There's still time for the government to do what's right, he said. "I'm still optimistic that the way forward will be done in a rational way," he said. "All we've been is an independent group that provides some advice. We're not the process."

That advice is needed, he said. "When you're dealing with any commodity that's heavily marketed, you need a trusted source that's looking at the benefits and harms from an independent perspective," he said. "It's particularly true for drugs."

Doctors are well meaning, he said, but they need information from a group like the Therapeutics Initiative to keep them current, he said. "Doctors aren't an independent source, unfortunately. They don't have the time to look into the evidence and they do often have a close relationship with the drug companies."

UBC's faculty of medicine is preparing to do an academic review of the Therapeutics Initiative, he said, and he welcomes the government to take a look as well. The pharmaceutical task force spent just a few hours with four members of the Therapeutics Initiative before writing its report.

"This is certainly not a definitive report by a representative task force," said Wright. "Why doesn't the government look carefully at what we do, because they certainly haven't done that.... We'd be open to a thorough, fair review and assessment."

Saves money

The government will need independent advice, he said, no matter how it decides what drugs to pay for. "There's nobody else who'd be able to take that over. It would take four or five years to set up another group that can do what our group can do. It's a very complex process."

Asked about whether his group makes its assessments fast enough, he said, "I don't think we're the major hold up."

He'd be open to making minor changes to accelerate the process, he said, but added that comes with much risk. "Do you want it to be rigorous or do you want it to be fast? It's always a balance. I would never want to push it to a degree where you can't do it properly."

Wright said he is proud of the Therapeutics Initiative's track record. For $1 million a year, a relatively small amount of money, the government gets the advice of around 30 researchers. While it's hard to say how much money that advice saves the government -- some estimates put it at $50 million a year -- it is clearly a lot.

"We've helped the government save much more than what we cost," Wright said. "We can do for a very small investment an awful lot."

Lives saved

The advice of the Therapeutics Initiative also saves lives. For example, the group warned the B.C. government in 2001 about the painkiller Vioxx three years before Merck & Co. pulled it from markets around the world because it increased the risk of heart attacks and strokes.

The company continues to fight battles in court stemming from rushing Vioxx onto the market. This week, it paid out $58 million in settlements for downplaying the drug's risks in its advertising, and is expected to pay another $4.5 billion to settle tens of thousands of lawsuits related to the drug.

In B.C., thanks to the Therapeutics Initiative warning, fewer people received Vioxx. Drug policy researcher Alan Cassels, who in the past has done work for the group but does not presently, said that advice likely avoided 600 deaths in the province and saved the government millions of dollars.

"I think Vioxx should be a reason to look at the way drugs are approved," said Wright. If thousands of people were killed in a plane crash, there would be an investigation and a chance to learn from any errors, he said. But when a drug kills that many people, nobody is looking to see who made mistakes and why.

"It's a reason we need to go back and say, 'Should it have been approved in the first place?'" he said. "If they made a mistake they shouldn't have, how often are they making it? It's probably quite common."

Vioxx unusual: minister

Health Minister Abbott said the drug approval process has many stages and generally works well.

The process includes the Common Drug Review, a national body that assesses how well drugs work, he said. "Before the Common Drug Review ever looks at the efficacy of a drug, it is assessed by Health Canada for safety," he said. "And typically before Health Canada ever sees it, it has often gone through some safety review process in the United States and Europe.... There's some evidence base before we ever see it in Canada."

Asked about what was learned from Vioxx, Health Minister Abbott said, "Vioxx is a good example of where obviously the approval process had failed. I think they largely failed in the United States and there was probably too much dependence on those studies by other jurisdictions."

He said, "I'm sure on occasion there will be drugs that should have had greater scrutiny, but I don't think that's typically the situation."

In other cases, he said, a rapid approval is appropriate. People who had certain forms of breast cancer were pleased to get access to Herceptin fairly quickly, he said. B.C. was one of the first provinces to approve it. "Herceptin would be a good example," he said. "The very prompt approval of Herceptin, I can tell you, was greatly appreciated by that particular disease category and the people who had it."

Evidence suppressed

Wright said Herceptin is an ironic drug for the Health minister to pick as an example. The medical journal The Lancet reported just last week that the company only published the results of trials that were favourable, making the drug look three times more effective than it really was.

Asked whether Vioxx was an unusual case, drug researcher Cassels listed off the names of half a dozen drugs that are approved elsewhere, but where the harms likely outweigh any benefits. "There's a long list of drugs which are strictly controlled in B.C. because they are marginally effective and have safety issues."

He called the task-force report "stupid," and said the recommendations are against the best interests of patients and taxpayers. "It's going to be more dangerous to go into the pharmacy," he said. "This is a government that has a very fine record of evidence-based drug policy, and they've thrown it out the window in favour of marketing-based drug policy."

B.C. has been a model for controlling drug prices, he said, and he figures that's why the industry wanted to strike the task force and make these changes. "They want to limit the spread of evidence-based medicine," he said. It's shameful the province would play along, he added. "They didn't realize what a political liability this is going to be," he said. "This is a complete undermining of our pharmaceutical policy in B.C."

Related Tyee stories:

• What Should We Pay for Drugs?
  Critics say BC's new pharma panel, stacked with drug firm reps, may erode safety, raise costs.
• Drug Firms' Sway over BC's New PharmaCare Task Force
  Most panel members have strong links to drug industry.
• BC Health Advice: Censored and Skewed?
  Libs cancel a critic, open door to pharma lobbyists.