BC Liberals Forced to Reinstate Wrongly Fired Therapeutics Initiative Employees

“Dr. Maclure is renowned for his expertise in use of data for evidence-based evaluation, and is engaged by the ministry as a confidential consultant … on research and evidence development,” said the statement from the ministry.

“I feel exonerated,” said Maclure, who’d sued the ministry for wrongful dismissal in 2012 after it dumped him and a half dozen others over allegations of conflict of interest, wrongful sharing of confidential data and other misconduct. “I am happy that my collaboration of more than 20 years with the Ministry of Health has been renewed and that all the issues which led to my lawsuit against the ministry have been resolved.” Indeed, the ministry paid tribute to Maclure’s previous contributions to “improvements in health data privacy protection,” demolishing the notion that he’d somehow been negligent in that area.

Ironically, news of the reinstatement came three days after Finance Minister Mike de Jong paid tribute to the Health Ministry for its contribution to balancing the budget by reining in spending on pharmaceutical drugs. Maclure, through long involvement in the independent evaluation of pharmaceuticals, was one of the architects of the Therapeutics Initiative, the university-based drug vetting program that is as loathed by private drug companies as it is admired by big pharma’s critics everywhere. ...

Brown earlier this year reinstated one of the other victims of the mass firing, senior civil servant Bob Hart. He got 18-months back pay and a statement that cited “the government’s continuing confidence in him, as a loyal and dedicated public servant.” Hart, like Maclure, had filed suit against the government. Speculation abounds that the Liberals will settle other outstanding suits arising out of the firings. But I’ve also heard that they are driving a hard bargain, a reminder that deep-pocketed government can ruin people financially as well as by reputation.

Maclure, Hart and the others endured serious strains on their personal lives, not just loss of earnings and reputation. But some of the damage from this affair is beyond settlement at any price.  PhD candidate and researcher Roderick MacIsaac was working as a co-op student in the pharmaceutical services division when he was fired in September 2012. The dismissal, just three days before the completion of his co-op, effectively terminated any hope of obtaining his doctorate. Four months later he killed himself by carbon monoxide poisoning. ...

The search of his computer also determined “he was working on a document he had created related to the events that were causing him significant stress.”

Family members say the document was a lengthy airing of his frustrations about the Health Ministry’s treatment of him. “He just couldn’t believe anyone could get away with doing something like this in this day and age,” MacIsaac’s brother in law, Doug Kayfish, told Cindy Harnett of the Victoria Times Colonist.

Back when this case first broke, the then minister of health Margaret MacDiarmid was only in her second day in the portfolio. Later she promised a fuller accounting. None was forthcoming before she was defeated in the general election.

Right after the election, her deputy throughout her time as minister, Graham Whitmarsh, was terminated with $250,000 in severance. Readers may recall that during an earlier stint as deputy minister of finance, he waived repayment of legal fees for the two ex-Liberal aides who pleaded guilty in the BC Rail case.

The Liberals gave no reason for the Whitmarsh firing, saying only that it was a “personnel matter” Ironically, that excuse was also the refuge taken by the Health Ministry Friday in explaining why current minister Terry Lake couldn’t possibly comment on the reinstatement of Maclure.

That justification is as inadequate as it is outrageous.

This affair damaged several lives and, arguably, destroyed one of them.

By the government’s own account, it began with an anonymous accusation, relayed to the Ministry of Health from the office of the auditor general. It included a lengthy investigation, some of it undertaken by people still in government, costing $3.4 million.

It raised questions about whether Maclure and the others were targeted for their involvement in the independent evaluation of pharmaceutical drugs in general and the Therapeutics Initiative in particular. By taking refuge in the excuse of this being “a personnel matter,” the minister fuels suspicions that he’s providing cover for something more sinister.

The cone of silence won’t do. The public is entitled to a full accounting of what happened, who among those still on the public payroll is to blame, what it is costing to settle and how to make sure it never happens again. Anything less looks like a coverup, plain and simple.

B.C.’s drug watchdog agency will again be reviewing what’s in your medicine cabinet after the provincial government announced Tuesday it would restore funding for the Therapeutics Initiative.

The surprise move is an about-face for the provincial Liberals, who cut the University of B.C.-based Therapeutic Initiative’s $1-million funding in half in 2010, before severing it completely in September 2012.

The TI will also regain access to crucial health data, which it lost a year ago after being swept up in a health ministry investigation into inappropriate data sharing between researchers. Seven government workers were fired but none worked for the TI. ...

Opposition leader Adrian Dix, who vowed during the spring election campaign that an NDP government would restore funding to the TI, argued the agency “saves lives and money.”

He accused the last two Liberal premiers — Gordon Campbell and Christy Clark — of undermining the TI for political reasons.

“Coming at a time when commercial interests often distort prescribing decisions, having an independent voice on these decisions is just very important,” Dix said.

“Now what’s needed going into the future is some stability so the TI can make up for lost time.”

In July, The Sun published an investigative story about the TI, a small agency of university scientists who study the safety and efficiency of prescription drugs offered through B.C. Pharmacare. It is one of the few independent drug testers in North America.

Longtime TI employees maintain pharmaceutical companies and people they influence have tried to shut it down since it was formed two decades ago.

The TI’s supporters insist the agency has saved patients’ lives and saved taxpayers money by analyzing drug companies’ claims that a new drug is better than older, cheaper brands. They also argue Health Canada’s testing of drugs at the national level requires thorough, impartial followup

The TI’s detractors, which include pharmaceutical companies, patient advocacy groups and some doctors, argue it has bogged down the drug review process and kept potentially helpful medications out of the hands of chronically ill British Columbians.

The Liberals struck a pharmaceutical industry-dominated panel in 2008 to review the NDP-created TI, resulting in the reduction of the agency’s role in B.C.’s drug-review system and an increase in the influence of doctors, patient groups and drug companies.

The current government is still conducting an internal review into the privacy breach allegations, and Lake would not give an estimated date for its conclusion.

Initially drug research in B.C. was halted, but as of Tuesday all will resume again, once contractors sign declarations they will use the data properly. Only four of 21 contractors have not yet signed the declarations.

All seven fired workers say they have done nothing wrong, and have filed wrongful-dismissal lawsuits or union grievances.

Earlier this month, the B.C. Coroners Service ruled one of the seven dismissed workers, a PhD student fired just before completing his government work term, committed suicide in December.

In June, B.C. Information and Privacy Commissioner Elizabeth Denham released a report that found on three occasions B.C. patients’ health data was shared with “unauthorized” people. She scolded the health ministry for “deficiencies” in how it safeguards its data, recommending it implement a privacy policy on the collection, use and disclosure of personal information for research. ...

The previous health minister said last year that the government had forwarded evidence to the RCMP, but Lake would not reveal whether that is still happening. Police have refuse to confirm if there is a criminal probe into the data breach allegations.

Drug companies and pharmacies donated nearly $600,000 to the B.C. Liberals over the past eight years — almost 14 times more than they gave to the NDP. Many of the big donors are among the most active lobbyists in Victoria.

Lake has repeatedly denied his government is influenced by the drug companies.

Last spring, The Sun contacted five drug companies, but all refused to grant interviews about the TI’s past or future.

This just in from the Ministry of Health, in response to my questions earlier in the week about that two-year-old ministry-sought RCMP investigation of various drug researchers and staffers. “It would not be appropriate for the ministry to comment on personnel matters … Questions about RCMP investigations should be directed to them.” The stonewall remains intact.

 

The provincial Health Ministry looks to be trying to mend fences with drug researchers and close the book on a scandal that’s dragged on for almost two years. A July 18 media release boasts that the department has rehired a “renowned” medical-data expert. 

But one academic told the Straight a “chill” remains over pharmaceutical investigations in B.C.

“Things will never go back to the way they were,” said Alan Cassels, a drug-policy researcher affiliated with the University of Victoria. “There is probably almost two dozen people who I think have been affected, whose research projects have been shut down, who have been blacklisted, who have had data access denied. So in my opinion, this fixes almost nothing.” ...

“The government has proven itself perfectly capable of shutting down important public-interest research,” he said. “If they’ve done it once, they can do it again.”

The Ministry of Health refused to grant the Straight an interview on the topic, as it has done for roughly the past 18 months.

Adrian Dix is a long-time champion of UBC’s Therapeutics Initiative, one of the academic bodies that was caught up in the ministry’s clampdown. In a telephone interview, the NDP MLA for Vancouver-Kingsway argued the public remains without an explanation for why the ministry reacted so severely to alleged misconduct that the province’s information and privacy commissioner deemed relatively minor.

“The damage at a personal level has been great; the damage to the system of drug evaluation, though, has been even more,” he told theStraight. “There was significant drug-evaluation capacity within the Ministry of Health and that has been permanently damaged by this.”

RCMP officers were blindsided by the B.C. government’s claim that they were investigating eight fired Health Ministry researchers, and never conducted a criminal investigation because the ministry never provided any evidence of wrongdoing, internal records show.

Mounties weren’t warned that Margaret MacDiarmid, who was then the health minister, would announce she had sent the case to the RCMP at the Sept. 6, 2012 press conference where she announced the employee firings, newly released emails show.

Despite claims from MacDiarmid’s ministry that its had “provided the RCMP with interim results of an internal investigation,” RCMP emails show the ministry simply gave “high level explanations of the allegations,” and that “the province’s investigation had not reached any conclusions that could support a criminal investigation.”

RCMP investigators tried five times over almost two years to get more information, but received none of the reports the Health Ministry had promised into what it had publicly billed as one of the biggest privacy breaches in B.C. history.

The Mounties closed the file on July 16, 2014, and informed the province. But it wasn’t until seven months later that the government publicly admitted it no longer expected police to pursue the matter.

The records, obtained by The Vancouver Sun through the federal Access to Information Act, show that the B.C. government repeatedly pointed to an RCMP investigation over several years, while at the same time doing virtually nothing to inform police about the case and failing to provide any evidence of a crime.

“Despite inferences in the media that the RCMP has undertaken an investigation or received information from the Province, this has not been the case,” wrote Const. Dean Miller from the RCMP’s Federal Serious and Organized Crime section, in a late 2014 report. “No tangible evidence or reports related to the allegations have been handed over. As such, no investigation has been initiated.”

NDP critic Adrian Dix said the documents “show a government that not just misled the public but misled the police. And it’s a very serious thing.”

The government “smeared” the reputation of the researchers by repeatedly lying about a police probe it knew did not exist, said Dix.

One of the researchers, co-op student Roderick MacIsaac, committed suicide after he was fired and it was suggested he was under police investigation.

An independent legal review last year concluded ministry staff botched the internal investigation, leaped to conclusions not supported by evidence and were unfair to accused employees.

The internal documents show the RCMP was reluctantly dragged in and wrestled with how to explain its role to the public.

Meanwhile, politicians kept mentioning the supposed police probe. At one point, the government even used the RCMP “investigation” as a reason to withhold public documents from a Freedom of Information request.

“Informing the RCMP of the matter was, I think, a responsible thing to do,” Health Minister Terry Lake told media, after announcing an apology to the MacIsaac family on Oct. 3, 2014. “It then falls upon the RCMP to look at it and see if it warrants further investigation.”

 But the RCMP had no information to review.

“At this point, we have stopped asking for the information and have concluded our file,” Sgt. Duncan Pound, an RCMP spokesman, wrote in an email to colleagues the same day as Lake’s comments. “To continue implying we are in contact with and potentially assessing the matter from a criminal perspective would be less than accurate.”

The B.C. Liberals, which received “major” political donations from pharmaceutical companies, suddenly halted drug-safety research that could have meant big financial losses for drug companies, alleges a new lawsuit filed Monday against the provincial government.

The allegations are contained in a lawsuit filed in B.C. Supreme Court in Victoria by William (Bill) Warburton – the fifth person to sue the Ministry of Health over a scandal in its pharmaceutical services division. Last year, seven people lost their jobs and several researchers – including Warburton – lost access to key health data, which was used to investigate possible harmful side-effects from some prescription drugs.

Four of those fired health employees – including Warburton’s wife, Rebecca – have filed wrongful-dismissal lawsuits. Two union employees have filed grievances. The seventh person, a PhD co-op student who was fired three days before his work contract ended, was found dead in December. ...

Bill Warburton’s lawsuit goes further than the other four in alleging a link between powerful pharmaceutical companies and the termination of the employees.

“Warburton’s research ... included investigation of harmful side-effects, including mortality, and risk assessment of drugs purchased by the Province through its programs, and had the potential of disrupting financially significant payments to large pharmaceutical companies,” says the lawsuit. The allegations have not been proven in court.

“The Liberal Party was receiving significant contributions from these drug companies, and the Province was eliminating drug safety programs that could cause restrictions on sales of the products of these drug companies ... and these actions includ[ed] ending drug analysis programs such as that of Dr. Warburton and of the Therapeutics Initiative at the University of British Columbia.”

The NDP has made the Therapeutics Initiative an election issue, by making a campaign promise to bring back the drug-review agency if elected to form government. ...

Warburton’s lawsuit denies the ministry’s claims that he attempted to obtain improper access to certain provincial data.

He claimed the ministry’s investigation was “flawed” and conducted by “inexperienced investigators,” and that press releases issued by the ministry about the scandal were defamatory.

“The Province’s acts against Dr Warburton are part of a bad faith program by the Defendants to end the investigation of harmful effects of drugs which risk leading to diminishing payments to their political contributors, and constitute misfeasance in public office as the Defendants were aware that their deliberate acts against Dr. Warburton were illegal and would likely harm him,” the document says.

Paul Webster provides a good overview in the Vancouver Observer of the BC liberal government’s gutting of public-service drug research and analysis in the province, including this admission from Premier Christy Clark about axing the Therapeutics Initiative:

Unplugging the Therapeutics Initiative, the premier suggested, was in keeping with her commitment to “a businesslike manner” in running the government. “We are managing the costs of drugs as best we can,” she insisted in language verging on doublespeak. “Since I have been Premier, we have lowered the cost of generic drugs for seniors. And we have done that by working hard with the pharmacies that provide those drugs.”

But the need to control drug costs has to be balanced with “respecting the private sector,” she explained. The attack on the teams that audit drug safety and spending, she seemed to want people to believe, was necessary in “supporting an economy that is growing, that is going to pay for the things we need.”

Clark appeared to be suggesting the TI was being sacrificed to appease private interests.

Which would be a fitting outcome to the TI’s history, starting in the years when Gordon Campbell served as premier and began whittling down the TI’s budget and scope.

In 2008, the Liberals -- anxious to encourage pharmaceutical research investments -- convened an industry-dominated Pharmaceutical Task Force to investigate the Initiative. Five members of the nine member Task Force had drug industry ties, including Russell Williams, Canada's leading pharmaceutical industry lobbyist. The Task Force swiftly concluded the TI (which had won international praise by issuing early warnings about Vioxx, a drug named in 27,000 lawsuits for injury or death) needed "replacing or reconstituting."

The Task Force was especially anxious to eliminate the Therapeutic Initiative's role in determining what drugs should be covered by PharmaCare -- a recommendation the government quickly implemented, notes TI’s Jim Wright.

B.C.’s Premier has finally commented about the RCMP’s investigation into the B.C. Liberals’ controversial Ethnic Outreach Plan.

Not much from Christy Clark while she was at a news conference in Toronto.

Last week, news broke that a Special Prosecutor and police were looking into whether the Liberals broke any laws in their so called “quick wins” plan to court the ethnic vote.

The investigations were prompted by a complaint made by Clark’s N.D.P. rival, Adrian Dix.

Today, Clark reiterated what her spokesman said in a statement, that Dix has the right to make such a complaint.

She says, “I have confidence that the RCMP are going to do the right job on this, investigate it thoroughly, and I certainly have no intention of interfering in anyway.”

Her office says no one from her government has been interviewed , yet, by police.

Bill Warburton, whose health ministry contract was cancelled in 2012 amid a spate of firings, says his research that used data from British Columbia patients shows that about 60,000 people now taking anti-psychotic drugs will die prematurely.

The finding is one example of the public interest research that came to an abrupt end due to a botched health ministry investigation, Warburton said.

In a phone interview, he noted that his research shows there is a two per cent increase in mortality for people who use second generation anti-psychotic medication to treat depression, a "huge increase," he said.

More than three million people take the drugs, he added.

"There are 60,000 people who are going to die needlessly because they haven't been warned of the side effects of these drugs," said Warburton, a health economist, who in late February presented his findings to a seminar at the University of Victoria.

Prior to the abrupt dismissal, Warburton had access to medical data from millions of B.C. patients and enjoyed many opportunities to present his research to the government for use in health policy. Now those opportunities are gone.

In his drug research, Warburton's research looked at the health of people who had been taking an anti-depressant drug before switching to either a different anti-depressant or to an atypical anti-psychotic. ...

"People taking the anti-depressants tended to die more quickly in the early years," Warburton said, speculating the drugs had a stimulating effect that caused heart attacks. In later years, however, more people taking the anti-psychotics died, likely due to circulatory or heart problems caused by the drugs, which are known to increase diabetes, he said.

"We figured that someone in the ministry got their wires crossed," Bill Warburton says about what started as an obscure misunderstanding but has ignited into a threat to province-wide medical safety. But after eight months of growing financial and emotional distress, he now believes he and his wife are ensnared in something far larger than a petty squabble over data management.

Alan Cassels, a UVic pharmaceutical policy analyst, sees distressing implications in the firings. "Most of the enterprise of drug policy research has ground to a halt in B.C.," he says. "Many of the research leaders within the government are gone." The affected scientists were all closely involved in staging major studies of physician prescribing practices, and the safety of a wide array of drugs, he notes. MacIsaac's work, for example, was to assess smoking cessation drugs including Champix, which PharmaCare began paying for in September 2011. Warburton was investigating antipsychotic drugs that are often used with little medical supervision in old folks' homes and are attracting increasing scrutiny. Mattson and Maclure were deeply involved with a major study of Alzheimer drugs that PharmaCare is funding pending the studies' outcome. Maclure was also investigating whether physician prescribing patterns are influenced by drug companies: in recent scientific publications he has probed the medical basis for the vast sums spent by the B.C. government and B.C. patients on drugs prescribed for diabetes, depression, and respiratory disease.

All of this research had the potential to seriously dent the international drug companies whose products were being investigated, Cassels says. "The Alzheimer drugs, especially, are expensive drugs with huge potential for market growth internationally that face important questions about effectiveness. The pharmaceutical industry really doesn't like people doing this kind of research because it's independent research, it's clean and hopefully objective, and they don't have control over the results. So you can imagine how much pressure there is to discredit it and perhaps even shut it down." Not surprisingly, no government official has publicly validated his theory.

So far, the government has revealed next to nothing about the results of the investigation into the confidential records, underway since last May. In September, Health Minister Margaret MacDiarmid issued allegations of misconduct in a terse press conference, saying that the RCMP had been asked to investigate. (When contacted by Vancouver Magazine she and other ministry officials refused to expand on those comments.) In an interview with Victoria's CFAX radio in mid January, however, MacDiarmid did say, "While on one hand we don't believe that anybody is personally in jeopardy because names weren't attached, it's still highly personal information....It's only been used for research as far as we know, and we just haven't found anything to indicate that it's been used for other than research." For their part, the RCMP are saying nothing; Corp. Darren Lagan, a Mounty spokesman in Victoria, won't even confirm they are investigating.

On average, every person in B.C. spends $575 a year on pills, which puts pharmaceuticals on par with the forestry industry-although with exponentially greater growth potential: government spending on the PharmaCare Plan-which pays for drugs for seniors and people with disabilities, and administers programs like the smoking-cessation regimen MacIsaac was reviewing-has increased roughly 30 percent since 2005, and the number of pills popped in the province is growing about 10 percent every year. The number of registered pharmacists in B.C. has risen by 23 percent over the past five years, in part because the variety of pills available to patients is so vast: more than 8,000 drugs are approved for use in the province, and PharmaCare covers over half of them based on detailed appraisals of their medical validity.

Provincial officials tasked with managing this vast pharmacopeia walk a fine line. Asserting budget and safety concerns in the face of pressure from the famously aggressive, powerful international companies presiding over the trillion-dollar global pharma industry requires enormous sensitivity. Deciding what drugs to include within the provincial drug plan, and how much to pay their manufacturers, is a high-pressure task that sees officials barraged with competing pressures from pharmaceutical companies, physicians, patients, and a plethora of public watchdog groups. Yet thanks to the 1996 creation of the PharmaNet database, which researchers use to help inform government healthcare policies, British Columbia has one of the most successful (and unsung) drug safety regimes in the world. PharmaNet uniquely includes records of every prescription filled in the province, so B.C. captures better data on pharmaceutical consumption than any other province or state in North America, explains Steve Morgan, a UBC drug policy researcher who has published a series of studies in recent years that validate the tens of millions of dollars invested in the program.

Among the findings that Morgan and his UBC colleagues have gleaned from the data is that 80 percent of the increase in drug expenditure between 1996 and 2003 (a period during which per capita expenditure on prescription drugs more than doubled) was explained by the use of new, patented drugs (dubbed "me-too" drugs) that copy cheaper existing drugs. Because the me-too drugs cost as much as four times more than the older drugs they mimic, they substantially raise pharmaceutical makers' profits. But few systematic benefits to patients are gained, Morgan emphasizes. "The rising cost of using these me-too drugs at prices far exceeding those of time-tested competitors deserves careful scrutiny," he and his colleagues concluded in a warning that sent a chilly message to the industry.

In his latest paper, Morgan revealed that while prescriptions were filled during 63.5 percent of pregnancies in B.C., "evidence on safety is limited for many of the medicines most frequently filled in pregnancy"-an unwelcome finding for the manufacturers of the drugs in question. And a 2011 study offered even broader advice to health policymakers. Based on a probe of pharmaceutical data alongside other healthcare data, he forcefully disputed the widely held belief that B.C.'s aging population is inflicting unsustainable costs on the system. After drilling into the data, he concluded that population aging contributes less than one percent per year to spending on medical, hospital, and pharmaceutical care. A major cause of health cost inflation, he suggested, is the rising price of pharmaceuticals. ...

There are few people who know more about B.C.'s passion for pills than Bob Nakagawa. A pharmacist by training, Nakagawa directed the Ministry of Health's Pharmaceutical Services Division from 2006 until last April, when he left the ministry to become registrar of the College of Pharmacists of British Columbia. (He was council president for the College in the late 1980s when he played a leading role in coaxing the province to establish the PharmaNet database.)

During his tenure running the ministry's pharmaceutical programs there were three highly publicized data scandals, including one that involved millions of personal files, yet while running the branch that governs PharmaNet Nakagawa never heard a word about the recent troubles that led the ministry to fire Malcolm Maclure, the Warburtons, and the rest. (He does acknowledge that according to his replacement in the branch, Assistant Deputy Minister Barbara Walman, the investigation began when he was still in charge.) And the news that Maclure was singled out "absolutely shocked" him, Nakagawa recalls. "I've known Malcolm for many years," noting that the two men helped structure B.C.'s drug pricing regime-a topic on which Maclure enjoys commanding international status. "He is the researcher in the world," Nakagawa says before adding that he's nonplussed as to why MacDiarmid fired Maclure: "From the outside looking in, we're not hearing very much," he laments. "People seem to think its nefarious pharma pressure. I don't know."

Tensions over the use of the PharmaNet data had been mounting for years, but in 2008 conflict openly flared after the provincial government-anxious to encourage pharmaceutical research investments-established the industry-dominated Pharmaceutical Task Force to investigate the work of UBC's Therapeutics Initiative, the province's leading drug research team. According to the nine-person force-five with ties to the drug industry, including Russell Williams, Canada's top pharmaceutical industry lobbyist-the Therapeutics Initiative (which won international plaudits by issuing early warnings about Vioxx, a drug named in 27,000 lawsuits for injury or death) needed "replacing or reconstituting." The task force was especially anxious to eliminate the Therapeutic Initiative's role in determining what drugs should be covered by PharmaCare-a recommendation the government quickly implemented, notes the co-managing director of the Therapeutics Initiative, UBC professor Jim Wright.

Seeking to put the situation in perspective, Nakagawa notes that many researchers express frustration with the ministry's unwillingness to grant scientists access to data-a point recently underscored by Elizabeth Denham, B.C.'s information and privacy commissioner. Last June, Denham met with a group of PharmaNet experts, including Dr. Bruce Carleton, a UBC pharmacology professor who, as chair of the Ministry of Health's Data Stewardship Committee, has significant influence over who gets drug data and for what purpose. In a report on the meeting's outcome, Denham concluded there is a "real and systemic" problem: "Researchers in British Columbia are simply not getting access to the health data they need to conduct medical research. This is unacceptable." Even more pointedly, in a passage that seems to address Carleton's role chairing the province's data committee, she complained of "data stewards with no efficient processes to approve data access requests and inefficient administration." ...

A data stewardship committee that overprotects the security of the data and a government that conducts witch-hunts that demolish scientific careers may wind up not protecting the public at all, but leaving us exposed to ever more drug safety disasters

A Greater Victoria drug researcher has dropped his lawsuit against the B.C. government but is pursuing a defamation claim against former health minister Margaret MacDiarmid.

William Warburton, a labour and health economist, lost his contract with the Health Ministry and access to health data, necessary for his employment, in 2012 as part of what the government said was a major privacy breach that it had asked the RCMP to investigate. Seven Health Ministry employees were also fired.

Warburton, who lives in Oak Bay, filed a lawsuit claiming defamation, breach of contract and interference with contract in May 2013. In court documents, he alleged that the B.C. Liberal government tried to silence him over fears that his findings on the harmful side-effects of drugs purchased by the province would shrink lucrative political contributions from drug companies.

He filed his notice of application to drop part of the case in B.C. Supreme Court on May 25, 2015. The final terms were hammered out with the government this week.

Warburton’s remaining defamation action is based on statements made by MacDiarmid, according to court documents. ...

The government has settled with six of the fired researchers, reinstating two and apologizing to the family of a third, co-op student Roderick MacIsaac, who killed himself months after he was fired.

The only other outstanding wrongful dismissal lawsuit was filed by Bill Warburton’s wife, Rebecca.

Rebecca Nunn Warburton was co-director of research and evidence development in the policy, outcomes and evaluation branch of the Health Ministry. She was suspended without pay on July 16, 2012, and was fired in October 2012 in a move she claims in court documents “was calculated by the defendants to inflict, and did inflict, emotional and economic injury.”

Bill Warburton, whose health ministry contract was cancelled in 2012 amid a spate of firings, says his research that used data from British Columbia patients shows that about 60,000 people now taking anti-psychotic drugs will die prematurely. 

The finding is one example of the public interest research that came to an abrupt end due to a botched health ministry investigation, Warburton said. 

In a phone interview, he noted that his research shows there is a two per cent increase in mortality for people who use second generation anti-psychotic medication to treat depression, a "huge increase," he said. 

More than three million people take the drugs, he added. 

"There are 60,000 people who are going to die needlessly because they haven't been warned of the side effects of these drugs," said Warburton, a health economist, who in late February presented his findings to a seminar at the University of Victoria. 

Prior to the abrupt dismissal, Warburton had access to medical data from millions of B.C. patients and enjoyed many opportunities to present his research to the government for use in health policy. Now those opportunities are gone. 

In his drug research, Warburton's research looked at the health of people who had been taking an anti-depressant drug before switching to either a different anti-depressant or to an atypical anti-psychotic. 

Atypical or second-generation anti-psychotics include more than a dozen drugs produced by various companies. At least five are used to treat depression and as a class they are among the top money makers for pharmaceutical companies. 

Premature deaths 

"People taking the anti-depressants tended to die more quickly in the early years," Warburton said, speculating the drugs had a stimulating effect that caused heart attacks. In later years, however, more people taking the anti-psychotics died, likely due to circulatory or heart problems caused by the drugs, which are known to increase diabetes, he said. 

The study did not include anyone diagnosed with a psychosis or who had been hospitalized for any reason. Warburton found that over a period of 10 years, the people who switched to the anti-psychotic drugs were more likely to die. 

Until a couple years ago Warburton had a $1-a-year contract that gave him access to B.C. pharmaceutical data that he could use in his research. 

That contract was cancelled in 2012 as part of a botched investigation that led to the firing of at least seven people, a freeze on drug research and the suicide of co-op student Roderick MacIsaac. 

Premier Christy Clark and Health Minister Terry Lake have apologized for most of the firings and the government has settled lawsuits or grievance claims with the majority of the workers. Two have returned to work for the ministry. 

But two wrongful dismissal and defamation suits remain before the courts. One is Warburton's and the other was filed by his wife Rebecca Warburton, a University of Victoria associate professor in the school of public administration who had been cross-appointed to the health ministry as a co-director of research and evidence development in the pharmaceutical services division. 

Bill Warburton's notice of claim filed in B.C. Supreme Court in 2013 said, "The province's acts against Dr. Warburton are part of a bad faith program by the defendants to end the investigation of harmful effects of drugs which risk leading to diminishing payments to their political contributors." 

Speed vs. knowledge 

Often, not much is known about the safety of a new drug when it first becomes available, Warburton told The Tyee. There is initial testing for safety, but not on a scale large enough to detect something like a two per cent difference in mortality, he said. 

At the same time, there's often a strong desire to make potentially helpful drugs available quickly to people who need them, he said. 

"The stuff that we were doing is needed because of the trade-off between speed and thoroughness with the initial safety protocols they have," he said. "Any small side effect can't be detected at the time of approval. You have to do post market surveillance for the safety of the public." 

B.C. shut that kind of research down in 2012 and to his knowledge is yet to restart it, he said. "Stopping it from being done altogether is reprehensible." 

A health ministry spokesperson said that access to data for research was restored in 2013. While the new process allows researchers to apply for access to data, it does not provide the kind of wide access Warburton and some health ministry employees previously enjoyed. 

"Researchers can now equally and fairly access the data they need for their research through population data and the Data Stewardship Committee," he said in an email, noting the process has been streamlined and made quicker. 

Adrian Dix, the NDP opposition MLA for Vancouver-Kingsway, said Warburton's revelation reveals how much research was lost when the health ministry fired the employees. 

"In addition to the lives that were damaged by the government's fiasco in the health firings, there was just a huge impact on research," Dix said. 

Warburton's research -- on prescribing anti-psychotics to children and to people in seniors' homes -- was significant, Dix said. "This is exactly the thing doctors and parents and other health care workers need to know, and that work was effectively stopped by what we now know was a dramatically flawed process." 

Research on drug effectiveness helps ensure the government doesn't waste money on medications that don't work, but also protects patients, he said. 

It’s worth noting that data breaches are not unusual. In response to a freedom-of-information request filed by North Vancouver-based journalist Bob Mackin, the B.C. government produced a list of 350 such incidents recorded between January 2, 2010, and December 31, 2012.

At the same time that the British Columbia health ministry was cracking down on alleged data breaches in 2012, it was actively discussing selling patient health information to private companies.

"This is what was happening concurrently with the process around the health firings -- a significant effort by the ministry to conceal the opening up of health information for private hands," said Adrian Dix, the MLA for Vancouver-Kingsway.

Referring to 32-pages of documents the government released recently through the freedom of information process, Dix said, "It's laid out pretty explicitly in there that was the direction they were going in."

The records include notes on meetings starting in April 2011 between representatives of the Ministry of Health and Life Sciences BC, an industry group whose members include drug and biotech companies. The industry sought access to personal records such as drug prescription information and the government's linked databases, claiming the data could help B.C. become a leader in clinical research. ...

"Life Sciences BC believes there are two opportunities to drive revenue, without compromising privacy," draft meeting notes from April 1, 2011 said. One was "gathering health outcomes data through post-marketing surveillance/patient studies in British Columbia."

The other opportunity to generate revenue was the "sale of aggregate data from BC's Health databases." Aggregate data is consolidated data relating to a number of patients, so that it can't be traced back to a specific patient. ...

The government was open to Life Sciences BC's idea at the time, according to the meeting notes. "The Ministry has interest in discussing this topic further, provided that PharmaNet data is used only on an aggregate basis, with no disclosure of any personal or individual information."

But in the background, ministry staff had serious concerns.

Senior research methodology analyst Deanna Amos and chief data steward Chris Norman drafted a Nov. 18, 2011 briefing note for Graham Whitmarsh (who was directly involved in the Therapeutics Initiative firings), then the deputy minister of health. "While Life Sciences BC identifies that their industry's primary interest is in aggregate data, their proposals speak to the value of data linking opportunities, which would not normally be contemplated with aggregate data," they wrote.

Amos and Norman questioned what kind of "linkages" Life Sciences BC hoped to make with the data and whether that would make it possible for researchers to identify individuals. ...

Whatever happened to Life Sciences BC's bid for data access, it is not front of mind for Terry Lake, who has served as health minister since June 2013. When The Tyee recently asked Lake for an update on the discussions with Life Sciences BC, he said, "I'm not aware they've been asking for greater access to data."

The NDP's Dix said it's ironic that the government was firing researchers who were doing work in the public interest at the same time that it was discussing selling data to private companies. "There was pushback in the ministry, for obvious reasons," he said.

Smyth: Government still refuses much-needed inquiry into tragic health-care researcher case ...

But even this idyllic retreat was not enough to protect Mattson from the emotional turmoil inflicted on him by the B.C. government. “I went through hell,” he said. “We all did. It was terrible. And it’s not over until we get all the answers.” ...

The workers were involved in researching prescription drugs for the Ministry of Health. The government said they were fired because of breaches in data-sharing protocols.

The government repeatedly said the RCMP was investigating, even though a full-blown investigation never got off the ground because the government didn’t supply evidence of criminal wrongdoing.

Eventually, amid a flurry of wrongful dismissal suits, the government apologized and said it had over-reacted with the “heavy-handed” firings. Most of the workers were reinstated and/or received financial settlements But, tragically, one of the people fired — University of Victoria PhD student Roderick MacIsaac — committed suicide amid his public humiliation. “Poor Roderick,” Mattson said, shaking his head sadly at the memory of his colleague. “He was a shy, sensitive person. He didn’t have a lot of family around. They destroyed him.” ...

When Mattson was fired, he was manager of a ministry program that researched drugs for Alzheimer patients, testing their safety and effectiveness and making recommendations about whether the provincial PharmaCare program should pay for them.

His nightmare began when a ministry manager quietly approached him at an Alzheimer conference in Vancouver and told him he had to return to Victoria for a meeting.

“They read a statement and advised that I was suspended without pay,” he said.

“I was then ushered out of the office … in a complete state of shock. I then had to go tell my wife that our income was gone.”

The government told him there would be an internal investigation into suspected data breaches and he would have an opportunity to defend himself.

“I went through three months of hell,” he said. “It was incredibly brutal in terms of the way they interviewed me. ...

In a termination letter, he was told he had arranged to give confidential health data to an unapproved researcher at the University of Victoria. But Mattson said he never gave any confidential data to the UVic researcher or anyone else.

He sued the government for wrongful dismissal and defamation. Last year, he reached an out-of-court settlement with the government, which admitted Mattson’s firing was “a regrettable mistake.” Though vindicated, Mattson said it didn’t make up for the trauma he and his family suffered. “I was under the care of my physician for depression,” he said. “I saw a counsellor. I was on antidepressants for a period of time.”

His wife, Linda, also suffered badly. “It was like our world dropped out from under our feet,” she said. “I started having anxiety attacks and had to go on medication.”

The worst part, Ron Mattson said, was the government’s frequent claims that a criminal investigation was underway. “I had the added pressure of basically being accused of criminal wrongdoing,” said Mattson, who is also a View Royal municipal councillor. “You get this feeling that people think you did something really wrong.”

The government eventually said no confidential data had been misused and the RCMP closed its file. A review of the mass firings by labour lawyer Marcia McNeil found the termination process was flawed, the workers were subjected to intimidation tactics and the employees were not given a fair chance to defend themselves.

But, perhaps most disturbingly, McNeil found a lack of documentation on the firings and no one in the government would take responsibility for making the ultimate decision to fire the workers. That’s why Mattson, and many others, are demanding a public inquiry. “We want this resolved,” he said. “Roderick lost his life.

“For the people to have faith that this can’t happen again, and for the public to have faith that their government is not lying to them, a public inquiry is required.” He is absolutely right. This tragic case cries out for a public inquiry.

But the government is refusing to hold one, the final indignity to the people who were harmed.