Ministry of Health carpet-bombs drug safety monitoring
The tragedy of Roderick MacIsaa
• Unanswered questions around the death of a Ministry of Health employee might hold some clues to the biggest scandal to ever hit BC’s drug evaluation system.
Linda Kayfish’s voice weighs heavily with exasperation as she speaks to me about her brother Rod. He was the only family member she had left and he died in December 2012, three months after having been fired from a co-op position at the BC Ministry of Health.
Last summer, he and other employees involved in evaluating drug safety in the BC Ministry of Health were told of an investigation into alleged wrongdoings. Since then, a massive inferno of scandal and mystery has engulfed the Ministry of Health Pharmaceutical Services Division (PSD). The death of Roderick MacIsaac is just one more inexplicable flame.
“Why do we have to wait so long?” Linda asks me, frustrated because there are no answers and because it’s clear to her no one is in any hurry to supply them.
This story involves a dizzying array of actors: The BC Coroner, the RCMP and the Privacy Commissioner. They are all part of “ongoing investigations” along with the BC Ministry of Health, which is facing a series of lawsuits and grievances from employees who are suing the organization for wrongful dismissal and defamation.
So far, nine people have lost their jobs – most of them terminated suddenly – and several contractors have had their contracts cancelled with no explanation. A number of important drug safety evaluations have been halted, studies that were trying to determine whether a number of widely prescribed and very profitable drugs for the companies that make them are harming us.
It all started on March 28, 2012, when a complaint was filed with the BC’s Auditor General about the way contracts were being awarded and how research was being conducted within PSD.
PSD oversees annual spending of $1.2 billion on pharmaceuticals, the fastest growing of all areas of health spending. This growth is fuelled by unrelenting pressure from pharmaceutical companies that strive to ensure their products are generously covered by the public purse.
Roderick MacIsaac was a student at the University of Victoria working on a PhD in Public Administration and examining the safety of a handful of drugs used to help people quit smoking. One of the drugs he was studying was the controversial drug Champix, which carries serious warnings of risks of heart attacks and psychiatric effects. Rod worked with a small evaluation unit within PSD, a handful of economists and data analysts under the direction of two academic researchers who helped them design and facilitate drug evaluations. In the course of this work, the evaluations could show that some medications are not doing what their manufacturers’ claim and may, in fact, be shown to be killing or injuring people.
The Ministry of Health created a team of government investigators to try to “examine financial controls, contracting, data management and employee/contractor relationships.” By mid-summer, the PSD’s head, Assistant Deputy Minister Barbara Walman, suspended without pay a handful of employees alleging misuse of health data and contracting methods, but there were no specifics. Other drug evaluators had their data access suspended and were left in limbo.
All drug safety evaluations carried out by the UBC-based Therapeutics Initiative (TI) were halted. The TI has been an independent voice on pharmaceuticals since the mid 1990s, with an international reputation for its meticulous and thorough drug reviews. Because it couldn’t be bamboozled by the pharmaceutical industry, over time, the TI became Big Pharma’s Enemy #1 in BC. Five years ago, the reigning Liberal government created a “Pharmaceutical Task Force” to review the activities of Pharmacare and stacked it with people with pharmaceutical industry ties. Its main conclusion? Dismantle the TI. See www.health.gov.bc.ca/library/publications/year/ 2008/PharmaceuticalTaskForceReport.pdf
The TI’s budget was subsequently cut, its influence reduced and the important work of advising government on the value and safety of new drugs was severely curtailed.
On September 6, 2012, the day after being appointed by the Premier as the new Minister of Health, Dr. Margaret MacDiarmid and her Deputy Minister Graham Whitmarsh called a press conference in the Legislature. They announced that four employees had just been fired and three more were suspended without pay. Once again, no specific reasons were given but media reports which followed painted a picture suggesting the personal health data of millions of British Columbians might have been breached and the Ministry was taking steps to punish wrongdoers and protect our future privacy.
At last count, at least nine people have lost their jobs in this scandal. There are three lawsuits against the government and Roderick and two other employees, represented by the BC Government Employees Union, filed grievances.
All of these firings are perplexing, but none more so than the firing of a lowly co-op student with three days left in his term. When Rod was fired, his evaluation of smoking-cessation drugs stopped so we’ll never know whether the drugs he was evaluating were harming or killing people.
There have been many requests for information, but the stock response from the Ministry, “The matter is under investigation,” has stifled all requests, save one. That one freedom of information request asked for data on the numbers of co-op students who have ever been canned from the BC government. Ever. Over the last 10 years, there have been thousands of students who have completed co-op work terms with the BC government. There is only one record of a student being fired. One. It was Roderick.
As someone who has worked in pharmaceutical policy research for 19 years, I have never witnessed a more unsettling atmosphere around the Ministry of Health. No one has any answers as to why government employees, some with more than 25 years of service in the Ministry, were simply discarded. Other parts of BC’s pharmacovigilance (drug safety monitoring) work has been disrupted. BC is part of a national group called DSEN, the Drug Safety and Effectiveness Network, which, along with other provinces, is carrying out evaluations on a range of commonly prescribed drugs.
Last month, DSEN published a very important study on the safety of cholesterol-lowering statin drugs in the British Medical Journal. See www.bmj.com/content/346/bmj.f880 Using large data sets across multiple jurisdictions and weapons-grade epidemiologic expertise, these researchers carried out the kind of “real world” (by definition, outside clinical trials) research the drug industry doesn’t do.
Statins are known to cause muscle weakening and adverse effects on cognition, but we don’t even have a complete picture of their overall safety, as some of the major statin trials (funded by the pharmaceutical companies) don’t even release the full serious adverse effects data.
This DSEN study found that high dose statin users were 34% more likely to be hospitalized for acute kidney injury within four months of taking the drug, compared to those on low-dose statins. When you consider the millions of Canadians swallowing a statin every day, the overall number of people being harmed is likely in the thousands.
This study also shows why BC needs to be involved in independent, publicly funded drug evaluation. BC researchers are among Canada’s best in this type of research and are skilled in using large anonymous databases where personal health privacy is never an issue.
You can look in any jurisdiction in Canada where data breaches and improper employee conduct are suspected and never find a case this aggressively pursued. After her initial alarm, the Minister told us that, in this case, there is no evidence that anyone’s personal health records have been used inappropriately.
For a precedence on how bad privacy breaches in Canada can be, one need look no further than the case of Captain Sean Bruyea, a Canadian Air Force officer who served in the Persian Gulf War in 1991. Without his permission or knowledge, all of his personal, medical and financial files were distributed across a wide swath of officials in the Department of Veterans Affairs, who used this as ammunition to try to silence what was a fierce critic of Canada’s returning veterans. A total of 54 people had inappropriately accessed Bruyea’s file; 36 received an ‘administrative memo;’ nine were reprimanded and nine received one-day suspensions. Nobody was fired. No one. Let’s put this in context: When government employees were actually found to be egregiously breaking the law in accessing personalized files, not a single person was fired.
Which makes those firings in BC all the more mysterious. No one is more shocked than Doug Kayfish, Roderick’s brother-in-law. “I come from the corporate world,” he told me, adding, “You don’t just go and fire senior people. But a whole department? That’s sending a message.”
He admired Rod who he called a “pure scientist” with an impeccable level of integrity. When his family heard that Rod had been fired, he said, “We thought that was the stupidest thing we’d ever heard. How could that possibly be? How does this even fit?”
Minister MacDiarmid said she was “deeply troubled” and told media, “The Ministry provided the Royal Canadian Mounted Police with the interim review of this investigation in August 2012.” My calls to the RCMP confirmed they are “awaiting files” from the Ministry, but none of the fired employees has even been questioned by the RCMP. Some have suggested the RCMP ‘involvement’ is a red herring and, from the point of view of the fired employees, constant media references to the RCMP do nothing but colour the whole affair in more ominous hues.
At one news conference, the Health Minister, with a deeply furrowed brow, told reporters, “I can’t really overstate how deeply troubled I am.” She said she “instructed the Ministry to continue to take whatever steps are necessary to respond to these matters thoroughly.” Those words, “whatever steps necessary” scare everyone involved in this nightmare, especially given the Kafkaesque interrogations of the Ministry employees who were terminated, the dread felt as the people who remain get brought in for questioning and the impenetrable secrecy which hangs over the entire affair.
I asked Linda Kayfish if she had any theories about what was going on and she didn’t hesitate: “Follow the money,” she said.
With BC’s PharmaCare program spending more than $1.2 billion of our money on drugs every year, there is a lot of cash to follow. Many people wonder if the drug safety evaluations done by employees like Roderick and other evaluators were finding things the pharmaceutical manufacturers didn’t like. Would that be enough to lead to an anaphylactic reaction in the bureaucracy and a carpet-bombing of the Ministry of Health?
“Follow the money,” repeats Linda Kayfish. “I’m looking in that direction. Makes me really wonder who else would benefit from this?” The people who were fired certainly didn’t benefit from this.”
Linda’s voice verges on anger when she thinks of the wider impact on the other fired staff who are now filing grievances or suing the government and she asks the question many observers have asked: “Is there someone who had it in for all these people?”
The reason for our current lack of answers might be due to the revelations emerging from the Liberals’ “Ethnicgate” affair, which showed that employees doing ministry business use personal email or verbal decision making to avoid the prying eyes of Freedom of Information (FOI) requests. (None of a dozen or so FOI requests submitted by myself and other journalists revealed any information.)
This complete lack of information is particularly heart wrenching. “If the goal is to keep kicking the can down the road so everyone forgets about it, then we’re well on our way,” Doug notes.
There are several dominant theories bubbling up in this government town as people try to explain this massive, unprecedented destruction of BC’s drug safety system.
The first is the Keystone Kops theory where those Ministry officials carrying out the investigation have run amok, firing people on a whiff of wrongdoing. Many decision makers involved are relatively new: the Health Minister, her Deputy Graham Whitmarsh – who signed the letters firing people – Barbara Walman, the new ADM at PSD, Lindsay Kislock, the ADM in charge of data access and Wendy Taylor, the lead interrogator. This theory suggests the bureaucrats behind this fiasco are inexperienced and thus vulnerable to bad advice from the top. Taking a lesson from Stanley Milgram, the famous obedience researcher, they might just say, “I’m just following orders.” The question then arises: “Who gave the orders?”
We can all speculate about who might benefit from the destruction of BC’s independent drug safety system and that leads to the final theory, which we call the Big Data theory. This is premised on the potentially huge ‘economic opportunity’ represented by the meticulously collected health and drug use data of British Columbians. For the past year or so, we’ve seen people such as Colin Hansen and BC’s Chair of the Data Stewardship Committee, Bruce Carleton, out there waving the ‘open data’ flag, suggesting that BC’s health data should be shared on a for-profit basis, including selling access to it to drug companies. Last fall, Margaret MacDiarmid echoed this sentiment in the Globe and Mail, saying, “Instead of asking why should we open things up, what we really want to ask is, why shouldn’t we?” See www.theglobeandmail.com/news/ british-columbia/ plan-to-unlock-bcs-trove-of-medical-data-raises-privacy-concerns/article4100976/?service=mobile
Some have theorized that halting everything, cutting off data access and implementing interminable delays in restarting things will ultimately lead to the destruction of our current system for equipping publicly funded independent scientists with data to evaluate. Once you’ve blown that up, it’s time to move on to step #2: Open the doors to privatize our health information.
BC voters will soon go to the polls. They deserve to know one thing: What is really going on in the Ministry of Health that warrants risking our health by depriving us and our doctors of reliable information about drug safety in British Columbia?
Those of us who swallow prescription drugs deserve the best evidence about their safety. We deserve answers from this government and the next.
The Best Place on Earth (for pharmaceutical companies) by Alan Cassels, Focus online, March 2013, www.focusonline.ca Six Fired, Two Lawsuits, One Dead – But Still No Answers by Alan Cassels, Vancouver Sun, March 12, 2013, www.vancouversun.com Adverse Reactions by Paul Webster, Vancouver magazine, April 2013, www.vancouvermagazine.com Pharmageddon by Dr. David Healy (University of California Press, 2012), www.davidhealy.org
Alan Cassels is a pharmaceutical policy researcher and the author of Seeking Sickness. For the past 19 years, Cassels has worked on national and provincial studies of drug benefits policies. None of his income comes from any of the interrupted studies mentioned in this article.