By Jenny Manzer – 2005 Michener-Deacon Fellowship recipient (published December 2006)
As an Ontario MPP during the Mike Harris regime, Terence Young was known for his right-leaning ways. Young, who represented the well-heeled Oakville area, was a zealous defender of family values.
Back in those heady days, Young used to tour drug company plants and golf with their executives at party fundraisers. He believed in the good intentions of the pharmaceutical industry. He had ample faith in our drug safety system.
Then in March 2000, his life changed forever. His 15-year-old daughter Vanessa, who had been taking the stomach drug Prepulsid to cope with bloating, collapsed in front of him and died. Two months later, regulators withdrew the drug from the Canadian market due to its link with heart abnormalities and sudden cardiac deaths. By August, the drug was off pharmacy shelves.
The experience turned Terence Young into a radical. He founded the non-profit group Drug Safety Canada and has spent the past six years buzzing at the industry’s head and lobbying government for a better regulatory system. These days he sits around conference tables with other drug-safety advocates, many of whom tackle the issue from a leftist, social justice perspective.
“Here’s the irony: I’m a conservative,” says Young. “That’s what I am politically, that’s what I am personally: a small c conservative and a large C conservative. But I’ve been radicalized with regards to the drug industry by the loss of my daughter.”
Young ran in the 2006 federal election and came a split-end away from claiming Oakville for the Tories. Exposing the frailties of our drug safety system is a big part of his life. “It’s a way for me to keep being Vanessa’s father,” he says.
Even in our post-Vioxx world, most Canadians put a lot of stock in our prescription medications and in our regulatory system – as did Young. He can now tell you spine-curling stories about the drug industry, all fodder for his upcoming book tentatively titled Death by Prescription: How to Avoid Cures that Kill.
Health Canada has been characterized as a slow-moving, highly secretive organization that remains far less transparent than their American cousins, the U.S. Food and Drug Administration (FDA). In 2004, Health Canada received the Code of Silence Award from the Canadian Association of Journalists. Health Canada earned this dubious distinction for its repeated refusals to make the database that contains drug side-effects available to journalists and researchers. (The database has since been made public).
The drug industry’s shortcomings have been well documented in recent years as it has bobbed and weaved through various public relations crises. Still, there are many facets of our drug safety system that might surprise Canadians, particularly how closely Health Canada works with the drug industry.
Not only do pharmaceutical companies fund and choose the types of clinical testing done on our new medications, their user fees also pay half the bill to run the Therapeutic Products Directorate (TPD), the Health Canada branch that regulates drug safety. Drug companies might pay anywhere from $250 for a licensing fee to $300,000 or more for a new drug submission. The typical fee for a new drug submission is in the neighbourhood of $150,000, according to Brigitte Zirger, Director, Bureau of Policy, Science and International Programs.
The amount that industry coughs up to keep the lights on at Health Canada varies by department. The Health Products and Food Branch, an umbrella organization that includes the TPD, takes in 20% of their budget from industry user fees. The TPD receives about 53%. The branch’s Inspectorate, which handles compliance and enforcement, including drug recalls, takes in more than 60% of its budget from the very industries it is policing.
All told, the TPD raked in close to $21 million in 2004-2005 from fees paid by the makers of drugs or medical devices. The Biologics and Genetic Therapies Directorate took in $2.5 million and the Inspectorate tallied up about $10.6 million, for a total of about $34 million in industry fees for that year alone, according to figures obtained from Health Canada.
Some would argue that these numbers show good business sense. Industry is paying for a service that will later pay off, in a big way, if the new product is approved. But critics say the funding situation, in which industry is essentially paying the salaries of the scientists who vet new drugs, creates a client-customer culture that could jeopardize the public interest.
Young and other drug safety advocates claim that the current system has compromised Health Canada. He argues that the companies don’t view the fee as paying to have the drug reviewed. “They view it as paying to have a drug approved.”
“There are Health Canada memoranda that have been published that refer to the drug company as their ‘clients’ – not us, the people they’re protecting, but the drug companies,” says Arthur Schafer, Director of the University of Manitoba Centre for Professional and Applied Ethics. Schafer says Health Canada’s dependence on industry dollars verges on privatization.
“You’ve let the poacher become the gamekeeper,” charges Schafer, adding that regulators in both Canada and the U.S. have allowed themselves to be “captured” by the drug industry. Hugely successful lobbying efforts have turned regulators into industry boosters, not public guardians, he says.
“It’s a disastrous situation. I think at first blush it looks as if the public is getting a good deal. Why should we pay taxes in order to hire scientists and pay those scientists to test new drugs for their efficacy and safety, when we can make the drug companies do it?” he asks. “If what this means is that dangerously unsafe, or useless drugs come to market, it’s not such a good deal.”
Dr. Joel Lexchin, emergency department physician and a professor at York University’s School of Health Policy and Management, suggests the funding creates a situation in which regulators feel obligated to the companies and adopt their point of view. “Drug approvals are not all science,” he says. “There’s always decisions to be made around how much risk are we willing to take in terms of drugs, and I think as the industry takes on a larger role in funding the regulatory bodies that those kinds of decisions tend to be made more in favour of the drug companies.”
The system does tie the financial future of the Therapeutic Products Directorate with the fortunes of the drug industry. If companies start chasing down fewer new molecules looking for the next blockbuster, the TPD would take a fiscal hit.
“Stable funding continues to be a concern,” states a 2004 report on the progress of Health Canada’s “Financial Models Project,” which is aimed at reworking the current fees schedule. “The drop in the number of new active substances translates into a reduction of funding (i.e. revenues) to the Directorate,” the report notes.
The project will determine how much it costs Health Canada to provide these services to industry and what the fees should be. The drug industry was even involved in helping shape its future fee schedule, becoming part of the committee looking at the new financial model. Brigitte Zirger insists the committee acted merely as a “sounding board” and noted that other non-industry associations, such as the Canadian Healthcare Association, also took part.
Members of Canada’s Research-Based Pharmaceutical Companies (or Rx&D) and Health Canada meet regularly to discuss “joint projects.” Mary Wiktorowicz, chair of York University’s School of Health Policy and Management, says she hadn’t expected that Health Canada would present the drug industry with draft policy.
“I was certainly, as a member of the public, very surprised that you would ask your regulated industry to develop the first draft of a policy that you would revise and work with,” says Wiktorowicz. By allowing industry to lay down the framework of an issue, they have a huge influence on emerging policy, she says. Health Canada may have the final word on policy, she acknowledges, but she says such early consultation is “perhaps going too far.”
In recent years Health Canada has spent a lot of energy keeping industry happy. Faced with sluggish drug approval times and a large backlog in new drug submissions, the TPD vowed to pull up their socks. Zirger says its improved performance has appeased industry, which had complained that Health Canada was charging them fees, but not providing the services on time, which affected how they viewed any revision of the fees.
The TPD has eliminated its backlog of submissions and is now meeting its commitment to review within the target period 90% of the time. These inroads were possible in part due to an infusion of $190 million allocated in the 2003 budget as part of the Therapeutic Access Strategy, Canada’s master plan for giving the public faster access to new drugs. Of that money, about two-thirds went towards speeding up the drug review process.
Strangely, even though Health Canada’s major action plans for drugs and health products are built around the concept of user fees, industry doesn’t always pay its bills on time. In 2000, Canada’s Auditor General reported that Health Canada had a “larger than expected overall balance of unpaid accounts.” As of March 2000, the TPD had roughly $7.6 million in “outstanding receivables,” according to a report from the consulting firm KPMG. While the TPD managed to collect some of the overdue amount by the end of that year, getting industry to pay up is apparently an ongoing problem.
As of January 2006, Health-product manufacturers owed Health Canada roughly $7.5 million in outstanding accounts receivable, with $3 million overdue by more than 90 days. The manufacturers of drugs and medical devices owed Health Canada almost $5.6 million in unpaid fees related to services such as drug submission reviews or licensing, of which about $2.9 million was overdue by more than 90 days.
While performance standards can be set for areas such as drug approval times, it is much harder to make such specific goals for improving drug safety. Could Health Canada, for example, vow to reduce drug recalls or adverse drug reactions by a certain percentage by a given time?
“The problem here is, that, what can you measure?” says Dr. Lexchin. “It’s much easier to measure things around how quickly do you approve drugs than it is to measure things around safety.”
Mary Wiktorowicz agrees it is tougher to set benchmarks for safety, but it can be done. “It is harder, but for example product withdrawals, they have never been part of Health Canada’s annual reports or any kind of measurement in terms of accountability. Their targets are all based on number of products approved. If you take a look at how they measure their performance, those are the targets,” she says.
“I just find it interesting that decisions around asking for additional research, or additional clinical trials on products, they’re almost viewed negatively because it causes delay for industry.”
As part of his research, Dr. Lexchin asked Health Canada for a list of all drugs that had been withdrawn from the Canadian market for safety reasons since 1963. He had thought it would be basic information to obtain. “This turned out to be a rather naïve assumption,” reflects Dr. Lexchin.
He discovered that Health Canada filed information by drug name, so in order to find out which were withdrawn, you would have to ask about each specific product, then analysts would be able to go to the records and determine if a drug had been removed and why. Dr. Lexchin spent days digging up the information himself – at his own expense.
He wasn’t surprised at which drugs were withdrawn – just that Health Canada didn’t have the information at hand. If Health Canada doesn’t collect that information, it’s lost the ability to analyze the drug system in a number of ways, such as looking at trends over time, he says.
Similarly, Wiktorowicz asked Health Canada for its rate of drug withdrawals and found the figure was also unknown. She eventually discovered that another researcher had gone through the data and crunched the figures. “I think it’s a reflection of the involvement of industry that all their targets are based around indicators that industry is interested in,” she says.
Critics insist that the ties between the drug industry and Health Canada are too close and that the funding umbilical cord should be severed. Still, the two sides seem to be becoming more closely linked than ever, thanks to various long-term strategies that are predicated on the presence of industry money. Health Canada was even considering allowing the drug industry group, Rx&D, to organize and implement a “collaborative initiative” in the form of an educational forum.
Citing the fact that the science of medicines is rapidly changing, Rx&D offered to help Health Canada’s drug reviewers deal with the challenges of new and developing areas. “Rx&D proposes to assist in addressing this challenge by working in partnership with Health Canada to develop the infrastructure to provide educational opportunities to HC reviewers and other interested staff,” read minutes from a December 2005 meeting between the two groups.
“Rx&D proposes to work with HC [Health Canada] to conduct a needs assessment, recommend the necessary infrastructure, and if the both parties agree, proceed with implementation of an ongoing educational program based on developing science.” Rx&D suggested this initiative could improve the drug-review process by “enhancing understanding of new scientific concepts which will be encountered during drug review.”
Health Canada seemed keen on the concept of this ongoing educational forum. “TPD is very interested in exploring this partnership proposal as part of ensuring its review community has the opportunity for continuous learning.”
Dr. Supriya Sharma, associate director general for the TPD, said the proposal was being considered. “But the perimeters around it would have to be quite tight, and quite specific, and we’d have to be assured that it’s appropriate for the reviewers,” she stresses.
Rav Kumar, vice-chair of the regulatory affairs committee for Rx&D, says industry often has the expertise on its side when it comes to breakthrough areas, so the idea would be along the lines of having specialists come in as guest lecturers to teach. He says Rx&D want to help Health Canada have the best scientific background for their drug reviews. “The concept here is that we would objectively help to educate, in certain defined areas, Health Canada employees.”
Colleen Fuller, co-founder of the Vancouver consumer advocacy group PharmaWatch, calls the proposal an “outrage.” Health Canada officials should have considered whether they were undermining their ability to conduct reviews 10 years ago, when they slashed the department’s budget, she contends. “There’s such a conflict of interest there. Not only does it undermine the capacity within Health Canada to bring a level of objectivity and so on to the job, it changes the attitude of people within Health Canada as well,” she says, adding that it reinforces the idea that they are partners with industry. “And even Health Canada in this sense would undoubtedly see itself playing the junior role, because they don’t have the expertise internally that they would see the drug industry having.”
Fuller, a diabetic who experienced a severe adverse drug reaction from a type of insulin, says it’s no accident that the lion’s share of funding is allocated to drug approvals, rather than safety.
“For anybody who’s been involved with Health Canada, and I’m speaking now just purely as a consumer, every step is filled with astonishment. Every time you sit down and talk to Health Canada as a person who has been injured by a drug what impresses you more than anything else is that they see their job as not promoting the public interest to the drug industry, but rather promoting the drug industry to the injured consumer.”
While Health Canada has laboured to improve drug approval times, it has also vowed to be more transparent. For years, observers inside and outside Health Canada, including the House of Commons Standing Committee on Health, have urged it to throw open the blinds on drug approvals and make more clinical trial data available. During the after-tremors of Vioxx, then-health minister Ujjal Dosanjh also devoted some sound bites to the subject.
Health Canada has made some inroads. In May of 2005 it posted the Canadian adverse drug reaction database (www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index_e.htmll), which allows the public and researchers to view the reports. (It had, however, already been posted by the CBC, who fought to acquire the data through an Access to Information request.) Health Canada also started making the Summary Basis of Decisions, which provide a snapshot of their scientists’ rationale for approving a drug, available.
But researchers say the summary does not provide enough information to be able to identify potential problems. Dr. Lexchin and B.C. researcher Barbara Mintzes put the Summary Basis of Decisions to the test. They studied three of the decisions to determine whether the serious flaws that later emerged in the drugs would have been evident from the data. They concluded that the summaries lacked important details and problems such as the cardiovascular risks of hormone replacement therapy would never be discovered through them. “Compared to what is already available in the U.S., this initiative for greater transparency is grossly inadequate,” the team wrote in the Canadian Medical Association Journal,
Larry Sasich, a pharmacist and consultant for the consumer watchdog group Public Citizen in Washington, DC, said there are abundant reasons that Health Canada should give the public the whole picture. Sasich cited the example of a new diabetes drug that went before an FDA advisory committee in 2005. A lawsuit filed by Public Citizen in 2000 required that data on the drug had to be made public at least 24 hours before the committee meeting. There were concerns with cardiovascular effects, so physicians from the Cleveland Clinic downloaded the FDA information and did a reanalysis of five clinical trials that were submitted, of which only one had been published. “They found a doubling of risk of serious cardiovascular events with the drug. I think they performed a super public service,” says Sasich, who is married to a Canadian pharmacist and well- schooled in our regulatory system. “They brought a potential problem, a problem that could have harmed an awful lot of people, to public attention and the study was released early on the Journal of the American Medical Association’s web site. Now that’s impossible to do in Canada. We never see what’s going on, or it takes years to finally see what’s going on.”
Health Canada has long insisted that various laws hamper their ability to disclose drug information, including the North American Free Trade Agreement and the Access to Information Act, which they argue excludes such commercially sensitive information from being disclosed without the company’s consent. The FDA, by contrast, posts information from clinical trials that would never see the light of day in Canada.
But critics like Dr. Lexchin and Sasich insist that the power to make this information public is already contained within our Access to Information Act under a section that allows release in matters of the public interest and health.
Sasich says if there is trade secret information in U.S data, the FDA blacks it out, without backing and forthing with the company. He has studied our Access of Information Act and thinks it contains the ingredients for transparency. “But it doesn’t seem that Health Canada is implementing it properly,” he says. “It seems like Health Canada defers to a company first.”
Diane Gorman, the former assistant deputy minister for the Health Products and Food Branch of Health Canada, has also suggested it is more vulnerable to being sued than other regulatory agencies, including the FDA, and that fear of litigation helps keep its lips buttoned. “This is indeed a challenge and can create tensions between wanting to inform the public and needing to prepare for legal action in the courts,” she said, according to minutes from a 2005 public advisory meeting. The minutes also say it is “very easy” to add Health Canada as a party to class action suits and that this is done regularly.
Is Health Canada really so vulnerable to lawsuits? Most litigants in Canada seem to focus their energies on suing drug companies rather than taking aim at the public purse. In fact, Health Canada has apparently made just one settlement in recent years that involved litigation stemming from pharma-ceuticals. The settlement was made in 2003 for $30,000, according to figures obtained under an Access to Information request.
Still, Health Canada spends considerable time and money defending actions. Over the years 2002 to 2005, the public paid more than $1 million in costs related to lawsuits stemming from prescription drugs, according to figures culled from an Access to Information request. As of February 2006, there were 19 active lawsuits that include Health Canada as a party. That number can only be expected to rise in the future, since legislation allowing class action lawsuits have sprouted up across the country.
Health Canada is being named as a party in class action cases involving the top-selling COX-2 inhibitors Bextra, Celebrex and Vioxx. In February 2006, Evatt Merchant, a partner with the Merchant Law Group, said his firm alone already had about 1,500 clients on board for its Vioxx case. Merchant, who is based in Saskatoon, says it was a conscious decision to include Health Canada as a party. The move reflects the view of his clients that the public regulator had an obligation to make sure these drugs were safe, he says. Including Health Canada will also help the firm obtain more information to build a stronger case, he adds. “We think it’s what’s in the best interest of the class. Health Canada played a role in these drugs coming to market to Canada.”
If certified, these cases, which will no doubt involve thousands of patients and millions of dollars, could allow the public unprecedented insight into Health Canada’s approval process.
Still, the main target in litigation is drug companies and these cases are on the rise in Canada, says Gary Will, an Oakville lawyer who represented the Young family during the coroner’s inquest into Vanessa’s death. He attributes the spike in part due to the rise and fall of top-selling drugs like Vioxx as well as legislation sprouting up around the country that allows class actions.
Will says what he found most surprising about Health Canada is how reliant they are on what drug manufacturers tell them. Will has no doubt that Health Canada regards industry as its client, and suggests the decision to base a large part of its budget on industry fees is a “fundamental flaw” in our system.
“I think most Canadians assume that if Health Canada has approved it, it must mean that it is a good drug, it’s a safe drug. But the reality is otherwise. They’re very dependent on the drug manufacturers, which is not a real comforting thought. These drug manufacturers have a monetary interest in selling as much drug as possible.”
Will is one of several lawyers pursuing a class action on behalf of all Canadian patients who took Prepulsid. It’s a slow process.
Meanwhile, Terence Young slogs away on his book. Progress in drug safety is made in baby steps – but empowering people to understand their own health could make a profound difference, says Young. The drug industry has spent years peddling the message that prescription drugs are synonymous with good health, he says – but they aren’t. Many of us can live without them, and many can live with less of them. “They are a two-sided coin,” he says. “Sometimes they help us, sometimes they hurt us and knowing the difference is the key.”