From the window of her classroom at Nechako Elementary, Elisabeth Stannus can enjoy a view of the mountains; at home she looks over the Kitimat Valley, but after 16 years in Kitimat, Stannus is worried that what she sees from her windows will change from clear skies to a haze of pollution.

Growing up in Ontario in the 1970s, Stannus, 53, is familiar with the “acid rain” phenomenon and knows that high levels of sulphur dioxide (SO2) are a prime cause of acid rain. It is that same chemical that brings her, and fellow Kitimat resident Emily Toews, to the front of a legal appeal to stop a local multi-million dollar smelting facility from releasing more sulphur dioxide into the environment.

The grade one teacher moved to Kitimat, a city that that is at the heart of a dispute over the Northern Gateway Pipeline and three proposed liquefied natural gas facilities, 16 years ago with her husband, an engineer. The couple arrived in Kitimat while the city was in a slump, but with Stannus’ love of the small town life, they decided to build a house there. For Stannus, the positives of living in small town Kitimat, surrounded by mountains and clean, northern air, far outweighed the sometimes-bad weather and the economic slump.

Now, Stannus is worried about being so close to such a serious pollutant. “It makes me really disappointed… I love living here because of all the clean air, clean water; there’s so much forest around, so it really upset me.”

Together with Toews, Stannus is making a last-ditch effort to stop a permit that allows the city’s largest employer to increase its release of sulphur dioxide to the air. Rio Tinto Alcan says the expansion from the Kitimat Modernization Project to expand the aluminum smelter will create jobs and have minimal effect on the environment; Stannus and an increasing number of citizens say the changes will pollute the air and threaten their health.

A company on the rise

According to an analysis of data obtained from the National Pollutant Release Inventory, Rio Tinto Alcan’s sulphur dioxide emissions were already increasing before it applied for the permit. Emissions from the smelter went up 20 per cent from 2011 to 2012.

The levels of sulphur dioxide are directly related to the amount of aluminum the facility produces per year, according to Colleen Nyce, Corporate Affairs manager for Rio Tinto Alcan.

“The increase in 2012 that you’re seeing at the local level is a result of a combination of factors – production levels, reduced quality of our raw material coke (a bi-product of the oil and gas industry), and an aging smelter in urgent need of modernization,” said Nyce in an emailed response.

Despite the existing increase of sulphur dioxide, on April 23, 2013, the B.C. Ministry of Environment approved a change to Rio Tinto Alcan’s permit to allow them to increase sulphur dioxide emissions by 56 per cent, as part of the Kitimat Modernization Project to upgrade the more than 50-year-old aluminum smelter. The Ministry refused repeated requests for interviews, but in the press release from April 13 said that the Ministry was satisfied with the information provided by Rio Tinto Alcan. The Ministry also stated that it will work with the Northern Health Authority as the increased emissions are phased in.

Sulphur dioxide is one of more than 300 chemicals that must be reported to the National Pollutant Release Inventory, and according to a 2012 study by the Fraser Institute, poses significant health risks, including lung cancer, respiratory diseases, such as asthma, and heart diseases. It is also one of the reasons why Canada’s environmental protection efforts boomed in the late 1970s.

Rio Tinto Alcan’s Sulphur dioxide Technical Assessment Report, states that the increased pollution will have a “moderate effect” on people with respiratory illnesses, such as asthma, but Stannus and other critics of the permit believe that a moderate health risk is still too high.

“The world is working so hard to promoting a healthy environment, healthy living… there’s huge money invested by the health ministry promoting healthy living,” said Stannus.

After hearing Kerry Moran, an official for Rio Tinto Alcan, say that the increased emissions would be at the same daily levels as Vancouver and Montreal, Stannus’ concerns mounted. She says doesn’t believe that people in the small community of Kitimat are ready to deal with that level of air pollution.

According to the National Pollutant Release Inventory Data, the levels of sulphur dioxide in Kitimat in 2012, from the Rio Tinto Alcan aluminum smelter, were higher than the total emissions for Vancouver and Montreal.

“The government’s doing all kinds of things like the… Air Quality Health Index, and they’re all down there [Vancouver],” said Stannus.

“And they’re all “Oh the cruise ships are going past Victoria, oh we better really do a study on that,” …and then in our community, another sector of the government can say, ‘Yeah, you can blast that out, that’s okay.’”

Changes to employment

Despite a growing number of concerned citizens, recent closures in the city have caused the population to decrease. With less than 9,000 people, the modernization and other projects will bring jobs to Kitimat, but the influx of workers and their families could possibly end “the worst of its economic storm,” according to an October 30, 2012 statement by Mayor Joanne Monaghan.

After two major facility closures, more than 600 people lost their jobs in the last eight years.

In January 2006, the closure of the Methanex methanol plant in Kitimat brought a 12 per cent decrease in sulphur dioxide to the area, but left 127 workers without jobs. The Eurocan paper mill closed in 2010 and 535 people lost their jobs. Again, the sulphur dioxide emissions in Kitimat lowered by 20 per cent.

After the paper mill closed, the city was struggling. According to Trish Parsons, Executive Director of the Kitimat Chamber of Commerce, many labourers and skilled workers left the area, leaving the city with a 40 per cent vacancy rate in housing and employment. Parsons said that things started to turn around in 2012, when work started on the modernization, creating jobs where there had been vacancies. Now, Parsons says there is a zero percent vacancy rate in the city, with room for more development as work continues on the modernization.

Rio Tinto Alcan’s aluminum smelter is now the major employer in Kitimat, just as it was when it was built over fifty years ago. According to Rio Tinto Alcan, the Kitimat Modernization Project has created jobs for more than 2,500 workers during construction, with 1,000 specialized jobs for workers inside the finished facility. The expansion of the smelter is part of an extended effort through the B.C. Liberal Party’s jobs plan, according to a 2012 budget announcement by MLA John Rustad, investing in the “Northern decade” for job creation and encourage growth across the province.

Being part of a community where residents have been in and out of work, Stannus understands how important industry is to Kitimat. Because of the importance of Rio Tinto in their community, Stannus worries that this is why fewer people were willing to stand against the increased pollution when it was first announced. Though she supports the opportunity for her community to expand, time spent as an activist on Kitimat’s Advisory Planning Committee has taught her that everyone has a right to stand up against community issues.

“I felt that being a teacher… and I have nothing really to do with RTA, so although some of my children’s (students) parents work there, so I felt that I could have a voice and that its important for somebody to be formal about it.”

The upgrade will add 30 years to the smelter’s operations, and according to Colleen Nyce, Corporate Affairs manager for Rio Tinto Alcan, marks an accomplishment for the company, modernizing the smelter, reducing some pollutants and increasing jobs in the community.

“We are very proud of the accomplishment and of the many benefits, including economic and social impacts, that will result from modernizing our operations in Kitimat,” said Nyce in an emailed response.

When Rio Tinto Alcan first announced the plans for the modernization project to the community, it emphasized that there would be a reduction in the release of greenhouse gases, particulate matter and polycyclic aromatic carbons, three major environmental pollutants that the previous smelter freely released into the air before the modernization.

“It is important to remember that the Kitimat Modernization Project will result in an overall emissions reduction of nearly 50%, inclusive of the increase in sulphur dioxide,” said Nyce.

“This is a huge environmental improvement related to the new smelter.”

Opposition grows as the clock ticks

As a required part of any permit amendment, a 30-day public comment period is mandatory so that citizens in the affected area can complain, consult companies and address problems. According to officials from Rio Tinto Alcan, 16 open public meetings took place after the first meeting on February 28.

Stannus did not attend the first meeting, only four people from Kitimat were there. The room at the Kitimat Valley Institute however, was well attended by Rio Tinto Alcan officials, ready to present their Sulphur dioxide Technical Assessment Report and to talk to community members about the permit changes and the increase in sulphur dioxide.

Once information about the increase, and news of the poorly attended first meeting with the community in Kitimat, spread through social media and email, residents of Kitimat and Terrace came to a second meeting, this time in Terrace, ready to hear more.

After the second meeting, Rio Tinto held 16 more meetings with concerned community members in Kitimat and Terrace. According to Stannus, these meetings were filled with concerns about the impact on air quality, effects on the environment and questions about health impacts for people in the area.

“Absolutely every question was answered,” said Rio Tinto Alcan spokesperson Colleen Nyce in an emailed response. Stannus disagrees saying, “they were trying to keep these meetings really small, they were telling people they couldn’t go in and people were just bringing their friends… they were trying to just minimize it.”

The questions and comments during the consultation period were recorded for public record, but despite multiple requests, Rio Tinto Alcan refused to provide copies.

It was a question of health that brought Toews, a Kitimat resident who also teaches elementary school, into the appeal, because she asthma and allergies that are aggravated by pollution. Toews did not want to be interviewed, because she felt she came into the appeal later than Stannus and did not want to comment on the process. She teaches dance in the community and worries about the effect that air pollution would have on her students. She also enjoys exercising outdoors, and is worried that an increase in sulphur dioxide would effect her health, increasing her risk of an asthma attack and aggravating her allergies.

Moving forward

On April 23, 2013, the B.C. Ministry of Environment gave Rio Tinto Alcan the go-ahead to increase sulphur dioxide emissions as part of the project to modernize and expand its smelting operations.

After deciding to appeal the ministry’s decision, Stannus was not alone. SkeenaWild Conservation Trust, Lakelse Watershed Steward Society and a group of other concerned residents from the Kitimat-Terrace area also filed for appeal. By May 22, 2013, seven letters of appeal were filed, each giving a reason for their objections and how they could be affected by an increase in pollution.

After submitting their appeals, the group was considered by the Environmental Appeal Board to determine if each appellant was a “person aggrieved,” by looking at how they would be affected by the increase in pollution. Because Stannus and Toews both live and work in Kitimat, and because of Toews’ health concerns, both were granted standing after the first stage of the appeal, moving on to appeal the decision before the Environmental Appeal Board.

None of the others in the group were originally considered to be a “person aggrieved,” but the group did not stop there. They challenged the Environmental Appeal Board’s decision before the B.C. Supreme Court, and on March 14, 2014, the B.C. Supreme Court overturned the decision.

The court ruled that the Environmental Appeal Board’s reason for denying the group standing, each person in the group lives or works in Terrace and was not considered “affected” by the increase, were too restrictive. The Environmental Appeal Board must now reconsider each person for standing in the appeal against Rio Tinto Alcan’s permit change.

According to a legal representative for the Environmental Appeal Board, the group will not appear before the board until a written copy of the judgment is released. As of April 2, 2014, the B.C. Supreme Court has not released the official record of the judgment.

The aluminum smelter in Kitimat is a division of Rio Tinto’s aluminum operations in North America, which last year reported total revenue of $3.92 million. To install the scrubbers that Stannus and other concerned groups are asking for could add more than $150-million to Rio Tinto Alcan’s $3.3-billion dollar upgrade of the smelter, according to Nyce.

Because the B.C. Ministry of Environment has approved the change to Rio Tinto Alcan’s permit, the success or failure of the appeal will decide whether the emissions from the aluminum smelter increase and if the company will install scrubbers to remove the sulphur dioxide from the facility’s stacks.

Assessing change

A change to the Canadian Environmental Assessment act, introduced by Prime Minister Stephen Harper’s Conservative government in the 2012 Economic Action Plan was made to “streamline” the process for environmental assessments, and create jobs through what the government calls “responsible resource development.” According to Canadian environmental lawyers, the change redefines how environmental assessments are conducted and narrows the list of projects that require a federal environmental assessment.

In a March 30, 2012 announcement, former Natural Resources Minister Joe Oliver discussed the “one project, run review” goal. This process takes assessments away from the old system of long review periods and accelerates the process to create jobs through major economic projects.

“Major economic projects in Canada are currently subject to long, unpredictable and potentially endless delays because of a needlessly complex and duplicative approval process,” said Minister Oliver, who became finance minister on March 19, 2014.

Rick Lindgren, a lawyer for the Canadian Environmental Law Association describes the government’s changes to the Canadian Environmental Assessment Act as “cutting and gutting,” to take out parts of the law that previously protected Canada’s environment from pollution.

The federal government, through the Canadian Environmental Assessment Act, is conducting environmental assessments on 118 projects, including the Northern Gateway Pipeline in Kitimat. Each assessment looks at the environmental effects of each project individually. According to a letter Lindgren wrote to John McCauley, Director of Legislative and Regulatory Affairs for the Canadian Environmental Assessment Agency, some projects, like the Rio Tinto Alcan Kitimat Modernization Project, after the change to the Canadian Environmental Assessment Act, are now left to provincial, independent regulators, including the B.C. Ministry of Environment.

The ministry is responsible for provincial environmental assessments, permit approvals and for monitoring and assessing provincial air quality. The B.C. Ministry of Environment refused repeated requests for interviews.

The smelter is the first project in the Kitimat-Terrace area that will increase emissions of harmful pollutants to the air, with at least 4 more proposals – three liquefied natural gas facilities and the Northern Gateway Pipeline –being considered in the area. The upgraded smelter will release 56 per cent more sulphur dioxide per day.

The B.C. Ministry of Environment completed a study of the Kitimat airshed on March 30, 2014 that will look at the impacts of any further increases in sulphur dioxide in Kitimat and Terrace. The report has not been released to the public yet.

From the work done by Rio Tinto Alcan in the Sulphur dioxide Technical Assessment Report, models of the area show that Terrace, a city 50 km away from Kitimat, is downwind from the smelter and its emissions. The study shows the potential impact, but models and monitors only show part of the effects. Monitoring around the smelter is done with instruments that measure from a single point. According to Randall Martin, professor of Physics and Atmospheric Sciences at Dalhousie University, this single point can be impacted by wind speeds, and where the instrument is measuring.

Charles Claus, owner of Baker Extraordinaire in Terrace, is worried about the impact the increase will have on his business. As someone who enjoys farming on his land and selling his produce at the local farmers market, he is worried that a change in soil quality will affect the quality of his food, and customers will seek out other growers.

“It’s (sulphur dioxide increase) going to cost me more, it’s going to potentially affect some of my customers, if they’re concerned about quality food, grown in a pristine environment, then they’ll just shop elsewhere,” he said.

In what Claus describes as a sensitive ecosystem with so much work being done in the preserving of the Great Bear Rainforest, he believes there is more that could be done to preserve the environment, without harming it.

“I think it’s a biased decision, in favour of the industry,” said Claus.

Claus and other critics of the B.C. Environment Ministry decision to allow more sulphur dioxide pollution from the Kitimat smelter, believe that the airshed assessment came too late.

“There’s lots of potential here and there’s lots of food being grown here, much more than the government statistics show,” said Claus.

Repeating history

Concerns over acid rain, air pollution and air quality effects were raised in an October 9, 2013 meeting of the Select Standing Committee on Finance and Government Services, when Nadia Nowak, an environmental planning expert with the Northwest Institute for Bioregional Research, proposed that government look at total levels of pollution in the area.

“We don’t have to look much further than southern Ontario to understand firsthand what the impacts of air pollution are to humans and water… we all remember the acid rain crisis.”

Acid rain was the catalyst for a boom in environmental law that began in the 1970s, leading to the creation of the Canadian Environmental Protection Act in 1987, and the Canadian Environmental Assessment Act in 1992. The boom in environmental law led to the gradual decrease in pollutants like sulphur dioxide across Canada.

According to Lindgren, since the changes to the Canadian Environmental Assessment Act, that took effect on July 6, 2012, there is a significant gap in environmental assessment coverage.

The assessments being done in Kitimat examine the area as it prepares to take on new industry, and the release of sulphur dioxide and nitrogen oxide; all information about the increases coming from Rio Tinto Alcan’s modernized smelter came from the company’s Sulphur Dioxide Technical Assessment Report.

The B.C. Ministry of Environment did not require an environmental assessment before the permit to increase sulphur dioxide emissions was approved.

Changing processes

According to an October, 3, 2013 press release, the study of the Kitimat airshed will serve as part of the B.C. Ministry of Environment’s work to re-evaluate the approval process for industrial projects in Kitimat and in other areas of the Province.

Despite the increase in sulphur dioxide, Rio Tinto Alcan states that the overall emissions from its upgraded smelter will decrease 50 per cent. In an emailed response, Colleen Nyce, Corporate Affairs Manager for Rio Tinto Alcan, did not respond to questions about the possible outcome of the appeal.

A change to the approval process could slow down the work towards B.C. liquefied natural gas developments that citizens are already concerned will add more pollution to the area.

Sitting at her computer desk at Nechako Elementary School, reading over emails from the past year, she knows that the pressure will start to build soon, as the eyes and ears of the community turn back to her, Toews and Rio Tinto Alcan.

Beginning May 26, 2014, Stannus will take two weeks off from her job to oppose the changes to Rio Tinto Alcan’s permit.

Right now, only Stannus and Toews will appear before the Environmental Appeal Board. Stannus says that it’s not about the number of people standing with her, but the support she feels from her community and the chance to do what she feels is right for herself, for her students and for her community.

Going into the appeal she knows there will be a lot of industry jargon to listen to, but she isn’t worried about it. Her copy of the Rio Tinto Alcan Sulphur Dioxide Technical Assessment Report is dog-eared, highlighted and underlined. She has been collecting her own library’s worth of information in preparation for the appeal. After talking about the appeal with her husband, and with the support of friends and residents in Kitimat and in Terrace, Stannus is ready for anything.

If the appeal is successful, Stannus’ appeal submission requests that the sulphur dioxide increase be “struck” from the permit, and that Rio Tinto Alcan install scrubbers to remove any sulphur dioxide that the facility releases from it’s stacks.

According to Rio Tinto Alcan, there is space set aside in the upgraded facility for the scrubbers to be installed, but the cost could add more then $150-million to the already $3.3-billion dollar upgrade. On March 8, 2014, the company announced that the upgrade is behind schedule, and will not finish until early 2015.

Though she knows there is a chance her appeal might not succeed, Stannus is focused on what will happen during the appeal. She says that she doesn’t want to think about the outcome until the end.

If the appeal were unsuccessful, Stannus would have to take her case to the B.C. Supreme Court, which would require more time and legal expenses, which Stannus is not sure she can continue to afford.

For now, Stannus says, she is only looking as far as May 26. “Emily (Toews) and I will just go ahead, at least there is somebody.”

Light streams through the windows of MP Terence Young’s office on Parliament Hill. The walls are decorated with framed family photos and his desk is neatly piled with papers and books. On one wall is a framed newspaper article about his middle child Vanessa. On this cold but sunny winter day, he sits at his desk in a high-backed chair. His hands are in a prayer like position, elbows on his desk, thumbs pressed against his lips. His brows are thoughtfully furrowed and his light blue eyes seem to be faraway. He’s thinking about Bill C-17. A bill that was inspired by the untimely death of 15-year-old Vanessa, 14 years ago.

After his daughter’s death, Young began a journey to prevent other families from experiencing the loss of a loved one due to prescription pharmaceuticals. This lead Young to write a book, Death by Prescription, detailing his experience with Vanessa’s death and his quest to answer questions about why she was prescribed a drug associated with causing irregular heartbeats, heart attacks and sudden death. Prepulsid had reports of serious side effects and even death associated with it recorded in the Health Canada database used to track adverse drug reactions.

This year Young hopes to reach a new milestone in his journey as Bill C-17, subtitled Vanessa’s Law, which he has worked hard to craft with Health Minister Rona Ambrose, makes its way through Parliament. The bill aims to amend the Food and Drugs Act, and to give the federal government more power to fine drug companies and pull their products from the market.  The result is a debate between those who support tougher regulations and the pharmaceutical industry about how to improve drug regulation in Canada.

If passed, Young says the bill will amend the Food and Drugs Act. Most notably, it will take some power away from pharmaceutical companies and give more power to Health Canada. If Health Canada thinks a warning needs to be added to a drug label or a drug needs to be recalled,  it has to negotiate with a drug company. If Bill C-17 passes, Health Canada will be able to order a company to change a label or recall a drug. “If I had to pick any prime way to improve patient safety, it’s the drug labeling. It’s so patients and doctors get plain language labeling that lists the true dangers of the drugs they’re taking. So, that is addressed in Vanessa’s Law,” says Young about the proposed amendments. A full summary of the amendments can be found here.

Jared Rhines, Vice-President of Rx&D, which represents more than fifty pharmaceutical companies in Canada says, “We have a fantastic track record of producing and developing safe medications.” Young disagrees saying, “One out of five new drugs that’s approved in the United States and Canada by our regulators will later either be taken off the market for killing or injuring patients or have to have new warnings issued so doctors prescribe them more carefully.”

Balancing the two sides of the debate is a team that includes David Lee, Director of Legislative and Regulatory Modernization, who worked on writing Bill C-17. He says he and his team researched regulations in other countries to help them write a bill with a “safety focus.” Some feel that this bill misses the mark in that area.

Interim step before recall

One of the new clauses in Bill C-17 allows Health Canada to recall a drug that it deems to be unsafe. Rhines, would like to see an interim step added before a recall is ordered by Health Canada. He points to the US Food and Drug Administration where regulators have the option to issue what’s known as a “stop sale” order. This means that manufacturers, distributors and stores must stop selling the drug. It is less serious than a recall where companies must replace or reimburse customers for the recalled products and customers are told to stop using the product. “[The stop sale process] was in previous version but it’s fallen out of this [bill],” says Rhines.

Lee says having a “stop sale” type clause is unnecessary because when Health Canada knows a drug is unsafe, its goal is “to get product away from the harm it’s going to cause, so you want to get it away from the market.” He says a “stop sale” clause is a “softer step” that is unnecessary in a situation as serious as a recall.

Opposition wants more

Megan Leslie, MP and NDP Deputy Leader is happy to see Bill C-17 on the table, however in an e-mail, she says it falls short in some areas. “I would like to see a more comprehensive drug safety plan that goes beyond the measures in this bill.  Ideally, we would have legislation that includes: optimal prescribing practices, mandatory registration of clinical trials, strengthening the common drug review, post-market approval studies, better communication of drug safety issues to doctors and pharmacists.”

She feels that this bill has a very narrow focus and would like to see something that encompasses more areas of health safety.

Why is Bill C-17 less comprehensive?

Lee says this bill has a narrow focus for a reason, “the department sat down and said let’s really focus on the main safety provisions, that really go towards getting better information about adverse drug events and then being able to do something about them, so the labeling and the recall and the further studies power so that we can really understand and validate that there’s a problem out there and then make an appropriate response.” He expects to get some recommendations on amending the bill before it is passed.

While all political parties support Bill C-17, they also plan to propose changes. The bill’s second reading took place on March 28^th and the bill will now be sent to the Health Committee where members can give feedback and propose amendments.

Experts weigh in with concerns about transparency

Dr. Navinder Persaud, a scientist, lecturer and physician at St. Michael’s hospital raises a point that other researchers, physicians and even Terence Young are also concerned about; the steps Health Canada takes to review a drug company’s data to determine if the drug is safe enough to market in Canada. Persaud isn’t alone in saying that Canada’s drug approval process should be more transparent. When Health Canada approves a drug, it can keep clinical trial data secret. “Certainly all of the information that regulators use should be publicly available. It should be easily available to physicians and it should certainly be easily available to patients.”

When regulators are making a decision about whether or not to approve a drug they use clinical trial data, studies and other research. However, the process happens behind closed doors and none of the information used is made public. For this reason, many people believe the approval system lacks transparency.

An article published in the Canadian Medical Association Journal in March 2014 points this out as well. Lead researcher Matthew Herder says, “The US, Europe, other places have made their regulatory systems more transparent by changing their laws and some policies and there’s been lots of news coverage and lots of academic critique about how Canada is behind the times when it comes to transparency and this bill wouldn’t help at all in that regard.” Herder and his colleagues support the bill in general but would like to see a few things, such as a transparency clause, added.

The 2011 Auditor General’s report also addresses this issue concluding that, “Health Canada does not disclose information on drug submissions that it has rejected or information on the status of the drugs it has approved with conditions.” Researchers and patient advocacy groups echo this concern.

Bill C-17 not the first of its kind

In fact this lack of transparency is not a new concern. Potential amendments to the Food and Drugs Act were proposed in 2008, through another bill known as Bill C-51: An act to amend the Food and Drugs Act and to make consequential amendments to other acts. An election killed that bill, which contained similar-but-more-extensive changes than Bill C-17. “There was a new provision to make information that Health Canada had transparent to the public. So, there was a specific change that was proposed to the Food and Drugs Act that didn’t get passed that would help with transparency,” says Herder which he adds makes it even more strange that this has been left out of Bill C-17. “It’s not like the government doesn’t have a language or provision that it could use to help with transparency. It had one in the last version of the bill that would change the Food and Drugs Act and it’s left that out this time around and that to me is pretty puzzling.”

Consumer advocacy groups support the bill but want more

The drug research group, Pharmawatch, supports Bill C-17. However, like Young, Persaud, and Herder, its members would like to see a few things added to the bill.

Barbara Mintzes, an epidemiologist and reviewer of new medicines at Pharmawatch, points to the case of Vioxx as an example of how a lack of transparency in the approval process may have helped. Vioxx was a drug that was used to treat arthritis. It was on the market in Canada from 1999-2004. It was pulled off the market in 2004 after it was revealed to be causing an increased number of cardiac events including heart disease and heart attacks. Mintzes believes that if the full clinical trial data had been available and if there was a more consistent way of collecting adverse drug reaction reports like the one proposed in Bill C-17, then Vioxx would have been taken off the Canadian market sooner and lives would have been saved.

Colleen Fuller, a health policy researcher and writer at Canadian Doctors for Medicare would like to see further changes as well, however, she is still thrilled to see Bill C-17 on the table, “I think that we live in dark times in terms of the federal government and any kind of progressive legislative or regulatory direction in terms of pharmaceuticals and health policy generally and so forth. So given that is where we’re at, I think that C-17 is a good step, it’s an important step, it’s a really positive direction to go in.”

Money and pharmaceutical drugs in Canada

The pharmaceutical industry in Canada generates billions of dollars each year. In drug sales alone, the amount generated has nearly doubled from $11.7 billion in 2001 to the most recent figure of $21.6 billion in 2012.

The top ten selling drugs in Canada in 2012 made up 14 per cent of total drug sales in Canada that year.

Because of the profits pharmaceutical companies make, Young says imposing bigger fines for breaching regulations will make a difference. He uses the example of Glaxosmithkline, an American drug company forced to pay a large fine in 2012 for problems related to three of its drugs Paxil, Avendia, and Wellbutrin, “Glaxosmithkline paid a $3 billion fine but sales of those three drugs in the previous years was $26 billion so it’s like a speeding ticket for the drug companies.” When Prepulsid, the drug Vanessa Young was taking at the time of her death, was on the market in Canada, it was generating millions of dollars a year for Janssen-Ortho, a subsidiary of American company Johnson & Johnson.

One of the clauses in Bill C-17 would allow Health Canada to impose unlimited fines on drug companies and manufactures who do not adhere to regulations.

 

Bill C-17 – Terence Young from Priya Sam on Vimeo.

Getting dangerous drugs off the market

Terence Young will never forget March 19, 2000. It started off as a normal day, he went out in the afternoon to renew his daughter’s prescription for Prepulsid, something she was taking once in a while to help with bloating related to what he calls a mild case of bulimia nervosa. Then, he went shopping with his wife, Gloria. Feeling a bit tired after coming home, he was reading the newspaper before dinner.

He was in his study when his 15 year old daughter Vanessa came in to ask him something. Young assumed it was a routine Saturday question about extending her curfew and told his daughter they would discuss it later. As she was leaving the room, she suddenly fell to the ground. In his book, Young says it was “as if she had been pushed by a giant invisible hand.” He describes the next few minutes as being a blur of calling for his wife and giving his daughter mouth to mouth. A nurse who lived down the street arrived to help while his wife called 9-1-1.

A few minutes later, ambulances arrived with paramedics who asked if there was any chance Vanessa has used any drugs other than Prepulsid. While Young and his wife were confident that she hadn’t, they ran upstairs and did a thorough check of all her belongings. They found nothing.

Time stands still

As the healthcare professionals in the emergency room worked to revive Vanessa. He heard them discussing Prepulsid. Someone consulted the CPS (the Compendium of Pharmaceuticals and Specialties), which can be found in every doctor’s office. After finding the entry about Prepulsid, the discussion shifted from puzzled talk about what could have caused Vanessa’s reaction to concern about who had prescribed Prepulsid to her.

As family members began to arrive, one of them, Young’s brother suggested moving Vanessa to McMaster University Hospital. She was taken there, but a few hours later, Young realized he was going to lose her forever.

A journey begins

After she died, Young made a promise to get justice for Vanessa and his mission continues today.

His phone calls and discussions with doctors, pharmaceutical industry insiders and other politicians lead him to discover that Vanessa should not have been prescribed Prepulsid in the first place. He discovered it should not have been prescribed to anyone who had a health condition connected to vomiting. All of Vanessa’s doctors, including the one who prescribed Prepulsid were aware that she had bulimia nervosa of which one of the symptoms is vomiting.

Young says that Janssen-Ortho was aware that Prepulsid had been causing heart irregularities in some patients. He also discovered, the doctors had received several letters warning them to prescribe Prepulsid (also known as Cisapride) carefully. In the Canadian Adverse Drug Reaction Newsletter from January 2000, just two months before Vanessa’s death, an article was published saying, “As of Sept. 16, 1999, the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) received 127 reports of suspected adverse drug reactions (ADRs) associated with the use of cisapride; 70 reports were of a serious nature. Of concern were 35 reports involving heart rate and rhythm disorders.” Despite this, Vanessa was still prescribed the drug.

Prepulsid recalled

On May 30, 2000, just two months after Vanessa’s death, Health Canada notified health professionals that Janssen-Ortho would be voluntarily recalling Prepulsid and that it would be taken off pharmacy shelves by August. The advisory note to doctors said, “Between its introduction in 1990 and February 2000, Health Canada received at least 44 spontaneous domestic reports of potential cardiac rhythm abnormalities associated with Prepulsid, including at least 10 reports of death. In the United States, the Food and Drug Administration has received 341 reports of cardiac rhythm abnormalities, including 80 fatalities. The continuing occurrence of such adverse events, despite several letters to health care professionals and changes to the Product Monograph, has led to the conclusion that the risks associated with Prepulsid are not manageable in the setting of licensed drug use.”

Life-saving changes

Young believes Bill C-17 will save lives, had the bill been in place, he says there would have been clear warnings on the label about the side effects and circumstances in which Prepulsid should not be used. He or his wife would have seen a warning about it not being meant for someone with a condition involving vomiting and their daughter would still be alive, “So would thousands of other Canadians. Prescription drugs taken as prescribed, without error, are the fourth-leading cause of death of Canadians today, and Americans. The drug companies, they love to talk about drug errors when a doctor makes a mistake or a patient takes the wrong drug, they always change the conversation to that. But I’m not talking about drug errors, I’m not talking about when the patient or doctor makes a mistake. I’m talking about their products that they promised met regulatory conditions and Canadians were safe for us to take and our families to take.”

Mission accomplished?           

Young says if Bill C-17 is passed, it will be a big improvement for drug safety in Canada. However, his work will not be done after this. He plans to run for at least one more term, maybe two. “I still have a time in the coming years for a private member’s bill in Parliament…my plan at this point is to initiate it on integrity and transparency in research in Canada. So, that’s what’s going to be my next hurdle.” In saying this, he also notes that his fight against drug companies is far from over.

Supporting change

Bill C-17 will be reviewed by the Health Committee later this month. So far, it seems to have the support of the other parties, NDP Health critic Libby Davies says, “The bill, as far it goes, is obviously an improvement over what we have now. The fact that the minister previously did not have any power to recall unsafe drugs or to require drugs to undergo further testing was a huge problem…so this is actually long overdue.”

Young is hopeful, but realistic about what the outcome will be, “When the government of Canada acts based on information in the death of an innocent 15 year-old girl, to me that’s the highest expression of democracy, so I’m very, very pleased. On the other hand, I’ve also been at this so long, fourteen years now, I get a little nervous that somehow it could be undermined through the legislative process.”

He knows Vanessa would be pleased with how far he’s come. “I think she’d say, “Great job, Dad. I’m proud of you.”