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 28th 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.”