Editorial Note: This post is excerpted from After the Error: Speaking Out About Patient Safety to Save Lives by Susan McIver, Ph.D. and Robin Wyndham. © 2013 Susan McIver and Robin Wyndham. Published by ECW Press Ltd. ecwpress.com
The day after Terence Young’s 15-year-old daughter, Vanessa, suddenly died on March 19, 2000, he began his journey to find out why. Questions and comments by attending medical professionals led him to suspect that Prepulsid, which Vanessa had been prescribed for mild bulimia and bloating, had played a role and that he and Vanessa’s mother had not been told the whole story about the drug’s known dangerous, even lethal, side effects. He searched the internet for everything he could find about Prepulsid, prescription drugs and the companies that make them. He researched company and government policies regarding testing, warnings and monitoring once the drugs were on the market. He spoke with hundreds of medical and scientific experts to shed light on why Vanessa died.
Strengthened with a formidable amount of disturbing knowledge, Terence successfully argued for an inquest into the circumstances associated with Vanessa’s death. He established the research and advocacy organization Drug Safety Canada (drugsafetycanada.com), launched lawsuits and wrote the book Death by Prescription (2005), an investigative journey into the world of “Big Pharma.”
To help raise awareness of the dangers associated with prescription drugs, Terence has spoken at conferences and universities and to community groups and the media across the country. He stood by other families who lost children as a result of prescription medications. In 2008, he ran successfully for Member of Parliament (MP) for Oakville, Ontario, in order to influence federal regulation of prescription drugs. Respected for his integrity and courage, he was re-elected in May 2011.
Tragedy, questions and realization
As Terence Young said, there wasn’t much that made his family different from any other except for their many blessings. Terence and his wife, Gloria, and their three children, Madeline, Vanessa and Hart lived in Oakville, Ontario, an attractive community with good schools and a low crime rate. A manager with Bell Canada from 1981 to 1994, Terence was elected to the Parliament of Ontario in 1995. He made the news for his private member’s bill titled “An Act to Promote Zero Tolerance for Substance Abuse by Children.” Four years later, his riding of Halton Centre was eliminated when the number of provincial ridings was reduced. The next year, when the Young family’s life changed forever, Terence was building a consultancy business and Gloria was working in public affairs for a hospital.
On a Saturday evening in mid-March 2000, Vanessa, 15, went downstairs to greet her father, who was reading the newspaper in his study. He and Gloria had been out shopping and returned home around 6 p.m., tired and hungry. Terence remembers that Vanessa wanted to ask him something. Suspecting her request had to do with her curfew, he said, “Not now, Vanessa,” preferring to delay the discussion until he’d had dinner and was in a better frame of mind.
As Vanessa started to go upstairs, she fell backward, striking the back of her head on the carpet. Terence rushed to his daughter and found her limp, motionless and pale. The possibility that Vanessa had suffered a fainting spell flashed through his mind, but she had never fainted before. In the following few minutes, an ambulance was called, Terence’s brother Ted, a surgeon, was contacted and a neighbour, Anna, a registered nurse, came to help Terence with CPR and mouth-to-mouth resuscitation.
Soon Terence was telling the paramedics and an attending police officer that Vanessa’s only medication was Prepulsid, which had been prescribed for bloating. She wouldn’t have taken any other medication and never used recreational drugs. “She was fine today. She was baking cookies. She probably ate some of them. Nothing like this has ever happened before,” Terence told the paramedics. In a search of Vanessa’s room and personal items, Gloria and Terence found no drugs other than the prescribed Prepulsid, not even Aspirin or Tylenol.
In hospital, hope flickered briefly when Vanessa’s heart began to beat after she had been technically dead for almost half an hour. In the middle of the night, lying exhausted on a couch in the intensive care waiting room, Terence realized there would be no miracle for Vanessa. Too much time had elapsed with her heart being stopped, and then there were the looks on the doctors’ faces and their careful choice of words. Vanessa died on Sunday, March 19, 2000, at 1:12 p.m.
In Terence’s words: “Why did this happen? I had to find the answer. I began my search the day after Vanessa died.”
Questions about Prepulsid (the trade name for the drug cisapride) began in the emergency room. Who had prescribed it? Why did the cardiologist who had revived Vanessa’s heart tell Terence, “They dish it [Prepulsid] out like water.” Who were “they”? Why were the doctors referring to a large blue book called the Compendium of Pharmaceuticals and Specialities? The doctors said that Prepulsid was a dangerous drug for some patients. Something to do with “long QT,” which Terence didn’t understand. Terence became suspicious that Prepulsid might have played a role in his daughter’s death and that he wasn’t being told the whole story:
I am not unworldly. I’d been in business for 25 years, and had been a member of the Provincial Parliament for four years. I knew that people make mistakes. I knew they try to cover them up. But this was simply unbelievable.
We were fully aware of Vanessa starting on Prepulsid. No one had cautioned us in any way. If they had, we wouldn’t have let her take it. There was simply no reason I could imagine why Vanessa should have fallen down dead. It wasn’t just the bleak sadness of Vanessa’s death that haunted me. The truth is I had come face to face with a startling truth: even when you try your utmost to protect the ones you love, unseen things can put them in danger. The optimism I had enjoyed for as long as I had known had been supplanted with fear.
That Monday morning I slumped over my desk, head in my hands, playing back the previous two days’ events — like rewinding a movie. Tears came without control.
Why did Vanessa die?
The first thing Terence wanted to do after Vanessa’s death was to warn others about any dangers associated with the use of Prepulsid. Before visiting the funeral home to arrange for Vanessa’s funeral, he called Johnson & Johnson’s Canadian drug division, Janssen-Ortho in Toronto, which sold Prepulsid in Canada. Terence wanted to tell them what had happened so they could issue an urgent public warning, and he wanted to ask how on earth this could have happened. What he learned from those phone conversations and the internet was stunning.
Prepulsid was sold worldwide in 119 countries and U.S. news sources claimed that 341 adverse reactions as well as 80 deaths had been reported from this “heartburn drug.” In conversation with a representative of Janssen-Ortho, Terence realized that he wasn’t telling the company anything it hadn’t known for years. He also came to understand that “the blame game” was on. Janssen had faxed four letters to doctors and there had been two warnings in the Canadian Medical Association Journal concerning risks associated with Prepulsid. It would not be the company’s fault that Vanessa died, but rather the fault of her physician who prescribed Prepulsid and either didn’t see or didn’t appreciate the significance of the warnings. Terence recalled:
But Vanessa had seen three other doctors in the previous 14 months. Our gastroenterologist had seen Vanessa in January to test for any blockage in her digestive system that might make her bloated and throw up after meals. A little over a year before Vanessa had gone to see a psychiatrist for advice on how to deal with her bloated feeling and off-and-on problem of throwing up after meals. And in the previous few weeks, Vanessa had seen a specialist in child psychology twice to talk about it. Presumably these four doctors had been sent form letters from Prepulsid’s manufacturers outlining any dangers. Neither Gloria nor I had ever been told, however, of any potential risks.
Soon Terence would learn that the dangers associated with Prepulsid had been known for years. A 1992 World Health Organization study raised concerns about the drug. In July 1996, the Canadian Adverse Drug Reaction Newsletter1,2, a quarterly Health Canada publication that appears on the department’s website and in the Canadian Medical Association Journal,2 carried a report noting that “serious ventricular arrhythmias” had been observed in some patients taking the drugs who had pre-existing heart problems or risk factors for arrhythmia.
Also in 1996, the Vancouver General Hospital’s Drug and Therapeutics Newsletter2 warned doctors to use caution when prescribing Prepulsid to patients with a history of arrhythmia, cardiac disease or electrolyte imbalance.
In late June 1998, the U.S. Food and Drug Administration (FDA) sent a letter to American doctors warning about the danger of an irregular heartbeat associated with Prepulsid.
As of September 16, 1999, Health Canada had received 127 reports of adverse reactions associated with Prepulsid. Seventy of these were of a serious nature, including 35 reports involving heart rate and rhythm disorders. There were 12 reports of fatalities associated with the use of Prepulsid. In the same January 2000 Adverse Drug Reaction Newsletter containing the reports, Health Canada said that changes had been made to the Prepulsid’s official drug profile, including updated prescribing information.
On January 24, 2000, the FDA sent out another letter advising patients to have an electrocardiogram before taking Prepulsid. The administration also said the drug should not be prescribed to patients with eating disorders.
A warning letter was sent to Canadian doctors on February 25, 2000, at which time Health Canada decided to review the drug more thoroughly. Prepulsid was withdrawn from the U.S. market on March 23, 2000, and from the Canadian market on May 31, 2000. As of August 7, 2000, the drug was no longer available in Canada. At the time of withdrawal, Health Canada said that it had received 44 reports of potential heart rhythm abnormalities, including 10 deaths associated with the drug. In the United States, Prepulsid had been associated with 341 serious adverse reactions and at least 80 deaths.
Death by prescription
In April 2000, a few weeks after Vanessa’s death, Terence obtained a copy of the U.S. Prepulsid Medication Guide, the information sheet given to American patients with their pills. Key sections included:
What is the Most Important Information I Should Know About Prepulsid (cisapride)?
- PREPULSID may cause serious irregular heartbeats that may cause death.
- If you feel faint, become dizzy or have irregular heartbeats while using PREPULSID, stop taking PREPULSID and get medical help right away.
- The safety and effectiveness of PREPULSID in children younger than 16 years has not been demonstrated for any use. Serious adverse events, including death, have been reported in infants and children while being treated with PREPULSID, although there is no clear evidence that PREPULSID caused them.
- Also, you should not take PREPULSID if you have any of these conditions [four of the nine conditions follow]
- low levels of potassium, calcium or magnesium
- an eating disorder (such as bulimia and anorexia)
- your body has suddenly lost a lot of water
- persistent vomiting
Vanessa displayed all four of these conditions. As a bulimic, she vomited, which can lead to dehydration and the loss of chemicals such as potassium, calcium and magnesium. Imbalance of these chemicals affects the functioning of heart muscle and the nervous system.
At the time patients in the United States were being warned that Prepulsid could cause irregular heartbeats, possibly with fatal outcomes, Canadians were being told the drug had few or no side effects. Why did Canadians not see this up-front, clearly worded warning about the adverse reactions to Prepulsid? Where was Health Canada?
A coroner’s inquest that began exactly one year after Vanessa’s death found the cause of death to be acute hypoxic/ischemic encephalopathy (lack of oxygen to the brain) due to arrhythmia followed by cardiac arrest resulting from the effects of bulimia nervosa in conjunction with cisapride (Prepulsid) toxicity and possibly an unknown co-factor such as congenital cardiac defect. This multi-faceted cause allowed the drug company, Vanessa’s doctors and Health Canada to exempt themselves from any blame or responsibility. The purpose of an inquest is to find fact, not to lay blame.
Facts to emerge during the inquest that concluded on April 24, 2001, revealed that prescription drugs, which can be highly beneficial, even life-saving, are one of Canada’s most serious and under-reported causes of health problems.
“The federal government should review why the system is failing to protect Canadians against dangerous drugs,” Terence told the coroner’s jury as part of his own long list of recommendations. Among his other recommendations were to advise patients in clear language of all risks and benefits associated with a drug; make it mandatory for drug companies, doctors and pharmacists to immediately report any adverse drug reactions to Health Canada; and implement stiff fines for drug companies and sales representatives that withhold important drug safety information.
At the top of the jury’s 59 recommendations was establishing a national body to examine how critical drug safety information is delivered to Canadians. Relevant recommendations were directed to the pharmaceutical industry, the Ontario College of Physicians and Surgeons, Ontario College of Pharmacists, Ontario College of Family Physicians, Ontario Medical Schools, Ontario College of Nurses, Ontario Ministry of Health, Coroner’s Office of Ontario and Health Canada. In November 2010, Young said that of the 16 key recommendations for Health Canada only a few had been implemented and they were “easy stuff” such as developing a website and setting up a toll-free number for general inquiries regarding drug information for the general public.
In a December 21, 2006, report, Jenny Manzer of the Ottawa Citizen newspaper wrote, “There are many facets of our drug safety system that might surprise Canadians, particularly how closely Health Canada works with the drug industry.” Two years earlier, the Canadian Association of Journalists selected Health Canada for the Code of Silence Award for its repeated refusals to make the database that contains drug side effects available to journalists and researchers. Subsequently, the database was made public.
Why did marketing continue when people were dying?
At the conclusion of the inquest Gary Will, the lawyer representing the Young family, told the National Post newspaper, as reported by Anne Marie Owens on April 25, 2001, that he was not surprised when Janssen’s spokeswoman walked away from reporters when asked if the company accepted any responsibility for the death: “This company spent four weeks at the inquest trying to blame Vanessa Young and trying to blame the Young family. They didn’t take responsibility for their actions.” He also said that a larger federal inquiry is necessary to uncover what he called the Prepulsid scandal and to answer important questions such as, “Why did Janssen continue marketing this drug when they knew people were dying? Why are they marketing this drug to 100 countries around the world today?”
In July 2001, Terence initiated a $100 million class-action lawsuit against Health Canada and Janssen-Ortho Corporation for allegedly failing to notify patients about the potentially harmful side effects of Prepulsid. From its approval in 1990 until 2001, Prepulsid was prescribed as a “heartburn drug” to approximately a million Canadians. In April 2001, a man in Sault Ste. Marie, Ontario, filed a $600 million class-action motion. The man allegedly had two heart attacks after taking the drug. In the United States there were more than 500 individual and class-action lawsuits against the pharmaceutical company and doctors before the courts in 2001 regarding the side effects of Prepulsid.
In January 2007, a judge ruled that the class-action suit initiated by Terence could move toward trial. The decision to certify the case followed years of legal wrangling. The drug company appealed the certification, but lost in May 2007. They appealed the appeal decision and again lost. Although pleased with the decision, supporters of the suit were concerned that it had taken six years to get the case to this stage. A similar case in the United States was settled in 2004 with a payout of up to US$90 million to 16,000 Prepulsid users.
While the class-action suit was moving toward certification, Terence and his family pursued a separate individual lawsuit which was settled in February 2006. Although wanting a public trial to expose alleged failures, Terence was unwilling to risk having to pay the legal costs of the defendants if he lost. The thought of losing the family home was too much to contemplate on top of all his family had suffered. “There is no balance of power between powerless individuals and huge international corporations as there is in the U.S.”, he wrote.
Drug Safety Canada
In 2002, Terence founded the organization Drug Safety Canada (DSC), which is dedicated to reducing the number of patient deaths and serious adverse reactions by improving prescription drug safety. Looking to the future, DSC wants a new perspective on health care, one in which “pharmaceuticals do not dominate medicine and are prescribed only when they will be truly safe for patients. This would reduce patient deaths in North America by as much as 140,000 a year and reduce serious injuries by over 1,000,000 per year.”
We believe that prescribing a drug safely should include the doctor’s full medical understanding of two things:
- the true risks of the drug for each patient, taking into consideration not just their symptoms but their condition, age, sex and all other drugs and natural health products they are taking, along with foods they are consuming.
- the proven efficacy of the drug for that patient, using the best available objective evidence based on reports of adverse reaction injuries and deaths in every country where the drug is marketed.
Patients should provide informed consent for each prescription after hearing the true potential risks along with the proven potential benefits of any therapy and after receiving professional advice on possible alternatives to prescription drug therapy such as changes in work, diet, exercise, sleep habits and other safer therapies that are clinically proven to benefit patients.
DSC’s website also provides information regarding prescription drugs by citing studies from recognized medical, scientific and government sources.
Terence is a stalwart supporter of other families whose children and other members have died under circumstances in which prescription drugs may have played a role. “Sara Carlin hanged herself,” an upset Hart Young told his family after taking a phone call at 9 p.m. on May 7, 2007. Sara, 18, belonged to Hart’s group of friends and had been at the Young house a few weeks earlier.
Terence’s first thought was about the family and what they must be feeling. His second thought was suspicion. A beautiful, vibrant girl, Sara had been a high achiever at school until early 2006 when she had been prescribed the SSRI antidepressant Paxil, and her behaviour began to change. She quit sports and her part-time job, suffered from insomnia and became involved with recreational drugs and alcohol. No one had told Sara or her family that Health Canada had already issued two warning letters to health-care professionals about Paxil and suicide. The second letter in particular warned about the risk of self-harm and behavioural and emotional changes, including agitation, hostility, depersonalization and several symptoms that could manifest as an almost indescribable sense of terror and doom. “Sara had apparently hung herself in the basement of her home some time on Saturday night. Her father found her fully suspended at 4:30 p.m. on Sunday. I could only imagine his horror,” Terence wrote.
An inquest into Sara’s death was held in summer 2010. Terence’s testimony at the inquest was described by David Lea in a June 18, 2010, article in the Oakville Beaver newspaper as showing no mercy for Health Canada, GlaxoSmithKline (manufacturer of Paxil) and others for not doing enough to protect Canadians from the dangers of prescription drugs. During the two-week-long inquest, some experts argued there was no evidence that Paxil caused Sara’s suicide, while the Carlin family, their lawyer and others maintained she became increasingly depressed after starting to take Paxil in February 2006.
The need for global transparency
The inquest resulted in 16 recommendations, including a call for the federal government to create an arm’s-length body called the Drug Safety Board to investigate the side effects of prescription drugs and issue warnings to the public, doctors and hospitals. This recommendation came after Terence told the inquest that Health Canada’s use of trials partly funded by pharmaceutical companies to decide which drugs to put on the market creates a bias. He also recommended that drug companies be required to publish the results of all their clinical trials, not just the favourable ones, and that patients should be made aware if the drug they are taking has a history of adverse reactions in other countries. In addition, health-care professionals should be required to report all suspected adverse drug reactions to Health Canada within 48 hours of the reaction taking place.
At the time of the inquest, Terence, who had been elected Member of Parliament representing Oakville, Ontario, two years earlier, had a private member’s motion before Parliament. Bill M-355 states: “That, in the opinion of the House, the government should create an arm’s-length Independent Drug Agency similar to the Transportation Safety Board and Canadian Nuclear Safety Commission, to be responsible for making and keeping Canadians safe when using prescription drugs and over-the-counter drugs, and for reducing injuries and deaths caused by or related to their use.” The proposed agency would have the power to order (not negotiate) unsafe drugs off the market, and the power to distribute clearly worded warnings to doctors and patients for all approved drugs. At the Carlin inquest, Terence said it would be some time before the motion would be discussed. The situation remained the same two years later.
An end to inappropriate partnerships between companies and regulators?
When Terence ran for federal office in 2008, he promised to be an additional voice in Ottawa for improved regulations, especially about the need for effective safety warnings given to patients with their prescriptions. He also promised to work toward ending the inappropriate partnerships between large pharmaceutical companies and doctors and regulators. On January 24, 2011, Terence told CTV News: “Nothing significant has changed since Vanessa died. There are dangerous drugs on the market right now, because regulators still aren’t issuing proper safety warnings. Twenty-two prescription drugs that Health Canada and the pharmaceutical industry told us were safe have been taken off the market since 1977 for injuring and killing patients.”
Always concerned about health issues, especially those related to children, Terence supported the government’s regulations announced in January 2011 to restrict the use of six phthalates, chemicals that may case adverse health effects in children and infants, in toys and childcare items. Terence was re-elected as MP for Oakville in the May 2011.
On March 26, 2009, Terence made a presentation to the Ontario Legislative Assembly Standing Committee on Justice Policy, which was considering changes to the Coroner’s Act. Terence was joined by Neil Carlin, Sara’s father and Maryanne Murray, whose 22-year-old daughter, Martha, died in September 2002 after being given lithium when it was contraindicated. All three parents wanted the addition of a new category in the classification of deaths for those deaths caused by administration of drugs. The existing categories are natural, accidental, homicide, suicide and undetermined. Terence explained to the committee the rationale for proposing the new category: “Our chief concern is that deaths caused by prescription drugs are almost always classified under the act as ‘natural.’ You read that right. According to the Ontario Coroner’s Act deaths caused by an adverse reaction to a drugs are classified as ‘natural.’ The only way to help reduce drug deaths is to identify the problem, not cover it up. We are calling for a new fifth category in the act.” The parents’ proposal was not adopted.
Who killed Vanessa?
Terence’s well-researched book, Death by Prescription, was released in April 2009. At the book’s launch, Terence spoke about how pharmaceuticals came to dominate medical care, citing that more is spent on drugs ($24 billion in 2005 in prescription and over-the-counter sales of drugs) than on doctors ($18 billion). In the meantime, more than 100,000 Canadians and more than two million people in the U.S. are seriously injured each year.
Death by Prescription contains many of Terence’s thought-provoking insights:
I had always thought risk management referred to the risk to the patients. I remembered what Alex Demerse had told me. “From their [the pharmaceutical companies] view, it’s better to keep selling it if the lawsuits are minimal — especially in Canada. It’s just the cost of doing business.” If they start losing in court, he’d said, their insurance will cover most of the costs. So that was risk management. It wasn’t the risk to patients they were worried about. It was risk to the corporation! Risk management is a practice that puts human life on the same continuum as money. Money versus lives. Lives versus money […]
In 2003 a leading expert on prescription drugs made an astonishing statement at a scientific meeting in London, England. Dr. Allen Roses, vice-president of genetics for GlaxoSmith Kline (GSK), the world’s second-largest drug company, reported, “The vast majority of drugs — more than 90 percent — only work in 30 or 50 percent of people.” GSK marketed the blockbusters Advair, Avandia, Paxil, Zophran, Wellbutrin and Augmentin . . . Prescription drug sales hit the $600 billion mark worldwide in 2006. Dr. Roses was saying indirectly that perhaps $200 billion a year spent worldwide on prescription drugs is really wasted. And since all drugs cause adverse reactions, millions of patients are put at risk daily for no good reason […]
The Canadian Pharmacists’ Association says that the cost of underuse, misuse, and overuse of prescription drugs could range between $2 billion and $9 billion a year. How much healthier would Canadians be if we invested that money in preventative health care, such as regular checkups, physical activity, stress management, diet education, tobacco intervention, and tests like pap smears and colonoscopies?…
Gloria and I had always taught our children they were incredibly lucky to live in Canada. I recalled a happy time — the first time we listened to Vanessa and her classmates sing “O Canada” — her grade one concert at Abbey Lane School. “We stand on guard for thee,” the children sang. But shouldn’t loyalty work both ways? Wasn’t there an unspoken promise for the government to stand on guard for Vanessa? The government and Health Canada have broken faith with the rest of us. And Vanessa paid the ultimate price.
Terence wrote his book to save lives and to fulfill an oath he had made the day after Vanessa died — to find out why and how she died. In the book’s epilogue, he wrote:
Who killed Vanessa? When it was all said and done, I think the ultimate enemy was self-interest. Professional people in positions of trust neglected to do what they knew they should have. Others concerned about their jobs and careers turned a blind eye to dangers to which they would never have exposed their own families. They turned off their sense of right and wrong when they went to work each day.
But the people who casually manipulated the self-interest of others, and acted to delay and undermine effective warnings that would have saved Vanessa’s life deserve special recognition.