* See NEWS UPDATE below
When I first heard him interviewed on CBC Radio, I had to stop chopping my red peppers for that night’s pasta sauce. I was utterly riveted by Terence Young‘s compelling story about the tragic death of his 15-year old daughter, Vanessa. His story began 11 years ago on an ordinary spring evening at home near Toronto, while his wife Gloria was also preparing dinner for the family, just as I was doing. Vanessa suddenly collapsed to the floor. Her heart had stopped.
When ambulance paramedics asked if Vanessa had been taking any drugs, her stricken parents replied: “Just Prepulsid.” Prepulsid was the brand name for the drug cisapride, commonly prescribed at the time to treat gastrointestinal issues like indigestion or constipation.
What Terence Young later learned was that cisapride was clearly contraindicated for Vanessa, and that the drug had been associated with hundreds of suspicious deaths in Canada and the United States. The FDA in the U.S. for example, had originally approved cisapride (sold there as Propulsid) to ease nighttime heartburn. But as an investigative report published in the Los Angeles Times* showed, a sign of danger had loomed since 1993:
“FDA medical officer Dr. Andre Dubois found that the drug’s chemical makeup could disturb cardiac function. But he agreed with drug maker Janssen Pharmaceutica, a Johnson & Johnson subsidiary, that deaths observed during early studies were attributable to other causes. He recommended approval along with labelling disclosure of potential cardiac effects.
“Dubois, however, worked in a division of the FDA that focuses on drugs for the gastrointestinal tract. No one at the FDA consulted with the agency’s division of cardiac specialists before approving Propulsid on July 29, 1993.
“But by early 1995, Propulsid’s danger to the heart was certainly identified as a concern within the gastrointestinal division, agency records show.
“On March 23, 2000, the FDA announced that Propulsid would be taken off the market in July as a normally prescribed drug because of scores of confirmed heart-rhythm deaths. Overall, Propulsid has been cited as a suspect in 302 deaths.
“FDA administrators now concede that the agency failed to contain Propulsid’s fatal risk.”
Terence Young also discovered that Health Canada for unknown reasons had delayed alerting doctors about cisapride’s potential dangers due to its reported link with a fatal cardiac arrhythmia – the same one that had killed his daughter.
I was moved by what he has been trying to achieve since Vanessa’s death to make sure no other Canadian family would suffer a similar tragic loss because of the way all pharmaceutical drugs are approved, marketed and regulated.
For example, he founded Drug Safety Canada, a non-profit organization whose goal is to “find ways to reduce patient deaths and serious adverse reactions by improving prescription drug safety.”
He’s also the author of Death by Prescription: A Father Takes on His Daughter’s Killer — the Multi-Billion-Dollar Pharmaceutical Industry.
And Terence Young happens to be a federal politician, representing the Toronto-area constituency of Oakville in the Canadian Parliament.
Ironically, the same month his book was published in 2009, Young proposed a Private Member’s bill to Parliament that would create an independent drug agency for Canada, similar to the Nuclear Safety Agency or Transportation Safety Board, focusing solely on prescription drug safety. *
He’s not alone in calling for such a national watchdog agency. Three years after Vanessa’s death, an editorial in the Canadian Medical Association Journal (CMAJ February 4, 2003 vol. 168 no. 3) said:
“We’ve argued for the creation of a National Drug Agency ever since the preventable death of 15-year-old Vanessa Young from an adverse drug reaction provided a tragic demonstration of the inadequacy of drug surveillance in Canada.”
In a book review of Death by Prescription, also published in the Canadian Medical Association Journal**, Dr. Thomas L. Perry of the University of British Columbia in Vancouver observed:
“Young, while at times naive about science and medicine, also displays formidable analytical skills. As an experienced businessman, Young “knew I must follow the money.”
“Eight years of research and contemplation allow him to generalize from personal experience to a broad and free-thinking critique of how the global economy promotes unwise and unethical use of prescription drugs.
“He describes systematic flaws in the processes of drug discovery, licensing, regulation and marketing, most referenced with detailed footnotes. Young is harshly critical of what he sees as Health Canada’s lax regulatory approach and of how the federal government appears to favour drug manufacturers’ economic interests over consumer protection.
“Young does not spare the medical profession, either. He emphasizes that the pharmacology education of medical students is in shocking disarray, while continuing medical education for practising doctors is fatally conflicted by commercial sponsorship.
“He is disappointed that few doctors report adverse drug reactions, and explores why they may consider it futile to file such reports to a government agency that often appears to ignore them.” © CMAJ
Terence Young is up against a formidable adversary in the marketing machine that is Big Pharma. And Health Canada’s own drug safety procedures leave a lot to be desired, according to a 2009 study released by the Canadian Centre for Policy Alternatives.
Their investigative report, Drug Safety and Health Canada: Going, Going… Gone? by Dr. Joel Lexchin, says Health Canada’s priorities are skewed in favour of rapid approval of new drugs at the expense of the post-marketing pharmaco-surveillance system.
“In Canada, 3-4% of drugs approved will eventually be withdrawn from the market because of safety issues. The number of people exposed to these drugs is increasing because of aggressive marketing tactics by the pharmaceutical industry.
“Health Canada cannot force a drug company to recall drugs deemed harmful from pharmacy shelves. Nor can they directly compel a company to revise product labels to reflect new safety information.”
Find out more about the book: Death by Prescription: A Father Takes on His Daughter’s Killer – the Multi-Billion Dollar Pharmaceutical Companies
Or watch Terence Young’s television interview about Vanessa’s story.
UPDATE, October 2012: Terence Young expressed incredulity during a Maclean’s interview this month that prescription drugs are not regulated as stringently as other public safety threats, explaining:
“The minister of transportation doesn’t ‘negotiate’ with truckers to keep unsafe vehicles off roads. By law, doctors must report unfit drivers, and are paid to do so. Fast-tracking drugs to market is like air-traffic controllers being told to land planes more quickly.”
Eleven years after his daughter Vanessa’s inquest, none of its major recommendations have been implemented, he says.
“Nothing has changed since Vanessa died. It has only gotten worse.”
* BREAKING NEWS UPDATE, December 6, 2013: Canadian government announces new patient safety legislation, known as the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). Terence Young tweeted this message:
* Los Angeles Times, December 20, 2000 – “PROPULSID: A Heartburn Drug, Now Linked to Children’s Deaths”
** CMAJ “We (Do Not) Stand On Guard For Thee” – September 1, 2009 vol. 181 no. 5 First published August 24, 2009, doi: 10.1503/cmaj.091353
Deaths from prescription drugs do not make news like those from “illegal” drugs. Apart from Propulsid, there have been deaths associated with various ADHD drugs such as Stratera and Ritalin – yet nothing seems to be done.
Keep up the good work of publishing this information Carolyn.
Hi Dr. Joe – add to your list of deadly prescription drugs: Darvon (finally recalled last November); Avandia (already banned in Europe, the New England Journal of Medicine described this drug as “raising heart attack risk by 43%”, about the same time GlaxoSmithKline was charged $3.4 BILLION to settle injury and death claims); Yaz/Yasmine (4,000 lawsuits this year alone but still on the market as a birth control pill); Accutane (acne patients must now sign a disclaimer form before being prescribed this, confirming that they understand all the risks associated with the drug, including depression and suicide) or Nuvaring (a birth control device) among many others.
Thanks for your comment here.
This is a heartbreaking family tragedy that might have been prevented had the government not been so hamstrung by Big Pharma lobbying efforts. Thanks for telling us this story and also about Terence’s book.
I was on prepulsid for several years and developed a serious heart problem as a result. However, I did not hear about the tragedy of Vanessa until about 2010. By that time, I had really been through the ringer with my heart prolems. I almost died because of the strange arrhythmias and critically low heart rate (31 bpm) with up to 3 second pauses. Luckily my doctor heard some of the stories about Prepulsid and took me off of it. However, I had already sustained irreparable damage to the rhythmic system of my heart. My slow and irregular heart beat led to extreme fatigue until, finally In 2004, I had a dual chamber pacemaker implanted.
I have not been the same person since taking the prepulsid. Even with the pacemaker, I have never been restored to the person I was prior to taking it. I have already had the original pacemaker replaced in 2011. My life has changed drastically. But, I am still alive.
I am glad that I heard about the book Death by Prescription. I ordered it immediately and read it cover to cover. I applaud Terence Young!
Your story is tragic, Florence, and apparently all too common. You are still alive – a miracle! – but you have paid a heavy price because you’d been prescribed a dangerous drug. Thanks for sharing your perspective here, and good luck to you.
Y a-t-il une seule personne ayant été compensée dans le recours collectif?
Je ne sais pas, Richard. Settlement update, USA (2008):