Mr. Speaker, I am very pleased to stand in the Parliament of Canada today to endorse Vanessa's law, the protecting Canadians from unsafe drugs act.
I am honoured to be a member of the first Canadian government ever to tackle the insidious and largely hidden problem of the injuries and deaths routinely caused by prescription and over-the-counter drugs. I thank two consecutive ministers of health and the Prime Minister, who acted boldly to make Canadians safer, directly taking on the most influential industry in the world, big pharma, and the status quo in the practice of medicine, which has been corrupted by that industry.
Today is a milestone for me and the Young family as well as for the Government of Canada. I stand here today due to a tragedy in my family that took place exactly 14 years ago last week, on Saturday, March 18, 2000. Without warning, our 15-year-old daughter Vanessa, for whom this act is named, fell down dead in front of me, her heart stopped by the Johnson & Johnson blockbuster prescription drug Prepulsid, a drug we later discovered she should have never been given. Despite emergency ambulance services and the valiant efforts of doctors at two hospitals, Vanessa never regained consciousness and died the next day. We never had a chance to say goodbye.
On March 20, 2000, I began the journey that led me to the House of Commons this morning. The facts of this tragedy shock every layperson who hears them, yet I was to quickly discover that the insiders, the doctors, researchers, and people of big pharma, were never shocked. They knew all along that potentially life-threatening drugs were being pushed on patients with non-life-threatening conditions, as the drug business had become all about Wall Street, and they were benefiting financially big time.
Our doctors are groomed through highly sophisticated big pharma relationship marketing programs. They get their first free lunch the first week of medical school. They then go on to naively accept up to $4 billion a year in North America in gifts, lunches, dinners, event tickets, and free trips from drug companies, imagining that those debts of gratitude do not change their prescribing behaviour. Sometimes I would ask them, “Do you think a drug company takes a bunch of doctors to Bahamas out of kindness?” They also accept and hand out, without any prescription, $3 billion a year worth of free samples of new prescription drugs, creating debts of gratitude in their own patients. It is a dangerous practice, because patients get no safety warnings.
In November 2010, 18-year-old Brennan McCartney, of Bolton, Ontario, took a free sample of the anti-depressant Cipralex, with no safety warning about suicide, which is written right on its label. He went out and hanged himself from a tree in a public park.
Four doctors knew that Vanessa was taking Prepulsid for bloating and a mild form of bulimia, yet neither Vanessa nor we, her parents, were given any warning that the drug was already responsible for 80 deaths. Why? How could this happen to the beautiful, innocent child her doctor described as the picture of perfect health? How could four doctors, people we totally trusted, allow Vanessa to continue to take a drug that could stop her heart?
I began the next day to find out how Vanessa died and why, and I have uncovered many dark secrets. Prescription drugs, taken as prescribed, the right way, are the fourth leading cause of death in North America. There are over 106,000 deaths a year just in hospitals and another 100,000 outside hospitals. That is about 20,000 deaths a year in Canada and 200,000 serious drug injuries.
The drug industry representatives who infest Parliament Hill love to talk about when doctors make errors or when patients use the wrong drug or take too much of a drug. What they never talk about is when a drug used the right way kills or injures a patient, causing 10,000 deaths a year in Canada. In fact, one in nine patients in Canada who goes into hospital will suffer a serious adverse drug reaction in hospital.
All drugs are poisons. Any drug can be toxic; it is just a matter of dose. All drugs cause adverse effects. Some people think over-the-counter drugs are totally safe, yet ordinary Tylenol, acetaminophen, causes hundreds of deaths every year and more cases of acute liver failure than all other medications combined. Too much taken with alcohol can destroy one's liver. Has anyone's doctor ever mentioned that?
Ordinary aspirin and ibuprofen cause thousands of deaths every year across North America, mostly from internal bleeding, yet most patients have never heard this. Why not? There is only one reason. It is because the people who market the drugs, big pharma, do not want patients to know the truth. That would reduce sales.
What happened to Vanessa and Brennan McCartney could happen to anyone who takes drugs without proper safety warnings. Nothing significant has changed since 2000 except the current introduction of plain language labelling for drugs and this bill.
Vanessa's law will empower the Minister of Health to compel drug companies to change their labels to clearly reflect the true risk to patients from their drugs. Patients would be empowered to make informed decisions to take the drugs or not. Patients could then take drugs only when they are relatively safe.
Twenty-seven drugs have been pulled from the Canadian market since 1997 for injuring and killing patients. Prepulsid is one. Another, the painkiller Vioxx, killed 55,000 to 65,000 people worldwide in four years on the market. Why do most Canadians not know that? It is because the drug companies never admit that their drugs have harmed anyone. They spend months and months investigating serious reactions, and then they attempt to blame the patient. They conclude that patients must have taken too much, that they must have had a previously undiagnosed and unknown conditions, or that it must have been a combination of the company's great drug with the patients' other drugs. They then contraindicate their drug with the other drug and change the print on a 50-page label, which most doctors and few patients ever read. Then they carry on promoting it, including for off-label use, meaning for conditions for which it was never proven safe or effective.
Doctors can prescribe any drug at any time for any condition for any patient, even if it is never proven safe for such use. In fact, 70% of doctors prescribe off-label at least some of the time. Modern medicine can be the wild west.
That is what the Johnson and Johnson detail reps did to Vanessa's doctors. They whispered to them that Prepulsid was effective for teens who threw up after meals, yet it was contraindicated and dangerous for anyone throwing up. That was the official warning, but they did not whisper that in her doctors' ears, because Prepulsid was heading for blockbuster status. It was a golden calf, with $1 billion a year in sales.
Just before Health Canada is about to take action to expose risks, the drug companies will pull drugs off the market voluntarily. That way they can keep selling them in over 100 other countries in the world, because they have never admitted that the drug could cause anyone harm. That is the drug business.
Vanessa's law will give the Minister of Health the power to order drugs that present as serious or imminent risk of injury or death off the market without delay. Had this been done with Prepulsid, instead of negotiating over weeks with Janssen-Ortho, Prepulsid would have been recalled. Vanessa would be alive today, along with many others.
Drug companies refuse to provide the true number of serious adverse drug reactions to Health Canada. They report what they hear about, but what does not appear on their label is this crucial fact: only 1% of serious adverse drug reactions are ever reported by doctors. Whatever the number is on the label can usually be multiplied by 100 to get the true number, which the drug companies never do.
Most doctors never report adverse drug reactions. Outside of the doctors I have worked with in prescription drug safety, I have never met a doctor who has reported one.
Despite my advocacy for over 14 years that reporting adverse drug reactions saves lives by providing a widely based early warning system for dangerous drugs, the Canadian Medical Association and the Ontario Medical Association, to this day, do not support making adverse drug reaction reporting a standard practice or mandatory. Doctors are fooled by their own negligence in not reporting life-saving information. Patients die as a result.
On October 9, 2011, 18-year-old Allison Borges of Oakville was found in a stairwell of her residence at Queen's University, dead, having suffered a pulmonary embolism caused by Apri 28, a birth control pill that her doctor told her was safe. She received no warning that the newer birth control pills are more likely to cause deadly blood clots than the older ones.
No woman should be given a birth control pill without a clear warning about deadly blood clots, yet it happens all the time. Sadly, 18 year old Marit McKenzie of Calgary suffered the same fate in January 2013. Had Vanessa's law been in place and implemented, both deaths would have been prevented.
Vanessa's law will impose, for the first time, a duty on health care institutions to report all serious adverse drug reactions, which will capture any adverse drug reaction that causes patients to end up in a hospital or clinic. That will hopefully capture the majority of serious adverse drug reactions so that officials can be alerted to dangerous drugs faster. This will help get them off the market faster and save lives. We must rely on the provinces to persuade doctors themselves to stop covering up adverse drug reactions caused by their prescriptions.
Over half the serious side effects of new drugs will not be revealed during testing. In fact, in the first two years on the U.S. market, one in five, or 20% of new drugs, will be pulled off the market for injuring or killing patients or will be assigned the highest level of warning, a black box warning, to be handed to each patient with the prescription. It is a more effective warning than Canada has ever had and that, under Vanessa's law, it will have.
In May 2007, 18-year-old Sara Carlin of Oakville stopped taking her prescription anti-depressant Paxil abruptly. Then she doubled up, to catch up, two days later. She had no warning that Paxil could cause suicidal ideation and akathesia in those circumstances. Her father found her the next day, hanging by her own hand, in the basement of their home. Neither Sara nor her family had heard about the five “Dear Doctor” letter warnings Health Canada had sent out about Paxil.
Vanessa's law will for the first time allow the minister to order assessments of a drug, including conducting tests or studies and reporting them to Health Canada, and to change the drug labels to better reflect the newly identified risks. Proposed regulations for drug labelling will empower Health Canada to order drug companies to issue labels and patient information leaflets that are written in plain language, with the rare but dangerous potential side effects listed up front, on page one, where patients need to see them. Patient can then decide if they want to accept those dangers or not.
In 2003, Dr. Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline, the world's second largest pharmaceutical company, made this statement at a scientific meeting, thinking there were no journalists present: “The vast majority of drugs—more than 90 per cent—only work in 30 or 50 per cent of the people”.
What this means is that with a worldwide market of about $800 billion for prescription drugs, as much as $400 billion a year is not only wasted but millions of patients are exposed to dangers with no chance of benefiting.
According to the Canadian Pharmacists Association, between $2 billion and $9 billion a year is wasted in our drug system. This means that as patients increasingly reject the drug industry's pill for every ill, our health care system would save billions of dollars, hopefully to be invested in preventive care.
Seventy percent of adverse drug reactions are preventable. They are caused by the aggressive over-marketing of drugs, misleading sales pitches, and the covering up of harms that victimize patients.
How could any moral corporate executive push a drug that could stop a child's heart to treat bloating? That is exactly what the executives at Johnson and Johnson's drug arm Janssen-Ortho did, and they broke the law in doing it. It is quite normal in the drug business.
Drug safety is about one thing: does the potential risk of this drug outweigh the potential benefits for me? Yet the big pharma companies do everything they can to make sure that patients have no way to answer that question. They exaggerate the benefits and they hide the risks.
I know that this sounds outrageous. It sounds like a father who lost his daughter and then lost his objectivity, so let me give a few factual examples of where big pharma companies have openly admitted to crimes to increase sales of their drugs.
In 2012, GlaxoSmithKline, the people who made our H1N1 vaccine, paid a fine of $3 billion, the highest in history, to U.S. governments for illegally marketing three drugs: Paxil, an anti-depressant, which causes suicides; Avandia, a diabetes drug that causes heart attacks and strokes; and Wellbutrin, another anti-depressant with similar adverse effects. Yet GlaxoSmithKline had grossed $26 billion in sales for these three drugs in the previous six years. With markups on drugs at more than 100% and 1000%, a $3 billion fine is really just the cost of doing business for GlaxoSmithKline. It is kind of like a speeding ticket.
Shortly after Vanessa died, I asked adverse drug reaction expert Dr. Neil Shear, in Toronto, why drug companies do not take dangerous drugs like Prepulsid off the market. Here is what he replied: “In the drug industry, killing people is not bad for business. As long as it's not too many”. Nothing has changed since that time. Big pharma companies put the legal costs for injuries and deaths right in their business plans.
Here are some more examples of big pharma corporate criminals. I will read a short list from a list that could be pages long.
Merck has paid $1.6 billion in settlements since 2008, in part for paying illegal kickbacks to health care providers. Ely Lilly paid $1.3 billion in 2009 for illegally promoting Zyprexa, leading to the deaths of many seniors. Novartis paid $422 million in 2010 for off-label promotion of Trileptal. Forest Labs paid $313 million in 2010 for off-label promotion of Celexa and Levothroid. Allergan paid $825 million in 2010 for off-label promotion of Botox. AstraZeneca paid $520 million in 2010 for misleading doctors and patients about the safety of Seroquel. The list goes on, and these are just since 2008.
The question is, how do the big pharma companies get away with this?
They have power and influence. They are some of the wealthiest companies in the world and have no loyalty to any country, but, above all else, despite the thousands of deaths, no big pharma executive has ever gone to jail.
Imagine if murderers, rapists, or extortionists could simply negotiate payments with some government official to keep out of jail and to keep on doing what they are doing. The only way these companies will ever stop their corrupt practices is: one, if the practices become unprofitable; and, two, if those responsible face real jail time. Vanessa's law, for the first time, would impose tough new penalties for unsafe products, increasing fines from $5,000 a day to $5 million a day and including jail time for up to two years. That is the only way to actually get their attention and change their ways. And if these serious violations are caused intentionally, court-imposed fines could be unlimited.
My hope is that when life-threatening dangers are intentionally covered up, judges will fine offenders the entire amount of their sales of their blockbuster drug, or more, because nothing else will change their practices.
Vanessa's law would be the beginning of the end for the unscrupulous and corrupt marketing practices in big pharma companies in Canada. It would no doubt reduce drug injuries and deaths in Canada by thousands. It is much needed and it is long overdue. We can never have Vanessa back, in this life, or Sara Carlin, or Allison Borges, or Brennan McCartney, or Marit McKenzie, but we can change things moving forward. We can do what governments are supposed to do: protect vulnerable people.
Vanessa's law represents the highest calling of a government, in my view. When the death of an innocent child can lead to definitive action by the Government of Canada to help prevent others from the same fate, our democracy is at its best.
Every school day, across Canada, millions of children sing:
From far and wide,
O Canada, we stand on guard for thee.
However, that promise has to be a two-way street.
Vanessa Young would be proud to see that with Bill C-17, Canada is standing on guard for its school children, its seniors, and its other vulnerable patients.
