According to Mr Young, his 15y daughter Vanessa suffered from BULIMIA (Nervosa). For some reason a local MD prescribed cisapride (Prepulsid) a`serotonin receptor agonist which increases acetylcholine release
in the enteric nervous system. Prepulsid was indicated for GERD & diabetic gastroparesis.'.Mr Young said he knew that the prescription was "off label" : there was no indication for use in children with bulimia.
Vanessa died in hospital from arrhythmia .It was known that Prepulsid was a drug that could prolong Q-T interval. 2.5% of popn have prolonged Q-T. 10-15% with LQTS (Long Q-T syndrome) have normal ECGs. LQTS can be an inherited condition: usually AUTOSOMAL DOMINANT. . TORSADE de POINTES is a complication.
Mr Young did not say whether his daughter had been treated by a Paed. psychiatrist or attended an Eating disorder clinic.Bulimia nervosa,"an ominous varient of Anorexia nervosa" first described by UK Psych Prof . G.F.M. RUSSELL BMBCh(Edin 1950) FRCP in PSYCHOLOGICAL MEDICINE.
Psychol Med. 1979 Aug;9(3):429-48.
Bulimia nervosa: an ominous variant of anorexia nervosa.
Abstract
Thirty
patients were selected for a prospective study according to two
criteria: (i) an irresistible urge to overeat (bulimia nervosa),
followed by self-induced vomiting or purging; (ii) a morbid fear of
becoming fat. The majority of the patients had a previous history of
true or cryptic anorexia nervosa. Self-induced vomiting and purging are
secondary devices used by the patients to counteract the effects of
overeating and prevent a gain in weight. These devices are dangerous for
they are habit-forming and lead to potassium loss and other physical
complications. In common with true anorexia nervosa, the patients were
determined to keep their weight below a self-imposed threshold. Its
level was set below the patient's healthy weight, defined as the weight
reached before the onset of the eating disorder. In contrast with true
anorexia nervosa, the patients tended to be heavier, more active
sexually, and more likely to menstruate regularly and remain fertile.
Depressive symptoms were often severe and distressing and led to a high
risk of suicide. A theoretical model is described to emphasize the
interdependence of the various symptoms and the role of
self-perpetuating mechanisms in the maintenance of the disorder. The
main aims of treatment are (i) to interrupt the vicious circle of
overeating and self-induced vomiting (or purging), (ii) to persuade the
patients to accept a higher weight. Prognosis appears less favourable
than in uncomplicated anorexia nervosa.
(The following is a full text of Terence’(YOUNG) speech.)
Mr. Speaker I am very pleased to stand here 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 our Prime Minister who have 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 one for the Government of Canada.
I stand here today due to a tragedy in our family that took place exactly fourteen years ago last week, on Saturday March 18, 2000.
Without warning, our fifteen year old daughter Vanessa—for whom this act is named—fell down dead in front of me, her heart stopped by the Johnson and Johnson blockbuster prescription drug Prepulsid, a drug we later discovered she should never have been given.Despite emergency ambulance services and 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 lay-person who hears them. Yet I was to quickly discover the insiders: doctors, researchers, and people at 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 St. And they were all benefiting financially, big time.
Our doctors are groomed through highly sophisticated Big Pharma relationship marketing programs and get their first free lunch the first week of medical school. They 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 these debts of gratitude don’t change their prescribing behaviour. Sometimes I’d ask them, “Do you think the drug company takes 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; a dangerous practice because patients get no safety warnings. In November 2010 eighteen year old Brennan McCartney of Bolton, Ontario took a free sample of antidepressant Ciprolex with no safety warning for suicide which is written right on the drug’s label, and went out and hanged himself from a tree in a public park.
Four doctors knew 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 taking a drug that could stop her heart?
I began the next day to find out how Vanessa died, and why, and uncovered many dark secrets.
Prescription drugs taken as prescribed, the right way, are the fourth leading cause of death in North America — over 106,000 deaths a year just in hospitals. Another 100,000 occur outside hospitals. That’s about 20,000 deaths a year in Canada, with 200,000 drug injuries.
What they never talk about is when a drug used the right way injures or kills a patient, causing 10,000 deaths a year in Canada.
In fact one in nine patients in Canada suffer serious drug reaction in hospitals.
How could any moral corporate executive push a drug that could stop a child’s heart to treat bloating? Because that’s exactly what the executives at Johnson and Johnson’s drug arm Janssen-Ortho did. And they broke the law doing it. This 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 patients have no way to know the answer to this question. They exaggerate the benefits, and hide the risks.
So let me give you just a few factual examples of hundreds, where Big Pharma companies have openly admitted to crimes to increase sales of their drugs:
In 2012 GSK — the people who made our H1N1 vaccine in Canada — paid a fine of $3 billion, the highest in history, to US 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 antidepressant which causes suicides.
Yet GSK had grossed $26 billion in sales for these three drugs in the previous six years. And with markups in drugs in the hundreds and thousands of percent, a $3 billion fine was just a cost of doing business for GSK. Like paying a parking ticket.
Shortly after Vanessa died I asked ADR expert Dr. Neil Shear why drug companies don’t just take dangerous drugs like Prepulsid off the market. 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 from injuries and deaths right in their business plans.
Here are some more examples of Big Pharma corporate crimes:
And above all else, despite the thousands of deaths, no Big Pharma executive ever goes to jail. Imagine if murderers, or rapists, or extortionists could simply negotiate payments with some government official to keep out of jail... and keep on doing what they have been doing.
The only way these companies will ever stop their corrupt practices is (1) if the practices become unprofitable... and (2) if those responsible face real jail time.
So Vanessa’s Law for the first time will impose tough new penalties for unsafe products, increasing fines from $5,000 a day to $5 million a day and include jail time for up to two years. That’s 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 were intentionally covered up, judges will fine offenders like this the entire amount of their sales of a blockbuster drug or more. Nothing less will change their practices.
Mr. Speaker, Vanessa’s Law is the beginning of the end for the unscrupulous and corrupt marketing practices in the Big Pharma companies in Canada. It will no doubt reduce drug injuries and deaths in Canada by thousands. It is much needed and long overdue.
We can never have Vanessa back in this life; or Sara Carlin; or Alison Borges; or Brennan McCartney; or Merit 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. 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.
Mr. Speaker, every school day across Canada millions of school children sing “From far and wide, Oh Canada, we stand on guard for thee.” But 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, and seniors, and other vulnerable patients.
(Comment: no mention of prescriber)
(The following is a full text of Terence’(YOUNG) speech.)
Mr. Speaker I am very pleased to stand here 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 our Prime Minister who have 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 one for the Government of Canada.
I stand here today due to a tragedy in our family that took place exactly fourteen years ago last week, on Saturday March 18, 2000.
Without warning, our fifteen year old daughter Vanessa—for whom this act is named—fell down dead in front of me, her heart stopped by the Johnson and Johnson blockbuster prescription drug Prepulsid, a drug we later discovered she should never have been given.Despite emergency ambulance services and 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 lay-person who hears them. Yet I was to quickly discover the insiders: doctors, researchers, and people at 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 St. And they were all benefiting financially, big time.
Our doctors are groomed through highly sophisticated Big Pharma relationship marketing programs and get their first free lunch the first week of medical school. They 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 these debts of gratitude don’t change their prescribing behaviour. Sometimes I’d ask them, “Do you think the drug company takes 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; a dangerous practice because patients get no safety warnings. In November 2010 eighteen year old Brennan McCartney of Bolton, Ontario took a free sample of antidepressant Ciprolex with no safety warning for suicide which is written right on the drug’s label, and went out and hanged himself from a tree in a public park.
Four doctors knew 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 taking a drug that could stop her heart?
I began the next day to find out how Vanessa died, and why, and uncovered many dark secrets.
Prescription drugs taken as prescribed, the right way, are the fourth leading cause of death in North America — over 106,000 deaths a year just in hospitals. Another 100,000 occur outside hospitals. That’s about 20,000 deaths a year in Canada, with 200,000 drug injuries.
What They Never Talk About
The drug industry representatives who infest parliament hill love to talk about when doctors make errors, or patients take the wrong drug, or too much of a drug.What they never talk about is when a drug used the right way injures or kills a patient, causing 10,000 deaths a year in Canada.
In fact one in nine patients in Canada suffer serious drug reaction in hospitals.
1. All drugs are poisons. Any drug can be toxic. It’s just a matter of dose. And all drugs cause adverse effects. Some people think OTC drugs are totally safe. Yet ordinary Acetaminophen (Tylenol) causes hundreds of deaths every year, and more cases of acute liver failure than all other medications combined. Too much taken with alcohol, and it can destroy one’s liver.Mr. Speaker, 70% of adverse drug reactions are preventable. They are caused by the aggressive over-marketing of drugs, the misleading sales pitches, and the covering up of harms that victimize patients.
Yet has your doctor ever mentioned that?
Ordinary aspirin and Ibuprofen cause thousands of deaths every year across North America, mostly by internal bleeding. Yet most patients have never heard this. Why not? There is only one reason: Because the people that market them — Big Pharma — don’t 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 risks to patients from their drugs, so patients can make an informed decision to take that drug... or not. Patients can then take drugs only when they are relatively safe.
2. Twenty seven drugs have been pulled off the Canadian market since 1997 for injuring and killing patients. Propulsid is one. Another, painkiller Vioxx, killed 55,000 to 65,000 patients worldwide in four years on the market. Why don’t most Canadians know that? Because the drug companies never admit their drug harmed anyone; they spends months and months investigating serious reactions. Then they attempt to blame the patient, concluding –
“He must have taken too much;”
“She must have had a previous undiagnosed and unknown condition;”
“It must have been the combination of our great drug with the other drug he was taking. We hereby contraindicate our great drug with their drug.”
So they change the fine print on the 50-page label that few doctors and even fewer patients ever read.
Then they carry on promoting it, often off label, which means for conditions it has never been proven safe or effective.
Doctors can prescribe any drug, at any time, for any condition, for any patient, even if it’s never been proven safe for such use. In fact, 70% of doctors prescribe off-label sometimes. Modern medicine is the Wild West.
That’s what the Johnson and Johnson detail reps did to Vanessa’s doctors. They whispered to them that Prepulsid was effective for teens that threw up after meals. Yet it was contraindicated, dangerous for anyone throwing up. That was the official warning. But they didn’t whisper that in her doctor’s ear. Because Prepulsid was heading for blockbuster status: the golden calf: a billion dollar a year drug!
And Just before Health Canada is about to take action to expose the risks, the drug companies will pull deadly drugs off the market “voluntarily.” That way they can keep selling them in over a hundred other countries in the world – because they never admitted their drug caused any harm.
That’s the drug business.
Vanessa’s Law will give the Minister of Health the power to order drugs that present a 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.
3. 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 the label is this crucial fact: only 1% of serious adverse drug reactions are actually reported by doctors. Most doctors have never reported an ADR! In fact, outside of the doctors I’ve met who specialize in drug safety, I’ve never met a doctor who reported an ADR. And despite my advocacy in this matter for 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 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 lifesaving information. Patients die as a result.
On October 9, 2011 eighteen 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 a birth control pill 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 of deadly blood clots. Yet it happens all the time. Sadly, 18 year old Merit McKenzie of Calgary suffered the same fate in January 2013. Vanessa’s Law, if implemented, would have prevented these two tragic deaths.
Vanessa’s Law wil, for the first time, impose a duty on healthcare institutions to report all serious ADRs, which will capture any ADR that causes the patients to end up in a hospital or clinic. That will hopefully capture the majority of serious ADRs, so 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 to stop covering up adverse drug reactions caused by their prescriptions.
4. Over half of the serious side effects of new drugs won’t be revealed during testing. In fact, in the first two years on the US market, one in five –20%– of new drugs will be pulled off the market for injuring or killing patients, or be assigned the highest level of warning – a Black Box warning to be handed to each patient with their prescription – a more effective warning Canada has never had.
In May 2007 18 year old Sara Carlin of Oakville stopped taking her prescription antidepressant Paxil abruptly, then 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, hanged by her own hand in the basement of their home. Neither Sara nor her family heard about the five Dear Doctor letters warnings that Health Canada had sent out about Paxil.
Vanessa’s Law will for the first time allow the Minister to order an new assessment of a drug, including conducting tests or studies and report them to Health Canada – to change the drug label 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, so doctors and patients can decide if the true dangers are worth risking treating their condition.
5. In 2003 Dr. Allan Roses, World-Wide Vice President of genetics at GSK – the world’s second largest Big Pharma company – made this statement at a scientific meeting, not knowing a journalist was present: “The vast majority of drugs, more than 90%, only work in 30 or 50% of people.” What this means is, with a worldwide market of $800 billion for prescription drugs, as much as $400 billion a year is not only wasted on drugs, but millions of patients are exposed to the dangers with no chance of benefitting. According to The Canadian Pharmacist Association between $2 billion and $9 billion is wasted in our drug system every year. This means that as patients increasingly reject the drug industry’s pill for every ill, our health care system will save billions of dollars, hopefully to be invested in preventative care.
How could any moral corporate executive push a drug that could stop a child’s heart to treat bloating? Because that’s exactly what the executives at Johnson and Johnson’s drug arm Janssen-Ortho did. And they broke the law doing it. This 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 patients have no way to know the answer to this question. They exaggerate the benefits, and hide the risks.
Does This Sound Outrageous?
I know this sounds outrageous. It sounds like a father who lost his daughter AND has lost his objectivity.So let me give you just a few factual examples of hundreds, where Big Pharma companies have openly admitted to crimes to increase sales of their drugs:
In 2012 GSK — the people who made our H1N1 vaccine in Canada — paid a fine of $3 billion, the highest in history, to US 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 antidepressant which causes suicides.
Yet GSK had grossed $26 billion in sales for these three drugs in the previous six years. And with markups in drugs in the hundreds and thousands of percent, a $3 billion fine was just a cost of doing business for GSK. Like paying a parking ticket.
Shortly after Vanessa died I asked ADR expert Dr. Neil Shear why drug companies don’t just take dangerous drugs like Prepulsid off the market. 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 from injuries and deaths right in their business plans.
Here are some more examples of Big Pharma corporate crimes:
- 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 Levothyroid;
- 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;
- Johnson and Johnson paid $81 million in 2010 for off-label promotion of Topomax;
- Elan paid $203.5 million in 2010 for illegally marketing Zomegran;
- Sanofi-Aventis paid $ 96.5 million in 2009 for illegal pricing of a nasal spray;
- Abbott paid $22.5 million in 2010 for blocking 23 states from getting a cheaper alternative for Tricor;
How do they get away with all this?
Power. And influence. They are some of the wealthiest companies in the world, with no loyalty to any country.And above all else, despite the thousands of deaths, no Big Pharma executive ever goes to jail. Imagine if murderers, or rapists, or extortionists could simply negotiate payments with some government official to keep out of jail... and keep on doing what they have been doing.
The only way these companies will ever stop their corrupt practices is (1) if the practices become unprofitable... and (2) if those responsible face real jail time.
So Vanessa’s Law for the first time will impose tough new penalties for unsafe products, increasing fines from $5,000 a day to $5 million a day and include jail time for up to two years. That’s 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 were intentionally covered up, judges will fine offenders like this the entire amount of their sales of a blockbuster drug or more. Nothing less will change their practices.
Mr. Speaker, Vanessa’s Law is the beginning of the end for the unscrupulous and corrupt marketing practices in the Big Pharma companies in Canada. It will no doubt reduce drug injuries and deaths in Canada by thousands. It is much needed and long overdue.
We can never have Vanessa back in this life; or Sara Carlin; or Alison Borges; or Brennan McCartney; or Merit 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. 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.
Mr. Speaker, every school day across Canada millions of school children sing “From far and wide, Oh Canada, we stand on guard for thee.” But 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, and seniors, and other vulnerable patients.
(Comment: no mention of prescriber)
