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October 12, 2014, Sunday Night Channel 7 (Australia)

The truth about Trasylol

The company that was responsible for a dangerous drug given to tens of thousands of Australians without their knowledge knew of its potentially lethal side effects and ignored them, a Sunday Night investigation reveals.

see full documentary here: https://au.news.yahoo.com/sunday-night/features/a/25220609/the-truth-about-trasylol

Background:
=> Massive side effects of TRASYLOL known for a long time
=> NYT: Bayer failed to report risks of drug
=> Researcher Estimates 22,000 Lives Could Have Been Saved

//Reporter: Ross Coulthart | Producer: Alex Hodgkinson //

Made from the lung tissue of cows and used to stop excessive bleeding during surgery Trasylol was the wonder drug for the German pharmaceutical giant, Bayer.
At over a thousand dollars a dose, it made them hundreds of millions for decade after decade.
But there were problems Bayer kept secret; evidence that Trasylol massively increases the risk of heart attacks, kidney disease and strokes.
Evidence that Trasylol was killing the patients it was meant to save.
At 30 years old, David Lloyd was given Trasylol following surgery.
The next morning he was dead.
"The main question I wanted to know was, how did it end up in Australia, how did my dad get injected with this drug 15 years before it was approved by Therapeutic Goods Australia?"
Jenny has been on a lifelong mission to find out the truth about her father's death.
"It took many years to pin point what had happened," she said,
"I have gone through everything instruments technique everything."
There is no doubt is there that Bayer knew full well there were dangerous side effects from their drug.
David came to Australia from England as a teenager.
He became a carpenter then met and married Janette. They settled in Melbourne and planned a big family.
In 1978, David and Janette had four children and she was six months pregnant with their fifth.
In May, David was in a car crash.
Ambulance officers mistakenly thought David had been thrown through the windscreen of the car. They suspected serious brain trauma and he was taken to Royal Melbourne Hospital.
While doctors treated his suspected brain injury, they initially missed a tear in his bowel. By the time it was discovered, he had lost a lot of blood. Surgeons used Trasylol to control the bleeding.
The operation to repair the tear was a success but the next morning, David died from a heart attack.
Today it is know that one of the deadly side effects of Trasylol is heart attacks, but in 1978, Australia's drugs regulator - the TGA - was not in existence.
When Bayer flooded the market with Trasylol, there was no testing and almost no supervision.
Surgeons at Australia's major hospitals, such as Royal Melbourne Hospital, favoured Trasylol because it was very good at stopping bleeding.
With no one monitoring its use, no one was piecing together a sinister pattern of deaths that led back to the same drug.
"(Losing dad) Broke us apart," Jenny said.
"They took our world away… mum crumbled, so basically losing dad that day… we lost mum too."
Janette suffered from manic depression after the death of her husband.
Jenny, who was two years old when her father died, grew up asking herself one nagging question: why had he died so suddenly?
As soon as she was old enough, she began looking for answers.
"So I went and got his medical records from Melbourne hospital, I went through Freedom of Information," Jenny said.
But the truth would take many more years to uncover.
When Jenny left school she trained to become a theatre nurse in the hope it would help her better understand what was contained in her father's medical notes.
The more experience she got, the more she realised that even in 1978, her dad’s surgery was routine and should not have led to his death.
"I still just couldn't put the pieces together. I just could not put them together. What actually made the heart stop? There has to be a reason why your heart stops," Jenny said.
Then in 2011 at the hospital where she worked, surgeon Paul Flanagan offered to look over the records Jenny had gathered.
In amongst the pages one word caught his eye.
Jenny's dad had been given Trasylol.
What she uncovered next was a cover-up that lastest decades about the dangers of Trayslol.
But most doctors and all patients were in the dark for the whole time Bayer sold this drug.
Yet, as far back as the early 1980s, in their own hometown Bayer was being warned by researchers at the University of Cologne of severe kidney damage in animals that had been given Trasylol.
Bayer ignored the warning.
In 1992, a study in humans showed the same side-effects. Bayer showed the same lack of interest.
Meanwhile, in 1991, Australia's TGA had finally approved Trasylol's use.
Hundreds of thousands of Australians were put in danger after being given Trasylol.
How many died in total is unknown, but one study puts the death rate at one thousand people per month in America.
Erik Clarke and his wife Marcelle are English journalists who began investigating the victims of Trasylol after Erik became one of them.
In October 2004 he had heart by-pass surgery and in March 2005 he suffered a stroke.
"My GP was stunned, my cardiologist was stunned, the cardiac surgeon was stunned, partly or very largely because only a few months before I’d had virtually every test known to mankind to see what kind of state I was in," Erik said.
Erik requested a copy of his hospital treatment notes
"I went through them carefully, I had to go through them with a pencil going down through every line, and finally I found the only two references to Trasylol in the whole document," he said.
"I was told that, in fact, after the stroke and when all my medical records were examined I was told that (the risk of stroke) was less than one per cent."
The risk was 181 per cent after he had Trasylol.
Like every Australian patient given Trasylol, Erik was never told of those potentially lethal side-effects.
In the same year Erik suffered his stroke, Bayer was rolling in money.
In 2005, the company forecast future Trasylol sales of $600 million per year.
For that kind of money there is a big incentive to ignore warnings and to keep secret the trouble with Trasylol.
Eight years ago, Bayer testified to the USA Food and Drug Administration. An independent study had been published suggesting that Trasylol was deadly.
Bayer persuaded the FDA to keep the drug on the market.
Then it was revealed that Bayer had not told the full truth about what the company really knew.
Jim Ronca is an American trial lawyer who sued Bayer on behalf of 50 families.
"We have had some clients for whom the kidney failure was so bad that their kidneys failed completely and they had to go on dialysis," Jim said.
It was in January 2006 that it all began to unravel for Bayer.
The New England Journal of Medicine published the largest study on Trasylol, over 5000 patients.
It found that they were twice as likely to experience kidney failure; had a 55 per cent increase of heart failure and 181 per cent increased risk of stroke than patients using cheaper alternative drugs.
But BAYER disputed the study and commissioned for their own but when it too found problems, they suppressed the evidence and failed to tell the authorities.
Bayer did not expect the author of the study turning into a whistle blower and telling the FDA all he knew.
In 2006, Trasylol sales were predicted to top three quarters of a billion dollars.
However, the USA Food and Drug Administration discovered Bayer had failed to disclose its own study suggesting Trasylol was killing patients.
At the end of 2007, Trasylol was finally pulled off the market.
But not before terrible harm was done to countless families all over the world.
Thirty-six years after her father died, Jenny prepared to confront the company she believes is responsible for his death.
Bayer had refused us an interview.
But in Germany shareholders are allowed to speak at their AGM.
With the help of a sympathetic shareholder, we were able to address Bayer board.
Bayer's rules say we have to address the Board in German, so we've brought along a translator.
Our microphones are turned off when Trasylol is mentioned.
Kicked off the podium, Jenny Lloyd did not budge.
"I was there for a purpose to let them know what they done and they didn't want to listen so I made them listen," she said.
Jenny is passionate her story needs to be told, not just for her family's sake.
"I really need it to be told, because I don't think it was only dad affected by this drug," she said.
"Dad cannot be the only one in Australia that has had this drug administered and not told about it, there must be many more."

http://www.abc.net.au/local/stories/2015/02/25/4186962.htm

26 February, 2015

Why did Dad die? Riverland nurse leads Trasylol fight after long crusade

A 20-year crusade by a Riverland nurse into her father's death has turned a spotlight on the risks of a drug which was once widely used on Australian patients.

By Catherine Heuzenroeder

Jennifer Lloyd-Bishop was just two when her dad died of a heart attack following surgery after a car crash in May of 1978.
For years she searched for answers, even securing his medical records when she was 17.
Confused by the medical jargon, and with a young daughter to look after, it was not until she trained as a nurse and moved to the Riverland that she finally got the answer she was seeking.
"I got into theatre and then questions really started bombarding me," Jennifer said.
"I was asking how long has that machine been around for, or that technique.
"One day in theatre we had just been doing a procedure and I said to visiting surgeon Dr Paul Flanagan, 'I just don't get it, I don't get how a 30 year old man dies from bowel resection'.
"It should have been successful."

Drug raises questions
Dr Flanagan offered to look through Jennifer's notes, including her father's medical records.
That night he came across an unfamiliar drug name in the medical notes.
The drug Trasylol, which contains the active ingredient aprotinin, had been given to Jennifer's father to control internal bleeding, as he had lost a lot of blood by the time hospital staff realised they needed to perform a bowel operation.
Dr Flanagan did an internet search for Trasylol and found it had been the subject of legal action in the United States. A medical journal in 2006 published the results of a study showing it doubled the risk of kidney and heart failure and increased the risk of stroke.
The use of the drug had been suspended in Australia in 2007.
"He said 'this is why your father died'," Jennifer said.
"From there, I just ran with it."

Jennifer confronts drug company
Jennifer took her story to the media.
She confronted the shareholders of pharmaceutical company Bayer, the makers of Trasylol, while filming a feature for Channel Seven's Sunday Night program.
She appointed Melbourne-based law firm Rennick Briggs, which is currently building a class action in Australia against Bayer.
She has also appealed to the Australian government, seeking answers from the Federal Health Minister about the use of the drug in Australia.
"I want them to acknowledge this, I have questioned why warning letters weren't sent out," Jennifer said.
Jennifer said that when Trasylol was finally registered for use in Australia by the Australian Therapeutic Goods Administration, it was only registered as a cardiac drug.
"Who and how on earth did it get into Australia? Who gave permission for it to be used in a laparotomy?" she said.
"It was used willy-nilly since the 1960s, until 1993 and then it was finally approved just for cardiac.
"This drug was on the market until 2007.
"These patients can have symptoms for up to 15 years.
"You have a cardiac operation and seven years later have a stroke, you're not going to think the operation caused it but it quite possibly could."

Death devastating for family
Jennifer's father David Lloyd was just 30 when he died in May of 1978.
He left behind four children and his wife, who was expecting his fifth child.
Without his income as a carpenter, the family fell on hard times, being forced to live in government housing.
"When Dad died Mum couldn't take over the mortgage of our house, because she was a single mum with five children now and no income coming in beside social security," Jennifer said.
"The churches fed us and looked after us.
"The house fell through because she couldn't keep it and then we got really chucked into welfare mentality.
"We did rent a few homes but Mum couldn't do it, she couldn't keep up financially.
"We went into commission homes, and that was Broadmeadows, which is known as the biggest scumsville of Melbourne."

Jennifer's tough childhood drove her to find out more about her father's death.
She admits her single-minded crusade has taken its toll.
"The only way I got through it was to tell myself emancipate, recharge, and once I'm feeling all good again, get back up and fight.
"It is not right and I want people to know.
"How many victims are there out there that don't know, whose families don't know?
"I can't stop, I just can't stop. I was going to stop after it went to Channel Seven, but then you get the victims that come out.
"How do I say to somebody I've opened up the can of worms but I don't want to deal with it now?
"Well I do, I do want to and I'm strong enough to."
Australia's Therapeutic Goods Administration (TGA) has published a statement about Trasylol on its website, which states in part:
Between February 2006 and November 2007, the TGA undertook a safety review of Trasylol, as well as ongoing reviews as more data became available. It sought advice from the Adverse Drug Reactions Advisory Committee (ADRAC) in March 2006, June 2006 and March 2007.
Trasylol was withdrawn from the market on 6 November 2007 after preliminary results from the Blood Conservation Using Antifibrinolytics: A Randomised Trial in High-Risk Cardiac Surgery (also known as the BART clinical trial) suggested an increased risk of death for patients receiving Trasylol compared to those receiving the alternative medications of aminocaproic acid or tranexamic acid for control of bleeding during heart surgery.
Trasylol is now supplied by Nordic Group pharmaceuticals and the TGA further states:
TGA is aware that after reviewing the currently available information the therapeutic goods regulators in Canada and Europe have allowed Trasylol back into the marketplace for use in cardiac bypass surgery