TRANSCRIPT: Trasylol, the killer drug
WOMAN: They took our world away.
CHRIS BATH: First tonight - our worldwide investigation into how nearly 200,000 Australians have been put at risk by the secrets and lies of the pharmaceutical giant, Bayer. Tonight, families across Australia will finally learn the truth that even now Bayer wants kept out of court and out of the public eye - the truth about sudden heart attacks, unexplained strokes and massive kidney failures. The truth about thousands of mysterious deaths and the drug Bayer discovered was potentially lethal but continued to flood the Australian market with anyway. And, as we'll reveal, there are still Australians out there who have no idea that they are still at risk because once it gets into your system, this drug is a ticking time bomb. Here's Ross Coulthart.
ROSS COULTHART: You've come a long way to confront the heads of the company that you believe sold a dangerous drug.
JENNY LLOYD: Yes, I did. ..
ROSS COULTHART: That you believe killed your father.
JENNY LLOYD: Yep.
JENNY LLOYD: This is not good enough, Bayer, it's not good enough! Do any of you have a heart?
ERIC CLARK: The real villains of this have to be Bayer and I think this is simply because it was such an enormous money-earner for them that the last thing they wanted was for it to become known how big a risk a drug it was.
JENNY LLOYD: How come you can't talk about an intravenous drug that killed my dad? I will keep on talking over you, so stop!
(APPLAUSE)
JENNY LLOYD: The main question I wanted to know - how did it end up in Australia? How did my dad get injected with this drug? How is this possible? And how many other people have had this drug and it's just been gone to the grave with them?
JENNY LLOYD: It took many years to pinpoint what had happened. I've gone through everything.
ROSS COULTHART: And the only explanation for why your father died is?
JENNY LLOYD: The drug that they injected into him, Trasylol.
ROSS COULTHART: 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 $1,000 a dose, it was making them hundreds of millions of dollars a year but there were problems Bayer kept secret - evidence that Trasylol massively increased the risk of heart attack, kidney disease and stroke. Evidence that Trasylol was killing the patient it was meant to save.
ROSS COULTHART: At 30, David Lloyd was given Trasylol following surgery. The next morning, he was dead.
JENNY LLOYD: My mum absolutely thinks he was the best man in the world. She's never met anybody like him. He was a skinny little Pommy man with lots of nice little curls. He was a hard worker and loved all of us kids.
ROSS COULTHART: Was he a healthy man?
JENNY LLOYD: Yes, yep.
ROSS COULTHART: 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.
ROSS COULTHART: Janette, tell me about David.
JANETTE LLOYD: He was a rascal. Excellent carpenter, absolute tradesmen. Even the furniture he built, we've still got. Was he a good dad? He was a wonderful dad. And the children just worshipped him and found every excuse to be out there in his company, whether they should be or not.
From this moment how can it feel # This wrong? #
ROSS COULTHART: By 1978, David and Janette had four children and Janette was six months pregnant with their fifth.
MAN AND CHILDREN: (ON TAPE) A, B, C...
JANETTE LLOYD: Mum has a tape of him with his voice going and he was just doing ABC, singing, carrying on with us kids. But that's about all I've got.
MAN AND CHILDREN: M, N, O... That's a long time to get that bloody P. (LAUGHS)
ROSS COULTHART: In May that year, an accident would change their lives. David had gone out with two friends for some beers. On the way home, he was in the front passenger seat of his mate's Holden Monaro when it hit this Datsun.
JENNY LLOYD: As far as I know, he had a laceration on his forehead which I believe was from the impact of the dashboard.
ROSS COULTHART: 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.
JANETTE LLOYD: About 10:30, the hospital rang me and said he was in there, so I went in.
ROSS COULTHART: Was he conscious at the time?
JANETTE LLOYD: He was already unconscious. The only - last time I saw him I heard the doors open, I turned around and recognised his feet. And that was when they were taking him up to theatre so I didn't really get to see him.
ROSS COULTHART: While doctors treated his suspected brain injury, they initially missed a tear in his bowel. By the time it was discovered, he'd lost a lot of blood. So surgeons used Trasylol to control the bleeding. The operation to repair the tear was a success but the next morning, inexplicably, 30-year-old David died from a heart attack…
ROSS COULTHART: Did you think that was unusual that a man his age...
JANETTE LLOYD: Absolutely, because he was so darn healthy and never he'd missed a day's work sick or anything. I always did wonder why such a minor injury killed such a healthy young man.
ROSS COULTHART: We now know that one of the deadly side effects of Trasylol is heart attacks. But in 1978, Australia's drugs regulator, the TGA, didn't exist. So when Bayer flooded the market with Trasylol, there was no testing and virtually no supervision. Surgeons at Australia's major hospitals, including Royal Melbourne, favoured Trasylol because it was so good at stopping bleeding, leading to successful outcomes from surgery, or so it seemed. In reality, with no-one monitoring its use, no-one was piecing together a sinister pattern of deaths all leading back to the same drug.
ROSS COULTHART: Did anybody ever explained to you why he'd suffered a heart attack?
JANETTE LLOYD: No. There was no discussion at all. It was just, "He's dead, get over it."
ROSS COULTHART: What did it do to your family?
JENNY LLOYD: Broke us apart. Absolutely broke us apart. My older brother - hang on... gonna sook. My older brother was... (TEARFUL): ..made ward of the state within five years, and, so I lost him too. They took our world away. Mum crumbled. So basically losing Dad that day, we lost Mum too. Mum, back then they said that she had manic depression. She was always crying and smashing up the house. Every week, we'd have a new dinner set, she'd smash up the house. So I could tell she was very angry. There'd be times where she'd go to her room and put the music up loud and scream, "Why did you do this to me, Dave? You know, "Why do you leave me?"
ROSS COULTHART: But you know now, you believe it was nothing to do with Dave.
JENNY LLOYD: Mm. And I think that's what I wanted to prove - he didn't leave because he wanted to leave, he left because he had no choice.
ROSS COULTHART: 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.
JENNY LLOYD: So then I went and got his medical records from the Royal Melbourne Hospital. I went through Freedom of Information.
ROSS COULTHART: How old were you when you do that?
JENNY LLOYD: 17.
ROSS COULTHART: But the truth would take many more years to uncover. When Jenny left school, she trained to become a theatre nurse, hoping it would help her better understand what was contained in her father's medical notes. The more experienced she got, the more she realised that even in 1978, her father's bowel surgery was a routine operation that should not have led to his death.
JENNY LLOYD: I haven't seen not one patient pass away from having that operation. And there should have been no reason why they shouldn't have been able to do this successfully, absolutely no reason.
ROSS COULTHART: So you kept coming back to these notes and going, "Gee, why did my dad die?"
JENNY LLOYD: I couldn't put the pieces together. I just could not put the pieces together of what made the heart stopped. There has to be a reason why your heart stops. What was it?
ROSS COULTHART: 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.
DR PAULFLANAGAN: They were using the Trasylol, as far as I understand it, to minimise blood loss.
JENNY LLOYD: Yeah.
DR PAULFLANAGAN: But what it was causing was clotting.
ROSS COULTHART: 33 years after her father's sudden heart attack, Jenny was now discovering the probable cause.
DR PAULFLANAGAN: In my opinion, the most likely cause was a heart attack caused by a clot which was caused by Trasylol.
ROSS COULTHART: So the Trasylol caused the death?
DR PAULFLANAGAN: Yes.
ROSS COULTHART: What Jenny would next begin to uncover was the decades-long cover-up by Bayer about the dangers of Trasylol. Knowing what you know now, would you ever have used Trasylol on a patient?
DR PAULFLANAGAN: Definitely not.
ROSS COULTHART: Yet, as far back as the 1980s, Bayer already knew there were potentially deadly side effects. In Cologne, their own hometown, university researchers alerted them to severe kidney damage in animals who'd been given the drug. Bayer ignored this warning. And another in 1992 when a trial in humans showed exactly the same side effects. Instead, they continued to aggressively market the drug. Hundreds of thousands of Australians were exposed to the dangers of Trasylol but just how many in total died because of it is unknown. But in America, one study put the death rate as high as 1,000 deaths a month.
ROSS COULTHART: So there are possibly many families across the world who have lost loved ones because of this drug?
WOMAN: Yes.
ERIC CLARK: They have lost them because of things that have been put down to something else. They died of stroke or they've had a heart attack or they've had kidney failure. All of these things could well have happened without Trasylol and as nobody knows they have taken Trasylol in the first place, no-one is going to blame Trasylol for it.
MARCELLE BERNSTEIN: So they get away with it. So it's like a crime with no victims. But it isn't a victimless crime.
ROSS COULTHART: Eric and Marcelle Clark are English journalists who began investigating the victims of Trasylol after Eric became one of them. In October 2004, Eric had successful heart bypass surgery. Then five months later, he suffered a stroke.
ERIC CLARK: 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.
ROSS COULTHART: Searching for an answer, Eric asked for his hospital treatment notes.
ERIC CLARK: And finally, I found the only two references...
ROSS COULTHART: Trasylol. ..
ERIC CLARK: to Trasylol in the whole document. And as you can see, they are so tiny that in fact if I gave you these pages now without the markings, even though you knew it was on the pages, Trasylol, you'd have a job finding it.
ROSS COULTHART: Before you had Trasylol, what was your risk of stroke?
ERIC CLARK: I was told it was less than 1%.
ROSS COULTHART: After you'd had Trasylol, what was your risk of stroke?
ERIC CLARK: 181%.
ROSS COULTHART: So almost double the risk of a normal person?
ERIC CLARK: Oh, yes, yes. It is quite large.
ROSS COULTHART: Yet, like every Australian patient given Trasylol, Eric was never told that stroke was one of its side effects.
ERIC CLARK: Bayer should actually have made known the risks of this.
ROSS COULTHART: In 2005, the same year he had his stroke, Bayer was rolling in money, predicting future Trasylol sales of $600 million a year.
ERIC CLARK: You have this lopsided thing of marketing pushing the benefits and at the same time, pushing behind the scenes the risks of it and that is unethical and deadly.
PART 2:
ROSS COULTHART: Eight years ago, Bayer came here to testify to the US Food and Drug Administration. It is America's, and indeed the world's, most powerful drug regulator. Bayer was very worried because an independent study had been published suggesting that Trasylol was deadly but 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 it really knew.
JIM RONCA: The cover-up always does them in. It's a public health issue - you need to report it.
ROSS COULTHART: What was the increased risk of death that was highlighted by that study?
JIM RONCA: Roughly 50%.
ROSS COULTHART: Jim Ronca is an American trial lawyer who now knows what Bayer long knew and tried to cover up - that Trasylol can kill, that Trasylol can maim.
JIM RONCA: We had some clients who, the kidney failure was so bad that the kidneys failed completely and had to go on dialysis.
ROSS COULTHART: For the rest of their lives?
JIM RONCA: Yes, because unless you get a kidney transplant, there is no other answer.
ROSS COULTHART: In January 2006, it all began to unravel for Bayer. The New England Journal of Medicine published the largest study on Trasylol - over 5,000 patients. It found it doubles the risk of kidney failure, increases the risk of heart attack by 48%, of heart failure by 109% and stroke by 181% compared to patients given alternative drugs. But Bayer disputed the study and commissioned its own. Yet, when it too confirmed the overwhelming evidence of the damage that Trasylol can cause, it was withheld from the American FDA. That damning information was not made public. There is no doubt, is there, that Bayer knew full well there were dangerous side effects from their drug?
JIM RONCA: I don't think there is any doubt.
JENNY LLOYD: This is not good enough, Bayer. It is not good enough.
ROSS COULTHART: So because they weren't being upfront to the drugs regulator, people started dying?
JIM RONCA: I don't think they were upfront from the beginning, so people started dying from the beginning.
ROSS COULTHART: But Bayer didn't count on the author of their own study turning whistleblower and telling the FDA all he knew. Bayer tried to salvage the situation by blaming two employees for not releasing the study.
ERIC CLARK: Bayer passed the buck to individuals and said, "It wasn't us, Guv, it was them," and fired them.
MARCELLE BERNSTEIN: They sacrificed them. Yes.
ROSS COULTHART: It was too late. Six days after the whistleblower came clean, Bayer formally admitted to the FDA the existence of the evidence that had been withheld. In November 2007, Bayer finally took Trasylol off the market but too late for countless thousands of families and the terrible harm that had been done to them.
ERIC CLARK: In this case, I think it was murderous.
ROSS COULTHART: So it was all about money, profits?
JIM RONCA: It is typically always about money.
ERIC CLARK: There's one thing about the drug that struck me which is not today's thing but Trasylol developed from a drug that was developed in the war in Germany and obviously, the Germans wanted a drug that was going to stop bleeding. And so they used the drug which is basically the same drug and they gave it to Russian prisoners. One Russian prisoner had the drug. The next Russian prisoner didn't have the drug. And they stood them side-by-side and they shot them both at the same time and they waited to see which prisoner would stop bleeding first. It's not only an immoral drug but its background is hardly the most salubrious.
VOICEOVER: The following is a health alert. You may have received the drug Trasylol.
ROSS COULTHART: Bayer has never admitted liability but in the US, it has spent hundreds of millions of dollars settling case after case before they go to trial. Jim Ronca won a reported $20 million payout on behalf of just 50 families. The fact that Bayer has settled the cases with you before they went to court means there is no precedent on the books that makes a finding in the American courts that Bayer has done something wrong, doesn't it?
JIM RONCA: That's true. In addition, the documents don't become public.
ROSS COULTHART: You subpoenaed thousands and thousands of pages of documents from Bayer's own records, didn't you?
JIM RONCA: 25 million pages.
ROSS COULTHART: When you saw what Bayer knew about the dangers of its own drug Trasylol, were you surprised?
JIM RONCA: I was surprised by the depth of their knowledge.
ROSS COULTHART: In America, Bayer has paid out a quarter of $1 billion. In Australia, as far as we can find, not one cent. Nor has it made any public attempt to try to find the families of Australian victims, like Janette Lloyd who was left a widow at 28. When you saw the evidence pointing to this drug, Trasylol, were you surprised?
JANETTE LLOYD: I was horrified. I went cold all over. I couldn't believe anyone would do that. He was a human being. It really, really angered me.
ROSS COULTHART: How important was it for you to get an answer, to get an explanation? Why does it matter after 35 years?
JANETTE LLOYD: The peace of mind to me and the children, especially Jenny, being a nurse, because she knows. She goes to work every day and the first thing is, "First do no harm." And in this case, there was harm done and then hidden, covered up.
PART 3:
Bayer is big. As one of the world's largest pharmaceutical companies, it's a massive employer. So much so that its factory here, near Cologne, is a large town all of its own.
ROSS COULTHART: You've come a long way to confront the heads of the company that you believe sold a dangerous drug...
JENNY LLOYD: Yes, I did.
ROSS COULTHART:..that you believe killed your father.
JENNY LLOYD: Yep.
It's Bayer's annual general meeting. Under heavy security, airport scanners, guards, security cameras, Jenny Lloyd from Australia is about to bravely face the directors of Germany's giant pharmaceutical company, Bayer. 36 years ago, Jenny's father died after being given Trasylol.
ROSS COULTHART:..Your whole life has gone in a particular direction because of what happened to your dad.
JENNY LLOYD: It has.
ROSS COULTHART: If you could talk to him now, what would you say to him?
JENNY LLOYD: (TEARFUL): Well, I can't, can I? He's gone. He's gone a long time ago. He's missed every day by every one of us.
Bayer have refused all our requests for an interview with Sunday Night but in Germany, shareholders are allowed to speak at their AGM and a shareholder sympathetic to Jenny's plight made us their nominated proxy.
ROSS COULTHART: Mr Chairman, thank you very, very much for the opportunity to speak to you and the members of the board of Bayer. Bayer's rules say we have to address the board in German so we've brought a translator.
(TRANSLATES INTO GERMAN)
And briefly, we're listened to. That is, until the mention of one word - Trasylol.
ROSS COULTHART: There is a young woman here today, her name is Jenny Lloyd. Her father, David Lloyd, was given the drug Trasylol in 1978.
Bayer turns off the mic. But what they don't realise is that the next nominated speaker is Jenny Lloyd and she's come too far and suffered too much to be silenced.
ROSS COULTHART: She is the next speaker. Do you want to read that? No?
TRANSLATOR: They're blocking us completely.
JENNY LLOYD: Well, I'm not moving! Will you listen to me? I'm not moving! I am not going to move! I have flown so far for you to listen to me! This drug was not approved. It wasn't approved until 15 years after it was injected in my dad! Do you understand I was only two years old? Five children! Dad didn't see his last baby born! Listen to me! Have a heart!
(TRANSLATES INTO GERMAN) (APPLAUSE)
ROSS COULTHART: This young woman's father died, she believes, because of a drug that Bayer sold and you should be ashamed of yourselves as shareholders for shutting it down.
Kicked off the podium, Jenny isn't budging - not without answers.
JENNY LLOYD: I don't care! Well, I'll sit here all night. Why should I move? How can they not have a heart?
MAN: I understand you.
JENNY LLOYD: How come you talk about an intravenous drug that killed my Dad and I'll keep on talking over you, so stop! (APPLAUSE) No. No.
Then, another speaker offers her spot to Jenny so she can once more address the board.
JENNY LLOYD: How did it end up in Australia... (TRANSLATES INTO GERMAN) ..not approved, and how many other people have passed away... (TRANSLATES INTO GERMAN) ..and this is all been hidden?
Questions to which Bayer's chairman does not respond. But in the end, Jenny has the satisfaction of knowing she made her points and made them well.
JENNY LLOYD: I thank you for at least giving me a couple of minutes for you to listen to me. (TRANSLATES INTO GERMAN) Thank you.
Then, Bayer's security guards escort Jenny out.
JENNY LLOYD: I was there for a purpose - to let them know what they'd done and they didn't want to listen so I made them listen.
ROSS COULTHART: I think they know what you think, though! Yeah. Have a look at that photo in your hand. Who's that?
JENNY LLOYD: My dad.
ROSS COULTHART: What do you think he would've thought about what you did? I think he was there and I think he helped us. Oh, God.
HOME VIDEO OF FATHER AND KIDS: # A, B, C, D, E, F, G # H, I, J, K, L, M, N, O, P # MAN: It takes a long time to get to that bloody P!
ROSS COULTHART: We've got a saying in our line of work that sometimes, secrets have a way of bubbling to the surface.
JENNY LLOYD: Yep.
ROSS COULTHART: Do you think this is a story that wanted to be told?
JENNY LLOYD: It really needed to be told, yes, because I don't think it was only Dad affected by this drug. Dad can not be the only one in Australia that can have this drug administered and not told about that. There must be many more.
CHRIS BATH: Ross Coulthart with our special investigation. And one of the frightening aspects of Trasylol is that the drug can stay in your body for up to 10 years, meaning that the side effects can still strike within that time. If you have had surgery and now fear you may have been given it or if you are worried that a loved one suffered or died as a result of Trasylol, then the first step is to obtain the hospital medical records. How you do that varies from state to state so on our website, you'll find an easy guide on who to apply to. You'll also find a statement from the Royal Melbourne Hospital where David Lloyd was treated as well as Bayer's response to our requests for an interview and information. We've also posted our correspondence with Australia's Therapeutic Goods Administration. And if you wish to reach out to the TGA with your concerns or for further information, you can email them a info@tga.gove.au
