Ross Coulthart, the Sunday Night investigative reporter from Channel 7 TV, broke a story involving the drug Trasylol, its grim history and the trail of destruction created after its original launch in the global marketplace.
The story revolved around Jenny Lloyd, a Victorian woman who was two years old when her father (David Lloyd) died following surgery at the Royal Melbourne Hospital in 1978.
David originally 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 and they suspected serious brain trauma. 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 and 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,this information was suppressed.
Trasylol was first discovered during some of the darker days of World War Two.
One of its clinical trials was simple and brutal and involved Russian prisoners of war.
Prisoners were lined up to receive an injection.
One was a placebo and the other Trasylol and after the trial group had received their injections they were shot.
The blood loss from the trial victims was then noted and in this gruesome manner, Trasylol was given birth.
With a legacy story like that, it is little wonder that it eventually became a horror story in the 21st century, even reaching the backwaters of Australia.
While the initial motivation may have been saving battlefield casualties, this changed post-war to become a money-making machine, eventually producing the lethal dose that was to destroy the Lloyd family after the death of David Lloyd.
Jenny felt this loss severely and vowed that she would find the real cause of her father’s death.
This eventually culminated in Jenny becoming a theatre nurse, thus putting herself in a position to understand the procedures and processes of surgical operations, and to recruit skilled advisers to her cause.
During that period she discovered her father had been given Trasylol during his operation.
Eventually, the Sunday Night program assisted Jenny through their investigative journalist resources, where a massive cover up by Bayer was discovered, revealing that they were well aware of the problems and dangers of Trasylol.
It was decided that after the support of some expert medical testimony that Jenny Lloyd and Ross Coulthart would confront the board of Bayer at their annual general meeting where the company rules allowed for any shareholder to address the meeting.
On attending the AGM impediments were immediately put in their way, with an insistence that the address be only given in German.
An interpreter was secured and proceedings began once again until the name “Trasylol” was mentioned and the microphone was turned off.
At this point Jenny refused to leave the meeting and other shareholders came to her rescue giving up their microphones for her use.
In this way Jenny was able to deliver her message to the stoney-faced chairman of the board, and other directors.
The following is from the transcript of the Sunday Night program:
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.
One of the unusual aspects of Jenny’s story is that it actually gained support in mainstream media, because the story of Bayer is not dissimilar to the story of other global Pharma’s and their efforts in producing fraudulent evidence or evidence that was biased because of incomplete details being reported or a deliberately faulty trial design.
Perhaps Jenny’s story will mark a turning point in Australian medical history where fraud will no longer be accepted into reference databases.
Hopefully we will also see the organisation set up to defend the science in medicine take a more active and higher profile role in the prevention of damage to Australian patients by global Pharma’s, instead of harassing registered health professionals such as chiropractors.
Currently, Trasylol has been sold to another manufacturer, Nordic Pharma, in 2012.
The following information has been taken from a media release:
Hoofddorp, July 13th, 2012 — Nordic Group announced today that it has reached an agreement with Bayer HealthCare in which Nordic will acquire Trasylol® (aprotinin injection) worldwide excluding the United States. Under this agreement, Nordic will become the Marketing Authorization Holder for aprotinin in the relevant Territories. This follows the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from February 2012, recommending that the marketing authorisation for aprotinin should be reinstated in the European Union. The recommendation took into account a full review of the benefits and risks of all antifibrinolytic medicines, which found that the results of the study on which the suspension of aprotinin was based were unreliable. This positive opinion is expected to be ratified by the European Commission later in 2012. Nordic will be managing global supplies of aprotinin in the relevant Territories.
The CHMP has recommended lifting the suspension for aprotinin in the following indication :
Aprotinin is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e., coronary artery bypass graft surgery that is not combined with other cardiovascular surgery). Aprotinin should only be used after careful consideration of the benefits and risks, and the consideration that alternative treatments are available. Since 2007 both Nordic (which was already marketing an aprotinin product) and Bayer have maintained compassionate limited access programmes in some 16 countries. In September 2011, the marketing authorisation for aprotinin was reinstated in Canada.
About Nordic Group BV
The Nordic Group is a privately owned, fast growing, fully integrated, pan-European pharmaceutical company, with a strong focus on the development and commercialization of niche hospital and orphan products and services that cater to the specific needs of clients and patients. In addition to its sales and marketing companies in 14 European countries, operating under the name of Nordic Pharma and Nordic Drugs, the Nordic Group operates as well a number of specialized Pharmaceutical Services companies, specialized in product development, manufacturing, supply logistics, clinical studies and regulatory activities. These companies are operating under the name of Prague Clinical Services, QPharma, Disphar and Indeus. Since its creation, Nordic has enjoyed an average growth of 20% in revenues, and it pursues its expansion through organic growth and strategic collaborations. Additional information can be obtained by visiting Nordic Group’s website at www.nordicpharmagroup.com.
It is not known how close the ties are between Nordic and Bayer executives.
It is known that Nordic is seeking a reinstatement of aprotinin (Trasylol) injection in Australia for similar conditions listed for Canada and Europe, where this product has been reinstated.
I sincerely hope that on moral issues alone, this drug is forced off the Australian market forever.