This week marks the end of a turbulent time of my life. For the past three years I’ve been travelling to the other side of the world for lifesaving treatment at a huge personal cost. This week, I will walk into the Peter MaCallum Hospital in Melbourne to collect my lifesaving drugs from the pharmacy.
In 2015 I was set to die. I had an incurable form of Chronic Lymphocytic Leukaemia from which I’d relapsed after chemotherapy failed. But for a 40-year-old mother with three young children, death was not an option.
Following online research I discovered there were novel drugs in development that might just save my life.
The problem was I couldn’t access them in Australia. Only 3 per cent of terminally ill patients can get onto trials of such drugs.
After a trip to the US, and a lucky meeting with a British doctor, I moved to London to join a clinical trial of an experimental drug at Bart’s Hospital.
Ironically my wonder drug, venetoclax, was invented in Australia but I had to travel to London to take it.
I was lucky enough to become patient 49 on a ‘phase 1’ trial. This combination therapy followed a first in human safety trial of 80 brave patients, but came before the drug was listed by the Food and Drug Administration in the US.
I was one of just 75 people worldwide who received the treatment. Within three months I was in complete remission and within seven months I had no detectable cancer — it just melted away.
I had to fly to London for monthly appointments for a year, then three monthly appointments up until now. I have had no traceable disease for 29 months and take my drug daily with no side effects.
I work full-time and my children have their mother. But I am one of the very few lucky ones. Red tape is preventing dying patients from accessing lifesaving drugs.
I am now campaigning for all terminally ill patients to have access to the latest drugs.
Right to Try, letting patients legally access these, is an important part of that. As it stands, dying patients have to wait for phase 1, 2 and 3 clinical trials to be completed before drugs are made available.
My CLL drug has taken 30 years to reach that stage.
It has since received Therapeutic Goods Administration approval for use in Australia — but is still not available on pharmacy shelves.
Right to Try laws in the US were created to enable terminally ill patients — with advice from their treating doctors — to try experimental therapies which have completed phase 1 testing but have not yet been approved for use by the FDA.
The legislation has its roots in the HIV epidemic. The Dallas Buyers Club movie shows how people with HIV sought access to experimental drugs through illicit means.
Legislation in the US began in 2014, thanks to the work of the Goldwater Institute, a libertarian think tank objecting to government interference between patients, doctors and pharmaceutical companies.
“This is really a law for people who are very sick, who have exhausted all treatment options and who cannot enrol in a clinical trial,” Goldwater’s Starlee Coleman explains.
If a doctor believes an investigational drug is your best hope, they can initiate contact with that drug manufacturer’s compassionate use program to discuss options for access.
“It’s only for people who say, ‘I understand the risk. I know this drug is not fully approved,” Coleman says.
The TGA’s Special Access Scheme allows doctors to prescribe a drug listed anywhere in the world to dying patients.
Australia should extend this to the US model of allowing access to all drugs which have passed phase 1 testing.
Doctors knew my drug was working years ago. Signing the consent form to take part in the clinical trial was terrifying but it was more terrifying knowing the alternative. All patients, with informed consent, should have the opportunity to save their own lives.