A mother’s love has driven Coralie Graham to tirelessly raise funds for a clinical trial into an arthritis drug to treat stroke patients.
- The mother of a 32-year-old man with an acquired brain injury raised money for a clinical trial using perispinal Etanercept
- Previously used to treat arthritis, Etanercept is injected into the spine to enter the vascular system
- Doctors believe it could also be used to treat other neurological conditions, but there is red tape around its affordability and availability
Her son, Joel Shepherd, 32, suffered a brain injury when he was three years old as a result of complications from gastroenteritis.
“He was on life support, in a coma for eight weeks, and left with a catastrophic disability across his life,” Ms Graham said.
The registered nurse, from Toowoomba, completed a degree in psychology to understand more about his condition and mortgaged the family home to get the off-label treatment in the United States in 2014.
“So we lived at the doctor, he lived on antibiotics, and was often really, really sick,” she said.
“Previous to treatment he was very, very aggressive because he couldn’t get his needs met.
“[After treatment] Joel had significant improvements in his swallowing, his speech, his concentration, mobility, and a whole range of things.
“To me that is worth it; there’s no amount of money that you can measure that against.”
‘I’m not giving up’
She started the charity Stroke Recovery Trial Fund, which funded the first clinical trial into the treatment involving perispinal Etanercept.
“I can spot a neurological injury a mile away … And I just think there’s a treatment for you,” she said.
Entanercept is a drug commonly used to treat arthritis, but American doctor Edward Tobinick developed a new use for the drug.
The perispinal method involves injecting the drug into the spine to enter the vascular system.
“The perispinal Etanercept treatment really is very likely to be able to treat other neurological conditions as well because, at a cell level, the pathology is very similar in things like cerebral palsy, even schizophrenia, some types of depression, Parkinson’s disease,” Ms Graham said.
Associate Professor Stephen Ralph said Griffith University’s School of Medicine was conducting a randomised clinical study of 22 patients.
“There was a significant reduction in pain levels and mobility improved greatly in terms of their ability to raise their arm from the shoulder,” Dr Ralph said.
“It’s nerve-wracking pain that they cannot treat with other drugs and it just does not go away.
“In fact, it was quite surprising because patients would go from 65–70 out of 100 on the pain scale down to zero after the treatment, so almost immediate responses within 15 to 30 minutes.”
He said 90 per cent of patients in the group who received the drug showed a significant increase in their ability to raise their arm above the shoulder.
Their mobility improved by 35 degrees on average after the first treatment and went up to 55 degrees on average in the second treatment.
“That improvement was dose related, so that’s even more significant because it shows that it’s related to the treatment,” he said.
“Some of our patients did not respond … but there was a benefit for the majority of patients.
“They [patients] say it’s fantastic, it’s amazing, and it’s basically … a breakthrough treatment.”
Dr Ralph said no change was noticed in the control group, which had “no apparent effect at all”.
Dr Ralph said stroke patients were forced to rely on very strong sedative drugs to deal with their pain, which really limited their scope in terms of their ability to function.
“These sedative drugs basically knock them out. They either have poor quality of life, or they suffer the pain.”
He said larger studies were now needed to fight the “tremendous resistance” to approving the treatment in Australia.
“The problem was that I think it was almost too miraculous for people to believe that it was possible,” he said.
“I’ve seen patients who are now back to work, basically functioning normally … back to their normal life again.”
Dr Ralph said it was “extremely disappointing and frustrating” to see the benefits of the treatment firsthand, but it was not available publicly.
He was in the planning stages of a future bigger study looking into the drug’s ability to treat fatigue.
Red tape limits availability
Australian National University Emeritus Professor Ian Clark has studied the TNF protein, which is elevated in stroke patients in the area around the stroke site, in Australia and internationally for decades.
He said the patent of the drug had expired and there were large legal battles regarding its use in the United States.
“It’s about patent expiry and money and keeping out cheaper versions of the drug,” he said.
“It’s [the drug] had an effect that got people intensely interested when it was published, but a trial never ran because no-one wanted to pick it up and run with it because ‘big pharma’ didn’t want it done.
“This is really the key.
“For any drug like this they [Therapeutic Goods Administration] need a number of trials for them to gain confidence that it’s worth the government subsiding and therefore becoming available and more cheaply.”