Confused and shocked, I sat on the chair next to the hospital bed while two other medics approached.
It was December 2020 and the day before I had spent over ten hours in A&E bashing through tests and checkups and popping birth control pills after a suspected stroke.
I was talking to a friend on the phone when, without warning, I felt severe dizziness and increasing nausea. Then I couldn’t control my right hand anymore, my right leg was wobbly and I felt exhausted.
I was admitted in the early hours, that day was full of checkups and tests, still in disbelief as I went from seemingly healthy to having a stroke.
It was December 2020 and the day before I spent over ten hours in A&E bashing through tests and checkups and popping birth control pills after a suspected stroke
The two people who identified themselves as hospital researchers had something on my mind that I could help with. They wanted to enroll me in a clinical trial studying the effect of a new anticoagulant, a drug to prevent blood clots, the cause of the most common type of stroke – an ischemic attack, that I had.
This happens when the blood vessels that supply the brain are blocked – brain cells and tissues can begin to die within minutes, which explains the sudden onset of catastrophic symptoms.
Anticoagulants help by reducing the formation of fibrin, a protein that will form a fibrous network over a wound or injury to reduce blood flow.
It was clarified that I would take two pills a day for a year and have a 25 percent chance of being a placebo or the drug (known as Bay 2433334) in one of three doses – 10mg, 20mg or 50mg.
Because the experiment was “double-blind,” neither the researcher nor the participant knew who got what.
The trial would include five visits to the hospital (Charing Cross, London, part of Imperial Health Care Trust) for various tests, and in the other seven months the researcher would phone to check on my health.
Over the course of a year, I had up to four ECGs to check how my heart was working and up to three MRIs of my brain. I received a 15-page information sheet to read, which told me there would be about 1,900 participants in 24 countries.
Because the experiment was “double-blind,” neither the researcher nor the participant knew who got what. The stock image above is used
The information is no longer any straightforward advantage, but she said study participants may benefit from all the additional health checks.
Of course, as a health journalist, I couldn’t help but think of the disastrous drug trial in 2006, which left six young men in intensive care. The trial, which took place in a private ward at Northwick Park Hospital in London, was the first of its kind in humans, using a drug designed to treat leukemia and chronic inflammatory conditions.
The drug worked by manipulating the immune system, sending the youth’s organs into a state of overdrive. Five of them spent three weeks in the hospital, and the sixth, whose face swollen significantly, remained there for four months.
The dizziness I was experiencing at the start of the stroke has largely disappeared and my mind is starting to feel clearer. I am still stunned by the events, but I was surprised at how rational I was in evaluating the option to go to trial.
I was able to ask questions and found that increased safety measures were introduced after the Elephant Man disaster.
I’ve been told that the drug I was asked to take had already been tried on humans in previous, smaller trials, so I thought the safety risks were much lower.
Unfortunately, doctors cannot determine the cause of the stroke, even though my blood pressure was very high upon admission.
I’ve had Covid-19 badly, and because the virus makes the blood more viscous, it could be because of that, but no one has been able to confirm the link.
Without any known cause, the chance of having a second stroke, always more disabling, within two years is a terrifying 30 percent.
This was enough to get me into trying the drugs, but the experience struck me at a difficult time.
The stroke was in the cerebellum, the part of the brain responsible for balance, coordination, and posture, as well as helping with eye movement and vision.
So in addition to balance and coordination issues on my right side, I’ve lost fine motor skills in that hand, including handwriting, something so integral to my life and work. I thought that anything that might prevent worse was worth it, because I signed my consent to the trial by scribbling – all I could manage.
Looking around in the acute stroke ward, unfortunately I saw several severely injured patients who did not seem to move, speak or eat. When I was discharged from the hospital a day later, I was genuinely excited about doing some things to help improve medicines for others—it also gave me a sense of purpose at a time when I couldn’t even write a Christmas card.
A year later, the lost functions gradually returned, with exercises to improve balance and coordination and to practice writing and typing. I just finished trying the drug. There is no doubt that regular monitoring was reassuring, not least when my EKG in June and December, as well as my MRI in June, as part of the trial, showed there were no silent strokes and my heart was fine.
I was terrified of the risk of a second stroke, especially since I didn’t smoke and already eat a Mediterranean diet – two of the suggested ways to avoid further events – so all I was left with was the newly prescribed pills. enthusiastically.
Although the MRI was not fun, it was a huge bonus and relief. My blood pressure checks about every two months (I had five in total) were reassuringly normal.
It’s not yet clear when the results of this trial will come out – and of course I don’t know if I’m taking an experimental drug or a placebo. I was the first patient inducted into Charing Cross and being an optimist, I would like to believe the drug was customized for me and it worked for me.
This will only be disclosed if I have a medical emergency and the doctor needs to know what I have been taking. But there is no doubt that I gained a lot from participating.
One difficulty for those who recruit patients for such trials is whether the patients will be healthy enough to see it through. Another is that, for example in stroke medicine, patients can arrive at night or on weekends when recruiters are not on duty. There is also patients’ fear of the unknown at a time when they are already dealing with a new health scare – and the “reputation” of the experiences themselves.
Jane Armitage, professor of clinical trials and epidemiology at Oxford University, was conducting a trial on statins at the time of the Northwick Park trial in 2006, which “impacted our ability to recruit,” she says. But she believes that Covid vaccines and recovery trial work, to determine which treatments do not work for Covid patients, ‘has restored some of that confidence’.
Dr Dheeraj Kaladka, a consultant neurologist and stroke physician at Charing Cross Hospital, who was involved in the stroke trial, adds: “Clinical trials are not randomly dreamed-up experiences, and patients should not think of themselves as guinea pigs.
Much thought goes into developing clinical trials. And the more patients who participated and considered experiences positive, the more we could improve care and customize medications.
Interestingly, Professor Armitage notes that subjects in the trials, even those who received a placebo, were shown to be in better health than those with the same condition outside of the trial.
Some of this is because health problems may be caught earlier because participants are monitored.
She adds: “Drug trials are very important to make sure the medications our doctors prescribe are safe and effective. We don’t get a huge response rate, but we like people to think about it carefully.”
To find out more about participating in a trial in the UK, check the websites of relevant medical charities, and the Be Part of Research website: bepartofresearch.nihr.ac.uk
History Status Notes
Ancient medical practices still exist today. This week: honey for wounds
Today, the NHS uses dressings impregnated with medicinal honey to keep wounds clean, something we can thank for a long history of doctors, including Dioscorides, a physician from ancient Greece (who lived around AD 40 to 90).
He wrote that “honey cleans, unclogs pores and draws out fluids”—and it was a lot in place. “Honey contains hydrogen peroxide, which is antibacterial,” says Dr. Maninder Ahluwalia, Lecturer in Biomedical Sciences at Cardiff Metropolitan University.
It’s hygroscopic, which means it can draw moisture from a wound and dry out bacteria until they die. It also reduces inflammation, increases new blood vessel formation, and helps remove dead tissue.
But you can’t just use any honey. “Medical honey must be free of contaminants and organic matter, sterilized with gamma rays and follow strict production and storage standards,” says Dr. Ahluwalia. Table honey may be contaminated with pollen or microbial spores, which means it is not safe to use.
If you want to try medicinal honey, Medihoney dressings are available in drugstores – but talk to your doctor first.