#TalkClinicalTrials: Rare Disease, Hydroxychloroquine & COVID-19

Margaret French’s daughter has a rare disease known as Peroxisomal Biogenesis Disorder – Zellweger Spectrum Disorder (PBD-ZSD). To manage her symptoms, she receives the drug hydroxychloroquine, which is also being tested in COVID-19 clinical trials. Below, Margaret opens up about her family’s experience with clinical trials as well as her concerns about hydroxychloroquine as potential treatment for COVID-19.

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Peroxisomal Biogenesis Disorder – Zellweger Spectrum Disorder

A friend of mine shared a great statement on social media: “If you’re upset about lack of testing and care and treatment for this virus…Welcome to the life of rare diseases!!!” Truer words have never been spoken. The panic, uncertainty and anxiety that many of us are facing currently around the globe has been my family’s reality for three years.

I am the mother of a beautiful 5-year-old daughter, “Miss G”, who is feisty and independent. She also happens to have a rare genetic metabolic disorder known as Peroxisomal Biogenesis Disorder – Zellweger Spectrum Disorder (PBD-ZSD). The mortality rate is very high for this disease – most children don’t live to see their 2nd birthday. The disease is classified as ‘life-limiting’, and patients are considered ‘medically fragile’.

Miss G is lucky in that her symptoms are mild – bilateral sensorineural hearing loss, low vision, some low muscle tone (she’ll never have a six-pack is how her pediatrician put it); and, a language delay, mainly due to her delayed hearing loss diagnosis. More severe cases of PBD-ZSD present with liver and/or kidney issues, lung issues, frequent seizures, and a host of gastrointestinal issues that often result in requiring a feeding tube.

When we heard those fateful words “PBD-ZSD” back in April 2017 we had never heard of this disease. We were fearful for our daughter’s future, felt guilty for being carriers of a defective PEX1 gene mutation and had no idea what our next steps were.

Sound familiar?

I’d wager to guess that most Canadians outside of the health care system, never even knew about coronavirus before this year, let alone that this class of viruses is the cause of the common cold. Now COVID-19 is all any of us talk about. Canadians are fearful about how to go about their daily lives. They’re hearing conflicting reports on the news about possible treatments or cures. However, there is currently no approved treatments or vaccines for COVID-19.

A lack of cures or treatments is a staple in the rare disease world. For PBD we have ‘symptom management’. For Miss G, symptom management includes: eye drops, glasses, hearing aids, regular check-ups with her specialists at Sick Kids where they conduct a whole battery of blood draws, sedated eye tests and physical exams.

Innovative drug usage study at SickKids

But we do have hope. Miss G was involved in the early stages of an ‘innovative drug usage’ for a drug known as HCQ – hydroxychloroquine. An innovative drug usage is the catalyst for a clinical trial. There is evidence that this medication, known as the ‘malaria drug’, has been helpful for patients with lupus, rheumatoid arthritis and other inflammatory illnesses. Given the complex presentation of PBD, it was thought that HCQ may have a beneficial property. Miss G’s involvement in this stage helped researchers at Sick Kids to secure funding to advance onto a clinical trial.

We were offered an opportunity to participate in the randomized control trial, but after much careful consideration and review of how the trial was set up (there was a 50% chance of Miss G being off HCQ for 7 months straight due to receiving the placebo), we decided it was too much of a risk for us to take. The biomarkers that her physicians at Sick Kids have been monitoring have decreased slightly since she began the medication and more or less held steady. We view this as very promising, since (*knock on wood*) we haven’t witnessed a regression.

Hydroxychloroquine and COVID-19

There are some anecdotal testimonies of COVID-19 patients being treated with a drug cocktail that includes HCQ. There have been some in authority who casually suggested that perhaps people should take this medication prophylactically. Soon afterwards, the Canadian Pharmacists Association noticed a sharp increase in HCQ prescriptions https://www.pharmacybc.com/xanax-alprazolam/.

All this speculation is causing a shortage of HCQ for Ontarians who are legitimately prescribed this medication (and routinely monitored under a physician’s care, for any potential side effects) for their medical conditions. When I heard about HCQ being floated around as a ‘cure’, I immediately contacted Sick Kids to ask what our next steps are to secure my daughter’s medication. They contacted my local pharmacist and we secured medication for a month. However, I worry I may not be able to fill her prescription moving forward.

I am genuinely afraid that there could be dire consequences to Miss G stopping her medication cold turkey. She has been on this twice daily medication for 2 and half years. Will she have a regression? Will her health decline? Will she now be even more susceptible to COVID-19? Many in my PBD rare disease family have made the realization that if their child contracts COVID-19 they will die. I don’t want this to be how my daughter’s story ends.

I implore everyone to hold off on promoting ‘miracle cures’ for COVID-19. Let the experts explore this medication in a controlled setting: as a clinical trial. They can access the risks and efficacy. HCQ, along with other medications, is being tested as a treatment for COVID-19 in clinical trials in Ontario and elsewhere. For more information on these studies visit this page. Should Health Canada agree that HCQ is an appropriate treatment option, I, along with other HCQ users, will have in-depth conversations with our health care providers and pharmacists to determine how we can secure our access to this vital medication.

Stay safe and wash your hands!

#TalkClinicalTrials

#TalkClinicalTrials is a campaign led by CTO with the a goal of building awareness around clinical trials. Why? Because clinical trials matter to all of us. They help to generate better treatments and technologies and ultimately help shape the future of medicine. Explore more stories from the series and join the conversation on social media using #TalkClinicalTrials.