Please help Laura get treatment in Canada

Dear. Hon. Ms. Ambrose,

I was moved by your message last week on Cancer Day where you encouraged Canadians living with cancer to seek the support and treatment they deserve. I am a Canadian father of a 7 year old girl with brain cancer and hope that you, as our Minister of Health, can help save my daughter’s life. We need your help in understanding why our daughter’s doctor was refused Special Access for a drug he believes has a chance of helping her.  The Special Access file numbers are 39015 and 39424.

My daughter Laura was diagnosed with DIPG (diffuse intrinsic pontine glioma) in October 2013. It is an aggressive and inoperable tumour in her brain stem. Children with this type of cancer live on average only one year after they are diagnosed. When she was diagnosed, we told were told there is nothing they could do to save her. Her doctor became aware of an experimental drug, antineoplaston, and believes Laura is a candidate for that treatment. Our doctor was rejected TWICE by Special Access for this drug. Special Access Program was put in place to help give doctors access to drugs for patients with terminal illnesses, like cancer (it says so on the website!). We are especially confused since other drugs previously approved on Special Access were for non-life threatening conditions such as drug addiction. Hence, it is not clear to us why a drug previously approved by the FDA for use in a clinical trial is not being made available to the Canadian doctor treating our daughter. Furthermore, this drug is currently being used in Australia under their similar Special Access program. We look to you for help with this.

I understand that it is Laura’s doctor who is responsible for filing the Special Access request and it is his responsibility to make sure the drug my daughter needs is safe and effective.  Health Canada is refusing to give her doctor the medication which he has asked for. He is only asking for a 4 month supply to find out if Laura’s tumour will respond to this treatment. If she does not respond to it, then he will not request any future doses for her and will return any unused drugs to the manufacturer.

In their rejection letter, the Special Access Program cites FDA warning letters. Based on what I have read and what I have been told, those warning letters are NOT related to the drug. The US government approved the drug in a clinical study which confirms that there was no issues with the quality of the drug or the way is it made. One warning letter had to do with advertisement of the drug. When you do a search of the FDA website, dozens of drug companies have warning letters on advertisement and it is nothing new. The most recent warning mentioned in the refusal letter states “failing to protect the rights, safety and welfare of his subjects”. It is my understanding that these findings have to do with the way the data was recorded in the medical records and has to do with that particular hospital collecting the data and not with the actual drug. I understand that the US government did not agree with the way patients were informed about the cost of the drug during the study and the way information was recorded (all this is available on the FDA website). This is a not a concern for us as Laura will receive treatment from a clinic in Toronto. As well, payment of the drug is not a concern for us especially if it means there is a chance that our daughter will survive her brain cancer.

Another Special Access denial letter states that the drug should be used in a clinical trial. I have spoken to our doctor and his team they have informed us that a clinical study is not taking place in Canada and, unfortunately, we do not have time to wait for the lengthy government approval for a new study to start. Laura has only a few months left to live.  I hope you understand that, if there any chance of stopping this disease from taking our daughter away, we need to act very quickly and Special Access is our only option.

My wife and I are fully aware of the possible side effects and risks associated with this experimental drug–the worst risk is that it may not help Laura. Today, the biggest threat to my daughter is having no treatment.  If there is a chance that this new drug will save my daughter, then it is better to have this drug than not to have any options at all. Without access to this new drug, we will be forced to spend day and night by her bedside waiting for her to take her last breath. I look to you to help our doctor get access to this new drug. We have no other options.

When Laura’s doctor got the second Special Access refusal letter from Health Canada he said to me “I’m sorry. There’s nothing else I can do”. These are not the words any parent wants to hear from the doctor caring for their sick child. I hope that you can help our doctor get access to this unapproved drug for Laura. I believe our very sick 7 year old daughter deserves that the Canadian government step in and help save her life. Special Access Program was created to give doctors access to drugs to treat patients like Laura. I believe she should not be denied this opportunity for a second chance at life. Please help my doctor by letting him treat my daughter with the drug he believes may make a difference. Thank you, Ms. Ambrose, for your attention to this urgent matter. In the meantime, we are preparing an online public petition in support of our Doctor’s request for this drug on Special Access. We await to hear back from you.

Sincerely,
Janusz, Miroslawa Nowosad