THUNDER BAY – POLITICS / HEALTH – Canadian physicians are, at times, even in life threatening situations, prevented from using the drugs they believe they should be using. My private members bill, which begins it’s legislative journey Friday looks to change that by making significant changes to the Special Access Program (SAP). These changes will considerably reduce the red-tape associated with the program and transfer the authority to make difficult decisions about whether to use an unapproved drugs, in a life-threatening situation, to expert clinicians rather than Ottawa bureaucrats.
Yesterday I was at SickKids (Hospital for Sick Children), in Toronto, finalizing the bill. A bill that is as much theirs as it is mine. I want to thank all of the people at SickKids- particularly Charlotte, Katherine, and Gwendolyn for all of their very considerable work in writing the bill. But let me first explain a little more about the bill and the SAP.
The Special Access Program allows physicians to access medications that are not approved by Health Canada. There are a multitude of reasons why a medication may not be approved by Health Canada. Sometimes these are new medications which are still undergoing clinical trials but at times they are medications which have gone through vigorous trials showing their efficacy but are still awaiting approval. Some medications have previously been approved but the Canadian market isn’t lucrative enough to warrant a manufacturer keeping them approved.
For drugs for rare diseases the number of patients who have been treated may be too small to be able to statistically prove a medication actually works and as a result the drug can not be approved. Furthermore for drugs for rare diseases the size of the Canadian market may not be big enough to warrant a company paying the price, or jumping through the hoops, to get it approved by Health Canada.
Currently medications that have not been approved can be accessed through the SAP or clinical trial with an N=1. The SAP and the clinical trial process need to be reformed.
Before telling some of the troubling stories I heard while writing the bill let me first preface my remarks by saying I know there are many excellent people working at Health Canada. People who are compassionate and work tirelessly to help Canadians. Indeed many clinicians I talked to told me that the people at Health Canada are generally “very good.” However some of the other stories I heard were-
1) Many pharmacists, particularly pharmacists working in children’s hospitals, are forced to spend considerable amounts of time sending faxes and filling out forms for the SAP- at times for drugs that have been widely used in Canada for years.
2). A doctor working in the intensive care of a children’s hospital told me of her pharmacist being on the phone for hours trying to get approval for a life saving drug. This while they were in the process of trying to resuscitate the child! The drug in question is the first line treatment for the condition in the USA.
3) I heard of children dying before having their SAP request approved.
4) I have heard of numerous cases of progressive neurological cases in children where access to a medication, which would significantly delay the progress of the disease, was either been refused, stayed, or significantly delayed. Even though in the words of one paediatric neurologist “if you give a kid the medication while the kid can walk they will continue to walk, when they can speak they will continue to speak, but if you do not- they will not.”
5) Infectious Disease (ID) specialist tell me when they need to use an antibiotic, that is only available through the time consuming SAP program, they frequently need to use it “right away.” The problem caused by having to go through the SAP is significant enough that some doctors say Canadian ID programs have trouble keeping residents, and fellows, from the USA. This is because they feel they are forced to practice an “inferior quality of medicine” in Canada.
6) Canadian paediatric ICU doctors are forced to use phenobarbital at exceptionally high doses rather than pentobarbital, the preferred drug, in treating children who won’t stop seizing. Pentobarbital is the drug of choice in the USA, and approved by the FDA, but in Canada is only available through the SAP. Given the difficulties entailed in using the SAP they instead use phenobarbital which is approved.
7) Paediatricians say they are frequently denied access to a drug under the SAP because they have not tried an alternative drug, authorized by Health Canada, beforehand- even when they know the alternative is far less likely to work and far more likely to cause adverse effects. It was suggested that because clinicians are so frequently forced to tell their patients, or their families, “you ought to be on drug A but instead we are using drug B”- faith in the doctor-patient relationship often gets eroded.
😎 Access to medications under the SAP is often denied because a drug is in on-going clinical trials. Although certainly it is better to enrol patients in clinical trials, sometimes doing so creates considerable hardship for the patient and their families. For example I had a friend who’s brother had to drive him back and forth to Duluth for his chemo after his SAP application was denied. Similarly Montreal paediatricians told me children there were denied access to medications because there was a clinical trial underway in Toronto.
9. Several people told me that because an older injectable steroid was no longer approved by Health Canada they were forced to use a newer drug that was. The newer drug costs thousands of dollars, the older drug I don’t quite remember but something like $20.
I trust my bill will help to address all of these issues.
The system needs to be improved. Moreover given that more treatments in cancer are now often being increasingly targeted to the specific genetic sequence of the cancer, and new therapeutic products, that address life-threatening conditions, are constantly coming out, we need a system of drug approval which is more nimble than what we currently have. But we also need to be cautious. We must, as much as we can, safeguard against marketing drugs which have not been proven safe. In addition we do not want the SAP to be used as an end run around our drug approval system. So many drugs will not be affected by this legislation.
I would like to thank the team at SickKids particularly Dr Charlotte Moore Hepburn, Katherine Aldred and Gwebdolyn Moncrieff-Gould for all of their considerable help in drafting the bill. I would also like to thank the many other people at SickKids, the number one ranked children’s hospital in the world, and the place where I learned paediatrics, for all that they did. SickKids wrote the first draft of the bill and reviewed all of the subsequent changes. I would also like to thank Dr Catherine Litalien and the doctors, and pharmacists at CHU Sainte Justine in Montreal, and the doctors and pharmacists at HSC Winnipeg, Princess Margaret Hospital (Toronto) and BC Children’s Hospital, that met with me and offered some good suggestions. Many of these suggestions ended up incorporated in the act. I would also like to thank Lori Anderson for her input and William Stephenson- the House of Commons lawyer/ legislative drafter extraordinaire who patiently listened to me and more than exceeded my expectations when putting my thoughts into words. Legislative drafting is both an art and a science.
Lastly I would like to thank my staff: Bill, Simon, Jalen, and Josh and to everyone who provided me invaluable advice in shaping this bill. In addition although I complain, a lot, about the bureaucracy I have to say, as a result of this process, I am reminded that we have some really excellent people working in our government.
This bill as much the work of all of the above as it is of mine. To all of the people who helped with this- thank you, thank you, thank you!
