Drug research and treatment for children in Canada: A challenge

Question 1

What percentage of drugs on the Canadian market do not carry safety or dosing recommendations for use in children?

Answer 1

75%

Question 2

What are some examples of historical drug tragedies?

Answer 2

1. “Elixir Sulfanilamide” tragedy - >100 deaths in US in 1937 from nephrotoxicity
2. Thalidomide crises lat 1950s to early 1960s -> 1000s infants born with phocomelia following intrauterine exposure to thalidomide

Question 3

What was Health Canada’s response to issues around drug therapy for children?

Answer 3

Creation of the Office of Pediatric Initiatives as part of the Health Products and Food Branch

Question 4

What are the recommendations regarding drug research in Canada?

Answer 4

1. Health Canada, CIHR, and industry should develop a national research network focused on children
2. Networks should work with CPS, CSPT, and Canadian academic child health centres
3. CIHR, Health Canada and Canadian academic child health centres should work to enhance human capacity in drug investigation in children, including in paediatric clinical pharmacology and complementary scientific disciplines such as pharmacoepidemiology, biomedical ethics, in silico pharmacology, and systems biology.
4. CIHR, Health Canada, and Canadian academic child health centres should support training opportunities for drug research in children
5. The CIHR, Health Canada and Canadian academic child health centres should support drug studies in children, notably for drugs and diseases where optimal therapy is poorly defined.
6. The CIHR and the National Council on Ethics in Human Research should work with organizations, such as the CPS, to define and address the evolving ethical challenges of drug research in children, with a view toward how these issues are addressed both nationally and internationally.
7. The CIHR, Health Canada and Canadian academic child health centres should support innovation in drug research in children
8. The federal government must demonstrate its commitment to optimal treatments for Canadian children by providing robust, dedicated and sustained support for and training in drug research for this group
9. Federal government must continue to evaluate and establish incentives that will best encourage industry to submit paediatric data when presenting information to Health Canada.