Secrecy and the health protection branch.

Information about drugs undergoing the regulatory approval process in Canada is shrouded in secrecy. The Health Protection Branch (HPB) of Health Canada considers confidential the information submitted by a manufacturer in requesting approval for a drug and at present does not publicly disclose that a product is under review. (In April 1998, the HPB proposed to list products under review on its Web site; this has still not been finalized.) Nor does the HPB have external advisory committees that meet in public to discuss drugs under consideration. The net effect is to deny health care professionals and consumers the right to make any intervention with the HPB before a drug comes to market. After a drug has received approval for marketing, information about it is still highly restricted. The HPB will release information contained in the submission only with the consent of the sponsoring company. If consent is denied, that information remains confidential. The end result is that health care professionals may be unable to review and validate the information that the HPB used in deciding to allow a product to be sold. This lack of access to health and safety data can be illustrated by my experience with regard to pediatric antidiarrheal agents. The World Health Organization (WHO) has concluded that these products have no place in the management of acute diarrhea in children. This conclusion has been backed up by Public Citizen, a health research group in the US, which analysed studies identified through a MEDLINE search and the files of the US Food and Drug Administration (FDA). I wrote to the companies that make pediatric antidiarrheal products in Canada and asked them, among other things, to send me a copy of all the studies they had showing that their products were both safe and effective for the treatment of diarrhea in children. None of the 7 papers I received met the methodological criteria outlined by the WHO for proving that antidiarrheal agents are effective. The fact that the manufacturers could not supply any methodologically sound literature to support the use of their products raised a question in my mind about the quality of the studies that had been submitted to the HPB to obtain approval for their use in children. Accordingly, in November 1996 I made a request to the Access to Information Centre of Health Canada for all studies that the HPB had that dealt with the question of the efficacy of a range of commonly used antidiarrheal agents. As of August 1998, or 21 months after my request was filed, I am still waiting for a final answer. Does it really matter whether or not I was able to obtain the requested documents within a reasonable time? After all, inappropriate use of antidiarrheal medications is probably not a significant problem in Canada, and there have been very few reports in children in this country of adverse events associated with these products. In this case the lack of access to information is not critical, but the principle that health care professionals and the public should have access to health and safety data on drugs is one that needs to be established. It is not hard to conceive of a situation in which lack of access to clinical information could be hazardous to patients’ health. It often happens that after a drug appears on the market it becomes widely used for an indication for which it has not been approved. It is entirely possible that the manufacturer initially apEditorial