Declarations of interest by members of Health Canada’s special advisory committees and panels: a descriptive study

Joel Lexchin

doi:10.9778/cmajo.20190010

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Table 1:

Description of the types of interests itemized in Health Canada’s Affiliations and Interests Declaration Form for Advisory Body Members

Type of interest	Description
Direct financial interests	Current employment, investments in companies, partnerships, equity, royalties, joint ventures, trusts, real property, stocks, shares or bonds, with the regulated industry
Indirect financial interests	Within the past 5 years, payment from regulated industry for work done or being done, including past employment, contracts or consulting; or financial support including research support, personal education grants, contributions, fellowships, sponsorships and honoraria
	Within the past 5 years, materials, discounted products, gifts or other benefits, or attendance at meetings where all or part of the travel and accommodation costs were provided by the regulated industry
	Within the last 3 years, grants or other funding from the regulated industry to any of the organizations where you are currently employed or participate in internal decision-making
Intellectual interests	Within the last 5 years, any formal advice or opinion to industry, a government organization or a nongovernment organization on a matter of relevance to the scientific advisory committee or scientific advisory panel
	Within the last 5 years, any published or publicly stated point of view on issues of relevance to the scientific advisory committee or scientific advisory panel mandate
	Current professional or volunteer affiliations such as membership in professional societies, lobbying, public interest or advocacy groups, of relevance to the scientific advisory committee or scientific advisory panel
Other interests	Any other affiliations and interests or potential circumstances that might give a well-informed member of the public reasonable grounds for concern regarding the integrity and objectivity of your participation

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Table 2:

Interests declared, by perspective/sector

Perspective/sector	Total no. of members	No. of members; type of interest
Perspective/sector	Total no. of members	Direct financial	Indirect financial	Intellectual	Other
Academia	13	3	10	10	0
Academia + health professional	22	3	20	18	1
Academia + health professional + research	8	0	6	7	1
Academia + research	8	1	3	5	0
Health professional; health professional + research	17	1	11	12	2
Industry; academia + industry	3	2	2	3	0
Infectious diseases	4	1	2	4	0
Patient/consumer	4	1	2	4	0
Pharmacy	2	0	0	2	0
Total	81	12	56	65	4

Note: SAC = special advisory committee, SAP = special advisory panel.

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Table 3:

Interests declared, by advisory body

Advisory body	Total no. of declarations	No. (%) of declarations; type of interest
Advisory body	Total no. of declarations	Direct financial interest	Indirect financial interest	Direct or indirect financial interest	Intellectual interest	Other interest
Oncology therapies SAC	21	3 (14.3)	18 (85.7)	18 (85.7)	16 (76.2)	2 (9.5)
Pharmaceutical sciences and clinical pharmacology SAC	13	4 (30.8)	9 (69.2)	10 (76.9)	12 (92.3)	0 (0)
Respiratory and allergy therapies SAC	19	3 (15.8)	14 (73.7)	14 (73.7)	16 (84.2)	0 (0)
Anti-infective therapies SAP	6	1 (16.7)	2 (33.3)	2 (33.3)	6 (100)	0 (0)
Bioequivalence requirements for gender-specific drug products SAP	7	0 (0)	4 (57.1)	4 (57.1)	6 (85.7)	0 (0)
Bioequivalence requirements for modified-release dosage forms SAP	6	0 (0)	5 (83.3)	5 (83.3)	5 (83.3)	0 (0)
Diclectin SAP	4	0 (0)	1 (25.0)	1 (25.0)	1 (25.0)	0 (0)
Opioid analgesic abuse SAP	6	1 (16.7)	4 (66.7)	4 (66.7)	4 (66.7)	0 (0)
Opioid use and contraindications SAP	6	0 (0)	1 (16.7)	1 (16.7)	6 (100)	2 (33.3)
Opioids SAP	6	0 (0)	2 (33.3)	2 (33.3)	6 (100)	2 (33.3)
Isotretinoin risk management SAP	5	0 (0)	2 (40.0)	2 (40.0)	3 (60.0)	0 (0)
Total	99	12	62	63	81	6

Note: SAC = special advisory committee, SAP = special advisory panel.

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Table 4:

Topics discussed at SAC/SAP meetings and summary of recommendations

Committee or panel	No. of meetings	No. of meetings where a record of proceedings was available	Date(s) of meeting(s) where a record of proceedings was available^*	Summary of topic(s) discussed	Summary of recommendation(s)^†
Oncology therapies SAC	7	1	August/September 2011	Regulations prohibiting the use of arsenic as an ingredient in drugs sold for human use	The section of the Food and Drugs Act that prohibits the sale of drugs containing arsenic should be revoked.
Pharmaceutical sciences and clinical pharmacology SAC	4	0
Respiratory and allergy therapies SAC	11	3	Mar. 14, 2012 Oct. 26, 2013 Feb. 23, 2018	Data requirements for safety and effectiveness of subsequent market entry inhaled products for use in the treatment of asthma	An in vitro data package is adequate in lieu of clinical data to demonstrate bioequivalence of a subsequent market entry budesonide suspension for inhalation using a suitable nebulizer. Depending on the type of product, clinical outcome studies using FEV1 are acceptable as long as a difference in the mean of at least 12% is demonstrated.
Anti-infective therapies SAP	1	1	Oct. 6, 2016	Issues around the safety and efficacy of fluoroquinolones for different indications	The product monograph for fluoroquinolones should include a statement about disabling and potentially irreversible persistent adverse reactions. Fluoroquinolones should not be used for acute sinusitis of less than 7 d duration.
Bioequivalence requirements for gender-specific drug products SAP	1	1	June 22, 2011	Requirements for market authorization of a second entry or subsequent entry gender-specific drug product	The current practice of using only males, males and females or only females for bioequivalence studies should be continued.
Bioequivalence requirements for modified-release dosage forms SAP	1	0
Diclectin SAP	1	1	June 2, 2016	Data from study of Diclectin	The panel would not recommend any changes to the current labelling of Diclectin for the management of nausea and vomiting of pregnancy.
Opioid analgesic abuse SAP	1	0
Opioid use and contraindications SAP	1	1	Mar. 24, 2017	Information about opioids that should be included in product monograph Should low-dose codeine products be made prescriptiononly?	Information about a threshold dose for chronic noncancer pain should be in the dosing and administration section of the product monograph in such a way as to draw the attention of the prescriber. The indication for extended/long-acting opioids should be changed to say that patients should first have tried a nonopioid medication. Prescriptions for opioids for acute pain should be limited to 3 d. No changes should be made to the nonprescription status of low-dose codeine products at present.
Opioids SAP	1	1	Nov. 15, 2016 and Nov. 16, 2016	Public information about opioid overdose and addiction Risk management plan for opioids	A warning sticker should be placed on prescriptions for opioids to highlight the issues of physical dependence, addiction and overdose. Industry involvement in risk management plans and educational programs should be monitored and limited.
Isotretinoin risk management SAP	1	1	Nov. 17, 2017	Pregnancy prevention program for isotretinoin	Although there is no evidence to show that the Canadian pregnancy prevention program is not ineffective, improvements should be made.

Note: FEV1 = forced expiratory volume in 1 s, SAC = special advisory committee, SAP = special advisory panel.
↵* A record of the proceedings of the meeting of the respiratory and allergy therapies SAC on Nov. 2, 2018, was not available at the time of writing.
↵† Italics are as in the original text.