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Research

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

Joel Lexchin
May 19, 2019 7 (2) E334-E340; DOI: https://doi.org/10.9778/cmajo.20190010
Joel Lexchin
School of Health Policy and Management, York University, and University Health Network and Faculty of Medicine, University of Toronto, Toronto, Ont.
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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 interestDescription
    Direct financial interestsCurrent employment, investments in companies, partnerships, equity, royalties, joint ventures, trusts, real property, stocks, shares or bonds, with the regulated industry
    Indirect financial interestsWithin 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 interestsWithin 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 interestsAny 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
    • View popup
    Table 2:

    Interests declared, by perspective/sector

    Perspective/sectorTotal no. of membersNo. of members; type of interest
    Direct financialIndirect financialIntellectualOther
    Academia13310100
    Academia + health professional22320181
    Academia + health professional + research80671
    Academia + research81350
    Health professional; health professional + research17111122
    Industry; academia + industry32230
    Infectious diseases41240
    Patient/consumer41240
    Pharmacy20020
    Total811256654
    • Note: SAC = special advisory committee, SAP = special advisory panel.

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    Table 3:

    Interests declared, by advisory body

    Advisory bodyTotal no. of declarationsNo. (%) of declarations; type of interest
    Direct financial interestIndirect financial interestDirect or indirect financial interestIntellectual interestOther interest
    Oncology therapies SAC213 (14.3)18 (85.7)18 (85.7)16 (76.2)2 (9.5)
    Pharmaceutical sciences and clinical pharmacology SAC134 (30.8)9 (69.2)10 (76.9)12 (92.3)0 (0)
    Respiratory and allergy therapies SAC193 (15.8)14 (73.7)14 (73.7)16 (84.2)0 (0)
    Anti-infective therapies SAP61 (16.7)2 (33.3)2 (33.3)6 (100)0 (0)
    Bioequivalence requirements for gender-specific drug products SAP70 (0)4 (57.1)4 (57.1)6 (85.7)0 (0)
    Bioequivalence requirements for modified-release dosage forms SAP60 (0)5 (83.3)5 (83.3)5 (83.3)0 (0)
    Diclectin SAP40 (0)1 (25.0)1 (25.0)1 (25.0)0 (0)
    Opioid analgesic abuse SAP61 (16.7)4 (66.7)4 (66.7)4 (66.7)0 (0)
    Opioid use and contraindications SAP60 (0)1 (16.7)1 (16.7)6 (100)2 (33.3)
    Opioids SAP60 (0)2 (33.3)2 (33.3)6 (100)2 (33.3)
    Isotretinoin risk management SAP50 (0)2 (40.0)2 (40.0)3 (60.0)0 (0)
    Total99126263816
    • 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 panelNo. of meetingsNo. of meetings where a record of proceedings was availableDate(s) of meeting(s) where a record of proceedings was available*Summary of topic(s) discussedSummary of recommendation(s)†
    Oncology therapies SAC71August/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 SAC40
    Respiratory and allergy therapies SAC113Mar. 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 SAP11Oct. 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 SAP11June 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 SAP10
    Diclectin SAP11June 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 SAP10
    Opioid use and contraindications SAP11Mar. 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 SAP11Nov. 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 SAP11Nov. 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.

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CMAJ Open: 7 (2)
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Declarations of interest by members of Health Canada’s special advisory committees and panels: a descriptive study
Joel Lexchin
Apr 2019, 7 (2) E334-E340; DOI: 10.9778/cmajo.20190010

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Declarations of interest by members of Health Canada’s special advisory committees and panels: a descriptive study
Joel Lexchin
Apr 2019, 7 (2) E334-E340; DOI: 10.9778/cmajo.20190010
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