CONFLICTS AND SPONSORSHIP ATTESTATIONS
Strict requirements of speakers
ACCO policy is that no pharmaceutical company shall be permitted to sponsor or endorse any education event or ACCO function in any manner.
This ban includes manufacturers, distributors and marketers of products associated with skin cancer management*.
(*includes management of premalignant conditions)
All ACCO presenters donate their time to present at ACCO education events. As a not-for-profit entity, all proceeds after costs are directed by the Board to further education and research in skin cancer management.
CONFLICT OF INTEREST DECLARATIONS
ACCO has strict conflict of interest requirements regarding any speaker / contributor to our education programs. All conflicts of interest must be declared. A speaker / contributor shall be considered to have a conflict of interest in an entity associated with a product in managing skin cancer if the person:
- Has shares or stock in the entity
- Has been provided with support in the form of travel or accommodation by the entity
- Has been provided with any other goods or services by the entity for which the person obtains benefit
- Is a director of the entity
- Charges for services that make use of products of the entity
- Sells products of the entity
- Obtains any other benefit from an association with an entity
No speaker at an ACCO event is permitted to have their registration, travel or accommodation for that event subsidised by an entity.
ATTESTATION of ACCO speakers and directors
As a speaker / moderator / panel member / director at this activity run for / by ACCO, I attest that:
All recommendations that I make for patient care as part of my presentations and/or discussions will be based on the best available evidence accepted within the profession of medicine unless explicitly stated as such
All research referred to, reported on, or used in my presentation will conform to the generally accepted standards of experimental design, data collection, analysis and ethics approval
My presentations and/or discussions will give a balanced view of therapeutic options
If any portion of my presentation/slide is not original work, I have obtained the necessary copyright permissions
My presentation is HIPAA compliant (i.e. I have used only de-identified patient information).
Levels of evidence
In all presentations I will apply levels of evidence in evaluating which research material is presented.
In brief levels of evidence shall be regarded as follows:
1) A systematic review such as Cochrane analysis
2) A large randomized controlled trial (RCT) with analysis restricted to intention to treat (ITT) data
3) Smaller RCTs with analysis on ITT basis only
4) A pseudo-randomized controlled trial (i.e. alternate allocation or some other method)
5) Randomized controlled trial data that is not on intention to treat basis
6) A comparative study with concurrent controls:
▪ Non-randomised, experimental trial ▪ Cohort study ▪ Case-control study ▪ Interrupted time series with a control group - PROSPECTIVE
7) A comparative study with concurrent controls:
▪ Non-randomised, experimental trial ▪ Cohort study ▪ Case-control study ▪ Interrupted time series with a control group - RETROSPECTIVE
8) A comparative study without concurrent controls:
▪ Historical control study ▪ Two or more single arm study ▪ Interrupted time series
9) Case series with either post-test or pre-test/post-test outcomes
10) Personal views, "In my experience . . ." " I have seen . . ." etc
** Regarding levels (1) to (10) above, I will only cite research of the top two levels available for a given management aspect. For example, if there is a published systematic review and large RCTs with ITT data available, no evidence of a lower level will be included in any presentation.
Usage of generic versus brand names in ACCO education
In general all ACCO education that involves discussion of pharmaceutical products should refer only to the generic names of the products. Agents such as lignocaine, dicloxacillin, paracetamol, adrenaline, cephalexin, aspirin, chloramphenicol, dabrafenib, vemurafenib, iplimumab, imiquimod, nivolumab, trametinib, pembrolizumab, ingenol mebutate, warfarin and erythromycin should be referred to only in generic form. There are many other examples.
When a generic drug name is mentioned in ACCO education, the understanding will be that the specific agent being used is a relevant authority approved** version of the drug.
EXCEPTIONS
There are circumstances where usage of brand names is preferable and other times when usage of brand names is needed in quality and accurate education. This guideline serves to provide assistance to ACCO members regarding circumstances when drug company brand names can or should be used.
1) Multiple agents:
At times a product is a combination of numerous active ingredients. An example is sunscreens. At times the individual ingredients are not widely recognized and understood. The formulation base also often varies from brand to brand. As such, describing multiple agents in a given base is not likely to convey to the audience exactly which product is under discussion. Naming the brand of sunscreen may be the best method of conveying accurate and understandable education. Only approved** sunscreens should be so discussed.
2) Generic not enough
At times the generic drug name is insufficient to identify the product in discussion. An example is topical diclofenac. There are several marketed and approved** versions available. However, most of these products are designed for joint / muscle discomfort and are not designed, tested or intended as an agent to manage actinic keratoses. A different formulation with alternate strength and base has been tested and approved** for actinic keratoses. To provide accurate information to the audience it will be necessary to explain these differences and identify the brand names of the products intended to treat topical actinic damage.
3) Bioequivalence issues
In most cases bioequivalence of two agents is not an issue. However, at times there are differences or concerns and these might need to be addressed in education. An example is botulinum toxin. There are published concerns that some versions by some producers are not the equivalent of others. With this in mind, education might need to identify which specific product was used, and in what strength and quantity, to ensure accurate education is affected. A further bioequivalence example occurs with aminolevulonic acid, an active ingredient used in photodynamic therapy. Different preparations have been shown to have different properties and adverse events. A distinction in education may be required by using brand names. Other bioequivalence issues also often arise when there are variations in delivery systems for topical agents.
4) Non approved** agents
Other than approved** therapeutic goods there are many other products marketed and available that may be discussed in the context of skin cancer education. Education should exercise caution when these products are described, especially when other products with the same active ingredient are approved**. It is inappropriate for any ACCO college members to support the use of a medicine which is not approved** and could be a potential detriment to individual patients. Whenever such agents are discussed in education, it should be made clear that the product is not approved** and not recommended. If there is an approved** product with the same active ingredient, this product(s) must be distinguished from others and the rigour and process of regulation recognised.
5) Other circumstances
There will be other circumstances when education material might include brand name details rather than only generic names. Whenever this occurs it will be expected that the educator can identify and explain why the generic name was not used alone.
If there is a concern about a specific preparation then it would be irresponsible not to clearly specify the product, generic or otherwise.
** In Australia, the relevant authority is the Therapeutic Goods Administration. In USA the authority is the Food and drug Administration. Other authorities apply in other countries.
Commercial Supporter Influence: Faculty members are not permitted to receive any direct remuneration or gifts from the commercial supporter of this activity as it relates to this specific activity, nor should they be subject to direct input from a commercial supporter regarding the content of their presentations. ACCO directors shall not endorse or promote any product or service pertinent to skin cancer medicine for the duration of their appointment.
Fear or favour: Faculty / Board members are not permitted to alter education content as a result of offers of inducement or threats from industry including any commercial entity of potential conflict as defined. From time to time ACCO may become aware of safety or adverse event issues pertaining to a commercial entity associated with skin cancer management. ACCO shall inform the general College membership as well as relevant authorities
Shareholder / director conflicts: ACCO directors shall not be permitted to be directors in any company considered to be commercial entity of potential conflict. Should the director be a shareholder or equity partner in any entity of potential conflict they shall be required to transfer responsibility / management of such shareholding to an independent manager for the duration of the director appointment. Any decisions regarding such shareholding shall be made by the appointed independent manager without input or involvement of the director.