This document sets forth policies and procedures to help ensure that individuals involved in clinical evaluation, content authoring, and peer-review for Elsevier/Gold Standard drug information databases and products are free from financial conflicts of interest.
Elsevier/Gold Standard is committed to providing unbiased, complete, and accurate drug information. It is important to define the Editorial Team policy regarding relationships with manufacturers of drug products or other potential conflicts of interest, and to identify and provide resolution to any potential conflicts of interest.
Elsevier/Gold Standard employs clinical pharmacists to write, peer-review, edit, and manage clinical content within our databases. As a condition of employment, all editorial team members and freelance authors must comply with the Conflict of Interest Policy and Procedures. Individual editorial team members may have past relationships with the industry, as the knowledge and skills obtained from such positions are beneficial to the mission of the Elsevier/Gold Standard team: provision of complete, timely, and accurate drug information. Current direct relationships with any pharmaceutical company or their representative are not acceptable, and violate the Elsevier/Gold Standard editorial policy. Editors may not be employees or receive payment for any rendered services from such companies. Sponsored programs, events, publications, etc. can be presented or authored by Elsevier/Gold Standard editors as long as the content is not dictated, suggested, or reviewed by the sponsoring company; if remuneration is given, the program must be supported by an unrestricted grant from the corporation sponsoring the event. Editors may receive benefits from the pharmaceutical industry extended to any other participant attending a professional conference or continuing education session, such as the acceptance of professional continuing education credit. Elsevier/Gold Standard editorial team members cannot accept any individualized gifts, payments, or benefits from any other corporate organizations. Elsevier/Gold Standard editors are required to file an annual conflict of interest disclosure form with Elsevier/Gold Standard, stating compliance with the policies of the organization.
Elsevier/Gold Standard will offer disclosure of any significant external relationships of individual editorial team members to the public whenever they arise and will note the actions taken to resolve the conflicts. Disclosing these relationships to the public increases the transparency of the content development process at Elsevier/Gold Standard, and also ensures that no conflict biases the drug information content of Elsevier/Gold Standard products.
On very rare occasions, Elsevier/Gold Standard finds it necessary to solicit the advice of a wide range of health care professionals with respect to the presentation of content and/or content review. It is essential that these formal advisory individuals be impartial and unbiased.
Before utilizing any external advisor, Elsevier/Gold Standard will require a disclosure of the individual’s financial relationships with pharmaceutical companies at the onset of advisory service, and annually thereafter. Information will be collected on the standard Conflict of Interest Disclosure Form of Elsevier/Gold Standard.
The Elsevier/Gold Standard Editorial Team, directed by the Editor-in-Chief, is responsible for ensuring that the forms are completed and maintained by the organization. If any advisor refuses to provide information about his or her financial and other relevant interests, the person shall be disqualified from participation in content development for Elsevier/Gold Standard. It is always the desire of the Elsevier/Gold Standard Editorial Team to select authors, editors, and advisors without pertinent financial conflict relationships to assist with our content development.
Not all financial relationships within the industry (e.g., pharmaceutical industry) are disqualifying. Financial relationships vary in type and size, and an overly broad conflict of interest policy would inappropriately preclude individuals with critical expertise from contributing to content development or becoming employees of the company. This document thus sets forth a process to identify and categorize relevant financial relationships. Specific criteria are then applied for each category to determine whether disqualification or disclosure is necessary.
The following interests in pharmaceutical companies are considered to create a potential conflict of interest. In each case, the policy describes the tiers of the scope of the interest and how each should be addressed.
Employment, Partner, or Director Positions:
An individual who currently or within the past six months (a) is or was an employee, or (b) holds or held a position as a director of, or a partner in, any pharmaceutical company shall be excluded from participation.
Where the individual’s spouse is an officer or director of, or a partner in, any pharmaceutical company, the individual shall be excluded from participation.
Equity or Stock Ownership:
This section applies only to stock or equity ownership in a pharmaceutical company where the individual has direct control over the disposition of that ownership interest. It does not include an interest in stock held via a diversified fund, such as a mutual fund, which is under the control of another.
Where the combined value of the stock or equity ownership in any single pharmaceutical company held by the individual totals $10,000 or less, the individual shall be allowed to participate.
Where the combined value of the stock or equity ownership in any single pharmaceutical company held by the individual is greater than $10,000 but less than $100,000, the individual shall be allowed to participate and the individual’s interest shall be disclosed.
Where the combined value of the stock or equity ownership in any single pharmaceutical company held by the individual is greater than $100,000, the individual shall not be permitted to participate.
Advisory/Consulting Role; Lecture/Speaking Fees, Payments and Gifts of Other Sorts:
This section addresses fees and payments for an individual’s service as an advisor or consultant to a pharmaceutical company, lecture fees, or other honoraria or gifts from a pharmaceutical company.
Where the individual has received payments with a combined value of less than $5,000 from any single pharmaceutical company within the past twelve (12) months, the individual shall be allowed to participate.
Where the individual has received payments with a combined value of more than $5,000 but less than $25,000 from any single pharmaceutical company within the past twelve (12) months, the individual shall be allowed to participate and the individual’s interest shall be disclosed.
Where the individual has received payments with a combined value of more than $25,000 from any single pharmaceutical company within the past twelve (12) months, the individual shall not be permitted to participate.
Research Funding:
Where an individual or an individual’s spouse has received research funding as a principal investigator in the past twelve (12) months from any pharmaceutical company, the interest shall be disclosed.
No individual may be permitted to participate in the review of their own or their spouse’s research.
Drug Patents or Royalties:
Where an individual or an individual’s spouse holds a patent or other intellectual property or royalty rights in a drug that is the subject of the current content development, or that is related to the current content development, the individual shall not participate.
The determination of whether a drug in question is related to the current content development task will be made by the Elsevier/Gold Standard Editorial Team.
Whenever a financial or conflict relationship is disclosed, the disclosure will be acknowledged. The Elsevier/Gold Standard website at www.goldstandard.com, and associated editorial policy pages, will be the central location for such disclosures. These disclosures may identify the name of the individual, the name of the pharmaceutical company or companies, and the general nature of the financial relationship (e.g., consultant, grant recipient, equity ownership).
For employees, Elsevier/Gold Standard will offer an annual disclosure summary of any financial or conflict relationship of individual editorial team members to the public. Whenever such arises in employment, we will note the actions taken to resolve the conflict. Disclosing these relationships to the public increases the transparency of the content development process at Elsevier/Gold Standard, and also ensures that no conflict biases the drug information content of Elsevier/Gold Standard products. Elsevier/Gold Standard may be contacted if questions arise regarding any individual employee and conflict of interest.
In some circumstances, it may be appropriate to deviate from the basic conflict of interest rules set forth, either to grant a waiver or exception to the policy, or to require an individual’s disqualification where otherwise permissible under the policy terms. For example, an advisor solicited for advice on a very rare medical condition may be the foremost expert on the condition, and it may be appropriate to still seek the advice of that individual, offering the proper disclosure of their conflicts to the public.
Elsevier/Gold Standard reserves the right to limit, on any basis, any individual’s participation in content development. Any waivers and exceptions must be reviewed and approved in writing by the Editorial Team. We reserve, as publishers, the right to seek legal organizational counsel regarding any waivers or exceptions to our policies. Changes may be made to this Conflict of Interest Policy at the discretion of Elsevier/Gold Standard.
No significant external relationships of any individual editorial team member are identified. No editorial team member disclosed conflicts (financial, organizational, or corporate) that would inappropriately influence Clinical Pharmacology drug compendium content or the clinical drug content of other Elsevier/Gold Standard products. While most editorial team members did disclose the contribution to 401-K or mutual fund holdings (which may at times have a complement of pharmaceutical interests as part of a balanced portfolio), no team member disclosed direct financial holdings or relationships with any pharmaceutical corporation. No conflicts were identified with any participation in speaking events, academic or industry grants, professional affiliations, advisory committees, boards, or panels. Elsevier/Gold Standard will offer disclosure of any significant external relationships of individual editorial team members to the public whenever they arise; such disclosure statements will be posted annually at a minimum. Disclosing these relationships to the public increases the transparency of the content development process at Elsevier/Gold Standard, and also ensures that no conflict biases the drug information content of Elsevier/Gold Standard products.