Press room ... 1999 archive

Proposed Guidelines for Ethical Relations Between
HIV Community Agencies and Pharmaceutical Companies

November 19, 1999

San Francisco, CA—* This initial draft of Proposed Guidelines for Ethical Relations is being circulated by Project Inform in the interest of stimulating dialogue on these important issues facing our community. We understand that not everything described here will be possible in every situation, but we at least hope to illuminate some key issues and contribute toward raising the standards by which all of us operate. We are very eager to receive input from other community agencies and leaders so we can further refine this document to reflect a broad spectrum of concerns. Please contact us with your feedback and suggestions: Project Inform, 205 13th St., Suite 2001, San Francisco, CA 94103. Phone 415-558-8669 x310; Email web@projectinform.org. We will look forward to hearing from you.

Background
The success of new HIV treatment options over the last several years, coupled with the need for greatly extended educational services to help people benefit from these treatments, has refueled an old debate about what constitutes appropriate relationships between community organizations and private industry. Advocacy organizations in almost any field at times find themselves in conflict with the interests of large national and international industries that provide products related to the advocates’ field of interest. This relationship between advocacy groups and industry is often at least partially adversarial though it may at times also be partially cooperative and even collaborative.

The mix of conflicting and common interests is perhaps nowhere more stark, and complex, than in the relationship between the pharmaceutical industry and patient interest groups, and in particular, groups working in the field of AIDS treatment education and advocacy. Advocates uniformly decry the high cost of pharmaceutical goods and the crass commercialization of life-saving medications and procedures. On the other hand, most advocates recognize that no other source, including government, has the resources and infrastructure needed to design, develop, and distribute critically needed medication. Government’s direct contribution to drug design usually ends at the level of basic science and private industry takes over from there. Like it or not, this is the worldwide system which exists for drug development. Thus, advocates and educators associated with the cause of AIDS treatment have little choice but to work as productively and ethically as possible with industry if they hope to have any influence at all over the outcome. Likewise, industry has an inherent interest in working with AIDS advocates and educators, needing input from those who constitute the market for their products.

Industry of all types has long sought to influence government, the public, and, in particular, advocates working in fields related to their products. From industry’s point of view, this is merely good marketing. However, taken to an extreme, this effort can stretch the limits of ethical behavior. In many fields, for example, non-profit agencies posing as “watch dog” groups have sometimes been found to be little more than wholly owned or funded fronts for individual companies or industries. At a more common level, industries frequently contribute to related non-profit agencies in hopes of influencing their beliefs and behavior. To some, such relationships create at least the perception of a conflict of interest, especially when advocacy groups become solely or primarily dependent upon industry funding. Why should the public trust that a nonprofit agency will act in the public good when it is entirely funded by an industry with a highly vested interest?

The AIDS epidemic has put a bright spotlight on both the problems and opportunities presented by the relationship between industry and non-profit service and advocacy agencies. There is nothing new to this, since the pharmaceutical industry has long played an enormous role in most of the major “disease interest” group causes. Moreover, the pharmaceutical industry spends billions annually in its efforts to influence physicians and health care workers through an endless stream of marketing materials, promotional junkets, gifts, and research funding.

Since the beginning of the epidemic, many have argued that the simplest way to prevent any perception or opportunity for conflict of interest is to steer clear of all industry funding. While this may work, it may be unnecessary. It also would have a serious impact on the delivery of services to people with AIDS, since industry has indeed been a significant giver to AIDS-related causes, probably the single largest source of funding other than government. Those who support the acceptance of industry funds argue that since the pharmaceutical industry is one of the few groups profiting, and handsomely, from AIDS, it has a moral obligation to turn a large portion of those profits around to help support community based services, advocacy and education.

Those who choose to believe that any acceptance of industry funding automatically compromises an advocate’s or agency’s integrity have a right to their views, but must recognize that others of good will and conscience may see things differently. Those who choose to take advantage of the opportunities presented by industry funding should not be accused of compromising their integrity unless there is clear evidence that this is in fact the case.

The decision to accept industry funding brings with it the obligation to make sure that we, as a community of non-profit service agencies, do our best to maintain standards that recognize and grapple with the ethical questions that may be raised by such funding. Make no mistake, good faith alone may not be enough to guaranty that industry funding won’t subtly or overtly affect the objectivity and balance of organizations and individuals. To minimize these concerns, and to raise the highest possible ethical standards while still acknowledging the legitimacy of industry funding, the following General Principles and Related Guidelines are suggested as a starting point for discussion. It may or may not be possible for all community agencies to act in accordance with the principles here, however desirable that may be. But there is value in raising the discussion nonetheless. We hope, however, that within the limitations imposed by a wide diversity of funding and staffing, community groups can come to agreement on basic standards of ethics that can be used by each of us to evaluate our own policies and practices.

Goals of the Guiding Principles and Related Guidelines:
• To establish principles of interaction which, to the greatest extent possible, discourage the reality or perception of conflict of interest between AIDS service organizations and sources of funding tied to the pharmaceutical industry;
• To establish general systems and procedures that will help maintain independence of thought and action on the part of AIDS agencies providing treatment information and/or advocacy services;
• To describe ethical standards of contact between AIDS service agencies and pharmaceutical companies which make products used by people with HIV;
• To avoid potential situations which might create undue or biased influence by pharmaceutical companies over the programs, policy positions, educational materials, or beliefs of AIDS service agencies and the people who work for them.

Guiding Principles: These proposed ethical guidelines are derived from three Guiding Principles:

Disclosure
Structured Communication
Independence and Ownership

Each of these guiding principles generates suggested guidelines for individuals and agencies, as follows.

Guiding Principle #1:
Disclosure: All significant financial relationships between the pharmaceutical and biotech industries and any for profit or non-profit community service agencies should be explicitly stated and acknowledged.

This is the simplest of the principles. It merely asks that community agencies be entirely up front about their sources of funding in general and in regards to specific programs and materials.

Related Guidelines:
Major grants of $5,000 or more should be announced publicly at the time they are received. This can be accomplished in newsletters, on websites, or by special press releases or announcements.
Any documents or educational material of any form that are explicitly paid for by pharmaceutical and biotech industry support should be clearly identified as such in the materials themselves.

A summary of all pharmaceutical and biotech industry support should be published annually and provided to supporters and the public at large. This summary should define what is and is not included as “pharmaceutical support.” For example, some agencies list only major grants while not counting industry purchase of tables at fund- raising dinners, reimbursement for travel to company and product- specific meetings, honoraria, or travel to scientific and medical conferences not specific to the company’s products. Whatever an agency chooses to include and not include should at least be made explicit.

On an annual basis, non-profit agencies should describe how they use funding received from the pharmaceutical and biotech industry. Some form of annual reporting is part of being responsible to the public as well as one’s funders.

Agencies should develop and make publicly available a statement of its policies regarding pharmaceutical and biotech industry support or funding. A few examples of policy positions:
Some agencies set a specific limit for the percentage of their funding that will come from the pharmaceutical and biotech industry.

Some require that neither board members nor staff may own stock in pharmaceutical and biotech companies which are engaged in developing products for HIV disease (except perhaps in the form of 401K retirement plans where the individual does not choose or actively trade specific stocks).

Some require that any honoraria offered by industry for speaking engagements or participation in meetings be paid to the agency rather than the individual.

Guiding Principle #2:
Structured Communication

This is a complex and multi-faceted principle designed to establish effective communications pathways between agencies and the members of pharmaceutical and biotech industry. This principle speaks about all the ways in which industry seeks to communicate with and influence agency views and practices.

In the earlier years of the epidemic, there was little direct contact between agencies and members of pharmaceutical and biotech industry. When contact occurred, it usually happened at the request of advocates or educators chosen by their respective agencies or activist organizations. In more recent years, this process has been reversed, and most contact now occurs at the request of industry members seeking to influence the views or positions taken by agencies and advocates. The lines of communication are further complicated when meetings to discuss education and advocacy issues are also used to discuss grants and funding opportunities.

In the past several years, some members of the pharmaceutical and biotech industry have increasingly targeted not the agencies themselves, but rather individual people within agencies, particularly those who most directly influence patient treatment choices or advocacy positions. Once identified, such individuals are sometimes targeted for in-depth relationships with the company involved, including offers of attendance at special meetings, travel reimbursement for industry meetings and scientific conferences, provision of industry developed materials and marketing promotions, etc. Several companies have further facilitated this “relationship-oriented” process by hiring community people once associated with local agencies as adjuncts to their marketing staff. While in the best of circumstances this may provide a helpful form of input to industry, at its worst it becomes a way for industry to put a friendlier face on its proprietary interests and to take inappropriate advantage of individuals and their relationships within the community.

Unrestricted personal and professional relationships between pharmaceutical or biotech industry representatives and the personnel of non-profit community agencies present an unprecedented opportunity for industry. If industry is permitted to contact and work with any and all agency personnel at its own discretion, it acquires widespread ability to influence that agency’s treatment knowledge and advocacy positions. This can create many problems for an agency. If industry is permitted to “call on” people as individuals however it chooses, much as it does individual physicians, it may easily create conflicting viewpoints within an agency depending on how effectively the company “sells” its message to those individuals. This is a dangerous formula for running an agency or serving a clientele, and it often creates a “divide and conquer” strategy for companies that seek to influence an agency’s views. If permitted to do so, a company which doesn’t like an agency’s “official” position on an educational or advocacy position may whittle away at the position one person at a time, sowing dissent and confusion in its wake.

The personnel of non-profit agencies providing treatment information and advocacy services need to work as a team, providing consistent messages to constituents and clear, uniform positions on advocacy matters. To provide coherent messages and advocacy positions, every agency needs to create its own structure for processing information and taking positions. Accountability must be a part of that process. The agency, and only the agency, should decide how it wishes to communicate with the pharmaceutical and biotech industry. In turn, both agency and industry must respect and adhere to the chosen channels of communication.

Another aspect of this concerns the relationship between seeking grants and expressing educational or advocacy positions. These two interests can collide within an agency. For example, an agency providing treatment information may find serious fault with the data or promotion of a given company’s product, at the same that the agency is seeking funding from the same company. Should the need to publish accurate information be tempered by the agency’s need for funding from the related pharmaceutical and biotech company? Obviously not, but the conflicting pressures will almost certainly arise. This conflict can be particularly perilous when the treatment advocate is a junior staff member opposing the interests of a powerful and established fundraising and administrative staff. Those working in advocacy or treatment information must be free to take positions without concern for how this might or might not affect potential funding from a company. Companies must not be permitted to use funding as a way to leverage an agency’s views on treatment or advocacy positions; otherwise, the conflict of interest goes beyond mere perception into hard reality. Agencies need to find a way to keep funding and advocacy/education on separate tracks. Industry, in turn, must be willing to support agencies solely for the good and necessary work they do, and never as a reward for the positions they take regarding the company or its products.

On one level, people of integrity may simply assert that they will not permit the proprietary interests of companies to influence their activities or perspectives. For some, this may be enough, though the perception of conflict of interest can never be fully resolved when this is the only answer an agency can give. Moreover, whatever the integrity of individuals, it is ultimately the integrity of the agency as a whole that must be maintained.

Thus, the second Guiding Principle is to proactively structure all communications between agencies or advocacy groups and members of the pharmaceutical and biotech industry.

Related Guidelines:
Agencies should establish clear and explicit lines of communication to govern all contact between its personnel and members of the pharmaceutical and biotech industry. Whenever feasible, agencies should separate the channels of contact regarding financial/ development matters and regarding educational or advocacy matters by assigning different personnel to each. Agency personnel responsible for educational or advocacy matters should not be burdened with concerns about how their actions might affect grant or funding requests (ideally, they should not even be aware of pending grant applications or sources of funding). Conversely, agency personnel responsible for financial and development matters with pharmaceutical and biotech companies should not be responsible for educational or advocacy positions. By separating these functions whenever possible, an agency greatly strengthens its ability to assert that its financial interests do not influence its educational or advocacy positions.

Unfortunately, the ability to fully separate these functions is somewhat determined by an agency’s size, with smaller agencies being less able to realistically designate fully separate personnel. However, even within the limitations of a smaller staff size, the general goal of separation can still be pursued by minimizing the number of people who carry dual responsibilities. In many cases, dual responsibility might be carried solely by the executive director.

All other agency personnel not specifically given responsibility for contact should be discouraged from having any form of substantive contact with industry representatives and should refer any request for contact to the appropriate agency personnel. When industry seeks to access an entire class of personnel, such as case managers or treatment advocates, the request should be reported and directed to the appropriate management personnel.

Members of the pharmaceutical and biotech industry should support and mimic this process by assigning separate teams of people responsible for financial/development matters and others responsible for educational and advocacy matters. By doing so, the company will be less likely to use funding (or lack of funding) as a “reward” for taking positions favorable to the company, or a “punishment” for taking unfavorable positions. Companies should support agencies because they believe in and respect the work done by those agencies on behalf of people with HIV, not because the agency “behaves” in a way the company likes. When the people at a company who are responsible for disseminating product information and taking advocacy positions also share the responsibility of deciding who does or does not get funding from the company, they are put in a position of inherent conflict of interest. When such people are evaluated based on the success or failure of the promotion of the company’s products, it is all but impossible for them to be neutral and unbiased in making decisions about who will and will not receive funding. The simplest way to resolve this conflict to decisively separate the two functions, as many companies have successfully done. Few if any companies lack the resources to implement this separation of duties, so company size should not be an acceptable excuse to avoid taking this step.

Members of the pharmaceutical and biotech industry should proactively ask agencies to define their “rules of engagement” and should respect them without question. Industry should be discouraged from attempting to build personal relationships with agency personnel outside the normal chain of contact, or from using the existing personal relationships of people hired from within the community as a way to circumvent the chain of contact. Similarly, each company should clearly declare its own chain of contact that it will expect agencies to follow.

Agencies should determine, in advance, who will attend meetings sponsored by pharmaceutical and biotech companies. Industry is sponsoring an ever-increasing number of “educational” and “consultant” meetings that invite members of community organizations to attend presentations about the sponsor’s products. While a few such meetings are indeed consultative in nature - directed at getting feedback for the company on a variety of legitimate topics - others amount to little more than extended sales promotions in a unique, company controlled environment. Increasingly, such meetings are held at resorts or other desirable locations, undoubtedly to build good will with the attendees. At the meetings, company spokespeople, or “community doctors” who receive some form of funding from the sponsor, present a favorable view of the sponsor’s products, in the good name of treatment education. Unlike legitimate medical conferences, there is no “peer review” process at such meetings, no qualified researchers who might challenge the company’s interpretation of data, nor any government regulatory presence to cope with. Some companies have begun to use such meetings as a form of outreach to treatment educators and case managers. This leaves the onus of decision-making about the relative merits of each meeting with the invited staff and their immediate supervisors, a particularly troublesome challenge for those organizations with little or no history of ongoing treatment activism.

People advocating to government as representatives of community interests, particularly in matters that may impact on pharmaceutical or biotech industry interests, should do so only on their own funds and at their own volition. Industry, in turn, should scrupulously avoid any effort to pay “community representatives” to testify in matters affecting their proprietary corporate interests. It is not uncommon for community and industry interests to overlap, most commonly in matters of drug licensing and federal funding for drugs. But when industry is allowed or invited to pay the way of community representatives to speak before government, it inherently creates a conflict of interest. When acting as “community representatives” before government, either as individuals or employees of an agency, neither government nor the public should need to wonder who is paying the tab or what motivates the testimony. The issue is not that payment or reimbursement of expenses for such meetings always and necessarily sways the viewpoint of advocates or their agencies. Rather, it is that a company’s selective payment or reimbursement to support testimony by people whose views coincide with their own represents an inherent conflict of interest for the company. It goes without saying that companies do not offer to pay or reimburse the travel expenses of people who wish to testify against their interests.

Guiding Principle #3:
Independence and Ownership

The goal of seeking funding from the pharmaceutical and biotech industry should be the same as the goal of seeking funding from any other source: to help the agency fulfill its mission of service to the HIV-affected communities. The agency and the agency alone, under the auspices of its Board, should determine what the agency does. Unfortunately, funding sometimes comes with strings attached, no matter what the source. Government funding brings with it certain requirements and responsibilities and is seldom if ever directed at general support for the agencies that receive funding. Instead, government offers funding to meet needs that have been determined by government agencies, sometimes with the input of non-profit agencies. Major foundation funding is likewise often directed toward specific, predetermined goals. The most elusive form of funding, and perhaps the most important to many agencies, is the kind of funding which permits the agency, its leadership and staff and Board to determine how the money will be used. In some instances, the pharmaceutical and biotech industry have provided funding of this type, though only with considerable reluctance. Only the largest or most established agencies routinely have the ability to attract funding that has virtually “no strings attached.” Nonetheless, the goal of independence and ownership of the services and programs of an agency remains a guiding principle for financial and funding relationships, especially when it comes to funding from sources, like the pharmaceutical and biotech industry, which have a vested interest of their own in the outcome of funding.

Since the advent of highly effective combination therapy in 1996, much of industry funding has been directed at supporting programs that provide information about treatment or advocating the use of treatment. Clearly, industry has a strong interest in this arena. While non-profit agencies are seldom in a position to tell industry what it must fund, they often have the power to influence how industry will fund this particular area. At the ideal end of the continuum, industry support is given “no strings attached” to agencies that then develop their own materials and programs as they see fit. Such funding is usually called an “unrestricted educational grant.” At the opposite extreme, industry itself supplies finished program packages to agencies along with funding to support the delivery of the programs to the agency’s constituents. The risk of such an approach, obviously, is that the funder’s proprietary interests will be woven into the program content, perhaps in ways that are not readily visible to the casual viewer. At the very least, such programs are unlikely to describe the comparative benefits of products from competing companies, or to acknowledge that for some people at certain stages in the course of HIV disease, their best choice may be to hold off on treatment altogether. In the middle of this continuum lie compromises between these extremes, typically situations in which industry provides not only financial support but also varying degrees of technical support and oversight in the creation of educational programs. These supposedly “balanced” approaches may be the most invasive of all, since they depend upon regular and intensive contact between industry and the participating agencies. In such a context, it is all but impossible to avoid the influence of a wealthy and sophisticated major corporation.

Yet another approach employed by industry is the creation of programs by industry without any pretense that they are the product of non-profit agencies. Sometimes they include varying degrees of consultative input from community groups, who are often paid for their participation. Some groups are then paid to play a role in the distribution of such programs and to permit the use of their names in their promotion.

The greatest trust in the quality and accuracy of information comes when community groups are able to develop and produce their own materials without outside interference. This must continue to be the goal when seeking funding, and Independence and Community Ownership must be the guiding principles in the development of materials and programs. The greater the influence of industry in the development of the programs or content of educational efforts, the greater the risk of conflict of interest, whether intended or merely permitted on a relatively unconscious level.

Related Guidelines
Whenever possible, community agencies should seek support in the form of “unrestricted grants” or (second best) “unrestricted educational grants” with little or no input by industry into program content. Ideally, agencies should not be required to meet the program interests of pharmaceutical and biotech industry and instead should be permitted to use funding as they see fit.
Community agencies should avoid unsolicited offers of funding from members of the pharmaceutical and biotech industry in return for developing industry-determined programs. Some companies may deliberately target financially troubled agencies with offers of funding directed toward specific, industry-determined programs. Such programs, while offering a possible financial lifeline, cross the line into uncharted and highly problematic ethical territory. In many instances, such offers amount to little more than efforts by industry to publish material, under the cover of a non-profit agency, that would not meet the standards required of the company by the Food and Drug Administration. Companies may not be held responsible for errors of content in community-sponsored materials. Financially trouble agencies are an ideal target for such unprincipled efforts, since in addition to their urgent need for support, they are often short on staff and may need to work more directly with industry or an appointed “medical information company” (which is little more than a front for the company).
Community agencies should avoid offers of support to distribute industry-created educational packages. While it may be possible for some companies to write such programs from an altruistic perspective and be as neutral as they can, the situation simply offers too great an opportunity for bias in program materials or content. Agencies should not have to serve as the judge of what is fair or biased in such materials. It is better to avoid their use altogether.

Understandably, some agencies lack the internal resources to create their own materials and the industry offer of professional, packaged programs is tempting indeed. A better solution, however, may be to work with and share materials from other non-profit agencies that have demonstrated fairness and objectivity in their own work.

Before participating in industry sponsored educational programs or permitting use of the agencies name on such programs, community agencies should insist upon the right of rejection over program content. Unless community agencies assert this right when their names are used, program content will be left solely in the hands of the sponsor or the “medical services” companies supported by the sponsor. If community interests and perspectives can be overridden by the interests of sponsors, community agencies should not lend their names industry-developed programs or materials.

Concluding Commentary
These Guiding Principles and Related Guidelines represent an effort to establish an ideal relationship between community agencies and the pharmaceutical and biotech industry. Ideals cannot always be achieved, and despite such guidelines, it is likely that not every relationship can meet the standards defined here. Nonetheless, they can serve as goals and as standards for comparison in any situation. As more and more agencies insist upon such an ethical framework, the more likely it will become that industry will behave in a manner consistent with the concerns and values of the agencies they support.