The Ties that Bind: Industry Sponsorship of Patient Groups

by Lisa Hayes

Following in the wake of the last decade's proliferation of patients' groups, there has been a surge in pharmaceutical industry funding for these organizations.

Patient groups frequently begin as small-scale, grassroots organizations created by people with a disease who wish to reach out to others with the same condition in order to share experiences and to provide emotional support and information. They frequently act as advocates for better health care and are typically voluntary organizations. Such patient groups can provide a valuable channel of understanding and expertise in obtaining appropriate medical care.

But that is not why drug companies are funding them with increasing generosity.

The pharmaceutical companies are attracted to the active role that patient groups have played, especially in the United States, in securing research funding, accelerating drug approval times, shaping public policy and advancing patient education - especially related to drug treatments.

Partnerships, Stephen Whitehead, director for corporate affairs at Eli Lilly told Scrip Magazine, are about "the recognition of shared interests."

Pfizer's director of corporate affairs in Europe, Eva Grut agrees with Whitehead. Partnerships are "about identifying issues where you are working towards a common interest, although you may not always be doing it for the same reasons," she told Scrip.

Sponsorships and Information Shading

The leading concern of sponsorship critics is that industry financing affects patient group activities in subtle and not-so-subtle ways.

One serious concern is that they will shade the information they provide to consumers to make possible drug treatment options appear in a positive light.

In the UK, for example, a patient booklet on infertility produced by Women's Health Concern, an organization receiving industry funding, includes information on the drug clomiphene. The booklet assures women that "Most women do not experience any side effects. If they occur, none are serious but include ..."

Such information differs significantly from the advice of the UK Committee on Safety of Medicines, included in the British National Formulary (BNF) which states, "The CSM has recommended that clomiphene should not normally be used for longer than 6 cycles (possible increased risk of ovarian cancer in patients treated for longer than recommended)."

The listed side effects in the British National Formulary include visual disturbances and ovarian hyperstimulation, both of which require immediate drug withdrawal.

However, the Women's Health Concern booklet only lists "hot flushes, mild headaches and occasional abdominal discomfort most pronounced at mid-cycle" as side effects of clomiphene. The booklet's text also mentions nothing about the increased risk of multiple births following use of clomiphene. The Women's Health Concern publication makes no mention of the fact that the organization receives industry funding.

Pointing to such examples, Barbara Mintzes, author of "Blurring the Boundaries: New Trends in Drug Promotion," a Health Action International report that criticizes industry sponsorship and other promotional practices, says, "There is a fundamental conflict of interest involved in accepting funding subsidies from a company that is in the business of selling products to one's membership."

However, some patient advocates think the risks are worth it.

"Our approach has been developed out of the specifications of our disease," said Darien Taylor of the Toronto-based Voices of Positive Women, a grassroots organization for women with HIV/AIDS, at a conference on industry sponsorship held in Toronto in 1997.

"We are increasingly marginalized and require multiple interventions to maintain our health and security. We are happy to take money from drug companies and turn it into Vitamin C for women with HIV and AIDS."

The hazards of industry sponsorship are heightened, say critics, by a frequent failure of industry-funded groups to identify their corporate ties. Often it is difficult for the public to know if an NGO receives partial or complete industry funding even after reviewing its brochures or attending an open meeting held in its name. The suppression of industry financing enables even industry-dominated patient groups to appear independent, with potentially serious consequences.

"Vehicles" for Industry

Sponsoring well-targeted patient groups allows the pharmaceutical industry to promote its products to consumers using methods unavailable to drug companies acting on their own, Mintzes says.

Patient groups can help spread awareness of new drugs at a pre-launch stage. When Glaxo Canada launched its new treatment for migraine, sumatripan (Imitrex), for example, the company gave a substantial grant to the Canadian Migraine Foundation.

A series of public meetings, held in the foundation's name, were orchestrated by Glaxo. Eventually this patient group began to feel uncomfortable about the heavy-handed treatment by its sponsor and refused to continue its participation. In response, Glaxo managers diverted the funding to the Canadian Association of Neuroscience Nurses.

Patient groups often see dissemination of information about new treatments as one of their primary functions and may distribute industry promotional information about new drug treatments without assessing it critically. Alerting people with certain medical conditions that new treatment may soon be available helps ready a market for when the drug is approved.

Patient groups can also disseminate information about new drugs more freely than companies often can.

In an article in the industry magazine, Pharmaceutical Visions, reporter Sean Milmo explains, "Because patient associations are so intent on gathering and passing on to their members information about drugs under development, they have become useful vehicles for pharmaceutical companies for disseminating information about new medicines at the pre-launch stage."

In some countries, companies cannot disseminate this information directly to the public due to regulations governing drug promotion.

Patient-based organizations provide a more credible endorsement of a product than if the information comes directly from the company. Consumers may be at least somewhat skeptical of a company's exaggerated claims about a drug's benefits and downplaying of its risks. Consumers are less likely to discount similarly biased information from a patient group funded by a company.

A 1998 fact sheet produced by the Osteoporosis Society of Canada, an industry-funded patient group, for example, strongly emphasized the possible protective effects of hormone replacement therapy and minimized the risk of serious side effects.

"Researchers believe it helps to prevent heart disease; and it may provide protection against colon cancer, Alzheimer's disease and stroke," the fact sheet stated. "On the other hand, questions remain about the link between hormone therapy and breast cancer, largely due to inconsistent research results."

The fact sheet did not mention the organization's sponsors.

Patient groups can also generate political support for government research subsidies and other industry-desired policies.

At a public meeting organized by a Pfizer-funded public relations firm and sponsored by the industry-funded Alzheimer Society of British Columbia in Canada, two clinical experts spoke glowingly about the promises of a new drug, donepezil (Pfizer's Aricept). During the following discussion, members of the audience offered testimonials of how well the drug worked and what a difference it made in their lives and those of family members they cared for. The provincial drug reimbursement plan does not cover the drug's costs, due to concerns about the drug's effectiveness and its high price.

Following the testimonials, participants were urged to contact their elected representatives and urge them to pressure the Ministry of Health to fund the drug. Had this entreaty come directly from the manufacturer, it would have been seen as self-serving. Coming at a meeting that was ostensibly organized by the Alzheimer Society, it carried much more legitimacy.

Funding patient groups may also help soften criticism against a product or company because sponsored groups, dependent on future funding, may feel constrained from speaking out.

A case in point: when the American Thyroid Association discovered in a media report that Boots/Knoll, which provided 60 percent of its funding, had prevented publication of an important study showing that the company's thyroid product, Synthroid, was not better than alternatives, the association debated whether to write to the company to ask it to allow publication, but the move was narrowly defeated.

"An outsider is left with the sad impression that the ability of the association to influence these events by speaking with moral authority was weakened by its heavy dependence on money from Knoll," concluded an editorial in the Journal of the American Medical Association.

Similarly, the Canadian Heart and Stroke Society declined to participate in a series of educational workshops that would have provided information on who would benefit from cholesterol-lowering drugs. The Society told the Therapeutics Institute, an independent Canadian university-based organization providing drug education and information, that it did not want to offend a drug industry sponsor which has a major market in cholesterol-lowering drugs.

A Tool to Advance Industry's Political Goals

Pharmaceutical companies are mastering public relations skills with increasing finesse, says Judith Richter, author of "Engineering of Consent," a briefing paper on public relations strategy issued by the British environmental group The Corner House.

NGOs that believe a company is contributing funds simply because it is the right thing to do, probably do not see how the larger game of winning public approval for corporate actions is being played, she argues. Richter fears that well-intentioned NGOs can become unwitting collaborators in advancing a company's own agenda.

With industry increasingly able to define who gets invited to conferences, who sits on committees which recommend drugs and whose opinions are most widely quoted and published, pharmaceutical companies are gaining new levels of influence over public policymaking.

Gradually the sharp edges of debate, leadership and decision-making are removed. Charles Medawar of the UK consumer group Social Audit likens the process to a square being turned into a circle by a constant process of cutting corners.

Tackling the Problem

The World Health Organization's (WHO) Ethical Criteria for Medicinal Drug Promotion are a set of guidelines on drug promotion which aim to keep drug promotion in line with national health policies. The guidelines define promotion broadly as "all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs."

Many activities of sponsored patient groups fit within this definition of drug promotion, although they are carried out indirectly rather than by the company itself.

Some such activities appear to violate the principles of the Criteria.

For example, the guidelines state, "Promotional material should not be designed so as to disguise its real nature" and that "scientific and educational activities should not be deliberately used for promotional purposes."

"Any patient group, charity or institute with financial links to the industry or a specific company which spreads awareness of a disease so that more people may seek drug treatment, endorses specific products, or presents positively biased drug information is helping to promote product sales," Mintzes says, and therefore should be subject to the Criteria, including requirements for disclosure of corporate funding.

Lisa Hayes is publications and information officer for Health Action International's regional office for Europe in Amsterdam.