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Pharmaceutical companies and patient advocacy groups: Natural allies in the support of patients

Published on 25/05/17 at 09:59am

As published in the special Market Access section of the latest issue of Pharmafocus, Liz Lewis, Chief Counsel & Compliance Officer and Head of Patient Advocacy at Takeda Oncology, explains why patient advocacy groups are such a crucial tool in securing access to medicines, as well as presenting a range of other benefits for patient and industry alike

If your doctor told you that you had a serious illness, where would you turn? For many, the answer is either immediately or eventually a patient advocacy group (PAG).

Patient advocacy organisations play an integral role in providing patients and their families with the tools and resources they need to face the challenges of living with a serious disease. Just as patients need access to treatments, they also depend on advocacy organisations to help them better understand their disease, fight for their rights in policy-related discussions and help them find emotional support. Furthermore, advocacy groups are no longer willing to take a back seat when it comes to issues that will impact the patients they represent – whether it’s with industry, government, medical societies or other key stakeholders. These groups expect – and deserve – a seat at the table during critical discussions affecting the wellbeing of patients.

One of the key ways these associations can ensure that the needs of patients are incorporated during drug development and that they have access to medicines is through partnerships with drug companies. Both stakeholders have a shared interest in and commitment to improving the lives of patients and recognise that working together can help further their common cause. Some third parties, such as physicians, academics and media, assert that these groups can use all the help they can get regardless of the source, while others question the appropriateness of PAGs receiving support from pharma companies.

These beneficial interactions, however, can and should continue with appropriate safeguards in place to ensure the enduring independence of these support organisations. Yet, the development of such guidelines has been slow. The [New England Journal of Medicine] recently published research concluding that, while a majority of groups examined received financial support from biotechnology companies, few of them had mechanisms for addressing institutional conflict of interest and that disclosure requirements should be put in place.

How can we achieve balance between enabling collaboration among industry and advocacy and avoiding situations in which pharma has undue influence? The answer is for companies to adopt and adhere to guidelines governing their interactions with advocacy groups that will guarantee the continued autonomy of these organisations. Through this approach, both parties can work together effectively to truly benefit patients.

Why industry needs advocacy, and vice versa

Relationships between industry and patient groups can be – and typically are – mutually beneficial. Pharma companies have extensive scientific knowledge, resources and experience to share with patient groups. In turn, PAGs bring the unique perspectives of their constituents to the table, provide a lens into the patient journey, and lend their expertise on the needs of the community to pharma in developing innovative patient care solutions. Instead of passively waiting for industry, government and other key stakeholders to make decisions impacting patients, PAGs are demanding to be part of the conversation whether it’s about policymaking or research and development.

We have seen numerous examples of successful collaboration between advocacy and pharma on clinical trial design. Getting patient input on trial protocols not only empowers them in the research process, it also helps to ensure that trials examine the endpoints and outcomes that matter most to patients. When designing a clinical study, researchers may focus on measures such as the time it takes for the disease to progress, while patients also want to know how a treatment may affect their day-to-day quality of life. Both points of view must be addressed for a truly effective trial – one that enables patient compliance with the study protocol by balancing the need to meet scientific endpoints and the burden to the patient.

Additionally, companies like Takeda Oncology have introduced patient input even earlier in the process by hosting open dialogue and interaction with advocates as part of the research and development process. By working with patient groups to hear about unmet needs, the burdens of current treatments and the patients’ experiences living with cancer, we can tailor our efforts and pursue the drug candidates that have the most potential to overcome the daily challenges patients face.

PAGs not only support patients by ensuring the patient voice is heard during the clinical development of drugs, they also provide a united voice for them at the government level, ensuring that patient perspectives are heard when it comes to policymaking and reviewing new therapies. Sponsors and regulatory bodies like the FDA are showing increased interest in systematic patient engagement because it enables companies to interact with patients in a meaningful way and gather a real-world understanding of the burden of disease. In order to incorporate patient perspectives, a report issued last year by the FDA called for more workshops and partnerships to promote cooperation among patients, industry, clinicians, the scientific community and itself. It’s clear that more – not less – collaboration is the way of progress.

The need for independence – a joint responsibility

All parties can agree that maintaining public trust in patient groups is essential for their continued success in effectively serving their patient constituents. Just as there is mutual benefit from relationships between pharma and patient groups, there is a joint industry-advocacy responsibility for ensuring continued independence, which in turn inspires trust.

Pharma companies can encourage independence by following best practices in industry-patient group relations. The industry has already taken steps to establish guidelines for being respectful and compliant partners of patient groups. By aligning their activities with the [BIO Guiding Principles for Interaction with Patient Advocacy Organizations] or the [PhRMA Principles on Interactions with Patient Groups], companies like Takeda Oncology commit to respecting the autonomy of advocacy groups, safeguarding the privacy of patients and adhering to ethical standards.

PAGs are equally accountable for maintaining their independence and can do so by ensuring they have diverse funding bases and reliable methods of disclosure, among other practices. They should communicate regularly to their members about the nature and benefits of their partnerships with industry, in addition to demonstrating a commitment to prioritising the needs of patients over the promotion of specific therapies. To further protect their independence, patient groups can put internal conflict of interest processes into place.

Accepting support from the pharma industry does not in any way preclude PAGs from remaining independent, nor does it obligate them to act as mouthpieces for their collaborators. The onus is on both industry and advocacy groups to step up and ensure mechanisms are in place to guarantee the continued neutrality of these essential organisations – to do so will both enhance existing partnerships and create an environment that fosters new collaborations to benefit patients.

Ultimately, the interests of pharma companies and PAGs are aligned – at the core of their efforts are the patients and families themselves. They are both stakeholders in long-term scientific investment, and the constructive relationships forged between them stem from a common goal of improving the lives of patients.

Liz Lewis, Chief Counsel & Compliance Officer and Head of Patient Advocacy at Takeda Oncology

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