Patient advocacy groups (PAGs) have been around since the 1950s and have fulfilled various roles such as providing material resources, knowledge and emotional support to those in need. They’ve also been vital conduits between pharma companies and the patients these companies are looking to recruit for clinical trials.
However, there are criticisms surrounding these relationships when it comes to questions of financial donations and the subsequent independence of PAGs.
In this post, we’ll explore why pharmaceutical companies should build relationships with PAGs, how to make these partnerships mutually beneficial and jettison criticisms of lost independence.
The way a patient advocacy group views its pharma partner is critical for the success of the relationship. The initial barrier is that many distrust pharma’s motives, often linking a company’s interest solely to a desire for increased profits, says John Maslowski, chief commercial officer at gene therapy development company Forge Biologics. And in many ways, PAGs are dependent on pharma for the treatment and future well-being of its patient members, further creating an imbalance of perceived power.
Pharma companies can work to overcome these barriers. Instead of being considered a necessary evil, Maslowski advises pharma companies to understand what a PAG hopes to gain from the relationship and be clear about what they hope to gain too. For pharma companies, this requires a better understanding of patient conditions and insights or to recruit the right type of patient.
The key to a successful relationship is trust. The pharma company must show through its actions that its intentions to create helpful treatments are true. Another part of building solid relationships, Maslowski adds, is sending the right representatives to meet with PAGs. These should be senior representatives of the pharma company to demonstrate the importance of the PAG’s contribution.
Conducted correctly, the relationship between pharma and PAGs is usually mutually beneficial, says Liz Lewis, head of global oncology patient value at Takeda Oncology. The pharma industry has extensive medical knowledge, resources and experience, while PAGs offer the personalized, human experience of conditions and struggles along the patient journey.
Patients are empowered by having a voice and often benefit in terms of healthcare provision as PAGs help to shape trial protocols and identify endpoints that matter most to patients.
Another vital contribution PAGs make is their representation at government level, which can result in policy-making adhering to their input, Lewis notes. The FDA sees the value in patient engagement as this helps to provide treatment that better suits the reality of people suffering with a disease.
Indeed, the case of Stephen Smith, a rare disease patient advocate whose own son has a rare disorder, reveals the power of PAGs. In 2000, Smith and two other fathers of children with rare diseases approached the FDA to highlight what the advocates believed the agency was doing wrong and how they thought it should be changed.
Smith and his allies focused mainly on the agency being more interactive with drug developers and to expedite time to market for breakthrough therapies. Smith can claim victory, even though it took 12 years for his petitioning to become part of FDA official policy in the form of the Safety and Innovation Act.
Connecting with PAGs early on can help pharma companies avoid access issues to treatment drugs later in the development process. Ellen Coleman, president and CEO at patient advocacy advisory services firm VOZ Advisors, explains how early engagement ensures drug companies develop treatments that patients really want and that provide health outcomes they desire.
Value-based treatment, she says, comes about when pharma companies treat PAGs as equal partners. By doing so, drug developers can meet the needs of patients hitherto unfulfilled by treatment options. What Coleman refers to as “deep dive engagement” facilitates a dynamic relationship between sponsor and PAG as both are open to meeting patient needs and those of an ever-changing healthcare landscape.
As with any partnership, both parties should research their prospective partners. This is no different for pharma companies aiming to partner with PAGs, says Jeff Christensen at Signal West PR, which represents pharmaceutical clients. He suggests auditing the PAGs and creating an up-to-date directory of all prospective partners tailored to the pharma company’s needs.
An audit should follow this process: First, research the PAG’s mission, vision, audiences, issues, and programs and campaigns; then, create a report that functions as a catalog or directory of relevant PAGs. The report should include the reason for the audit, a summary of findings and a recommendation of a handful of groups to consider for future partnerships.
Following that, Christensen advises, the pharma company should conduct introductory phone-based interviews before determining whether the partnership would be mutually advantageous.
During the HIV/AIDS epidemic in the 1980s and 1990s, PAGs performed the role they do today of bringing the patient’s voice to pharma companies and regulatory bodies. But they also provided patients with additional services, says lawyer Mark Senak who consults with pharmaceutical and biologic companies engaged in bringing new drugs to market.
These services, which included care, community and practical assistance, were often patients’ last hope in a society that was unsympathetic to their needs. When doctors would not treat them, family members shunned them and landlords evicted them, patients sought help from PAGs.
Hearing patients’ first-hand accounts of their struggles with and victory over disease is a powerful means to recruit patients to trials. Survivor testimony is best told in collaboration with PAGs, argues portfolio manager Anne-Marie Mongan at Clinical Trials Arena.
The reason for this approach is two-fold: The message resonates when it comes from sources patients already trust, and PAGs have a wide-reaching network across which to share it.
While PAGs and pharma companies should collaborate to help the latter recruit patients and the former access care for its members, the PAG ultimately remains the conduit for communication between patient and drug developer, writes Kelly Davio at the American Journal of Managed Care.
Indeed, any direct contact should be done with the PAG’s knowledge, she says. Ideally, this direct correspondence is limited and any learnings or outcomes should be shared as a group to maximize benefit to the most patients.
Placing patient advocacy groups in the mediator position also helps to ensure healthy dialogue among pharma companies, PAGs and patients, writes Henry Featherstone, global head of public affairs at Sanofi UK. Treat an open dialogue as an ongoing process, which seeks to review, evaluate and apply findings as well as to share information and ideas.
This form of communication can help change public perceptions of pharma companies as well. Strive for Five founder Steve Clark notes that “there can be a degree of scepticism about pharmaceutical involvement in patient facing activities.” Patients and the public may see this involvement as a self-serving attempt at marketing.
Yet when pharmaceutical companies communicate effectively with patient advocacy groups, this view can change. PAGs can become a conduit for positive, accurate information about clinical trials and their outcomes, which can improve public perceptions of pharma.
According to the 2018 Edelman Trust Barometer, just 38 percent of the U.S. population trusts pharma companies, a 13 percent drop from the year before, reports Steve Weiss, vice president of media advocacy at the American Heart Association. Trust in the healthcare industry as a whole continued to erode between 2020 and 2021, despite heroic efforts from healthcare workers during a global pandemic, according to the 2021 Edelman Trust Barometer.
With those statistics, it’s no wonder there is concern regarding the ethics of pharma funding PAGs.
Advocacy groups that are members of the National Health Council already have to comply with 38 standards of accountability and ethics. These include direction on areas such as governance, fundraising, transparency and accountability, and accounting and reporting. And, before PAGs can apply for membership, they must meet 10 minimum standards.
Yet patients and the public are often unaware of the standards to which pharma companies and PAGs are held regarding ethics and accountability. Building better communication allows pharma companies and PAGs to work together both to ensure ethics standards are met and to inform the public about the standards to which their respective work is held.
Set up by a group of international pharmaceutical associations, the Consensus Framework provides a code of conduct for pharma companies to follow, such as promoting ethical research, putting patients first and always seeking transparency. The responsibility of all parties to the agreement, says Corinna Cornejo at WEGO Health, is to state in clear language their principles and boundaries, and address how these might come into conflict or support one another.
An important consideration, she explains, is that there is no quid pro quo. Pharma is not buying a spokesperson by finding a patient advocacy group and a PAG cannot expect funding simply by partnering with a pharmaceutical company.
Assigning a specific role within a pharma company to deal specifically with PAGs can help ensure these relationships are given the proper amount of attention. This is what pharma company GSK does with its Global Patient Advocacy Team, which facilitates engagement with PAGs to develop a patient-centric approach to the relationship.
It also coordinates a standard for collaboration that all its global departments need to follow. This governs questions of funding and disclosure, and it outlines best practices between the team’s relationship managers and advocacy coordinators.
Partnerships between PAGs and pharma companies can be mutually beneficial and lead to positive health outcomes for patients. Clinical trials can adopt a more patient-centric approach with the help of PAGs, and trial managers are able to recruit patients more effectively. These relationships need to be built on trust and transparency, always putting the patients first. Get this right and the relationship can benefit all concerned.
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