Open communications can promote stronger, more resilient collaboration among pharma companies and patient advocacy groups. In a challenging market environment, these alliances are crucial to the continued delivery of life-changing medicines.
Since the fall of 2015, and against a backdrop of harsh media attention to pharmaceutical pricing, patient advocacy groups that form partnerships with pharma companies have received negative coverage in the New York Times, USA Today and other publications. There is a familiar yet misinformed line of analysis in these articles: patient organizations support lobbying initiatives by industry partners in return for much-needed cash.
Many readers lack an understanding of the quintessential services advocacy groups provide to patients. As a result, some probably believe the accounts they read in the papers. But is money really at the heart of advocacy-industry partnerships? In early 2015, Syneos Health Communications conducted in-depth interviews with 43 patient advocacy groups across a range of diseases to learn what they seek from their pharmaceutical partners. This year, we did follow-up interviews with many of the same organizations and some new ones—this time focusing on rare diseases. We also interviewed physicians and drug industry executives and asked a select group of payers involved in prescription and formulary decisions what they thought of advocacy-industry relationships.
The insights we collected in more than 18 months of research tell a very different story from what you may have read in newspaper accounts. The wish list from the groups we interviewed had nothing to do with building war chests to cover administrative costs or fluffy salaries. On the contrary, the No. 1 priority for nearly all organizations was to form deeper, more effective partnerships with industry—early in the drug development cycle—in order to speed the creation of new medical treatments. Patients are the only individuals with first-hand knowledge of an illness: what it feels like to participate in a clinical trial, how symptoms change as a result of treatment, and what impact this has on daily life. Such knowledge is immensely valuable and advocacy groups want this asset to be accessible so that companies can craft better medicines.
In short, patient organizations and pharmaceutical companies recognize the benefits that flow in both directions when collaborative ties are forged on trust, open communications, robust data sharing and a commitment to putting patients first. Despite a recent spike in negative publicity, companies and advocacy organizations are building durable and far-reaching relationships, especially in areas such as rare diseases where patients are widely dispersed and resources are constrained.
If the real patient advocacy wish list were more widely understood, the facts would help neutralize suspicions and misunderstandings about advocacy-industry collaboration. Some press reports have planted the notion that pharma companies funnel tax-deductible charitable dollars to advocacy groups in a self-serving fashion, to help patients pay for the high-priced drugs the companies themselves manufacture and market. In fact, when you ask many cancer advocacy groups what ranks highest among their members’ charitable funding needs, you learn it is transport to care—not coverage for cancer medicines.
The most effective tactic to avoid misunderstandings is to manage expectations. That means involving key stakeholders early in the design phase, whether you’re developing a new drug or launching a public health initiative. Managing expectations also means communicating the goals in language any stakeholder can understand. At the same time, the public needs more nuanced portrayals of how pharma, physician, patient and payer organizations exchange information and conduct negotiations, and what specific goals they seek. Obviously, this window is not available when communications among stakeholders are occluded or hidden from view.
Among the obstacles to smooth interchange are federal rules and guidelines that inhibit discussion among industry players, advocacy organizations, media outlets and other constituencies. The roadblocks are particularly troubling when they stifle conversations about medicines in the research pipeline. For example, federal guidelines bar manufacturers from talking with patients and organizations about benefits of investigational drugs “in a promotional context”—although that is always a matter of interpretation. Among other things, manufacturers must not discuss with stakeholders what the product might eventually cost, even though this is a key concern to patients as well as manufacturers and investors.
The FDA has legitimate concerns about broadcasting a product’s safety and efficacy before it receives marketing authorization. But in many cases, information is nothing but that—data collected and published as part of a formal research investigation. The FDA acknowledges as much. Its warnings about promotional activity are paired with statements saying there should be no restrictions on the “full exchange of scientific information.”
Compounding the confusion, separate FDA guidance urges drug companies to pay heed to patients’ accounts of their experiences in the course of clinical trials, so that both the process and the ensuing products will better serve patients needs. This patient-centric focus is a welcome development, and it’s embedded in Prescription Drug User Fee Act V, as well as in federal initiatives such as the Patient-Focused Drug Development Initiative. But which mandate has the force of law? Would government prefer that pharma never discuss investigational drugs with advocacy? Or does it want companies to listen to the patient voice when developing new products? It’s no surprise that companies and their collaborators are sometimes afraid to move forward or back, and that media mistakes the confusion for secretive behavior.
We are left in a murky domain where drug companies— the stewards of society’s most significant medical breakthroughs—have no clear idea what they can and cannot communicate. Meanwhile, advocacy groups that patients turn to for advice on treatment strategies, emerging therapies, and support services sometimes have no seat at the table where such matters are discussed. The failure to manage expectations can lead to a crisis, like the ongoing friction over drug pricing. When regulations or negative publicity shuts down discussion, promising medications don’t find acceptance. Without commercial success, there is no future funding for innovation.
In an ideal world, conversations among key stakeholders would continue, within certain defined boundaries, from early stage drug development all the way through negotiations on market access, formulary placement, support services and price. And the public would understand that the purpose of advocacy-industry alliances is the swift design of better medicines and associated patient services.
Syneos Health’s position is that none of the stakeholders in the fast-changing panorama of U.S. healthcare has a full or unfaltering view of the whole landscape. But our research strongly indicates that, from the patient’s vantage point, the benefits of advocacy-industry partnerships vastly outweigh the risks or liabilities. In fact, the value of these relationships increases as collaboration deepens and matures. No doubt, the media will continue to scrutinize a relatively small group of “bad actors,” as they should. The danger only arises when entire industries are painted with the same brush.
The best remedy, both for the healthcare industry and for the patients we serve, is to continue pushing for open and transparent communications. Indeed, the need for this will only grow as the biopharma industry evolves “beyond the pill.”More than ever, manufacturers and patient advocates will need sustained discussions ranging from research agendas to education programs for medical professionals, community-based lifestyle interventions and population health. Open dialogue among pharma companies and advocacy groups is one of the keys—and drugs are just the beginning.
