Non-governmental organizations NGOs are an increasingly important constituency for Big Pharma, particularly in repairing frayed relations with regulators and managing the rising expectations of patients and payers. Another factor is the necessity to build a wider circle of partnerships as companies execute a diversified commercial model. To take the pulse of a key NGO healthcare player, Pharm Exec recently sat down with Allan Coukell, a pharmacist who directs the Pew Health Group medical safety portfolio, including the Pew Prescription Project. Both are initiatives of the Pew Charitable Trusts, which ranks in the top three of Washington-based policy operations in terms of size and funding. — William Looney

PHARM EXEC: Pew has a high profile in areas like the environment and climate change. What is unique about your franchise in health and pharmaceuticals?

Allan Coukell: The Pew Health Group is the health and consumer product safety arm of the Pew Charitable Trusts, a nonprofit organization that applies an analytical approach to improve public policy, inform the public, and stimulate civic life. Unlike traditional foundations, Pew is a public charity, which allows us to operate our own projects and to raise funds independently. Regarding health and pharmaceuticals, we take a data- and research-driven approach to consumer issues like fostering good evidence, advancing transparency and ethical behavior, and stimulating pharmaceutical innovation.

Coukell: We launched in 2007 to focus on two areas where we believed industry practices were placing consumers at risk. The first is the conflict of interest inherent in the way drug companies market medicines and influence prescribing. The second is the safety of the drug supply for US patients. As with other consumer products, pharmaceuticals manufacturing is increasingly outsourced, particularly to developing countries. There is real concern that reduced GMP compliance and the absence of FDA oversight pose danger to consumers.

With reference to physician–industry financial relationships and drug promotion, the project has successfully advocated for transparency laws at the state level, and through the federal Physician Payment Sunshine Act that Congress passed as part of comprehensive healthcare reform. But progress does not depend on tougher laws alone: advocacy with the health professions, medical schools, and academic teaching hospitals has been very important. One of our initiatives, with the American Medical Student Association, is a "PharmFree" scorecard, a competitive rating tool inducing medical schools to re-examine their industry relations policies. Academic–industry collaboration is essential, but certain kinds of relationships, such as gifts to providers, don't contribute to patient care, and should be eliminated. We agree with the Institute of Medicine that more transparency is in the public interest.

PE: How well have drug companies managed updating relations with healthcare practitioners to reflect current regulatory standards and political realities?

Coukell: Some companies have embraced an ethos of disclosure and updated internal standards in dealings with professionals, while others have sat on the sidelines. In general, the industry continues to follow a business model that includes extensive financial ties with the medical profession. Some questions are difficult. For example, we need solutions that don't require CME and other priority activities to be subsidized by companies. In other industries, continuing education is self-financed, at relatively low cost. Why not in healthcare?

PE: Are there new initiatives you intend to prioritize in the year ahead?

Coukell: Recognizing the serious health impact of resistant bacteria, we continue to press for changes that will reduce the use of antibiotics as growth promoters on industrial farms. We have also launched a new initiative to advance incentives that will stimulate innovation and address the desperate need for new treatments for drug-resistant infections. We are engaging a broad range of stakeholders, including the Infectious Disease Society of America. We are delighted that Congress will examine this issue in a hearing later this month.

PE: What's most important in helping companies work with the nonprofit community?

Coukell: Dialogue is essential. We talk to a wide range of companies and industry groups. Sometimes our goals align, but when they don't, there is still benefit from discussion. Ultimately, I think everyone wants consumers to have access to safe and effective medicines.