Pushing for vaccines in poor nations, profit or not

The inherent - but difficult to resolve - conflict in for-profit medicine and drugmaking shows up in many places, and one is the way vaccines are made and delivered in the world's poorest countries.

"We need to find a way to de-link research and development of innovative drugs and profits," said Kate Elder, a Philadelphia native and vaccines policy adviser for Doctors Without Borders, also known by its French name Médecins Sans Frontières (MSF). "We think the R&D model is not serving the needs of people in the places that MSF serves."

Doctors Without Borders, the Drugs for Neglected Diseases initiative (DNDi) and the Mount Sinai School of Medicine hosted a conference in New York titled "Lives in the Balance: Delivering Medical Innovations for Neglected Patients and Populations," which began Thursday and will end Friday.

The availability of clean water and electricity, much less refrigerators, cannot be assumed in many regions of the world, so drugs requiring coolers delivered on donkeys for many miles might sound heroic, but some say it is unrealistic for treating tens of thousands of people who might be in need.

And prices matter.

Doctors Without Borders and Pfizer Inc. recently argued about pricing for the drugmaker's pneumococcal vaccine, Prevnar 13, for a pneumonia outbreak in South Sudan. Prevnar has passed Lipitor (which lost patent protection) and is now Pfizer's third-best selling drug, bringing in $2.7 billion in the first nine months of 2012.

World Bank president Jim Yong Kim, who used to run the United Nation's HIV/AIDs program, told the conference by video that the goal is to "lay the foundation of a health science that works for the poor." That means innovative research on diseases and delivery systems geared to people in developing nations, not the more affluent ones, greater sharing of ideas, and support for developing nations so they can assist in the process from beginning to end.

"Let me be frank," Kim said. "The current model of health innovation is failing millions of the world's poorest and most vulnerable people. Honestly acknowledging this fact must be the first step in any serious discussion."

Elder grew up near 20th and Green in the Fairmount section of Philadelphia and graduated from Germantown Friends School. "A lifer, as they say," Elder said.

Hardly. After graduating from Tufts University, Elder used a Fulbright Scholarship to study adolescent sexual and reproductive health in Botswana. After studying tropical diseases, she worked for the International Red Cross and Red Crescent and the U.S. Centers for Disease Control and Prevention before Doctors Without Borders.

The Global Alliance for Vaccines and Immunization (known as the GAVI Alliance) is a consortium of governments, organizations such as the United Nations and World Bank, and private donors such as the Gates Foundation. Created in 2000, the organization has been a "game-changer," F. Marc LaForce, director of technical services for the Serum Institute of India, told the conference.

But Elder argued against GAVI's Advance Market Commitment program, which subsidizes the drugmakers in exchange for lower prices and promises to produce the medicine.

"Pfizer believes the Advance Market Commitment program is the best method to provide accelerated, affordable and sustainable access to pneumococcal conjugate vaccines for GAVI-eligible countries that carry the greatest burden of pneumococcal disease," a Pfizer spokeswoman said. "The price of the pneumococcal conjugate vaccine under the AMC framework is $7.00 for the first several years. The vaccine price will include a $3.50 subsidy to be paid by the AMC donor fund, and $3.50 to be paid by GAVI with a co-financing contribution paid by the developing country governments that introduce the vaccine.

"The special AMC price actually reflects a more than 90 percent reduction to the Prevenar 13 price per dose paid by some industrialized nations and is reflective of the low economic status of the GAVI-eligible countries participating in the AMC. The AMC price was determined by an AMC Implementation Working Group, which was created by the AMC Donors and comprised of a group of leading economists and vaccine experts. Importantly, under the current AMC framework, participating vaccine manufacturers must make a binding commitment to supply vaccine for 10 years at a maximum "tail" price of $3.50 per dose to meet long-term demand and ensure affordability of the vaccine in developing countries even after the donor contributions are exhausted. In light of Pfizer's engagement in the AMC and the link between maintaining the integrity of the model and its anticipated public health impact, Pfizer has urged MSF to engage directly with the GAVI Alliance and UNICEF to secure Prevenar 13 under the AMC program."

A GAVI spokesman noted his group has helped immunize 370 million children and that GAVI brokered an offer of a donation from one manufacturer and a GAVI price of $7 per dose from another for pneumococcal vaccine for Doctors Without Borders in South Sudan.

Elder said the offer was for a different version of the drug, made by GlaxoSmithKline, and it was a onetime offer. Pfizer was willing to make a onetime donation - or charge $16 per dose.

"We don't want to go back each time for individual negotiations," Elder said. "If drug companies were giving donations all the time, that would be great, but they aren't."