Doctors Without Borders Refuses Vaccines from Pfizer - The Atlantic

This week the medical-aid organization Doctors Without Borders refused a donation of one million vaccine doses from the pharmaceutical corporation Pfizer. It offered inoculations against a commonly fatal pneumonia—deliverable immediately, to people in need anywhere—and the doctors said no.

The decision is the result of a fundamental impasse in modern healthcare. The heart of the refusal—which could well imperil children who would have received those vaccines—is a principled stand against the extremely high cost of many vaccines.

Pfizer tells me that their revenue from the vaccine in question last year was $6.245 billion. (That’s the same as the revenue of United Airlines.) The enormous business includes much profit from countries that are willing and able to pay inflated prices for a life-saving vaccine. It necessarily leaves others behind.

How has this system come to such a head that humanitarian doctors would refuse a million vaccines on principle?

The medical background: The leading cause of death in children is pneumonia. In the lungs, alveoli fill with pus, which blocks the passage of oxygen. A person is essentially suffocated by their own immune response. This happens to 1.4 million kids every year. The process is often the result of one bacterium, Streptococcus pneumoniae. Decades ago, scientists were able to isolate proteins and carbohydrates from S. pneumoniae and expose children to only those benign molecules, instead of the entire bacteria. The kids’ bodies learned to recognize and destroy S. pneumoniae without having to be exposed to it.

Pfizer’s modern iteration of this vaccine is known among doctors as PCV13. It’s recommended to be given to all children by medical authorities worldwide. Since its introduction, cases of severe Strep pneumonia in the U.S. have gone down by 88 percent.

Elsewhere, death from pneumonia remains commonplace, especially in subsaharan Africa and southeast Asia. This is where much work is done by Doctors Without Borders—known outside the U.S. as Médecins Sans Frontières (MSF)—to provide care. So I was initially shocked to hear MSF refused a million PCV13 doses from Pfizer, who seemed shocked themselves.

“Pfizer is committed to making vaccines available to as many people as possible,” company spokesperson Sally Beatty told me by email, “particularly those needing emergency humanitarian assistance.”

Beatty explained that Pfizer “strongly disagrees” with MSF’s decision, and that “to suggest that donations are not valuable defies logic.”

Of course, the doctors do see donations as valuable—simply not worth the costs in this context, which transcends seemingly straightforward philanthropy and medical science.

Pfizer sells its PCV13 pneumonia vaccine under the name Prevnar 13. Among the best-selling vaccines on the market, its technology is protected by multiple patents—not just on the final product, but also on the process by which the vaccine is made. This makes it difficult for competitors to produce anything comparable at all. The South Korean company SK Chemicals came close to producing an analogue, but Pfizer sued the company and was supported by the country’s Intellectual Property Tribunal in 2015.

MSF has been trying to get their hands on Prevnar 13 since it was introduced in 2009, but the price has been too high. Outside of dire situations—as when the group purchased some Prevnar from pharmacies in Athens a few months ago (for 60 euros per dose)––the group has lacked the resources to purchase it.

And this cost is the fundamental issue to Jason Cone, the executive director of Doctors Without Borders in the United States. He explained that donations from pharmaceutical companies are ineffective against a problem of this scale. While the donation would benefit people under the care of Doctors Without Borders immediately, accepting it could mean problems for others, and problems longer-term. Donations, he writes, are “often used as a way to make others ‘pay up.’ By giving the pneumonia vaccine away for free, pharmaceutical corporations can use this as justification for why prices remain high for others, including other humanitarian organizations and developing countries that also can’t afford the vaccine.”

Which is to say that for a disease of this scale, isolated donations are inadequate.

“I'm not absolutely against donations,” MSF’s vaccine pharmacist Alain Alsahani told me by phone from Paris. In cases of neglected disease where there is little or no market for a product, he explained, “donation becomes a more interesting option for some countries to get access. But in the case of PCV, that's not a solution at all, in any way.”

In this case, to accept a donation is to accept the status quo in which health technology is beholden to the priorities and values of multinational monopolies and duopolies whose interests exceed simply finding a solvent path to technological progress and human wellbeing. Last year Pfizer returned $13.1 billion to its shareholders. By every estimate, Prevnar 13 is a “blockbuster” contributor to the company’s profits, though they declined to share specific numbers.

Prices paid by patients, insurers, and aid organizations can remain high in part because of this sort of opacity. Last year MSF determined that a single dose of the vaccine—a complete course requires three to four doses over time—runs $63.70 in Morocco and $67.30 in Tunisia, while it’s somehow cheaper in France at $58.40. (In the U.S., the group put the cost at closer to $136.)

“The companies really operate on opacity of price data,” explained Kate Elder, the Vaccines Policy Advisor at MSF. People in the dark have no bargaining power. (Not unlike office workers negotiating salaries.)

Isn’t there at least some list price for reference, I asked, like the price of a car?

“What they try to avoid at all costs—no pun intended—is to avoid governments or other purchasers doing price referencing,” she added. “They won’t even quote us a price. So step one is them being a business and selling us a product.”

I asked Pfizer if they would be open to a deal to make the vaccine affordable to humanitarian organizations like MSF. Beatty wrote, “We are actively exploring a number of new options to enable greater access to our pneumococcal vaccine … to aid NGOs facing humanitarian emergency settings.”

I asked if that meant changing the price for MSF, and she copied and pasted the same response.

One deal that Pfizer will talk about, even unprompted, is that with the Global Alliance for Vaccines and Immunization (GAVI), an organization that purchases vaccines in bulk on behalf of poor countries. In 2009, Pfizer agreed to sell Prevnar to GAVI for $9.15 per course.

That price is really what MSF wants, and has been requesting for years. So I put it to Pfizer directly, one final time: Why can’t you give the $9.15 price to NGOs? After all, their patients represent a relatively small part of the multibillion-dollar market for a vaccine that’s supposed to be given to all people.

Pfizer’s representative didn’t answer the question directly, but again pasted “we are actively exploring a number of new options to enable greater access to our pneumococcal vaccine to aid NGOS facing humanitarian emergency settings.”

Until that active exploration bears fruit, MSF is forced to choose the less imperfect option that will yield the greatest good. In the short term, does MSF’s decision threaten the wellbeing of children who might have received the donated vaccines?

“We're taking every step we can to minimize that risk,” Elder said. “But our priority is to vaccinate as many children as possible in the long term.”

In medicine, sometimes do no harm is an imperfect principle. It’s only possible to do the least harm. And Pfizer disagrees with MSF about how to do the least harm. In a cold phone call to my cell, Beatty reiterated that the company sees donation as a humanitarian endeavor. “Is policy really more important than the opportunity to vaccinate and protect vulnerable people in emergency settings?”

In another email, she reiterated that the donation offer is still on the table, deliverable immediately, and that Pfizer would offer to store the doses prior to distribution, if adequate storage for the entire one million is not available.

I felt like somehow I had become the negotiator. I’m still trying to identify the impasse for Pfizer, but I got the impression the standoff would persist. And its resolution could establish a precedent across the industry, because more than this dangerous pneumonia is at stake. Many new vaccines are still made by only one or two manufacturers, and monopolies and duopolies are a real factor in why prices remain high. The HPV vaccine is only made by GSK and Merck. The rotavirus vaccine against diarrhea (the second leading cause of childhood death worldwide) is only made by GSK and Merck. The new malaria vaccine is only made by GSK.

If there is a reason for people to be concerned about vaccines, it is a problem with people not having access, and a legal and economic system that keep prices high. The spirit of MSF’s decision highlights the same principle behind herd immunity: Vaccines are not about individuals. They are not even about individual organizations. They’re microcosm of all health: We’re in this together.

In an attempt to rectify consumer blindness, the World Health Organization (WHO) recently established a vaccine price and procurement database initiative, where all purchasers can share what they know, but there's still a scarcity of data.

And on Wednesday, Elder was in Geneva at a meeting that WHO convened this week on vaccination in emergencies. There they proposed a humanitarian mechanism where manufacturers can participate to sell their vaccines to NGOs and others vaccinating in emergency settings at further reduced cost. Elder reported that GSK was the first to commit, and Pfizer did not, but was represented at the meeting.

“So the onus is on them, from MSF and from WHO and UNICEF,” said Elder. “The ball is in their court.”

http://www.theatlantic.com/health/archive/2016/10/doctors-with-borders/503786/