Cost-Effectiveness and Bioethics

I just finished reading Mountains Beyond Mountains, a story of one man's – Paul Farmer – indefatigable fight against the injustice of inequality, specifically in regards to spreading modern medicine in an effort to curb infectious disease in countries such as Haiti, Peru, Cuba and Russia in the 1990s and early 2000s. Farmer’s brain-baby, Partners In Health (PIH), continuously ran up against astronomical drug prices and cynicism from their peers directed towards the substantial costs of their public health projects aiming to provide the right treatments for their patients. Over my bowl of cereal today, I heard a story on NPR’s All Things Considered about the rising prices for meningococcal vaccines in America, a story with themes that harkened back to Farmer’s own struggle with drug prices and ethical treatments.

In the mid 1990s, the drugs to treat just one patient with multiple-drug resistant tuberculosis (MDR-TB) at Farmer’s PIH branch in Peru cost between fifteen and twenty thousand dollars. However MDR-TB patients might have only represented something like ten percent of TB patients within one Peruvian slum. In April of 1998, Farmer and his colleagues attended a special meeting of TB experts at the American Academy of Arts and Sciences in Boston, and at this meeting Alex Goldfarb, a renowned microbiologist played devil’s advocate to the PIH's exorbitant spending on only a handful of MDR-TB patients. He began, 

I want to share with you a simple reality. I have six million dollars. With three million dollars I can implement DOTS (directly observed therapy for five thousand Russian inmates. And assuming that ten percent have MDR-TB, forty-five hundred will be cured and five hundred will go down with MDR-TB and die. And there’s nothing much you can do. So. I have a choice. And my choice is to use another three million dollars to treat the five hundred with MDR-TB, or go to another region and treat another five thousand. I’m working with limited resources. So my choice is not involved in the human rights of five hundred people, but five hundred people versus five thousand people. And this is a very practical question for me, because I have six million dollars. And the second question is that if I disclose to the Russian people that I spent six thousand dollars per case in MDR-TB in the prisons with tens of thousands of people dying all around, they will tell me that I am building a golden palace for a selected few. So for those of us who have to make those decisions with limited resources, it’s a very serious question. – 162

This morning I thought back to this passage from Mountains Beyond Mountains as I read about the ongoing debate within the Advisory Committee on Immunization Practices (ACIP) concerning the cost-effectiveness of distributing meningitis vaccines among infants and toddlers in the U.S. For the record, ACIP recommendations are used by both the government and private insurers to decide which vaccines they'll pay for,

and back in 2005 the ACIP recommended that every adolescent in the U.S. get the vaccine. It costs nearly $100 a dose, which means hundreds of millions of dollars a year paid by the government and private insurers. But the bacteria cause illness in only a couple of thousand people in the U.S. each year, and that number was going down even before the vaccine arrived.

Furthermore, last year researchers determined that adolescents would need a booster just five years after the vaccination, now a $189 vaccination. With the additional booster the cost of the vaccination practice rose up to about $387 million for the federal government annually to implement – a measure that would prevent just 23 deaths, according to ACIP committee members.

On All Things Considered, the piece transitioned from a debate on cost-analysis towards a debate about whether you can put a price on a human life. How much is too much to spend on measures that save the lives of children? Who can really make that call?

William Schaffner, chair of preventive medicine at Vanderbilt University and an ACIP liaison representative from the National Foundation for Infectious Disease, told NPR, "We are drifting slowly to a conservative position which is, maybe it doesn't have to be recommended universally," which is the committee's current recommendation. 

As I had read Goldfarb's appeal to see the necessity for cost-effective strategies in countries with "limited resources," I knew in the back of my mind that many countries lacked the infrastructure, resources and capabilities to create sustainable public health projects without primarily leaning on cost-effectiveness. However, I had never figured the U.S. would ever be lumped into that particular crab cake, like Schaffner and other ACIP members seem to be predicting as prices continue to rise. 

In Farmer’s case back in 1998, PIH worked with the World Health Organization (WHO) to create the Green Light Committee to accelerate universal access to prevention, early diagnosis and effective patient-centered treatment for MDR-TB to poor countries which demonstrated the capability to use the drugs correctly. The idea behind the original committee was to create a body in charge of distributing second-line drugs at reduced prices, with reductions coming in stages. By 2000, projects buying second-line TB drugs through the GLC paid about 95 percent less for four of the second-line drugs than they would have in 1996, and 84 percent less for two others.

My point: This type of streamlined access has been made possible for the poorest of the poor, and yet the U.S. finds itself dangling from a precarious ledge at the mercy of drug companies. We're talking about going against a universal recommendation for lack of a creative solution to rising prices, which seems unacceptable when faced with the very real possibility of risking the lives of infants and small children. Why is a Green Light initiative possible in the bleakest corners of the world - Peruvian slums or Siberian prisons – but public health administrators, legislators, and researchers don’t have a similar way to streamline access to the most basic vaccines, such as meningitis vaccines, in the U.S?