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Unbearable Costs?
Trevor Butterworth, February 28, 2011
At the end of 2010 the World Health Organization announced a groundbreaking vaccination program to eliminate epidemic meningitis in Africa. “This is within reach,” said Dr Margaret Chan, WHO Director-General. “We must not fail.” But in the U.S., a similar goal using newly available vaccines may just be too costly for the government to bear.

On Friday March 30, 1996, Sarah Amann began running a slight fever. By nightfall, she started vomiting, and her mother, Lisa Naumann, stayed up all night to watch over her; by morning, she seemed a little better. “I thought,” said Lisa, “she was coming down with the flu.”

That was until the spots appeared around her daughter’s mouth and began to spread. “I wondered what in the world that was,” said Lisa, who began to look through her medical books. “It didn’t look like measles; it was like you took grape juice and spattered her face.” Lisa called her pediatrician - he was triple booked – but feeling a growing sense of alarm, she decided to take Sarah to the clinic anyway. As she was getting ready, her pediatrician called back telling her to get there as fast as she could.

It took twenty minutes to drive to the clinic in Belleville, IL. At a stoplight Lisa turned around to check on Sarah in the back seat: her face had turned gray. By the time they got to the clinic, she was bleeding through her nose and she was immediately rushed to the nearby intensive care unit at St. Louis’ Cardinal Glennon hospital in Missouri.“The doctors,” recalled Lisa, “had an ‘Oh my God’ look on their faces.”

Sarah had meningococcal septicemia (also known as meningococcemia), a bacterial form of meningitis that was rapidly poisoning her blood. She was 13 months old.

meningitisIt can start with irritability or drowsiness or a headache or fever; or, possibly, nausea and vomiting. Or all of these symptoms in any order over four hours. Parents think it’s just gastroenteritis or a bad cold or, as Lisa Naumann did, the onset of the flu. And most of the time, they will be right. But if, in the next few hours, the symptoms shift to breathing difficulty, leg pain, abnormal skin color, a rash, cold hands and feet or, depending on the age of the child, thirst, sore throat, and neck pain, time will be running out.

Charlotte Cleverley-Bisman

Time had almost run out for Sarah. The doctors told Lisa that they “knew for sure” her daughter would lose part of or all of her fingers. But over the course of the next 72 hours, they amputated Sarah’s legs above the knee and her right arm above the elbow. They had to amputate her nose, her upper lip, her front palate and the tip of her left pinkie too. Sarah also suffered swelling to her brain, which would lead to developmental delays. “It was,” recalls her mother, “horrendous.”

meningitis“I think it is fair to say that meningococcemia is one of the most feared infectious diseases that we see in the developed world,” says Dr. Steven Black, Professor of Pediatrics at the University of Cincinnati Children’s Hospital’s Center for Global Health and a consultant for Novartis vaccines. “The onset is sudden, morbidity and mortality are high despite good treatment and the initial symptoms are non specific making every physician fear that they will send a febrile child home with this disease.”

Charlotte Cleverley-Bisman


“It is a frightening disease,” says Dr. Henry Shinefield, former Chief of Pediatrics at Kaiser Permanente in San Francisco, and a leading researcher on infectious disease. “I’ve seen its whole spectrum, the amputations – the disasters. It requires doctors to be very attentive, to have a high degree of suspicion, and to treat as if there is meningococcal meningitis rather than wait for confirmation.”

Once the meningococcal bacteria, which usually live only in linings of the human nose and throat, penetrate the bloodstream, death can come within 24 to 48 hours. Indeed, by the time the spots appear – Naumann’s “grape juice spatter”– the infection is often beyond the reach of antibiotics. The bruise-like spots, which don’t change color under pressure, are the result of the bacteria emitting small toxic bubbles (a process called blebbing) which cause the blood to coagulate and clot. The bacteria is so effective at doing this that it drains the blood of clotting agents, which leaves victims clotting and bleeding out at the same time. As blood flow stops to tissue and organs, the first rot and the second fail.

In the 1990s, it seemed as if Meningococcal disease was beyond the reach of medicine – unless you caught it quickly enough to administer antibiotics (and even that wasn’t a guarantee of recovery). It was just too complicated, with 13 varieties, five of which are responsible for most disease (serogroups A, B, C, W-135, and X), and cycles of peaks and troughs that seemed to occur without reason. It struck infants, especially those under a year old, teenagers, especially those in college, and the elderly; but it was less common in children and adults. It spread by direct contact with respiratory secretions and was more prevalent in winter than summer. Anywhere from five to 20 percent of the population carry one or more varieties of the Neisseria meningitidis bacteria at any one time; but for reasons that are not entirely clear, it will suddenly overwhelm a few, causing either meningitis (inflammation of the brain or spinal cord) or septicemia (blood poisoning) or pneumonia, while leaving the many untroubled.

Once the infection starts, the fatality rate can range from five to 50 percent, depending on where you are in the world, the serogroup, and the stage of the infection at the time of medical intervention. Sub-Saharan Africa is the worst affected. In 2009, there were 88,199 suspected cases and 5,352 deaths, according to the World Health Organization, in an area stretching from Senegal to Ethiopia, known as the “Meningitis belt.”

In 1999 The Centers for Disease Control noted that the eradication and elimination of meningococcal disease, while desirable, was unfeasible. But in the same year, the first of an extraordinary series of medical interventions would challenge the CDC’s pessimism. The British government launched an infant vaccination program for group C, accompanied by a major public health campaign, “Look Out 4 Meningitis, Look Out 4 Others.” It was spearheaded by film director Ken Loach, whose grand-daughter Holly lost her hearing from the disease when she was 13 months old. Over the course of the next decade, there was a 67 percent decrease in the incidence of group C cases. Europe quickly followed Britain’s lead.

Even more remarkable, the Meningitis Vaccine Project (MVP)--a partnership between the World Health Organization (WHO), PATH, a nonprofit global health organization, and the Bill & Melinda Gates Foundation announced a new, powerful group A meningococcal vaccine that will be distributed at minimal cost throughout the “Meningitis Belt,” starting with Burkina Faso, Mali and Niger. As Dr Margaret Chan, WHO Director-General, noted, “In fewer than 10 years, we have overcome obstacles that have in the past seemed insurmountable.”

Finally another massive obstacle is all but set to fall in 2011 now that Bexsero, a group B infant vaccine from Novartis, has completed clinical trials in Europe and is under review by the European Medicines Agency. Bexsero could eliminate 50 percent of infant infections.

But what of the United States? It did not follow Europe in recommending an infant C vaccine, but in 2005 it recommended that all teenagers should be given an A, C, Y and W135 conjugate vaccine. The uptake rate is just 33 percent. It is further behind on the B vaccine clinical trials than Europe, and the CDC appears to be backing away from endorsing new infant vaccines for A, C, W-135, and Y serogroups, which are currently awaiting approval from the Food and Drug Administration.

The issue is complicated. If the FDA says the vaccines are safe, it is up to the CDC’s Advisory Committee on Immunization Practices (ACIP) to determine whether, as public health policy, infants should be vaccinated. If ACIP says they should, then the Government, under the Vaccines for Children Program (VFC), will have to foot the bill for vaccinating all those children who are not insured. Currently the VCF program accounts for 55 percent of all infant vaccination in the U.S., or approximately two million children. Each child would cost the government and additional $320 dollars for four shots, or roughly $640 million dollars per year.

ACIP’s “Meningococcal Working Group” estimates that infant vaccines for C and Y serogroups would “prevent 80-120 cases and 4-6 deaths” per year in children under five, but the immunization would not last into the teenage years. If ACIP decides against recommending vaccination, private insurers may be unwilling to reimburse on the grounds that the government doesn’t think vaccination is necessary.

Dr. Robert Goldberg, co founder and Vice President of the nonprofit, non-partisan Center for Medicine in the Public Interest believes that the failure to recommend an infant A, C, W-135, and Y vaccination would be “extremely short sighted.” The world,” he says, “is getting smaller and serogroup distribution changes all the time. The Y strain has grown rapidly as a leading source in the US. Not to protect against all strains can lead to unchecked outbreaks.” Moreover, he says, the CDC needs to take into account the indirect costs of not vaccinating.

One illustration of the potential for meningitis to cause havoc through indirect costs comes from an outbreak of meningococcal disease over Superbowl weekend in Mankato, Minnesota, in 1995. Public health officials ended up having to vaccinate 35,000 people as much to contain the outbreak as to contain the panic that followed the media coverage of a boy dying from the disease. As Michael T. Osterholm, Ph.D, who was in charge of the massive response noted in an article for Public Health Reports, “Every parent thought that their son or daughter was another kid dying of meningitis. Their child woke up one morning with a fever, the same way as the boy who died.”

Six hundred people worked for three weeks to bring the outbreak under control at the cost of millions of dollars. At one point, truck drivers refused to drive through the town. Dealing with the outbreak, wrote Osterholm, was a logistical nightmare that “pushed one of the premier state health systems in this country to the edge.” He doubted whether any state could handle any kind of outbreak of infectious disease that required vaccinating more than 10,000 people a day. Think, he wrote, what might happen if an outbreak started somewhere like the Mall of America, which at peak shopping times had hundreds of thousands of visitors.

Dr. Paul Offit, chief of infectious diseases at the Children's Hospital of Philadelphia, and the author of “Deadly Choices: How the Anti-Vaccine Movement Threatens Us All” (Basic Books, 2011), is on ACIP’s Meningococcal Working Group. He refuses to talk directly about the approval process but he outlines the dilemma: “How,” he says, “do you put a price on suffering? How do you cost that out in health care?”

“In a statistical argument, you don’t know who will die,” says Offit, “but it’s different when you know the victim. We spend amazing amounts of money treating people we know.”

Lisa Naumann does not know which meningococcal serogroup attacked her daughter. Over the past 15 years, Sarah has endured repeated operations to reconstruct her face. Because the amputations were above her knee joints, she cannot wear prostheses to walk and sitting in a wheelchair has left her back bent from scoliosis; she recently had a metal rod implanted to support her spine. “If there’s a vaccine out there,” says Lisa, “nobody should have to go through this.”

 

Further resources:

Lisa Naumann is currently a part of the National Meningitis Association's Moms on Meningitis program, working to educate others about meningococcal disease.

Meningitis Angels, a national non-profit organization dedicated to the support of victims of bacterial meningitis and their families.

Images: Charlotte Cleverley-Bisman is believed to be the youngest ever survivor of meningococcal septicemia who required amputation of all four limbs. Photos were retrieved from http://babycharlotte.co.nz. A full account of Charlotte Cleverley-Bisman's story is available here.




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