statism watch

As illustrated in John LeCarre’s The Constant Gardener (and scores of non-fictional reports), controls on pharmaceutical company’s operations in Africa are largely non-existent. The people are right to be wary.

Flashback: HIV positive women in Africa sterilized, stigmatized | France Considers Mandatory Flu Vaccinations | Children Who Get Flu Vaccine Have Three Times Risk Of Hospitalization For Flu, Study Suggests | Lessons of 1976: swine flu, fear, mass vaccinations, wasted millions | ‘Accidental’ Contamination Of Vaccine With Live Avian Flu Virus Virtually Impossible | Officials investigate how bird flu contaminated vaccines in Europe | Vaccine Court: Autism Debate Continues | Revealed: The serious health concerns about the cervical cancer jab | Vaccines Found to Cause Diabetes in Children | Pfizer to be called on carpet in Nigeria for experimenting on children | Homeless people die after bird flu vaccine trial in Poland | Vaccine-linked polio hits Nigeria | Polio Warning Issued for Travel to Nigeria

Zoe Alsop, Globe and Mail
June 17, 2009

Failure to inform some participants of vaccine’s experimental status leads to ‘bitterness’

The chiefs in the Kenyan coastal district of Kilifi called people to meetings recently and asked them to co-operate with the researchers who would be arriving along the pocked road to launch a malaria-vaccine trial. The mothers told their chiefs that they would participate, if asked. But, among themselves, they worried.

For one thing, there was that snake in the logo painted on the sides of the sleek, white SUVs the researchers drove. A ubiquitous sign of healing in the West, to these women the snake was a demonic symbol. Then there was the problem of the blood samples.

“When they come, they take a lot of blood,” said Agnes Ndoro, a farmer and mother who is unsure of her age. “We fear where this blood is going. We have a belief that demons feed on blood.”

On the face of it, these farm women might seem like people that time has abandoned to the cyclic, all-consuming struggle of survival. Death comes so often and in so many forms that it seems better explained by superstition than reason.

In fact, the mothers of Kilifi find themselves at the forefront of the most technologically sophisticated and costly onslaught ever to be brought to bare [sic] on malaria, a scourge that kills a million children each year.

This year their children will become part of the largest and most advanced trial ever of a malaria vaccine. It’s funded by the multinational pharmaceutical giant GlaxoSmithKline and the Bill and Melinda Gates Foundation.

The stories of the mothers of Kilifi open a window on the challenges faced by researchers as they build a trial that will include more than 16,000 babies from 11 sites spread across sub-Saharan Africa.

The first five babies were inoculated in Tanzania in late May. Scientists and doctors are readying millions of dollars worth of new laboratory equipment, training field workers and canvassing mothers in rural villages in Burkina Faso, Gabon and Ghana in the west, Mozambique and Malawi in the south and Kenya and Tanzania in the north to sign up the final volunteers.

Malaria is so deadly and the search for a vaccine has been drawn out over more than two decades, in part, because of the fluid adaptation of the parasite. It shuffles its surface proteins to adapt to new circumstances. If a vaccine is to be worth implementing, it must be capable of taking on malaria no matter where it is or what its guise.

“It’s a historic milestone in the fight on malaria,” said Patrick Duffy, who directs the malaria program at the Seattle Biomedical Research Institute and is a grantee of the Gates Foundation. “It’s such a huge undertaking. Like a trial anywhere, you need to get a diverse group of people all aligned on this single goal and to meet the same standards for an international trial.”

It is a task that pits hundreds of scientists, doctors and field workers against floods, famine and corruption that corrode the very core of health infrastructure and breeds deep public distrust. They believe it’s worth it.

Pediatrician Patricia Njuguna, who will help oversee the trial, first came to Kilifi as a medical officer. During the rains of April, May and June, when malaria spreads fastest, small bodies — some comatose, others struggling through seizures — are packed two or more to a bed in the pediatric intensive care ward.

“You would do an on-call and find five very sick children needing intensive care,” said Dr. Njuguna, who is a principle investigator on the crucial phase-three trials. “So the idea of a vaccine to really reduce the cases was very enticing to me.”

Erudite and elegant, Dr. Njuguna spoke quietly of her work on this and an earlier trial with the vaccine, known as RTS,S. The work has sent her deep into the jungle and far out along muddy paths to explain the vaccine to chiefs and mothers, and to tend to babies who become sick over the course of the trial.

Last year, Dr. Njuguna and her colleagues worked with dozens of field workers and clinicians on a smaller trial of the same vaccine. With the help of a cocktail of ingredients meant to boost immune response to the vaccine, also patented by GSK, that trial broke new ground, demonstrating that rates of malaria among babies and toddlers who received the vaccine were 53-per-cent lower than those of children who did not.

That efficacy rate, while low for a vaccine, was far beyond what had been seen in earlier trials, and presents the possibility of a shield sufficient to protect the lives of hundreds of thousands of children each year.

“We still believe that if we really want to control the disease and perhaps one day eliminate it, a vaccine will be an indispensable tool,” said Joe Cohen, vice-president of research and development for GlaxoSmithKline, who also helped invent the vaccine more than 20 years ago. “We all know what vaccines have achieved in controlling other diseases.”

Spreading that enthusiasm to poor villages buried at the rough ends of old roads, where medical care is rare and deadly illnesses abundant, is no small feat.

Dr. Njuguna and her colleagues know. As the long rains set in, trucks wallowed and got stuck in thigh-deep mud, everything from samples in need of refrigeration to sick children had to be moved across dozens of kilometres by motorbike or on foot. Field workers in rubber boots struggled to access homesteads, some of them mere islands in a sea of mud.

They had no choice. They had been made to understand that any failure in follow-up on their part would mar results representing hundreds of millions of dollars in investment.

Recruitment was perhaps the hardest part. It took nearly six months to recruit just 400 participants for last year’s trial.

Still, local suspicions of the project saw one field worker mock-lynched and abandoned naked in a forest. One of his attackers was the father of a baby enrolled in the trial.

That skepticism is partially the product of a long history of neglect and corruption in Kenya’s public health-care sector and government in general.

In many places on the continent, regulations are scant or easy enough to evade. As recently as a year ago, a South African drug trial injected garden fertilizer into HIV positive Tanzanians. But such cases are thought to be uncommon.

“People are very astute,” said Mr. Duffy who has worked in East Africa for years. “They are not shy about asking questions on the one hand. On the other, if you don’t have credibility you’re not going to get participation.”

The people of Kilifi have been watching warily for the past 20 years, as KEMRI has built a glistening block of laboratories of bright white concrete, which belch cool air whenever its doors open into the shimmering heat.

Many kilometres away, Rehema Kenga sat in the dust, propped against the mud house where she lives with her seven children, her eyes downcast.

She could not recall her son’s age.

“I really had a sick heart,” said Ms. Kenga, whose son Simon also participated in the earlier trial. “My neighbours really discouraged me. They told me that these things are demons. They said you have now sacrificed your son.”

She felt better though after meeting other mothers whose children were in the trial. She even began to believe that her son has been healthier than her other children because of the vaccine.

“The others have been suffering that malaria because whenever they go to the clinic it is diagnosed malaria,” Ms. Kenga said. “Since when Simon was vaccinated, up to date, he does not suffer serious illnesses. He just feels bad the normal way, and then he recovers.”

The meticulous explanations and consent required to bring malaria trials to an international standard seems to be winning the trust of Kilifi’s people, if not always the understanding.

“I have full confidence and faith in that organization,” said Josephine Mwaburu, whose 16-month-old daughter, Willimina, participated in the most recent trial. “If this research should give good results, then I will be among the pioneers on behalf of my community.”

But, just as it seems that the chasm between the gleaming laboratories and Rehema’s dusty hut have been bridged, it opens again.

Asked how she will feel if the trial is successful and her son can lay claim to a role in the delivery of a vaccine that could save the lives of millions, Ms. Kenga observes a confounded silence.

She had been told of trials in the United States and in Mozambique and, she says, she thought the vaccine had already been approved.

“I will feel bitter,” she said. “I was not aware that this was a trial.”

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