Merck continues campaign against river blindness in the DRC

By Elaisha Stokes

BENI, Congo — Every summer since 2010, Kasereka Mahamba has visited each of his neighbors, one by one.

They live in mud houses that dot the side of a steep hill in north Kivu, Democratic Republic of Congo. While neighborly visits are always welcome in this part of the country, Mahamba’s are of an official nature. His job is to hand out free medicine.

The drug is called Mectizan, and it is used to treat onchocerciasis, better known as river blindness, a debilitating and neglected tropical disease that renders its host painfully itchy and, if untreated, can blind them. Mahamba distributes the drug as part of the Mectizan Donation Program, launched in 1978 and the oldest disease-specific drug donation program of its kind. The program is part of a public-private partnership between Merck & Co. Inc, a pharmaceutical company that donates the drug; the World Health Organization; the World Bank and several nongovernmental organizations.

Pharmaceutical companies have had a complicated history of distributing patented drugs in the developing world. Historically, profits have come first. Drugs like Mectizan cost millions of dollars in research and development to produce. When the resulting product can only be used to treat the world’s poorest people, many pharmaceutical companies will abandon production and distribution altogether. Merck’s commitment to Mectizan is a rare exception. But it is not entirely altruistic. What the company loses in profits, it gains in good publicity and a tax break.

“They used to refuse it,” says Mahamba, who travels the village with a large pole that helps him determine the treatment dose for his neighbors. Depending on the individual’s height, they receive between one and four pills every year for 15 years.

“They saw me, a man with a stick moving up the mountain, and they assumed I was practicing witchcraft.”

But with time, members of Mahamba’s village noted that those who took the pills stopped itching, and so they learned to trust the program.

The few roads that pass through the center of the remote village are fashioned from mud and often wash away in the rain. Because of a lack of security, hardly any aid organizations visit the region. There are no doctors in the town, just a small pharmacy that caries the bare essentials. Those who need substantial medical attention must hire a motorcycle to take them 45 minutes to Beni, where they can find the nearest major hospital.

People here rely on subsistence farming to get by. The area is surrounded by three rivers, where Mahamba’s neighbors wash their cloths and gather water. It’s these rivers that are home to the tsetse fly, a relatively harmless insect, unless it is carrying the onchocerciasis parasite. When a fly with the parasite bites a human, it passes along the microscopic parasitic worm. These worms multiply under the skin of their hosts, causing them to become painfully itchy. Eventually the worms can migrate up to surface of the person’s eyes, causing them first to see shadows, and then, with time, to lose their vision completely. Even Mectizan cannot treat this blindness.

“This job, it’s an honor,” Mahamba says as he approaches another neighbor’s home. He was elected by the village elders to distribute the medicine and receives no financial compensation for doing so. He will make this journey every day until he is convinced that all of his neighbors have received treatment.

“These days, people welcome me with respect,” he says.

Donation program

The Mectizan Donation Program has become one of the world’s most successful public-private global health initiatives. In the last 27 years it has provided more than one billion treatments to people in more than 117,000 communities in 30 African countries, six Latin American countries, and Yemen.

The total population at risk for contracting the disease in Africa will reach about 253 million in 2016.
“Merck has pledged to donate the medicine to those who require it for as long as they require it,” says a spokesperson from the WHO’s African Programme for Onchocerciasis Control (APOC), a major partner. “Without the medicine, the achievements of the program would not have been possible.”

Mectizan was first discovered in a Merck laboratory in 1978, when Dr. William Campbell suggested the drug, which was initially developed to fight worms in horses, might also prove useful in fighting river blindness in people. In 1981, clinical trials commenced in Senegal. When the drug was finally approved for mass distribution, Merck could not find a partner interested in a distribution program. So the company decided they would make a donation themselves.

“It was a very dramatic announcement at the time,” said Dr. Adrian Hopkins, the current director for the Mectizan Donation Program. “It was suicide from a business point of view. But it was ethically the right decision. The people who needed this drug could never afford to buy it.”

Today, Merck donates Mectizan and covers the clearing charges to get the drug into government warehouse across Africa. From there, APOC along with local ministries of health oversee the delivery of the medicine and collect data on community distribution, with help from local NGOs. In 2013 the partnership treated 100 million people in 31 African nations.

“To date, we have contributed about $63 million in financial support grants and donated over 1.3 billion treatments,” says Brenda Colatrella, Merck’s executive director of corporate responsibility. “But this is a very large multisector partnership. We recognized that we didn’t have any experience in how to get a drug like this out to remote villages and into the furthest areas of the globe. It is using Merck’s drugs, but it is the expertise of a coalition of organizations that ensure coverage rates are high enough.”

Situation in the DRC

In the Democratic Republic of Congo, about 20 million people are at risk of contracting river blindness, according to the World Health Organization. That makes the country the second highest in terms of potential infection rates, after Nigeria. But the DRC is also plagued with a number of issues that make distribution particularly challenging. The country is very large, and there are few roads connecting the remote villages where the disease is endemic. War and insecurity mean the populations often must flee their homes.

“Almost all the roads are in advanced dilapidated conditions,” an APOC spokesman says, “which dramatically increases the operational costs of the health programs.”

According to APOC, treatments take place irregularly, and displaced populations often miss treatment rounds altogether.

“The health system is very weak in the DRC,” says Dr. Tony Ukety, the coordinator of the World Health Organization’s river blindess program. “Ideally you want to be working within a health system that is functional.”

Politics can also pose a problem. The 2014 drug shipment has been held in a warehouse in Kinshasa for months. A federal cabinet shuffle, combined with a culture of bribery, has made getting the signatures required to release the drugs a challenge.

“As a point of principle, we don’t pay customs,” Hopkins says.

The partnership is based on the premise that engaging local governments and communities increases treatment coverage significantly.

“You have to find a way to work in the Congo without any corruption. It can be a challenge. But ultimately, the people want the drugs. The Ministry of Health wants the drugs. It can just take more time.”

Despite all these challenges, the treatment coverage rate in DRC today is more than 60 percent. The main method of distribution is community-based mass treatment, in which volunteers are elected to bring medicine to every member of the community until the community is no longer at risk, for about 15 years, a worm’s life cycle. The World Health Organization has found that engaging local people into the process of planning and distributing treatment creates high coverage rates and increases the likelihood of elimination.

“We are getting Mectizan into every corner.” Hopkins says. “That’s the partnership at work.”

From control to elimination

Previously, it was believed that river blindness in Africa could at best be controlled and not eliminated, as it has been in parts of South America. But last year the World Health Organization declared that elimination was possible, following the news that Colombia had become the first nation in the world to eliminate the disease. In Congo, initial followup results indicated that parts of the Kasai region are already potentially free of the disease.

“The APOC program has a list of countries that should succeed in eliminating river blindness,” says Dr. Frank Richards, who works with the Carter Center, a nonprofit that has worked extensively to eliminate the disease, particularly in Uganda. “The first two countries that can eliminate the disease by end of 2014 or early 2015 are Niger and Senegal. DRC is amongst the last countries, along with the Republic of South Sudan, for 2025. So that’s 10 years from now.”

Lack of security, infrastructure, and human resources mean that distributing the drugs remains a challenge.

But Merck Pharmaceuticals has consistently reiterated its commitment to continue to donate Mectizan for as long as needed. The company, headquartered in New Jersey, had revenues of $44.03 billon in 2013, and profits around $4.4 billion. Its total corporate giving in 2013 was $1.86 billion.

Merck receives a tax break for its Mectizan donations, as Colatrella explains, “Any donation made under an IRS requirement, you are entitled to a tax benefit.”

When asked how large the tax break is for the Mectizan Donation Program, Merck did not share the number saying the information is proprietary. A representative of the company said Merck’s tax break is calculated based on all of its charitable giving, not individually by program.

What is known is that each pill is valued at $1.50, according to the World Health Organization, and the company approved 167,984,016 treatments in 2013 alone. That’s a total value of just over $250 million. 

It is worth noting that Merck & Co Inc has a history of exploiting federal tax loopholes. In 2006 the company was investigated by the Internal Revenue Service for using complicated offshore patent filings to avoid paying taxes. The company was forced to pay the IRS $2.3 billion, and Merck & Co. Inc. is consistently cited by pro-tax lobby groups as one of the worst offenders for its attempt to avoid paying taxes.

But Merck is adamant that its donation is completely unrelated to its tax strategy and is about more than just tax incentives.

“The biggest benefit for us is the relationship factor,” Colatrella says. “It has enabled us to build strong relationships in the public health, academic, and NGO communities. As a good partner, our relationships have allowed us to do other things.”

Colatrella cites a HIV program in Botswana, launched in 2010, that she believes was possible only because of the relationship the company has built with the nation during the Mectizan Donation Program.

While the Mectizan Donation Program has proved the company’s generosity in providing life-changing drugs to those who cannot afford them, that has not always been the case. In 1998 the company joined 38 other pharmaceutical companies in a lawsuit against South Africa, which at the time was exploring generic drug treatments for HIV patients, which pharmaceutical companies argued violated intellectual property rights. Developing new treatments is expensive, and these companies argue that there must be a financial incentive for them to continue to take the risk. Merck eventually dropped the case and now provides the drugs to the developing world at cost.

Still, Mectizan, which had almost no commercial value when it was first discovered largely due to the patients it would aim to treat, is a prime example of how big pharma can do good, if it chooses to.

“The people who suffer from this river blindness would never be able to buy the medicine,” says Richards. “If you look at the big pharma industry with a tainted eye on how they tend to develop their pharmaceuticals, very often they won’t even start researching on things that do not look like they are going to be a blockbuster. I can easily be critical of the pharmaceutical industry, but in this instance I think this is really the better angel of the pharmaceutical industry that we are looking at.”

For its part, APOC is currently scheduled to end in 2015, but plans are already under way to transition to a new entity. Tentatively called the Program for the Elimination of Neglected Diseases in Africa, or PENDA, the new incarnation will attempt to co-treat river blindness with lymphatic filariasis. Both are vector-borne diseases and coendemic in 80 percent of areas. Both can be treated using Mectizan. The transition is an ambitious iteration of a well-established program, but stakeholders believe it can work.

Dr. Hopkins believes that perhaps the greatest success of the program is its longevity.

“Most development programs try and do something in three to five years, and then people get impatient when they don’t see results,” he says. “Merck has been at this for 27 years. Mectizan is a magic bullet, but it needs a lot of support. Results take time.“

For now, all the partners have their eyes focused on 2025, when the global health community hopes to declare river blindness officially eliminated. Most countries will reach the goal by 2020, with only the DRC and South Sudan remaining. Insecurity and lack of infrastructure will slow their progress. But no one is ready to throw in the towel just yet.

“We’ve proven that even in a remote areas, like in the Congo, you can put forward a process,” Hopkins says. “You can make it work.”