Isaac Seeman, Ebola survivor, did not give his consent for blood samples to be taken abroad CREDIT: EMMANUEL FREUNDTHAL

Ebola’s lost blood: row over samples flown out of Africa as ‘big pharma’ set to cash in

By 

Health workers take a patient to a treatment centre during the 2014 Ebola epidemic in Liberia CREDIT: KENZO TRIBOUILLARD/AFP PHOTO
Health workers take a patient to a treatment centre during the 2014 Ebola epidemic in Liberia CREDIT: KENZO TRIBOUILLARD/AFP PHOTO

A row is simmering over the ownership of thousands of Ebolablood samples taken from patients during the 2014-16 epidemic in West Africa and now held in secretive laboratories around the world.

The samples have enormous value to researchers involved in creating new vaccines and medicines but also to defence facilities such as Porton Down in the UK where research on bio-chemical agents and their antidotes is conducted.

Now several African scientists and Ebola survivors accuse the laboratories of biological asset stripping. Despite the samples having been taken from thousands of Africans, scientists from these patients’ home countries – Sierra Leone, Guinea and Liberia – are unable to access them for their own research.

“When you take samples you should keep them,” says Dr Fatorma Bolay, the director of the Liberian laboratory where Ebola samples were stored before they were shipped to the United States in 2016.

During the epidemic, more than 269,000 samples were extracted from patients for diagnosis, according to the World Health Organization. Many were destroyed but thousands were exported abroad, including more than 10,000 to the UK.

 After the epidemic, the WHO tried to create a global inventory of all the Ebola samples but was unable to complete the project when laboratories in South Africa, France and the United States refused to disclose how many they held.

 A Freedom of Information request lodged by The Telegraph with Public Health England (PHE) in 2017 highlights the sensitivity of the subject.

The agency, which operated four laboratories in Sierra Leone during the epidemic, initially rejected the request, saying much of the information was classified for reasons of “national security”.

The UK Information Commissioner overruled PHE, although the location of the samples remains classified. The commissioner slammed PHE, saying it had “identified that it does hold information within the scope of some of the complainant’s requests, having originally stated more than once that it did not.” She concluded that “situations like that diminish the public’s trust and confidence in PHE”.

PHE, it turns out, holds more than 10,000 Ebola blood samples in a UK biobank whose location remains secret but is most likely at Porton Down near Salisbury.

How were the samples shipped from Sierra Leone? “We’re not allowed to tell you,” says Dr Tim Brooks, the head of PHE’s Rare and Imported Pathogens Laboratory.

Dr Brooks says the samples were brought to the UK “so that they could be stored in a proper curated biobank system”, but that they belong to the government of Sierra Leone.

He admits that none of the people whose blood was taken gave their consent for research and the samples are still linked to the clinical and personal data of the patients. He says that research can be done “so long as you don’t have any way of identifying that person, who they were, where they lived”.

 Regarding the profits from any vaccine or medicine created with this research, Dr Brooks says this would be a question for the committee that approved the study, which includes the government of Sierra Leone. He adds: “I think it would be inappropriate to do anything more than to publish that in the open literature.”

While the British and French laboratories were working in their former colonies during the 2014-15 outbreak, the US was most active in Liberia, where it has been involved in medical research since the 1950s.

When the Ebola crisis hit, the US quickly dispatched a team to Liberia’s Institute for Biomedical Research (LIBR) from its Army Medical Research Institute of Infectious Diseases, a unit tasked with countermeasures against biological warfare.

Most of Liberia’s Ebola samples were stored at the LIBR until 2016, when they were spirited away to a high security laboratory in the US where they remain today.

During the epidemic, the US alone spent over £330 million on Ebola-related research and several patents have been filed using West African samples.

“Why do the United States hold Liberian samples?” asks Dr Stephen Kennedy, a researcher at the LIBR who was one of the first to conduct Ebola tests in Liberia. “It’s true we don’t have a BSL3 [high-security lab] but we could have stored and catalogued these samples until we got funders to build a BSL3.”

 “The whole thing was done in secrecy,” he says. And the agreements signed between Liberia and the US remain under wraps. In January 2017 Dr Kennedy and several colleagues met the Liberian Minister of Health to request that the samples be returned to Liberia – but without success.

“The samples have to return, they have to come back. There’s no question about that,” says Dr Kennedy.

One of the Ebola treatment centres funded by the UK during the 2014-15 outbreak in Kerry Town, Sierra Leone CREDIT: LOUIS LEESON/SAVE THE CHILDREN
One of the Ebola treatment centres funded by the UK during the 2014-15 outbreak in Kerry Town, Sierra Leone CREDIT: LOUIS LEESON/SAVE THE CHILDREN

“We took risks and we never benefited,” says a Liberian technician who drew over 1,000 samples of blood – knowing that a single drop could kill. “After the samples were collected, we were left out of the picture,” he says, speaking on condition of anonymity.

He was angry the samples were sent abroad. “The research that you’re going to do with these samples [abroad], should be done here so that the citizens of this country benefit from that research.”

Many scientists across West Africa only realised the importance of the samples after they had left their countries. Dr Sakoba Keita, who led Guinea’s fight against the virus and then became the head of the National Health Security Agency, says: “It’s only later on that we realized that they were of scientific interest … at the time of the epidemic, my focus wasn’t on that kind of question. For me, the concern was to stop the disease and its spread, and the death of my fellow citizens.”

 In 2017, he sent a letter to all the laboratories holding Guinean samples to reaffirm his country’s ownership over them and any benefits derived from them; not all replied, he said. He also requested that labs send updates on the research conducted with the samples, but few keep him informed.

While most researchers are now aware that research is conducted with these samples, the former patients are not. The Telegraph interviewed two dozen Ebola survivors in Guinea, Sierra Leone and Liberia, and none of them knew that their blood was being used for research – nor had they given their consent to it. None of the research institutes we contacted could provide written consent forms.

Nearly all survivors said that they would have preferred to be asked before their samples were used for research. Some said that they would have agreed, others would have refused.

Isaac Seeman, who nearly died of Ebola and lost his wife and three children to the disease, didn’t know his blood samples had gone abroad. “They didn’t ask for my consent. They didn’t ask for my approval … I wouldn’t have said no,” he says.

He would like to benefit if any products are made using his blood. “They are using it to make research, make billions of dollars … that medicine they produce will not be free. It will be something that you will sell,” he said.

“If it’s true there was no consent process, then it’s pretty bad, it’s unethical research,” says Dr Susan Hall, a researcher in bioethics at the University of Stellenbosch in South Africa.

 It’s generally “ethically unacceptable” agrees Dr Ruth Faden, the founder of the Johns Hopkins Berman Institute of Bioethics in the United States. Nevertheless, she said that the patient’s rights and interest have to be balanced with the potential benefits of the research to humanity as a whole.
Dr Sakoba Keita from Guinea contacted labs around the world to affirm his country's ownership of samples CREDIT: EMMANUEL FREUNDTHAL
Dr Sakoba Keita from Guinea contacted labs around the world to affirm his country’s ownership of samples CREDIT: EMMANUEL FREUNDTHAL

“The answer surely shouldn’t be, let’s not share our samples because if we can’t benefit, no one should benefit,” she argues. “There has to be another way, there has to be a way in which we all realise the shared interest that we have.”

Among the patients whose blood was exported without consent is a woman from Guinea whose sample is anonymised under the code C15.

She does not know that the Ebola virus isolated from her blood is advertised on the website of the European Virus Archive, for sale by Germany’s Bernhard Nocht Institute (BNI) at a price of €3637,38 for 0.5ml. That is 170 times the price of gold.

According to medical publications, she was about 30 years old at the time, living in a small town called Kissidougou in southern Guinea when in March 2014, she fell sick with a mysterious illness.

A team from the Guinean Ministry of Health was sent to investigate and they took blood samples from her and several others which they sent to the Pasteur Institute in Lyon and the BNI in Hamburg. Researchers here detected Ebola and raised the alarm.

“These viruses came from the very first specimens [around 20 samples] which were sent by Médecins Sans Frontières to us in Hamburg, in March 2014,” says Dr Stephan Günther, director of the BNI lab. “So we isolated the virus.… And this virus isolate was distributed to many many institutions around the world to make sure everyone who needs the virus can work with this virus.”

 Nevertheless, Dr Günther says that there was no genetic material from C15 in these isolates. The fee charged for the virus, he says, covers the production costs as well as a contribution to maintaining the high-security laboratory.

The virus isolated from the blood of C15 and others was exported to labs around the world, some of which cultivated the virus and shared it with other labs.

“The distribution of viruses to all labs requesting it has been usual practice for the past 100 years and there was nothing wrong about it,” adds Dr Günther in an email. But this changed on 12th October 2014 when the Nagoya protocol entered into force.

This agreement, ratified by 116 countries including the UK, guides how benefits derived from research on biological materials should be shared with their countries of origin. Although blood is excluded from the agreement because it is human genetic material, the pathogens contained within it are included.

 “Everyone knows it’s a holy mess. At the moment, it means all sharing [of samples] is on hold,” explains Dr Günther. But the virus swimming in the blood of C15 was exported before Nagoya came into force “so it means we are somehow on the safe side that this material we distributed does not fall under Nagoya.” The BNI stores 8,930 samples from Guinea but most of those have not been shared.

Isaac Seeman, Ebola survivor, did not give his consent for blood samples to be taken abroad CREDIT: EMMANUEL FREUNDTHAL
Isaac Seeman, Ebola survivor, did not give his consent for blood samples to be taken abroad CREDIT: EMMANUEL FREUNDTHAL

“There’s a huge backlash in Europe over their implementation of the law for the Nagoya protocol,” says Edward Hammond of the advocacy organisation Third World Network. “Scientists are very protective of their labs,” he says, and they don’t like having to account for the samples stored in their fridges.

Yet, he argues, the Nagoya agreement could be an opportunity to establish a more organised sharing of samples that ensures benefits flow back to the countries of origin.

Enormous stakes hang on the application of the protocol because valuable pharmaceutical products can be developed using pathogens collected in human blood. The vaccine against Ebola that is being used right now in the Democratic Republic of Congo – rVSV-ZEBOV – was developed with a strain of Ebola exported from the country in 1995.

Another Ebola vaccine, GamEvac-Combi, was developed using the genetic information of the virus isolated from the blood of C15. This vaccine is now being tested on 2,000 patients in Guinea in a lab built by Russia during the epidemic. A dozen scientists work there but it’s impossible to get in or talk with anyone.

“When you’re talking about the Russians, it’s a total blackout,” complained a high-ranking member of the Ministry of Health who preferred to remain anonymous.

But physical samples were not needed to develop the Russian vaccine, because the virus’ genetic sequence could be easily found on the internet, for free. Whether such information is covered by the Nagoya protocol will be hotly debated over the next few years – as will who should benefit.

*Source The Telegraph This story was financed by the European Journalism Center via its Global Health Journalism Grants for France programme

Share

Comments

comments

Leave a Comment

Your email address will not be published. Required fields are marked *

*