News / Africa

Africa Urged to Increase Monitoring of Drug Trials

New drugs must be tested before they can be sold. Ethical testing requires what’s called 'informed consent,' which means the participants must not only agree to take part but also have a real understanding of the procedure. But some of those tests, or clinical trials, have come under criticism. Some pharmaceutical companies have been accused of exploiting the test subjects, who may not understand how the process works.

A number of international documents set ethical standards for drug trials, including the World Medical Association’s Declaration of Helsinki and the WHO’s Good Clinical Practice Guidelines. They stipulate that medical experiments with human subjects must uphold the highest respect for the rights and welfare of study participants.

Some drug companies say they do meet ethical standards. For instance, the U.S.-based Pfizer company has its own guidelines. They include allowing independent ethics institutions to validate the process before the trials begin and obtaining informed consent from trial subjects. They also call for limiting risks as much as possible and guaranteeing healthcare for participants who emerge with complications.


But the international guidelines and strong ethical frameworks are not mandatory.

Critics point to controversies that they say involved wealthy Western drug companies and poorly informed subjects. An official in Cameroon’s Ministry of Health who wished to remain anonymous said researchers testing new drugs in the country have sidestepped both national and international guidelines.

Health care activists want to be sure all participants understand what's involved in a drug trial
Health care activists want to be sure all participants understand what's involved in a drug trial

One case in 2005, an antiviral AIDS medication, made headlines around the world, and other clinical trials have led to abuses as well.

In that case, ethics violations in Cameroon put an end to clinical trials for tenofovir, an antiviral AIDS medication that was being developed by the U.S. pharmaceutical company Gilead Sciences. Among other complaints, French-speaking trial subjects were given questionnaires written in English. Critics say the company was using Cameroonians as guinea pigs for profit-making.

Reasons for Testing

Until about 1995, most clinical trials were conducted in Europe, the United States and Japan. Today experts estimate that more than 100,000 trials are conducted in different countries every year, with 10 percent of them in the developing world and one percent in Africa.

There are several reasons why drug companies are relocating clinical trials.

Some researchers note that to obtain valid and timely results from HIV trials, the companies must test people in areas with high rates of infection. They also say the genetic variability of HIV requires that candidate vaccines be tested in different areas of the world where different strains are present.

Dr. Mona Khanna of  the University of Illinois College of Medicine, says for the drug companies, there’s also a large number of willing participants.

"I think the reason so many clinical trials are being done in Africa is because they have a lot of people," said Khanna. That’s the first thing. So you can find many men, women and children, whatever you need, very quickly. They also have low cost. In other words, for companies to conduct trials in the US there’s a lot of cost associated with it, whereas in Africa, you go and set up a clinic; it’s much less cost."

Sonia Shah, author of the book Body Hunters, says many subjects are not aware of the procedure, or their rights, thus reducing the risk of expensive litigation.

Critics say many subjects also do not understand the rules of the trials: literacy rates are low, written agreements are misunderstood and many come from cultures that accept authority without question. In some cases, subjects are pressured into the trials by local committees, some which may receive pay from the companies. They may also feel they can not quit a clinical trial because they or their children would lose out on good health care or treatment.

Calls for change

One of those advocating change is Professor Ames Dhai, director of the Steve Biko Center for Bioethics in Johannesburg and a lecturer at Witswatersrand University. She says Africa must stop blaming the West and assume responsibility for monitoring the trials.

"I think we need to blame ourselves if nothing is changing," said Dhai, "and I think it’s time we stopped blaming the West and started looking at ourselves and how we can approach the issue. We all spend a lot of time looking at informed consent, regulatory and administrative issues. But we don’t spend enough time looking at justice in terms of what’s going to happen after the trials – have our populations been exploited in the process of research?"

Dhai mentions poor governance, corruption, conflicts, illiteracy and lack of knowledge about drugs as factors contributing to the inability of many African countries to review the proposals and monitor the trials.

Dr.  Mona Khanna of the University of Illinois says African countries must set up effective ethics committees and establish sanctions.

"If there are no penalties associated with enforcement," she said, "people will do whatever they want to do. If the local authorities or regulatory bodies find companies that are doing ABC or D, you have to fine them or tell them [they] can never come back."

Author Sonya Shah says African leaders should introduce legislation requiring drug trial funders to contribute to local scientific research with medical equipment and programs that would benefit communities.

Others say because the US Food and Drug Administration lacks the resources to monitor overseas trials, countries should form their own ethics committees to ensure drug testing benefits the communities involved.

They also say some procedures could be changed.

Today, many test a new drug against a placebo, a treatment known to be ineffective. That’s cheaper for the companies, but patients taking placebos are not receiving any treatment. Critics say a better idea would be to replace a placebo – when possible -- with an older or less effective drug. At least that way, they say all of the subjects will get some type of treatment that may benefit them.

But even critics like Professor Khanna agree that the trials, when scrutinized more effectively, can help advance the fight against HIV, malaria and other diseases on the continent.

Today Africa is one of the biggest beneficiaries of free and discounted medicines from the West. The Global Fund for the Fight against HIV/AIDS, Malaria and TB, and the U.S.-backed President’s Emergency Plan for AIDS Relief (PEPFAR) are among several programs working to ensure that Africans get medication at affordable rates.

You May Like

Syrian Rebels Poised for Anti-Russia Collaboration

Forty-one insurgent groups issue joint statement vowing retaliation for Russian air offensives More

Political Maneuver Revives Export-Import Bank's Chances

Parliamentary tactic gets bill out of committee, but it faces opposition in the Senate More

Beijing Warns US on S. China Sea Patrols

Warning follows news reports Thursday that US military is planning to sail warships close to artificial islands Beijing has been aggressively building More

This forum has been closed.
There are no comments in this forum. Be first and add one

Featured Videos

Your JavaScript is turned off or you have an old version of Adobe's Flash Player. Get the latest Flash player.
House Republicans in Chaos as Speaker Favorite Withdrawsi
Jim Malone
October 09, 2015 12:32 AM
The Republican widely expected to become the next speaker of the House of Representatives shocked his colleagues Thursday by announcing he was withdrawing his candidacy. The decision by Majority Leader Kevin McCarthy means the race to succeed retiring Speaker John Boehner is now wide open. VOA National Correspondent Jim Malone reports.

Video House Republicans in Chaos as Speaker Favorite Withdraws

The Republican widely expected to become the next speaker of the House of Representatives shocked his colleagues Thursday by announcing he was withdrawing his candidacy. The decision by Majority Leader Kevin McCarthy means the race to succeed retiring Speaker John Boehner is now wide open. VOA National Correspondent Jim Malone reports.

Video German, US Officials Investigate Volkswagen

German officials have taken steps to restore some of the reputation their car industry has lost after a recent Volkswagen diesel emissions scandal. Authorities have searched Volkswagen headquarters and other locations in an effort to identify the culprits in the creation of software that helps cheat on emission tests. Meanwhile, a group of lawmakers in Washington held a hearing to get to the bottom of the cheating strategy that was first discovered in the United States. Zlatica Hoke reports.

Video Why Are Gun Laws So Hard for Congress to Tackle?

Since taking office, President Barack Obama has spoken out or issued statements about 15 mass shootings. The most recent shooting, in which 10 people were killed at a community college, sparked outrage over the nation's gun laws. But changing those laws isn't as easy as many think. VOA's Carolyn Presutti reports.

Video Hungary Criticized for Handling of Refugees

Amnesty International has accused Hungary of breaking multiple international and European human rights laws in its handling of the refugee crisis. As Henry Ridgwell reports, thousands of migrants and refugees continue to travel through the Balkans to Hungary every day.

Video Iraqi-Kurdish Teachers Vow to Continue Protest

Sixteen people were injured when police used tear gas and rubber bullets to disperse teachers and other public employees who took to the streets in Iraq’s Kurdish north, demanding their salaries from the Kurdish Regional Government (KRG). VOA’s Dilshad Anwar, in Sulaimaniya, caught up with protesting teachers who say they have not been paid for three months. Parke Brewer narrates his report.

Video Syrian Village Community Faces Double Displacement in Lebanon

Driven by war from their village in southwestern Syria, a group of families found shelter in Lebanon, resettling en masse in a half-built university to form one of the biggest settlements of its kind in Lebanon. Three years later, however, they now face being kicked out and dispersed in a country where finding shelter as a refugee can be especially tough. John Owens has more for VOA from the city of Saida, also known as Sidon.

Video Bat Colony: Unusual Tourist Attraction in Texas

The action hero Batman might be everyone’s favorite but real bats hardly get that kind of adoration. Put more than a million of these creatures of the night together and it only evokes images of horror. Sarah Zaman visited the largest urban bat colony in North America to see just how well bat and human get along with each other.

Video Device Shows Promise of Stopping Motion Sickness

It’s a sickening feeling — the dizziness, nausea and vomiting that comes with motion sickness. But a device now being developed could stop motion sickness by suppressing certain signals in the brain. VOA’s Deborah Block reports.

Video Making a Mint

While apples, corn, and cranberries top the list of fall produce in the US, it’s also the time to harvest gum, candy, and toothpaste—or at least the oil that makes them minty fresh. Erika Celeste reports from South Bend, Indiana on the mint harvest.

Video Activists Decry Lagos Slum Demolition

Acting on a court order, authorities in Nigeria demolished a slum last month in the commercial capital, Lagos. But human rights activists say the order was illegal, and the community was razed to make way for a government housing project. Chris Stein has more from Lagos.

Video TPP Agreed, But Faces Stiff Opposition

President Barack Obama promoted the Trans-Pacific Partnership on Tuesday, one day after 12 Pacific Rim nations reached the free trade deal in Atlanta. The controversial pact that would involve about 40 percent of global trade still needs approval by lawmakers in respective countries. Zlatica Hoke reports Obama is facing strong opposition to the deal, including from members of his own party.

Video Ukranian Artist Portrays Putin in an Unusual Way

As Russian President Vladimir Putin was addressing the United Nations in New York last month, he was also being featured in an art exhibition in Washington. It’s not a flattering exhibit. It’s done by a Ukrainian artist in a unique medium. And its creator says it’s not only a work of art - it’s a political statement. VOA’s Tetiana Kharchenko has more.

VOA Blogs