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.

Problems

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

As US Strikes Syria, China Sees Parallels at Home

Beijing is debating how much support to give international coalition against IS militants and trying to figure out how many Chinese nationals may have joined group overseas More

CDC: Ebola Could Infect 1.4 M by 2015

US health officials say if efforts to curb the outbreak are not increased, cases will soar dramatically by early next year More

Video USAID Provides $231 Million for Girls Education in 5 Countries

US Agency for International Development partners with celebrities to call attention to importance of education for girls worldwide More

This forum has been closed.
Comments
     
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.
Washington to Pyongyang: 'Shut This Evil System Down'i
X
Scott Stearns
September 23, 2014 10:52 PM
U.S. Secretary of State John Kerry is calling on North Korea to shut down prison camps and other human rights abuses following a United Nations Commission of Inquiry into "widespread and systematic human rights violations." VOA State Department Correspondent Scott Stearns reports from the United Nations.
Video

Video Washington to Pyongyang: 'Shut This Evil System Down'

U.S. Secretary of State John Kerry is calling on North Korea to shut down prison camps and other human rights abuses following a United Nations Commission of Inquiry into "widespread and systematic human rights violations." VOA State Department Correspondent Scott Stearns reports from the United Nations.
Video

Video US, Gulf Allies Strike Islamic State Militants in Syria

United States forces have carried out strikes against Islamic State or ISIL militant positions in Syria - the first time Western forces have taken action on Syrian soil. Five U.S. allies from the Gulf joined the military action. Local reports suggest dozens of militants were killed. The U.S. also carried out unilateral missile strikes against a Syria-based terror group which Washington says poses an imminent threat to the West. Henry Ridgwell reports from London.
Video

Video High Intensity Focused Ultrasound Used to Kill Cancer Tumor

There is a new way of killing certain cancer tumors that allows the patient to go home on the same day. Surgeons at the Keck Medical Center of the University of Southern California became the first doctors to use this procedure on a patient with the help of high intensity focused ultrasound, or HIFU, and new robotic technology. Elizabeth Lee reports from Los Angeles.
Video

Video USAID Provides $231 Million for Girls Education in Five Countries

Hollywood stars Alicia Keys, Jennifer Garner and 30 others have voiced their support for a U.S.-backed initiative called "Let Girls Learn." The $231 million program, funded by the U.S. Agency for International Development, is aimed at ensuring public and quality education for girls worldwide. As VOA's Mariama Diallo reports, this new program will focus on five countries in Africa, South Asia, Latin America and the Middle East.
Video

Video UN: Relocation of Bedouins in Israel Weakens Two-state Solution

Rural Bedouins living in disputed lands east of Jerusalem could soon find themselves forcibly relocated. VOA's Sharon Behn reports from Jerusalem that while Israel defends the move as in the Bedouins’ best interests, the United Nations says the plan threatens the survival of the two-state solution with Palestinians.
Video

Video NASA’s MAVEN Probe Enters Mars Orbit

NASA’s newest Mars probe, called MAVEN, has successfully entered its designated orbit around the Red Planet. Scientists will use its sophisticated instruments to try to learn what happened to the atmosphere Mars had a few billion years ago. VOA’s George Putic has more.
Video

Video Prolonged Drought Plagues SW Oklahoma Farmers

Parts of western Texas and southwestern Oklahoma have been in drought conditions for several years running and the deficit in rainfall has taken a heavy toll on cotton and grain production. Oklahoma Governor Mary Fallin says the state has suffered $2 billion in agricultural losses since 2011. There has been rain in recent weeks, but, as VOA’s Greg Flakus reports from Altus, Oklahoma, for most farmers it has been too late.
Video

Video For West Ukraine City, Conflict Far Away Yet Near

The western Ukrainian city of Lviv prides itself on being both physically and culturally close to Western Europe. The Russian-backed separatists in the eastern part of the country are 1,200 kilometers away, and seemingly even farther away in their world view. Still, as VOA’s Al Pessin reports, the war is having an impact in Lviv.
Video

Video Saving Global Fish Stocks Starts in the Kitchen

With an estimated 90 percent of the world’s larger fish populations having already vanished, a growing number of people in the seafood industry are embracing the concept of sustainable fishing and farming practices. One American marine biologist turned restaurateur in Thailand is spreading the word among fellow chefs and customers. VOA Correspondent Steve Herman reports from Bangkok.
Video

Video Chinese Admiral Key in China’s Promotion of Sea Links

China’s President last week wrapped up landmark visits to India, Sri Lanka and Maldives, part of a broader campaign to promote a new “Maritime Silk Road” in Asia. The Chinese government’s promotion efforts rely heavily on the country’s best-known sailor, a 15th century eunuch named Zheng He. VOA's Bill Ide reports from the sailor’s hometown in Yunnan on the effort to promote China’s future by recalling its past.
Video

Video Experts Fear Ebola Outbreak ‘Beyond Our Capability to Contain’

Each day brings with it new warnings about the deadly Ebola outbreak already blamed for killing more than 2,600 people across West Africa. And while countries and international organizations like the United Nations are starting to come through on promises of help for those most affected, the unprecedented speed with which the virus has spread is raising questions about the international response. VOA's Jeff Seldin has more from Washington.
Video

Video Migrants Caught in No-Man's Land Called Calais

The deaths of hundreds of migrants in the Mediterranean this week has only recast the spotlight on the perils of reaching Europe. And for those forunate enough to reach a place like Calais, France, only find that their problems aren't over. Lisa Bryant has the story.
Colonel Steve ‘Spiros’ Pisanos left Greece and came to the U.S. to learn to fly. He flew fighters for the Allies in World War II, narrowly escaping death multiple times.Colonel Steve ‘Spiros’ Pisanos left Greece and came to the U.S. to learn to fly. He flew fighters for the Allies in World War II, narrowly escaping death multiple times.

AppleAndroid