June 8, 2010


Thousands of babies with HIV/AIDS face the risk of death due to a pharmaceutical plant closing during a rise in demand for medication.

Bristol-Myers Squibb is shutting down a plant in France this month - the only one that produces of a pediatric HIV/AIDS medication approved by the World Health Organization.

The closing creates a medicine shortage that threatens the lives of 4,000-7,000 babies living in developing countries according to UNITAID.

The European non-profit organization, which distributes HIV/AIDS medications in developing countries, publicly released a letter written to Bristol-Myers asking the company to outline steps it will take to avert interruption of treatment.

“We’re concerned for the children’s lives,” said Daniela Bogozzi, from UNITAID communications. “They depend on it.”

It is very dangerous to change the treatments a baby is receiving for HIV and AIDS, said Bogozzi. It is important that they stay on the same drugs and not switch to another, she said.

Bristol-Myers took precautions to avoid a disruption in medication availability by raising production to twice the 2009 demand in expectation of the plant closing, said Sonia Choi, Bristol Myers Squibb communications director for HIV/AIDS.

“We looked at the inventory that was necessary historically and planned against that,” said Choi. “The supply strain that we are under right now is a result of an unforeseeable and significant demand for Videx,” a drug for infant HIV/AIDS.

“We are still trying to identify where the demand is coming from,” said Choi.

“They shouldn’t have been caught by surprise,” said Douglas Foster, a Northwestern University journalism professor who has reported widely on South Africa. “They should know how many patients are being treated with their medications.”

Foster said it is well-known by physicians, nurses and politicians in Africa that there is a rising need for the medication based on birth rates. U.S. government policy in 2002 pledged to raise funding for HIV and AIDS medications in developing countries, he said.

Bristol-Myers, based in Princeton, New Jersey,  plans to open a new plant in Europe to produce the medication, Videx, in 2011, Choi said.

Videx is a second-line drug, didanosine, used to treat infants with HIV/AIDS. Second-line drugs are given to patients after primary medications fail to produce results.

“We have, as a company, become a more focused biopharmaceutical company and as part of that, we’ve looked at our manufacturing network and have found inefficiencies,” said Choi.“And so we have moved manufacturing from certain sites to others to be more efficient.”

The World Health Organization has prequalified only Bristol-Myers’ as the manufacturer of 25 mg and 50 mg Videx tablets and hasn't approved any generic drug manufacturers, according to Bogozzi.

“We only buy medications prequalified by WHO,” said Bogozzi. She said this is the policy of many NGO’s for safety reasons.

Generic manufacturers need to apply to WHO to get on its list of prequalified drugs and both sides agree this should be done.

“We’re having a look at who else manufactures the generic drug and encouraging them to apply for prequalification,” said Bogozzi. “We will also encourage WHO to speed approval of the generics.”

“We hope that the generic alternatives are taking the appropriate steps to receive that prequalification,” said Choi.

Choi said Bristol-Myers is taking the matter very seriously and realizes this is a chronic condition that the babies face. She said the company is working to ensure agencies put newly-diagnosed infants on alternative drug treatments; and use the sparsely available Videx efficiently and appropriately for those already on the drug.

“We as a company take the concerns of UNITAID very seriously we're committed to working with all stakeholders to ensure pediatric patients remain on treatment,” said Choi.

New studies on the risks associated with perceptions and behaviors regarding the AIDS pandemic in Nigeria were unveiled May 24, at Northwestern University.

Through a four-year collaborative research effort funded by the Bill and Melinda Gates Foundation, Northwestern’s Research Alliance to Combat HIV/AIDS, known as REACH, and the University of Ibadan, Nigeria studied strategies to end the country’s AIDS pandemic and released an interim report on the findings.

“Changing people’s habits is hard,” said Jay Walsh, vice president of research at Northwestern University. “We all like change in others but not in ourselves.” He said this change is needed to bring an end to HIV transmission.

The problem

According to a United Nations General Assembly Special Session country progress report, nearly 3 million Nigerians are living with HIV/AIDS in 2009 – the second largest infected population after South Africa.

The number of people living with HIV/AIDS is on a continual rise. Reports from UN AIDS and the World Health Organization, UNAIDS/WHO, show 2.2 million Nigerian people were affected in 2001 and rose to 2.6 million by 2007.

The number of children orphaned due to the virus is a rising statistic that has nearly doubled to 2.2 million from 2007 to 2009, those same reports indicate.

The perceptions

Fear is a factor in social perception of AIDS.

“There is a stigma associated with walking into a clinic for testing,” said Layi Erinosho, president of the African Sociological Association. “Most people getting tested believe they have HIV. They are surprised when they find out they don’t.”

The REACH/Ibadan interim report indicated that among respondents, over 86 percent of those never tested thought they would die soon if they were diagnosed with HIV.

Lack of education is a problem.

The interim report indicated only 49 percent of Nigerians know condoms prevent transmission of HIV/AIDS and 69 percent know where a testing center is located.

More women than men lacked awareness of testing and counseling centers, and those with higher education are more likely to complete HIV counseling and testing according to the REACH/Ibadan research.

The women

 The UNGASS report indicates more women than men are diagnosed with HIV and die from it.

“We need to focus more on gender equality programs,” said Gbenga Sunmola, research coordinator for the National Agency for the Control of AIDS, Nigeria. He said women are disproportionately at risk because they are expected to be passive and not reject their partner.

The REACH/Ibadan report shows nearly 65 percent of all respondents did not get tested during their most recent pregnancy (within prior three years).Only 27 percent of pregnant women in the study got tested for HIV/ AIDS and returned for the results.

The researchers concluded: Addressing the key social and economic factors that disproportionately affect women is fundamental to addressing HIV and AIDS. Issues that affect women and girls need to be specifically addressed to increase HIV knowledge among women, support their ability to negotiate safe sex, and economically empower them to reduce transactional sexual activities.

The cost

Treatment prices are rising because of the growing number of African patients needing to be put on different combinations of drugs as a result of drug resistance according to the REACH/Ibadan report.

“The cost for HIV testing is about $4.60,” said Erinosho. “That’s too expensive in a country where people make less than $2 per day.”

In 2003, President George W. Bush founded the President’s Emergency Plan for AIDS Relief . This was the largest source of funding to combat global AIDS. Recently, President Barack Obama has leveled off funding through PEPFAR, which is resulting in inadequate resources to stave the growing epidemic.

The Kaiser Family Foundation reported the United States will fund $5.1 billion for bilateral activities in PEFPAR-supported countries in 2011. It also allocates $1 billion for the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund), a 5 percent decrease from 2010 funding levels. Most of this is used to fund antiretroviral drugs.

The fix

The research by REACH and the University of Ibandan concluded the following are the best ways to take action to change the social barriers blocking the successful eradication of HIV/AIDS from Nigeria:

• Rapidly increase the number of persons tested – 35 percent of those studied had ever had an HIV test.
• Provide earlier treatment to those infected – early introduction of antiretroviral drugs reduces the ability to transmit the virus.
• Design policies to target those not being tested – rapid testing methods and traveling clinics could make such programs feasible.
• Engage Nigerian communities in collective preventative action – active support of communities is vital to success.
• Devise appropriate use of material incentives – no major public policy initiative can succeed without appropriate incentives.
• Reduce ignorance of AIDS and combat stigma more effectively – ignorance is AIDS greatest ally, education causes more testing.


“We will make a lot of progress if we have transparency and good governance,” said Sunmola. The researchers hope this collective data will be integrated into new AIDS policies being developed in Nigeria.

A change in social behaviors and perceptions within the country is necessary to success.
“Communities know more about their needs than outsiders,” said Sunmola. “Community is very strong in times of social change.”