For ten years, Armenians have been told about the wonders of Armenicum, the locally produced formula whose makers claim it has curative powers over the deadly HIV virus.
And while doctors who use the drug say it does seem to relieve some of the symptoms of HIV, after a decade the company has yet to produce any viable clinical trials proving more substantive curing options.
What most Armenians probably do not know is that their tax dollars are paying for Armenicum, which is more than triple the cost of the world's only proven treatment for HIV, antiretroviral (ARV) drugs. They probably also are not aware that in a few months Armenicum may be the only choice available in Armenia for future HIV-infected patients.
In Armenia, treating HIV-positive patients should not be a major problem -- and on the surface, the system seems to be working. The HIV-positive population is small, with only 649 reported cases. Even when one includes the estimated 3,000 unreported cases out there, they still make up a mere 0.1 percent of the total population. Armenia does offer an efficient, government-funded National Center for AIDS Prevention, which not only records, but also offers testing and treatment to anyone who needs it, based on World Health Organization standards of care.
But instead of paying for all accepted treatments for HIV patients, the government is throwing all its money and resources towards supporting Armenicum, and is requiring that AIDS Center doctors offer the drug, while unproven, as a choice. Currently, it costs about $6,000 per patient per year to be treated with Armenicum, while the standard ARV regimen costs $1,700 per patient per year. That means it costs the Armenian taxpayer $300,000 to treat just the 50 Armenicum patients approved this year. Compare that to the estimated $160,000 it costs to treat 93 patients with ARV funded by the Global Fund.
So far, the international US-funded Global Fund, through the local World Vision office, has been paying for and procuring ARV treatments. But, technically, that money ran out in June, and though the grant has been extended until February and the National Centre for AIDS Prevention is currently applying for another five year grant, there is no guarantee that the Global Fund will continue to fund future ARV treatments.
"If the Global Fund does not finance Armenia again, the national HIV program will be in great jeopardy," said Mark Kelly, World Vision National Director. "Currently the Global Fund pays for the majority of testing and prevention programs, and all ARV treatments."
Compounding the problem, according to World Vision Procurement Officer Mher Barseghyan, is that ARVs are currently not a registered drug in Armenia and the government has so far been unable to pay the approximate $15,000 it will cost to register these internationally accepted drugs as "safe to import." Because the drugs are not registered, each shipment takes about six months to arrive in the country, from the hundreds of phone calls he must make to individual drug companies in an effort to convince them to send such small batches, to the months those boxes of ARVs spend sitting in customs aging to the point of expiration.
"Right now, we are managing to get treatment to everyone who needs it," he said. "But as the HIV problem gets worse, it will be more difficult to bring enough drugs into the country."
When Armenicum was first introduced in Armenia ten years ago, founders called it a "revolutionary cure for AIDS," and it immediately captured high-ranking government officials' interest. Early on, initial payments for Armenicum treatments came from the Defense Ministry, hoping to promote the drug's research and development. Armenicum's possibilities caused a buzz of excitement in the tiny country. Businessmen, it was reported in some newspapers in 1999, were buying up property so that they could rent it to all the people who would fly to Armenia to take the cure.
Yet a decade on, only about 800 people have actually taken Armenicum.
Worldwide, the most effective treatment for HIV are antiretroviral drugs, which in internationally accepted clinical trials have been the only proven way to keep patients alive, often for years. The drugs work by directly attacking and reducing the amount of HIV virus in the body, keeping the patient from developing Acquired Immunodeficiency Syndrome (AIDS), a complete immune system failure that leads to death. The drugs, offered in cocktails of three or four at a time, are often changed as the virus becomes resistant.
Alternatively, the makers of Armenicum, whose primary ingredient is iodide, claim it boosts the immune system, allowing the body to fight the virus. Armenicum clinic doctors also contend the drug has been shown to reduce a patient's viral load -- the amount of HIV virus in the body -- and that the HIV virus never becomes resistant to it.
The problem is that company scientists have never even tried to prove any of these claims -- at least, not according to the World Health Organization international standards of clinical trials that ARVs have passed. They admit to not even formally monitoring the 250 patients who have been treated with the drug in the past four years, though they contend "many" have lived for ten years using the drug.
"It's still experimental and we are in the middle of the testing phase," said Ashot Melkonyan, head of the Armenicum Clinical Center in Yerevan. "But when we are ready, we will show the world what we have."
Despite the lack of evidence supporting Armenicum's claims, the National Center for AIDS Prevention clinicians say they consider Armenicum doctors colleagues in the fight against HIV, and have supported anecdotal claims that some of their patients have responded well to the treatment.
"We are cooperating all the time, and we always discuss every case to find a better solution," said Dr. Arshak Papoyan, head of the National Centre for AIDS Prevention Epidemiology Unit.
But it's hard to find a doctor treating HIV patients who will be quoted publicly saying the drug doesn't work, some say, because the pressure for the Armenian-made drug to succeed is so high that criticizing it is not allowed.
"I know many clinicians who don't believe in Armenicum, but they are not allowed to say anything," said one doctor involved in the HIV treatment field, who refused to be identified. Even if the jury is still out on Armenicum, World Vision and Global Fund representatives say the most important thing is to make sure HIV patients have an informed choice between all the treatment options.
"We just want to make sure ARVs are available," said Kelly. "The most important thing is that every person living with HIV can be treated with ARVs if they choose."
Sara Khojoyan is a reporter with ArmeniaNow.com in Yerevan. Leah Kohlenberg is a journalist, trainer and editor of "This Month," a monthly collection of articles from Armenian journalists published by the IREX Core Media Support Program.