TEN YEARS ON, ARMENIA’S SO-CALLED "MIRACLE CURE" FOR AIDS STILL UNPROVEN
By Sara Khojoyan and Leah Kohlenberg

EurasiaNet
Nov 25 2008
NY

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."

Editor’s Note: 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.