|Thursday 20 July, 2000
Late last year BBC World Service science presenter, Helen Sewell, travelled to Armenia to uncover the truth about the so-called new wonder cure for HIV and Aids – Armenicum. After interviewing the scientists involved in administering the drug, the patients and even the drug's creator, her findings revealed the complex nature of the treatment and questioned its effectiveness. The resulting Discovery programme went on to win the Glaxo Wellcome Science Writer of the Year award for Best Science Radio Programme.
Here, Sewell presents her findings and offers you the chance to listen to the award-winning programme again.
I’m at the departure lounge at London's Heathrow airport, and it feels like I'm at the end of a long, long journey - although I haven't even started travelling yet. I'm about to board a plane to Armenia, to have a look at what's being hailed by doctors at a hospital there as a new wonder cure for HIV and Aids. But it's been a long, hard trek to get this far. I first heard about the drug, Armenicum, a couple of months ago. It's not had much publicity outside the former Soviet Union, because until very recently it's been kept a total secret by the Armenian government.
Dr Sergei Litvinoff of the World Health Organisation is one of the scientists I talked to before leaving for Armenia. As the Director of Infectious Diseases for the WHO in Europe, he told me the organisation supports any moves to try to eradicate HIV and Aids. But he says virtually nothing is known about the trials carried out in Armenia, or the results:
‘We don’t know very much about what is going on in Armenia. We have just rumours but we did not get any sort of official information on the issue. My question is whether their treatment with this Armenicum was also undertaken by other institutions or laboratories in different countries, or perhaps in neighbouring countries, - whatever, whether there is some sort of confirmation from other institutions on the efficacy of this drug. But as I told you that still repeat and repeat again we have not enough information, I would like to know more.’
Dr Joss Perriens, is the Team Leader in the Care and Support department of UNAIDS, the joint United Nations programme on HIV and Aids. He comments:
‘We know about the existence of the drug and we have seen some very fragmentary data of the drug but what we don’t know is what is in Armenicum. I would like them to tell us what’s in the drug. How it is characterised chemically, how the drug performs in the test tube. We have not been presented with toxicity data gathered in animals, how the drug is absorbed, how it is excreted, with what toxicity, when somebody claims that there is a cure for HIV it makes one a little suspicious. I think it’s casting the information in too optimistic a light.’
At the Armenicum clinic in Yerevan, a doctor is checking on one of his patients. The medical staff here, led by Dr Levon Makhatarian, are convinced about the power of Armenicum. Makhatarian outlines their aim:
‘Armenicum is highly effective in improving the patients’ quality of life. In particular it improves the most common symptoms like fatigue, weakness, malaise, sweating, itching, pain in the liver and gall bladder area, etc etc…we would never say that Armenicum is a cure for the disease - that would be tactless. Our aim is only to get a positive effect using this preparation.’
You’d never know from being here that all these people are infected with a virus, which is likely to kill them in the long run. They’re all highly optimistic that Armenicum will help. There are even two American patients here, David and Andre, who’ve flown in especially from San Fransisco.
David explains the treatment procedure:
‘Armenicum is simply transfused into you and it’s like a cleansing of the blood, three times a week for a week, and then you have 21 days off and then you return again. When Andre and I came here we were at the end of our tether. But this is so uplifting energy-wise that they’ve got something here, they’ve really have something.’
Andre explains how the treatment has affected him individually:
‘ For me it has been doing very, very well. My energy has increased dramatically; my total outlook on things has actually increased as well, mentally and physically. I’m told by friends all the time that I seem as though I’ve put on a lot more weight. And actually the physical evidence itself has been good.’
This whole experience is quite different from anything Andre or David has been through before. They are in an unfamiliar country and they know the whole procedure is experimental. Andre recalls the first time the bag of Armenicum solution was plumbed into his vein:
‘I remember David and I lying here in the beds next to one another when the infusion began and us looking up at these IV bags filled with this black solution that was just sort of creeping towards our veins and not knowing at all really what side effects we would have. That part was very scary. And then feeling the burning going into your veins. It was a very distinct burning sensation that went into your vein and all the way down the arm. And after about maybe an hour or so, two hours, feeling the fevers and the chills and almost going into a state of delirium at one point, with a really high fever. But then when it was all over, maybe three or four hours later, we just looked at each other and said, “How are you feeling?” And he’s like “Well I’m okay, is that it?”’
Although they’re full of hope that Armenicum will help keep their HIV under control, David and Andre are horrified at the clinic. The patients are locked in 24 hours a day. Many are friendly people, who’ve had really bad luck. Some have contracted HIV through blood transfusions. One girl here was raped. But I’ve been told that most people here are drug addicts and prostitutes, and the Armenians fear that if they’re allowed out, they’ll commit crimes or have unprotected sex with people in the town, and spread the disease. The patients stay in long, cell-like rooms with no soft furnishings. They sleep on narrow beds with thin mattresses. Luckily David and Andre have managed to escape for the night.
‘ First of all we were quite frightened by the clinical standards, which were very much below any standard in any professional medical place. The other thing was we were very secured in there, with armed guards with guns on their hips. We felt like caged animals. Generally there was no concern for the health of the patient. Only the concern of administrating the drug.’
‘We witnessed a case whereas no-one came in to take our temperature for the entire day after the treatment, yet at the end of the day a log appeared that showed that they had taken our temperature for every single hour for at least seven hours.’
Well, it’s day two here. Yesterday I met the patients and some of the doctors, and today I’m going to have a look at some of the science that’s going on.
Now HIV, the human immunodeficiency virus, kills people by attacking their immune system. The virus invades the white blood cells, the CD4 cells, which form one of our body's major lines of defence against disease. Once a virus penetrates a cell, its genetic material combines with the cell's own genetic material, turning the cell into a virus factory. When it has produced so much virus that it can't hold any more, the cell bursts and the new viruses are released into the blood stream to attack other CD4 cells. As the number of protective CD4 cells goes down and the amount of virus in the body goes up, a person with HIV will eventually develop Aids - which means their body can no longer protect itself against disease. And it’s these changes in viral load and CD4 count which doctors use to monitor their patient’s health. Here they’re comparing the CD4 cells with a similar type of cell called CD8.
I’ve put on a white coat now and come into the laboratory where the blood is just coming through for testing. I’m here with Tigran Davtyan, who is the head of the laboratory service here. Davtyan what’s happening at the moment?
‘Technicians separate fractions of serum, plasma and cells. And next step is testing of CD4 and CD8 cells, and next step is testing for viral load…CD8 and CD4 cells are testing in this room with this machine and this is not very good method for CD8 and CD4 count but is approximately show CD4 CD8 cells in patient…we know margins of error and can calculate real result…’
I don’t know many scientists who’d say you can use an erroneous testing method and still come up with the real results…But the CD4 count isn’t the only test needed to establish how far HIV is being kept under control. Back in his office, I ask Davtyan what criteria have to be fulfilled before he sends a patient away telling them that they’re better:
‘We never tell the patient that he is cured. We just tell them the laboratory results - whether their viral load is below 400. This test is not terribly accurate. There are more sensitive methods being developed elsewhere. I’ve heard that there is a test, which can detect as few as ten viral copies. We hope that we will soon get this machine, and then we could measure the viral load not only in plasma, but even in infected cells.’
You’ve admitted that your viral load test isn’t as accurate as it could be, you’ve admitted that your CD4/CD8 counting test isn’t as accurate as it should be, you’ve tested only 140 patients in clinical trials - yet nowadays the standard would be hundreds of patients. How can you be sure that this medicine is having any effect whatsoever?
‘The clinical trial is first of all scientific work - research, an exploration. And in this field, even if the method is poor, and has some errors, if you see a change between before and after the experiment, then you will see a real dynamic, and that shows you that something is happening.’
What Is Armenicum?
Since coming here, I’ve managed to find out a bit about what’s in Armenicum. But only a bit. Its main component is iodine - which is a pretty basic antiseptic. It’s also got some unspecified ‘natural’ compounds, and they’re all dissolved in saline solution.
Maybe the man who invented the drug will tell me more. When I first got here the Armenicum company refused to let me meet him. They wouldn’t even tell me his name. But then someone let it slip in conversation. Alexander Ilyen has been developing Armenicum since Soviet times. He’s never given an interview - until now…
‘When the preparation is injected it never destroys the cells - the healthy cells. Because it has the specific ability to recognise anything foreign - foreign substances - and by this I mean the virus.’
Once the virus gets into the cell it combines with the cell’s own genetic material, so how can your drug act against the virus when the virus is already part of the human being?
‘Well, as I already said, Armenicum has specific abilities to recognise the virus, and I believe that when the virus has infected the cells, it does not become part of the human genome.’
Have you found a cure for HIV?
‘At the moment it’s premature to say it’s a cure. I’m very careful about the results we have achieved. But I’m convinced that we will prove that we can cure HIV.’
That’s the most positive statement I’ve heard so far, the other scientists maintain it’s just a treatment. Anyway, my quest for information continues and my search takes me to the National Academy of Sciences, to meet the director of Armenia’s Drug and Medical Technology Agency, Emil Gabrielian, who’s closely involved with the Armenicum project. His version of how the drug works seems slightly different:
‘It has no specific action, it has a more general action. Now in medicine is used many antiviral drugs against HIV. They have specific actions. It acts more generally, like acts iodine outside of the organism. So it developed antiviral, antibacterial and immunostimulating actions.’
Gabrielian explains how current drugs, which act against specific parts of the human immunodeficiency virus, tend to fail as the virus develops resistance towards them. But with Armenicum, he says, the lack of specific action means no resistance can develop. He says more time is needed before the final results of the clinical trials can be assessed, but he hopes that the drug will be properly evaluated, both by scientists and the press. He adds that he can’t tell me everything - it’s his secret and he has an agreement with the scientific organisations, but promises that as soon as the results are ready he’ll let me know.
|I’m convinced that we will prove that we can cure HIV |
I think I’ve learned all I can here. It’s time to fly home. But what should I make of this drug? The science isn’t quite what I’d expected. But the patients say they feel better, although the chief doctor admits there’ve been no tests to rule out whether this could be psychological - a placebo effect. This is important, because they’ve just built a brand new hospital and they’re about to start treating paying patients. I asked repeatedly about the cost of treatment, after hearing rumours it’ll be thousands of dollars, but they refused to tell me.
How Effective Is Armenicum?
So my plane’s just about to take off and I’m going back to Britain to find out what the experts make of the information I’ve been give and to see how they feel about the million or so people whom I’m told are waiting for this treatment.
Dr Sergei Litvinoff from the World Health Organisation comments:
‘Frankly speaking I am very much concerned. Put yourselves in the shoes of one of them. You’re full of expectation. But we don’t know what we expect. I’m afraid that if it’s true that one million people are full of the expectation that in nearest future they will get the very effective treatment…and they will not get it, how you would feel? I’d feel very badly. So that I would prefer not to have this huge line of the people full of the hopes, but first to get the convinced results of the effectiveness of the drug, and after that to deal with the numbers of the patients which required some treatment.’
Meanwhile the high level of secrecy surrounding Armenicum worries Dr Joss Perriens of UNAIDS:
‘Compared to what we are used to from Western pharmaceutical companies the amount of information that the Armenians are willing to disclose at this very advanced stage, at which a significant number of people are being treated with this drug in an efficacy evaluation is more than what you expect. The amount of secrecy we encounter here is unusual.’
Exacerbating The Disease
There are concerns that far from being an effective treatment against HIV, Armenicum could actually exacerbate the disease. Dr Manfred Dietrich of the Institute for Tropical Medicine in Hamburg, Germany, carried out blood tests on one of the first patients to be treated with the drug. The Armenian laboratories reported a reduction in viral load and an increase in CD4 cells. But Dr Dietrich found a high viral load and a low CD4 lymphocyte count. He’s worried that Armenicum could have a short-term immune stimulating effect without killing the virus. And that, he says, could be dangerous.
‘Since we saw high numbers of virus in the blood, it did not have any anti retroviral effect. We know that stimulated lymphocytes may be prone to be infected by virus much easier than other, lets say more resting lymphocytes. I would not recommend at all to take such a drug.’
I’m not the only one back from Armenia. The American patients too have returned home. David, who picked up a gut parasite during his time in Armenia, says he’s been in agony since his trip. But there’s much worse news. David has had his blood monitored by his own doctors since starting to take Armenicum in September. His latest results show that the virus has taken hold in his body again. He’s badly infected and his immune system is failing.
‘The treatment hasn’t done anything and it’s actually…we’re in a worse state than we were before we went. What we’re getting is the T-cell count is so low it’s in the danger level of 42. That means that you’re susceptible to opportunistic infections, which one wasn’t before. Emotionally it’s a very hard thing to deal with. It was sort of the last resort.’
| TV Report
|In July 1999 The Armenian National Television broadcast a program looking at Armenicum. It included an interview with Armenia's chief infectionist Levon Mkhitarian. He told about the patients' health condition and described the treatment as follows:
‘One course of treatment with Armenicum may include three to ten injections depending on the stage the disease has developed. Such a course of treatment fully makes up for the immunodeficiency in the organism and simultaneously remedies all other negative phenomena caused by the virus. Sores heal up soon, voice and breathing get restored, etc.. All patients using Armenicum say they can feel great changes after receiving injections so that they feel a strong desire to walk, run and simply live on.’