AIDS activists in Thailand are seeing red over claims that a product called V-1 Immunitor can be used to treat HIV infection.
V-1, made from the blood of HIV-infected people, has been approved only as a food supplement in Thailand. But Immunitor, the company that makes it, says it not only helps people with AIDS live longer, but may prevent HIV and even hepatitis infection.
A row is now raging in the pages of the peer-reviewed journal HIV Clinical Trials, which has published two studies on V-1. But in letters in the latest issue, doctors and Thai AIDS organisations question the claims made about V-1. They fear the journal is lending credibility to an unproven treatment. Worse still, they say, V-1 is diverting attention from the anti-retroviral drugs that have slashed AIDS deaths in the West, cheap versions of which are now becoming available in Thailand.
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鈥淚 had hoped that V-1 would die a natural death,鈥� says Paul Cawthorne of M茅decins sans Fronti猫res, author of one of the rebuttal letters. 鈥淣ow I see the new reports and the new claims they are making, and alarm bells are ringing.鈥�
The battle is the latest twist in the strange history of V-1. The pills were invented by a pharmacist named Vichai Jirathitikal, financed by an ex-police general and have been touted in ads in Thailand for over a year. V-1 has even been doled out to thousands of HIV-positive people at venues such as soccer stadiums.
鈥淲e were giving it for free to 40,000 people,鈥� says Aldar Bourinbaiar, a colleague of Vichai鈥檚 who helps run the Ban Ban Pakong clinic near Bangkok where the pills are dispensed. 鈥淲e ran out of money so we now ask patients to contribute a minimum $20 a month for pills.鈥� He claims that Immunitor makes no profit from the sales.
The clinic hasn鈥檛 been so generous with information about V-1. Last year, Vichai told Time magazine the pills contained magnesium, calcium and 鈥渘on-living chemical matter鈥�. Bourinbaiar now says the pills contain heat-inactivated HIV from the blood of patients at his clinic, treated by a 鈥渧ery unique technique鈥�, which Immunitor is patenting and won鈥檛 discuss. In recent press releases, Immunitor calls V-1 an 鈥渆xperimental, polyvalent AIDS vaccine鈥�.
In one HIV Clinical Trials paper, Vichai and Bourinbaiar report on 40 HIV-positive patients who took the pills for three months. They claim that on average the patients gained weight and had higher numbers of CD4 immune cells, which are killed by the virus. In a separate letter, they claim that 53 AIDS patients lived at least 5 weeks longer than 64 others who declined the treatment.
Cawthorne and his colleagues say the papers don鈥檛 prove anything. They point out, for example, that only 24 patients actually had a CD4 cell increase. And while the average count was up, there is no breakdown on individual counts, which makes it impossible to determine how many patients showed a significant increase.
In a separate letter, Caroline Sabin of the Royal Free and University College Medical School in London says the survival study also has obvious flaws. Since the people taking V-1 were self-selected, they might also have been healthier and sought other treatments more actively. That alone could explain the differences in longevity.
Indeed, last year the Thai government said its own tests showed V-1 had no effects. What鈥檚 more, immunologist John Moore of Weill Medical College in New York City says trials of other forms of inactivated HIV haven鈥檛 revealed any benefits. 鈥淭hese patients have plenty of virus already,鈥� says Moore. 鈥淓ating more isn鈥檛 going to help.鈥�
Bourinbaiar claims his opponents want to discredit home-grown cures and make Thailand dependent on foreign drugs. His clinic has made great play of the publications, running ads touting the foray into the scientific literature, and another congratulating two patients at their clinic who apparently went from HIV-positive to HIV-negative. 鈥淚n essence they are telling people they are curing AIDS,鈥� says Cawthorne.
But Bourinbaiar disagrees: 鈥淚f you view the ad as a legal document there is no claim whatsoever that V-1 is a cure or being claimed as a cure. Obviously, if one reads this ad with the background local knowledge, the association may occur in a reader鈥檚 rich imagination.鈥�
Maurice Staquet, the editor of HIV Clinical Trials, says he does not regret publishing the Immunitor data. But he admits he was unfamiliar with V-1鈥檚 history and will provide that information to future reviewers.
They may need it. Bourinbaiar plans to start investigating whether V-1 can prevent healthy people contracting HIV, and also claims to have evidence that V-1 can treat hepatitis.