A clinical trial that isn’t

The sweet, tiny white pills that even the surliest of kids munches without a murmur of protest are now curing the world of one of its most deadly scourges: the HIV virus. Or so claim homoeopaths at a government-run homoeopathy hospital in Hyderabad.

In what they term as a ‘clinical trial’, a homoeopathy drug is being administered to people living with HIV (PLHIV) at the Jayasurya Potti Sreeramulu Government Homoeopathic Medical College and Hospital in Hyderabad. Doctors here are ‘treating’ over 10,000 patients and claim eight patients have already turned negative. They are awaiting procedural clearance to declare that they can “cure” HIV.

Meanwhile, the National AIDS Control Organization (NACO) will be initiating legal and administrative action against doctors for misleading 10,664 HIV patients — for conducting a clinical trial without registering it with Clinical Trials Registry — India (CTRI) and for not seeking permission from NACO.

Takers for the venom drug

The drug being administered is made out of the venom of the timber rattlesnake (Crotalus horridus) that is endemic to eastern United States. “The drug is not new and has been in use in homoeopathy for the last 200 years. It can reportedly be used to treat the Ebola virus as well as HIV and works by inhibiting the enzyme reverse transcriptase — which helps convert RNA into DNA — thus preventing multiplication of the virus,” explains Dr. S. Praveen Kumar, Principal of the medical college and the man behind the ‘discovery’. A team of doctors from the hospital and scientists from the Indian Institute of Chemical Technology (IICT), Hyderabad, held 16 meetings in two years and came up with a regimen for the drug with the latest guidelines of CD4 count (a predictor of HIV progression) of less than 500 as a benchmark.

Every Thursday, hundreds of patients line up for the pill and nearly a dozen junior doctors hand them their dose after noting down patient details, CD4 count and viral load (the amount of HIV in blood) from the reports. A total of 10,664 people have been registered for this experiment.

Some patients believe the drug is helping. “I have been on ART (Antiretroviral Therapy) for the last six years and started taking this medicine four months ago. I feel better, have a better appetite,” says Jatavath Ramu from Siddipet district in Telangana. Does he expect to get cured? “The doctors keep telling me every month that I will be cured soon,” he says wryly.

But here is the clincher: nearly 73% of these patients who think they are being ‘cured’ by homoeopathy are taking ART, which keeps the viral load down. The homoeopathy doctors ask the patients already on ART to continue the regimen while adding their pill to the treatment protocols.

Miracle drug or not?

How, then, does one determine that the drug is working? “The patient speaks of a general sense of well-being. We give medicines for opportunistic infections (like TB) and other small ailments as well. We noticed a definite fall in viral load. These are effectively clinical trials and we take consent from every patient and explain to them about the treatment regimen. It is a safe drug with no side effects,” claims Dr. Kumar. “But I consider CD4 count as deceptive and would rather consider the viral load as an indicator,” he adds.

The National AIDS Control Organisation’s (NACO) annual report for 2015, released last month, pegs HIV prevalence in Andhra Pradesh and Telangana at 0.66%. Undivided Andhra Pradesh and Telangana have the highest estimated number of PLHIV at 3,95,000.

While the ‘discovery’ was announced at the World Homoeopathy Summit in Mumbai in April 2015, the Telangana State AIDS Control Society (TSACS) — responsible for treatment of HIV patients — has not yet been taken into confidence. Additional Project Director, TSACS, John Babu refused to comment on the ‘cure’ saying “this is a serious matter that needs thorough discussion”. The TSACS is yet to follow up on a complaint filed by a patient, Hemalatha, alleging that her condition worsened after she was put on homoeopathy therapy.

Meanwhile, in Delhi, the NACO officials are initiating legal and administrative action against doctors involved in such ‘trials’. “These fraudulent claims are absolute rubbish. It is mandatory for them to get permission from us even before they start ‘trials’ on HIV patients and there has been no permission granted from NACO. Across the world there is no evidence of a cure for HIV. Patients cannot be turned negative by taking homoeopathy pills. We have informed State governments to take action against people making such claims — both legally and administratively. We will be initiating a police complaint against the institution and doctors involved,” said Dr. R.S. Gupta, Deputy Director General, NACO. He further added that the trial was not registered at the Clinical Trials Registry — India (CTRI).

But the seriousness and possibility of a legal case against them has not deterred the principal investigators. “There is nothing secret about our work. The formula is not secret; anyone can give it, provided they follow the regimen. The Commissioner, AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy), and the Principal Secretary (Health) are quite aware of what we are doing. We have always informed them about the research, the findings as well as the progress we have achieved,” asserts Dr. Kumar.

“We should have shared our experiments with them. We will now be taking steps to meet them across the table,” assures A. Rajender Reddy, State AYUSH Commissioner. “At this point, I would like to call it a treatment option rather than a cure. There’s still time for that announcement,” he adds.

Meanwhile, the homoeopathy clinic in Hyderabad still sees almost a thousand hopefuls lining up for the pills, their confidence boosted by the fact that the prescription is simple, the pills are sweet and there are no apparent side effects, unlike the toxic ART drugs.

Usha Turaga-Revelli is a freelance health journalist. With inputs from Vidya Krishnan.

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Printable version | Oct 14, 2021 1:48:12 AM |

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