US halt to plasma therapy brings a severe jolt to treatment plans...

US halt to plasma therapy brings a severe jolt to treatment plans in India

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New Delhi: The US Food and Drug Administration (FDA) has put on hold an emergency authorisation for blood plasma arguing that emerging data on the treatment is too weak, raising concerns for countries like India which are going big on plasma therapy, experts say.

Amar Jesani, editor of the Indian Journal of Medical Ethics, said that the therapeutic effectivity of the therapy has to be established through clinical research. “So far there is no evidence providing that evidence,” he told ET.

Many states and hospitals have not only backed the therapy but have set up plasma banks as well. For example in Maharashtra, Delhi and Haryana doctors have been prescribing therapy for the moderate patients. To assess safety and efficacy of plasma therapy, the ICMR had in April sought participation in the randomised controlled study.

While ICMR is yet to publish the results, those familiar with the preliminary results say that it has not shown promising results, as reported earlier by ET and believe that ICMR should come out clean on the issue.

“There are many recommendations by ICMR that are based either on hope or the premise that even if it doesn’t work it does no harm. However, the correct approach is to test the hypothesis and if it is proven that it doesn’t work they should be brave enough to reverse the recourse,” said an epidemiologist.

The study on plasma therapy (PLACID trial) by the Indian Council of Medical Research (ICMR) is still ongoing, and the results will be shared on completion of the study, a senior official of the ICMR said. The sample size for the study is 452. “The clinical trial started way back in April in India and today we are in Aug. I am amazed at this that the data has still not come,” Jesani further said.

The ambiguity, experts say, is helping the private hospitals that are prescribing it claiming that it is a magic bullet. “Private players are trying to say it works and they are making money whereby they are putting undue pressure to opt for this expensive therapy.

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As a scientific community, ICMR should be brave enough to accept that the therapy doesn’t work and stop the hospitals from prescribing it,” said another epidemiologist, on the condition of anonymity.

Adding, that the US FDA’s review on the therapy should be a wake up call for India, which is blindly following it. The authorization by the US FDA has been put on hold as more data is reviewed, according to the clinical director at the National Institute of Allergy and Infectious Diseases.

Several top health officials — led by Dr. Collins, the director of the National Institutes of Health; Dr Fauci, the government’s top infectious disease expert; and Dr Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic. They thought the study’s data to date was not strong enough to warrant an emergency approval.





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