User driven learning conversational outcomes(UDLCO) of Unethical Conduction of Adult BCG Revaccination Trial All over India(except 5 states)

[19-06-2024 19:07]R: Hi G! I have been looking into the adult BCG vaccination recently, and here's what I have come across in the consent forms that feels more than mildly unethical:

1. The consent "form" is in the form of a book, ie, the patient information sheet is the first page, and the consent is basically taken as a list of signatures.

2. There is no pre-vaccine AFB smear/ follow up. If it is a trial, how do they intend to find efficacy? 

3. There is no mention of AEFI monitoring.

4. The rates of AEFIs are mentioned, but a lot of literature shows that revaccination has increased risk of AEFIs, which is not conveyed to the participant/beneficiary.

[19-06-2024 19:09]R: I am yet to read up the SOP on adult BCG vaccination, but all of this seems shady. And all of this is on paper.

[19-06-2024 19:10]R: My centre has refused to start the trial, but I hear adult BCG is going on full swing all over Delhi. 

Are your centres doing it @P ?

[19-06-2024 19:19] P: My centers are not doing it but ASHAs in my area are taking people for it

[19-06-2024 19:20] P: The SOP is shait 

In one place it says 30% efficacy and in other 50%

[19-06-2024 19:23] G: Agreed @R . It is more than a little shady in more than a few ways. I discovered that this trial was going to happen from my friend who is an ASHA worker in  pretty much the way the comic details. I started digging and the things I found I was sure I was missing something. But after talking to a few people involved with TB in India, most have said that they have expressed their disagreement with this campaign/trial. Someone on the MFC group has also said that at their centre consent is taken as a signature in a register, but I’m not sure that translates to informed consent. Also in Maharashtra it is unclear if it is a study or a campaign.

[19-06-2024 19:26] G: Some are quoting the Chingleput study but I just read some literature revisiting the Chingleput study, as well as previous studies done in Brazil and Malawi . There is no place that says it helps. Even the studies down by ICMR and SJRI say that though it generates an amplification of immune mediators, it does not seem to translate to prevention of disease. Though you have to go through the fine print for that

[19-06-2024 19:30] G: In addition it remains unclear if it is a trial. In Maharashtra participants are being called beneficiaries and not participants. And the community is unaware that one part is going to be the control arm and is not going to be receiving the vaccine. And as the last mile bridge, ASHA workers are being almost used to encourage if not coerce their ward members to attend these vaccination camps. Ethical issues at quite a few levels I feel. I couldn’t help but feel quite strongly about this. Hence this noise generation

[19-06-2024 19:30] P: Yes! Even ICMR document doesn't say it 100% helps. They themselves are not sure.

[19-06-2024 19:31] C: This is such an important conversation that you guys have brought

[19-06-2024 19:31]R: Yes. I followed the conversation in the MFC group as well. I don't think any area has PIS that is given to the patient

[19-06-2024 19:31] P: All this pain and frustration will come in the following up article I hope. Go all out. Don't hold yourself back.

[19-06-2024 19:32]R: Yes, I saw this! The ethical violations of this alone are INSANE. 

Even the PIS I saw doesn't detail it being an RCT.

[19-06-2024 19:33]R: I'm so glad you are generating this noise! Honestly, it is needed.

[19-06-2024 19:33]R: The "unfortunately" is silent :p

[19-06-2024 19:33] C: Indeed, I hope this article will be eye opening to all the stakeholders!

[19-06-2024 19:46] G: we are generating. I cannot imagine doing this on my own.

[19-06-2024 19:49] you: @G are they conducting this trial all over india?

[19-06-2024 19:49] G: I found a Hindu article saying 23 states have ‘consented’

[19-06-2024 19:50] G: https://cdn.who.int/media/docs/default-source/immunization/position_paper_documents/tuberculosis-(bcg)/bcg-evidence-recommendation-table-revaccination.pdf?sfvrsn=7eb27cf3_2

[19-06-2024 19:50] G: WHO says boo

[19-06-2024 19:50] P: The operational guidelines mentions those 23 states

[19-06-2024 19:51] G: There is also a high dose Isoniazid program for hugh risk TB contacts that again has no benefits and significant risks

[19-06-2024 19:51] P: In this together!

( Sings if we go down the we go down together :P)

[19-06-2024 19:52] G: Someone also mentioned that because these are national programs and not traditional studies they escape ethical review. That makes absolutely no sense to me

[19-06-2024 19:52] G: I would think National programs would undergo more scrutiny than usual before implementation

[19-06-2024 19:52] P: Were you there for the Thursday truth seekers?

[19-06-2024 19:54] P: https://drive.google.com/drive/folders/14ttHw1xPR4BCkPU2kVYk2BNSLl2N2mYt?usp=share_link

Jump to the point when Dr Yogesh starts speaking

[19-06-2024 19:54] G: What are we trying to achieve? Something on paper to say we tried many things, see? And of course, exchange of copious amounts of 💰

[19-06-2024 19:54] P: Bang on.

[19-06-2024 20:03] G: Another big issue I feel is that this campaign targets rural and urban poor populations that are already vulnerable and do not have full agency over their health. The rest do not even know this is happening. Even doctors. This is further widening the gap, discouraging solidarity and keeping the privileged in their own bubble. This leads to ex Supreme Court lawyers saying astonishingly ignorant things like unemployment is not a problem in urban areas

[19-06-2024 20:03]R: Sus.

[19-06-2024 20:06]R: One would hope. :p

[19-06-2024 20:07]R: Absolutely. The socioeconomic strata have widened to ludicrous levels. Most non PSM doctors I know don't even know about the adult TB vaccine - much less other people.

[19-06-2024 20:08] G: These are some great points. Do you think you would like to bring this up on the MFC email thread?

[19-06-2024 20:09] you: can you share link ?

[19-06-2024 20:09]R: I hadn't thought of how insidious and manipulative it is to use ASHAs to mobilize "trial participation" for this, if we can call it that. Using their rapport to conduct revaccination without being fully aware of risks, in a vulnerable population.

 

[19-06-2024 20:10] G: https://www.thehindu.com/sci-tech/bcg-revaccination-study-in-high-risk-adults-to-begin-in-23-states/article67594580.ece

[19-06-2024 20:13] G: Crazy, who’s going to read this and then understand this?

[19-06-2024 20:15] G: So my friend, the ASHA worker was saying that the reason she thought this was fishy was because they employed similar tactics during Covid, and then every time someone had an adverse effect the ward would become hostile towards her. Apparently they used to threaten her with their chappals when she went near their houses.

[19-06-2024 20:17] G: This is not an attempt to villainise the government but there is clearly something grossly wrong. And there is need for a strong countervailing power. I mean, we are at least on paper attempting to have some ethics involved no. There is enough evidence to say that merely increasing GDP is not equal to progress.

[19-06-2024 20:18] G: Okay guys, sorry, my rant for the day is over 😅 thank you for listening patiently

[19-06-2024 20:22] C: A brilliant and educational rant I must say

[19-06-2024 20:22] C: I had no idea about this adult tb vaccination thing until now

[19-06-2024 20:22] you: true

[19-06-2024 20:22] C: And this was the most exciting part of my day, learning this from someone clearly knowledgeable and passionate about this

[19-06-2024 20:22] G: Welcome to the club! I thought I was the only one who had somehow missed this

[19-06-2024 20:23] D: 100% agreed

[19-06-2024 20:24] G: Hardly 😅 as an ER physician I was least educated about TB . The last three months have led to this. The spectrum ranges from people who have no idea this is going on to people who are absolutely not surprised that yet another program is unethical

[19-06-2024 20:25] C: Actually this is a measure of how intelligent the govt thinks we are lol

[19-06-2024 20:25] G: Two years ago I could not imagine being so passionate about TB 😅. This made me realise how much of a bubble I was in and of course how privileged I was

[19-06-2024 20:25] C: If they think they can pull off something so obviously unethical

[19-06-2024 20:25] C: Without ppl understanding it or opposing it

[19-06-2024 20:26] G: You know, call me a conspiracy theorist, but I have a feeling that the reason most of us don’t know about it is not accidental but possibly intentional

[19-06-2024 20:27] G: Like coercive sterilisation in sickle cell anemia. But as med students if some guideline said this is the right way, I don’t know if I would question it.

[19-06-2024 20:27] G: I mean people have opposed it but we’ve looked the other way

[19-06-2024 20:27] C: Okay excuse me what

[19-06-2024 20:27] C: Coercive sterilisation?

[19-06-2024 20:28] C: Okay just found a recent investigation published on that

[19-06-2024 20:29] you: India is not for beginners

[19-06-2024 20:30] G: I have learnt in the last year that maybe India is not for one beginner but a million beginners may just leave a dent

[19-06-2024 20:33]R: +1

[19-06-2024 20:34]R: Truly. Medical ethics is something we just skim over, and are never quizzed upon either.

[19-06-2024 20:36] G: Agree. I was not taught medical ethics at my college and I’m ashamed to say I learnt about Alma Ata a decade after earning my degree. But I say it because there must be more like me.