Plausible Deniability. A long 🧵 👇

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Over the last couple of days, scandalous news of the arrest of a Joint Drug Controller in @CDSCO_INDIA_INF has made waves. While much of the reporting is perfunctory until now, it helps to peel the onion and see how far the stench
2/n
of corruption pervades the unholy nexus between the pharmaceutical industry and the DCGI’s office.

Lets start with a few facts, shall we:

A.“CBI officers claimed Bioinnovat Research Services Private Limited had been asked to get regulatory clearance for the Biocon
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product. Bioinnovate, in turn, engaged Synergy Network to get the work done, the officers claimed.”
indianexpress.com/article/india/…
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Isnt it interesting that a sponsor pharmaceutical company, in this case @Biocon, apparently engaged a third party “BioInnovat Research Pvt Ltd” to “get” regulatory clearance for their product. Why would any pharma company do that? Does it not employ people with expertise in
5/n
Regulatory Affairs who know how to work with the drug regulator?

For those of us who have dealt with US FDA or EMA know full well that communications with these regulatory agencies are only with a designated employee of the pharma company seeking market authorization.
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B.“The agency dug into her background to find that she had several pharmaceutical companies as her clientele. She allegedly delivered huge bribes through Dua and others to senior officers of CDSCO on different occasions for processing the files favourably on behalf
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of her clients, officials said.”
thequint.com/news/india/cbi…
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Hmm. So BioInnovat has “several pharma companies as its clientele? Let’s see who, shall we?
bioinnovat.com/clients/

Big names here. Not just Indian pharma companies, but MNCs too. Ever wonder why big pharma would need the services of “BioInnovat”?
9/n
Do they not have people with expertise in clinical research and regulatory affairs? What do you think?

As they say, the existence of scores of “liaisons” whose only function is to liase with the DCGI’s office on behalf of “reputable” pharma companies
10/n
is not a bug but a feature of the system. BioInnovat is not an isolated “facilitator” or “consultant” that represent pharma companies, the fate of whose business is decided by these high-handed functionaries in the DCGI’s office.
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This arms-length model affords what is called “plausible deniability” just in case something “untoward” happens, like it did this time. The sponsor can take a holier-than-thou attitude and say we have nothing to do with it and throw these facilitators/consultants
12/n
under the bus. I suspect that is probably what will happen here.

Question is why do these consultants exist in the first place? Why does the @CDSCO not deal directly with the sponsor? That my friend is the million-dollar question.
13/n
These intermediaries exist primarily because the regulator “encourages” them. That is the only way a sponsor can get their studies approved. The pharma companies know that, and they are happy to use these “facilitators” because it affords them plausible deniability.
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C.He manipulated the minutes of the meeting of SEC held that day by changing some key words in the recommendations, giving “substantial wrongful gain” to the company, the agency alleged.

thequint.com/news/india/cbi…
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"Information has also revealed that Dr. S. Eswara Reddy, JDC has manipulated the Minutes of the Meeting of SEC held on May 18, 2022 by changing the word 'Data' to 'Protocol' in the recommendations and thereby causing substantial wrongful gain to Biocon Biologics Limited,"
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the CBI FIR has alleged.

theweek.in/wire-updates/b…
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If you think this is a one-off thing, let me remind you what the @CDSCO itself told us, albeit grudgingly (for two years until the night before our appeal before the CIC):
dineshthakur.com/wp-content/upl…
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This is how our drug regulator functions. It is opaque, unaccountable and its actions raise questions about its ability to regulate the industry which makes millions from poor unsuspecting patients.
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BTW, recall that @malini and @das_seed had to fight tooth and nail to just get the names of the members of the SEC which approved Covaxin. Remember this?

22/n
Now ask yourself why? Does that sound Kosher to you? Why would the @CDSCO_INDIA_INF not disclose the SEC minutes until they were publicly shamed to do that? What is the process by which these minutes are reviewed and approved by members of the SEC
23/n
to make sure their decisions are accurately transcribed before making them formal?

Yeah, you. Who took Covaxin shots because it was #atmanirbhar!

Sounds like a pattern, doesn’t it? Yeah, I know, we are dealing with the “Best Regulator in the World”
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D.“The guidelines provide a framework for waiver of phase 3 clinical trials to be conducted in India based on a commitment to undertake a phase 4 trial, the design of which should be approved by the Central Licencing Authority.
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In line with the above regulations, Biocon Biologics presented a proposal for import and marketing of Insulin Aspart with a waiver of Phase 3 clinical trial in India. The Company presented a detailed proposal along with CMC, pre-clinical and clinical trial data,"
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the company said in a statement.
livemint.com/companies/news…
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Hmm.. sounds legit, does it not? Well, there are two problems.

First, most pharma companies who promise to do Phase IV studies in India just don’t honor their commitments. And the @CDSCO does nothing to compel them:

scrip.pharmaintelligence.informa.com/SC123070/Why-P…
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These sponsors make empty promises of conducting Phase IV studies to get their marketing authorizations and then conveniently forget them. It is not like the CDSCO ever follows up and penalizes them for not honoring their commitments.
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Second, the clinical and scientific reasons why one would waive a requirement for a pivotal phase III studies is complex. It cannot be a blanket yes or no. One has to clearly evaluate the basis on which such a waiver is requested.
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Waiver of local phase 3 studies has been a contentious issue for 10 years. It was first highlighted in the 59th Parliamentary Report on the functioning of the CDSCO.

casemindia.org/wp-content/upl…
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But you say we have a law that does that, right? Didn’t the sponsor say that they comply with the law of the land?

Good that you ask.

What role does the industry play in framing these laws? I wrote this years ago:
scroll.in/article/754277…
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But what do I know. I am just a poor IT guy and not a research scientist:

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If you have stayed with me this long, here is an 'easter egg' for you. Bonus points for guessing who all are in this picture 👇

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More from @d_s_thakur

Nov 9, 2021
#longthread

Remember the claims made about Coronil?

science.thewire.in/the-sciences/h…

1/n
2/n

Or the still unresolved questions about the way clinical studies for Covaxin were conducted in Bhopal?

thequint.com/coronavirus/ex…
3/n

Last week, we sent a petition to the Minister of @MoHFW_INDIA asking for the Clinical Trial Registry of India to be fixed once and for all. Here it is:

casemindia.org/wp-content/upl…

Much of the dysfunction in the way we conduct clinical studies can be traced back to the CTRI
Read 10 tweets
Jun 2, 2021
Longish thread 👇

This past week has seen much name calling and hyperventilation on TV debates between the representatives of the industry which practices evidence based medicine and the spokesperson who supposedly speaks on behalf of the Ayurvedic industry.

1/n
2/n Want to know why the administration is relegated to writing love-letters pleading "withdrawal" of "objectionable" comments?
@Preddy85 and I wrote about it here in the summer of last year:
livemint.com/opinion/online…
3/n

Our regulation does NOT require the Ayush manufacturers to prove that their product has any therapeutic efficacy as is the case for drugs that are marketed by the pharmaceutical industry.

In fact, in 2018, the @moayush amended India’s Drugs & Cosmetics Rules, 1945
Read 10 tweets
Apr 23, 2021
Long thread…. Please bear with me

Can someone explain to me why there is no central TRIAGE of all positive cases in cities like Delhi? Let me explain what I mean
Last night, I participated in a @TwitterSpaces discussion organized by @PSampathkumarMD 1/n
2/n We had a gentleman who provides ambulance services in Delhi on the call. This question is based on what I learnt from him
Watching the tragedy unfold, the question we need is what can be done so that people who need help are not left waiting to get the care they need.
3/n Why do we make people run around pillar to post to look for beds?

Large cities like Delhi need to set up a central triage where a group of physicians evaluate every positive case and determine:
1.If the patient can be cared for at home with assistance
Read 10 tweets
Apr 21, 2021
This clip is a good example of why it is important to screen your panelists before putting them on. 1/n



Dr. Joshi says that he uses Remdesivir to treat moderate and severe disease; and makes broad statements like the drug is recommend by @US_FDA.
2/n Look up what *moderate* and *severe* mean in this context. The other panelist, Dr Parikh provides a history lesson on how this drug came to be used for treating Covid-19; how relevant that is to the question being discussed is anyone's guess.
3/n Remdesivir has a role in treating the disease in a narrow population demographic and at a very specific stage in disease progression. Here is the current clinical evidence: altnews.in/remdesivir-is-…

Clinicians like Dr Joshi dont seem to give very little weight to such evidence
Read 6 tweets
Jan 7, 2021
This is a limited point about availability of efficacy data for vaccines under development in the context of the approval for CovidShield and Covaxin in India.

There have been many so-called experts on the idiotbox opining about apparent availability of P III data which 1/n
2/n apparently the SEC had access to based on which it "supposedly" approved Covaxin. Another argument that is prevalent is other regulators (US FDA and MHRA) also approved vaccines based on P II data alone. Let me give you a few facts so that you can make your own decision.
3/n The protocols for both mRNA vaccines are publicly available. You can check. Both protocols *define* when the interim analysis will be done. This is not subjective. They clearly define how many infections need to be documented before the Data Safety Monitoring Board meets.
Read 10 tweets
Jan 5, 2021
Thread 👇

One of the reasons *opinions* drive such conversations and impact #publichealth is the fickle nature of the Indian drug regulator @CDSCO_INDIA_INF. Allow me to explain.

Scientific method requires you to define the hypothesis and the outcome *prior* to the 1/n
2/n experiment, not find ways to justify unpredicted changes either in experimental design, process or true outcomes. This is the realm of faith which manifests as *opinion*, which is anything but Scientific.

We have a history of the drug regulator changing its allegiance
3/n from the industry to ideology to sometimes unexplained rationale over a decade now. Sadly, any attempts to hold the regulator accountable is labeled anti-national.

Step and ask what damage to #publichealth does this nonsense affect to the country, especially during
Read 5 tweets

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