#longthread

Disclaimer: This is a hypothetical story; a work of fiction. Any resemblance to actual events or locales or persons, living or dead, is entirely coincidental.

Long long go, in a land far far away, there was a country of *believers* called Country *A*. 1/n
2/n

People of Country A believed pretty much anything that was sold to them on the idiotbox and through a ritual called *nationalization*. As long as anything was framed in terms of this ritual, most believers bought it lock, stock and barrel.
3/n
In country A, there was this company *B* that made a product *mB*. The business of that company was regulated by a government department named *C* atop which a functionary presided called *D*

One year, a bad plague hit the country. People fell sick, and some died.
4/n
No one could diagnose what it was making the believers sick. There was panic all around. Company B saw an opportunity in this panic

It hired some actors to tell the believers on the idiotbox that its product really helped cure the plague.
5/n
It cooked up a silly experiment to show the believers that its product actually helped cure sick believers. It fiddled with the experiment to make the results look good.

Regulator C led by D and a bunch of their cronies who either had no idea how to evaluate ...
6/n

... the claims B was making or were influenced by other means let B sell its product mB to believers. This was not the first time this sort of thing happened, C & D had a sordid history of doing this time and time again.
7/n
Company B made a lot money selling its product mB to unsuspecting believers, even though there was very little evidence that is product mB actually did anything to help the afflicted people. For most believers, that is how the story ended.

But wait …
8/n

🥁🥁
Something interesting was being orchestrated behind the scenes. Company B wanted to attract investment from people with deep pockets, called *bankers* to expand its business.
9/n
But it wanted to preserve as much equity in the company as it could while still attracting the investment.

So it came up with a brilliant plan.

Using clever PR, it created a campaign to tell some believers who were questioning whether its product mB ...
10/n

... actually did anything to treat the plague (called anti-nationals) that it will conduct a “real” test, unlike the crappy one they did the first time around and provide proof that its product mB truly worked to treat the plague.
11/n

Except that, it did not want to do the test in the country of believers; rather in the country of bankers who it was trying to attract to invest in B.

B partly owned a different Company, company *E* in the country of bankers.
12/n

B told believers that it will license its product mB to E so that E can then test it in the country of bankers and prove once and for all that mB was the best thing since sliced bread.

Also, B said, testing mB in the country of bankers was better than ...
13/n

... testing it in the country of believers because it could then sell mB to the people of the country of bankers too and make more money.

The only problem was that product mB was owned by B and not company E.
14/n
Therefore, E signed a contract with B saying that once E proves that mB was as good as sliced bread, it will pay B hundreds of millions of cookies which the bankers trade.

This contract artificially inflated the valuation of B because it could now show great future ...
15/n
... earnings to its investors and stock market from the commercialization of mB in the country of bankers.

E made a big announcement about doing a real test, the kind that proved that its product mB actually treated the plague.
16/n
It told the regulator in the country of bankers *F* that it would conclusively prove that its product worked. It got the permission from F to test mB all over again.
17/n
While this was happening, B completed the investment. A big bank *G* from the country of bankers made a very large investment into Company B. It got the investment it wanted to grow its business.
18/n
After the investment was done, E made an announcement quietly that it was no longer interested in proving that product mB was as good as sliced bread. And this, is the real story.
19/n
By showing an agreement that E signed with B assuring future milestone payments of hundreds of millions of cookies upon the commercialization of mB in the country of bankers, Company B had artificially inflated its value just prior to the investment from Banker G.
20/n
B had to give away a small portion of the equity to G because it had valued itself much higher using the contract it signed with E showing large future returns. However, the contract was not much more than a piece of paper. It was never intended to amount to anything.
21/n
Whatever B made selling mB to unsuspecting believers was insignificant to the value it retained from the investment because of this inflated valuation during the transaction.
22/n
Sadly, the actors who B had hired, the regulator C and its head D played an unwitting role in making this happen. Ultimate losers in this entire scheme were the believers who were not only sold a dud, but were played along with a story ...
23/n
... of how good mB was to distract their attention from the real story that unfolded behind the scenes.

The End.

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More from @d_s_thakur

7 Aug
Here is the petition that a few of us have sent to the Health Minister asking for more transparency: dineshthakur.com/wp-content/upl…

@PrabhaRaghavan reported on this here: indianexpress.com/article/india/…
2. First, we think all clinical trial data should be made public regardless of whether the drug succeeds or fails. This is a demand being made in most countries and several of them are making this information public.
3. Second, we ask for all file notings and decisions related to New Drug Approvals to be made public prior to the decision to approve the drug. This is important so as to give some time for public scrutiny and opposition.
Read 8 tweets
15 Jun
Long thread 👇

One of the biggest issues with our drug supply in India is that there is a high probability that what we purchase at the chemist shop/local pharmacy has never been proven to be therapeutically effective. Want to know why? Read on 1/n
2/n How do you know if a particular drug is actually therapeutically effective against a disease target? Well, it has to go through a series of gates, checkpoints, where it is tested to see if it is therapeutically effective against a particular disease.
3/n For example, there has been a lot of discussion recently about HCQs to treat COVID-19. If you recall, it was first reported that the drug was effective against the virus in-vitro, meaning when tested in a lab, in a petri-dish, the drug killed the virus. We were all excited.
Read 25 tweets
12 Jun
A few weeks ago, it was reported that the GoI was considering an overhaul of the drug approval process. On behalf of CASEM, I sent yet another petition to the @MoHFW_INDIA to setup a committee for a comprehensive relook of the stability testing requirements for generic drugs 1/n
Here it is: casemindia.org/a-petition-to-…
Establishing stability is extremely important to ensure drug quality because most drugs are inherently unstable over the long run.
If there is even a slight error in the mfg. process, the drug will degrade because of heat/humidity/light 2/n
An unstable drug will either not have therapeutic efficacy or like in the recent Ranitidine case, result in potential carcinogens as it degrades.

When I began researching Indian laws 5 years ago, I was shocked to learn that 'stability testing' was not compulsory 3/n
Read 10 tweets
2 Jun
So here is the backstory on this excellent piece from @PrabhaRaghavan. This is a long thread, so please bear with me.

@CDSCO_INDIA_INF stonewalled us for over two years before they gave us an unsigned copy of this report (sans annexures) 15 hrs before the CIC hearing 1/n
2/n Here is the Parliamentary Standing Committee Report from 2012 that pointed out serious lapses in how certain drug approvals were granted: http://164.100.47.5/newcommittee/reports/englishcommittees/committee%20on%20health%20and%20family%20welfare/59.pdf
@Teensthack @rdivia
3/n One of the drugs in question was Buclizine, which originally was approved as an anti-histamine; was surprisingly approved later for an additional indication as an "appetite stimulant" - targeted mainly at children. @Apothecurry @VikasReports @anupsoans @sunilattavar @BLRrocKS
Read 15 tweets
21 Feb
Propylene glycol is a food additive. It is also used as a drug solubilizer, an excipient. It carries flavors in food and beverages, helps retain taste. Diethylene glycol is a chemical used to make polymers and anti-freeze. 9 children died in J&K because it appears that a mfg 1/n
2/n mistook one for the other. This is a long thread, please bear with me.

The death of 9 children is printed on page 10 of a national newspaper. What does it say about us I wonder?

But I digress, if you read the piece carefully, you will see that the switch/contamination
3/n was detected by a lab at PGIMER. What was our drug regulatory system doing, should we ask? PGIMER’s results have NO legal standing, test results from RDTL do.

This thread is a plea to all health reporters @PrabhaRaghavan @Teensthack @AnooBhu @PriyankaPulla @ChandnaHimani
Read 13 tweets

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