Saturday, December 19, 2015
This paper was originally published here, in French. We provide the google translation for your convenience. Proper translation will come soon. Some practical aspects may differ where you live.
Jackpot and small cachoteries
PADDLE, unveiled at the EACS-2015, and already commented here and there (see the slides) is the hot topic. For those who understood my page on monotherapy Tivicay ®, and my comments on its effectiveness, these results are not a surprise ... It works, illico monotherapy Tivicay, attack, on 7 patients on 10 of the trial NCT00708110 (ING111521), which lasted only 10 days ... So, obviously, we're not surprised.
And we are not after our surprises (which are not ...)
This is not only very powerful but also overdosed! Just wait ...
It will eventually come out ... If you read well ING111521 test is in it.
soon we will ask two questions:
- Stribild ® he still has a place on the front line?
- Triumeq ® it is a useless medicine?
And ... How did it happen? How is it that a clinician or Argentine ahead of the (alleged) 'flagship' American or French? There has not been a clinician in the US, the country's pharma-business, for having had the idea; idea that they denigrate the pretext that all these little tests are done off the 'declaration' official '. We, who cares ...
® Shionogi, ViiV Healthcare ®: Jackpot and other cachoteries
Sovaldi ® was made famous by its exorbitant price. Gilead Science has for itself in one year the acquisition of Pharmasset, small-scale company, with the sofosbuvir for 11 Billion Dollars. The insured the solvent world have felt pass. Stribild ®, the same manufacturer is 1/2 million dollar income per new patient enrolled: 2500 USD / month / patient: US $ 30,000 per year for the duration of patents ... What we will do last at least 20 years ... it's been at least $ 600,000 / patient.
Shionogi, with its dolutegravir will not be outdone. Unknown to the general public, Shionogi, Osaka, Japan, has already made famous for inventing the best inhibitor '3-coenzyme A reductase Hydroxymethylglutaryl' rosuvastatin. Rosuvastatin? Yes, the famous Crestor ®, as useless as dangerous, but has excellent potential inhibition. Marketing via the English Astra Zeneca (formerly Imperial Chemical) makes a blockbuster, one of the biggest profits of the pharmaceutical industry.
So to inhibit, inhibit Shionogi knows ... And it relates. It remains to find a business partner: this time it will ViiV Healthcare. Dolutegravir will generate huge profits at the expense of Stribild ® and insured, but that was already officially recorded. The squabble ViiV vs Gilead is hilarious, except that the victims are the patients and the financial statements (hence employment ...). With its excellent result, Shionogi will sell quite expensive to ViiV its molecule, in a deal that is of the same order as the acquisition of Pharmasset. Technically less obvious but of the same order of magnitude. Sales in 3 parts:
HYPO-DOLU monotherapy Tivicay dolutegravir Shionogi ViiV healthcare
- Shionogi is allocated, free of charge, 10% of ViiV Healthcare,
- Shionogi therefore recover 10% of all profits ViiV without deadline
- Shionogi also earn a royalty fee on its molecule for life.
ViiV Healthcare is estimated at 23 billion Euros, thus 2.3 billion live in the pocket of Shionogi. The agreement was sealed in 2012. Welcome gift. The course is multiplied by 5! This is the Jackpot! (Deserved or not according to the convictions of each).
At GSK, the main shareholder of ViiV Healthcare, we are happy, it was the molecule that kills, but was allowed to pass 2 billion, plus royalties. Then we have a plan (which, Shionogi, thief at the fair, will find nothing wrong, his silence is acquired, at great cost ...).
As Astra Zeneca (perfidious Albion ...), ViiV (GSK), is very familiar with the workings.
First, from there, the Japanese researchers are invited to return to their dear studies and not trumpeting the extraordinary power of DTG. The language elements are: DTG is good.
And above all, we do not go further ...
Was the article cited above, published three years after the trial (3 years! ...), And its formalism imposed (Table patient characteristics before treatment), we would not be aware of anything ... only this table allows us to affirm that Emax is higher than the 2.6 announced (and probably much higher ...). If you do not have the picture, you can not you realize qu'Emax is underestimated. So do not worry ... This table will disappear.
HYPO-DOLU monotherapy Tivicay dolutegravir Emax NCT00708110 ING111521 undetectable Will also disappear 7 patients (70%) undetectable after just 10 days. monotherapy.
Shionogi while its complacency, brings up the 7 Samurai in the body of the article and in the table. They are there ... But once the agreement is signed, they are silenced: the article is completed by a pharmacokinetic graph, where the designer has made two mistakes; an erratum will be also published to correct an error (but not the other ...). In short, the authors and auditors (reviewers) have missed without seeing the error. The most obvious is that the 7 Samurai became the 3 Musketeers, who, as everyone knows, were 4 ...
In all communication that follows, especially monographs submitted to the FDA, the original table is withdrawn in favor of a differential picture, and 3 of the 7 undetectable through the cracks. It buries ... The FDA does not even mention, and in the documentation provided to the HAS (. See p 11), the ING111521 trial is not even subject: as it is even simpler!
The ViiV plan will allow recovery of the 2 Billion (and more): adding a junk 2 francs 6 under (Kivexa = ABC + 3TC), généricable and manufactured at very low cost, and increases in the price of the drug 50%. In coformulant diamond and glass beads, it increases the profit of 50%. Combined with DTG, here valued at 350 Euros per month ... For patients and potential side effects, too bad for them ...
And now ... Life is beautiful ...
Good weekend and good fuck!
Posted by Charles Edouard (prise hebdomadaire unique) at December 19, 2015