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Saturday, March 11, 2017

Trials vs Real Life


This was originally published here, in French. For your convenience, we provide this translation. Practical aspects may differ where you live.

Is real life different from trials?

by Charles-Edouard! (in bad mood...)

One of our readers testifies here, Feb. 24. 2017:

Thank you notes are my only reward! Thanks to you too ...

We will soon get to DOMONO, and its mixed results, having in mind the BMM cohort (Barcelona, ​​Montreal, Munich), whose results, after use of a selection algorithm are very good.

Why is true practice so different from 'science'?


monotherapie trithérapie Dolutegravir Tivicay MonoDolu DOMONO CROI 2017 jose blanco
Following the excellent presentation by J. Blanco at CROI 2017, the attack is cheerfully applauded. As the controversy can not be substatiated (monotherapy works for selected patients), lobbying focuses on the form. This is waged by Dr Joel Gallant, adored by web readers (althought this is disputable as Joel Gallant serves as a paid consultant/scientific advisor to Bristol–Myers Squibb, Gilead Sciences, Merck & Co., Theratechnologies and ViiV Healthcare/Glaxo-SmithKline) .

The charge is against DOLUMONO. Read the original article by Dr. Celia Oldenbüttel (photo opposite, abstract here): read, re-read, it required a motivated consultant to find a fly in the ointment ... Gallant lends his name and bankable e-reputation. (I had been fooled myself, but no more!). Grrr !! Hang on, here is the "argument" (cf article):
In a nutshell, Dr. Oldenbuttel would have evaded her prior authorization obligations, offered individualized care, but to many patients, so to get a mini trial, surreptitiousl, and get authorizations afterwards.

Bad faith, insinuations: beware of fakes!


The blame is extended to the other groups. Dr. Gallant even includes a factual error:
This is wrong !: the article by Dr. C. Gubavu [cf Hocqueloux, Orléans] states:
Dr. Gallant makes use of a (questionnable) US practice to create a misconduct by people merely enforcing their national regulations. Dr. Oldenbuttel measures GGT, CD4, CD8, lipids at the switch, that US doctors would supossedly not do: he sees the mark of a human experiment! My doctor does this tests, and with frequent follow-up. Who will blame Oldenbuettel? On the other hand, what do you think of those who do not ask for a complete panel and repeated blood draws, during a switch.
Dr. J. Blanco (opposite) explains why he makes this proposal to a patient, in front of him, with multiple failures. In a similar situation, what does Dr. Gallant do? Hmmm ??? Yet another switch with TRItherapy, then another TRItherapy, yet another TRItherapy, until the exhausted patient becomes 'lost to follow-up' (i.e. a cessation of treatment)?

Patients who have been (poorly?) treated badly with orthodox and abusive treatment take a leave with resulting health and epidemic damage. Guilt of US doctors, their standardized and ill-tolerated offering! They can escape legally (even ethically) but not morally. At least, Europeans have a suppression rate of 90%, where the US hardly gets to 50%! This kind of (sponsored?) lecturing is hard to swallow!

abusive nit-picking, "the argument" is spinned to commercial argumentation


The Germans overdo it: their technicality is unchallenged. The invisible, capitalist, hand exposes its voracious capture pattern: delay innovative trials, entrust them to the sacrosanct market players, and boo those who still practice their medical art with patients at heart.

J. Leibowitch, who contributed to the discovery of the virus, treatment, and alleviation much more than poor Dr. Gallant, was having dogs set on him, to the delight of the Great Capital.

Except that ... Except that ... The ANRS-4D trial , which was aimed at buying time and invalidating ICCARRE came back right on: ZERO intrinsic failure. Dr. Gallant knows how to find a fly on Dr. Oldenbuttel's ointment, but (how surprising!)> never mentions ICCARRE ...

The trial confirmed Leibowitch, who, for ICCARRE, had all necessary clearings. There is an exact match (ZERO intrinsic failure!) between the innovative team, and the formal ANRS test.

In Tivicay® mono it is the opposite: the BMM cohort, after proper screening (no Achille's heel, no poor compliance, nor initial viremia) gives good results. DOMONO, a randomized, inclusive trial, is a mixed success. A bit like IP monotherapy, authorized in France (on a case by case basis), and catastrophic in the MOBIDIP trial ...

Why does DOMONO leads to an interpretation opposite to that of BMM?


First, patients cheat ... They cheated in ANRS-4D, they cheated here too. The trial is in Amsterdam ... Where a high cheat rate and a 'I give the investigator the answer that pleases ...' effect has been reported. This is amplified by the linguistic problem identified here.
Dr. Vries-Sluijs comments (source):

Now, DOMONO is a cheater's realm and investigators credulity paradise !

Please explain how vL can go up with a perfect observance (sic) and without mutations of resistance (sic), yes! Please explain! On the other hand, patients who do not take their medicine and swallow 5 pills, the day before the blood test, that, I can understand!

In real life: ICCARRE


Many patients succeed in the Tivicay® mono: they are happy!

The price to pay for a safer Tivicay® monotherapy is not too hight:
- try, using a selective algorithm, the risk being low, and the harm null, and / or
- strengthen with Lamivudine (or Rilpivirine, should you prefer)

Leibowitch patent brevet US20120270828   EP2332544 US9101633 B2 once weekly hiv
Many do not understand the Eclipse ... It's a pity! What can we do?

Eclipse is the necessary counterpart to chronicity. Your DNA is modified and now includes the recipe for apple pie [i.e. Of the virus ...]: it is not because your DNA has the recipe of the apple pie, that it begins to make apple pies like crazy!

The best solution: ICCARRE, and, the best ICCARRE is 1/7!


There, you have the choice between Leibowitch's patented formula or try to integrate Dolutegravir in your strategy (that is to say in 7/7, 4/7 or 1/7)

As far as I am concerned, both strategies worked very well. Then the little piss, the sold, the corrupt who sell their soup under cover of ethical concern, it disgusts me.

ICCARRE is good and above all ICCARRE is a tool for eradication ...

Note April 16: more fun? Try: How to make a clinical trial say whatever you want
And also more to come about Dr Joel. Gallant's own ethical issues : stay tuned

Good Weekend and good Fuck


This was originally published here, in French. For your convenience, we provide this translation. Practical aspects may differ where you live.

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