Quatuor et Stratégie #2
By Charles-Edouard!
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
A reader's question illustrates the reluctance ...
This will grant him a detailed answer, later. To complicate the thing, he has a small resistance to Edurant® (which one ???). Obviously, there are solutions, and in particular to leave this dictator-liar doctor ... The question illustrates well the distress of patients and reminds our ANRS its Quatuor commitment.
Quatuor and Strategy # 2
This post follows
this previous post. We can also read
our page on ANRS-4D.
Avoid cheating
Cheating occurred in ANRS-4D trial. Sabotage too. So, it's going to happen again, we need to be aware and protect accordingly.
Obviously, a good support for patients would help! And not an support by the usual seronegatives idiots: conviction and credibility is required!
People should not want to enter the trials in order to interrupt their treatment. This should be the first criterion of non-inclusion in the trial. Exclude anyone who wants to get into the trial in order to stop treatment.
Monitoring and even excluding "cheating" sites, and, for the sake of precaution, preventing one or two hospitals from providing more than the others, with, as is easily understandable, increased caution regarding Bichat and Salpêtrière, known ennemis of ICCARRE.
Include the maximum number of therapies
Non inclusion of usual therapies (eg Nevirapine), means forbidding the patients who use them to do the 4/7. As a result, this distorts the market, already largely distorted in favor of Big Pharma.
I hope that the Quartet will not distort ICCARRE by setting too many barriers.
It is very important to open up to as many patients as possible. It is also important to have as little failure as possible.
To choose between the two, I prefer the least possible failure: if the medico-administrative registration is a bit too restrictive, it will be possible to open the window, thereafter.
If the medico-administrative registration can not take place, then we will not be able to do anything any more ...
If INIs based therapies (Isentress ®, Stribild ®, Triumeq ®) blow the whole trial, then, we are f**ked once more. The safety instructions should distinguish between proven therapies (including Nevirapine) and INI-based therapies. We must be careful that Bichat and Salpêtrière are not directly or indirectly involved in the safety oversight committee: they can be the instrument of cheating.
Avoid moving cursors
The famous criteria by Rouzioux-des-Critères got it in the neck, thanks to ANRS-4D: they will want to come back: it is necessary to avoid that these stupid criteria (Nadir, proviral DNA, CD4 level > X) at the inclusion, do not resurface. If they are relevant, it will show at the conclusion. No one gives them any credit, but hey ... Better be careful with the Parisian virology clique!
Dare Transparency
The existence of cheating and, we believe, sabotage (voluntary cheating), calls for absolute transparency: real-time publication, patient-by-patient, anonymized by assigning a unique and confidential identifier, VLs, recruitment centers, inclusion assessments, treatments, etc.
We are tired of crooked trials, practices and conclusions: Vioxx, Jupiter, SMART, START, YperGay, GS-US-236-0102, etc. Enough!
We're in 2016! Internet has become a reality! The patient's anonymity can be guaranteed while offering transparency: patients and physicians require new transparency and better practices in scientific research. See this article in le monde By Luc Perino (General practitioner): Advocating for more science in medicine ...
Doctors are tired of crookery. Patients too!
The problem of Premium inclusion: Eclipse observation
The inclusion Premium (see
practical guide) is the a priori verification of the effectiveness, on the Genotype (aka Resistance test). At inclusion in ANRS-4D approximately 4% of patients could not produce their genotype.
| conditions | Simple Eligibility | Premium Eligibility |
| a priori efficiency validation | No | Yes (genotype required) |
validation of usage efficacy
| 2 successives UD VL
| 3 times VL < 50
(make sure it is undetectable) |
| minimal duration of current ART | 12 months | 4 months |
Advantages
| no Genotype
| 4/7 direct
frequent VL unnecessary? |
| disadvantages | 6/7, 5/7; frequent VL | Genotype required or redone |
In France, we will know how to redo a missing genotype. In Zimbabwe, no ...
Knowing what to do in the absence of the Genotype is a matter of global importance. this issue will show up as soon as we want to extend ICCARRE away from our immediate borders.
In France, we can redo this genotype: it will suffice to do an analytical interruption, going beyond the simple resurgence of the virus. Instead of going to the simple T50, we go as far as T500 ... (the rebound time up to 500 copies). This gives a tremendous opportunity to study, for the first time in France, the T50, i.e. time to viral rebound, that foreign studies estimate to an average of 14-21 days.
The Eclipse, in this context, is exactly this phenomenon observed universally:
when we stop taking the drugs, the virus remains under the rug, and takes several days or weeks to become detectable again. Knowledge worth using!
Animation
Patients are mobilized, and it would help to have a network animation, funded by (and therefore indebted to) public funds (
not BigPharma, of course, that already exists, just see in North America, a true Scandal!), so to support all this little world, especially since Social Security would be a big winner!
Good Weekend and good Fuck!
Comments
Jim Dec. 4 2016 à 05:39
Charles-Edouard Dec 5 2016
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
