Recent Device Approvals: LifeVest Wearable Cardioverter Defibrillator

Recent Device Approvals: LifeVest Wearable Cardioverter Defibrillator

The FDA has recently approved the LifeVest Wearable Cardioverter Defibrillator to be marketed. The Zoll LifeVest is a wearable cardioverter defibrillator to monitor and treat dangerous, abnormally fast heart rhythms. These abnormal rhythms can lead to a complete absence of heartbeat (sudden cardiac arrest) and death (sudden cardiac death) if they are not treated. This device was first approved for patients 18 years of age and over in 2001, and it is now available for children.

The LifeVest is worn outside the body day and night. It treats abnormal rhythms by applying a high energy shock similar to that of a traditional defibrillator.

U.S. Food & Drug Administration (FDA) Clinical Pharmacology Corner Update: FDA Approves PORTRAZZA (necitumumab)

U.S. Food & Drug Administration (FDA) Clinical Pharmacology Corner Update: FDA Approves PORTRAZZA (necitumumab)

Clinical Pharmacology Corner Banner

*FDA Approves PORTRAZZA (necitumumab) in Combination with Gemcitabine and Cisplatin, for First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer*

On November 24, 2015, the United States Food and Drug Administration (FDA) approved PORTRAZZA (necitumumab) in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). PORTRAZZA is not indicated for treatment of non squamous NSCLC. The approved recommended dosage of PORTRAZZA is 800 mg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle (Q3W) prior to gemcitabine and cisplatin infusion. Patients receiving PORTRAZZA should be pre-medicated as follows:

* For patients who have experienced a previous Grade 1 or 2 infusion-related reaction (IRR), pre-medicate with diphenhydramine hydrochloride (or equivalent) prior to all subsequent PORTRAZZA infusions.
* For patients who have experienced a second Grade 1 or 2 occurrence of IRR, pre-medicate for all subsequent infusions, with
diphenhydramine hydrochloride (or equivalent), acetaminophen (or equivalent), and dexamethasone (or equivalent) prior to each PORTRAZZA infusion.

_Mechanism of Action (MOA), General Pharmacokinetics (PK) and Pharmacodynamics (PD) of Necitumumab_

* /MOA:/ Necitumumab is a recombinant human IgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR) and blocks the binding of EGFR to its ligands.
* /Dose proportionality:/ Necitumumab PK is characterized by a target-mediated drug disposition, exhibiting dose-dependent kinetics on total clearance and steady state volume of distribution. * /Accumulation:/ Steady state exposure is achieved after 3 cycles of treatment.
* /Terminal half-life (mean):/ Approximately 14 days.
* /Exposure-safety:/ No apparent relationship between average serum necitumumab concentrations (C_ss,ave ) and all grades
hypomagnesemia, rash, arterial (ATE) or venous (VTE) thromboembolic events.

_Drug Interaction Potential_

* Coadministration of necitumumab (800 mg) with gemcitabine (1250 mg/m^2 ) and cisplatin increased the geometric mean dose-normalized gemcitabine AUC by 22% and C_max by 63% compared to administration of gemcitabine and cisplatin alone. This increased exposure to gemcitabine may have contributed to the higher toxicity observed with the necitumumab containing arm. The coadministration of necitumumab did not have an effect on the exposure to cisplatin (as measured by dose-normalized AUC_0-5h and dose-normalized Cmax for total platinum) in the presence of gemcitabine.
* Gemcitabine and cisplatin have no effect on the exposure to necitumumab.

_Use in Specific Populations_

The following population characteristics were not associated with a clinically significant effect on the PK of necitumumab: age (range: 19-84 years), sex (75% male), race (85% Whites), renal function [as measured by Cockcroft-Gault creatinine clearance (CL_cr ), range:11-250 mL/min] or hepatic function [as measured by alanine aminotransferase (range: 2-615 U/L), aspartate aminotransferase (range:1.2-619 U/L) and total bilirubin (range: 0.1-106 μmol/L). Body weight is identified as a covariate in the population PK analysis; however, weight-based dosing is not expected to significantly decrease the variability in exposure. No dose adjustment based on body weight is recommended.

_Efficacy and Safety_

The efficacy and safety of necitumumab at the recommended dose were demonstrated in an open-label, global, multi-center, 2-arm, randomized trial in 1093 patients with squamous NSCLC (Trial JFCC [SQUIRE]). A 1.6-month improvement in median overall survival (OS) among patients in the gemcitabine/ cisplatin + necitumumab Arm compared with those in the gemcitabine/cisplatin Arm (HR = 0.842 [0.736, 0.962]; p=0.012) was demonstrated. The most common adverse reactions (all grades) observed in PORTRAZZA-treated patients at a rate of greater than or equal to 30% and greater than or equal to 2% higher than gemcitabine and cisplatin alone arm were rash and hypomagnesemia. Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after PORTRAZZA administration.

Medical Device Safety and Recalls: eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm

Medical Device Safety and Recalls: eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm

A recall has been issued for eVent Medical LS, 5i, or 7i Inspiration Ventilators. eVent Medical is recalling the LS, 5i, or 7i Inspiration ventilators because a faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm. If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. The company has received one report of this issue occurring, with no injuries and no deaths. For more information, please see:

Obelisks in Plain Sight…

I have been fascinated with Egyptian mythology and history since I can remember but after 2008, my interest grew even more. In 2011, I traveled to Egypt and in 2012 to Rome, where more Obelisk can be found than Egypt.

Then I looked back to my past, and I did not realize I grew up around Obelisks. In my home country, there are at least 3 Obelisk in strategic places and I played around them without even knowing.

So what exactly is an Obelisk? Obelisks are monuments honoring the pagan GOD SUN of Egypt called AMUN RA. The spirit of this pagan GOD is set to reside within the Obelisk. At the based of the Obelisk, this symbolizes the vagina,  and the erection the male parts; together, they described the male and female sexual union.

Those who worships RA (aka Amun or Amen) believes that Amun = Amen is the suprime GOD creator of all things, and can transform himself into other GODS like OSIRIS the GOD of the underworld or SETH the GOD of evil and caos.

Today AMUN=AMEN is one of the most popular words used in this world and repeated by many religions like Muslim, Hindus, Christians and Jews at the end of a prayer. Without realizing, people all over the world are praising AMUN.

The OLD TEST AMENT = bible, is the holy book of Christians. AMUN=AMEN is repeated over and over again throughout the bible. The word AMEN means ‘the hidden one’.

Many are fool into believing that Amen means ‘so be it’. But in Kings bible old test AMENt, AMEN is identified as ‘the LORD God of my lord’.

So why in the world the Vatican, apparently full of Christians values, erect a monument symbolizing the pagan GOD ‘AMUN RA’ and sexual intercourse right in his front yard?

On the political aspect, any country that has an Obelisk represents a colony. Rome conquered the entire planet and left behind Obelisks, that they stole from Egypt. In each country I traveled, I have seen at least one Obelisk. Does your country has an Obelisk? I bet it does!


The White Symphony

An early Amsterdam September cold and cloudy morning day (pretty much like every other day), as I started my regular routine of walking the dogs, I looked at the sky and noticed the ‘white symphonies‘ all over the sky. As I kept walking, I saw an airplane releasing what it appears to be ‘white smokes’. It was obvious to me that the plane has been spraying what I called now ‘white symphony’ for more than an hour. The trails left behind can be seen from miles away and the entire sky was covered. The plane was going back and forth from the same location (more or less above my building/area). The Schiphol international airport is just on the other side and I have never seen the skies this white nor the lines or trails before this day.

As I returned to the apartment, I decided to google ‘white stuff on the sky’ of The Netherlands. I came across a dutch article where this individual spoke about seeing similar trails and decided to follow the trails. This person mentioned that it ended at a local military based nearby.

Then I remember reading about a phenomenon called CHEMTRAILS. According to eyewitnesses of these `Chemtrails` – and by now there are several hundred thousands of such people – the following observations are made, particularly on warm, clear days:

Over rural and urban areas one can see a conspicuously large number of aircraft (at any given moment 5 to 15 of them) flying back and forth at an altitude of at least 6000 metres. These aircraft are often completely unmarked grey transporters of the Boeing KC-10 or KC-135 type – more rarely also passenger jets – which are, however, never observed in take-off or landing manoeuvres.

At first these aircraft appear to be leaving vapour trails, but after observing them for a while one starts to have one`s doubts: These `vapour trails`, which are laid out in a regular, gigantic criss-cross pattern do not disperse in a matter of minutes, but hang motionless in the air; one could almost speak of an adhesive effect. Often a pearl-necklace-like pattern of the vapour is recognizable, which can also turn into a sequence of large `drops`.

Slowly but surely, these `vapour trails` or drops broaden within a time span of 30 to 60 minutes, and as they do so they form a dense, viscous cloud-like mass that looks like stirred milk-foam. The supposed vapour trails join together more and more to form cloud-banks.

After 2 to 5 hours the sky is covered with a diffuse layer of mist and cloud. However, this only arises where the aircraft have been active flying back and forth spraying intensively. Strangely enough, the original chemtrails remain recognizable hours later as condensed white cords in a milky broth.

All this time the aircraft continue to fly across the sky in a rough chessboard pattern, until they too start to fade from view in the thickening mist. Interestingly enough, if a take-off or landing manoeuvre is observed nearby, one is struck by the qualitatively quite different – because normal – vapour trail. In this case it extends a few kilometres at most behind the aircraft, and after a few minutes evaporates completely. This difference in consistency could not be more striking!

Between our observer and the previously blue sky an impenetrable mist bank has now formed, which soon covers the entire sky. If the sun can still be made out amongst the chemtrail clouds, a light halo can often be seen around it in which a pale rainbow effect is visible. This effect can be explained by the diffraction of light in the aluminium powder of the chemtrails (see Chapter 2).

After a few hours the air temperature falls markedly – that is, it drops by 5-7 degrees. At the same time, the air humidity invariably sinks to levels around 30%. A really observant person will be able to sense physically how the surrounding air is deprived of its moisture. This effect is attributable to the barium salts contained in the chemtrails (see Chapter 2). It is worth noting that the fall in temperature mentioned here generally occurs at the beginning of a series of spraying operations. Such `series` normally last several weeks, and the temperature fluctuation in the middle of a series is less pronounced as the result of the artificial lowering of the overall values.

The cold and dry conditions that now set in can continue unrelentingly for days. As a result there is mostly fine, but noticeably misty, cooler weather. Consequently there is no rainfall whatsoever. A conspicuous `bleaching` of the sky also occurs. This bleaching is so extreme that no blue can be seen, especially if one`s gaze is directed towards the horizon. Here, all we see is a pale, white ribbon that at most shows the brownish tone of fossil fuels in the air. It is this quality of the `white skies` that is the most distinctive, being the most persistent, feature of completed chemtrail activity. Hence the title of this article.

Often a whole week elapses before the weather returns to `normal` – i.e. to what is typical for the season in question. For this reason a chemtrail spraying series generally follows a weekly rhythm.

So what in the world are their spraying?


Methodical Illusion = Methodical Deception

In this interview Rebekah drops some bombshells that prove not only that 9/11 was a false flag event long in the planning, but that the operation leads directly back to companies and intelligence assets deeply rooted in and connected to the state of Israel. In fact, some of the information shared in this remarkable interview is so critical for every American to understand that if you don’t want to listen to the full interview, at least make sure you fast forward to the 31:20 mark. Because as Rebekah says, “This is the elephant in the room that nobody wanted to talk about.” The pictures you will see and the information you will hear may well shock you to your core. Share it with your friends and family. Every single American citizen should know the truth about what happened on 9/11 and the months leading up to it – and who the REAL culprits were.

For further investigation: research all companies participating on 911 or benefitiating from this event:


Michael Chertoff | Kenneth Feinberg | Philip Zelikow | Dov Zakheim | Richard Perle | Paul Wolfowitz | Jack Abramoff | Adam Yahiye Gadahn | Yaron Shmuel Oded Ellner | Sivan Kurzberg | Paul Kurzberg | Larry Silverstein | Odigo | ZIM Urban Moving Systems | Kroll Associates | ICTS International | Ptech Software systems | System Planning Corporation |Tracor Littelfuse | BB18 | Gelatin art group | Kellex Mitre


Specializing in Pharmaceutical Technologies