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I will try my best to make this page as interesting as I can but the subject matter is quite technical and therefore makes simple explanations very hard to accomplish.  However, I will do my best to put the information in the simplest of terms so everyone can, hopefully, grasp the impact and importance of each pertinent detail.  The object of this discussion is to educate ALL individuals about Aldara whether injured by Aldara or simply interested in Aldara for other reasons and do so in an atmosphere without using  hysteria  and inaccuracies.   Once you have absorbed this information, you will be better prepared to understand  the clinical papers on trials and other studies that will follow.

FIRST OF ALL, WHAT IS ALDARA ?

Aldara is small molecule "immune response modifier".  The only thing it does and can do is influence your normal immune system to do things it cannot do in its natural, healthy state of operations.   The only active ingredient in Aldara cream is a chemical known as "imiquimod" or IQ for short.  IQ is almost 100% insoluble in water.  The cream in Aldara contains a number of various chemicals known as "excipients" and together they make up what is known as the "vehicle"  for Aldara .  The vehicle's primary job is to create a path of  absorption by which IQ molecules can be efficiently driven out of suspension in the cream and into your skin.   This job must be accomplished so the IQ molecules can be disbursed throughout the layers of the treatment site and go about doing their job of "altering" the immune system in an around the application site. 

The vehicle itself can be toxic to some degree more especially when the application site develops into an open wound exposing broken blood capillaries within the skin or just below the eroded first layers of the skin.  Once you see plasma or blood oozing from these open wounds, you can be assured these damaged capillaries have been and are capable of absorbing both vehicle excipients and more importantly IQ molecules efficiently into the bloodstream.  This erosion occurs in almost every indicated use for Aldara whether it is for genital warts, skin cancer, or any number of treatments for other conditions. 

As we have discussed, the weaker your normal immune system seems to be the less reaction you will have to Aldara.  Conversely, the stronger your normal immune system is the more aggressive your response will be to Aldara.  So, those of you in the normally stronger immune group can almost certainly expect to see serious erosions in and near the application site.  The warnings are very clear and widely distributed in the literature "do not apply Aldara into open wounds", "let open wounds heal before restarting Aldara" .    

JUST WHAT DOES ALDARA DO THAT IS SO BAD ?

Well, if you have a normally low to moderate operating immune system then Aldara will probably be a very good choice of treatment for you and will probably create no problems for you whatsoever.  But if you belong to the stronger group then let me answer this question in this manner.

The following discussion applies primarily to those individuals belonging to the stronger group of immune system.

Let's recap what we need to know about the immune system as it relates to Aldara and IQ drug action.  The immune system is made up of all sorts of cells that secrete many different chemicals that actually control and stimulate the activity as needed by the immune system to combat the invaders of our body known as antigens.  Now antigens come in a number of different forms.  There are viruses, bacteria, heavy metals, and a host of other things that can become an antigen once it has entered our bodies.  Once this has occurred whether entrance was made through breaks in the skin or ingesting the antigens, through the nose, mouth or what ever our immune system must then spring into action at the earliest possible moment to catch this infection of foreign matter while its numbers are at its lowest.  Otherwise, the more infectious antigens the immune system has to deal with when it finally does recognize it should go into action, the longer and more difficult the job becomes for the immune system to mount a large enough attack to timely eradicate these rogue antigens.   When, however, the response mounted by the immune system is quick enough, the individual most often never knows it took place thus never felt the feeling of any type illness taking place which is ideally  what one would like to achieve. 

Just to name a few of these immune related items, you have interferon's, interleukin's, growth factors, white cells, and many more as well.   We are interested in the interferon's and interleukin's for this discussion because depending upon when the immune system tells these various chemicals to enter the battle against an antigen infection depends on when others enter.  So it is all about timing and having these chemicals produced at just the right time in the right amount so others can then see that, hay, I need to get in on the fight too and then they are produced in the exact amount and enter the fight as well.  This goes on and on to build into what is known as an immune response. 

Interferon's are a type of messenger.    One interferon might tell specific cells to produce another interferon which in turn tells another cell to produce interleukin's and so forth until the immune system has completed this whole cascading effect of progressively building up all these materials in the exact respective quantities and at the precise timing for each to join the others in building an immune response toward an infection.

If everything goes as nature designed it, this immune response will remain well below an activity level capable of seeing and detecting normal self-cells or the good cells of the body thus preventing the immune system from spinning out of control and begin seeing the good cells, too, as antigen's.  When this happens, this misguided immune response is known as an autoimmune response where the immune system has broken away from its intended role as the protector of the body and becomes the enemy. 

Now, autoimmune responses certainly occur in nature, that's a fact.  Arthritis is certainly the most well known of all autoimmune diseases and has been found in ancient individuals dating back thousands of years.  In nature, when this happens usually something environmentally around us or something within us imposes some type of negative influence on our immune system to break out of its safe operations as described above and mount an autoimmune response, in the case of arthritis, against collagen, a protein found, among other places in the body, in cartilage of joints that keep them gliding along smoothly and painlessly.     

Believe it or not, 3M researchers actually designed Aldara with the active agent imiquimod (IQ) to do exactly what we have been previously describing.    IQ has a built in mechanism that, for the lack of terminology, "high-jacks" these normally safe regulatory features of the natural immune system and causes the cell producers of these interferon's, interleukin's, and others to be produced at abnormally high amounts while some are blocked from being produced, while still others enter the response at very unnatural times.  

3M'S HOPES FOR ALDARA / IQ ARE DASHED ..........

Rogue cells such as those found in genital wart virus, and cancer cells all appear to the normal immune system as self-cells or good cells so it never mounts an immune response toward them.  These cells are free to live, thrive and grow as we all know they do.  Now, 3M's theory behind Aldara / IQ is to first take over the normal safe operations of our immune system.  Then have IQ alter the natural production process, in terms of immuno production of interferon's and interleukin's thus leaving our "altered" immune system running at such an abnormally high level that it will then be capable of seeing these rogue cells it could never see before while running in the normal mode.   The 3M theory would then have this new immune system "on steroids " attack these heretofore undetectable cells and for the first time have the immune system itself destroy these rogue cells. 

3M had also hoped that Aldara and IQ would, in this process, reset the memory of this altered immune system to remember the sequence it used to identify these rogue cells so that in the future the process could be duplicated by automatically setting off an immune response on its own to eradicated these types of cells when ever they were first identified inside our bodies without the reuse of Aldara.

Sounds like a great plan to me but all is not well with 3M's theories for Aldara and IQ.

You see, where 3M went astray was counting on IQ to target just the desired cells of choice.  However, they learned very quickly IQ could not be designed to cause the altered immune system to seek out any specific cell such as just a virus cell or just a cancer cell.  It was indeed uncontrollable in every respect. 

Instead of 3M abandoning the IQ / Aldara project all together once learning of their inability to safely, through design, control the drugs negative impact on the normal immune system, 3M made the conscious decision to go forward with developing this drug.   Listen to the Director of 3M's Pharmaceutical Division at the time, Dr. Herbert Slade, as he testifies in deposition during my suit with 3M.

Dr. Slade states: the drug signal to the system is quite non-specific.  It doesn't have a signature, doesn't say you have a virus or you have a bacteria or even cancer.  It just says you have got something that is not supposed to be there, and have a look at it, do something about it ...

So, some 20-years later, Dr. Slade openly states that Aldara and IQ is not a controllable  mechanism of drug action.  It is non-specific in what it identifies for destruction.  It has no signature meaning it is not pre-set or pre-designed to go after any specific cell or antigen.  It can't tell if you have a virus, bacteria or even cancer.  So, it goes after anything and everything it sees in its path including good cells.  For this reason, 3M and Graceway must and do promote the lie and illusion for Aldara's drug action as remaining strictly a local response that is contained "in every instance" within the application site and is incapable of reaching blood circulation.

Now you know, in the simplest of terms, what Aldara is, that it is designed to reprogram your immune system through means of a drug induced alteration process that leaves the immune system in an extremely unsafe state of hyper operations.  That this newly altered immune system activity is capable of forcing your immune system to do things it never is supposed to do for the sake of safety.  And, that when these unnatural acts of immune activity are unleashed for lengthy periods of time (experts say 21-days or more) autoimmunity can be the results.

On the next page titled "WHAT IS  ALDARA AND IMIQUIMOD, REALLY" we will examine the pharmacological aspects of Aldara and IQ.  This is the information I maintain every doctor should know before he/she considers writing that next prescription for Aldara, in their practice.   Doctors knowing and wisely using this information to curb the use of Aldara, is the only hope we have for reducing the number of serious injuries each year to thousands of international victims of Aldara.   3M and Graceway have no desire nor incentive to do the right thing and take Aldara off the market.  The FDA has no authority left to deal with problems such as this and is totally in the pockets of Big Pharma, anyway.  So, the primary doctors have got to become educated on exactly what this drug is capable of doing to a vast portion of the patient population and then take the initiative to stop prescribing it in their practices.

 

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