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DIABETES TYPE 1 RESEARCH & WHY STILL NO CURE?
FDA CORRUPTION?
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Newsletter #10 – March/2015
I recently spoke with a former clinical research lab assistant about Dr. Faustman's BCG trials to cure Diabetes type 1 (D1).  I told her that even though there had previously been 20 years of safety testing on mice of this compound (BCG – Bacillus Calmette Guerin), and had been used safely by more than 4 billion people since 1928, the FDA would only allow repeat testing in Phase 1 human trials of what was already known.
          She was shocked.  But after some discussion, she raised some very good points, which are as follows: 
ROCKIN’ THE BOAT
1.    Take a look at the preliminary studies.  Was there something there that implied caution? The use of this drug should not have a negative effect on any of the body systems for the rest of the participants' lives.  
 
2.     Has it been indicated for the disease under consideration?  If not, then studies have to look at the effects of the compound on that particular disease.
3.     Going from mouse studies to humans is huge.  You might not get the same reaction in humans as in mice.
          Ahem, no small task.  Let’s start with the first point, possible negative effects in preliminary mouse studies.  
          Since 1900, BCG has gone through many trials and adjustments.  There were some problems in its early use but the contemporary strain has now been proven safe.  It has been used to vaccinate to over 4 billion people in world against TB(Tuberculosis) with an excellent safety record.  Ref:
A more recent preliminary mouse study was done in 1990.  In this study, BCG cured mice of D1 with a single intravenous injection, with no reported side effects.  ref: 
            Thus preliminary studies of BCG of both TB and Diabetes 1 have been performed with stellar safety results.  (Not only were the mice healthy in every respect, but the study with D1 cured the mice of that disease).
          Back to point 1.  The drug should not have a negative effect on any of the body systems…. 
            BCG has not had ill health effects on any other system in preliminary mouse studies, or in its human use.  Not in the over 4 billion people who have taken BCG to cure TB (tuberculosis) nor at the higher dosage to treat Bladder Cancer. 
Compare the doses between TB and Bladder Cancer:
Tuberculosis:               standard dose intradermally 0.1 mg at 0 and 4 weeks. 
Bladder Cancer           standard dose intravesical 81 mg 2 or 3 times per week for a year
As you can see, the dose for Bladder Cancer is much higher than for TB.  As well, an intravesical dose is more powerful than an intradermal one. however, we cannot assume Phase I human study would begin at the dose for Bladder Cancer because Cancer is a special case.  Even so, no ill effects have been observed in any of the other physical systems in its use for Bladder Cancer at that elevated dose and frequency.  Ref:  
 
 
Quote:  "To date, BCG remains as the most widely used vaccine worldwide and has been given to more than 4 billion individuals with astonishing safety records."
 
 
            To continue point 1, “…for their entire lives.”  Nowhere in the literature of methodology on clinical trials have I found this to be a concern.  The preliminary mouse trials are considered adequate.  Even though safety is always considered in all Phases, only in Phase 4 are long term effects required to be monitored.  Pls see chart below.  
 
        
 
 
Phase
Aim
Notes
Phase 0
Phase 0 trials are the first-in-human trials. Single subtherapeutic doses of the study drug or treatment are given to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs).[27] For a test drug, the trial documents the absorption, distribution, metabolization, and removal (excretion) of the drug, and the drug's interactions within the body, to confirm that these appear to be as expected.
Phase 1
Screening for safety.
Testing within a small group of people (20–80) to evaluate safety, determine safe dosage ranges, and begin to identify side effects. A drug's side effects could be subtle or long term, or may only happen with a few of people, so phase 1 trials are not expected to identify all side effects.
Phase 2
Establishing the efficacy of the drug, usually against a placebo.
Testing with a larger group of people (100–300) to see if it is effective and to further evaluate its safety. The gradual increase in test group size, allows less common side effects to be progressively sought.
Phase 3
Final confirmation of safety and efficacy.
Testing with large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.
Phase 4
Sentry studies during sales.
postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use. As such, they are ongoing during the drug's lifetime of active medical use.
           
Think about it.  If preliminary mouse testing takes about 5 years and testing on humans in all phases takes at least 10 years, then waiting until the entire lifetimes of participants, say 40 or 50 years, that would put the drug on the market in 55 or 60 years?  Is that what has happened to most life-saving drugs in the past?
 
          In recent times, pharmaceutical companies/FDA have been known to study new drugs for as little as 6 months before passing them.  Some which later turned to be extremely harmful.  Ref:
www.drugwatch.com
 
under "General Information"  So why the discrepancy?  Why is the FDA dragging out the methodology of Dr. Faustman’s study so extremely while other drugs are passed so quickly?
 
        Point 2.  Has it been indicated for that particular disease?  If it hasn't, then studies must address the new disease.  
        BCG has been indicated for TB and for Bladder Cancer, but not for Diabetes type one.   (Google Pharmacology, BCG)  This means doctors will not prescribe BCG to treat D1.  Often this is because preliminary studies have not been done of the compound on the new disease or that exact dosing and frequency have not been determined.  
Theoretically doctors can prescribe a drug off-label if they feel it could help based on the existing medical literature.  But most doctors will not prescribe bcg for D1.  This is very strange considering the medical literature is clear.  My guess is that the exact dosage isn't known, and variable blood sugars from an untried drug are not something doctors want to risk.  Thus the dosing schedule must first be determined under close scrutiny.
            As mentioned before, the 1990 study focused specifically on effects of BCG on Diabetes type one and insulin production in mice. 
            Dr. Faustman’s studies also focused exclusively on the effects on D1.  In those studies, she used not BCG but a similar substance called Freund’s adjuvant.  Freund’s adjuvant cured mice of D1 by killing the killer T cells responsible for attacking the pancreas.  Because Freund’s adjuvant is not used on humans due to of dangerous side effects, Dr. Faustman then sought a safe drug that would have the same effect of killing T-cells, and that was BCG.  And we’ve already proven BCG is safe for human use in both low and high doses.
            
            Thus pre-studies and Phase I human study have focused specifically on effects on D1 in order to be indicated, and all tests have shown an undisputed safety record of BCG in treating all diseases it’s been tested for.
However research trials also have a mandate of proofing efficacy as well as safety.  And as we will discuss later, it seems Dr. Faustman's Phase I was not normal in important ways, and the proposed Phase II is also questionable. 
Point #3.  “Going from mouse studies to human is huge.  Reaction in humans may not parallel mice.”   
Studies going from mice to humans have already been done using BCG on both TB and  Bladder Cancer.  Dr. Faustman’s Phase I studied BCG’s effects specifically on Diabetes 1 in humans.
In phase I, the dosage allowed was the TB dose:  BCG 0.1 mg at 0 and 4 weeks.  In all of over 4 billion people treated so far with BCG for TB, there has never once been reported any effect on D1 or any untoward production of insulin, either too much or too little. 
In the case of too much insulin, you have an insulin reaction.  As diabetics know, a reaction has profoundly unique symptoms and would have at least once been noted and reported in over 4 billion bcg tb shots worldwide!
One wonders why, since the TB dosage was already known NOT to have an effect on Diabetes 1, that Phase I didn't begin with a higher dosage or frequency.  In other words, why such a small dose for Phase I, and why not at least one more dose in succession due to no effect on D1 in the past?  It's common practice to avoid Phase I if adequate safety data is available on humans, which there is.
 
SAFETY VS EFFICACY
In descriptions of Phases of clinical research, efforts focus on two issues of a compound – safety and efficacy.  The mandate of efficacy means that there should be some effect on the disease studied.
Mandate of efficacy
            In the 1990 preliminary study of BCG on diabetic mice mentioned previously, one dose cured mice of D1.  That dose was:
 “a single intravenous injection between 0.25 to 1 MG of BCG,” source:
When you extrapolate the mouse dosage to humans by weight, if on average a mouse weighs 30 g, the amount transposed to a human weighing 70 kg. would be 2333,333 mg of BCG!   Compare this to a human dose of BCG for Tuberculosis:  0.1 mg of BCG at 0 and 4 weeks.   Just a little out of whack, wouldn’t you say?  
We’re not suggesting beginning a study such as Phase I with this high a dose.   However we are giving this as an example, linking to other doubts about small dosage of both Phase I and the proposed Phase II, that there may NOT be good scientific reasoning happening here on the part of the FDA.  
(For a more detailed description of an ideal methodology, please see our previous newsletter here:    http://hdiabetes.com/blog/78-methodology-cure             
Doesn’t it seem logical to you that Phase I could have begun with one more dose than the standard TB dose?  What scientific reason prevented the FDA from allowing a larger or more frequent dose in Phase I?  Is this good science to just turn a blind eye on the work that has gone before?  You have to wonder why the negotiations are done in secret.
CONCLUSION OF PART ONE
            Nothing in preliminary studies has shown safety concerns.  Nothing in BCG’s human use has shown safety issues, either in body systems or in its effect on Diabetes 1 and insulin production.  Also in going from mouse to human studies, the fact that the lower TB dose was used instead of at least one more dose shows caution in the extreme.  Maybe even caution without reason.  Especially since the much higher dosage used regularly in Bladder Cancer has not shown any health concerns, and indeed, has engendered the remission of that disease in a high percentage of cases.  Ref: 
           In many cases when a drug has a proven safety record, the FDA will allow pharmaceutical companies to jump directly to Phase IV to test for another disease.  
 
Again this procedure was not followed, likely because  BCG has no patent on it and wouldn't make money for pharma companies.  But there is no reason why Dr. Faustman's trials couldn't have moved directly to Phase II because of a proven safety record.
EXACTLY WHAT YOU TALKIN’ ‘BOUT?
Phase I may be excused for Dr. Faustman’s first human study of BCG on D1.  Maybe the FDA wanted a baseline reaction in biomarkers.  (Who am I kidding?)   However the small dosage allowed by the FDA in Phase II raises questions about the reasoning of the FDA and what they base their decision for Phase II on.
Following are the differences between Phase I and Phase II.  Note the differences in frequency.  (All doses are a standard strength of BCG).
Phase I   -   2 successive doses, 0.1 mg at 0 and 4 weeks apart.   (completed)
Phase II  -   6  doses in 5 years, with successive doses 0.1 mg at 0 and 4 weeks     apart only in the first year.
            Results of Phase I are as follows:
“Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion.”    
 
                  
You could say that Phase II IS an increase in dosage, but what drug is testing by the year instead in successive weekly doses?  If Phase I showed such a small improvement with 2 successive doses, then maybe the change in biomarkers were from having the doses in succession.  Why then test by the year instead of by the week, if what has worked before has been doses in succession?
As we have seen, the safety of BCG has been proven at the TB dose.  So if there was very little effect on insulin production in Phase I -- i.e. small transitory internal insulin production, then why continue to conduct methodology of Phase II at way below effective levels?
Let me put this another way.  If Phase I did not have an effect on insulin production, why would we assume 5 successive Phase I’s in a row will have any greater effect?  Especially since the effects of BCG leave the body within two weeks!
And how do we know the effects of BCG are this transitory?  By the existing treatment for Bladder Cancer, which is a standard dose 2 or 3 times per week for up to a year, or longer.  Might it be given this often in order that the therapeutic effect builds on the previous dose to maintain effectiveness?  If it wasn't given this often, would the effect then wear off?
So I ask again:  what is preventing Phase II from having 3 or 4 successive doses weeks apart, or even weekly?  The ideal methodology, as we described in our last newsletter here:   http://hdiabetes.com/blog/78-methodology-cure    
 
 
By disallowing successive doses in Phase II, giving yearly doses instead of weekly, and allowing only fixed dosing, isn’t the FDA aborting / preventing the mandate of Phase II to test for efficacy?  Can the FDA provide us with a scientific reason for this decision?  Are they once again not allowing what has scientifically gone before?  Are their decisions even based on science?
 
 
WHO TO BELIEVE?
Getting back to Dr. Faustman’s Phase II, we know she wanted a methodology that would have an increased dosage and/or frequency from Phase I. 
Quote:  “The prospect of a cure  A Phase II study, which will explore higher doses and an extended dosing schedule, is currently being planned.”
Quote:  “Since she observed an increase the number of these dead cells after both doses of the vaccine, she also believes that the dose they used in the study is probably too low.     http://asweetlife.org/feature/faustman-lab-research-how-excited-should-you-be/#sthash.3NMHKpYe.dpuf
Please see other quotes and interviews of newsletter #8  click here:
        The ideal dose in Dr. Faustman’s patent, is BCG 2 or 3 times a week for a minimum of 40 days, up to 6 months.  Ref, patent:
This dose is not necessarily what Phase I or II should begin with.  It instead is the ideal dose -- it is what human studies would work up to.  However the dissimilarity to Phase I and II is striking, almost painful.  It certainly raises questions, the major one being: 
Shouldn’t tests be as similar to the patent as possible, i.e. having weekly doses instead of yearly?  Even if the FDA was concerned with long term effects, why not dose consecutively in the first year, and then follow it for 4 years?  Is this good science, or is it stalling?
Wouldn’t Dr. Faustman, of all people, know what is both an effective as well as safe dosage?  Dr.  Faustman is a leading doctor and research scientist.  She is among the best of the best in the world.  As anyone who’s heard her speak, she knows what she’s talking about.
            It’s interesting to think that if she and her colleagues at the Immunology Dept. at Harvard were on the board who advised the FDA on methodology of Phase II instead of the pharmaceutical reps, they would have recommended a higher dose to the FDA than what the Pharma reps did.  Who would you sooner believe:  Dr. Faustman and colleagues, or profit motivated Pharma?
OTHER POSSIBLE OBJECTIONS
What else could the FDA be thinking?  What elevated and far-sighted reasons would the FDA restrict Phase I and the proposed Phase II?  The only thing I can think of is unpredictable insulin regeneration.  If participants are still taking insulin, and internal insulin levels would rise with therapy, then there could be unexpected and unpredictable rise in insulin levels, resulting in reactions.
First of all, participants in Phase II would be well monitored with a CGMS.  Secondly, we as Diabetic 1’s are familiar to our core with unpredictability.  We deal with it every day of our lives.  We know how to monitor and read the signs of low blood sugars. 
            Phase II is expressly for determining the dosing schedule of the compound.  Therefore the efficacy of the drug must be explored at a more intense dosing schedule than before.  Certainly when internal insulin production comes on board, it IS advisable to be cautious; but it isn't a reason for the FDA to restrict dosing of Phase II at way, way below efficacy, especially on a proven and tested drug.
HUSH, HUSH
           
         After exploring all the reasons the FDA might have ruled against a reasonable methodology for both Phase I and II, I can’t seem to get out of my mind that the FDA might be playing stalling games for what they've been accused of before – the profit motive.  It’s no secret that their advisory boards are made up of Pharma employees, and that there is a revolving door of people first working for one and then the other, suggesting collusion.  
            Our readers are also familiar with other antics of both the FDA and Pharma such as 1.  Contracting trials with researchers who had no qualifications.  2.  Ignoring trials that found unsafe results.  3.  Paying for trials, thereby having total control of what information was released to the public.  4.  Intimidating researchers and other employees to pass drugs that were known to be harmful.  And this just scratches the surface.  Please see our newsletter:  The FDA and You:  Up Close and Personal here:
and   www.drugwatch.com    under ‘General Information’
                           
            Thus if, as it has been alleged, the FDA is run by Big Pharma, and Big Pharma’s main motive is the profit motive, then it’s probably the reason behind the FDA’s decisions too.  We all know too well that Pharma refused to fund Dr. Faustman’s studies because BCG doesn’t have a patent on it, and its use wouldn’t have a return if a cure was found.  Also profits from diabetic supplies and drugs are absolutely huge compared to what Pharma would make if a cure for D1 was found.
            So could there possibly be faulty methodology in Phase II?  The FDA doesn’t have to give their reasons for any decision they make, scientific or otherwise.  They won’t tell us because they don’t have to.  There is no accountability for the FDA’s decisions.
            If you think the FDA is looking pretty ugly right now, there is another ground-breaking study that says more about the FDA than the actual test results, and those results are pretty astounding all by themselves.
Did the Earth Move for You?
            In this 1994 study, 17 human subjects who were recently diagnosed with D1 were given one dose of BCG.   Of those subjects, 65% had remission of Diabetes 1 !!!  It was recommended by the researchers at that time that further testing begin “without delay” on the D1 population.  (My God, how innocent we were then!)
Guess what happened to that study?  Well, it wasn’t actually buried, because you and I can access it on the internet, at least as of this writing.  But I didn’t hear about it.  Did you?  Apparently the medical establishment knows about this study, which makes medical personnel all the more culpable that it was never followed up on.
  You can buy it here or see the synopsis:
www.thelancet.com/journals/lancet/article/PIIS0140-6736(05)62100-9/abstract
In other words, Phase I or even Phase II could have started in 1995!  This is more than bad science of not being aware of previous scientific work, especially this ground-breaking precedent of curing D1 in humans.  This sounds like a cover-up, using scientific protocol to hide evidence. 
The FDA is well within its rights however, because no agency, whether Pharma or government has an obligation to publish any information.  In this case it was published in the Lancet, but not acted on.  And the reason for this likely was, as we’ve seen before, that Pharma would not sponsor further studies because a cure would not make money. 
 
I wish I could say they’d been caught red-handed, but that’s the system – that’s how it works.  It’s not criminal in any way.  But it sure feels like it is!
           
A PUBLIC STUDY
            If the FDA does not have to provide reasons why it is being unreasonably and unscientifically restrictive in its methodology of Phase II, then what is to prevent the FDA from legislating bad methodology forever, and indefinitely preventing the cure from being proven?  We’ve seen a motive.  
            If we do what we’ve done before, the FDA will only do what they’ve done before – profit mongering. 
            Phase II negotiations are still going on right now.  This means that what the FDA wants is different than what Faustman wants for Phase II.  If the FDA wins, they can go against the good judgment of non-Pharma experts, and we will spend another 5 years studying something we already know.
            Or we the public can stand up with Dr. Faustman against greed and profit mongering and tell the FDA what we want.
Dr. Faustman is doing all she can in negotiations with the FDA right now.  However the fact that she is one of the most respected researchers in the world does not affect the FDA’s decisions in any way.  The FDA can rule whatever idiotic methodology it wants to with no explanation, no justification.
            This is a publicly funded study, people.  How many more bike-a-thons and walk-a-thons have we done to raise millions, and we’re still not at our goal.  How many would we be motivated to do at the end of Phase II in 5 years, if the results are as miniscule as Phase I?
            Wasting time and feeling helpless in the face of Stupidscience is what Big Pharma wants. 
            Now- right now – is a nexus point.  A turning point from which these studies can progress.  But Dr. Faustman will follow protocol, and will do what the FDA rules. 
She didn’t have to take on this impossible challenge.  She’s doing this for us.  And now she needs our help.  Because there is only one way the FDA will even know what we want, and that is to tell them.
ARMCHAIR ACTIVISM?
            What if readers would post their feelings about the insane restrictions on Faustman’s Phase II trials on the FDA’s facebook page?  Challenge the administrators to show their understanding of previous scientific research and scientific procedure by stating publicly exactly their reasoning for what looks like a decision based on anything BUT reason. 
            Questions we need answered are:
What scientific reason was Dr. Faustman’s human trial not begun with Phase II or Phase IV, considering that safety data on BCG has already been completed?
What scientific reason is Dr. Faustman’s Phase II not allowed to have 3-4 (or more) successive doses of BCG?
What scientific reason was Dr. Faustman’s Phase I not allowed the full number of participants, i.e. 8-20?
            If the answers are not forthcoming, then we need to deeply question “why” and if they have anything to hide. 
            Some comments you could post on their facebook page include:
“FDA, let Dr. Faustman use a reasonable dosage for Phase II.  What are your reasons?  Let science speak for itself!”
            “Why no reasons for your decision on Phase II?  What are you hiding – your lack of scientific knowledge?”
            “Let science speak for itself -- what are your reasons for restricting Dr. Faustman’s Phase II methodology?
            “What kind of science are you allowing FDA?  Tell us your reasons for restricting Dr. Faustman’s Phase II.
            Then watch your posts and see if they get removed.  If they do, put them up again.
            Why shouldn’t we be answered reasonable questions??  We deserve a reasonable response to a reasonable question; science is science, right?  You can also put a link to this newsletter for further reference.
            It would be nice to have scientists and doctors on our side; we welcome their opinions on this debate, and in fact need their feedback.  But we realize it’s very dangerous for highly educated people to speak out.  So many doctors who have discovered cures have had their medical licenses taken away from them or have been taken to court in an attempt by the Pharma establishment under the guise of government agencies to break their spirit.  Also some scientists and activists have been found dead under very suspicious circumstances.   
            However we know this will NOT happen to Dr. Faustman because it will be just too obvious what Big Pharma and its puppet the FDA are doing, considering the circumstances.  And we the public WILL NOT forget.
            If anything happens to her, the FDA will be setting the stage for its own demise because it will make the public even MORE aware of its deception and damage to the social fabric.  The blood of alleged slain activists already cries out for justice. 
Dr. Faustman is beyond reproach.  She has taken on this impossible task even though she DIDN’T HAVE to.  She’s taken this on because she wants to make life better for D1’s – she’s taken on a compassionate endeavor amongst a ruthless industry.  And a non-profit endeavor in a for-profit world.  She deserves our help in making Phase II have reasonable methodology instead of a sham.
In addition to stating the FDA’s scientific reasons for the above questions (in understandable layman's language, under 5 pages per question), it is not unreasonable to demand 4 – 6 consecutive doses at 0 and (1 or 2 or 3 or 4) weeks or twice a week, all the while taking biomarker readings.  There is NO safety issue at this level.  Is there FDA?
As well, most trials allow adjustable dosing depending on biomarkers or other diagnostic testing.  (See newsletter #9).  This would be ideal, but may not be necessary at this stage.  
As well we must demand that Phase II have 100 – 300 participants, as the table on page 2 states is allowed for every study.  As you may know, Phase I asked for 12 participants, (even though Phase I is usually allowed 20 – 80 participants) and was granted only three, for no reason.  We must be vigilant that the number of Phase II remain at what Dr. Faustman requests and that it approaches what should be allowed any other study 
CONCLUSION
            In many areas of our society now, more than ever before, injustices are being brought to public attention.  The paradigm of the strong having power over the weak that has allowed rulers to coerce the public for centuries, is shifting.  Instead public knowledge and public opinion is creating positive change where rulers in every sector are negligent or are damaging to society in some way.  (See www.avaaz.org)   The public is nudging its way to employing direct democracy by petitions, marches, economic actions, peaceful protests and in a growing number of cases, litigation. 
            But it’s not without work and involvement on the part of the public….   and we hope that you will help in this worthy cause.    
              The growing record of documented abuses stands against Big Pharma and their puppet the FDA as proof they feel they are above the law.  It’s proof that in these cases, their science is not science at all, but an illusion, a sham, a lie that keeps doctors tied to the process of the lie.
It is my hope that one day soon, doctors will begin looking at this issue with open minds and that they will lend their voices to those already questioning the practices and decisions of the FDA.  For it is in the darkest corners that we must shed the most light.  And to this end I ask our readers to add to this tide of light that’s already rising.
            If doctors are unable to speak out at this time, then we must lead in this effort.  They have more to lose than we do.  So let’s start.   Here is the FDA’s facebook address.  Take a look at it first.  See how everything’s so orderly.  Let’s get some questions happening in the minds of all the people visiting and reading this page.  If you need not to be traced, you can go to the library, or find other ways not to be traced.
 
            Keep the end goal in mind – that the FDA must answer the above questions in understandable laypersons language first.  If there are no good reasons forthcoming, then veracity of the FDA's scientific advisors will be called into further question.
        Also the end goal is that Dr. Faustman can use all the scientific precedents that have gone before, and that Phase II be allowed successive doses depending on biomarkers.  There should be at least 4 - 6 consecutive doses preferably every week, but not more than 4 weeks apart.  Considering the studies that have gone before, this is not too much to ask. 
           
            If we work together, we can do this.
 
If you didn't read yet our article about methodology importance, you could read it. The Importance of Methodology in Curing Type 1 Diabetes or Other Disease
 
 
 
Sincerely and Respectfully,
Editors, Hdiabetes.com
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