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The global threat of drug-resistant infections: a breakthrough solution from evidence based homeopathy (ContraFlu)

 

SUMMARY

Nobel laureates say that drug-resistant infections is threat #1 to humankind that can be mitigated by science (link). According to experts, drug-resistant infections (super-bugs) can kill 50 million people annually by 2050 leaving cancer behind (link, scientific link).

The pharmaceutical business has no either working or prospective solutions to tackle this threat, including the threat of pandemic influenza.

The rescue can come from homeopathy: Contraflu is the first representative of evidence-based homeopathy, an innovative product with global patent protection (for details, visit www.contraflu.com).

Developer and holder of IP right on Contraflu is looking for investors to perform the pivotal clinical trial of the product in influenza. After marketing approval of Contraflu in the EU, the rights on the product will be sold to a company ready to commercialize it.

 

 

Brief analysis of facts and history

 

 

- The only cause of super-bugs is … antibiotics that stimulate bacteria to adapt and develop resistance. Hence the most deadly infections are those contracted in hospitals. Antibiotics are routinely used in animal husbandry to speed up weight gain; from this source they contaminate meat and water (through sewage); they generate super-bugs at the farms (look at content of antibiotic-resistant bacteria in meat, 2011 data, link). Another field where antibiotics are overused is the treatment of common cold and flu. Though antibiotics are useless in these illnesses caused by viruses, they are still routinely prescribed ‘to prevent secondary infections’.

- Why are there no drugs against super-bugs? First, the Pharma doesn’t find them profitable enough to develop (that is, making profits on overuse of antibiotics is OK, and taking on responsibility about emergence of super-bugs is not). More importantly, the Pharma just cannot develop new effective medications for drug-resistant infections because it has lost in this arms race due to its flawed scientific mindset. The flawed pharma’s paradigm can be formulated as the following: the human can be reduced to physical body, and regulation in the body – to chemical signaling (link).

- The issue of epidemic viral infections threatening the mankind is also gloomy. Seemingly, there are antivirals (Tamiflu for influenza, the major threat) and vaccines. But how effective are they? Can flu vaccines and medications be relied upon?

Here are the facts:

1) According to the most respected experts in evidence based medicine, the real life effectiveness of flu vaccines is very doubtful (link); according to another study performed in the USA, flu vaccination increases the risk of flu-related hospitalization and complications (link); the studies of vaccine efficacy suffer from strong conflict of interests, as independent researchers report (link). Recent research has shown that flu vaccination impairs immunity to influenza in subsequent years (link).

2) There are objective obstacles in development of both flu vaccines and medications; they are related to the properties of flu viruses (link).  Influenza-like illnesses during flu season are caused by 200 different viruses; influenza viruses account for about 10% of the circulating viruses.

3) Let’s look at the existing flu medications: the OTC products don’t even deserve mentioning, they are proven ineffective in either reducing disease duration or the rate of complications (link). As to the “last hope”, neuraminidase inhibitors (oseltamivir-Tamiflu): the grounds for inclusion of this medication in all international flu treatment standards now appear to be falsified. This was discovered by Cochrane society in 2014 (link). In fact, Tamiflu reduces disease duration in flu by about 12 hours and provides no protection from flu-related complications or hospitalization. However, after this finding of fake efficacy had gone public, nothing changed with Tamiflu status as the “golden standard” of flu treatment.

What does this all mean? “The King” (medicine headed by pharmaceutical business) appears to be naked. The mankind in general and each of us personally are not protected from the threat of pandemic influenza like ‘spanish flu’ that killed dozens of millions in 1918.

What about those whose duty is to provide the solution (regulators, healthcare professionals, pharmaceutical business)? Obviously, they hope for a good fortune.

Take home message:

None of us and personally you are protected from neither super-bugs nor the threat of deadly pandemic flu; what’s more, today’s medicine offers no protection from them.

 

The history that has led to the current state of affairs

The story began in early 20th century, with rapid development of pharmaceutical business that originated from large chemical and petrol companies (link); in the 1920s, the pharma took control over the medical professional community (in the USA) through control of medical education; later on, it pushed all competitors out of the market: the major competitors were homeopaths and chiropractors (there are several books on this topic, link to one of them).

By late 1950s, the pharma had gained total control over medical education, biomedical research, decision making and policies in healthcare, as well as public opinion on all of the above issues (a book by Marcia Angel, a book by Ben Goldacre).

With this, as statistics show, mortality from the major chronic diseases (cardiovascular diseases, cancer, diabetes) has not changed much over the last 50 years. On the other hand, iatrogenic causes (consequences of wrong medical procedures) have become one of top killers in developed economies like USA (link). Today’s pharmaceutical business boasts super-profits, while medicine has turned into profit-driven business on diseases.

 

The brief story of influenza:

- pandemic ‘Spanish flu’ killed about 50 million people (link); most deaths were due to secondary bacterial infection (pneumonia) (link).

- the first flu vaccine was manufactured in the 1940s; it was tested in the US army and found ineffective in preventing flu (link); it failed again in the pandemic of 1957 when flu killed about 1-2 million people globally. Nevertheless, these failures didn’t prevent further active introduction of flu vaccines.  And they are still marginally effective today (Cochrane review).

- Today’s over-the-counter flu drugs based on acetaminophen (paracetamol) were first synthetized back in late 19th century and first approved for marketing in the 1950s. Since then (for more than 60 years) almost nothing has changed in self-treatment of flu. Fever reducers have been proven not to affect flu duration or severity (link); what’s more, acetaminophen is one of the most important drugs responsible for predictive drug-induced liver injury in the world (link).

- The 1990s saw marketing approval of prescription drug oseltamivir (Tamiflu); Cochrane review published in 2014 (link) revealed that its effectiveness had been overstated (to put it mildly), and in fact it works just a little better than homeopathic Oscillococcinum. However, since late 1990s doctors, decision-makers and patients have been in a state of groundless security, a false perception that influenza treatment is at hand. The reality is something opposite.

 

The brief story of antibiotic resistance

(Source: a book by Sebastian G.B. Amyes ‘Magic Bullets, Lost Horizons. THE RISE AND FALL OF ANTIBIOTICS’, 2001, ISBN 0-203-34645-9; ‘Bad Bugs, No Drugs. As Antibiotic Discovery Stagnates ... A Public Health Crisis Brews. Infectious Disease Society of America, 2004):

- Antibiotics (penicillin) were first put into practice in the 1940s; the issue of resistance first emerged in the 1960s, with wide use of antibiotics in transplant surgery.

- The “Arms race” between manufacturers of antibiotics and bacteria ended in late 1980s with victory of MRSA – methicillin resistant staphylococcus aureus; later the list of winners expanded to include other dangerous bacteria (enterococcus, klebsiella, etc.). Some bacteria also developed resistance to antiseptics – agents designed to limit the spread of infections inside hospitals.

In the USA, 80% of sold antibiotics are used in animal breeding to speed up weight gain; due to this fact more than 50% of meat and meat products are contaminated by antibiotic-resistant bacteria (2011 data, link).

The super-bugs, bacteria resistant to all antibiotics, are no longer limited to hospitals as it used to happen 10-15 years ago; they are able to spread within groups of generally healthy people (for example, US athletes (link).

Over the last 20 years pharmaceutical companies have closed development of new antibiotics due to economic reasons, including their insufficient profitability (link).

Accordingly, you have measurable chances to catch a deadly bacterial infection in the following cases: 1) if you get into hospital (due to any cause); 2) if you get complicated influenza; 3) if you have a chronic condition with impairment of immune system (then you have a high risk of events #1 or #2); 4) if you regularly eat processed meat (in addition to risk of bacterial contamination, you have a higher risk of problem #3).

 

What measures are proposed by governments to fight drug-resistant infections, bacterial and viral?

- spend more money on development of antibiotics and antivirals;

- look for new incentives to pharmaceutical companies to facilitated R&D activities in this field;

- limit the unnecessary use of antibiotics.

It’s obvious that antibiotics cannot be completely abandoned in animal husbandry, since otherwise this branch of economy may be brought to the edge of unprofitability.

NO MORE PROTECTION, no more solution either for persons or for communities or nations.

 

Does humankind and each of us depend that much on the good faith of Big Pharma? Does this good faith exist at all, bearing in mind that Big Pharma is profit-driven and thus pursues only its own goals?

Does the humankind have no other way out of this deadlock?

 

Let’s look at the following question: what does the outcome of any infection depend on?

Any infection is a process and result of interaction between a microorganism (bacteria, virus) and macro-organism (our body). And at least 50% (in fact, somewhere about 90%) of the outcome is determined by how strong the body’s protective forces are and how adequately they are employed during the infection. This is not just a logical assumption; this statement has a sound scientific proof.

An outstanding discovery in this field took place in 1998 and was awarded Nobel Prize in medicine in 2011 (link). This was discovery of receptors of innate host response that determine the effectiveness of the first, the fastest line of defense from pathogens. It is those receptors that are responsible for the first 5-7 days of the infection, and for turning on of the slow-acting and long-term adaptive immunity (link). Excessive activation of these receptors is responsible for septic shock (link).

What are the mechanisms behind lethal flu?

- High lethality of pandemic influenza is connected with secondary bacterial pneumonia caused by bacteria generally present in the airways (streptococci and pneumococci) (link). These bacteria are usually well controlled by the immune system. The major reason why they turn into dangerous killers is the body’s response altered by the preceding influenza.

Normally, flu virus induces fast-acting innate response through special receptors called TLR3. TLR3 binds virus-specific molecular pattern (viral RNA) and activates to limit viral replication locally on the one hand, and recruit adaptive slow-acting specific response necessary to clear the virus from the body – on the other hand. The second arm of this response involves general inflammation, and it is responsible for general symptoms of flu (fever, malaise, head and muscle aches, etc.). Infection severity depends on how balanced these two arms are: if the inflammatory arm is over-activated, the symptoms are severe.

The innate response to bacteria is somewhat similar, but it is launched through other TLR receptors detecting bacteria-specific molecular patterns (link).

What happens to this response in lethal secondary pneumonia?

1) After influenza infection, bacteria-specific TLRs become ‘blinded’ to bacteria (link), that’s why they fail to launch the first arm of response designed to locally contain bacterial replication and spreading.

2) The general inflammatory arm of response to bacteria, on the contrary, appears excessive and overwhelming due to earlier priming with influenza, and it actually becomes the cause of death (link).

Thus, whether the body would develop deadly secondary pneumonia, depends rather not on the presence of viruses (viral infection may pass without symptoms at all) or bacteria (which are commonly present in the respiratory tract), but on the adequacy of the body’s innate immune response. And the host response (for example, TLR activation) is recognized an important and promising target for therapeutic intervention in infectious diseases (link), probably more important than any molecular targets within the pathogen.

However, the scientific paradigm introduced by the pharma has its in-built limitations for drug development.

Bearing in mind the huge resources available to the Big Pharma and the above-mentioned discoveries, over the last 20 years the pharma should have launched numerous effective medicines from all kinds of infections – medicines that are not vulnerable to any drug resistance because they target the host response.

But what happened in reality? As of 2016, there was only one marketing approval of a product targeting innate host response: this was Imiquimod, a medication for topical use that targets TLR7 designed to treat warts (link). Interestingly, imiquimod was first synthetized as long ago as in 1985 (link).

Thus the pharmaceutical industry has proven its bankruptcy.  

 

Let’s give a brief overview of the situation:

1) The humankind is threatened by deadly incurable infections, bacterial and viral, including pandemic infections, influenza being #1 of them. Over the next 10-15 years they can kill dozens of millions. These infections are even more probable and dangerous with the current worsening of socioeconomic conditions, with debt and migration crisis.

2) The society is misled by the pharma industry regarding the available means of control over the grave situation (with illusions about effective vaccines, drugs, and ongoing successful development of new medicines).

3) The situation is caused by criminal activity (making profits on abuse of antibiotics) or inactivity (lack of R&D efforts) of the Big Pharma.

4) The Big Pharma has proven its scientific and technological incapacity in development of new tools against deadly infections, despite the breakthrough discoveries in basic science.

5) At the same time, the Big Pharma controls the ideology of biomedical sciences, trends of scientific research, education of healthcare professionals, experts, and the policies in health care. As a matter of fact, the Big Pharma does everything to suppress alternative methods designed to solve the problem. And the motivation behind all this is keeping its super-profits as high as possible.

6) What’s more, the Big Pharma is responsible for one of the major causes of mortality in high income countries – iatrogenic causes (wrong medical treatment).

 

What solution do we see?

- any complex, long-term and multiple-factor problem cannot be very simple. It obviously demands a complete change of the mindset that created the problem (according to Albert Einstein, link).

- the problem of drug-resistant infections is created, in the first place, by the monopoly on truth established by the Big Pharma. This monopoly has resulted in suppression of all alternative opinions, approaches and technologies.

- one of these suppressed alternative approaches is homeopathy – a branch of medicine working effectively for over 200 years and based on a holistic understanding of human nature.

Advocates of the Big Pharma use the concept of “evidence based medicine” to claim that homeopathy lacks proof, contradicts the basic principles of science, and is even quackery.  

These accusations can be easily repulsed as soon as one answers the following three questions:

1) The real life medical practice is based on the products of the Big Pharma – how does it complies with the principles of evidence based medicine if more than 70% of prescriptions are made not in line with (against) the principles of evidence based medicine (link), that is without proof?

Interestingly, back in 2003, Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline (GSK) admitted that most prescription medicines do not work on most people who take them (link). He literally said the following: «The vast majority of drugs — more than 90 per cent — only work in 30 or 50 per cent of the people. I wouldn’t say that most drugs don’t work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don’t work in everybody.»

 

2) How effective and safe is the medical practice based on the products of Big Pharma if it cannot cope with the major chronic diseases on the one hand, and serves one of the major causes of mortality – on the other hand?

3) How sound is the scientific basis of the “pharmaceutical medicine” if it uses the following simple axiom as the starting point of its foundation: “regulation in the body can be reduced chemical signals” (link). Literally it reads as the following:

“Chemical signalling is the main mechanism by which biological function is controlled at all levels, from the single cell to the whole organism.”

 

 

There is a branch in homeopathy that has attempted “to play by the rules” of the pharmaceutical business: use homeopathic medicines without the similia principle, only based on the formal diagnosis (the name of the disease). This branch is represented by actively developing businesses; their products are in high demand of consumers. This demand rising at 20% annually rather reflects the problems of effectiveness and safety of the Big Pharma’s products. We admit that these products don’t have sound proof of efficacy.

We are putting into practice our proprietary technology that can combine the advantages of homeopathy and the deep knowledge of molecular mechanisms of diseases accumulated by biomedical science over the last decades. This technology enables development of medications for specific conditions with the use of evidence based methods and homeopathic manufacturing.

The first product developed with the new technology platform is designed to solve one of aspects of drug-resistant infections – influenza and influenza-like illnesses. It combines three features most demanded and valued by the patients: safety, proven efficacy and low manufacturing cost.

We have succeeded in attaining the task that the Big Pharma is failing at: develop a remedy regulating innate host response to viral infection. Based on the breakthrough discoveries in the field of Toll-like receptors, we have created an innovative remedy having absolute novelty and global patent protection, Contraflu.

We have accumulated proof of efficacy and safety sufficient to perform the pivotal clinical trial of Contraflu. What proof is this? 1) Contraflu considerably reduced influenza duration and severity in mice; 2) In a placebo-controlled clinical trial, Contraflu considerably reduced the duration of respiratory viral infection (common cold) in patients with more severe onset symptoms, and was as safe as placebo (link).

The overall investment in Contraflu development has amounted to 2 mln Euro; everything is ready for the clinical trial in Belgium and France; the investment necessary to bring the product to marketing approval in the EU is 1,5 mln Euro.

The total cost of Contraflu development (within 4 mln Euro) will be two orders of magnitude less than usual costs incurred by the Big Pharma for development of their products (at least 1 billion USD).

The product is protected by patents in the USA, EU, China, and Canada, and is patent pending in India; Cont®aFlu trade mark is registered in the largest countries.

After successful pivotal clinical trial, the rights on Contraflu as the product and global brand #1 for flu will be bought by one of the largest pharmaceutical companies. This will become an important step towards global recognition that homeopathy is an evidence based branch of medicine; probably, this will help in revising the “chemical” ideology of today’s medicine.

We are looking for an investor in the pivotal clinical trial (with exit in 3 years with IRR>150%) or a partner ready to buy the rights on Contraflu right now.