The Semmelweis Reflex

How Pharmaceutical Giants Slumber Away Their Future

The year of 2015 is going to be another fateful year for the pharmaceutical business already plagued with substantial problems. Major drugs including some bestsellers are coming off patent, among them sales giants such as Lantus, an insulin medication, (almost 5 billion USD annual sales) and the anti-depressant drug ABILIFY (almost 4 billion USD). These and many other medications reach the patent cliff, as the industry calls the notorious and feared moment when their patents expire and generics begin to steal away important parts of the profit pie. No one knows how much revenue the Pharma Giants will lose next year, but it is definitely going to be substantially more than the industry can gain with new drugs and other innovations. In 2015, flagships worth 60 billion in annual revenues unleashed in a world without adequate controls and into the competitive marketplace with omnipresent copycats.

Even the greatest among the drug manufacturers tremble while facing their “Dooms-day”, when one or several of their blockbusters has to start grappling with cheap imitations, and their secure profits begin to vanish into thin air. The entire industry must reinvent itself, and analysts predict that up to 50,000 jobs will disappear in the next few years, and this is predicted to happen in a business that was thriving until recently. Lots of money and energy is therefore being invested in laboratories and R & D departments, where scientists and pharmacologists are working feverishly to find ways and means to extend the patent protection of the money-making block busters. An extension is possible, if, for example, a new and more efficient combination of old substances is found, or if the drug can be combined with other medications or if new applications are possible. One of the tricks with which the patent life of a drug can be prolonged is to find new indications for the old drug, a so-called new method of use.

Usually customers or patients should expect few to no improvements or benefits based this process and the manufacturer’s efforts to extend their patents. The manufacturer’s attention is strictly focused on the rules and regulations that determine how an extension of the patent can be achieved quickly and without unpleasant discussions with the FDA. Once the extension is successfully accomplished, the lucky manufacturer rewards itself normally with a drastic price increase of the medicine. What almost never occurs is that creative, useful, or even groundbreaking solutions are invented to extend the life of a patent. To step outside the box, to find new solutions is not only unusual, it is not desired by cautious managers because it might be risky, time-consuming and expensive.

It is no wonder that in an atmosphere of fear and risk aversion, pharmaceutical companies overlook even obvious solutions to their problems, which would not only save most of their patents, but would also drastically improve quality and bioavailability of their medicines. The entire industry has basically slept through a technology revolution that for years has provided major advances in other fields where it has caused a fervor at an ever increasing tempo, this technology presents a multitude of innovations, and just where it could fulfill the most, where it could save an infinite number of human lives, this technology is overlooked and widely ignored. I am talking about the much-discussed nanotechnology, which promises, and in few cases already proves, dramatic improvements for hundreds of medical applications, especially when it comes to bioavailability, the eternal problem of the pharmaceutical business.

In medicine, progress has always happened at a snail’s pace. The hostility and resistance faced by doctors and scientists who dared to swim against the current are legends. The phenomenon, where innovators and creative minds in medical science are punished or ignored rather than being rewarded and celebrated, has even been given a name, the “Semmelweis reflex”. Ignaz Semmelweis was a Hungarian physician who found out that lack of hygiene by his colleagues and other staff members was responsible for the alarmingly high death rates of mothers and children in the maternity hospitals of the 19th century. But rather than implementing the findings of the doctor, who after his death was celebrated as the “Savior of mothers”, Semmelweis was rejected and abused, and what’s worse is that they finally locked him in a mental institution, where he died. There are even indications that he was killed.

Dealing with innovators is, fortunately, a little more palpable in our days, but to stop progress or at least to delay it is still more the rule than the exception in medicine. For example, there is nano-technology, that can shrink substances down to 3 to 10 nanometers, so they become soluble in water and thus fully digestible for the body. Or to put it this way, the major challenge with an infinite number of medicinal products is to ensure they have an acceptable bio-availability, which is not an issue anymore, because nanoparticles of this size are almost 100% bio-available. To better illustrate: 7000 particles of 10 nanometers each can fit across the width of one human hair. Because these particles are so incredibly tiny, they are distributed to the whole body in minutes, largely bypassing the stomach and its drug-hostile acids. These acids are the major reason why the effects of thousands of drugs are limited or even largely destroyed.

A German scientist finally resolved the Nano puzzle three years ago, after endless failed attempts in dozens of laboratories. Presently, the German team is still the only one that has mastered this specific technique that shrinks and solubilizes all kinds of substances, which are used as medicines, supplements, cosmetics, beverages, etc. This was a major breakthrough. As proof that the technology works well and is fully developed, the production company dared to transform one of the most difficult and stubborn medicinal remedies, Curcumin. For thousands of years, doctors and healers in Asia have known that the turmeric plant and it’s medically active substances, which are called Curcumin, are among the most versatile and effective remedies medicine knows. Most doctors and scientists who know about the plant are convinced that Curcumin is way better than a whole battery of expensive drugs, which are not only less effective, but also consist of a daunting list of dangerous side effects. Some, but by far not all of the properties of Curcumin are anti-inflammatory, antioxidant, antiviral, antibacterial, anti-fungal, anti-cancerous and so on. Moreover, all of these benefits but with no serious side-effects. So far, however, the problem with Curcumin was that the cure is not soluble in water, and thus for the body almost not digestible. More than 90 percent of the valuable ingredients are excreted unused by the human body. Researchers in the laboratories around the world have therefore tried diligently for years to increase the so-called bioavailability of Curcumin. To enhance bioavailability, they even used such desperate means as adding Piperine, black pepper, which elevates bioavailability of Curcumin slightly, but it is poison for sensitive stomachs and even toxic in larger quantities. To make a long story short, so far no manufacturer has succeeded in enhancing the bioavailability of Curcumin substantially, even if boastful claims in advertising and sales brochures tell the opposite. Only with the new Nano technique from Europe, the full potential of Curcumin can now be utilized.

In initial clinical trials, doctors observed that Nano Curcumin spreads quickly in the body, and even hours later it is clearly detectable. This level of efficacy has never been observed before. Reports from doctors and patients soon came in stating that the new Nano solution showed very promising results especially in illnesses caused by chronic inflammation. This is incredibly good news, because the vast majority of doctors worldwide, agree that almost all of the common diseases, including myocardial infarction, stroke, Alzheimer’s disease, arthritis, psoriasis, diabetes, and even cancer are triggered or even caused by chronic low-grade inflammation. Scientists concur that a formula that transforms stubborn and not water soluble Curcumin into a fully bioavailable remedy is also capable to enhance all kinds of other supplements and medications. Currently, these substances are produced and successfully tested in Germany: various vitamins, Bilberry, CoQ10, Curcumin, Ginseng, Alpha Lipoic Acid, CBD, and Insulin.

Let’s go back to the patents. Almost all drugs, whose patents expire, can be altered through nano technology, as a result, their bioavailability will be enhanced, and production becomes cheaper.

We did a little survey in the industry and found out that most scientists and specialists in the laboratories know about the Nano solubilization technology, although very few are familiar with the details. Almost none of the decision makers have any idea that this technology exists, and therefore have no clue how to use it, for example to extend their patents. When we explained it to them, disbelief was a common reaction. What is the reason behind the ignorance? One scientist has a plausible answer: “There is such a tsunami of scientific information that drowns us every day, that it is easy to overlook certain developments and findings, even if they are important.” Perhaps another explanation is the Semmelweis reflex…

Apparently, to save as much revenue as possible in the insulin business and to compensate for the patent loss of Lantus, France’s drug titan Sanofi just closed a “global licensing pact” with the California development force, MannKind Corp. Sanofi must spent $150 million for an upfront payment, and later it will pay up to $775 million if the deal is a success. MannKind has developed the insulin inhaler, Afrezza, replacing the daily injections for diabetics, but instead they have to inhale an insulin powder. Pfizer developed an insulin inhaler some time ago, and it was a spectacular failure, and the company had to write off $2.8 billion just recently. Pulmonologists are skeptical that the way of insulin through sensitive and delicate lungs into the body is a good idea. Especially older people certainly will be unhappy with the inhalation of a powder through a device, which has to be replaced every two weeks. One has to suspect that this new complicated procedure will be expensive, thus very costly for diabetics.

The reasons why Sanofi will pay a lot of money for an application that just failed for a competitor can be explained only with a huge degree of pressure to succeed and a corresponding panic. All insulin manufacturers are looking desperately for their Holy Grail, a serviceable oral insulin. But an oral insulin already exists and it works. You guessed it, it is a Nano insulin. It was tested in India, and researchers found out that the Nano solution works better than the products currently on the market. In addition, it is cheaper to produce and it is so easy to take, even children love it. Take a few drops, put them in a small glass of water and drink the mixture. All done.

The Semmelweis reflex is by no means a thing of the past, instead it is, quod erat demonstrandum, still alive and quite popular in circles of the medical and pharmaceutical community. A person who swims against the current has a good chance of being ignored, or even discriminated against and thought of as a crackpot. Even if an innovation is considered promising, even if millions and billions can be earned, or lives of humans might be saved, the resistance from the institutions and huge corporations will be stronger and more powerful. At least for a certain period of time. Of course nanotechnology will succeed sooner than later, even in the medicinal and pharmaceutical industry, but until then they fight the new idea…