Medical Science & Tourism
The history of medicine is filled with stories of strange tonics, outlandish remedies and curious “cures”. Medical treatment in the 19st and 20th Century has advanced substantially with the discovery of antibiotics, and numerous chemicals and biologicals to treat illnesses, but also surgery and tools advanced substantially.
The 21th Century will advance even more as we have changed in the last two centuries from a farming society to a technology driven one where visions of the future and reality sometimes conflict. We are even not aware of this rapid changing development any more, as the young generation’s uses computers and the internet, matrix like, where vision of the future and reality starts to become hazy even potentially conflicting. Just jump into the internet and search for “second life”. You will enter a world where you can create with your avatar, everything what you have not achieved in reality, even meet people looking for a second life like you!
Well, we are reviewing medical science, but just think back, it’s not that long ago where the first car was starting to become a dangerous adventure for those riding it and those walking in the street.
The picture with Henry Ford and his first car the “Quadricycle”, which he built in 1896, a little bit over hundred years ago, may remind us of the exponential science and technology development!!
Technology with its application has changed our life and society in ways nobody could imagine beside maybe some people like Jules Verne. In 1869 and 1870, Jules Verne’s books Twenty Thousand Leagues under the Sea, Round the Moon and Discovery of the Earth, had been published. He often is referred to as the “father of science fiction,” as he conjured hundreds of memorable characters and countless innovations years before their time, including the submarine, space travel, terrestrial flight and deep-sea exploration.
The exponential advances and development in medical science where regeneration and stem cells are opening up complete new avenues of treatment in the beginning of the 21st century will revolutionize medicine as we know, like the change of production of the first car as an individual masterpieces to assembly line vehicles available and affordable by everybody.
Medical treatment methods, which just yesterday had been considered science fiction,
like the Tricorder from Star Trek are under development and will be available not in 10 or 20 years but potentially as first prototypes already next year, 2016!
Medical science, Know-how and treatment advanced in the last two centuries also in ways only few imagined and the word which excites today medical research, physicians and the public alike is: “Stem Cells”. Although, still in its infant stage, there is not one week where we cannot find in science related publications “breakthrough of……”. Like in every field of science, scientist but also physicians in clinics like to use the new technology even though it is still experimental to fulfill unmet medical need.
It is human nature to try, to explore to understand, which brought us so far already and like in any advancement there are elements which like to go slow, in the case of medicine, the argument is patient safety, while others like to advance quickly to explore the potential of treating so far unmet medical need.
In our global environment and information flow there is not anymore one way only to find out what works and what not, and this is true also for medical treatments. Western regulators argue that the treatment with drugs has to follow the evidence based path, and declared quickly that own stem cells are drugs! Well, luckily not every culture agrees to it and even in western countries patients and patient advocates are trying to voice concern of this “government invasion” into personal property. With this philosophy and regulatory interpretation own cells and their treatment will become the playground of industry where big money is patenting something which belongs exclusively to a person.
Medical science is experimenting with gene technology, manipulating cells in a way that even before a life is becoming a life, where potential illnesses or negative mutations can be treated and changed. Well this kind of “drug development” needs to be regulated there is now doubt on it, also in our assessments. A medical intervention as a surgical procedure, however, to transplant own cells and tissues from one place to another to support the natural healing of a human body, is different. Here, we are supporting the natural capability of a human body to regenerate and heal itself with its own cells, just being purified and minimal manipulated.
As this are terms of regulators, they recently in the US have started to redefine what is minimal manipulation and what is a surgical procedure. While the West apparently is protecting industrial interest by this suddenly appearing “guidelines and regulations”, Eastern, but also some Western and Central American countries have started to explore the technological advanced treatment method, by adjusting their regulation to support those new technologies.
There is no doubt, that today’s stem cell treatment, is still an investigational and experimental activity, but instead to artificially try to slow down development, Western countries should look out of the box and see the medical advances and Know how which has already established elsewhere and is advancing quickly.
Unfortunately the “NOT INVENTED / APPROVED HERE – SYNDROME” is hindering the open minded development in many Western countries. Japan as an example, is inviting investment from the US and Europe to join their recently approved fast trek path of stem cell research and treatment, establishing advanced Know how and application in Japan, benefiting Japanese population first, and in parallel commercialize it as an export opportunity to the world.
As mentioned before, there are various methods to treat patients with illness. Where standard treatment has been proven to be supportive, we may potentially wait for more advanced methods, but if we look into the mounting unmet medical need, we have to review alternatives. For many illness, there are at this moment no, or no effective treatments. Existing approved drugs potentially just only slow down the symptoms but do not reverse the situation.
Stem cells and regenerative medicine have a high potential to help where standard medicine stops and regulators should wisely support the emerging new medical method, although established industries may be effected with new, even disruptive methods. Japanese government, other Asian and Central American countries have clearly given the sign to support the new medical advances by adopting the regulatory framework to the new technology, quite different than in FDA regulated Western countries where regulators impose the old outdated philosophies and standard regulation on the new medical concept.
Asian countries have a different philosophy, they work today on a better future healthcare system which will substitute their existing business in 10 or 25 years from now. We have seen this in the electronic industry from tapes to memory sticks , CRT to LCDs. Asian countries and industries are not anymore the cheap low end producer for the West only, they have advanced in technology much quicker than many Western Countries. This trend certainly can be seen at this moment also in medical advancements, whether it is equipment or medical treatment, the West develops the science, the East fine-tunes and uses it quickly commercially.
Western regulators argue that the scientific Know-how and its application is not fully understood yet and as we talk about human health it has to be carefully evaluated before approved. Fine, but why are research oriented Biotech Company in China doing today more stem cell treatments in one year than all US regulated clinics and institutes together? Is the US Know How so low that we cannot advance quickly or is it just the artificial regulated environment?
Maybe both, otherwise we could not really explain the exploding of medical tourism to places where unmet medical need is “experimentally” treated. Patients know it, signing freely a consent and understand the risk, pay for the treatment and hope its working.
What can somebody lose, once quality of life is so poor and western medical help cannot improve their health situation further! Are they exploited, because they pay for a treatment directly? I do not think so, except in a few cases where clinics may offer really only the famous “snake oil” for a lot of money. I think it is rather “inhuman”, by any regulatory government body, to force patients with unmet medical need, to leave a country because of a misinterpreting of their regulatory reach to protect and support health of patients.
This overprotective regulatory reach of government organisations is one reason of medical tourism. Let’s go into it just a little bit. The question we have to ask is why does medical tourism exist? Well, its certainly part of the globalization and nearly unlimited information flow of data and knowledge.
Goods and service industry moved their production in the West to cheaper places in the East, installing quality standards at a much lower cost structure. Medical service provider used the same opportunity by helping patients with e.g. dental problems or even some more complex illnesses like hip replacements to show them where they can be treated well, have even holidays, but pay only a fraction of the payment of their home country.
Some of those clinics saw the high income potential and developed further their activities and asked government to help them to support this with legislation’s which reflects more new and advanced treatment methods, like stem cell treatments. When you go to Panama, Mexico, India or China, all of those medical doctors and experts there, went to the US or Europe to get their diploma in prestigious universities and special research institutes, but as they can only apply this, or only with much limitation in the countries where they learned their know how, they go where they can use their knowledge. …the famous science drain!
Many experts in those clinics are even US or European citizens who are now in the forefront of applied medical Know how. Medical tourism is sponsored by many governments in those “cost efficient” countries, and treatments as a medical tourism is growing at a rate never seen before. Just as an example in Europe, Turkey is outside the EU, but borders the EU and has developed a substantial medical tourism. Clinics in Turkey, especially in holiday resort areas have upgraded their know how, by having official relationships with famous western hospitals and research institutes offering high quality low priced treatment, something what cannot be provided in the EU or the US.
A Swiss cord blood bank is cooperating with an Indian high tech biotech company to treat patients, as cord blood can only be really of therapeutic use when stem cells are expanded. As treatment with expanded own cells is more than minimal manipulated in Europe too, patients who even need to be treated with their own cryopreserved cord blood need to go to India to get their own stem cells expanded for treatments. Appears to be not logical and a complete outdated philosophy of regulations claiming to protect the safety of patients!.
A recent court rule in the US does not allow certain stem cell treatments with bone marrow anymore because the institute uses a registered drug in a non-approved interstate commerce situation. They openly mentioned at the court, that they are moving this activity to a Central American Country, where such a strange interpretation of regulation is not followed. The regulator just simply admitted this is outside the US and your decision. The treatment, although done for years and showed positive results without any adverse event, was not accepted because of malpractice reasons, but on the ground of using a FDA approved product in a non-authorized interstate commerce activity.
FDA, beside having declared own stem cells as drugs, tryingare now also to regulated what is a surgical procedure, reinterpret what is minimal manipulated medical process in order to stop established quality stem cell treatment in US clinics and doctors’ offices in the frame of practice of medicine. Why, there are no adverse events reported nor seen, is it just the principle of how we regulated medical products, or is supporting the established clinical trail route only a business concern not related to health care concerns.
What can we say, besides Hello regulators: “See how Asian and Central American countries support their patients with new technologies“.
This Western philosophy will be certainly not in the interest of patients and their treating physicians and most certainly increase further medical tourism to countries open minded in helping patients with their unmet medical need.
Question we are always asked: Would you go to be treated in a foreign country for a serious illness? Well, I always answer. “It depends” If my physician has nothing more to offer to improve my worsening condition, I would, provided financial situation allows it, use the opportunity too. I would however prefer to have this experimental treatment in my home country, if not, well I will review the clinics carefully and as a personal back-up for health I have established contacts with qualified clinics from which I believe that they are able to provide “investigational studies with stem cells” at the highest standard.
A qualified stem cell clinic, if we believe that stem cells are an opportunity to improve health conditions, from my point of view, in this emerging 21 century environment has just a few important milestones to cover, to be considered as potentially qualified:
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The doctor/s have to be trained in stem cell treatment and should have some years of experience.
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The clinic should have a medical board overseeing new treatments or at least the clinic should have an affiliation with a clinic providing methods in the frame of an IRB or ERB approved protocol.
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The clinic has to have specialists reviewing the case, providing a qualified informative discussion and inform about the risks and potential side effects.
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The clinic should explain the process. A good process appears to be own adipose derived stem cell treatment minimal manipulated in the frame of practice of medicine as a surgical procedure, rather than some unknown allogeneic cell treatment.
In case of allogeneic treatment methods, this should be at present the domain of clinical trails and approved medicinal products in FDA / EMA regulated countries. A clinic providing allogeneic treatments should be able to give details of the product, is expansion method and cell structure and count. In such a case, where stem cells are more than minimally manipulated and processed even in a different place, potentially with gene modifications, the clinic has to have GMP facilities, and relevant certificates.
We believe, that some international clinics in non FDA / EMA regulated countries have already today the capability to go beyond minimal manipulated surgical procedures. Those treatments are, however, even more experimental than autologous (own) adult stem cell treatment and it might be a good idea to review via stem cell advocate organisations and its members, which countries and clinic’s had been already showing some positive results of those experimental therapies.
If someone is interested in any stem cell treatment we are able to connect with Stem cell advocates or review for you, potentials of an experimental treatment, there is no charge involved for this review, except the request to inform about the experience if using the experimental therapy to share it with others looking for treating their unmet medical needs.
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The patient must be well informed about the consent-form he receives and has to sign it as an acceptance that the treatment is investigational and has no guaranty of success. Any clinic offering today stem cell treatment guaranties might be not really a good one for experimenting with unmet medical need!
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The clinic should have a clear follow up program and embed the personalized study in a registered clinical trial which follows up safety and treatment success, which eventually can be published.
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The treating clinic should have a registered, closed technical equipment which in the frame of an approved protocol does not rise the question of contamination during the treatment.
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The patient should ask and receive documentation of how many treatments had been performed with what success rate.