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:
The doctor/s have to be trained in stem cell treatment and should have some years of experience.
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.
The clinic has to have specialists reviewing the case, providing a qualified informative discussion and inform about the risks and potential side effects.
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.
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!
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.
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.
The patient should ask and receive documentation of how many treatments had been performed with what success rate.
Well, this is my personal view, and there might be other points by other people, but when my wife, who had already two standard approved mainstream meniscus operations on one knee had because of a wrong movement, to see a doctor on her other knee, we investigated potential clinics by this method.
The reason, why we looked for a qualified clinic, was because our physician diagnosed again a meniscus tear, now on the other knee and mentioned: ”In your age (64), the problem will, as you see with the treatment performed on the other knee, not go away but only get bigger and I strongly recommend a knee replacement for both knees! ……. An unpleasant surprise for the day!! Especially as a friend, who did recently the knee replacement operation on one knee still has problems and pain, beside the information that in about 15 to 20 years the artificial knee should be replaced! We looked also to statistics regarding “success and side effects” of knee replacement operation and had not been impressed that the recovery period being in the average nearly a year, our friend is a good example, we do not intend to follow, in spite of the assurance of the physician that he has not seen such problems in his clinic!
Well, we went last year to a clinic, we, after all investigations considered as qualified, doing autologous stem cell treatment in the frame of an investigational study financed by the patient (us) as a surgical procedure with minimal manipulated Stromal Vascular Fraction (SVF). There was no negative side effect nor any adverse event, neither on the day nor now 4 months later.
We -to our surprise – had been able to continue our intended holidays and did fly two days after to surgical procedure to our holiday destination without any difficulties. Now several month later my wife has clear improvements in respect of pain and movements and has stopped all pain medication since the treatment. Quality of life is slowly returning and the idea to go for a knee replacement is postponed, hopefully for ever!
So what happens here, people with a certain financial background willing to risk alternative health improvements via advanced medical treatments, not available in their home country go out and help themselves! As regulators in the US and some European countries tend not to authorize stem cell treatments (Although the EU regulation permits it in the frame of minimal manipulated activity with no medical claim pursued or in the frame of hospital exemption) those in need are forced to look for alternatives which often means an increase of medical tourism.
A legal adviser in the US once mentioned: “If regulators in the US increase their unfavorable interpretation of stem cells and stem cell treatment, it does not automatically mean that the world, besides maybe Europe will follow; — luckily for patients in those other also free and democratic countries! Well, it appears, there is always a potential to interpret what is free and democratic.
Lets review a little bit further the “Phenomenon of Medical Tourism”. Medical tourism had been originally created by travel agencies to use their know how of holiday places by combining this with potential medical needs of their clients, while on holidays. Medical tourism has increased in part because of rising health-care costs in developed countries, but also due to qualified cross-border medical training and widespread air travel.
The medical tourism industry has been growing worldwide and is considered to have generate in 2012 about 60 billion USD in revenues. Stem cell treatment alone, though considered experimental, is estimated to have reached about 2,0 to 3,0 billion USD annually already, with a rapidly growing tendency.
Medical Tourism involves about 50 countries in all continents and several Asian, but also Central American and some Middle East countries are clearly in the lead, as their governments are supporting the development of new medical treatments differently than in those FDA / EMA regulated countries claiming to defend patient safety.
In Asia, medical tourism is developing quickly in China, South Korea, the Philippines and highest in India, Singapore and Thailand. These last three countries, are considered to had a share of about 90% of the medical tourism market in Asia in 2008, but this ratio has changed with other Asian, Central American and even Middle East countries like Dubai competing for clients. All those countries have invested heavily in their health-care infrastructures to meet the increased demand for accredited medical care through first-class facilities. You can find clinics in China, Dubai, Turkey or Panama, to name a few having technical and clinical standards easily outperforming existing clinics and hospitals in the West.
Today, therefore, medical tourism covers not only dental or cosmetic treatments but has attracted also patients who cannot satisfy their medical need in their home country due to inflexible health care regulations, claiming to protect patients from any harm with unauthorized medications and treatment method.
Safety concerns are correct when patients are lured into non-qualified clinics promising successful treatments for any difficult to treat illnesses. Qualified clinics however have international recognized clinical standards, well qualified physicians, doing documented patient funded experimental therapies with remarkable success.
Clinics involved in autologous stem cell treatment have documented success all over the world, although those stem cell treatment are not fully approved, mainly by Western Countries, via health care regulators like FDA or EMA. We also believe that those successes mentioned single successes, personal experiences as stem cells are reflecting the individual health potential with own stem cells, a kind of very personalized treatment method.
Interestingly to see is, however, that health authorities in Asian Countries are presently trying to find the right regulatory mix to support this newly developing medical treatment possibilities with stem cells, while it appears that Western regulated countries, at this very moment, are increasing the barrier of this emerging technology, limiting the potential success in improving quality of life of patients in an emotional defense in respect of patient safety……which appears to be odd and not sensitive, as highly advanced medical centers in Asian countries offering those unauthorized FDA / EMA treatments in the legal frame of experimental medical treatment quite successfully.
Are there risks involved, certainly there are, but with an honest consent discussion explaining risks and side effects a patient can participate in investigational studies potentially improving their quality of life.
As an example of the difference between Western and Asian countries approach we have reviewed Beike, a Chinese biotechnology company with main offices in Shenzhen, near Hong Kong and Taizhou as well its affiliated company in India. Beike’s stem cell research and clinical applications were developed starting in the 1990s. Over 60 PhDs from leading Chinese universities contributed to advancing Beike’s treatment technologies. Many of Beike’s scientists also have experience at leading Western universities, including Stanford, the University of Minnesota, and UCLA. The treatments in China reaching thousands of people already in 2012, only by Beike, is impressive, when we compare American and European activity.
The first patient, happening to be diagnosed with ALS, to be treated with Beike processed cells was in 2001. Over 200 patients participated in studies and were treated between 2001 to 2005 in order to determine treatment efficacy for a small number of end-stage and otherwise incurable diseases. Beike was incorporated in July 2005 and has since provided partner hospitals with stem cells for the treatment of over 16,000 patients. Beike currently maintains 25 laboratories for both research and cell processing for clinical use and has received over US$6 million in government grants. Beike even had the honor of welcoming Chinese Premier Wen Jiabao for a tour of our Shenzhen facilities in August of 2010. …..Well, which Western Premier would visit an experimental treatment facility and give such visible support for medical treatment of the 21st Century?
The Western problem on this appears again to be the
“NOT INVENTED HERE SYNDROME”!
As we are embedded in Western regulations, not allowing the free promotion of medicine or medical treatment, we need to draw your attention to our disclaimer, that we are not promoting any unauthorized medicine nor treatments and that any information given on our website had not been reviewed nor approved by FDA / EMA and therefore reflects opinions for educational / informational purpose only.