FDA wait brings US cancer doctor to Cayman

| 12/06/2013

wagner.JPG(CNS): A US-based doctor and biomedical researcher who has developed a radiation and chemotherapy-free cancer treatment has opened a clinic in the Cayman Islands because, he says, the wait for the Food and Drug Administration’s approval is years away. Thomas Wagner, PhD, said Cayman was the best available option while the FDA decides if his treatment regimen will be accepted for use in the United States. Describing his treatment as a lifesaver which can benefit patients now, the doctor told a South Carolina newspaper that it involves injecting patients with a vaccine made from their own tumour cells.

Although the clinic’s arrival was noted by the former health minister earlier this year, there has been no official information about the treatment released to the general local media in the Cayman Islands.

However, Wagner spoke with the GSA Business, a bi-weekly newspaper in his native South Carolina about the treatment.

“Every human being is different and every cancer is different,” Wagner said. “If we take every molecule that is in a patient’s tumour and use that complete molecular profile to activate their immune system, that is the best you can get.” He added that “cancer starts in all of us about 10 times a day” and is naturally treated by some bodily process. Wagner said drugs interfere with that natural treatment, while his method enhances it.

Wagner, who has served as a scientific adviser to the World Health Organization, to Congress and to the Reagan administration, described his treatment as providing a better quality of life than other invasive treatments. “It is my belief that the future of medicine will not involve small molecules put in pills or injected into a patient,” he said.

The Perseus PCI (Personalized Cancer Immunotherapeutics) clinic is based at the Smith Road Centre in George Town, and Dr Sook Yin is the clinic’s treating physician for patient care plans. Each patient plan is being coordinated by a team of US-based and licensed doctors who are also licensed to practice in the Cayman Islands.

Wagner is said to be a pioneer in cell-based therapies. In the early 1980s he co-founded Diagnostic Hybrids, which makes and markets cellular and molecular diagnostic kits used for respiratory and other diseases. He is a founder of the Ohio Edison Biotechnology Institute and formerly directed the Greenville Health System’s Oncology Research Institute and Clemson University’s Biomedical Institute. He currently is a director of the Orbis Health Solutions medical research firm in Greenville, a funding partner of Perseus.

The clinic has started scheduling treatments for patients, including some from the doctor’s Greenville area, and his US supporters believe that, despite the lack of FDA approval, his treatment method should be available to patients now as an alternative to sickening chemotherapy and radiation and other immunotherapy treatments that do not only use a patient’s own cells.

Wagner said he “thought long and hard” about how to best make the treatment an option for patients now and decided on the Cayman Islands clinic.

“It’s not a question of escaping the United States or anything like that,” Wagner said, adding he had complied with local regulations and law. He predicted that results from treating patients at the clinic will show his immunotherapy method should be allowed there.

Although insurance won’t cover treatment at the clinic or the out-of-country travel costs for US patients, which could range from $40,000 to $100,000, Wagner said that this is still half the cost of some other cancer treatments and his method doesn’t use drugs and isn’t embraced by powerful pharmaceutical companies. Wagner added that his non-pharmaceutical method “doesn’t fit most business models” and is at odds with a corporate mind-set that steers the course of cancer treatment financially.

Wagner said eligibility for clinical trials is limited to “people who have failed everything else. If they die from this they are going to die anyway.” He said 14% of the patients who have participated in his treatments are still alive.

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  1. Anonymous says:

    I would encourage people to watch the Documentary about Dr. Burzinski.  He has a clinic somewhere in Texas and has been treating cancer patients with a high success rate.

    The FDA gave him approval to try his cancer therapy years ago and probably did not think he was going to be as succesful at treating cancer as he has proven.  The FDA gave him the condition that he use only subjects who have been diagnosed terminal cancer by their Doctors and have been through the conventional chemotharapy sessions before Dr. Burzinski could try his therapy.  His success rate of curing canceer is unbelievable (I think it was well over 60-70 %.  Manyt of the people he has cured of  cancer have died from complications of the chemotherapy that was administered to them before Dr. Burzinsk and not the cance.  Just imagine if he were allowed to practice on people with cancer before they went through conventional chemotherapy treatments.

    Since giving the approval for his therapies, the FDA have tried to recind their authority to Dr. Burzinski and have tried to shut him down through the US courts several times and have been defeated every time.  His patients have testefied in front of US congress and everything is well documented.

    I think Dr. Wagner should be given some good consideration to try his therapies here.  The FDA is in the business of protecting the big pharmaceutical companies. There are numerous examples of that if you research it enough.

  2. Anonymous says:

    A problem with medical tourism for unique treatments is once the patient returns. Since the physicians in the patient's home country are unfamiliar with the treament, they have difficulty dealing with after-care, prescribing pharmaceuticals. and, of course, dealing with complications. 

  3. Anonymous says:

    Funny, we don’t see any support for our own “Medicine man” – how many of you think his natural cures might just be as effective as Dr Wagner’s? With so many families having to bear the financial, emotional and other losses due to cancer, I don’t understand why Government hasn’t done something to try and help him – not necessarily financial help but perhaps cutting through some of the red tape involved. Medicine/drugs are usually approved much quicker in the UK and Europe than in the US. With most of our insurance companies based in the US, they don’t cover treatments not Pproved by the FDA.

    Since Cayman is a British OS Territory, treatment approved in the UK /Europe should be covered for use in Cayman. Would probably be a lot less expensive too.

  4. Anonymous says:

    Please don't think the FDA has any interest in protecting the people!  It's one of the most lobbied administrations there are.  The FDA approves poisons in our food EVRYDAY so there is no surprise that they would road block treatments that don't make the pharmecutical companies boatloads of money! 

    This treatment is ground breaking and qualifying patients deserve treatment.  Seriously, if you already have Cancer, why wouldn't you want to try a treatment that has no side effects and if it doesn't work, you're no worse off than you already were?  No brainer to me.

  5. Anonymous says:

    Anyone that can say this is horrible have never had a family member be told there is nothing else we can do for you. Give it a chance people.

    • Anonymous says:


      I have had threeclose family members advised their condition was terminal. Their attitude was, 'I've had a good life, how much longer have I got?'

      One went as far as refusing to consent to any proposed course of treatment because it was clear they were going to die anyway.

      They then all got on and made the most out of what time they had left.

      I've also had friends who were subjected to intensive, and very unpleasant, therapy right up to the day they died because the doctors refused to accept that it was time to back off and let nature take its course.

      No one lives forever and when your time comes it's better to accept it gracefully than spend you last few months as little more than a lab rat.

  6. Anonymous says:

    Please research flaxseed and cottage cheese – cost less than $10 bucks

  7. Anonymous says:

    i don’t think most people realize that we have many pharmaceutical drugs here that are not found in the us or canada, plus we have people already going to Cuba for treatment , FDA approved does not always mean its the best thing that happened to man or woman they have many recalls so it shows they make their blunders, i think people with cancer are willing to try most treatments it’s a gamble either way .

    • Anonymous says:

      Very good point.  The article also points out that his patents are those “people who have failed everything else." meaning they have tried conventional treatment to no avail. 

      I know if I was in that position  I would understand that I had nothing to lose by trying an "unconventional" treatment.   It also makes the point that insurance does not cover the treatments so it is not threat to our insurance system. 

      I would think that most of his patients would be from overseas mostly the US.  The people who choose his treatment will do so knowingly and make a conscious decision to do so.

      I have a friend who is terminally ill with cancer right now. I am sure she would love to be in the 14% a year from now.



    • Anonymous says:

      and please someone tell me what poor soul has 40T-100T for this man.  where i know everyone who is dying wants to have some sort of a chance but don't you think this is a bit high???

  8. Anonymous says:

    His logic is probably that quack treatment administered in the Cayman Islands is exempt from punative litigation in the USA. I suspect that the only reason he's coming here is that the Cayman Islands look more respectable on his website than alternatives like Haiti, Honduras or Mexico. This is a case where CIG should have said 'thanks, but no thanks' and sent him back to the USA.

  9. Anonymous says:

    Only 2-3 percent of cancer patients who take conventional “approved ” treatments survive so its sounds like a very promising improvement !

  10. Anonymous says:

    “It’s not a question of escaping the United States or anything like that,” Wagner said.  Yes it is.  It 100% is. 

  11. Anonymous says:

    After doing a little research on the doctor he certainly appears to be the right person to come up with a new treatment and considering his resume why would he suddenly now decide to put his reputation at risk for a treatment he doesn’t believe in. There are different treatments and drugs allowed in Europe versus the US so the FDA doesn’t have the monopoly on what is or isn’t appropriate and considering the ridiculous litigation in the US it is no wonder the FDA is more cautious. I guess we have to trust that our local authority is properly staffed to consider the potential of the treatment.

  12. Dennis Smith says:

    This is a difficult thread to comment on.

    I have friends involved in cancer research and I've watched them go through the FDA clinical trials process. Imagine that its might take 10 to 20 years to discover and develop a new treatment and then you get approved for Clinical Trials. – Happy Days – Celebrations! – 10 years later you are still in trials and guess what. You or your company has paid for all of the trails. It can be a journey through hell.

    I gather that there is now a fast track program but its still a long, costly and arduous process. So I can see the allure of stepping out and moving to a less restrictive foreign country. Especially if you are convinced of the efficacy of your treatment and you don't have 10 or more years to wait.

    I would be concerned that this effort might undermine the FDA approval process. I know of a firm that did independent trails in the DR and it cost them dearly when they submitted their studies to the FDA. That was 20 years ago so maybe things have changed, maybe not.

    On the other side I would be very concerned that it is happening here. I'm surprised that we are unregulated. Also from the cost of treatment point of view why not offer the treatment somewhere cheaper? Perhaps in Panama, Cuba or Dominican Republic?

    I would love to see Cayman become an important medical centre. That’s a great long-term economic expansion idea but if we go that route we need to develop a smart, globally competitive, sophisticated medical industry development plan that will enable us to get there step-by-step. I don’t know how to do that and this isn't that approach, we could regret the consequences.

    The 14% percent success rate is impressive. Remember that these are people who failed all other forms of treatment so they are dying. Part of the problem with treating only terminal patients is that a vast range of previous treatments leaves them contaminated. This is part of the problem with early stage clinical trails as well. They start with people who have failed every other form of treatment.

    I have my fingers crossed on this one.

  13. Anonymous says:

    "He said 14% of the patients who have participated in his treatments are still alive."

    Doesn't sound like a very high success rate, perhaps even lower than a "placebo" effect typically is.

    • Anonymous101 says:

      Errrrrr… "are still alive"  what about "alive and well"?

    • Anonymous says:

      Not if it is 14% who were going to die without it.

    • misunderstood says:

      What he said was that this is for patients where all else failed.  He said that they were going to die anyway!!  He was able to keep 14% alive, who would have been dead already!  Am I reading this wrong, or did you just read the 14%.

      There are many cancers that are completely deadly, meaning there is no cure for them.  If he can save 14% of those people, that is amazing!  With that said, the FDA will not approve a cure.  If they did that, many businesses will close their doors.  This is all about money!  There are cures for everything out there, and those cures will NOT be approved by the FDA.  Itis all political!

      I hope this center is accepted with open arms.  If I was diagnosed with a cancer and had a 0% survival rate, I would most definitely try a "new" unapproved method for curing me.

  14. Anonymous says:

    Cayman is not the place to start this clinic. He's looking at this from the point of view that health insurance is mandated by Law here and sees dollar signs. Here's a news flash Doctor; health insurance DOES NOT cover procedures or testing that IS NOT FDA approved. You're wasting your time here.

    • TheGoodDoctor says:

      He'swell aware that the insurance here will not cover the costs. It's not an effort to goad money out of people. It's a system that allows him to offer potentially lifesaving treatment for patients with terminal cancer an option whilst clinical trials are ongoing.

      Clinical trials are an incredicably complicated state of affairs where patients can only be considered for inclusion after meeting a multitude of criteria. This process allows him to offerthe treatment to patients that may not fulfill the necessary criteria.

      Why should a patient have to wait for FDA approval when they have exhausted all options? This allows them an extra chance after surgical excision, after chemotherapy, after radiotherapy to use a process with far fewer side effects…giving them one last shot to beat horrendous life-ending conditions.

      Its narrow minded to simply shut off opening this avenue for treatment simply because it is not FDA approved. The truth is that if the treatment proves to be unsuccessful then it will fizzle out in time. It will have no avenue for success if the patients do not show positive results.

      Open your mind. It could be a breakthrough in cancer treatment, which if it occurs will be linked with Cayman forever.

  15. The Rt. Hon. Anon. says:

    This makes me feel uncomfortable. If the FDA won't approve his treatments (quite rightly tests must be carried out extensively and objectively over a period of years) then why should Cayman approve its use on patients here? Mexican clinics have historically offered all sorts of alternative therapies for the sick and desperate, mostly unproven but all have the common thread of charging the poor patients a small fortune. How is this different I wonder. 

    • Anonymous says:

      You have a point, however, people need to realize that the pharmaceutical industry is cut throat and a very dirty business. I am also pretty sure that there are many, many kick-backs from the pharmaceutical industry to the approving and regulating authorities. Pharmaceutical industry is not in business to heal people, they are in the business to make money – and lots of it!

      Not saying that what the doctor says or does is correct, as I am no expert, however, I am not surprised when new treatment methods who are potentially significantly more e effective and/or cheaper than the established ones are not being approved, or if approval is delayed as this would be detrimental to the pharmaceutical industry.  A lot of people would potentially lose a lot of money…………

  16. Anonymous says:

    Why are unapproved treatments being offered here?  Have they been approved in the UK?  If not, then why are we allowing Frankenstein treatments?

    • Yup says:

      Isn't that what Cayman is all about?  Escaping the regulation of the First World nations?