Foreign Clinics Lure Americans With Unproven Treatments
Stem cells are on offer, but do they work?
Reader Comments
Adult stem cell/medical tourism
The discussion has descended into name calling and has blurred the real dilemma. One side is looking to reduce the options by relying on fear, the only thing that we americans seem to respond to. In reality the options should be up to the individual. Are not most studies on drug and medical procedures here in the US funded by the interested corporations? They do not appear objective at all and time and again have been found to be using distorted figures to benefit these same corporations. I don't wish to besmirch the motives for Harry J. DePietro, Esq., but he seems to be rather biased based on his personal results. It looks as if he was hoping to save his own life after running out of alternatives or at least hit the "lottery" by suing if a "miracle" did not occur.
As both a medical tourism business owner (www.patientvacation.com), and, more importantly, a patient successfully treated in Thailand for a badly broken shoulder and, more recently, a heart condition (I had a stent implanted), I can personally attest to the quality of medical care in Thailand. It is true, just as it is in the USA, that all results are not miraculous successes. But I can say without reservation that the care I received in Bangkok on at least 12 occasions-blood tests, colonoscopies, root canals, bone biopsy, emergency visits, physical exams, three surgeries- was far superior in medical quality, timeliness, quality of facilities, and courtesy than anything I have experienced here in the US. These are my personal opinions as well as the sentiments of all our clients at Patient Vacation. And we are not the only company who have found these things to be true. My heart goes out to the pain you are suffering, but do not attack the Thai medical profession and the concept of medical tourism because of personal disappointment.
Calling adult free choice by a patient, without options, seeking radical treatment "ethically suspicious circumstances" seems rather judgmental. But what is morally and ethically wrong is withholding medical and health care from those without money and insurance. Medical tourism is the only option for many. We at Patient Vacation hope for the day when a single payer system treats all Americans equally and insurance is a thing of the past. But until that time we will seek superior healthcare where we find it and where we can afford it. That is free will.
Adult Stem Cells/TheraVitae
Adult stem cell research does hold promise for new treatments. However, in this situation, people should be concerned about the procedure being offered without any structured clinical trials, that include adequate follow up. New therapies and interventions typically undergo close scrutiny, as they should, to establish their benefit versus risk, prior to being offered to patients.
This may be seen as "the last chance", but at what cost? Understand that those patients who participated here, willingly subject themselves, under ethically suspicious circumstances, because if not, they may "die". It is (and should be) difficult to accept, with any reason, personal anecdotes over real evidence of benefit. Unfortunately, we will not know if any of these patients who have had this procedure truly benefit due to it, or some other uncontrolled factor not identified.
One must also be concerned that physicians actually endorse such therapies when the field of medicine stresses practicing ethically sound, evidence-based medicine. It is important that patients make their own decisions, and we, their physicians, need to be their advocates. However, we (physicians) must realize that the weight of our own opinions, though "benign" they may seem, when expressed to our patients, may have unanticipated ramifications.
There is also an art to the practice of medicine when an approach is pursued when sound evidence is lacking. The risks in such cases must be disclosed, even stressed.
'''But if patients have the money, ... 'Why not?' " - It appears that when offered, this procedure is presumed to have minimum to no risk. We do not know that this is true (again, as follow-up and outcome data are lacking). What ever happened to "First, do no harm"?
We do want to be supportive of Tammy, and are praying that she does demonstrate improvement, be it due to TheraVitae or otherwise.
Tammy Henderson
I am very disapointed with this artcile casting a dark shadow on such a great
thing. Adult stemcell holds the promise for many diseases but it has to deal with
money or lack of making money on it here in America. I have learned recentley
yes theraviate wishes to corner the market in this field so everyone would have
to travel abroad.they wish to make a huge profit but two other companys are in the
running and one doctor in florida.they feel if it makes it to America no money would
be made for them because who would travel to asia then if it's available here.I
have studied adult stemcell for years and i'm still convinced i did the right thing.
i don't wish to die, have a trasplant, or any other implantable device.i still believe
i will recieve my miracle in time.depite what this article saids.
Adult Stem Cell/Theravitae
This is directed toward Harry Depietro, the one that went to Bangkok and came back or is still alive because of the treatment there. Because he is a quassy medical expert and of course a lawyer, he suggests that the people including myself that went there were less than wise. His problem is like most lawyers, he doesn't look at the positive affects that have helped people that were told to go home and die. I had 3-4 months to live, no other treatment available, yes I went to Bangkok and the treatment, no matter what works, I am alive and doing positive things to make it available in the U.S., Harry is trying to take away the last chance for some people. SHAME ON YOU HARRY!
One question Harry, are you alive?
Adult Stem Cell/Theravitae
This is directed toward Harry Depietro, the one that went to Bangkok and came back or is still alive because of the treatment there. Because he is a quassy medical expert and of course a lawyer, he suggests that the people including myself that went there were less than wise. His problem is like most lawyers, he doesn't look at the positive affects that have helped people that were told to go home and die. I had 3-4 months to live, no other treatment available, yes I went to Bangkok and the treatment, no matter what works, I am alive and doing positive things to make it available in the U.S., Harry is trying to take away the last chance for some people. SHAME ON YOU HARRY!
One question Harry, are you alive?
WORSE THAN UNPROVEN
My name is Harry J. DePietro. I am actually in Bangkok, Thailand preparing formal complaints to be made with the Thai Medical Council and the Thai FDA regarding stem cell treatment in Thailand. These formal complaints follow more than a year of evidence gathering and discussions with members of the Thai medical community. I hold a bachelor degree in Medico-legal Science, was a licensed Paramedic before going to law school and am a licensed attorney.
On September 19, 2005, I was one of the first patients to have the myocardium of my left ventricle directly implanted with stem cells done via the thoracoscopic procedure in Bangkok using TheraVitae's “Vescell” stem cell product manufactured from my own blood. I was told that I was the third patient to have this procedure done. Currently, I believe that I am the longest survivor of the procedure. (TheraVitae touted me as one of its earliest “success” stories. Google the misspelling of my last name “DePeitro” to find an early, and slightly inaccurate, press release regarding my initial success.) TheraVitae does not include information regarding former patients critical of TheraVitae or its Vescell stem cell product, and bases its claims on the initial, subjective comments made by patients during their “honeymoon” post-op periods, and ignores patients who objectively demonstrate that they have not improved since their Vescell treatments. Worse yet, although many patients have died within twelve months of their Vescell treatments, those patients' deaths are overlooked by TheraVitae when they aggressively push Vescell as if were snake oil.
TheraVitae does no long term study of its former patients. One would think that the longest survivor of their treatment might be followed up for at least research purposes, but TheraVitae is unconcerned with the long term results of their Vescell treatment. TheraVitae does not want you to know that the longest survivor of their treatment has had his cardiac output to deteriorate back to pre-operative numbers. TheraVitae doesn't want you to know that the patient whose surgery followed mine has never had any objective improvement in his cardiac output. Worse yet, TheraVitae simply does not want anyone to know the truth about the way it started treating patients commercially in their for profit operation in Thailand which they are now expanding to other countries via proxy companies or individual medical practitioners who use their Vescell stem cell product.
TheraVitae's start in the business of treating patients is Thailand is reminiscent of the way the mob in the U.S. Took their operations “legit” by getting into legitimate businesses. After a time, the illegal beginnings of the mob was forgotten as their “legitimate” businesses built reputations far removed from the originally illegal activities which provided the capital to launch them.
Thailand was chosen by TheraVitae as the location from which to launch the commercial offering of its Vescell stem cell product for the invasive administration to “no option” heart patients. Although TheraVitae explained to the Thai FDA and Medical Council of Thailand that its Vescell stem cell product was numerically expanded “soup” of the patients' own specifically selected cells. In fact, it is a “biologic” product manufactured from a patient's biological sample which should have fallen under FDA regulations and scrutiny.
In December 2006, TheraVitae's research paper, “Isolation of an adult blood-derived progenitor cell population capable of differentiation into angiogenic, myocardial and neural lineages,” Y. Porat, et al., © TheraVitae Ltd., Journal Compilation © Blackwell Publishing Ltd., British Journal of Haematology doi:10.1111/j 1365-2141.2006.06344.x was published.
In that paper, TheraVitae scientists describe TheraVitae's “method for the isolation of a multipotent progenitor cell population, designated a synergetic cell population (SCP), from adult peripheral blood” from which, (after the processing described in detail in the paper) a population of angiogenic cell precursors (ACP -- ultimately that which TheraVitae calls its “Vescell” stem cell product) is derived.
The proof that the Vescell product is not merely a numerically expanded version of the patient's own cells can be found in TheraVitae's own published research paper where TheraVitae's scientists stated that they “found that the majority of CD31Bright cells in the ACP (“angiogenic cell precursor”) population, but not in the source SCP [“synergetic cell population”], demonstrated Ac-LDL uptake and binding of Ulex-Lectin.” (Emphasis added.) (Second sentence, first partial paragraph, page ten of twelve.) These Ac-LDL uptake and Ulex-Lectin binding CD31Bright cells were not present in the patients' blood sample, but were created through the process described in the TheraVitae research paper. “Isolation of an adult blood-derived progenitor cell population capable of differentiation into angiogenic, myocardial and neural lineages,” Y. Porat, et al., © TheraVitae Ltd., Journal Compilation © Blackwell Publishing Ltd., British Journal of Haematology doi:10.1111/j 1365-2141.2006.06344.x
The fact that TheraVitae manufactures a biologic from the patient's biological materials which contains cells which were not present in the patient's blood sample is absolutely opposite what the TheraVitae company told the Thai authorities when it sought permission for Thai medical practitioners to use its Vescell stem cell product on human beings. TheraVitae told the Thai authorities that it was taking a patient's blood, harvesting the stem cells from the patient's blood and expanding the numbers of the stem cells harvested from the patient's blood so that a therapeutic number of stem cells could be assembled for administration to critically ill patients. The Thai authorities accepted that description and found that using a patient's own cells to provide them with a therapy without which they had no other option for a successful outcome was an ethical and appropriate therapy. However, TheraVitae deliberately obscured from the Thai authorities the fact that its laboratory expansion of a patient's blood product created new cells which were not present in the patient's own blood from which the Vescell stem cell product was created for administration to the blood donor patient. The creation of those new biologics should have been disclosed to the Thai authorities, and specifically to the Thai FDA, under whose authority biologic products would have been regulated.
In addition to the misidentification of Vescell as a numerically expanded solution of the patient's own blood derived cells, TheraVitae defrauded its patients and the Thai authorities by deliberately stating on its website that its Vescell product is created in a certified “Good Manufacturing Process” (cGMP) laboratory. The same false claim was made in TheraVitae literature supplied to physicians worldwide, and I will be submitting copies of those documents to the Thai authorities along with the other evidence of what is claimed here, and regarding other claims which will be made in thoe formal complaints being prepared at this time. While every sophisticated nation on earth requires manufactured products, biologics and drugs intended to be introduced into human beings to be manufactured in cGMP facilities, TheraVitae provided the Thai authorities with a private survey which stated the TheraVitae Israeli lab met cGMP standards as if it were an official GMP certification, TheraVitae knew that their lab was not a certified GMP facility. In fact, even six months after Vescell treatment started on human being in Thailand, TheraVitae personnel identified in company emails that the Israeli lab where TheraVitae produces the Vescell it provides to doctors in Thailand to use on patients in Bangkok was still not certified GMP. To date, the Israeli facility remains uncertified, yet still manufactures the Vescell product for administration to unsuspecting patients.
While patients have died following treatment with Vescell, no routine legitimate follow up of patients who have received Vescell is done. None of the deceased patients' hearts have even been examined forensically to determine whether or not complications due to compromised or contaminated Vescell may have contributed to the patients' deaths, notwithstanding the fact that the laboratory in which Vescell is manufactured lacks certification to produce biologic products for commercial use in human beings - at least not to US or EU GMP standards as they've falsely claimed in the past.
By and through these frauds, TheraVitae was able to have Vescell, its untested and unregulated biologic product, used on unsuspecting human guinea pigs.
Harry J. DePietro, Esq.
Ohio, U.S.A.
hari.depietro@gmail.com
stemcells
You can always find good reports on any topic. If you are desperate then go for it -- BUT read the last paragraph again before you do.
Adult stemcells
In march of 2005 my heart function was down to 10to15% the doc said nothing
more we can do for you. to make a long story short in dec 2005 I went to Bangkok
heart hospital and had stemcells made from own blood 74 million. Injected into
my heart my heart function is now 42 to 45% almost normal 50 to 75. there are
case studys going on all over this country and the world theravitae was the co that handled my case it has worked out well for me good luck for Henderson like
Henderson I had nothing to lose.YOU PEOPLE NEED TO GET THE WORD OUT
PEOPLE ARE DYING EVERY DAY .WITH CHF AND OTHER HEART DISEASE.
GET WITH IT PRINT SOME GOOD NEWS FOR A CHANGE
RICHARD
Adult stemcells
In march of 2005 my heart function was down to 10to15% the doc said nothing
more we can do for you. to make a long story short in dec 2005 I went to Bangkok
heart hospital and had stemcells made from own blood 74 million. Injected into
my heart my heart function is now 42 to 45% almost normal 50 to 75. there are
case studys going on all over this country and the world theravitae was the co that handled my case it has worked out well for me good luck for Henderson like
Henderson I had nothing to lose.YOU PEOPLE NEED TO GET THE WORD OUT
PEOPLE ARE DYING EVERY DAY .WITH CHF AND OTHER HEART DISEASE.
GET WITH IT PRINT SOME GOOD NEWS FOR A CHANGE
RICHARD
