William C. Rader obtained his medical degree with honours from the State University of New York (Buffalo) in 1967, subsequently carrying out his psychiatric fellowship at the University of Southern California Medical Center in 1971. He controversially had his medical license revoked in California, following a series of complaints by patients.
In June of this year, a new documentary was released by the name of, The God Cells: Fetal Stem Cell Controversy, a movie by investigative journalist and filmmaker, Eric Merola, following the progress of a handful patients undergoing stem cell treatment under Rader’s supervision in Mexico. The film was truly mind-blowing, and definitely presents a strong argument in favour of such treatment for “incurable” diseases.
We're certainly not oblivious to the huge amount of negative press concerning stem cell treatment, a lot of which attacks individuals, including plenty of complaints in the media regarding Mr. Rader - though seemingly convincing a lot of the time, we have strong reasons to believe that not everything we read and watch presents us with impartial evidence. Our minds are still open regarding whether such treatment is all that it claims to be, and we merely urge the reader/listener for now to keep an equally open mind, both pro and contra.
Up until now, there has been minimal positive press about Rader, and stem cell treatment in general, at least as regards the U.S. In the spirit of fairness, we believe Rader deserves at least some defending in this discussion and the chance at an unbiased analysis. As Frank mentions at the end of the interview, we try to give listeners another piece of the puzzle in this whole discussion that hopefully will help people make up their minds, no matter which side of the fence they are on.
The media is powerful, and there are few devices out there that have been more powerful in the last several decades than the television – notice that a lot of the anti-Rader (and anti stem-cell in general) reactions have been sparked by TV, which tends not to be considered the most open and reliable of information sources. There’s a reason why we have the sarcastic saying, “If you heard it on TV, it must be true!” or perhaps more apt for nowadays, “If you read it on the Internet, it must be true!” Both CBS and the BBC have released anti-stem cell documentaries, both containing interesting information, but unfortunately also both blatantly biased. The two documentaries were painful to watch at times, shamelessly prejudiced in their approach of the matter. For instance, the BBC documentary sends an “undercover” patient, a lady with Multiple Sclerosis, to investigate Rader and his practice. She poses as a legitimate client (though from the get-go has no intention to actually pay or undergo any treatment), secretly filming her conversation with Rader. At times, it undoubtedly seems that Rader is being rather pushy with the treatment, earning himself the harsh title of “used car salesmen” by another medical researcher that appears in the documentary. Of course, pushiness makes no-one look good, especially not when it comes to medical services – Rader’s services may well be driven by the prospect of financial gain, something that unfortunately can’t be denied for most people selling a service. Then again, it’s not exactly a crime to have at least some interest in earning a good income from one’s job; in fact, it would be odd not to. Furthermore, let it be known that all of Rader’s patients sign a consent form, which contains the phrase, “I understand that Dr. Rader has [a] financial interest in the (FCTP) [Fetal Cell Therapy Program]”. So, if there ever was any doubt, it should at least be clear from that. For now, though, we’d like to give Rader the benefit of the doubt, at least as regards his sincerity when it comes to the treatment itself; for now, we’d rather not condemn a potentially world-changing treatment because of the unpleasant display of an individual.
However, this is unfortunately exactly what both of the documentaries do: they try to make stem-cell treatment look bad by making the service-providers look bad. At very least, I feel that they should have made it clear at which point criticism of individuals and organisations ends, and criticism of the treatment itself begins.
In my opinion, it seems that perhaps a fairer review could have been given if the undercover patient had actually undertaken the treatment; though, admittedly, some doubts as to its safety were presented, which is presumably why this did not take place. Nevertheless, it still seems somewhat ridiculous to put so much effort into exposing Rader, but never once actually investigating the possibility that the treatment itself may be beneficial. In any case, it is pretty clear that what the exposé boils down to is an attack on Rader, rather than an attack on the treatment type itself; it’s just unfortunate that most people will not see it in that way, and such reports undoubtedly tarnish the face of stem cell research overall.
As a small side-note, it’s interesting to point out that the press nowhere near as much covers “normal” doctors in the US, who are nearly all under contract by various pharmaceutical enterprises to push medications on patients, despite often being unnecessary. Yes, $25,000/$30,000 is a lot of money (those are the prices that Rader has been known to charge for initial stem cell injections); however, what about treatments such as chemotherapy? Given “standard” anti-cancer drugs, the average cost for one extra year of life, as paid by patients and insurers, was determined by researchers to be $207,000 in 2013. And that’s just the average for one year of life. If Rader is a “used car salesmen,” then the medical industry in the US must surely be a used car market; if being pushy when encouraging treatment for terminally-ill patients is his crime, then we are all surrounded by criminals.
Disappointingly, such documentaries uncannily resemble yellow journalism, what with their scandal-mongering and sensationalism, which is rather discouraging when you consider the high esteem in which companies such as the BBC and CBS are held.
Below is a transcribed excerpt from the “60 Minutes” documentary segment on stem cell research, specifically addressing the undertakings of a man named Dan Ecklund (aired January 8th 2012). We do, in fact, have our doubts about Ecklund’s practices and reliability – he certainly did not paint a good portrait of himself, and when the fetal stem cells used by him were put up against lab scrutiny, they were disappointingly shown to be of very low quality (most of the cells appeared to already be dead).
Unfortunately, it seems that he was a man who truly believed in the cause, but was simply not knowledgeable enough about the procedures involved (he had had no prior medical training). Alas, this in no way justifies what he was doing (he certainly shouldn’t be carrying out medical procedures unless fully trained in the field), but, once again, we seem to be presented with an example of where the individual exhibits reasons to doubt them and their practice, but the practice itself is not to blame.
As always, though, most people will not differentiate between the two; most likely, the majority of viewers will end the documentary with a negative opinion of stem cell treatment, further diminishing the chances of such treatment being publically accepted in the near-future.
Context of excerpt: Ecklund has just been questioned about whether his practice is a con or not, upon which he answers that he has injected himself with stem cells, and that he would not do so if he believed it to be a con. The conversation continues:
Scott Pelley (Journalist): “Putting them in an 11-year-old boy is an entirely different matter […] without any medical studies that have been published in major journals that have suggested that stem cells have any efficacy.”
Dan Ecklund: “You keep going back to this point, that they are not published in major medical journals.”
Pelley: “It is the standard of the world, I do keep going to that point.”
Ecklund: “I keep telling you that they are not going to get published in this country, because when someone does try to do it, then they have 60 Minutes come and visit them.”
There are a couple of interesting points brought up in this excerpt, which Rader himself has also mentioned on numerous occasions. Firstly, foetal stem cell researchers are often criticised for not having published research papers; the fact is, there have been several papers published in other countries, but the medical field in the U.S. seems to be highly lacking in this department. It seems safe to assume that the reason is not so much that U.S. researchers don’t want to publish papers, or that they have no publishable evidence, but rather that the stigma attached to stem cell treatment is so negative, that most doctors and scientists are not willing to risk the ensuing demonisation, and even possible medical license revocation – and that is, if the paper is even permitted to be published in the first place. As Ecklund says during his interview/interrogation: “they are not going to get published in this country, because when someone does try to do it, then they have 60 Minutes come and visit them.”
Another interesting point, though, is the journalist’s constant emphasis on established “standards” – he always brings it back to the point that Ecklund is operating outside societal and medical norms. But, wait a minute – when has a true revelatory discovery ever been made without deviation from the “norms”? How are we ever to expect a paradigm shift to occur, if the rules dictate that we can only stick to the set standards of society? That would surely just be oxymoronic: the very definition of a paradigm shift is, “a fundamental change in approach or underlying assumptions.” And, until that happens, it appears that many medical researchers will remain stuck in this Catch 22 (not just when it comes to stem cells, but other treatments included, such as potential cancer cures).
Furthermore, the unfortunate truth is that those who are ill, or those with loved ones that have a serious disease, simply do not have the time to wait around for all the boxes to be ticked (the average time for FDA drug approval is 12 years, costing an estimated $800 million per drug): they need treatment, and they need it now. Waiting another ten, twenty years is simply not an option for many – and they’re willing to take the risks necessary, especially if not taking them means certain death or lack of quality-of-life. For many people, the odds are a no-brainer.
At WoTR, we generally oppose ambush journalism, and even more so when an individual has clearly been lead into an entrapment-style situation; again, we believe in fair game. From the get-go, people who find themselves in such ambush situations have no real chance of explaining themselves properly or coming off as respectable in any way. The very act of interviewing them in such a manner evokes negative feelings and thoughts in the audience: alas, why would someone be interviewed in such an interrogative fashion if s/he were a good and respectable person in the first place (or so the thought goes)?
One of the main arguments put forth against stem cell treatment, and the reason why Rader’s medical license was revoked, is that it appears to be ineffective for a number of people. Rader was taken to court, and had three patients testify against him, one of whom only had one injection (declining any follow-up treatment), another who had never even undergone any treatment, and only one of whom actually underwent the recommended course of treatment (the injections were discontinued after the third unsuccessful transplant). In both of the latter instances, when the initial stem cell transplant indicated no signs of improvement, the patients were offered follow-up injections free-of-charge. The patients in question had no negative side effects as a result of the unsuccessful treatment.
The following is taken from the official court document: “It is possible that the Respondent is completely correct in his assessment of the efficacy and future of foetal stem cell therapy. If he is, neither science nor the standard of care has caught up with him. If he is not, he poses an unacceptable risk to the health, safety, welfare and interest of the public. Either way, he is operating outside of the standard of care.” Again, we encounter this emphasis on the “standard” of care: even if it means at the cost of the patient’s welfare. Conformity is always valued above doing the “right” thing.
Furthermore, it should be added that the cells used are harvested in the Republic of Georgia, tested in Germany, and then shipped to Mexico, never once touching U.S. soil, meaning that Rader was therefore operating outside the jurisdiction of the State of California. Also, Rader himself had 18 witnesses fly in to testify in court; yet, the medical board convinced the judge that they could only have four witnesses. To add insult to injury, the California Medical Board could not find a single expert who had any clinical experience with the application of foetal stem cells to testify on their behalf, leaving the expert witnesses they did find utterly confused by the variety of remissions that Dr. Rader’s company had acquired, subsequently trying to explain them away by blaming it on the “placebo effect.”
One of the other main issues brought up in the trial was that of genetic matching, as is done in an organ transplant or a stem cell bone-marrow transplant, arguing that, without genetically matching each patient to respective foetal stem cells injections, the body will reject the cells; thus, in order to avoid this, each patient should require immunosuppressive drugs (so they say). However, in all of Rader’s twenty years of practice, during which he has treated well over 3,000 patients, he never once gave immunosuppressants to his patients, nor did he ever genetically match their foetal stem cell injections. He did not do this out of malice or callousness, but rather because he had genuine reason to believe that neither was medically required. Even though Rader was aware that he was not operating within the “standards of care,” he refused to give his patients (some very young and/or immunocompromised) immunosuppressive drugs, knowing that they might well kill them, if not their disease. In fact, some time prior to the trial, he had actually voluntarily surrendered his license, but this surrender was rejected. Why? For no other reason than that the legal system wanted to see his license revoked. Not even Robert Shapiro (O. J. Simpson’s lawyer during his murder trial) could save him. This is truly shocking. Does the government really view a doctor’s attempt to cure terminal diseases as worse than a double homicide?
In any case, let’s return to the main point of ineffective treatment. Firstly, ineffectiveness to some patients (or even many, for the sake of argument) is simply not a legitimate reason to denounce any medical treatment, and certainly not reason enough to revoke someone’s medical license. Even less so, when said treatment is generally found to be ineffective at worst, as opposed to dangerous/fatal at worst. And, furthermore so, when that treatment has already been explained to have a chance of being ineffective – Rader, alongside many other scientists, make it very clear that the treatment might help, but that there is no guarantee (this is also made very clear in the documentary, The God Cells: Fetal Stem Cell Controversy). In many cases, the treatment is indeed unsuccessful; however, it is extremely important to remember that, in those cases, the stem cells generally have no effect on the body. That is, unlike something like chemotherapy, where the treatment may help at best, but damage or even kill the victim (sooner than otherwise) at worst, stem cell treatment generally has no negative side-effects. How many oncologists have their license revoked for pushing unsuccessful (and often seriously harmful) treatments on their patients? If mere inefficacy of a medication or treatment is sufficient to have someone’s medical license revoked, then we’d be living in a world without any doctors…
Despite this, it has to be said that we would certainly like to see more statistics and research findings concerning this matter, especially on Rader’s website, StemCellOfAmerica.com, where no statistics are presented whatsoever; instead, we encounter qualitative descriptors such as “often” (i.e. “Often, in cases where the diseases continued to worsen, our patients have reported substantial improvements following the Stem Cell treatment”), and vague phrases such as, “Utilizing tests more sophisticated than those regularly used in the United States,” unaccompanied by any further explanation.
Yet, despite the lack of statistics and details on the website, the results displayed in the documentary are nevertheless astonishing, and even when assuming a low success rate, it appears that this is enough to justify the efficacy of stem cell treatment. That is to say, even if we, for the sake of argument, were to assume that only those patients shown in the documentary had a success story, then (considering that Stem Cell of America has, thus far, treated approximately 3,000 patients) a success rate of 25 out of 3,000 still seems like an amazing figure, considering that the illnesses encountered were all “incurable.” I would think that most people in the world that either had an incurable disease, or a loved one suffering from such, would probably give a 1/120 statistic a chance, if it meant cure or at least considerable improvement in symptoms.
What other doubts are there when it comes to stem cell treatment’s safety? One of the main (and hopefully only) evidenced medical concerns was that a young Israeli boy suffering from ataxia telangiectasia (AT), an incurable, neurodegenerative disease, developed brain and spinal cord tumours four years after his neural stem cell treatment in Moscow (this was also brought up in the BBC documentary). Doctors are certain that the tumour was a direct result of the injected stem cells. However, things that were not mentioned by the documentary host include the fact that the tumours were found out to be benign, and that researchers claim the cells were poorly characterised prior to transplantation. Understandably, no tumour is good news, benign or not. Especially when occurring in the brain or spinal cord, they can still wreak havoc (the boy had already begun to experience headaches). However, there is still a huge difference between a malignant and a benign tumour, especially as regards the reactions that it might evoke in people. It particularly matters when it comes to evaluating a type of medical treatment: for many, a miniscule chance of developing benign tumours may well be outweighed by the prospect of potentially having a “normal” life again, so it seems wrong to omit such details. We all risk a potentially adverse reaction and negative side-effects every time we take any sort of medication – even something as simple as aspirin can result in death (if an anaphylactic reaction occurs). If the possibility of a negative reaction were to put everyone off taking any medication, then the entire medical industry would surely crumble, most of all the anti-cancer businesses. My point is, as it stands, one bad reaction in thousands is nothing compared to the close certainty of, say, chemotherapy having negative side-effects (often including a faster and/or more painful death than by cancer itself).
On to the second point, though, the likelihood that the stem cells in question were poorly characterised prior to transplantation – that is to say, the preclinical safety measures were most likely not adhered to, thus increasing the risk of the cells growing inappropriately. Not only that, however – it seems likely that other clinical guidelines were not followed as well. I won’t go into all the details here, but some googling and reading of online discussions will provide more information for anyone interested. The comment section at
the-scientist.com/?articles.view/articleNo/27148/title/Stem-cell-therapy-triggers-tumor/
is interesting, as is the blog entry on molphil.wordpress.com/2009/02/20/primum-non-nocere.
As one commenter on the-scientist.com points out:
“Although the Russians claim to be using "neural stem cells", they are not. They essentially take a whole fetal brain, put it in a cuisinart, and inject it uncharacterized as a graft slurry. This case has no bearing whatsoever on the legitimate biology and uses of stem cells, particularly neural stem cells.”
Furthermore, it should be noted that there had been no prior indication that stem cell treatment would help the disease in question (AT), so it was a highly experimental risk to take at best. In addition to that, the boy’s disease listed symptoms such as neurodegeneration, immune deficiency, and cancer susceptibility (among others), which must surely be taken into account when judging the fact that he developed tumours; at very least, it should make us question whether the treatment should have been carried out in the first place. Given these facts, can we really judge stem cell treatment in general, when we are only looking at a very specific case where standard protocol and clinical guidelines were most likely not met? Once again, it would be nice to know what the exact statistics are, specifically how often tumours are formed as a result of stem cell treatment. Without that knowledge, we can only assume for now that it was a one-off occurrence.
In any case, though we unfortunately only had an hour with Mr. Rader, and would certainly jump at the opportunity to discuss matters further with him, we managed to crank out a super informative and interesting interview, questioning Rader on ethical, functional, and political issues of stem cell treatment.
One of the main ethical issues attached to this topic is the question of whether it is morally right to allow the use of cells from aborted foetuses. In general, those opposing the use of dead foetuses are those with a religious background that believe in the sanctity of the foetuses’ life. Many of these people will argue that, because the foetus is viewed as being on par with any other human life, it is therefore wrong to use it, because using it would involve killing it. However, such arguments appear to completely miss the point of the foetuses being dead already.
At its core, the question should probably read more like this: given that the foetuses have already been aborted, and the appropriate permissions obtained, should there be any more of an ethical issue in using the cells for research and treatment than there would be in using the body of someone who has died and provided prior permission for use of their body (e.g. is on the organ donor list) for research or transplant components? Or, perhaps more closely relevant, in using tissue or organs from a deceased child, given permission from its parents? If someone believes that organ donation post-death is acceptable, it should follow that stem cell donation after the death of a foetus should also be allowed.
Another commenter on The-Scientist.com article made some really great points relevant to this:
“The practice of taking stem cells from aborted foetuses is no more or less desirable than the act of aborting foetuses in the first place. I suppose the extra distaste comes from creating a market for aborted foetuses, but whether this would ever affect the actual number of abortions being carried out is debatable. There is an argument (an old argument, I admit, and used for all sorts of questionable research) that, if the research is not done in countries operating under world's best practice methodologies (due to current legislation), then it will be done in less optimal environments and in countries with fewer scruples. And there is a plentiful supply of customers from the West willing to fund it. The end result is poor research and more suffering to the families who choose to try such therapies.”
Of course, there is also the question of how to avoid deliberate conceptions, with an abortion already in mind (most likely for financial gain); that is, how does one prevent abortion from becoming a business? Or how do we prevent a female family member from intentionally planning an abortion, in the hope of saving another ill family member? Though practical more so than ethical, such questions were also posed to Rader during our interview.
Religious or not, one could also apply the Slippery Slope form of argument so often used in ethical debates – though openly regarded as fallacious, it’s something that we should nevertheless bear in mind, since it is so often thrown about. In fact, this topic has various “slippery slopes” open for analysis. For instance, where do we draw the line at who really needs stem cell treatment? Should it be open to everyone and anyone? Someone with a life expectancy of two months? Two years? Youngsters with debilitating diseases? Or anyone, no matter how old, with a debilitating disease? Only someone who has tried all other options? At what point does one declare “all other options” to have been attempted? What if someone merely wants to maintain, say, their youthful looks, and thus regularly undergoes stem cell treatment, essentially in an attempt to delay the onset death. Is this right? (Not that it ever stopped billionaire David Rockefeller from obtaining his six heart transplants, though admittedly not officially proven; and, considering how well he hides his medical history, I guess we’ll never know for certain. In any case, it definitely is not illegal to obtain numerous organ transplants, and it’s certainly conceivable that someone rich and/or famous enough could do so, which is the main issue).
We touch on the above, alongside other, ethical dilemmas during the course of the interview. Putting the ethical aside for now, though, there are far more questions even beyond this: we also approach Rader concerning the trustworthiness of stem cell treatment, especially as pertains to the claims made by those who provide the service, and whether or not this type of treatment may be just another ploy by pharmaceutical companies to put more money in their pockets (much like, say, the increasing push for anti-depressants in the last few years).
We were extremely intrigued and somewhat relieved by Dr. Rader’s response. It appears that stem cell treatment cannot be patented, at least at the time of writing (in the US, as well as in Europe) – in the same way that DNA or any other part of the human body cannot be patented. This is clearly a huge drawback for Big Pharma, making it thus unattractive for most pharmaceutical corporations to get involved in this business. This, alongside the fact that successful stem cell treatments would severely reduce the earnings of such companies in regards to sales of medications and treatments (specifically those that treat terminal or “incurable” diseases). If you believe the Big Pharma Conspiracy to be true, or at least possibly true, then this should definitely set off some alarm bells. On the plus side, it means that we can rest (relatively) assured that Big Pharma is not behind the pro-stem-cell hype.
Admittedly, this cannot prove that individual clinics and independent doctors are trustworthy when it comes to the treatment, but it is nevertheless a relief to know that pharmaceutical companies cannot claim stem cell treatment for themselves, monopolise it, and then charge extortionate prices, unreflective of its actual costs and effects.
The legalisation of foetal stem cell treatment still seems to be a while away though, and for now we need to remain wary of why the medical industry and the government in the U.S. is so adamant to keep this type of treatment at bay. It is no secret that the medical industry is a huge business here. Should we not be suspicious that medication such as Nexium, also known as the “purple pill” commonly prescribed for acid reflux, could cost us more than $200 in U.S. (these prices are based on the year 2013), whilst only costing $60 in Switzerland, the next-most-expensive price in the world for the same drug? In the Netherlands, it costs $23. Neither of the latter are third-world, or even developing, countries. Specialty drugs for chronic diseases such as multiple sclerosis carry similarly inflated prices, e.g. prescriptions of Copaxone and Gilenya cost approximately $4,000 and $5,500, respectively, nearly three times more than the most-expensive price in other countries. This surely tells us enough about the pharmaceutical agenda in the U.S., and it doesn’t appear to be good news.
There is simply not enough room to discuss this topic in full here. For a great overview of the points mentioned above, we recommend checking out The God Cells: Fetal Stem Cells Controversy, for yourself. There are pros as well as cons to foetal stem cell treatment, and we merely want to clarify the pros a little more, both as regards the treatment itself as well as Rader’s involvement thereof. I think the question that all these discussions boil down to is this: If it were you, or a loved one, that had a terminal illness, would you give foetal stem cell treatment a try? I think the reality we have to face is that a lot of people would be willing to take the risk, if not doing so meant certain death. Legal or not, tried-and-tested or not, the prospect of impending pain simply outweighs the cons for the majority of human beings.