Civil discourse: addressing criticism from GDD sufferers
When I reflect over what I have done in my career, with a great emphasis throughout on patient safety, I think the best explanation of why I have been prepared to stand up for the rights of patients, and not simply follow along with the status quo (the latter course vastly easier, more profitable, and less stressful). I do my best to imagine myself in the situation of others.
When I hear stories of individuals who were more-or-less quite well or healthy, undergo an MRI study with GBCA, that they were told in advance would be safe.... then get very sick.... then are told by doctors that it could not be the GBCA ....and/or to find out what is wrong with them, put them through another MRI with GBCA, or multiple of them. I can put myself in their shoes. That is why I am prepared to put enormous efforts into getting them better or whole in some comprehensive fashion. This is even though it goes against much of the work I have done in my career, and also up against a powerful medical industrial complex, and against friends and colleagues. I am doing this work to help and advocate for these people who are suffering.
When I think about the sacrifices I have made in my career to help these sufferers from GDD, many extremely sick, many now impecunious, I think that my sacrifices are nothing compared to what they are going through.
From 2005- 2011 approximately, my major focus was on medical radiation, especially the overuse of CT. I was especially struck, not only regarding the criticism I took from radiologists doing a lot of CT, but criticism of major studies. There were two major studies on CT radiation and the risks of cancer. One a pan-Australian study, another a UK study. Also there was a great study from Quebec that looked at medical radiation experienced by cardiac patients (so not cancer patients) also demonstrating the risk of cancer development. Critics of these studies, invariably stakeholders in the medical radiation arena, criticized these works endlessly, mainly on the statistical methods. I was myself very impressed by the works, knowing as I do how much effort went into such enormous studies, and studies of this size necessary to make meaningful observations. And some CT radiologist, or who-ever, sitting in an arm chair, eating a donut while watching a football game, writing the study was no good because the statistics were not correct. Really? My response to that, and really to all critics of major thought-changing works. If you have a problem with the study, then rather than criticize it - repeat the study where-ever you are, North Dakota, Georgia, where-ever, and then challenge the findings with actual data. From 2007-2010 I wrote some of the largest papers on NSF - less violent objection to those, as dialysis unit nephrologists had already paved that path.
From the experience of having written 360+ peer-reviewed papers: It is really difficult to write a meaningful paper, and it is extremely difficult to get it published in a good journal> This latter is especially true, if it goes against the powerful status quo, because many of the reviewers are likely to be members of the status quo.
So rather than criticizing theories or opinions, which is of no benefit to anyone, I recommend coming up with your own study, using your own theories, and hopefully with the experience and integrity to describe what is actually occurring and not what you hope is occurring (the latter often happening in studies), and then publish in a scientific peer-reviewed journal.
What I realize with the challenging subject of GDD, it is so complex, that I am open to any idea, any treatment, that may help patients, and that may be better than what we are doing.
Controlled studies are expensive and time-consuming. Any meaningful controlled study takes a minimum of 3 years and $1 million. There are probably atleast 20 good studies that should be done. So I have to focus on what I think is important, based on my knowledge and experience. A comparison for example between iv EDTA and iv DTPA would be of no value. The science of it is clear, Gd with DTPA is 300,000 times more stable than Gd with EDTA - so I question the importance of spending 3 years and $1million to study that. This is an example where the chemistry alone is sufficient. Most studies that relate to GDD, right now have to be done on GDD patients. There are no animal models of GDD and some findings cannot be extrapolated from just chemical principles, animal studies, or 'normal' human studies. One has to have the knowledge and experience to know which is which. A number of sufferers have contacted me about what I think about certain published papers. I tell them, well the study is true for rats in the experimental design performed. But this may not be, and likely not be, true for GDD patients in the standard clinical setting. Now, my theory that immune cells in GDD patients are able to cleave macrocyclic agents - that is very interesting and novel - that interests me very much. To do that though I would have to elicit the interest of research groups who are able to do this sort of chemical cellular research. This may end up being the contrast research groups of the major GBCA companies who have experience with this. So, if I rant and rave that the MR contrast companies are all criminals, how likely would I be at getting buy in from them to do such a study? Even taking the reason-based middle path, may have at least for the present time, made this impossible for me.
I don't mind using treatments that: 1) make some reasonable sense, 2) are not expensive, and 3) likely don't cause harm (the Semelka trilogy) - but for me to say that something is definitely important, or essential, and it does not fit exactly into that trilogy, then there has to be a scientific study. The best would be atleast 100 subjects in each arm, where investigators are blinded to the subjects and treatments, then have age, gender, GBCA agent, duration of GDD, other diseases, as matched subjects. If in that setting it shows long-term benefit, then it is important> If there is no such study, then MAYBE it may help. Essentially every alternative treatment everyone is using, and virtually everyone is doing something alternative to help themselves (I get it, I would too), is unproven. The incredible complexity that some have developed for these therapies is remarkable - yet it is all scientifically unproven - if however it fits the Semelka trilogy then why not try it, is my current position. Some products are marketed by individuals with no apparent credentials, neither they or the product, which frightens me as it looks like snake oil salesman taking advantage of desperate and poor people.
I was saddened a few days back, when CNN reported on the social media that Dr Cindy MacCain received from some anonymous individual, regarding her late husband and her daughter. This individual was clearly angry and hateful. Unrelated yet on a similar note- I went on FaceBook to look for questions to address in upcoming blogs - I was shocked to see insulting posts about me by sufferers. I can understand how industry and radiologists may be angry at me because of me describing the disease GDD, describing the symptoms, and efforts at treatment. I am going against economic interest. However, to see the people who I am actually working extremely hard to help writing hostile posts was very disheartening. I like to give the GDD sufferers the benefit of the doubt and think that it is general anger at the medical community at the predicament that they have been put in.
I had a conversation with Rebecca Smith-Bindman, MD of UCSF, who is currently one of the leaders in the field of improving safety with CT, by reducing radiation dose, and standardizing studies with lower radiation in children. I shared with her "there is no money in focusing on safety to help out patients." Unfortunate, but true. Outside individuals not doing this type of research, even if they are radiologists, may not realize the truth of the situation. I am making about 5-10% on all the gadolinium work, even as a world authority on the subject. So unlike world experts like Roger Federer or Lebron James in their areas, by helping out people who are very sick and generally have no money, I am being generous with my time regarding.
To change the system in order for GDD to be recognized and insurance companies to pay for treatment requires a few critical steps. The best way to sabotage making change as an inside expert in Medicine is to antagonize (too overtly and too rashly) the powers that be, in the FDA, the radiology community, the medical community, insurance, and in industry. I am choosing the middle path to result in important change and benefit to GDD sufferers, and this point may not be something that GDD sufferers would be attuned to. I think many of the outraged criticisms sufferers vent at me probably relate to that I am not aggressive enough, I don't for instance call it poisoning. How likely would I get buy-in from radiologists, neurologists, hospitals if I rant that they are poisoning patients? Take a breath and think about it, it would make them in direct opposition to anything that I do, and they would be deaf to any of my recommendations or writings, and dismiss the entire subject of GDD. I can understand why patients can think it is poisoning, you have to understand why strategically it would be suicide for me to say this, but more importantly genocide for all patients. Among the worst things I could do is to call it poisoning, to set back recognition, treatment, insurance for patients for years, maybe decades. For sure then I would also not be able to get all-important peer-reviewed papers published, which insurance coverage depends on.
I am striving to come up with and write major peer-reviewed articles to benefit patients. However, it may be that some people cannot help but be critical and angry, even at me. I'm disheartened to experience hostility from some of the very people who I am working hard to support.