Gadolinium Deposition Disease is a Medical Disease and not a Litigation Disease

August 19, 2019

 

As many sufferers are now aware, a Federal judge has decided that based on the available literature and the presentations by 4 experts representing plaintiffs, there was insufficient evidence to determine that GBCAs caused the symptoms patients experience. It is always easy to armchair quarterback events, so I don't intend to do that. It is noteworthy, including by me, that I was not one of the experts asked to present, and many of the presenters focused on NSF, which may not be compelling when describing GDD. The fact that I was not one of the presenters should serve to show that my interest in this disease is not in litigation, but in understanding the disease, preventing the disease, and treating the disease.

 

Critical points that came out from the judge's decision, is that there was not sufficient peer-reviewed literature to ascertain the diagnosis, and not sufficient separate research groups documenting disease.

 

For those following my blogs closely, I have mentioned this aspect on a couple of occasions.

 

Peer-reviewed articles. This is the gold standard for acceptance of a disease process, which is critical in virtually all aspects of disease maintenance: from this litigation to insurance coverage. I must confess, that having seen a number of TV ads by disability attorneys using the term GDD (and at times also incorrectly GSC), on the one hand it was flattering, as this was the term I coined, but more importantly I realized this was going to be trouble. Trouble for me, but more important, trouble for patients at large. The reason is: the litigation aspect of GDD was the initial impression received by most physicians prior to the medical diagnosis of GDD. So for physicians to learn of GDD as a subject of litigation, prior to them learning of it in the medical literature, it has served to bristle the quills  of physicians, especially radiologists, that this entity may make them culpable for medical litigation. This therefore, with having no particular knowledge on the subject, has made many physicians think that the diagnosis is a litigation diagnosis and not a medical diagnosis.

 

Beyond the larger community of physicians, in particular relevance to this subsection,  are those physicians who are reviewers. How the review process works in brief: the manuscript is sent in to the editor of the journal, and the editor then sends out the article to reviewers, usually 3 of them. Based on the reviews the editor then decides the fate of the manuscript> publish or reject. The problem with papers on GDD is that the reviewers considered experts on the subject of GBCAs are composed of radiologists who perform GBCA-enhanced studies, and some scientific directors of the companies that make these agents. The conflict of interest ofcourse at the best of times is enormous, but add to that if the reviewers consider it a litigation diagnosis it will almost certainly be rejected regardless of how well it is written and how solid the data is. Equally disturbing,  reviewers may actually see GDD as a medical diagnosis (that they may also know exists) but that it has self-perilous litigation aspects to it. So the litigation-first diagnosis of  GDD has made it extraordinarily difficult now to publish articles on the subject> reviewers are afraid of the litigation prospects. 

 

       The requirement for independent research groups also explains, as I have said before, that I do not reach out to the HOPO developers, as I hopo that they will independently look at treating GDD patients.

 

It is critical for all sufferers to realize that it is absolutely essential for them to contribute to any research intended for peer-review works. This recent devastating legal decision confirms that.

 

I intend to reach out to the community on specific topics that I expect everyone who can contribute to it. will. It benefits all aspects of the disease to all sufferers, starting with insurance coverage of the disease if there is sufficient literature.

 

My first request is I want all individuals who have had just 1 GBCA injection, and they know the agent, and have had nonprovoked (native urine) 24 hr urine  Gd determined, to send me that information. The actual report is ideal. I am interested in these values obtained soon after the GBCA injection. The intention is to publish peer-reviewed articles, and your name will be confidential. I will post this separately.

 

Health Care Coverage. One of the major problems that this disease has revealed has been the failings of the American health care system as it currently exists. The first blog I ever wrote on my webs-site has been on the health care system. It is shameful that so many patients have been rendered destitute by the disease, and there is essentially no coverage for their healthcare.

 

It is interesting that health care has been a major policy subject in the upcoming election. It however involves a number of changes to occur in lock-step, which I am not sure how well that is understood. I will re-issue a larger blog on this subject: but the critical points are: 

 

1. Combined universal coverage with private insurance. The Australian health care system may be the best model. Wherever it says Australia in their policy, it is crossed out and USMedcare put in its place.

 

2.  Decreasing charges for drugs in the US by negotiating with pharmacy companies. Many drugs cost more than 10 times in the US compared to other countries. Insulin charges in Canada vs the US has recently been in the news.

 

3.  Changing the medicolegal system to diminish excessive defensive health care practice, that has been estimated as much as a trillion dollars/year. Perhaps 1/3 to 1/2 of health care in unnecessary, which explains why in the US the health care costs are about twice that of the next most expensive system per capita. A major cause that charges are so extremely high in the US for procedures, compared to every other country, is practitioners and hospitals have to build in a huge financial buffer to cover the likely prospect of costly legal action. A situation no other country faces.

 

4.   Strong regulations on accountability for all members of the health care system with stiff penalties. This includes medical experts testifying in medicolegal cases.

 

5.   Regulating and creating transparency of hospital charges.

 

6.   The major fear of universal health care, and it is a legitimate fear, is that some procedures and some drugs are so expensive, that in 1 year the entire US government could be bankrupt. by unfettered health care There has to be well informed committees composed of physician experts, pharmacy experts, and health care experts, who are independent and not stakeholders, to determine the best value for reasonable treatment, within the universal health care system. Annual updating would be essential. Drugs that cost 1 million/year and may provided 6 extra months of poor quality life will not be available in the universal system. That is where individuals can purchase supplemental private insurance for this type of care. Everyone should get health care coverage, but there may be waits, and drugs that are excessively expensive without significant translation to benefit will not be available. That is the trade-off that all other nations have made, and their citizens understand that: better good health care than no health care.

 

7.   Health care coverage for foreigners has to be studied. It may be more cost effective to offer basic care, than having Emergency Departments flooded by them. It would be smart to study other nation's experience. Spain for example may experience the highest percentage of foreigners receiving health care in their system. In large measure from individuals from Latin America and the rest of Europe. 

 

In a largely uninformed and combative, uncompromising two party system in the US, it is unfortunately hard to imagine anything of importance can happen. That is why a step-wise program, such as promoted by Joe Biden, may be the only way to get to a smart health care system as written above.

 

Richard Semelka MD Consulting 
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