Gadolinium Contrast Injection in MRI: Yes or No.The Devil's Bargain.

There are principally 3 parties invested in the bargain of whether or not to receive a GBCA injection in MRI, although each category can be expanded:

the patient, the radiologist (this can be broadened for simplicity to include hospital/imaging center, and referring physicians as well), and the contrast manufacturers.

The patient is primarily focused on some combination of safety and accuracy,

The radiologist interested in safety and accuracy, and also not being sued (I am a radiologist so I can attest to this).

The contrast company manufacturing a good product, but they have spent around 1 billion dollars to get it on the shelf, so they are fundamentally invested in the concept that if there are issues with safety and accuracy of their product, it is not a matter of trivial importance that issues of safety are brought up... They want it to be 1000% sure that there is trouble at the old mill before putting limitations on their product. This may not be necessarily always Mephistophelian in nature. One can understand that concept.

So from the radiologist perspective: if a GBCA is not administered and a tumor then is not seen which may only be well seen if GBCA is given - in my area of expertise this would include small neuroendocrine tumors, small pancreatic cancers, small hepatocellular cancers, and small liver metastases, as only some of the important lesions in the abdomen. So no cancer called, and then 6 months later the patient is found to have inoperable cancer and decides to sue because of missed diagnosis. One can see why radiologists would be very nervous about patients refusing a GBCA administration. It may well be appropriate that patients sign a waiver that in not receiving a contrast agent they hold the radiologist and imaging center blameless. if an important disease process is missed. But perhaps the lesion was missed regardless of whether the contrast agent was not given. Who could make that call? Who even just in the abdomen would I trust to make that decision in an informed even-handed way, whether the error arose because GBCA was not given or because the radiologist just simply missed the diagnosis that was there. Who would I trust to umpire that decision? I hate to say, but in my experience in medicolegal cases, the only person that I would trust their opinion as a medicolegal expert is me (maybe a few others... who I have trained and know their character and knowledge level)..

The general problem in health care in developed nations, and especially in the USA, is too much unnecessary imaging and by extension too much contrast.. and this does not apply only to MRI it applies to all imaging. I have written major peer-reviewed papers on this subject atleast since 2005. Much of this excess unnecessary imaging is driven by fear of litigation primarily, and for profit in some/most centers. So when a patient is told they need GBCA contrast to make an informed interpretation of an MR study, would I trust an MR technologist or a radiologist? May be not. I believe it does take enormous experience to make even a reasonable determination of that. Who would I trust to make that call in the abdomen? I don't need to tell you what I would say.

So a few things I would have to say at the imperfect state of the social contract we are in, and maybe have always been in:

Radiologist

1. radiologists fear not giving a contrast agent, or not doing one more followup MRI with GBCA they will have missed something, and even if it is 1 in 100,000 chance that ti would occur, they still can be sued, and the plaintiff can still win. The likelihood that something could occur needs to be at most 95% likely, maybe 80% is more reasonable. I have been involved in legal cases, on all sides, where the likelihood that something untoward would occur is in the 1 in 100,000 range. This obviously has to change.

2. Medical experts need to be agents of the court, not of the opposing parties. Medical experts also need to be held culpable for their opinions.

3. Juries should be composed of retired physicians, judges, and lawyers (knowledgeable jurors.

4. If patients refuse to receive GBCA they should sign a waiver that they hold the radiologist and imaging center blameless in the event a serious finding missed, that was missed because GBCA was not administered (who can make that call, just me?).

5. At this time, I do not think a radiologist is responsible if GDD develops from the first GBCA injection, or the first GBCA injection to cause GDD. Should they be held responsible (including MR tech and imaging center) if it is someone who already has GDD and then receives another injection of GBCA being told "don't worry everything will be fine you have normal kidney function, it is impossible to get sick from it". These are the numbers: maybe 1 in 10,000 individuals will get GDD from a GBCA injection, so very low risk (but there are factors that make it more likely: i) white, ii) female, iii) multiple chemical sensitivities.. etc), Once you have GDD the chance you will get worse with a subsequent GBCA injection is 100%.... so should the health care practitioners and facility be responsible?... I have written something like 16 peer-reviewed papers, atleast 6 in major journals, so there really is no excuse for not knowing about GDD. Also now other research groups have separately written on the subject so the experience has achieved generalizability.

Patient

1. I tell patients when asked if I think they need a certain study, and I tel them yes or no, often no. But here again there is a 1 in 100,000 chance that anything could be there and anything can happen. So is there a risk for me, probably. but I operate on the basis of having very good knowledge about diseases, likelihood of diseases, and risks inherent in all imaging modalities (not just MRI) and their relative accuracies.

2. Patients have the right to refuse examinations without being bullied. Understand then you have responsibility if something is present that could have been detected if GBCA given. To be frank, this is relatively rare, but does exist, and some people are more likely to have certain things.

3. Patients have the right to refuse GBCA or anything else (iodine contrast for example) but recognize the study will no longer be optimal in detecting everything. That is generally a fair trade-off.

4. Right now it is blatantly absurd that the diagnosis of GDD is still made most often by the patient themselves. One can understand how laypeople may not trust doctors.

Manufacturers

1. Unfortunately all aspects of medicine have become fundamentally adversarial. If a company has spent $1 billion to bring a drug to market, it is not a trivial matter if the drug is considered unsafe. It is reasonable to want reasonable proof.

2. Because of the money involved, there is a very high bar to the awareness companies have about the safety of their products (Oxycontin and Purdue). Sometime their lack of awareness truly borders on the criminal. The money they have spent to get through FDA phases is just so high, which makes blindness to the truth almost universal. Perhaps the federal government should be involved in the expenses involved with approval, so the safety-aversion is less potent amongst companies.

3. Personally I do not like the medicolegal system as it exists in the USA. I have described it as a bingo system. Most sufferers lose (because of lack of awareness, awareness stifled, legal activity, expenses, difficulty with finding proof, statute of limitations, negative efforts by defendants) and there is generally only 1 or a few people who can say BINGO. I prefer a system where the companies are not automatically adversaries, so they actually can be part of the solution for everyone, and not just the Daddy Warbucks for a couple of lucky sufferers. I think fundamentally the companies probably would be prepared to fund treatment for victims, and maybe some compensation, if the risk for multimillion dollar settlements for a few did not exist. Rather than 5 sufferers each getting 5 million dollars, a much better solution is the companies be part of the research and treatment enterprise and every sufferer receive the $20,000 or so treatment to get adequately treated, without a statute of limitation.

Richard Semelka, MD