Issues with my approach to informed consent

May 22, 2019

 

I have proposed a new informed consent for GBCA, as the first step of increased awareness of the disease GDD. A number of sufferers have felt that I have not gone far enough. I fully understand that sentiment, however in my position as a senior member of the Radiology and MRI community, I have to approach the subject in a measured step-wise fashion.  I would lose all credibility if I rushed head-long in attacking GBCA use - in large measure because most of my colleagues would interpret it as rash, radical and ill-conceived, without there being sufficient peer-reviewed literature by a number of independent research teams.

 

 In focusing on patients who have previously received GBCA and have experienced symptoms of GDD, to prevent them from receiving GBCA again would potentially eliminate 70% of the cases - and many of the most tragic cases, where individuals have received more GBCA-enhanced MRI studies in order to investigate what turns out to be GDD to begin with. But critics are correct that atleast 30% of individuals develop severe GDD following their first GBCA-injection. My approach does not prevent this.

 

I have to agree with this view. But, I have to proceed in a step-wise thoughtful fashion if I intend to get acceptance from radiologists, other physicians, the FDA and other organizations. If I alienate all of them, and appear like a crazed zealot, then I will set the recognition of GDD back years, maybe decades. Human behavior shows that if individuals are attacked and made to feel they are doing unethical work, the natural tendency is to reject the words of the messenger - in their entirety. I have mentioned this before. I ultimately need all their buy-in, so I have to lead them to the knowledge as a guide or shepherd and not as an adversary. Realistically I am also trying to ascertain how to have high confidence in recognizing who are the 30% of first exposure GDD sufferers. When this is more certain then the informed consent should address this.

 

 I have also stressed in a number of other blogs, the risks of alternative strategies also have to be described. Some of the risks are worse and more likely for some individuals.

 

I have seen enough sufferers that I can well understand how for some of them, their opinion is more of anger and outrage.

 

Is it cowardice, as suggested, that I don't speak out more forcefully? Far from it, even with measured and moderate comments, it actually takes a lot of courage. To be the radiologist who has most visibly stood up in the face of the tempest of opposition of those who want to maintain the status quo, is not at all easy or timid. This is also just the right arm of the entire body of my efforts to stand up and protect patients from health care misadventures and mistakes.

 

In conclusion, in my position I have to act in a measured rational fashion. Ultimately this will be most helpful for patients. Others can be more aggressive in their approach, and I would say some (really all) sufferers are justified in this strategy.

 

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Richard Semelka, MD. Consulting

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