The ultimate price of a false diagnosis

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In one of the original natalizumab studies a 46-year-old woman unfortunately died from progressive multifocal leukoencephalopathy (PML) after having received 37 doses of natalizumab. Although PML was confirmed at post-mortem there was no pathological evidence that this person had MS.


Kleinschmidt-DeMasters and Tyler. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med. 2005 Jul 28;353(4):369-74.


According to the established definition of MS used at the time the patient should probably not have been diagnosed as having MS. The following letter to the journal high-lighted this issue very well.


Berger and Deisenhammer. Progressive multifocal leukoencephalopathy, natalizumab, and multiple sclerosis. N Engl J Med. 2005 Oct 20;353(16):1744-6; author reply 1744-6.


“In all likelihood this patient probably did not have MS. The great tragedy is that she died of a complication of receiving natalizumab.” 


“The lesson here is not to rush into making a diagnosis of MS; if there is uncertainty it is better to wait for the disease to fully declare itself. To quote one of my great clinical mentors Professor Tom Bothwell: ‘Time is often the best diagnostician’.”

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.

4 comments

  • Hello, I don't understand what the difference is between a lesion and a plaque, and what makes an MS lesion different to other lesions which may show up on an MRI of the spinal cord and brain? Would be grateful for an explanation! Thanks!

  • Re: "… are you a scientist or an artist?"

    This refers to my clinical hat! I wish the practice of neurology was a science.

  • Re: "I don't understand what the difference is between a lesion and a plaque, and what makes an MS lesion different to other lesions which may show up on an MRI of the spinal cord and brain?"

    A lesion is a non-specific term that must be interpreted in context. On MRI a lesion could be referring to a MS lesion or a lesion caused by a stroke. There are many different diseases that cause lesion on MRI that can look like MS lesions. This is why we have to be careful when making a diagnosis of MS.

    In comparison a plaque is a term that we use when we are referring to a MS lesion at post-mortem; plaques are the demyelinated lesions that can be seen with the naked eye in the brain and spinal cord.

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