UsAgainstAlzheimer’s Proposes Key Measures to Advance Treatment Development

UsAgainstAlzheimer’s Proposes Key Measures to Advance Treatment Development
As the disappointment over the failure of solanezumab begins to wane, George Vradenburg, co-founder and chairman of UsAgainstAlzheimer's, seeks to address the efforts needed to continue research and clinical development for Alzheimer’s disease. Despite the inability of Eli Lilly to bring the goods to the table, Vradenburg applauded Lilly’s efforts in the open letter, along with that of patients and caregivers who contributed to the solanezumab trials. The studies, he argued, brought valuable knowledge that will help any future drug development efforts. Vradenburg specifically pointed to a number of factors that he believes are crucial. First, he stated that Alzheimer’s is a disease that needs aggressive treatment. Comparing Alzheimer’s to cancer, he suggested that affected patients and their families are prepared to take the consequences of more aggressive treatments if they can reap the benefits of a slowed or prevented disease progression. Second, he stated that the current approach to Alzheimer’s clinical trials makes a system in which the time before a drug can become available to the patients become unacceptably long. The failure of past trials has made developers target increasingly earlier disease stages. But these trials become both costly and lengthy, with an estimated time to completion of up to eight years. The UsAgainstAlzheimer’s chairman emphasized that even if such a trial become successful in producing a drug, healthcare payers, such as Medicare, may not want to pay for the treatment until they have "real-life" evidence of
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One comment

  1. Lance V. Packer says:

    I commend Mr. Vradenburg for his Open Letter anaysis of recent clinical trials and his recommendations for future needs. Although not directly mentioned but implied, a needed addition to his list is the inclusion of off-label prescription of approved FDA drugs which show experimental potential for repurposed use with symptomatic Alzheimer’s patients. There are many which research has shown to have great potential but individual pysicians, hospital treatment centers, and university research centers are hesitant and actually refuse to consider such an approach to AD. I have personal experience in trying to find someone or an organization which is willing to prescribe such medications for my wife. The usual response, if any, is “We don’t do that”, in spite of the specific drugs and research evidence I cite for them. I don’t argue, but my thoughts are, “My wife is condemned to die, but you won’t even try to help? Isn’t that the essence of medical practice?” Try responding that way to a cancer patient and see what kind of uproar would ensue; but somehow it’s OK for AD patients to be turned away.
    Aside from the personal loss looming over me, I think the AD research community is missing a huge opportunity for solving some of its problems. Without getting into a lot of detail, such off-label prescription is a great opportunity to acquire huge amounts of data for inclusion in big-data banks for analysis as well as treatment potential for inviduals. It would need standardization (at some point) of input and output and to be available for physicians and institutions alike, as a self-feeding process from which recommendations and new discoveries could be made. It’s good to have preventative research but the millions of existing patients cannot be ignored, morally or for their potential information input for research. The problem has to be attacked from both ends of the spectrum. Moreover, with immediate prescription available and a clear explanation of potential upside and downsides of the drug, I guarantee that AD patients and caregivers will be very willing to volunteer for a chance to have some possible positive effect of participating in an experiment, in contrast to the current problem of low trial recruitment. It’s quite simple: there’s something in it for them, right now. It’s called “Hope,” and we all live better with hope. If it isn’t personally successful, there’s always another drug possibility and maybe it will help someone else–that’s a kind of hope that motivates the willingness to try. Somehow, this message hasn’t gotten through to the profession as a whole. It needs to be.

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