"'Miracle Dementia Drug', Actually a Scam?" [Reading Science]

New York Times: "Major Academic Journals Express Public Concerns Over Research Results and Retract Papers One After Another"

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[Asia Economy Reporter Kim Bong-su] The so-called "miraculous Alzheimer's treatment" announced in the United States last year is effectively being "expelled" from the academic community following controversies over research methodology and efficacy.

According to the New York Times (NYT) on the 21st (local time), major U.S. academic journals have recently been retracting or publicly expressing concerns about research papers related to the Alzheimer's treatment "simufilam" developed by Texas-based biotech company Cassava Sciences, which was announced last year.

The company announced the development of simufilam in July last year, claiming that small-scale clinical trials showed improvement in cognitive function among Alzheimer's patients. After administering the drug to 50 patients with mild to moderate Alzheimer's over nine months, the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores increased by 3.0 points, indicating approximately an 18% therapeutic effect. Notably, two-thirds of patients who took the drug for one year showed cognitive improvement, and some patients reportedly experienced complete remission of symptoms.

With about 6 million dementia patients in the U.S. and projections estimating this number to rise to 12 million by 2050, the announcement of such a treatment drew significant attention. The company's stock price soared over 1500%, reaching a peak of $135 per share, and its market capitalization once climbed to around $5 billion.

However, recently, major academic journals have raised doubts about Cassava Sciences' research results related to the treatment. Retractions and concerns have sparked allegations of "fraud." First, there are criticisms of flawed experimental methodology. There was no comparison with a placebo-controlled group. Since all patients knew they were taking the treatment, any temporary improvement could be attributed to a placebo effect.

In December last year, the journal "Journal of Neuroscience" initiated the scrutiny. The journal publicly questioned the authenticity and accuracy of two papers: one by Wang Houyan, a professor at the City University of New York and Cassava Sciences' senior co-researcher, and another co-authored by Lindsay Burns, Cassava Sciences' senior scientist. In March, the journal "Neurobiology of Aging" also issued a public warning about suspected errors in other key research papers authored by Professor Wang and senior scientist Burns. The journal stated, "While we have not found evidence of data manipulation, we identified various methodological errors." Both journals have held off on further action pending the results of an investigation by the City University of New York, where Professor Wang is affiliated. On the 30th of last month, another scientific journal, "PLoS One," announced the retraction of five papers by Professor Wang after a five-month investigation revealed serious concerns about the reliability and integrity of the research.

As doubts about the treatment's efficacy have surfaced, Cassava Sciences' stock price has plummeted sharply. The company also announced this month that it had recruited only 60 out of the 1,750 dementia patients needed for a large-scale clinical trial, which negatively impacted investor confidence. As of the 18th, the company's stock price had fallen to $25 per share.

Moreover, in September last year, the company was investigated after two scientists filed a complaint with the U.S. Food and Drug Administration (FDA) alleging stock short-selling fraud. The U.S. Securities and Exchange Commission (SEC) is also investigating allegations of research data manipulation, and the U.S. National Institutes of Health (NIH) has launched an inquiry.

However, Cassava Sciences denies the allegations. In November last year, the company stated, "We are cooperating with the investigations, and no government agency has informed us of any wrongdoing."