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Gregg Gonsalves

Really important piece by Seb Walsh in for people with and their loved ones. We don’t need hype and hope, we need drugs with demonstrable, clinically relevant evidence of efficacy. Researchers and clinicians saying is a game changer are not telling the truth. bmj.com/content/379/bmj.o3010

The BMJLecanemab for Alzheimer’s diseaseNew trial reports little to celebrate for patients and carers The detailed results of a phase 3 randomised controlled trial of lecanemab,1 the latest monoclonal antibody drug for Alzheimer’s disease, prompted feverish media coverage heralding a new era of disease modifying treatments. Such treatment has been long hoped for, for differing reasons, by patients, clinicians, researchers, governments, and drug companies. However, the null effects on cognition of other anti-amyloid agents,23 the tiny effect on cognition reported for lecanemab, and concerns about safety4 mean that perspective is needed. Hyperbolic rhetoric gives patients and their families false hope, which clinicians must address, and pre-empts regulatory decision making. Unlike previous trials of anti-amyloid immunotherapy, the lecanemab trial found a statistically significant result, indicating that the reported difference between placebo and treatment groups in average rate of cognitive decline was unlikely to be due to chance. The prevailing narrative is that this trial “succeeded” where others have “failed.” In reality, lecanemab, like other anti-amyloid agents, successfully cleared amyloid from the brain. This clearance had no discernible effect on cognition …

@gregggonsalves Thank you. My awakening about media and study team hyping of study drugs came from taking part in FDA ODAC deliberations. The chasm between reality and media reporting was astonishing.

@gregggonsalves

Frustrating. The same can be said about psychedelics being this new frontier break through perpetuated by people who are basically criminals who mentored clients and sexually assaulted them. There has to be much better oversight.

@gregggonsalves Unfortunately, these people's claims get uncritically reported in the mass media.