bias in clinical trials: cassava's case

Serious questions have been posed by scientists about a new drug which has claimed to combat symptoms of Alzheimer’s disease.

Texas-based Cassava Sciences announced last year that simufilam improved cognition in Alzheimer’s patients.

With Alzheimer's currently affecting approximately 6 million Americans - a number set to double by 2050 - there is huge appetite for a new, effective treatment. It’s also something which could also be very lucrative for drug producers. Indeed, interest in Cassava shot through the roof following the announcement, and their stock soared, at one point the company was worth $5bn.

However numerous members of the scientific community have been deeply sceptical of the claims and have challenged them, asserting that Cassava’s studies were flawed, producing improbable results through opaque methods.

Many experts have said that they trust neither the company’s methods nor results. Observations include that the trial which reported improved cognition after using simufilam didn’t have a placebo group, and that the patients weren’t followed for a sufficient period of time to confirm that improvements were genuine.

Some experts have gone as far to assert that Cassava manipulated its scientific results.

A number of prominent medical journals have questioned and retracted papers regarding studies authored by Cassava collaborators citing methodological errors and irregularities in work, taxpayer funding of which has angered other prominent scientists.

Cassava says that simufilam works by restoring the normal shape and function of a protein called filamin A which becomes warped in the brains of people with Alzheimer’s Disease, causing dementia and impaired cognition. It’s a theory which has left many experts scratching their heads. Alzheimer’s experts say they know of no independent studies that support this hypothesis, despite claims to the contrary by Cassava.

Cassava, previously known as Pain Therapeutics, and a newcomer to Alzheimer’s research, has denied the criticism but its reputation has been severely dented by the controversy, and it has taken a sharp hit on the stock market. To further add to their woes, reports indicate that a number of federal government agencies are investigating alleged manipulation of research results by the company.