Many questions linger on this possible treatment of Alzheimer's. So why the avalanche of news coverage?

Molchan, a psychiatrist and former clinical researcher at NIH, said that many of the experts cited in the reports are not part of the BAN2401 research, they or their institutions may receive business funds that benefit if a new Alzheimer's treatment gets FDA approval.

Everyone wants a drug that will provide significant benefits to patients, but the danger lies in making marginal drugs seem more beneficial than they are in reality.

"There are other amyloid drugs. Once it is approved, it will make things easier for others, "said Molchan

This context is often not recognized in reports on potential treatments.

Solid coverage

provided at least some reservations, including earlier failures in the field and the need for a definitive positive study.

The developers of BAN2401, Eisai Co. and Biogen Inc., reported in December that the drug had failed in its primary goal of producing a measurable result after 12 months

On Wednesday, companies unveiled what it was. they described as more rosy secondary outcomes, showing after 18 months the drug reduced amyloid plaques and improved cognition and function, although the study was so small that cognitive benefit could have

Some organs of The press did a particularly useful job of expressing the limits of the evidence.

The hopes of the Associated Press are rising again for a drug to slow down. Alzheimer's Disease reported that the trial was "considered a flop" because it did not achieve its primary purpose, and further wrote:

There is many warnings about work, which was conducted by scientific researchers and not reviewed by external experts. The study was also too small to be definitive and the results need to be confirmed with more work, according to experts in dementia

The benefits for patients are not clear

The AP also asked what the supposed benefit could mean for patients: It's unclear what difference makes a 30% deceleration of decline – whether it allows someone to continue to bathe or feed, for example. "

Meanwhile, the Alzheimer's drug of the Wall Street Journal shows benefits Testing Essays contained this critical report:

Using an older measure that is widely accepted in the field of disease research. Alzheimer's, known as ADAS-COG, Eisai stated that the highest dose of the drug conferred 47% less than a period of 18 months, compared with placebo.

But with another older measure known as clinical dementia rating, the 26% improvement was not statistically significant, which means that it could have been due to chance. 029] This month, the Journal published another article on BAN2401, which we reviewed.

The optimistic title of STAT – The Alzheimer's experimental drug significantly slowed the cognitive decline of patients, fueling hopes of treatment – was out of step with the more skeptical text, which noted the experimental drug "failed its main purpose. Four doses of BAN2401 did not outperform the placebo, and the high dose was tested on only 161 patients. "

CNN's Alzheimer's experimental drug raises hope after early trials have explained a potential flaw in the study in patients with the APOE4 gene for the disease." Alzheimer's, were less likely to belong to the group of high beneficial doses, which could skew the results.

It should also be noted that some publications, such as Vox and STAT, were trying to preempt the hype [19659002] A blatant exception to measured coverage was Fortune's global teasing that wanted to put an end to Alzheimer's disease by 2025. A breakthrough in drugs, that is, say "a decisive moment" proof of concept "to clear the plate.

From Other Newspapers That Covered the Story:

Fudging Potential

Some did a better job than others to point out that the drug m & # 39; failed and its primary endpoint, as mentioned in a press release from the Alzheimer's Association. This is disappointing because changing the goal of a trial introduces the potential for researchers to create positive results by selecting the outcome measures that they report.

There could be dozens of secondary results that have been followed by researchers but not revealed. to the public.

"It is important to say what you are going to do in advance to minimize prejudices.If you make any changes in your protocol, that would include extending the study or the your statistical analysis, it may come to a point where it may seem fudged and massed, "said Molchan.

Unknown that were not mentioned

For example, it is not clear exactly how many patients abandoned the study and who they were, which could have left a disproportionate share of healthier people who would not decline in the treatment group.

The AP was the only outlet we have seen who reported this, reporting that "the effects leading to discontinuation of treatment occurred in 19% of those receiving the high dose and 6% of the fictitious treatment group. Cases of swelling of the brain, which have been observed in other treatments targeting the plaques in the brain, occurred in two people in the placebo group and in 16 people in the high dose group.

Some patients in the study did not discuss the unknown long-term side effects that could accompany taking the drug for decades

Covering the Societal Impact

So that many media have noted the impact of this research on companies "The price of shares, neglected, were the potential cost to consumers and society if the drug had to be approved, which could be huge given the high cost of new drugs and millions of people at risk for Alzheimer's. "19659002 memory complaint" could ask for tests to see if they would benefit from such a drug, noted Molchan. And PET scanners, that may cost $ 6,000 or more, would be part of the work required for the prescription.

Future reports should strive to examine the situation as a whole if any of these medications What is the benefit for individual patients, and what is the cost to society?

"We do not want an approved drug that has a great effect on amyloid but that just sinks on cognitive things, because it's going to cost zillions of dollars Medicare dollars between the drugs and scans, and most people with dementia have a number of ongoing processes, "said Molchan

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