Susan Molchan, MD is a psychiatrist in Washington D.C. She was previously the program director for the National Institutes of Health’s Alzheimer’s Disease Neuroimaging Initiative.
More disease advocacy organizations are enlisting business consulting groups to conduct research to further their causes and, not coincidentally, those of their pharmaceutical company sponsors.
This week the strategy paid off for the Alzheimer’s Association: An article in Bloomberg News headlined “Spotting Alzheimer’s Early Could Save America $7.9 Trillion” came from the annual Facts and Figures report published by the association — and was based specifically on the addition of a study by consulting firm Precision Health Economics.
The study concludes that these trillions would be saved due to a variety of factors, including earlier initiation of drug treatment that can supposedly keep patients functional for a longer period of time and avoid medical costs related to disability.
But are these projections of massive savings based on sound economic analysis?
The study is presented as if might have been published in a scholarly journal. I looked to see if perhaps it had been peer-reviewed and published; it hadn’t been, as far as I could tell, given that no authors were listed. To estimate the projected savings of early diagnosis, those who conducted the study — whoever they may be — made many assumptions, the validity of which would be best evaluated through a review by their unbiased peers.
I conducted and oversaw Alzheimer’s research for years, but had a difficult time understanding exactly what the mysterious researchers did in this study, although they did include over two dozen fine print “end notes” explaining some calculations they included in various analyses. And 546 references.
Last year ProPublica described how the pharmaceutical industry uses research and reports from Precision Health Economics to help justify high drug prices. The ProPublica article noted, “Critics have at times questioned the assumptions underlying the consultants’ economic models . . .and suggested that some of their findings tilt toward their industry clients.” The article also notes inconsistent disclosure of pharmaceutical company ties by Precision Health consultants, though most of their publications over the past few years have been pharma-funded. ProPublica said the firm has counted at least 25 different pharmaceutical companies on its roster of clients.
Possible bias favoring the drug industry can be perceived in this confusing statement from the Bloomberg story — “Identifying [Alzheimer’s] early can allow it to be better managed, in part with existing drugs that treat its symptoms” — which is directly contradicted by the first sentence of the article which notes there is “no effective treatment” for the disease.
Drugs do exist that provide marginal benefit for a limited time to a minority of patients with dementia, but none are approved or have been shown to be helpful in the earlier phase of mild cognitive impairment. Nor does the article, or the report by the Alzheimer’s Association, explain how earlier diagnosis would happen, although in the latter, reference is made to biomarkers and brain scans. While these are important for research, none have proved useful in the real world.
The Bloomberg article seemed to be based largely on a news release from the Alzheimer’s Association. It includes no analysis or perspective from anyone outside of the association. Some of the references in the report itself (for example reference #517, Dubois et al., 2016), note that “evidence is lacking” for benefits of early diagnosis, at least in the peer-reviewed literature. Although early diagnosis may sound like a great idea for a lot of things, we’re learning more about the drawbacks of it — including unnecessary interventions that in some cases can be worse than the disease itself. (Screening to find early prostate cancer is a good example of this phenomenon.)
In the elderly, the case against too-early diagnosis of cognitive impairment or dementia is summarized here. At this time, there’s little that can be done to slow or stop the progression of Alzheimer’s disease. In the mean time, relatively healthy and functional older adults may suffer from this knowledge in variety of ways, including negative self-perception and the stigma of being labeled with Alzheimer’s. There’s also the threat of over-medication and early institutionalization, as well as increased likelihood of prematurely stopping beneficial activities. Not to mention the fact that diagnosis is not an exact science, especially early on, and can result in false-positive or incorrect diagnosis. And how quickly dementia worsens varies from person to person, but we don’t really know why.
Although not mentioned in the Bloomberg article, in my view, the news release from the Alzheimer’s Association makes an explicit plug for a product designed to help make an early diagnosis:
“…due to awareness of Alzheimer’s and recognition of early symptoms, as well as the development and approval of beta-amyloid imaging biomarkers, Alzheimer’s diagnosis can occur earlier in the disease process than ever before…”
These “imaging biomarkers” are also discussed favorably in the Facts and Figures report, at least with the caveat that they “cannot be used to diagnose the disease. Nor is amyloid imaging covered by Medicare or most insurance companies, as it had not been shown to be clinically useful.”
I suspect the “study” and the push for early diagnosis are part of the long game, already going on for years, to help push through approval for payment by Medicare and subsequently by insurance companies for these scans. The growing elderly population is an increasingly popular marketing target, including for these $3,000-plus brain scans. Another economic consulting firm presented data at the 2013 Alzheimer’s Association conference, together with Eli Lilly which manufacturers the product used to detect amyloid in the scans. This study also promoted the potential for cost savings from earlier diagnosis, and received similarly superficial coverage from a handful of media outlets, including MedPageToday. Eli Lilly is also a long-time sponsor of the Alzheimer’s Association.
The idea that Alzheimer’s disease is “growing increasingly lethal” is a favorite hyperbole of the Alzheimer’s Association. Bloomberg obliged by setting this claim off in a pull quote with large blue letters.
While it’s true that more people are dying of or with Alzheimer’s disease, or more accurately dementia (most dementias are a mix of Alzheimer’s pathology, blood vessel disease, and other degeneration), this trend should more accurately be framed as a success story.
The reality is that more people are avoiding death from heart disease and cancer. Since age is the biggest risk factor for Alzheimer’s disease/dementia, the longer people live, the more likely they will develop dementia (and arthritis, cataracts, glaucoma, hearing problems, incontinence, etc). For a disease-focused advocacy organization, though, the more people afflicted, the better it is for fundraising — so there’s little incentive to explain the factors that are really driving this trend.
Many news outlets have have picked up on the “death sentence” motif — including HealthDay/CBS which warns that Alzheimer’s deaths “have more than doubled, rising 123 percent between 2000 and 2015.”
The statistic may be accurate but the implication is misleading. To say that Alzheimer’s/dementia is becoming more “lethal” is like saying old age is becoming more lethal.