Healthy Skepticism Library item: 18431

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Publication type: news

NYT Promotes Alzheimer's Expansion
Alliance for Human Research Protection 2010 July 19
http://www.ahrp.org/cms/content/view/714/9/

Full text:

New York Times reporter Gina Kolata, broadcasts medical hype on the front page of the paper much the way Judith Miller broadcast hype fed to her by Ahmed Chalabi and the Iraq war lobby.¹
Miller promoted unsubstantiated claims about “Weapons of Mass Destruction” on the front page of The New York Times, providing legitimacy for going to war against Iraq. Kolata’s recent series of articles promoted the controversial push to screen healthy, asymptomatic seniors for amyloid plaques in the brain.

However, the assumption that those plaques are the causal evidence for diagnosing Alzheimer’s Disease is a matter of intense controversy.

Kolata’s glowing profile of Dr. Daniel Skovronsky, whose company, Avid Radiopharmaceuticals, has much to gain from widespread screening, is but a promotional piece that could have been written by a PR agency.
See: Promise Seen for Detection of Alzheimer’s , June 23, 2010

Kolata’s articles, Drug Trials Test Bold Plan to Slow Alzheimer’s , July 16, 2010 and Rules Seek to Expand Diagnosis of Alzheimer’s, July 14, 2010, are a ringing endorsement for the new diagnostic guidelines proposed by the National Institute on Aging in collaboration with the Alzheimer’s Association.

The proposed guidelines rely on screening for amyloid beta—even as there is growing skepticism among experts in the field about the validity of the amyloid theory as the cause or definitive biomarker for Alzheimer’s.

The recommended tests are: PET scans, which merely detect amyloid plaques; and spinal taps, which measure tau and amyloid. Yet, post mortem analyses have shown that some people with dementia have plaques, others, do not. And some people without dementia have plaques. So, the tests pose high risk of overdiagnosis.

Furthermore, the invasive tests pose risks—even at prestigious academic centers: PET scans pose potential risk from radiation, and exposure to impure (i.e., contaminated) radio tracers—as has been documented by the FDA’s investigation of Columbia University’s PET imaging lab. Spinal taps are painful and to prevent harm, they require expertise which is not routinely available.

REALITY CHECK: Dr. Sanjay Pimplikar a neurologist at the Cleveland Clinic argues against the use of these tests to diagnose Alzheimer’s in a New York Times OpEd piece (below) because their predictive potential is uncertain, at best.

“we now know that roughly one-third of all elderly adults have such plaques in their brains yet function normally. And eleven clinical trials, recently made public by a group of drug companies, that were aimed at reducing these plaques in Alzheimer’s patients all failed to show cognitive improvement, even when the brains were cleared of plaques.”
As Peter Whitehouse , MD, PhD a neurologist at Case Western, and the co-author of The Myth of Alzheimer’s, notes on his blog: “we still do not know what amyloid-related proteins do normally in the brain. Past trials have shown safety issues and have not demonstrated efficacy.”
Indeed, even drug-makers have acknowledged publicly that their years of effort to develop an effective drug to treat Alzheimer’s have been a failure:
“We really believe the drugs are failing because we honestly don’t understand the disease.”

See: Wall Street Journal, Shirley Wang, Drug Makers Will Share Data From Failed Alzheimer’s Trials, June 11, 2010.
posted here.

Although a rational, empirical- approach would dictate that years of fruitless effort of seeking effective treatments by focusing on amyloids as the single cause of Alzheimer’s is no longer sustainable, “the reasoning behind [the proposed NIA/ Alzheimer’s Association diagnostic guidelines] is still mired in the “single protein (plaque), single drug, single cure” mentality.”

Much like the diagnostic / treatment guidelines in psychiatry—i.e, the DSM-V—which are commercially-driven, crafted by psychiatrists with considerable financial conflicts of interest—the new Alzheimer’s diagnostic guidelines are commercially driven, without regard for patient’s best interest.

REALITY CHECK: Dr. Whitehouse notes that Alzheimer’s “is proving to be quite heterogeneous and resistant to a singular pathogenic target…Anti-amyloid drugs have engineered the removal of amyloid from the brain, but none have led to improvements in cognition and functioning (and have, in some cases, caused lethal encephalitis).”

He suggests that: “Odds are that plaques are a downstream manifestation of lifelong damage rather than being causal. Thus, a scan that shows us plaques on the brain doesn’t really do much except make a lot of money for whoever is doing the testing.”

Kolata’s reports entirely ignore the skepticism among experienced experts in the field—including the particularly sobering acknowledgment by drug manufacturers: all the drugs targeting beta amyloid and plaques have failed to improve patients’ deteriorating cognitive function.

Instead, Kolata quotes as Gospel, Dr. Paul Aisen, who claims that 90% of scientists believe Alzheimer’s is “caused” by an amyloid problem. He eagerly “foresees a day when people in their 50s routinely have biomarker tests for Alzheimer’s and, if the tests indicate the disease is brewing, take drugs to halt it.” Kolata’s report makes no mention about Dr. Aisen’s copious financial conflicts of interest.²

REALITY CHECK: Since there is no cure, not even effective treatments for Alzheimer’s, and no proven preventive measures against the onset of the disease or its progression—what possible benefit does screening to detect amyloid plaques have for seniors?

Indeed, as Dr. Richard Mayeux , a Columbia University neurologist points out:
“It’s not going to be helpful in diagnosis because a lot of people without Alzheimer’s have plaque that can be seen on scans. These people may go on to develop Alzheimer’s someday, but more study would have to establish that for it to become a definitive diagnostic test, rather than a tool to monitor plaque levels in research.”

REALITY CHECK: The new criteria for early diagnosis, based on early screening will hugely inflate the number of people diagnosed with Alzheimer’s—predictions estimate a two- to threefold increase. The proposed screening is EXPECTED to lead to many false-positive diagnoses. Indeed, the authors of the NIA/ Alzheimer’s Association proposed guidelines acknowledge that the earlier a diagnosis is made the less certain it is. As a result, people without the disease will be mislabeled and “treated” with drugs of little or no value.

Dr. P. Murali Doraiswamy, a psychiatry professor and Alzheimer’s disease researcher at Duke University seems of two minds: he applauds the proposed diagnostic screening but acknowledges that they will have “implications for everybody alive, anybody who is getting older.” Among other things, he said, “it will encourage a lot more testing… diagnosis rates, like testing rates, only go in one direction – up.”

He went on to say, “We ought to be cautious that we don’t stimulate all this testing before we can give people something to manage their disease. There is no point in giving them just a label.”

No one acknowledges the very real risk for people “diagnosed” with Alzheimer’s: the diagnosis—whether substantiated or not—is a cause for irrevocable denial of insurance. The earlier the diagnosis the greater the harm resulting from screening.

The beneficiaries of the proposed expansive diagnostic Alzheimer’s guidelines will be drug companies and the Alzheimer’s industry who will make fortunes by pathologizing millions of healthy young elderly people. Drug companies that failed to develop drugs that improved the condition of patients with the disease, wiill instead market drugs to unaffected people who would be screened and labeled as “probably” on their way to developing Alzheimer’s.

But what about the resources wasted on expensive screening and clinically ineffective interventions that could otherwise be used for honest scientific research to identify the underlying complex causes that trigger a disease that manifests as impaired memory, confusion, cognitive impairment and cascading brain damage—what we call Alzheimer’s?
And what about the psychological devastation for people misdiagnosed? Will the promoters of mass screening bear responsibility for the emotional pain and suffering incurred by a misdiagnosis of a debilitating disease?

Below, Dr. Pimplicar’s OpEd, followed by a synopsis of the 2010 award winning article by Dr. Rudy Castellani in the Journal of Alzheimer’s Disease which rebukes the proponents of the amyloid causal theory for Alzheimer’s; followed by an unpublished letter to the NYT editor by Dr. Peter Whitehouse; and a commentary by Geoff posted on the NYT blog about the experts Gina Kolata quotes without ever mentioning their financial conflicts of interest. References:
1. “If Kolata’s reporting faults were only a reflection of her own journalistic shortcomings, that would be bad enough. But to the extent that they reflect the attitudes of the Times as an institution, they suggest a Times policy toward coverage of controversial products of technology, pro-corporate and fundamentalist in its approach to scientific inquiry.”
See: Gina Kolata: What’s Wrong With the New York Times’s Science Reporting? a critique by Mark Dowie, The NATION July 6, 1998 that still resonates.
See also, SourceWatch, which includes a bibliography of her controversial articles and a bibliography of articles criticizing her biased reporting—including a letter from her own doctor, dated Jan. 2010.

2 The NIH Consensus Development conference, April, 2010, lists the following financial relationships for
Dr. Paul Aisen:
Medivation, Neurophage: Stock options, consulting fees received during role as consultant/advisor;
Pfizer Pharmaceuticals, Baxter: Research grants received during role as PI; received sonsulting fees during role as consultant for Elan Pharmaceuticals, Roche, Novartis, Eli Lilly & Company, Martek, Amgen, Genentech, Abbott Laboratories, Bristol-Myers Squibb, Schering-Plough, Wyeth Pharmaceuticals, Eisai, Glaxo SmithKline, AstraZeneca, Bellus, Merck Pharmaceuticals, Astellas Pharma, Dainippon Pharmaceutical, BioMarin, Solvay, Otsuka, Daiichi Sankyo