Monday, May 12, 2008 10:32 AM UTC

Brain scam

Why is PBS airing Dr. Daniel Amen's self-produced infomercial for the prevention of Alzheimer's disease?

Brain scam

It’s 10 on a Saturday night and on my local PBS station a diminutive middle-aged doctor with a toothy smile and televangelical delivery is facing a rapt studio audience. “I will show you how to make your brain great, including how to prevent Alzheimer’s disease,” he declares. “And I’m not kidding.”

Before the neurologist in me can voice an objection, the doctor, Daniel Amen, is being interviewed by on-air station (KQED) host Greg Sherwood. Sherwood is wildly enthusiastic. After reading Amen’s book, “Change Your Brain, Change Your Life,” Sherwood says, “The first thing I wanted to do was to get a brain scan.” He turns to Amen. “You could start taking care 10 years in advance of ever having a symptom and prevent Alzheimer’s disease,” he says. “Yes, prevent Alzheimer’s disease,” Amen chimes in.

Wait a minute. Prevent Alzheimer’s disease? Is he kidding? But Sherwood is already holding up Amen’s package of DVDs on learning your risk factors for A.D., as well as his book with a section titled “Preventing Alzheimer’s.” Then, as though offering a landmark insight into a tragic disease — and encouraging viewers to pledge money to the station — Sherwood beams and says, “This is the kind of program that you’ve come to expect from PBS.”

If so, that’s a shame. One of the messages of Amen’s PBS special and his book on Alzheimer’s is that early detection of A.D. can lead to methods that both slow the progression of the disease and prevent it. But this opinion isn’t shared by the vast majority of the medical community. Despite decades of studies, there are at present no definitive long-term treatments for A.D. or its prevention, as Amen would have viewers and readers believe.

At the core of Amen’s crusade — both in print and on TV — is a type of functional brain imaging known as SPECT (single photon emission computed tomography), a radioisotope-enhanced CAT scan that measures blood flow in certain regions of the brain. Amen relies heavily on SPECT to make an early diagnosis of Alzheimer’s so that it can be prevented. But medical science does not support his view.

“SPECT scans are not sufficiently sensitive or specific to be useful in the diagnosis of A.D.,” neurologist Michael Greicius , who runs the Stanford University memory clinic, and has a special interest in the use of functional brain imaging in the diagnosis of A.D., tells me. “The PBS airing of Amen’s program provides a stamp of scientific validity to work which has no scientific validity.”

Throughout March and April this year, “Change Your Brain, Change Your Life” aired nearly 1,300 times on PBS stations across the country, reaching more than 75 percent of U.S. television households. As I was to learn after several frustrating phone calls and e-mails with PBS spokespersons, the nation’s public broadcasting system did not vet “Change Your Brain, Change Your Life” for scientific validity. As a result, it broadcast what amounts to an unregulated infomercial for Amen’s unproven treatments.

When I come across a controversial medical opinion, I try to look at how it might have arisen. Amen, who appears as a medical expert on TV news and talk shows, including CNN and Fox News, the “Today” show and “Oprah,” has not followed a traditional scientific path. He received a biology degree from Southern California College, a Pentecostal school, now Vanguard University (“We believe The Bible to be the inspired and only infallible and authoritative Word of God”), and earned his medical degree from Oral Roberts University School of Medicine, defunct as of 1989.

“One of the sustaining factors in my work has been my own personal faith,” he declared in his 2002 book, “Healing the Hardware of the Soul: How Making the Brain-Soul Connection Can Optimize Your Life, Love, and Spiritual Growth.” “From the first month that I started to order these (SPECT) scans, I felt that they had a special place in science and that I was led by God to pursue this work.”

It’s hard to dismiss the religious undertones of Amen’s work. On his Web site in 2003, he stated, “How your brain and soul work together determines how happy you feel, how successful you become, and how well you connect with others. The brain-soul connection is vastly more powerful than your conscious will. Will power falters when the physical functioning of the brain and the health of your soul fail to support your desires, as seen by illogical behaviors like overeating, smoking, drug and alcohol abuse, and compulsive spending.”

And yet Amen’s sense of calling hasn’t led him to undertake the high-quality clinical investigations that would lend scientific credence to his claims. He is a board-certified psychiatrist and assistant clinical professor at University of California at Irvine School of Medicine, as his current Web site claims. But as U.C. Irvine assistant director of health sciences communications Tom Vasich explains, the title “assistant clinical professor” is the name for an untenured volunteer faculty member, of which the U.C. Irvine School of Medicine has more than 1,000. Amen is not affiliated with the university’s Brain Imaging Center; all of his studies on SPECT scanning have been privately performed at his proprietary Amen Clinics.

To understand my concerns regarding Amen’s claims, we first need to take a quick look at A.D. and why unsubstantiated promises of prevention and treatment raise real ethical and health considerations. A.D. affects about 5 million Americans; the number will rise as our population ages. Although the disease isn’t sufficiently well-understood to assign specific causes, it’s clear that there are multiple risk factors, ranging from age to genetics, coexisting heart disease to prior serious brain injury. So far, addressing such risk factors either isn’t possible (we can’t change our genes or stop getting older), hasn’t been prospectively demonstrated to prevent A.D., or is simply part of any common-sense medical practice.

The problem remains: We have abundant information about the underlying abnormalities in A.D., but don’t know exactly how the pathology creates the illness. The brain of a patient with A.D. will show clumps of protein fragments (plaques) as well as disruption of the normal architecture of the neurons — neurofibrillary tangles. From a biochemical standpoint, there is a diminution of function of various neurotransmitters, especially acetylcholine.

To date, the mainstay of symptomatic treatment has been a class of drugs that prevents the breakdown of acetylcholine — cholinesterase inhibitors. Although they do not slow or alter the course of the disease, they can provide modest but temporary improvement in cognition and behavior, usually on the order of months to a couple years. Importantly, the American Academy of Neurology states that available medications “do not reverse or change the progression of the disease.” The NIH National Institute on Aging also warns: “It is important to understand that none of these medications stops the disease itself.”

Amen, however, claims that he can arrest the progression of the disease. In his 2004 co-authored book, “Preventing Alzheimer’s,” he writes: “Contrary to popular belief, with current medical and scientific knowledge, the onset of Alzheimer’s Disease can be delayed by six years.” He makes a more expansive claim: “Through prevention strategies, you may be able to delay the onset of Alzheimer’s long enough so that you will never have symptoms.”

Faced with the prospect of overlooking a preventable disaster, the public is a sitting duck for Amen’s medical sales pitch. And what exactly is he offering that the rest of the medical community has overlooked? He reiterates the usual common-sense recommendations: mental and physical exercise, good nutrition, avoidance of excess alcohol, not smoking and stress reduction. All of these are modestly helpful in preventing general cognitive decline. But none of them has a specific anti-Alzheimer’s effect.

The rest of his recommendations, including those gathered from his Web site and other published writings, aren’t specific evidence-based treatments for A.D., but rather a potpourri of unproven treatments, such as antioxidants and proprietary nutraceuticals.

For example, on his Web site, Amen touts NeuroMemory, a non-FDA-approved combination of folic acid and various plant extracts, including Huperzine A, a moss extract that has some anti-cholinesterase properties. The Alzheimer’s Foundation warns that such drugs are “unregulated and manufactured with no uniform standards.” Even the manufacturer issues (in small print) the following warning: “These products are not intended to diagnose, treat, cure, or prevent any diseases.” With NeuroMemory, you will be paying out-of-pocket for a non-regulated product that, at best, might turn out to have a similar temporary effect as the more rigorously controlled cholinesterase inhibitors already on the market, and routinely covered by most health insurance policies.

Other proprietary nutraceuticals for sale on his Web site also suffer from lack of good control studies. For example, Amen refers to omega-3 essential fatty acids (found in high concentrations in certain fish oils) as “brain food.” He writes that you can purchase NeuroGuppies — “ideal for children to support healthy brain development and vision” — and NeurOmega. In “Preventing Alzheimer’s,” Amen’s lead supporting evidence for the efficacy of nutraceuticals like NeuroGuppies is a 2002 British Medical Journal study in which “French researchers reported that there is a significantly lower risk of developing Alzheimer’s disease among older people who eat fish at least once a week.”

But the whole study from the British Medical Journal in 2002 reads quite differently. The lowered incidence of A.D. in those study participants who ate fish or seafood at least once a week was described as having “borderline significance.” Borderline means possibly significant, not significant, especially when you factor in that fish or seafood consumption was higher in those participants with higher education. Higher levels of education have been shown to be associated with a lower statistical risk of A.D. When the authors added the level of education to their risk model, the results “indicated that the ‘protective’ effect of weekly fish or seafood consumption was partially explained by higher education of regular consumers.” The study’s conclusion — fish consumption provided a borderline significant effect partially explained by other factors — is a far cry from proof that fish oils can help prevent A.D.

Amen makes other medically questionable recommendations, such as the use of estrogen replacement in post-menopausal women. The role of estrogen in the prevention of A.D. remains hypothetically possible but as yet unproven; clinical trials are in progress, but to date there is no definitive evidence that taking estrogen will reduce the chances of getting A.D.

In “Preventing Alzheimer’s,” Amen states that post-menopausal women “should avoid Premarin and other forms of estrogen that are not made by the human ovary. However, a severe reduction in female estrogen hormones is equally harmful and should be treated.” Amen suggests that taking the smallest amount of human estrogen that will keep estrogen (estradiol) levels from falling too low “is reasonably safe.” But how can we know that estrogen replacement, no matter how small a dose, is safe, when safety standards for estrogen replacement haven’t been established in clinical trials, and so remain controversial? Also, note Amen’s use of vague language: “smallest amount” (unspecified), “falling too low” (unspecified), “reasonably safe” (unsupported by evidence).

By cleverly wording his claims and cherry-picking his evidence, Amen has created the false impression that an earlier diagnosis of A.D. can ultimately slow down or prevent its devastating effects. The implications and potential risks of such unsubstantiated claims are very real.

If Amen were correct, consider how negligent the rest of the medical community must be in withholding such treatments. And imagine how you’d feel if you were the spouse or child of a patient devastated by A.D., and you were told by an “expert” that an earlier diagnosis might have delayed or prevented your family member’s catastrophic condition.

Even the well-standardized genetic testing for risk factors for A.D. isn’t used to diagnose A.D. in the absence of symptoms. The markers only serve as information for calculating the odds, not for making the diagnosis. Yet Amen believes that with SPECT, he can accurately identify persons with “early stage Alzheimer’s Disease up to four years before the first symptoms appear.”

However, a multi-institutional task force of neurologists and neuro-radiologists — the Neuroimaging Work Group of the Alzheimer’s Association — disagrees. Based upon their evidence-based literature review, they have concluded: “Current clinical neuro-imaging techniques are poor at predicting which non-demented individuals will develop AD or other dementias.” They also concur that the practical value of such determinations is limited in the absence of preventive therapies for A.D.

Amen’s published response is that he doesn’t rely solely upon a SPECT scan to make the diagnosis of A.D.; he also relies on clinical judgment, including memory testing. This somewhat circular argument raises the serious question of the value of a screening test that can’t stand on its own predictive merits. How are we to interpret an abnormal scan in an asymptomatic patient? At least with genetic testing, we can tell the patient the likelihood of eventually getting A.D. without resorting to subjective clinical judgment.

Amen states that he has read more than 40,000 SPECT scans and holds himself up as a world expert. But a brief quote from his TV special quickly reveals a very peculiar method of determining what constitutes a normal SPECT scan. “You know, it took us almost 3,000 people screening to find about 90 healthy brains.” He then added, “So, if your brain is struggling, welcome to normal. Normal is not healthy.”

If, by normal, Amen is referring to the idealized brain and mind, none of us is normal. We all have quirks and asymmetries; no two brains are identical, not even those of identical twins. But if we are to use normal in the conventional medical sense of meaning biological values shared by a major percentage of a population, we have a serious problem. Using Amen’s figures from his TV program, only 3 percent of those he has studied have been interpreted by himself and his staff as being normal. Put another way, 97 percent of patients who attend Amen’s clinic can expect to be told that their SPECT brain scan is abnormal.

Compounding the problems generated by his idiosyncratic definition of normal is his failure to adequately address several major ethical concerns. Amen skirts the well-recognized potential for profound psychological consequences of a healthy asymptomatic patient learning that he or she will develop a devastating illness, particularly in the absence of definitive treatments. A second serious oversight is the potentially devastating consequence of falsely receiving the diagnosis of A.D. Every attempt should be made to minimize any false-positive diagnoses; any test used to predict the likelihood of A.D. should first have undergone strict peer-reviewed scrutiny, including reproduction of the data by independent scientific studies.

As might be anticipated, Amen is not a stranger to controversy. In 2005, on Quackwatch.org, a nonprofit that investigates health-related frauds, myths, fads and fallacies, Dr. Harriet Hall, a retired family physician, outlined concerns regarding Amen’s practices. In addition to those I’ve mentioned, Hall was critical of Amen’s unsupported claims that SPECT scanning provides “guidance in the application of specific medications or other treatments such as supplements, neurofeedback, transcranial magnetic stimulation, and hyperbaric oxygen therapy.”

In a recent phone call, Hall tells me, “Amen’s recommendations defy science, common sense and logic. I feel much worse about him now than I did when I wrote the piece because I went back and looked at his Web site again, and I’m just appalled by some of the things that are on it now. He’s selling vitamin supplements and he’s selling his own line of products. He’s turned into big business.” According to its Web site, Amen Clinics charges $3,250 for a “comprehensive evaluation,” which includes the patient’s history, two SPECT scans, a physician consultation, and a 30-minute treatment follow-up appointment. Follow-up scans after treatment are $795 each.

In trying to divine PBS’ role and obligations in airing such an obviously controversial figure as Amen, I got the proverbial runaround. I first e-mailed my local PBS station, KQED. The station’s executive director of communications, Scott Walton, responded that “KQED only aired the program and was not involved in any decision concerning content.” He pointed out that KQED isn’t staffed to review 60,000 hours of programming per year and relied upon other PBS stations that offer shows to do proper vetting. KQED, Walton added, took into consideration “a copy of the press kit, which … contains profiles and articles about Dr. Amen from Newsweek, Men’s Health and other well-known publications as well as information about his appearances on Oprah, CNN and more.”

Did a local PBS station, or PBS headquarters, do proper vetting? Michael Getler, the PBS ombudsman, didn’t have an answer for me and forwarded my message to “the top people.” I then got a note from Joseph Campbell, PBS vice president of fundraising programming, who said, “PBS is not responsible for the content of those programs obtained from outside sources (other than PBS); it is up to each individual station to decide on the merits of such non-PBS produced programs.”

In fact, “Change Your Brain, Change Your Life” was neither produced nor distributed by PBS headquarters. It was co-produced by Amen and High Five Entertainment, a production company in Nashville, Tenn., which has produced live award shows and videos for, among others, Wynonna Judd. It was distributed by Executive Program Services, a regional PBS distributor, which places programs on the PBS satellite, where local PBS affiliates can find and select them for their stations. Alan Foster, co-principal of Executive Program Services, explains that’s how stations acquired “Change Your Brain, Change Your Life.” He stresses that Executive Program Services “programming is unrelated to the programming that comes from PBS programming, and vice versa.”

Foster, who says he consulted with Amen to make the program “better suited for public television,” is not troubled by its content. “I look at it in the sense of, ‘Are there any problems with this?’ I can’t verify or say in a medical sense whether the information is accurate. PBS doesn’t do that either. But if I felt there was any reason for alarm, then we wouldn’t be involved with it. But I didn’t find that.”

In a recent Slate article, critical of the Los Angeles Times for publishing an Op-Ed by Amen, in which Amen argued that all presidential candidates should be given brain scans, Daniel Engber wrote, “Perhaps the paper’s editors assumed Amen was credible because of all his appearances in other publications. In that case, they’ve only exacerbated the problem, further padding his resume as an ‘expert’ on the brain.”

The same criticism surely applies to those PBS stations that aired “Change Your Brain, Change Your Life” without internal review or audience notification that no program review had been performed. At the least, the stations should simultaneously display a disclaimer indicating that the program’s contents haven’t been specifically vetted by PBS. Without such a disclaimer, anyone watching a PBS-aired program must assume a caveat emptor default position.

According to the PBS mission statement, “as a non-commercial enterprise, we can maintain our commitment to delivering quality, innovative and distinctive media content as our utmost priority. By guaranteeing our programs treat complex social issues with journalistic integrity and compassion, our audiences know they can rely on us to provide accurate, impartial information.” In the case of Amen, that is simply not true.

Reporting assistance by Erin Renzas

(Daniel Amen responds here.)