Dr. Daniel Amen's Response to
Criticism on Quackwatch

Harriet Hall, M.D.

Daniel G. Amen, M.D., runs the Amen Clinics, writes books, gives lectures, maintains a Web site, and makes other media appearances. He recommends single photon emission computed tomography (SPECT) to help diagnose and manage cases of brain trauma, underachievement, school failure, depression, obsessive compulsive disorders, anxiety, aggressiveness, cognitive decline, and brain toxicity from drugs or alcohol. He claims to use SPECT to "re-balance a brain whose activity patterns are clearly abnormal.” He describes SPECT as a "window into the hardware of the soul." He 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 2005, Quackwatch published an article in which I expressed skepticism about Amen's work. In 2007, attorneys representing Amen complained that the article placed him in a negative light that was unfair. Our response included questions similar to those I raised in my article. Here are the questions, the answers we received from Attorney Gayle Mayfield-Venieris of Mayfield & Associates, and my comments about the answers.

Question: What evidence is there that patients treated at the Amen Clinics that have SPECT tests do better than patients treated by competent professionals who do not use SPECT? Has any case series or controlled trial demonstrated such benefit?

Amen response: Amen Clinics tracks treatment response among its patients. 85% of our patients report a high degree of satisfaction with our services. We are not a typical psychiatric clinic. We typically see patients who have failed 3 or 4 other mental health professionals, and who have an average of 3.5 psychiatric disorders using standard DSM diagnostic measures. No one keeps response rates on such a complex diagnostic group, yet our results are very encouraging.

Comment by Dr. Hall: This is an admission that there is no evidence. High satisfaction rates are not relevant to the question of efficacy. I don't doubt that Dr. Amen helps many of the people who consult him. The key question, however, is whether or not SPECT scanning is justifiable for most of them.

Question: Are Dr. Amen's SPECT findings consistent enough that blinded observers could agree on the diagnosis from the scan alone?

Amen response: We never make the diagnosis from the scan alone. We treat whole people, not brain scans. Having said that, we have a high degree of inter-rater reliability in reading the scans and teach others how to read them with the same accuracy.

Comment by Dr. Hall: This admits that their scans have a low specificity, and that they are relying in part on subjective factors to make their diagnoses.

Question: What are the rates of false positives and false negatives?

Amen response: For which disorders? Children, adults and the elderly are all treated at Amen Clinics. SPECT is a very reliable measure of blood flow and activity patterns in the brain. We always use it with clinical information. If you take our work with ADHD, we have scan patterns that predict with 85% accuracy who will respond and who will get worse with stimulant medication.

Comment by Dr. Hall: The answer is “We don’t know.” And unless it is published for peer review, and replicated, the 85% claim for ADHD remains questionable.

Question: Have the effects of different treatments on the scans actually been compared? If so, how and where has such data been published?

Amen response: We have published a study on EMDR and have one in the works on meditation. On Amen Clinic's Web site, we have a "medication and treatment response section" where we list many scientific abstracts concerning before and after treatment with SPECT.

Comment by Dr. Hall: Since EMDR itself has not been validated, I do not believe it is possible to use it to validate SPECT results. Before-and-after treatment scans are meaningless until they are put into perspective in a controlled study. If a scan changes after treatment, it should be asked whether other treatments or placebo might lead to the same change. Amen is claiming to base treatment choices on scans, but he hasn’t established a firm basis for those choices. 

Question: What is "brain balance," and how is it measured?

Amen response: We measure it through before and after SPECT studies. We look for three things: (i) areas of the brain that work well; (ii) areas of the brain that work too hard; and (iii) areas of the brain that do not work hard enough. We also compare our work through a large normal database that we have. The goal is to balance brain function, such as calm the overactive areas and enhance the underactive ones.

Comment by Dr. Hall: The statement above does not define balance or state how it is quantified.

Question: What do SPECT scans show that should change how a patient is treated?

Amen response: Many things:

Comment by Dr. Hall: The above list contains lots of claims but little substance. For instance, do we really need thousands of dollars worth of radioactive injections and scans to “help patients understand” the treatments we prescribe? Where are the objective data showing what percentages of patients have a better outcome with this information?  This reminds me a bit of the ultrasound pictures of fetuses offered at some malls—nice to have for your scrapbook, but not medically necessary or useful..

Question: Does Dr. Amen claim that SPECT can help evaluate the patient's "soul"? If so, what gets measured?

Amen response: No. Dr. Amen uses the analogy that the brain is the Hardware of the Soul, but has never said he could measure the soul. You can read his book, "Healing the Hardware of the Soul," to get a better understanding of his thoughts in this area.

Comment by Dr. Hall: The first chapter of the book is called "The Brain Is the Soul's Fragile Dwelling Place: The Feedback Loop Between the Brain and the Soul Offers New Answer." It claims that the brain-soul connection can "help us understand good . . . evil . . . sin. . . . love . . . hate . . . and. . . child abuse." The passage in which this claim appears also speculates that "Mother Teresa and Mahatma Gandhi had optimal brain function" whereas "Adolph Hitler and other brutal dictators had faulty brain wiring." The book describes SPECT as a "window into the hardware of the soul." The book also promises that "clinically based brain-soul healing techniques . . . will help you optimize your brain and improve your relationships, work, and spiritual connections in the deepest ways possible." It seems to me that Dr. Amen regards the soul as more than an analogy.

Question: Why did Dr. Amen leap into clinical applications, writing for the public, appearing on television, and lecturing about findings that most doctors would consider preliminary?

Amen response: Dr. Amen started this work in 1991. At the time, other doctors, including academics, were using this technique, including Ismael Mena at UCLA, Nora Milne at UC, Irvine, James Merikangas at Georgetown, and Thomas Jaeger at Creighton. The American Psychiatric Association sponsored all-day workshops on brain SPECT in child and adult psychiatry. Dr. Amen has taught at the APA annual meeting on five occasions. He also started publishing on his work. The Society of Nuclear Medicine has procedure guidelines on the use of SPECT in clinical practice and recommends it for brain injury and dementia, two common uses of the Amen Clinics. Dr. Amen is a clinician and he found dramatic positive results from using the scans. Others were doing the work as well in 1991. Dr. Amen is the most visible because of his writing and speaking skills, and his ability to attract patients.

Comment by Dr. Hall: The fact that Amen “believed” he was seeing dramatic positive results does not mean that his explanation for what he saw was correct. It is all too common for clinicians and patients to deceive themselves. That is why beliefs should be tested with scientific studies. The APA may welcome Amen's opinions, but its current (2006) Psychiatric Evaluation of Adults Guideline states that "the clinical utility of neuroimaging techniques for planning of individualized treatment has not yet been shown."

Question: Do the Amen Clinics use a consent form that indicates what uses of SPECT are experimental? If so, please supply me with a copy.

Amen response: Amen Clinics has a general. consent form for SPECT. It states some professionals consider SPECT experimental, but many do not: Amen Clinics has nearly 2,000 mental health professionals who refer patients to its clinics. You can see Amen Clinics' SPECT Consent form in its intake packet.

Comment by Dr. Hall: The pertinent paragraph in the consent form states:

Brain SPECT studies are widely recognized as an effective tool for evaluating brain function in seizures, strokes, dementia and head trauma. There are literally thousands of research articles on these topics. In our clinic, based on our fifteen years of experience, we have developed this technology further to evaluate neuropsychiatric conditions.  Unfortunately, many physicians do not fully understand the application of SPECT imaging and may tell you that the technology is experimental, but over 1,000 physicians and mental health professionals from across the United States have referred patients to us for scans.

This is not a fair representation of the facts. Doing research that follows a clearly stated protocol that can lead to valid conclusions is one thing. But exposing patients to expense and unnecessary radiation based on hunches is something else. A consent form is supposed to place a procedure in proper perspective. It's true that SPECT has been extensively studied and has recognized medical uses. However, the above paragraph fails to make it clear that many (and possibly most) of the Amen Clinic's scans are taken for nonrecognized uses—such as a "general brain health checkup." The consent form acknowledges that opposition exists, but it implies that physicians who consider SPECT experimental for these purposes are ignorant. It should state that the prevailing medical opinion does not support SPECT use for most psychiatric disorders.

The front page of the 20-page intake packet states that the clinic does not bill insurance but provides receipts that may be submitted to insurance carriers for reimbursement. I believe this statement is misleading because insurance companies do not cover SPECT scans for most of Amen's patients. SPECT is indeed approved for a few specific indications, but the Amen Clinic is using it for other indications that are clearly experimental at this stage. The policy statements of Aetna, BlueCross BlueShield of Georgia, CIGNA provide detailed discussions of what these companies considers proven versus experimental uses.

The letter from Attorney Mayfield-Venieris also stated:

There is no indication that Dr. Hall has any clinical experience with SPECT or any other experience that justifies her assertions or qualifies her as an expert in this field. On the contrary, Dr. Hall is a family physician and cites no references in support of her opinions.

No, I do not have any clinical experience with SPECT, but I am as qualified as any other critical thinker to read the claims on Amen’s Web site and recognize that they are not backed up with good evidence. Experience is not an issue; I would not have to have experience practicing homeopathy to determine that it is bogus, or experience doing C-sections to determine that they save babies’ lives. Experience can even be a detriment because those who work in the field may be unduly influenced by personal experiences, testimonials, and financial interests, and sometimes it takes an outsider to see things more objectively.

It is natural to be enthusiastic about any new imaging or treatment procedure, but initial promises are not always fulfilled. If Dr. Amen’s method is not as good as he thinks, he is subjecting patients to unnecessary radiation and expense; if it is as good as he thinks, his lack of rigorous research is postponing the day when it will be generally recognized and offered to everyone and paid for by insurance. There are arguments for doing everything possible to help difficult patients before the research is complete, but there are also arguments for limiting treatment to closely monitored research settings until the truth is known.

For Additional Information

Dr. Hall is a retired family practitioner and Air Force colonel who resides in Puyallup, Washington.

This article was posted on November 12, 2007.

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