Dr. Daniel Amen’s Response to  Criticism on Quackwatch

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:

  • SPECT shows the function or dysfunction of specific brain regions implicated with specific problems, such as the prefrontal. cortex with executive function and the medial temporal lobes with getting information into long-term storage. Thus, we can target brain systems, not just vague DSM diagnoses.
  • SPECT shows unexpected findings that may be contributing to the problem(s), such as toxicity, potential areas of seizure activity, or past brain trauma. This dramatically changes treatment,’ such as eliminating the toxin.
  • SPECT shows potential underlying seizure activity that may be contributing to the problem (often more accurately seen by SPECT than standard EEG, especially in the areas of the medial temporal lobes).
  • SPECT shows specific target areas for treatment, such as an overactive anterior cingulate gyrus (seen with OCD spectrum disorders) or an underactive temporal lobe (seen in seizure disorders and other disorders such as trauma).
  • SPECT shows the specific effect of medication on the brain and subsequently how to adjust dosages. Patients often report that SSRI’s are helpful but also cause demotivation or memory problems. SPECT studies can show when SSRI’s are causing excessive decreased prefrontal or temporal lobe activity that clinical evaluation only hints at.             .
  • SPECT scans helps provide real, demonstrable answers to refractory symptoms and, in addition, helps clinicians ask better and more targeted questions—about toxic exposure, brain injuries, anoxia, inflammation, or infection, that patients may have initially denied or forgotten.
  • SPECT scans help clinicians prevent mistakes or hurting patients by prescribing the wrong treatments, such as unnecessarily stimulating an already overactive brain or calming an underactive one.
  • SPECT scans help to evaluate those who may be. at risk for dementia—the brain starts to change long before people show symptoms of dementia. One. study reported that there has to be a loss of 30% in the hippocampus before symptoms occur. Using autopsy data in 54 patients, Bonte reported that brain SPECT had a positive predictive value for Alzheimer’s disease of 92% . SPECT scans can help differentiate between types of dementia.
  • SPECT scans can identify specific areas of the brain hurt by trauma to better target treatment and help deal with insurance, legal and rehabilitation issues.
  • SPECT scans can often identify a specific cause or reason that contributes to recovering alcoholics, drug addicts, eating disordered, or sexual addicts relapse behavior in their recovery from an addictive process. For example, the patient may have suffered ‘an injury in the prefrontal cortex or temporal lobes or have overactivity in basal ganglia, limbic system, or prefrontal cortex, each of which could contribute to the relapsing behaviors.
  • SPECT scans allow patients to have a specific physical representation of their problems that is accurate and reliable.
  • SPECT scans help develop a deeper understanding of the problem and lead to decreased shame, guilt, stigma and self-loathing. They can increase self-forgiveness. Patients can see that their problems are, in part, a medical problem.
  • SPECT scans help to increase compliance. The images can powerfully influence a patient’s willingness and ability to accept and adhere to a treatment program as they realize they are not taking medication for their problems of anxiety, depression, rage, or ADD, but rather to optimize brain function, an idea similar to needing glasses for their eyesight.
  • SPECT scans may help families understand when things will not get better, such as having permanent brain damage from an injury, which allows patients and families to accept the condition and provide accordingly.
  • SPECT scans help substance abusers decrease denial and increase motivation for treatment by seeing the damage they have done to their own specific brain. SPECT scans can help motivate recovering alcoholics and addicts to continue in sobriety as it becomes clear that further use will cause increased brain damage.
  • SPECT scans. physically show patients, how treatments have impacted (improved or worsened) brain function.
  • SPECT scans help motivate verbally and physically abusive spouses to follow medication protocols by seeing they have a physical abnormality that may be contributing to their problems.
  • SPECT scans are useful for. patients who are suffering with a “post chemotherapy toxic brain.” It gives them insight into their cognitive struggles and also helps their doctors see what is physical and what might be emotional or traumatic sequelae of having cancer.
  • SPECT scans allow patients to understand why specific treatments are indicated, which medications are helpful, and why certain medical interventions are chosen.

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 AetnaBlueCross BlueShield of GeorgiaCIGNAprovide 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

This article was originally published in Quackwatch.

Dr. Hall is a contributing editor to both Skeptic magazine and the Skeptical Inquirer. She is a weekly contributor to the Science-Based Medicine Blog and is one of its editors. She has also contributed to Quackwatch and to a number of other respected journals and publications. She is the author of Women Aren’t Supposed to Fly: The Memoirs of a Female Flight Surgeon and co-author of the textbook, Consumer Health: A Guide to Intelligent Decisions.

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