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An interview with Dr. Sterling Clarren, co-chair of Treatment Improvement Protocol (TIP) #58, Addressing Fetal Alcohol Spectrum Disorders (FASD) - May 2014

SAMHSA has recently announced the publication of a new Treatment Improvement Protocol (TIP) titled Addressing Fetal Alcohol Spectrum Disorders (FASD), number 58 in the long-standing TIP series. This landmark publication discusses effective methods for FASD prevention and treatment across behavioral health settings, and is the first TIP to directly address FASD.

TIP 58 was the product of a consensus-based process coordinated by the FASD Center for Excellence and co-chaired by two leading figures in the field of FASD; Dr. Sterling K. Clarren, of the Canada Northwest FASD Research Network (CanFASD) (now retired) and the faculties of the University of British Columbia and the University of Washington, and Melinda M. Ohlemiller, M.A., of the St. Louis chapter of Arc and an Adjunct Assistant Professor in the Saint Louis University School of Medicine’s Department of Pediatrics.

To mark the occasion of the publication of TIP 58, Dr. Clarren has agreed to sit down with us this month and talk about his career in FASD, the growth of the FASD field, and his hopes for how the field will utilize this TIP.

1. Dr. Clarren, when did you first become aware of the effects of prenatal alcohol exposure and its associated risks to the fetus?

I came to Seattle, Washington to train as a resident in Pediatrics in 1973. David W. Smith was the creator of the field of “dysmorphology,” the study of the etiology and classification of birth defect syndromes, and was one of the great teachers on the faculty. He generally involved the residents in his research. Because the residents were involved in his studies, frequently Dave’s work was discussed informally by the trainees over a meal or at gatherings. Smith’s team had just published their article on FAS in the Lancet as I arrived in town. The resident discussions were lively. Smith had hardly proven that alcohol was the cause of this new syndrome that he and his team had identified in a handful of children. We all had had enough methodological training to know that. But the possibility of a common substance (that we were all consuming as we talked) could cause such injury lead to a good deal of common concern and interest in work that might follow.

2. What made you want to pursue this field of study? Did you realize at the time that it was going to shape your career in the way that it did?

During my residency I took a rotation with Dr. Smith and found that I enjoyed the diagnostic process of dysmorphology and that I was good at it. I was especially interested in the diversity of brain challenges that were found in children with so many birth defects syndrome. In some disorders the neurodevelopmental problems were similar case-to-case, in others they seemed to be clinically different from one to another person. Yet very little had been written that explained this. I began to wonder if children with birth defects syndrome were not “experiments of nature” who could help us to understand normal and abnormal brain development. Dave asked if I would like to be his fellow at the end of my general training. I proposed in turn a three-year fellowship in neuroembryology, neuropathology, dysmorphology, and birth defects management. Today that would be a specialty within Developmental Medicine.

While studying neuroembryology, the brain of an infant who had died with FAS came to my bench for analysis. Dave had described another infant’s brain in his first paper. That first brain was still available for more evaluation and this second brain grossly looked different. But in further study of both, I realized that there was a common microscopic pattern to the damage and that both brains were globally abnormal. The pattern was not easily found in the literature. I was astonished. During the next year I collected papers that were being written from all over the world describing additional cases of patients with FAS. Through comparisons, the basic common problems of the patients came through. I proposed to Dave that we write a summary article and he agreed. That paper eventually appeared in the New England Journal in 1978. I was convinced then that alcohol could cause specific and varied birth defects and that most importantly it altered the brain. I was fascinated and horrified and I have been so ever since.

3. What are some of the factors that led the University of Washington to become a focal point in FASD research, training, and prevention/intervention?

I am not sure that I can fully answer this question. But in the 1960’s to 1980’s the University of Washington attracted a number of faculty members in numerous disciplines who either were interested or became interested in the broad field of birth defects. Certainly the Child Development and Mental Retardation Center (now called the Center for Human Development and Disabilities), long funded by the NICD, played a role in bringing these scientists together, too, and a few of those notables included David Smith in Dysmorphology, Thomas Shepard in Teratology and Embryology, Judy Hall in Clinical Genetics, Bruce Beckwith in Pathology, Michael Cohen in Dentistry, and David Shurtleff in Congenital Defects Management.

David Smith had recruited Dr. Ann Streissguth to evaluate the cognitive function of the children that he included in the first papers on FAS. Ann then secured her own research funding to study this condition. After Dr. Smith died in early 1981, I was asked by Dr. Streissguth to confirm diagnoses of FAS for her research projects. I was inundated with requests for FAS diagnoses that went far beyond Ann’s requests. It was quickly apparent that the issues in brain development were complex and varied and that most of the patients were not intellectually handicapped but were still very maladaptive. From the stories that the families told I was not convinced that this poor adaptation was due to environment alone. This led to engaging colleagues in developing the multidisciplinary clinic for FAS diagnosis that has become a national standard.

As Ann and I work both separately and collaboratively in this milieu of general interest in all aspects of congenital defects, many others were drawn to the field of fetal alcohol in all aspects of research, training, prevention, and intervention.

4. The general consensus in the field seems to be that Canada is ahead of the FASD curve as compared to many other countries. What does the U.S. need to do to close that gap?

I am not sure that I know the complete answer to this question. Canada like the United States divides the funding of medical, educational, and social services between the federal and the provincial governments. FASD awareness and interest varies dramatically among the provinces. The Western Provinces (British Columbia, Alberta, Saskatchewan, Manitoba, and the Northern Territories (the Yukon, Northwest Territories, and Nunavut) have been the most interested and active for the longest time; Ontario and New Brunswick have shown more interest of late.

In each of these places, there was first a demand for diagnostic services from physicians and families and a response by government to fund clinical sites. As more and more individuals were then identified, more clinical capacity was built. When individuals with diagnosed FASD were then found to be in significant numbers in long-term foster care, special education, mental health, the criminal justice system, etc., the reactive needs to do something about this challenged the governments further. It was out of this need for data from the clinical experience for use in improving and expanding public policy that the Canada FASD Research Network was established. Canada has a long way to go to fully manage the condition, of course, but the growing numbers of accurately diagnosed individuals of all ages will provide the political pressure needed to create and improve provision over time.

In my view, the field has been stymied in the United States by the lack of diagnostic capacity. Without accurate diagnosis, prevalence cannot be accurately calculated, intervention programs cannot be built based on experience with the population over time, and money for prevention is not made available in large enough amounts because there is no real proof that the condition warrants the effort nor is there proof that prevention efforts are effective. Diagnosis of this condition should be done in the same kinds of programs that diagnose autism, cerebral palsy, or other neurodevelopmental conditionals that require a team approach.

Most of the clinics in the United States that routinely provide FASD diagnostic services are funded by grants, philanthropy, or underwritten by their academic institutions. Insurance companies have never been effectively challenged across the country to shoulder the responsibility to pay for this multidisciplinary assessment. There is a huge need for governmental demand that this change. Perhaps with the advent of the Affordable Care Act, FASD diagnosis could be demanded as a deliverable.

5. The FAS Diagnostic & Prevention Network at the University of Washington has done extensive diagnostic work in the field of FASD; however, in general, mechanisms for getting a formal diagnosis within this spectrum remain limited. What will be necessary to grow this network to the needed level?

There are always professionals and organizations that are willing to work on a problem because of an overriding interest or passion. The FASD diagnostic capacity in Washington State and elsewhere in the United States has primarily been built and maintained by such individuals, often working for free or at reduced rates of compensation. Increased funding for clinical research and clinical care will encourage others to enter the field, as happened with Autism Spectrum Disorder and most areas of medicine. Increased funding for neurodevelopmental disorders of any kind is hardly an easy sell in the current fiscal and political environment, but political leadership will be the only way, in my view, that the situation will improve. This means both political leadership in Washington, DC, the State Houses, and from within organized medical leadership and lobbying (ACOG, AAP, APA, etc.).

6. In the DSM 5, one of the diagnoses in the category of Neurodevelopmental Disorders is Neurodevelopmental Disorder Associated with Prenatal Alcohol Exposure, with a DSM code 315.8 and an ICD-10-CM code F88. As this is the only term connected with the effects of prenatal alcohol exposure in the DSM that has a code, do you think that this will impact the diagnostic terms that we use for this spectrum?

Yes, the codings will help. But the field needs to lead the coders, not the other way around. The labeling of diagnoses must be consistent across the world for surveillance, research, and the application of improvements in treatment and intervention. Many people have very strong opinions about the words that should be used within the umbrella term of FASD and do not agree with one another, but in the end we all need to call the same things by the same names. Last year we (CanFASD) called for an international consensus conference to be sponsored by the World Health Organization (WHO) and bring the diagnostic words into harmony. The WHO was not able to act on this request at that time, but hopefully this can be accomplished soon.

7. TIP #58 has just come out, but you've already begun to utilize portions of the content in Canada. What have been the results of that work?

The implementation of TIP #58 in Canada, like in the United States, is left to the capabilities and interest of Provinces or Territories. The Province of Alberta was willing to be the lead in using the TIP in Canada. Then, based on that experience, several other provinces will consider using it, as well. CanFASD has been given a contract to track the results of the work in Alberta and develop a business model for use there and in the rest of the country.

Alberta has directed four large programs in mental health and substance abuse treatment to participate. Each line front worker in each program was given a copy of part 1 of the TIP, which had been rewritten for a Canadian audience (with permission from SAMHSA). The workers were then given a half-day training, as well, to fill in their knowledge and review the proposal. Basically the clinicians were asked to consider the possibility that all of their new patients might have an FASD, and, if female, might be at risk to have a child with FASD, or be at risk for both. We are now tracking the following questions for a 6-month period in these four programs:

  • In what percentage of new patients will the clinician consider the possibility that the client is at risk for one of the conditions above or both?
  • In what percentage of those clients will the clinician think it appropriate to share this concern with the client at this time?
  • In what percentage of clients who are told that there is an FASD concern, as above, will the client want to follow up with diagnostic or prevention services?
  • What percentage of those interested in follow-up will be successfully seen in an FASD diagnostic clinic or in a support program for those at risk to have a child with an FASD?

The answers to these questions will help to establish the referral burden and the utility of continuing this type of screening routinely. Clearly it is not ethical or fair to suggest new diagnoses of this importance to already troubled individuals if screening cannot lead to appropriate and timely diagnosis and follow-up. This initial study will be completed in the summer of 2014, and the results will be made available through publication thereafter.

8. What is your hope for TIP #58 going forward? Ideally, what would you like to see the field do with this publication?

It has been clear for a vey long time now that many women who have had children with FASD are patients themselves with high rates of mental health and substance abuse problems. Finally TIP #58 takes action and requests that this important problem actively be screened for within the systems that should see them for their benefit and for FASD prevention. The question remains: How often will there be individuals who screen positive, and will there be appropriate and easily accessed diagnostic supports? At this time, no one knows how often patients with FASD or at risk for having children with FASD or both are in these systems. No one knows how much care will change if this is recognized. Clearly, however, the screening will not continue if diagnostics services are not prepared for the referrals that are created.

I hope that the Canadian approach can be replicated in the United States and that funding will be available to track the clinical experience and prepare appropriately for the patients needs. This may be the most powerful route to FASD prevention so far proposed, but planning and leadership will be needed to understand the impact and prepare for the future.

About the Expert

In addition to co-chairing TIP 58, Sterling K. Clarren, M.D., FAAP, is the Clinical Executive Officer and Scientific Director of the Canada NW FASD Research Network in Vancouver, British Columbia, and a Clinical Professor of Pediatrics at the University of British Columbia and the University of Washington in Seattle. He is also a member of the Expert Panel that oversees the work of the FASD Center for Excellence. Since the early 1970's, he has been a leading researcher and author on the effects of prenatal alcohol exposure and effective methods of FASD prevention and intervention.

DISCLAIMER: The views, opinions, and content of this column are those of the authors/experts and do not necessarily reflect the views, opinions, or policies of SAMHSA or HHS.