While I fully endorse the entrepreneurial spirit that has driven the economic success of this country, the application of this mindset to the area of medicine creates ethical conflicts that have become far too commonplace. Let’s face it—- health care is a very profitable business and as such, there will always be practitioners who either unwittingly or intentionally disregard their fiduciary duty to those who rely on them for advice and guidance during times of significant vulnerability. As an academic surgeon, who benefits from a wonderful hospital system that largely avoids the perverse financial incentives to “produce” so common in most health care settings, I have been fortunate to largely side-step such a philosophy. Frankly, I would rather quit medicine all together than view treating patients as a profit center.

The business of medicine is alive and well in the evaluation and treatment of plagiocephaly and other forms of cranial deformation. The rise of head flattening that followed the 1992 AAP Back to Sleep Campaign recommendations was met with a rush of commercial products and services that claim to treat or prevent this entity. The scope of the microeconomy that has formed around the diagnosis of “flat head syndrome” (a misnomer at best) is far too expansive to include in this blog segment, but I will systematically address each component in due time. For now, let’s focus on the companies that make cranial orthotics or molding helmets. In spite of some recent studies to the contrary, these device work very well to correct cranial asymmetry and flattening assuming:

1. They are well correctly and contoured/adjusted regularly.

2. Wear is started at a young age, ….the younger the better. Virtually every study has shown that age correlates with rapidity and completeness of correction.

3. The orthotic is worn consistently.

These devices were introduced by Sterling Clarren in 1979 (so yes, head flattening was around long before back sleeping became common in the West) and are now a multi-million dollar business. In general companies fall within two categories- large nationwide orthotic companies (e.g. Star Cranial, Hanger, Cranial Technologies), or small regional orthotic firms. In my experience, the outcomes with the larger companies are more predictable than the smaller firms. This is due to several factors. First, these larger companies, in general, see a much greater volume of plagiocephaly patients than the small individual shops. As a result, they usually commit more resources to the process- i.e., training and education of the orthotists, diagnostic equipment, etc. In addition, most have a high degree of consistency in their helmet design, manufacturing, and modification processes. Lastly, they are usually very proficient at representing patients needs to the insurance companies for reimbursement purposes. With this said, there are some things to look out for when dealing with any orthotic shops, especially the corporates.

As a rule, I would avoid any helmet or orthotic company that suggests the need for multiple helmets for uncomplicated flattening (one should suffice if it is made properly). This is a common tactic by a few to run the family through a series of helmets and multiply the profit margin. I would also avoid any group who suggests that failure to treat the flattening will cause medical issues such as developmental delay, visual changes, otitis media, disorders of the temporomandibular joint, or the like. The data to support these claims is weak to none (see text for more commentary). Such scare tactics draw into question the integrity and motivations of the company, its employees, and the entire process. I would also seek a second opinion if your doctor refers you to a helmet company that is in his/her office or in which they have an ownership stake. This type of arrangement is not common but is very suspect and creates an inherent conflict of interest. I recall a medicolegal case I reviewed in which a patient was suing their treating plastic surgeon for failing to diagnosis evolving pancraniosynostosis (premature fusion of all cranial sutures, a serous medial issue). The missed diagnosis was defensible since the head shape was normal and the fusions were not easily detected by CT scan at the time of evaluation. What really astonished me in reviewing the record though was that the surgeon had prescribed a molding helmet for what was a totally normal head shape! I later found out that he owned the shop….

The last comment is that I have found that some helmet companies have joined with physical therapists or PT home health agencies to gain referrals of patients seen by the PT’s for torticollis. As the text describes, many patients with torticollis will develop some cranial flattening. Nevertheless, such a referral should be made by the child’s health care provider (pediatrician, NP) and not by the physical therapist who has no specific training in this area. I have seen many of such referrals as a second opinion and found the recommendation for helmet therapy to be inappropriate. The bottom line- try to find an objective opinion about the need for treatment or intervention, and avoid advice that is clouded by a financial conflict of interest.