Guiding light | Physician Engineered Products introduces a new device for sufferers of the winter blues

Swedish director Ingmar Bergman, British songwriter Morrissey, Maine's own Stephen King: They all specialize in gloomy, even dark projects, and each of them lives in the northern latitudes. Whether their inspiration comes from overcast skies and long nights, it's hard to say. Still, psychiatric medicine tells us this: Millions of people suffer a form of winter depression brought on not by the cold, but by a lack of light.

"This is not the typical depression in which you don't sleep, you don't eat, you lose weight," said Dr. Cindy Boyack, medical director for outpatient mental services at Maine Medical Center in Portland. "With seasonal affective disorder, we are closer to hibernating. We sleep more, eat more, crave carbohydrates, are perhaps a bit more irritable, more lethargic and dragging yourself around."

If those symptoms sound familiar, get in line. Estimates put the number of "winter blues" sufferers at seven million to eight million in the United States and Canada, never mind the light-starved hordes of northern Europe.

Fryeburg resident Dr. Rob Rose has plans to ease that misery. A physician, inventor and business owner, Rose recently introduced a new version of what he calls the Feel Bright Light, one in a growing number of phototherapy products designed to treat SAD. As chief executive of Physician Engineered Products, the 56-year-old Rose is no newcomer to phototherapuetics. Since 1984, PEP has been selling a light bed the doctor created for home treatment of jaundiced newborns.

That experience, however, doesn't guarantee that PEP's new product will be a success. Insurance companies are just coming to grips with the reality of SAD as a valid diagnosis, let alone the use of light as an effective treatment. Even advocates of phototherapy debate the precise wavelengths and intensities of light that are optimal for treatment.

Rose, however, thinks his new product solves a persistent problem in SAD treatment. While all SAD-related phototherapy devices purport to provide some of the benefits of sunlight, most are packaged as light boxes. Patients who use them must stay put, eyes open, in order to soak up their 30 minutes of medicine each day. The flaw, Rose argues, is that many SAD sufferers wake up wrestling with symptoms of anxiety (or running late for work) and aren't apt to sit still for their fully prescribed dose of lumens. "One thing we struggle with in medicine is trying to make it easier for the patient to get the treatment," he said. "So we weren't really creating new technology here. We were just packaging [existing] technology in a way that made sense."

In its original form, introduced in the mid-1990s, the Feel Bright Light was worn like a pair of spectacles. Early users, however, complained that heat from the product's incandescent bulb dried out their eyes. The model introduced in October weighs just 1.7 ounces, clips under the brim of a ball cap and uses LEDs, which don't produce heat, rather than a bulb. The design turns patients loose to cook breakfast, exercise or go about other visually undemanding parts of their routine while taking their medicine. (There is at least one other visor product on the market, sold by Newbury, N.H.-based Life with Ease.)

To Rose, the logic is obvious: Proven technology plus a higher rate of compliance equals a higher and more predictable dose of light. To some others, though, the visor lights are making unverified claims, threatening a discipline struggling for credibility. "A convincing, published, controlled clinical trial is needed before visor products are marketed for treatment of SAD," wrote Dr. Michael Terman, professor of Clinical Psychology at Columbia University, in an e-mail response to questions for this story. "Thus far, there have been none."

Toward the light
Rose developed his interest in phototherapy as a young family practitioner in Park Rapids, Minn., in the early 1980s. He saw nurses attending infants in hospital light beds and parents spending hours of time and too much money on light treatments for their jaundiced ˆ— but otherwise healthy ˆ— children. The treatment, in which infants absorb light through capillaries in their skin to dissolve blood-borne bilirubin until the liver begins to function, was simple, bore little risk and could be attended to more economically by concerned parents.

By 1984, Rose had developed a home care light bed, the Ultra Bililight Bed, which remains the company's flagship product. He partnered with Larry Sundsrud, a local business associate who managed the marketing and manufacturing end of the operation. Eventually, PEP expanded with an eye toward developing a full line of infant home care products, including an angled, reflux-reducing baby bed and a mist tent to treat respiratory problems in infants. Profits, produced mainly by the jaundice bed, were solid, Rose said, but the market was limited and the number of competitors was on the rise. Sales rose briefly to more than $1 million in the mid-90s, then backed off as new fiber optic treatments for jaundice grew popular.

Rose bought out Sundsrud in 2002 and moved the company to Fryeburg. He, his wife, Heidi (also a physician), and their five children had moved to Maine in 1985, when Rose accepted a position as director of emergency medicine at Memorial Hospital in North Conway, N.H. (In 1996, the Roses and several partners established the Saco River Medical Clinic in Conway, of which Rob Rose is president. He works one day a week as a physician, spending the rest of his time at PEP.)

Before moving PEP to New England, Rose had his accountant look into whether the company would be better off in Maine or New Hampshire. The accountant saw Maine as the better choice, in part because, as a Maine resident, Rose would need to pay Maine income tax regardless of the business' location. "The week we moved everything was during a political campaign," Rose said with a chuckle. "And a candidate from Maine was on the radio saying something like, 'You would have to be a total idiot to move a business to Maine.'"

So far, he reports no regrets. On PEP's arrival in Maine, he pulled the mist tent, which accounted for less than two percent of annual sales, from the market; he plans to rework the design in the future. Shortly thereafter, he hired Tom Sheehan, a veteran marketer, to help begin refocusing the company. "We had developed a certain expertise in phototherapy in general through infant phototherapy," Rose said. "But it was clear that adult phototherapy ˆ— winter blues, SAD, circadian clock adjustments ˆ— was becoming a very sizable market."

Sheehan, a 44-year-old Massachusetts native, came to PEP after a brief retirement. With his three brothers, he had built Alpine Computer Systems in Holliston, Mass., into a remote network services provider with $35 million in annual revenues. (The brothers then sold the company in a recapitalization deal in June 2000.) Sheehan's new task was to expand sales of Ultra BiliLight beds; he increased PEP's revenues (which Rose did not disclose) a total of 10% in the past two years, despite discontinuing sales of the mist tent. In the meantime, the doctor went to work designing a new, wearable Feel Bright Light.

A long day's journey into night
With regard to SAD, there are at least several points of general consensus in the medical community, first of which is that seasonal affective disorder is a valid diagnosis. Maine Medical Center's Boyack said she first understood the disorder when she served her residency in Montreal in the early 90s. There, she learned that brutally short winter days had long ago made SAD an accepted diagnosis in Canada, northern Europe and Alaska.

The continental United States has caught on more gradually. "But [the diagnosis] is established enough that it is in the DSM-IV, our diagnostic statistical manual for psychiatric disorders. So it is pretty well established that such an entity does exist," Boyack said.

Also accepted in the psychiatric community is the idea that light therapy can be an effective treatment for the condition. At the correct wavelength and intensity, light travels through the eye and the optic nerve to the pineal gland and suppresses production of melatonin, the chemical source of the winter blues. However, on rare occasions, Boyack said, light treatment can trigger manic episodes in patients with bipolar tendencies. On the more mild side, some patients experience eye strain or headaches from the treatment.

In the phototherapy field, there is consensus that, although ultraviolet light is effective in some types of light treatment (for psoriasis, for example), it should be screened out of visual SAD therapies. Opinions differ, however, on precisely which other components of the light spectrum generate beneficial effects.

Rose has studied the work of two research groups focusing on the problem. Studies on one side indicate the range of blue light, around 480 nanometers, is the most effective wavelength for treating SAD. The other shows that green, roughly 520 nanometers, produces the maximum effect. "The vast majority of products out there use white light, and it's the blue-to-green range within that white" ˆ— white light includes a broad swathe of the spectrum ˆ— "that is effective," Rose said. "We are right in the middle, at around 500 nanometers."

There is another school of thought, one that includes Columbia's Terman, who established the Clinical Chronobiology Program at New York State Psychiatric Institute and is now president of the Center for Environmental Therapeutics. The CET website (see "Light and dark," previous page) provides a list of recommendations for patients considering light treatment of SAD, including use of lamps that give off white light rather than colored light. "'Full spectrum lamps and blue (or bluish) lamps," the warning reads, "provide no known therapeutic advantage."

Terman declined an interview on the subject, offering only a brief, e-mailed response. But the CET site explains that SAD phototherapy has grown into a cottage industry, with many entrants allegedly selling clinically untested apparatus and making unjustified claims for efficacy and ocular safety. "There is a whole new set of concerns now," the CET caveat reads. "Without federal or professional regulation of standards, the medical and scientific basis of the field is placed at risk by inadequate products and advertising."

Sheehan agrees that, at this point, most anyone can stick a light bulb in a lamp and call it phototherapy treatment for SAD. "The [Food and Drug Administration] knows this stuff works but is staying out of it right now," he said. "Unless someone was wildly making claims beyond what we know to be true, they are not going to get slapped."

The PEP business plan clearly intends to boost the Feel Bright Light's credibility. For starters, PEP's Ultra BiliLight Bed has been registered with the FDA since the company's early days. Sheehan said PEP has used those registration standards as guidelines for the visor product. "We are planning for FDA involvement at some point," he said.

In addition, Rose plans to pursue ISO 13485 certification, which would certify Feel Bright Light's adherence to customer and international regulatory standards, opening the door to sales in Canada and Europe and other world markets. Sheehan and Rose hope to be approved for sale in Europe by next fall to catch the seasonal onslaught of SAD symptoms.

Today, Sheehan and Rose are working out which avenues will be most successful for marketing their new device domestically. (The Feel Bright Light is assembled in Fryeburg from components supplied by 14 different vendors in the United States and China.) Sheehan leans toward talk radio, while Rose gravitates toward television infomercials. Both agree that, in addition to individual consumers, who must pay the $199 cost out of pocket, since most insurance companies don't cover SAD products, the primary Feel Bright customers will be home medical equipment retailers across the country.

Sheehan spent the fall making sales calls to medical equipment retailers and attending trade shows; PEP also sent a direct mail piece to psychologists in the northern tier of the country. He says those efforts have resulted in the sale of "hundreds" of Feel Bright Lights since October and that the company is receiving some "very large orders," though he declines to give specifics.

Does Rose expect the Feel Bright Light to boost the 10% revenue growth PEP has seen over the past two years? "Oh, absolutely," the doctor said. "It feels to me like we are on the bottom end of a logarithmic curve that is going to kick in if we do our jobs correctly."