Head Games

Parents are being told to sleep babies on their backs to avoid SIDS. The medical establishment has ignored the unintended consequences -- and that's making one Tempe company very, very successful

Three months later, if everything goes well (and in 87 percent of cases, it does), the band comes off for good.

This is Jeanne Hertz's patented process. In 1993, Hertz incorporated a new company in central Phoenix, Cranial Technologies. That same year, she was able to open a second office in Dallas. She announced to her clients in 1994 that she would no longer take orders for the spinal products that used to be her specialty.

Hertz eventually opened clinics in 11 U.S. cities and licensed the DOC Band to therapy centers in four others. Cranial Technologies has also taken its product to clinics in Canada, Spain and Great Britain. When it outgrew its 5,000-square-foot headquarters in Phoenix, it opened a new headquarters in a Tempe office park -- this one three times bigger.

Gabriella Licano (left), with her mother and brother Kobe, got a helmet when her mother insisted.
Peter Scanlon
Gabriella Licano (left), with her mother and brother Kobe, got a helmet when her mother insisted.
Josh Tolbert's head today is perfectly normal -- thanks to his mom's long fight with their insurance company.
Peter Scanlon
Josh Tolbert's head today is perfectly normal -- thanks to his mom's long fight with their insurance company.

Today the company has 110 employees. It sold almost 6,000 helmets last year, at $3,000 a pop.

Petite, with a Midwesterner's openness and brisk energy, Hertz takes a hands-on approach to the company's work. Literally. She's the CEO, but you can still spot her most days in the manufacturing area, in her lab coat and sneakers, putting the final touches on a DOC Band.

"Every one of these cases is absolutely particular to that infant," Hertz says, carefully touching up the crown. "We are absolutely entrenched with these families."

A number of other companies have gotten on the bandwagon. Hertz's company, Cranial Technologies, was the first helmet provider licensed by the Food & Drug Administration, in 1998. Twenty-seven others have gotten approval since, according to FDA records.

Orthomerica Products, whose STAR Band is based on the original design from Seattle, got FDA clearance in 2000. Company representatives say they now sell close to the same number as Cranial Technologies, though they refuse to discuss specific sales numbers or prices.

"It's such an enjoyable business, because kids get better," says Dulcey Lima, the company's clinical education manager. "They wear the helmets three or four months, and they're done. And then the parents are happy."

Soon after Lisa Licano's twins were born, her husband approached their pediatrician with a question about the baby girl: "What's wrong with her head?"

The doctor was unfazed. Gabriella's twin brother had squished her a bit in the womb, he said. So maybe her head seemed a little flat in some areas. Not to worry; it would even out.

It didn't. "I'd ask at every doctor's appointment," says Licano, who lives in Phoenix. "I'd say, 'Will this change?' He'd always say it would." She'd ask if there was anything she could do. Every time, he said no.

Licano was increasingly worried. "Gabby's head wasn't just flat, it was odd-shaped," she says. "There were different flat spots all over."

When the twins were seven months old, Licano reached her breaking point. She sat down at the computer and punched "odd shaped head" into a search engine.

Up popped a list of pages about a medical condition she'd never heard of: plagiocephaly. There was even a Yahoo! message board for parents to talk about the problem.

"It literally led me right to the information," Licano says.

Not that her doctor was listening. At the next visit, Licano pulled out the charts she'd pulled off various Web sites, the printouts that were her effort to explain the unexplainable.

"Sure," he told her. "That's what she has. But when she gets older, if she wears her hair long, you won't even notice."

In the early days of the Back to Sleep campaign, even as some doctors were treating the misshapen heads surgically, others continued to claim that even buying a helmet was a radical overreaction.

Sometimes, when Hertz would present about the DOC Band at medical conferences, the older doctors in the room were openly dismissive. They'd been seeing flattened heads for years, they jeered. The heads would correct themselves once the babies started rolling around and sitting up.

After the talks, the younger physicians would invariably approach Hertz, quietly. They were looking for something just like the DOC Band, they'd say. Could she help?

In 1996, physicians published three landmark studies: two in the Journal of Craniofacial Surgery and one in Pediatrics. All three noted the dramatic increase in plagiocephaly. All three talked about how the right helmet could prevent surgery.

All three connected the increase to the American Academy's back-sleeping recommendation.

To this day, the three studies are the most frequently cited papers about plagiocephaly. But they were virtually ignored at the time.

The National Institutes of Child Health and Development, which was spending nearly $1.2 million annually to promote Back to Sleep, issued a press release crowing about how colds decreased as a result of the campaign. It never issued any statement about the increase in skull deformities.

"We spent three years trying to get a paper accepted," Hertz recalls. "We wanted to say, 'Do you know this is happening, and this is how we're treating it?' But the spokespeople for the Back to Sleep campaign kept saying it wasn't true, that there was no connection."

It wasn't until 2000 that the American Academy of Pediatrics issued a statement about back-sleeping that acknowledged skull deformities.

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