Jenna Hamon, 4, whose heart defect was repaired by U doctors, got help putting on a necklace from her dad, Mark, and mom Lori.

David Joles, Star Tribune

Mark Haman got a hug from daughter Jenna, 4, as her sister Josie, 5, ran toward them. Both girls were treated for congenital heart defects.

David Joles, Star Tribune

For high-tech lifesavers, an urgent push in Congress

  • Article by: KEVIN DIAZ
  • Star Tribune
  • April 27, 2012 - 10:35 AM


Mark Haman recalls his face going white when University of Minnesota doctors first told him that his bubbly 23-month-old daughter Josie might need open-heart surgery to fix a little hole in her heart.

Luckily, Josie was talking and acting like her "silly" self just hours after a far less invasive procedure using a new device that had just received government approval.

"For us, it was a total godsend," said Haman, a 39-year-old printer from Mankato.

Haman and his wife, Lori, a second-grade teacher, recently offered their testimonials to Sen. Al Franken, one in a growing number of lawmakers in both parties trying to streamline the way the Food and Drug Administration approves new medical inventions.

The Hamans' story -- both their young daughters were treated for congenital heart defects with cutting-edge Amplatzer technology pioneered in Minnesota -- underscores how time, as well as safety, often is of the essence.

Just a few months' delay in the FDA approval of the device doctors used to patch Josie's heart, "and she would have needed open-heart surgery," her mother said. "It was that close."

A rare bipartisan urgency also is being felt in an otherwise gridlocked Congress this year as lawmakers look to boost innovation and shorten the time it takes to approve medical technology that often gets a tryout in Europe long before reaching U.S. patients.

The effort comes as Congress readies wide-ranging FDA legislation that has pitted a $350 billion global medical device industry against consumer advocates in an ongoing battle over the U.S. oversight system, which alternately is criticized for being too stringent and too lax.

"Relaxing review standards for medical devices, as proposed in recently introduced bills, would be exactly the wrong course of action, further weakening an inadequate system," the consumer watchdog group Public Citizen wrote in a recent report.

Consumers Union lobbyists also have been making the rounds, talking about patients injured by defective devices, including a North Carolina man who was shocked by a faulty lead in a defibrillator made by Minnesota-based Medtronic.

But the little Haman sisters could serve as the poster girls for Minnesota-made medical miracles like the Amplatzer and Medtronic's revolutionary pacemaker technology.

"They say these things save lives, and any delay can cost lives," Franken said.

'Wait for a decision'

While safety concerns have not disappeared, the emerging consensus in Congress is that the government review of potentially lifesaving devices is needlessly slow, hampering U.S. companies in a difficult economy and sending business abroad.

One of the leaders in the House effort is second-term Republican Erik Paulsen, whose Twin Cities district includes some of the biggest names in a medical technology industry that employs 35,000 people in Minnesota.

Paulsen is co-chairman of the House Medical Technology Caucus, which is replicated in the Senate by Minnesota Democrat Amy Klobuchar. Joined by Franken, both are pressing congressional committees in the coming weeks to clear the regulatory red tape often blamed for slowing companies in Minnesota and across the nation from delivering critical medical products.

"We've been focused on this for a few years and now we're seeing the fruits of our labor come together, where we're going to have some positive results before the end of the year," Paulsen said.

Among the changes in the works are measures to pare down some conflict-of-interest restrictions for review by industry experts, reduce regulatory burdens and streamline a decisionmaking process that has been growing longer as advanced technology becomes more complicated.

At the heart of the legislation is an agreement to double the fees paid by device makers to help the FDA review their products. "Safety is the key part of this," said Klobuchar, who crafted language providing for voluntary early notification of potential drug shortages. "The major piece is to give them the resources to enforce standards, to not just have things wait for a decision, good or bad."

Franken also has created a measure that would extend profit incentives for "humanitarian" devices aimed at rare conditions that affect small patient populations. Those incentives now are limited to pediatric devices. Franken would include adults as well as children.

'Doing great'

That's where Josie Haman, now 5, and her little sister Jenna, 4, came in. Although the Amplatzer devices that saved them from open heart surgeries several years ago were not approved under a "humanitarian" exemption, their family's ordeal illustrates what is at stake.

Both girls faced the prospect of major open-heart surgery if doctors had not been able to fit them with relatively new devices stemming from ground-breaking technology developed by Dr. Kurt Amplatz, whose legacy often is compared with that of Medtronic co-founder and pacemaker inventor Earl Bakken.

But the financial investment in devices for pediatric medicine aren't always as easy to recoup, according to the girls' physician, Daniel Gruenstein, director of pediatric interventional cardiology at the University of Minnesota's Children's Hospital.

After years in development, a related device already has been approved for use in Europe, but not in the U.S.

"We're five years out now, we've spent millions of dollars, and we can't even offer this to kids," Gruenstein said.

Even the devices that the Haman girls received were benefiting children around the world for several years before they received FDA approval.

That forced many U.S. children to undergo open-heart surgery that might otherwise have been avoided.

Gruenstein speaks of the importance of testing and safety, but also of inherent risks in any new technology, including the legal risks that he believes inhibit the FDA approval process. "All devices will have side-effects and failures," he said. "But so does surgery, and so does not doing anything for these kids."

When Jenna Haman's procedure was scheduled, the size of the hole in the wall of her heart was so big that a surgical team was standing by, scrubbed and ready to perform open-heart surgery if needed.

Within 20 minutes, a nurse went out to talk to the family.

"We thought it was to tell us it didn't work and they needed to do open-heart," said her father, Mark Haman.

"Instead, it was to tell us she's done and doing great," recalled a relieved Lori Haman.

The next day, the girls were playing on a back-yard swing set. Said their father, "It was amazing."

Kevin Diaz is a correspondent in the Star Tribune Washington Bureau.

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