Collins’ tissue bank stance gets TV time

WASHINGTON – A two-year struggle by Sen. Susan Collins, R-Maine, to see safety regulations placed on businesses providing human tissue for medical purposes will fetch prime-time attention at 8 tonight on CBS television.

While an estimated 750,000 people undergo surgery involving the use of donated human tissue each year, 60 Minutes II will report on the story of a 23-year-old college student, Brian Lykins, a Minnesotan who mysteriously died soon after knee surgery last November when he received a tissue implant from another person.

After investigators from the Centers for Disease Control and Prevention were called in, they discovered that Lykins received tissue carrying rare bacteria that quickly spread and took his life.

Lykins was not alone in receiving an infection from a human tissue transplant. According to a recent CDC report, investigators found 25 other cases of patients who suffered from serious bacterial exposure after receiving tissue transplants in the last several years. Fourteen of those, including Lykins, were singled out as receiving tissue from the same distributor. Although unnamed in the report, the tissue bank is widely believed to be located in Georgia.

As the former chairman of a Senate subcommittee on investigations, Collins began to warn several years ago that such events might occur after she began studying the growing but largely unregulated human tissue industry. While the lawmaker credits the use of tissue for helping people in a variety of ways – from providing skin grafts to burn victims to helping people with needed bone replacements – Collins discovered during one Senate hearing that there are “some very large gaps” in how the federal government regulates the industry.

Businesses that sell human organs are carefully regulated, but the Food and Drug Administration has done little to address the tissue industry she says. “The FDA didn’t even have an idea of how many tissue banks are operating in the country,” she said on Tuesday.

More frustrating, she said, is the long delay in adopting stronger regulations that would help ensure that human tissue remains free of germs and bacteria. Although poised to adopt regulations for years, the FDA seemingly has been unable to go through with them.

“The FDA has proposed regulations that would deal with these issues, so I am puzzled why they have been so slow,” she said. “I never have gotten a satisfactory answer.”

What’s more, Collins says the FDA has yet to present her office with suggestions about what kind of additional funding might be needed to police the tissue industry.

What’s the solution?

In April, Collins went to a higher authority, Health and Human Services Secretary Tommy Thompson, and expressed concern about the delay in new regulations. She also requested that the department provide Congress with an estimate of the necessary resources to finalize the regulations.

Moreover, the senator plans to introduce legislation in the near future that would make it very clear to FDA officials that it’s time to adopt stricter safety standards.

The measure likely will authorize the FDA to require tissue banks to register with the agency in order to conduct business in the United States; demand that tissue establishments report adverse incidents within 15 days after the occurrence; and call for creating a comprehensive reporting database to store information relating to adverse events.