Northwest Tissue Services’s director, Margery Moogk.

Should for-profit companies sell tissue, and if not, who should enforce the law prohibiting it?

Are there shortages of some vital tissue allografts because companies are offering higher prices and guaranteed contracts for tissue?

Should patients with medical/therapeutic needs get access to transplant tissue preferentially over patients who choose cosmetic procedures?

Are families being provided enough information at the time of their consent to donation to make an informed consent?

These are some of the questions being asked by the Office of the Inspector General (OIG) at the request of Health and Human Services Secretary Donna Shalala. The inquiry, requested by Congress, was triggered in large part by a series of articles published in the Orange County Register under the title, “The Body Brokers.”

The expose began with a five-part series that ran sequentially beginning April 16. To date, the newspaper has published more than 75 articles that are still available on its website, www.ocregister.com.

The articles are full of hyperbole and oversimplifications that mislead. They often do not make clear the distinctions between tissue donation programs and other whole body donation and research programs. Nevertheless, the paper also identifies some real abuses. Accordingly, the issues surrounding them are reverberating through the tissue banking community and the government agencies with oversight responsibility.

Such controversy follows significant and widespread changes in tissue banking over the past few years. The involvement of for-profit companies, first limited to contract processing for tissue banks, expanded dramatically as device manufacturers and biotechnology firms saw potential for new tissue-based products.

Initially, these companies obeyed the law that prohibits the sale of tissue for profit and their nonprofit tissue bank partners distributed the new products. But when legal counsel found that the law was full of loopholes and essentially unenforceable, for-profit companies began competing to buy donated tissue and to market and sell the products manufactured from it.

One new company, Regeneration Technologies Incorporated (RTI), a for-profit spin-off of the University of Florida Tissue Bank, went public this past summer and sold $70 million in company stock in its initial public offering.

RTI has grown rapidly, buying other tissue banks (the Georgia and Alabama banks), pursuing contracts to buy tissue, and establishing new procurement agencies to compete in areas already served by tissue banks not interested in contracting with them. RTI has also sought relationships with coroners and funeral homes to gain access to donated tissue.

Press coverage of these changes has been widespread. The Chicago Tribune ran three articles and an editorial calling for a cleanup of the abuses. Molly Ivins wrote a syndicated editorial titled, “ Where’s the Outrage?” In fact, many newspapers across the country ran all or part of The Register’s series, while others reported on the extent to which their own community tissue banks were involved.

Consequences
In the aftermath of such reports, the University of Wisconsin’s organ procurement agency director resigned under pressure after admitting he received — in violation of the university’s conflict of interest policy — more than $80,000 in undeclared income. He had cofounded a new tissue procurement agency and shifted its affiliation to RTI after canceling an agreement with the American Red Cross tissue bank that had provided services in Wisconsin for years.

And in California, legislation has been introduced to gain some control over abuses. Also, a class-action lawsuit has been filed in that state on behalf of donor families who were not fully informed at the time of consent about how the tissue bank would use their loved ones’ gifts.

To ensure public confidence in donation programs after the recent spate of negative media attention, the American Association of Tissue Banks (AATB), has appointed a task force comprised of representatives from six member banks, including the Northwest Tissue Services’s director, Margery Moogk. The group is charged with reviewing and recommending changes to Association policies, standards and guidelines and with helping to positively position the organization and its members.

In addition, efforts are underway to revise standards for obtaining informed consent to ensure families are given the information they need. AATB also surveyed its members to try to determine if contracts that direct skin donations to for-profit companies that promote products for cosmetic surgery are resulting in shortages of skin grafts for burn patients, as reported by The Register.

What’s ahead
It remains to be seen whether all of this attention will halt or limit some of the many ways for-profit companies are participating in and changing tissue banking. Much depends on the report from the OIG due out soon. If its inquiry concludes that some companies do in fact violate the intent of the law that prohibits profiting from the sale of human tissue, new and clearer federal legislation may be required to close current loopholes.

Whether or not companies that offer incentives to access donated tissue are already jeopardizing the availability of transplant tissue for patients in need of therapeutic procedures, the mere suggestion of that possibility indicates that more stringent control is needed. If that control does not come from local or regional community boards that require tissue banks to first meet the needs of patients, additional government regulation may be required.

In any case, the most critical change the tissue banking community must make is to insure that families who are asked to consent to donation are given complete and accurate information about how their gifts will be used and the involvement of for-profit companies, especially in tissue distribution.

The intense public education efforts that focus on the fairness of access to organ transplants and the prohibition of their sale have led society to expect that the same safeguards apply when they donate tissue. Families have a right to know if this is not the case; failing to inform them will undermine their trust in donation and result in many choosing not to donate.

Regardless of what changes must be made to bring new, more effective tissue-based therapies to patients, tissue banks must not allow business pressures make them lose sight of their responsibility to act as faithful stewards for those who donate.