Editorial: Track human tissue business to protect patients
When altruistic organ donors sign up to provide that precious gift to save lives, few know that their other body parts could be funneled into a for-profit, global trade in human tissues that is poorly regulated and open to dangerous abuse.
The tissues they donate, including bones, skin and tendons, are incorporated into products that can save and dramatically improve recipients' lives, the same as organ transplants. But the companies that harvest and distribute the tissues need dead bodies to turn a profit. The competition is fierce and that has led to abuses, according to stories by Thomas Maier published in Newsday and broadcast on News 12 Long Island last week.
Unlike the well-regulated not-for-profit organ donor system, there is lax regulation and oversight of for-profit "body wranglers" who locate donor bodies, and the companies that harvest tissues. This makes it difficult to ensure that the corpses are obtained legally and ethically. It also makes it hard to ensure that infected or diseased tissue won't be distributed, or to locate tainted products and pull them off the market. Sometimes recipients of tainted products can't even be identified.
The industry is too important to be allowed to continue operating in the shadows. Sen. Charles Schumer (D-N.Y.) sponsored a bill calling for reform in 2006, but it died, a victim of hard lobbying by the industry. Congress should try again.
Body tissue is harvested all over the world, and the worst abuses -- stealing bodies without consent or with forged signatures, or with consent secured through threats and coercion -- occur most often in Eastern Europe.
But the United States is home to the industry's major players. It's illegal to sell body parts in the United States, but private companies are allowed to charge fees for the collection and processing of human tissue. This country is the biggest supplier, and with an estimated 2 million products derived from human tissue sold here each year, it's also the world's biggest market for the products. So the United States should take the lead in reforming how the industry operates.
Congress should strengthen the informed consent requirement. Donors and their families deserve to know that in addition to providing organs such as hearts and lungs for transplant, their tissues could be sold for profit.
The Food and Drug Administration must have an aggressive oversight role. Tougher licensing requirements are needed for those in the business of locating bodies and harvesting tissues for companies that produce medical products. "I submitted the form online and in three days I was an official recovery tissue bank registered with the FDA," Phillip Guyett told the International Consortium of Investigative Reporters. The consortium produced a series on the human tissue industry that included contributions from Newsday and News 12. The series reported that Guyett forged information on donor files and was convicted of fraud in 2006. Regular inspections and audits by the FDA are needed. And a system should be put in place to track body parts and tissues from donor to recipient.
Tissue donors provide the essential raw material for products used in procedures like skin grafts for burn victims, breast reconstruction for cancer patients and joint reconstruction. Washington should make sure those products are safe for patients, and that donors who made it all possible are treated with the respect they deserve.