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cellspacing="0" border="0" width="649"><tr><td height="36" bgcolor="#26386B" class="ff1 cDEF p12"><span class="f65"><a href="/web/20060615014211/http://msnbc.msn.com/" class="lk1">MSNBC Home</a></span><span class="cFC0 b f70"> » </span><span class="f65"><a href="/web/20060615014211/http://msnbc.msn.com/id/3032076/" class="lk1">Health</a></span></td></tr></table><div class="clr"></div><a name="skipnav"></a><h1>Cadaver tissue poses growing risk to the living</h1><h2>Body-parts business plagued by shoddy practices, lax regulations</h2><div class="p14"><div id="finalPos"></div><div class="WCCol w300 fR clrR"><table cellpadding="0" cellspacing="0" border="0"><tr><td style="padding-bottom:20px;"><script>getCSS("3053751")</script><div class="box_3053751" style="width:300;"><script></script><table width="300" cellspacing="0" cellpadding="0" class="boxH_3053751"><tr><td width="1%" class="boxHI_3053751"><img src="/web/20060615014211im_/http://msnbc.msn.com/images/icons/slideshow.gif" width="20" 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name="launch10" width="77" height="25" border="0" id="EAABFA" hspace="20"></a></div></div></td></tr><tr valign="top"><td class="boxBI_3053751"><div class="textHang"><span class="bulletRedSmall">• </span><span class="textMedBlackBold"><a href="javascript:SSOpen('13212529','0');">Inside a tissue plant</a></span><br><span class="textMed">Click to see pictures from inside Tissue Bank International which processes some 600 cadavers a year, using appropriate precautions.</span></div></td></tr></table></div><div class="credit aR">Noah Berger / AP</div><div class="caption" style="padding:10 0 0 0;">** ADVANCE FOR SUNDAY, JUNE 11 **Viewed through the lens of a microscope, a culture taken from a sclera, commonly known as the white of the eye, is examined at Tissue Banks International's San Rafael, Calif., processing facility on Friday, May 12, 2006. (AP Photo/Noah Berger)</div></td><td width="100%"></td></tr></table><div style="padding-bottom:20;"><link href="/web/20060615014211cs_/http://msnbc.msn.com/css/html40.css" rel="stylesheet" type="text/css"><script src="/web/20060615014211js_/http://msnbc.msn.com/js/std.js"></script><script>var cssList = new Array();</script><script>getCSS("3053751")</script></div><div style="padding-bottom:20;"><link href="/web/20060615014211cs_/http://msnbc.msn.com/css/html40.css" rel="stylesheet" type="text/css"><script src="/web/20060615014211js_/http://msnbc.msn.com/js/std.js"></script><script>var cssList = new Array();</script><script>getCSS("3053751")</script><div class="box_3053751" style="width:300;"><script></script><table width="300" cellspacing="0" cellpadding="0" class="boxH_3053751"><tr><td width="*" nowrap="true" class="boxHC_3053751"><div class="textSmallBold"> Most Popular</div></td></tr></table><table width="300" cellspacing="0" cellpadding="0" class="boxB_3053751"><tr><td><table 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</span><span class="textMed"><b><a href="/web/20060615014211/http://msnbc.msn.com/id/7468311/">Most viewed on MSNBC.com</a></b></span></div></div></td></tr></table><script>pop_pushTabBox('boxB_3053751');</script></div></div><div style="padding-bottom:20;"><script language="javascript"> document.write('<scr'+'ipt language="javascript" src="https://web.archive.org/web/20060615014211/http://web.webrelevance.com/msnbc/ads.ashx?pt=health&at=mpt&ct=js&u='+escape(document.location)+'">'); document.write('</scr'+'ipt>'); </script></div></div><div class="CCol w160 fR clrR"></div><div class="mR165"><div><img border="0" src="https://web.archive.org/web/20060615014211im_/http://media.msnbc.msn.com/i/msnbc/Components/Sources/sourceAP.gif" height="20" width="140" vspace="0" hspace="0"><div class="textTimestamp"><div id="udtD">Updated: 3:44 p.m. ET June 11, 2006</div><script language="javascript"> function UpdateTimeStamp(pdt) { var n = document.getElementById("udtD"); if(pdt != '' && n && window.DateTime) { var dt = new DateTime(); pdt = dt.T2D(pdt); if(dt.GetTZ(pdt)) {n.innerHTML = dt.D2S(pdt,((''.toLowerCase()=='false')?false:true));} } } UpdateTimeStamp('632856518714100000'); </script></div></div><p class="textBodyBlack"><span id="byLine"></span>Don’t worry, the doctor told Brian Lykins’ parents, as he prepared to use cartilage from a cadaver to fix their son’s knee.</p><p class="textBodyBlack"><span id="byLine"></span>A million people a year have operations that use tissue from donated dead bodies. The nation’s largest tissue bank had supplied this cartilage. It was disinfected and perfectly safe, he assured them.</p><p class="textBodyBlack"><span id="byLine"></span>But it wasn’t.</p><div class="aC"><div class="textSmallGrey w320"><a href="#storyContinued">Story continues below ↓</a><hr noshade size="1"> advertisement <div style="padding:0 10 10 10;"><script>ad_dap(250,300,'&PG=NBCMSH&AP=1089');</script></div><hr noshade size="1"></div></div><a name="storyContinued"></a><p class="textBodyBlack"><span id="byLine"></span>Four days after this routine, elective surgery, Lykins — a healthy, 23-year-old student from Minnesota — died of a raging infection.</p><p class="textBodyBlack"><span id="byLine"></span>He died because the cartilage came from a corpse that had sat unrefrigerated for 19 hours — a corpse that had been rejected by two other tissue banks. The cartilage hadn’t been adequately treated to kill bacteria. The Georgia-based tissue bank, CryoLife Inc., knew that the donor had the germ and released the tissue anyway.</p><p class="textBodyBlack"><span id="byLine"></span>None of this broke a single federal rule.</p><p class="textBodyBlack"><span id="byLine"></span>And it could happen again today — likely is still happening today — because of shoddy practices by some in the billion-dollar body parts business and the lack of government regulation.</p><p class="textBodyBlack"><span id="byLine"></span><b><strong>Thousands of Americans at risk</strong></b><br>The industry is in the news because a New Jersey company is accused of scavenging corpses without families’ permission and then selling those parts to tissue processors. But apart from this scandal, thousands more Americans each day are put at risk in more insidious ways by legitimate tissue suppliers.</p><p class="textBodyBlack"><span id="byLine"></span><table cellpadding="0" cellspacing="0" border="0" width="1%" align="left" style="padding:5 15 0 0;"><tr><td><img border="0" src="https://web.archive.org/web/20060615014211im_/http://msnbcmedia.msn.com/i/msnbc/Components/Art/HEALTH/060608/AP_TISSUE_INSPECT.gif" align="Left" height="363" width="183" vspace="0" hspace="0"></td></tr></table>A three-month investigation by The Associated Press found problems ranging from inadequate testing for potentially deadly germs to lack of a system for tracking tissues as they travel from donor to recipient.</p><p class="textBodyBlack"><span id="byLine"></span>At every step — from funeral homes, where the journey often begins, to hospitals and doctors’ offices, where it ends with patients receiving the eyes, bones, skin and other parts of the dead — poor oversight invites abuse and creates danger.</p><p class="textBodyBlack"><span id="byLine"></span>Most tissue transplants involve reputable companies and do a lot of good. Olympic skiers, people who have lost eyesight and children born with bad hearts are among the millions who have benefited. But when things go wrong, the consequences are horrific.</p><p class="textBodyBlack"><span id="byLine"></span>Ken Alesescu died May 14 in his San Luis Obispo, Calif., home, victim of a fungus-infested heart valve.</p><p class="textBodyBlack"><span id="byLine"></span>Alan Minvielle, of Santa Cruz, Calif., lost a job and almost lost a leg to gangrene from a bad tendon.</p><p class="textBodyBlack"><span id="byLine"></span>Bonny Gonyer in Chippewa Falls, Wis., has pain and walks with a limp because of tainted tissue.</p><p class="textBodyBlack"><span id="byLine"></span>“It angers me when I read these stories,” Pam Alesescu, the heart valve recipient’s widow, said in an interview shortly before he died. “My kids are losing their dad, and I am losing my husband.”</p><p class="textBodyBlack"><span id="byLine"></span><b><strong>FDA regulations inadequate<br></strong></b>The federal agency responsible for tissue safety, the Food and Drug Administration, is well aware of the problems. Its own report in 2001 estimated that 519 cases of serious heart inflammation and 207 deaths occurred each year from fungus-contaminated heart valves alone.</p><p class="textBodyBlack"><span id="byLine"></span>Yet, many experts believe the rules it enacted last year as a long-promised overhaul fall short<table cellpadding="0" cellspacing="0" border="0" align="right" style="padding:5 0 0 15;"><tr><td><script>getCSS("3053751")</script><div class="box_3053751" style="width:152;"><script></script><table width="152" cellspacing="0" cellpadding="0" class="boxH_3053751"><tr><td width="*" nowrap="true" class="boxHC_3053751"><div class="textSmallBold"> MSNBC HEALTH</div></td></tr></table><table width="152" cellspacing="0" cellpadding="0" class="boxB_3053751"><tr valign="top"><td></td></tr><tr valign="top"><td class="boxBI_3053751"><div class="textMed"><b>Flesh and Bone: Inside the body-parts business</b></div><div class="textHang"><div style="padding-bottom:3px"><span class="bulletRedSmall">• </span><span class="textMed"><a href="/web/20060615014211/http://msnbc.msn.com/id/13165909/" id="gted" ce="Link-1">Demand for body parts fuels trade</a></span></div><div style="padding-bottom:3px"><span class="bulletRedSmall">• </span><span class="textMed"><a href="/web/20060615014211/http://msnbc.msn.com/id/13165926/" id="gted" ce="Link-1">Few regulations on body-parts industry</a></span></div><div style="padding-bottom:3px"><span class="bulletRedSmall">• </span><span class="textMed"><a href="/web/20060615014211/http://msnbc.msn.com/id/13208662/" id="gted" ce="Link-1">Cadaver tissue poses growing risk to the living</a></span></div><div style="padding-bottom:3px"><span class="bulletRedSmall">• </span><span class="textMed"><a href="/web/20060615014211/http://msnbc.msn.com/id/13086368/" id="gted" ce="Link-1">Need a transplant? Be sure to take precautions</a></span></div><div style="padding-bottom:3px"><span class="bulletRedSmall">• </span><span class="textMed"><a href="/web/20060615014211/http://msnbc.msn.com/id/13192052/" id="gted" ce="Link-1">A look inside a tissue processing plant</a></span></div></div></td></tr></table></div></td></tr></table> of providing the level of oversight needed. Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses.</p><p class="textBodyBlack"><span id="byLine"></span>When it does inspect, public health isn’t always protected. In 2003, an FDA inspector saw that Biomedical Tissue Services — the now-notorious New Jersey company — wasn’t documenting what it did with tissue unsuitable for transplant. The FDA let the matter drop after the company sent a letter saying it had fixed the problem. For two more years, thousands of people received tissue.</p><p class="textBodyBlack"><span id="byLine"></span>“I’m not surprised that a BTS (incident) occurred. And there will be others,” said Areta Kupchyk, a former FDA lawyer who drafted rules that ultimately were adopted in watered-down form. “We continue to be at risk.”</p><p class="textBodyBlack"><span id="byLine"></span>Here are some of the ways:</p><ul><li class="textBodyBlack">A trade group, the American Association of Tissue Banks, requires accredited members to follow high standards, but without the FDA doing the same, hospitals and doctors can buy from unaccredited suppliers that offer tissue quicker or cheaper.</li><li class="textBodyBlack">Tissue isn’t tested as thoroughly as blood is for infectious diseases.</li><li class="textBodyBlack">The FDA sets no limits on age or health of donors, or how long after death tissue can be taken.</li><li class="textBodyBlack">Funeral homes don’t have to report deaths to organ procurement groups, leaving them outside a regulatory system and able to cut side deals to supply body parts.</li><li class="textBodyBlack">Doctors often know little about the origins of tissue they use. Some hospitals buy it like surgical gloves and other supplies — based on price and availability. Patients are not always told they are receiving tissue from a cadaver or offered alternative treatments.</li><li class="textBodyBlack">Hospitals and doctors do not have to report tissue infections to health officials, and evidence suggests that many are missed.</li><li class="textBodyBlack">The FDA requires no medical training to run a tissue bank or procure tissue.</li></ul><p class="textBodyBlack"><span id="byLine"></span><table cellpadding="0" cellspacing="0" border="0" align="left" style="padding:5 15 0 0;"><tr><td><script>getCSS("3053751")</script><div class="box_3053751" style="width:152;"><script></script><table width="152" cellspacing="0" cellpadding="0" class="boxH_3053751"><tr><td width="*" nowrap="true" class="boxHC_3053751"><div class="textSmallBold"> Coming Monday</div></td></tr></table><table width="152" cellspacing="0" cellpadding="0" class="boxB_3053751"><tr valign="top"><td class="boxBI_3053751"><div class="textHang"><div style="padding-bottom:3px"><span class="textMed">— Grotesque story like 'a cheap horror movie'</span></div><div style="padding-bottom:3px"><span class="textMed">— Few regulations on body parts industry</span></div><div style="padding-bottom:3px"><span class="textMed">— Demand for body parts fuels booming trade</span></div></div></td></tr></table></div></td></tr></table></p><p class="textBodyBlack"><span id="byLine"></span>And business is booming. The number of tissues distributed for transplants rose from 350,000 in 1990 to 650,000 in 1999 and 1.3 million in 2003. Tissue companies are awash in cash — even the nonprofits. The biggest is the Musculoskeletal Transplant Foundation Inc. of New Jersey. In 2004, it had $243 million in revenues and paid its chief executive $542,212.</p><p class="textBodyBlack"><span id="byLine"></span>The FDA, on the other hand, lacks staff and money. It spends $5.4 million a year on tissue regulation — less than two days’ revenue for the industry. Inspections of tissue businesses peaked at 285 in 2004, but the number of companies rose from 1,325 two years ago to 2,030 now.</p><div class="t1 f70 c666"><span cm="PageNavBot"><a class="b" id="gted" ce="2" href="/web/20060615014211/http://msnbc.msn.com/id/13208662/page/2/">CONTINUED: Better industry oversight needed</a><hr size="1">1 | <a class="b" id="gted" ce="2" href="/web/20060615014211/http://msnbc.msn.com/id/13208662/page/2/">2</a> | <a class="b" id="gted" ce="2" href="/web/20060615014211/http://msnbc.msn.com/id/13208662/page/2/">Next ></a></span></div><div class="userRating t1 b f11 c000" style="margin-top:20px;"><nobr> Rate this story </nobr><span style="white-space:wrap;"></span><nobr> Low <span id="URplace"></span> High </nobr></div><span class="t1 f11 c000" style="display:none" id="userRatingTotal"></span><span> </span><span class="bulletRedSmall"> • </span><a href="/web/20060615014211/http://msnbc.msn.com/id/7468311/" class="t1 b f11 c000">View Top Rated 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