The Boston Globe from Boston, Massachusetts • 4

A4 The Nation The Boston Globe TUESDAY, JULY 20, 2004 Bryant hearing leaves media guarded Stent maker says items safe and to televise the trial would only be a "titillating and salacious" experience. Months of closed-door hearings have been held on whether IMIIIIIIIIIIKIIIIIIMHIIIIIIIIIIIIIIIIIIMIHIIII Setting a stent Boston Scientific Corp. is recalling 96,000 of its heart stents because of potential problems with deflating the balloons used to deploy the stents in clogged arteries. Accuser's sexual history kept out By Judith Crosson REUTERS EAGLE, Colo. The Colorado Supreme Court ruled yesterday that the media cannot disclose details of the sex life of a woman who accuses basketball star Kobe Bryant of rape as prosecutors and defense attorneys urged a judge to bar TV cameras from the trial.

Last month, seven media organizations mistakenly received e-mailed transcripts of a closed hearing about the young woman's sexual history an error by the court that left her so shaken she nearly abandoned the case, her lawyer said. The decision in Denver by the state's highest court and issues taken up at yesterday's pretrial hearing in Eagle, Colorado, revolved around the intense media attention that the case has generated and the accuser's right to privacy. The young woman has received death threats and, while not identified by the mainstream media, she has seen her name and picture on Internet sites and in supermarket tabloids. Her attorney, John Clune, said she had been shaken by the accidental disclosures by court officials, who in September also failed to delete her name from a filing published on its Web page. "The only times she considered not going forward with this case is when people sworn to protect her have failed," Clune told Judge Terry Ruckriegle.

Bryant, a Los Angeles Lakers guard, pleaded not guilty to the sexual assault charge. He is scheduled to go on trial Aug. 27. Bryant, 25, said he had consensual sex in his hotel room in June last year with the then 19-year-old hotel worker. Clune said having the trial televised would be painful for the young woman.

Bryant's lawyer, Hal Haddon, said the overriding concern in a criminal trial is to "adjudicate guilt or innocence" evidence about the young woman's sexual history could be admitted at trial. The defense has said that a genital injury prosecutors say she sustained when Bryant allegedly raped her could instead have come from consensual sex with another man. In a split decision, the Colorado Supreme Court ruled that the right to privacy of victims of sexual assault enshrined in Colorado's rape shield law overrode press freedom rights. Ml. 1 Fatty plaque jg? ff in artery cuts sV ff flow of blood -eAM to the heart.

Artery 2 Drug-coated stent Jlf surrounding the yfiwff catheter 3 Inflating balloon opens the stent jj" Jjf and crushes the plaque deposit J'j-Kj jYS? Stent 4 Balloon deflates, yff so catheter can be jsfiJ ff removed while ppiS5c leaving stent lj in place. -'I 'V-Stent 4 AP PHOTO THE PROBLEM Some balloons aren't deflating properly, requiring emergency surgery to remove them. PICKING UP THE PIECES Nancy Noot looked through rubble yesterday on her farm near Marion, N.D., after a tornado tore through the area the night before. Noot fought back tears as volunteers tried to sweep debris into piles and salvage spilled grain. SOURCES: www.open-heart.net; Boston Scientific; www.nucleusire.cornmedical-animations; GLOBE STAFF GRAPHICJOAN MCLAUGHLIN President eyes Iran link to Sept.

11 plot STENT Continued from Page A 1 ilar complaints about the early version of the stent, Express2. The numbers of deaths and injuries remained the same, according to the note. Patients who have received the stents are not affected by the recall, doctors said, since the risk of malfunction occurs as the stents are being implanted, not after they are in the body. Still, several prominent hospitals have stopped implanting the Boston Scientific products. Yesterday, Boston Scientific sent nearly 300 sales representatives to visit doctors nationwide with the dual mission of collecting the recalled stents and reassuring them that the rest of its inventory is safe.

"We appreciate your understanding as we take action to ensure patient safety and customer satisfaction," wrote Nancy Leli-coff, a Boston Scientific vice president in a letter to customers. A Food and Drug Administration official said the agency learned of problems with the stents in April, but did not require a total recall becaase the benefits of the new drug-coated stent outweighed the risks of cutting supplies for some patients. Stents are small wire-mesh tubes implanted to prop open clogged arteries during a common procedure known as angioplasty. Taxus, one of only two drug-coated stents on the market, was considered a major advance when it was launched in March because it reduces the buildup of scar tissue after the procedure. Surgeons thread the stents into patients with catheters and expand them into place with tiny balloons.

Then the balloons are deflated and withdrawn from the body. The recall, the second this month, followed reports of balloons that failed to deflate and blocked blood flow, which in some cases required emergency surgery to remove the balloons. The recall comes at a critical moment for Boston Scientific, which is locked in a fierce battle with Johnson Johnson to dominate the lucrative market for drug-coated stents, estimated at $3 billion annually. Over the past year, anticipation for Taxus has driven up Boston Scientific's share price to make it the most valuable life-sciences company in Massachusetts. Taxus stents have been implanted in about 500,000 patients, the company says.

The recall affects 85,000 Taxus stents, and 11,000 Express2 bare-metal stents, which lack Taxus's drug coating. Many stock analysts maintained positive ratings on Boston Scientific, believing it can fix its production problem. Yesterday, the shares lost 3 percent, falling $1.25 to close at $36.15 the lowest this year. Boston Scientific has not disclosed the number of injuries associated with another problem dogging Taxus: scattered reports from doctors who said they had trouble withdrawing balloons because they seemed to stick to the stent's drug coating. Still, several prominent hospitals, including Lahey Clinic in Burlington and Boston's Beth Israel Deaconess Medical Center and Brigham and Women's Hospital, have stopped using Taxus until the company provides more data.

Richard Nesto, chairman of Lahey Clinic's department of cardiovascular medicine, said doctors have stopped implanting Taxus stents in part because patients who received the stents might sue. "You would have to explain to a patient why you're putting in the stent," he said. One prominent cardiologist criticized Boston Scientific, saying it was trying to downplay the incidence of problems by comparing the numbers of deaths and injuries to the number of Taxus stents implanted so far. "The relevant number is one death and 18 serious injuries out of 43 no-deflation complaints," said Dr. Jesse Currier, co-director of the Adult Cardiac Catheterization Laboratory at UCLA Medical Center in Los Angeles.

"When this happens, it's a bad thing." Rival Johnson Johnson's Cordis unit which makes the Cypher drug-coated stent sent a salesperson yesterday to the Lahey Clinic to see what the company could do to win back the hospital's stent business. Alleges Tehran hid Qaeda figures By Adam Entous REUTERS WASHINGTON President Bush said yesterday the United States was trying to determine whether Iran was involved in the Sept 11 plot and accused the government of harboring Al Qaeda leaders. "We want to know all of the facts," Bush said when asked about reports that at least eight of the 19 hijackers passed through Iran before attacking the United States. The commission investigating the attacks will detail these and "If the Iranians would like to have better relations with the United States, there are some things they must do," including halting the country's alleged nuclear weapons program and support for terrorism, Bush said. Former CIA director Robert Gates, who coauthored a Council on Foreign Relations report on Iran, said Al Qaeda "probably has either, if not used Iran as base, then used it for safe passage and various other things." Iran acknowledged some of the Sept.

11 attackers may have passed through illegally, but said it had since tightened border controls. It said attempts to tie Iran to Al Qaeda were part of US election-year "news propaganda." CIA director John McLaughlin Sunday questioned whether it was necessary. Bush noted McLaughlin had said "there was no direct connection between Iran and the attacks of Sept. 11." But Bush said the case was not closed. "We will continue to look and see if the Iranians were involved.

As to direct connections with Sept. 11, we're digging into the facts to determine if there was one," he said. Bush said Iran, which he branded part of an "axis of evil" along with Iraq and North Korea, was "harboring Al Qaeda leadership." He urged Tehran to have them "turned over to their respective countries" of origin. other Al Qaeda links to Iran in its final report this week, raising new questions about why Bush turned his focus to Iraq soon after Sept. 11, 2001.

The commission has found more Al Qaeda contacts with Iran than with Iraq, officials said. White House spokesman Scott McClellan said there was "no evidence that there was any official involvement between Iran and the Sept 11 attacks." The US intelligence community has been harshly criticized for overstating the Iraqi threat before the war, leading to calls for its overhaul and for the creation of a Cabinet-level intelligence czar. McClellan said Bush was willing to consider this step, although acting Clinton adviser probed on secret terrorism files "They felt they had the market, they felt they lost the market, and now they see the chance to get it back," Nesto said. "It's almost like a three-act play." A Cordis spokesman declined to discuss the company's efforts in detail. Tufts-New England Medical Center continues to use Taxus, since the number of complaints was low, said Carey Kimmelstiel, director of interventional cardiology.

He also said Johnson Johnson probably couldn't meet the demand for drug-coated stents alone. Boston Scientific makes Taxus stent systems in Galway, Ireland, and Maple Grove, Minn. On Friday, the company said the majority of those being recalled were made at the Irish plant, where the company did not keep records in enough detail to identify batches likely to have the defect. A manufacturing glitch in some batches left the hole between the catheter and balloon too small, apparently interfering with the deflation of the balloons. Boston Scientific first discussed manufacturing problems in April and asked the FDA for permission to alter its production and inspection processes.

The FDA approved the changes May 5. Boston Scientific officials said they initiated the first recall, of 200 stents, on July 2 after finding three with narrow holes. They expanded the recall last week after discovering the defects were not limited to individual batches. Dr. Daniel G.

Schultz, acting director of the FDA's office of device evaluation, said the agency felt a total recall of Boston Scientific stents made before the May 5 manufacturing change would have left some patients waiting for stents. If the agency were to require a total recall, "These stents would not be available for a long period of time," he said. FDA inspectors will continue to monitor Boston Scientific's two plants. "I can't provide a 100 percent assurance that the problem is over at this point," Schultz said. "But we feel reasonably comfortable the problem has been corrected and that moving forward we won't see these problems Berger was given a second copy that day, Breuer said.

Officials familiar with the investigation said Archives staff specially marked the documents, and when the new copy and others disappeared, Archives officials called Clinton attorney Bruce Lindsey to report the disappearance. Berger immediately returned all the notes he had taken, and conducted a search and located about the Clinton administration's handling of the millennium terror threats as well as identification of America's terror vulnerabilities at airports and seaports. Berger had ordered his antiter-ror chief, Richard Clarke, in early 2000 to write the after-action report and has publicly spoken about how the review brought to the forefront the realization that Al Qaeda had reached America's Samuel R. Berger said he inadvertently took copies of documents while reviewing classified files. two copies of the classified documents on a messy desk in his office, Breuer said.

An Archives official went to Berger's home to collect those documents, but Berger couldn't locate the other missing copies, the lawyer said. He retained counsel, and in Jan shores and required more attention. Berger said in testimony earlier this year that during the millennium period, "we thwarted threats and I do believe it was important to bring the principals together on a frequent basis" to more regularly consider terror threats. The missing doc taken from the secure room, but said he could not locate two or three copies of the highly classified millennium terror report. "In the course of reviewing over several days thousands of pages of documents on behalf of the Clinton administration in connection with requests by the Sept.

11 commission, I inadvertently took a few documents from the Archives," Berger said. "When I was informed by the Archives that there were documents missing, I immediately returned everything I had except for a few documents that I apparently had accidentally discarded," he said. Breuer said Berger believed he was looking at copies of the classified documents, not originals. Berger was allowed to take handwritten notes but also knew that taking his own notes out of the secure reading room was a "technical violation of Archive procedures, but it is not all clear to us this represents a violation of the law" Breuer said. Government and congressional officials familiar with the investigation, who spoke only on condition of anonymity because the probe involves classified materials, said no decision has been made on whether Berger should face criminal charges.

The officials said the missing documents were highly classified, and included critical assessments BERGER Continued from PageAl "I deeply regret the sloppiness involved, but I had no intention of withholding documents from the commission, and to the contrary, to my knowledge, every document requested by the commission from the Clinton administration was produced," Berger said in a statement to the AP. 'A. Lanny Breuer, one of Berger's attorneys, said his client has offered to cooperate fully with the investigation but had not yet been interviewed by the FBI or prosecutors. Berger has been told he is the subject of the criminal investigation, Breuer said. Berger served as Clinton's national security adviser for all of the president's second term and most recently has been informally advising Democratic presidential candidate John F.

Kerry. Clinton asked Berger last year tJ review and select the administration documents that would be turned over to the commission. The FBI searches of Berger's home and office occurred after National Archives employees told agents they believed they witnessed Berger place documents in his clothing while reviewing sensitive Clinton administration papers, officials said. When asked, Berger said he returned some classified documents that he found in his office and all of the handwritten notes he had uary the FBI executed search warrants of a safe at Berger's home as well as his business office where he found some of the documents. Agents also were unable to locate the missing documents.

Justice Department officials have told the Sept 11 commission of the Berger incident and the na-ture of the documents in case commissioners wanted more information, officials said. The commission is expected to release its final report Thursday. uments involve two or three draft versions of the report as it was evolving and being refined by the Clinton administration, according to officials and lawyers. The Archives is believed to have copies of some of the missing documents. Breuer said the Archives staff first raised concerns with Berger during an Oct.

2 review of documents that at least one copy of the post-millennium report he had reviewed earlier was missing. Ross Kerber can be reached at kerberglobe.com; Jeffrey Krasner, at krasnerglobe.com..