Kosovo's Leader Says Parliament Will Meet to Declare Independence From Serbia
http://www.foxnews.com/story/0,2933,330941,00.html
Kosovo's prime minister said parliament will meet Sunday for a special session to declare the province's independence, a bold and historic bid for statehood in defiance of Serbia and Russia.
By sidestepping the U.N. and appealing directly to the U.S. and other nations for recognition, Kosovo's independence sets up a showdown with Serbia -- outraged at the imminent loss of its territory -- and Russia, which warns of a dangerous precedent for separatist groups worldwide.
Prime Minister Hashim Thaci said top leaders would meet at noon to decide the exact timing of the extraordinary session, at which the breakaway province would proclaim the Republic of Kosovo and unveil the new country's flag and national crest.
"We are on the brink of a very crucial moment -- an important decision that will make us one of the free nations of the world," said Thaci, a former leader of the Kosovo Liberation Army whose ethnic Albanian guerrillas clashed with Serb troops in a 1998-99 conflict that claimed 10,000 lives.
President Bush, speaking in Tanzania on a tour of Africa, said the United States "will continue to work with our allies to the very best we can to make sure there's no violence" in the aftermath of Kosovo's proclamation.
Underscoring Serbian anger, about 1,000 people staged a noisy protest in Belgrade on Saturday, waving Serbian flags and chanting "Kosovo is the heart of Serbia."
Bush said it was in "Serbia's interest to be aligned with Europe and the Serbian people can know that they have a friend in America." He also praised Kosovo's government for showing "its willingness and its desire to support Serbian rights in Kosovo."
Kosovo has formally remained a part of Serbia even though it has been administered by the U.N. and NATO since the war ended in 1999. The province is still protected by 16,000 NATO-led peacekeepers, and the alliance boosted its patrols over the weekend in hopes of discouraging violence. International police, meanwhile, deployed to back up local forces in the tense north.
"It would be best for the Americans to take the Albanians to America and give them a part of their territory, so that they could have a small republic there," said Ljubinko Stefanovic, a resident of the ethnically divided northern town of Kosovska Mitrovica.
At Sunday's ceremony, parliament speaker Jakup Krasniqi would read out the independence declaration in a live television broadcast, and lawmakers would be asked to adopt it. Krasniqi would then proclaim Kosovo independent from Serbia, and lawmakers would vote on the new nation's flag and crest.
The Kosovo Philharmonic Orchestra planned to play Beethoven's "Ode to Joy" at a sports hall, where top leaders would gather for speeches and toasts. They planned to sign their names on giant iron letters spelling out "NEWBORN" to be displayed in downtown Pristina, the capital.
Fireworks and an outdoor concert were scheduled for later in the evening.
Spontaneous street celebrations broke out for a second straight night Saturday, with giddy Kosovars waving red and black Albanian flags and sounding car horns.
"This will be a joyful day," said Besnik Berisha, a Pristina resident. "The town looks great, and the party should start."
Ninety percent of Kosovo's 2 million people are ethnic Albanian -- most moderate or non-practicing Muslims, the rest Roman Catholics -- and they see no reason to stay joined to the rest of Christian Orthodox Serbia.
With Russia, a staunch Serbian ally, determined to block the bid, Kosovo looked to the U.S. and key European powers for swift recognition of its status as the continent's newest nation. That recognition was likely to come Monday at a meeting of EU foreign ministers in Brussels, Belgium.
Russian President Vladimir Putin, arguing that independence without U.N. approval would set a dangerous precedent for "frozen conflicts" across the former Soviet Union and around the world, pressured the Security Council to intervene.
Serbia's government ruled out any military response as part of a secret "action plan" drafted earlier this week as a response, but warned that it would downgrade relations with any foreign government that recognizes Kosovo's independence.
Russia: U.S. Satellite Shot a Weapons Test
http://www.newsmax.com/newsfront/Russia:_U.S._Satellite_Sh/2008/02/16/73265.html
MOSCOW -- Russia said Saturday that U.S. military plans to shoot down a damaged spy satellite may be a veiled test of America's missile defense system.
The Pentagon failed to provide "enough arguments" to back its plan to smash the satellite next week with a missile, Russia's Defense Ministry said in a statement.
"There is an impression that the United States is trying to use the accident with its satellite to test its national anti-missile defense system's capability to destroy other countries' satellites," the ministry said.
The Bush administration says the operation is not a test of a program to kill other nations' orbiting communications and intelligence capabilities. U.S. diplomats around the world have been instructed to inform governments that it is meant to protect people from 1,000 pounds of toxic fuel on the bus-sized satellite hurtling toward Earth.
The diplomats were told to distinguish the upcoming attempt from last year's test by China of a missile specifically designed to take out satellites, which was criticized by the United States and other countries.
Known by its military designation US 193, the satellite was launched in December 2006. It lost power and its central computer failed almost immediately afterward, leaving it uncontrollable. It carried a sophisticated and secret imaging sensor.
Left alone, the satellite would likely hit Earth during the first week of March. About half of the 5,000-pound spacecraft would probably survive its blazing descent through the atmosphere and would scatter debris over several hundred miles.
Military and administration officials said the satellite is carrying fuel called hydrazine that could injure or kill people who are near it when it hits the ground.
The operation to shoot down the dead satellite could happen as soon as next week.
US: Satellite Shoot-Down Not Offensive
http://www.cbn.com/CBNnews/323452.aspx
WASHINGTON - The Bush administration is trying to convince foreign countries that the Pentagon's plan to shoot down a dying spy satellite is not a test of a program to kill their orbiting communications and intelligence capabilities.
The State Department has instructed U.S. diplomats around the world to inform their host governments that the operation, which could be conducted as early as next week, is aimed solely at protecting people that could be affected by about 1,000 pounds of toxic fuel on the bus-sized satellite now hurtling toward earth.
"Our role is to reassure nations around the world as to the nature of what we are tying to do," spokesman Sean McCormack said Friday. "It's an attempt to try to protect populations on the ground."
In a cable sent to all U.S. embassies abroad, diplomats were told to draw a clear distinction between the upcoming attempt and last year's test by China of a missile specifically designed to take out satellites, which was criticized by the United States and other countries.
"This particular action is different than any actions that, for example, the Chinese may have taken in testing an anti-satellite weapon," McCormack told reporters. "The missions are quite different and the technical aspects of the missions are quite different."
Other than intent, he said the key difference is that the Pentagon's planned shoot-down will be done at a much lower altitude than that of the Chinese, whose 2007 destruction of a satellite left a large debris field in orbit. The U.S. plan, it is hoped, will leave little in the way of debris that could complicate efforts to place future satellites in orbit.
U.S. officials said the satellite is carrying fuel called hydrazine that could injure or even kill people who are near it when it hits the ground. That reason alone, they said, persuaded President Bush to order the shoot-down.
The Pentagon has predicted a fairly high chance - as much as 80 percent - of hitting the satellite, which will be about 150 miles up before it enters Earth's atmosphere when a single missile will be fired from a Navy cruiser in the northern Pacific Ocean. If it misses, there may be a second shot, officials say.
Left alone, the satellite would be expected to hit Earth during the first week of March. About half of the 5,000-pound spacecraft would be expected to survive its blazing descent through the atmosphere and would scatter debris over several hundred miles.
Known by its military designation US 193, the satellite was launched in December 2006. It lost power and its central computer failed almost immediately afterward, leaving it uncontrollable. It carried a sophisticated and secret imaging sensor.
Powerful Council Opposes Iran President
http://www.newsmax.com/international/iran_politics/2008/02/16/73248.html
TEHRAN, Iran -- Iran's constitutional watchdog on Saturday opposed an attempt by President Mahmoud Ahmadinejad to expand his administration's power, saying the move "lacks legal justification."
The decision by the Guardian Council was the second major rebuke in less than a month for the hardline president, whose popularity has plummeted recently in the face of Iran's ailing economy.
Last month, Iran's supreme leader Ayatollah Ali Khamenei rebuffed Ahmadinejad and ordered him to implement a law supplying natural gas to remote villages after he initially refused to do so.
The most recent conflict began earlier this month when Iran's parliament opposed Ahmadinejad's attempt to bring several cultural, economic, technological and environmental institutions under tighter government control.
The institutions were composed of a mix of government-appointed and independent representatives, but the Iranian president wanted to have total control of their activities.
The parliament countered Ahmadinejad's attempt by passing its own bill that explicitly prevented the president from taking any steps to bring the institutions under greater government control.
The Guardian Council, a hardline body that must vet all legislation before it becomes law, objected to portions of the new bill and sent it back to parliament for revision.
Instead of waiting for parliament's next move, Ahmadinejad ignored both institutions and issued a decree ordering the merger of the institutions, a decision Guardian Council spokesman Abbas Ali Kadkhodaei said Saturday was illegal.
The order "lacks legal justification because ... the president can't carry out measures directly and without parliamentary law," Kadkhodaei told reporters.
Parliament speaker Gholam Ali Haddad Adel, a conservative like Ahmadinejad, criticized the president Saturday for acting without legislative approval.
"If the government wants to know the final decision, it has to wait for parliament's reaction," the daily Aftab-e-Yazd newspaper quoted Adel as saying.
Ahmadinejad was elected in 2005 on a populist agenda promising to bring oil revenues to every family, eradicate poverty and tackle unemployment. Now he is facing increasingly fierce criticism for his failure to meet those promises.
Prayers of hope, healing after latest US university shooting
http://www.christiantoday.com/article/prayers.of.hope.healing.after.latest.us.university.shooting/16902.htm
As students at Northern Illinois University (NIU) still recover from shock after a fatal shooting left six dead, including the gunman, Christian campus groups have opened their doors around the clock to offer comfort and prayers.
"We walk in hope, we pray for healing," says one message outside the Lutheran Campus Ministry Center. The Rev Diane Schmidt Dard, the Lutheran campus pastor, has been ministering with families and friends since Thursday's campus shooting.
Dard stood with families of those wounded and killed at Kishwaukee Community Hospital, according to the ELCA (Evangelical Lutheran Church in America) News Service.
Six large crosses have been set up outside the Lutheran center, inviting people to write messages expressing their grief and to join evening "remembrance prayers" everyday, Dard told the news service.
"The crosses have become a huge witness to this community," she said.
On Thursday at around 3pm, Steven Kazmierczak, who was armed with three handguns and a pump-action shotgun, opened fire on a geology class. He had stepped out from behind a screen on stage at the lecture hall and killed five students before turning the gun on himself.
Kazmierczak had been a graduate student in sociology at Northern Illinois as recently as spring 2007. He was described as a successful student by his professors and also received a dean's award as an undergraduate at the university.
He was not an outcast, reports say.
Many who knew him were baffled by Thursday's attack.
The only signs of trouble from Kazmierczak came in the weeks leading up to Thursday's shooting. The 27-year-old had become erratic after he stopped taking his medication. What the medication was for, law enforcement authorities would not say.
In the latest reports, however, a former employee at a Chicago psychiatric treatment centre told The Associated Press that Kazmierczak was placed there after high school by his parents. She said he used to cut himself and had resisted taking his medications.
Last September, he worked as an officer at the Rockville Correctional Facility in Indiana. But after two weeks, he failed to show up on the last day of training and never returned. He was also in the army for about six months in 2001-02, but he told a friend he'd gotten a psychological discharge, according to AP.
As more investigation is underway, six white crosses have been placed on a snow-covered hill around the center of the NIU campus. The crosses bear the names of the five victims – Daniel Parmenter, Ryanne Mace, Julianna Gehant, Catalina Garcia and Gayle Dubowski – and the gunman.
"Let me say that their (families of victims) response, as you can imagine, is heart-rending, but I was impressed with their internal strength," NIU president Dr John Peters said Friday. "They will get through this with our help and the help and prayers of a lot of individuals across this country and the world."
The campus remains closed and a reopening date will be announced, Peters said.
"But first, we really have to deal with this healing process," he said. "Let me say to our community, to the NIU community, parents, victims and students, faculty and staff, we will get through this together."
Candlelight prayer vigils have lit the campus in the evenings, with Christian students seeking to have a presence on campus during a time of grief.
"We are deeply saddened by such events on our American campuses," said InterVarsity president Alec Hill, "and we ask God to guide our [InterVarsity Christian] Fellowship in bringing the life of Jesus Christ to colleges and universities."
NKorea Wants Aid Before Nuclear Report
http://www.cbn.com/CBNnews/323716.aspx
BEIJING -- North Korea wants promised energy aid and removal from U.S. terrorism and sanctions blacklists before it will provide a complete declaration of its nuclear programs, American researchers said Saturday after a trip to the North.
North Korean officials also said they slowed the removal of fuel rods from the country's Yongbyon reactor because the United States and other nations have fallen behind in supplying aid under an Oct. 3 disarmament pact, said Siegfried Hecker, a Stanford University physicist, and Joel Wit, a former State Department expert on the North.
Hecker and Wit said they visited Yongbon and met with top foreign affairs officials and those in charge of the nuclear program but declined to disclose their names. Also traveling with them was Keith Luce, a staff member for Sen. Richard Lugar, an Indiana Republic.
The October deal calls for the North to disable its nuclear facilities and fully declare its nuclear programs in exchange for energy aid and political concessions, including removal from the U.S. terrorism list by the end of 2007.
"To them, the most significant hurdle was ... the lack of the delivery of fuel oil and the lack of any motion in removal from the states sponsoring terrorism list and the Trading with the Enemy Act," Hecker said in Beijing. "They said until that is done, they will not be able to produce what (U.S. nuclear envoy) Ambassador (Christopher) Hill calls a `complete and correct' declaration."
Hecker and Wit's account suggested North Korean officials were confirming U.S. claims that they have failed to provide the accounting of nuclear programs required by the October deal.
North Korean officials had rejected earlier U.S. criticism, saying they provided a full nuclear declaration.
At Yongbyon, officials said they were removing 30 fuel rods per day from the reactor, below the maximum safe rate of 80, according to Hecker. He said they told him they have removed 1,440 of approximately 8,000 rods in the reactor.
"They claim that the other five parties have fallen behind in meeting their obligations," Hecker said, referring to the United States and four other countries involved in nuclear talks with the North.
"They are not prepared to provide a complete list (of nuclear programs) until the other parties meet their obligations under the Oct. 3 agreement," he said.
Officials said North Korea has received only 200,000 of the promised 500,000 tons of heavy fuel oil and little of the energy-related equipment that China and South Korea were to provide, Hecker said.
U.S. officials have said the North must provide a nuclear declaration before Washington will provide further aid.
"You have a problem as to who goes first, and I think at this point that is unresolved," Hecker said.
Hecker, who has visited the North annually for the past five years, said the trip was unofficial. He also is a former director of the U.S. government's Los Alamos nuclear laboratory in New Mexico.
The North has one functioning five-megawatt reactor at Yongbyon. It began building 50- and 200-megawatt reactors but that was suspended, and Hecker said they were in such poor condition due to lack of maintenance that they could not be salvaged.
Despite the diplomatic standoff, Hecker and Wit said North Korean officials at Yongbyon appeared to be working well with U.S. officials and inspectors from the International Atomic Energy Agency who are overseeing the dismantling effort.
"My feeling coming away from this visit is that the level of cooperation is very good, better than I have seen it in 10 years," said Wit, now a visiting fellow at Johns Hopkins University's School of Advanced International Studies.
Bush Chides Congress Over Spy Law Lapse
http://www.cbn.com/CBNnews/323752.aspx
WASHINGTON -- President Bush scolded Congress for allowing a government eavesdropping law to expire at midnight Saturday, saying the failure to act will make it more difficult to track terrorists and "we may lose a vital lead that could prevent an attack on America."
Bush used his weekly radio address to escalate his war of words with the Democratic leadership of Congress. The Democrats accuse Bush of fear-mongering and misrepresenting the facts.
The president wanted the House to approve a Senate bill that would have renewed a law that made it easier for the government to spy on foreign phone calls and e-mails that pass through the United States. Bush opposed a temporary extension of the bill, and lawmakers left for a 12-day recess without extending the law.
"Some congressional leaders claim that this will not affect our security," the president said. "They are wrong. Because Congress failed to act, it will be harder for our government to keep you safe from terrorist attack. At midnight, the attorney general and the director of National Intelligence will be stripped of their power to authorize new surveillance against terrorist threats abroad. This means that as terrorists change their tactics to avoid our surveillance, we may not have the tools we need to continue tracking them - and we may lose a vital lead that could prevent an attack on America."
Democrats chose Sen. Sheldon Whitehouse, a former U.S. attorney and attorney general of Rhode Island, to deliver their Saturday radio address on the same subject.
"We know this president dislikes compromise, but this time he has taken his stubborn approach too far," Whitehouse said. "He is whipping up false fears, and creating artificial confrontation. As the president himself said in the Rose Garden, 'There is really no excuse for letting this critical legislation expire. So let's get it done.'
"But the president instead chose political gamesmanship, rejecting a short extension of the Protect America Act that would allow Congress to complete its work," Whitehouse said. "Make no mistake: If the surveillance law expires, if any intelligence loss results, it is President Bush's choice. Period."
White House officials seethed over the fact that the House, rather than passing the eavesdropping bill, approved contempt citations against two Bush confidants, chief of staff Joshua Bolten and former counsel Harriet Miers, over their refusal to cooperate with an investigation into the firings of U.S. attorneys.
"House leaders chose politics over protecting the country - and our country is at greater risk as a result," Bush said.
"My administration will take every step within our power to minimize the damage caused by the House's irresponsible behavior," he said. "Yet it is still urgent that Congress act. The Senate has shown the way by approving a good, bipartisan bill. The House must pass that bill as soon as they return to Washington from their latest recess."
Bhutto Party: Terror War Is Pakistan's
http://ap.google.com/article/ALeqM5gzt4QGqUcokRMSYDbtfGbOt_ui7gD8US1M300
LAHORE, Pakistan (AP) — Benazir Bhutto's widower said his party must try to convince Pakistanis that the fight against Islamic militancy is their own war — not just America's.
Asif Ali Zardari blamed authorities under President Pervez Musharraf, who seized power in a 1999 military coup and became a key U.S. ally after the Sept. 11, 2001 attacks, for the widespread skepticism among Pakistanis toward fighting terrorism.
"They have made the people think and realize that we are fighting a war for the sake of the Americans, which is not the true position," Zardari said in an interview Saturday with The Associated Press.
He said Bhutto's Pakistan People's Party would try change that perception if it wins Monday's parliamentary elections.
The key question is "are we ready to become a Taliban state? And the answer is: 'No, we're not,'" he said. "That means we are fighting our own battle, we are fighting our own war."
Opinion polls suggest opposition parties are set for a sweeping victory in the parliamentary vote. But the enthusiasm of candidates and voters is minimal in the wake of Bhutto's assassination and amid fears voting will be rigged and marred by more bloodshed.
Bhutto, a two-time former prime minister, died in a shooting and suicide bombing as she waved to supporters from her car following a campaign rally on Dec. 27.
The attack unleashed a wave of sympathy and revulsion that could carry her liberal, secular party to victory on Monday at the expense of Musharraf supporters.
That has raised the question of whether Zardari, who has assumed the party leadership, will sustain his late wife's tough line against extremists linked to the Taliban and al-Qaida waging a growing war against the Pakistani state in the troubled northwest.
A new government of the PPP and its allies "hopefully will redefine the struggle against terrorism and really help the cause of the world rather than be an obstacle to it," he said.
Security concerns have severely curtailed Zardari's movements. He has addressed only two public rallies and his appointments are kept secret until the last moment.
He spent much of Saturday, the last day for campaigning, giving interviews to journalists.
"I think it's better to be on TV and visually affect people, rather than go from place to place," he said, seated in the sumptuous villa of a party supporter in the eastern city of Lahore.
But he also made time to meet with Nawaz Sharif, another opposition leader hoping to return to government nine years after he was ousted as prime minister in Musharraf's coup.
Sharif, once a favorite of Pakistan's military-dominated establishment, was involved in a bitter power struggle with Bhutto throughout the 1980s.
His governments leveled corruption charges against Zardari relating to kickbacks. Zardari, who spent years in prison on corruption and murder charges, is still struggling to shake off the nickname "Mr. 10 Percent."
But a public rapprochement between their parties has raised the prospect of forming a coalition government powerful enough to impeach Musharraf.
U.S. officials have criticized Musharraf for imposing six weeks of emergency rule last year in a bid to halt legal challenges to his October re-election as president.
But they continue to praise him as a stalwart ally against Islamic extremism and have stopped short of calling for the reinstatement of dozens of judges fired under the emergency.
Zardari said the United States had been "misled" about the situation in Pakistan.
"They need to stand even further for democracy and stretch out now and stand with the democratic forces and the people of Pakistan. I would like to see that role improve," he said.
U.N. humanitarian chief condemns Palestinian rocket attacks
http://www.iht.com/articles/ap/2008/02/17/africa/ME-GEN-Israel-UN-Rockets.php
SDEROT, Israel: A Palestinian rocket struck a house in this southern Israeli border town on Sunday, shortly after the U.N.'s top humanitarian official condemned Palestinians for the near-daily rocket barrages and urged the Gaza Strip's Hamas rulers to halt the attacks.
No one was wounded in the attack, but Sderot has been struck by thousands of homemade rockets from Gaza. Twelve people have been killed in recent years and dozens wounded, including an 8-year-old boy who lost a leg in an attack last week.
"We condemn absolutely the firing of these rockets. There's no justification for it. They are indiscriminate, there's no military target," John Holmes, the U.N. undersecretary general for humanitarian affairs, told The Associated Press during a visit to Sderot.
Israeli airstrikes and ground incursions into Gaza have killed dozens of militants in recent months, but have failed to stop the rockets. Israeli leaders have warned that a broad ground operation is increasingly likely if the rocket fire persists.
Holmes, however, said the only way to solve the problem is through a peace agreement between Israel and the Palestinians.
"At the end of the day, the only thing that will make a lasting difference is a peace settlement," he said. "You can't stop these problems militarily. They have to be solved through negotiations."
Israel is trying to negotiate a peace agreement with the moderate Palestinian government in the West Bank. At the same time, Israel is battling the rival Hamas government in the Gaza Strip.
Holmes is on a five-day trip to the region, his first visit as humanitarian affairs chief. He visited Gaza on Saturday, and will spend Monday in meetings with Israeli leaders in Jerusalem.
He opened his visit on Friday by saying the Israeli closure of the Gaza Strip has created "grim and miserable" conditions that deprive Gazans of their basic dignity and urged a reopening of the borders.
During Sunday's tour of Sderot, Holmes visited a school, a lookout point onto Gaza and met with trauma victims.
Holmes nodded quietly as residents, some in tears, told their personal stories of anguish. A local men lifted his shirt and showed Holmes a shrapnel wound on his belly as a woman told him how she had lost a fetus after going into shock when a Qassam rocket landed near her. The woman added that a teenage daughter of hers had attempted to cut her wrists after one rocket attack.
Holmes said he felt "incredibly sorry" for the people of Sderot, noting the traumatic psychological effects the attacks have had on children. "We just need to keep on saying to the people in Gaza, to the Hamas leadership, they have to stop these rockets. They do no good. They cause suffering," he said.
Hamas, which violently seized control of Gaza last June, has refused to rein in rocket-firing militants, who have stated their goal is to empty Sderot of its people.
Sderot residents have been staging protests against the government for the past week, demanding more protection and harsher action against Gaza militants.
On Sunday, Prime Minister Ehud Olmert told his Cabinet that the government would soon allocate the needed funds to fortify all homes within 4.5 kilometers (3 miles) of the Gaza Strip.
Also visiting Sderot Sunday was U.S. Sen. Jon Kyl, Republican of Arizona. He voiced his support for the residents and also commended the killing of Hezbollah mastermind Imad Mughniyeh, who was targeted in a car explosion Tuesday in the Syrian capital of Damascus by unknown attackers.
"Whoever took this terrorist out sent a message that there is a price they have to pay," he said. "I know some say this is a rallying cry for the terrorists. But they don't need a rallying cry. They already created the problem. There's no reason not to go after their leaders with everything we have."
China Didn’t Check Drug Supplier, Files Show
http://www.nytimes.com/2008/02/16/us/16baxter.html?hp
A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews.
Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.
Baxter announced Monday that it was suspending sales of its multidose vials of heparin after 4 patients died and 350 suffered complications. Why the heparin caused these problems — and whether the active ingredient in the drug, derived from pig intestines, was responsible — has not been determined.
The plant in Changzhou, west of Shanghai, appears to fall into the type of regulatory void that American and Chinese health officials are trying to close — in which chemical companies export pharmaceutical ingredients without a Chinese drug license.
China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration. However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency’s jurisdiction.
In December, American and Chinese regulators signed an agreement under which China promised to begin registering at least some of the thousands of chemical companies that sell drug ingredients. Some of these companies are the source of counterfeit or diluted drugs, including those used to treat malaria.
Discussions that led to the accord began after an unlicensed chemical plant in China made a tainted drug ingredient that poisoned more than 170 people in Panama, killing at least 115.
The heparin plant in China has not been accused of providing a harmful product. The American majority owner of that plant, Scientific Protein Laboratories, also owns a plant in Wisconsin that produces the active ingredient in heparin for Baxter.
In response to questions, Scientific Protein issued a statement confirming that its Chinese plant had no license from the Chinese agency, but said that its raw ingredients come from a licensed supplier.
The statement added that an “independent private U.S. validation company” had found the plant to be in compliance with good manufacturing practices. And a spokeswoman for Baxter, which buys heparin’s active ingredient from Scientific Protein, said it had inspected the China plant less than six months ago.
A spokesman for China’s State Food and Drug Administration, Shen Chen, said Friday that “as far as we know, it is not a drug manufacturer — it is a producer of chemical ingredients.”
Eric S. Langer, managing partner of BioPlan Associates, which prepares and publishes reports on the biopharmaceutical and biotechnology industry, said he found it hard to believe that a company exporting the heparin ingredient would not be licensed by Chinese drug regulators.
“Being able to produce a pharmaceutical or a biologic in the U.S. or anywhere without having regulatory oversight really doesn’t happen,” Mr. Langer said, adding, “I find it surprising from a regulatory perspective, and I find it surprising from a business perspective.”
Karen Riley, a spokeswoman for the United States Food and Drug Administration, said inspectors from that agency would be visiting the Changzhou plant soon. Ms. Riley said she could not be more specific. Earlier in the week she described her agency’s failure to inspect the plant as a “glitch.”
Congress has criticized the oversight by the Food and Drug Administration of bulk pharmaceutical ingredients made by foreign manufacturers and sold in the United States. A growing number of those ingredients now come from China. Of the 700 approved Chinese drug plants, the United States agency has inspected only 10 to 20 each year.
Baxter makes roughly half of the United States supply of heparin, which is used widely for surgical and dialysis patients. Problems with Baxter’s heparin were first noticed late last year when four children undergoing dialysis in Missouri had severe allergic reactions minutes after being injected with the drug.
The F.D.A. then allowed Baxter to deliver heparin that it was in the midst of shipping, for fear that a total recall would lead to a shortage of the drug, but cautioned doctors to use as little of it as possible and to administer it very slowly.
The agency also suggested that doctors give steroids or antihistamines with the Baxter heparin to help prevent allergic reactions.
Erin Gardiner, a spokeswoman for Baxter, defended Scientific Protein, saying it had been making the heparin ingredient for more than 30 years. “They have been a good supplier,” she said.
Although the cause of the adverse reactions has yet to be determined, she said tests performed by her company had detected unspecified differences between some lots of the ingredient. She did not say whether the lots had come from China or from the Wisconsin plant, which Scientific Protein also owns.
Those differences had not turned up in routine testing that the company does on active ingredients, Ms. Gardiner said, but she said Baxter had used “advanced testing techniques” to find the differences. She added that it was unclear whether the finding was significant.
Two Congressional committees have asked the Food and Drug Administration for more information about inspections of plants making the active ingredient of heparin.
Bush: Keep abstinence in AIDS program By BEN FELLER, Associated Press Writer
http://news.yahoo.com/s/ap/20080217/ap_on_re_af/bush_africa;_ylt=AhFe43MLvAFyvQNbQIXh3y.s0NUE
President Bush on Sunday said Congress should renew his global AIDS program and preserve a requirement that steers money into abstinence efforts.
"We don't want people guessing on the continent of Africa whether the generosity of the American people will continue," Bush said in Tanzania, the second stop of his African trip.
Congress strongly backs the program, which is credited with getting medicine and preventive treatment to millions of people — most of them in sub-Saharan Africa. Yet its renewal has gotten hung up over ideology and political debate about disease prevention.
Some Democrats want to eliminate a provision in the bill that requires one-third of all prevention spending go to abstinence-until-marriage programs. Critics say that while they don't oppose abstinence programs, the inflexible requirement hampers the effort.
Bush said the time for debate is over, and that those seeking changes on both ends of the political spectrum should "stop the squabbling."
The President's Emergency Plan for AIDS Relief, or PEFPAR, expires this year.
"My attitude toward Congress is, see what works," Bush said. "PEPFAR is working. It is a balanced program. It is an ABC program — abstinence, be faithful and condoms. It is a program that's been proven effective."
Tanzania is one of the countries targeted by Bush's emergency AIDS relief effort; more than two-thirds of all people infected with HIV across live in sub-Saharan Africa.
Standing with Bush, Tanzanian President Jakaya Kikwete thanked U.S. lawmakers for the program, but also prodded them to keep it moving. "If this program is discontinued or disrupted, there will be so many people who will lose hope," he said.
Bush is pushing to renew the program at $30 billion over five years, twice his original commitment. Congress has put more than $18 billion into it so far. It is the largest effort to ever target an infectious disease.
Nearing the end of a presidency dominated by the war in Iraq, Bush is targeting disease and poverty in his visits to five African nations. The president and first lady, Laura Bush, began their African trip in Benin in West Africa, then flew to the east coast of the continent to Tanzania. He also plans to visit Rwanda, Ghana and Liberia.
Unlike in the United States, where his approval rating hovers near his record lows, Bush is treated here with reverence. A crowd of people, some wearing clothing bearing Bush's image, waved tiny U.S. and Tanzanian flags to welcome him as he walked down a red carpet toward the State House.
"People may have different views about you and your administration and your legacy," Kikwete said. "But we in Tanzania, if we are to speak for ourselves and for Africa, we know for sure that you, Mr. President, and your administration, have been good friends of our country."
Later, Dar es Salaam's dusty, rutted streets were again lined with the curious as he drove to Amana Hospital. Strolling through the complex of low-slung buildings and sun-drenched courtyards, Bush met with HIV-positive patients and doctors in the facility's AIDS treatment wing, funded in part with PEPFAR dollars.
"I'm very lucky,' said Tatu Msangi, who was tested for HIV while pregnant, received treatment and delivered a healthy baby, Faith, now 2.
Bush said the hospital was the best exhibit he could imagine in his campaign to convince Congress to fund the program the way he wants. He made another appeal for the HIV/AIDS program to be extended beyond his presidency, as Congress is expected to do.
"One of the main reasons I want to make sure the American people know that the program is successful is because I want this program to continue to be funded," Bush said.
The president, who started his remarks at a news conference with a folksy "Howdy" in Swahili, signed a nearly $700 million aid pact with Kikwete to help Tanzania build up its infrastructure.
It's the largest deal under a Bush program that offers economic aid to countries that treat their people fairly, rule justly and root out corruption.
"I'll just put it bluntly, America doesn't want to spend money on people who steal the money from the people," Bush said. "We like dealing with honest people, and compassionate people. We want our money to go to help human condition and to lift human lives as well as fighting corruption in marketplace economies."
At the news conference, both leaders dodged a question about the presidential race in the United States and the candidacy of Sen. Barack Obama, D-Ill., whose father was Kenyan.
Bush, momentarily taken aback by a question about the excitement surrounding Obama's candidacy, said: "Seems like there was a lot of excitement for me."
Kikwete would say only: "Let him be as good a friend of Africa as President Bush has been."
In the afternoon, Bush visited with the families of victims from the 1998 bombing of the U.S. embassy here. He said a silent prayer in front of a plaque in the garden of the new embassy before going inside for private talks. A total of 224 people were killed in the twin bombings in Dar es Salaam and Nairobi.
In their customary gift exchange, Bush received a stuffed lion and leopard, and a zebra skin. In return, Bush gave his Tanzanian host a big black box. Inside was a large pair of autographed basketball sneakers, courtesy of the 7-foot-1 basketball star, Shaquille O'Neal.
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