Summary Box: Web portal Sina posts quarterly loss

THE RESULTS: Sina Corp., a popular Chinese Web portal operator, had a loss of $336 million in the latest quarter.

BEHIND THE NUMBERS: The chief reason was writedowns on investments in two online businesses — …

6 new caps in Fiji test side to meet Australia

Prop Campese Ma'afu will likely pack down against his older brother Salesi after being named among six new caps in the Fiji lineup to meet Australia in Saturday's one-off rugby test at Canberra.

Salesi Ma'afu is also expected to make his test debut for Australia, completing a rare international treble for the Ma'afu family whose youngest brother, Apakuka, has played sevens rugby for Tonga.

It will be the first time siblings have made their test debuts on opposing teams.

France-based winger Rupeni Caucaunibuca will play out of position at center in his first test for Fiji since 2006. The selection of Agen's Caucaunibuca rescinds his vow last year …

Wood-Mizer introduces new hobby mill

The portable sawmill experts at Wood-Mizer Products Inc, have a new sawmill designed for wood enthusiasts who want to saw part time as a hobby or to supplement their income. The LT28 has an 18-hp engine and will cut 200 bdft/hr using a manual crank and walk along cutting techniques. It handles up to 32-in diameter logs to 21 feet and comes standard with a trailer package. Options include …

A look at the rights suspended by Pakistan's state of emergency

A look at some of the rights that were suspended in the state of emergency declared over the weekend by Pakistani President Gen. Pervez Musharraf:

_ Protection of life and liberty.

_ The right to free movement.

_ The right of detainees to be informed of their offense and given access to lawyers.

_ Protection of property rights.

…

Stars rally, beat Minnesota 4-3

Loui Eriksson had a goal and two assists and the Dallas Stars overcame a two-goal deficit to beat the Minnesota Wild 4-3 on Wednesday night.

Down 3-1 late in the second period, Dallas tied it on goals by James Neal and Brad Richards, then took the …

Homeless need official action

DEAR JOYCE BROTHERS: I live in a small town and I was shockedwhen I came to New York City to see hundreds of homeless peoplesleeping on the street and at the entrance to subways. Whatdisturbed me more is that no one helps these people or seems to care.What's wrong? What's happened to caring? Why do some reach outwhile others walk on by? B. J.

DEAR B. J.: People tend to become immune to human suffering.The picture of urban life you describe has happened gradually in ourcities, and while it's sad and depressing, many people now are almostunaware of the misery around them.

In big cities, people tend to mind their own business, partlyout of fear and partly because …

Towles, Astros Trounce Cardinals 18-1

ST. LOUIS - The day a report linked Rick Ankiel to human growth hormone and the feel-good story of the former pitcher's comeback as an outfielder began to prompt skepticism, he fell into a prolonged slump.

The drought finally ended on Saturday night. Ankiel had three hits and homered for the first time in 17 games, leading the St. Louis Cardinals over the Houston Astros 7-4.

"When I started not hitting good, I think I was pressing a little bit," Ankiel said. "Who wouldn't be?

"But that's over. I just want to come out here and relax and play."

Ankiel had been in a 7-for-55 slump since a Sept. 7 report linking him to HGH in 2004 - that came the morning …

Buffett and Munger share lessons of turmoil

Billionaires Warren Buffett and Charlie Munger say companies have been borrowing too much money and that executives need better incentives.

Berkshire Hathaway's top executives say those are key lessons from the ongoing financial turmoil. Buffett and Munger held their annual news conference on Sunday.

Buffett says having severe disincentives for failure and proper incentives for success is key to ensuring large financial institutions are run well.

…

Million XI may lose two more entrants

The latest scoop on the Arlington Million XI on Sunday is thatAnshan and Jolie's Halo are not certain starters. They won't bemissed too much if they don't start because they're longshots whodon't figure to win. If they don't start, the big event still willhave 10 great turf stars.

The only horse without a jockey assignment is H.H. Aga Khan'sfilly, Kartajana.

Other starters with riders: Algenib (Kent Desormeaux), CheninBlanc (Julie Krone), Dr. Root (Jean-Luc Samyn), Filago (PatValenzuela), Hundra (Jorge Velasquez), Itsallgreektome (ShaneSellers), Izvestia (Jose Santos), Sagace's Choice (Steve Cauthen) andTight Spot (Laffit Pincay Jr.).

If Jolie's Halo …

Malaysian girl, 14, celebrates wedding in public

KUALA LUMPUR, Malaysia (AP) — A 14-year-old girl and 23-year-old man have celebrated their recent marriage in public in Malaysia's largest city, a report said Sunday, fueling a debate on teen weddings.

Underage marriages are allowed for Muslims with court permission and parental consent but are not common in this Muslim-majority country.

The New Straits Times reported the Muslim couple, whose union was arranged by their parents, were married in July after obtaining permission from an Islamic court.

The couple, whose photo was published on the government-linked newspaper's front page, celebrated their union at a mosque in Kuala Lumpur Saturday together with about 250 …

Tomic to play Davis Cup for Australia

Bernard Tomic has been chosen by Australia to play singles against Taiwan, making the 17-year-old the country's youngest Davis Cup player in 77 years.

Tomic will play alongside Peter Luczak in singles, while Carsten Ball and Paul Hanley will team up for doubles.

The draw was held Thursday for the Asia Oceania Zone Group One match which Australia is favored …

Leading index shows economy is cooling

NEW YORK A key measure of future economic activity indicates theU.S. economy is cooling off, but it remains unclear whether theslowdown will be enough to head off another interest-rate increase bythe Federal Reserve.

The Index of Leading Economic Indicators held steady Wednesday at106 for the month of June, forecasting a break from rapid economicgrowth for the rest of 2000, according to the Conference Board, aprivate industry group based in New York. The results met economists'expectations.

The index, which attempts to forecast economic trends for the nextthree to six months, stood at 100 in 1996, its base year. It dropped0.1 percent in May after holding steady in April.

In a separate report Wednesday, the Commerce Department said salesof new homes fell 3.7 percent in June to the slowest sales pace inmore than two years, hurt by rising mortgage rates.

Stocks were generally higher following both reports' release, withthe Dow Jones industrial average up 80.58 to close at 10,687.53.

The numbers released Wednesday could be potential factors when theFederal Reserve considers raising interest rates when it meets Aug.22. Concerns about too-rapid economic expansion and fears ofinflation have prompted the Fed to raise interest rates six timessince last summer.

The central bank left rates unchanged at its most recent meetingin June, but left the door open to another rate increase this month.

Most observers agree the economy is slowing, but differ over howthe Fed will interpret the recent data.

"The question is how much is the economy slowing and the bigquestion is, `Is it slowing enough so that the Fed doesn't have toraise interest rates again?' " said Ken Goldstein, an economist forthe Conference Board. "My vote is no hike in August. . . . But that'sjust a guess."

Paul Ferley, assistant chief economist at Harris Bank/Bank ofMontreal in Toronto, disagreed.

"Our view is that the Fed will have to . . . raise rates inAugust, and probably in November and December," said Ferley. Thenumbers suggest that if more tightening is not done, the economy willbounce back, erasing all of the effects of the cooldown, heexplained.

The economy is still exhibiting some strength, according to theConference Board. The board's Index of Coincident Indicators, whichgauges current economic activity, rose 0.2 percent in June, the sameas the previous month, on gains in employment, income and industrialproduction.

The Index of Lagging Indicators, which reflects changes that havealready occurred, also increased in June, jumping 0.8 percent,primarily because of outstanding commercial and industrial loans,prime rates and changes in labor costs. In May, the index was up 0.2percent.

Son of Eagles Coach Gets Jail Time

Philadelphia Eagles coach Andy Reid's eldest son, who said he got a thrill out of selling drugs in both poor and tony neighborhoods, was sentenced Thursday to up to 23 months in jail for smashing into another motorist's car while high on heroin.

Garrett Reid, 24, could leave jail early if he applies for and is accepted into a special drug court program that would require him to hold down a job, report to authorities regularly and undergo rigorous drug testing.

He tested positive for heroin and admitted having used it that day of the crash. He ran a red light and hit another car. Authorities found syringes with heroin and testosterone in his SUV.

Speaking in court and in a statement to a probation officer, Reid said he made a fast descent into hard drugs and enjoyed being the rich kid who dealt drugs in poor, violent Philadelphia neighborhoods and in the tony Main Line suburbs.

"I don't want to be that kid who was the son of the head coach of the Eagles, who was spoiled and on drugs and OD'd and just faded into oblivion," Reid said in court.

His addiction persists, according to authorities, who found 89 prescription drug pills in Reid's jail cell Thursday morning. They believe he smuggled them in his rectum when he was jailed earlier this week.

Reid told the judge he would apply to the drug court program, which could shorten his time behind bars.

"I am more than willing to do drug court ... if that's what it's going to take to get clean and sober," Reid said.

Reid's descent in drug use and dealing was steep, according to a probation report read in court. Reid said he started using marijuana and alcohol at age 18. That was followed by prescription pain killers Percocet and OxyContin, and then cocaine and heroin.

By 20, he was in drug rehab.

Reid said he sold drugs to his friends and their parents in the suburbs and in a notoriously tough section of Philadelphia.

"I liked being the rich kid in that area and having my own high status life," Reid told a probation officer in a statement read by the judge. "I could go anywhere in the 'hood. They all knew who I was. I enjoyed it. I liked being a drug dealer."

He said in court Thursday that he has stopped selling drugs.

Andy Reid and his wife, Tammy, were in court but declined to comment.

"Andy and Tammy are supportive of their son. That has been their position since this all began. He will not comment on it," said defense attorney Ross Weiss.

Reid's 22-year-old brother, Britt, also was in court Thursday to be sentenced for pointing a handgun at another driver Jan. 30, the same day as his brother's crash. He pleaded guilty to a string of charges, including carrying a firearm without a license, a felony.

Both sons lived at their parents' home in suburban Villanova at the time of their arrests.

Andy Reid had taken a five-week leave from the Eagles in the offseason to deal with his family's troubles.

French bishop lauded for shielding priest

A letter confirmed by the Vatican shows top Holy See official in 2001 congratulated a French bishop for shielding a priest convicted of raping and sexually abusing minors.

The Sept. 8, 2001 letter from Cardinal Dario Castrillon Hoyos, then the head of the Vatican office in charge of priests, praised bishop Pierre Pican for risking prison time to defend the Rev. Rene Bissey.

French Catholic publication Golias published a copy of the letter on March 30. The Vatican has faced accusations of secrecy that allowed priests to rape and molest children unchecked for decades.

Vatican spokesman the Rev. Federico Lombardi on Thursday called the letter "proof" that cases of sexual abuse of minors must be handled by the Congregation of the Doctrine of Faith. They have been since 2001.

Tour of Switzerland Results

GRINDELWALD, Switzerland (AP) — Results Monday from the Tour of Switzerland third stage, a 107.6-kilometer (66.9-mile) trek from Brig to Grindelwald:

1. Peter Sagan, Slovakia, Liquigas-Cannondale, 3 hours, 9 minutes, 47 seconds.

2. Damiano Cunego, Italy, Lampre, same time.

3. Jakob Fuglsang, Denmark, Leopard-Trek, 21 seconds behind.

4. Laurens ten Dam, Netherlands, Rabobank, same time.

5. Giampaolo Caruso, Italy, Katusha, :48.

6. Tejay van Garderen, United States, HTC-Highroad, 1:04.

7. Frank Schleck, Luxembourg, Leopard-Trek, same time.

8. Bauke Mollema, Netherlands, Rabobank, same time.

9. Juan Mauricio Soler, Colombia, Movistar, same time.

10. Francis De Greef, Belgium, Omega Pharma-Lotto, same time.

Overall Standings
(After 3 of 9 stages)

1. Damiano Cunego, Italy, Lampre, 7 hours, 43 minutes, 16 seconds.

2. Juan Mauricio Soler, Colombia, Movistar, 54 seconds behind.

3. Bauke Mollema, Netherlands, Rabobank, 1:16.

4. Laurens ten Dam, Netherlands, Rabobank, 1:19.

5. Tejay van Garderen, United States, HTC-Highroad, 1:21.

6. Frank Schleck, Luxembourg, Leopard-Trek, 1:25.

7. Jakob Fuglsang, Denmark, Leopard-Trek, 1:32.

8. Danilo Di Luca, Italy, Katusha, 1:53.

9. Steven Kruijswijk, Netherlands, Rabobank, 2:00.

10. Levi Leipheimer, United States, Team RadioShack, 2:10.

Developing countries want G20 to refocus on world

CANNES, France (AP) — This week's G-20 summit was dominated by Europe's debt crisis, but developing countries want the grouping of major economies to refocus on a bigger global agenda that includes creating jobs, improving farming and fighting climate change.

China, Brazil and other rising powers won a bigger voice in U.S.- and European-dominated global affairs following the 2008 financial crisis. But flare-ups in the eurozone have distracted leaders from what they say should be efforts to reform global finance and improve life in poorer societies.

Now, as Mexico succeeds France as leader of the G-20, developing countries are pushing for more attention to long-term changes aimed at making the global economic system more equitable, increasing investment in Africa, making farming more productive and stimulating investment and trade.

"The key issue is not to allow the G-20 to be overwhelmed by the crisis in Europe," said Mac Maharaj, a spokesman for South African President Jacob Zuma. Instead, "it should attempt to come up with a plan that incorporates bringing about growth in developing countries."

The two-day G-20 summit in this Mediterranean resort was dominated by rapid-fire developments in debt-ridden Greece's chaotic politics and talk of how to strengthen the International Monetary Fund, both to play a bigger role in a European bailout and to help shaky economies elsewhere.

A joint communique issued Friday promised to reform financial industries to prevent a repeat of excesses that have prompted protests; invest in research to improve farm productivity; reform energy subsidies that encourage waste; and create jobs for young people.

But the financial crisis might mean governments are not paying enough attention to the long term, said Daniel Schwanen, an economist at Canada's Center for International Governance Innovation, a think tank.

"Where is the employment agenda? Where is the growth agenda?" he said. "We've been sidetracked by the emergency debt issues."

A G-20 panel produced a list of priorities ahead of the Cannes meeting that included improving conditions to attract investment in infrastructure to Africa, increasing food security and regulating capital flows.

Mexico is expected to make employment and the needs of poorer countries a priority during its yearlong tenure as the G-20 president.

"There's a recognition that lack of jobs for young people brings social challenges and a decline in social cohesion," said South Africa's finance minister, Pravin Gordhan. "The public around the world has been making clear that these are challenges that require urgent attention."

The G-20 emerged as a major forum after the 2008 financial crisis battered the United States and Europe, which turned to China, India and other fast-growing developing economies for help in reviving global growth. It has given midsize economies such as Turkey, Indonesia and Mexico a seat at the top policymaking table for the first time.

"It is developing countries over the next five to 10 years that have the best prospects of ensuring the world grows at the required level," said Gordhan.

Still, the G-20 has yet to replace the more influential Group of Eight that groups together the United States, Japan and Europe's biggest economies.

On Thursday, Chinese President Hu Jintao called for a still larger role for emerging countries in "a more equal and balanced global partnership."

"We should further unleash the development potential of emerging markets and developing countries and boost the economic growth of developing countries," he said in a speech to other G20 leaders, according to a transcript released by the Chinese government.

Preparing for team biologics inspections

Central to preparing for Team Biologics inspections is knowing what to expect and how those inspections will differ from what has gone before.

During the past year FDA implemented a new program called Team Biologics for inspecting the biologics industry (1). The program will have a significant impact on companies covered under the initiative because FDA will be using techniques and approaches unlike those previously used by Center for Biologics Evaluation and Research (CBER) personnel. Under Team Biologics, the lead responsibility for biennial inspections has been transferred from CBER to the Office of Regional Affairs (ORA). This article provides some insight into the changes that will result from implementation of Team Biologics and offers information for predicting FDA actions in the biologic industry as a whole. Described are some techniques that may be used by companies to systematically verify readiness.

Prudent managers will provide training to ensure that all employees know what to expect when their company undergoes its first inspection under Team Biologics. Responsible staff should fully anticipate the activities of FDA and take the necessary steps to prepare for an inspection. In contrast, some companies will not recognize the trends and are likely to be caught unaware, suffering severe consequences if found to be noncompliant with GMPs. Unless companies anticipate the new inspection approaches and take certain steps, they may well experience an unfavorable outcome from their first Team Biologics inspections. In fact, certain segments of the biologics industry have already been inspected, and some companies have experienced adverse consequences including lengthy FDA 483s, warning letters, and consent decrees.

PreapprovalInspections

The recent number of biologics companies that Team Biologics has found to be in noncompliance and the severity of the Team's findings at certain facilities are unprecedented for the biologics industry. But that is similar to what has happened in other segments of the pharmaceutical industry. Notable parallels exist between recent findings of Team Biologics and problems that occurred in other segments of the pharmaceutical industry over the past two decades. For example, in the 1970s FDA initiated systematic inspection coverage of the large-volume parenteral (LVP) industry following a number of septicemia outbreaks in the United States and Europe. FDA dispatched teams of investigators, microbiologists, and engineers to focus on conditions and practices related to sterility assurance. FDA teams found virtually the entire industry to be noncompliant with CGMPs. Following those inspections, numerous plants were shut down for renovations, and shipments of products were suspended. Product recalls numbered in the hundreds, FDA initiated rigorous regulatory sanctions that led to the requirements for sterilization process validation, and in 1978 the GMP regulations were revised (2,3).

Industry-widenoncompliance During the 1970s and 1980s, several FDA initiatives sent teams of specialists out to perform intensified inspections across entire segments of several industries. Those teams found widespread compliance problems. During those first rounds of intensified inspections, FDA found what it considered to be serious noncompliance across entire segments of the health industry. Industry surveys detected widespread problems in facilities that previously were considered by the industry to be in a reasonable state of compliance. For the medical device, lowacid canned food, blood bank, and computer software industries, FDA initiated compliance sanctions or issued new regulations, guidelines, or guidance documents.

Preapproval inspection (PAl) program launched. In the early 1990s, FDA initiated the PAI program in response to an investigation by Congressman John Dingell's (Democrat, Michigan) House Oversight and Investigations Subcommittee of the Committee on Energy and Commerce (4). FDA assembled teams of investigators, analysts, and other specialists to survey record-keeping practices and GMP compliance in the generic drug industry. (Another outcome of the PAI program has been the routine use of teams made up of FDA investigators and national experts, analysts, and engineers.) Those inspections detected serious GMP violations and application integrity discrepancies, including fraud, in many companies. FDA initiated various regulatory sanctions including criminal prosecutions, debarments under section 306 of the Food, Drug and Cosmetic (FD&C) Act, warning letters, and withholding application approvals. Because of the high incidence of compliance problems found at manufacturers of generic and nongeneric drugs, FDA continued intensified coverage under the PAI program for almost a decade because the inspections detected a relatively high rate of problems with application integrity and GMP compliance.

CDER currently recommends

withholding approval at about 20 percent of sites inspected under the PAI program. According to Stephanie Gray, director of FDA's Office of Compliance, during fiscal year 1995, 42 percent of the international pharmaceutical facilities FDA inspected under the PAI program resulted in recommendations to withhold application approval (5). Unquestionably, the PAI initiative has improved industry awareness of FDA requirements, and many companies have made significant improvements as a direct result of that program.

0IG questions FDA. In June 1997 the Office of Inspector General (OIG) issued a report that described its investigation of how FDA handled a number of incidents involving plasma fractionation products (6,7). The OIG report raised questions about how effectively CBER handled certain situations involving contaminated biologicals and/or recalls, and it included FDA's comments about information contained in the draft report. Because FDA actions were scrutinized by OIG, it is not surprising that FDA gave this matter priority attention. Team Biologics is FDA's attempt to achieve corrective action to the issues that were raised in the OIG report. FDA management is well aware that its actions are likely to be under further review by OIG or other special interest or oversight groups. Therefore, the agency has already initiated actions to ensure uniformity of inspections and enforcement between biologics and drug products.

A cadre of experts. One outcome of the OIG report has been a significant change in the way inspections are conducted. The transfer of lead responsibilities for biennial biologics inspections from CBER to ORA ensures the same approach for all drug products. The new partnership between CBER and ORA is intended to ensure more effective and efficient regulation of biological products by using a cadre of specialized staff who will devote their attention to biologicals (see "A Cadre of Experts" box).

learn Biologics: A New Approach As FDA rolls out its Team Biologics initiative, many biologics manufacturers will see differences between the Team Biologics approach and those approaches formerly used by CBER. Inspections may be longer in duration, they may focus more intently on documentation issues, and more rigorous sanctions may be enforced when deviations are encountered.

For many years, inspection approaches and regulatory enforcement by CBER and CDER differed notably. Before Team Biologics, CBER staff from its headquarters in Rockville, MD, performed inspections of biological products, and investigators from ORA field offices performed pharmaceutical inspections. Historically, personnel from CBER and ORA used separate inspection programs and followed different approaches. The scope and content of their inspections were not the same. Until recently, CBER inspections were generally shorter in duration and frequently focused primarily on scientific or technical issues dealing with establishment license applications (ELAs) or product license applications (PLAs).

In contrast, ORA field investigators conducted CDER inspection programs, and inspections were usually of longer duration. ORA field investigators typically gave greater attention to GMP compliance and documentation issues. Although statistics comparing enforcement rates between CBER and CDER are not readily available, there has been a long-standing perception that enforcement sanctions by CBER were less aggressive than CDER and ORA. With the implementation of Team Biologics, manufacturers of biological products who are not in substantial compliance with CGMPs are likely to face more rigorous enforcement sanctions -- sanctions that FDA considers to be consistent with actions that have been taken for drug products than in previous years.

Prudent companies will anticipate those changes in FDA priorities and take proactive steps to prepare for Team Biologics inspections. One of the more important steps is to ensure that personnel are well aware of the changes and know what to expect before FDA arrives so they can ensure GMP compliance for the quality systems that are most likely to be given priority attention by FDA (see the "Inspection Priorities" box).

Emphasis on field operations. Several factors contribute to the differences between CBER and CDER. For example, for many years field investigators were generally discouraged (or prevented) from inspecting facilities that manufactured biologics. The biologics portion of a facility was often "off limits" to ORA field investigators. Past CDER inspections were performed by staff from the headquarters unit with minimal interaction between CBER and the field offices. Team Biologics inspections will be performed by teams with representatives from both units (see "A Cadre of Experts" box). Previously, it was common for CBER personnel to perform inspections at a facility located in one of FDA's geographical regions without notifying the local district or providing it with copies of their inspection reports. In contrast, Team Biologics inspections will be carefully coordinated, and reports will be written jointly. Another notable change is the transfer of lead responsibility to ORA, which is likely to result in a significant increase in the frequency of enforcement actions. As Team Biologics inspections give greater attention to GMP compliance and documentation issues, FDA expects to find a disproportionate number of biologics manufacturers in noncompliance, as when FDA began its intense coverage under the PAI program in the early 1990s.

As FDA intensifies its scrutiny of the biologics industry and begins to find evidence of noncompliance, personnel in affected companies may believe that FDA is being unfair or is changing the rules. Such persons may feel that FDA is now applying a different standard and that they have not been given sufficient notice or opportunity to come into compliance before FDA initiates legal proceedings. ORA field staff are likely to take an alternate view that enforcement actions under the Team Biologics initiative are consistent and uniform with the standards that have been applied to the pharmaceutical industry for a number of years.

Now Team Biologics trans. Preparing for Team Biologics starts with understanding how the team trains. Preinspection training at your company should describe the new paradigm FDA will follow to prepare for Team Biologics inspections because this is unlike techniques that were previously followed by CBER. Before a Team Biologics inspection, the team will review relevant central files to determine the compliance history of the facility to be inspected. That review may include obtaining copies of relevant CBER inspection reports for biologic products and copies of pharmaceutical inspection reports from the local district office or CBER headquarters unit. Team members may meet for preinspection briefings or coordinate their efforts by phone, fax, or email as appropriate.

In some cases, FDA inspection teams may be briefed for two to three days before an inspection when they have an opportunity to meet directly with the staff from various headquarters units and to review original copies of ELAs, PLAs, biologics license applications (BLAs), or drug master files (DMFs). During such meetings Team Biologics members will discuss strategies with chemists or microbiologists from field laboratories and/or CBER staff who have reviewed applications. If a company has a history of compliance problems, Team Biologics members will consult with district or headquarters compliance staff to determine the appropriate follow-up to previous inspection findings. The team will review previous inspections for evidence of significant problems and will use that information to prepare an inspection strategy.

In addition, the team will review applicable correspondence with special attention to corrective actions that may have been promised or responses that reflect incomplete or inappropriate actions from problems that may have been detected previously. Each team member will provide input about areas of concern, priority issues that should be addressed, or any other discussion as appropriate.

Inspection Techniques

Team Biologics inspections will vary with each of the product areas identified in the program and the experience level of the team members. Team Biologics inspections will use the same inspection techniques and will focus on the same type of quality systems commonly covered for medical devices and drug products. When GMP deviations or application integrity deficiencies are encountered, FDA enforcement practices will be the same as those that ORA field offices have used for many years. For example, an ORA compliance officer team member will be responsible for immediately notifying the CBER Office, of Compliance and the ORA Office of Enforcement, and CBER will jointly provide administrative support for civil and/or criminal actions.

Enforcement act^OO The Core Team will develop its own recommendations about the actions deemed necessary to resolve compliance issues. Team Biologics is intended to facilitate enforcement sanctions by allowing the development of direct reference authority such as those that have been in place for many years in FDA's Compliance Policy Guides (CPGs). ORA field offices have for many years been given direct reference seizure authority for CDER products under certain situations as described in the CPGs. For example, CPG 7132a.03 authorizes district offices to submit seizure recommendations, charging adulteration under section 501(b), directly to the Office of Enforcement without CDER review under certain specified conditions (9).

Under Team Biologics, team members have been given greater latitude to develop enforcement actions and coordinate those actions with the appropriate compliance staff in ORA and CBER. The net effect of that change will likely be more frequent and more swift enforcement actions than occurred previously for biologics. For example, warning letters and relatively routine compliance actions will be forwarded to the CBER Office of Compliance to ensure expedited review and consistency, and more complex and/or serious regulatory actions will be sent to ORA's Office of Enforcement for review on an ad hoc basis. Before an inspection is completed, the inspection team will develop an enforcement strategy on an ad hoc basis in cooperation with the appropriate offices within CDER, CBER, and ORA.

Preinspection Training

To ensure a successful inspection under Team Biologics, companies should anticipate the need for considerable preparation and attention to a number of details. The odds of a successful inspection under Team Biologics will be determined by the level of preparation by key staff and by the overall level of compliance in the areas inspected by FDA. Personnel at biologics companies will be at a disadvantage if they do not fully understand the requirements, expectations, and inspection techniques that ORA field investigators routinely use. Problems may develop when employees do not know what to expect or when they do not effectively anticipate the needs of the FDA team. Prudent companies will train their staffs to ensure that everyone understands what to expect and to confirm that key personnel initiate the actions necessary to verify that each facility is in substantial compliance with GMPs and is following the commitments made in ELAs, PLAs, and BLAs.

Companies should design training programs based on their own experiences with FDA inspections under ORA and CDER programs. Companies that have little or no prior experience with ORA field investigators should prioritize training for their key staff members. Unless key personnel fully appreciate what to expect, companies may not take the actions necessary to ensure compliance. And if FDA detects substantial noncompliance, the company may suffer adverse consequences.

Senior management (directors and vice presidents) and key personnel (managers, supervisors, and technical staff) in each department (production, laboratories, QA/QC, engineering, development, and so on) should participate in pre-inspection training. Training sessions should describe the Team Biologics initiative and identify the respective roles and responsibilities of key personnel and the actions needed to prepare for such inspections. Training should include effective techniques for dealing with FDA investigators and the expected role of each participant during Team Biologics inspections. Upon completion of the training, key employees should clearly understand what is expected of them before, during, and after a Team Biologics inspection. Not only will they know what duties are expected within their respective work groups to prepare for the inspections, they will also be responsible for ensuring that their direct reports understand what to expect and how to act during a Team Biologics inspection.

Anticipating inspection Priorities

Team Biologics inspections will normally focus on two main issues: verifying the integrity of information supporting applications (ELAs, PLAs, and BLAs) filed with FDA, and determining conformance with GMPs at the facilities used for manufacturing, processing, packing, and holding a biological product. FDA inspection techniques and priorities are well known for most conventional manufacturing processes, and the same basic approaches will be applied to biologics. FDA techniques vary for each dosage form (sterile injections, oral tablets or capsules, topicals, transdermals, and so on) and will address key manufacturing processes (powder blending, granulation, and compression; liquid ultrafiltration; gel chromatography purification; aseptic filling; and terminal sterilization). For a given dosage form or manufacturing process, FDA can be expected to apply the same basic requirements to drug products and biologicals (unless the biological product has unique attributes or requirements that will be taken into account as appropriate). The following are a few examples of the priorities likely to emerge as FDA rolls out the Team Biologics initiative across the biologics industry (see also the "Inspection Priorities" box).

Application integrity. Companies should anticipate that Team Biologic team members will have had substantial experience under the ORA-DER PAI program and may give considerable attention to application integrity issues (4). Team Biologics inspections will provide an inspection focus unlike previous CBER inspections, and biologics manufacturers should anticipate that FDA may systematically compare application commitments against current practices. Biologic manufacturers should expect rigorous attention by Team Biologics if application integrity issues are suspected, and severe consequences will result if FDA obtains documented evidence of application integrity problems. The Team Biologics inspection team may spend considerable time and efforts reviewing documents that have been created during the development project (or changes made since application approval by FDA) and will compare that information with application commitments contained in ELAs, PLAs, and BLAs.

Companies that submitted ELAs or PLAs many years ago should verify that current conditions and practices in each facility are consistent with commitments contained in approved applications. FDA will be alert for changes to equipment, manufacturing processes, specifications, regulatory analytical methods, and other areas where companies may have made changes without obtaining approvals. FDA will review change control documentation and will compare information contained in approved applications to determine if there are discrepancies. If significant discrepancies are detected, FDA will likely expect companies to recall affected products (or FDA may initiate seizure actions). If FDA detects serious application integrity discrepancies, the preferred action will be to invoke the Application Integrity Policy (AIP), formerly called the "fraud policy" (10,11).

AIP is a program that FDA uses to deal with instances where it has reason to believe that persons have committed wrongful acts that raise questions about the reliability of data contained in filed applications. The consequences of being under the AIP are extreme, and while validity assessments are in progress, FDA will generally suspend review of pending applications until integrity questions have been resolved. When FDA investigations reveal substantial questions about the reliability of data and information contained in an application, several potential sanctions may be invoked. See the "FDA Sanctions" box for a list of those sanctions.

Prudent biologics manufacturers will ensure that key staff are fully aware of any application integrity problems that have been detected in other segments of the drug and medical device industry during recent years and will take proactive steps to verify the integrity of their applications and supporting documentation. Companies that do not ensure application integrity will face serious consequences if FDA finds evidence of integrity problems during Team Biologics inspections. FDA staff will obtain copies of current filings, including supplements and amendments, and will examine original supporting documentation at the manufacturing or testing facility to verify conformance with commitments.

During the first few years of intensified coverage under the PAI program, FDA encountered a relatively high percentage of companies that were not in conformance with their regulatory commitments. Various FDA enforcement reports and trade publications in recent years have shown that FDA continues to find application integrity problems in a number of companies that manufacture finished pharmaceuticals, active pharmaceutical ingredients, and medical devices (13-19). For example, in fiscal year 1995 FDA investigated more than 38 medical device applications under the AIP (19). Daniel Michels, director of ORA's Office of Enforcement, reported that 74 arrests were made in fiscal year 1996 by FDA's Office of Criminal Investigations (OCI), the unit responsible for investigating criminal actions by industry or FDA personnel (20).

Standard operating procedures (SOPs). Many biologics manufacturers have not established written SOPs for verifying the accuracy of documents contained in ELAs and PLAs before filing them with FDA and may not have verified their accuracy at time of original filing or postfiling. Companies should anticipate that Team Biologics may perform application integrity audits, and before FDA inspections, responsible personnel should become fully aware of the company's documentation systems (locate the records supporting any application filings). Personnel should review procedures that describe the schemes for identifying records, verify the adequacy of the document filing and retention practices, and identify the storage locations of documents cited in applications (such as those in support of batch production and control activities).

When it is practical, key personnel should prepare lists that identify available supporting records and the specific location of the records if they need to be retrieved during an inspection. For multinational companies that work at several sites or for companies that use contract services, it is important to ensure that records and data are retained at the locations where the activities were actually performed.

FDA expects that laboratory data (raw data and original records) will be retained at the site where testing is performed and that batch production records will be kept at the plant where batches were formulated. FDA does not want companies to move records from their original storage locations for the purpose of inspection. As necessary, inspection teams will go to the facilities where the various activities were performed to inspect the raw data and original records. For example, FDA would review data for testing performed by a contract laboratory at the contractor's facility. If necessary, inspection teams may visit remote sites to audit data and practices.

To the extent possible, companies should review current applications for products that are likely to be inspected by FDA under Team Biologics to ensure application integrity. If applications were not systematically verified for accuracy before filing, then it is advisable to perform such verifications before the inspectors arrive. If practical, companies should perform an internal audit of each ELA, PLA, and BLA to ensure the filings are factually correct and contain complete and up-to-date information (the information should reflect current conditions, practices, specifications, and test methods). Audits should verify that appropriate amendments or supplements have been filed to cover any changes made since the original submissions. If discrepancies are detected, the appropriate amendments and supplements should immediately be filed with the agency.

Mack FDA inspections. Application integrity audits systematically compare information that is contained in applications with raw data and original records. Such audits serve two important purposes. First, they allow a final opportunity for the company to independently verify that information in its applications is accurate and supported by raw data. Second, they provide plant personnel a chance to undergo a simulated FDA audit, providing valuable experience for those having to answer questions and locate supporting documentation. Audits also provide management with the opportunity to observe how well their key personnel deal with the pressures of an audit and to judge how effectively they communicate. Management may use this experience to decide the roles and responsibilities of key personnel during a Team Biologics inspection. In some cases it may be necessary to provide additional training or instruction on how to be more effective during audit situations.

Scale-up and postapproval changes (SOPAC). Since 1994 FDA has been actively developing SUPAC guidance documents for the pharmaceutical industry (21-24). Generally those documents do not directly apply to most biological products, but it is prudent that manufacturers of biological products understand the background and reasons that led to their development. For biological manufacturers who may have filed their ELAs or PLAs many years in the past, it is likely that conditions and practices used in production and control have been changed over the years. Team Biologics will likely focus on change control issues, and the team will be alert for changes that may be outside the application commitments.

Targeting Priority Systems

Team Biologics inspections will focus on certain quality systems to determine whether a facility is in substantial compliance with CGMPs per section 502(a)(1)(2) of the FD&C Act (25). Although each FDA investigator, chemist, and microbiologist may have a particular style, approach, or unique set of priorities, there will be a predictable similarity between inspections of drug and biological products. For example, Team Biologics inspection approaches and priorities will obviously vary by dosage form and method of manufacture. But there are a number of priority systems that can be expected to be covered during most inspections, and the approach for document review will follow the techniques that have been used for years by ORA field staff. For the same reasons described for application integrity audits, it is advisable to perform internal GMP audits before a Team Biologics inspection. Such audits may focus on product development, scale-up to fullsize production batches, qualification of equipment and utilities, validation of processes and laboratory methods, batch records and SOPs, and many other areas. Biologics manufacturers should identify a comprehensive list of systems most likely to be covered under Team Biologics and, before FDA arrives, take the necessary steps to ensure GMP compliance for each.

Laboratory controls. Expect most Team Biologics inspections to focus on laboratory controls (microbiological, chemical, physical, or other). Depending on the dosage form and product category, the inspection team will include an analyst and/or a microbiologist. Under the PAI program for a number of years laboratory controls were one of the most commonly cited deviations, and under Team Biologics companies should anticipate a similar focus. At each site, for example, FDA will examine the laboratory controls to ensure that instruments are calibrated at suitable intervals according to established written procedures.

Team Biologics will give special attention to determining the adequacy of documentation for results of analyses that are out of specification (OOS), including indepth review of investigation reports used to support decisions to release or reject batches with OOS results. FDA will look for instances in which batches with OOS results may have been released based on inappropriate decisions or retest results that were not supported by sound scientific rationale. FDA will review procedures used to maintain records for trending laboratory OOS results and test failures, their reasons, and corrective actions. FDA analysts can be expected to focus on methods validation and documentation for preparing, testing, and standardizing laboratory reagents and reference standards.

Production and process controls. FDA will verify that each facility has appropriate systems in place to ensure that production and process controls are followed and documented at the time of performance. Appropriate SOPs and specifications should have been established to monitor the performance of processes that can affect variability in the characteristics of a drug or biologic product. Inspectors will review process validation protocols, testing data and documentation, and final reports to determine if there is documented evidence that processes can consistently produce a product that meets predetermined specifications and quality attributes. They will likely review the adequacy of procedures in place for documenting any deviations and will determine whether adequate documentation exists to justify decisions. Team Biologics will give priority attention to evidence of deviations or discrepancies not adequately investigated by a company (or incomplete documentation). If the agency finds repeated documentation discrepancies or egregious instances of improper actions, Team Biologics members are likely to recommend regulatory sanctions as described in the Team Biologics program (1).

Reprocessing, reworks, returned goods, and rejected materials. Team Biologics will give considerable attention to situations in which companies are reprocessing or reworking in-process batches or finished products that do not meet specifications. Of particular concern to FDA will be whether the reprocessing or reworking process is defined in an application that has been approved by FDA. If Team Biologics finds that batches failing specifications have been reprocessed or reworked by an unapproved process (that is, if the methods, controls, or parameters differ from the approved process) or by processes that have not been validated, FDA will consider that to be a serious regulatory issue and will likely collect evidence to support potential regulatory sanctions.

Prudent companies will review existing procedures and completed batch records to verify conformance with regulatory commitments and to verify that reprocessing or reworking processes are supported with documented evidence of validation. If reprocessed or reworked batches are detected that do not meet regulatory commitments (or processes were not validated), companies should seek legal counsel and determine the appropriate actions (recall affected products, validate the process, update applications, or take other actions as appropriate). FDA may review SOPs that relate to processing materials that have been returned or that do not meet specifications. Inspectors will be especially alert for evidence of reprocessing or reworking batches that do not meet specifications where there may not be an adequate documented investigation or where unvalidated processes were used to rework or reprocess nonconforming products.

Record-keeping practices. Team Biologics will focus on documentation and SOPs with the approaches that have been used by ORA field investigators for many years. Some biologics companies may find that priorities differ from their previous experiences with CBER personnel. Team Biologics will determine whether there are effective policies and procedures for maintaining records covering the production and control of drug or biologic products and ensure that such records are readily available for inspection. Special attention will be given to reviewing original records for analytical testing, in-process batch production and control records, validation documentation, and others. For example, FDA will evaluate record-keeping systems covering OOS and failure investigations and the steps taken to correct failures of drug or biologic products to meet specifications. FDA will be especially alert to determine whether the investigations have extended to other batches or similar products that may be affected by the nonconforming results. Also, FDA may perform data audits to verify the adequacy of techniques used to enter, store, and retrieve raw data and original information during production and control activities.

Buildings, facilities, and equipment. Team Biologics members will examine each building used in the production and control of drug or biologic products to determine whether it is of suitable design, size, construction, and location to ensure effective maintenance and cleaning and proper operation for its intended use. Included in this review will be a systematic evaluation of the design and maintenance of utility systems such as purified water, water-forinjection, compressed gasses, and HVAC and HEPA systems to ensure that aseptic processes are carried out under suitable environmental conditions. For biologic products, special attention will be given to aseptic process validation and the controls used to ensure effectiveness of viral inactivation. For example, FDA will be alert to employee practices and construction defects that may allow the potential for viral contamination (such as exposure to environment after viral inactivation, ineffective or nonvalidated processes for inactivation, or inappropriate employee practices).

FDA will look for any equipment that is not suitable for its intended purpose or is not of suitable design, size, and construction to allow proper maintenance, cleaning, and performance, especially in older facilities where equipment may not have been upgraded to current industry standards. Inspectors may identify the computer systems that are used in production and control and verify that validation and qualification data are sufficient to demonstrate that the systems operate reliably. Depending on the focus of the inspection, Team Biologics members may review qualification (installation, operation, and performance qualification protocols and the corresponding testing data and final reports) of key equipment. Biologics companies that installed equipment many years ago may find they do not have IQ, OQ, and PQ data or reports or that they have made changes to the equipment. Such companies should be prepared to demonstrate that equipment can perform its intended functions uniformly and reliably. Retrospective qualification and validation is theoretically possible but will be of questionable validity if FDA detects changes to the equipment or processes.

Employee training. Team Biologics members are always alert for evidence that employees may not have the education, training, and experience to carry out their duties and responsibilities. FDA will observe employee behavior and actions to verify that personnel are familiar with and follow SOPs within their areas of responsibilities. FDA expects that each employee will have documented evidence of GMP training, that such training is described in procedures, and that personnel are supported with continuing education and training to keep their skills in line with advances in quality practices and CGMPs. FDA may give special attention to new employees, temporary staff, and contractors to verify that they have documented evidence of training before assuming functions involved with production and control of biologics.

Roles amd responsibilities of QA and QC. Inspectors may review company policies and procedures to determine that they establish uniform, mandatory standards for GMP compliance. They will be alert to evidence of areas where certain GMP responsibilities may not have been adequately defined (such as all facets of compliance monitoring; procedures used to monitor complaints; reports of adverse experiences; and investigations of product or process failures and other quality-related issues that affect the safety, identity, strength, and purity of drug and biologic products). FDA will review SOPs and specifications to ensure that they are up-todate and that they accurately reflect requirements. FDA will determine whether there are written SOPs that require filing reports under 21 CFR Parts 600.80, 314.70, and others (as appropriate) to ensure compliance with regulatory requirements.

Team Biologics will look for documented evidence that the Quality Control Unit is empowered to fully and effectively carry out their responsibilities as set forth in 21 CFR 211.22. Some teams may audit the overall organizational structure and evaluate the specific responsibilities of each work unit involved in the production of biologicals. FDA expects biologics manufacturers to have procedures in place for detecting and correcting any deficiencies that are noted on FDA 483s and internal audits.

Preparing for Success

This article began with a brief review of the parallels between what is currently happening in the biologics industry and what happened to other segments of the pharmaceutical industry when FDA initiated directed inspections by teams made up of specialists. I believe that history is repeating itself with Team Biologics.

Under Team Biologics, a number of companies are sure to experience serious regulatory challenges and/or legal sanctions. But proactive steps can be taken to reduce or eliminate the risk of an unsuccessful inspection. By publishing the Team Biologics initiative and its schedule for implementation (see the "Team Biologics Inspection Schedules" box), FDA has served its notice, and prudent companies will heed the warning and act accordingly.

[Reference]

References

[Reference]

(1) FDA, "A Plan for Reinventing FDA's Ability to Optimize Compliance of Regulated Biologics Industries," Updated 10 November 1997. Available on internet at www.fda.gov/cber/genadmin/teambio.htm.

(2) R.F. Tetzlaff, R.E. Shepherd, and A.J. LeBlanc, "The Validation Story: Perspectives on Systematic GMP Inspection Approach and Validation Development," Pharm. Technol. 100116 (1993).

(3) "Human and Veterinary Drugs, Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding," Federal Register 43, 190 (29 September 1978), pp. 45014-45089.

(4) FDA, "Pre-approval Inspections/ Investigations," Compliance Program, CP 7346.832, Chapter 46, New Drug Evaluation (August 1994).

(5) S. Gray, "FDA's International GMP Inspections," paper presented at International GMP Conference, Athens, GA, 4-7 March 1996.

[Reference]

(6) Office of Inspector General, "Review of the Food and Drug Administration's Inspection Process of Plasma Fractionators," Gibbs Brown, Inspector General, Report A-03-9700350 (June 1997).

(7) T. Roslewicz, "Testimony before the Committee on Government Reform and Oversight, Subcommittee on Human Resources, FDA Regulation of Blood Safety, Statement of Thomas D. Roslewicz," Office of the Inspector General (5 June 1997).

(8) P.A. Peterson, "BioPharm Conference '98: PC3," presentation at BioPharm Conference, San Francisco, CA, 4-6 May1998.

(9) FDA, "Adulteration of Drugs Under Section 501(b) and 501(c) of the Act. Direct Reference Seizure Authority for Adulterated Drugs Under Section 501(b)," Compliance Policy Guide 7132a.03 (1 May 1992).

(10) "Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities; Final Policy,"

[Reference]

Federal Register 56, 175 (10 September 1991) Docket 90N-0332.

(11) FDA, "Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities," Compliance Policy Guide, 7150.09 (July 1991).

(12) FDA, "Points to Consider for Internal Reviews and Corrective Action Plans" (Bethesda, MD, June 1991).

(13) FDA, "DEBARMENT LIST' (updated 16 June 1998). Public listing of companies or persons debarred pursuant to sections 306(a) and (b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 335(a) and (b)], www.fda.gov/ora/compliance_ref/debar/debar. txt.

[Reference]

(14) FDA, Internet site listing drug and medical device companies currently under Application Integrity Policy www.fda.gov/ora/ compliance_ref/aiplist05l9.html. (15) FDA, Internet site, FDA Enforcement Reports,

www.fda.gov/opacomlEnforce.html. (16) The Gold Sheet, "Recall Trend Continues Downward in 1995," 30 (1), January 1996. (17) The Gold Sheet, "Change Controls Draw FDA

Enforcement Action," 29 (9), September 1995. (18) The Gold Sheet, "AADA Deviations Spur Drug Product Recalls," 32 (1), January 1998. (19) J.G. Dickinson, "38 Device Frauds Probed by

FDA," MD&DI 34-35 (June 1996). (20) D. Michels, "FDA's Enforcement Program," RA Focus 2 (7) (July 1997).

(21) FDA, "Immediate Release Solid Oral Dosage Forms; Scale-up and Post-approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation, Guidance Notice," SUPAC Guidance, Scale-up and Postapproval Changes (Bethesda, MD, 30 November 1995).

(22) FDA, "Modified Release Solid Oral Dosage Forms; Scale-up and Post-approval Changes: Chemistry, Manufacturing and Controls, In Vitro dissolution Testing, and In Vivo Bioequivalence Documentation, Guidance Notice," SUPAC-MR Guidance, Scale-up and Post-approval Changes (Bethesda, MD, September 1997).

(23) FDA, "Nonsterile Semisolid Dosage Forms; Scale-up and Post-approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing, and In Vivo Bioequivalence Documentation, "SUPAC-SS Guidance, Scale-up and Post-approval Changes (Bethesda, MD, May 1997). (24) FDA, "Guidance for Industry, Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products" (Bethesda, MD, July 1997).

(25) Federal Food, Drug and Cosmetic Act as amended, 21 U.S. Code 301 et seq. BP

[Author Affiliation]

eoN id F. Tittlo is vice president of compliance services at KMI/Parexel, Inc., 1303 Hightower Trail, Suite 330, Atlanta, GA 30350, (770) 641-9100, fax (770) 992-4002, rtetzlaff@belmont.kminc.com.

Latest Fitch Ratings move illustrates spiral of US debt downgrades and their effects

Deterioration in the credit cycle has taken a new twist, as Fitch Ratings warned Friday a number of bonds might be downgraded _ because the bonds' insurer is facing a downgrade from Fitch.

Standard & Poor's made the same move earlier this week, downgrading hundreds of municipal bonds after it had downgraded the insurer of those bonds, ACA Capital.

It is a cycle that could continue as rating agencies warn bond insurers, such as MBIA Inc. and Ambac Financial Group Inc., might not have enough capital to cover claims.

Earlier in the week, Fitch warned MBIA will need to raise an additional $1 billion on top of the $1 billion (euro700 million) capital investment private equity firm Warburg Pincus pledged earlier in the month. The money is needed as a safety net in case insurance claims rapidly rise in 2008.

Unless insurers _ considered the last line of defense protecting investors from defaulting bonds _ can meet rating agencies' standards to stabilize capital and guarantee they have enough money to pay out potential future claims, the number of bond downgrades may climb.

As that continues, investors may avoid buying new debt because it is too risky without the added insurance, leaving the credit markets locked up.

The tightening of the credit markets began over the summer with an avalanche of downgrades of asset-backed securities, collateralized debt obligations and other debt tied to rising mortgage defaults.

Asset-backed securities are groups of consumer loans and mortgages packaged together and sold in pieces to investors. Collateralized debt obligations, or CDOs, are complex financial instruments that combine slices of debt, many of which are in part backed by mortgages.

Until recently, a majority of asset-backed securitizations were backed by subprime mortgages and home equity loans and lines of credit. Those types of home loans have increasingly gone delinquent and into default in recent months.

Because of those rising delinquencies, investors and credit rating agencies have worried the securities and CDOs backed by the troubled loans will default as well. That spurred rating agencies to start mass downgrades of the debt.

Fitch, S&P and Moody's Investors Service have all downgraded billions of dollars worth of debt over the past six months. S&P was the latest to announce a mass downgrade, lowering ratings on Thursday of 793 classes of securities underpinned by nearly $23 billion (euro16 billion) in home loans.

Many of those downgraded deals _ that investors and rating agencies are now worried might default _ are insured by companies like MBIA.

The problem is, because credit rating agencies downgraded so many instruments, there is a now a fear bond insurers will not have enough cash to cover potential defaults. That has led ratings agencies to place warnings on and downgrade the insurers.

Senators notch 10th straight win, down Sabres

Daniel Alfredsson scored twice in the final minute to extend the Ottawa Senators' franchise-best winning streak to 10 with a 4-2 victory over the Buffalo Sabres in the NHL on Wednesday.

Jason Spezza also scored two goals and added an assist, as the surging Senators closed to within three points of the first-place Sabres in the Northeast Division.

Spezza has scored in seven consecutive games, including five since returning from a right knee injury.

Andrej Sekera and Tim Connolly scored 27 seconds apart to tie it in the third period for the Sabres, who lost their eighth in a row to Ottawa.

Blues 3, Blackhawks 2

In Chicago, David Backes scored twice during a three-goal second period as St. Louis edged Chicago.

Chris Mason made 32 saves for the Blues, who scored three times in the final 8:26 of the second to spoil Chicago's first game at home after a two-week, eight-game road trip.

Jay McClement also had a goal for the Blues. Patrick Kane and Marian Hossa scored for Chicago.

Ducks 3, Red Wings 1

In Anaheim, the hosts' run of home victories was extended to nine with a win over Detroit.

Ryan Whitney and Kyle Chipchura scored first-period goals, and Bobby Ryan added the third as the Ducks moved within one win of its record home winning streak of 10.

Pavel Datsyuk scored a power-play goal for the Red Wings.

Flames 4, Hurricanes 1

In Calgary, Curtis Glencross recorded his first NHL hat trick to lead Calgary over Carolina.

New Flames forward Matt Stajan scored in the second period.

Carolina captain Eric Staal scored the lone goal for the Hurricanes.

Oilers 1, Flyers 0

In Edmonton, Ryan Potulny scored the sole goal during a power play with 17 seconds left, lifting Edmonton over Philadelphia.

The Oilers have won both of their games in February after going all of January without a victory.

Relief over early end to roadworks

The good news is two months of traffic lights in a busy villageroad will end early.

And the slightly better news for traders is another road closurehas been postponed. Wales and West Utilities said temporary trafficlights on Church Street in Cheddar will be removed tomorrow evening.

However, the A371 through the village was supposed to be closedfor resurfacing during the nighttime by Somerset County Council fora week from November 19. But the council has now said the work ispostponed. No new date has been set.

The temporary traffic lights have caused queues of traffic inboth directions since September 6.

But a knock-on effect has been felt by the nearby Sue Ryder Careshop on Union Street.

Manager Andrea Cox has noticed a drop in out-of-villagedonations.

She said: "We pride ourselves on ladies clothing and accessories,but also continue to need bric-a-brac and men's clothing.

"The works have really put off donations from Draycott and otherareas because the traffic lights are delaying motorists."

She is now appealing for readers and others to spread the wordthat donations, which can include cash, are gratefully received.Keith Hollick, manager of Budgens in Cheddar, agrees the donationdrop can be blamed on the lights.

He said: "Everybody has been effected by these lights.

"In the post office they said they were much quieter than usual.It has hit Cheddar hard and they won't be missed."

The road works involved replacing 200m of old metal gas pipeswith new plastic ones. The non-corroding pipes should last more than80 years and is part of a 30-year multi-million pound programme inWales and the South West.

A statement from Wales and West Utilities said the work was to befinished and the road fully re-opened on Friday evening - a weekearlier than the original November 12 completion date. Confusingly,warning signs at the traffic point state work should be finishedOctober 31 - last Saturday.

The length of the A371 in Cheddar was slated for resurfacing bySomerset County Council's highways department from November 19 to26.

The closure would have been enforced from Witheridge Farm byCheddar Bridge to Hanam Manor on Station Road, by the Kings ofWessex School, during the evenings.

Sue Ryder Care is selling tickets for the charity's nationalraffle. First prize is Pounds 5,000, second is a cruise for two andthird is Pounds 500. Closing date is December 1.

A Benedictine Mennonite [A Mennonite pastor describes the spiritual community and personal discipline he has found in the Benedictine order]

Prefer nothing whatever to Christ

As part of my spiritual discipline, I regularly study a spiritual classic that is heavily inspired by the Sermon on the Mount. It teaches about prayer, worship, nonresistance, community, not swearing oaths, loving enemies, mutual aid, Matthew 18's Rule of Christ, and the importance of faithful works.

This is no Anabaptist document (although I believe it inspired Anabaptists). The Rule of St. Benedict was written by an abbot in the sixth century as a guide to running monasteries. It became the prevailing guide for most monasteries in the West, second only to the Bible.

Many who are not monastics find that the theology and counsel of this spiritual treasure -- in between advice on diets, bedtimes, kitchen work -- has much to teach all Christians.

I have been going to an Anglican Benedictine monastery, St. Gregory's Abbey, since 1981. At times, especially on peaceful retreats, I fantasize about joining a monastery. But God calls me to be a Mennonite minister, husband, and father. When I remember that, my regular rhythm of retreats helps me to be more faithful in those commitments.

Longing to deepen that rhythm, I began several years ago to relate more intentionally with St. Gregory's. As a "confrater" (brother), I made a promise to live out Benedictine values, to love of God and neighbour, to prayer, humility, silence, creation, and life in Christ. Yet I wanted something more. I tested with the Abbot the possibility of being an oblate.

"Oblate" means "offering," and here implies offering one's life to God. Oblates live outside a monastery but are accountable to a monastery for how they live out their spiritual commitments.

Intriguingly, while monasteries have increasing difficulty attracting new monks, the number of oblates is growing. Kathleen Norris (a Presbyterian) did more than anyone to celebrate what it means to be an oblate with her book, The Cloister Walk.

The Abbot was clear that my oblation would mean strengthening my commitment to the church I serve and to my family. It would mean living by the Benedictine motto "ora et labora" (pray and work). This calls for a practical spirituality that balances work with prayer and worship (both corporate and individual).

Being Benedictine means:

- Being involved with the church and encouraging Christian community.

- Being committed to continual self-improvement and renewal (spiritually, intellectually, culturally, through prayer, retreats and study).

- Growing in ministry to others, especially by learning contentment, patience, generosity, and hospitality.

- Growing in virtues, with special attention to wisdom, prudence, justice, fortitude, and moderation.

- Being peacemakers. A Benedictine watchword is "pax" (peace). Benedict sees nonresistance as a primary step of growth in the Christian life. Joan Chittister, a nun, says that nonviolence is the centre of the monastic life.

- Practising accountability and seeking guidance in one's Christian life.

As part of my testing of whether I was called to be an oblate, I submitted my personal rule (or discipline) for spiritual life and reported regularly on how my commitment was going.

I discovered that promising before others to stay faithful encouraged me when I was tempted not to pray. And when I do pray, I know I am upheld by the prayers of brother monks (just as I pray for them). Never have I been offered such support by other Christians.

After a year and a half as an "aspirant," I became an Oblate Novice. This was a further time of discernment by both the monastery and me. I received a monastic name, "Brother Barnabas." After a year and a half, at a worship service in the monastery with my family present, I did my oblate profession. This is a life-long commitment.

Being an oblate deepened all the other important commitments I have made: baptism, marriage, family, ordination. For many years I explored different forms of intentional Christian community, but either I or the group did not endure. Now I am part of a community that is over 1,500 years old.

I am not alone. I am in contact with other Mennonites who are Benedictine oblates. Some people wonder whether being a Benedictine Mennonite is a contradiction. But Anabaptism has much in common with monasticism. Many Anabaptist leaders received spiritual formation as monks.

Spiritual cousins

Anabaptists and monastics are at least spiritual cousins. We see their reliance on similar scripture passages, especially the Sermon on the Mount, Matthew 18, and Acts descriptions of common life. Monasticism, like Anabaptism, is rooted in protest against compromise in the culture and the church.

Anabaptists, like the original monastics, showed suspicion toward clergy. Monasticism was originally a movement of lay Christians and clergy were not encouraged to apply!

Schleitheim, the first Anabaptist confession, reiterates many themes of the Rule of Benedict. (Hardly surprising, as one of its primary authors, Michael Sattler, was formerly a Benedictine official.) Anabaptists were accused of being "new monks." They encouraged all believers to live up to the Sermon on the Mount's high "standards of perfection" which were previously considered the responsibility only of monastics.

As well as affirming my Anabaptism, through my oblation I made deeper connections with the wider church. Benedictinism is ecumenical. Benedictines are in a good position for fostering Christian unity because their foundation and inspiration go back beyond the schism between the eastern and western church, and the controversies which split western Christendom in the sixteenth century.

Benedict reminds us that God's "divine presence is everywhere." That is one reason for all his practical advice (which resonates well with both my Dutch heritage and my chosen Anabaptism). Norvene Vest, an oblate, notes that Benedict "truly believes that our sanctification is realized in our daily choices and habits." Benedict taught us, as did Anabaptists later, to translate God's "holy teachings" into action.

All of my Benedictine commitments are summarized in my desire to "seek God." The monastery helps me and is, in Benedict's words, a "school of the Lord's service," a place that teaches me, inspires me, and calls me to be a better Christian.

Ever since I was a child, I believed that if Christianity is true then it must be the most important aspect of one's life. Thus I continually remind myself, in Benedict's words, to "prefer nothing whatever to Christ." My oblation as a Benedictine Mennonite compels me to be more faithful to this challenge. "Ora et Labora." -- Arthur Paul Boers, ObISB

Finley, Nash lead Mavericks: NBA Roundup

DALLAS - Michael Finley scored 29 points, Steve Nash had a career-high 19 assists and the Dallas Mavericks beat the Western Conference-leading - and suddenly struggling - Sacramento Kings, 127-117.

The Kings lost for the fourth time in five games, and fell into atie with the Los Angeles Lakers, who defeated Houston, for the topseed in the West.

Finley made seven straight field goals in one stretch. The firstfour came in a 10-0 run at the end of the first half that pushed theMavericks ahead, 67-50.

Nash had 20 points to go along with his 19 assists, the most inthe NBA this season and a franchise record for a regulation game.Jason Kidd had 25 assists in a double-overtime game in 1996.

Dirk Nowitzki followed a 35-point, 18-rebound effort Tuesdayagainst Cleveland with 27 points and 10 rebounds. Marquis Daniels andAntawn Jamison had 16 points each.

Mike Bibby led six Kings in double figures with 23 points. ChrisWebber had 22 points and Peja Stojakovic 21.

Trail Blazers 88, 76ers 82 - Zach Randolph scored 18 points, andDarius Miles had 18 points and 10 rebounds to lead the surgingPortland Trail Blazers.

The Blazers have won nine of their last 12 games and moved into atie with the Utah Jazz for the eighth and final playoff spot in theWestern Conference.

Miles, acquired in a midseason deal, had his second straightstrong game. He scored eight points in the fourth quarter, includingtwo baskets that both times pushed the lead back to four.

A day after the Trail Blazers hit a season-high 61 percent oftheir shots and Miles scored 31 points in a win over Boston, Portlandshot 49 percent.

The Sixers played again without Allen Iverson, out for the rest ofthe season with a knee injury. Willie Green led Philadelphia with 22points, Kenny Thomas had 14 points and 12 rebounds, and SamuelDalembert had 11 points and 19 boards.

Lakers 93, Rockets 85 - Kobe Bryant scored 26 points, and KarlMalone had 20 points, 14 rebounds and six assists to lead the Lakerspast the Houston Rockets, 93-85, for their 10th straight victory toequal a season high.

Shaquille O'Neal had 18 points and eight rebounds and Gary Paytonadded 12 points and a season-high 13 rebounds for the Lakers, whoshot just 37.7 percent.

but outrebounded the Rockets 58-35.

The Lakers moved into a tie for the Western Conference lead withslumping Sacramento, who lost to Dallas. The Lakers play four oftheir remaining seven games at home. The Kings play four of theirlast seven on the road. The teams meet in Sacramento on April 11.

Cuttino Mobley scored 26 points and Steve Francis had 17 pointsfor the Rockets, who lost for the sixth time in nine games.

AP-ES-04-02-04 0146EST

Rights Group Chides Ethiopia on Rebels

ADDIS ABABA, Ethiopia - A human rights group accused the Ethiopian army on Wednesday of burning homes and displacing thousands of civilians in a crackdown on rebels in the volatile east.

The report, by New York-based Human Rights Watch, cited witnesses who said the army burned villages and blocked humanitarian aid to the Ogaden region, where ethnic Somali rebels have been fighting the government for more than a decade. The report also said troops were seen firing on fleeing civilians "in a few cases."

"Ethiopian troops are destroying villages and property, confiscating livestock and forcing civilians to relocate," said Peter Takirambudde, Africa director of Human Rights Watch.

The government last month announced a crackdown on Ogaden National Liberation Front rebels, who attacked a Chinese-run oil exploration field in April, killing 74 people.

Bereket Simon, special adviser to Prime Minister Meles Zenawi, denied the Human Rights Watch accusations.

"The facts on the ground are absolutely different from what they say," Bereket said.

He added that the army tries to ensure civilians are not harmed as Ethiopian forces chase out rebels.

"This is an army that does not target civilians," he said. "That is outside the constitutional mandate of the army and they are not going to do it."

Human Rights Watch also condemned the ONLF, saying civilians are trapped between warring parties.

"The Ethiopian government appears to be pursuing an illegal strategy of collective punishment of the civilian population, and the ONLF has targeted civilians for attack," Takirambudde said.

The ONLF is fighting to overthrow the government for what it says are human rights abuses in the eastern Ogaden region of Ethiopia and to establish greater autonomy.

The ONLF claimed to have ambushed and killed 43 soldiers on Tuesday, but a government spokesman denied any fighting took place.

Dr. King's dream: A dream deferred

Dr. King dreamed of the day that African-Americans would enjoy a full measure of freedom; however, he knew that we would not enjoy a full measure of freedom until we gained economic empowerment The last speech that he gave before his assassination in Memphis, Tennessee on April 4, 1968, dealt with the subject of the necessity of African American economic empowerment. Many of the major corporations that he challenged will take out full-page ads commemorating Dr. King and his dream, and on the other hand, will deny any business opportunity on shelf space to African American business interests.

I believe that Dr. King would be greatly disturbed, if he were to return to see nearly all of the businesses in the African-American community being run by everyone, to the exclusion of the Black people that live there. If you but look to the businesses in all other ethnic communities, these businesses reflect the people that live there. This holds true for every community except the African - American community, where the opposite is true.

It would sadden Dr. King to see a large percentage of major retailers who are strategically located in the African-American community, and supported almost exclusively by African-American consumer dollars, routinely deny any business opportunity or shelf space whatsoever in African-American business interests. The most egregious of this group is Target, the second largest retailer in the country, with a store at 85th and Cottage Grove Avenue and whose consumer base is 99 percent African American, who boasts of the handouts they give to community residents and at the same time, deny Parken House Sausage, Baldwin Ice Cream and Reggio's Pizza the only three African American food manufacturers in the country, any shelf space whatsoever, at that store or any of their stores throughout the United States.

It would move Dr. King to tears, if he were to return and see African American and Hispanic young men brutalizing and killing each other at an alarming rate. African Americans and Hispanics occupy the lowest wrung on the economic ladder and am convinced that these young men involve themselves in acts of violence because of the overall poor economic conditions that exist in their communities and translate to their homes. When they can't find the basic economic necessities and other needs at home, they seek these basic resources through the gangs and in the streets. Without question, there is a direct correlation between economic empowerment and the quality of life.

If we would but empower and change the economic landscape in the African- American and Hispanic communities, the social problems that exist there would fall into place and the killing would stop.

On a high note, Dr. King would be overjoyed if he were to return and see that the 44th president of the United States is of African descent. Nevertheless, he would drop his head in shame when he learned that we are still struggling with the issue of discrimination and inequality. He would be astounded to learn that although African- Americans represent 12-15 percent of the population of the United States, less than one-half of one percent of the contracts and business opportunities go to African American business interests from the federal government.

Recently, the Black Caucus challenged President Obama to do more for the African American community, who have suffered the longest and the most. The rationale was that the government bailed out the financial institutions to the tune of 700 Billion dollars or more and that something should be done during these tough economic times, when the least of these needed some help. Conventional wisdom would say that doing something special for the African American community or poor people generally, should be in order. Notwithstanding the fairness of this proposition, some people say he would be committing political suicide if he would do anything "special" for the downtrodden and African American community. My belief is that President Obama should not necessarily do anything special for the African American community, nevertheless, he should insist upon fairness. Fairness would mean that the government should distribute on a fair basis, the percentage of contracts, grants, and educational appropriations, etc. commensurate with the level of our population representation. If the playing field was made level and we received our fair share, then, there would be no need to ask for anything special.

Case in point, it took Reggio's Pizza the only African American frozen pizza manufacturer in the country, who employs about 200 people, 15 years of struggle, to get any type of distribution of our frozen pizza product in the military commissaries, when African American soldiers represent approximately 22 percent of the armed forces. This opportunity came just recently. The Defense Commissary Agency is part of the federal government and as such, should be in the forefront of providing opportunity to those of us who have been historically disenfranchised.

During the Bush administration, Reggio's Pizza was selected by the United States Department of Commerce as the National Minority Retail Firm of the Year. Nevertheless, when we asked about distribution opportunity at the Defense Commissary, the response was in essence "your selection for the award did not mean that we were really serious about promoting economic opportunity for minorities."

There will be many celebrations to commemorate Dr. King's birthday, as there should be. I only hope that those who celebrate and commemorate this man of greatness will begin and renew the fight to make Dr. King's dream of justice and equality a reality. To paraphrase him, as he began on his long journey for freedom for an oppressed people that began in 1955 in Montgomery, Ala. when he spoke the words of Amos from the Old Testament: Let justice roll down like water and righteousness Like a mighty stream. Then finally, Dr. King's dream would be a dream fulfilled."

[Author Affiliation]

John Clark Jr. is president/CEO of Reggio's Pizza, Inc.