Monthly Archives: June 2005

Nissan Maxima and Suzuki Verona Receive Marginal Ratings in Crash Tests

According to a report published today the 2005 Nissan Maxima and the Suzuki Verona received marginal ratings in crash tests. The problem concerned side impact collisions.
The Insurance Institute for Highway Safety gave the Chevrolet Malibu and Audi A4 its top score, good, in side impact tests of five 2005 model midsize sedans. The Volvo S60 rated the second-highest score of acceptable.
According to the report, passengers in the Nissan and Suzuki vehicles may sustain rib fractures and back injuries as a result of side impact crashes.

Bristol-Myers Squibb to Settle for $300 Million

Drug maker to settle case for $300m
By Associated Press | June 6, 2005
NEW YORK — Bristol-Myers Squibb Co. is expected to settle a federal probe of its past accounting practices for $300 million, according to published reports.
As part of the so-called ”deferred prosecution” agreement, the New York pharmaceutical company would be able to avoid criminal charges if it complies with certain terms, The New York Times and The Wall Street Journal reported last night on their websites, citing unnamed sources.
An announcement of the agreement could come this week, the reports said.
Among the terms of the deal with the Justice Department are expected to be the separation of the chairman and chief executive titles held by Peter R. Dolan, and other changes in the company’s corporate governance practices.
No current Bristol-Myers Squibb executives are expected to be indicted, thought it’s possible former executives may be indicted, according to the Journal.
Retired federal Judge Frederick B. Lacey will remain on board as the company’s independent monitor of accounting, internal controls and financial-reporting practices, both papers said.
Last year, Bristol-Myers Squibb reached a $150 million accounting-fraud settlement with the SEC after it was accused of manipulating its inventory of drugs to inflate earnings.

Auto Safety or Auto Privacy?

(AP)
According to the National Highway Transportation Administration, about 15 percent of vehicles — or about 30 million cars and trucks — have black boxes. About 65 percent to 90 percent of 2004 cars and trucks have them, according to the NHTA.
Rusty Haight, director of the Collision Safety Institute, which researches crashes and trains accident investigators, said black boxes were introduced in cars along with air bags in the 1970s.
Air bag sensors already collected the information and it was a small step to allow researchers to see how well other systems were performing, Haight said.
North Dakota Highway Patrol Capt. Mark Bethke said crash investigators must have a warrant to access information from a recorder. He said the patrol collects such information less than once a month and has never used it in court.
John Buchanan, a Miami accident reconstruction expert, said investigators must compare what the recorder says to the physical evidence at an accident scene.
“I’m a big believer in the box,” he said. “But you cannot just take a box, read what it says and say that’s what happened.”
Insurance companies already have limited access to some data.
State Farm requires its customers to help with investigations, including allowing insurance employees to look at their vehicles, said Dick Luedke, a spokesman for the Illinois-based insurer.
Progressive Insurance began a voluntary program last year in which the company gives drivers a chip similar to a black box that can be used to transmit data, said spokeswoman Shannon Radigan.
Progressive offers drivers the possibility of a break on their insurance rates based on when, how much and how fast they drive, she said. The average discount is between 12 percent and 15 percent, she said.
North Dakota auto dealers say they have not heard many complaints about black boxes. Sales people say customers rarely ask about them. And police say the devices are not common.
“They’re just not very prevalent,” said Fargo Sgt. Joel Vettel.
“Most people don’t realize these devices are in their vehicle, that the information recorded may be used against them and there’s no sort of regulation about who owns that information,” he said.
North Dakota is one of 11 states considering black-box regulation this year, said Pam Greenberg, who tracks privacy issues for the National Conference of State Legislatures.
California has a law on the books requiring dealers and vehicle rental companies to inform drivers when a car has a black box. In New York, it is illegal for rental companies to use global positioning system technology to track drivers and use the data to charge extra fees or penalties.
Accident investigators argue that the privacy concerns are overblown.
“These guys are trying to roll back North Dakota courts to the Dark Ages,” said Jim Harris, owner of Harris Technical Services, a Florida-based accident investigation company. “What are you going to do? Leave out videotapes?”

Child Safety in Vehicles

CBS/AP) According to the National Highway Transportation Safety Administration, 3,300 children between the ages of 4 and 7 died in a motor vehicle crashes between 1994 and 2002.
On Sunday, March 27, New York State joined more than two-dozen other states requiring that children from ages 4 to 6 sit in booster seats when riding in a car.
Kim Kleman, managing editor of Consumer Reports Magazine, tells The Early Show co-anchor Rene Syler booster seats are important for children because when they get out of toddler seats, they are too small for a regular seat belt to hold them properly.
She explains, “The top catches the child’s neck and the bottom part goes around the child’s abdomen as opposed to the hips where it’s supposed to go.”
Therefore, if there is an accident, a regular seat belt can strangle a child or cause abdominal bleeding. The booster seat hits the child in the right place – that is around the hips, which are the strongest part of the body, she notes.
Demonstrating how toddler booster seats work, Kleman says, “The good thing about these is you buy it when your child is forward-facing, when they’re about 20 pounds. When they get about 40 pounds, you take off the harness in the back and it can be used as a booster.”
While the state law covers children until age 7, the National Highway Traffic Safety Administration recommends children remain in booster seats until they reach 4-feet-9 inches tall or 80 pounds. Since the weight limits of booster seats vary by model, parents should check the guidelines on the seat they buy.
“They’re really not expensive. These are 40 to $45,” Kleman notes.
Previous New York State law required children up to age 4 to be in a booster seat. The law covers all children in the front and back seats, so parents car-pooling kids to kindergarten, first or second grade will have to have a car seat for every child.
Only liveries, taxis and public buses are exempt. Failure to comply carries a $25 to $100 fine and could cost drivers three-point infractions on their licenses.
In July, a similar law will go into effect in Indiana that will require children under age 8 to use a booster seat. Similar laws are pending in 16 other states.

Sex Abuse Allegations Continue to Swirl Around Founder of Legionnaires of Christ

Maciel scandal won’t go away
If Fr. Marcial Maciel Degollado, founder of the religious order the Legionaries of Christ, were a priest in the United States, he would not be permitted in active ministry.
Some may not consider the U.S. norms ideal, but the crisis caused by the sex abuse scandal and the concomitant crisis of authority in the church demand bold and determined measures. Few cases have generated the notoriety and challenge to the church’s integrity and credibility that the Maciel case has. Maciel was warmly praised by the late Pope John Paul II and, by all accounts, was able to raise enormous amounts of money that have gone to establishing a religious empire in a short time.
Clergy sex abuse victims the world over who have heard pious words and statements of resolve from the hierarchy were waiting to see if the church at the highest levels would discontinue the practice of protecting priests at all costs and do a thorough investigation of the charges against Maciel, as well as a thorough accounting of its findings.
So, when the news reports said that the Vatican had apparently dropped the investigation, had not launched a formal canonical procedure in response to allegations, and that it had no plans to do so, many saw the development as a stinging disappointment. The announcement raised far more questions than it answered. The lack of resolution to the case eventually could be far more damaging to the church’s credibility than the jolt of bad news that might issue from a thorough airing of the case against Maciel.
As it turns out, however, the real problem may not be any decision by the Congregation for the Doctrine of the Faith, but rather papal palace intrigue involving an old friend of Maciel and the willingness of the Legionaries to mislead the world and allow the misconception to stand until a reporter happened to ask the right question of the right person.
It turns out that the reasonable presumption that everyone was working under — that the statement had been issued by the Congregation for the Doctrine of the Faith, the agency with the responsibility for making such judgments — was incorrect. The statement on which the Legionaries had based their release, a release that itself overstates the Italian in translation, actually came from the Vatican’s Secretariat of State, an office run by Italian Cardinal Angelo Sodano, a longtime friend of Maciel and an enthusiastic supporter of the order.
To be fair, the Legionaries didn’t misstate anything. The release reported that the “Holy See” said that “there is no investigation now” and that one was not foreseen in the future. “Holy See” covers a multitude of possibilities.
However, had the Legionaries said in the release that the Vatican’s Secretariat of State had made the statement, anyone familiar with the workings of the Vatican and with who’s responsible for what, would immediately have exercised a great degree of skepticism and started asking more questions.
For the record, it should be noted that the wording of the communication from the Secretariat of State is not quite as categorical as the Legionaries’ May 20 news release implies. The Vatican has not said definitively that there never will be a process, but that one “is not foreseen,” leaving open the possibility of future developments. It may seem a small point, but it adds to the mountain of disinformation that the Legionaries have generated over the years about their founder.
Further, that small point will be cold comfort to Maciel’s alleged victims, who believe their day in court has already been long delayed, and whose hopes were raised by recent meetings with the congregation’s chief investigator, Msgr. Charles Scicluna. Given Maciel’s age, 85, not moving forward now is perhaps tantamount to a decision never to do so at all.
To date, the Vatican has offered no explanation for the decision. It’s not clear whether it’s because Scicluna or his superiors, including Pope Benedict XVI, don’t believe the charges against Maciel; whether they determined that the evidence is compelling but not beyond a reasonable doubt; whether they decided that in view of Maciel’s age, his resignation in January as superior of the order, and his service to the church, that it did not make sense to prosecute; or whether the logic is something else altogether. Leaving this up in the air is simply not satisfactory. It is unfair to many in the Legion because suspicion will linger over their founder, and it is unfair to the larger Catholic community, which once again is left to deduce that protecting the reputation of the clergy and of the institution is more important than getting at the truth.
The Legion itself has been of little help in pursuing the truth. In response to queries, it sends people to its Web site, which contains a tired and wholly inadequate defense of Maciel, even as new charges and evidence piles up. That Maciel once declared his innocence is irrelevant in the face of the accusations and the lack of a process that gives the charges a fair hearing. Citing the reluctance of young seminarians decades ago to come out against a leader who has been described repeatedly by responsible witnesses as a dominant and domineering personality overseeing a culture in which he demanded absolute and unquestioning loyalty to himself is an absurd way of trying to dispel suspicion. Anyone who has had anything to do with abuse victims knows that reasonable people, in far less intimidating circumstances, have been cowed into silence for decades by the awful experience of being sexually abused.
Church authorities have been understandably hesitant to discuss individual cases in public, on the grounds that both the accused and the victims have a right to their good names and to privacy. In this case, however, silence does not serve the interests of any of the parties. In the U.S. vernacular, what is happening in Rome on the Maciel case is a whitewash, a continuation of the cover-up and deception that has so deeply wounded the church here.
If Vatican officials believe that Maciel is innocent, justice demands that they say so, especially given the way these charges have enjoyed wide international circulation. If they believe the evidence is inconclusive, that too should be said, so that at least the parties will know where they stand. If officials have prudential reasons for not moving against Maciel, the accusers have a right to know that this inaction does not presume a judgment about the veracity of their accounts.
Moreover, it’s not just the rights of Maciel and his accusers that are at stake. The broader Catholic public has justifiable concerns about the pattern of official response to the sexual abuse crisis, and a laconic statement that the church does not intend to move against an accused priest, with no explanation offered, will do little to assuage those concerns. On the contrary, it will deepen the cynicism and resentment that is already too pervasive in the Catholic community.
For pastoral reasons, therefore, as well as due process of law, the Vatican needs to offer an explanation.
Pope Benedict XVI’s motto as the archbishop of Munich was cooperators veritatis, “coworkers of the truth.” He has challenged Western culture to recover its confidence in objective truth, over against a lazy relativism. All the more reason, therefore, for the church to practice what its leader preaches — it needs to tell the truth, and the whole truth, about the Maciel case.
National Catholic Reporter, June 3, 2005

Pharmacists Can Be Liable

Court: Druggists can be liable for failing to warn of risks
An appeals court rules in the case of a man whose wife died of an overdose after druggists filled her prescriptions.
By Associated Press
Published June 4, 2005
MIAMI – A Florida appeals court has ruled for the first time that pharmacists can be held liable for failing to warn people about the risks associated with the use of drugs repeatedly or in harmful combinations, even if they are filling doctors’ prescriptions.
The 4th District Court of Appeal, reversing a lower court, decided this week that Robert Powers can pursue claims of negligence against two pharmacies – Your Druggist and the Medicine Shoppe – that filled his wife’s prescriptions for neck and back pain. Gail Powers died of an overdose.
Pharmacists already must have “general knowledge” of the medicines they dispense, as well as knowledge of the risks they present, the court found.
“Thus, a strong policy basis already exists supporting a pharmacist’s duty to warn customers of the risks inherent in filling repeated and unreasonable prescriptions with potentially fatal consequences,” Judge Mark E. Polen wrote for the court.
The pharmacies plan to appeal.
Peter Herman, Powers’ attorney, said the ruling is “important because from a consumer’s standpoint, a pharmacist is probably going to be in the best position to raise a red flag.”
Gail Powers, a 46-year-old waitress, died in October 2002 from an overdose of prescription drugs. She had been taking six drugs, including the powerful painkillers OxyContin and Percocet and the antianxiety drug diazepam. These drugs can be harmful if taken together, and some are highly addictive with long-term use, according to the Food and Drug Administration.
In his lawsuit, Powers said the druggists wrongly filled all of his wife’s prescriptions without question, even though many were filled within days of previous prescriptions – raising the possibility of dangerous combinations or easy access to too many pills. The lawsuit also named his wife’s doctor, a neurologist.
The negligence claims against the pharmacies were dismissed by a trial judge in Broward County who said that, under Florida law, druggists aren’t liable if they’re filling legal prescriptions.
The 4th District Court of Appeal’s reversal of that decision Wednesday gives Powers another chance to pursue his claims. The ruling did not address whether Powers might succeed on the merits of the lawsuit.
Jay Greene, attorney for the Medicine Shoppe, said the decision will be appealed to the Florida Supreme Court within 30 days.
The appeals court, sitting in West Palm Beach, noted that its decision conflicts with rulings issued by the 1st District Court of Appeal in Tallahassee and the 5th District Court of Appeal in Daytona Beach in similar cases. But the judges cited recent cases in Pennsylvania, Arizona, Nevada, Missouri and Tennessee in which courts found that pharmacists have a duty to warn patients, doctors or both about the possible risks of using prescription drugs repeatedly, over a lengthy period or in certain combinations.

Bextra, Celebrex, and Vioxx Manufacturers Hide Drug Risks

AP Business WriterTue May 24,12:49 AM ET
Pfizer Inc., GlaxoSmithKline PLC. and Merck & Co. are “making a mockery” of efforts to create more transparency in drug clinical trials, according to a prominent medical journal editor.
Dr. Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine, said the companies are not providing enough useful details in their posting on a government trial registry and that their reluctance to provide meaningful information may hamper their ability to have their studies published in important medical publications
Last September, the members of the International Committee of Medical Journal Editors said they would not publish any studies that are not registered in a public database as they are launched. Drazen’s comments came as the editors delivered more details about what they expect from pharmaceutical companies. The group is asking for 20 disclosures, including what each study is designed to evaluate, how many patients will be studied and who is funding the research.
Drazen based his comments on a review of the information drug companies posted on www.clinicaltrials.gov., which is run by the U.S. National Institutes of Health. He said the review was conducted by Dr. Deborah Zarin of the NIH at the request of the committee.
“They (the three companies) are giving nonsense details,” Drazen said in an interview on Monday. “They are written in a way that they are trying to hide what they are doing.”
Merck spokeswoman Janet Skidmore said the company didn’t agree with Drazen’s characterization of its entries on the government web site.
“We have done everything we can to expedite medical information and enhance transparency,” Skidmore said.
Glaxo spokeswoman Mary Anne Rhyne said the company has listed 55 ongoing trials on the NIH site as well as 400 studies on its own site. Rhyne said the company intends to supply journal editors with all the trial protocols along with any manuscript for publication so the editors can see the article accurately represents the study conducted.
Pfizer didn’t return calls for comment.
The editors created the policy after some drug companies were accused of stifling negative data from clinical trials. Last year, New York state Attorney General Eliot Spitzer sued GlaxoSmithKline for suppressing unfavorable studies of its antidepressants. He also asked Forest Laboratories for information about studies of its antidepressants.
Meanwhile, trial lawyers have accused Merck of hiding negative information about Vioxx, the pain killer it withdrew from the market last year because a study showed it doubled patients risk of heart attack and strokes.
Zarin said first she looked at whether pharmaceutical companies were giving drugs a distinguishable name. She said a name is crucial because it allows editors, patients and doctors to track a medicine’s progress through the trial process.
“You need a name to search a data base,” said Zarin. “You wouldn’t know if you were missing something if the drug doesn’t have a name you can search.”
Indeed, the problem that has vexed editors is that they can’t readily find out if negative data exists when they are only given glowing manuscripts. The registry is supposed to give editors, doctors and patients a complete picture of a drug’s development but that would be difficult if a medicine can’t be tracked through its name.
Of the over 400 companies with trials listed on the registry, only 5 neglected to list specific names, often calling the products simply “investigational drug”, Zarin said.
Zarin said that 90 percent of the time Merck didn’t provide a name. Glaxo didn’t provide a name 53 percent of the time while Pfizer lacked a name 36 percent of the time. The other two companies were Eli Lilly & Co. and Bristol-Myers Squibb Co. but they lacked names less than 5 percent of the time.
Drazen said another problems with the information submitted by three companies included a failure to clearly outline the primary and secondary outcome measures of their studies. For example, a study should say that it is attempting to see if a drug can lower heart attacks over a year.
However, Zarin noted that most companies didn’t provide such data and that it wasn’t required by the NIH. Since October, there is space for companies to include such information, however.
Drazen said that Lilly and Abbott Laboratories are “90 percent in compliance” with what the editors are expecting. Zarin gave high marks to Novartis for the quality of its disclosures.
Drug companies are legally required to register trials dealing with serious or life-threatening diseases to the NIH site. But since the controversy over trials, companies have been listing various types of studies on the site. Some companies have also begun listing the trials on their own web sites.
Earlier this year, four major international pharmaceutical associations agreed that companies should provide submit information on their trials to a public registry. The U.S. association, the Pharmaceutical Research and Manufacturers of America, recommended its members list trials on the NIH site beginning in July.
The editors have given the companies until September 13, 2005 to register ongoing trials. It applies to new trials starting on or after July 1, 2005.
Drazen said that if the companies don’t comply, editors will refuse to publish their studies. He said that other medical journals had adopted the registry standards of the international committee so companies that don’t comply may find their choice of publication venues is limited. Drug companies often use studies published in medical journals in their marketing.
“We think they will want our stamp of approval,” Drazen said.

Will Bextra Return to the Market?

Pfizer Wants Bextra Which Causes Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Back on Market
CHICAGO, May 16 (UPI) — Pfizer Inc. wants to put its second-generation COX-2 drug Bextra back on the market but lawyers for patients who contend they were harmed by the drug warn it was approved too hastily in the first place.
The pharmaceutical giant voluntarily suspended sales of the $1 billion-a-year anti-inflammatory painkiller April 7, one day after a 19-page Food and Drug Administration memo raised concerns of possible health risks of COX-2 inhibitors, the class of painkillers touted as being easier on the stomach lining than aspirin. Bextra, Pfizer’s second generation COX-2 after the success of Celebrex, was prescribed for treatment of arthritis, rheumatism and menstrual pain.
Pharmacists no longer are allowed to fill prescriptions for Bextra and people who think they have suffered harm by taking the drug are filing personal injury lawsuits.
Pfizer Chief Executive Officer Hank McKinnell hopes Bextra gets FDA re-approval for at least limited use. He told the Boston Globe FDA reviewers saw unpredictable skin reactions in Bextra users but had not seen “increased cardiovascular risk,” the problem seen with Merck’s Vioxx, which was pulled from the market last fall.
“Pfizer continues to believe that Bextra could be an important treatment option for certain patient populations. In the future, the company plans to discuss options with the FDA under which Bextra might be made available to those patients,” the company said in a statement released last week.
Should FDA reintroduce the drug, patients likely would have to sign consent forms before filling a prescription.
FDA placed its strongest black box safety warning for risk of cardiovascular events on Celebrex last month and recommended pulling Bextra after seeing at least seven reports of people dying from severe skin reactions.
Stevens Johnson Syndrome and Toxic Epidermal Necrolysis are the most severe skin rashes triggered by full-blown allergic reactions to NSAIDs and sulfonamides. Both diseases are rare and life-threatening. SJD causes skin to burn from the inside and TENS occurs when the damage covers more than 30 percent of the body.
FDA have said Bextra, Celebrex and Vioxx — and possibly all nonsteroidal anti-inflammatory drugs drugs — come with an increased risk of serious adverse cardiovascular events. Vioxx was shown to double the risk of heart attack and stroke among patients in a clinical study who took the medication for longer than 18 months.
A Dec. 23, 2004, public health advisory on NSAIDs warned long-term use of naproxen — sold as Aleve, Naprosyn and other trade names — “may also be associated with an increased cardiovascular risk.”
Pfizer said Bextra, however, does not have the same heart-related risk as Vioxx.
Two studies released in January suggested combining Bextra with aspirin could increase risk of blood clots leading to heart attack or stroke. FDA asked makers of all NSAIDs to revise labels to warn of potential cardiovascular events, as well as serious stomach ulcer bleeding.
A study involving 6,000 people in clinical trials presented at the American Heart Association’s annual conference in November found Bextra doubled risk of heart attack or stroke.
Bextra was marketed as a kind of non-sulfa Celebrex. Critics branded it a COX-2 “me-too” possibly rushed to market because of Vioxx’s popularity. Bextra sales increased 355 percent worldwide in a single year.
This was a drug that according to Pfizer’s own admission was not studied in any clinical trial over 12 months duration and they knew that there was a huge market for these drugs so that there would be a patient population taking these drugs. I think that they saw the incredible early success of Vioxx and they wanted a share of that.

Diocese of Covington Class Action Settlement

By Jim Hannah
Enquirer staff writer
The Enquirer/Andrea Remke
The Catholic Center in Erlanger, which is closing in part because of settlement fees for sexual abuse claims paid by the Covington Diocese.
BURLINGTON – The Covington Diocese announced this afternoon it will pay $120 million to settle the nation’s first class-action lawsuit involving priest sexual abuse.
A settlement fund will be made up of $40 million from investments and real estate. The remaining $80 million will be paid by insurance companies.
No parish property, parish funds or Diocesan Parish Annual Appeal money will be used for the settlement, said diocesan spokesman Tim Fitzgerald.
The diocese has, over the past two years, been settling sexual abuse claims. In addition to today’s settlement, the diocese has paid about $10.5 million to settle 56 sexual-abuse claims in the past 18 months.
The diocese’s share of those earlier settlements was $4 million, while insurance companies picked up the difference.
It is not clear how many people are eligible to collect money from the class-action settlement, which still requires court approval, though the plaintiffs’ attorneys have said there are hundreds of victims.
As part of the settlement, claimants will be grouped into four categories, based on the nature and severity of the abuse. Both sides have agreed that victims will get from $5,000 to $450,000 each.
“From the moment I was made aware of the extent of the abuse of children by priests in this diocese, I made a promise that I would do all I could to reach out to the victims,” Bishop Roger Foys said in a written statement. He was appointed in July 2002.
“After personally meeting with more than 70 victims, I am painfully aware that no amount of money can compensate for the harm these victims suffered as innocent children,” he wrote. “Nevertheless, I pray that this settlement will bring some measure of peace and healing to victims and their loved ones.”
Cincinnati attorney Stan Chesley, lead counsel for the plaintiffs, said any person who claims to have been sexually abused by any religious person or employee of the diocese may make a claim no matter when it occurred.
“The additional anxiety and stress that would have occurred to the victims had there been a trial has been eliminated,” Chesley said in a statement. “While this took a long time to accomplish, it could not have occurred without the commitment of both sides to work toward a fair and reasonable resolution.”

Anglican Church Pedophile Scandal in Australia

Fresh allegations have been raised about a pedophile ring operating within the Anglican church in Australia in the 1980s.
Former Anglican archdeacon Louis Victor Daniels was sentenced to seven-and-a-half years in jail last month for molesting 10 youths aged between 11 and 19.
One of his victims, Tasmanian Brett Andrew Skipper, killed himself last year just months before Daniels was arrested.
Brett Skipper’s mother, Zena, says her son was sent from Hobart to Adelaide, where he was abused by then-Anglican youth worker Bob Brandenburg.
“He did on two occasions,” she told the ABC TV’s program.Stateline
“This again was bribery – with promises to go to the grand prix and literally do what they wanted.”
She says she has no doubt the priest’s abuse contributed to her son’s suicide.
“[The abuse] had a great impact on Brett’s life,” she said.
“He had really deep bouts of depression and sometimes he’d lock himself in his flat for three or four days at a time.
“He wouldn’t answer the door, he wouldn’t answer the phone.”
The latest allegations have led to further calls for an investigation into the church’s role in pedophilia during the 1980s.