Ranbaxy, a Generic Drug Maker, Stops Making Cholesterol Pill

Ranbaxy Pharmaceuticals, the largest producer of the generic version of Lipitor, has halted production of the drug until it can figure out why glass particles may have ended up in pills that were distributed to the public, the Food and Drug Administration announced Thursday.

The agency said it had not received any reports of patients being harmed by the particles, which are about the size of a grain of sand. Earlier this month, Ranbaxy recalled more than 40 lots of the drug because of the glass contamination.

The company has declined to say where the drug was manufactured or why the problem occurred, but a spokeswoman for the F.D.A. said Thursday that the company would stop making the pill’s active ingredient, which is made in India, until the investigation is completed.

The contamination was the latest episode in a history of manufacturing lapses at Ranbaxy, which is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo. The company has been operating under a court-ordered consent decree since January, one that federal authorities have called “unprecedented in scope,” after they identified a host of manufacturing problems at the company’s plants in India and the United States, and concluded that Ranbaxy had submitted false data in drug applications to the F.D.A..

The decree prevents Ranbaxy from manufacturing drugs at its most troubled facilities until it can show it is meeting United States standards, although it was allowed to continue making products — including the generic version of Lipitor — at other plants.

The F.D.A. spokeswoman, Sarah Clark-Lynn, said the affected lots were not made at “the same facilities whose conduct gave rise to the consent decree.” Nonetheless, she said in an e-mail Monday, “the consent decree provides the F.D.A. with additional tools to address violations for other Ranbaxy facilities.”

A spokesman for Ranbaxy declined to comment beyond an informational statement on the company’s Web site.

Some drug manufacturing experts said Ranbaxy’s latest troubles highlight the disparities in oversight of plants in the United States versus those overseas. “I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job,” said Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education, who previously worked in manufacturing and global outsourcing for pharmaceutical companies, including Searle and Pharmacia. “But my confidence is not that high when we are getting products from outside the country.”

He pointed to studies that have shown the F.D.A. inspects foreign generic manufacturing plants about once every seven to 13 years, compared with once every two years for domestic manufacturers. A law passed over the summer will eventually require the F.D.A. to apply the same standards when inspecting all manufacturing plants, regardless of which country they’re in.

Allan Coukell, director of medical programs at the Pew Health Group and an expert on drug safety, said the new law would level what he described as an uneven playing field, but “it’s incumbent on F.D.A. to hire the staff and to make the shift to a risk-based inspection system.” Under the law, fees collected from generic manufacturers will help pay for more inspectors.

Mr. Basu said the law, called the Generic Drug User Fee Amendments of 2012 and known as Gdufa (Gah-doofuh) was a step in the right direction, but fixing the problem would require more than simply hiring more people. “This is a very difficult and complex system, and how do we ensure the integrity of this supply chain?” he said. “I don’t know how much Gdufa will help.”

Ranbaxy has held a significant share of the market for generic Lipitor, also known as atorvastatin, since it became one of the first companies to sell it after Pfizer lost patent protection for the top-selling drug last November; another company, Watson, sold a generic version that was authorized and manufactured by Pfizer. In October, Ranbaxy’s product accounted for 43 percent of prescriptions for atorvastatin, a widely used drug to lower cholesterol levels, according to an analysis by Michael Faerm, an analyst for Credit Suisse who used prescription data from the research firm IMS Health.

In its statement on Thursday, the F.D.A. said it did not expect a shortage of atorvastatin. Erin Fox, who tracks drug shortages as director of the Drug Information Service at the University of Utah, said drugs in pill form have long shelf lives and suppliers can keep large quantities in stock. Other generic manufacturers with approval to sell the drug include Apotex, Dr. Reddy’s Labs, Mylan, Sandoz, and Teva, according to the F.D.A. Web site.

Ranbaxy has posted a list of the recalled lots on its Web site, and has warned that patients should not stop taking the drug without guidance from their doctor. The lot numbers are found on the side of Ranbaxy pill bottles and the company advised patients to check with their pharmacist if customers received pills in a container dispensed by the pharmacy.

The agency said the potential for injury because of the contamination appeared to be low and “if any adverse events are experienced, they would be temporary.”

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Syrian Internet Connections Cut for Second Day

BEIRUT, Lebanon — Activists in Syria reported on Friday that Internet connections were cut for a second successive day, fanning speculation among opponents of President Bashar al-Assad about the government’s intentions in coming days.

But some supporters of the rebels seeking Mr. Assad’s overthrow in the country’s bloody civil war said they could bypass the blackout on Internet servers by using satellite communications.

“Generally speaking, in Idlib we haven’t had an Internet connection or working landlines since the very beginning of the uprising,” said Ahmad Kadour, an activist in the northern province of Idlib. “Right now, the Internet is not working in any part of Syria, but most activists use satellite Internet connections and own satellite phones, so all is well. This operation won’t affect activists’ work much.”

However, a sniper for the Free Syrian Army calling himself Abu Bakr said via Skype that while rebels in Homs had a satellite Internet connection, they had no satellite phones, and were having trouble communicating with each other. “We’re relying on very basic hand-held devices that the regime could tap to communicate with our people in Jobar,” he said, referring to a neighborhood of Homs, “but we also need to be in touch with activists in other neighborhoods, and that’s the problem we’re facing.”

“We are under the the regime’s siege and airstrikes, and now the regime is tightening the siege and isolating us further,” he said. “But we’re trying to manage. What can we do? We won’t give up.”

Despite the Internet blackout on Thursday, people outside the country could still access Syrian government Web sites for much of the day because they were hosted in foreign countries, including the United States. After being contacted by The New York Times on Thursday, several host companies said they were taking down those sites, including those for the Syrian state news agency, SANA; the Syrian General Authority for Development; and the Ministry of Religious Affairs. All three were down on Friday.

On Thursday, Syria lost two major links with the outside world as the largest commercial airport in the capital canceled flights because of fighting nearby and the disappearance of Internet access, perhaps signaling an impending escalation by the government against the uprising.

The disruption at the airport, Damascus International — a crucial conduit for supplies, money and weapons for the government — was a measure of how intense the conflict has become around the capital in recent weeks. As security forces launched a major counteroffensive against rebels nearby, the government’s willingness to carry out military operations in the area suggested that it was feeling the pressure of rebel advances. Keeping the airport open helps the government project a sense of normalcy, and the interruption of service creates problems, activists said, because the large planes needed for supplies cannot land at smaller military airports. News reports from Syria on Friday offered confused accounts of the fighting, quoting activists as saying that the main road to the Damascus airport had reopened after intense clashes in the early hours, in which rebel forces destroyed government vehicles.

A reporter for The Associated Press said Damascus was largely quiet, although there were sounds of fighting in the suburbs — a report corroborated by a Reuters dispatch quoting Damascus residents as saying black smoke could be seen from the east and south of the city, with the constant sound of shelling.

Reuters also said government forces used airstrikes against rebel targets near the road leading to the airport, while a regional flight operator said civilian flights were not landing there on Friday. for a second day.

On Thursday, two companies that monitor Internet traffic, Arbor Networks and Akamai, released data demonstrating that the Internet went out across the country around 10 a.m. The Internet has been a strategic tool of the uprising and the government alike, allowing activists to organize and communicate but also exposing them to surveillance. Videos uploaded by both sides have made the conflict extraordinarily visible to the outside world.

Rebels have put the government under increasing pressure in recent weeks, taking oil fields in eastern Syria and a major air base near Aleppo, and demonstrating their growing ability to shoot down aircraft.

On Thursday, several airlines said they had halted flights to Damascus. An official at EgyptAir said it had indefinitely suspended flights because of the security situation there, though morning flights to the northern city of Aleppo were operating.

“They’ve turned it into a military airport lately,” said Abdul Rahman al-Barra, 27, an activist in the Damascus suburbs, adding that rebels had recently captured 40 pro-government militiamen in ambushes on the airport road. “Helicopters and warplanes land there, and Russian and Iranian experts travel through it.”

Speaking via Skype, which he said he was using with a satellite connection, Mr. Barra said fighters with the Free Syrian Army were battling government forces about a mile from the airport. “It’s a hit-and-run kind of battle,” he said. “The Free Syrian Army is using mortar shells without getting close to the airport, which the regime is firmly gripping now.”

Hania Mourtada and Anne Barnard reported from Beirut, Lebanon, and Hala Droubi from Dubai, United Arab Emirates. Kareem Fahim and Mai Ayyad contributed reporting from Cairo, Christine Hauser and Amy Chozick from New York, and Alan Cowell from London.

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IHT Rendezvous: Our Brussels Correspondents Answer Readers' Questions About the Euro, Europe and the Union

The news this week from besieged Europe was — relatively — good, sort of. Yields on Italian government bonds — the amount Italy has to pay investors to assume a piece of their debt — fell to the lowest levels in more than a year. The German parliament, the Bundestag, approved Germany’s latest contribution to bailout broke Greece. And though unemployment in the euro zone reached record heights, the head of the European Central Bank, Mario Draghi, predicted today that the euro zone’s economy would begin to recover in the latter part of next year.

But how long will it last? We have been here before, a lot. The market decides things are OK for the moment, before souring on Europe again. The spectacle of European leaders failing to agree on the outlines of a European Union budget came only last week — and that specter will rear its head again next year when those same leaders have to fashion a budget, and Greece will have to stay afloat, and Spain, Italy and Portugal will have to continue implementing structural reforms, and France may face a reckoning of its own, and Britain….Well, you understand.

We recently asked readers for their questions about the future of the European experiment. To bring some long-term clarity to all the short-term clutter, our Brussels correspondents, James Kanter and Andrew Higgins, have supplied the answers.

Judy W. from Cumberland, Maryland, asked, “Do you think the U.K. will end up leaving the E.U. and would be in their best interest to leave?”

Well, Judy, opinion polls in the Britain certainly suggest that hostility to the E.U. is mounting and nobody has ever lost votes in the U.K. by campaigning against Brussels. In fact, our colleague Stephen Castle reports today that the UKIP, “the party that wants Britain to quit the European Union, made spectacular gains in three by-elections held Thursday, increasing pressure on the Conservative Prime Minister, David Cameron, to take a tough line on Europe.”

But saying and doing are two different things. And should a referendum on Britain’s membership in the European Union be held, I doubt a majority would vote to actually pull out altogether. Britain would gain a financial windfall by leaving as it would no longer have to make annual contributions to the E.U. budget, but it would likely pay a very heavy economic price if it separates itself from the “single European market.” Potential losses will, I suspect, tilt opinion away from the exit, no matter how suspicious many Britons are of the “European project.” And, if a British withdrawal ever became an imminent possibility, the influential banking lobby in the City of London would pull out all the stops to try and make sure this doesn’t happen. It would want to make sure Britain is not absent from a decision-making process in Brussels that has a direct impact on global banking. Having financiers and hedge fund managers on its side will not endear the E.U. to the general public but would help mobilize money for a referendum campaign. (Andrew Higgins)

Abo in Paris and Judy W. got into a mini-debate over what countries contribute how much to Europe and how much they get back, leading to the question, “Does it make sense for countries to look at what they ‘put in’ and what they ‘get out’ as far as subsidies and benefits?”

The question goes to the heart of why the European Union summit aimed at agreeing to a seven-year budget for the Union collapsed last week. Net contributor countries like Britain, Germany and Sweden were at loggerheads with net recipient countries like Poland, Lithuania and Spain over the size of the budget — about €1 trillion between 2014 and 2020, or $1.3 trillion. Britain was fighting hard to maintain an annual rebate that was worth about €3.5 billion last year. Denmark was demanding a rebate, too. But that kind of haggling is mostly pointless, according to the European Commission, the Union’s policymaking arm.

The commission says none of what countries “put in” and “get out” truly reflects the advantages of being part of a single market of 500 million people. As an example, the commission says the benefits of E.U. membership to the British economy are many times higher than its annual net contribution of around €7 billion (after subtracting the rebate and after subtracting the money from the E.U. budget spent in Britain in 2011). The commission also says there are many hidden benefits to membership such as common rules on health, environment and consumer protection. Of course, the commission has a dog in this fight: Its refusal to trim its costs, including generous salaries and pensions, earned it a rebuke last week from British Prime Minister David Cameron, who said its officials continue to “exist as if in a parallel universe.” (James Kanter)

A popular question among readers — and markets — continues to be, “Wouldn’t the E.U. be better off if Greek were made to leave the euro?” A related question we received was: “Why doesn’t the E.U. draw up sensible plans for a country to leave the euro?”

To the second question, Prime Minister Mark Rutte of the Netherlands suggested today that a country should indeed be able to leave the euro and stay in the European Union.

Most observers assume that plans for Greece to leave the euro zone have been drawn up. But there are a host of reasons why such a plan hasn’t been put into effect. One is that the euro project is as much political as economic. For many European policymakers, it’s anathema that a country that is part of a flagship project for ever closer Union like the single currency could be shown the door. There also are fears that removing Greece from the euro area would actually do very little to solve some of the problems underlying the single currency. Once Greece goes market speculators could drive up the bond spreads of other countries like Portugal and Italy with economies that are a lot weaker than those of countries like Germany, which could still force the euro zone to unravel. (J.K.)

Judy W. also asked, “With the current impasse over the budget, is there any thought given to stopping E.U. enlargement since so many of the new countries are in need of large subsidies? Do you think Turkey will ever be admitted to the EU or will its candidacy just fade away?”

Turkish accession has been moving at a snail’s pace since formal negotiations began with the government in Ankara seven years ago. Currently the process is in a deep freeze partly because Cyprus holds the rotating E.U. presidency and wants a solution to the Turkish occupation of the northern third of the island. Yet Turkey, too, is looking beyond the E.U. as its economy booms.

That’s all the more understandable when you recall that Turkey first applied to become a member in 1987. Rather than Turkey, the countries most likely to be next are from the Western Balkans. Croatia already is set to join in mid-2013. Brussels officials say that refusing membership for candidates like Serbia would be foolish because that would add to the risks of instability in the region. Containing violence there could be costlier than Serbian membership.

One of the biggest concerns about enlargement is whether newer members from Eastern and Central Europe are sticking by the rules on pluralism, human rights and openness. Cases of corruption in Bulgaria and suggestions of an authoritarian drift in Hungary may be factors dampening the appetite for enlargement more than the costs of welcoming additional countries with lower levels of economic development. (J.K.)

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Medicare Is Faulted in Electronic Medical Records Conversion

The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators.

Mike Spencer/Wilmington Star-News, via Associated Press

Celeste Stephens, a nurse, leads a session on electronic records at New Hanover Regional Medical Center in Wilmington, N.C.

Centers for Medicare and Medicaid Services

Marilyn Tavenner, acting administrator for Medicare.

The use of electronic medical records has been central to the aim of overhauling health care in America. Advocates contend that electronic records systems will improve patient care and lower costs through better coordination of medical services, and the Obama administration is spending billions of dollars to encourage doctors and hospitals to switch to electronic records to track patient care.

But the report says Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions.

Medicare “faces obstacles” in overseeing the electronic records incentive program “that leave the program vulnerable to paying incentives to professionals and hospitals that do not fully meet the meaningful use requirements,” the investigators concluded. The report was prepared by the Office of Inspector General for the Department of Health and Human Services, which oversees Medicare.

The investigators contrasted the looser management of the incentive program with the agency’s pledge to more closely monitor Medicare payments of medical claims. Medicare officials have indicated that the agency intends to move away from a “pay and chase” model, in which it tried to get back any money it has paid in error, to one in which it focuses on trying to avoid making unjustified payments in the first place.

Late Wednesday, a Medicare spokesman said in a statement: “Protecting taxpayer dollars is our top priority and we have implemented aggressive procedures to hold providers accountable. Making a false claim is a serious offense with serious consequences and we believe the overwhelming majority of doctors and hospitals take seriously their responsibility to honestly report their performance.”

The government’s investment in electronic records was authorized under the broader stimulus package passed in 2009. Medicare expects to spend nearly $7 billion over five years as a way of inducing doctors and hospitals to adopt and use electronic records. So far, the report said, the agency has paid 74, 317 health professionals and 1,333 hospitals. By attesting that they meet the criteria established under the program, a doctor can receive as much as $44,000 for adopting electronic records, while a hospital could be paid as much as $2 million in the first year of its adoption. The inspector general’s report follows earlier concerns among regulators and others over whether doctors and hospitals are using electronic records inappropriately to charge more for services, as reported by The New York Times last September, and is likely to fuel the debate over the government’s efforts to promote electronic records. Critics say the push for electronic records may be resulting in higher Medicare spending with little in the way of improvement in patients’ health. Thursday’s report did not address patient care.

Even those within the industry say the speed with which systems are being developed and adopted by hospitals and doctors has led to a lack of clarity over how the records should be used and concerns about their overall accuracy.

“We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago. The association, which contends more study is needed to determine whether hospitals and doctors actually are abusing electronic records to increase their payments, says it supports more clarity.

Although there is little disagreement over the potential benefits of electronic records in reducing duplicative tests and avoiding medical errors, critics increasingly argue that the federal government has not devoted enough time or resources to making certain the money it is investing is being well spent.

House Republicans echoed these concerns in early October in a letter to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.

In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff.” She said Medicare was trying to determine whether electronic records had been used in any fraudulent billing but she insisted that the current efforts to certify the systems and address the concerns raised by the Republicans and others were adequate.

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Medicare Is Faulted in Electronic Medical Records Conversion

The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators.

Mike Spencer/Wilmington Star-News, via Associated Press

Celeste Stephens, a nurse, leads a session on electronic records at New Hanover Regional Medical Center in Wilmington, N.C.

Centers for Medicare and Medicaid Services

Marilyn Tavenner, acting administrator for Medicare.

The use of electronic medical records has been central to the aim of overhauling health care in America. Advocates contend that electronic records systems will improve patient care and lower costs through better coordination of medical services, and the Obama administration is spending billions of dollars to encourage doctors and hospitals to switch to electronic records to track patient care.

But the report says Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions.

Medicare “faces obstacles” in overseeing the electronic records incentive program “that leave the program vulnerable to paying incentives to professionals and hospitals that do not fully meet the meaningful use requirements,” the investigators concluded. The report was prepared by the Office of Inspector General for the Department of Health and Human Services, which oversees Medicare.

The investigators contrasted the looser management of the incentive program with the agency’s pledge to more closely monitor Medicare payments of medical claims. Medicare officials have indicated that the agency intends to move away from a “pay and chase” model, in which it tried to get back any money it has paid in error, to one in which it focuses on trying to avoid making unjustified payments in the first place.

Late Wednesday, a Medicare spokesman said in a statement: “Protecting taxpayer dollars is our top priority and we have implemented aggressive procedures to hold providers accountable. Making a false claim is a serious offense with serious consequences and we believe the overwhelming majority of doctors and hospitals take seriously their responsibility to honestly report their performance.”

The government’s investment in electronic records was authorized under the broader stimulus package passed in 2009. Medicare expects to spend nearly $7 billion over five years as a way of inducing doctors and hospitals to adopt and use electronic records. So far, the report said, the agency has paid 74, 317 health professionals and 1,333 hospitals. By attesting that they meet the criteria established under the program, a doctor can receive as much as $44,000 for adopting electronic records, while a hospital could be paid as much as $2 million in the first year of its adoption. The inspector general’s report follows earlier concerns among regulators and others over whether doctors and hospitals are using electronic records inappropriately to charge more for services, as reported by The New York Times last September, and is likely to fuel the debate over the government’s efforts to promote electronic records. Critics say the push for electronic records may be resulting in higher Medicare spending with little in the way of improvement in patients’ health. Thursday’s report did not address patient care.

Even those within the industry say the speed with which systems are being developed and adopted by hospitals and doctors has led to a lack of clarity over how the records should be used and concerns about their overall accuracy.

“We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago. The association, which contends more study is needed to determine whether hospitals and doctors actually are abusing electronic records to increase their payments, says it supports more clarity.

Although there is little disagreement over the potential benefits of electronic records in reducing duplicative tests and avoiding medical errors, critics increasingly argue that the federal government has not devoted enough time or resources to making certain the money it is investing is being well spent.

House Republicans echoed these concerns in early October in a letter to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.

In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff.” She said Medicare was trying to determine whether electronic records had been used in any fraudulent billing but she insisted that the current efforts to certify the systems and address the concerns raised by the Republicans and others were adequate.

Read More..

Medicare Is Faulted in Electronic Medical Records Conversion

The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators.

Mike Spencer/Wilmington Star-News, via Associated Press

Celeste Stephens, a nurse, leads a session on electronic records at New Hanover Regional Medical Center in Wilmington, N.C.

Centers for Medicare and Medicaid Services

Marilyn Tavenner, acting administrator for Medicare.

The use of electronic medical records has been central to the aim of overhauling health care in America. Advocates contend that electronic records systems will improve patient care and lower costs through better coordination of medical services, and the Obama administration is spending billions of dollars to encourage doctors and hospitals to switch to electronic records to track patient care.

But the report says Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions.

Medicare “faces obstacles” in overseeing the electronic records incentive program “that leave the program vulnerable to paying incentives to professionals and hospitals that do not fully meet the meaningful use requirements,” the investigators concluded. The report was prepared by the Office of Inspector General for the Department of Health and Human Services, which oversees Medicare.

The investigators contrasted the looser management of the incentive program with the agency’s pledge to more closely monitor Medicare payments of medical claims. Medicare officials have indicated that the agency intends to move away from a “pay and chase” model, in which it tried to get back any money it has paid in error, to one in which it focuses on trying to avoid making unjustified payments in the first place.

Late Wednesday, a Medicare spokesman said in a statement: “Protecting taxpayer dollars is our top priority and we have implemented aggressive procedures to hold providers accountable. Making a false claim is a serious offense with serious consequences and we believe the overwhelming majority of doctors and hospitals take seriously their responsibility to honestly report their performance.”

The government’s investment in electronic records was authorized under the broader stimulus package passed in 2009. Medicare expects to spend nearly $7 billion over five years as a way of inducing doctors and hospitals to adopt and use electronic records. So far, the report said, the agency has paid 74, 317 health professionals and 1,333 hospitals. By attesting that they meet the criteria established under the program, a doctor can receive as much as $44,000 for adopting electronic records, while a hospital could be paid as much as $2 million in the first year of its adoption. The inspector general’s report follows earlier concerns among regulators and others over whether doctors and hospitals are using electronic records inappropriately to charge more for services, as reported by The New York Times last September, and is likely to fuel the debate over the government’s efforts to promote electronic records. Critics say the push for electronic records may be resulting in higher Medicare spending with little in the way of improvement in patients’ health. Thursday’s report did not address patient care.

Even those within the industry say the speed with which systems are being developed and adopted by hospitals and doctors has led to a lack of clarity over how the records should be used and concerns about their overall accuracy.

“We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago. The association, which contends more study is needed to determine whether hospitals and doctors actually are abusing electronic records to increase their payments, says it supports more clarity.

Although there is little disagreement over the potential benefits of electronic records in reducing duplicative tests and avoiding medical errors, critics increasingly argue that the federal government has not devoted enough time or resources to making certain the money it is investing is being well spent.

House Republicans echoed these concerns in early October in a letter to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.

In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff.” She said Medicare was trying to determine whether electronic records had been used in any fraudulent billing but she insisted that the current efforts to certify the systems and address the concerns raised by the Republicans and others were adequate.

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State of the Art: Tablets Are Hot Holiday Gifts, but Which One to Buy? — Review

From left: J. Emilio Flores for The New York Times, Jim Wilson/The New York Times, Everett Kennedy Brown/European Pressphoto Agency

From left, the Kindle PaperWhite, the iPad Mini and the  Nexus 7.

The other day, I joined NPR for a segment about high-tech holiday gifts. I was ready for the calls from listeners. I’d brushed up on cameras, phones, laptops, music players and game consoles. I was prepared to talk about limiting screen time, digital addiction, cyberbullying. I knew where to get the best deals.

But all six callers had the same question: “What tablet should I get?”

There were variations, of course. “— for my kid?” “— for my elderly father?” “— just for reading?” “— for not much money?” But in general, it was clear: the gadget most likely to be found under the tree this year is thin, battery-powered and flat.

No wonder people are confused. The marketplace has gone tablet-crazy. There’s practically a different model for every man, woman and child.

There’s the venerable iPad, of course. And now the iPad Mini. There are new tablets from Google, also in small and large. There are Samsung’s Note tablets in a variety of sizes, with styluses. There are $200 touch-screen color e-book/video players. There’s a new crop of black-and-white e-book readers. There are stunningly cheap plastic models you’ve never heard of. There are tablets for children (and I don’t mean baby aspirin).

So how are you, the confused consumer, supposed to keep tabs on all these tablets? By taking this handy tour through the jungle of tablets 2012. Keep hands and feet inside the tram at all times.

DIRT-CHEAP KNOCKOFFS You can find no-name tablets for $100 or even less. You can also find mystery-brand Chinese tablets in toy stores, marketed to children.

Don’t buy them. They don’t have the apps, the features, the polish or the pleasure of the nicer ones. The junk drawer is already calling their names.

E-BOOK READERS The smallest, lightest, least expensive, easiest to read tablets are the black-and-white e-book readers. If the goal is simply reading — and not, say, watching movies or playing games — these babies are pure joy.

Don’t bother with the lesser brands; if you’re going to get locked into one company’s proprietary, copy-protected book format, you’ll reduce your chances of library obsolescence if you stick with Amazon or Barnes & Noble.

Each company offers a whole bunch of models. But on the latest models, the page background lights up softly, so that you can read in the dark without a flashlight. (These black-and-white models also look fantastic in direct sun — now you get the best of both lighting conditions.)

The one you want is the Kindle PaperWhite ($120), whose illumination is more even and pleasant than the equivalent Nook’s.

Of course, plain, no-touch, no-light Kindles, with ads on the screen saver, start as low as $70. But the light and the touch-screen are really worth having.

COLOR E-READERS/PLAYERS Amazon and B.& N. each sell a seven-inch tablet that, functionally, lands somewhere between an e-book reader and an iPad. They have beautiful, high-definition touch-screens. They play music, TV shows, movies and e-books. They can surf the Web. They even run a few handpicked Android apps like Netflix and Angry Birds.

They’re nowhere near as capable as full-blown, computerlike tablets of the iPad/Nexus ilk, mainly because there are so few apps, accessories and add-ons. But they cost $200; you’re paying only a fraction of the price.

The big two here are, once again, Amazon and B.& N. If you’re not already locked in to one of those companies’ books and videos because you owned a previous model, the Nook HD is the one to get. It’s much smaller and lighter than the Kindle Fire HD. It has a much sharper screen. And the $200 price includes a wall charger (the Fire doesn’t) and no ads (the Fire does). Or get the classy Google Nexus 7, also $200. Although its book/music/movie catalog is far smaller, its Android app catalog is far larger (but see “iPad versus Android,” below).

BIG COLOR READERS/PLAYERS This year, both Amazon and B.& N. have introduced jumbo-screen (9-inch) versions of their HD tablets. Here again, B.& N. offers a better value than its 9-inch Kindle Fire HD rival. For $270, the Nook HD+ offers a sharper screen, lighter weight, no ads, a memory-card slot and a wall charger.

E-mail: pogue@nytimes.com

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Hacking Report Criticizes Murdoch Newspaper and British Press Standards

LONDON — The leader of a major inquiry into the standards of British newspapers triggered by the phone hacking scandal offered an excoriating critique of the press as a whole on Thursday, saying it displayed “significant and reckless disregard for accuracy,” and urged the press to form an independent regulator to be underpinned by law.

Dan Kitwood/Getty Images

Lord Justice Sir Brian Leveson on Thursday with his inquiry on press standards.

The report singled out Rupert Murdoch’s defunct tabloid The News of the World for sharp criticism.

“Too many stories in too many newspapers were the subject of complaints from too many people with too little in the way of titles taking responsibility, or considering the consequences for the individuals involved,” the head of the inquiry, Lord Justice Sir Brian Leveson, said in a 46-page summary of the findings in his long-awaited, 1,987-page report published in four volumes.

“The ball moves back into the politicians’ court,” Sir Brian said, referring to what form new and tighter regulations should take. “They must now decide who guards the guardians.”

The report was published after some 337 witnesses testified in person in 9 months of hearings that sought to unravel the close ties between politicians, the press and the police, reaching into what were depicted as an opaque web of links and cross-links within the British elite as well as a catalog of murky and sometimes unlawful practices within the newspaper industry.

“This inquiry has been the most concentrated look at the press this country has ever seen,” Sir Brian said after the report was made public.

But in a first reaction, Prime Minister David Cameron resisted the report’s recommendation that a new form of press regulation should be underpinned by laws, telling lawmakers that they “should be wary” of “crossing the Rubicon” by enacting legislation with the potential to limit free speech and free expression.

Mr. Cameron’s remarks drew immediate criticism from the leader of the Labour opposition, Ed Miliband, who said Sir Brian’s proposals should be accepted in their entirety.

Mr. Cameron ordered the Leveson Inquiry in July, 2011, as the phone hacking scandal at The News of the World blossomed into broad public revulsion with reports that the newspaper had ordered the interception of voice mail messages left on the cellphone of Milly Dowler, a British teenager who was abducted in 2002 and later found murdered. Sir Brian said there had been a “failure of management and compliance” at the 168-year-old News of the World, which Mr. Murdoch closed in July, 2011, accusing it of a “general lack of respect for individual privacy and dignity.”

“It was said that The News of the World had lost its way in relation to phone hacking,” the summary said. “Its casual attitude to privacy and the lip service it paid to consent demonstrated a far more general loss of direction.”

Speaking after the report was published, Sir Brian said that while the British press held a “privileged and powerful place in our society,” its “responsibilities have simply been ignored.”

“A free press in a democracy holds power to account. But, with a few honorable exceptions, the U.K. press has not performed that vital role in the case of its own power.”

“The press needs to establish a new regulatory body which is truly independent of industry leaders and of government and politicians,” he said. “Guaranteed independence, long-term stability and genuine benefits for the industry cannot be realized without legislation,” he said, adding: “This is not and cannot reasonably or fairly be characterized as statutory regulation of the press.”

In the body of the exhaustive report, reprising at length the testimony of many of the witnesses who spoke at the hearings, the document discusses press culture and ethics; explores the press’s attitude toward the subjects of its stories; and discusses the cozy relationship between the press and the police, and the press and politicians.

John F. Burns, Sandy Lark Turner and Sandy Macaskill contributed reporting.

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Ex-NASA Scientist’s Data Fears Come True

In 2007, Robert M. Nelson, an astronomer, and 27 other scientists at the Jet Propulsion Laboratory sued NASA arguing that the space agency’s background checks of employees of government contractors were unnecessarily invasive and violated their privacy rights.

Privacy advocates chimed in as well, contending that the space agency would not be able to protect the confidential details it was collecting.

The scientists took their case all the way to the Supreme Court only to lose last year.

This month, Dr. Nelson opened a letter from NASA telling him of a significant data breach that could potentially expose him to identity theft.

The very thing he and advocates worried about had occurred. A laptop used by an employee at NASA’s headquarters in Washington had been stolen from a car parked on the street on Halloween, the space agency said.

Although the laptop itself was password protected, unencrypted files on the laptop contained personal information on about 10,000 NASA employees — including details like their names, birth dates, Social Security numbers and in some cases, details related to background checks into employees’ personal lives.

Millions of Americans have received similar data breach notices from employers, government agencies, medical centers, banks and retailers. NASA in particular has been subject to “numerous cyberattacks” and computer thefts in recent years, according to a report from the Government Accountability Office, an agency that conducts research for Congress.

Even so, Dr. Nelson, who recently retired from the Jet Propulsion Laboratory, a research facility operated by the California Institute of Technology under a contract with NASA, stands out as a glaring example of security lapses involving personal data, privacy advocates say.

“To the extent that Robert Nelson looks like millions of other people working for firms employed by the federal government, this would seem to be a real problem,” said Marc Rotenberg, the executive director of the Electronic Privacy Information Center, an advocacy group which filed a friend-of-the-court brief for Dr. Nelson in the Supreme Court case.

In a 2009 report titled “NASA Needs to Remedy Vulnerabilities in Key Networks,” the Government Accountability Office noted that the agency had reported 1,120 security incidents in fiscal 2007 and 2008 alone.

It also singled out an incident in 2009 in which a NASA center reported the theft of a laptop containing about 3,000 unencrypted files about arms traffic regulations and wind tunnel tests for a supersonic jet.

“NASA had not installed full-disk encryption on its laptops at all three centers,” the report said. “As a result, sensitive data transmitted through the unclassified network or stored on laptop computers were at an increased risk of being compromised.” Other federal agencies have had similar problems. In 2006, for example, the Department of Veteran’s Affairs reported the theft of an employee laptop and hard drive that contained personal details on about 26.5 million veterans. Last year, the G.A.O. cited the Internal Revenue Service for weaknesses in data control that could “jeopardize the confidentiality, integrity, and availability of financial and sensitive taxpayer information.”

Also last year, the Securities and Exchange Commission warned its employees that their confidential financial information, like brokerage transactions, might have been compromised because an agency contractor had granted data access to a subcontractor without the S.E.C.’s authorization.

In a phone interview, Dr. Nelson, the astronomer, said he planned to hold a news conference on Wednesday morning in which he would ask members of Congress to investigate NASA’s data collection practices and the recent data breach.

Robert Jacobs, a NASA spokesman, said the agency’s data security policy already adequately protected employees and contractors because it required computers to be encrypted before employees took them off agency premises. “We are talking about a computer that should not have left the building in the first place,” Mr. Jacobs said. “The data would have been secure had the employee followed policy.”

The government argued in the case Dr. Nelson filed that a law called the Privacy Act, which governs data collection by federal agencies, provided the scientists with sufficient protection. The case reached the Supreme Court, which upheld government background checks for employees of contractors. The roots of Dr. Nelson’s case against NASA date back to 2004 when the Department of Homeland Security, under a directive signed by President George Bush, required federal agencies to adopt uniform identification credentials for all civil servants and contract employees. As part of the ID card standardization process, the department recommended agencies institute background checks.

Several years later, when NASA announced it intended to start doing background checks at the Jet Propulsion Laboratory, Dr. Nelson and other scientists there objected.

Those security checks could have included inquiries into medical treatment, counseling for drug use, or any “adverse” information about employees such as sexual activity, or participation in protests, said Dan Stormer, a lawyer representing Dr. Nelson.

But Dr. Nelson and other long-term employees of the lab challenged the legality of those checks, arguing that they violated their privacy rights. NASA, they said, had not established a legitimate need for such extensive investigations about low-risk employees like themselves who did not have security clearances or handle confidential information. Dr. Nelson, for example, specializes in solar system science — concerning, for example, Jupiter’s moon Io and Titan, a moon of Saturn — and publishes his work in scientific journals

“It was an invitation to an open-ended fishing expedition,” Dr. Nelson said of the background checks.

In friend of the court briefs for Dr. Nelson, privacy groups cited many data security problems at federal agencies, arguing that there was a risk that NASA was not equipped to protect the confidential details it was collecting about employees and contractors.

In 2008, the United States Court of Appeals for the Ninth Circuit in San Francisco temporarily halted the background checks, saying that the case had raised important questions about privacy rights. But last year, the Supreme Court upheld the background investigations of employees of government contractors.

Dr. Nelson said he retired from the Jet Propulsion Laboratory last June rather than submit to a background check. He now works as a senior scientist at the Planetary Science Institute of Tucson.

NASA has contracted with ID Experts, a data breach company, to help protect employees whose data was contained on the stolen laptop against identity theft. Mr. Jacobs, the NASA spokesman, said the agency has encrypted almost 80 percent of its laptops and plans to encrypt the rest by Dec. 21. He added that he too received a letter from NASA warning that his personal information might have been compromised by the laptop theft.

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Nurses Sue Douglas Kennedy for $200,000

Yana Paskova for The New York Times

Two nurses have accused Douglas Kennedy, a son of Robert F. Kennedy, of assault and battery, negligence and causing them emotional and physical distress after an episode involving his newborn son.

Two nurses in Westchester County have filed a $200,000 lawsuit against Douglas Kennedy, a son of Robert F. Kennedy, accusing him of assault and battery, negligence and causing them emotional and physical distress after an episode involving his newborn son.

The Journal News of Westchester reported that the lawsuit was filed on Tuesday, a week after a court in Mount Kisco, N.Y., acquitted Mr. Kennedy of child-endangerment and harassment charges.

The charges stemmed from Mr. Kennedy’s attempt in January to take his newborn son from a maternity ward.

The two nurses said Mr. Kennedy hurt them as they tried to prevent him from leaving with the newborn. Mr. Kennedy said he was just taking the baby outside for some fresh air.

In a statement, Mr. Kennedy vowed to fight the lawsuit and said it was an attempt to extort money from his family.

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