Wealth Matters: Dealing With Doctors Who Accept Only Cash





A FEW weeks ago, my wife and I were at our wits’ end: our 4-month-old daughter wouldn’t sleep for more than an hour at a time at night. We had consulted books and seen our pediatrician, but nothing was working. So my wife called a pediatrician who specializes in babies who struggle with sleep problems.




The next day, he drove an hour from Brooklyn to our house. He then spent an hour and a half talking to us and examining our daughter in her nursery. He prescribed some medicine for her and suggested some changes to my wife’s diet. Within two days, our baby was sleeping through the night and we were all feeling better.


The only catch was this pediatrician did not accept insurance. He had taken our credit card information before his visit and given us a form to submit to our insurance company as he left, saying insurance usually paid a portion of his fee, which was $650.


A couple of weeks later, our insurance company said it wouldn’t pay anything. Here’s how the company figured it: First, it said a fair price for our doctor’s fee was $285, about 60 percent less, because that was the going rate for our town. Then, it said the lower fee was not enough to meet our out-of-network deductible.


While we were none too happy with the insurance company, we remained impressed by the doctor: he had made our baby better and was compensated for it, all the while avoiding the hassle of dealing with insurance.


Last year, I wrote about doctors who catered only to the richest of the rich and charged accordingly. But after my experience, I became interested in doctors for the average person who take only cash. What pushes a doctor to go this route, often called concierge medicine? And how hard is it to make a living?


As to why doctors decide to switch to a concierge practice, the answer is almost always frustration.


“About four years ago, one insurance company was driving me crazy saying I had to fax documents to show I had done a visit,” said Stanford Owen, an internal medical doctor in Gulfport, Miss. “At 2 a.m., I woke up and said, ‘This is it.’ ”


Dr. Owen stopped accepting all insurance and now charges his 1,000 patients $38 a month.


“When I decided to abandon insurance, I didn’t want to lose my patient base and make it unaffordable,” he said. “I have everything from waitresses and shrimpers to international businessmen. It’s a concierge model, but it’s also the personal doctor model.”


Dr. Owen, who once had three nurses and 10 examining rooms, said it was now just him and a receptionist. He has become obsessed with keeping overhead low, but he said that, for the first time since the 1990s, his income was going up.


At the other end of the spectrum is David Edelson, who runs a practice called HealthBridge in Great Neck, N.Y. In addition to five doctors, the practice has a full fitness center and provides the services of a personal trainer, nutritionist, acupuncturist, sleep expert and stress-management consultant.


“The current model for primary care is broken,” Dr. Edelson told me. “Either I can go down with the ship, sell my practice to a hospital or take my practice in the wrong direction. Or I can develop a better mousetrap, which is more time dealing with patients and their care.”


Dr. Edelson has reduced his own practice to 300 patients, from more than 3,000. Of those, 250 pay $1,800 a year for concierge services and 50 others receive scholarships. He estimated that from the combination of the membership fee for the extra services and what gets billed to insurance for typical care, he will make $600,000, and more of that will end up in his pocket.


“We’re bringing in the same fees but we’re reducing our overhead,” he said. Fewer patients means fewer medical assistants, receptionists and staff members to deal with insurance.


But of the five doctors in the practice, he is the only one to go fully concierge. Another, William Klein, is testing the model, with 15 percent of his patients in the concierge program. Dr. Klein said he was hedging his bets because he was not sure what the new federal health care law would mean for primary care physicians.


Weren’t some patients getting shortchanged by this hybrid model? He said he saw no difference in care.


“It’s like paying for first class and not coach,” Dr. Klein said. “Everyone is getting to the same destination, but some people have a better seat.”


This approach to medicine is not without risks for the doctors and downsides for patients.


This article has been revised to reflect the following correction:

Correction: November 23, 2012

An earlier version of this column gave an incorrect middle initial for Mr. Harris. It is M., not V.



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Online options multiply for holiday greeting cards, party invites









We've all received them — cheesy holiday greeting cards and party invites with messages like, "Ho ho hope you have a very merry Christmas."


Pre-written mass-produced cards are getting passed over in favor of a slew of new options, both digital and paper, created online via websites or apps. The expanded offerings come as card companies gear up for the busiest time of the year.


Planning on throwing a holiday party? Evite last month launched Postmark, the West Hollywood company's first new offering since its 1998 launch. The digital-only invitations are being touted as premium products that are more visually attractive — think digital glitter effects and cutout angels — than typical text-on-rectangular-background evites.





Customers can choose from a variety of envelope colors and coordinating patterned liners, write their own unique message and incorporate their own photos. Unlike Evite's free invitations, the products from the Postmark line cost money: For $12, users can send 75 personalized e-invitations with a coordinating designer stamp, for example.


Hans Woolley, president of Evite, said the idea for Postmark came from users who said they wanted the ease and convenience of digital evites with the style of designer paper invitations.


"It's a new manifestation of the medium," he said. "We want to inspire you, break the mold a little bit, reinvent the category. It's like a juxtaposition of old and new."


If you still like the idea of a physical card, premium e-card company Paperless Post last month expanded its selection to include paper products. Paper by Paperless Post lets customers access the company's website to create holiday cards and other products that are then printed on stationery in thick and double-thick card stock.


Cards from the Paper by Paperless Post line start at $1.10 including envelope; production of custom cards takes three to seven business days, with deliveries to buyers via FedEx.


Siblings James and Alexa Hirschfeld, who co-founded Paperless Post three years ago, said they decided to roll out paper products ahead of the busy holiday season after realizing customers didn't want to be limited to online-only cards and invites. Despite having to pay more for products from the Paper line, customers don't seem to mind, they said.


Even technology giant Apple Inc. last year launched its homegrown Cards app, free in the App Store, which customers can use on their mobile devices to make letterpress cards personalized with text and photos. Physical versions of the cards can be sent directly to recipients within the U.S. for $2.99 and internationally for $4.99, saving the hassle of buying stamps and a trip to the post office.


The online card industry is a competitive space, and the next few weeks are "going to be the most intense time of the season," said Heather Maddan, chief storyteller at Shutterfly. The photo printing company has rolled out 600 new holiday card designs for the season, including 60 new religious card designs, and introduced a large 6-inch-by-8-inch photo card format. Photos can be uploaded from Instagram or other sources, and finished cards can be shipped to the buyer or directly to recipients.


Traditional card makers are also trying to stay ahead by offering apps to send custom holiday greetings. The Hallmark Go Cards app enables users to send greeting cards and photo cards with personal touches straight from their iPhone or iPod Touch. Hallmark will then mail the card anywhere in the U.S. for $3.49.


andrea.chang@latimes.com





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Middle East shifts may weaken Iran's influence with Palestinians









CAIRO — Iran for years has supplied Hamas with weapons as part of its own struggle against Israel, but the conflict in the Gaza Strip reveals a shift in regional dynamics that may diminish Tehran's influence with Palestinian militant groups and strengthen the hand of Egypt.


The longer-range missiles fired by Hamas over the last week — believed to be modifications of Iran's Fajr 5 missiles — startled Israel by landing near Jerusalem and Tel Aviv. A front-page story in Iran's conservative daily, Kayhan, boasted: "The missiles of resistance worked." Tehran would not confirm the weapons' origin, except to say it sent rocket "technology" to Hamas.


Instead, Foreign Ministry spokesman Ramin Mehmanparast told reporters: "What is important is that the people of Palestine must be equipped to defend themselves, and it is the responsibility of all countries to defend the rights of the people of Palestine."





But the Gaza fighting erupted during a new era in the Middle East brought about by the rise of Islamist governments, notably in Egypt, that have replaced pro-Western autocrats. The political catharsis has spurred anti-Americanism, which Iran relishes, but it also has upset Tehran's regional designs.


In Syria — which along with the militant groups Hamas and Hezbollah has been Iran's proxy opposing Israel — a revolt inspired by the "Arab Spring" could force President Bashar Assad from power and bring in a government less friendly to Tehran. Hamas angered Iran by opposing Tehran's continued support of Assad and siding with the Syrian rebels, who are mostly fellow Sunni Muslims.


Iran's immediate concern in Gaza is keeping Hamas from strengthening its ties to Arab capitals. This may be difficult, as evidenced by the fact that Egypt's Muslim Brotherhood, which inspired the founding of Hamas and now is in charge of the Egyptian government, played a key role in brokering the cease-fire announced Wednesday.


Egyptian President Mohamed Morsi is likely to press the militant group not to further agitate the region — and Egypt's many domestic problems — with sustained violence against Israel. But Egypt has been criticized for tacitly arming Hamas by not tightening its border with Gaza to stop weapons smugglers from Libya and Sudan.


"The Iranians [had] better understand the paradigm is shifting in the Middle East," said Nabil Fahmy, former Egyptian ambassador to the U.S. and founding dean of the School of Public Affairs at the American University in Cairo. "Hamas needs Cairo tremendously. It really has no other interlocutor to deal with Israel."


But he added that the region is so fluid and unsettled that it is too early to predict winners and losers: "If there are peaceful resolutions, this will lead to a reduced Iranian role. If, on the other hand, you have an increased use of violence," he said, "then ultimately any player that has been supportive of a more aggressive posture will gain ground."


Iran characterized Hamas' rocket fire on Israel as part of an effort to keep the government of Prime Minister Benjamin Netanyahu off balance. Netanyahu has threatened to attack Iran's nuclear program, and some suggest the airstrikes on Gaza have been a warm-up exercise. Tehran viewed the Gaza conflict as a means to distract Israel and further inflame anti-Jewish sentiment in a region tipping increasingly toward Islamists.


"Hamas' ties with Muslim Brotherhood and Egypt's current government are different from its ties with Iran," said Nader Karimi, a journalist and political analyst in Tehran. "In peace, when diplomacy is needed, Hamas is closer to Egypt at the expense of Iran. But when it's at war with Israel, Hamas' relations with Iran are more important."


Khaled Meshaal, Hamas' political chief, acknowledged as much after the cease-fire was announced Wednesday. "Iran played a role in this achievement as well," he said. "We have differed with Iran on the Syrian issue, but we agree against the oppression and occupation of Zionists."


The Muslim Brotherhood in Egypt "let down Hamas in the current war," said Hamid Reza Taraghi, a conservative Iranian analyst who criticized Cairo for not opening Egypt's border with Gaza to supply Hamas with arms. "Hamas now realizes that Iran is the genuine supporter of the Palestinian cause."


Former Egyptian President Hosni Mubarak was suspicious of both Hamas and Iran. Mubarak, a close U.S. ally, had no formal ties with Iran for decades. Morsi visited Tehran last summer and indicated a change in tenor, even as he has angered Iran by condemning Assad's mass killings of Syrians.


But Egypt's domestic problems, including economic turmoil, the battle over a new constitution and gas and water shortages, are his steepest challenges. Morsi also is attempting to stem increasing instability in the Sinai Peninsula, where resurgent militant groups, some believed to be aided by Hamas, have killed Egyptian security forces and launched attacks at Israel.


Trouble in the Sinai jeopardizes Egypt's 1979 peace treaty with Israel but plays into Iran's efforts. Analysts suggest that Cairo will work to rein in Hamas, and other rivals of Iran including Sunni Muslim Persian Gulf nations such as Qatar will also be more deeply involved. The emir of Qatar, Sheik Hamad bin Khalifa al Thani, visited Gaza in October and promised $400 million in aid.


Egypt, however, poses the biggest obstacle to Iran's plans in Gaza. Morsi and the Muslim Brotherhood regard Cairo as the unquestioned regional mediator between the Palestinians and Israel.


"Egypt has historic, geographic and religious ties with Palestine and Gaza. These ties cannot be bought," said Sadegh Hosseini, an expert on Iranian politics. "Gaza is the backyard of Egypt. In recent years, we have seen that ideologically Hamas is another branch of the Muslim Brotherhood."


jeffrey.fleishman@latimes.com


Times staff writer Fleishman reported from Cairo and special correspondent Mostaghim from Tehran.





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Halle Berry's ex arrested after fight at her house

LOS ANGELES (AP) — Halle Berry's ex-boyfriend Gabriel Aubry was arrested for investigation of battery Thursday after he and the Oscar-winning actress's current boyfriend got into a fight at her Hollywood Hills home, police said.

Aubry, 37, was booked for investigation of a battery, a misdemeanor, and released on $20,000 bail, according to online jail records. He's scheduled to appear in court Dec. 13.

Aubry came to Berry's house Thanksgiving morning and police responded to a report of an assault, said Los Angeles Police Officer Julie Boyer. Aubry was injured in the altercation and was taken to a hospital where he was treated and released.

Emails sent to Berry's publicist, Meredith O'Sullivan, and Aubry's family law attorney, Gary Fishbein, were not immediately returned.

Berry and Aubry have been involved in a custody dispute involving their 4-year-old daughter, Nahla. The proceedings were sealed because the former couple are not married. Both appeared in the case as recently as Nov. 9, but neither side commented on the outcome of the hearing.

Berry has been dating French actor Olivier Martinez, and he said earlier this year that they are engaged.

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Inquiry Sought in Death in Ireland After Abortion Was Denied





DUBLIN — India’s ambassador here has agreed to ask Prime Minister Enda Kenny of Ireland for an independent inquiry into the death of an Indian-born woman last month after doctors refused to perform an abortion when she was having a miscarriage, the lawyer representing the woman’s husband said Thursday.




The lawyer, Gerard O’Donnell, also said crucial information was missing from the files he had received from the Irish Health Service Executive about the death of the woman, Savita Halappanavar, including any mention of her requests for an abortion after she learned that the fetus would not survive.


The death of Dr. Halappanavar, 31, a dentist who lived near Galway, has focused global attention on the Irish ban on abortion.


Her husband, Praveen Halappanavar, has refused to cooperate with an investigation being conducted by the Irish health agency. “I have seen the way my wife was treated in the hospital, so I have no confidence that the H.S.E. will do justice,” he said in an interview on Wednesday night on RTE, the state television broadcaster. “Basically, I don’t have any confidence in the H.S.E.”


In a tense debate in the Irish Parliament on Wednesday evening, Robert Dowds of the Labour Party said Dr. Halappanavar’s death had forced politicians “to confront an issue we have dodged for much too long,” partly because so many Irish women travel to Britain for abortions.


“The reality is that if Britain wasn’t on our doorstep, we would have had to introduce abortion legislation years ago to avoid women dying in back-street abortions,” he said.


After the debate, the Parliament voted 88 to 53 against a motion introduced by the opposition Sinn Fein party calling on the government to allow abortions when women’s lives are in danger and to protect doctors who perform such procedures.


The Irish president, Michael D. Higgins — who is restricted by the Constitution from getting involved in political matters — also made a rare foray into a political debate on Wednesday, saying any inquiry must meet the needs of the Halappanavar family as well as the government.


In 1992, the Irish Supreme Court interpreted the current law to mean that abortion should be allowed in circumstances where there was “a real and substantial risk to the life of the mother,” including the threat of suicide. But that ruling has never been codified into law.


“The current situation is like a sword of Damocles hanging over us,” Dr. Peter Boylan, of the Irish Institute of Obstetricians and Gynecologists, told RTE last week. “If we do something with a good intention, but it turns out to be illegal, the consequences are extremely serious for medical practitioners.”


Dr. Ruth Cullen, who has campaigned against abortion, said that any legislation to codify the Supreme Court ruling would be tantamount to allowing abortion on demand and that Dr. Halappanavar’s death should not be used to make that change.


Dr. Halappanavar contracted a bacterial blood infection, septicemia, and died Oct. 28, a week after she was admitted to Galway University Hospital with severe back pains. She was 17 weeks pregnant but having a miscarriage and was told that the fetus — a girl — would not survive. Her husband said she asked several times for an abortion but was informed that under Irish law it would be illegal while there was a fetal heartbeat, because “this is a Catholic country.”


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Demand for grass-fed beef is growing









Jeremy Parker is a rancher who raises his cattle the old-fashioned way. His herd feeds on grass.

"There's definitely growing demand" for grass-fed beef, he said. "There's more demand than there is availability."

Although still only about 3% of the beef consumed in the U.S., grass-fed beef will keep rising in popularity, advocates, consumers and producers predict. One study put demand growth at 20% a year.





"It's expanded dramatically," said Alan Williams, a grass-fed beef producer and member of the Pasture Project, an effort to get more conventional producers in the Midwest switching to pasture-based systems. "In the late 1990s there were only 100 producers. Now there are more than 2,000. The market has grown from being $2 million to $3 million to over $2.5 billion in retail value."

Most cattle raised in the U.S. are sent to feedlots, in Kansas and Nebraska mostly, where the animals are fattened and "finished" on a diet of corn and other grains.

This feedlot system has enabled the country to develop its massive beef industry cheaply, efficiently and with less manpower.

Cattle ranchers contend that a wholesale, or even partial, transition to a grass-based system would be impractical and would drive up costs.

In recent years, however, critics of the feedlot system say the industry's growth has come at too high a cost for the environment, for human health and for the animals themselves.

About 40% of the country's corn now goes to livestock, helping make corn the most grown, and most valuable, crop in the country. But corn production is nitrogen-intensive, and critics say that run-off from nitrogen fertilizer has contributed to polluted waterways, most notably the growing "dead zone" in the Gulf of Mexico.

At the same time, cattle's corn-centric diets have contributed to fattier, less-nutritious beef that is higher in cholesterol and lower in good fatty acids, some say.

Because the cost of that beef is relatively low, consumers can afford to eat more of it, often in the form of fast-food burgers.

"Basically, it comes down to time," said Patricia Whisnant, president of the American Grassfed Assn., and a Missouri producer whose Rain Crow Ranch is among the largest grass-fed beef operations in the country. "You take an animal off of pasture, you give him antibiotics and corn, you're looking at harvesting that animal in 12 to 14 months. On grass, you're looking at 24 months, and more likely 28."

Altogether, these factors appear to be getting the attention of consumers who are willing to pay a premium for grass-fed beef. Producers and retailers are responding.

Until recently, most grass-fed beef was sold directly by the producer to the consumer, who often arranges to buy a whole side of beef through a special arrangement. Some grass-fed beef is also sold directly through buyers clubs.

But now it's becoming a bigger business, with some supermarket chains now stocking grass-fed beef.

Gustin writes for the St. Louis Post-Dispatch





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Growing up with grandma









NEW YORK — Each day at 5 a.m., Denise Peace rises and begins the task of waking and feeding five grandchildren, ages 2 to 17, and shepherding them out the door of her cramped but miraculously neat apartment in Brooklyn.

The 5-year-old needs to be on his school bus by 6:26. The eldest has to catch a 7 a.m. train. The 4-year-old must be walked to school in time for the 8:10 bell. The 2-year-old plays while Peace prepares the 3-year-old for day care. In the early afternoon, she reverses the drill, fetching children from bus stops and schools and getting them home for dinner, baths and bed. Peace collapses about 9 p.m.

"Then I just start all over again," the 56-year-old said of the moment when her alarm sounds the next morning.

It's a routine that changes once a month, when Peace travels to a Brooklyn church and meets with dozens of other grandmothers — and some great-grandmothers — in similar situations. All have been catapulted back into full-time parenting by the sudden losses of their own children. All have been brought together by the New York Police Department and local clergy for a chance to swap stories, compare legal and parenting advice, cry on a friendly shoulder, pray and simply let off steam.

"It comforts you. It lets you know you're not alone in this," said Peace, who learned of the close-knit group called Grandmothers LOV — for Love Over Violence — as she searched for programs last year to help women like herself. "They have your back. It's like another family."

It's a family that is growing. According to the 2010 census, the number of grandparents who are primary caregivers to grandchildren has risen 12.8% since 2000, from about 2.4 million to more than 2.7 million. Between 1990 and 2000, census figures indicate that the number of U.S. children being raised by grandparents rose 30%. And the Annie E. Casey Foundation, which studies children's issues, says that in 1970, 3.2% of U.S. children lived in grandparent-run households; by 1997, it was 5.5%.

With today's grandparents — particularly grandmothers — living longer and often staying healthier, they are more likely to be able to step in if parents die or are unable to raise their children because of illness, incarceration, drug abuse or other problems. The recession is believed to have played a role in the increase, with grandparents more apt than many parents to have the financial stability needed to raise children, said Robert Geen, the Annie E. Casey Foundation's family services policy director.

"I think there is a concern that the tough economic environment is putting pressure on parents — that it is simply overwhelming them," Geen said. "The big concern is that our social services system is completely oriented toward a nuclear family, so support available to grandparents is fairly lacking."

Joanne Jaffe, the housing chief for the New York Police Department, had noticed how many grandmothers were becoming the anchor for disjointed families. LOV, which first met in September 2010, evolved from her observations, and from Police Commissioner Raymond Kelly's work with Brooklyn clergy to combat youth violence.

Jaffe focused on grandmothers — not grandfathers — for several reasons. Among them: far more grandmothers than grandfathers are thrust into parenting roles because they often have more time, experience and willingness than men of their generation to rear their children's children. Jaffe wanted to empower those women to become leaders in combating violence and other problems in their communities.

"It's a giant family therapy group," Jaffe said recently as LOV members trickled into the Mt. Sion Baptist Church, on a busy corner near a loud highway overpass. There were women leaning on walkers and on canes, and at least one in a wheelchair. Another came with a squirming toddler in her arms.

There were squeals of joy and cries of "Welcome back!" as the women who had not seen each other in eight weeks — the group had taken a summer hiatus — huddled like giddy teenagers. For the next 21/2 hours, with their grandchildren and great-grandchildren in day care, at school, or being cared for by baby-sitters or other family members, they could focus on themselves and one another.

Inez Rodriguez said she had canceled hip and knee replacement surgery to come to the gathering. Daphne Georgalas lamented the challenge of resting babies on her tired shoulders. "I thought I was done — and lo and behold I have little Princess Emily now," she said of her infant granddaughter.

Jaffe, whose NYPD uniform was in sharp contrast to the colorful dresses and hats worn by many of the grandmothers, made a point not to sound too cheery as she greeted the crowd. Instead, she alluded to the city's bloody summer, when shootings left several children and teenagers dead and wounded in the very neighborhoods that many of the grandmothers call home, and hope to change by keeping their own grandkids out of trouble.

"I'm not going to say it was a wonderful summer. I'm not coming here saying it's been a wonderful year," Jaffe said as cries of "Amen" and knowing "Uh-huhs" filled the room.

As police officers in uniform dished out a hot buffet breakfast, the women began catching up with one another. One of them was Carolyn Faulkner, a slender 74-year-old, who raised two grandchildren, now 21 and 19, and is now raising a third — a 10-year-old girl.

"Between running to school and going to PTA meetings, it's a lot of work, but you know what they say to me?" she said of her grandchildren. "'Thanks, Grandma.' That's more than money can buy."

Faulkner says she stepped in to care for her eldest daughter's three children when it became clear their mother was not up to the task.

"She didn't do drugs or anything. She just didn't grow up," said Faulkner, who with her husband of 50 years has run a wedding planning business among other enterprises, and who sits on her neighborhood's community board.

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Carpe Twitter: Vatican tweets on new Latin academy
















VATICAN CITY (Reuters) – A senior Vatican cardinal tweeted in Latin on Wednesday to urge people to attend the inauguration of, you guessed it, the Holy’s See’s new Academy for Latin Studies.


“Hodie una cum Ivano Dionigi novam aperiemus academiam pontificiam latinitatis a Benedicto conditam, hora XVII, via Conciliationis V,” was the tweet by Cardinal Gianfranco Ravasi.













The approximate translation: “Today at 5 p.m., along with Ivano Dionigi, we will open the new Pontifical Academy for Latin Studies founded by Benedict. Via della Conciliazione, 5.”


It was not the first tweet in Latin – an Italian professor has been doing it for some time – but evidently Ravasi wanted to seize the day, or “carpe diem”.


The pope earlier this month announced that he had instituted the Pontifical Academy for Latin Studies, placing it under the auspices of the Vatican’s ministry for culture.


Dionigi, a Latin scholar who is rector of Bologna University – widely recognized to be the world’s oldest – is the academy’s first president.


The pope started the academy to promote the study and use of Latin in the Roman Catholic Church and beyond.


When instituting the academy, the pope said Latin, which is still the official language of the universal Church, was the subject of renewed interest around the world and the academy was mandated to encourage further growth.


(Reporting By Paolo Biondi and Philip Pullella)


Social Media News Headlines – Yahoo! News



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Chevy Chase is leaving NBC's sitcom 'Community'

LOS ANGELES (AP) — The NBC series "Community" will finish the season without Chevy Chase.

Sony Pictures Television said Wednesday that the actor is leaving the sitcom by mutual agreement with producers.

His immediate departure means he won't be included in the last episode or two of the show's 13-episode season, which is still in production.

Chase had a rocky tenure playing a bored and wealthy man who enrolls in community college. The actor publicly expressed unhappiness at working on a sitcom and feuded last year with the show's creator and former executive producer, Dan Harmon.

The fourth-season premiere of "Community" is Feb. 7, when it makes a delayed return to the 8 p.m. EST Thursday time slot. The show's ensemble cast includes Joel McHale and Donald Glover.

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Documents Show F.D.A.’s Failures in Meningitis Outbreak





Newly released documents add vivid detail to the emerging portrait of the Food and Drug Administration’s ineffective and halting efforts to regulate a Massachusetts company implicated in a national meningitis outbreak that has sickened nearly 500 people and killed 34.




In the documents, released on Tuesday in response to a Freedom of Information Act request, the agency would threaten to bring the full force of its authority down on the company, only to back away, citing lack of jurisdiction.


The company, the New England Compounding Center, at times cooperated with F.D.A. inspectors and promised to improve its procedures, and at other times challenged the agency’s legal authority to regulate it, refused to provide records and continued to ship a drug in defiance of the agency’s concerns.


Some of the documents were summarized last week by Congressional committees that held hearings on the meningitis outbreak. Republicans and Democrats criticized the F.D.A. for failing to act on information about unsafe practices at the company as far back as March 2002.


By law, compounding pharmacies are regulated primarily by the states, but the pharmacies have grown over the years into major suppliers of some of the country’s biggest hospitals. The F.D.A. is asking Congress for stronger, clearer authority to police them, but Republicans have said the agency already has enough power.


Records show that the agency was sometimes slow in pursuing its own inspection findings. In one case involving the labeling and marketing of drugs, the agency issued a warning letter to New England Compounding 684 days after an inspection, a delay that the company’s chief pharmacist complained was so long that some of the letter’s assertions no longer applied to its operations.


The agency said in a statement Wednesday that it “was not the timeline we strive for,” but that much of the delay was because of “our limited, unclear and contested authority in this area.” Because of litigation, it said, there was “significant internal discussion about how to regulate compounders.”


The agency first inspected the company in April 2002 after reports that two patients had become dizzy and short of breath after being injected with a steroid made by the company.


 On the first day of the inspection, Barry Cadden, the chief pharmacist, was cooperative, but the next day, the agency inspectors wrote, Mr. Cadden “had a complete change in attitude & basically would not provide any additional information either by responding to questions or providing records,” adding that he challenged their legal authority to be at his pharmacy at all.


The F.D.A. was back at New England Compounding in October 2002 because of possible contamination of another of its products, methylprednisolone acetate, the same drug involved in the current meningitis outbreak.


 While the F.D.A. had the right to seize an adulterated steroid, officials at the time said that action alone would not resolve the company’s poor compounding practices. In a meeting with Massachusetts regulators, F.D.A. officials left authority in the hands of the state, which “would be in a better position to gain compliance or take regulatory action,” according to a memo by an F.D.A. official summarizing the meeting.


 David Elder, compliance branch director for the F.D.A.’s New England District, warned at the meeting that there was the “potential for serious public health consequences if N.E.C.C.’s compounding practices, in particular those relating to sterile products, are not improved.”


 The company fought back hard, repeatedly questioning the F.D.A.’s jurisdiction. In a September 2004 inspection over concerns that the company was dispensing trypan blue, a dye used for some eye surgeries that had not been approved by the F.D.A., Mr. Cadden told the agency inspector that he had none in stock.


But in the clean room, the inspector noticed a drawer labeled “Trypan Blue,” which contained 189 vials of the medicine.


A few days later, Mr. Cadden was defiant. He told the agency that he was continuing to dispense trypan blue and that there was nothing in the law saying a compounder could not dispense unapproved products.


 The conversation turned testy. “Don’t answer any more questions!” Mr. Cadden told another pharmacy executive, according to the F.D.A.’s report.


Mr. Cadden rejected many of the assertions in the warning letter that finally came in December 2006. The next correspondence from the agency did not come until almost two years later, in October 2008, saying that the agency still had “serious concerns” about the company’s practices, and that failing to correct them could result in seizure of products and an injunction against the company and its principals.


It is not known whether any corrective actions were taken. The agency did not conduct another inspection until the recent meningitis outbreak.


Denise Grady contributed reporting.



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