Health - Small-Town Doctors Made in a Small Kansas Town |
- Small-Town Doctors Made in a Small Kansas Town
- Your Money: Tuition Refunds, but Not Quite on Equal Terms
- Recipes for Health: Yogurt Soup With Spelt, Cucumbers and Watercress
- Lawsuits and Intrigue Over 3M Diagnostic Test
- Lilly Profit Skids as It Prepares for Patent Expirations
- F.D.A. Issues Alerts on the Heart Drug Multaq
- Decoding DNA With Semiconductors
- Despite Risk, Embalmers Still Embrace Preservative
- Study Links Male Infertility to a Missing Protein
- Consults: Expert Answers on Stargardt's Disease
- AstraZeneca Anticlotting Drug Wins Approval
- Panel Recommends Coverage for Contraception
- Well: Why Would Anyone Choose to Become a Doctor?
- Well: Could You Run the Nation With a Migraine?
- Well: Athletic Performance and the Monthly Cycle
- Fixes: Sharing Patents to Wipe Out AIDS
- The New Old Age: A Push to Repeal the Class Act
- The New Old Age: A Fair Wage for Home Care Workers
- Johnson & Johnson Hurt by Recalls in Second Quarter
- Diabetes Drug Dapagliflozin Rejected by F.D.A. Panel
- Recipes for Health: Watermelon Gazpacho
Small-Town Doctors Made in a Small Kansas Town Posted: 23 Jul 2011 06:41 AM PDT SALINA, Kan. — This state, so sparsely populated in parts that five counties have no doctors at all, has struggled for years to encourage young doctors to relocate to rural communities, where health problems are often exacerbated by a lack of even the most basic care. Related
On Friday, a new medical school campus opened here to provide a novel solution to the persistent problem: an inaugural class of eight aspiring doctors who will receive all their training in exactly the kind of small community where officials hope they will remain to practice medicine. The new school, operated by the University of Kansas, is billed as the smallest in the nation to offer a full four-year medical education. More important, supporters say, the students will remain personally and professionally rooted in the agricultural center of the state — a three-hour drive from the university’s state-of-the-art medical and research facilities in Kansas City. It will be a different experience, one that administrators say will better prepare students for the realities of a rural practice. Lectures on subjects like anatomy will be delivered via streaming video, lab work will be overseen by more practicing generalists and fewer academic specialists, and the problems of patients will tend more to the everyday than to the extraordinary. And, the thinking goes, spouses picked up along the way are less likely to complain about moving to a small town. “It just makes sense, and it’s great that it’s been put into practice,” said Alan Morgan, the president of the National Rural Health Association. “From a rural policy perspective, this is big news.” Increasingly, medical schools across the country have been looking for ways to add to the ranks of physicians in rural areas. Some are using incentives like guaranteeing admission or forgiving loans to students who commit to practicing in small communities. Others are recruiting students from rural areas and giving their applications preference, in the hope that they will return after graduating. And a number of schools encourage students to spend one year or more training in rural areas. Kansas has tried each of these approaches in recent years, all of which are being used at the Salina campus. But with more than half the primary care physicians concentrated in the four largest counties, a vast majority of the state is considered medically underserved. And with many rural doctors near retirement age, the shortage could grow more acute. The medical school program here, which is similar to a program at the Indiana University campus in Terre Haute, emerged as the top recommendation several years ago in a state report on the shortage of rural physicians. It was supported by research suggesting that students who trained in urban areas faced hurdles in adjusting to the more bare-bones life of a country doctor, said Dr. Heidi Chumley, a senior associate dean at the University of Kansas. “When they go off to the ritz and the glitz and pick up a spouse from the big city, it’s always hard to get them back to small-town America,” said Micheal Terry, president and chief executive of Salina Regional Health Center, which donated the three-story building being used by the school, as well as enough money to run it for a year. (The school cost $1.1 million to start and $1.1 million in reserve to operate it for the first year.) Situated at the intersection of two highways, Salina, which has a population of nearly 50,000, serves a crucial role as a regional hub supporting surrounding rural communities; the hospital where the school is based receives patients who travel as many as four hours to get there. University officials were relieved when one visitor from the Liaison Committee on Medical Education, an accrediting body whose approval was considered a major hurdle, remarked with surprise that the area was not just cornfields. Barbara Barzansky, co-secretary of the accrediting agency, said there had been concerns about the size of the school: Salina is the smallest city in the country to host a full medical degree program. But she said the committee found the resources to be adequate. “It’s an interesting model, and if the outcomes are good, it could be a stimulus for other schools to do it,” Ms. Barzansky said. On Friday, the eight students met for the first time for orientation, sitting nervously alongside one another before breaking into enthusiastic chatter. Dr. William Cathcart-Rake, a longtime physician here who is the director of the school, said that while they were the first class of “something very, very special,” they should not think of themselves as experiments. Though a couple of students said they would have preferred to attend at the campuses in Kansas City or Wichita — one plans to commute from there — the rest said the smaller school had been their first choice. Most of them grew up in small towns themselves and have agreed, in exchange for free tuition and monthly stipends, to start their careers in rural areas. They know the life of a rural physician is not easy. Patients tend to be older, poorer and often uninsured. The job generally pays less than lucrative specialties. And many rural doctors have so little support that they are essentially on call permanently. But the students also spoke firsthand of the need for doctors — one recalled a half-hour drive to the city, relieved by four Advil and an ice pack, to see a doctor about his broken arm. “I’m a small-town girl, and I always wanted to be back in a small town,” said Kayla Johnson, 23, who grew up west of here in Odin (population 101) and did not like the idea of living in a city to study medicine. “When I heard that the Salina program was starting, I was so excited.” Dr. Robert Moser, who had a rural practice before becoming the secretary of the Kansas Department of Health and Environment, said he expected the number of students who go into primary care in rural areas to at least double each year. And while the number is still small, he said, the impact on communities will be significant. That would be the case in Jewell County, where the only two doctors have moved away, forcing the county to pay outside physicians to provide services a few days each month and to be on call for emergencies. “It would be great to have a doctor full time here,” said Angela Murray, the administrator of the County Health Department. “Hopefully that will happen.” |
Your Money: Tuition Refunds, but Not Quite on Equal Terms Posted: 23 Jul 2011 11:43 AM PDT Sallie Mae wants to be a cradle-to-grave resource, helping parents save for their children’s college educations until they’re 18, then lending students money for tuition, helping them save for their own children’s bills and so on until they’re great-grandparents. Jerry Swope for The New York TimesBucksHow Tuition Refund Insurance Works at Your SchoolBy RON LIEBERHow did you decide whether to purchase a policy when your tuition bill arrived? Your MoneyRon Lieber writes the Your Money column, which appears in The Times on Saturdays. Follow Ron Lieber on Twitter: twitter.com/ronlieber Jerry Swope for The New York TimesIn the last couple of years, Sallie Mae has been trying to deepen its financial ties with customers, adding an online bank and a credit card. And earlier this month, it added a curious product known as tuition refund insurance, which can make you whole if an ill child must withdraw from college sometime during the term. The insurance, which Sallie offers in partnership with Next Generation Insurance Group, a company it recently bought a stake in, doesn’t treat all sickness equally, though. If a student withdraws because of a physical illness or injury, a family gets 100 percent of its money back. People who leave because of mental health problems, however, get only 75 percent back. This would probably be illegal if tuition refund policies were deemed health insurance, instead of insurance that just happens to be based solely on your health. Federal law now mandates equal coverage for mental and physical illness in many instances when employers offer any health insurance for mental illness. Even if disparate tuition insurance coverage is legal, however, it’s still offensive to people who spent their careers fighting for so-called mental health parity. “There should be a buyer beware sign blinking on and off,” said Ken Libertoff, who ran the Vermont Association for Mental Health for 30 years. “Parents need to know that there is a fatal flaw in these plans’ constructions.” Indeed, that construction suggests a question: Is it even worth taking an insurance offer seriously when it forces you to accept less coverage for the debilitating illness that is most likely to befall you? Tuition refund insurance in the United States dates back to 1930, when a company called A. W. G. Dewar offered a plan that provided tutors to families whose children were home sick for an extended period. Eventually, the insurance became a policy that paid out cash to make up for whatever a private primary or secondary school would not refund. Dewar’s offering took root at private schools, and today it serves about 1,200 private elementary and secondary schools along with 180 colleges, where the tuition stakes can be even higher. According to Dewar, just over half of secondary schools (though only one college) that offer the insurance make it mandatory for some or all families — say, for new students, who may have adjustment problems — or for anyone who doesn’t pay tuition in full up front. At colleges, fewer than 10 percent of parents choose to buy the tuition refund plans. That low take rate at colleges probably reflects the “it can’t happen to me” syndrome, but perhaps some parents who have dug into the details discovered that these policies often covered mental illness differently from physical injury. Not only is the payout less, but the insurance often requires a multiday hospital stay as a sort of proof that the depression or anxiety is real. A couple of years ago, a University of Vermont student named Sherry Williamson discovered that the Dewar policy available to her fellow students worked like that. As a registered nurse suffering from depression, she found the differing treatment difficult to stomach. “I couldn’t believe that UVM, which tries to promote diversity and be all-encompassing, would take on a policy that was clearly discriminatory,” she said. She found her way to Mr. Libertoff, who got her complaint in front of the appropriate state agencies. Like the federal government, Vermont had its own mental health parity law, but the state ultimately used a separate nondiscrimination statute to force Dewar and the university to equalize its coverage. In the wake of that decision, another insurance company called Markel that offers tuition refund policies decided to offer equal coverage on all policies nationwide that it sold through schools, rather than risk the wrath of state insurance commissioners. Sallie Mae, however, chose to adopt the disparate treatment approach even though it’s using Markel as its underwriter. According to John Fees, president of the Sallie partner Next Generation, it had no choice if it wanted to offer affordable premiums to everyone in the United States and do away with any mental illness hospitalization requirement. How much more would it have cost to offer equal coverage? “I’m not at liberty to say that at this point,” he said. “It’s a confidential business relationship with Markel.” Mr. Fees seemed a bit miffed by my suggestion that his policy might be discriminatory on its face. “I live with a clinical psychologist, and I had this conversation with her,” he said. “The aim is never to discriminate against anyone.” When I asked Dana Tufts, Dewar’s president, about the potential for discrimination, his public relations representative, Carmen Duarte, interrupted and refused to let him answer. Discriminatory or not, it’s possible that Sallie’s policy is actually too generous. The price starts at $599 for the maximum $50,000 in school year coverage for tuition, room, board and other related expenses, with some identity theft and medical evacuation insurance thrown in gratis. The price goes down from there if families want less coverage. Also, undergraduates who borrowed money from Sallie Mae starting July 1 get $5,000 in tuition refund coverage free.
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Recipes for Health: Yogurt Soup With Spelt, Cucumbers and Watercress Posted: 21 Jul 2011 11:20 PM PDT A summer soup with a lot of texture and crunch, this is both substantial and refreshing. Recipes for HealthMartha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.
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1/2 cup spelt, farro or wheat berries, preferably soaked for an hour or more and drained (don’t worry if you haven’t done this, although they make take longer to cook) 2 cups water Salt to taste 1 quart plain low-fat or whole-milk yogurt (free of gums and stabilizers) or buttermilk, or a mixture of the two 2 ripe but firm tomatoes, cut in small dice 1 cup finely chopped seeded cucumber (no need to seed if using Persian or European cucumbers) 1 small bunch watercress, thick stems discarded, coarsely chopped 1 to 2 garlic cloves (to taste), finely minced or puréed with a little salt in a mortar and pestle 2 tablespoons freshly squeezed lemon juice 3/4 cup cold water (more as desired) 1/4 cup finely chopped dill, parsley, mint or cilantro 2 tablespoons snipped chives Freshly ground pepper to taste 3 or 4 radishes, thinly sliced, for garnish 1. Combine the spelt, water and salt to taste, and bring to a boil. Reduce the heat, and simmer about 50 minutes to an hour until tender and some of the kernels have begun to splay. Remove from the heat, drain and set aside. 2. While the spelt is cooking, place the cucumber in a bowl and sprinkle with salt. Toss and place in a strainer set over the bowl. Allow to drain for 30 minutes. Rinse well, and drain on paper towels. 3. Combine all the ingredients except the radishes. Season to taste with salt and pepper. Chill for two hours or longer. Serve, garnishing each bowl with the sliced radishes. Yield: Serves six. Advance preparation: You can make this several hours to a day before serving. It will keep for three or four days in the refrigerator. Nutritional information per serving (six servings): 166 calories; 2 grams saturated fat; 0 gram polyunsaturated fat; 1 gram monounsaturated fat; 10 milligrams cholesterol; 25 grams carbohydrates; 2 grams dietary fiber; 126 milligrams sodium (does not include salt to taste); 12 grams protein Martha Rose Shulman is the author of "The Very Best of Recipes for Health." |
Lawsuits and Intrigue Over 3M Diagnostic Test Posted: 22 Jul 2011 12:30 PM PDT It is a legal scrap with tabloid sensibilities: extortion charges, libel claims, British royalty — and a prominent American protagonist, the 3M Corporation, purveyor of staples like Scotch tape and Post-it notes. Joshua Roberts/Bloomberg NewsCarl Court/Agence France-Presse â" Getty ImagesIt began three years ago as a routine lawsuit over a diagnostic test to be marketed by 3M that detected a highly resistant bacterium often found in hospitals. But it has since escalated into a trans-Atlantic swill of suits and countersuits that now ensnare 3M’s chairman and chief executive, Britain’s secretary of defense and a well-known Washington lawyer and lobbyist, Lanny J. Davis. In one lawsuit, 3M charged that a big investor in the diagnostic test had tried to blackmail the company into settling its lawsuit for $30 million by suggesting that a knighthood conferred on the 3M chief executive, George W. Buckley, could be derailed. In turn, that big investor, Harvey Boulter, filed a libel suit against 3M, Mr. Buckley and a lawyer for the company. And in a legal filing on Thursday, 3M suggested Mr. Davis — probably best known for his role in defending President Clinton during his impeachment — had been part of a conspiracy to shake down the company. Mr. Davis, who represents Mr. Boulter’s equity fund, had masterminded a series of attacks on 3M that “began as a defamatory media blitz and culminated in the outright attempted blackmail of 3M and its chairman,” the company asserts in papers filed in state Supreme Court in Manhattan. A 3M spokeswoman declined to make Mr. Buckley available for comment. Mr. Davis said the company’s filing was untrue and intended to divert attention from 3M’s own problems. “I am accustomed when speaking publicly in only dealing in facts that can be documented,” he said. The dispute can be traced to 2005 when the equity fund headed by Mr. Boulter acquired a majority interest in the diagnostic test, which was based on technology developed by the British Ministry of Defense. The test, known as BacLite, offered a faster way to identify hospital patients who were carriers of the bacterium methicillin-resistant Staphylococcus aureus, or MRSA. In recent years, MRSA infections, which are resistant to antibiotics, have caused patient deaths and injuries. Initial studies indicated that BacLite was highly accurate and, in 2007, 3M struck a multimillion-dollar deal to acquire the test, though the majority of that payout was tied to future BacLite sales. Just a year later, however, 3M dropped BacLite, saying that its subsequent studies found a high rate of false results. By then, several competing MRSA tests had also been introduced. Entities associated with Mr. Boulter’s fund, the Porton Group, responded with a lawsuit filed in 2008 in London, claiming that 3M had failed to fulfill its agreement to diligently market BacLite. And over the next three years, the case puttered along quietly until just before it went to trial last month. Several months ago, Mr. Davis began firing off a series of salvos on behalf of Porton. In May, Mr. Davis and some patients held a demonstration outside 3M’s corporate headquarters in St. Paul, at which he accused 3M of abandoning a “lifesaving” technology. In addition, Mr. Davis filed a petition with the Food and Drug Administration asking it to investigate how 3M had conducted its tests of BacLite, which he says the company botched. He also helped set up a Web site, www.mrsa-injustice.com, that tells the dispute from the side of Mr. Boulter’s fund. Early last month, Queen Elizabeth announced that Mr. Buckley, who holds American and British passports, would receive a knighthood. And as the lawsuit against 3M began to unfold in a London court, Mr. Davis and 3M’s outside lawyer, William A. Brewer III, spoke about a settlement, though those discussions apparently did not advance far. Then, in mid-June, Mr. Davis suggested that Mr. Brewer and Mr. Boulter speak directly with each other. Soon, accusations began to fly. To hear Mr. Brewer tell it, he was biking in Sag Harbor, N.Y., when he received a cellphone call from Mr. Boulter, who had just arrived in Italy from Dubai, where his fund is based, and was driving down the coast to reach his yacht. After exchanging pleasantries, Mr. Brewer said that the businessman began making references to talks about BacLite he had been having with Liam Fox, the British defense secretary. The call between the two men then broke off, Mr. Brewer said, as Mr. Boulter drove through a series of tunnels along the Italian coast. Not long after, the lawyer received a lengthy e-mail from Mr. Boulter that 3M said in the lawsuit contained the blackmail threat. Along with the reference to the “embarrassing situation of George’s knighthood,” Mr. Boulter also wrote in the e-mail that he had a lengthy conversation earlier that day with the defense secretary on “our current favorite topic.” He stated that British officials viewed 3M’s decision not to market BacLite as a violation of trust and that, while 3M might prevail in a courtroom, there could be business ramifications for the company. “It might leave Gov quietly seething for a while, with ramifications for a while — they have memories like elephants,” he wrote. He suggested that 3M settle the case, adding that at a “headline of $30mn+ you will allow MoD to internally save face.” Mr. Boulter rejected any suggestion that his e-mail contained a threat to 3M, adding that he had discussed the note’s contents with Mr. Brewer before sending it. He also said that his reference to his discussion with Mr. Fox about “our current favorite subject” was not about BacLite. “I thought I was in a good-faith confidential settlement discussion,” Mr. Boulter said. Mr. Brewer said that Mr. Boulter’s threat was clear and that he reinforced it in a second e-mail, in which Mr. Boulter cited Mr. Fox again, writing “I need to tell something” to him. “3M quickly decided that the only way to treat this type of behavior was to push it out into the sunlight immediately,” Mr. Brewer said. Mr. Boulter said that he and the defense secretary had briefly discussed the BacLite lawsuit as part of a broader conversation and that he brought up the potential public relations problems for Mr. Buckley given his knighthood and 3M’s behavior in the case. “I said it was unfortunate because it was going to attract a lot of media attention,” Mr. Boulter said. Asked about Mr. Boulter’s comments, a spokesman for the ministry of defense said that Mr. Fox and Mr. Boulter had not discussed the BacLite case or anyone’s knighthood. A decision in the MRSA-related lawsuit against 3M is not expected for some time. |
Lilly Profit Skids as It Prepares for Patent Expirations Posted: 21 Jul 2011 11:10 PM PDT The drug maker Eli Lilly said second-quarter earnings fell 11 percent as it spent more on marketing and research to prepare for a wave of patent expirations. The company said on Thursday that marketing, selling and administrative expenses climbed 16 percent to $2.04 billion as the company supported introductions of Tradjenta and Bydureon, both type 2 diabetes treatments. Research expenses also rose because of a collaboration agreement with a German drug maker. A 9 percent revenue increase buoyed by strong sales from several drugs blunted some of those expenses, and Lilly raised its 2011 earnings forecast. Lilly said it earned $1.2 billion, or $1.07 a share, in the three months that ended June 30. That’s down from the $1.35 billion, or $1.22 a share, Lilly earned in the same quarter last year. Revenue rose 9 percent to $6.25 billion. Excluding restructuring charges, the company’s profit was $1.18 a share. Analysts surveyed by FactSet expected, on average, earnings of $1.19 a share on $6.01 billion in revenue. Lilly said the health care overhaul reduced earnings by about 12 cents a share in the quarter. Sales for Lilly’s best-selling drugs, the antipsychotic Zyprexa and the antidepressant Cymbalta, climbed. But sales for the cancer treatment Gemzar tumbled 62 percent to $112.4 million, including a 91 percent drop in the United States, after it lost patent protection. Patent expirations will sweep over the pharmaceutical industry in the next few years and hit Lilly especially hard. The drug maker loses American patent protection of Zyprexa in October, a month after it loses protection in most of Europe. Lilly said it expected a “rapid and severe” sales decline for the drug, which generated $5 billion last year. By 2014, Lilly will have lost patents protecting drugs that generated 64 percent of its American product sales last year. Lilly also plans to cut costs by $1 billion by the end of this year. For 2011, Lilly now expects adjusted earnings of $4.25 to $4.35 a share, up from $4.15 to $4.30 a share. Analysts expect $4.29 a share. |
F.D.A. Issues Alerts on the Heart Drug Multaq Posted: 21 Jul 2011 09:50 PM PDT American and European regulators issued safety alerts on Thursday about Multaq, a drug approved two years ago to treat abnormal heart rhythms. The Food and Drug Administration said a study of the drug in patients with a long-term form of the disease, known as atrial fibrillation, showed twice as many deaths as those who did not take the drug. The alerts provided the first details of a 3,000-patient trial halted by Sanofi-Aventis two weeks ago. The company had cited “a significant increase in cardiovascular events.” Multaq was approved for short-term arrhythmia lasting less than six months. Since then, the F.D.A. said, 241,000 Americans have received prescriptions. The agency said “a critical question” remained: whether the halted study would also foretell problems with those patients who took Multaq for the approved uses. Those patients should talk to their physicians, the F.D.A. said. The European Medicines Agency said that it would provide further guidance in September. Sanofi, in a statement, said “the benefit-risk profile remains positive” for the approved use. Dr. Robert A. Harrington, a Duke University professor, said that the study was “concerning” but that he would await final data. He was chairman of the panel that voted for approval. Dr. Sidney M. Wolfe, a member of the panel who opposed Multaq, said, “The drug is really too dangerous.” Regulators and Sanofi-Aventis emphasized that physicians should never prescribe Multaq to patients with longer-term fibrillation. Multaq is one of Sanofi’s most important new drugs, with sales of $246 million last year. |
Decoding DNA With Semiconductors Posted: 20 Jul 2011 10:48 PM PDT The inventor of a new machine that decodes DNA with semiconductors has used it to sequence the genome of Gordon Moore, co-founder of Intel, a leading chip maker. The inventor, Jonathan Rothberg of Ion Torrent Systems in Guilford, Conn., is one of several pursuing the goal of a $1,000 human genome, which he said he could reach by 2013 because his machine is rapidly being improved. “Gordon Moore worked out all the tricks that gave us modern semiconductors, so he should be the first person to be sequenced on a semiconductor,” Dr. Rothberg said. At $49,000, the new DNA decoding device is cheaper than its several rivals. Its promise rests on the potential of its novel technology to be improved faster than those of machines based on existing techniques. Manufacturers are racing to bring DNA sequencing costs down to the point where a human genome can be decoded for $1,000, the sum at which enthusiasts say genome sequencing could become a routine part of medical practice. But the sequencing of Dr. Moore’s genome also emphasizes how far technology has run ahead of the ability to interpret the information it generates. Dr. Moore’s genome has a genetic variant that denotes a “56 percent chance of brown eyes,” one that indicates a “typical amount of freckling” and another that confers “moderately higher odds of smelling asparagus in one’s urine,” Dr. Rothberg and his colleagues reported Wednesday in the journal Nature. There are also two genetic variants in Dr. Moore’s genome said to be associated with “increased risk of mental retardation” — a risk evidently never realized. The clinical value of this genomic information would seem to be close to nil. Dr. Rothberg said he agreed that few genes right now yield useful genetic information and that it will be a 10- to 15-year quest to really understand the human genome. For the moment his machine is specialized for analyzing much smaller amounts of information, like the handful of genes highly active in cancer. The Ion Torrent machine requires only two hours to sequence DNA, although sample preparation takes longer. The first two genomes of the deadly E. coli bacteria that swept Europe in the spring were decoded on the company’s machines. The earliest DNA sequencing method depended on radioactivity to mark the four different units that make up genetic material, but as the system was mechanized, engineers switched to fluorescent chemicals. The new device is the first commercial system to decode DNA directly on a semiconductor chip and to work by detecting a voltage change, rather than light. About 1.2 million miniature wells are etched into the surface of the chip and filled with beads holding the DNA strands to be sequenced. A detector in the floor of the well senses the acidity of the solution in each well, which rises each time a new unit is added to the DNA strands on the bead. The cycle is repeated every few seconds until each unit in the DNA strand has been identified. Several years ago, Dr. Rothberg invented another DNA sequencing machine, called the 454, which was used to sequence the genome of James Watson, the co-discoverer of the structure of DNA. Dr. Rothberg said he was describing how the machine had “read” Dr. Watson’s DNA to his young son Noah, who asked why he did not invent a machine to read minds. Dr. Rothberg said he began his research with the idea of making a semiconductor chip that could detect an electrical signal moving across a slice of neural tissue. He then realized the device he had developed was more suited to sequencing DNA. George Church, a genome technologist at the Harvard Medical School, said he estimated the cost to sequence Dr. Moore’s genome at $2 million. This is an improvement on the $5.7 million it cost in 2008 to sequence Dr. Watson’s genome on the 454 machine, but not nearly as good as the $3,700 spent by Complete Genomics to sequence Dr. Church’s genome and others in 2009. Dr. Rothberg said he had already reduced the price of his chips to $99 from $250, and today could sequence Dr. Moore’s genome for around $200,000. Because of Moore’s Law — that the number of transistors placeable on a chip doubles about every two years — further reductions in the cost of the DNA sequencing chip are inevitable, Dr. Rothberg said. Stephan Schuster, a genome biologist at Penn State, said his two Ion Torrent machines were “outstanding,” and enabled a project that would usually have taken two months to be completed in five days. There is now “a race to the death as to who can sequence faster and cheaper, always with the goal of human resequencing in mind,” Dr. Schuster said. This posting includes an audio/video/photo media file: Download Now |
Despite Risk, Embalmers Still Embrace Preservative Posted: 20 Jul 2011 11:40 PM PDT With the government declaring formaldehyde a carcinogen, these might be boom times for alternative embalming fluids — if it weren’t for the so-called everlasting effect funeral directors stake their reputations on. “Formaldehyde is the perfect product for fixation and short-term preservation,” said Debbie Dodge, president of the Dodge Company in Cambridge, Mass., which markets embalming fluids to funeral homes. “Formaldehyde will firm up the body tissue more than any of the nonformaldehyde products out there.” The formaldehyde industry fought the government’s designation for years, arguing that the science was fuzzy on the link between the chemical and certain cancers. Consumer advocates hope a government warning in June will spur increased demand for products with little or no formaldehyde — for items as diverse as plywood, pressed wood, wrinkle-free shirts and hair straighteners. Among funeral directors? Not likely. Next to arsenic, which is no longer used, undertakers insist nothing else preserves the body long enough so that it is presentable for public viewing and can be shipped. In embalming rooms across the country, the focus is on limiting exposure while still using enough of the chemical to keep the customer looking as lifelike as possible. “Family members,” John H. Fitch Jr., senior vice president of advocacy for the National Funeral Directors Association, “have a fairly high expectation.” Undertakers have been aware of formaldehyde’s dangers for more than a decade — the first workplace restrictions on formaldehyde came in the 1980s — and many have been changing their embalming practices to make the process safer. “In our new facility, the ventilation is very good,” said Michael J. Lensing, co-owner of the Lensing Funeral and Cremation Service, in Iowa City, Iowa. “In our old facility, oh, my God. It was different.” At the Lensing funeral home, roughly 60 percent of the bodies are embalmed. The array of precautions were on display at the A. A. Rayner & Sons Funeral Home on Chicago’s South Side, where Charles S. Childs Jr. provided a tour last month of a funeral home started in 1947 by his grandfather. Back then, he said, embalmers went about their work without gloves or masks or much ventilation. Years later, ducts were installed in the ceiling so the fumes wafted in front of their faces as they were sucked out of the room. But now Mr. Childs’s embalming area is fume-free. There were five bodies lying on gurneys, in various states of preparation, and a sixth in a harness, prepared to be lowered into a casket. A colleague who was preparing to embalm one of the bodies wore gloves and a protective apron, and planned to add eyewear and a mask once he got started. Mr. Childs pointed to ventilation ducts installed at table level. “We have to protect ourselves,” Mr. Childs said. Various forms of body preservation have been around for eons, including mummification by the ancient Egyptians. During the Civil War, embalmers prepared the bodies of soldiers on the battlefield and shipped them their family by train or horse and buggy. A high point in embalming lore is that President Lincoln’s body traveled by train from Washington to Springfield, Ill., with public viewings on the way. Arsenic was then one of the primary preservatives. Formaldehyde eventually replaced it. Modern-day embalming fluid is a mixture of formaldehyde, other less toxic chemicals and water. The embalming fluid that is injected to the arterial system, to replace blood, is up to 5 percent formaldehyde, while a more concentrated form — up to 50 percent formaldehyde — is injected into the body cavity. An average embalming requires a minimum of three gallons of the embalming solution, said Melissa Johnson Williams, executive director of the American Society of Embalmers. Ms. Dodge’s company began selling embalming fluids without formaldehyde a few years ago, and some companies now market “green burials” in which less toxic chemicals are used. But while the sales of nonformaldehyde products are increasing, she said that as of yet they simply do not work as well and cost nearly three times as much.
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Study Links Male Infertility to a Missing Protein Posted: 20 Jul 2011 10:48 PM PDT Scientists say they have found a potential cause for a number of otherwise unexplained cases of male infertility: the absence of a protein that coats sperm and allows them to reach an egg more easily. In a study published online on Wednesday in the journal Science Translational Medicine, researchers report that the protein is generated by a specific gene. Men with two copies of the defective gene do not produce the protein. The exact influence the protein has on the chances of a woman’s becoming pregnant is still unclear. But the researchers said the absence of the protein might slow or, in fewer cases, hamper a couple’s ability to conceive. Studying about 500 couples in China who were trying to become pregnant, the scientists found that those with men with two copies of the abnormal gene were 30 percent less likely to have a baby over a period of about two years. For those couples who had babies, it took nearly two months longer if the men had two copies of the abnormal gene. Citing the definition of infertility as the inability to conceive after trying for 12 months, Gary Cherr, the study’s senior author, said, “Our data suggests a likelihood or probability that couples are unable to conceive in the 12-months window will increase significantly if men lack the normal gene.” Still, for most couples, it is unlikely that two defective genes for the protein, called DEFB126, are enough to prevent pregnancy by themselves. The abnormal gene is very common, it turns out, and the scientists report that about a quarter of all men have two defective copies. Clearly it does not prevent all those men from reproducing. Many men may be able to “overcome the mutation” because other factors, like the shape, number or mobility of their sperm, help them fertilize the egg, said Dr. Cherr, a professor of environmental toxicology and nutrition at the University of California, Davis. But if those offsetting factors are not so robust, he added, then the mutation may have “a very dramatic impact.” In the Chinese couples, two abnormal genes appeared to delay pregnancy even when measurements like sperm counts and mobility were taken into account, said Scott Venners, a co-author and professor of health sciences at Simon Fraser University in British Columbia. He did not say by how much. The protein is normally secreted by the epididymis, where sperm are stored after they are produced in the testes. Without that protein, sperm were about 20 percent less likely to penetrate the mucus at the entrance of a woman’s cervix and enter her reproductive tract. And Dr. Cherr said sperm without the protein might enter the tract only to be “rapidly dispatched” as “foreign invaders.” The scientists discovered the abnormal gene while exploring the possibility of a male contraceptive, in the form of a vaccine to make men temporarily infertile. In terms of evolution, the mutation appears to be very old and, besides the 25 percent of men with two mutated copies, half of men have one mutated and one normal copy with no effect on fertility, said Dr. Charles Bevins, a co-author and microbiologist at U.C. Davis. While it seems counterintuitive that a mutation that is so common would be related to preventing the reproduction of a species, Dr. Bevins said the mutation might have survived because it has another function, still unknown but useful. Some fertility experts said the research was too preliminary to prove that the mutation affects couples’ ability to conceive. “I don’t know exactly what it means yet,” said Dr. Robert Oates, a urology professor at Boston University School of Medicine and president-elect of the Society for Male Reproduction and Urology. “The science was very, very good. But does it apply to the population I’m seeing in Boston? We don’t know yet. “The only thing you can say is that it appears in a very young Chinese population that the time to pregnancy is slightly extended.” But Dolores Lamb, professor of urology at Baylor College of Medicine and president-elect for the American Society of Reproductive Medicine, said “this really is a real thing that they’re looking at,” and “it’s affecting a function of the sperm that I think was given very little attention.” Dr. Cherr said it would be relatively simple to develop a test for the mutation to be performed in a clinic or at home. Eventually he envisions a treatment, possibly a cream or gel, that would essentially restore the protein to help sperm enter the reproductive tract. For now, he said, if couples find a double mutation, they could avoid some additional expensive fertility testing and undergo fertility treatments that directly inseminate the woman’s egg. Dr. Lamb said such a test could suggest an even cheaper option. Since some Chinese couples “were able to achieve pregnancy on their own — it was just taking a longer time,” she said, couples “could simply be told to maybe wait a little longer than a year.” |
Consults: Expert Answers on Stargardt's Disease Posted: 21 Jul 2011 09:46 AM PDT |
AstraZeneca Anticlotting Drug Wins Approval Posted: 20 Jul 2011 10:00 PM PDT The Food and Drug Administration on Wednesday approved Brilinta, a new blood thinner from AstraZeneca that the company hopes can rival Plavix, the No. 2 best-selling drug in the world. The agency will require a boxed warning about how the drug’s effectiveness will be reduced if it is taken with higher doses of aspirin. But the approved label — critical to marketing the drug — also says Brilinta was proved superior to Plavix in reducing heart attacks and deaths from cardiovascular causes. “It’s good news for patients, and it’s a good result for AstraZeneca as well,” said Dr. Alex Gold, the company’s brand development leader. “We think the label has been a good outcome and will enable physicians to use the drug appropriately.” The F.D.A. opened the United States market to Brilinta — already approved in 38 other countries — while also imposing a monitoring program to require AstraZeneca to inform physicians of the aspirin risk. The agency’s move followed the rejection on Tuesday of another AstraZeneca drug, dapagliflozin, an experimental diabetes drug that an F.D.A. advisory panel decided in a 9-6 vote carried too high a risk of bladder and breast cancer. The F.D.A. usually but not always follows its advisory panel advice. The blood drug Brilinta had also been under tough scrutiny by the F.D.A., analysts said, because test results in an industry-sponsored clinical trial were far worse among patients in the United States than those from the rest of the world for reasons that remain unclear. In December, the F.D.A. rejected Brilinta in a surprising move, opposing the views of a scientific advisory panel that had voted 7-1 in favor of the drug in July 2010. The F.D.A. asked for and received more information from AstraZeneca. In a note to investors, Timothy Anderson, analyst for Bernstein Research, said he continued to believe commercial prospects would be limited because of the pending lower prices for Plavix. The aspirin warning may be significant, he said. “It may give physicians one more reason not to use Brilinta but to stick to gold-standard Plavix.” Brilinta also has a boxed warning about bleeding risk that also applies to other antiplatelet agents, such as Plavix. Another side effect of Brilinta, but not Plavix, is difficulty breathing in some cases. Brilinta is the latest attempt by pharmaceutical companies to outdo Plavix in the lucrative market for a pill to prevent strokes and heart attacks in coronary patients. The F.D.A. in 2009 approved a new blood thinner called Effient from Daiichi Sankyo and Eli Lilly. But it attached a black-box warning about excessive bleeding, and sales have fallen short of expectations. Plavix was the second-best-selling drug in the world last year behind Lipitor, a cholesterol drug from Pfizer. The patent for Plavix, held by Sanofi Aventis and Bristol-Myers Squibb, expires in May 2012, and should lead to lower prices that may make Plavix more attractive as doctors and insurers weigh the costs, risks and benefits of new drugs. In Europe, where generic forms of Plavix have been available since 2009, the low generic prices have stalled sales of the European version of Brilinta, called Brilique. It was approved by the European Union last year based on a study of 18,624 coronary patients in 43 countries. The study, paid for by AstraZeneca, compared Brilinta and aspirin head-to-head with Plavix and aspirin. It found 16 percent fewer deaths, heart attacks and strokes in a year among Brilinta patients, with no more bleeding problems. But paradoxically, the results were opposite that among the 1,400 Americans in the trial. They had a higher rate of negative outcomes, a figure that was not statistically significant over all because of the lower number of patients, but that certainly caught regulators’ attention. AstraZeneca has attributed the difference to higher aspirin dosing in the United States. The F.D.A. accepted that reasoning in the boxed label warning that says more than 100 milligrams a day of aspirin would “reduce the effectiveness of Brilinta and should be avoided,” but lower doses were recommended. Brilinta prevents blood platelets from sticking together and forming clots. It is faster-acting than Plavix and reversible if the patient bleeds. Some patients respond to Brilinta who do not respond to Plavix, for genetic reasons. |
Panel Recommends Coverage for Contraception Posted: 19 Jul 2011 10:40 PM PDT WASHINGTON — A leading medical advisory panel recommended on Tuesday that all insurers be required to cover contraceptives for women free of charge as one of several preventive services under the new health care law. Obama administration officials said that they were inclined to accept the panel’s advice and that the new requirements could take effect for many plans at the beginning of 2013. The administration signaled its intentions in January when Kathleen Sebelius, the secretary of health and human services, unveiled a 10-year program to improve the nation’s health. One goal was to “increase the proportion of health insurance plans that cover contraceptive supplies and services.” Administration officials, who say they hope to act on the recommendations by Aug. 1, are receptive to the idea of removing cost as a barrier to birth control — a longtime goal of advocates for women’s rights and experts on women’s health. But the recommendations immediately reignited debate over the government’s role in reproductive health. Women’s groups and medical professionals applauded the recommendations while the Roman Catholic Church raised strenuous objections. The recommendations came in a report submitted to Ms. Sebelius by the Institute of Medicine, an arm of the National Academy of Sciences. The new health care law says insurers must cover “preventive health services” and cannot charge for them. Ms. Sebelius will decide on a minimum package of essential health benefits, and her decision will not require further action by Congress. The panel said insurers should be forbidden to charge co-payments for contraceptives and other preventive services because even small charges could deter their use. The recommendation would not help women without insurance. The administration asked the Institute of Medicine, a nonpartisan, nongovernmental arm of the National Academy of Sciences, to help identify the specific services that must be covered for women. “This report is historic,” Ms. Sebelius said on Tuesday in accepting the document. “Before today, guidelines regarding women’s health and preventive care did not exist. These recommendations are based on science and existing literature.” In addition to contraceptive services for women, the panel recommended that the government require health plans to cover screening to detect domestic violence; screening for H.I.V., the virus that causes AIDS; and counseling and equipment to promote breastfeeding, including the free rental of breast pumps. The panel also said all insurers should be required to cover screening for gestational diabetes in pregnant women; DNA testing for the human papillomavirus as part of cervical cancer screening; and annual preventive-care visits. Such visits could include prenatal care and preconception care, to make sure women are healthy when they become pregnant. Defending its recommendations on contraceptive coverage, the panel said that nearly half of all pregnancies in the United States were unintended, and that about 40 percent of unintended pregnancies ended in abortion. Thus, it said, greater use of contraception would reduce the rates of unintended pregnancy, teenage pregnancy and abortion. The chairwoman of the panel, Dr. Linda Rosenstock, dean of the School of Public Health at the University of California, Los Angeles, said, “We did not consider cost or cost-effectiveness in our deliberations.” But the panel’s report says that “contraception is highly cost-effective,” averting unintended pregnancies that would be far more expensive than contraception. To reduce unintended pregnancies, the panel said, insurers should cover the full range of contraceptive methods approved by the Food and Drug Administration, as well as sterilization procedures and “education and counseling for all women with reproductive capacity.” This recommendation would require coverage of emergency contraceptives including pills like ella and Plan B, panel members said. Under rules issued last year, many health plans are already required to cover numerous preventive services like blood pressure and cholesterol tests, colonoscopies and other cancer screenings, and routine vaccinations. A provision of the law drafted by Senator Barbara A. Mikulski, Democrat of Maryland, requires coverage of “additional preventive care and screenings” for women. Most private insurance provides contraceptive coverage, but co-payments have increased in recent years, the panel said. The report touched off a fierce debate Tuesday. Obstetricians, gynecologists, public health experts and Democratic women in Congress hailed the recommendations. “We are one step closer to saying goodbye to an era when simply being a woman is treated as a pre-existing condition,” Ms. Mikulski said. “We are saying hello to an era where decisions about preventive care and screenings are made by a woman and her doctor, not by an insurance company.” Representative Lois Capps, Democrat of California, said the recommendations would remove cost as a barrier to birth control — and in hard economic times like these, she said, cost can be a formidable barrier. The United States Conference of Catholic Bishops and some conservative groups, including the Family Research Council, denounced the recommendation on birth control. “Pregnancy is not a disease, and fertility is not a pathological condition to be suppressed,” said Deirdre A. McQuade, a spokeswoman for the bishops’ Pro-Life Secretariat. “But the Institute of Medicine report treats them as such.” Ms. McQuade expressed deep concern about requiring coverage of surgical sterilizations and contraceptive drugs and devices. Jeanne Monahan, the director of the Center for Human Dignity at the Family Research Council, said: “Some people have moral or ethical objections to contraceptives. They should not be forced to violate their conscience by paying premiums to health plans that cover these items and services.” One panel member, Prof. Anthony Lo Sasso, a health economist at the University of Illinois at Chicago, filed a dissent, saying the committee did not have enough time to conduct “a serious and systematic review” of the evidence. The report, he said, includes “a mix of objective and subjective determinations filtered through a lens of advocacy.” |
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Johnson & Johnson Hurt by Recalls in Second Quarter Posted: 19 Jul 2011 11:20 PM PDT Johnson & Johnson posted a 20 percent decline in second-quarter profit on Tuesday, hurt by product recalls, flat sales in the United States and costs related to litigation and restructuring. Johnson & Johnson executives said they were making progress on fixing manufacturing problems that resulted in several recalls and had numerous new drugs, medical devices and toiletries hitting the market or coming soon. The company said it earned $2.78 billion, or $1 a share, down from $3.45 billion, or $1.23 a share, a year earlier. Revenue rose 8.3 percent, to $16.6 billion, from $15.33 billion a year ago. Excluding one-time items, income would have been $3.55 billion, or $1.28 a share. Analysts polled by FactSet, on average, were expecting earnings of $1.24 a share and sales of $16.21 billion. Shares of Johnson & Johnson, which is based in New Brunswick, N.J., fell 37 cents, to $66.72. “The expectations were austere,” said Steve Brozak, an analyst with WBB Securities. He noted that J.& J. executives repeatedly cited pressures from austerity measures by European government health programs and flat or declining prices in the United States for things like joint replacements. Revenue was flat in the United States; consumer health product sales were down 8.5 percent because recalled products remained off store shelves. Foreign sales were up 16 percent, but mostly because of favorable exchange rates. Sales were up in all three divisions — consumer health, prescription drugs and medical devices and diagnostics — for the first time since the fourth quarter of 2009, shortly after the start of a series of more than 25 product recalls. Revenue growth was led by prescription drugs, with an increase of 12 percent, to $6.23 billion, in sales. Sales of medical devices, J.& J.’s biggest division, rose 7 percent to $6.57 billion. Consumer health products, which includes nonprescription medicines and skin, dental and hair care products, increased 4 percent to $3.79 billion. The company maintained its profit forecast for 2011, at $4.90 to $5 a share, excluding one-time items. Analyst expect $4.95 a share, on average. “We are making solid progress in our product launches, pipelines and investments” in product development, Dominic Caruso, the chief financial officer, told analysts in a conference call. “I expect to see additional improvement in third-quarter sales as our business momentum continues and as the overall market improves.” |
Diabetes Drug Dapagliflozin Rejected by F.D.A. Panel Posted: 20 Jul 2011 12:46 AM PDT A federal advisory committee voted 9 to 6 on Tuesday that a first-of-its-kind diabetes drug should not be approved for use because of safety concerns, including a possible increased risk of breast and bladder cancers. The advisory committee to the Food and Drug Administration said that while the drug, dapagliflozin, had some attractive features as a treatment for type 2 diabetes, there were too many unanswered questions about safety and in which type of patients it should best be used. The drug, being developed by Bristol-Myers Squibb and AstraZeneca, could become the first to work to lower blood sugar by causing it to be excreted in the urine. Many other companies are in a heated race to develop similar drugs, which are called SGLT2 inhibitors. “While I really liked the concept, we just don’t have enough right now, in my opinion, to ensure safety and efficacy and how to use it,” said Dr. David M. Capuzzi, a professor at Thomas Jefferson University and a member of the committee, who voted no. The F.D.A. is not bound to follow the advice of its committees, and it has often said that when a vote is close it pays more attention to the discussion than to the final tally. Still, it would be highly unusual for the agency to immediately approve a drug after a negative vote. The agency is supposed to make a decision by Oct. 28. Because of safety concerns, analysts had been somewhat lukewarm on the prospects for the drug. Mark Schoenebaum, an analyst at the ISI Group, projected peak annual global sales of $735 million in 2019. He estimated after the vote that the drug had only a 20 percent chance of approval, and he lowered his projected 2015 earnings for Bristol-Myers by 2 percent. Bristol’s shares rose 15 cents yesterday to $28.81, though the committee vote did not come until after the close of regular trading. In the first hour of after-hours trading, the stock fell 21 cents to $28.60. AstraZeneca’s American depositary receipts were unchanged in regular trading and rose 8 cents, to $48.81, after hours. More than 25 million Americans are said to have diabetes, most of them with type 2, which was once called adult onset diabetes and is often associated with obesity. Some doctors on the committee said that there was a need for new drugs and that dapagliflozin would be useful in treating type 2 diabetes. One reason, they said, was that its mechanism of action was different from many other diabetes drugs, which work by affecting the supply or use of insulin. That could make it easier to combine dapagliflozin with other drugs. Also, since so many calories are excreted through the urine, dapagliflozin causes a small weight loss while many other diabetes drugs cause weight gains. “Finding anti-diabetic agents that are weight-neutral is going to be a huge advance,” said Dr. Ellen W. Seely, an endocrinologist at Harvard Medical School and Brigham and Women’s Hospital, who voted in favor of approval. “Although there is a scare factor to the word ‘cancer,’ ” she said, diabetes “is a devastating disease.” Several committee members said they could have voted either way. “I changed my mind about four times in the last 10 seconds,” said Erica H. Brittain, a statistician at the National Institutes of Health who voted no. The biggest safety concern was that in clinical trials, patients who got the drug were more likely to develop breast and bladder cancers than those in the control groups. About 0.4 percent of women taking the drug got breast cancer, compared with 0.1 percent of the women in the control groups. About 0.3 percent of men getting the drug got bladder cancer, compared with about 0.05 percent of men in the control groups. The numbers were very small, however, making it hard to draw definitive conclusions. Bristol-Myers and AstraZeneca argued that many of the cancers occurred too soon to have been caused by the drugs. Still, some committee members said the imbalance could not be overlooked. “The breast and bladder cancers, I can’t dismiss as being irrelevant or minor,” said Dr. Doris B. Strader of the University of Vermont. Another safety concern was that there was one case of liver damage probably caused by the drug. And some committee members said Bristol-Myers and AstraZeneca had not done enough studies of how exactly the drug affected the kidneys. Some also said the clinical trials did not include enough minorities and very old patients, demographics that were prone to diabetes. The committee members agreed that more study of the possible cancer risks and other safety questions would be needed. Those who voted no mainly believed that the studies needed to be done before approval, even though that might delay approval by years. Those who voted yes tended to think it would be impossible to do large enough studies to rule out the cancer risk before approval. Rather they said the studies could be done after approval, in part by observing the effects of the drug as it is used. |
Recipes for Health: Watermelon Gazpacho Posted: 21 Jul 2011 12:00 AM PDT This is adapted from a watermelon and tomato soup in Anya von Bremzen’s wonderful book "The New Spanish Table." I’ll admit that I was skeptical about this recipe when I tried it, but it turned out to be a delicious surprise. The celery brings this combination together, so don’t leave it out. Recipes for HealthMartha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.
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4 cups cubed seedless watermelon, about 1 1/4 pounds 1 pound ripe tomatoes, quartered or cut into sixths 2 to 3 tablespoons fresh lemon juice, to taste 2 tablespoons extra virgin olive oil Generous 1/2 cup chopped celery (2 ounces) Salt and freshly ground pepper Thin celery slices or sticks for garnish 1. Working in batches, purée all of the ingredients except the garnish in a blender for two minutes or longer until frothy and smooth. Taste and adjust seasonings, making sure you have used enough salt and lemon juice for a vivid flavor. Transfer to a bowl, and chill for several hours. Taste and adjust seasonings. Serve, garnishing each bowl with thinly sliced celery or, if serving in glasses, with a thin lengthwise slice of celery stick. Yield: Four to six regular servings, or 8 to 12 aperitifs. Advance preparation: You can serve this soup the day after you make it. Leftovers are good for two or three days. Nutritional information per serving (four servings): 130 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 5 grams monounsaturated fat; 0 milligrams cholesterol; 17 grams carbohydrates; 2 grams dietary fiber; 19 milligrams sodium (does not include salt to taste); 2 grams protein Martha Rose Shulman is the author of "The Very Best of Recipes for Health." |
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