New H.I.V. Cases Steady Despite Better Treatment


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Despite years of great progress in treating AIDS, the number of new infections with the virus that causes it has remained stubbornly around 50,000 a year in the United States for a decade, according to new figures released on Wednesday by federal officials.
Mary Altaffer/Associated Press
Activists urged full financing for AIDS treatment during a demonstration in New York in June.
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The American epidemic is still concentrated primarily in gay men, and is growing rapidly worse among young black gay men.
That realization is causing a rift in the AIDS community. Activists say the persistent H.I.V. infection rate proves that the government prevention policy is a flop. Federal officials are on the defensive even as they concede that the epidemic will grow if prevention does not get better, which they know is unlikely while their budgets are being cut.
And some researchers believe it is impossible to wipe out a fatal, incurable disease when it is transmitted through sex and carries so much stigma that people deny having it and avoid being tested for it.
Looking back, epidemiologists at the Centers for Disease Control and Prevention believe that new cases peaked at 130,000 a year in the 1980s, sank slowly during the ’90s and reached a plateau at 50,000 around the year 2000.
Larry Kramer, a longtime AIDS activist and the author of “The Normal Heart,” a play about the epidemic’s early days, said: “It means I don’t see an AIDS policy, and I don’t see anyone in charge. It’s so dispiriting that it’s hard to find something to say about it. How many times can you yell ‘Help!’ without ever getting anywhere?”
Both Dr. Kevin Fenton, chief of AIDS prevention for the C.D.C., and Dr. Anthony S. Fauci, chief of AIDS research at the National Institutes of Health, took issue with Mr. Kramer’s interpretation. While both agreed that 50,000 new annual infections was, in Dr. Fauci’s words, “a great concern,” both pointed to some areas where substantial progress had been made. They said that new studies were seeking ways to get more people tested and treated early in the course of the illness, which would make them less infectious and drive transmission rates down.
“The C.D.C. is absolutely not resting,” Dr. Fenton said. “It was a major accomplishment to drop infections from 130,000 to 50,000, and we’re dealing with an epidemic that is dynamic.”
But, he conceded, 50,000 is an “unacceptably high level,” and without better prevention efforts “we’re likely to face an era of rising infection rates.”
Philip Alcabes, a public health epidemiologist at Hunter College in Manhattan, noted that 50,000 is close to the number of Americans who die in road accidents each year — almost 40,000 — “and in some ways, we consider dying on the road an ordinary thing.”
By contrast, he said, nearly one million Americans a year die of heart disease and strokes.
“So it’s not clear that prevention is a failure,” he said. “The average adult’s chances of encountering H.I.V. infection — 0.02 percent a year — are rather low. It’s not reasonable to expect that a sexually transmitted virus will disappear in America, or anywhere else. But I agree with Larry Kramer that there has been a dearth of new policy ideas.”
For most risk groups, infection rates are stable, with 61 percent of cases contracted through gay or bisexual sex, 27 percent through heterosexual sex and 9 percent through drug injections.
But they are increasing rapidly in one subgroup: young gay black men. Black teenage boys who realize they are attracted to men are often too poor to move to gay-friendly cities like San Francisco or New York, researchers said, and often must keep their homosexuality hidden from relatives and friends, making it more likely they will have furtive, risky sex.
They often lack health insurance, meaning they do not get checkups where a doctor might suggest testing. And while new surveys find that they use condoms at about the same rates as young gay white and Hispanic men, sex tends to stay within racial groups and more older black gay and bisexual men are infected. Also, untreated syphilis, whose sores open a path for H.I.V., is more common among blacks.
The National Institutes of Health is supporting studies in the Bronx, Washington and other heavily black urban areas seeking new ways to reach these men, Dr. Fauci said. Results will be ready in two or three years.
Prevention has worked for two groups, Dr. Fenton said. The number of women infecting their children at birth or through breast-feeding has dropped to only 100 a year from about 1,300 two decades ago. In that respect, the United States is like Africa: scarce public clinics focus on women and children, and many poor women see a doctor only when pregnant.
Also, the number of infections through drug use has dropped 80 percent, although that may be a result of changing fashions among addicts: Fewer inject heroin and more smoke or inhale heroin, crack, crystal meth and cocaine or swallow prescription opiates like OxyContin. Only needle-sharing passes virus-tainted blood.
Chris Collins, director of public policy for amfAR, the Foundation for AIDS Research, said the decade-long persistence of 50,000 infections “shows that we’ve failed to target prevention services adequately and have not gotten treatment coverage in many communities that would bring down community viral loads.”
A recent study has shown that getting people on antiretroviral drugs early makes them 96 percent less likely to infect others, so there is a growing outcry for “test and treat” — shorthand for actively seeking out gay men and those injecting drugs and asking them to get tested, and then helping them find medical care if they have the disease.
Dr. Fauci and Dr. Fenton said there was no discussion now of making such tests mandatory — as, for example, syphilis tests once were for marriage licenses.
San Francisco and Vancouver, British Columbia, have lowered new infection rates, Mr. Collins noted. But how applicable those lessons are to the United States as a whole is debatable; both cities have very small black populations, and Vancouver’s success relies partly on a government-approved center where drug addicts can shoot up under the eyes of a nurse and without fear of arrest — an experiment unlikely to be repeated in the United States.
The new C.D.C. figures are based partly on a new blood test that can tell recent infections from old ones, said Joseph Prejean, who led the team that made the new estimates. The test, invented in 2005 and nicknamed the “BED test,” for the B, D and E viral subtypes it uses, measures H.I.V. antibodies in the blood relative to total antibodies. That ratio rises rapidly from infection to about six months, then levels off, he said.

Dr. Alcabes, who was once a harsh critic of C.D.C. estimates, said he believed the new numbers were as accurate as they could get. “They’ve done an enormous amount of number-crunching with stupefying amounts of detail,” he said.

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Antiasmaticos en el NYT


Warning Given on Use of 4 Popular Asthma Drugs, but Debate Remains

Published: December 5, 2008

WASHINGTON — Two federal drug officials have concluded that asthma sufferers risk death if they continue to use four hugely popular asthma drugs — Advair, Symbicort, Serevent and Foradil. But the officials’ views are not universally shared within the government.

The two officials, who work in the safety division of the Food and Drug Administration, wrote in an assessment on the agency’s Web site on Friday that asthma sufferers of all ages should no longer take the medicines. A third drug-safety official concluded that Advair and Symbicort could be used by adults but that all four drugs should no longer be used by people age 17 and under.

Dr. Badrul A. Chowdhury, director of the division of pulmonary and allergy products at the agency, cautioned in his own assessment that the risk of death associated with the drugs was small and that banning their use “would be an extreme approach” that could lead asthmatics to rely on other risky medications.

Once unheard of, public disagreements among agency experts have occurred on occasion in recent years. The agency is convening a committee of experts on Wednesday and Thursday to sort out the disagreement, which has divided not only the F.D.A. but also clinicians and experts for more than a decade.

Sudden deaths among asthmatics still clutching their inhalers have fed the debate. But trying to determine whether the deaths were caused by patients’ breathing problems or the inhalers has proved difficult.

The stakes for drug makers are high. Advair sales last year were $6.9 billion and may approach $8 billion this year, making the medication GlaxoSmithKline’s biggest seller and one of the biggest-selling drugs in the world. Glaxo also sells Serevent, which had $538 million in sales last year. Symbicort is made by AstraZeneca and Foradil by Novartis.

Whatever the committee’s decision, the drugs will almost certainly remain on the market because even the agency’s drug-safety officials concluded that they were useful in patients suffering from chronic obstructive pulmonary disease, nearly all of whom are elderly.

Dr. Katharine Knobil, global clinical vice president for Glaxo, dismissed the conclusions of the agency’s drug-safety division as “not supported by their own data.” Dr. Knobil said that Advair was safe and that Serevent was safe when used with a steroid.

Michele Meeker, a spokeswoman for AstraZeneca, said that the F.D.A.’s safety division improperly excluded most studies of Symbicort in its analysis, and that a review of all of the information shows that the drug does not increase the risks of death or hospitalization.

Dr. Daniel Frattarelli, a Detroit pediatrician and member of the American Academy of Pediatrics’s committee on drugs, said that he was treating children with Advair and that his committee had recently discussed the safety of the medicines.

“Most of us felt these were pretty good drugs,” Dr. Frattarelli said. “I’m really looking forward to hearing what the F.D.A. committee decides.”

About 9 percent of Advair’s prescriptions go to those age 17 and under, according to Glaxo. Ms. Meeker could not provide similar figures for Symbicort.

In 1994, Serevent was approved for sale, and the F.D.A. began receiving reports of deaths. A letter to the New England Journal of Medicine described two elderly patients who died holding Serevent inhalers. Glaxo warned patients that the medicine, unlike albuterol, does not work instantly and should not be used during an attack.

In 1996, Glaxo began a study of Serevent’s safety, but the company refused for years to report the results publicly. In 2001, the company introduced Advair, whose sales quickly cannibalized those of Serevent and then far surpassed them.

Finally in 2003, Glaxo reported the results of its Serevent study, which showed that those given the medicine were more likely to die than those given placebo inhalers. Glaxo said problems with the trial made its results impossible to interpret.

Asthma is caused when airways within the lungs spasm and swell, restricting the supply of oxygen. The two primary treatments are steroids, which reduce swelling, and beta agonists, which treat spasms. Rescue inhalers usually contain albuterol, which is a beta agonist with limited duration. Serevent and Foradil are both beta agonists but have a longer duration than albuterol and were intended to be taken daily to prevent attacks.

Advair contains Serevent and a steroid. Symbicort, introduced last year, contains Foradil and a steroid. In the first nine months of this year, Symbicort had $209 million in sales.

The problem with albuterol is that it seems to make patients’ lungs more vulnerable to severe attacks, which is why asthmatics are advised to use their rescue inhalers only when needed. The long-acting beta agonists may have the same risks.

But drug makers say this risk disappears when long-acting beta agonists are paired with steroids. The labels that accompany Serevent and Foradil instruct doctors to pair the medicines with an inhaled steroid.

Antiasmaticos en el NYT


Warning Given on Use of 4 Popular Asthma Drugs, but Debate Remains

Published: December 5, 2008

WASHINGTON — Two federal drug officials have concluded that asthma sufferers risk death if they continue to use four hugely popular asthma drugs — Advair, Symbicort, Serevent and Foradil. But the officials’ views are not universally shared within the government.

The two officials, who work in the safety division of the Food and Drug Administration, wrote in an assessment on the agency’s Web site on Friday that asthma sufferers of all ages should no longer take the medicines. A third drug-safety official concluded that Advair and Symbicort could be used by adults but that all four drugs should no longer be used by people age 17 and under.

Dr. Badrul A. Chowdhury, director of the division of pulmonary and allergy products at the agency, cautioned in his own assessment that the risk of death associated with the drugs was small and that banning their use “would be an extreme approach” that could lead asthmatics to rely on other risky medications.

Once unheard of, public disagreements among agency experts have occurred on occasion in recent years. The agency is convening a committee of experts on Wednesday and Thursday to sort out the disagreement, which has divided not only the F.D.A. but also clinicians and experts for more than a decade.

Sudden deaths among asthmatics still clutching their inhalers have fed the debate. But trying to determine whether the deaths were caused by patients’ breathing problems or the inhalers has proved difficult.

The stakes for drug makers are high. Advair sales last year were $6.9 billion and may approach $8 billion this year, making the medication GlaxoSmithKline’s biggest seller and one of the biggest-selling drugs in the world. Glaxo also sells Serevent, which had $538 million in sales last year. Symbicort is made by AstraZeneca and Foradil by Novartis.

Whatever the committee’s decision, the drugs will almost certainly remain on the market because even the agency’s drug-safety officials concluded that they were useful in patients suffering from chronic obstructive pulmonary disease, nearly all of whom are elderly.

Dr. Katharine Knobil, global clinical vice president for Glaxo, dismissed the conclusions of the agency’s drug-safety division as “not supported by their own data.” Dr. Knobil said that Advair was safe and that Serevent was safe when used with a steroid.

Michele Meeker, a spokeswoman for AstraZeneca, said that the F.D.A.’s safety division improperly excluded most studies of Symbicort in its analysis, and that a review of all of the information shows that the drug does not increase the risks of death or hospitalization.

Dr. Daniel Frattarelli, a Detroit pediatrician and member of the American Academy of Pediatrics’s committee on drugs, said that he was treating children with Advair and that his committee had recently discussed the safety of the medicines.

“Most of us felt these were pretty good drugs,” Dr. Frattarelli said. “I’m really looking forward to hearing what the F.D.A. committee decides.”

About 9 percent of Advair’s prescriptions go to those age 17 and under, according to Glaxo. Ms. Meeker could not provide similar figures for Symbicort.

In 1994, Serevent was approved for sale, and the F.D.A. began receiving reports of deaths. A letter to the New England Journal of Medicine described two elderly patients who died holding Serevent inhalers. Glaxo warned patients that the medicine, unlike albuterol, does not work instantly and should not be used during an attack.

In 1996, Glaxo began a study of Serevent’s safety, but the company refused for years to report the results publicly. In 2001, the company introduced Advair, whose sales quickly cannibalized those of Serevent and then far surpassed them.

Finally in 2003, Glaxo reported the results of its Serevent study, which showed that those given the medicine were more likely to die than those given placebo inhalers. Glaxo said problems with the trial made its results impossible to interpret.

Asthma is caused when airways within the lungs spasm and swell, restricting the supply of oxygen. The two primary treatments are steroids, which reduce swelling, and beta agonists, which treat spasms. Rescue inhalers usually contain albuterol, which is a beta agonist with limited duration. Serevent and Foradil are both beta agonists but have a longer duration than albuterol and were intended to be taken daily to prevent attacks.

Advair contains Serevent and a steroid. Symbicort, introduced last year, contains Foradil and a steroid. In the first nine months of this year, Symbicort had $209 million in sales.

The problem with albuterol is that it seems to make patients’ lungs more vulnerable to severe attacks, which is why asthmatics are advised to use their rescue inhalers only when needed. The long-acting beta agonists may have the same risks.

But drug makers say this risk disappears when long-acting beta agonists are paired with steroids. The labels that accompany Serevent and Foradil instruct doctors to pair the medicines with an inhaled steroid.

Procuran reducir los nacimientos multiples por fertilizacion asistida


NUEVA YORK (The New York Times) .- En el mundo complejo, caro y emocionalmente cargado de los tratamientos de fertilidad, los médicos están llamando a revertir el creciente número de nacimientos múltiples.

Los especialistas están respondiendo a una consecuencia involuntaria del éxito de la fecundación asistida: que frecuentemente es demasiado exitosa. Desde 1980, cuando la técnica comenzó a practicarse en los Estados Unidos, el número de mellizos aumentó un 70%, al 3,2% de todos los nacimientos en 2004.

Parte del aumento, afirman los expertos, es resultado de estos tratamientos. El número de trillizos y otros nacimientos múltiples aumentó aún más entre 1980 y 1998. No es que los mellizos o los trillizos sean indeseables, afirman los médicos. Pero los embarazos múltiples frecuentemente conducen a partos prematuros y otras complicaciones. Con esto en mente, los centros de fertilidad están tratando de disminuir la probabilidad de estos embarazos, incluso aceptando el riesgo de tener tasas de éxito algo inferiores.

“Es el momento de que todos repensemos cuál es el paradigma de un embarazo asistido exitoso”, dijo el doctor Aaron K. Styer, endocrinólogo reproductivo del Centro de Fertilidad del Hospital General de Massachusetts, en Boston. “¿Es un embarazo del que no se tenga en cuenta el número de gestaciones, o un embarazo con un único bebe?”

En la fecundación asistida, se le dan a la mujer hormonas que inducen la ovulación para que produzca muchos óvulos, que se extraen, se fertilizan con los espermatozoides de su pareja y se le implantan en el útero. Cuantos más embriones sean transferidos, más alta será la probabilidad de tener un embarazo múltiple.

Para alcanzar la meta de un único bebe, las clínicas están transfiriendo menos embriones y desarrollando formas más precisas para identificar los más saludables, que poseen las más altas chances de éxito.

“Hemos mejorado la fecundación asistida a lo largo de los años, y a medida que los índices de éxito crecen, el número de embriones que transferimos debe bajar proporcionalmente -dijo la doctora Judy E. Stern, directora del laboratorio de embriología y andrología humana del Centro Médico Dartmouth-Hitchcock, de Lebanon-. Donde tres embriones funcionaban bien y producían hijos únicos, ahora transferimos dos, porque estamos logrando mejores embriones y tasas más altas de implantación.”

Transferencias exitosas

El número de tratamientos de fecundación asistida en los que se transferían cuatro o más embriones ha bajado drásticamente: del 62%, en 1996, al 21% en 2004. A pesar de que los esfuerzos han hecho descender el número de trillizos, no lograron alterar el número de mellizos.

Esto es porque muchos médicos y pacientes son reacios a dar el paso final para asegurar el nacimiento de un solo niño, un proceso llamado “transferencia de un único embrión”.

Entre 1996 y 2004, la cantidad de tales procedimientos aumentó modestamente, del 6 al 8 por ciento.

La Sociedad Norteamericana de Medicina Reproductiva ahora recomienda que a las mujeres de menos de 35 años con buen pronóstico se les transfiera un solo embrión. Es el grupo que recibe el 44% de los tratamientos de fecundación asistida.

A las mujeres de más de 37 años, que tienen una mayor incidencia de embriones con defectos cromosómicos, todavía se recomienda que se les transfieran entre tres y cinco embriones, según la edad.

El principal obstáculo que presentan las transferencias únicas es su baja tasa de éxito. Algunos especialistas acuerdan con sus pacientes realizar dos ciclos. En el primero, transfieren un embrión y congelan otros. Si el primer implante falla, pueden transferir el otro, procedimiento menos oneroso. Ese enfoque ofrece similares índices de éxito que la transferencia doble, pero reduce drásticamente los partos de mellizos.

Las clínicas ahora se concentran en elegir los embriones que más probabilidad de éxito tienen. Algunos investigadores están tratando de identificar los rasgos de las mujeres que tienen alto riesgo de tener nacimientos múltiples.

En un trabajo publicado recientemente en la reunión anual de la sociedad de medicina reproductiva, Stern vinculó el número de ovocitos encontrados en los ovarios con las chances de tener embarazos únicos o múltiples. “Esto cambiará nuesta práctica -dijo-. Si extraemos más ovocitos, querremos transferir menos embriones.”

Cuestión de costos

Sin embargo, muchas mujeres que pasan por tratamientos de fecundación asistida afirman que ellas no consideran que tener mellizos sea una situación riesgosa y que están deseosas, si no ansiosas, de tenerlos para acelerar la formación de su familia, evitar los altos costos de futuros tratamientos o asegurar que sus hijos tengan un hermano, entre otras razones.

Para una pareja de Brooklyn que pidió que se la identificara con el nombre de pila, seis años de tratamientos y varios procedimientos frustrados fueron suficientes. Cuando María llegó a los 28, pidieron que le transfirieran tres embriones, aunque el médico recomendaba dos.

“Quería mellizos -dijo ella-. Es un procedimiento tan complicado y a veces doloroso, que no quería pasar por eso otra vez.”

En el tercer ciclo, en junio último, María quedó embarazada de trillizos, pero perdió un niño a las cuatro semanas, y todo el embarazo a los cuatro meses. Estaba devastada, dijo, pero agregó que no se arrepentía de su decisión.

A pesar de que es ampliamente aceptado que los embarazos múltiples son más riesgosos, muchos especialistas no consideran lo mismo de los mellizos, siempre y cuando la paciente esté cuidadosamente controlada.

Fuente: La Nacion y original del NYT.

Procuran reducir los nacimientos multiples por fertilizacion asistida


NUEVA YORK (The New York Times) .- En el mundo complejo, caro y emocionalmente cargado de los tratamientos de fertilidad, los médicos están llamando a revertir el creciente número de nacimientos múltiples.

Los especialistas están respondiendo a una consecuencia involuntaria del éxito de la fecundación asistida: que frecuentemente es demasiado exitosa. Desde 1980, cuando la técnica comenzó a practicarse en los Estados Unidos, el número de mellizos aumentó un 70%, al 3,2% de todos los nacimientos en 2004.

Parte del aumento, afirman los expertos, es resultado de estos tratamientos. El número de trillizos y otros nacimientos múltiples aumentó aún más entre 1980 y 1998. No es que los mellizos o los trillizos sean indeseables, afirman los médicos. Pero los embarazos múltiples frecuentemente conducen a partos prematuros y otras complicaciones. Con esto en mente, los centros de fertilidad están tratando de disminuir la probabilidad de estos embarazos, incluso aceptando el riesgo de tener tasas de éxito algo inferiores.

“Es el momento de que todos repensemos cuál es el paradigma de un embarazo asistido exitoso”, dijo el doctor Aaron K. Styer, endocrinólogo reproductivo del Centro de Fertilidad del Hospital General de Massachusetts, en Boston. “¿Es un embarazo del que no se tenga en cuenta el número de gestaciones, o un embarazo con un único bebe?”

En la fecundación asistida, se le dan a la mujer hormonas que inducen la ovulación para que produzca muchos óvulos, que se extraen, se fertilizan con los espermatozoides de su pareja y se le implantan en el útero. Cuantos más embriones sean transferidos, más alta será la probabilidad de tener un embarazo múltiple.

Para alcanzar la meta de un único bebe, las clínicas están transfiriendo menos embriones y desarrollando formas más precisas para identificar los más saludables, que poseen las más altas chances de éxito.

“Hemos mejorado la fecundación asistida a lo largo de los años, y a medida que los índices de éxito crecen, el número de embriones que transferimos debe bajar proporcionalmente -dijo la doctora Judy E. Stern, directora del laboratorio de embriología y andrología humana del Centro Médico Dartmouth-Hitchcock, de Lebanon-. Donde tres embriones funcionaban bien y producían hijos únicos, ahora transferimos dos, porque estamos logrando mejores embriones y tasas más altas de implantación.”

Transferencias exitosas

El número de tratamientos de fecundación asistida en los que se transferían cuatro o más embriones ha bajado drásticamente: del 62%, en 1996, al 21% en 2004. A pesar de que los esfuerzos han hecho descender el número de trillizos, no lograron alterar el número de mellizos.

Esto es porque muchos médicos y pacientes son reacios a dar el paso final para asegurar el nacimiento de un solo niño, un proceso llamado “transferencia de un único embrión”.

Entre 1996 y 2004, la cantidad de tales procedimientos aumentó modestamente, del 6 al 8 por ciento.

La Sociedad Norteamericana de Medicina Reproductiva ahora recomienda que a las mujeres de menos de 35 años con buen pronóstico se les transfiera un solo embrión. Es el grupo que recibe el 44% de los tratamientos de fecundación asistida.

A las mujeres de más de 37 años, que tienen una mayor incidencia de embriones con defectos cromosómicos, todavía se recomienda que se les transfieran entre tres y cinco embriones, según la edad.

El principal obstáculo que presentan las transferencias únicas es su baja tasa de éxito. Algunos especialistas acuerdan con sus pacientes realizar dos ciclos. En el primero, transfieren un embrión y congelan otros. Si el primer implante falla, pueden transferir el otro, procedimiento menos oneroso. Ese enfoque ofrece similares índices de éxito que la transferencia doble, pero reduce drásticamente los partos de mellizos.

Las clínicas ahora se concentran en elegir los embriones que más probabilidad de éxito tienen. Algunos investigadores están tratando de identificar los rasgos de las mujeres que tienen alto riesgo de tener nacimientos múltiples.

En un trabajo publicado recientemente en la reunión anual de la sociedad de medicina reproductiva, Stern vinculó el número de ovocitos encontrados en los ovarios con las chances de tener embarazos únicos o múltiples. “Esto cambiará nuesta práctica -dijo-. Si extraemos más ovocitos, querremos transferir menos embriones.”

Cuestión de costos

Sin embargo, muchas mujeres que pasan por tratamientos de fecundación asistida afirman que ellas no consideran que tener mellizos sea una situación riesgosa y que están deseosas, si no ansiosas, de tenerlos para acelerar la formación de su familia, evitar los altos costos de futuros tratamientos o asegurar que sus hijos tengan un hermano, entre otras razones.

Para una pareja de Brooklyn que pidió que se la identificara con el nombre de pila, seis años de tratamientos y varios procedimientos frustrados fueron suficientes. Cuando María llegó a los 28, pidieron que le transfirieran tres embriones, aunque el médico recomendaba dos.

“Quería mellizos -dijo ella-. Es un procedimiento tan complicado y a veces doloroso, que no quería pasar por eso otra vez.”

En el tercer ciclo, en junio último, María quedó embarazada de trillizos, pero perdió un niño a las cuatro semanas, y todo el embarazo a los cuatro meses. Estaba devastada, dijo, pero agregó que no se arrepentía de su decisión.

A pesar de que es ampliamente aceptado que los embarazos múltiples son más riesgosos, muchos especialistas no consideran lo mismo de los mellizos, siempre y cuando la paciente esté cuidadosamente controlada.

Fuente: La Nacion y original del NYT.

NYT: Worrisome Infection Eludes a Leading Children’s Vaccine


New York Times

A highly drug-resistant germ has become a common cause of meningitispneumonia and other life-threatening conditions in young children. The culprit — a strain of strep bacteria — can conquer almost all antibiotics in pediatrics, and has dodged a vaccine otherwise credited with causing the number of serious infections in children to plummet.

GJLP/Photo Researchers

Infection with one type of strep bacteria is steadily rising.

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Hybrid Medical Animation/Photo Researchers

The rates of diseases caused by strep bacteria have increased.

Since 2000, American toddlers have been immunized against Streptococcus pneumoniae, or pneumococcus, an organism that preys largely on children younger than 5 and the elderly. Pneumococcal meningitis can be fatal, and survivors are often left with deafness and other lifelong neurological problems.

And by most measures, the vaccine has worked: by 2002, rates of infection from these bacteria had dropped as much as 80 percent in some places. But progress has now stalled, and infection with a particular type of pneumococcus, Serotype 19A, is steadily rising.

“It’s very much a concern,” said Bernard Beall, a pneumococcal expert at the federal Centers for Disease Control and Prevention. Last year, in The Journal of the American Medical Association, pediatricians described an outbreak of Serotype 19A ear infections in Rochester that could be cured only by surgically implanting tubes, or by turning to adult medicines not yet tested for safety in children.

A greater worry, however, is the frequency of meningitis, pneumonia and bloodstream infections from Serotype 19A. Since 2001, rates of these and other invasive pneumococcal diseases have crept upward, to more than 10 per 100,000 children from about 2 per 100,000. A fourfold increase in life-threatening infections has also occurred among the elderly.

The vaccine, Prevnar, is aimed at seven types of bacteria that were responsible for 70 to 80 percent of pneumococcal illness during the 1990s. Because pneumococci come in 91 forms, experts have worried from the start whether bacteria that were just as deadly, but not wiped out by the vaccine, might move in as opportunists when the competition suddenly vanished.

“Nature abhors a vacuum,” said Dr. Steven Black of Cincinnati Children’s Hospital. Indeed, almost all pneumococcal infections among American children today are caused by versions not covered by the vaccine, and 19A is leading the way. “People hoped against hope it wouldn’t happen,” he said.

The vaccine’s manufacturer, Wyeth, says it has been working quickly to develop a new product to counter 19A and five other pneumococcal variations, along with the original seven. The company will release results of the first large studies of the newer version this month at an infectious disease meeting in Washington.

“There was no point where we said to ourselves, ‘We missed it, we need to put in 19A,’ ” said Emilio A. Emini, head of vaccine research and development for Wyeth. The company was always prepared to remake the product, he said.

Once a new vaccine demonstrates that it can protect against pneumococcus, it must work its way through the approval process — passing tests of effectiveness and safety — before it can be licensed. Researchers will also try to determine whether young children who have been immunized with the old Prevnar should be revaccinated to protect themselves from 19A.

The remodeling of a vaccine so soon after its approval is highly unusual, but so was the effort to tackle pneumococcus.

The bacteria live in the nose and throat, usually as microbial freeloaders of no consequence. Occasionally — often after a simple viral infection — pneumococci slip into inner areas of the body and cause disease. Weaker immune systems in the very young and the very old leave them most vulnerable. (The pneumonia shot in older people includes 19A, but many elderly people have not received the immunization.)

Not all of the 91 incarnations of pneumococcal bacteria are dangerous. They developed so much variety by mingling in the back of the throat, exchanging genetic material as eagerly as children trading Halloween candy. The variation in genes slightly alters how the bacteria function and how they are received by the immune system.

For vaccine manufacturers, pneumococci’s diversity presented a challenge: how to teach the immune system to recognize a target that may look a little different from child to child. “This is the most complex biological product ever made,” Dr. Emini said.

Serotype 19A was around in the 1990s, though uncommon, and the vaccine includes a similar version called 19F. The hope in 2000 was that 19F looked enough like 19A to set off an immune reaction. It did not.

Experts say it is hard to know what role the introduction of Prevnar may have played in the rise of the bacteria, which was gaining momentum in some countries before the vaccine’s adoption. For example, researchers from GlaxoSmithKline, which is introducing its own pneumococcal vaccine, reported last month that Serotype 19A became more common in Belgium from 2001 to 2004 — years when pneumococcal vaccination was rare in that country. Similar reports have emerged from China, South Korea and Israel.

Pneumococci ebb and flow in natural cycles, and some types have gained a survival advantage by growing resistant to a host of drugs. The vaccine may have simply amplified natural trends..

“I don’t think anyone can tell you the relative contributions of these factors,” said Dr. Sheldon L. Kaplan of Texas Children’s Hospital in Houston. This summer, he and his colleagues described a growing number of cases of drug-resistant mastoiditis, an infection of an inner-ear bone, from 19A.

Experts are now watching to see how forcefully the organism will spread before the new immunization arrives. Wyeth says it hopes to file an application with the Food and Drug Administration in 2009.

Disease experts also wonder what organisms like 19A mean for the future of pneumococcal infections. Public health experts once hoped the infection could be defeated, but it now appears that pneumococci may be playing a game of cat and mouse.

“The pneumococcus has shown an extraordinary ability to evolve to our strategies,” said Dr. Beall of the C.D.C.

Yet he and others are quick to say that immunization remains highly effective, even if it leaves some children behind. “This is not a failure of the vaccine,” said Dr. George H. McCracken Jr. of the University of Texas Southwestern Medical Center at Dallas. Even with the rise of 19A, children are much less likely to become ill from pneumococcal infections.

Dr. McCracken hopes that researchers will one day avoid threats like 19A entirely by developing a vaccine that primes the immune system to recognize some element common to all 91 types of pneumococci — in the way a quiche, an omelet and a custard pie are all versions of eggs. But until such an immunization comes along, he said, pediatricians will be forced to battle the pneumococcus as they always have, by trying to stay one strain ahead of its game.

NYT: Worrisome Infection Eludes a Leading Children’s Vaccine


New York Times

A highly drug-resistant germ has become a common cause of meningitispneumonia and other life-threatening conditions in young children. The culprit — a strain of strep bacteria — can conquer almost all antibiotics in pediatrics, and has dodged a vaccine otherwise credited with causing the number of serious infections in children to plummet.

GJLP/Photo Researchers

Infection with one type of strep bacteria is steadily rising.

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Hybrid Medical Animation/Photo Researchers

The rates of diseases caused by strep bacteria have increased.

Since 2000, American toddlers have been immunized against Streptococcus pneumoniae, or pneumococcus, an organism that preys largely on children younger than 5 and the elderly. Pneumococcal meningitis can be fatal, and survivors are often left with deafness and other lifelong neurological problems.

And by most measures, the vaccine has worked: by 2002, rates of infection from these bacteria had dropped as much as 80 percent in some places. But progress has now stalled, and infection with a particular type of pneumococcus, Serotype 19A, is steadily rising.

“It’s very much a concern,” said Bernard Beall, a pneumococcal expert at the federal Centers for Disease Control and Prevention. Last year, in The Journal of the American Medical Association, pediatricians described an outbreak of Serotype 19A ear infections in Rochester that could be cured only by surgically implanting tubes, or by turning to adult medicines not yet tested for safety in children.

A greater worry, however, is the frequency of meningitis, pneumonia and bloodstream infections from Serotype 19A. Since 2001, rates of these and other invasive pneumococcal diseases have crept upward, to more than 10 per 100,000 children from about 2 per 100,000. A fourfold increase in life-threatening infections has also occurred among the elderly.

The vaccine, Prevnar, is aimed at seven types of bacteria that were responsible for 70 to 80 percent of pneumococcal illness during the 1990s. Because pneumococci come in 91 forms, experts have worried from the start whether bacteria that were just as deadly, but not wiped out by the vaccine, might move in as opportunists when the competition suddenly vanished.

“Nature abhors a vacuum,” said Dr. Steven Black of Cincinnati Children’s Hospital. Indeed, almost all pneumococcal infections among American children today are caused by versions not covered by the vaccine, and 19A is leading the way. “People hoped against hope it wouldn’t happen,” he said.

The vaccine’s manufacturer, Wyeth, says it has been working quickly to develop a new product to counter 19A and five other pneumococcal variations, along with the original seven. The company will release results of the first large studies of the newer version this month at an infectious disease meeting in Washington.

“There was no point where we said to ourselves, ‘We missed it, we need to put in 19A,’ ” said Emilio A. Emini, head of vaccine research and development for Wyeth. The company was always prepared to remake the product, he said.

Once a new vaccine demonstrates that it can protect against pneumococcus, it must work its way through the approval process — passing tests of effectiveness and safety — before it can be licensed. Researchers will also try to determine whether young children who have been immunized with the old Prevnar should be revaccinated to protect themselves from 19A.

The remodeling of a vaccine so soon after its approval is highly unusual, but so was the effort to tackle pneumococcus.

The bacteria live in the nose and throat, usually as microbial freeloaders of no consequence. Occasionally — often after a simple viral infection — pneumococci slip into inner areas of the body and cause disease. Weaker immune systems in the very young and the very old leave them most vulnerable. (The pneumonia shot in older people includes 19A, but many elderly people have not received the immunization.)

Not all of the 91 incarnations of pneumococcal bacteria are dangerous. They developed so much variety by mingling in the back of the throat, exchanging genetic material as eagerly as children trading Halloween candy. The variation in genes slightly alters how the bacteria function and how they are received by the immune system.

For vaccine manufacturers, pneumococci’s diversity presented a challenge: how to teach the immune system to recognize a target that may look a little different from child to child. “This is the most complex biological product ever made,” Dr. Emini said.

Serotype 19A was around in the 1990s, though uncommon, and the vaccine includes a similar version called 19F. The hope in 2000 was that 19F looked enough like 19A to set off an immune reaction. It did not.

Experts say it is hard to know what role the introduction of Prevnar may have played in the rise of the bacteria, which was gaining momentum in some countries before the vaccine’s adoption. For example, researchers from GlaxoSmithKline, which is introducing its own pneumococcal vaccine, reported last month that Serotype 19A became more common in Belgium from 2001 to 2004 — years when pneumococcal vaccination was rare in that country. Similar reports have emerged from China, South Korea and Israel.

Pneumococci ebb and flow in natural cycles, and some types have gained a survival advantage by growing resistant to a host of drugs. The vaccine may have simply amplified natural trends..

“I don’t think anyone can tell you the relative contributions of these factors,” said Dr. Sheldon L. Kaplan of Texas Children’s Hospital in Houston. This summer, he and his colleagues described a growing number of cases of drug-resistant mastoiditis, an infection of an inner-ear bone, from 19A.

Experts are now watching to see how forcefully the organism will spread before the new immunization arrives. Wyeth says it hopes to file an application with the Food and Drug Administration in 2009.

Disease experts also wonder what organisms like 19A mean for the future of pneumococcal infections. Public health experts once hoped the infection could be defeated, but it now appears that pneumococci may be playing a game of cat and mouse.

“The pneumococcus has shown an extraordinary ability to evolve to our strategies,” said Dr. Beall of the C.D.C.

Yet he and others are quick to say that immunization remains highly effective, even if it leaves some children behind. “This is not a failure of the vaccine,” said Dr. George H. McCracken Jr. of the University of Texas Southwestern Medical Center at Dallas. Even with the rise of 19A, children are much less likely to become ill from pneumococcal infections.

Dr. McCracken hopes that researchers will one day avoid threats like 19A entirely by developing a vaccine that primes the immune system to recognize some element common to all 91 types of pneumococci — in the way a quiche, an omelet and a custard pie are all versions of eggs. But until such an immunization comes along, he said, pediatricians will be forced to battle the pneumococcus as they always have, by trying to stay one strain ahead of its game.

El DSM IV vinculado a la industria farmaceutica


Psychiatry Handbook Linked to Drug Industry

The D.S.M. is used to diagnose a wide range of mental disorders. (Cary Conover)
More than half of the task force members who will oversee the next edition of the American Psychiatric Association’s most important diagnostic handbook have ties to the drug industry, reports a consumer watchdog group.

The Web site for Integrity in Science, a project of the Center for Science in the Public Interest, highlights the link between the drug industry and the all-important psychiatric manual, called the Diagnostic and Statistical Manual of Mental Disorders. The handbook is the most-used guide for diagnosing mental disorders in the United States. The guide has gone through several revisions since it was first published, and the next version will be the D.S.M.-V, to be published in 2012.

The American Psychiatric Association’s Web site has posted the financial disclosure of most of the the 28 task force members who will oversee the revision of the D.S.M.

It’s not the first time the D.S.M. has been linked to the drug industry. Tufts University researchers in 2006 reported that 95 — or 56 percent — of 170 experts who worked on the 1994 edition of the manual had at least one monetary relationship with a drug maker in the years from 1989 to 2004. The percentage was higher — 100 percent in some cases — for experts who worked on sections of the manual devoted to severe mental illnesses, like schizophrenia, the study found. (For a Times story on that report, click here.)

The American Psychiatric Association allows members who work on the upcoming fifth edition of the handbook to accept money from drug firms. However, from the time of their appointment until the completion of the work, their annual individual income from industry sources cannot exceed $10,000. “We have made every effort to ensure that D.S.M.-V will be based on the best and latest scientific research, and to eliminate conflicts of interest in its development,” said Dr. Carolyn B. Robinowitz, president of the organization, in a press release.

The Integrity in Science group described the financial conflicts of interest by the task force members as ranging from “small to extensive,” including one member who over the past five years worked as a consultant for 13 drug companies, including Pfizer, Eli Lilly, Wyeth, Merck, AstraZeneca and Bristol-Myers Squibb.

Fuente: NYT

Salud y crisis financiera


Publicacion del NYT donde se hace referencia al efecto de distintas crisis financieras sobre el impacto de las mismas en distintos paises, y su efecto en los sistemas de salud: http://tinyurl.com/4toewu

Salud y crisis financiera


Publicacion del NYT donde se hace referencia al efecto de distintas crisis financieras sobre el impacto de las mismas en distintos paises, y su efecto en los sistemas de salud: http://tinyurl.com/4toewu

Eli Lilly E-Mail Discussed Unapproved Use of Drug


ALEX BERENSON

Published: March 15, 2008
ANCHORAGE — John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote an e-mail message in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators.

Mr. Lechleiter’s comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors.

The e-mail message was discussed this week in an Anchorage courtroom in a lawsuit against Lilly by the State of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa.

The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes.

Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it “off label” for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug.

The federal government has investigated drug companies before for off-label promotion of their medicines, but Mr. Lechleiter’s note provides rare documentation of a senior drug executive’s openly discussing the practice.

A spokeswoman for Eli Lilly said Mr. Lechleiter was not advocating off-label promotion in his note but simply wanted the company to respond to physicians’ requests for information.

In his e-mail message, Mr. Lechleiter discusses the use of Zyprexa by children and teenagers.

Mr. Lechleiter, who was then the company’s executive vice president for pharmaceutical products, noted to other Lilly officials that company representatives were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with such doctors, he said.

“The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,” Mr. Lechleiter wrote in the message.

He also encouraged Lilly to get data on the use of Zyprexa in treating “disruptive kids” in order to increase the drug’s sales.

The company declined to make Mr. Lechleiter available for comment.

Because of Zyprexa’s physical side effects, many psychiatrists now say it is appropriate only for severely mentally ill patients. Clinical trials have shown that its tendency to cause dangerous weight gain appears to be especially pronounced in younger patients. The Food and Drug Administration has for more than a year declined to act upon an application by Lilly to broaden the drug’s label to allow its use in people under 18.

Mr. Lechleiter’s e-mail message has not previously been discussed publicly. In the Alaska trial, after plaintiff lawyers presented it without the jury present, Judge Mark Rindner said it could not be admitted into evidence in the trial because off-label use was not at issue in the case.

Its disclosure nonetheless comes at a sensitive moment for Lilly, which is also under federal criminal investigation for the way it promoted Zyprexa and played down the drug’s risks to doctors.

From 2000 to 2002, internal Lilly documents show that the company tried aggressively to expand Zyprexa’s sales into markets for which the drug was never approved, including elderly patients with dementia.

To settle that investigation, and related investigations by several states, Lilly is negotiating with federal prosecutors in Pennsylvania on a deal that could result in the company’s paying $1 billion to $2 billion in fines and restitution, according to people involved in the investigation. The prosecutors declined to comment on Friday.

Because Mr. Lechleiter, an organic chemist who is Lilly’s president and chief operating officer, is a senior official about to become the chief executive, the public disclosure of an e-mail message in which he appears to have encouraged off-label promotion of Zyprexa could complicate the talks.

He is scheduled to become chief executive on April 1, succeeding Sidney Taurel, and is to succeed Mr. Taurel as Lilly’s chairman at the end of the year.

Since 2003, as information about the drug’s risks has spread, prescriptions for Zyprexa have fallen sharply in the United States. But Lilly has repeatedly increased the drug’s price to counteract the slumping prescriptions, and Zyprexa remains by far Lilly’s best-selling product, with worldwide sales of $4.8 billion last year, about half in the United States. Zyprexa now costs about $8,000 a year at commonly prescribed doses.

Marni Lemons, a spokeswoman for Eli Lilly, said Mr. Lechleiter’s e-mail message was meant to encourage Lilly representatives to answer questions from doctors who were already prescribing Zyprexa off label to children and teenagers.

“Rather than driving physician demand, what he was doing was responding to demand from physicians, which we are allowed to do,” Ms. Lemons said.

Federal law does let companies send “medical letters” with additional information about off-label uses to physicians who request the information, although sales representatives are not supposed to discuss it.

In the e-mail message, Mr. Lechleiter made several other references to off-label use of Zyprexa. He wrote, “We are losing scripts to Risperdal for treatment of disruptive kids, because Johnson & Johnson has the data and we don’t.”

Risperdal, made by Johnson & Johnson, is another drug for schizophrenia and bipolar disorder. Unlike Zyprexa, it has been approved for pediatric use.

Mr. Lechleiter also wrote that “Zyprexa is getting traction with some neurologists for treatment of pain,” another off-label use of Zyprexa, which has never been approved for pain relief.

The Alaska trial over Zyprexa began March 5 in Anchorage and is expected to last until late this month.

In its initial complaint, the state tried to recover costs associated with Lilly’s off-label promotion of Zyprexa. But just before the jury was chosen, Judge Rindner dismissed that claim. As a result, jurors have not been permitted to hear any evidence relating to off-label promotion in the case.

But lawyers for the state tried on Tuesday to introduce the e-mail message into evidence anyway. Although the judge ruled against them, the message became part of the court record.

Fuente: NYT 

Muchos medicos, muchos tests


Many Doctors, Many Tests, No Rhyme or Reason

Ulla Puggaard

 

Published: March 11, 2008

I recently took care of a 50-year-old man who had been admitted to the hospital short of breath. During his monthlong stay he was seen by a hematologist, an endocrinologist, a kidney specialist, a podiatrist, two cardiologists, a cardiac electrophysiologist, an infectious-diseases specialist, a pulmonologist, an ear-nose-throat specialist, a urologist, a gastroenterologist, a neurologist, a nutritionist, a general surgeon, a thoracic surgeon and a pain specialist.

Readers’ Comments

“We need major reform of the entire system, legal controls with real penalties for abuse, and somebody like Teddy Roosevelt to make it happen.”

Jim, Oak Ridge, TN

if (acm.rc) acm.rc.write();He underwent 12 procedures, including cardiac catheterization, a pacemaker implant and a bone-marrow biopsy (to work-up chronic anemia).

Despite this wearying schedule, he maintained an upbeat manner, walking the corridors daily with assistance to chat with nurses and physician assistants. When he was discharged, follow-up visits were scheduled for him with seven specialists.

This man’s case, in which expert consultations sprouted with little rhyme, reason or coordination, reinforced a lesson I have learned many times since entering practice: In our health care system, where doctors are paid piecework for their services, if you have a slew of physicians and a willing patient, almost any sort of terrible excess can occur.

Though accurate data is lacking, the overuse of services in health care probably cost hundreds of billions of dollars last year, out of the more than $2 trillion that Americans spent on health.

Are we getting our money’s worth? Not according to the usual measures of public health. The United States ranks 45th in life expectancy, behind Bosnia and Jordan; near last, compared with other developed countries, in infant mortality; and in last place, according to the Commonwealth Fund, a health-care research group, among major industrialized countries in health-care quality, access and efficiency.

And in the United States, regions that spend the most on health care appear to have higher mortality rates than regions that spend the least, perhaps because of increased hospitalization rates that result in more life-threatening errors and infections. It has been estimated that if the entire country spent the same as the lowest spending regions, the Medicare program alone could save about $40 billion a year.

Overutilization is driven by many factors — “defensive” medicine by doctors trying to avoid lawsuits; patients’ demands; a pervading belief among doctors and patients that newer, more expensive technology is better.

The most important factor, however, may be the perverse financial incentives of our current system.

Doctors are usually reimbursed for whatever they bill. As reimbursement rates have declined in recent years, most doctors have adapted by increasing the quantity of services. If you cut the amount of air you take in per breath, the only way to maintain ventilation is to breathe faster.

Overconsultation and overtesting have now become facts of the medical profession. The culture in practice is to grab patients and generate volume. “Medicine has become like everything else,” a doctor told me recently. “Everything moves because of money.”

Consider medical imaging. According to a federal commission, from 1999 to 2004 the growth in the volume of imaging services per Medicare patient far outstripped the growth of all other physician services. In 2004, the cost of imaging services was close to $100 billion, or an average of roughly $350 per person in the United States.

Not long ago, I visited a friend — a cardiologist in his late 30s — at his office on Long Island to ask him about imaging in private practices.

“When I started in practice, I wanted to do the right thing,” he told me matter-of-factly. “A young woman would come in with palpitations. I’d tell her she was fine. But then I realized that she’d just go down the street to another physician and he’d order all the tests anyway: echocardiogram, stress test, Holter monitor — stuff she didn’t really need. Then she’d go around and tell her friends what a great doctor — a thorough doctor — the other cardiologist was.

“I tried to practice ethical medicine, but it didn’t help. It didn’t pay, both from a financial and a reputation standpoint.”

His nuclear imaging camera was in an adjoining “procedure” room. He broke down the monthly costs for me: camera lease, $4,500; treadmill lease, $400; office space, $1,000; technician fee, $1,800; nurse fee, $1,000; and miscellaneous expenses of $200.

“Now say I get on average $850 per nuclear stress test,” he said. “Then I have to do at least 10 stress tests a month just to cover the costs, no profit going into my pocket.”

“So,” I said, “there’s pressure on you to do more than 10 stress tests a month, whether your patients need it or not.”

He shrugged and said, “That is what I have to do to break even.”

Last year, Congress approved steep reductions in Medicare payments for certain imaging services. Deeper cuts will almost certainly be forthcoming. This is good; unnecessary imaging is almost certainly taking place, leading to false-positive results, unnecessary invasive procedures, more complications and so on.

But the problem in medicine today is much larger than imaging. Doctors are doing too much testing and too many procedures, often for the sake of business. And patients, unfortunately, are paying the price.

“The hospital is a great place to be when you are sick,” a hospital executive told me recently. “But I don’t want my mother in here five minutes longer than she needs to be.”

Dr. Sandeep Jauhar is a cardiologist on Long Island and the author of the new memoir “Intern: A Doctor’s Initiation.”

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