Eli Lilly E-Mail Discussed Unapproved Use of Drug


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.”

Next Article in Health (2 of 11)

Un estudio cuestiona la utilidad de los modernos antidepresivos

El análisis de 4 fármacos, entre ellos Prozac, revela que no son mejores que el placebo. El estudio incluyó los datos de varios trabajos no publicados previamente.

Se calcula que una de cada seis personas sufrirá depresión a lo largo de su vida. Para los casos más graves, el tratamiento indicado suele combinar la psicoterapia con el uso de fármacos antidepresivos. Un estudio ha puesto a prueba los más modernos tratamientos de este tipo, los llamados de última generación (el más famoso de ellos, Prozac), y ha descubierto que su efecto no mejora el que logra una simple pastilla inocua de placebo.

Para poder extraer sus conclusiones libres de posibles prejuicios, un equipo de investigadores de la Universidad de Hull (en el Reino Unido) seleccionó tanto trabajos que se habían publicado en revistas médicas como aquellos que no (que suelen ser los que tienen peores resultados y a menudo no llegan a ver la luz). Para ello solicitaron a la agencia estadounidense del medicamento (la FDA), todos los estudios recibidos entre 1987 y 1999 sobre seis antidepresivos
diferentes; un trámite obligatorio durante el proceso previo a la autorización de un fármaco.

El resultado de su investigación (un meta-análisis de 47 trabajos en el que también han colaborado centros de EEUU y Canadá) acaba de darse a conocer en las páginas de la revista “Plos Medicine” y sus conclusiones han sido muy cuestionadas por varios psiquiatras españoles consultados por elmundo.es.

Finalmente, el equipo del doctor Irving Kirsch, centró su análisis en cuatro de los modernos inhibidores de la recaptación de la serotonina (SSRIs, según sus siglas anglosajonas): fluoxetina, más conocida por su nombre comercial, Prozac; venlafaxina; paroxetina (Seroxat, Paxil) y la nefazodona (que se comercializa bajo los nombres de Dutonin,
Menfazona o Rulivan; aunque es el único de los cuatro que no está a la venta en España). Los otros dos medicamentos inicialmente estudiados (sertralina y citalopram) fueron excluidos del análisis final porque fue imposible obtener todos los datos.

Sólo en pacientes muy deprimidos
Cuando analizaron conjuntamente todos los estudios, tanto los que habían visto la luz como los que no, los ensayos revelaron que el beneficio de los antidepresivos no era superior al de la pastilla de placebo en los pacientes con depresión moderada o grave. Únicamente aquellos que más gravemente puntuaban en la escala depresiva se beneficiaban moderadamente del tratamiento.

Sin embargo, según los autores, esta diferencia favorable al tratamiento detectada en este subgrupo únicamente se debió a que estos pacientes, más gravemente afectados por la depresión, respondían peor al placebo que los otros grupos.

Aunque la causa directa de una depresión no está del todo clara, sí se sabe que en los sujetos deprimidos existe una alteración de algunos neurotransmisores cerebrales que regulan el estado de ánimo.
Y aunque se supone que el uso de antidepresivos permite reorganizar este equilibro químico, hace tiempo que la polémica rodea a este tipo de medicamentos. De hecho, en 2004, la propia FDA decidió incluir una advertencia en su prospecto alertando de que estos tratamientos podían incrementar el riesgo de ideas o comportamientos suicidas
entre jóvenes y adolescentes.

“Aunque los pacientes experimentan cierta mejoría con los antidepresivos”, explica el doctor Kirsch, “también mejoran cuando toman una sustancia inocua y la diferencia [entre uno y otro] no es significativa”. A su juicio, estos resultados demuestran que estas personas también podrían experimentar mejorías sin ningún tratamiento farmacológico. Y añade, “con estos datos en la mano hay pocas razones para prescribir la nueva generación de antidepresivos excepto a los pacientes más gravemente deprimidos en los que otros tratamientos alternativos no hayan sido eficaces”.

Las compañías farmacéuticas fabricantes de estos medicamentos han respondido al estudio asegurando que existen toda otra serie de datos y de trabajo que han demostrado la utilidad de los antidepresivos. “Desde su descubrimiento en 1972, la fluoxetina es uno de los medicamentos más estudiados del mundo”, ha asegurado Eli Lilly respecto a su “superventas” Prozac, una píldora que se calcula que toman cerca de 40 millones de personas en todo el mundo.

“Una información alarmante y equivocada”.
Por su parte, el doctor Jerónimo Saiz Ruiz, jefe del Servicio de Psiquiatría, Hospital Universitario Ramón y Cajal de Madrid (que actualmente se encuentra en Nueva York), asegura que la información es “alarmante y equivocada”. Se trata, recuerda, “de un metaanálisis que ha jugado con los números”, cuyos resultados “no sorprenderán a ningún psiquiatra”.

Según este especialista, “nadie tiene dudas de que estos fármacos son buenos y eficaces y son tan útiles que se han prescrito muchísimo y los pacientes perciben claramente sus beneficios”. De hecho, subraya, su espectro de acción va mucho más allá de la depresión, y son más utilizados, por ejemplo, para tratar trastornos de ansiedad, fobias, estrés postraumático… Prozac, añade, no es la indicación más habitual “para un paciente con depresión melancólica [la de síntomas más intensos], ya que en estas personas seguimos empleando los medicamentos más antiguos”.

También Francisco Montañés, psiquiatra de la Fundación Hospital Alcorcón (Madrid), defiende que la experiencia clínica demuestra que “sin estos fármacos muchos pacientes con depresión no mejorarían nunca”.

Montañés subraya que los datos de los ensayos que se remiten para obtener la autorización de un medicamento “suelen realizarse con pacientes muy seleccionados, poco graves, por lo que es normal que las diferencias frente a placebo sean menores de lo que luego vemos realmente con la población general”. En su opinión, este modo de “triturar los datos” es “un disparate” y no permite “extraer ninguna conclusión seria”. Por eso además insiste en que ningún paciente interrumpa la medicación por su cuenta.

El Mundo Salud – España

Reports of Gunman’s Use of Antidepressant Renew Debate Over Side Effects

Fuente: New York Times 

Steven P. Kazmierczak stopped taking Prozac before he shot to death five Northern Illinois University students and himself, his girlfriend said Sunday in a remark likely to fuel the debate over the risks and benefits of drug treatment for emotional problems.

.Over the years, the antidepressant Prozac and its cousins, including Paxil and Zoloft, have been linked to suicide and violence in hundreds of patients. Tens of millions of people have taken them, and doctors say it is almost impossible to tell whether the spasms of violence stem in part from drug reactions or the underlying illnesses.

“It’s a real chicken-and-egg sort of situation,” said Dr. Jane E. Garland, director of the Mood and Anxiety Disorders Clinic at BC Children’s Hospital in Vancouver, British Columbia.

Dr. Garland said some people could and did become agitated and unpredictable in response to the drugs, usually just after starting to take them or soon after stopping.

“But it’s hard to make a case for a withdrawal reaction here, because Prozac comes out of the system gradually,” she said.

The girlfriend, Jessica Baty, said in an interview on CNN that Mr. Kazmierczak took Prozac to battle anxiety and compulsive behavior but that it “made him feel like a zombie and lazy.”

She said that in the days leading up to the shooting he was not behaving erratically, as university officials had suggested.

Much of the debate over the side effects of antidepressants focuses on erratic behavior like the cautious college student who stabs herself or the good husband and father who buys a gun and shoots himself.

The drug labels warn about agitation and severe restlessness, and display a prominent caution that the medications increase the risk of suicidal thinking and behavior in some children and young adults.

Psychiatrists said Monday that stopping an antidepressant could cause effects like lightheadedness, nausea and agitation as the brain adjusted. Among the most commonly prescribed drugs, Prozac is the least likely to cause withdrawal effects because it stays in the system longest, the doctors said.

“A small dose of Prozac is what you might use to block withdrawal symptoms when you take a patient off one of the other drugs,” said Dr. Donald Klein, an emeritus professor of psychiatry at Columbia who has consulted with drug companies.

Sara Bostock, of Atherton, Calif., whose daughter committed suicide shortly after taking Paxil, acknowledged that the interaction between drug effects and underlying emotional distress was hard to untangle.

Ms. Bostock wrote in an e-mail message, “As an observer and suicide survivor, my main wish is that medical professionals, regulatory authorities and other scientists will examine closely the entire medical and treatment history of the perpetrators of these violent incidents in which innocent people are victims.”

She is a founder of ssristories.com, a Web site that has tallied 2,000 news reports of violent acts in which people were thought to be taking antidepressants or had recently stopped them.

“If it weren’t for us, many of these stories would be lost to oblivion forever,” Ms. Bostock said.

Psychiatrists say the debate on such side effects, particularly suicide in the last four years, has driven many patients from drugs that could help save their lives. The psychiatrists emphasize that patients should be closely monitored for changes in behavior when starting or tapering off a medication.

Advocates on both sides agree that catalogs of violent acts are not enough and that news reports are incomplete. Only more thorough investigation and careful tracking of drug side effects, they say, will clarify the links between drug treatment and violent behavior.

Dr. Michael Stone, a professor of clinical psychiatry at Columbia, maintains a database of 1,000 violent crimes, including mass murders, going back decades. In many cases the accused had stopped taking drugs for schizophrenia, Dr. Stone said.

“I only have a handful of cases,” he added, “where the person was on an antidepressant.”

Times Health Guide: MRSA Infection

SAN FRANCISCO — In a matter of days, it jumped from a routine press release to a medical controversy.

On Monday, a team of researchers led by doctors from the University of California at San Francisco announced that gay men were “many times more likely than others” to acquire a new strain of drug-resistant staphylococcus, a nasty, fast-spreading and potential lethal bacteria known as MRSA USA300. And sure enough, the study, published online in the Annals of Internal Medicine, was quickly picked up by reporters round the world and across the Internet, including a London tabloid which dubbed the disease “the new H.I.V.

But for gay men in the Castro neighborhood here, which was an early epicenter for the AIDS epidemic and a current hot spot for MRSA, the report also seemed to cast an unfair, and all too familiar, stigma on their sexuality.

“The way they keep targeting gays as if gays alone are responsible for it, its like H.I.V./AIDS all over again,” said Colin Thurlow, 60, who is gay and lives in San Francisco. “And we’re sick and tired of it.”

The report also inadvertently offered ammunition for many antigay groups, including the conservative Concerned Women for America, which issued a release on Wednesday citing the “sexual deviancy” of gay men as leading to AIDS, syphilis and gonorrhea.

“The medical community has known for years that homosexual conduct, especially among males, creates a breeding ground for often deadly disease,” the release read.

Another group, Americans for Truth About Homosexuality, also cited the report as a way of proving that “homosexual behavior is unhealthy.”

“Why aren’t all schoolchildren being taught that there are special health risks associated with homosexual behavior and that they should ‘just say no’ to homosexuality?” read a released posted on the group’s Web site.

National gay rights groups were quick to label such talk as “hysteria,” even as researchers as the university scrambled to clarify their findings. On Friday, it issued an apology, saying their release had “contained some information that could be interpreted as misleading.”

“We deplore negative targeting of specific populations in association with MRSA infections or other public health concerns,” it concluded. Dr. Henry Chambers, one of the report’s authors and a professor of medicine at the university, said he was surprised by how the report had been spun.

“I think we were looking at this from a scientific point of view and not projecting any political impact,” he said. “We were focusing on the data. You want to make sure it’s as right as possible and written up in a form that reviewers would understand what you’re trying to say, and do it in a clear manner so it’s not subject to misinterpretation. Which is what happened later, it appears.”

One of the major sore points for some critics was a quote attributed to the report’s lead author, Bien Diep, a researcher who said he was concerned about “a potential spread of this strain into the general population.”

Mr. Diep, 29, said on Friday he regretted not being more thorough in communicating his research to reporters. He said that the term “general population” was part of medical jargon used in the report, which did not translate well.

“It’s really meant to be used to mean all inclusive, including the men-who-have-sex-with-men population,” he said.

Worries about the negative press resonated even as some gay men here expressed concern about the disease itself. The report looked at nine San Francisco hospitals in 2004 and 2005. A separate part of the study, conducted at an AIDS clinic in the city from 2004 to 2006, found that gay men were 13 times more likely to be infected with MRSA USA300.

Josh Figurido, 27, a bartender at Metro, a popular gay bar in the Castro, said he had only heard about the strain this week, but was already taking precautions when it came to sex. “I’m definitely going to be a lot more careful with what goes on,” he said.

But Mr. Figurado said he was less concerned about antigay rhetoric. “It’s not just gay people that get it,” he said. “You can get it anywhere.”

Indeed, the Centers for Disease Control and Prevention in Atlanta, which helped finance the study, affirmed on Wednesday that the disease was not sexually transmitted or limited to a certain type of person. It is transmitted through skin-to-skin contact, the agency said in a statement, and is widespread in hospitals and among hospital workers.

“These infections occur in men, women, adults, children and persons of all races and sexual orientations,” the statement read, adding that while the particular strain identified in the report had been found in gay men, it had also been found in people who were not gay.

For those who do come down with the disease, there are various treatments, including antibiotics. Preventive measures include frequently cleaning hands, clothes and open wounds. MRSA can cause painful sores, which should be lanced and treated to prevent the disease’s spread.

Jason Overcash, 37, a sales representative who lives near the Castro and is gay, said he was upset by the initial presentation of the report, which he said seemed geared to panic people both inside and out of the Castro.

“The way they presented it, it makes people think if they come here, they’re going to get MRSA,” he said.

That is an experience Mr. Overcash says he knows all too well: he contracted MRSA in 2002, and soon found a lesion on his left buttock. “It got to be like a golf ball in a matter of 36 hours,” he said. He tried three different antibiotic treatments, even as the lesions spread, before finally knocking it out.

“It was horrible, and that’s why I’m super hyper-aware of it,” Mr. Overcash said. “Because I don’t ever want to go through that again.”

Ocultan la falta de efectividad de los antidepresivos

NUEVA YORK.– Los laboratorios fabricantes de antidepresivos, como el Prozac (fluoxetina), jamás publicaron los resultados de cerca de un tercio de los ensayos clínicos que hicieron para obtener la aprobación de esos medicamentos, por lo que engañaron así, deliberadamente, a médicos y consumidores sobre su verdadera efectividad. Así lo reveló un estudio publicado ayer en la revista The New England Journal of Medicine.

En los estudios clínicos publicados sobre antidepresivos, cerca del 60% de las personas que los tomaban reportó obtener un alivio significativo de la depresión, en comparación con alrededor del 40% de aquellas que tomaron píldoras de placebo. Pero si se incluyen los estudios clínicos menos positivos, no publicados, las ventajas se desvanecen: los antidepresivos son mejores que los placebos sólo por un modesto margen, concluyó el citado informe.

Estudios previos habían hallado una tendencia similar al reportar los resultados positivos en una amplia variedad de medicamentos, y muchos investigadores han cuestionado la supuesta efectividad de los antidepresivos. Pero este nuevo análisis, que revisó datos de 74 estudios clínicos con 12 drogas distintas, es el más profundo realizado hasta la fecha.

Y documenta una gran diferencia: mientras que el 94% de los estudios con resultados positivos llegó a ser publicado, sólo el 14% de aquellos que obtuvieron resultados decepcionantes o inciertos lo logró.

Los hallazgos seguramente avivarán el continuo debato sobre cómo la información de los estudios clínicos sobre drogas es reportada. En 2004, después de revelaciones de que hallazgos negativos de estudios clínicos con antidepresivos no eran publicados, un grupo de revistas líderes acordó dejar de publicar los ensayos clínicos que no fueran registrados en una base de datos pública.

Los grupos comerciales que representan a las principales farmacéuticas del mundo anunciaron que sus compañías miembros comenzarían a difundir más información sobre sus estudios más rápido, en su propia base de datos: www.clinicalstudyresults.org . Y el año pasado, el Congreso estadounidense dio curso a legislación que expande el tipo de ensayos clínicos y la profundidad de la información que debe ser reportada a www.clinicaltrials.gov , una base pública de datos operada por la Biblioteca Nacional de Medicina de ese país.

La página web de la Administración de Alimentos y Medicamentos (FDA), de los Estados Unidos, ofrece un acceso limitado a recientes revisiones de ensayos clínicos, pero los críticos dicen que es mur difícil de “navegar”.

Prescribir con seguridad

“Este es un estudio muy importante por dos razones -dijo el doctor Jeffrey M. Drazen, editor en jefe de The New England Journal of Medicine -. La primera es que cuando uno prescribe una droga, uno quiere estar seguro de que cuenta con la mejor información posible; uno no lo haría si sólo conociera un tercio de la verdad sobre un medicamento.”

La segunda, continuó el doctor Drazen, es que “debemos ser respetuosos con las personas que participan de un estudio clínico”.

“Ellos asumen algún riesgo al ingresar en el estudio, ¿y luego la compañía farmacéutica esconde la información?”, se preguntó. “Este tipo de cosas hace que tomemos con pasión este asunto.”

Alan Goldhammer, vicepresidente de asuntos regulatorios de Pharmaceutical Research and Manufacturers of America, que agrupa a las farmacéuticas estadounidenses, dijo que el nuevo estudio no menciona que la industria y el gobierno ya han dado pasos para que la información de los estudios clínicos sea más trasparente.

“Todo esto se basa en información previa a 2004, y desde entonces hemos acabado con el mito de que las compañías tienen algo que esconder”, dijo Goldhammer.

En el estudio, un grupo de investigadores identificó todos los estudios clínicos sobre antidepresivos enviados a la FDA entre 1987 y 2004. Los estudios involucraron a 12.564 pacientes para el testeo de drogas como el Prozac (fluoxetina), de Eli Lilly; Zoloft (sertralina), de Pfizer, y Effexor (venlafaxina), de Wyeth.

Los investigadores obtuvieron datos no publicados de las drogas aprobadas más recientemente a través de la página web de la FDA. Para drogas más viejas, rastrearon copias en papel de estudios no publicados a través de sus colegas o valiéndose de la ley de libertad de la información. Luego contrastaron todos los estudios con bases de datos de estudios publicados, y también escribieron a las farmacéuticas preguntando si determinado estudio había sido publicado.

Hallaron que 37 de 38 estudios que la FDA consideró positivos fueron publicados en revistas médicas. Esa agencia consideró otros 36 estudios como negativos o no convincentes, y de ésos sólo 14 fueron publicados.

Pero 11 de esos 14 artículos publicados “comunicaban resultados positivos” que no coinciden con la revisión de la FDA, dijo el autor principal del estudio, el doctor Erick H. Turner, psiquiatra y ex revisor de la FDA.

Turner dijo que el reporte selectivo de los estudios favorables predispone a decepcionar a los pacientes. “La conclusión es que las personas que estén considerando tomar un antidepresivo deberían ser más prudentes al tomarlos -dijo-, y no asombrarse si no funcionan la primera vez, y no pensar que algo está mal en ellos.”

En cuanto a los médicos, concluyó, “terminan preguntándose “cómo puede ser que estas drogas funcionen tan bien en los estudios, pero yo no esté obteniendo esa respuesta”.”

250 Millones
de pesos al año genera en la Argentina la venta de medicamentos antidepresivos.

En “El Supositorio” Vicente Baos da también su opinión sobre este tema.

Nueva cepa de Stafilococo Meticilino Resistente en varones homosexuales

Fuente: La Nacion 

NUEVA YORK (The New York Times).- Una nueva cepa altamente resistente a los antibióticos de la bacteria Staphylococcus aureus resistente a la meticilina (MRSA, según sus siglas en inglés) se está expandiendo en la población de varones homosexuales de San Francisco y Boston, informaron investigadores.

Según un estudio publicado en revista Annals of Internal Medicine , la bacteria parece propagarse más fácilmente a través del sexo anal, pero también a través del contacto casual piel con piel y al tocar superficies contaminadas con la bacteria.

Los autores del estudio advirtieron que a menos que los laboratorios de microbiología sean capaces de identificar esta cepa y que los médicos prescriban las antibióticos apropiados, la infección podría extenderse rápidamente a otros grupos y convertirse en una amenaza mayor.

El estudio se basa en el análisis de los registros de clínicas de San Francisco y Boston, y de nueve centros médicos de San Francisco. El distrito Castro, de San Francisco, posee el mayor número de residentes homosexuales de los Estados Unidos. Uno de cada 588 de sus residentes contrajo la infección por esta nueva cepa multirresistente de MRSA, halló el estudio, en comparación con una de cada 3800 personas de todo San Francisco.

Los investigadores sugieren que lavarse con agua y jabón quizás sea la forma de frenar la transmisión a través del contacto piel a piel, en especial después de una relación sexual.

La infección puede causar abscesos y úlceras cutáneas, así como puede provocar neumonía, problemas cardíacos o infecciones del torrente sanguíneo (sepsis).

Las MRSA son bacterias que solían hallarse en los hospitales, pero en los últimos años también se las encuentra en infecciones adquiridas en la comunidad. La nueva cepa, llamada MRSA USA300, es difícil de tratar porque no sólo es resistente a la meticilina. “Es resistente al menos a otras tres drogas”, dijo el doctor Henry Chambers, autor del estudio.