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Showing posts with label drugs. Show all posts
Showing posts with label drugs. Show all posts

15 May, 2015

Who can we trust

Source: Selling Sickness

Who Can We Trust?

A new study just published in the Journal of General Internal Medicine involving Canadian, US and French physicians shows that the majority of family doctors receive little or no information about a drug’s harmful side effects by the pharmaceutical sales reps. The study found that in nearly 60 per cent of promotional visits to the doctors office, the drug reps failed to provide any information about common or serious side-effects of the promoted drug, and also failed to inform doctors about the types of patients who should not use the drug.
This is frightening news for patients. If our doctors are being kept in the dark about harmful side effects, who can we trust? Clearly, this study is revealing and we need a better system for educating our doctors. They shouldn’t be educated by the pharmaceutical sales reps who have financial gain in promoting the benefits of their products. Maybe it’s time for academic detailing? I (KW) have personally been involved in testifying on the state level in Minnesota and Wisconsin promoting academic detailing legislation.
Just yesterday I saw a TV commercial promoting Cymbalta for lower back pain.  Its advertising message was “Imagine a day with less pain.” The only thing I could imagine was the # of people flocking to their doctors offices asking about this drug. I wonder, however, how many will be told that Cymbalta is actually an antidepressant that carries a serious black box warning for suicidality and other psychiatric side effects. According to this study, it’s very unlikely that the sales reps offered up this information to the doctors.
Who pays the price for this lack of disclosure? We do. If the doctors are unaware of the potential harms from the drugs they prescribe, patients inevitably suffer the consequences.
It’s time for a new system. Patients and doctors deserve better.

09 May, 2015

Buena y Mala Noticia de la OMS

La buena noticia es que ayer se ha publicado, como cada 2 años, la última edición del Listado de Medicamentos Esenciales de la OMS, una herramienta fundamental para los gobiernos a la hora de plantear sus propios Formularios Terapéuticos. La mala: es que se ha publicado, como cada 2 años, la última edición del Listado de Medicamentos Esenciales de la OMS, una herramienta fundamental para los gobiernos a la hora de plantear sus propios Terapéuticos, nuevamento con antivirales para la gripe dе reconicida inutilidad.
El tema no terminaria ahi, si no fuera porque mientras varias agencias regulatorias y otras de tecnologias sanitarias se debaten con los nuevos medicamentos para Hepatitis C, no se olvidaron de poner a ninguna, esten o no aprobados por la EMA, la FDA. El NHS de Reino Unido postergó el dictamen de NICE para Julio (estarán negociando el número), pero no hay dudas que el precio estará más cerca de Francia que de la India o Egipto.
Nuestra nueva panacea nos va a "curar" (leasé por una variable subrogada como la Respuesta Viral Sostenida a 1 año), de la hepatits C. A unos módicos precios, que si hubiera que tratar a todos, colapsan los sistemas sanitarios, o se cierran algunos hospitales (tampoco estaria mal en algunos paises), pero es más probable que los recortes (muchos gobiernos empecinados en este tema), siempre irán primero, a los ya magros servicios de atención primaria.
Otra opción, podría ser deshacerse de todos los médicos de atención primaria y cambiarlas por unos dispensers que con una moneda de mil dolares (no será para problema para la Fedex hacerla), la gente vaya a buscar diariamente su nuevo cóctel salvador, al fin y al cabo, depende lo que tomen, va entre 12 y 48 semanas el tratamiento. Todo sea por salvar al mundo de esta nueva pandemia.
Nunca está de más repetir lo que es público, el medicamento más caro, Sofosuvir, es propiedad de Gilead, quien se lo compró a otro laboratorio por 10 veces menos de que ganó el año pasado. Tampoco es cuestión de criticar a alguien por ganar dinero. Y menos si uno de sus dueños es el inefable Donald Rumsfeld, muy conocido en Iraq por contratos de constructoras que no reconstruyeron nada, por ser el Secretario de Defensa de Bush Jr., y también el propietario de la patente del Tamiflú. Hombre con suerte si los hay.

19 March, 2014

Australian Prescriber: new drugs Clevidipine

Clevidipine

Approved indication: hypertension
Cleviprex (The Medicines Company)
glass vials containing 25 mg/50 mL and 50 mg/100 mL
Australian Medicines Handbook section 6.3.5

Occasionally, patients present with a hypertensive crisis which requires their blood pressure to be rapidly reduced. Controlling hypertension is also vital in patients having cardiac surgery.

Clevidipine is a short-acting intravenous dihydropyridine calcium channel blocker. In perioperative patients, the blood pressure is reduced by up to 5% within 2–4 minutes of starting an infusion. Clevidipine is rapidly metabolised and has a terminal half-life of 15 minutes. Its effect on blood pressure is gone within 5–15 minutes of stopping the infusion.

Six different doses of clevidipine were tried in a placebo-controlled study of 91 patients who had undergone cardiac surgery. The proportion of patients whose blood pressure reduced in response to clevidipine increased with the dose. Despite blood pressure falling by at least 10% there was no significant change in heart rate although beta blocker use was not controlled for.1

The ESCAPE trials enrolled patients having cardiac surgery. In ESCAPE-1, 152 hypertensive patients were randomised to receive clevidipine or a placebo infusion before surgery. The target blood pressure was reached in a median of six minutes with clevidipine. Treatment only failed in 7.5% of the patients given clevidipine compared with 82.7% of the placebo group.2 ESCAPE-2 assessed the effect of clevidipine on postoperative hypertension. After surgery 110 patients were given clevidipine or a placebo. Only 8.2% failed to respond to the drug compared with 79.6% of the placebo group. The median time to reach the target blood pressure with clevidipine was 5.3 minutes.3

The ECLIPSE trials were safety studies, but also reported on blood pressure control. They compared clevidipine with nicardipine, sodium nitroprusside and glyceryl trinitrate in 1512 hypertensive patients having cardiac surgery. Clevidipine was significantly more effective than sodium nitroprusside and glyceryl trinitrate at keeping the blood pressure within a target range. There was not a significant difference between clevidipine and nicardipine for the specified range.4

Clevidipine has also been used to control acute severe hypertension. In an open-label trial, 131 people who presented with a systolic blood pressure above 180 mmHg or a diastolic blood pressure above 115 mmHg were given an infusion of clevidipine for at least 18 hours. The dose was titrated to keep the blood pressure within a target range. That range was reached within 30 minutes by 88.9% of the patients. Most patients were able to switch to oral therapy within six hours of stopping clevidipine.5

Patients who are not given oral antihypertensives need monitoring, after prolonged infusions, for at least eight hours after the infusion stops. This is because of the risk of rebound hypertension. More common adverse effects of clevidipine in severe hypertension are headache, nausea and vomiting.

Some of the adverse effects of clevidipine can be anticipated from its action. These include hypotension, tachycardia and a negative inotropic effect which can exacerbate heart failure. In perioperative use there are reports of atrial fibrillation.2,3 In ESCAPE-1, 9.4% of the patients developed acute renal failure compared with 2% of the placebo group.2 In the ECLIPSE trials, the overall incidence of death, myocardial infarction, stroke or renal dysfunction at 30 days was similar for clevidipine and its comparators.4

Clevidipine is presented as an emulsion containing phospholipids. It is contraindicated in patients who are allergic to egg and soy products. Severe aortic stenosis is also a contraindication.

Clevidipine is likely to be more expensive than the drugs currently used to reduce blood pressure urgently, and it may be no safer overall. Although there were fewer deaths than with sodium nitroprusside, clevidipine did not reduce the overall rate of death, myocardial infarction, stroke or renal dysfunction significantly more than its comparators.4

T-Score manufacturer provided additional useful information

References * A

    Bailey JM, Lu W, Levy JH, Ramsay JG, Shore-Lesserson L, Prielipp RC, et al. Clevidipine in adult cardiac surgical patients: a dose-finding study. Anesthesiology 2002;96:1086-94.
    Levy JH, Mancao MY, Gitter R, Kereiakes DJ, Grigore AM, Aronson S, et al. Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1. Anesth Analg 2007;105:918-25.
    Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Aronson S, et al; ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg 2008;107:59-67.
    Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, et al. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg 2008;107:1110-21.
    Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med 2009;53:329-38.


First published online: 17 March 2014

The Transparency Score ( new drugs ) is explained in 'New drugs: transparency', Vol 37 No 1, Aust Prescr 2014;37:27.

† At the time the comment was prepared, a scientific discussion about this drug was available on the website of the European Medicines Agency (www.emea.europa.eu).

A At the time the comment was prepared, information about this drug was available on the website of the Therapeutic Goods Administration (www.tga.gov.au/industry/pm-auspar.htm)

18 February, 2014

Medicamentos más utilizados en la consulta de atención primaria (actualizado con efectos adversos )

Medicine drugs
Medicine drugs (Photo credit: Wikipedia)




Este no constituye una listado exhaustivo, sino los que yo uso habitualmente. Basados en un buscador Farmacoterapéutico, que Ernesto Barrera Linares ha dedicado mucho esfuerzo en ello, y recoge la mayor, y mejor información existente sobre los mismos. Este post no queda cerrado, simplemente iré agregando los medicamentos según su nombre genérico, y el enlace los llevará a los resultados que el buscador nos provea.  ( por hoy agrego otros 5 y van 10 ). Si a alguien se le ocurren más que lo comente.
Ningún medicamento es seguro, todos tienen sus efectos adversos, sus contraindicaciones, y en muchos casos como la aspirina, con más de 100 años, no existen evidencias escritas de su efectividad. Lo que no quita que no lo sea para aliviar un paciente con cefalea por ejemplo. Pero dificil para avalar, con las metodologias de la medicina basada en la evidencia, su efectividad en pacientes que reciben este medicamento en forma crónica, para la prevención del ictus. Incluso en países cómo Argentina, la aspirina es un medicamento que puede ser adquirido, para esta condición, bajo receta ( de modo tal que la seguridad social lo debe cubrir ), como Cardiospirina, mientras que la Aspirineta es de venta libre y con iguales dosis es vendida hasta en kioscos y farmácias en góndolas.
Para esto, al excelente buscador actualizado de Ernesto Barrera Linares, incluimos ahora también, la búsqueda en boletines farmacoterapeuticos, un trabajo realizado por Martín Cañas, en dónde se resaltan también los efectos adversos de las mismas.
Esperamos que ésto, contribuya más, al empleo de medicamentos como plantea GAPURMED ( Grupo Argentino para la utilización racional del medicamento ).
Hacemos esto, porque la mayoria de los medicos en la práctica clínica, se plantean más las bondades de los mismos, y casi nunca, los efectos adversos de los medicamentos más comunes.
Co-existen en este blog, también algunas mal llamadas guías de práctica clinica, que en realidad no son más que protocolos, sin basados en las evidencias, tanto a favor como en contra que existen para cada uno de los medicamentos más comunes que utilizamos.
No es mucho lo que se pide desde aquí, sino tan sólo evaluar las ecuaciones riesgo-beneficio, y costo-beneficio en cada una de las alternativas.
La MBE también está en un cambio sustantivo, dónde no sólo se tienen en cuenta los beneficios, a partir de Riesgos Relativos, sino también, de una manera más realista, los beneficios reales, a partir de números absolutos, que el sistema GRADE contempla (mis respetos a Galo Sanchez, que sigue trabajando en España, pese a haber sido desplazado de sus funciones por alguien de Farmaindustria ), y a Rafael Bravo Toledo, que  desde su página y su blog, y también desde su lista, hace años lleva adelante esta tarea de romper con mitos.

BFT = Boletin Farmacoterapeútico ( buscador de Ernesto Barrera Linares )
MC = Medicamentos-Comunidad ( blog y buscador de Martin Cañas )

Listado de Medicamentos Esenciales ( OMS 2013 )


Amoxicilina 
BTF y MC

Enalapril
BTF y MC

Hidroclorotiazida
BFT y MC

Fenoximetilpenicilina
BFT y MC

Carbamezepina
BFT y MC

Furosemida
BFT y MC


Luego los iré ordenando según la clasificación ATC.

29 January, 2014

Medicamentos: general

Un médico general, lo que abarca también a los pediatras, no utiliza más de 30 medicamentos en su práctica ambulatoria. Un especialista de enfermedades muchos menos. Es mucha la información que existe en internet sobre medicamentos, asi cómo mucha la información que la industria farmacéutica, y aún las agencias regulatorias, guardan o ocultan para ellas. En Argentina, no existe ninguna base de datos que reporte aún la escasa farmacovigilancia que existe, y tanto médicos como pacientes nos vemos más expuestos a las supuestas virtudes de los mismos. Somos, al igual que muchas otras sociedades del hemisferio norte, una sociedad medicalizada, no necesariamente bien medicada.
Veinte años atrás, se hizo un estudio en un pacientes ancianos hospitalizados, y se encontró que recibian una media de 13 medicamentos por dia. Ese trabajo se perdió en algun papel, ya que no alcanzó nunca a ser publicado.
El pensamiento mágico hace pensar que los medicamentos siempre nos habrán de curar. No es casual que el costo de un medicamento original, y nuevo, lleve más presupuesto en marketing que en investigación y desarrollo. Claro, esto siempre y cuando exista investigación. El 50% de los medicamentos que se comercializan en Argentina, no llevan un sólo centavo de investigación, son copias ( "similares ") , a los que se desarrollan en otros paises del mundo. Los laboratorios "nacionales" sólo se dedican a copiar, sin embargo el precio de los mismos es casi idéntico al de los propios originales.
No existen medicamentos genéricos en Argentina. Para ello, tendrian que atravesar algunas pruebas de laboratorio que ningún gobierno ha puesto nunca en marcha, como la biodisponibilidad de los mismos.
Se toma al medicamento como un producto más de consumo, y en Argentina se puede conseguir en góndolas de algunas cadenas de farmacia, o aún en supermercados o kioscos.
La propia medicina pre-paga, ofrece más medicamentos que los que el Programa Médico Obligatorio (ya anticuado ), y luego se quejan por el aumento de los mismos. La obligación de prescribir por el nombre genérico ha quedado en el olvido. Sin dudas, por los arreglos que existen entre éstas grandes y "prestigiadas" instituciones, y los descuentos que deben hacer las farmacias para "pertenecer" a algunas de estas "medicinas privadas". Y luego, el famoso "rebate" ( un premio que se dá a las mismas por parte de los laboratorios por prescribir esa marca ), sigue existiendo. De manera tal que habria que preguntarse bien, el porqué se quejan tanto, cuando están pagando en muchos casos el 5% o 10% del precio de venta al público. Sin embargo, sus cuotas siguen subiendo también.
El estado sigue ausente. La política de medicamentos estatales lleva años tratándose de implementar, y para que sea más efectiva su implementación, la misma está bajo la órbita del Ministerio de Defensa. Dónde quedó aquella política que proveia de medicamentos en todos los establecimientos públicos, desde fábricas estatales que se implementó entre 1947 y 1955 por Ramón Carillo. Si hasta un gobierno, muy débil por cierto, quiso modificar la politica de medicamentos, y sufrió el embate de la industria de farmacéutica durante la época de Illia ( hace ya 45 años ).
Todo medicamento que entre en Argentina si es aprobado en 27 paises que figuran en un anexo, son automaticamente aprobados aqui, no importa si son utiles o no. Un decreto de 1993 lo avala, y esta dependencia, ya no tecnológica, sino cientifica y política, sigue vigente. Sin que exista mecanismo alguno para que una vez que entraron sean eliminados de nuestras listas de medicamentos que deben estar ya superando los 10 mil medicamentos.
Medicalizamos los médicos, medicalizan las agencias regulatorias, medicalizan los laboratorios ( que al fin de cuenta es su trabajo ), pero el estado sigue ausente. Y este producto del mercado, ni siquiera lleva los mismos prospectos que en otros paises del mundo. Y aun siendo tratado como un producto del mercado, no cumple con la ley 24.240, que obliga a que la letra no sea inferior a 1,8 mm......leer un prospecto en Argentina, necesita lupa o microscopio.
Más medicamentos, no es más salud. Y no existe ningún medicamento que no tenga efectos adversos, pero en muchos, sus riesgos superan ampliamente los beneficios.
Quizás, y para muchos, sea necesario conocer, o recordar la historia de la Talidomida.

20 December, 2013

Tinsel or transparency? GlaxoSmithKline’s marketing overhaul

 Source:  The Conversation. By Bruce Baer Arnold

GlaxoSmithKline, one of the Big Five global pharmaceutical companies, this week gave the world an overdue Christmas present. Glaxo will stop paying doctors to promote its drugs and will no longer pay its sales representatives on the basis of the number of prescriptions written by those practitioners.
But before we say thanks – and ask Glaxo’s peers to follow its lead – we need to ask: is this tinsel or transparency?
Pharmaceuticals are big business. We like to believe that drug development and marketing “just happens”, but drug companies vigorously seek to influence government policy at home and abroad.
We have seen this in lobbying about free trade agreements, which typically privilege the interests of overseas drug companies over Australian consumers and taxpayers. The taxpayer is important because we subsidise prescription medications through the Pharmaceutical Benefit Scheme.
The secret Trans Pacific Partnership Agreement, for example, has rightly been condemned for threatening to increase the price Australians pay for pharmaceuticals.
Drug companies also influence medical practitioners and medical practices. One way is through pharmaceutical payola: practitioners get financial incentives for prescribing a particular company’s medications.
Some lucky practitioners, managers and partners have been getting presents in the form of free trips to professional conferences or, more egregiously, to educational opportunities at plush overseas resorts. There’s nothing like a week of golf in Hawaii interspersed with promo about drug x or drug y.
Glaxo’s new policy will see doctors having to pay their own way at conferences. Image from shutterstock.com
Given the money at stake, leading companies have gone further. They’ve influenced perceptions of their products through ghostwriting research papers in professional publications and through consulting arrangements for gatekeepers or “opinion leaders”.
Some companies simply haven’t reported problems with medications. And some have actively promoted products for unapproved uses, potentially with a tangible risk of serious injury or death. Dementia patients, for example, were at increased risk of stroke after being prescribed Johnson & Johnson medications that were only approved for the treatment of schizophrenia.
The Australian Competition & Consumer Commission (ACCC), informed by industry critics, has slowly started to address the lack of pharmaceutical transparency in Australia. In signing off on the industry self-regulatory scheme, it encouraged Medicines Australia – representing major non-generic drug companies – to move towards greater transparency about payments. Medicines Australia has agreed to aggregate disclosure but resisted transparency about benefits to individuals.
Regrettably, there is still no requirement for disclosure at the researcher or practitioner level and no expectation that gift-giving stop altogether.
Action by the ACCC followed news that the US government has imposed billion-dollar penalties on leading drug companies over a range of marketing abuses. Johnson & Johnson, for example, paid US$2.2 billion. The US Justice Department stated that a Johnson & Johnson arm knew patients taking Risperdal had an increased risk of developing diabetes but nonetheless promoted the drug as “uncompromised by safety concerns (does not cause diabetes)“.
Glaxo paid US$3 billion after the government found it unlawfully promoted Paxil for treating depression in young patients even though the drug was unapproved for paediatric use. Glaxo’s Wellbutrin was promoted for weight loss, treatment of sexual dysfunction, substance addictions and ADHD despite legally only being prescribed for severe depression.
Glaxo, along with its peers, concurrently indicated it would behave as a good citizen. Leading drug companies acknowledged that there had been misbehaviour, in some instances direct illegality. Their excuses? Some claimed over-zealous agents were primarily responsible, that such behaviour was standard practice across the industry and had been tacitly accepted by a range of regulators, or that market realities meant that they were at the mercy of practitioners.
The new Glaxo move to stop paying doctors for speaking engagements or to attend conferences and abolish sales targets for drug reps will come into effect in Australia and other nations during the next two years. We can expect Glaxo’s peers to follow. That emulation will reflect marketing – no-one wants to be left behind. It’s also a way of pre-empting government regulation.
But we still need to question the gift-wrapping. Glaxo’s announcement coincides with investigation in China of what would conventionally be described as bribes (claims doctors were paid handsomely for conferences that did not take place).
We still don’t know how much doctors receive in grants and consultancy fees. Image from shutterstock.com
It also anticipates disclosure under the Physician Payments Sunshine Act, as part of Obama’s controversial health plan.
But Glaxo has not revealed how much it has been paying to individual researchers, reviewers, ghost writers and practitioners. And it will continue to make “unsolicited, independent educational grants” to doctors.
A truly beneficial Christmas present – one with more substance than tinsel – would be a commitment by drug companies to publicly reveal where the money is going on such “grants”, “consultancies” and ghostwriting. Public health specialists advocate disaggregated disclosure – and it is possible.
Next Christmas let’s see how much is going to individuals. If there is nothing wrong with the payment, there is nothing to hide and everyone can enjoy the festivities.

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