sábado, 21 de julio de 2018

SuperGlu...no "pega" como medicamento.

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Super Glue es hoy el pegamento más famoso del mundo, disponible en las tiendas de casi un centenar de países. Sin embargo, su destino original era bien distinto: ser un arma de guerra. 
Como tantos artículos de nuestra vida cotidiana, es un producto nacido de la investigación militar. Pasó de ser una mirilla de precisión de los rifles del ejército americano a un imprescindible en las cajas de herramientas de cualquier hogar, pasando por un fármaco de emergencia en Vietnam.
(...)

Los médicos y sanitarios militares descubrieron que la capacidad adherente del Super Glue también servía para pegar partes del cuerpo humano. Concretamente, para cerrar hemorragias abiertas provocadas por heridas de bala o metralla, que fueron una de las principales causas de mortalidad entre el contingente norteamericano durante este conflicto.


Gran parte de los soldados estadounidenses no morían de forma instantánea durante los combates. Otros resultaban heridos durante las refriegas y debían aguantar el tiempo suficiente hasta que un helicóptero de evacuación pudiera llevarles a un punto médico donde cerrar sus hemorragias y extraer las balas y la metralla.

Según datos del ejército norteamericano, durante este conflicto se evacuó por aire a cientos de miles de soldados heridos y las tasas de mortandad durante estos desplazamientos descendieron por debajo del 1% gracias a este remedio instantáneo.

Sin embargo, resulta especialmente llamativo que, en aquel momento –y hasta hoy–, el Super Glue no estaba ni siquiera aprobado para el consumo humano por la Agencia del Medicamento de Estados Unidos.

La razón eran los efectos secundarios perjudiciales para la salud. Sin embargo, tras su uso en la guerra de Vietnam alcanzó mucha popularidad en la sociedad civil estadounidense gracias a su bajo coste. Lo cierto es que posteriormente se han desarrollado derivados del cianoacrilao aptos para su empleo en humanos y animales. 
En cualquier caso, el Super Glue fue el primer paso, el inspirador de otros medicamentos para cerrar heridas abiertas que sí han sido aprobados por las autoridades sanitarias. (Más)

viernes, 20 de julio de 2018

Ratón de biblioteca: El médico perplejo / Robert S. Bobrow

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El médico perplejo, del médico y profesor clínico Robert S. Bobrow trata de casos médicos que la ciencia, en su gran mayoría, todavía no ha sabido explicar satisfactoriamente.
...Bobrow introduce algunos casos desde un punto de vista demasiado magufo, aunque haya otros que estén presentados con más rigurosidad. El problema para el lector es, pues, separar el grano de la paja. 

Ojo, no se afirma aquí que determinadas pseudociencias puedan ser veraces y que algún día se incorporen a la ciencia, lo que se afirma es que, por el momento, no hay ninguna prueba. Al menos ninguna prueba importante. Y los hechos extraordinarios, los que violan las leyes de lo que ya conocemos, deben exigir pruebas igualmente extraordinarias para ser considerados. (Ver)

jueves, 19 de julio de 2018

NOVARTIS "pierde de vista" ALCON ?

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Basel, June 29, 2018 -  

Novartis today announced its intention to spinoff Alcon, its eye care division, into a separately-traded standalone company. 

The planned spinoff would enable Novartis and Alcon to focus fully on their respective growth strategies. Completion of the transaction is subject to general market conditions, tax rulings and opinions, final Board of Directors endorsement and shareholder approval at the 2019 AGM in line with Swiss corporate law.


Ver

  • Alcon strategic review concludes that 100% spinoff in best interest of shareholders and consistent with the Novartis strategy of focusing as a medicines company
  • Planned spinoff would create world leading eye care devices company
  • The Alcon ophthalmology pharmaceuticals portfolio will remain with Novartis, further strengthening its leading ophthalmology pharmaceuticals business
  • Transaction expected to be tax neutral to Novartis and subject to general market conditions, tax rulings and opinions, final Board endorsement and shareholder approval at the AGM in February 2019; completion expected in H1 2019
  • Alcon CEO Mike Ball to become Chairman-designate; COO, David Endicott promoted to Alcon CEO, both appointments effective July 1, 2018
  • Alcon would be incorporated in Switzerland; with Fort Worth continuing to be a key location. Listings planned on SIX Swiss Exchange and New York Stock Exchange
  • Share buyback of up to USD 5 bn planned to be executed by end 2019, in line with capital allocation priorities highlighting confidence in top line growth and margin expansion (Más)

miércoles, 18 de julio de 2018

Colombia: Pharma se hace "transparente"...

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Para nadie es un secreto que por años la industria farmacéutica ha financiado de distintas maneras a diferentes actores del sector salud. Médicos, funcionarios administrativos y asociaciones de pacientes han recibido “ayudas” de las compañías. Invitaciones a viajes, a comidas, a congresos internacionales y pagos por conferencias son algunas de las prácticas más frecuentes. Se trata de una compleja relación que ha generado dificultades pues suele desembocar en serios conflictos de interés.

Desde hace cuatro años en el Ministerio de Salud ha estado cocinándose una norma para reglamentar ese viejo vínculo y esos mecanismos de financiación. El camino para concretarla no ha sido fácil. Se han publicado varios borradores y esa cartera ha recibido comentarios tanto de la industria como de ONG con aportes e ideas. Sin embargo, esa resolución está a punto de ver la luz. Aunque aún no ha sido publicada en su totalidad (al parecer eso sucederá a principios de la próxima semana), el Minsalud, a través de un comunicado, anunció la primera medida de ese documento: la creación de una aplicación en la que las farmacéuticas deberán reportar todos los pagos que hagan a los actores del sistema.

La idea es que las compañías hagan una declaración cuando los montos superen los $78 mil pesos (US$ 26), en el caso de que se trate de comidas o recordatorios, o cuando la cantidad sea equivalente a un salario mínimo ($781.242) en el caso de que se trate de otras transferencias. Las deberán reportar cuando se las hagan tanto a médicos, pacientes y sociedades científicas como a EPS y jefes de compras de hospitales. También cuando se las hagan a periodistas.

El motivo detrás de esta medida es sencillo: en muchas ocasiones se ha demostrado que la entrega de obsequios o viajes tiene una correlación con la prescripción de medicamentos. Algunos de ellos suelen estar entre los más costosos del sistema.

La resolución de transferencias de valor está basada en buenas prácticas internacionales que buscan revelar estas formas legítimas, pero que deben ser de conocimiento público, sobre cómo las compañías farmacéuticas se relacionan con prescriptores, investigadores y científicos. En un sistema de salud como el colombiano, en el que el 85 por ciento de los recursos son públicos, se necesitan normas de transparencia para buscar la legitimidad, la confianza, la sostenibilidad del sistema y en últimas la salud de la gente”, asegura Alejando Gaviria en el comunicado.

Ver:

FARMAINDUSTRIA: "Transferencias de valor" nuevo eufemismo por... ¿Cuánto pagan las farmacéuticas a los médicos?


La aplicación web en la que se harán estos registros se desarrolló gracias al Proyecto Anticorrupción y Transparencia de la Unión Europea para Colombia, Actúe Colombia. 




Ver:
Proyecto Anticorrupción y Transparenciade la Unión Europea para Colombia

Farmacéuticas deberán reportar pagos a actores del sistema

Pese a que aún no se sabe la fecha en la que empezará a funcionar, cuando empiece a marchar cualquier ciudadano podrá consultar la base de datos y podrá hacer filtros por laboratorio, profesional o asociación de pacientes. (Ver)

martes, 17 de julio de 2018

El amigo americano de Joe Jimenez...Michael Cohen.



Democrats are accusing a major pharmaceutical company of trying to influence the Trump administration's plan to lower drug prices.

Emails obtained by Democrats and publicly released Friday show that Novartis sent Michael Cohen, a former lawyer for President Trump, a list of proposals to lower drug prices.

Several of those proposals later appeared in the administration's "blue print" to lower drug prices.


In an email dated June 5, 2017, ex-Novartis CEO Joe Jimenez sent Cohen an email with a document attached called "drug pricing initiatives."

"Based on our conversation last week, I am forwarding you some ideas to lower drug costs in the US," Jimenez wrote.

Cohen responded a few hours later: "Received and I will forward to you their suggestions."

Several of the recommendations later ended up in the administration's blueprint, which was released in May. Those included proposals to speed up the approval of generic drugs and reforming the rebate system between pharmacy benefit managers and drug manufacturers.

Novartis previously acknowledged a $1.2 million agreement with Cohen last year. Cohen allegedly promised the company access to the Trump administration.

Ver:

NOVARTIS Amistades peligrosas: Trump attorney Michael Cohen


Novartis said it ended the relationship with Cohen in March 2017, but Democrats say new documents show communication continued until September.


U.S. Senate Democrats 
are questioning the truthfulness 
of Novartis AG’s account 
of its relationship 
with Donald Trump’s lawyer, 
saying its ties were deeper 
than the Swiss drugmaker 
has acknowledged.(Más)

Ver:
Novartis, Michael Cohen contacts were more extensive than previously disclosed
Senators Assail Novartis Account of Cohen Connection

 

The report suggests 
Cohen tried to persuade Novartis 
to invest in a healthcare company 
connected to “sanctioned Russian oligarch” 
who has also been questioned 
by investigators working 
on the Russian interference probe.

"These documents indicate that Mr. Cohen and Mr. Jimenezwho was still the Novartis CEO at the time – had at least four phone calls, and, between April and September 2017, exchanged multiple emails on substantive issues, including the Trump administration’s drug pricing proposals, Novartis’s potential investment in a small drug company backed by Columbus Nova, and with regard to opioid lawsuits," according to the report.

Democrats have characterized the relationship as Cohen capitalizing on his ability to offer companies access to Trump administration officials.

Cohen's attorney Lanny Davis, a contributor to The Hill, said in a statement to ABC that Cohen provided "strategic advice" and did not "sell access."

Novartis spokesman Eric Althoff said Jimenez provided Cohen with a list of "well-known ideas for lowering the cost of pharmaceuticals that had been discussed publicly in the industry."

Althoff also said the company disagrees with the report's conclusion that Novartis misled the public about the extent of its engagement with Cohen.

"As the documents we produced show, Novartis had [its] one and only meeting with Mr. Cohen on March 1, 2017, and then concluded he was not able to provide the substantive consulting advice and insight for which he was hired. We never asked Mr. Cohen to perform any services on our behalf after March 1, nor did he perform any," he said. (Ver)





Narasimhan, who rose through the company’s ranks and moved into the top job earlier this year, is taking a number of steps to try to strengthen the company’s ethics and manage risk. 

Ver:
NOVARTIS: Exceso de llamadas...

Regaining trust is important for Novartis as the company seeks reimbursement for costly, cutting-edge medicines for cancer and other diseases and navigates the health-care market in the U.S., where high drug prices have come under fire. (Más)

Felix Ehrat
Novartis links to Cohen have already resulted in the resignation of legal head Felix Ehrat .

Ver:

NOVARTIS: Dimitido responsable jurídico. 

Le responsable juridique de Novartis démissionne 



In May, he accepted responsibility for the embarrassment surrounding $1.2m in payments made by Novartis to the lawyer, exposed amid the journalist digging and legal wrangling that followed porn star Stormy Daniels’ claim that she had an affair with the President and was paid $130,000 for her silence.(Más)

domingo, 15 de julio de 2018

Marijuana green grey zone...patients, Dr´s & pharmaceuticals.

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If you live in one of the 20 states where marijuana is legal but only for medical use, access to the drug begins at the doctor's office. But unlike most other treatments, it is not granted via a prescription pad.

That's because marijuana remains a schedule 1 substance. (Physicians can only write prescriptions for schedule 2 drugs or higher.) This classification encapsulates a wider paradox: marijuana is defined as a drug with no medical value and a high potential for abuse by the federal government, but it is now legal for medical use in most states. Once dismissed as a drug for slackers, marijuana has entered the mainstream so completely it's been embraced by wellness enthusiasts. Sixty-one percent of Americans support its legalization.

But because the federal government continues to classify marijuana as a schedule 1 drug, along with heroin and LSD, it's very difficult for researchers to study its health effects. While the available evidence suggests marijuana can be an effective treatment for chronic pain, the body of studies is far from robust.


Meanwhile, doctors are barred from prescribing cannabis products. Instead, certified physicians in states where the drug is legal can provide patients with a medical marijuana card.

The disconnect likely contributes to the overall confusion and lack of information surrounding marijuana's medical benefits. Patients are increasingly curious about the drug, but doctors often don't have answers. In a recent survey of oncologists published in the Journal of Clinical Oncology, around 80% said they've discussed marijuana with their patients in the past year, but only 30% felt they have enough information to advise patients on its medicinal use.

Even for providers who are informed about the drug and can talk knowledgeably about treatment options, such guidelines aren't easily integrated into a patient's health records. Because of the drug's scheduling, doctors can suggest dosages and products (most doctors likely won't recommend that a lung cancer patient smokes a joint, for example), but they can't prescribe anything specific. Instead, patients visit a dispensary, card in hand, and select what they want.

Physicians are cut out of the loop,” said W. David Bradford, a professor of public policy at the University of Georgia. Rescheduling marijuana would allow physicians to write cannabis prescriptions, and “integrate it into a care plan.” It would open the door, albeit a crack, for pharmaceutical companies to work with dispensaries to create more uniform doses of the product, as Sandoz has done in Canada. Patients, particularly those with complex drug regimens, could benefit from an added layer of coordination and precision.

Ver: 
Sandoz / Novartis y la marijuana (no "combustible")...

Dr. Andrew Epstein, an oncologist with Memorial Sloan Kettering Cancer Center in New York City, supports marijuana's use to help with pain, nausea, and fatigue after more traditional medical treatments have been tried and exhausted. But unlike Bradford, he does not feel the drug is not ready for the prescription pad treatment.

Researchers simply don't know enough about what marijuana can – and can't – do to justify having doctors prescribe the drug in specific dosages, he said. “I'm concerned it would add to the confusion.” (...)

Impact on pharma

Despite doctor's inability to prescribe the drug, medical marijuana is nonetheless having an effect on prescribing patterns.

In every state where medical cannabis has been legalized it has “this benefit of people being able to use less prescription medication,” said Jessica Gelay, a policy manager at the Drug Policy Alliance. Indeed, a recent study published in JAMA Internal Medicine by Bradford and colleagues found that after states legalized medical marijuana, opioid prescriptions under Medicare Part D declined significantly. 


Ver

In those states that introduced a system of dispensary outlets, opioid prescriptions under Medicare Part D dropped by 14.5% following legalization. “People are reacting to the availability of cannabis as if cannabis was medicine,” Bradford said. “They're doing exactly what they would do if a pharma company introduced a new blockbuster drug.

Bradford estimates that if every state were to turn on a dispensary-based cannabis program, Medicare and Medicaid spending would drop by around $4 billion to $6 billion. Legalization represents a potentially significant “reduction in the revenue flowing to prescription drugmakers.” 



Which hasn't gone unnoticed by manufacturers. Some have publicly lashed out: Insys, an opioid maker, contributed $500,000 to an anti-legalization campaign in Arizona, for example. 
Others (including, ironically, Insys again) have invested in harnessing elements of the drug to create FDA-approved treatments.

The FDA is expected to green light an epilepsy medication from GW derived from marijuana later this summer. If the decision goes through, it would be the first cleared drug made from the marijuana plant, although the agency has already approved a few drugs derived from synthetic cannabinoids.

The approval would open the door for other medications derived from marijuana, particularly those, like GW's epilepsy drug, that do not contain properties that make users high. For broad, lucrative categories such as pain management, however, marijuana-based medications could lack the financial windfall necessary to justify heavy R&D investment.

You can't patent the cannabis plant,” Bradford said. Were a manufacturer to invest heavily in determining the most effective strains and dosages for treating chronic pain, “everyone could just go buy it from their local dispensary instead.” (Más)

Ver también:

USA: FDA aprueba EPIDIOLEX primer cannabinoide
SANDOZ con Tilray (pioneros) y la marijuana "no cumbustible"