John LaMattina Vs Marcia Angell

Dr. Marcia Angell, the former editor of The New England Journal of Medicine, was recently interviewed by Russ Roberts, the host of EconTalk. 

Some years ago Angell wrote: The Truth About Drug Companies: How They Deceive Us and What To Do About It. Her book attacked the industry essentially saying that it produces little innovation and that its primary mission is to exploit consumers. That’s a pretty serious accusation. The problem with Angell’s arguments is that they are rife with inaccuracies and fallacies. Furthermore, she makes no accounting for changes in the industry that have occurred over the last decade.

In her interview with Roberts, she continued to hammer away at the same themes that she has harped on for years, as if saying them repeatedly will make them true. But it is time to call her out on some of her most egregious positions. Here are a few.

 “The drug companies do almost no innovation nowadays….. All they have to do is the late development. And that’s the clinical trials. Now that is an expensive part of the process. But it is not an innovative part of the process.”

“When the drug companies sponsor trials of their new drugs….they will design the study, and the studies are designed in such a way that the new drug is compared with a placebo – that is, with a sugar pill. It’s not compared with an older drug.”

.../...

Angell’s critique of clinical trial design is just not true any longer. First of all, the FDA reviews all clinical programs and if a company doesn’t follow the guidance, it risks spending hundreds of millions of dollars for results that the FDA will deem “unapprovable”. But the biggest impact that has occurred in the last few years has been that of payers. Why should a new drug be reimbursed by health plans or governments if it hasn’t been shown that the new agent is superior to existing therapies, particularly if generic drugs already exist for that disease indication? 

But the attack that I find to be particularly offensive is that on health standards. Angell implies that medical experts are being paid off by pharmaceutical companies to influence national health guidelines to favor the greater use of drugs. This is a very dangerous accusation, because it suggests that unnecessary drugs are being prescribed. Thirty years ago, it was thought that total cholesterol levels of 280 were “normal”. However, decades of clinical studies, studies that have cost literally BILLIONS of dollars have shown that lowering cholesterol to under 200 does, in fact, reduce heart attacks and strokes. That is medical science. For Angell to imply otherwise is irresponsible.

Dr. Angell was profiled by the New York Times earlier this year. Interestingly, the article pointed out that not everyone at Harvard Medical School subscribes to Dr. Angell’s views. (Más)

Ver también:

Marcia Angell en PHARMACOSERÍAS

Marcia Angell / The NYT: Transparencia no frena corrupción...

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On Thursday, Dr. José Baselga resigned from his position as chief medical officer at Memorial Sloan Kettering Cancer Center. Earlier this month, ProPublica and The New York Times revealed that he’d received millions of dollars from drug and device companies whose fortunes he stood to affect. He also sat on the board of at least six companies, where his fiduciary responsibility to them might conflict with his obligations to the cancer center. Most of his outside income was not disclosed to the journals in which he published, in violation of their requirements. 

Ver:

Baselga "se oculta" del fisco (USA)

Although his case is extreme, these kinds of conflicts of interest are virtually universal in the upper levels of academic medicine.

I was an editor of The New England Journal of Medicine for over two decades, and was there in 1984 when we became the first major medical journal to institute a policy that required authors of research articles to disclose all financial ties to companies that could be affected by their research. We had become aware that academic researchers were receiving large payments from drug companies and that it was distorting their work. For example, I once phoned the senior author of a paper submitted to us to ask why he had neglected to mention the side effects of a potent new drug he was testing. Without any apparent embarrassment, he said that the sponsor wouldn’t let him. We didn’t publish the paper, but another journal did.

In order to get prescription drugs approved by the Food and Drug Administration, companies must conduct clinical trials to show that the drugs are safe and effective. But drug companies don’t have direct access to human subjects, so they’ve always contracted with academic researchers to conduct the trials on patients in teaching hospitals and clinics. Traditionally, they gave grants to the institutions for interested researchers to test their drugs, then waited for the results and hoped that their products looked good. The grants were at arm’s length; the companies didn’t design or analyze the studies, they didn’t own the data, and they certainly didn’t write the papers or control publication.

That began to change in the 1980s, partly as a result of a new law that permitted researchers and their institutions, even if funded by the National Institutes of Health — that is, the taxpayers — to patent their discoveries and license them exclusively to drug companies in return for royalties. That made them business partners, and the sponsors became intimately involved in all aspects of the clinical trials.

It also gave the drug companies direct access to highly influential physicians, like Dr. Baselga, known to the industry as key opinion leaders. These are the people who write textbooks and medical journal articles, issue practice guidelines, sit on the F.D.A. and other governmental advisory panels, head professional societies and speak at the innumerable meetings and dinners where clinicians are taught about prescription drugs. Having key opinion leaders on the payroll is worth every penny a drug company spends.

Ver:

KOL´s en PHARMACOSERIAS

Ratón de Biblioteca: K.O.L. (Líder de Opinión) / Rafael Sepúlveda Blanes

 
What do they get for their money? 

• First, there are the intangibles. It’s human nature to feel warm toward people with whom one collaborates closely, particularly when they’re so generous, and key opinion leaders become a sort of informal sales force.
• Second, there’s good evidence that drug company involvement biases research in ways that are not always obvious, often by suppressing negative results. A review of 74 clinical trials of antidepressants, for example, found that 37 of 38 positive studies — that is, studies that showed that a drug was effective — were published. But 33 of 36 negative studies were either not published or published in a form that conveyed a positive outcome.

Bias can also be introduced through the design of a clinical trial. For example, the sponsor’s drug may be compared with another drug administered at a dose so low that the sponsor’s drug looks more powerful. Or it can be compared with a placebo, when the relevant question is how it compares with an existing drug. In short, it’s often possible to make clinical trials come out the way you and your sponsors want.

Disclosure is better than no disclosure, but it does not eliminate the conflict of interest. It’s simply a way of saying caveat emptor, and leaving it to readers to decide whether the research was biased. But most people — even doctors and science reporters — aren’t really equipped to make those judgments, particularly when data are suppressed.

I would suggest two reforms. 

• First, researchers at academic medical centers should not accept any payments other than research support from drug companies, and that support should have no strings attached — no control over the design, interpretation and publication of trial results. We should go back to arm’s length grants.  
• Second, doctors should not accept gifts from drug companies, even small ones, and they should pay for their own meetings and continuing education, as is standard in other professions. They can afford it.

Ver:

Pagos d la Industria: Los conflictos de intereses y su efecto en Rx...

In the meantime, those of us who read these studies should remain skeptical about them until several different trials reach the same result.

The indignation about Dr. Baselga is justified. But the fact that other physicians disclose their myriad conflicts of interest does not solve the underlying problem. Collaboration with industry can lead to important scientific contributions, but we should not let drug companies buy the hearts and minds of researchers. The cost of this is high, and not just in drug prices. It means both doctors and patients believe prescription drugs are better and safer than they really are. (Ver)

Marcia Angell, a member of the faculty of global health and social medicine at Harvard Medical School and former editor in chief of The New England Journal of Medicine, is the author of “The Truth About the Drug Companies.”

Ver también:

MARCIA ANGELL: La verdad acerca de la industria farmacéutica. Como nos engañan y que hacer al respecto

 Todo sobre Marcia Angell en PHARMACOSERÍAS

Precio: El mayor de todos los incrementos...Daraprim (Turing) / Marcia Angell* (II)

The $750 pill: Why do drug companies charge so much?
Marcia Angell*

In 1953, a new drug was released by Burroughs Wellcome, a pharmaceutical company based in London. Pyrimethamine, as the compound was named, was originally intended to fight malaria after the microorganisms that cause the disease developed resistance to earlier therapies. The drug was used against malaria for several decades, often in combination with other compounds. It’s mostly used now to treat toxoplasmosis, a parasitic infection that can be life-threatening in people whose immune systems are suppressed, for example, by HIV/​AIDS or cancer. 

More than 40 years later, Burroughs Wellcome merged with the British pharmaceutical giant Glaxo. In 2010, the company, now GlaxoSmithKline, sold the U.S. rights to pyrimethamine — which is marketed under the brand name Daraprim — to another firm, CorePharma. By then, the patent on the drug had long since expired, but because nobody bothered to make a generic, Daraprim was essentially a monopoly. 

In August, there was another significant development in the drug’s history: CorePharma’s parent company, Impax Laboratories, sold it to Turing Pharmaceuticals. Almost immediately, the company raised the price from $18 a pill to $750, a more-than-40-fold increase, and then sent out its brash chief executive, Martin Shkreli, to aggressively defend the new cost.

Ver:
Martin MShkreli, a provocateur in the pharmaceutical wars 

A course of treatment for toxoplasmosis is about 100 pills, which under the new pricing would run $75,000. Why the astonishing increase? The answer is: Why not? 

Unlike every other advanced country, the United States permits drug companies to charge patients whatever they choose. (In this case, with Daraprim’s patent expired, Turing is probably in a hurry to make as much as possible before a generic version can enter the market. It announced after the fury over the increase that it would lower the price again, but you can bet it won’t fall all the way back to $18 a pill.) In Britain, in contrast, GlaxoSmithKline sells the drug for 66 cents a pill, and in India, it costs even less. 

 The new U.S. price grabbed public attention because it was so sudden and extreme. But exorbitant charges for drugs that treat serious diseases are hardly unusual. Avastin, for example, a cancer medication of dubious benefit, can cost close to $100,000 for a year’s treatment. And prices for almost all prescription drugs are rising much faster than the background inflation rate. 

Drug companies say high prices are necessary to cover their research and development costs, enabling them to discover innovative new medicines. Turing says it planned to use the profits from Daraprim’s higher price to fund research into better treatments for toxoplasmosis. 

But in fact, Daraprim illustrates the way most drugs are priced: They are invented not by the companies that sell them now but by someone else. Then, like big fish swallowing little fish, larger companies either buy small firms outright or license promising drugs from them. 

Very often, the original discovery occurs in a university lab with public funding from the National Institutes of Health, then licensed to a start-up company partly owned by the university and then to a large company. There is very little innovation at the big drug firms. Instead, their major creative output is trivial variations of top-selling medications that are already on the market (called “me-too drugs”), to cash in with treatments just different enough to justify new patents. 

For example, the first of the statins, drugs that lower cholesterol, was Merck’s Mevacor, which came on the market in 1987. There followed a whole family of me-too statins, including Zocor (also made by Merck), Lipitor, Pravachol and Crestor. There is little reason to believe that one is more effective than another at equivalent doses. 

Moreover, the major drug companies are hardly strapped for money to cover their R&D: A look at their annual reports shows that they spend more on marketing and administration than on R&D. Pharmaceutical manufacturers are consistently among the most profitable companies. 

 Drugmakers are now getting some pushback from the public in response to their claims that they need the money, but they fall back on the rhetoric of the free market. They are investor-owned businesses, after all, they say, and they have a right to charge whatever the market will bear (which for desperately sick patients or their insurers is quite a lot). 

 But the pharmaceutical market is hardly an example of unfettered capitalism, because the companies are totally dependent on government support. In addition to receiving huge tax breaks and government-granted exclusive marketing rights, they are permitted to acquire drugs that resulted from NIH-funded university research. 

For example, Gleevec, a drug to treat a form of leukemia, stemmed mainly from work by an NIH-funded scientist at Oregon Health & Science University; its development was relatively quick. Still, Novartis priced it at about $30,000 a year when it came on the market in 2001. So the public paid twice: once for the research and then an exorbitant amount to buy the drug. Gleevec, meanwhile, now costs triple its initial price. 

About half of the major drug companies are European, including the makers of Avastin and Gleevec. But their research arms are often located in the United States, not only because this is their profit center but also because they want to be near universities that receive generous NIH funding, in order to develop close relationships with the researchers. 

The public should demand something in return for all that governmental support. Other advanced countries regulate drug prices in one way or another: Some cap profits, some cap the rate of price increases, some have formularies that limit drugs in each class to those that are most cost-effective, and some regulate in more than one way. But they all have some form of regulation, and the result is much lower prices for the same drugs. 

In the United States, by contrast, Congress has blocked even Medicare from negotiating the price of drugs or creating a formulary for patients. It’s time that we, too, move to stop price-gouging by the pharmaceutical industry — even when no one notices. (Ver)

(*) Marcia Angell is a senior lecturer in social medicine at Harvard Medical School and a former editor in chief of the New England Journal of Medicine. She wrote this for The Washington Post.

Ver anterior:
Precio: El mayor de todos los incrementos...Martin Shkreli /  Daraprim (Turing) (I)

Ver también:

MARCIA ANGELL: La verdad acerca de la industria farmacéutica. Como nos engañan y que hacer al respecto

USA: Estatinas... "razón de estado" (I) / Marcia Angell* o "demonio..."?

"The only sure benefit of doubling the market for statins 

is to the bottom line of the drug companies."

 
Guidelines for medical treatment promulgated by medical specialty societies greatly influence doctors and public attitudes. The guidelines on cardiovascular risk released last week, if followed, would result in a doubling of the number of Americans taking statin drugs to prevent heart attacks and strokes. 

But, as is often the case with specialty societies, the groups behind these new proposals, the American College of Cardiology and the American Heart Association, are heavily dependent on financial support by drug companies to support their meetings. 

Moreover, members of their guideline committees often work as paid consultants or speakers for companies whose sales will be affected by the guidelines. About half the members of the committee that wrote the cholesterol guidelines had financial ties to the makers of statins, The Boston Globe reported.

 

 In 2005, a Food and Drug Administration advisory committee said it was O.K. to keep arthritis drugs like Vioxx on the market, despite evidence that their use increased the risk of heart attacks and strokes. But it was later revealed that 10 of the 32 members of the committee had ties to the companies that made the drugs. If their votes were discounted the decision would have gone the other way. 

Conflicts of interest are not just a matter of form; they do matter.
 

Another problem: Instead of targeting cholesterol levels, the new cardiac guidelines target all risk factors that together would predict at least a 7.5 percent chance of a heart attack or stroke in 10 years – including age, smoking and high blood pressure. Thus, you might be subject to statin treatment even if your “bad” cholesterol is quite low. 

But why take a drug designed to lower cholesterol if that's not your problem? That seems nonsensical, unless there is very good evidence that statins have other, relevant effects. 

And that gets to the heart of the matter. 

Far-reaching guidelines should be based on strong scientific evidence from randomized controlled clinical trials. Without it, all we have is the opinion of a group that, even though expert, has a financial conflict of interest. 

The only sure benefit of doubling the market for statins is to the bottom line of the drug companies.(Ver)

(*) Marcia Angell is a senior lecturer in social medicine at Harvard Medical School. She is the former editor in chief of The New England Journal of Medicine.

Ver también:

USA: Estatinas..."razón de Estado"

Marcia Angell en PHARMACOSERÍAS

MARCIA ANGELL: La verdad acerca de la industria farmacéutica. Como nos engañan y que hacer al respecto

Mi amigo Germán Guerrero, nuestro "hombre en Bogota", me envia este libro que ya conocia en su edición en inglés y del que a veces hemos hecho referencia.

Algún día pasará a Raton de Biblioteca y le dedicaremos más espacio.

De momento diremos que:

Este trabajo pone al descubierto a las grandes empresas de la industria farmacéutica en Estados Unidos, que en las últimas dos décadas se han alejado de su propósito inicial de descubrir y producir fármacos nuevos y útiles, para convertirse en máquinas comerciales de venta de drogas de dudosos beneficios.


Marcia Angell muestra acertadamente que no es cierta la afirmación de las compañías según la cual los altos costos de las drogas son resultado de los programas de investigación y desarrollo de los nuevos medicamentos, sino que se deben principalmente a los costos de mercadeo de los mismos. Angell afirma que la industria farmacéutica norteamericana debe ser salvada, principalmente de sí misma, y propone una serie de reformas vitales. La verdad acerca de la industria farmacéutica es una fuerte denuncia de una industria que parece estar fuera de control.


Editado por Grupo Editorial Norma

Se puede descargar

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PLACEBO: Males que se curan con nada...(V)

Marcia Angell fue editora en jefe de The New England Journal of Medicine y ahora es miembro de Harvard Medical School’s Department of Social Medicine. Es una autoridad en los campos de política pública de salud, ética médica y sistema de seguridad social. La revista Time la consideró como una de las veinticinco personas mas influyentes de Estados Unidos. Marcia Angell es también autora de The Truth About the Drug Companies

No declaran...

Twenty-five out of 32 highly paid consultants to medical device companies in 2007, or their publishers, failed to reveal the financial connections in journal articles the following year, according to a study released on Monday.

The study compared major payments to consultants by orthopedic device companies with financial disclosures the consultants later made in medical journal articles, and found them lacking in public transparency.

“We found a massive, dramatic system failure,” said David J. Rothman, a professor and president of the Institute on Medicine as a Profession at Columbia University, who wrote the study with two other Columbia researchers, Susan Chimonas and Zachary Frosch.

The study, published on the Web site of The Archives of Internal Medicine, focused on 32 medical doctors and doctoral researchers who were each paid at least $1 million in 2007 and published one or more journal articles the next year.

Most of the doctors and most of the orthopedic journal articles did not disclose their financial relationships with companies, the study found.

.../...

Dr. Marcia Angell, a former editor of The New England Journal of Medicine, who was not involved with the study, called it “an ingenious study, with unsurprising results.”

She added,

“It is one more indication of the widespread corruption of the medical profession by industry money.”

“The journals’ lax enforcement of disclosure policies probably reflects the fact that journals, too, are dependent on industry support,” Dr. Angell said in an e-mail to a reporter after reviewing the study.

Mas...

Marcia Angell "contraataca"...

Hablamos de ella como autora de "La verdad acerca de la industria farmacéutica" (Como nos engaña y que hacer al respecto). Ahora ha vuelto a "hacerse sentir" con sus recomendaciones a las nuevas autoridades de la FDA.

Como directora que fué de The NEW ENGLAND JOURNAL of MEDICINE (NEJM) nadie mejor para opinar sobre la industria y "marcar" reglas de juego.

La recepción que estos consejos puedan tener por parte de Margaret Hamburg, nueva comisionada y Joshua M. Sharfstein, su mas cercano colaborador, no se presume dificil. A todos ellos les une su vinculación con Harvard Medical School.


Los consejos los resume y comenta, de manera excelente (es habitual en él), Vicente Baos en El Supositorio (Gracias)

1.- Rechazar la Prescription Act User Fee Act. Por esta norma, los laboratorios pagan una tasa por la evaluación de sus medicamentos. En el criterio de Marcia, ésto provoca que la industria se considera un cliente y favorece la aprobación. En España, también hay una tasa en la Agencia Española del Medicamento y Productos Sanitarios, para aumentar la financiación, siempre escasa. Parece razonable que una financiación independiente garantiza una mayor independencia, aquí y allí.

2.- Cualquier consultor de una compañía farmacéutica no podría formar parte de un Panel de Expertos de la FDA. El conflicto de intereses está presente. Parece que no solo vale con declararlo, sino que habría que cumplirlo a rajatabla.

3.-Hay fármacos que se aprueban bajo la condición de realizar estudios postcomercialización que aseguren su seguridad. Marcia denuncia que no siempre se realizan (más de 1000 estudios no se han realizado) y propone que sean obligatorios.

4.- El tiempo de evaluación de los medicamentos genéricos debe ser el mismo que el de los medicamentos con marca.

5.- La FDA debe tener autoridad para imponer a la industria farmacéutica estudios comparativos de los nuevos medicamentos con los preexistentes en el tratamiento de la enfermedad estudiada. Los medicamentos homólogos "me too" son aprobados en comparación al placebo y no es un requisito de aprobación (en la EMEA es igual) la comparación entre los previos. Algo que se ha denunciado repetidamente. Recientemente, han aparecido diversos metaanálisis comparando antidepresivos, en los que los matices son difíciles de aprobar. No es a través del metaanálisis donde debemos establecer diferencias sino en el ensayo "head to head".

6.- No se deben aprobar fármacos homólogos "me too" en base a objetivos subrogados. Un objetivo subrogado es una medida que está relacionada con el evento final (colesterol e infarto de miocardio) pero no siempre tienen el valor predictivo esperado y posteriormente su eficacia clínica final no se ve demostrada (homocisteína y eventos cardiovasculares, por ej.) el objetivo subrogado puede tener interés en una enfermedad grave donde no hay ningún tratamiento o donde por razones éticas o de otro tipo no se puede esperar, pero en un homólogo no parece apropiado. Si el fármaco pretende desbancar a uno previo debe demostrar algo más de que sea igual que el anterior.

7.- La FDA debe prohibir la publicidad directa al consumidor en los 3 años previos a la comercialización de un nuevo medicamento. Aquí nos libramos de esa lacra, aunque como vemos, muchos se la saltan elegantemente (Viagra, Gardasil...)

Ver...

Nota: Para aquellos interesados en la lectura del libro de Marcia Angell (imprescindible), si es posible, haganlo en su versión en inglés. La traducción al castellano que publica Norma (que acá aparece) es casi de "juzgado de guardia". En mi vida he visto algo tan improvisado...Al menos, antes de imprimir, deberián habér consultado con algún profesional de la industria para su corrección.

Raton de biblioteca:LOS CRIMENES DE LAS GRANDES COMPAÑIAS FARMACEUTICAS

Teresa Forcades es religiosa benedictina y médico.
El pasado 26 de noviembre presentó en Caracas, CELARG (Centro de Estudios Latinoamericanos Rómulo Gallegos)* su libro/cuaderno.




LOS CRIMENES DE LAS GRANDES COMPAÑIAS FARMACEUTICAS

Editado en 2006 en Barcelona (España) por CRISTIANISME Y JUSTICIA

El acto fue organizado por el Ministerio del Poder Popular (?) para la Cultura.

Es un análisis simplista (así lo hice notar en la rueda de preguntas), un cocktail/refrito de “lugares comunes” que intertextualiza a M.Angell, R. Moynihan, P. Pignarre y M. Gozner y que toma la vía del tremendismo:



“En el breve período que va de 2000 a 2003, casi la totalidad de las grandes compañías farmacéuticas pasaron por los tribunales de EEUU, acusadas de prácticas fraudulentas”.

Así arranca…

La autora, una altermundista más en turismo revolucionario, visitaba Venezuela invitada por el gobierno chavista como jurado de un premio de ensayo. Aprovechó el viaje para hacernos partícipes de su catarsis…


La “escenografía” en la sala reproducía el más puro fundamentalismo en el hábito (de vestir se entiende…).

Ella lucía de monja (en pleno siglo XXI). El compañero de mesa, que vestía la camisa “roja rojita” que identifica los más radicales de su partido, era el Dr. Eduardo Samán, farmacéutico y Presidente de un organismo de reciente creación, INDEPABIS, Instituto para la Defensa de las Personas en el Acceso a los Bienes y Servicios. (El que le puso nombre descansó…La “taxonómica” ha sido uno de los logros trascendentales de este gobierno…de la revolución).

Todo retrotraía a imágenes en películas de los 50´s con monjas en hábito cruzándose por calles con fascistas de Falange en camisa azul, o secuaces de Benito, Adolfo o Juan Domingo Perón en Argentina


La Madre Teresa, así la nombraban, fue bien aplaudida por un público de adictos seguidores del régimen que, entre otras “linduras”, agregó a los crímenes de la industria el de “bloqueo” a la medicina alternativa (Homeopatía, Flores de Bach, vitamina C…sic).

Mis comentarios y preguntas fueron acogidos con frialdad, silencio y creo que hasta desprecio.

En PHARMACOSERÍAS no homologamos como defensores de una industria, que conocemos bien (por dentro) pero…

Ni muy muy…ni tan tan…


El cuaderno se puede descargar en la web de la Fundación “Luis Espinal”

o solicitar copia impresa gratuita a

Cristianismo i Justicia
R. de Lluria 13
08010 Barcelona (España)


Notas:

-Por más que a lo largo del libro, reiteradamente haga referencia a la Dra. Agnell el nombre correcto de la ex editora en jefe de The New England Journal of Medicine (NEJM) es Marcia Angell.



(*) El lugar donde tuvo lugar la presentación, días después, apareció en prensa como escenario de las "tropelías" continuadas a la libertad de expresión. Algo asi como el "templo del pensamiento único"

-En esta ocasión omitimos la habitual biblioteca. No encontramos una adecuada...

"Lamentablemente casos de censura y veto se repiten hoy en una institución adscrita al Ministerio de Cultura: el Centro de Estudios Latinoamericanos Rómulo Gallegos"

(EL NACIONAL SABADO 13 DE DICIEMBRE 2008)

Por supuesto a ella no se la aplicaron, les decía todo lo que querian escuchar...

ARICEPT es? / no es?...

By Melissa Healy, Los Angeles Times March 22, 2012

Watching Alzheimer's disease steal away the memory, talents and very selves of its victims is hard enough for the people who love them. Now, a new pill formulated by a respected pharmaceutical company and approved by the Food and Drug Administration will do little to help most patients and will bring misery to some, say two medical investigators.

The drug, Aricept 23 mg, is no more effective on the whole than the disappointing ones already on the market — but is more likely to cause gastrointestinal problems, wrote Drs. Steven Woloshin and Lisa Schwartz of Dartmouth Medical College in an article published Thursday in the medical journal BMJ.

The new formulation was devised to serve commercial objectives, they say, and was approved despite a poor showing in company-sponsored tests.

Woloshin and Schwartz described Aricept 23's march to market in 2010 as "perplexing" and "depressing" and wrote that "there is no excuse for manipulating vulnerable patients, desperate family members and their doctors to use a product that is most likely to cause net harm."

Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of "The Truth About the Drug Companies," said the critique was important. "It illustrates very well how drug companies exaggerate the benefits of their drugs, minimize the side effects, and through misleading marketing to both doctors and the public convince them that a new version of a drug, with a new patent, is better than the old one, whose patent has expired," Angell told The Times.

sigue...

El lobby tras los medicamentos / Emilia Duclos*

Ilustración Mathias Sielfeld

A nivel internacional, las grandes compañías del sector invierten más del doble en marketing que en investigación. Desde muestras médicas hasta viajes con todo pagado: los promotores de la industria farmacéutica cuentan con una artillería de regalos para que los médicos escriban las marcas que ellos representan en las recetas médicas.

Osvaldo, un visitador médico que prefiere no dar a conocer su nombre verdadero, está desde la mañana recorriendo consultorios y clínicas en una comuna de la zona sur de Santiago. En 45 minutos ya ha visitado a tres doctores y le queda el último, un pediatra centroamericano. Osvaldo viste chaqueta y corbata, lleva los zapatos bien lustrados, la insignia de su laboratorio en la solapa y un maletín negro lleno de jarabes para la tos. Con una sonrisa, entra a un consultorio que atiende por Fonasa y saluda de beso a las secretarias. Pregunta por el médico y lo hacen pasar directo a su despacho. 

 —¿Y cómo le fue en el curso doctor? ¿Le gustó? 
 —Sí, estuvo bueno. 
 —Cuando me salga otro le aviso. Le vengo a dejar unas muestras—dice el visitador mientras saca de su maletín diez cajas de jarabe y le explica rápido para qué sirve cada uno. El médico los ordena en hileras junto a otros remedios de distintas marcas, en una mesa cerca de la ventana. 
 —¿Todavía le quedan las tarjetitas de nuestra campaña o quiere más? 
 —No, de esas me quedan. 

Osvaldo tiene 51 años y hace 20 que es visitador médico. Trabaja en uno de los laboratorios nacionales más importantes de Chile, cuyo nombre pide no mencionar. Su labor consiste en promocionar los medicamentos de la empresa a la que pertenece para que los doctores los receten a sus pacientes. “Esto es como vender cualquier cosa, pero con un poco de información científica”, dice. 

La industria farmacéutica chilena produce un 70% de los medicamentos que los médicos prescriben y está compuesta por más de 159 empresas, nacionales y multinacionales. Entre los años 2007 y 2008 las ventas totales de estas empresas alcanzaron los 1.060 millones de dólares. Los laboratorios líderes de este mercado son Recalcine, el grupo Andrómaco, Laboratorio Saval y el multinacional Laboratorio Chile. 

Según Osvaldo, un visitador médico gana, en promedio, 800 mil pesos mensuales. Su empresa tiene 200 visitadores en todo el país, lo que significa que gasta 160 millones de pesos mensuales solo en los sueldos de sus promotores. A nivel internacional, las grandes compañías de este sector invierten un treinta por ciento de su ingreso anual en marketing, más del doble de lo que invierten en investigación y desarrollo según el libro La verdad acerca de la industria farmacéutica de la investigadora estadounidense Marcia Angell, exeditora jefa del New England Journal of Medicine.

Ver:

MARCIA ANGELL: La verdad acerca de la industria farmacéutica. Como nos engañan y que hacer al respecto

Los visitadores ofrecen muestras médicas, folletos y objetos de mercadeo, como lápices o llaveros, pero también regalan entradas a congresos de más de 150 mil pesos, cursos de capacitación y viajes al extranjero. Las invitaciones a eventos o partidos de fútbol son otra herramienta de seducción. “A veces los médicos te dicen: ‘yo te saco un par de recetas’. Entonces ahí lo consideras y cuando el laboratorio da entradas, tú invitas al doctor paleteado, bajo el supuesto de que te va a devolver la mano. Nada acá es por buena onda o gratis”, cuenta Osvaldo. 

El trabajo de un visitador médico depende de la cantidad de recetas en las que logra insertar su marca. Antes del escándalo por colusión de las farmacias en 2009, las consultoras internacionales IMS Health y Close Up, que en la actualidad se limitan a hacer estudios de marketing y venta, entregaban información acerca del contenido de las prescripciones médicas, de modo que cada laboratorio sabía qué doctores lo recetaban y podía medir la efectividad de sus visitadores. 

Pero los promotores tienen sus propias técnicas para saber aproximadamente cuántas recetas generan. Antes se medía la cantidad de prescripciones por zona de visitador, pero como ya no se pueden obtener los datos precisos, preguntan en las farmacias que están cerca del despacho del médico visitado. Osvaldo en general consulta con las secretarias lo que recetó el doctor o se fija si el paciente sale con alguna muestra médica de su laboratorio en la mano.(Más)


  (*)Emilia Duclos es alumna de cuarto año de Periodismo/Facultad de Comunicaciones de la Pontificia Universidad Católica de Chile. y este reportaje es parte de su trabajo en el curso Taller de Prensa Escrita, dictado por la profesora Jimena Villegas.

A Rx ISK is born...con David Healy y much@s más.

The RxISK website calls it “the first free, independent website where patients, doctors, and pharmacists can research prescription drugs and easily report a drug side effect–identifying problems and possible solutions earlier than is currently happening.” The website has pages dedicated to suicide, sexual dysfunction and “violence and extreme acts.” 

 The website adds: “Drug side effects are now a leading cause of death, disability, and illness. Experts estimate that only 1–10% of ‘serious’ adverse events (those causing hospitalization, disability or death) are ever reported. Not to mention the millions of ‘medically mild’ adverse drug events that occur each year–ones that compromise a person’s concentration, functioning, judgment and ability to care.” 

 RxISK points out that “most data on prescription drugs is owned by the multinational pharmaceutical companies who run almost all clinical drug trials (60% of which are never reported). They simply are not sharing data that may affect their bottom lines. There is a gap in the data that only patients, doctors and pharmacists can fill.”



One of the founders of RxISK is David Healy, a professor of psychiatry and authority on the side effects of psychiatric drugs.

Web_o_teca: Dr. David Healy blog

Unfortunately, pharmaceutical firms are only part of the problem. As the science journalist Charles Seife has reported in Scientific American, government agencies such as the National Institutes of Health and the Food and Drug Administration–and researchers themselves–often enable drug companies’ unethical behavior. 

 In “How Drug Company Money Is Undermining Science,” Seife notes that “neither scientific institutions nor the scientists themselves have shown a willingness to police conflicts of interest in research” involving medications. See these hard-hitting articles by Seife and colleagues here, here and here. 

 The corruption of modern medicine by the pharmaceutical industry has also been examined in books such as Pharmageddon by Healy,

Ratón de biblioteca: PHARMAGEDDON / David Healy

 The Truth About the Drug Companies by Marcia Angell, 

MARCIA ANGELL: La verdad acerca de la industria farmacéutica. Como nos engañan y que hacer al respecto

Bad Pharma by Ben Goldacre, 

Ratón de biblioteca: "Bad Pharma" / Ben Goldacre

Anatomy of an Epidemic by Robert Whitaker (which I have written about) and Side Effects by Alison Bass

Ratón de biblioteca: SIDE EFFECTS

Más