El lobby farmacéutico en Brasil: un tema ausente en la agenda de investigación en salud pública

(Pharmaceutical lobbying in Brazil: a missing topic in the public health research agenda)

Francisco José Roma Paumgartten

Rev Saude Publica. 2016; 50: 70.

Published online 2016 Nov 24. doi:10.1590/S1518-8787.2016050006508

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5152825/

Traducido por Salud y Fármacos

En EE UU, donde los grupos de presión (lobbyists) tienen la obligación de registrarse, la industria farmacéutica y los proveedores de servicios de salud privados gastan grandes cantidades de dinero buscando como influir en las políticas de salud y en las decisiones del gobierno. En Brasil, donde el cabildeo carece de transparencia, prácticamente no hay datos sobre el gasto de la industria farmacéutica para persuadir a los legisladores y funcionarios del gobierno e influir en la toma de decisiones que favorezcan sus intereses comerciales. Sin embargo, desde 1990, la Associação da Indústria Farmacêutica de Pesquisa (Interfarma – Asociación de la Industria de Investigación Farmacéutica), contraparte brasileña de la Asociación de Investigación y Fabricantes Farmacéuticos de América (PhRMA), principal organización de cabildeo de la industria farmacéutica estadounidense, ha desempeñado un papel importante en la defensa de los intereses de las principales compañías farmacéuticas. Los objetivos principales de las actividades de cabildeo de Interfarma son: acortar el tiempo promedio que invierte la agencia reguladora brasileña (ANVISA) en autorizar la comercialización de un nuevo medicamento; lograr que los criterios para la incorporación de nuevos medicamentos al SUS (Sistema Único de Salud de Brasil) sean más flexibles y acelerar la incorporación de las nuevas tecnologías; cambiar el sistema de revisión ética del país y de los requisitos éticos para los ensayos clínicos para satisfacer las necesidades de la industria innovadora, y el establecimiento de una Política Nacional para Enfermedades Raras que permita la rápida incorporación de medicamentos huérfanos en el SUS. Aunque el cabildeo afecta la salud y el bienestar de la comunidad, este tema no está en la agenda de investigación de salud pública. El impacto del lobby farmacéutico en las políticas de salud y los costos de la atención médica son de gran importancia para el SUS y merecen ser investigados.

Safety Concerns Raised for 2 Novel Agents

Pharmacy Practice News, 22 de enero de 2017

http://www.pharmacypracticenews.com/Clinical/Article/01-18/Safety-Concerns-Raised-for-2-Novel-Agents/46646/ses=ogst?enl=true

The postmarketing safety record of two recently approved dru gs with novel mechanisms of action has raised concerns, leading investigators to examine how these agents got approved in the first place, according to a report by the Institute for Safe Medication Practices (ISMP).

ISMP issued safety alerts for pimavanserin (Nuplazid, ACADIA Pharmaceuticals) and the combination of sacubitril and valsartan (Entresto, Novartis) following reports of adverse event (AE) data “warranting careful consideration, and likely further action” (http://ismp.org/?QuarterWatch/?pdfs/?2017Q1.pdf).

 Pimavanserin and Hallucinations

The FDA approved pimavanserin in April 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Approximately 50% of patients with Parkinson’s will develop hallucinations and other forms of psychosis as the disease progresses, according to the ISMP report. This often is caused by the medications commonly used to treat Parkinson’s, namely, levodopa—typically given in combination with carbidopa—and dopamine agonists (e.g., pramipexole).

Although most antipsychotic drugs primarily block normal signaling of the neurotransmitter dopamine, “pimavanserin acts to block signaling with an important subfamily of serotonin receptors (5 HT_2A) that mediate memory, cognition, learning and numerous other body functions,” the report noted. Pimavanserin initially was indicated for a very specific side effect of Parkinson’s, but the drug now is “being tested for use in larger patient populations, including those with psychosis in Alzheimer’s, and as adjunct therapy in schizophrenia,” the ISMP report stated.

In the 12 months ending March 2017, 2,236 AEs were reported to the FDA Adverse Event Reporting System related to pimavanserin. The ISMP team looked at the most frequently reported AEs and divided them into four groups: hallucinations (21.8%), drug ineffective (14.9%), confusion (11.5%) and death (10.9%). Further analysis provided additional evidence that AE reports of hallucinations likely were showing that the drug was making psychosis worse or was ineffective in some patients. “The number of reports of hallucinations was large [n=487], with 73% observed by health professionals, who could be expected to understand that hallucinations occur in 20% to 70% of Parkinson’s patients,” ISMP noted.

A Scary Picture

The most frequently reported adverse events related to pimavanserin:

• Hallucinations (21.8%)
• Drug ineffective (14.9%)
• Confusion (11.5%)
• Death (10.9%)

Source: FDA Adverse Event Reporting System.

The AE data mirrored results of the clinical trial of pimavanserin. In that study, “both hallucinations and confusional state also occurred more frequently as an adverse event in treated patients compared with those getting a placebo,” according to ISMP. A closer look at the FDA approval process revealed that pimavanserin was approved based on limited scientific evidence, the group noted. “[The approval] relied on a single clinical trial indicating a minimal treatment effect, used a measurement scale for symptoms that had not been validated, and succeeded only after three previous trials had failed to demonstrate a benefit,” ISMP noted. “Further, the agency’s medical reviewer recommended against approval and was overruled.” According to ISMP, the reviewer “noted that although other psychiatric drugs were often approved on limited evidence of benefit, in the case of pimavanserin, [the] treatment more than doubled the risk of death and/or serious adverse events in its pivotal trial.”

ISMP found that the post-approval AE reports disclosed an additional safety issue: “We identified 318 cases where pimavanserin was combined with quetiapine (Seroquel [AstraZeneca]) or other antipsychotics that block dopamine signaling. These drugs are not recommended for use in the elderly and are not approved for use in Parkinson’s.”

ISMP noted that it shared its preliminary results with the manufacturer, ACADIA. The company responded by claiming that the large volume of AEs attributed to its drug were due in part “to the manufacturer’s extensive contact with health professionals and consumers through a specialty pharmacy network that distributed the drug, and because of a company patient support program,” the ISMP report stated. “[ACADIA] also said the reports of hallucinations might have occurred before the drug became fully effective approximately four weeks after treatment started.”

ISMP took issue with at least some of that reasoning. “While the company’s contacts with health professionals and consumers likely expanded the number of adverse event reports after product launch, these reports nevertheless reflect the experiences of health professionals and consumers in a real-life, post-market setting … [where] hundreds of health professionals are trying this new drug with their patients and reporting that either it is not providing the expected benefit or [is] making some psychosis worse.”

ISMP urged the FDA and ACADIA to “consider additional warnings and other measures to deal with inappropriate combination therapy with antipsychotic drugs” such as pimavanserin.

Sacubitril-Valsartan Signals

Sacubitril-valsartan was approved in July 2015. The agent targets a new pathway involved in the regulation of blood pressure and “appears to improve mortality and cardiovascular outcomes in heart failure patients with reduced ejection fraction,” according to the ISMP QuarterWatch report.

Like pimavanserin, the combination therapy was approved with evidence from a single trial, in this case a 27-month trial involving 8,442 patients. The trial was stopped early because of reduced cardiovascular mortality: from 16.5% among patients taking enalapril to 13.3% among those taking the combination agent. However, according to ISMP, “only patients with the best chance of benefiting from the drug were selected for the trial after a six-week run-in period to ensure tolerance to the drug and eliminate those experiencing early adverse drug effects.”

In that study, 24.4% of patients experienced a hypotension-related AE, which FDA reviewers noted was likely an underestimate, given that the trial was conducted only with patients already known to tolerate the drug without AEs serious enough to warrant discontinuation.

When reviewing the AE data, ISMP found that hypotension was the leading AE reported for sacubitril-valsartan during the 12 months ending in March 2017, with symptoms ranging from dizziness to blackouts. “We identified 1,684 [AEs] indicating a hypotension-related event, more than with any other cardiovascular drug in this period,” ISMP reported. Morbidity associated with the AEs, which occurred in older patients (median age, 70 years), was “not severe in two-thirds of the cases,” but 69 deaths were reported. “The patient population taking this drug is substantial, with prescription growth increasing an average of 38% per quarter,” the report noted.

“While Entresto had consistently positive results in its one large clinical trial, the adverse event data illustrate the importance of clinicians being alert to the risks of hypotension,” ISMP stated, recommending that the “FDA and the manufacturer review existing safety data to see what additional warnings and precautions, such as more gradual escalation of the dose to the recommended level, might help reduce the risk of this adverse effect.”

—Nikki Kean

La OMS sugiere vacunarse contra la fiebre amarilla para viajar a Brasil

Nación y Salud, 19 d enero de 2018

http://www.nacionysalud.com/node/9956

En lo que va de 2018, las autoridades brasileñas confirmaron 20 muertes por fiebre amarilla.

La Organización Mundial de la Salud (OMS) recomendó a quienes van a viajar a destinos turísticos de Brasil, incluido el populoso estado de San Pablo, vacunarse al menos con diez días de antelación contra la fiebre amarilla. En lo que va de 2018, las autoridades brasileñas confirmaron 20 muertes por esta enfermedad. “Brasil está viviendo un aumento de la actividad de la fiebre amarilla desde diciembre de 2016”, señaló el organismo internacional en un comunicado.

La fiebre amarilla se trata de una enfermedad viral transmitida por el mosquito aedes aegypti (conocido también por ser portador del virus del dengue) que puede ser mortal. Los síntomas características que puede causar son: coloración amarilla en la piel, fiebre, dolor de cabeza y vómitos, entre otros.

En lo que va de 2018, las autoridades brasileñas confirmaron once muertes por esta enfermedad en el estado de Minas Gerais, cuatro en el de San Pablo, tres en el de Río de Janeiro -donde ya hubo al menos 34 muertes desde enero de 2017-, una en el de Bahía y otra más en el distrito federal de Brasilia.

Debido a las largas colas en los centros médicos, el Ministerio de Salud brasileño anunció el envío de un millón de vacunas adicionales a ese estado, con la expectativa de que se puedan vacunar 7,3 millones de personas en 53 municipios.

Las autoridades brasileñas tienen pensado habilitar controles sanitarios en los pasos fronterizos con el propósito de comprobar la inmunización de las personas. Por ahora, los casos de infecciones se produjeron en localidades del interior, según consignó la agencia Noticias Argentinas.

Para prevenir la proliferación de la enfermedad, deben vacunarse todas las personas de uno a 60 años que vivan, transiten o viajen a lugares de alto riesgo, como la zona de Río de Janeiro, Minas Gerias, San Pablo, Bahía y Espírito Santo, en Brasil; las zonas selváticas de Bolivia y Paraguay, y Misiones o Corrientes, en la Argentina.

Por otro lado, no se pueden vacunar por los riesgos que conlleva a embarazadas; mujeres en lactancia materna; menores de 12 meses; mayores de 60 años y los inmunosuprimidos.

La Organización Mundial de la Salud recordó además que aquellas personas que se hayan inmunizado hace diez años, no necesitan colocarse la vacuna en esta oportunidad.
Fuente original: perfil.com18/1/2018

http://www.cbc.ca/news/health/diclectin-pregnancy-nausea-vomiting-persaud-duchesnay-confidential-industry-documents-health-canada-1.4491300

Morning sickness drug Diclectin doesn’t work, confidential industry documents reviewed by doctor show

Drug fell short of company's own threshold for effectiveness, analysis reveals

By Kelly Crowe, CBC News Posted: Jan 17, 2018 3:37 PM ET Last Updated: Jan 18, 2018 11:00 AM ET

Confidential industry data reveals a morning sickness pill taken by hundreds of thousands of Canadian women did not meet the company's own targets for efficacy.

The drug is called Diclectin, a combination of vitamin B6 and a common antihistamine, and is recommended as a treatment for women suffering from nausea and vomiting during pregnancy. Canadian doctors write 300,000 prescriptions for Diclectin every year.

Yet when Toronto family doctor Nav Persaud reanalyzed the original data from a 2009 manufacturer-funded clinical trial, he could find no evidence the pill was effective. In fact, Persaud discovered the pill fell short of drug company Duchesnay’s own pre-established threshold.

“I have completely stopped prescribing this medication. I don’t think it should be prescribed. I don’t think patients should take it.” Persaud said.

His research on Diclectin started with a patient’s question: Does this pill work? With prescription pad in hand, Persaud realized he didn’t know, even though he’d been taught to give Diclectin to pregnant women if they were experiencing nausea and vomiting.

“I had been routinely prescribing the medication without thinking about it.”

When he checked the scientific literature, he couldn’t find data on Diclectin’s efficacy. So he made what he assumed would be a routine request to Health Canada for the information the agency has about the drug.

“If I’m a doctor who prescribes this medication, obviously Health Canada is just going to show me all the information about the clinical effect,” Persaud said.

He was wrong. The information was considered confidential business information and Health Canada refused to release it. That was in 2011.

7-year fight for data

For the next seven years Persaud filed access to information requests to both the U.S. Food and Drug Administration (FDA) and Health Canada with little success. But after Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act) was passed in 2014, Health Canada agreed to show him the manufacturer’s 2009 trial data. But only after requiring him to sign a confidentiality agreement promising to destroy the documents.

As he sifted through the thousands of pages, he realized the company did not meet its own standard of proof. In the original study plan, it was decided the drug needed to show an improvement of three points on a symptom scale. But in the end, the difference between the drug and the placebo was less than one point — falling far short of the company’s target.

“So it’s clear the results of the study indicate the medication is not effective,” Persaud said.

• Health Canada requires doctor to sign confidentiality agreement to see data
• Researcher issues ‘call to action’ to force release of drug safety data
• Doctor raises doubts over study into morning-sickness drug

Persaud is not the first to notice the weak evidence behind Diclectin.

The FDA approved the drug in 2013 but an internal review document notes “the treatment effect was small.” A Health Canada scientific advisory panel conducted a review of Diclectin in 2016  and noted the results of the study were “not definitive” and the clinical benefit of the drug was “unclear.” Still the committee did not recommend any changes to the drug’s label.

In an email sent today, Health Canada told CBC News: “The available evidence continues to support Diclectin in the treatment of nausea and vomiting during pregnancy.”

Duchesnay told CBC in a statement: “Both the safety and efficacy of doxylamine-pyridoxine have been proven in multiple cohort studies, meta-analyses, an ecological study and a neurological development study among others.”

Long history

Diclectin evolved from an old medication called Bendectin that was widely prescribed to pregnant women beginning in the 1950s. By 1979, there were two versions — the original U.S. pill and the Canadian version, Diclectin. The U.S. company, Merrell Dow Pharmaceuticals, stopped selling Bendectin in 1983 after a series of lawsuits claiming links with birth defects — a risk that was never proven. After many decades of use, Diclectin is considered to be safe.

Duchesnay says Diclectin has been used by 35 million women around the world.

Yet the company’s own data shows that no matter whether women took a placebo pill or the actual pill, they all felt better by the end of the two-week study. Persaud says both doctors and patients might assume the drug is the reason they got better, when in fact the condition improves on its own.

“If you’re a clinician and you prescribe it and women come back two weeks later and they feel better, what are you going to believe?”

Still, the Society of Obstetricians and Gynaecologists of Canada will continue to recommend the drug for morning sickness. And Health Canada has no plans to withdraw the licence.

Now what?

And Persaud expects little to change in the wake of his investigation.

“In an ideal world it would be removed because it’s proven ineffective. The reality is there’s lots of momentum to keep prescribing it.”

But should patients be prescribed a drug if there’s no evidence it works?  All drugs have some side-effects. With Diclectin, some women will feel drowsy from the antihistamine. And there’s also the cost — about $90 per month.

Steve Morgan, who studies pharmaceutical policy at the University of British Columbia, said one of the reasons for regulating drugs is to protect consumers from products that don’t work.

“Prescription drugs … are compounds that have the potential for both positive and negative impacts. If there is no proven benefit of a treatment, then there is no justification for exposing patients to risk of harm,” he told CBC News in an email.

Meanwhile, Nav Persaud is getting ready to start deleting files, as he is ordered to do under the terms of the confidentiality agreement Health Canada required him to sign. But he thinks other doctors should be able to look at the data and make their own decisions. So even as he deletes the files, he’s applied to Health Canada one more time for permission to make the documents public.

As for the patient who asked the original question?

“She didn’t take the medication and obviously she was right and I was wrong,” Persaud said. “I told her after she left I looked into it and that encounter has changed my practice and my whole approach to getting information about treatments.

“If that patient hadn’t questioned it, probably I would still be prescribing the medication today.”

E-DRUG: Dutch Advisory committee recommends Government to take urgent steps to lower medicines prices
————————————————————————————————-
[The extremely high prices for new medicines (cancer, hepatitis-c) has now reached a point in which the official Dutch Council for Public Health and Society has recommended the new Dutch Government to use 3 strategies to improve its negotiation position with the pharmaceutical manufacturers.]

1. Import more affordable generic alternatives from abroad for a single patient:
this is allowed under Dutch/European Medicines laws, in which an unregistered medicine can be imported for a single patient on the prescription by a physician, and when both patient and doctor sign a letter they are aware the product is not registered. Obviously the product should be good quality, so it would be recommended to use the services of a reliable “buyers’ club” or order the product from a quality assured source (in the case of hepatitis, the Egyptian PHARCO company which has obtained ERP for its product and a WHO prequalification for its API. The 12 week cure for hepatitis-C costs only USD 120 compared to the Euro 46000 cost in the Netherlands). Irrespective of the Dutch Government decision, this option is already open for any single patient in the EU who is not insured or who cannot afford to pay Euro 46000 for a hepatitis-C cure.
The importation could be seen as a patent infringement by the patent holder, but it remains to be seen whether they will actively want to sue patients using this approach. If the government also applies action 3, there would be no infringement.

2. production of the same product by a pharmacist for a single patient:
this is exempted from medicines registration, and has been advocated by Prof Huub Schellekens at the WHO Collaborating Centre of Excellence for Affordable Biopharmaceuticals in Utrecht, who says he can make a biosimilar for a fraction of the cost. Alternatively the raw material can be ordered by the pharmacist and compounded using his professional skills. This option is also legally possible without a government decision, and has been used occasionally by hospital pharmacists importing the API from Indian suppliers for the use by a single patient for rare metabolic disorders (at a fraction of the European cost). The production could be seen as a patent infringement by the patent holder, but it remains to be seen whether they will actively want to sue pharmacists making life-saving medicines for a single patient. If the government also applies action 3, there would be no infringement.

3. compulsory or government use license (in the interest of public health):
this power is present in the Dutch and most other countries’ patent laws, and has been used recently by the Malaysian government to reduce the cost of hepatitis-c treatment. European countries have used this power occasionally. A subsequent hurdle in the EU will be that registration of the generic equivalent might face “Data exclusivity” or “Supplementary Protection Certificates”. However, the registration requirement can be bypassed by using option nr 1.

The Dutch Parliament discussed the medicines pricing problem on 2 October, and will have another session on this in 2nd half November. The Health Minister of the previous Dutch government (Mrs Schippers) already wrote in the Lancet 8 Nov 2016 that the current system is broken.

It will be interesting to see how the new Dutch Health Minister, Cabinet and Parliament will respond.
I predict that pharmaceutical companies will now be more willing to lower prices as otherwise they lose control over their product.

The above strategies are obviously even more relevant in EU countries like Romania, Latvia etc where the hepatitis-c prevalence is much higher than in the Netherlands and the GDP much lower.
Interesting times!

Below the press release of the official report. WB]

https://www.raadrvs.nl/en/item/development-of-new-medicines.-better-faster-cheaper

Development of new medicines. Better, faster, cheaper
Date: 09 november 2017. Development of new medicines. Better, faster, cheaper

The governmental authorities need a different approach to pharmaceuticals manufacturers. If they are not prepared to ask a socially acceptable price for their products in negotiations, the authorities will have to make use of the options that national and international regulations offer for making the medicine available for patients nonetheless. Examples of these last resort options are tackling the misuse of positions of power by the manufacturers, encouraging pharmacy preparation, allowing patients to order medicines themselves via the Internet on a doctor’s prescription, and granting compulsory licences.

Enforcing socially acceptable pricing will encourage the commercial sector to develop medicines better, faster and more cheaply. They will in particular be forced to reduce the high probability of failures in the development of new medicines. That is stated in the recommendations entitled “Development of new medicines – better, faster, cheaper” that the Council for Public Health and Society (Raad voor Volksgezondheid en Samenleving, RVS) handed over today to the Dutch Minister for Medical Care, Mr Bruins.

‘A situation has arisen in the Netherlands that is impacting negatively on both society and the individual patients,” says Pauline Meurs, chair of the RVS. “The high prices are partially the consequence of an inefficient development process. The costs of failures are set off against the price of the medication that does reach the market. Another factor is the market power of the pharmaceutical companies and the limited counterweight provided by government, hospitals and health insurers.” Throw the duty of care that is widely accepted in this country into the mix and it becomes all but impossible not to give a medicine a licence. We are aiming to use these recommendations to show that it can be done differently, in the current international context as well. The Netherlands can lead the way in this.’

Reducing the risk of failure
The high prices of medicinal products are to a significant extent the consequence of inefficient development processes. An average of nine out of ten potential new medicines drop out during the costly clinical trials. There are too few stimuli for both scientists and pharmaceuticals companies to make efforts to reduce the development costs, in particular the risk of failures. It is currently too easy for companies to set off the costs of these failures in the price of a medicine that does make it to the market. In addition, lower development costs do not necessarily lead to lower prices in the current situation. Two reasons why the governmental authorities must tackle excessively high prices. The quality of the clinical trials also leaves a lot to be desired. There is a task here for the authorities in encouraging reliable and efficient clinical research. The authorities must also provide further stimuli for new forms of medicine development in the country. In addition, direct input from patients in the development of medicines can yield better results and lower risks of failure. If we are able to work together in the Netherlands, we will be able to show that medicines can indeed be developed better, faster and more cheaply.

Tackling excessively high prices
In order to obtain lower prices, the negotiating power of the authorities has to be increased. If the price of a new medicine is too high and price negotiations fail, then the authorities must make use of the available legal instruments such as compulsory licences. The governmental authorities could also permit patients to order cheaper medicines on a doctor’s prescription, for instance abroad through the Internet and have them delivered at home. Pharmacy preparation must also be encouraged. In addition, the governmental authorities can tackle the manufacturers’ abuse of their position of power. This not only provides a stimulus for more efficient development of new medicines, but at the same time also keeps care affordable.

Download the full report (70 pages, ENG):
https://www.raadrvs.nl/en/item/development-of-new-medicines.-better-faster-cheaper

Keeping Olmesartan on the Market Would Risk Patients’ Lives for Corporate Profits

Nov. 15, 2017

Contact: Angela Bradbery, abradbery@citizen.org, (202) 588-7741
Don Owens, dowens@citizen.org, (202) 588-7767

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should ban the sale of a certain hypertension medication because it can cause life-threatening health risks, Public Citizen said today.

Keeping the medication on the market would continue to put hypertension patients’ lives at risk for the sake of corporate profits, the organization warned.

Public Citizen is petitioning the FDA to stop the sale of olmesartan medoxomil – an angiotensin II receptor blocker (ARB) found in the widely prescribed hypertension medications marketed under the brand names Azor, Benicar, Benicar HCT and Tribenzor, as well as in other generic versions – because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss.

The condition is called sprue-like enteropathy because of its similarity to sprue or celiac disease – a gastrointestinal illness triggered by gluten ingestion. However, unlike with celiac disease, sprue-like enteropathy does not improve with a gluten-free diet.

The petition noted that with millions of prescriptions for olmesartan-containing medications filled each year, immediately banning the drug is essential to prevent avoidable serious harm to thousands of patients.

In 2012, researchers at the Mayo Clinic published the first study documenting the link between olmesartan use and sprue-like enteropathy. By 2013, the FDA had concluded that olmesartan “can cause” sprue-like enteropathy and issued a safety warning about the medication. However, rather than pulling olmesartan from the market, the agency required only the addition of a weak warning about this risk to the product’s labeling.

Since 2012, numerous studies together have documented more than 150 cases of this disorder in patients worldwide who took this medication. The studies found that most of the patients experienced serious complications – including profound malnutrition and kidney injury – and required hospitalization.

In addition, many other medications exist that are equally effective for treating hypertension and do not pose these risks to patients. In short, the petitioners say, olmesartan “has unique serious risks but no unique benefit.”

“There is overwhelming evidence that olmesartan causes severe sprue-like enteropathy and that the risk of this life-threatening complication is far greater with olmesartan than with the other seven FDA-approved ARBs,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “There is no justification, other than corporate profits, to subject any patient to this danger when there are so many effective but much safer alternatives for treating hypertension.”

View this release on our press page.

© 2017 Public Citizen • 1600 20th Street NW / Washington, D.C. 20009 • unsubscribe

https://miradaprofesional.com/ampliarpagina.php?npag=2&id=3957

GINEBRA, agosto 25, 2016 : Un análisis realizado por la cadena española SER asegura que los laboratorios entregaron en 2015 más de 30 millones de dólares en fondos, más 60 millones en donaciones de medicamentos y vacunas. Esto, afirman, condiciona el trabajo de la entidad. “Han privatizado la OMS, la financiación privada condiciona sus decisiones”, dijo un ex miembro de la OMS.

Desde hace años la Organización Mundial de la Salud (OMS), en un esfuerzo por mejorar su transparencia, difunde cuál es su fuente de financiación. Esta información es accesible y pública, y esta semana se conoció un análisis de los datos aportados por la agencia de la ONU para la salud al respecto. Se allí se desprende que las farmacéuticas son grandes aportantes, lo que generó crítica de algunos especialistas. Glaxo, Novartis y Sanofi, las más “generosas al respecto”.

Desde su origen, los 194 estados que pertenecen a la OMS aportan una cuota fija – que se calcula en base al nivel de riqueza y su población-, el problema es que esa aportación obligatoria “se ha reducido desde hace varios años”, según admiten fuentes de la OMS. De hecho, esa vía representa ya “menos de una cuarta parte de la financiación total de la Organización Mundial de la Salud”. El resto de la financiación es voluntaria. En los últimos tres años, la Organización Mundial de la Salud ha recibido casi 6.000 millones de dólares a través de ‘contribuciones voluntarias’ – esa fuente de financiación representa más del 75 por ciento de todo el presupuesto de la OMS-.

Se trata de donaciones que han llegado, principalmente, a través de los diferentes países de todo el mundo. Pero no son los únicos donantes. Según los datos oficiales de la OMS, entre las donaciones voluntarias también se encuentran fundaciones filantrópicas y algunos de los gigantes de la industria farmacéutica.

En 2015, los laboratorios dieron, al menos, 30.966.248 de dólares a la OMS en concepto de “contribuciones voluntarias especificadas” (los donantes son quienes autorizan qué programas concretos pueden ser financiados con su dinero). El ranking de esas donaciones de las farmacéuticas lo encabeza Glaxo, dio 7.769.202 dólares, le siguen Novartis con 6.992.742 dólares y Sanofi, que aportó 6.158.152 dólares, pero no solo se cuelan las grandes multinacionales, también otras compañías más desconocidas como Labiofam, el laboratorio más importante de Cuba.

En este documento también se publican las contribuciones “en especie” que la OMS ha recibido a manos de la industria farmacéutica, principalmente, medicamentos. Durante 2015, la Organización Mundial de la Salud recibió de estas compañías material valorado en 60.701.307 dólares. Los laboratorios que más aportaron fueron, una vez más Glaxo con más de 22 millones y Merck con 15 millones.

Por encima de todos los donantes privados destaca uno, prácticamente nadie le supera, sus cifras son inalcanzables, es la fundación Bill & Melinda Gates, la organización del creador de Microsoft fue la entidad privada que más aportó a la OMS en 2015, desembolsó 185 millones de dólares. Para que nos hagamos una idea de la magnitud de esa contribución, esta fundación donó 95 veces más que España.

Estas aportaciones no están exentas de polémica. Hay voces que consideran que “la financiación privada condiciona las decisiones de la OMS”, según denuncia a la cadena española SER el ex director del Programa Mundial de Medicamentos de la Organización Mundial de la Salud, Germán Velásquez. En una entrevista, este doctor que trabajó más de 20 años en esta agencia de la ONU, lamenta que la Organización Mundial de la Salud “funciona en favor de intereses privados” porque “ha sufrido un proceso de privatización”.

Desde la Organización Mundial de la Salud niegan a la SER que esto sea así, “las prioridades y los objetivos de la salud de la OMS los fijan los Estados Miembros (a través del Consejo de Administración y la Asamblea Mundial), ellos son quienes tienen la última palabra sobre los programas de salud, y no los donantes privados”, desde la OMS también aseguran que la escasa financiación obligatoria de los países “ayudan a reducir la dependencia de un grupo exiguo de donantes”.

A partir del 15 de noviembre de 2016, la nueva directora de la Oficina de Regulación de Medicamentos y Otras Tecnologías del Departamento de Medicinas Esenciales y otros Productos de Salud del Grupo de Sistemas de Salud e Innovación (HIS/EMP) de la OMS será la Sra Emer Cooke. La Sra Cooke es irlandesa y su último puesto ha sido como directora de la Oficina de Asuntos Internacionales de la Agencia Europea de Medicamentos en Londres.

FDA, 12 de mayo de 2016
http://www.fda.gov/Drugs/DrugSafety/ucm501413.htm

La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) advierte que los efectos secundarios graves relacionados con los medicamentos antibacterianos a base de fluoroquinolonas por lo general superan los beneficios para los pacientes con sinusitis, bronquitis e infecciones del tracto urinario sin complicaciones para los que existen otras opciones de tratamiento. En el caso de los pacientes con estos padecimientos, las fluoroquinolonas deben reservarse para aquellos que no tienen opciones alternativas de tratamiento.
Una evaluación de seguridad de la FDA ha demostrado que las fluoroquinolonas, cuando se usan de manera sistémica (ya sea en forma de comprimidos, cápsulas o inyecciones), están relacionadas con graves efectos secundarios discapacitantes y potencialmente permanentes que pueden presentarse juntos. Estos efectos secundarios pueden involucrar los tendones, los músculos, las articulaciones, los nervios y el sistema nervioso central.
Como resultado, estamos exigiendo la actualización de la etiqueta de información farmacológica y la guía para el paciente de todos los medicamentos antibacterianos a base de fluoroquinolonas para que reflejen esta nueva información de seguridad. Continuamos investigando los problemas de seguridad que involucran a las fluoroquinolonas y mantendremos al público al tanto de cualquier información adicional conforme vaya estando disponible.
Los pacientes deben comunicarse con su profesional de la salud de inmediato si experimentan efectos secundarios graves mientras toman el medicamento a base de fluoroquinolonas. Algunos indicios y síntomas de efectos secundarios graves son dolor de tendones, articulaciones y músculos; una sensación punzante o de “hormigueo”; confusión; y alucinaciones. Los pacientes deben hablar con su profesional de la salud si tienen alguna pregunta o inquietud.
Los profesionales de la salud deben suspender el tratamiento sistémico con fluoroquinolonas de inmediato si un paciente presenta efectos secundarios graves, y cambiar a un medicamento antibacteriano sin fluoroquinolonas para completar su curso de tratamiento.
Los fármacos a base de fluoroquinolonas funcionan eliminando o impidiendo el crecimiento de bacterias que pueden causar enfermedades (vea la Lista de fluoroquinolonas aprobadas por la FDA y actualmente disponibles para su uso sistémico).
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Anteriormente dimos a conocer información de seguridad relacionada con medicamentos antibacterianos a base de fluoroquinolonas de uso sistémico en agosto de 2013 y julio de 2008. Los problemas de seguridad descritos en este Comunicado sobre la seguridad de los medicamentos también se abordaron en una reunión de la Comisión Consultiva de la FDA de noviembre de 2015.