Farmacéuticas extranjeras hacen experimentos con más de 23 mil peruanos

El INS investigó casos por violaciones a las buenas prácticas clínicas que ocasionaron daños serios y muertes de participantes

Nueve farmacéuticas extranjeras reclutan voluntarios para probar la seguridad y eficacia de sus nuevos productos antes de presentarlos al mercado. Según los registros de autorizaciones del Instituto Nacional de Salud (INS), 23.207 personas están enroladas actualmente en 300 experimentos que realizan laboratorios internacionales en 137 hospitales, clínicas, consultorios y hasta organizaciones no gubernamentales del Perú. Se trata de una actividad que continúa creciendo en nuestro país.

Este millonario y poco transparente negocio rebasa la capacidad del Estado. Comenzó el 2007 luego de que el entonces ministro de Salud, Carlos Vallejos, flexibilizara los trámites y condiciones para la experimentación médica con personas a través de 35 modificaciones al Reglamento Nacional de Ensayos Clínicos, que había sido aprobado en julio del 2006.

Justamente, Vallejos fue propulsor del cambio que dio lugar a un ‘boom’ de permisos y hoy figura entre los 15 médicos que concentran de 10 a más contratos con laboratorios y entidades privadas para ejecutar experimentos médicos con personas en el país, de acuerdo con los reportes del INS a los que accedió El Comercio, a través de una solicitud de información pública.

La información financiera y los pagos por esta actividad se considera confidencial. Pero profesionales que laboran en el campo –y que prefirieron mantener su nombre en reserva- revelaron que por cada persona enrolada para las prácticas, los médicos reciben de 500 a 13 mil dólares, y que los montos aumentan dependiendo de los riesgos del producto en investigación y la complejidad de los procedimientos.

VIOLACIONES A LAS BUENAS PRÁCTICAS

Desde que existe un reglamento para la experimentación con personas en el país, el INS investigó 19 casos por violaciones a las buenas prácticas clínicas que ocasionaron daños serios y muertes de participantes en experimentos. Sin embargo, la norma no contempla una escala de sanciones a los financistas y médicos que violan las buenas prácticas clínicas durante investigaciones y ocasionan daños serios o la muerte de personas.

Un caso es el del cardiólogo Álex Gallegos Cazorla. El INS determinará si ratifica o levanta la sanción en su contra por reclutar a un paciente para el experimento de una farmacéutica, en el hospital Daniel Alcides Carrión del Callao, y abandonarlo cuando su salud sufrió daños irreversibles que lo condujeron a la muerte en el 2011.

Ramón Ríos Astudillo (56) ingresó el 9 de setiembre del 2009 a un estudio para probar la eficacia del anticoagulante Apixiban, del laboratorio Brystol Myers Squibb Perú S.A.C., dirigido a personas con el diagnóstico de síndrome coronario agudo (arterias obstruidas por la coagulación de la sangre). “El doctor Gallegos le dijo a mi esposo que sería una buena alternativa para su enfermedad, pero Ramón sufrió demasiadas complicaciones. Le tuvieron que amputar la pierna izquierda en el 2010 y el médico se desentendió del todo”, narró a El Comercio, Victoria Izarnótegui viuda de Ríos, quien desde hace dos años reclama justicia.

Fuente

Overweight children have higher risk of asthma

Children who are overweight or obese are more likely to develop asthma compared with children of a healthy weight, according to a study published in the American Journal of Epidemiology.

Researchers from Kaiser Permanente in California examined electronic health records of 623,358 children between the ages of 6 and 19.

 The children were divided into four groups based on their measured height and weight.:

- Normal weight
- Overweight
- Moderately obese
- Extremely obese

All children were monitored over the course of 1 year in order to analyze the prevalence of asthma.

The results of the study revealed that children who were overweight were 1.16 times more likely to develop asthma compared with children who were of a normal weight.

Moderately obese children were 1.23 times more likely to develop the condition, while extremely obese children were 1.37 times more at risk.

Of the children who developed asthma, it was found that moderately obese and extremely obese children were more likely to develop regular and aggressive forms of asthma compared with children of normal weight, resulting in hospital visits and treatment with oral corticosteroids - medication used to reduce inflammation and swelling in the airways.

Asthma risk dependent on age, race and sex

The research also revealed that the effects of body weight and asthma varied depending on race/ethnicity, age and sex.

Moderately obese girls between the ages of 6 and 10 had a 1.36 times higher risk of asthma than girls of normal weight the same age, while extremely obese girls had a 1.56 times higher risk.

Moderately obese Asian-Pacific Islander children had a 1.41 times higher risk of developing the condition, while extremely obese children of this race were at 1.67 times higher risk.

'Close monitoring' needed for asthmatic obese children

Mary Helen Black, lead study author, says:

"As a result of this research, we know that children who are overweight or obese - particularly young girls and Asian-Pacific Islander children - are more likely to develop asthma. With this knowledge, we can work to develop programs to prevent asthma in high-risk groups. Physicians might also monitor obese children with asthma more closely, since these children tend to have a more severe type of asthma."

According to the Centers for Disease Control and Prevention (CDC), there are currently 7.1 million children in the US suffering from asthma.

It is the most common chronic condition amongst children, and accounts for more than 13 million total missed days at school each year.

The researchers say that although other studies have acknowledged a link between childhood obesity and asthma, there have not been many large-scale studies in the US confirming this.

Therefore, the researchers at Kaiser Permanente plan to continue their ongoing work to better understand how body weight and body mass index in childhood can increase asthma risk.

Source

Tamoxifen for prevention in high-risk breast cancer

The global study was led by University of Melbourne and the Peter MacCallum Cancer Centre and published in the Journal of Clinical Oncology.

The study involved about 2,500 women from Europe, North America and Australia who have inherited mutations in BRCA1 or BRCA2, the breast cancer susceptibility genes, and who had been diagnosed with breast cancer. About one-third of these women were placed on tamoxifen.

Tamoxifen has been used for decades to treat breast cancer and has recently been shown to prevent breast cancers in many women.

Until now, there has been limited information about whether it reduces breast cancer risk for women who are at the very highest level of risk with BRCA1 or BRCA2.

Lead author, Professor Kelly-Anne Phillips says this study, the largest to date, suggests that it could work for these high-risk women by halving their breast cancer risk.

"In the past, the only way of reducing breast cancer risk for these high-risk women was to do invasive surgery to remove their breasts and/or ovaries. For women who choose not to undergo such surgery, or who would prefer to delay surgery until they are older, tamoxifen could now be a viable alternative."

Such was the case for US actress Angelina Jolie who was found to carry a mutation in one of these genes.

Previous research led by Professor Phillips revealed that only 1 in 5 Australian women with a mutation in BRCA1 or BRCA2 choose to undergo bilateral mastectomy to prevent cancer.

Professor John Hopper, co-author from the School of Population and Global Health at the University of Melbourne, says "In light of our findings, it is clear that women who have a mutation in BRCA1 or BRCA2 should review their management plan with their specialist and re-discuss the options available to them to lower that risk."

This important finding has come from more than 20 years of research involving breast cancer families recruited from cancer registries and clinics across the country.

"Without the generous contributions of those families we would not be able to make such discoveries which help future generations fight breast cancer," he says.

However, we should be aware of how the study was carried out. According to William Hait, director of the Cancer Institute of New Jersey, who pointed out that Tamoxifen is effective in ER(+) cancers about 50% of the time. Around 70% of breast cancer is ER(+), and that means that if you treat all patients with breast cancer with Tamoxifen, you will see responses only 35% of the time, whereas if you treat only ER(+) cancers you will see responses 50% of the time. Therefore, more details must be needed.  

Source

Overthinking can be detrimental to human performance

Trying to explain riding a bike is difficult because it is an implicit memory. The body knows what to do, but thinking about the process can often interfere. So why is it that under certain circumstances paying full attention and trying hard can actually impede performance? A new UC Santa Barbara study, published in the Journal of Neuroscience, reveals part of the answer.

There are two kinds of memory: implicit, a form of long-term memory not requiring conscious thought and expressed by means other than words; and explicit, another kind of long-term memory formed consciously that can be described in words. Scientists consider these distinct areas of function both behaviorally and in the brain.

Long-term memory is supported by various regions in the prefrontal cortex, the newest part of the brain in terms of evolution and the part of the brain responsible for planning, executive function, and working memory. "A lot of people think the reason we're human is because we have the most advanced prefrontal cortex," said the study's lead author, Taraz Lee, a postdoctoral scholar working in UCSB's Action Lab.

Two previous brain studies have shown that taxing explicit memory resources improved recognition memory without awareness. The results suggest that implicit perceptual memory can aid performance on recognition tests. So Lee and his colleagues decided to test whether the effects of the attentional control processes associated with explicit memory could directly interfere with implicit memory.

Lee's study used continuous theta-burst transcranial magnetic stimulation (TMS) to temporarily disrupt the function of two different parts of the prefrontal cortex, the dorsolateral and ventrolateral. The dorsal and ventral regions are close to each other but have slightly different functions. Disrupting function in two distinct areas provided a direct causal test of whether explicit memory processing exerts control over sensory resources - in this case, visual information processing - and in doing so indirectly harms implicit memory processes.

Participants were shown a series of kaleidoscopic images for about a minute, then had a one-minute break before being given memory tests containing two different kaleidoscopic images. They were then asked to distinguish images they had seen previously from the new ones. "After they gave us that answer, we asked whether they remembered a lot of rich details, whether they had a vague impression, or whether they were blindly guessing," explains Lee. "And the participants only did better when they said they were guessing."

The results of disrupting the function of the dorsolateral prefrontal cortex shed light on why paying attention can be a distraction and affect performance outcomes. "If we ramped down activity in the dorsolateral prefrontal cortex, people remembered the images better," said Lee.

When the researchers disrupted the ventral area of the prefrontal cortex, participants' memory was just slightly worse. "They would shift from saying that they could remember a lot of rich details about the image to being vaguely familiar with the images," Lee said. "It didn't actually make them better at the task."

Lee's fascination with the effect of attentional processes on memory stems from his extensive sports background. As he pointed out, there are always examples of professional golfers who have the lead on the 18th hole, but when it comes down to one easy shot, they fall apart. "That should be the time when it all comes out the best, but you just can't think about that sort of thing," he said. "It just doesn't help you."

His continuing studies at UCSB's Action Lab will focus on dissecting the process of choking under pressure. Lee's work will use brain scans to examine why people who are highly incentivized to do well often succumb to pressure and how the prefrontal cortex and these attentional processes interfere with performance.

"I think most researchers who look at prefrontal cortex function are trying to figure out what it does to help you and how that explains how the brain works and how we act," said Lee. "I look at it at the opposite. If we can figure out the ways in which activity in this part of the brain hurts you, then this also informs how your brain works and can give us some clues to what's actually going on."

Source

Lung cancer risk cut by eating raw garlic

Eating raw garlic twice a week could potentially halve the risk of developing lung cancer, according to a study published in the journal Cancer Prevention Research.

Researchers from the Jiangsu Provincial Center for Disease Control and Prevention in China carried out a population-based case control study between 2003 and 2010, to analyze the link between raw garlic consumption and lung cancer.

The researchers collected data from 1,424 lung cancer patients, alongside 4,543 healthy controls.

Data was compiled through face-to-face interviews with the participants, who were asked to answer a standard questionnaire disclosing information on diet and lifestyle habits, including how often they ate garlic and whether they smoked.

Results of the study showed that participants who consumed raw garlic on a regular basis as a part of their diet (two or more times a week), had a 44% decreased risk of developing lung cancer.

The study authors say:

"Protective association between intake of raw garlic and lung cancer has been observed with a dose-response pattern, suggesting that garlic may potentially serve as a chemo-preventive agent for lung cancer."

Lung cancer is the second most common type of cancer in both men and women. According to the Centers for Disease Control and Prevention (CDC), 205,974 Americans were diagnosed with lung cancer in 2009.

Long-term smoking is the most common cause of lung cancer, found to account for 9 out of every 10 cases of the disease.

Interestingly, when looking specifically at participants who smoked, researchers found that eating raw garlic still decreased their risk of lung cancer by around 30%.

The researchers say that the link between garlic and lung cancer prevention warrant further in-depth investigation.

Previous research has also shown that consumption of garlic may have preventive properties against certain forms of cancer.

A study from the New York Presbyterian Hospital and Weill Cornell Medical Center suggested that a compound found in garlic, selenium, may possess an anti-cancer property

Other research from the Medical University of South Carolina, found that organosulfur compounds found in garlic may play a part in killing brain cancer cells.

The widely used herb has also been cited as preventing and treating other ailments, such as high blood pressure, high cholesterol and diabetes.

Source

Dr. Joan Corbella, respecto a la sobremedicalización

Destacados:

"Actualmente, hay más enfermos sobremedicalizados que antes"

"Es importante ver a los enfermos con cierta frecuencia"

"Hay que atreverse a dar la mínima dosis necesaria"

"Los estados de ánimo colectivos afectan inevitablemente a la población en general"

"El enfermo agradece que se le trate bien y con normalidad. 

Inspirar pena no gusta a nadie"

Back from holidays!

Hello everybody!

As of tomorrow I will keep on posting unbelievable and astonished pharma news...

Hope you still are enjoying your vacation.