Study Links Vitamin D Deficiency To Accelerated Aging Of Bones

Everyone knows that as we grow older our bones become more fragile. Now a team of U.S. and German scientists led by researchers with the U.S. Department of Energy (DOE)'s Lawrence Berkeley National Laboratory (Berkeley Lab) and the University of California (UC) Berkeley has shown that this bone-aging process can be significantly accelerated through deficiency of vitamin D - the sunshine vitamin.

Vitamin D deficiency is a widespread medical condition that has been linked to the health and fracture risk of human bone on the basis of low calcium intake and reduced bone density. However, working at Berkeley Lab's Advanced Light ALS), a DOE national user facility, the international team demonstrated that vitamin D deficiency also reduces bone quality.

"The assumption has been that the main problem with vitamin D deficiency is reduced mineralization for the creation of new bone mass, but we've shown that low levels of vitamin D also induces premature aging of existing bone," says Robert Ritchie, who led the U.S. portion of this collaboration. Ritchie holds joint appointments with Berkeley Lab's Materials Sciences Division and the University of California (UC) Berkeley's Materials Science and Engineering Department.

"Unraveling the complexity of human bone structure may provide some insight into more effective ways to prevent or treat fractures in patients with vitamin D deficiency," says Björn Busse, of the Department of Osteology and Biomechanics at the University Medical Center in Hamburg, Germany, who led the German portion of the team.

Ritchie and Busse have reported their findings in the journal Science Translational Medicine. The paper is titled "Vitamin D Deficiency Induces Early Signs of Aging in Human Bone, Increasing the Risk of Fracture." Co-authors also include Hrishikesh Bale, Elizabeth Zimmermann, Brian Panganiban, Holly Barth, Alessandra Carriero, Eik Vettorazzi, Josef Zustin, Michael Hahn, Joel Ager, Klaus Püschel and Michael Amling.

Vitamin-D is essential for the body to absorb calcium. The body normally synthesizes vitamin D in the skin following exposure to sunlight - hence the "sunshine" moniker. However, when vitamin D serum concentrations become deficient, the body will remove calcium from bone to maintain normal calcium blood levels. This removal of calcium from existing bone hampers the mineralization process required for the formation of new bone mass. In children, vitamin D deficiency can lead to rickets. In adults, vitamin D deficiency causes osteomalacia, a softening of the bones associated with defective mineralization that results in bone pain, muscle weakness, and increased risk of bone deformation and fracture. While treatments with vitamin D and calcium supplements are effective, success has been achieved with only modest increases in bone mineral density, suggesting other factors also play a role in reducing fracture risks.

"We hypothesized that restoring the normal level of vitamin D not only corrects the imbalance of mineralized and non-mineralized bone quantities, but also initiates simultaneous multiscale alterations in bone structure that affects both the intrinsic and extrinsic fracture mechanisms," Ritchie says.

To test this hypothesis, Busse and his German team collected samples of iliac crest bone cores from 30 participants, half of whom were deficient in vitamin D and showed early signs of osteomalacia. For this study, a normal vitamin D level was defined as a serum concentration of 20 micrograms per liter or higher. For the vitamin D deficiency group the mean serum concentration was 10 micrograms per liter.

The bone samples were sent to Ritchie and his team for analysis at the ALS using Fourier Transform Infrared (FTIR) spectroscopy and X-ray computed microtomography. The FTIR spectroscopy capabilities of ALS beamlines 1.4.3 and 5.4.1 provide molecular-level chemical information, and ALS Beamline 8.3.2 provides non-destructive 3D imaging at a resolution of approximately one micron.

"We were interested in spatially resolved data that would help us to follow the formation of cracks under mechanical loading," Ritchie says. "The ALS beamlines enabled us to measure the structure/composition and mechanical properties of the bone samples at different size-scales, ranging from nanometers to micrometers. We measured the resistance to crack growth and by following crack growth in real-time were able to observe how cracks and structure interact. This enabled us to relate mechanical properties to specific structural changes."

Ritchie and his team found that while vitamin D-deficient subjects had less overall mineralization due to a reduction of mineralized bone, underneath the new non-mineralized surfaces, the existing bone was actually more heavily mineralized, and displayed the structural characteristics - mature collagen molecules and mineral crystals - of older and more brittle bone.

"These islands of mineralized bone were surrounded by a collagenous boundary that prevented them from being properly remodeled," Busse says. "Cut off from a supply of osteoclasts, the cells that normally remodel the bone, these isolated sections of mineralized bone begin to age, even as overall bone mineralization decreases from a lack of calcium."

Says Ritchie, "In situ fracture mechanics measurements and CT-scanning of the crack path indicated that vitamin D deficiency increases both the initiation and propagation of cracks by 22- to 31-percent."

From their study, Busse, Ritchie and their co-authors say that vitamin-D levels should be checked and kept on well-balanced levels to maintain the structural integrity of bones and avoid mineralization defects and aging issues that can lead to a risk of fractures.

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BMI - Is The Body Mass Index Formula Flawed?

BMI (Body Mass Index) has been used for over 100 years in population studies, by doctors, personal trainers, and other health care professionals, when deciding whether their patients are overweight. However, BMI has one important flaw - it does not measure your overall fat or lean tissue (muscle) content.

Body Mass Index, derived from a simple math formula, was devised in the 1830s by Lambert Adolphe Jacques Quetelet (1796-1874), a Belgian astronomer, mathematician, statistician and sociologist. BMI is said to estimate how fat you are by dividing your weight in kilograms by your height in meters squared. However, as mentioned earlier, the measurement is flawed, especially if the person carries a lot of muscle.

Nick Trefethen, Professor of Numerical Analysis at Oxford University's Mathematical Institute, wrote in a letter to The Economist that the BMI formula is flawed and is only a rough guide to helping people judge whether they have a healthy weight.

Trefethen said:

"If all three dimensions of a human being scaled equally as they grew, then a formula of the form weight/height3 would be appropriate. They don't! However, weight/height2 is not realistic either. A better approximation to a complex reality, which is the reform I wish could be adopted, would be weight/height2.5. Certainly if you plot typical weights of people against their heights, the result comes out closer to height2.5 than height2."

The current BMI formula leads to confusion and misinformation, Trefethen believes. The height2 term divides the weight by too much when people are short, and by too little when they are tall. The result is short people being told they are thinner than they really are, while tall people are made to think that they are fatter than they are.

When Quetelet devised the BMI formula, there were no computers, calculators or electronic devices, so he opted for a very simple system. Trefethen does wonder, though, why institutions today on both sides of the Atlantic continue using the same flawed formula.

Perhaps "nobody wants to rock the boat", Trefethen suggested. Various agencies and institutions have agreed on something, which is comforting.

There are probably other flawed formulae out there. There seems to be an exaggerated respect for measures which depend on mathematics. However, the BMI one probably beats them all, especially as the world population of obese people exceeds one billion.

Trefethen Offers an Alternative Formula to the Current BMI one

Trefethen said "Suppose we changed that exponent from 2.0 to 2.5 and adjusted the constant so that an average-height person did not change in BMI. Suddenly millions of people of height around 5' (five feet tall) would gain a point in their readings, and millions of people of height around 6' (six feet tall) would lose a point."

He proposes a new formula where:

BMI = 1.3*weight(kg)/height(cm)2.5 = 5734*weight(lb)/height(in)2.5.

"In our overweight world, such changes would distress some short people and please some tall people, but the number they'd be using would be closer to the truth and good information must surely be good for health in the long run," Trefethen said.

Quetelet would probably have viewed using the 2.5 exponent favorably, said Alain Goriely, a professor of Mathematical Modelling at Oxford University's Mathematical Institute. Apparently, Quetelet wrote in a Treatise on man and the Development of his Faculties in 1842:

"If man increased equally in all dimensions, his weight at different ages would be as the cube of his height. Now, this is not what we really observe. The increase of weight is slower, except during the first year after birth; then the proportion we have just pointed out is pretty regularly observed.

 But after this period, and until near the age of puberty, weight increases nearly as the square of the height. The development of weight again becomes very rapid at puberty, and almost stops after the twenty-fifth year. In general, we do not err much when we assume that during development the squares of the weight at different ages are as the fifth powers of the height; which naturally leads to this conclusion, in supporting the specific gravity constant, that the transverse growth of man is less than the vertical."

Goriely commented: "So according to Quetelet the scaling is 3 for babies (babies are spheres), 2 for kids (kids grow more like celery sticks, as we know), then 5/2=2.5 for grownups (beefing up so to speak). It seems Quetelet never cared about obesity (not a big issue in the 1840's)."

Many say that waist-to-height ratio is a better measurement than BMI. They say you should keep your waist circumference to less than half your height.

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Morir en las clínicas

Es sábado 6 de julio, en la mañana. Carlos Rodríguez, de 52 años, Comandante de la Brigada Motorizada de los Bomberos del Distrito Capital, sufre un grave accidente en una motocicleta, en una vía rápida del centro de Caracas. Sus compañeros lo trasladan rápidamente a la Clínica La Arboleda, centro de salud privado, situado en San Bernardino.

Pese a la gravedad de su estado de salud, producto de varias lesiones, la clínica se niega rotundamente a darle atención médica. Cuando se trata de plata, la gerencia privada siempre es clara y enfática: “el seguro de los Bomberos está suspendido”. Díganle que pague.

Tras hora y media de espera, Rodríguez es entonces trasladado al Hospital Miguel Pérez Carreño, y, luego de otra larga espera e innumerables excusas burocráticas, es atendido a finales de la tarde. Demasiado tarde. Desangrado y débil, a Carlos Rodríguez, bombero ejemplar, le sobreviene un paro respiratorio que le arranca la vida poco después. Más tarde se sabrá que el Gobierno del Distrito Capital está completamente al día con los pagos de la póliza que “asegura la vida” de los bomberos y otros servidores públicos.

Carlos Rodríguez encarna la tragedia de un hombre que, dedicado toda su vida a salvar vidas, no encontró en el sistema médico privado ni en el público, el apoyo, la solidaridad, la compasión o la ética que le ayudara a salvar su propia vida.

Pero su caso es también un síntoma de una enfermedad mayor, más profunda y grave. Oculta y subterránea. Se trata del diario desprecio por el derecho a la salud y a la vida que se practica en los establecimientos privados de salud. De la cotidiana práctica de negar atención médica a quienes no pueden demostrar inmediatamente solvencia económica. Al que no tiene billete, o no es respaldado inmediatamente por el Dios dinero. Se trata de una aborrecible exclusión dictada por la razón mercantil y amparada en un sistema establecido hace muchos años. Un sistema que nadie cuestiona, que es dado por natural, que la sociedad venezolana ha terminado aceptando con la misma resignación que la propia muerte.

La vida tiene precio y si no puedes pagarlo, no tienes derecho a ella. La salud convertida en mercancía.

En Venezuela, la salud es un derecho prioritario. La Constitución de la República Bolivariana de Venezuela establece en su artículo 83 la salud como un derecho humano esencial. Curiosamente, nuestra Constitución solo le asigna esta responsabilidad al Estado, y nada dice acerca de la responsabilidad de quienes amasan fortunas a partir de la enfermedad, el sufrimiento y los padecimientos de la gente.

El Código de Deontología Médica venezolano indica que el profesional de la medicina antepondrá la salud y la protección de la vida a cualquier otra circunstancia, y afirma enfáticamente que nunca discriminará ni dejará de brindar atención médica a quien lo requiera, en virtud de razones políticas, económicas o de otra índole.

¿Por qué entonces las clínicas privadas exigen como contrapartida obligatoria el depósito de varios miles de bolívares o un seguro para salvar la vida de una persona en emergencia? ¿Por qué todos los días son expulsados de los establecimientos de salud privados, mujeres embarazadas, niños, ancianos cuando su póliza se agota? ¿Por qué se ejerce terrorismo contra los familiares cuando reclaman?

¿Cuántas personas mueren a diario en las clínicas privadas al amparo del silencio y el cómplice celestinaje de los medios, del poder del dinero y de los intereses de la élite de la medicina?

¿Cómo puede operar tan tranquilamente un sistema tan inhumano, injusto e inmoral en una sociedad en transformación, que marcha rumbo al socialismo, y frente a una Constitución que postula la supremacía del derecho a la vida, al bienestar y la felicidad?

¿Dónde termina el derecho a la vida y comienza el negocio comercial y el afán de lucro con la salud? Según la Alianza Institucional para la Salud, instancia de articulación de organismos públicos, creada por el propio comandante Chávez, se estima que en Venezuela existen unos 2,5 millones de trabajadores y trabajadoras del sector público que poseen póliza de seguro de hospitalización, cirugía y maternidad (HCM). Sumando los familiares, la cifra de ciudadanos cubiertos por el modelo de seguro de riesgo se ubica entre 8 y 9 millones, digamos, una tercera parte de la población.

Para “asegurar” 9 millones de personas (entre ellos a los bomberos como Carlos Rodríguez) el Estado venezolano paga unos 7 mil millones de dólares al año, es decir, más de 42 mil millones de Bs (42 billones “de los viejos”). Este monto es aproximadamente igual al presupuesto total del Ministerio del Poder Popular para la Salud. Es decir, el Estado venezolano financia dos ministerios de salud: uno público, y otro privado; uno gratuito y otro privatizado. Un ministerio para impulsar el Sistema Nacional Público de Salud: crear hospitales, fortalecer la red primaria (Barrio Adentro), pagar a los trabajadores y trabajadoras, comprar equipos y medicamentos… otro ministerio (privado y privatizado) para pagar los honorarios de la élite médica, los precios dolarizados y especulativos de sus servicios, y alimentar la insaciable voracidad del sector privado de la medicina.

Este monto (7 mil millones de $) es, sin duda alguna, la transferencia neta de recursos del Estado al sector privado más grande de nuestra historia. Transferencia directa de las mayorías a un sector pudiente de nuestra sociedad. Es lo que los economistas llaman, con la parca amargura que los caracteriza, un proceso de redistribución regresiva del ingreso.

Lo dicen los números. Entre 75% y 80% de las ganancias de las clínicas privadas proviene de las pólizas de riesgo del sector público. La ruina del Estado son sus yates y avionetas. Tu dolor, o tu muerte, es su champán. La misma trampa histórica del capitalismo: pobres financiando a ricos.

La medicina privada no cree en semáforos ni regulaciones. Es tal su poder y arrogancia, que cuando, tras dos años de diálogo entre el Estado y los dueños de las clínicas, se acuerda una lista de tarifas (baremo) para regular los precios de algunos servicios médicos, en pocas semanas la élite de la medicina privada desconoce los acuerdos; y no contenta con ello, organiza y financia una campaña por los medios de comunicación para destruir el intento de regulación.

Detrás de todo, el choque de dos concepciones, dos formas de entender la salud. La visión neoliberal, privatizadora, antihumana que propone la salud como una mercancía dominada por la lógica especulativa del mercado; y otra, una visión social (y socialista) que la afirma como un derecho humano social, que debe ser garantizado por el Estado y la sociedad en su conjunto.

Es la batalla de siempre por construir un modelo distinto, que reivindique el derecho colectivo y el amor, sobre la perversión individual y dineraria. Que nos devuelva el ejercicio de la medicina como una actividad humana, basada en la solidaridad, la identificación con el sufrimiento del otro, la entrega al prójimo y la compasión. Que ayudando a curar al enfermo, ayude a sanar a la sociedad entera.

Esa es la batalla sorda que se libra en Venezuela. En los consultorios. En los quirófanos. En la Asamblea Nacional. En los medios. En la calle y en las conciencias. Una batalla por la vida que no podemos darnos el lujo de perder. Se lo debemos a los miles de invisibles Carlos Rodríguez cuyas vidas se las llevó el diablo del mercantilismo.

Fuente

Chinese clinical trials probed

Drugmakers have increasingly been turning to China for large clinical trials because they’re cheaper and there’s a bigger population of subjects to draw on.

Now U.S. regulators have stepped in, questioning sloppy data and irregularities from the world’s most populous country.

Bristol-Myers Squibb Co. and Pfizer Inc.’s blood thinner Eliquis, approved in December, was stalled for nine months because of misconduct, errors and an alleged cover-up attempt at a Chinese trial site overseen by Bristol-Myers, according to documents posted by the Food and Drug Administration. The delay came after the company told the FDA that patients got the wrong medicine, records were secretly changed and “serious adverse events” went unreported, the documents show.

The errors led to a lengthy reanalysis of the data and spurred a debate within the agency on what the drug’s label should say about its effectiveness. An agency official also questioned whether large trials in countries like China with similar data shortfalls were a viable basis for approving treatments, according to the documents.

The mistakes showed a “pattern of inadequate trial conduct and oversight,” according to minutes of a Feb. 9 agency meeting involving the two New York companies and the FDA, posted on the agency’s website.

Sales for Eliquis may one day reach $10 billion a year, according to analysts. The delay, though, may cut the time Eliquis is protected by patent, reducing revenue by billions of dollars.

The Eliquis case is an example of the increasing scrutiny the pharmaceutical industry is facing on its research in China, which offers a huge base of test subjects and costs that the Tufts Center for the Study of Drug Development says can be half those in the United States.

Drugmakers will keep having problems with sloppy data and misconduct as long as they keep doing trials in places like China without providing better oversight, said Thomas Marciniak, an FDA medical team leader who wasn’t directly involved in the Eliquis application but reviewed the trial independently.

“What we need is high-quality trials. If we’re not getting them in the low-cost areas, either fix the low-cost areas, or stop doing them,” Marciniak said in an interview, emphasizing that he was speaking for himself and not the agency.

Last month, London-based GlaxoSmithKline said it fired its head of Chinese research after the scientist allegedly misrepresented data that was published in a medical journal.

Bristol-Myers, which ran the Eliquis trial known as Aristotle, responded appropriately once the mistakes became known, said Elliott Levy, the company’s executive who oversaw the research. A reanalysis done by the company and the FDA deleted the questionable data and found it didn’t substantially affect the final, positive result, he said.

The mistakes “were not exceptional,” Levy said in a telephone interview. “The issues they raised required recourse to the primary source data and some months to fully evaluate, but they’re not exceptional issues.”

Asked whether the issues in China created concerns that other misconduct or bad data may have occurred in the trial, Levy said Bristol-Myers was confident they hadn’t. “I don’t think there’s anything unique about China in this regard,” Levy said. “We’ve looked closely at the quality of the data and reliability and it’s not distinguishable from the United States and Europe.”

Pfizer is confident in the trial results, said Mackay Jimeson, a spokesman for the company.

Christopher Granger, a professor of medicine at Duke University in Durham, N.C., who was the lead outside researcher on the trial, disagreed with Levy.

“There is a greater likelihood of some of this impropriety in certain regions,” Granger said in a telephone interview. “We’ve had experiences in India and China where we’ve had more than we would have expected.”

Eliquis was developed as a safer and easier-to-take replacement for warfarin, a half-century-old blood thinner widely used to combat blood clotting and strokes.

Pfizer, the world’s biggest drugmaker, and Bristol-Myers share sales on Eliquis, which competes with Boehringer Ingelheim’s Pradaxa, and Bayer and Johnson & Johnson’s Xarelto.

The final-stage trial of Eliquis began in 2006, and eventually grew to more than 1,000 sites in 40 countries, according to the FDA. About 16 percent of the 18,000 patients were in Asia, with three dozen sites located in China.

Doctors and hospitals who sign on as investigators are typically paid for getting patients to enroll in the trial. They’re overseen by the drug companies, which monitor the patients in coordination with the physicians. Much of that work is done by contract research organizations.

In the Eliquis trial, Bristol-Myers hired Pharmaceutical Product Development Inc., a closely held Wilmington, N.C., company known as PPD, to help oversee it.

The Eliquis trial was questioned on two issues, according to the FDA documents first cited by the journal Pharmaceutical Approvals Monthly.

One was the improper manipulation of records at a study site for 35 patients at the Shanghai 9th Peoples Hospital in China. The second involved the high percentage of the 9,000 patients who were supposed to be getting Eliquis, and instead were either given the wrong drug, or the wrong dose.

There was a broad list of issues at the Shanghai hospital, according to FDA documents.

They included failure to report four potential adverse medical events, late reports on three others and three medical outcomes that weren’t included in the data. The FDA also reported that some patient records disappeared just ahead of a site visit by agency inspectors.

“The records were altered in order to cover-up GCP violations which had occurred at the site,” the FDA said in its report. GCP stands for “good clinical practice.”

Levy disputed some aspects of the report. The company “examined the trial data at that site and found that all the primary endpoints and the key secondary endpoints were appropriately documented and reported,” he said.

Source

Citation de la journée

“L’industrie pharmaceutique à fait main basse sur toutes les autorités sanitaires”

Sylvie Simon

Écrivain français et journaliste

Are clinical trial data shared sufficiently today? No

When discussing transparency it is important to be clear on what is being requested, as obfuscation is sometimes used to avoid discussing simple fixes. At stake are four levels of information about trials:

1. Knowledge that a trial has been conducted, from a clinical trials register.
2. A brief summary of a trial’s results, in an academic journal article or regulatory summary.
3. Longer details about the trial’s methods and results, from a clinical study report where available.
4. Individual patient data.

The AllTrials campaign calls only for the first three to be published.

The status quo is plainly unsatisfactory. The most current review—with no cherry picking permitted—estimates that around half of all trials for the treatments being used today have gone unpublished; and that trials with positive results are twice as likely to be disseminated.1 This is a problem for both industry and academic trials.

Although some in industry claim that these problems are in the past, in reality all supposed fixes have failed. In 2005, journal editors passed regulations stating that they would publish only registered trials: the evidence now shows these regulations have been widely ignored.2 In 2007, US legislation was passed requiring all trials since 2008 to post results on clinicaltrials.gov within a year of completion: the best published evidence shows this law has been ignored by 60-90% of trials. If industry representatives believe these problems have been fixed, they should present published evidence to support their case, with methods and results that are available for public scrutiny.

Even if the latest rules on transparency were to be implemented perfectly—starting from now—they would still do nothing to improve the evidence base for the treatments we use today, because they all cover only trials from the past few years. More than 80% of the medicines prescribed this year were generic, and came on the market more than a decade ago. We need the results of trials on these treatments, which are still available, albeit on paper. It is both practical and reasonable to request that these documents should be simply scanned, and shared.

The arguments against this level of transparency are conflicted and misguided. John Castellani, of the Pharmaceutical Research and Manufacturers of America (PhRMA), has claimed previously that it’s enough for regulators alone to see all the information on trials, and to see it behind closed doors. But this goes against the fundamental principles of science: we rely on transparency about methods and results, so that every experiment can be double checked and critically appraised. Although he might not realise it, Castellani’s position also exposes patients to real and unnecessary risks. Many of the most notable recent problems with medicines—problems with rofecoxib (Vioxx) and rosiglitazone (Avandia), for example, and problems with the evidence base for oseltamivir (Tamiflu)—were spotted by independent academics and doctors, and not by regulators. This isn’t because regulators are incompetent; on the contrary, they are highly trained, intelligent, and well motivated. But risks and benefits can be difficult to detect, and like everything in science, these problems benefit from many eyes.

For similar reasons, it is peculiar to see industry argue that information should not be shared simply because there might be disputes about interpretation: disputed interpretations are widespread throughout science and medicine, they are normal, and this open debate is how we get closer to the truth. And likewise, we do not silence medical scaremongers in the media by hiding information about trials; if anything, routinely withholding trial results is more likely to undermine public trust.

Overall, the lack of progress on transparency has been startling. Some worry that these problems should not be discussed in public, while we fix them quietly behind closed doors. But the problem of withheld trial results has been documented since at least 1986, and industry has successfully delayed remedial efforts for three decades. The latest strategy has been to raise the spectre of patient privacy.

In February, for example, PhRMA released a colourful statement that misleadingly suggested that I and the BMJ have somehow called for the reckless public release of full individual patient data sets. They made this claim, despite the head of press relations at PhRMA already knowing that neither I nor the AllTrials campaign call for individual patient data to be published.

The BMJ has recently called for individual patient data to be made more widely available, in an editorial. 

Was this reckless and unreasonable? I don’t believe so. Where industry has shared data with researchers, it has been only piecemeal, and after enormous battles. But in many fields, there is already a long history of sensible and cautious sharing of detailed datasets—for example, to conduct individual patient data meta-analyses. These produce better estimates of treatment benefits, and improve care for patients, with appropriate concern for confidentiality. The Early Breast Cancer Trialists Collaborative Group’s meta-analyses, already published, represent just one notable example. The YODA project at Yale is looking at best practice for data sharing, as are many other groups. What’s more, the European Medicines Agency (EMA) has fully committed to sharing individual patient data after 2014, and are consulting only on the best mechanism to do so. These are reasonable and responsible things to discuss, as evidence based medicine moves forwards and becomes more effective. 

Is patient confidentiality also an issue when clinical study reports are shared, as AllTrials and I have suggested they should be? Clinical study reports are long documents—often thousands of pages—but they are important, because analyses have shown that the information published in academic journal reports on clinical trials can be misleading or inaccurate, when compared with these longer, definitive sources of information. These reports certainly do contain some information about individuals—for example, in narrative descriptions of adverse events—but such information can easily be removed, or shared only with named researchers, if this is deemed necessary. Some industry figures have claimed that removing this material is either impossible or prohibitively expensive. But in 2010 the European ombudsman made a ruling of maladministration against the EMA, for claiming exactly that. The ombudsman examined the clinical study reports requested from the agency in detail, and concluded that the administrative burden of removing patient information, where necessary, was small. The European ombudsman has also stated clearly that there is no important commercially confidential information in these reports—the fact that a drug is not as good as claimed is not, in itself, something any company can hope to ethically withhold from doctors and patients.13 Since then, the EMA has released 1.6 million pages of clinical study reports14 under its new policy.13 Because these documents are so informative—and because the EMA holds only a small proportion of all the clinical study reports in existence—alltrials.net is asking for all existing clinical study reports to be made available, on all medicines currently in use. 

This campaign has rapidly snowballed to become the mainstream position in the United Kingdom. AllTrials is now supported by more than 50 000 individuals, and 250 organizations, including more than 100 patient groups, the National Institute for Health and Care Excellence, academic funders such as the Medical Research Council and the Wellcome Trust, royal colleges, the Royal Pharmaceutical Society, the British Pharmacological Society, and the Faculty of Pharmaceutical Medicine, to name but a few. Ironically, within 24 hours of PhRMA denouncing our calls for greater transparency, GlaxoSmithKline—the world’s fourth largest drug company—signed up as supporters of alltrials.net. They have committed to do the very thing that PhRMA says is impossible, and share all clinical study reports going back to the foundation of the company.

If the transparency we ask for is practical, and reasonable, then what lies behind the colourful denunciations of PhRMA? Speaking to policy staff in some signatory organizations, one worrying theme recurs. We knew that withholding trial data was common, people have said, and we knew that it harms patients, but we felt embarrassed to talk about it, because even raising the issue seemed somehow subversive. This is a worrying state of affairs, and a testament to the power of aggressive lobbying by industry. But it is also perhaps a testament to the capture of key opinion leaders, and the dangers of longstanding inaction at senior levels in the medical establishment. In the UK, we have seen the same phenomena during prominent inquiries into failing hospitals: many senior staff, in numerous organizations, all saw a problem, but most were too busy—or too anxious about workplace conflict—to put patients first.

The problem of missing trials is one of the greatest ethical and practical problems facing medicine today. It also represents a bizarre paradox: we can spend millions of dollars on a trial, hoping it is free from bias, trying to detect a modest difference between two treatment groups; and then at the final moment we let all those biases and errors back in, by permitting half the results to disappear. Future generations may well look back at our tolerating this in amazement, in the same way that we look back on mediaeval bloodletting. The AllTrials movement is driving the solution forwards: patients need industry to engage constructively with this widespread consensus, on the practical details—urgently—so that we can all move on.

Source

Expertos piden que la obesidad se declare enfermedad

La Sociedad Española para el Estudio de la Obesidad (SEEDO) defiende la necesidad de declarar la obesidad una enfermedad, siguiendo la decisión aprobada recientemente en EE.UU, y teniendo en cuenta que, según datos del Estudio de Nutrición y Riesgo Cardiovascular en España, ENRICA (2009-2011), se trata de un problema que padece el 62% de la población española.

"Reconocer la obesidad como una enfermedad ayudará a modificar la praxis clínica, a incrementar el nivel de compromiso de los médicos con esta afección y a potenciar la inversión económica y científica para mejorar su prevención y tratamiento", afirma el presidente de la SEEDO, el doctor Felipe F. Casanueva.

Desde la SEEDO el objetivo es incluir la obesidad en las enfermedades crónicas, y establecerlas como prioridad dentro de los presupuestos públicos del Sistema Nacional de Salud, ya que "tan sólo así se logrará que las personas que padecen exceso de peso puedan acceder a un tratamiento, evitando otras enfermedades relacionadas con la obesidad.

"La atención de una persona con obesidad llega a ser hasta tres veces más costosa que la de otra con peso correcto . Si a eso le sumamos el alto porcentaje de población de la tercera edad con sobrepeso y el crecimiento de obesidad infantil tenemos cifras alarmantes que ponen en riesgo la sostenibilidad de la sanidad de nuestro país porque no hay sistema que pueda soportar mucho tiempo esta situación", explica el presidente de la SEEDO.

Para ello destaca el papel de Atención Primaria como una de las "armas más efectivas" para combatir la obesidad desde la prevención. Casanueva recomienda "lograr un alto nivel de empatía con el paciente", para ello es indispensable que el médico sea percibido como un aliado para que sus recomendaciones surtan efecto.

"Cuando un paciente no se siente comprendido o apoyado por su médico, no acostumbra a seguir sus consejos ni de hábitos de vida saludables ni de pérdida de peso", añade.

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