Comparación de precios de fármacos entre Colombia y España

Fuente

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"

Europa exige a España reducir su gasto farmacéutico en hospitales

Expertos reunidos por el Instituto Choiseul para la elaboración de su último informe, defienden el papel de las farmacias comunitarias en el Sistema Nacional de Salud (SNS)

El informe "La Farmacia ante los cambios estructurales" es un trabajo que supera escasamente las 200 páginas, destinado principalmente a defender el modelo de proximidad actual de la farmacia comunitaria e identificar las amenazas que se ciernen sobre él. Entre estos peligros, que ya están provocando que 3.000 oficinas sigan abiertas prácticamente sin generar ingresos, la crisis es el fenómeno más visible pero no el único, ya que es la posible pérdida de la titularidad de los establecimientos, tradicionalmente en reserva para los farmacéuticos, la que debe suscitar mayor inquietud.

El texto, que fue presentado por el presidente del Instituto Chosiseul, Eduardo Olier, transita por los puntos más calientes de la farmacia actual. Para tratar cada apartado, se ha contado con plumas de gran prestigio como la presidenta de los colegios oficiales de farmacéuticos, Carmen Peña, que analiza el estado nacional de la profesión, o John Chave, que disecciona los efectos de la liberalización de la titularidad de las farmacias en aquellos países de Europa donde ya ha tenido lugar. Olier reiteró además, en varias ocasiones, que las 23 medidas legislativas aplicadas contra el gasto farmacéutico, unidas a la larga crisis, han reducido este hasta un 30%. Para el presidente del Think Tank Choiseul, esta realidad va en contra de la propia sostenibilidad del sistema sanitario porque afecta a la farmacia, elemento financiaciador del propio sistema, al absorber parte de la demanda ciudadana en prevención y atención primaria, además de soportar impagos, especialmente de algunas CC.AA., con el efecto liberador (o aplazador) que eso supone para parte de los desembolsos que se deben realizar desde el erario público

En la presentación, realizada este martes en un hotel de Madrid, participó Juan Iranzo, presidente del Colegio de Economistas de Madrid. Iranzo, que es autor del capítulo destinado a explicar el contexto económico del sector farmacéutico en estos días, recalcó que el objetivo principal del informe es ayudar a mantener el actual modelo de Farmacia como garantía en el acceso a los medicamentos para el conjunto de la población. Para este profesor, el modelo actual viene a cubrir el déficit de políticas públicas de salud y aún prestaría mayores servicios, si se estableciera una buena coordinación con los hospitales, siendo muy útil su participación en la dosificación y seguimiento de los tratamientos. Sin embargo lamentó que 3.000 farmacias de las 21.300 que existen en España estén en situación de quiebra económica. Con un 15% de margen neto, elevados costes laborales, amortizaciones, gastos financieros y retrasos en los pagos, una farmacia media que puede facturar actualmente 850.000 euros, apenas supera los 40.000 de ingresos finales. En el plano internacional, Iranzo recordó que la única exigencia expresa de la troica europea es reducir el gasto farmacéutico en hospitales porque es allí donde se está produciendo, paralelamente a las bajadas que se están produciendo en la farmacia comunitaria.

Como es sabido, la troika, o troica, está formada por el Banco Central Europeo (BCE), el Fondo Monetario Internacional (FMI) y la Comisión Europea(CE).

Fuente

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

Quote of the day

"Money has transformed every watchdog, every independent authority. Medical

doctors are increasingly gulled by the lobbying of pharmaceutical salesmen"

Thomas Frank

American journalist

Former columnist for the Wall Street Journal

Las compañías farmacéuticas publicarán todas sus relaciones financieras con los profesionales sanitarios

La Federación Europea de Asociaciones de la Industria Farmacéutica (EFPIA), en la que está integrada la patronal española Farmaindustria, ha anunciado la publicación de su Código de Transparencia, que exige que, a partir de 2016, todos los miembros de EFPIA publiquen las transferencias de valor realizadas a profesionales y organizaciones sanitarias en 2015.

EFPIA se compromete así a introducir mayor transparencia en las relaciones de la industria con profesionales y organizaciones sanitarias, por entender que es necesario proporcionar un marco de colaboración bien gestionado para que estas relaciones sean lo más transparentes posibles.

La colaboración de la industria farmacéutica con los profesionales sanitarios requiere de un diálogo científico continuo y bien regulado en ambas direcciones. Se trata de algo fundamental para garantizar una positiva relación que repercuta en beneficio de los pacientes. Las colaboraciones y partenariados entre los profesionales sanitarios y la industria farmacéutica están sujetos a una estricta regulación y requieren que todas las partes respeten los más altos estándares éticos. El nuevo código EFPIA estimulará la transparencia sobre esas relaciones, y garantizará que el trabajo de la industria con profesionales y organizaciones sanitarias es bien conocido y entendido por la sociedad y por los agentes implicados.

En este sentido, Richard Bergström, director general de la EFPIA, ha afirmado que se trata de un paso muy importante dado por la industria farmacéutica, con el que se pone de manifiesto el compromiso del sector con la transparencia y su voluntad por garantizar la confianza de los pacientes a los que sirve nuestra industria. Este Código responde a los objetivos establecidos el pasado otoño por la EFPIA, por los que se comprometió a trabajar con todos los agentes implicados para dotar de transparencia a las transacciones financieras y otras declaraciones de interés.

"Sabemos que recorriendo con éxito este camino mejoremos las relaciones entre la industria y los profesionales y organizaciones sanitarias, de lo que en última instancia se beneficiará el colectivo para el que los tres agentes trabajamos: los pacientes", señaló Bergstöm.

El código fue formalmente aprobado en la Asamblea Anual de la EFPIA celebrado lugar el pasado día 24 de junio en Bruselas. Se requiere que cada compañía documente y publique en sus páginas webs o en sitios webs comunes:

- Los nombres de los profesionales sanitarios y organizaciones que hayan recibido pagos u otras transferencias de valor

- Las cantidades de valor transferido, y el tipo de relación, tales como honorarios de consultoría, y contribuciones a la formación (asistencia a congresos y reuniones científicas y profesionales).

Fuente

Pfizer Inc

Pfizer is a research-based global pharmaceutical company. The company discovers, develops, manufactures and markets medicines for humans and animals, as well as consumer products.

Pfizer is the largest and richest pharmaceutical enterprise in the world. Fortune® named Pfizer as the fifth-best ‘wealth-creator’ in America. The company is a global leader in human pharmaceuticals, and also has a large array of consumer health care, confectionery, and animal health care products. In 2000, its revenues equalled $29,6 billion (£20,14bn), eight of Pfizer’s pharmaceutical products attained sales of at least $1 billion (£680,4 million) each. Pfizer’s main competitors are Merck, Glaxo SmithKline, Novartis, Brystol Myers Squibb and AstraZeneca.

In 2001, Pfizer has budgeted approximately $5 billion (£3,402 bn) for research and development -more than any other drug company in the world. However, the company is likely to spend even more money on marketing. Extensive marketing practices (e.g. huge TV advertising campaigns) have turned some drugs, like Claritin and Viagra, into household names. According to the Financial Times (26 April 2001), ‘Pfizer has powered its way up the global ranking list to its unassailable position thanks mainly to its marketing prowess.’

History:

The company was incorporated as Charles Pfizer & Co in the US in 1942 but the original business dates back to a partnership founded in 1849. Until the turn of the century this partnership produced only citric acid but then began to expand into other chemicals and pharmaceutical products. A phase of rapid growth began with the production of penicillin in World War II (it was Pfizer penicillin that arrived with the Allied forces on the beaches of Normandy in 1944) and the development of the company’s most famous product, the antibiotic Terramycin in 1949. Based on this strength, Pfizer grew in the 40s and 50s through horizontal integration in the US as well as through internal development.

Under the methodical directive of John Powers, head of international operations and future president and chief executive officer, Pfizer’s foreign market expanded into 100 countries and accounted for $175 million (£199 million) in sales by 1965. It would be years before any competitor came close to commanding a similar share of the foreign market. Pfizer’s 1965 worldwide sales figures of $220 million (£149,7 million) indicated that the company might possibly be the largest pharmaceutical manufacturer in the US. By 1980 Pfizer was one of the two US companies among the top ten pharmaceutical companies in Europe, and the largest foreign health care and agricultural product manufacturer in Asia. Powers guided the company in a new direction with an emphasis on research and development.

By 1989, Pfizer operated in more than 140 countries. Pfizer entered the 90s facing controversy about heart valves produced by Shiley, a Pfizer subsidiary. In 1990, 38 fractures of implanted valves were reported (see also crime section). Pfizer became a household name in the late 90s with its development of the break-through male impotence drug Viagra, which became the world’s fastest-selling pharmaceutical product (until overtaken by another Pfizer brand).

It appears Viagra also had an effect on the company’s senior executives; in 1999 they began forcing their intentions on rival Warner-Lambert, finally harassing the smaller company into a shotgun marriage in the first ever-hostile take-over in the pharma sector. This take-over turned Pfizer into the largest and richest pharmaceutical enterprise in the world.

Pfizer has worked its way up the global ranking list by way of internal growth and development, acquisitions, the licensing of products from competitors (Pfizer generously borrowed research from its competitors and released variants of these drugs. While all companies participated in this process of ‘molecular manipulation’, whereby a slight variance is produced in a given molecule to develop greater potency and decreased side effects in a drug, Pfizer was particularly adept at developing these drugs and aggressively seizing a share of the market), research & development, and by way of comprehensive marketing efforts.

Pfizer’s successful marketing efforts impinged on other companies in the pharma sector. (Pfizer’s modern market campaigns broke tradition in the pharma industry. Pfizer’s Terramycin campaign turned the company –a relative newcomer to the industry—into the largest advertiser in the American Medical Association’s journal. Some companies did not appreciate Pfizer’s ‘hard sell’ tactics and attacked Pfizer. However, after Pfizer’s campaign proved to be highly effective, other companies took a similar lead) It is manifested in the "arms race" of escalating numbers of sales representatives, particularly in the US; the huge pre-launch marketing budgets when companies try to make as big a splash as possible; and aggressive TV advertising campaigns in which drugs are seemingly being treated and presented to the consumer audience as any other consumer product.

Pfizer recently announced a new mission: to become the world’s ‘most valued’ company. Pfizer CEO McKinnell declared that the new mission came about because the old mission set in the 1990s (to lead the pharmaceutical industry) had been achieved. He explains: ‘Becoming most values simply means that we emerge as the company recognised as the best by patients, customers, business partners, and the communities where we live and work. It’s a long term mission focused on making Pfizer’s success a winning proposition for everyone.’

Source

Gwen Olsen: Pharma Not in Business of Health, Healing, Cures, Wellness

Highlights

"Pharmaceutical industry are not in the business to cure cancer, to cure Alzheimer, to

cure heart disease because if they were, they will be onthe business putting themselves:

OUT  OF BUSINESS"

"Pharmaceutical industry doesn't want to cure people"

"Psychiatric drugs: these drugs encourage people to

remain customers of the pharmaceutical industry"

"Cholesterol drugs are lowering cholesterol excessively and causing other diseases states as a consequence"

"The drugs are always trailed against the placebo and clinical trials. Placebo is a sugar pill.

In fact, many drugs are not found to be much more efficaces than a sugar pill"

"Antidepressants are not more effective than placebo as per clinical study"

"Pharmaceutical industry makes 5 to 6 times the amount of

money as any of the others companies in United States of America"

AMA declares obesity a disease in USA

The American Medical Association (AMA) voted Tuesday to declare obesity a disease, a move that effectively defines 78 million American adults and 12 million children as having a medical condition requiring treatment.

In the end, members of the AMA's House of Delegates rejected cautionary advice from their own experts and extended the new status to a condition that affects more than one-third of adults and 17% of children in the United States.

"Recognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately 1 in 3 Americans," said Dr. Patrice Harris, an AMA board member.

Tuesday's vote is certain to step up pressure on health insurance companies to reimburse physicians for the time-consuming task of discussing obesity's health risks with patients whose body mass index exceeds 30. It should also encourage doctors to direct these patients to weight-loss programs and to monitor their often-fitful progress.

The AMA's decision essentially makes diagnosis and treatment of obesity a physician's professional obligation. As such, it should encourage primary care physicians to get over their discomfort about raising weight concerns with obese patients. Studies have found that more than half of obese patients have never been told by a medical professional they need to lose weight — a result not only of some doctors' reluctance to offend but of their unwillingness to open a lengthy consultation for which they might not be reimbursed.

"As things stand now, primary care physicians tend to look at obesity as a behavior problem," said Dr. Rexford Ahima of University of Pennsylvania's Institute for Diabetes, Obesity and Metabolism. "This will force primary care physicians to address it, even if we don't have a cure for it."

The new designation follows a steep 30-year climb in Americans' weight — and growing public concern over the resulting tidal wave of expensive health problems. Treatment of such obesity-related illnesses as cardiovascular disease, Type 2 diabetes and certain cancers drives up the nation's medical bill by more than $150 billion a year, according to the Centers for Disease Control and Prevention.

Projected increases in the obesity rate could boost that figure by an additional $550 billion over the next 20 years, a recent Duke University study concluded.

In laying out the case for and against the redefinition of obesity, the AMA's Council on Science and Public Health argued that more widespread recognition of obesity as a disease "could result in greater investments by government and the private sector to develop and reimburse obesity treatments."

The Food and Drug Administration, which has approved just two new prescription weight-loss medications since 1999, would probably face increased pressure to approve new obesity drugs, spurring new drug development and more widespread prescribing by physicians, the council noted.

"The greater urgency a disease label confers" also might boost support for obesity-prevention programs such as physical education initiatives and reforms to school lunch, the council added. In addition, it speculated that "employers may be required to cover obesity treatments for their employees and may be less able to discriminate on the basis of body weight."

But the council also said that making obesity a disease could deepen the stigma attached to being overweight and doom some patients to endless nagging — even if they were otherwise healthy or had lost enough weight to improve their health.

It might also shift the nation's focus too much toward expensive drug and surgical treatments and away from measures to encourage healthy diets and regular exercise, the council wrote in a background memo for AMA members.

Dr. Daniel H. Bessesen, an endocrinologist and obesity expert at the University of Colorado Anschutz Medical Campus, called the AMA's shift "a double-edged sword." Though the semantic change may reflect "a growing awareness that obesity is not someone's fault," he worried that "the term disease is stigmatizing, and people who are obese don't need more stigmatizing."

Source

Fish on Prozac: Anxious, anti-social, aggressive

When fish swim in waters tainted with antidepressant drugs, they become anxious, anti-social and sometimes even homicidal. New research has found that the pharmaceuticals, which are frequently showing up in U.S. streams, can alter genes responsible for building fish brains and controlling their behavior. Antidepressants are the most commonly prescribed medications in the United States; about 250 million prescriptions are filled every year. And they also are the highest-documented drugs contaminating waterways, which has experts worried about fish. “At high doses we expect brain changes” said scientist Rebecca Klaper. “But we saw the gene expression changes and then behavioral changes at doses that we consider environmentally relevant” Male minnows exposed to a small dose of Prozac in laboratories ignored females and took more time capturing prey. When the dose was increased, but still at levels found in some wastewater, males became aggressive, killing females in some cases.

Exposure to fluoxetine, known by the trade name Prozac, had a bizarre effect on male fathead minnows, according to new, unpublished research by scientists at the University of Wisconsin-Milwaukee.

Male minnows exposed to a small dose of the drug in laboratories ignored females. They spent more time under a tile, so their reproduction decreased and they took more time capturing prey, according to Rebecca Klaper, a professor of freshwater sciences who spoke about her findings at a Society of Environmental Toxicology and Chemistry conference last fall. Klaper said the doses of Prozac added to the fishes’ water were “very low concentrations,” 1 part per billion, which is found in some wastewater discharged into streams.

When the dose was increased, but still at levels found in some wastewater, females produced fewer eggs and males became aggressive, killing females in some cases, Klaper said at the conference.

The drugs seem to cause these behavioral problems by scrambling how genes in the fish brains are expressed, or turned on and off. The minnows were exposed when they were a couple of months old and still developing.

There appeared to be architectural changes to the young minnows’ brains, Klaper said at the toxicology conference. Growth of the axons, which are long nerve fibers that transmit information to the body, was disrupted.

When the dose was increased, but still at levels found in some wastewater, females produced fewer eggs and males became aggressive, killing females in some cases.

The new findings build on Klaper’s previous research, which tested minnows with the gene changes to see how well they avoided predators. They swam longer distances and made more directional changes, which suggests that the drugs induced anxiety.

The drugs used in the study were among the most common in sewage: Prozac, Effexor and Tegretol. The researchers tested each drug alone and in combination.

“At high doses we expect brain changes,” Klaper said. “But we saw the gene expression changes and then behavioral changes at doses that we consider environmentally relevant.”

However, there is too little evidence to know whether pharmaceuticals are having any impacts on fish populations in the wild, said Bryan Brooks, an environmental science professor at Baylor University who has extensively studied pharmaceuticals in streams and fish.

Any changes in reproduction, eating and avoiding prey can have devastating impacts for fish populations, Klaper said.

The most vulnerable fish populations are those downstream of sewage treatment plants, where prescription drugs consistently show up in higher levels than in other waterways. It’s only within the past decade that technology has allowed plants to test for the chemicals in their wastewater and in waters downstream, though most still don’t, said Steve Carr, supervisor of the chemistry research group at the Los Angeles County Sanitation Districts.

One of the antidepressants tested in the fish – Tegretol – comes into the treatment plants and goes out at near constant levels, said Eric Nelson, a senior chemist with the Los Angeles County Sanitation Districts.

That means the county’s treatment technology does not seem to have any effect on the drug. It comes in and leaves in a very tight range, about 150 to 400 parts per trillion, Nelson said.

Nelson said the two other drugs tested on the fish – Prozac and Effexor – are discharged in effluent at even lower levels: between about 20 and 30 parts per trillion. In comparison, the levels that altered behavior of the lab fish were 50 times higher.

Source

Pharma industry accused of drug testing in poorer countries with lax regulation

Following reports of alleged drug testing on unknowing patients in communist East Germany, pharmaceutical firms are in the spotlight. The industry is accused of exploiting people for testing in poorer countries.

"Many people in India live in extreme poverty and rarely have access to medical care due to an inadequate state healthcare system," said Christian Wagner-Ahlfs, a chemist with BUKO, an organization that investigates pharmaceutical companies' activities in poorer countries. "They would have to pay for medical care themselves and they just don't have the money," he added.

"It's of course very tempting when they are given the option of receiving medical care as part of a clinical study," he said.
"Many trials are unnecessary since drugs are developed where it's already clear that they will not advance the treatment," says Wagner-Ahlfs

The pharmaceutical lobby rejects such accusations, but cannot completely rule out exceptions among local research institutes commissioned to do the studies. In highly populous countries like India and China, it's easier to find subjects with the relevant illnesses. The participants, of course, must agree to the trial beforehand, said the Association of Research-Based Pharmaceutical Companies (VFA).

"Pharmaceutical companies can even help to make improvements to the healthcare system by equipping hospitals and other medical institutes with modern technology and personnel," said VFA's Rolf Hömke.

Guidelines for medical tests

Medication that is supposed to help people must be tested on people - something that researchers agree on. A drug must undergo a long development process before it even gets to clinical trials on human subjects. And for that phase of clinical tests on people, there are clear regulations. The World Medical Association (WMA), to which medical organizations from more than 100 countries belong, established precise rules under which new drugs can be tested.

Patients must be thoroughly informed about the study, participation is voluntary and subjects are permitted to quit the trials at any time and without giving reason. Subjects must confirm their participation by signing an "informed consent form."

In addition, it must be determined how and in what form a patient will continue to receive medical attention once the study is over, said WMA Secretary General Otmar Kloiber. "That can be particularly important with chronic illnesses. People cannot be viewed as guinea pigs and then abandoned once the trial is over," he added.

Fewer studies, more supervision

German drug maker Boehringer-Ingelheim is currently conducting 125 clinical trials in 72 countries, according to the company. More than 70,000 people are participating in the studies. Other companies likely have similar figures.

Yet, "many trials are unnecessary since drugs are developed where it's already clear that they will not advance the treatment," said Wagner-Ahlfs. Many drugs being tested differ only negligibly in their composition from medication already on the market. "They are only developed to ensure new patent protection and reap higher profits," he noted.

In addition, subjects in clinical trials in poorer countries offer up their health for the development of a drug, but cannot afford the medication later once it ends up on the free market. "That's a major ethical issue," said chemist Wagner-Ahlfs.

No "outsourcing" of studies

The charge that pharmaceutical companies outsource the majority of their trials to Africa or Asia for financial reasons is something the Association of Research-Based Pharmaceutical Companies rejects. According to one US statistic, pharmaceutical companies last year initiated 2,590 studies in the United States, 715 in Germany, and Great Britain, Canada and France each had 500. In China and India, on the other hand, there were less than 200.

To ensure that criteria for medical testing is as uniform as possible around the world, state regulatory agencies in the United States, Europe and Japan have established the guideline for "Good Clinical Practice" that developed out of the WMA's "Declaration of Helsinki" first adopted in 1964. It outlines ethical principles for medical research involving human subjects.

Major pharmaceutical companies have pledged to respect these guidelines, and it is in their interest to do so because they can only submit a new drug for approval by regulatory agencies if they can prove they have fulfilled these standards.

Source