Del "off-shoring" en investigación clínica y/o el "deconstruir*" la "Doctrina Acebillo..."

Once upon a time, the drugs Americans took to treat chronic diseases, clear up infections, improve their state of mind, and enhance their sexual vitality were tested primarily either in the United States (the vast majority of cases) or in Europe. No longer. As recently as 1990, according to the inspector general of the Department of Health and Human Services, a mere 271 trials were being conducted in foreign countries of drugs intended for American use. By 2008, the number had risen to 6,485—an increase of more than 2,000 percent. A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000. In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. Increasingly, companies are doing 100 percent of their testing offshore. The inspector general found that the 20 largest U.S.-based pharmaceutical companies now conducted “one-third of their clinical trials exclusively at foreign sites.” All of this is taking place when more drugs than ever—some 2,900 different drugs for some 4,600 different conditions—are undergoing clinical testing and vying to come to market.

Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do. They note that the prevailing diseases in other countries, such as malaria and tuberculosis, can skew the outcome of clinical trials. But from the point of view of the drug companies, it’s easy to see why moving clinical trials overseas is so appealing. For one thing, it’s cheaper to run trials in places where the local population survives on only a few dollars a day. It’s also easier to recruit patients, who often believe they are being treated for a disease rather than, as may be the case, just getting a placebo as part of an experiment. And it’s easier to find what the industry calls “drug-naïve” patients: people who are not being treated for any disease and are not currently taking any drugs, and indeed may never have taken any—the sort of people who will almost certainly yield better test results. (For some subjects overseas, participation in a clinical trial may be their first significant exposure to a doctor.) Regulations in many foreign countries are also less stringent, if there are any regulations at all. The risk of litigation is negligible, in some places nonexistent. Ethical concerns are a figure of speech. Finally—a significant plus for the drug companies—the F.D.A. does so little monitoring that the companies can pretty much do and say what they want.

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$350 per Child

If the globalization of clinical trials for adult medications has drawn little attention, foreign trials for children’s drugs have attracted even less. The Argentinean province of Santiago del Estero, with a population of nearly a million, is one of the country’s poorest. In 2008 seven babies participating in drug testing in the province suffered what the U.S. clinical-trials community refers to as “an adverse event”: they died. The deaths occurred as the children took part in a medical trial to test the safety of a new vaccine, Synflorix, to prevent pneumonia, ear infections, and other pneumococcal diseases. Developed by GlaxoSmithKline, the world’s fourth-largest pharmaceutical company in terms of global prescription-drug sales, the new vaccine was intended to compete against an existing vaccine. In all, at least 14 infants enrolled in clinical trials for the drug died during the testing. Their parents, some illiterate, had their children signed up without understanding that they were taking part in an experiment. Local doctors who persuaded parents to enroll their babies in the trial reportedly received $350 per child. The two lead investigators contracted by Glaxo were fined by the Argentinean government. So was Glaxo, though the company maintained that the mortality rate of the children “did not exceed the rate in the regions and countries participating in the study.” No independent group conducted an investigation or performed autopsies. As it happens, the brother of the lead investigator in Santiago del Estero was the Argentinean provincial health minister.

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In 2009, according to the Institute for Safe Medication Practices, 19,551 people died in the United States as a direct result of the prescription drugs they took. That’s just the reported number. It’s decidedly low, because it is estimated that only about 10 percent of such deaths are reported. Conservatively, then, the annual American death toll from prescription drugs considered “safe” can be put at around 200,000. That is three times the number of people who die every year from diabetes, four times the number who die from kidney disease. Overall, deaths from F.D.A.-approved prescription drugs dwarf the number of people who die from street drugs such as cocaine and heroin. They dwarf the number who die every year in automobile accidents. So far, these deaths have triggered no medical crusades, no tough new regulations. After a dozen or so deaths linked to runaway Toyotas, Japanese executives were summoned to appear before lawmakers in Washington and were subjected to an onslaught of humiliating publicity. When the pharmaceutical industry meets with lawmakers, it is mainly to provide campaign contributions.

And with more and more of its activities moving overseas, the industry’s behavior will become more impenetrable, and more dangerous, than ever.

Mas...

USA: Preocupa el "off-shoring" en investigación clínica

"Doctrina Acebillo**" (Presidente de Novartis en España, ex Presidente de Farmaindustria)

"Las economías emergentes ofrecen, asimismo, oportunidades para mejorar los procesos de innovación a costes altamente competitivos, sobre la base de personal científico e investigadores muy competentes, formados en su mayoría en centros de excelencia investigadora de EEUU y Europa.
Esta oferta altamente cualificada está en el origen de lo que se denomina "off-shoring" o "externalización global", es decir la externalización de un número de operaciones de alto valor añadido, a proveedores situados en los mercados emergentes, en condiciones más atractivas y competitivas que las que ofrecen los especialistas y proveedores occidentales. China, India, Singapur y el este de Europa entre otros, son ejemplos claros de países emergentes que han priorizado el desarrollo de "Clusters" biotecnológicos de alta competitividad, donde se ofrecen servicios de I+D del más alto nivel científico, con compromisos óptimos de tiempos de ejecución y a unos costos muy por debajo de los existentes en los países desarrollados." La coincidencia en el espacio y en el tiempo de altos niveles tecnológicos, junto a bajos costes operativos es la causante de un desplazamiento histórico de riqueza y valor, desde el rico occidente al este emergente."

HUMOR...es lunes: Deslocalización...Jesus Acebillo la llama "off-shoring" o "externalización global" que suena mas bonito...

(*) La deconstrucción ( Jacques Derrida pensador francés n.1930, en El-Biar, Argelia) tampoco es una crítica en el sentido de una operación negativa, nihilista, irracional o escéptica. Frente a todas ellas, la deconstrucción acepta el riesgo y la necesidad de asumir de forma positiva, afirmativa, la única racionalidad que se da, es decir, una razón capaz de enfrentarse a su falta de garantías, de renunciar a su supuesta universalidad y de acoger su «otro» espúreo y conflictivo: la no-razón.

Cristina de Peretti/Diccionario de Hermenéutica.

(**) Since July 2004, in addition to his responsibilities as CEO, he (Jesús Acebillo) manages the new Emerging Growth Markets (EGM) Region from the Barcelona headquarters of Novartis Spain.
The EGM Region comprises China, India, Turkey, Russia, Australia, South Korea,, Taiwan, and the nations of the Asia Pacific region, the Middle East, Africa and Eastern Europe. These organizations are managed directly from Barcelona, with two international offices located in Singapore and Basel. (Web oficial de Novartis)Aviso para "navegantes..."