Medical Corruption: Lax laws on human guinea pig trials.

January 10, 2006

The Washington Times www.washingtontimes.com Using humans as guinea pigsBy David Evans, Michael Smith and Liz WillenBLOOMBERG NEW Published January 8, 2006 Big Pharma, as the world's largest drug makers are called, spends billions of dollars every year to test experimental drugs on humans. In the U.S., 37 million people have been human guinea pigs. Helped by human testing, drug makers have developed antibiotics capable of curing life-threatening infections as well as revolutionary treatments for diseases such as cancer and AIDS.

Few doctors dispute that testing drugs on people is necessary: No amount of experimentation on laboratory rats will reliably show how a chemical will affect people. These medical success stories mask a clinical drug trial industry that is poorly regulated, riddled with conflicts of interest -- and sometimes deadly. Rules requiring subjects to avoid alcohol and narcotics and to take part in only one study at a time are sometimes ignored by participants, putting themselves at risk and tainting the test data. Pharmaceutical companies distance themselves from the experiments on humans by outsourcing most of their trial to private test centers across the U.S. and around the world, said Daniel Federman, a doctor who is a senior dean of Harvard Medical School in Boston. By law, drug companies must conduct tests to determine whether potential drugs produce dangerous side effects,

such as organ damage, impaired vision or difficulty breathing -- called Phase I tests. In 1991, 80 percent of industry-sponsored drug trials were conducted by medical faculty at universities, with protection for participants provided by the schools' oversight boards, according to the New England Journal of Medicine. Now, more than 75 percent of all clinical trials paid for by pharmaceutical companies are done in private test centers or doctors' offices, according to CenterWatch, a Boston compiler of clinical trial data. Nobody has ever tracked how many people are injured or killed each year during clinical trials, said Dr. Federman, who headed a national committee on clinical trial safety in 2003. "An intelligent person would assume we know this," he said. "We don't know the number of persons harmed in clinical trials each year and are missing a registry of all subjects that participate in trials."

The chief executive officers of drug companies should be held accountable for any lack of ethics in the tests, Dr. Federman said. "The CEOs of the companies have to be publicly, explicitly and financially responsible for the ethical approach," said Dr. Federman, 77, who still sees patients. "It's not possible to insist on ethical standards unless the company providing the money does so." CEOs of 15 pharmaceutical companies that outsource drug testing -- among them, Pfizer Inc., the world's largest drug maker; Merck & Co.; and Johnson & Johnson -- declined comment. Read further at; http://www.washtimes.com/business/20060108-122358-3524r.htm "Our ideal is not the

spirituality that withdraws from life but the conquest of life by the power of the spirit." - Aurobindo.

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