Drug Maker Told Studies Would Aid It, Papers Say

By Gardiner Harris

An influential Harvard child psychiatrist told the drug giant Johnson & Johnson that planned studies of its medicines in children would yield results benefiting the company, according to court documents dating over several years that the psychiatrist wants sealed.

The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a proposed trial in preschool children of risperidone, an antipsychotic drug made by the drug company. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”

Dr. Biederman was the lead author of a trial published last year concluding that treatment with risperidone improved symptoms of attention deficit and hyperactivity disorder in bipolar children.

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Scientists to EPA: Risks of Chemicals That Alter Male Hormones Should Be Analyzed Together

Concluding that nearly everybody is exposed to a mix of chemicals that could be damaging male reproductive health, a national panel of scientists on Thursday advised the U.S. Environmental Protection Agency to shift its focus and group them together when judging how much of a danger they pose.

The committee, assembled by the National Academy of Sciences, looked specifically at phthalates, controversial compounds widely found in consumer products. Phthalates soften plastic to make vinyl for toys, building materials, medical devices and other items, and they also are used in fragrances and other beauty products.

The recommendation to combine the compounds when analyzing their threats to human health would mark a critical change in EPA strategy. It would likely lower the total amount of phthalates the agency considers safe for people and ultimately could lead to strict regulations on their use.

By analyzing each chemical individually, the EPA underestimates the health risks of phthalates, the committee reported. In human bodies, phthalates combine, amplifying the effects on male reproduction.

By only doing one, we underestimate the risk,” said Deborah Cory-Slechta, a professor of environmental medicine at University of Rochester School of Medicine and Dentistry who chaired the National Research Council’s phthalates committee.

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F.D.A. Scientists Accuse Agency Officials of Misconduct

By Gardiner Harris

WASHINGTON — Top federal health officials engaged in “serious misconduct” by ignoring concerns of scientists at the Food and Drug Administration and approving for sale unsafe or ineffective medical devices, the scientists have written in a letter to Congress.

The House Committee on Energy and Commerce will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to the F.D.A. commissioner, Andrew C. von Eschenbach.

“These allegations are deeply concerning,” said the committee chairman, Representative John D. Dingell, Democrat of Michigan, “and we intend to uncover whether any F.D.A. activity has compromised the health and safety of American consumers.”

Heidi Rebello, an agency spokeswoman, said, “The F.D.A. will respond directly to the committee’s concerns.”

The letter to Congress, dated Oct. 14, is part of a growing chorus of dissent from what had long been a tight-lipped agency. In decades past, scientists rarely disagreed publicly with their agency’s decisions, and any concerns they had about important decisions were whispered among veterans.

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More Kids Are Taking More Meds Than Ever Before

Pharmalot | Ed Silverman | More American children are taking pills for diabetes, high blood pressure and cholesterol than ever before, reflecting a rise in chronic diseases related to obesity. The use of drugs for type-2 diabetes, in particular, doubled in children ages 5 to 19 and statins rose by 15 percent between 2002 and 2005, according to a study published in the journal of the American Academy of Pediatrics.

The study tracked the prescription records collected by Express Scripts, the pharmacy benefits manager, for about 3 million children a year. The use of drugs for asthma rose 47 percent and high blood pressure meds rose 2 percent, the study found (here it is).

“Ten or 15 years ago we weren’t even discussing these conditions, which were mainly in adults,” Emily Cox, a senior director of research at Express Scripts, tells Bloomberg News. “Now, we are seeing a growing number of children being treated for chronic conditions that they are going to take into adulthood.”

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Prescription Drugs Kill 300 Percent More Americans than Illegal Drugs

Alternative News | David Gutierrez | A report by the Florida Medical Examiners Commission has concluded that prescription drugs have outstripped illegal drugs as a cause of death.

An analysis of 168,900 autopsies conducted in Florida in 2007 found that three times as many people were killed by legal drugs as by cocaine, heroin and all methamphetamines put together. According to state law enforcement officials, this is a sign of a burgeoning prescription drug abuse problem.

“The abuse has reached epidemic proportions,” said Lisa McElhaney, a sergeant in the pharmaceutical drug diversion unit of the Broward County Sheriff’s Office. “It’s just explosive.”

In 2007, cocaine was responsible for 843 deaths, heroin for 121, methamphetamines for 25 and marijuana for zero, for a total of 989 deaths. In contrast, 2,328 people were killed by opioid painkillers, including Vicodin and Oxycontin, and 743 were killed by drugs containing benzodiazepine, including the depressants Valium and Xanax.

Alcohol directly caused 466 deaths, but was found in the bodies of 4,179 cadavers in all.

While the number of dead bodies containing heroin jumped 14 percent from the prior year, to a total of 110, the number of deaths influenced by the painkiller oxycodone increased by 36 percent, to a total of 1,253.

Across the country, prescription drugs have become an increasingly popular alternative to the more difficult to acquire illegal drugs. Even as illegal drug use among teenagers have fallen, prescription drug abuse has increased. For example, while 4 percent of U.S. 12th graders were using Oxycontin in 2002, by 2005 that number had increased to 5.5 percent.

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“Worst coverup in the history of the military”, SECRET SHOTS

All military personnel who are headed to combat are required to take vaccinations.

Are these shots leaving some soldiers deathly ill?

8 Drugs Doctors Would Never Take

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Doctors know which prescription and over-the-counter drugs are the most dangerous. The writers of this article asked them the question, “Which medications would you skip?” Here were their answers