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Top U.S. lawmakers at a recent hearing criticized the FDA for drug safety problems.

(NewsTarget March 16, 2007)  Recently Congress held a hearing focused on the FDA's handling of a Sanofi-Aventis antibiotic, called Ketek, and several prescription anti-depressants. Problems with these drugs, and also Merck's now-withdrawn Vioxx, were cited.

The hearing included accusations that the FDA stifled scientific dissent regarding the safety of these drugs. Rep. Bart Stupak, D-Mich., the chairman of the Subcommittee on Oversight and Investigations for the House Committee on Energy and Commerce, questioned whether the FDA is working for the American people.

"With each of these drugs, it appears that the FDA is not seriously questioning whether the risks outweigh the benefits of the new drug," Stupak said at the hearing. "One must ask, if the FDA is not protecting its client, the American people, whose interest is being protected?"

The hearing included a whistleblower from inside the FDA who said the agency has not improved its ability to protect patients from harmful drugs like Vioxx. David Graham, an associate director in the FDA office that monitors how drugs on the market interact with patients, previously spoke in 2004 to Congress regarding the FDA.

"There is no longer any question whatsoever that the FDA acts primarily to protect the financial interests of pharmaceutical companies at the expense of public health," said consumer health advocate Mike Adams, author of a book blasting the FDA, titled Natural Health Solutions.

Sen. Charles Grassley, R-Iowa, said at the hearing that the FDA is not friendly to hearing problems with drugs, stating that within the agency "scientific dissent is discouraged, quashed and sometimes muzzled."

On Monday, the FDA withdrew its approval for two of the three uses for Ketek - treatment of sinusitis and bronchitis - after reports of severe liver damage among patients started to surface last year. It still is approved for pneumonia. Ketek was approved by the FDA in April 2004.

Vioxx, approved in 1998, was voluntarily withdrawn by Merck in 2004 due to concerns about an increased risk of heart attack and stroke associated with long-term, high-dosage use.

In addition to charging that the FDA works in favor of Big Pharma instead of the American citizenry, Adams said that the FDA has taken actions that cripple the advances of natural health remedies.

"They've raided vitamin shops with armed agents, terrorized a church that was helping people deal with mental health challenges, ordered the destruction of recipe books promoting a natural herbal sweetener, confiscated tens of millions of dollars in nutritional supplements, stifled scientific scrutiny within their own ranks, censored nutritional supplement companies and essentially have engaged in a war of medical tyranny against the alternative health community," Adams said.

Article by Mike Adams, the Health Ranger,


bullet How Independent is the FDA? - How is the pharmaceutical industry making its inroads into the FDA? Where is it exerting its influence? - Frontline at PBS


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