Archive for June, 2010

Avandia Back in the News

Tuesday, June 29th, 2010

CBS Evening News (6/28, story 10, 0:30, Smith) reported FDA experts meet in two weeks to decide whether or not to pull Avandia (GlaxoSmithKline) off the market, while Brian Williams of NBC News also reported yesterday (June 28,3010) , however, that the drug’s maker, GlaxoSmithKline, “said today the drug is effective and safe.” The drug (Rosiglitazone) is still used for millions of patients with type II diabetes, although several other drugs are available for treatment of the condition.The drug was linked to 304 deaths in the third quarter of last year.

Yet, three years ago in May 2007, and followed by many other reports, Avandia was linked to a 43 percent greater risk of heart attack and death in a study published by the New England Journal. See this link.The FDA is still in a bind despite a recommendation last February that the drug be taken off the market. (Supposedly) when a drug maker refuses to pull a potentially fatal medication off the market, the FDA, believe it or not, does not necessarily have the authority to force a recall. “In the interests of free commerce” (see link above), though The FDA has authority to force a black box warning be placed on the drug, the Agency does not have explicit power to force a company to remove the drug from the market. According to the above link “As long as the risks and benefits of a drug are fully disclosed to a patient and the patient voluntarily consents to its use, the FDA has no power to interfere in that patient’s treatment.”Stay tuned.

WHO Still thinks it’s a Pandemic

Monday, June 7th, 2010

According to the AMA Morning Rounds, World Health Organization (WHO) official still insist that the swine flu, H1N1 continues to be a “pandemic,” even though the period of most intense activity appears to have passed. The June 3 announcement came two days after a virtual meeting of international flu experts who advise Director-General Margaret Chan “on setting the global body’s pandemic alert level.”

This was surprising to many observers, because they “had expected the 15-member committee of experts, whose members are anonymous, to declare that the pandemic was in its ‘post-peak’ phase, or even in its ‘post-pandemic’ phase, which would mean that the pandemic was over.” But, Dr. Chan quickly pointed out that while “‘the period of most intense pandemic appears likely to have passed for many parts of the world,’ activity is continuing in some areas (Cuba, Central America) and many people remain vulnerable.”See my blog of Jan.26  and comments by Dr. Wolfgang Wodarg, chairman of the Parliamentary Assembly of the Council of Europe (PACE) Health Committee, cited previously, whom I quoted, “The WHO’s “false pandemic” flu campaign is “one of the greatest medicine scandals of the century.” Dr. Wodarg introduced the parliamentary motion to hold an emergency debate and inquiry into the “influence” exerted by the pharmaceutical industry on the World Health Organization’s (WHO) global H1N1 flu campaign.  “The definition of an alarming pandemic must not be under the influence of drug-sellers,” he added.