Connecticut Commentary: Red Notes from a Blue State

By Natalie Sirkin “The federal bureaucracies en masse are exogenous factors weighing on an economy that is taxed, regulated and coerced almost to death” -- Donald A. Benedetti The rationale for the food-safety act is food-contamination. Has there been any? Indeed there has. Examples are E. Coli and salmonella outbreaks in peanuts, eggs, lettuce, peppers, potatoes, spinach, and a million pounds recalled of sausage and salami. The Centers for Disease Control and Prevention (CDC) says that 5,000 people die every year from food-contamination and 76,000 people are hospitalized. These problems come from large-scale industrial food production or industrial agriculture, not from the small farmers covered by the Food Safety Modernization Act of 2010—but “one size fits all.” Safety is the rationale for the bill, fueled by competition to industrial agriculture from organic farmers whose business is growing rapidly. The Senate’s food safety bill, S.510 , passed easily last December 7 with...

Witnessing the process I can see how inadequate instruction by the FDA, unfamiliarity with the drug, and a biased presentation by the FDA reviewer led to this [hurtful] result -- Gabriel. Hortobagyi, MD It is not often that Avastin or any newly developed drug is a blockbuster for several cancers -- lung, kidney, breast, brain, colon -- and advanced macular degeneration. In this column, we restrict our coverage of Avastin for breast cancer because till December 17, the FDA has a chance to right a wrong and save a genuinely useful medicine. Avastin is manufactured in San Francisco by a specialist in cancer drugs, Genentech, which the Swiss drug manufacturer Roche has bought. FDA gave accelerated approval for Avastin in 2008 “based on a study suggesting it halted progression of breast cancer for more than five months. That study paired it with the chemotherapy drug paclitaxel. The manufacturer, Roche, then applied for standard approval. In 2009 it submitted two new large clinical...

The FDA’s philosophy seems to be that the way to protect the public from uncertainty about the safety of new drugs is to stop approving any at all. But who will protect the public from the FDA -- Henry I Miller, M.D. These past several months, the Food and Drug Administration has been under severe attack by former officials, by unfairly treated pharmaceutical companies, and by patients in pain. Let us list a sampling. Avastin, a breast-cancer drug, is delayed a year or more because FDA wants additional data. Moving the goalpost in the middle of the game is vexing for drug-developers, says Henry I. Miller, M.D., FDA official 1979-94. The FDA some times requires testing long after it has approved the therapy. FDA approved doxepin for depression in 1969. Doxepin may be useful as a sleeping pill at very low dosage. FDA has ordered animal testing, a procedure always done prior to use on humans. Vioxx, an arthritis drug for pain was withdrawn by Merck, its maker, when it was found to...