HAS THE FDA BECOME UNMANAGEABLE?

Whichever way it jumps it is going to displease someone. Time to abolish it and start a new agency devoted to ensuring reasonable drug safety only. Drug effectiveness should be something left for a different agency with advisory powers only. "First do no harm" (Hippocrates) is still hard to beat as an approach

Food and Drug Administration Commissioner Lester Crawford is out only two months after the Senate confirmed him to run the agency. President Bush designated Dr. Andrew C. von Eschenbach, the director of the National Cancer Institute, the acting replacement. Crawford's surprise resignation, submitted Friday and effective immediately, gave no specific reason for his departure. "It is time at the age of 67, to step aside," he wrote in his resignation letter.

Crawford's tenure was marked by increasing criticism of the agency by those who contended it had become more interested in politics than in its mission to protect consumers.

Earlier this year, the FDA-approved painkiller Vioxx was pulled off the market over health concerns. Thousands of heart monitors have faced recall over malfunctions. And the agency has delayed approving an emergency, morning-after contraceptive called "Plan B" for over-the-counter sales despite assurances it is safe. Some religious conservatives opposed the drug. Crawford's time at the agency included more than a year as acting commissioner during a lengthy confirmation process. He won the Senate's backing in July only after telling senators the agency would make a final decision on legalizing Plan B for over-the-counter sales by Sept. 1. Then in August word came of another delay, prompting intense criticism from proponents of Plan B and leading to the resignation of the FDA's top woman's health official.

Crawford, a veterinarian who specialized in food safety, was named acting commissioner in February 2004. Bush elevated Crawford to commissioner in part because his experience was deemed important as the FDA attempted to better safeguard the food supply against bioterrorism. In a speech last Monday in Washington, Crawford gave no sign he was planning to leave, instead discussing upcoming FDA policy on the safety of cloned beef and talking about agency plans to mark the 100th anniversary of the Food and Drugs Act of 1906. Health and Human Services Secretary Mike Leavitt accepted Crawford's resignation "with sadness," HHS spokeswoman Christina Pearson said. "We thank him for his service and wish him well," she said. Asked if he was forced to resign, Pearson declined to comment further, calling it a personnel issue.

Crawford's replacement, von Eschenbach, is a urologic surgeon. A Philadelphia native, he took over the National Cancer Institute, the government's lead agency in researching cancer treatments, in 2002. Prior to that, he served as chief academic officer of the University of Texas M.D. Anderson Cancer Center in Houston. Von Eschenbach wrote in 2004 that he has survived three cancer diagnoses: melanoma in 1989, and more recently, prostate cancer and basal cell carcinoma. In published articles, von Eschenbach has laid out an ambitious - some would say unrealistic - goal of eliminating suffering and death due to cancer by 2015, turning it into a manageable disease.

Many FDA critics lauded Crawford's departure. "The American consumer should shed no tears at Mr. Crawford's resignation," said Sen. Byron Dorgan, a North Dakota Democrat who voted against Crawford's confirmation. "The fact is, he took the side of the pharmaceutical industry and against consumers at virtually every opportunity." "In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information," said Sen. Charles Grassley, R-Iowa, who has spent 18 months investigating the agency.

But one consumer group lamented Crawford's departure, particularly the loss of his food-safety expertise. "The agency has had so much turnover in the top spot, and turmoil throughout, that it could have benefited from a period of steady leadership," said Michael Jacobson of the Center for Science in the Public Interest.

Crawford, who had worked at FDA on four separate occasions over the last 30 years, on Friday cited among his accomplishments new steps to improve drug safety, efforts to speed drug development, and bringing more funding to the cash-strapped agency through manufacturer-paid fees.

Source

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

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