Apr. 24, 2006 - 21:57 MDT

PROMISES ?

The formalities of federal governance seem to take the place of real reform. An article in this morning's Rocky Mountain News talks about reform. By Andrew Bridges of the Associated Press - herewith quoted in entirety, (bolds and italics mine):

FDA REFORM URGED

Agency needs better ways to enforce drug safety, report says

WASHINGTON -- "The Food and Drug Administration should have the power to require that drug makers conduct studies on the safety of prescription medications already on the market, congressional investigators recommend."

"Drug makers often promise timely follow-up studies, but they frequently delay going ahead, the agency said. As a result, the FDA can lack useful data in determining whether an approved drug really is safe, according to a report being released today by the Government Accountability Office."

"Investigators also are urging congress to change how the FDA tracks potential concens about drug safety, makes major decisions and settles internal disputes. especially between the two offices that now assess drug safety."

"FDA lacks clear and effictive processes for making decisions about and providing management oversight of, post-market safety issues," the report says."

"In a response included in the report, the FDA said the conclusions were reasonable and consistent with actions the agency had planned or already begun."

"Sen. Charles Grassley, R-Iowa and Rep. Joe Barton, R-Texas, requested the investigation after several recent drug safety cases, including the withdrawal from the market of the pain killer Vioxx in 2004."

"This report provided solid evidence that everything is not all right at the FDA and calls for long-overdue reform. The FDA's problems are systemic and cultural, not isolated or easily fixed," Grassley said.

"Grassley and Sen. Christopher Dodd, D-Conn., introduced legislation last year that would give the FDA the power to require drug companies to carry out studies of drugs already on the market."

"The bill was referred to the Senate Committee on Health, Education, Labor and Pensions nearly a year ago."

"The FDA recently reported that of 1,231 studies that companies pledged to conduct, often in exchange for expedited approval of a drug, nearly two-thirds had yet to get under way as of last Sept. 30."

"The FDA would have "real teeth" if it had the recommended authority, Grassley said."

"The agency has taken steps to address the issue raised in the report."

##"In 2005, the FDA asked the Institute of Medicine, part of the National Academy of Sciences, to study drug safety."

##"Also last year, the FDA set up a Drug Safety Oversight Board and seperately commissioned an evaluation of how the agency handles companies' committments to post-marketing studies."

##"Last week, Dr. Paul Seligman was named to a new position overseeing drug safety policies. Seligman said one goal was better managing the 600 reviews of drugs with potential safety concerns that the FDA carries out each year."

"Dr. Alastair Wood, associate dean of VAnderbilt Medical Schbool, URGED MORE SWEEPING CHANGES, INCLUDING CREATION OF A DRUG SAFETY BOARD THAT IS INDEPENDENT OF THE FDA."

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So, I wonder if this is a genuine effort to get things straightened out or if it is more smoke and mirrors in an effort to make it appear that something is truly being done ?

Somehow it seems that the more legislation, the more agencies and the more boards are set up the cloudier our situation and safety in many areas gets.

To my way of thinking "expedited approval" is a suicidal thing and the promises to carry out after the fact investigations are empty. As well, studies of drugs already on the market would not actually be needed if proper research and tests were conducted to begin with -- or does that make too much sense ?

More rollers to the mills of the governmental gods to take more time to do - - - - what ? ? ? ?

Case in point are the atomic workers of our country who are still vainly trying to get the money to pay for their medical treatment and care and still coping with their cases being handed off to still another arm of the government who have stated they are going to take care of it but still burden the sick folk with red tape and demands for proof of exposure. While they gradually die off.

What is the old saw ? "The road to hell is paved with PROMISES . . . . . . . .

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