Arrggh … pirates of the careless beings there be at the FDA and GlaxoSmithKline (GSK).

The common diabetic drug Avandia has been noted to increase risks of heart attack and heart death between 40 per cent and 70 per cent in recent reports.

GSK countered that the risk was 31 per cent. What kind of defense is that? Is that an acceptable risk?

A news report noted these risks were observed in a 2003 Avandia study.

A subsequent news report disclosed that FDA staff scientists in 2002 called for label warnings against congestive heart failure be added to Avandia.

“A lot of people just freak out. But there’s no cause for panic,” said Dr. John Buse, president-elect of the American Denialbetes Association after the above news reports. Dr. Buse recommended keeping the study “in perspective” according to The News & Observer (TN&O) newspaper in the hometown of the University of North Carolina diabetes center where he is director.

“We’re comfortable with that if they’re comfortable with it,” Buse told TN&O.

Pirate perspective?

The lead character of the ‘Pirates’ movie franchise expressed that he was comfortable with giving up scores of lives for his own.

The day following the “no panic” and “comfortable” remarks from Dr. Buse a New York Times story reported that he cited, “a worrisome trend in cardiovascular deaths and severe adverse events” among patients using Avandia in a letter he sent in early 2000 to the FDA.

The Times cited Buse as saying that his opinion of Avandia had not changed but urged waiting another 2 years for a study by the maker of the drug. That would be TEN YEARS after being in the marketplace. Currently more than 1 million Americans take Avandia.

The 2000 letter was only months after the drug was first approved.

Subsequent reports have noted heart problems first cited from studies conducted before the drug was even approved in 1999.

Evidence of benefits from Avandia when it was approved were “at best mixed” according to Drs. Bruce Patsy and Curt Feinberg in a New England Journal of Medicine (NEJM) editorial.

Avandia “represents a major failure of the drug-use and drug-approval processes in the United States” the doctors wrote in the NEJM editorial.

Big booty strapped bill

All of this is courtesy the United States Congress and their Prescription Drug User Fee Act (PDUFA) bill passed in 1992.

This bill was celebrated as requiring drug companies to contribute $250 million annually to drug approval processes. What was not trumpeted about was that the back end of the bill allowed faster approval of drugs without waiting for usual safety testing to be completed.

The pharmaceutical industry has profited tens of billions of dollars due to this little arrangement exceeding a 40 to 1 return on investment. Not a bad business deal at all. It appears that it pays well for the pharmaceutical industry to have more lobbyists in Congress than there are Congressional representatives in Congress.

PDUFA was originally for only five years but was reauthorized by Congress in 1997 and 2002. The Senate just approved reauthorization (SB1082) for 2007. The House is slated to vote on reauthorization soon (HR1561).

Unnoticed in all of this is all of the drug recalls, black box warnings, drug injuries and drug deaths from these fast-tracked drugs unlike anything seen before PDUFA.

Newly added language to PDUFA makes allowance for much more regulation and likely removal of nutrient supplements from the marketplace even as it continues to make drugs more easily available.

The return of PDUFA like that of the sparrow in spring may sink to new depths for health problems even as it continues the bloom of profits from these rush-to-market drugs like nightly mosquitoes sucking the life blood from those unable to extricate themselves from or even to see the problems.

Those in the United States House of Representatives should be disinclined to acquiesce to the request of the pharmaceutical lobbyists. Means “No” to PDUFA.

PDUFA may be the worst legislation for “we the people” ever passed by Congress.