Ol dog raises up new young pup

An announcement by FDA Commissioner Dr. Lester Crawford noted new appointments only a few weeks ago with no major media attention at that time.

Crawford named Dr. Scott Gottlieb first on his "senior team of experienced public health professionals".

"Senior team"?

Dr. Gottlieb is not many years removed from being a senior in college according to an extensive, investigative, front-page report by the Seattle Times last week. Gottlieb is not all that far removed from being a senior in high school. Does his background warrant membership (let alone leadership) on any "senior team"?

33 years old and barely out of medical school, Gottlieb has since 2003 seen "patients during weekend shifts two or three times a month at Stamford Hospital in Stamford, Conn.", according to last week's Seattle Times article. That qualifies one as an "experienced health professional" in FDA Commissioner Crawford's book?

The practice of medicine has been a part time job for Gottlieb. The first job of Gottlieb out of college was in an investment-banking firm. His undergraduate degree is in Economics.

In every year from 2000 and up until little more than a month ago Gottlieb worked as an investment adviser specializing in promotion of pharmaceutical and biotech companies except for the year 2003. The FDA failed to mention any of Gottlieb's Wall Street and investment banking ties to the pharmaceutical industry in its announcement of this appointment to the #2 position at the FDA.

Wall Street loves this FDA appointment.

The career to this point of Dr. Gottlieb has in short been that of a high-tech drug pusher. He is now the new FDA Deputy Commissioner for Medical and Scientific Affairs. He will be the Senior Policy Advisor to the Commissioner.

Medical professionals including a former editor of the New England Journal of Medicine are expressing great concern about this FDA appointment.

Commissioner Crawford noted in his announcing the appointment of Gottlieb, "We are now ensuring … that we communicate clearly with patients and physicians so they have the best information available to make well informed decisions about their health"

Yet the young pup Gottlieb has shown a dogged determination to restrict drug-warning information to doctors only. He has also held through the years with the tenacity of a pit bull to an insistence that drugs should be speeded up in the approval process.

The horrors of Thalidomide pale in comparison to an estimated 55,000 or more deaths from FDA fast track approved Vioxx. FDA approved anti-depressant drugs have been cited in numerous school shoot-em-ups and with black-box warnings regarding suicidal tendencies. Then there is the Institute of Medicine admitting to a likelihood of 100,000 deaths due to medical errors.

Is this really the time to speed up drug approvals and restrict consumer information?

Should the FDA be renamed 'Fraudulent Drug Administrators' or 'Federal Death Administration'?

This column will conclude exactly as another column on the FDA more than two years ago because it is at least as appropriate now as then.

Shoot that ol' dog?

The FDA has been a watchdog from even before its official founding to the present day. Problem is that this watchdog was supposed to be for the little people of this nation and has far too often been for industrial giants instead.

Can the old dog learn new tricks or is it time for a new dog? How many times do you let your dog turn on you before finally putting it down?