FDA's David Graham Says U.S. Drug Safety System No Better in 2005

Graham Criticizes Agency's Performance During The Year Since Vioxx Recall 

In November 2004 David Graham, associate director for science and medicine at the FDA's Office of Drug Safety, criticized the FDA's drug oversight practices during a Senate Finance Committee hearing.  During his testimony, Graham made the now well-known remark that the FDA is "virtually defenseless" against another "terrible tragedy and a profound regulatory failure," such as Merck's withdrawn arthritis drug Vioxx.

In a November 2005 interview with Rita Rubin, a reporter for USA TODAY, Graham said that not much has changed at the FDA in the year since the Vioxx recall.  Graham told US TODAY that, "Today the United States of America is worse off when it comes to drug safety than it was a year ago when I testified."  In addition, this November USA TODAY article by Ms. Rubin included these comments by Graham:

• The FDA's new drug safety initiatives operate only as a diversion without real solutions.
• The Office of Drug Safety should be independent from FDA.
• The Drug Safety Oversight Board is a "a kangaroo court" because many of the board's 15 members are FDA employees that help review and approve new drugs.
• The ongoing Institute of Medicine study requested by FDA to examine drug safety will not have a great impact, because it is based heavily on FDA-supplied information.
   

Ms. Rubin wrote an accompanying piece for USA TODAY, also, which listed the several unsafe drugs which David Graham is especially concerned about, now.  As some may recall, when Graham gave his November 2004 Senate testimony he named five prescription drugs that he believed had an undue propensity for serious side effects.  That 2004 list consisted of Accutane, Bextra, Crestor, Meridia, and Serevent.

Graham's 2005 list of unsafe drugs included the following:

Natrecor (nesiritide): an intravenous heart-failure treatment approved by the FDA to treat hospitalized patients with acutely decompensated congestive heart failure.  As pointed out by esteemed cardiologist Eric Topol, of the Cleveland Clinic, in a July 2005 New England Journal of Medicine article, no clinical trial has yet proved that Natrecor reduces the risk of death or repeated hospitalization from heart failure.  As such, Dr. Topol questioned whether Natrecor should stay on the market.

Risperdal (risperidone): an atypical anti-psychotic which has been approved by the FDA to treat schizophrenia but is widely prescribed "off-label" for behavioral problems in elderly patients with dementia.  After ignoring reports of serious side effects from Risperdal in this population of patients, in April 2005 the FDA finally mandated that the drug's maker, Jansen, put a "black-box" warning on the Risperdal package insert to remind prescribing doctors that treating behavioral problems in dementia patients is not an FDA-approved use of Risperdal, and that such off-label prescribing of Risperdal has been linked to a higher death risk in these elderly patients.

Senate Finance Committee chair Charles Grassley, a Republican from Iowa, told USA TODAY that "Dr. Graham and people like him make a big difference."

We concur with Senator Grassley that David Graham should be commended for his good work on the cause of drug safety.  We are discouraged, however, that much of Dr. Graham's advice about how the FDA should perform its drug safety oversight role is still being ignored in Washington.

(Posted by: Tom Lamb)