[tt] FDA slammed for being underfunded, too lax

[Hughes, James J.]

Since we were recently discussing it on wta-talk, you may be interested
in the report released today on the FDA's laxity, reported in the NYT
piece below, as well as in the piece I just had published in medical
Device Daily which touches on some my ideas for reforming clinical
trials using new information technologies:

"Technocitizenship, innovation and the biopolitics of medical devices"
by J. Hughes, Medical Device Daily, Sep 26, 2007
http://ieet.org/index.php/IEET/more/hughes20070926/

--------------------------

http://www.nytimes.com/2007/09/28/health/policy/28fda.html

Report assails FDA oversight of clinical trials
Agency does little to ensure the safety of the millions of people who
participate, investigator says.

By By Gardiner Harris

THE NEW YORK TIMES

Friday, September 28, 2007

WASHINGTON - The Food and Drug Administration does very little to ensure
the safety of the millions of people who participate in clinical trials,
a federal investigator has found.

In a report to be released today, the inspector general of the
Department of Health and Human Services, Daniel Levinson, said that
federal health officials do not know how many clinical trials are being
conducted, audit less than 1 percent of the nation's testing sites and,
on the rare occasions inspectors do appear, generally show up long after
tests are completed.

The FDA has only 200 inspectors, some of whom audit clinical trials part
time, to police an estimated 350,000 testing sites. Even when those
inspectors found serious problems in human trials, top drug officials in
Washington downgraded their findings 68 percent of the time, the report
found. Among the remaining cases, the agency almost never followed up
with an inspection to determine whether the corrective action that the
agency demanded had actually taken place, the report found.

"In many ways, rats and mice get greater protection as research subjects
in the United States than do humans," said Arthur Caplan, chairman of
the department of medical ethics at the University of Pennsylvania.

Animal research facilities must register with the federal government,
keep track of subject numbers, get unannounced spot inspections and
address problems speedily or risk closure, none of which is the case in
human research, Caplan said.

Indeed, because no one collects the data systematically, there is no way
to tell how safe the nation's clinical research is or ever has been.

The FDA oversees the safety of only trials done by companies seeking
approval to sell drugs or devices. Using an entirely different set of
rules, the Office for Human Research Protections oversees trials
financed by the federal government.

Privately financed noncommercial trials have no federal oversight.

"It's crazy that we have all these different sets of rules," said Dr.
Ezekiel Emanuel, chairman of the department of bioethics at the National
Institutes of Health. "It would facilitate things a lot if we had one
agency overseeing things."

Dr. Janet Woodcock, the chief medical officer at the FDA, acknowledged
that the agency needs to put more "teeth" in its enforcement.

"We are working to address these problems very aggressively," she said.

The FDA disqualified investigators from conducting further clinical
trials only 26 times between 2000 and 2005 and disqualified their data
just twice - even though the agency found serious problems at trial
sites 348 times during the period, the inspector general found.

Although some of the report's findings surprised ethicists, the fact
that the FDA's oversight of clinical trials is disorganized and
underfinanced has long been known. That criticism is, in many ways,
identical to ones leveled at other FDA functions, including its
oversight of imported food, foreign drug manufacturers, animal food and
the safety of older medicines.

In each case, the size and complexity of the tasks facing the agency
have grown enormously in recent years while the number of inspectors
needed to complete those tasks has generally declined.