Report
States FDA Drug Safety System is Broken Institute of Medicine Calls
for Greatly Increased Funding, Warning Labels
and
a Moratorium on the Advertising
of New Drugs; also Recommends a
Greater
Role for
Public Input on Drugs and Devices
September
23, 2006 -- In a sweeping critique of the way in
which the U.S. Food and Drug Administration (US FDA) currently
monitors the safety of drugs, a blue ribbon panel of the
Institute of Medicine (IOM), part of the National Academies,
has issued a
350 page report that concludes:
" Lack of clear regulatory authority, chronic underfunding,
organizational problems, and a scarcity of post-approval
data about drugs' risks and benefits have hampered the
U.S. Food and
Drug Administration's ability to evaluate and address
the safety of prescription drugs after they have reached
the market..."
A Reaction
to Vioxx
The report
was commissioned by the FDA itself In the wake of problems found
with
a number of
drugs
that had been approved,
but
subsequently
were
found to have serious adverse effects. A major example was the
Vioxx story and the three-year time lag between the time when independent
researchers found problems
and the drug's withdrawal. As Dr. Eric J. Topol, whose team discovered
the link between Vioxx and heart attacks, wrote in an Op-Ed piece
in the New York Times on October 2, 2004 ("Good Riddance
to a Bad Drug"):
"After
three years of denying that the arthritis drug Vioxx could induce
heart attacks and strokes, this week Merck bowed to reality:
it withdrew
Vioxx from the market. The impact of this decision is
far-reaching, and not only because tens of millions of people have
tried Vioxx.
It also highlights the absence of Food and Drug Administration
oversight of the pharmaceutical industry as well as the lack of
comprehensive long-term studies of not only Vioxx but its entire
class of arthritis drugs."
Eric
Topol's Criticism Echoed
Now, two years
after, Dr. Topol's essay was published, his specific criticisms
are being
confirmed by the National Academy of Sciences. The report states
that most of the FDA's financial resources are put into the
process of approving a new drug, but very little into monitoring
what happens in the population after the drug goes to market. Serious
side-effects and adverse events may not occur in the relatively
small group of patients
used to gain the drug's approval, even though that group is closely
watched. But when those adverse reactions start occuring in the
population at-large, they are not revealed because there is no
adequate means of tracking them in place.
As R. Alta Charo,
a panel member and bioethicist at the University of Wisconsin at
Madison,
stated to the Washington Post:
"...patients who participate
in drug trials are carefully selected, and hardly typical
of patients in
the real
world who
usually suffer
from more complex problems. 'A drug tested in a few hundred
or thousand people is very different when used by millions,
especially over long periods of time and in conjunction with
other supplements...'
Eschenbach Defends FDA
The FDA reacted
to the report with a tentatively defensive posture. Acting Commissioner
Eschenbach
stated in a press release that the FDA "appreciates"
the Institute's work and several times refers to efforts within
the
FDA that are
already underway to address these problems. He concedes that, "while
considerable work has been done over the past two years to improve
our approach to drug safety, work still remains to be done" and
he defended the Agency, stating:
"With regards to strengthening
FDA let me take a moment to recognize the dedicated staff who
serves
[sic] at
FDA.
I'd
like to
specifically
commend the staff of the Center for Drug Evaluation and Research
for the important role they play and job they do each and every
day"
Senator Grassley Responds
By far the most stinging rebuke
of the FDA, as well as its reaction to the report, came from Iowa's
Republican
Senator Charles
E.
Grassley who has chaired investigations of the FDA
in the past. In a press statement Grassley stated:
"Vioxx was like a dead canary
in a coal mine, a warning that worse may yet come. Today there’s
no question left that we need to strengthen post-market surveillance
in order to improve drug safety and save lives. The new report
validates what the watchdog community has been saying for the
last two years:
We need
more vigilance over the life-cycle of drugs, the FDA needs
to be more forthcoming with information about drug risks,
problems are
systemic, and solutions must reflect a new mind-set by
the agency’s
leadership. Remember, the FDA only grudgingly requested
this report to assess drug safety.
Additionally, in a letter
to Acting Commissioner Eschenbach, Grassley painted a
picture of the FDA's employee culture that differed significantly
from Eschenbach's commendation to the staff:
"I have worked to give voice
to the concerns of a number of rank-and-file scientists and
FDA managers
who share a common complaint: a deep-seated cultural divide
exists within the FDA, and it has led to systemic problems
that plague
the agency. Together we have shed sunlight on how frequently
differences of scientific opinion are quashed, the nature of
the cozy relationship
between the FDA and the industries it is supposed to regulate,
and the failure of the agency to be adequately transparent
and accountable to the public.... An agency that hemorrhages
whistleblowers is an agency needing critical care....
I am very troubled by FDA’s attempts to suppress scientific dissent
by muzzling its own scientists. Such actions by the FDA show a lack
of respect for the dedicated scientists working at the agency and
a lack of respect for the scientific process.
Senator Grassley continues:
In the
face of such criticism, the FDA appears to be focused on damage
control rather than addressing its core problems. As a science-based
agency, the FDA is remarkable for its lack of introspection, second-guessing,
and failure to assess its own performance and capabilities in a
systematic way...the FDA comes off as an agency in denial that
chooses to keep its head in the sand in the hope its problems will
go away.
Recommendations
for Change
The
Institute of Medicine's report is not all criticism. It contains
a comprehensive
list of recommendations
for realigning the way in which drugs are monitored and calls for
greatly increased funding from Congress, new enforcement powers
for the FDA, and special cautionary labeling of newly approved
drugs so that patients know if they are taking a drug
that,
although
approved,
has not yet
had
a long
history
of use (a plan currently in place in the U.K.). Additionally, pharmaceutical
firms would be prohibited from marketing Direct-To-Consumer (DTC)
newly approved drugs until their safety in a wide population has
been
established.
As for the impact of these recommendations
on the medical device industry (balloons, stents and defibrillators)
a subject more germane to readers of Angioplasty.Org, tucked away
on page
149
of the IOM
report is
this recommendation for all centers within the FDA, drugs, research
and devices -- a separate advisory committee on consumer issues
that would enhance
the value
of and provide
a mechanism
for
the public's experience:
...the committee believes that a separate,
external entity is needed to advise the agency on the diverse communication
needs of the public and patients and on the best evidence on risk
communication tools and strategies. Several FDA centers, including
CDER, the Center for Biologics Evaluation and Research, and the Center
for Devices and Radiological Health share similar communication challenges.
An advisory committee on consumer and patient communication issues
could have a dual function, serving as a conduit for public input
into FDA's decision making (for example, through surveys), and an
advisor to the agency on a range of communication issues.
The big question now is what Congress
and the Executive Branch will do towards putting these recommendations
into practice. Stay tuned....
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