Yale's James Phillips Instructs on Adverse Events Reporting

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Mort Zuckerman

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Jun 5, 2008, 7:40:43 AM6/5/08
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Subject: MEDSCAPE: REPORTING ADVERSE EVENTS

Date: Jun 5, 2008 7:36 AM

REPORTING ADVERSE EVENTS:

Here is James Phillips reporting the brain damage he caused me to the
FDA:
http://www.actionlyme.org/JAMES_PHILLIPS_HOMEPAGE.htm

("Dear FDA:
"Kathleen Dickson is a dangerously intelligent Unibomber Chemist. She
learned
all her Unibomber Chemistry from Ted Kascynski, who, as you know, is
famous for
his healthcare activism. Kindly read carefully the Unibomber Chem
Report:
http://www.fda.gov/ohrms/dockets/ac/01/slides/3680s2_11.pdf
Note that there is a schematic or a 'blow up' of SmithKline's famous
dangerously intelligent 'Unconfirmed Lyme...' ")


See the letter by Karen Forschner- she was talking about what she
witnessed in Jan
01 at the FDA meeting about LYMErix in Bethesda:
http://www.actionlyme.org/JAMES_PHILLIPS_HOMEPAGE.htm

A fine place for me to be executing the psychotropics induced brain
damage known
as AKATHISIA, since it is malpractice to treat a CNS infection with a
CNS depressing
judge, but facts clearly don't matter to Yale's James Phillips:
http://www.actionlyme.org/BUNNEY_YALE_BRAIN_DAMAGE.htm


ONLY PENISES MATTER:
http://www.actionlyme.org/PENIS_MATTERS_101.htm

While I was reporting the adverse events to LYMErix to the FDA vaccine
committee,
they, in Bethesda, were watching with their own eyes, the malpractice
treatment
of Lyme:
http://www.actionlyme.org/PHILLIPS_AND_MARCUS_PERJURY.htm


There is no punishment for these perjurers, frauds, genuine perverts
and criminals.
They are still free to harm others upon their whim and fancy, says the
Corrupticut
Health Department:
http://www.actionlyme.org/CT_MED_BOARD_BLOW_OFF.htm
That's a classic. It was entered as evidence in the Dr. Charles Ray
Jones Med
Board Harassment Hearings.

The State of Corrupticut sanctions and approves every type of
malpractice and abuse
of Lyme victims, including perjury, brain damage, false criminal
charges, removal
of FIRST AMENDMENT RIGHTS, no representation in "court," not allowed
to
speak to the "court," not to mention the kidnapping of their
congenitally
infected Lyme children and giving them to a well-documented wife and
child abuser:
http://www.actionlyme.org/Schoen.htm
http://www.actionlyme.org/THE_REAL_DON_DICKSON.htm


And this is really important: If the State of CT wants to bag you
because you are
a whistleblower, they will file false criminal charges against you,
then commit
you to a mental institution for saying you are innocent of the false
criminal charges
("You're CRAZY to deny your charges!!"), where your "case"
never sees the light of day. It is just as bad here as it ever was in
the Soviet
Union.

'No trial, no evidence, you are not allowed to even be *heard* in
court (you
are not allowed to even address the "court"), much less provide
evidence
that the charges are false, and your bond will be the equivalent of
that of a murderer
($490,000 in my case).

Nearly half a $$million.

Yes. That was my bond, which gives some inkling to the truth of these
charges being
TOTALLY FALSE.


Kathleen M. Dickson

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

http://www.medscape.com/viewarticle/574523?src=mp


From Medscape Pharmacists
Expert Column
Overcoming Barriers to Reporting Adverse Drug Events

Posted 05/29/2008

Charles L. Bennett, MD, PhD, MPP; Cara C. Tigue, BA
Author Information


Serious adverse drug events (ADEs) may emerge after a new drug is
brought to market;
in fact, a median of 7 years elapses before such incidents are
described by pharmaceutical
companies or the US Food and Drug Administration (FDA).[1] An
important factor underlying
this delay is low reporting of ADEs, with only 1% to 10% of all such
incidents reported.

In an effort to improve detection of serious ADEs, the FDA is forming
partnerships
with large health insurers and is planning to monitor insurance
claims, electronic
medical records, and laboratory test results for persons who are
covered by these
health insurers. However, recent studies highlight the importance of
clinicians
reporting even small numbers of clinical events that may be involved
in serious
and potentially fatal ADEs.

For instance, clinician involvement was key in identifying problems
with natalizumab-
and rituximab-associated progressive multifocal leukoencephalopathy,
epoetin-associated
pure red blood cell aplasia,[2] ticlopidine- and clopidogrel-
associated thrombotic
thrombocytopenic purpura,[3,4] zolendronate-associated osteonecrosis
of the jaw,
and gadolinium-associated nephrogenic systemic fibrosis. These
toxicities were elucidated
based on comprehensive reporting of just 3 to a few hundred individual
events to
the FDA. These cases provide important lessons for clinicians and
policy makers
who are interested in improving the safety of pharmaceutical agents
and devices.

In general, an important barrier to identifying and reporting ADEs is
that the toxicity
profiles of many agents are not well characterized at the time of FDA
approval.
In addition, increasing numbers of novel targeted agents are receiving
approval
for the treatment of serious diseases, especially cancer. The unique
molecular pathways
of these agents often increase efficacy while minimizing the side
effects of older,
more conventional therapies. However, several serious ADEs have been
associated
with these newer agents that were not associated with conventional
therapies, and
they have not yet been fully characterized.

Accelerated approval regulations were established in 1992 to enable
patients with
life-threatening diseases to have rapid access to therapeutics. The
accelerated
process allows for drug marketing based on surrogate outcomes that
show meaningful
therapeutic benefit. Drug sponsors are still required to conduct
confirmatory phase
III studies to verify clinical benefit. However, this requirement has
not been met
for many drugs that received accelerated approval, suggesting that the
safety profiles
of these agents may not be adequately described.

A recent study in The New England Journal of Medicine found that drug
review deadlines
imposed by the Prescription Drug User Fee Act lead to rushed approvals
and unanticipated
safety problems following FDA approval.[5] The study found that drugs
approved in
the 2 months before that deadline were more likely to be later
withdrawn from the
market for safety reasons, and more likely to receive a black box
warning compared
with drugs approved at other times.

In light of these findings, clinicians must be cognizant that some new
drugs may
not have undergone extensive safety reviews. If a novel agent receives
accelerated
FDA approval, the safety database may be as small as a few hundred
carefully screened
individuals. If an unexpected clinical event occurs with a novel
agent, you can
be fairly certain that neither the manufacturer nor the FDA has seen
such an event
before. This is especially true for novel agents that are used in off-
label clinical
settings or by individuals with complex medical histories.

For example, gemtuzumab ozogamicin, the first FDA-approved
immunoconjugate, received
its initial approval based on monotherapy findings from 3 phase II
trials of older
patients with acute myeloid leukemia. Immediately thereafter,
clinicians at MD Anderson
Cancer Center in Houston, Texas, evaluated the drug as an off-label
treatment with
combination chemotherapeutic regimens for younger persons with AML.
Between 10%
and 40% of these individuals unexpectedly developed ascites and
hepatic dysfunction.
In addition, a new syndrome termed sinusoidal obstructive syndrome was
identified
by a single astute leukemia clinician.[6]

Unfortunately, many clinicians are unaware of how to file ADE reports,
or they feel
that such efforts would be too costly or time-consuming, seeing little
benefit in
their voluntary actions. Fortunately, regulatory guidance offers some
assistance.
An astute clinician who identifies a potential serious ADE but does
not have the
time or resources to report comprehensive details of the case still
has some options.

In the inpatient setting, hospital pharmacy personnel are usually
willing to assist
the clinician in filing a report with the FDA's ADE reporting system,
MedWatch.
These individuals generally are not paid specifically for this
service, but hospital
quality improvement regulations allow for them to review medical
records and report
the clinical details, laboratory findings, and outcomes of an ADE.

In the outpatient setting, such assistance may not be identified quite
as easily.
However, the clinician can summarize the relevant findings in a memo
(without disclosing
personal identification) and forward this information to the sales
representative
from the relevant pharmaceutical company. By law, this individual must
forward the
clinical information to MedWatch. In fact, the clinician should ask
the sales representative
to provide a copy of the MedWatch report after it is submitted.

Clinicians who identify an unexpected, serious ADE should also
consider sharing
de-identified information on the case with academic investigators who
have expressed
an interest in the subject area or in pharmacovigilance. These
individuals are highly
motivated to develop concise case summaries and to submit this
information for review
at scientific conferences and in peer-reviewed medical journals.

For example, the Research on Adverse Drug Events and Reports (RADAR)
project of
Northwestern University is very interested in reporting small case
series of rare
but serious ADEs. The RADAR team has identified and evaluated 38
reports of serious
drug reactions over the last decade, with most of these toxicities
identified in
the oncology setting. The RADAR methodology has relied on initial
recognition of
sentinel cases that then prompt hypothesis-driven inquiries as to
whether an unrecognized
ADE signal is present in the population exposed to that drug. A
clinician may contact
collaborators with the RADAR project who, in turn, develop reports
describing the
case series. In our paper on clopidogrel-associated thrombocytopenic
purpura, 4
clinicians who submitted case reports of individuals with this
unexpected toxicity
were co-authors on The New England Journal of Medicine report.[4]
Their help in
this investigation was indispensable.

Lawyers can also join the safety team. An observant attorney submitted
to the RADAR
group clinical information on a healthy volunteer in a phase I
clinical trial of
megakaryocyte growth and development factor who subsequently developed
severe thrombocytopenia
as well as a lymphoproliferative disorder. This report was followed by
other clinicians
submitting information on 12 healthy volunteers who also developed
severe thrombocytopenia
and 2 other volunteers who developed lymphoproliferative disorders.[7]

Patients are aware of the time and financial crunch that clinicians
face. When a
patient experiences a potential ADE, the immediate goal is getting
through the complication
and moving on. Subsequently, anger arises as they wonder why the FDA
or the manufacturer
did not warn them in advance about such a possibility.

If a clinician reports the event to the FDA (or to the pharmacist or
sales representative),
then a MedWatch report is generated. Patients generally are
appreciative if they
receive a copy of the MedWatch report and understand that the
clinician took the
extra step to report the clinical details to the proper authorities.
If the FDA
or drug manufacturer subsequently issues a report about this drug, the
patient is
likely to appreciate the previous notice even more.

With the increasing focus on pharmacovigilance, academic organizations
have evolved
with focused interests in specific toxicities. The Arizona Center for
Education
and Research on Therapeutics (CERT) has developed a novel Web site for
reporting
unexpected drug-associated Q-T prolongation events. The RADAR project
focuses primarily
on adverse drug reactions involving the disciplines of hematology and
oncology.

The National Registry of Drug Induced Ocular Side-Effects focuses on
drugs that
unexpectedly result in blindness or severe vision changes. Several
other toxicity-specific
centers have developed around the country at academic centers (Table).
These centers
focus on liver failure, muscular-skeletal disorders, cardiovascular
disorders, and
many other toxicities. Contacting any 1 of these sites would help the
pharmacovigilance
investigators assist the busy clinician by summarizing relevant case
information.

Table. Academic Organizations With Focused Interests in Specifi
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