[[ Your Name ]]
[[ Your Address and/or Contact Information ]]
Date: 2014-01-02
Re: VASCEPA – The Statin Of Triglyceride Medications DENIED
ADCOM Panel Manipulated - Millions Of Life Years Lost
To: FDA
Dear [[ Recipient ]]
I have grave concerns regarding the FDA’S handling of the ADCOM meeting for
consideration of VASCEPA in the treatment of triglycerides in the 200 - 500 mg /
dl range. Below is a list of occurrences that I believe the FDA and its members
and consultants need to take note of:

The FDA could not reject Vascepa based on safety or efficacy so most
amazingly they rejected existing standards of care indicating that
Triglycerides between 200 - 500 mg/dl not be treated. This groundbreaking
information was never given to practitioners who continued to prescribe
billions of dollars of medication to treat Triglycerides in the 200 – 500 mg dl
range. The only public notification of this groundbreaking news was in an
SEC Form 8-K to AMARIN investors.

Since that time, new guidelines have been released regarding the treatment
of lipids. However, it should be strongly noted that the guidelines make no
mention of any revision of triglyceride treatment parameters. They have
neither removed nor changed guidelines with respect to triglyceride
treatment. The FDA has removed triglyceride parameters with no evidence
as to why.

We are all aware that the new guidelines indicate that treatment with statins
should occur based upon risk factors alone. The implication (as we have
known for some time) is that statins do more than lower LDL. Consider if
Zetia had been presented first to the FDA for the treatment of LDL. Utilizing
the same logic that was applied to Vascepa (that since other meds that lower
triglycerides do not change CAD incidence therefore Vascepa must not) –
statins would never have been approved and millions of life years would
have been lost. Therefore, of grave concern, is the inappropriate inclusion of
Vascepa in the same category as other medications that lower triglycerides.

The FDA prevented the most compelling evidence regarding lowering of
cardiovascular outcomes with EPA (Jelis Study) from being presented to the
ADCOM committee. So not only was an inappropriate link made between
Vascepa and other medications (as described above), actual evidence
regarding the specific drug itself was not allowed to be presented. This would
be equivalent to preventing any of the myriad of studies regarding statin
benefit from being presented and then saying statins are the same as Zetia
and therefore should not be approved.

After meeting all of the agreed upon ANCHOR endpoints the FDA,
amazingly, changed the requirements at the ADCOM meeting and asked the
panel to predict the results of a future study.

The FDA then indicated to the general public that trans-fatty acids – most of
which are converted to Triglycerides in the body should be reduced. In direct
contradiction to their statement that triglyceride levels in the 200- 500 mg / dl
range should not be treated (If one wished to argue about inflammatory
markers as a result of triglyceride consumption then this makes Vascepa’s
position even stronger)

The FDA then approved a drug (Antara) and their label, which states that
lowering Triglycerides has no effect on cardiovascular outcomes – the very
reason they rejected Vascepa!

The FDA’s website still indicates that triglyceride > 200 mg / dl be treated

The FDA indicates to Amgen and Sanofi that their new PCSK9 drugs do
NOT need to prove they prevent heart attacks and death before they’re
approved… but Vascepa does!

When one views the ADCOM meeting at approximately 22 minutes, in starts
the confusion – Dr. Colman advises panel members to use parameters
considering Vascepa’s effect on CAD – he then says members should
answer the question without REDUCE–IT (study on CAD occurrence). These
are DIRECTLY contradictory! It would be like saying take the test with your
calculator but you cannot use it. The fact that no panel member raised a
question on this should be of grave concern.

Rumors are now on the Internet that the FDA will punish AMRN by placing a
black box warning on the medication. Such inappropriate labeling threatens
patient health by confusing health care practitioners. Traditionally, black box
warnings alerted practitioners that the medication had the potential of very
serious consequences and, therefore, should only be utilized as a last resort.
All health care practitioners have come to associate a black box warning with
major risk and will intuitively pick other medications if at all possible. If true, it
would appear the FDA has now chosen to post warnings of life threatening
side effects and possible lack of effectiveness in the same box! This is clearly
an inappropriate linkage of two entirely different issues. One may kill you the
other simply may not work. This faulty linkage threatens patient health. When
the FDA places a black box – no matter what the reason – Health Care
practitioners immediately decline to use it. Thus many new medications for
which studies are currently being conducted to determine effectiveness are
not getting to patients as a result of black box labeling. It would seem to be a
simple matter for the FDA to develop two levels of warning - one in which
there is a risk to patient health (black box) and the other in which
effectiveness remains to be determined.
Of course the reason of having meetings such as the ADCOM is to seek input
from multiple sources and ultimately arrive at the correct conclusion for the
benefit of society in general. I do believe that we can right this wrong and ask all
of the dedicated scientists and physicians who have worked on this issue to
please seek out what is scientifically correct and do what will benefit humanity
the most.
Sincerely,
[[ Your Name ]]