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Jackson,
What follows may confuse you so please read it several times.
(1) I have drafted a letter for submission to DateLine and
20/20.
(2) Because I am not a professional writer, BEFORE I mail this
letter to these TV shows, I seek Professional editing
help.
(3) After MUCH consideration, I have decided that the best place
to get help drafting a letter would be from real
professional editors. Makes sense <g>
(4) With this in mind, I seek your help.
(5) Would you forward my draft (which is below) to the top
10 Womens magazines in the United States, addressed to
their editors.
(6) Now - this is important.
Explain to them that I am not writing a letter to them.
Rather, I am seeking their professional help - at no cost -
in drafting a letter to 20/20 and Dateline about
Breast and Ovarian cancer drugs.
Any help that they could provide would be appreciated.
Tell them that I have tried to be as factual as is possible.
Below is a copy of my draft.
Dear Dateline and 20/20
Below is the true story of a Mr. XXXXXXXX, told by him,
at an FDA meeting on September 19th of this year.
It is a compelling story, filled with high emotion, whose main
theme is the triumph of the human spirit over adversity.
Mr. XXXXXXXX has AIDS.
His story is an optimistic one, especially in the face
of some really harsh choices. And his experiences might give
others - male and female, young and old - faced with
similar harsh choices, a sense of renewed strength and optimism.
In a perfect world, I could conclude this note by
simply asking you to read Mr. XXXXXXXX's story and consider it.
My purpose in writing you, however, is to also tell you another
story - part true and part fiction.
It is the story behind Mr. XXXXXXXX's story.
Unfortunately, its' theme resounds more like the 'mean parts'
of a Charles Dickens novel - but without a happy ending.
This story begins in the late 1980's.
U.S. government scientists discover a chemical
in the Yew tree that has very beneficial effects on breast,
ovarian and skin cancer. The effects are so surprizing that
a famous scientist says publicly that this chemical is
the greatest discovery against cancer in the last 15 years.
This scientist's observation was correct then and still holds today.
At this point, we have to fast forward to 1992. In this year,
two seemingly incongruous events happen.
The first event involves the FDA. FDA as used here does not refer
to the entire FDA organization;rather, just 10 or 12 doctors
who comprise the cancer review panel.
In terms of their authority making powers, perhaps the
only available analogy would be the I.R.S.
In 1992, this panel awards Bristol Meyers Squibb the rights to
test and manufactuer this new Cancer drug. At this time,
everyone realizes that (1) Bristol Meyers Squibb is a billion
dollar company, (2) this right is for a billion
dollor block-buster drug and (3) the discovery of this drug was
paid for by the American people - not Bristol Meyers Squibb.
Bristol Meyers Squibb names the new drug - TAXOL.
The second event that happened in 1992, came about at the request of
several patient groups. And because of these requests, a congressman
from California sponsored what became known as the Orphan Drug law.
Its intent was straight-forward:
To motivate drug companies to develop drugs for diseases
with small populations. In return for their investment,
these drug companies would be free to sell their drugs for
7 years without any competition.
At this point, we now fast forward to the beginning of 1997.
Its the beginning of the year ...
(1) TAXOL sales in the United States reach $500 million dollars
and $100 million overseas.
It is estimated 1997 sales could reach $800 million. Of this
about $600 million would be from use in the United States.
(2) New breast and ovarian cancer cases in the United States
reach approximately 225,000 cases a year. The death rates
are shockingly high, and would be much higher, were it
not for TAXOL. TAXOL truly is a life saving drug.
(3) There is an outcry from some that too may Yew trees are
being destroyed to create Taxol. Weighed against the
alternatives, this faction is ignored.
(4) Chemists at several small bio-tech companies have discovered
a different way to create TAXOL.
One of these small bio-tech companies is called Napro.
(5) Bristol Meyers Squibb management begins to realize they are
at risk of losing their BILLION DOLLAR FRANCHISE drug and
they begin to react.
(6) Napro begins testing a TAXOL equivalent drug - named
PAXENE - on skin cancer patients, specifically patients
with AIDS. They do this for monetary reasons: it is the
least costly way to prove that PAXENE is equivalent to
TAXOL. The entire USA population group that have this type
of skin cancer is approximately 20,000.
Of greatest importance to the companies involved ...
If PAXENE is proved equivalent to TAXOL for this skin cancer,
then PAXENE can legally be used on all cancer patients
that TAXOL is approved for.
(7) Mr. XXXXXXXX enters the Paxene testing group. In a sense,
he really has very limited choices.
(8) In 1997, Bristol Meyers Squibb does something truly
unexpected. They file with the FDA to have their
billion dollar drug - TAXOL - already used by
10,000's patients, to be reviewed under the statutes of
the ORPHAN DRUG ACT.
This was the bill that was enacted to motivate drug
companies to discover and create drugs for small population
diseases.
Taxol was neither discovered or created by Bristol Myers Squibb.
It was discovered and created by the American taxpayer.
(9) By mid summer there is growing anticipation that PAXENE will
prove to be as potent as TAXOL.
(10) In the early summer the FDA does something even more
unexpected and agrees to review TAXOL - the billion dollar
drug - under the statutes of the ORPAN DRUG ACT.
The term FDA does not refer to the FDA organization.
Rather, it refers to the panel of 10 to 12 doctors
that constitute the Cancer panel.
(11) On August 7, the FDA cancer panel (10 to 12 doctors)
does something truly unforeseen. TAXOL, the worlds leading
cancer drug is ruled as an ORPHAN DRUG when used against
a certain type of skin cancer.
This cancer is the same cancer that PAXENE is being
tested against.
(12) On Sept. 19th Paxene is reviewed by the FDA's advisory
cancer panel (this is a prelim panel) and approved
for use against this skin cancer. It is now up to
the final FDA panel to make a decision.
(13) It is at the Sept. 19th meeting, and at his own expense that
Mr. XXXXXXXX tells the panel his story and his great
comeback thru the use of PAXENE.
(14) At this meeting, because TAXOL had received ORPHAN DRUG
STATUS on August 7th, for this skin cancer indication;
it becomes unclear to everyone whether or not PAXENE can be
used for this skin cancer indication.
And if it cannot, then it also cannot be used for
breast and ovarian cancers.
In essence, 10 to 12 people from the FDA Panel and
perhaps 10 people from BMS management -
at most 20 people - have successfully kept
a remarkable drug out of the reach of 225,000 cancer patients
- all of whom are women and all suffering from a fatal disease.
Lets say that slower:
At most 20 people have decided the fate, hopes, dreams,
and life outcomes of 225,000 women.
And this in the year of our LORD 1997 no less.
(15) Congress enacts legislation to speed up the FDA review process.
(16) It is November 10th. Still no decision on a life saving
cancer drug called Paxene.
Everyday that Paxene is off the market, BMS earns on average
$1.4 million dollars in revenues.
Everyday. 20 people. Everyday. 20 people. Everyday. 20 people.
In conclusion, I prefaced this second story by saying it is part
fact and part fiction.
I leave it to you and your resources to cut out the fiction.
Mr. XXXXXXXX's story is below. |
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