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FDA Talk

Talk by Frank Burroughs, President
Abigail Alliance for Better Access to Developmental Drugs

FDA Clinicaltrials.gov Meeting Capitol Hill Hyatt Regency Hotel Washington, D.C.
July 24, 2002

I am Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs.

My words this afternoon are dedicated to sweet and beautiful thirty-five–year-old Alita Randazzo who died on Saturday
of colorectal cancer. Alita and her allies worked to try and get developmental cancer drugs for her that had a significant
chance of extending or saving her life.

I am a father who lost his beautiful, compassionate, and very intelligent only child to cancer. Abigail could not get
developmental caner drugs that had a significant chance of saving her life. Abigail was only 21!

We are here today, because we all doing important work to save and extend lives. I want to sincerely thank the Food and
Drug Administration and the National Library of Medicine for their ongoing efforts to help cancer patients and others with
life threatening illnesses.

The very important website, clinicaltrials.gov, is one example of your good work. Like any of us who work outside of the
government, the government’s efforts are ongoing.

We need to make sure all clinical trials are listed on clinicaltrials.gov.

The clinicaltrials.gov web site must be kept up to date!

It is imperative that all company sponsored clinical trials get posted!

Expanded access programs need to be listed.

Clinicaltrials.gov needs to be promoted so more cancer patients and oncologists know about it.

Only 15 percent of oncologists refer patients to clinicaltrials.gov who have exhausted approved treatments!

It is important that there is an ongoing effort to make clinicaltrials.gov as user friendly as possible.

Since we are all gathered here together today I wanted to briefly talk about a few other issues the Abigail Alliance is
addressing. This is the logo for the Abigail Alliance for Better Access to Developmental Drugs. There were promising
cancer drugs Abigail needed, but we could not get that help to her. Abigail is a symbol of the other precious people
who are fighting for their lives.

Let me stress that there are ways to save more lives than are currently being saved.

If we have any bias or inclination to see things from our own turf, we need to try very hard to see things from the
perspective of our most important clients. These clients are our fellow human beings who are fighting for their lives as
they try and survive cancer and other life threatening illnesses.

We all need to work together to develop the best possible avenues to extend and save lives.

As President John F. Kennedy so well brought out in his book ‘Profiles in Courage’ we need to go against the tide and
do what is right. We need to find creative ways to get developmental cancer drugs and other drugs for life threatening
illnesses to patients sooner. We need to have the pharmaceutical industry committed to help in this endeavor. We need
the Congress of the United States to help in any possible way to facilitate saving and extending lives.

Senators and representatives ran so quickly to get in front of the cameras over corporate fraud.

Come on! Run in front of the cameras for cancer patients and others who have run out of options in trying to save their
lives!

The Abigail Alliance has worked hard to put together legislative ideas that could help get developmental drugs for life
threatening illnesses to people sooner. We continue to get our well thought out detailed legislative ideas to Capitol Hill.
We need the FDA to look at their own important organization and develop ways to help get developmental life saving
cancer drugs and other life saving drugs to patients sooner!

We need the current administration to pay more attention to this issue of life and death.
Cancer is terror too!

The media has done some great work to get these issues out to the public. However, we need more coverage!

I have talked to hundreds of cancer patients. Every one of these special people are vigorously for more expanded
access to new drugs! How can anyone be against them!

Patrick Doran is a loving father and husband who is fighting for his life and lives in Falls Church, Virginia. Here are his
exact words: "Cancer patients without other options are willing to assume many risks if taking a particular drug may
prolong their life. We are fighters and we need to be given the tools to fight for our lives. In exchange, we will provide
data on our efforts, success and failures, that may expedite the universal release of the drug to benefit others. Please
allow us to be pioneers. Allow us to take responsibility for our fight by providing immediate access to potentially
beneficial drugs when all other options have failed. Frankly, EVERY ONE has much to gain.... and the patient has
nothing to lose."

Last week Robert and Robin Krohn contacted me about their precious five-year-old daughter, Morgan, who has
exhausted approved cancer treatments. Are we not going to help a five year old?

There are solutions! Saving lives is our first and most important goal! If your child, spouse, sister, brother, father,
mother, were facing what Patrick, Morgan, and others are facing, what would you want! My guess is that you would
want action now! Clinicaltrials.gov is part of this important effort. Let us redouble our efforts to save lives, and let us
do it now!

As Martin Luther King said, "I have a dream". All of us need a dream to help the sick, whether rich or poor.

Please visit the Abigail Alliance web site (abigail-alliance.org).

I have copies of this talk and the Abigail Alliance legislative ideas that I can give you after this meeting.

Thank you very much