LEF Email List1 - http://www.lef.org
The Next FDA Commissioner Could Determine How Long You Live!
May 17, 2001
Dear Fellow Life Extensionist:
The greatest obstacle to your health and longevity is the FDA.
Bureaucratic barriers at the FDA stifle the development of novel
medicines, causing the suffering and death of Americans who desperately
need these therapies to stay alive.
While Congress and the Federal Courts have helped curtail FDA
over-regulation, today's flawed system continues to deny Americans access
to the best that science has to offer.
We now have a unique opportunity to change the course of medical history.
President Bush is considering whom to nominate as the next FDA
Commissioner.
There is one candidate for the Commissioner's job who has a plan to reform
the FDA in order to speed the delivery of the fruits of medical research
to every one of us.
The name of this candidate is Mary J. Ruwart, Ph.D. The information that
follows shows that Dr. Ruwart is uniquely qualified to reform an agency
that has lost touch with scientific objectivity.
It is imperative that you notify President Bush that Dr. Ruwart is the
best person to remedy the severe problems that exist at the FDA. Please
copy and mail the letter that follows to the President at the address we
have provided.
If you want to do more, and we hope that you will, we encourage you to
write a personalized letter to mail or fax to The White House.
We have also provided a phone number for those who want to call The White
House to emphasize the importance of appointing Dr. Ruwart as the next FDA
Commissioner.
Even if you have not participated in these types of FDA-reform campaigns
in the past, we urge you to do so on this critical issue.
Our fear is that lifesaving therapies will continue to remain bogged down
in FDA red tape if a change within the agency is not made. It has become
so burdensome to gain FDA approval that innovative therapies in the U.S.
are being abandoned because of extraordinarily high costs and uncertain
bureaucratic delays.
If Dr. Ruwart were to become the new Commissioner, this barrier against
medical innovation would be diminished. More Americans would gain rapid
access to novel medical treatments that could significantly extend the
healthy human life span.
What makes the FDA problem unique is the possibility that each of us will
die from a disease that could have been effectively treated if the FDA
didn't stand in the way.
Inefficient government thrives on citizen apathy, so please take the time
to mail the enclosed letter to President Bush. The life you save may be
your own!
For longer life,
William Faloon
P.S. Those who understand the urgent need for FDA reform and want to do
more should send The White House a personalized letter and/or make a phone
call. The information that follows reveals how you can get your message
through to The White House.
Dr. Mary J. Ruwart's Letter to President Bush:
Mary J. Ruwart, Ph.D.
408 County Road 138-C
Burnet, TX 78611
May 8, 2001
President G.W. Bush
Presidential Personnel Office
The White House
Washington, DC 20500
Dear President Bush,
I am enclosing my Presidential Personnel Application Form and resume in
order that you might consider my appointment as FDA Commissioner. Because
you have already invited a number of market-minded individuals to your
team, I hope that you will look favorably on my pro-market orientation.
My nomination for FDA Commissioner is likely to enjoy widespread support,
especially from the groups listed below.
1. Pharmaceutical industry. For almost twenty years, I was a research
scientist at a major pharmaceutical company and understand the impact of
regulatory delays. Former FDA Commissioner, Alexander Schmidt, once
remarked, "The failure to approve an important new drug can be as
detrimental to the public health as the approval of a potentially bad
drug." As your appointee, I would pursue a more cooperative approach with
pharmaceutical firms in order to speed the delivery of new, life-saving
medications to the American public.
2. Physicians. Doctors often prescribe approved medications for
off-label uses in order to give their patients the best health care
options. However, the FDA discourages drug companies from sharing
information that would educate physicians about these choices for their
patients. As your appointee, I would make this valuable knowledge on
off-label use available to our dedicated health care practitioners.
3. Alternative practitioners. Health care professionals who utilize
non-traditional methods of treatment are often subjected to prejudicial
treatment by the FDA, even in the absence of patient complaints. As your
appointee, I would intervene only when patients were at risk, thereby
broadening our health care choices.
4. American public. Whenever Congress considered giving the FDA more
control over nutritional supplements, voters inundated their
representatives with protests. The American public clearly wants the
freedom to choose what vitamins and minerals to take. As your appointee,
I would honor the choice of my fellow Americans.
5. Dedicated FDA employees. FDA examiners are in a no-win situation. If
they delay approving a drug with life-saving potential, many Americans,
especially those with terminal diseases, die needlessly. If the FDA
approves a drug and unpredictable side effects occur, the FDA is blamed.
As your appointee, I will alleviate this situation, by allowing terminally
ill patients to "opt-out" of the approval process. They will then have
access to potentially life-saving medications which are not yet through
FDA review.
In 1999, a Federal Appellate Court ruled 11-0 that the FDA must abide by
the First Amendment of the U.S. Constitution and permit truthful health
claims for antioxidants, fiber, folic acid, and omega-3 fatty acids
(Pearson vs. Shalala). The FDA ignored this decision and in February of
this year was censured by the court for its failure to comply. As your
appointee, I would make sure that the FDA abides by our Constitution, the
law of the land.
As your appointee, my goal will be to facilitate the conversion of the FDA
from a bureaucratic regulatory regime into a market-oriented support
system that maximizes our access to life-savings medications. Of course,
only a team effort will achieve this dramatic shift. Win-win strategies,
such as the ones described above, can help create alignment among groups
who may sometimes be at odds with each other. I believe that I have the
experience and the skills to create such an environment.
I hope that you will seriously consider moving the FDA in a direction that
will stimulate innovative drug development. After all, before we are
politicians or special interest groups, we are human beings. Whether we
enjoy a long life or a short one will largely depend on the availability
of life-saving medications. I would be honored, as your appointee, to
help the American people-and yourself-achieve the longest, most productive
life possible.
Sincerely,
Mary J. Ruwart, Ph.D.
Letter to send to the President:
Date:
President George W. Bush
The White House
Washington DC 20500
Dear President Bush:
I request that you appoint Mary J. Ruwart, Ph.D., as the next Commissioner
of the U.S. Food and Drug Administration. The reason for the urgency of
this appointment is that serious institutional problems exist within the
FDA that cause Americans to suffer and die needlessly. Dr. Ruwart has
identified what's wrong with the FDA and has proposed practical solutions.
I am concerned that anyone else you appoint will continue a "business as
usual" approach that will not result in the kind of reform that is needed
to prevent disease, injury and death by over-regulation. In her
application to you, Dr. Ruwart stated, "My goal will be to facilitate the
conversion of the FDA from a bureaucratic regulatory regime into a
market-oriented support system that maximizes our access to life-saving
medications." The public is becoming increasingly aware that the FDA is
largely responsible for the high cost of prescription drugs in the U.S.
When Americans are diagnosed with serious diseases, many are now seeking
therapies that have not yet been approved by the FDA. I find it
deplorable that the agency that is supposed to "protect the health of the
American public" has become a major impediment to their access of new
life-saving therapies.
The most important issue to me is my health and the cost of prescription
drugs. I therefore urge you to make a historic and humane decision by
appointing Dr. Ruwart as the next Commissioner of the Food and Drug
Administration.
Please let me know your position on this issue.
Sincerely,
___________________________________
Signature
Name____________________________________
Address___________________________________
City_____________________
ST______ZIP_______
LET YOUR VOICE BE HEARD AT THE WHITE HOUSE
It's Easier Than You Think!
We live in a democratic society, yet few Americans take the time to let
their elected officials know what is really important.
In the case of the FDA, severe problems have been repeatedly identified,
but a politically palatable solution has never been conveyed to the
President of the United States. Since the President will be appointing a
new FDA commissioner soon, it's time to speak out. If we fail to point
out an obvious way of reforming the FDA, it's hard to complain later about
the agency's continuing inadequacies.
For the first time in history, a qualified individual has emerged with a
specific plan to turn the FDA into an organization that will facilitate,
rather than impede, the development of new therapies to eradicate disease.
It is now up to those of us who understand the FDA problem to convey the
solution to the President. Our message to President Bush is simple. Dr.
Mary J. Ruwart is the best qualified individual to lead the FDA out of the
medical dark ages.
History has shown us that FDA Commissioners are primarily concerned with
maintaining the status quo, rather than resolving serious problems within
the agency. This lack of vision is why Americans continue to suffer and
die in the FDA's "waiting room".
Dr. Ruwart has proposed meaningful reforms within the FDA. For those
depending on scientific breakthroughs to stay alive, it is critical for
the next Commissioner to have the vision to tear down the FDA's barriers
against medical innovation. Dr. Ruwart has emerged as the most viable
candidate to implement these life-saving changes.
The White House is set up to receive suggestions and comments from the
public. The following are several ways to let your voice be heard:
Mail your letters to:
President George W. Bush
The White House
Washington, DC 20500
Fax your letters to The White House Comments Line Fax: 1-202-456-2461
To discuss these issues with The White House staff, call 1-202-456-1111
To read more about Mary J. Ruwart, Ph.D. check out her Website at
www.ruwart.com
To keep up with the breaking news, check out the Life Extension website
daily at www.LifeExtension.com
"That whenever any form of government becomes destructive of these ends,
it is the right of the people to alter or abolish it"
Thomas Jefferson
Declaration of Independence
July 4, 1776
This archive was generated by hypermail 2b30 : Mon May 28 2001 - 10:00:05 MDT