To: IAHF List
Subject: The Next FDA Commissioner Could Determine How Long You Live
From: "International Advocates for Health Freedom" jham@iahf.com
Date: Thu, 17 May 2001 12:05:01 -0400

IAHF list: Americans- See the information below about Mary Ruwart,PhD a libertarian and member of the Life Extension Foundation oriented to the use of dietary supplements who is applying for the job of FDA commissioner. I have spoken with her on the phone, read her resume (below) and feel that she would definitly be in our corner. Please join me in faxing the letter below to the White House comments line in support of Mary Ruwart's nomination. Please also call the White House comments line after you've sent the fax and forward this to more people so they can do the same- the life you save could be your own.

Date: 16 May 2001 23:55:07 -0000
To: List Member
From: "LEF Email List1
Subject: The Next FDA Commissioner Could Determine How Long You Live

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 people­and yourself­achieve 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 http://www.ruwart.com

To keep up with the breaking news, check out the Life Extension website daily at http://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