January 26, 2002

The Honorable Tommy Thompson
Secretary, Health and Human Services
Washington, DC  20010

Dear Mr. Secretary,

A new paradigm is needed at the National Institutes of Health that incorporates the spirit of free market economics - competition and monetary reward - with the search for effective treatments and cures for terrible diseases. Such a paradigm would set the Bush/Thompson administration of the NIH apart from all predecessors and might lead to a spectacular improvement in the Nations health.

We propose that the NIH begin sponsoring new treatment competitions for serious diseases. These competitions would pit new therapeutic ideas from companies, institutions and even individuals against one another in an impartial, Government controlled clinical setting. A key ingredient would be to require the competitors to pay non-refundable entry fees to the Government (rather than applying for a grant) as a means of screening frivolous entries. Each participant would be required to put up $20,000, $50,000 or perhaps $100,000 (any higher might tend to eliminate the best new ideas from small companies) as their entry fee. The entry money, perhaps matched dollar for dollar by the NIH, provides the prize money for the best therapy as determined by the NIH. Winner takes all.

The NIH would be responsible for administrating the clinical study that determines the winner - the best therapy or protocol. The competitors, with the NIH as arbiter, would agree on the outcome measures. The pool of patients would be selected and randomly assigned by the NIH in a blind fashion to each protocol. The NIH would itself run the study, or select impartial doctors with no financial interests in the outcome to administer the various therapies and record clinical results. Finally, the outcomes would be evaluated by yet another set of impartial physicians or scientists, again in a blind fashion with no knowledge which patient group had undergone what therapy. We think video tape interviews of all subjects, before stating their health, and after stating their health and impression of the treatment, would be an important control mechanism.

The therapy winner not only earns a monetary award to help market the best treatment or perhaps even the cure, but the Nation will have obtained invaluable knowledge it could not have otherwise. Also, note there would be no placebo groups, i.e., subjects not receiving any known therapy. Many new therapies are so effective they make it unethical to study them with a placebo or control group. This is an important component because it is well known that study subjects with serious disease leave studies, or do not adhere to the study protocol after they find out that they are on placebo.

We might suggest that an excellent NIH pilot competition to evaluate the benefit of this idea would be for new therapies that treat or cure the Nations number one killer, i.e., cardiovascular disease leading to heart attack and stroke. The ideas as presented here arose after the NIH declined our 1998 grant proposal to fairly investigate the Linus Pauling putative cure for cardiovascular and heart disease. At some point in the future, failing to investigate the Heart Disease cure will turn into another "black eye" for the Clinton administration. It is my sincere hope that the George W. Bush administration will not make the same mistake.

We would be happy to submit a more detailed proposal, or simply comment on NIH reactions to this letter. May be best therapy win.

Yours Truly,

Owen R Fonorow
President
www.PaulingTherapy.com
www.VitaminCFoundation.org


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