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Comments in response to the November 1, 2013 CPRIT (Cancer Prevention and Research Institute of Texas) solicitation to their draft of the Administrative Rules to assign grants for cancer research aimed to significantly reduce cancer deaths and cost.

From: Dario Crosetto [mailto:crosetto@att.net]

Sent: Tuesday, December 31, 2013 7:05 PM
To: ‘Kristen Doyle’
Cc: eread@cprit.state.tx.us; cprit@cprit.state.tx.us; unitedtoendcancer@att.net
Subject: RE: Comments to the proposed rules to the Texas Administrative Code Title 25, Chapters 701, 702, 703 and 704

 

Thank you for providing the extension for my reply until today, December 31, 2013.

 

Please find below my comments you requested to the changes proposed for Tex. Admin. Code Chapter 701, 702, 703 and 704 rules published in the November 1, 2013 edition of the Texas Register.

 

I would like to request that the final order on these rules will reflect my comments and recommended changes.

 

 

Kind Regards,

 

Dario Crosetto

President of the Crosetto Foundation for the Reduction of Cancer Deaths

 

Comments in response to the November 1, 2013 CPRIT solicitation
to their draft of the Administrative Rules to assign grants for
cancer research aimed to significantly reduce cancer deaths and cost.

 

I will do my best to provide constructive comments that CPRIT (Cancer Prevention and Research Institute of Texas) requested to their proposed Texas Administrative rules to assign grants for a total of $3 Billion of taxpayer money. These suggestions and comments are not intended solely for CPRIT but for all agencies raising and distributing funds for cancer research.

Because of the importance of this issue involving millions of people affected by cancer, which still is the most deadly and costly calamity in the world, I would like to share my proposal with the public and request 15 days delay in order to be able to receive their feedback before CPRIT makes the final decision.

We should analyze the errors made in the past, to make sure that the new rules prevent them from repeating in the future and also make sure that the new rules provide the best means to achieve the goal of significantly reducing premature cancer deaths and cost.

Public financing must act where private initiative, in compliance to market practice, fails to pursue the higher purposes of basic research devoted to enhance knowledge and human well-being. Therefore, applicants that are unable to provide financial guarantees should not be penalized. Public financing must give to any worthy project the same opportunity to reach the claimed objective, always keeping detailed control of the way public money is spent. A single inventor and a big company may convey the same value to the community, which must be suitably acknowledged by the institutions.

The following points should be addressed to best achieve the goal:

  1. The rules should state clearly at the beginning of the document and in the specific sections throughout the document that the $3 billion of taxpayers money should be used to fund projects which demonstrate having a high potential to significantly reduce cancer deaths and cost, and which:
    1. are based on solid scientific arguments,
    2. have been compared with other projects showing their advantages in achieving both reduction in cancer deaths and costs,
    3. no one has provided scientific arguments to invalidate the proposer’s substantial claims,
    4. provide a plan to test their expected results on a sample population.

These objectives are not stated a single time in the current draft of the CPRIT Administrative Rules. I have explicitly asked several agencies that assign grants to point out the administrative rules stating that the applicants must aim at reducing cancer deaths and costs. Unfortunately, none of the agencies was able to point to the relevant paragraph in their rules. Yet this objective is essential. This is why I recommend that CPRIT rules mention this requirement explicitly.

  1. Identify those taxpayers, legislators, philanthropists, physicians, cancer organizations, etc. who have as their main goal and objective to “substantially reduce cancer deaths and cost” and work with them to make these rules align more with their objective, asking them for comments and suggestions on the way to improve these rules to best achieve the declared goal.
  2. All comments and suggestions received should be published and addressed. Those that are inconsistent with best achieving the declared goal and show clearly they pursue a different agenda should be dismissed. However, before doing so, the proposers of the comments/suggestions must be contacted by CPRIT. CRPIT should point out the specific inconsistencies and invite them to explain or clarify their alternative strategy to contribute to achieving the primary objective of reducing cancer deaths and cost. In the absence of a reply or if the replies do not demonstrate an advantage for the taxpayer, the comments/suggestions should be dismissed. All documentation relative to this process should be made public in all cases.
  3. The roles of CPRIT and the applicants should be reversed:
    1. Instead of the applicant hunting for a “gift”, i.e. the grant, CPRIT should hunt for projects with highest potentials to reduce cancer deaths and costs. Reviewers should be held accountable for providing acceptance claims or rejection claims supported by scientific arguments. History will provide evidence of significant errors that damaged society, which were made by reviewers and should be made public to inform everyone, so that their influential position will not further damage society.
    2. The communication between the reviewers and applicants should not be prevented but explicitly requested and made public, so that everyone can evaluate the competence of both and through the dialogue based on scientific arguments the scientific truth can emerge.
  4. The scientific merit of submitted projects in best achieving the goal of significantly reducing cancer deaths and cost should prevail over any other criteria of evaluation.
  5. Only half of the funds made available by CPRIT should be allocated to the matching funds program, requesting the applicant to contribute with one half the Grant Award. This mechanism of awards assigned to companies which can afford matching CPRIT awards with millions of dollars can fall into subsidizing private investors or companies with taxpayers money. It is fair that companies or investors who request taxpayers to subsidize their projects to give a return to the community, otherwise these entities could pursue their business just with their own money. These companies should:
    1. provide public transparency of the research, mission, milestones that they intend to achieve and the results they finally achieved at the declared deadlines,
    2. provide a return to the taxpayers investment by assigning to the community a percentage of the income from the licensing of patents. The percentage should be lower than the percentage returned by an individual who received full funding of the project. For example, the return of investment could take the form of free drugs or medical equipment to hospitals, or free drugs or examinations to low income cancer patients.
  6. The other half of the CPRIT available funds should be assigned to projects with highest potentials to reduce cancer deaths and cost being unable to match available Grant Awards. Individual or entities who cannot afford to fund the project may receive awards for its full implementation because of the extraordinary scientific merit of their research. In this case, the applicants must provide:
    1. the full description of the way the Award Grant money is spent,
    2. the milestones that they intend to achieve and what they achieved at the declared deadline,
    3. a return to the taxpayers investment, by assigning to the collectivity a percentage of the income obtained from the licensing of patents. The percentage should be higher than the percentage returned by a company or investor who contributed with one half the Grant Awards. The return could be the donation of free drugs or medical equipment to hospitals and free drugs or examinations to low income cancer patients.

 

The objective of these rules is to satisfy the taxpayers, philanthropists, legislators, physicians, cancer organizations, hospitals, etc., who have the goal of “substantially reducing cancer deaths and cost”. If this is not the main purpose, the alternative would be for CPRIT (or any agency assigning grants for cancer research) to clearly state their objective, and legislators should make sure that voters and taxpayers are supportive of its alternative objective because they believe it to be in their best interest.

CPRIT is responsible for verifying that each chapter and paragraph of the 126 pages of the draft rules is legitimate, consistent, in agreement with, in compliance with and helpful in achieving the objective of substantially reducing cancer deaths and cost. Should this not be the case, rules should be modified to be consistent with the final objective.

The following are some inconsistencies found in the current version of the CPRIT Administrative rules that need to be addressed:

 

703.3

Page 63

Add: “…shall request to demonstrate the objective and capability to reduce cancer deaths and cost per each life saved compared to current costs and shall request to quantify the expected percentage of cancer deaths and cost reduction when tested on a sample population.”

Page 64

Add: “…demonstrating achieving a reduction in cancer deaths and cost per life saved compared to current costs.”

 

703.5

Page 70

Add: “Each committee member must provide scientific arguments, and/or references, calculations, demonstrations supporting their rejection claims of the project and/or the superiority in efficiency and potential to reduce cancer deaths and cost of one project that they approve for funding with respect to others that they do not approve for funding. When applicants will make measurements on a sample population, proving success or failure of the funded project due to a conceptual error and not because of a lack of implementation, these results will be used to improve the review process.  Reviewers who had the vision of the benefit to the public from an innovation that proved reduction of cancer deaths and cost will be included in a list of expert reviewers in the field. Those who rejected funding a project that later had success for the above mentioned goal (with CPRIT funding or with funding from a different source) will be attributed a lower priority in the list of experts in the field.”

 

703.6

Page 74

Add: “Applicants submitting any type of proposal to fight cancer, whether it be for a vaccine, drug, screening device, a program to educate individuals and promoting a change in their lifestyle, or any program aimed at reducing cancer deaths and cost, should estimate and then provide a plan to measure the results on a sample population. For example, the sample population could include 10,000 people in the age group 55 to 74 taken from a location where the mortality rate was constant (e.g. 0.5%) in the previous 20 years. Applicants and reviewers should keep in mind the mandate from the taxpayers to the Texas legislators, to CPRIT that is handling their money: taxpayers are prepared to invest provided that a significant reduction in cancer deaths and cost per life saved compared to current cost is obtained. A difference or no difference in the mortality rate will quantify the success or failure of the solution proposed.”

Add: “…with the highest potential to reduce cancer deaths and cost per each life saved compared to current costs.”

Add: “…identify projects with higher potential to reduce cancer deaths and cost. Their evaluation should base rejection or approval of a proposal not simply on the basis of reviewer’s “opinion”, expressed with a score (number or letter). Reviewers should support publicly their rejection or approval claims, with scientific arguments, calculations, reference data, logical reasoning to reject or approve the application. Reviewers should demonstrate the superiority in efficiency and/or lower cost of approved projects when compared to other projects, or inferiority in the case of a claimed rejection. The “score” should be calculated based on the written scientific arguments and comparisons provided by the reviewer. Both, scientific arguments and scores should be made public.”

page 75

Add: “When an application is funded and implemented, experimental results on a sample population will prove if the reviewer’s evaluation was from an expert, or a knowledgeable person or not. Reviewers who provided scientific arguments in support of projects that demonstrated with a successful test on a sample population to reduce cancer deaths and cost will be included in a list of experts. Reviewers who could not recognize the scientific value and potential of a proposal that demonstrated benefits, or who approved projects that demonstrate to be a failure, should be removed from the list of experts, and their arguments to reject or approve projects will be included in a list of pitfalls, so that the same errors are not repeated, resulting in stopping or delaying the benefits from innovations.”

Page 77

Add: “…based on the criteria that projects with higher potential to significantly reduce cancer deaths and cost will be top in the priority list.”

Add: “They should confirm or provide objections supported by scientific arguments in regard to the calculations, reference material, and logical reasoning that was provided by the reviewers.”

Page 80

Add: “All comments/remarks from any observer from the public that address and provide useful information in comparing and identifying projects with highest potentials to reduce cancer deaths and cost should be included in the minutes of the meeting. Any observer from the public could document and request to include in the minutes of the meeting any rules of the Institute’s Grant Review Process that are not followed/applied.”

 

703.10

Page 89

Add: “Applicants must estimate the percent of the reduction of cancer deaths and cost per each life saved compared to current cost, including the proposed measurement in achieving such results on a sample population (for example, measuring results in percent of cancer deaths reduction on a sample population of 10,000 people in the age group 55 to 74 taken from a location where, in the previous 20 years, the mortality rate was constant -e.g. 0.5%) and comparing those with the mortality rate of a similar group that did not receive the benefits from the proposed applications. All intermediate results during the implementation of the proposed application that will lead to the expected final result should be translated into measurable milestones in the contract that should be verified as the project is funded and implemented.”

Add: “Taxpayers money provided to the applicant as a grant should fund the specific proposed research that has been evaluated to have a higher potential to reduce cancer deaths and cost when compared to other proposals that did not receive funding. Justification of expenses must be provided. Using taxpayers money to build a capital improvement of the applicant’s business not directly related to the implementation of the application to reduce cancer deaths and cost is not permitted.”

Deleted Page 89: Section c.2.A and c.2.B

 

703.11

Page 93

Deleted Section a., b.1., b.2., b.3, b.4, b.5, c.1, c.2, c.3, c.4, c.5, d.1, d.2, d.3, d.4, d.5, d.6, d.7

Comment: “In 2007, taxpayers approved the assignment of $3 billion to the CPRIT project to fund research aiming at reducing cancer deaths and cost, without asking CPRIT to show they had $1.5 billion in their hands already allocated for that purpose. In fact CPRIT at that time did not have a CEO, a Scientific Director, etc.  CPRIT at that time did not even have an office with employees. Furthermore, an institution or a business submitting a $10 million grant proposal application to CPRIT that has in house $5 million (and perhaps has spent already hundreds of millions of dollars in cancer research without being able to demonstrate on a sample population to have achieved a percentage in cancer death reduction), has a better chance to attract money from private investors. Instead the applicant who does not have 50% of the money in house, but who has an invention that would reduce cancer deaths and cost that no one could invalidate and that has been recognized valuable from top experts in the field can provide benefits to taxpayers if they receive the funding from taxpayers. The key issue is to identify reviewers who are experts in recognizing what can reduce cancer deaths and cost. The best way to identify those reviewers is by looking at who approved funding of projects that provided results in cancer deaths and cost reduction and who funded projects that did not provide results. There are more details regarding the creation of the list of experts in cancer deaths and cost reduction in RULE 703.5.”

Deleted entire Page 95

Deleted entire Page 96

 

703.21

Page 113

Add: “…demonstrating the completion of the construction of the project.”

“The report of the measurements on a sample population that will quantify the success of the project should be provided after the test period, as specified in the contract.”

 

 

From: Kristen Doyle [mailto:kdoyle@cprit.state.tx.us] Sent: Monday, December 23, 2013 4:17 PM
To: ‘Dario Crosetto’
Cc: Kristen Doyle
Subject: RE: Comments to the proposed rules to the Texas Administrative Code Title 25, Chapters 701, 702, 703 and 704

 

Dr. Crosetto,

 

Thank you for your comments.  So that I can assure that CPRIT addresses each comment you have made, can you please submit a list of rules (e.g. 703.3, 703.5, etc) where you have embedded comments?  I would appreciate it if you could provide the list by December 30, 2013.

 

Thank you, Kristen

 

From: Dario Crosetto [mailto:crosetto@att.net] Sent: Monday, December 16, 2013 4:43 PM
To: Kristen Doyle
Cc: Ellen Read; Cancer Prevention and Research Institute of Texas; unitedtoendcancer@att.net
Subject: Comments to the proposed rules to the Texas Administrative Code Title 25, Chapters 701, 702, 703 and 704

 

 

To: CPRIT Oversight Committee:

 

Dear members of CPRIT Oversight Committee and CPRIT Executive Team,

 

Please find attached my comments you requested to the changes proposed for Tex. Admin. Code Chapter 701, 702, 703 and 704 rules published in the November 1, 2013 edition of the Texas Register.

 

I would like to request that the final order on these rules will reflect my comments and recommended changes.

 

 

Kind Regards,

 

Dario Crosetto

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