Harold’s Provocative Questions (PQs)

At long last, the R01 and R21 RFAs seeking “Research Answers to NCI’s Provocative Questions” have been released. One would think Harold would be the Scientific/Research Contact, but it is Jerry Lee.

Unlike most FOAs, the PQ solicitation does not list “examples” of research topics … you will address one (and only one) PQ per application submitted:

Each application must address one and only one specific PQ, exactly as defined in this FOA. … They should NOT be construed as “examples” of specific topics. The scientific scope of each individual application must clearly and distinctly correspond to one (and only one) of the PQs listed above. Within an area defined by a given PQ, applicants may propose and pursue any topic they deem relevant as a “research answer” to that PQ. It is essential, however, that applicants visit “Provocative Question” web site (http://provocativequestions.nci.nih.gov/) for additional information for each PQ pertaining to context, background, feasibility, and expectations of needs to be accomplished for a successful solving of these problems.

Note: Applicants who fail to choose a specific PQ from this list, address more than one PQ within a single application, and/or re-write the PQ will have their applications rejected without review as non-responsive.

And without further ado, the questions are:

    PQ1. How does obesity contribute to cancer risk?

    PQ2. What environmental factors change the risk of various cancers when people move from one geographic region to another?

    PQ3. Are there ways to objectively ascertain exposure to cancer risk using modern measurement technologies?

    PQ4. Why don’t more people alter behaviors known to increase the risk of cancers?

    PQ5. Given the evidence that some drugs commonly and chronically used for other indications, such as an anti-inflammatory drug, can protect against cancer incidence and mortality, can we determine the mechanism by which any of these drugs work?

    PQ6. What are the molecular and cellular mechanisms by which patients with certain chronic diseases have increased or decreased risks for developing cancer, and can these connections be exploited to develop novel preventive or therapeutic strategies?

    PQ7. How does the life span of an organism affect the molecular mechanisms of cancer development and can we use our deepening knowledge of aging to enhance prevention or treatment of cancer?

    PQ8. Why do certain mutational events promote cancer phenotypes in some tissues and not in others?

    PQ9. As genomic sequencing methods continue to identify large numbers of novel cancer mutations, how can we identify the mutations in a given tumor that are most critical to the maintenance of its oncogenic phenotype?

    PQ10. As we improve methods to identify epigenetic changes that occur during tumor development, can we develop approaches to discriminate between “driver” and “passenger” epigenetic events?

    PQ11. How do changes in RNA processing contribute to tumor development?

    PQ12. Given the recent discovery of the link between a polyomavirus and Merkel cell cancer, what other cancers are caused by novel infectious agents and what are the mechanisms of tumor induction?

    PQ13. Can tumors be detected when they are two to three orders of magnitude smaller than those currently detected with in vivo imaging modalities?

    PQ14. Are there definable properties of a non-malignant lesion that predict the likelihood of progression to invasive or metastatic disease?

    PQ15. Why do second, independent cancers occur at higher rates in patients who have survived a primary cancer than in a cancer-naïve population?

    PQ16. How do we determine the clinical significance of finding cells from a primary tumor at another site?

    PQ17. Since current methods to assess potential cancer treatments are cumbersome, expensive, and often inaccurate, can we develop other methods to rapidly test interventions for cancer treatment or prevention?

    PQ18. Are there new technologies to inhibit traditionally “undruggable” target molecules, such as transcription factors, that are required for the oncogenic phenotype?

    PQ19. Why are some disseminated cancers cured by chemotherapy alone?

    PQ20. Given the recent successes in cancer immunotherapy, can biomarkers or signatures be identified that can serve as predictors or surrogates of therapeutic efficacy?

    PQ21. Given the appearance of resistance in response to cell killing therapies, can we extend survival by using approaches that keep tumors static?

    PQ22. Why do many cancer cells die when suddenly deprived of a protein encoded by an oncogene?

    PQ23. Can we determine why some tumors evolve to aggressive malignancy after years of indolence?

    PQ24. Given the difficulty of studying metastasis, can we develop new approaches, such as engineered tissue grafts, to investigate the biology of tumor spread?

One unspoken PQ: will the payline for these fall at the 7th percentile and/or at Harold’s discretion?

59 Comments »

  1. AH said

    I don’t think that ICs Directors have to be the Scientific/Research Contact for RFAs seeking Answers to Provocative Questions. But I do think that IC Directors, in this case Harold Varmus, has a great responsibility in the oversight of resources and their management in these PROVOCATIVE TIMES.

    No reason to not believe that Jerry SH Lee would appropriately manage questions from investigators interested in responding to this RFA. However, Jerry SH has a lot of room for using a huge amount of resources wisely or let them drain in “operational costs”. This is what is said at the NCI:

    “Through the CSSI Office of the Director, he is responsible for scientific, programmatic, and operational management of CSSI’s broad scientific portfolio (~$145 million per year) carried out by more than 80 staff members within CSSI offices including: The Cancer Genome Program Office (TCGA PO), Office of Cancer Nanotechnology Research (OCNR), Office of Biorespositories and Biospecimen Research (OBBR), Office of Cancer Genomics (OCG), Office of Cancer Clinical Proteomics Research (OCCPR), and Office of Physical Sciences-Oncology (OPSO).”

    For complete description go to:

    http://cssi.cancer.gov/lee.asp

    145 millions are a lot of money and pay lines should go up, not down.

    • Ironies of life said

      “I don’t think that ICs Directors have to be the Scientific/Research Contact for RFAs seeking Answers to Provocative Questions”.

      And neither they are expected to be the ‘questions contact’ for critical leadership positions to be filled such as “ NIMH Scientific Director, Division of Intramural Research Programs”.

      1) The announcement for this position is not at “NIH jobs site, Executive positions” but at NIMH “Selected Job Opportunities”.

      2) What kind of confidence a candidate (s), honestly seeking to revolutionize Mental Health in the US, could have if the focal point for information is an NIMH Director who recommended Charlie Nemeroff for Chairmanship at University of Miami and placed him on Grant Review Committees in 2011?.

      What does “Selected Job Opportunities” mean?.

      Mental Health in the US needs a revolution to correct the stagnant feeling of wrongdoing, if not corruption, that has been going on. And true scientific and biomedical leaders, NO “MONEY PUPPETS”, are urgently needed.

  2. elbsightz said

    Just some Harold gossip. I had lunch with an old friend, a Deputy Director at another institute. He has a friend who is an NCI program manager. According to him:

    Harold reviews each and every proposal that scores in the gray range (8-30th percentile). He grills the program manager about details, “why do they want to use that cell line? don’t you know it has problems?” and then picks the ones he wants to fund. The program managers say it is like being a graduate student in his lab.

    • writedit said

      Thanks for sharing … I could easily envision such a scenario with Harold …

      • Jane said

        I have beee very frustrated with my unfunded 12%tile grant, in which i proposed a series of experiments with some novel animal models. I felt even much worse now after reading this gossip…..Why did he not look at those grants below 7%tile… He should look at them all……

    • Arnold said

      Dear elbsightz,

      When you say “program manager,” are you referring to program officers or something different? Is there anything PIs can do to help prepare the program manager? Should there be a phone call beforehand to make sure the program manager understands the science being proposed in the grant? Thank you for any insight you might have.

      Arnold

      • Frank Walter said

        NO. “No phone call before hand to make sure the PO understands the science behind the project”. Absolutely not.

        What is needed is TO OCCUPY HAROLD’S OFFICE until he goes. Too many big errors (so far) to believe that he will continue to lead NCI in the way the medical needs of the country, science and the Institute are needing so urgently.

        Having a Nobel Prize Award does not necessarily guarantee true leadership outside and beyond a specific area of expertise. No one will ever be able to sufficiently prepare a Program Officer when the strategy of the NCI Director is to override and grill his own leaders to satisfy his own views and attain his own objectives.

      • SG said

        Not to nitpick but HV did run NIH for 6 years and was President of Sloan-Kettering for 10 years. So he does have qualifications beyond the “Prize”. You can still hate his process and how he uses his power but you can’t call him unqualified.

      • S said

        Not to nitpick but HV did run NIH for 6 years and was President of Sloan-Kettering for 10 years. So he does have qualifications beyond the “Prize”. You can still hate his process and how he uses his power but you can’t call him unqualified.

      • Buds said

        S…….probably HV survived the other positions because he was listening to his advisors……..at NCI the advisors seem to have relegated to “post-doc” level. If he is going through every grant in the 8-15% range without really listening to his pgm managers, then he has too much time on hand; to keep him as NCI director is waste of tax payers money. I agree with the “occupation” theory mentioned above and would join in till HV is asked to move on from the NIH.

  3. Frank Walter said

    “HV did run NIH for 6 years…”

    Yes, he did run NIH for 6 years and he seems to be repeating the very same errors he made during his tenure.
    Since the beginning of his Directorship at NCI, HV has reminded us quite few times how he felt at disadvantage then (in regard to all Institutes) because the NIH Director’s Office did not have a budget and there were many things he would have liked to do but could not. Now he is the leader of the Institute with the biggest budget and the opportunity to open new avenues for cancer research by attracting and supporting a diverse biomedical workforce with new ideas and approaches. And with that he has also the possibilities for creating a solid, self-confident administrative team(s) to alert and encourage the biomedical community in their search for answers to the challenging questions. Well, he doesn’t seem to get it.

    In these very difficult times, we can’t afford to have an NCI Director whose strategies reproduce a pattern of the past (proven to be wrong) and seem oblivious to present challenges and the future of biomedical research. Have no idea about his leadership at SKCC. One wonders if his Nobel Laurate aura allows people the freedom to question his ways and whether he has the audacity to subject himself to self- criticisms and contrasting views by others.

    At any rate, NCI is a much larger institution in scope than SKCC and the consequences of a type of leadership could be of much broader and greater impact.

  4. ABCD said

    It seems like HV wants to promote his personal ideas and concepts (eg. genomics, stem cells etc). You can’t run research based on one man’s ideology/preferences. Advancement in research is always due to collective input. If HV approach was taken, who would have funded a project to isolate a polymerase from lowly thermus aquaticus?

  5. Marziel Lewonsky said

    Harold,

    You’re more than welcome to pursue your own ideas and objectives elsewhere. You have several active projects NIH-funded in various institutions. Please go and do what you like in your lab. But do not continue to interfere with the opportunities for younger generations and with different ways of building science than the ones you want. You had your opportunity when you needed it and you succeeded. Your turn is overdue. Please, GO.

    • Jane said

      It sounds great. I hope he truly gets this message….

      • Buds said

        Is anyone aware of how to get the message about HV’s irresponsible actions to someone who can make a difference?

  6. Frank Walter said

    The ‘someone who can make a difference’ is the authority that placed Harold Varmus at NCI in the first place. It is clear by now that HV will not listen to anyone who is not the President or his delegate. Since President Obama has too much in his plate at this moment, we need to send a message/report to the HHS authority Kathleen Sebelius and ccd it to the President and the NIH Director. It might not have been Harold’s intention. But, as matter of fact, he is making the three of them, the President, the Secretary and the NIH Director, “co-authors” in his irresponsible doing. If we continue to sit around doing nothing about it, we will all be responsible for the consequences of HV’s irresponsibility.

  7. whimple said

    What irresponsibility are you talking about? You mean not funding your grant application?

  8. Frank Walter said

    “You mean not funding Your grant application”?.

    No wimple. I am among the lucky ones with no concern about MY grant application now or in the near future. But I keep my fingers crossed because the big issue here is the Direction of the NCI and the huge investment the public has been making on NCI.

    HV’s responsibility is not to fund or not to fund my application or yours. He, himself, does not have to and should not have to. The authority for the funding of applications belongs to the IC Council, who works coordinately with Programs Directors, to ensure that the country’s priorities for cancer research are met and the scientific community is stimulated to move forward in the search for mechanisms and more effective treatments.

    Bold cancer research and global health do not come by talking from the pulpit with the Nobel aura and unilateral judgment from own’s brilliant science. It comes from the leadership that seeks to identify and drive the strengths of all possible mediators and effectors. And is also the leadership that works out of its way to correct weaknesses and redirect efforts. HV is excellent on the first but doing very poorly on second and third.

    His irresponsibility is one of a “pseudo leadership” that a) is breaking the instrumental link between biomedical scientists, effectors of US research priorities, and corporate mediators (POs, Council members..) by assuming unexpected and undesired roles that interfere with priorities implementation and b) is having short and long-term consequences in the perception and actual vision of biomedical research. Do not underestimate that setting precedent is a form, most of the time very effective, of advancing and effecting corporate strategies, policy and law.

    NCI is not about Harold Varmus and his brilliant science. It is about public investment, best possible benefits to the country and present and future cancer research, which should include but not be limited to HV brilliant science, your science or my science.

    Good luck to you.

    • whimple said

      I have to disagree with you. If you can’t successfully argue that the science being produced by NCI is diminishing in quality, you have no case. You sound upset by the process, not the result. I think HV irritates you because his actions point out that NCI has almost all the power, and that power resides largely with the Director if he chooses to exercise it, and you as a grant applicant, have almost none. Leadership is about actually leading, not just administrating, and you just don’t like HV’s strong leadership because you’re not used to having any real leadership from the NCI.

      Good luck to you too.🙂

      • Buds said

        whimple……we are discussing NCI, not HVI…………Frank Walter’s view represents the view of many, grant holders or not. The manner in which HV wants to operate will lead to many POs and pgm managers to become redundant at HVI.

      • Jane said

        whimple,
        Frankly, I have been frustrated (or upset) with the fact that my 12%tile RO1 was not funded in FY2011, which has negatively impact my lab, program, career, and even my personal life. I hope that we could appreciate the importance of funding as an investigator. However, the most disturbing issue is that I have never been given the reason why my grant was not selected for funding by the funding agency. If there is a scientific or programatic issue with my grant, why I could not be informed in a direct and constructive way…. That is my concern with the current process, which will become yours in the future.

      • drugmonkey said

        The NCI payline was 7%, 10% for noobs, no? So why do you need additional reason for why a 12% wasn’t funded?

      • whimple said

        Jane: I have never been given the reason why my grant was not selected for funding by the funding agency

        No one is ever told why their grant was not funded, other than via the study section summary of discussion and reviews. Sorry about your grant result; you’re in an unstable line of work. That sucks, but it’s not HV’s fault, since it is not NCI’s role (reviewers, POs, council or director) to help you improve the quality of your grant application. I personally don’t agree with this policy, but that’s an NIH-wide review philosophy that long predates HV.

    • drugmonkey said

      I wonder why they call them “Advisory Councils” instead of “grant Deciderer Councils”, Frank?

      • Jane said

        please don’t confuse yourself and others. You should know there was no hard payline in NCI last year. Don’t waste everyone time here, please!

    • iGrrrl said

      The authority for the funding of applications belongs to the IC Council,

      I’m not sure this is correct. My understanding was that every NIH grant is funded at the pleasure of the director. If that director pleases to go with a straight priority ranking (seems to be current NIAMS policy), and others look more seriously at programmatic priorities (such as has been discussed here, with one IC not funding a 3rd percentile application, for example), it’s within their purview to set such policy. I’m also a bit confused as to what you think a director is supposed to do. The title implies that the job is to provide direction, which it seems that Varmus is doing, whether you like the direction or not. These leaders are not charged with being administrative functionaries.

  9. Frank Walter said

    Wimple,

    Actually, I am not upset but concerned both about the process and the result. As scientist you know very well that process and result are greatly intertwined and interdependent. So, your argument is very weak. In addition,

    1) what are the objective/verifiable criteria and actual data on which you base your statement “the science being produced by NCI is not diminishing in quality”?

    2) And if that were the case, are you satisfied just with “science is not diminishing in quality” given the magnitude of the NCI expense?. Will or are taxpayers?

    NCI, per se, does not have any power but only the power and all the power that the taxpayers are willing to put in with their contributions and sacrifices. Furthermore, there is no precedent, bill or law in which Americans have ever bestowed full power with public moneys (to “exercise it if he chooses”) to a single person, namely Director or even the President of the United States. And as grant applicant, I have all the power provided by my scientific competence and efforts to advance understanding and treatment of cancer. Also, I have the responsibility to return the fruits of my activity to the people who gave me the opportunity and support to prove my ideas.

    You have not defined your concept of leadership or administration. That is critical in the discussion because the borders between the two are blurry. What I can tell you is that leadership at the top of successful organizations recognize intrinsic leadership thorough different levels emphasizing trust in their scientific competence and managerial skills. Together with an atmosphere of multilateral, collegial questioning on specific strategies or decisions, leaders at the top promote and bring into play the sense of self-accountability for the achievement of priorities and surmounting of challenges. In other words, participation, trust and multilateral questioning lead to self-accountability and viceversa.

    No wimple, your characterization is inaccurate, to say the least. HV doesn’t irritate me. He is, most of all, a great concern because there is so much at stake and he is not leading, neither is he administering. His actions point out that he ought to leave or be asked to leave.

    • whimple said

      are you satisfied just with “science is not diminishing in quality” given the magnitude of the NCI expense?. Will or are taxpayers?

      The NCI doesn’t have a great track record of returning quantifiable value to the American taxpayer. That’s why there isn’t much enthusiasm about increasing, or even maintaining, NCI (or NIH) funding levels. If HV can shake that up, Steve Jobs’ style, through attention to detail and long-range vision (micromanagement according to the detractors), I say go for it. I think NCI is going to turn out to be more productive under HV than it was under previous directors.

  10. Marziel Lewonsky said

    Did HV shake that up during his 6 years as NIH Director? Did he shake up people’s perception on the importance of cancer research during his 10 years at SKCC?.

    The best way to prove it is getting out of NIH and starting his own Institute/company. Yes, other people have themselves been very successful doing just that.

    • drugmonkey said

      You know the obvious comeback is that it would be “best” for you to just do your science without NIH funding, right?

  11. Frank Walter said

    Writedit,

    I would appreciate if you could send this letter to Secretary Sebelius and Chairman Tom Harkin. Thank you.

    Madam Secretary Kathleen Sebelius, HHS

    c/c Honorable Tom Harkin, Chairman US Senate Committee for Health, Education,Labor and Pensions

    Dear Madam Secretary,

    I would like to express my profound concern for the lack of transparency and apparent arbitrariness in the process of research funding at the National Cancer Institute (NCI). Dr Harold Varmus appears to be the main, if not the only, factual driver and effector in this critical process with undesirable results on the entire community. The strong evidence on his disregard of Program Directors, essential mediators in the decision process for achieving Institute priorities, and his arbitrary personal selection of applications without clear and/or publicly specified criteria raise multiple questions. One of them is on the absolute authority of the NCI Director to make final decisions on grant applications and the role, if there is one, of his National Advisory Council to modulate his so believed unrestricted power that is allowing undisclosed preferential selection, nepotism and potential corruption. It is unclear how the provisions of Public Law 92-463 are applied at different NIH Institutes.

    I have perused the websites of various NIH Institutes, not all and not NCI, and the specifications on the matter are irregular in extent and vagueness. Some Institutes (e.g., NIMGS, NIGHR, NINDS, NIDDK) clearly identify their National Advisory Council ‘s function “perform the second level of peer review for research and research training grant applications”.

    With a more precise language, NIEHS states: “The NIEHS as an NIH institute that makes grant awards for research projects and training, must by law, maintain an appropriate council to review and recommend approval of the project before an award can be made”.

    Others, the NICHD introduce their National Advisory Council as “charged with advising, consulting with, and making recommendations to the NICHD director on matters relating to the research and research support activities”, while NIMHD refers directly to Public Law and states: “Public Law 106-525 gives the Director of the National Center on Minority Health and Health Disparities the authority to establish an advisory council to provide advice regarding the Center’s research and research training activities with respect to minority health issues”.

    Madam Secretary, some degree of ambiguity in the expression of policies allows for freedom and flexibility in their application to better achieve priorities that are essential to the specific mission of an Institute. However, to avoid misuse and abuse of intended freedom whose purpose is one of enhancing public objectives, supplementary and/or corrective measures that enforce transparency and accountability from top to bottom are indispensable and should be publicly disclosed.

    The scientific community is an essential arm of the government in the achievement of public health and economics of the US. A constructive, participatory and transparent interaction between the two is the indispensable substrate to advance biomedical objectives and nurture public trust in our common goals. I urge you to establish a secure online tool to allow all stakeholders to communicate with you, without fear, and express our concerns and suggestions to solve this very challenging situation.

    Respectfully yours,

    Frank Walter

    • Buds said

      Frank Walter, thank you for your time in putting this letter together. I second it.

      For those who are indicating they have never received a reason why their grant was not funded, we have never had this 8-15% grey zone scenario at any institute. It would have been more acceptable if NCI had declared that the hard payline would be 7 percentile (or 10th percentile) for this year, and not proceed with the option of choosing between 8-15th percentile grants for funding. But since latter is the case, we would like to know why a grant in 8-15th percentile range is not funded, especially those for which this was the last attempt. Can you imagine how many jobs are at stake here? In addition, why did the decision to follow this approach come so suddenly in the middle of a funding cycle. No other institute has taken these same steps. So I wonder how this could be good “administratuve” process. Are all the other institutes run by incompetent directors?

  12. whimple said

    We have never had this 8-15% grey zone scenario at any institute…

    This is wrong both in theory and in practice. Most institutes have exactly such a scoring “grey zone” where some grants are funded against the (priority score) recommendation of the study section at the discretion of (ultimately) the Institute Director. At least NCI has the transparency to tell you that if your grant is not <=15%, it will not be funded.

    This data from NIGMS from last year clearly illustrates the unofficial "grey zone":
    http://loop.nigms.nih.gov/index.php/2011/01/07/fiscal-year-2010-r01-funding-outcomes-and-estimates-for-fiscal-year-2011/

    • Buds said

      whimple, you are discussing two different types of “grey zones” here…..an 8th percentile grant has never been in the same declared grey zone category as it is now at the NCI.

  13. A propos de said

    Using the link provided by wimple I found a comment by J Berg (below). Does anyone know where to find these posts re’s referring to?. Thanks.

    “I am working on posts on the roles of our Advisory Council and program staff in making funding recommendations. I hope that these will help clarify the process by which an application moves from its initial peer review to a funded grant”.

  14. einstein said

    “Frank Walter said
    November 14, 2011 @ 9:26 am
    Writedit,

    I would appreciate if you could send this letter to Secretary Sebelius and Chairman Tom Harkin. Thank you.”

    Dude, send it yourself. Why would you need Writedit (or anyone else) to send it on your behalf????

    • Frank Walter said

      Einstein,

      If you know the DIRECT e-mail addresses for Sebelius and Harkin, please provide it. I want to make sure that the message reaches them and doesn’t fall into a junk mail box.

      Thanks Dude

      • writedit said

        I am flattered that you think I might have these folks on speed dial, but, alas, I have no direct means of contacting these individuals either. The blog does register visits from both houses of Congress and HHS (and other federal agencies), but I cannot say whether they might take note of your letter while browsing through.

      • einstein said

        sorry, not gonna do your work for you…nor should you expect the moderator here to do so.

        we all know the point of posting your “letter” here was to attempt to impress everyone; otherwise, you could have just asked if Writedit had the direct email address, if that was truly your only purpose.

  15. Frank Walter said

    Come on einstein!. Don’t bullshit around. I don’t need to impress anybody. This is serious business. I care about the problems and try to look for ways to overcoming them. Don’t worry. I’ll find a way to get the message to Sebelius and Harkin.

  16. Arnold said

    Does anyone know how to find out how many grants were submitted in response to this RFA?

    Thanks.

    • writedit said

      I wouldn’t be surprised if the news release announcing the awardees next year mentions the total number of applications received, but these data aren’t (publicly) available for individual FOAs.

  17. Arnold said

    That is…the NCI Provocative Questions RFA…

  18. Frank Walter said

    Writedit,

    IMO, these data should be publicly available for all FOAs and right now for every single research funding initiative coming out of NCI as part of a treatment/preventative measure for neglected transparency. We should anticipate a “FOIA Request” accompanying the release of awardees announcement for the Provocative Questions. We should submit this request now to:

    Susan R. Cornell, Freedom of Information Officer and Chief FOIA Liaison, NIH.

    If anyone has a more effective alternative, please share it and let’s proceed as of today since November 15, 2011 was the deadline for application submission .

  19. Frank Walter said

    To ALL you guys,

    The letter I posted here on November 14, addressed to Secretary Sebelius and Chairman Harkin has been received. This is the response I received from the NIH Office of Federal Advisory Committee Policy (see below) that I am sharing with you. I think we should continue a constructive and active dialogue using this blog and all channels available as to advance resolution of difficulties and challenges together.

    Thanks

    Frank

    “I am responding to your e-mail and letter addressed to the Department of Health and Human Services Secretary Kathleen Sebelius and Chairman Tom Harkin of the U.S. Senate HELP Committee regarding your concerns about the research funding process at the National Institutes of Health.

    Applications received in response to Research Answers to NCI’s Provocative Questions, RFA-CA-11-011 and RFA-CA-11-012, will be reviewed at two levels by committees subject to the Federal Advisory Committee Act (5 U.S.C. App.). Personal and proprietary information is contained in grant applications and as such, the review deliberations are closed to the public under exemptions found in 5 U.S.C. Sec 552b, “The Government in the Sunshine Act.” Please refer to http://provocativequestions.nci.nih.gov/ to learn more information about how applications will be reviewed. The role of federal advisory committees is to provide advice and guidance to federal officials, not to make decisions on behalf of the U.S. Government. Funding decisions at the National Institutes of Health depend on funds available and Institute priorities. More information about what research is funded may be found at http://report.nih.gov/frrs/index.aspx .

    Please visit http://www.nih.gov/ for more information on the National Institutes of Health and opportunities for public participation.

    Jennifer S. Spaeth
    Director, NIH Office of Federal Advisory Committee Policy
    One Democracy Plaza
    Suite 1000, MSC 4875
    6701 Democracy Blvd.
    Bethesda, MD 20892-4875

    • Citizen said

      “The role of federal advisory committees is to provide advice and guidance to federal officials, not to make decisions on behalf of the U.S. Government. Funding decisions at the National Institutes of Health depend on funds available and Institute priorities”

      So,

      Federal Advisory Committees are to provide advice and guidance and Federal Officials are to make the final decisions. That’s fair.

      The question is: Where is the quality control on the final decisions made by Federal Officials?. Who is responsible of that quality control and where is the oversight?.

      At the highest level of US Government (House Representatives and Senators), the quality control and oversight is made periodically by all citizens at elections time. What is the counterpart mechanism at NIH?

      • whimple said

        The NIH Director is appointed by the President and confirmed by the Senate.

        The Director of NCI is appointed directly by the President:
        Under the 1971 Cancer Act, the NCI director reports directly to the president and submits a draft budget directly to the White House.
        http://www.sciencemag.org/content/328/5981/960.2.full (paywall)

        The director of the cancer institute is appointed by the president, but Senate confirmation is not required.
        http://www.nytimes.com/2010/05/18/health/18cancer.html

        Presumably QC and oversight of the NCI Director is provided by the President. QC and oversight of the President is next scheduled to be performed by the American citizenry in November 2012.

  20. Mark Schwanoff said

    The NCI Director is, then, the most powerful man in the country. The only restriction in his power is that of the US President willing to not sacrifice the interests of all citizens and that of the entire National Institutes of Health. The NCI Director is not even accountable in front of the US Senate because his confirmation is effected without US Senate questioning and/or approval.

    Interestingly, Harold Varmus endorsed Barack Obama’s candidacy for President and one is left wondering if our sitting President is in the best position to question HV’s exercise of power. Are we facing an unprecedented but real Conflict of Interest at the highest possible level?. Who is to bell the cat? Is the situation contemplated in the US legislation?. Does anyone know?.

  21. punky punky said

    why there are only 20 comments exposed out of 48 total ?. Any criteria for censorship?.

  22. punky punky said

    writedit,

    could you explain why you have erased 27 comments from this post?. They have been sitting in their place for weeks and all of a sudden being erased?. Is this a sign of power from Harold Varmus?

    • writedit said

      I have not erased any comments – I only do this blog in my spare time so leave it on autopilot once a post is up. I did find 2 comments, which I have restored, in the spam folder, but I have no idea how they were moved there or what might be happening to other comments. I am quite sure Harold is not involved, and I am not actively removing comments … no room for conspiracy theory here. I do recall this happening previously – a few dozen comments from the NIH Paylines & Resources page disappeared, and as I recall, the WordPress tech support folks could only get a few back from a back-up.

      • Frank Walter said

        Thanks for doing this in your spare time. The disappearing of comments is troubling though.

        I am taking the liberty to REPOST the response I received to the letter posted here to Sec Sebelius and Senator Harkin that I also emailed Sec Sebelius and faxed to the Senator´s Office.

        Here is the response

        ¨I am responding to your e-mail and letter addressed to the Department of Health and Human Services Secretary Kathleen Sebelius and Chairman Tom Harkin of the U.S. Senate HELP Committee regarding your concerns about the research funding process at the National Institutes of Health.

        Applications received in response to Research Answers to NCI’s Provocative Questions, RFA-CA-11-011 and RFA-CA-11-012, will be reviewed at two levels by committees subject to the Federal Advisory Committee Act (5 U.S.C. App.). Personal and proprietary information is contained in grant applications and as such, the review deliberations are closed to the public under exemptions found in 5 U.S.C. Sec 552b, “The Government in the Sunshine Act.” Please refer to http://provocativequestions.nci.nih.gov/ to learn more information about how applications will be reviewed. The role of federal advisory committees is to provide advice and guidance to federal officials, not to make decisions on behalf of the U.S. Government. Funding decisions at the National Institutes of Health depend on funds available and Institute priorities. More information about what research is funded may be found at http://report.nih.gov/frrs/index.aspx .

        Please visit http://www.nih.gov/ for more information on the National Institutes of Health and opportunities for public participation.

        Jennifer S. Spaeth
        Director, NIH Office of Federal Advisory Committee Policy
        One Democracy Plaza
        Suite 1000, MSC 4875
        6701 Democracy Blvd.
        Bethesda, MD 20892-4875

  23. writedit said

    Okay – are the comments all back now? If anyone does not see a recent comment restored, please repost … older missing comments may not be retrievable, but I think we have the recent discussion back online. I truly have no idea what happened, but I use the free version of WordPress so can’t complain too much about hiccups like this. I do appreciate someone posting a comment about problems, since that is how I am alerted to the need to attend to something on the blog … thanks again.

  24. Frank Walter´s Call said

    November 27, 2011

    Dear colleagues,

    This is to let you know that in the letter (11/14/2011) that I emailed Sec Sebelius and faxed to Senator Harkin, I identified myself with my real name. As one would expect, Sec Sebelius and Sen Harkin referred my letter to the interested agency, the National Institutes of Health. NIH responded to me on November 18 as reported here.

    NIH knows now the real identity of Frank Walter. But who´s Frank Walter? A biomedical scientist who in 2007, after questioning NIH for the lack of transparency and the injustices of peer review system, was placed in jail, ordered to spend time in a psychiatric hospital and forced to take drugs that affected her cardiac function, was finally rescued by an extraordinary lawyer, who in 2009 succeeded to send her to a safer home.

    I am landing at JFK airport on Nov 29 with AA 5679 at 4.10 p.m. on my way to Philadelphia where I have personal business to resolve. I have contacted my lawyer to ask if I will be safe and he is not sure but concerned that I sent that letter. I am an American citizen, pay taxes and feel the responsibility of contributing to a better country for all. I am scared to death that NIH might place me in jail again for that letter. But I refuse to surrender my rights to express opinions and question actions and policies that are detrimental to science, the scientific community and the interests of all US people.

    Upon my arrival in Philadelphia I will post my greetings here. If you don´t see my post on Nov 30. please ask Sec Sebelius and Senator Harkin. They might not know that NIH placed me in jail in 2007. Please, do it for my sake but also for your own sake. In
    these days and times, you never know.

    Thanks

    Frank Walter

    NIH

    • Einstein said

      Okay, that explains a lot. Sigh.

      Best wishes and good luck, “Frank”

  25. Arnold said

    Does anybody know if the NCI is planning to fund at least one grant per question?

    • writedit said

      They will fund enough R01s + R21s to do so … but who knows. I bet Harold would hate to see any left unanswered, though, since these were specifically selected from a much larger pool and therefore must each be very important (& the science highly significant).

  26. Arnold said

    Has anyone received a summary statement on their application responding to the Provocative Questions RFA at the NCI?

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