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FDA/NIH XMRV paper ON HOLD

Discussion in 'Media, Interviews, Blogs, Talks, Events about XMRV' started by CBS, Jun 29, 2010.

  1. judderwocky

    judderwocky Senior Member

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    CALL THE DHHS 2022055445

    Tell them that withholding scientific information is unethical.

    I wish we could get a Change.org Petition going....
     
  2. pollycbr125

    pollycbr125 Senior Member

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    yorkshire
    full text

    With Papers On Hold, Government Scientists Fuel Debate on Virus for Chronic Fatigue
    by Martin Enserink on June 30, 2010 4:42 AM | Permanent Link | 0 Comments
    Email Print| More
    PREVIOUS ARTICLE
    (This story is adapted from a longer one in the 2 July issue of Science)

    It was just a snippet of news, reported by an obscure journal in the Netherlands. And yet it lit up the Internet. Twitter was all atwitter, scientists' mailboxes on both sides of the Atlantic began filling up, and dozens of bloggers started jubilating. "It's happened. I cannot tell you all how this changes the world as we have known it for 25+ years," one patient wrote on her blog. "Now to work on the vindication part!"

    The reason for all the excitement? Scientists at the U.S. National Institutes of Health (NIH) and the Food and Drug Administration (FDA) were reported to have confirmed the link, first published in Science last year, between a human retrovirus and the elusive condition called chronic fatigue syndrome (CFS). Earlier this year, three other groups reported being unable to replicate such a connection. That federal scientists now confirmed it was huge mood-lifter for patients, many of whom are desperate to find a biological cause, and a cure, for their debilitating ailment.

    But the story wasn't as simple as that. Science has learned that a paper describing the new findings, already accepted by the Proceedings of the National Academy of Sciences (PNAS), has been put on hold because it directly contradicts another as-yet-unpublished study by a third government agency, the U.S. Centers for Disease Control and Prevention (CDC). That paper, a retrovirus scientist says, has been submitted to Retrovirology and is also on hold; it fails to find a link between the xenotropic murine leukemia virus-related virus (XMRV) and CFS. The contradiction has caused "nervousness" both at PNAS and among senior officials within the Department of Health and Human Services, of which all three agencies are part, says one scientist with inside knowledge.

    The debate over XMRV started in 2009 when a group of researchers led by Judy Mikovits of the Whittemore Peterson Institute (WPI) for Neuro-Immune Disease in Reno, Nevada, reported in Science finding traces of the virus in peripheral blood mononuclear cells, a type of white blood cell, of 67% of CFS patients. By contrast, only 3.4% of healthy controls were found to harbor the virus. The team also showed that XMRV could infect human cells and concluded that the viruswhich had previously been linked to prostate cancermight play a role in causing CFS (Science, 23 October 2009, p. 585).

    Many scientists were skeptical, however, and in May, Science published three Technical Comments that tried to poke holes in the study, along with a rebuttal by Mikovits and first author Francis Ruscetti of the National Cancer Institute. By that time, two groups in the United Kingdom and one in the Netherlands had also published papers failing to find a link; in fact, they found little or no evidence of XMRV infection at all, either in patients or in healthy people. Three other groups, two from the United States and one from Europe, have also reported negative findings at meetings, says Kim McCleary, president of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America, a patient advocacy group.

    The FDA-NIH paper would offer fresh hope that Mikovits is on to something after all, but so far, details about the work are scant. Ortho, a Dutch magazine about nutrition and food supplements, last week issued a press release saying that Harvey Alter, a renowned virologist at NIH's Clinical Center, mentioned the study when he gave a talk at a blood safety meeting in the Croatian capital Zagreb in late May. In his PowerPoint presentation, Alter wrote that the data in the 2009 study in Science "are extremely strong and likely true, despite the controversy." Another bullet point said: "We (FDA & NIH) have independently confirmed the Lombardi group findings." (WPI's Vincent Lombardi was the paper's first author.) But the presentation offered no detail beyond that tantalizing summary, and an NIH spokesperson says Alter is not available for comment.

    Meanwhile, a group working with retrovirologist William Switzer at CDC, which has done an independent study, has held its cards closer to its chest. But Science talked to several scientists who say they have seen the data, and they are negative. Although it's not unprecedented for government scientists to be on opposite ends of a scientific debate, two contradictory press releases on a flashpoint issue like CFS would look odd, scientists say. With publication deferred, "they want to find out what's going on first," says one researcher who says he has been briefed about the controversy.

    Last week, the AABB, an international association of blood banks, recommended to its members that they discourage CFS patients from donating blood. A special task force on XMRV conceded that the evidence was preliminary but decided it's "prudent" to err on the side of caution, says task force member Louis Katz, the medical director at the Mississippi Valley Regional Blood Center in Davenport, Iowa. "If [XMRV] turns out to be important," says Katz, "I don't want to be criticized for doing nothing when I could have done something."


    :Retro mad:That federal scientists now confirmed it was huge mood-lifter for patients, many of whom are desperate to find a biological cause, and a cure, for their debilitating ailment......... debilitating ailment how patronising is that?:Retro mad:
     
  3. Sean

    Sean Senior Member

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    I don't see anybody saying that.

    I am shocked and disappointed at how easily some here have reflexively flipped straight into uncritical conspiracy mode to try to 'explain' this temporary hold up. It does not help our cause to think like that.
     
  4. VillageLife

    VillageLife Senior Member

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    Fda / Nih v Cdc

    I'm on team fda!!! :victory::victory::victory::victory:
     
  5. hidlyn

    hidlyn

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    Parvo for President! ;-)
     
  6. Esther12

    Esther12 Senior Member

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    I kind of agree... kind of think that some conspiratorial thinking is legitimate here.

    I don't think that there's going to be any any giant cover-up here, but I do think that CFS is often treated strangely my medical authorities and much of that is due to the prejudices and ignorance which surround the condition. Does that count as a conspiracy?

    One of the resons I was so happy about the XMRV news is that it was such a solid claim. It left no room for the quackery we've been exposed to for so long: the results will either hold up, or not. Hopefully we'll find out which soon.
     
  7. hvs

    hvs Senior Member

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    Ding ding ding! And George nails it, for $500.
    Holy moly. We should actually feel a little sorry for HHS. The CDC has been denying any role for an infectious agent for decades and now this? And the day after the news breaks people will be refusing to accept surgery or blood transfusions, etc.? And the day after the news breaks the feds and blood industry have to be responsible for testing every ounce of the nation's blood supply? Now these are reasons why the feds would take the extraordinary (not normal, those who suggest so) step of withdrawing papers that were in print.
     
  8. shannah

    shannah Senior Member

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    Time For All Seasons

    I think the 'cooler head' response might be appropriate right now IF we weren't talking about the government agencies involved here.

    Personally I feel Dr. Yes is right on. In post 40 he writes,

    "So none of these government agencies had any clue that they had conflicting findings until after they submitted their papers? I find that hard to believe. Perhaps there is a major concern in the DHHS about public reaction to this news, and about 'getting to the bottom' of this issue, but if that were the case they would not have waited until after the peer review process to instruct the authors to delay publication."

    and

    "But there is no good scientific reason to suspend the publication of conflicting results, and it is unethical to interfere with the scientific process for political convenience when so many sick people depend on the results of a pure scientific process. Either there has been a great deal of incompetency/ lack of oversight until this late stage by various officials, or there is a power struggle going on."

    "The danger with allowing government agencies to work this out behind closed doors is that the CDC or their higher-ups could pressure the other group into editing (or, far less likely, even pulling) the positive study. To believe that government scientists are immune to pressure by the government is naive. It would be a mistake for us to relax and trust the government to do the right thing when experience tells us they are more likely to do the opposite. I think the best thing for us to do is put public pressure on the DHHS to allow the release of the FDA/NIH study (in its original accepted form) now; writing to the DHHS, to Congressional representatives, and attempting to get media coverage on this story could only help, in my opinion. "

    I also love the idea of the ticking clock as proposed by thegodofpleasure in post 45:

    "The clock is ticking
    Pehaps Cort could place a counter on the PR homepage / XMRV buzz page, highlighting the length of time it takes these comfortably placed Government Officials to get their act together and finally publish the information we crave ?

    There's a free one available at http://www.clocklink.com/gallery.php?category=COUNT

    By the way, it's now been 265 days (or 8 months & 22 days ) since the "Science" paper was published."

    and Otis in #64:

    "Tick Tock
    The ME/CFS clock marches onward. People are getting sick(er).and treatments are delayed. Prevention is on hold. The band plays on.

    The real credibility hit is to papers still in work which can more easily and quietly buried or "influenced".

    The stakes are high. I mentioned a week ago that we were on the cusp of a tipping point where we get one chance to help things fall in the right direction. We've reached it folks. It's time to let all our "leaders" and press contacts know we can't allow the science to be stopped. If that happens, we lose.

    "Tick tock people, time is slipping away." - Stevie Ray Vaughn "

    Look at the damage and months of delays the Wessely (edited - sorry wrong name posted originally) paper in January caused! Action/Reaction from the CFS community is needed NOW.
    (Can't wait to see what Hillary Johnson writes.)
     
  9. judderwocky

    judderwocky Senior Member

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  10. shannah

    shannah Senior Member

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    judderwocky:

    This petition can only be signed by those in the United States.
     
  11. muffin

    muffin Senior Member

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    USA!
    NIH, FDA, CDC Directors/Commissioner EMAILS - GO AHEAD AND EMAIL THEM

    Yesterday I had a strange thought that the FDA/NIH would come back with a statement saying that they messed up and that they did not find XMRV as first noted. So today I see that the FDA, NIH, and CDC studies are on hold. Am I surprised that the CDC did not find XMRV? Nope. The CDC is STILL playing games with CFIDS and XMRV and I guess they decided (by their PR/Marketing people) that it was least destructive to them to come out as negative on XMRV rather than positive.

    As I have said elsewhere, it doesn't matter anymore what the CDC says about XMRV, CFIDS or really anything at all -- the CDC's credibility is long gone now on all fronts. As others have suggested there have been the WPI, CC, NCI, FDA and NIH findings of XMRV as well as individuals having their own tests done and coming back as postitive. I think all those orgs and people outweigh the stupid/corrupt CDC by a huge margin.

    We probably do need to keep track of all people who tested postive for XMRV, their location, the test/test org, date, etc. to use that as fuel against the CDC and those that have a vested interest in not letting XMRV be seen/known as disabling/deadly as it is. Apparently an aggressive form of prostate cancer isn't enough to prove XMRV. So that means that those that have tested positive need to make it known (not their names, just locations) and for all of us to scream and make it known that WE ALL KNOW this is politics and not science.

    The Feds may well be terrified of the "findings" in the blood supply (AABB) plus the positives of the above oranizations. They may be trying to figure out how to keep the public (here/abroad) from getting hysterical and going after the CDC and other Fed health orgs with pitchforks. They also have the political problem (as seen by those with even a little background) that the CDC is yet again playing dangerous games with CFIDS and XMRV. So it probably will take them time to figure out how to lessen the damage done by the positive findings as well as the politically motivated negative CDC finding. Not a job I would want.

    Below are the names and email addresses of the NIH Director, FDA Commissioner, and CDC Director. I think it is time to email them all and tell them that not only the CFID sick are aware of the games being played out but also the public as well. We need to beat on them and ensure they know they are being watched. Also time to spew the game playing of the CDC over the past 30 years across the Internet everywhere you can think of including emailing the media. (see/cite www.oslersweb.com WHY speech). I am sure the media would be interested in this game going on right now between three Federal health organizations involving a deadly cancer-causing virus that has most likely has been in the nation's blood supply for a good three decades and the science/medical documents not being released for public dissemenation. WHY would they be witholding these scientific/medical studies if there weren't very serious government implications involved? Let's ensure the public knows this is going on now and that the public is the one being damaged. So again, email the NIH, FDA and CDC top folks with gracious emails. Ask WHY they are withholding scientific/medical studies from release to the public. Ensure Dr. Frieden (CDC Dir) knows we all are aware of the on-going games played by his organization. And hit the media HARD with this one. It stinks of something very rotten and dangerous to us all. (I have also placed info on the FDA org since that has not been on this website before and we need to know what they do and how they are structured. The FDA also plays a role in blood products.)
    --- NON-AMERICANS - EMAIL THEM AS WELL. WHAT HAPPENS IN THE US AFFECTS WHAT HAPPENS IN YOUR COUNTRY TOO -----

    1) National Institutes of Health (NIH)
    Dr. Francis S. Collins, NIH Director francis.collins@nih.gov 301-496-2433

    2) OFFICE OF THE COMMISSIONER, COMMISSIONER OF FOOD AND DRUGS (FDA)
    Margaret A. Hamburg, M.D. (Commissioner of Food and Drugs) margaret.hamburg@fda.hhs.gov

    3) Centers for Disease Control and Prevention (CDC) http://www.cdc.gov/
    Thomas R. Frieden, MD, MPH ftdh@cdc.gov
    Director, Centers for Disease Control and Prevention
    Administrator, Agency for Toxic Substances and Disease Registry


    -------------------------------------------------------
    FDA AND DR. HAMBURG BACKGROUND INFO - FYI (They also are involved in blood products)
    http://www.fda.gov/default.htm
    Margaret A. Hamburg became the 21st commissioner of food and drugs on May 18, 2009. The second woman to be nominated for this position, she is an experienced medical doctor, scientist, and public health executive.
    As the top official of the Food and Drug Administration (FDA), Dr. Hamburg is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. Strengthening FDAs programs and policies will help us protect the safety of the food supply, give the public access to safe and effective medical products, find novel ways to prevent illness and promote health, and be transparent in explaining our decision-making, says Dr. Hamburg. A strong FDA is an agency that the American public can count on.
    Dr. Hamburg graduated from Harvard Medical School and completed her residency in internal medicine at what is now New YorkPresbyterian Hospital/Weill Cornell Medical Center. She conducted research on neuroscience at Rockefeller University, studied neuropharmacology at the National Institute of Mental Health, and later focused on AIDS research as assistant director of the National Institute of Allergy and Infectious Diseases.
    From 2005 to 2009, Dr. Hamburg was the senior scientist at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. From 2001 to 2005, as the foundations vice president for biological programs, she advocated for broad reforms to confront the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu.
    In 1997, Dr. Hamburg accepted the position of assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services. In 1994, she was elected to the membership in the Institute of Medicine, one of the youngest persons to be so honored.
    From 1991 to 1997, Dr. Hamburg served as commissioner of the New York City Department of Health and Mental Hygiene. In this position, she improved services for women and children, promoted needle-exchange programs to reduce the spread of HIV, and initiated the nations first public health bioterrorism defense program. Her most celebrated achievement was curbing the spread of tuberculosis, which resurged as a major public health threat in the 1990s. As a result of Dr. Hamburgs reforms, New York Citys TB rate fell significantly over a five-year span. Her innovative approach, which included sending health care workers to patients homes to make sure they completed the drug regimen, is now a model for health departments worldwide."

    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    FOOD AND DRUG ADMINISTRATION
    The following is the communication box containing information to assist anyone who may want to communicate with the depicted organization via telephone, facsimile or mail.
    Main Tel: 301-796-5000
    Fax: 301-847-3531
    Address: WO Bldg. 1, Rm. 2217
    10903 New Hampshire Avenue
    Silver Spring, MD 20993-0002
    PRINCIPAL DEPUTY COMMISSIONER
    Joshua M. Sharfstein, M.D.
    Reports to the General Counsel of HHS, advises the Commissioner of Food and Drugs
    OFFICE OF THE CHIEF COUNSEL
    CHIEF COUNSEL
    Ralph S. Tyler, J.D.

    Reports directly to the Secretary, HHS
    OFFICE OF THE ADMINISTRATIVE LAW JUDGE
    Daniel J. Davidson, J.D.

    Reports to the Commissioner
    OFFICE OF WOMENS HEALTH
    DIRECTOR
    Marsha Henderson, M.C.R.P. (Acting)
    OFFICE OF POLICY, PLANNING & BUDGET
    DEPUTY COMMISSIONER
    David H. Dorsey, J.D. (Acting)
    Reports to the Deputy Commissioner for Policy, Planning & Budget
    ASSISTANT COMMISSIONER FOR POLICY
    Leslie Kux, J.D. (Acting)
    ASSISTANT COMMISSIONER FOR PLANNING
    Malcolm Bertoni
    ASSISTANT COMMISSIONER FOR BUDGET
    Patrick McGarey, J.D.
    Reports directly to the Commissioner and an indirect report to the Deputy Commissioner for Policy, Planning and Budget
    OFFICE OF LEGISLATION
    ASSISTANT COMMISSIONER FOR LEGISLATION
    Jeanne C. Ireland
    Reports to the Commissioner
    OFFICE OF THE COUNSELOR TO THE COMMISSIONER
    COUNSELOR TO THE COMMISSIONER
    John M. Taylor III
    Reports to the Counselor to the Commissioner
    OFFICE OF CRISIS MANAGEMENT
    DIRECTOR
    Ellen Morrison
    Reports to the Commissioner
    OFFICE OF THE CHIEF OF STAFF
    CHIEF OF THE STAFF
    Molly Muldoon
    Reports to the Chief of Staff
    EXECUTIVE SECRETARIAT
    Dotty Foellmer
    OFFICE OF SPECIAL MEDICAL PROGRAMS
    ASSOCIATE COMMISSIONER
    Jill Warner (Acting)
    Reports to the Associate Commissioner for Special Medical Programs
    OFFICE OF GOOD CLINICAL PRACTICE
    DIRECTOR
    Joanne Less, Ph.D.
    OFFICE OF COMBINATION PRODUCTS
    DIRECTOR
    Thinh X. Nquyen
    OFFICE OF ORPHAN PRODUCTS DEVELOPMENT
    DIRECTOR
    Timothy Cote, M.D., MPH
    OFFICE OF PEDIATRIC THERAPEUTICS
    DIRECTOR
    M. Dianne Murphy, M.D.
    Reports to the Commissioner
    OFFICE OF FOODS
    DEPUTY COMMISSIONER
    Michael R. Taylor, J.D.
    OFFICE OF THE CHIEF SCIENTIST
    CHIEF SCIENTIST AND DEPUTY COMMISSIONER FOR SCIENCE AND PUBLIC HEALTH
    Jesse Goodman, M.D., MPH

    Reports to the Chief Scientist and Deputy Commissioner for Science and Public Health
    OFFICE OF COUNTER-TERRORISM AND EMERGING THREATS
    ASSISTANT COMMISSIONER
    Boris Lushniak, M.D., MPH
    OFFICE OF CRITICAL PATH PROGRAMS
    DIRECTOR
    Leonard Sacks, M.D. (Acting)
    OFFICE SCIENTIFIC INTEGRITY
    DIRECTOR
    Vacant
    OFFICE OF SCIENCE AND INNOVATION
    DIRECTOR
    Vacant
    Reports to the Commissioner
    OFFICE OF INTERNATIONAL PROGRAMS
    DEPUTY COMMISSIONER
    Murray Lumpkin, M.D.

    Reports to the Deputy Commissioner for International Programs
    ASSOCIATE COMMISSIONER
    Mary Lou Valdez
    Reports to the Commissioner
    OFFICE OF ADMINISTRATION
    CHIEF FINANCIAL OFFICER
    DEPUTY COMMISSIONER FOR ADMINISTRATION
    Russell J. Abbott
    Reports to the Chief Financial Officer/Deputy Commissioner for Administration
    ASSOCIATE COMMISSIONER
    Caroline Lewis
    OFFICE OF ACQUISITIONS AND GRANTS SERVICES
    DIRECTOR
    Glenda Barfell
    OFFICE OF EXECUTIVE OPERATIONS
    DIRECTOR
    LTonya Davis
    OFFICE OF FINANCIAL OPERATIONS
    DIRECTOR
    A. Robert Miller (Acting)
    OFFICE OF INFORMATION MANAGEMENT
    CHIEF INFORMATION OFFICER
    Lori Davis
    OFFICE OF MANAGEMENT
    ASSISTANT COMMISSIONER FOR MANAGEMENT
    Kimberly A. Holden
    Reports directly to the Commissioner and an indirect report to the Deputy Commissioner for Administration
    OFFICE OF EQUAL EMPLOYMENT OPPORTUNITY AND DIVERSITY MANAGEMENT
    DIRECTOR
    Ricardo Grijalva, J.D.
    Reports to the Commissioner
    OFFICE OF EXTERNAL AFFAIRS
    ASSOCIATE COMMISSIONER
    Beth Martino
    Reports to the Associate Commissioner for External Affairs
    OFFICE OF EXTERNAL RELATIONS
    ASSISTANT COMMISSIONER
    Lawrence Bachorik, Ph.D.
    OFFICE OF PUBLIC AFFAIRS
    ASSISTANT COMMISSIONER
    George A. Strait, Jr.
    OFFICE OF SPECIAL HEALTH ISSUES
    DIRECTOR
    Theresa A. Toigo
    Approved by the FDA Reorganization Coordinator and Principal Delegation Control Officer
     
  12. grant107

    grant107 Jean

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    Ormond Beach, Fl
    Just because Dr. Reeves has been moved that doesn't mean the other people working with him are not of the same mind. He predicted they would find nothing and that has been a self-fulfilling prophecy. The CDC is showing its' ineptitude.
     
  13. muffin

    muffin Senior Member

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    USA!
    Dr. Yes said: "The danger with allowing government agencies to work this out behind closed doors is that the CDC or their higher-ups could pressure the other group into editing (or, far less likely, even pulling) the positive study. To believe that government scientists are immune to pressure by the government is naive. It would be a mistake for us to relax and trust the government to do the right thing when experience tells us they are more likely to do the opposite. I think the best thing for us to do is put public pressure on the DHHS to allow the release of the FDA/NIH study (in its original accepted form) now; writing to the DHHS, to Congressional representatives, and attempting to get media coverage on this story could only help, in my opinion. "

    THIS IS WHAT WE MUST DO NOW BEFORE THE CDC TERRIFIES THE NIH/FDA INTO SAYING THAT A MISTAKE WAS MADE AND THAT THEY DID NOT FIND XMRV. NAIL THE GOVERNMENT AND THE PRESS NOW BEFORE THE CDC CONTINUES TO DO ITS 30 YEARS OF DAMAGE!!!!!!
     
  14. judderwocky

    judderwocky Senior Member

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  15. Jerry S

    Jerry S Senior Member

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    Chicago
    I signed the petition, judderwocky. I also support Team NIH/FDA and Parvo for President.
     
  16. Megan

    Megan Senior Member

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    Hi all,

    We need to be posting comments against the WSJ article and also the ne Science article on this! Get in early on the Science one. I notice another patient got in early on the WSJ article and has posted something that may have well have been written by Wessley himself.

    http://news.sciencemag.org/scienceinsider/2010/06/conflicting-papers-on-hold-as-xm.html

    http://online.wsj.com/article/SB100...sj#articleTabs_comments=&articleTabs=comments


    I just posted the following to the Science article but it is awaiting moderator approval:

    "It is dissapointing that Science magazine seems to be uncritically accepting government interference in publication of a legitimate scientific study. So what if the papers are contradictory? Allow them to be published and let the scientific world determine for themselves which one is correct. Isn't this supposed to be how science works?"
     
  17. Dreambirdie

    Dreambirdie work in progress

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    N. California
  18. judderwocky

    judderwocky Senior Member

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    i tried... but i don't know how to on this system... i think you might need to be an admin
     
  19. Sing

    Sing Senior Member

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    New England
    Thank you, judderwocky, I signed the petition; and thanks to muffin for superb advocacy and information, and also to Megan for the links to follow up by commenting on the WSJ and Science Mag articles. Take action, everyone, please, on some part of this or all--

    Thanks again!
     
  20. Dreambirdie

    Dreambirdie work in progress

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    Okay then, let Otis know. He will help you.
     

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