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Thread: Director of NIH Agrees To Loosen Ethics Rules

  1. #1

    Director of NIH Agrees To Loosen Ethics Rules

    This is an important story because the new ethical restrictions were threatening to create an exodus of scientists from the National Institutes of Health.

    http://www.washingtonpost.com/wp-dyn...print/asection

    Director of NIH Agrees To Loosen Ethics Rules
    By Ceci Connolly
    Washington Post Staff Writer
    Friday, August 26, 2005; Page A19

    Flooded with 1,300 comments by employees and threats of high-level defections, the head of the National Institutes of Health agreed yesterday to loosen some of the ethics rules he unveiled in February.

    Under the final regulations, about 200 senior staff members will be required to divest large stock holdings in drug and biotechnology companies, NIH Director Elias A. Zerhouni said. That is far fewer than the 6,000 employees who would have had to divest under his original proposal to strengthen conflict-of-interest rules at the world's premier biomedical research agency.

    Zerhouni also lifted a prohibition that would have kept NIH scientists from participating in academic and independent science organizations -- as long as they are not underwritten by a pharmaceutical company or other health care entity.

    But Zerhouni refused to budge on the issue of outside consulting. Some scientists had balked at a proposal prohibiting paid work for biomedical, pharmaceutical or other health-related businesses. "Maintaining the ban is the best way to protect the agency at this juncture," he said in a telephone briefing.

    Rep. Chris Van Hollen (D-Md.), whose district includes NIH's Bethesda campus, cheered the changes, especially regarding personal investments. The earlier version "swept a lot of people up in a net unnecessarily," he said in an interview. "This is focused more on the decision makers."

    But Sidney M. Wolfe, director of the Health Research Group at the consumer organization Public Citizen, characterized the changes as a "huge retrenchment" that left plenty of loopholes for NIH employees to accept industry money. Although he said the ban on consulting was positive, he warned that researchers could collect money from companies "laundered" through a journal or a scientific association.

  2. #2
    http://www.nytimes.com/2005/08/26/po...gewanted=print

    August 26, 2005
    Health Agency Tightens Rules Governing Federal Scientists

    By GARDINER HARRIS
    WASHINGTON, Aug. 25 - After accusations that some government scientists used their official positions for private gain, the National Institutes of Health announced rules on Thursday that ban its scientists from consulting for drug companies.

    "Our research should be based on scientific evidence that is not influenced by any other factors," Dr. Elias A. Zerhouni, director of the health institutes, said at a news conference.

    The rules are being issued after disclosures that scientists at the institutes leveraged their positions to land lucrative consulting contracts that seemed to conflict with their official duties or at least overlap with them. Those contracts caused some critics to worry that research by the agency could be tainted.

    An investigation by the agency concluded that 44 of its 1,200 senior scientists appeared to have violated rules governing consulting and that 9 might have violated criminal laws.

    The conflicts were first reported by The Los Angeles Times.

    The regulations are not as draconian as those that an internal panel proposed in February. Under those proposals, which caused an uproar, not only was consulting banned, but 6,000 scientists would have also been forced to sell all shares they owned in pharmaceutical and biotechnology companies.

    Any remunerative activity outside of work - even selling jewelry or singing - would have had to be disclosed and approved by ethics overseers. All 18,000 employees would have been forced to limit their holdings in any one company to shares valued at no more than $15,000.

    Under the final rules, the top 200 executives will be required to keep the value of their holdings in any single drug company below $15,000. Some 6,000 other employees will have to submit for review their holdings in such companies. If the holdings are determined to conflict with official responsibilities, the employees will be asked to sell these shares, officials said.

    Agency scientists will also be allowed to hold fiduciary positions in medical societies as part of their lives outside the agency, a practice that the proposed rules would have banned.

    "Clearly, we do not want to impede the normal academic interactions that scientists need to have with the rest of the world," Dr. Zerhouni said.

    The changes were welcomed by scientists at the agency who had fiercely criticized the old proposals.

  3. #3

    One for the doc's, how about the patients

    Too often I hear propaganda about doctors rights and if I might say to little about patients rights on this website. I know, I know someone is gonna say doctors need to do their work if we want a cure, but gimme a break, the docs got allot more clout than their patients do. They want protection on all ends-Malpractice caps, the right to own stock in conflict of interest corporations, the right to get grants to do research and STILL Profit from their discovery. Thats like getting paid twice. And the poor bastard that gets his good kidney out instead of his bad one is a pig if he sues, and the lawyer that takes his case is a vulture, and even if he wins the case there's either a cap or the Mal- Practice insurer went bankrupt and there is a 300,000 dollar cap or maybe even less, by the state take over of the insurer in default.

    If you want to express your hot damns do it on a doctors website. Most of the people here are patients.

    Have you ever needed a wheelchair for a family member? And had to fight with the insurance company? Have you ever had a family member who was paralyzed and needed physical therapy and couldn't get more than a months worth from insurance? Hey, SCI ain't tennis elbow. If you want to fight for docs, how about fighting for some patient rights also?
    Do you have a daughter or son attending a University and they are paralyzed? Would you be happy sending them to a school where all their needs couldn't be met? Probably not, but you could afford to send your kid or even all your grandchildren to any school they wanted to go to. Get my point?
    Don't ignore the Reeve Legacy, Remember he and Dana supported open research and fought hard for ESCR

    StemCellBattles

    Support H.R. 810

  4. #4
    BTW, all Universities are supposed to be barrier free, there are laws about that. So it's not any reflection on the administration, however, I find it hard to believe that the University you study in, do research in, have this website from, is far behind others in being proactive towards people in wheelchairs. You could do better. Seems to me if you put in the same amount of time to a proactive policy in getting more students in wheelchairs to attend Rutgers as you do monitoring the stock price of Merck after Vioxx you might have made some gains in opening up the University as more wheelchair friendly. If you think it ain't your job to do that, then surely it ain't mine to be concerned about pharmaceutical or doctors rights.
    Last edited by bigbob; 08-26-2005 at 08:08 PM.
    Don't ignore the Reeve Legacy, Remember he and Dana supported open research and fought hard for ESCR

    StemCellBattles

    Support H.R. 810

  5. #5
    I cannot imagine the things spinning around in Director Elias A. Zerhouni's head!

    What do you think of the cap on industry stock holdings for senior executives at $15K mentioned in the article, Wise ? Could this announcement be the precipitator for something big??? Or just normal politics and industry.

  6. #6
    Quote Originally Posted by bigbob
    If you think it ain't your job to do that, then surely it ain't mine to be concerned about pharmaceutical or doctors rights.
    Nobody said it is.

    This is about keeping top scientists at the NIH to keep it competitive. If an exodus ensued because restrictive polcies were instituted, that would hurt research and keep us in our chairs longer. I'm sure you don't want that.
    ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

  7. #7
    Quote Originally Posted by Steven Edwards
    Nobody said it is.

    This is about keeping top scientists at the NIH to keep it competitive. If an exodus ensued because restrictive polcies were instituted, that would hurt research and keep us in our chairs longer. I'm sure you don't want that.
    Edwards, don't assume what I want. Don't assume that I think a conflict of interest free NIH would hurt a cure either, it might help it.
    Don't ignore the Reeve Legacy, Remember he and Dana supported open research and fought hard for ESCR

    StemCellBattles

    Support H.R. 810

  8. #8
    Quote Originally Posted by Lizbv
    I cannot imagine the things spinning around in Director Elias A. Zerhouni's head!

    What do you think of the cap on industry stock holdings for senior executives at $15K mentioned in the article, Wise ? Could this announcement be the precipitator for something big??? Or just normal politics and industry.
    Lizbv, much of the damage has already been done. Several of the top researchers at NIH have already left. It may be too late to save one of them, Jim Battey, who is the Director of the National Institute of Deafness and Other Communication Disorders and the Director of the NIH Stem Cell Task Force. See http://www.washingtonpost.com/wp-dyn...-2005Apr1.html

    In interviews recently, agency scientists said they have confronted problems as small as being turned down from accepting token travel reimbursements to professional conferences and as large as, in Battey's case, being expected to divest holdings from a trust fund he manages for his family.

    "The new rules imposed an insurmountable problem for me," said Battey, who has applied for the job of president of the new California Institute of Regenerative Medicine. "I manage a family trust . . . which supports the education of my father's seven grandchildren, and it contains assets I'm told I'd have to divest. That would cost a lot of money, and I can't do that to my family."
    It is a shame because people like Battey are what NIH must have to organize and develop good stem cell programs. No other federal agency imposes such drastic limitations on the private finances of its employees. Can you imagine what would happen to the Department of Defense if they imposed a $15,000 cap on how much stock their employees can own in the defense-related industry? Or if they were to impose a rule that judges and court employees have a $15,000 cap on any investments that might be affected by judicial decisions? Or, can you imagine Congress imposing upon itself a $15,000 cap on investments that they can hold in any industry that their legislation affects? In all other parts of the government, the rule is full disclosure and recusal from cases where they may have a conflict of interest. In the case of the President and Vice-President, they can establish a blind trust. Why should this be different for NIH employees?

    This situation is particularly strange given the NIH has been the cleanest and most incorruptible agency of the federal government for over 50 years. The last director of NIH Harold Varmus made a big effort to get more entrepreneurial scientists to come to NIH. He relaxed the rules for consulting and rejuvenated NIH by attracting the first really BIG scientific fish to NIH for nearly 20 years. NIH pays less than most universities for top academic talent, is less prestigious than being a big professor in a big university, and cannot offer the same tenure protection. To compete for the top administrative and scientific talent, NIH has to provide the best equipment, space, environment, and scientific opportunities. It had to attract good scientists because good scientists go where there are good scientists. Varmus was successful in rebuilding NIH, attracting many superb scientists and they were attracting good young scientists.

    Zerhouni (the current director of NIH) had a difficult decision to make. He is in a Republican Administration that is naturally suspicious of scientists and that is unpopular with a large majority of rank-and-file scientists of America. Congress had an investigation of NIH going on, instigated by Republicans who wanted to put pressure on the NIH to manipulate its budget. So, Zerhouni decided last February to impose draconian conflict of interest rules, including forcing all senior administration to divest stocks in biomedical industry and resigning from any service or consulting position that they might hold outside of NIH (including things like editing journals or being presidents of a research society). There are already strict rules in place that prevent government officials from accepting pay or gifts.

    The new rules created an uproar. Elias Zerhouni has now come back to a more reasonable position although there are still some who think that his position is too strict. People should understand that the Director of NIH does not make decisions alone. He is a director of directors. Under the current system, each director of an institute at NIH has his or her own budget directly from Congress. The conflict of interest decision was one that the directors of institutes agreed to and he may have been pressured to impose these rules by the Secretary of Heath and Human Services. Zerhouni has a very difficult job, probably more difficult than the head of any other agency. He heads an agency that awards $27 billion to scientists based on peer review. Most scientists are as independent as cats. Zerhouni is under enormous pressure from advocacy groups to keep the scientific herd under control, to keep them going in the desired direction, and to deliver therapies. He has to please his Secretary of Health and Human Services. He has to keep members of Congress and the White House happy.

    From the viewpoint of the consumers (i.e. the spinal cord injury community is a consumer of NIH research), it is important to understand the enormous political pressures that NIH has been placed in the past four years. Zerhouni has been the rope in the tug of war between Congress and the White House. All previous administrations have protected the NIH from pork barrel politics. The current White House has played with the NIH budget like no other previous administration. For example, in the past four years, this administration took a big chunk of the congressionally mandated NIH increase for bioterrorism research. It was no accident that NIH stopped posting information about how much they were spending for spinal cord injury beginning 2001. The administration has even interfered with appointments to advisory and peer review committees. This is the first administration that has opposed the recommendations of NIH on major scientific issues. The NIH needs our support. I was afraid that the draconian rules were going to stand and more good people would be forced out of NIH. There is no other agency in the federal government that can deliver better science for the buck. The spinal cord injury community needs the best people at NIH to deliver the biggest bang for the buck because we don't have a lot of bucks.

    Wise.
    Last edited by Wise Young; 08-27-2005 at 07:35 AM.

  9. #9

    Loosen Ethics,why? too much pressure?

    Dr. Young you continue to barrage us with rhetoric that points out how honorable doctors are. In all my life I have never seen a more self centered group. In my opinion they are always looking for money and never want to part with it. Are they really better than the vultcher Lawyers? Same shit, just flip side of the coin.

    Take for example the point you have made that Doctors don't want to make some therapies a standard of care because one of their buddies might forget to apply it and this way they won't get sued. If you break that down and analyze it, what it says is that there are doctors that know a certain option should be applied to patients. When they chose not to make this option a standard of care, they are not protecting themselves because they obviously know about this option and would use it, but are protecting another doctor who may not be up on his readings or diagnostic skills. What about the patients? Screw them And, might I say in what other field to you need to get another Doctor to be an expert witness against another Doctor if you want to pursue legal action? As far as that goes are you aware that it is extremely hard to accomplish that. Maybe thats why they have come up with a plan for anonymous reporting of doctor errors in hospitals to reduce the amount of hospital deaths. That says allot. And, BTW none of these anonymous reports will be allowed as evidence against a doctor.

    Yes, I want a cure, but not to the extent that I got to make it safe for doctors as part of the plan. I feel used when I hear all this stuff about how Honorable doctors are.
    Last edited by bigbob; 08-27-2005 at 03:42 PM.
    Don't ignore the Reeve Legacy, Remember he and Dana supported open research and fought hard for ESCR

    StemCellBattles

    Support H.R. 810

  10. #10
    DOCTORS' ETHICS?
    "Facts do not cease to exist just because they are ignored." Aldous





    EXAMPLES OF THE LACK THEREOF
    ** This site does not condemn all doctors. There are many dedicated, respectable and competent professionals. However, good doctors are not out demonstrating for limiting their patient's rights instead of attacking the actual problems: incompetent colleagues, unscrupulous corporate profit-orientation and unnecessary procedures and cover-up - and most of all INSURANCE COMPANIES and BIG PHARMA per se.
    Last edited by bigbob; 08-27-2005 at 10:24 PM.
    Don't ignore the Reeve Legacy, Remember he and Dana supported open research and fought hard for ESCR

    StemCellBattles

    Support H.R. 810

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