Medical Sentinel Announces New "Open Data" Policy
The following press release was aired on August 30, 1999:
With the increasing politicization of published scientific and medical research, e.g., gun and violence research, HIV-AIDS health policy, and now more recently, the unintended consequences of mandatory vaccinations (i.e., Hepatitis B and diarrhea due to rotavirus infection, etc.) in infants, the Medical Sentinel, the peer-reviewed journal of the Association of American Physicians and Surgeons (AAPS) is announcing a new policy with the upcoming (September/October 1999) issue of the Medical Sentinel.
As consideration of publication in the Medical Sentinel, the authors of clinical and scientific papers submitted to the Medical Sentinel must make available on the Internet the redacted raw data associated with their papers. The data from which conclusions are drawn will be posted at the lead author's website or at http://www.aapsonline.org.
The Medical Sentinel is thereby adopting a new standard of public access to research data for its published, scientific articles that goes beyond the heretofore, almost universal, editorial policy of peer-review. This new policy, which we call public review, will make scientific data available to other investigators and the public to facilitate the open exchange of information between scientists. This new policy will go hand in hand with the recently passed Congressional (Shelby) provision requiring public access to raw data of research studies funded by the federal government.
In the past, as revealed in congressional inquires, scientists, including government funded investigators, particularly in the area of gun and violence research, have breached accepted scientific practice by refusing to release and make available to other researchers their publicly funded original data for further critical analysis (See, Faria MA, Jr., "Perversion of Science and Medicine, Medical Sentinel, Spring and Summer 1997 issues, www.haciendapub.com).
In announcing this policy, Miguel A. Faria, Jr., M.D., Editor-in-Chief of the Medical Sentinel stated: "We invite the new editors of The New England Journal of Medicine (NEJM), the Journal of the American Medical Association (JAMA), and The Western Journal of Medicine (WJM), etc., to join us in restoring trust in published medical and scientific research in the medical literature by requiring public review of scientific information."
This was echoed by Jane M. Orient, M.D., Executive Director of AAPS, who in announcing journalistic independence added: "This new policy is exactly in line with the mission statement of the Medical Sentinel to promote scientific integrity and it will enhance academic freedom."
This new requirement dovetails our already implemented policy of double-blind, peer review of scientific and clinical articles submitted to the Medical Sentinel (which has been in effect since the Medical Sentinel's inception in 1996), as well as financial disclosure or other exposition of possible conflicts of interest by authors, as you may have noticed in the author's vignette describing their affiliations at the end of their papers.---Ed.
Regarding New Medical Sentinel Policy
I was extremely pleased and impressed that your publication has adopted "public review" as a way of forcing the real truth out in medical and other scientific research. It has long been time for bogus, government-sponsored results to be challenged. As an officer of a leading Republican organization in Georgia, newspaper publisher, and concerned citizen let me know how I can help you further....
My most sincere congratulations to you and the Medical Sentinel for the promulgation of a courageous, open, intellectually honest and "disarming" policy.
I challenge any and all other medical and scientific journals to adopt this cutting edge policy...one that can only foster intellectual integrity and blaze the trail for the eventual elimination of the junk science that litters the scientific landscape and pollutes the well of honest, scientific discourse.
Russ Fine, PhD, MSPH
Prof. of Medicine and Director
Injury Control Research Center
Univ. of Alabama at Birmingham
Dear Dr. Faria,
A gold star for the Medical Sentinel's new policy requiring public access to supporting data. I appreciate your policy that is an obvious requirement to maintain journalistic credibility and the scientific method. Thank you.
99-X Radio / WNNX-FM
I found this initiative very interesting. It parallels efforts by me and others within the American Society of Criminology to include in its new Code of Ethics the requirement that researchers make their data available to other scholars once findings are published.
Do you have a copy of the Congressional Shelby Provision that you mentioned? If so, could you send me a copy, or if not, direct me to where I could find one? Thanks.
Prof. Gary Kleck
School of Criminology and Criminal Justice
Florida State University
The Editor Responds
Here is the Shelby Provision Fact Sheet from the Senator's office:
° Senator Shelby believes that the American people have a right to know how billions of dollars in taxpayer money are being spent in support of federally funded research. In addition, he believes that any data that is used to support federal policies and rules should similarly be subject to public access through the Freedom of Information Act.
° The provision included in last year's Treasury and General Government Appropriations bill is largely an enhancement of existing data access requirements under the Paperwork Reduction Act of 1995. The issue became of particular interest to the Senator in practice when he sought access to underlying data used to support EPA regulations on ozone and particulate matter and was told that EPA was not in a position to provide the information. In addition, he was also supportive of previous efforts by Congressman Robert Aderholt in 1997 to achieve similar results.
° Contrary to the political rhetoric alleging that this provision was "slipped" into the Omnibus bill in the middle of the night, this provision was very publically considered and passed by the Congress. The provision was first included in the original Treasury and General Government Appropriations bill reported out of Committee in July of 1998. As the bill was considered on the floor of the Senate in September, several floor statements accompanied the language. These colloquies made it clear that efforts would be made to improve the language in conference.
° The final language included in the Treasury and General Government conference report was actually drafted and agreed to by the Office of Management and Budget in cooperation with the House and Senate appropriators. The conference report was then brought to the Senate floor for consideration in early October. The bill was later laid aside because of procedural delays on the floor. Ultimately, the Treasury and General Government Appropria-tions bill was wrapped into the Omnibus package along with several other appropriations bills in mid-October.
° This law will require publically-financed research as well as research used to underlie federal polices or rules to be subject to the Freedom of Information Act (FOIA). Additionally, these requests would be subject to the many safeguards and broad regulations employed by the FOIA to protect sensitive information. The FOIA has many exceptions, including exceptions for geological data, medical files, classified information, personal privacy, law enforcement techniques, and information which could compromise the safety of individuals.
Furthermore, Sen. Richard C. Shelby (R-AL) stated: "Given the prevalent use of government funded research data in developing regulations and federal policy, it is important that this data be available to other federal agencies, as well as the public. I believe the Freedom of Information Act is the appropriate vehicle for making these studies available, because the Act has such a comprehensive list of exemptions designed to protect medical privacy, classified information and personal safety, as well as other concerns."
Most of you are already familiar with the controversy over public access to federally-funded research data. In a nutshell, Senator Shelby inserted a two-sentence requirement into PL 105-277 last fall that permits public access to federally-funded research data under FOIA guidelines.
We all support the Senator Shelby requirement, and submitted comments early this year when the OMB issued its proposed regulations. Sunshine is a disinfectant, and public access to such data minimizes corruption, mistakes, and fraud concerning such data.
For example, the tragedy of the rotavirus vaccine would never have happened if the public had access to the data used by the FDA and CDC in recommending the vaccine. I have been studying the reports and have concluded that the FDA and CDC ignored and concealed data that showed the problems from the outset. The Shelby amendment, if properly implemented, would ensure that federally-financed research about vaccines could not be withheld from the public. Ultimately this rule should be extended to all data on which the government makes vaccine policy decisions, including privately-funded research data as well. This would greatly improve the integrity of vaccine policymaking.
Fifty-five percent of the commenters to OMB indicated their support for the Shelby amendment, but OMB has now issued proposed regulations that would eviscerate the amendment further, particularly with respect to vaccine data. We only had [a brief period until September 10th] to submit comments as text (not an attachment) in an e-mail to F. James Charney, Policy Analyst, OMB, Re: OMB Circular A-110, at email@example.com.
This recent proposal by OMB would effectively remove all federally-funded vaccine research from public access. It does this by only allowing public access for data "used by the Federal Government in developing a regulation" pursuant to formal rule making proceedings. The vaccine governmental recommendations would not qualify, although they would have qualified under the broader rule proposed by OMB earlier this year.
The OMB proposed regulation is available at http://www.whitehouse.gov/OMB/fedreg/2ndnotice-a110.html.
Andrew L. Schlafly, Esq.
AAPS General Counsel
Among the organizations writing to the OMB to support the Shelby Provision were: Eagle Forum, Gun Owners of America (GOA), AAPS, Medical Sentinel, Evergreen Freedom Foundation, etc.---Ed.
"Cost-Effectiveness of Killing"
Dr. John E. Gardella's article "The Cost-Effectiveness of Killing: An Overview of Nazi 'Euthanasia' " (Medical Sentinel, July/August 1999) puts American physicians on notice with respect to a future Nuremberg doctor's trial. American medicine, like Nazi medicine, does not operate under the Nuremberg code of ethics "which emphasized the primacy of the informed, voluntary consent of the patient in governing physician behavior," as Dr. Gardella correctly states. American Medicine continues to endorse the practice of involuntary treatment of the "mentally ill." Incidentally, that treatment should be read between the same quotation marks as the Nazi's "treatment" of patients in the gas chambers of the Brandenburg psychiatric hospital.
American Medicine continues to blindly accept the notion that a person may lose their moral agency due to mental illness, that mental illness is caused by brain disease, that there is scientific evidence that corroborates the existence of those alleged entities and that they correlate with each other. That is a mythology that tops the Nazi one.
The Nazi doctors tried to defend themselves by arguing "national preservation" as the reason for their "treatment" of the "unworthy." It did not work for them, nor will it work for the American doctors.
Nelson Borelli, MD
Dear Dr. Ruiz,
I read your letter to the AAPS Medical Sentinel, July/August 1999. I regret to inform you that not all of the Independent Medical Examiners are "hired guns." Some of them are even "honest physicians" who are truly independent.
There are physicians who are well trained in the field of IME's. And they often "call it like they see it" --- not the way some insurance companies wants or even another physician wants.
Actually, most of the Independent Medical Examiners that I know do not participate in medical malpractice cases. They are usually involved with work-related injuries or other accidents.
Roy Blackburn, MD
Fellow American Academy of Disability Evaluating Physicians
Wall Street Journal Letter and Market Forces
Dear Dr. Faria,
I obtained your address from directory assistance so that I could write to you and express my appreciation for your letter of July 23, 1999 to The Wall Street Journal.
I, too, have long believed that the best way out of the current mess is to make either all or none of health care expenses tax deductible, and to end the fiction that health insurance is a free "benefit" from employers, rather than representing compensation that might be much more wisely spent if the employee were in charge of it.
As a clinical psychologist in solo private practice with 30 years experience working in health care, I have witnessed the insurance-driven explosion of costs and the growth of the mistaken notion that health care insurance is necessary to obtain ordinary health care. If insurance were really insurance, purchased to cover the catastrophic event rather than as a third party payer for ordinary expenses, costs would very quickly respond to market forces and doctors would again be doing what they do best rather than betraying their patients' trust and wasting valuable time fighting with the clerks at the managed care office.
I find it truly distressing that the official line of my professional organization is to attempt to gain parity of reimbursement for psychologists, rather than to address the real problems.
Kathleen J. Burch, PsyD, RN
I received a call from Murray Sabrin last week. He had read the excellent letter by Dr. Miguel Faria in The Wall Street Journal and was in complete agreement. Dr. Faria wrote that physician unionization was a bad idea, and was vehemently opposed to any suggestion that a single-payer system will save the day.
Murray Sabrin is an economics professor who ran for New Jersey Governor last time as a Libertarian, almost yielding Governor Christine Whitman's seat to the Democrats. Mr. Sabrin had left the Republican Party in 1972 after reading Ayn Rand's Atlas Shrugged, and then watching President Nixon institute wage and price controls. But, this year, he realized that he could accomplish more as a winning Republican than a losing Libertarian. He rejoined the Republican Party.
Murray claims that the Libertarians ought to do for the Republican Party what the Communists have done to the Democratic Party --- change it!
He is now running for the Republican nomination for U.S. Senator from New Jersey (and with Gov. Christine Whitman out of the race, his winning is a real possibility), but he needs your help, the help of freedom-lovers from across the country. He believes a true free market, with MSAs and full tax-deductibility for all premiums for all Americans, is the only meaningful health care reform.
Every AAPS member has the opportunity to do something positive and we could have a Senator in the Senate just like Ron Paul in the House of Representatives. His website is "Murray Sabrin for U.S. Senate" and his address is P.O. Box 445, Leonia, NJ 07605. Contact him, and help us restore the nation to its freedom-loving roots.
Alieta Eck, MD
Dear Doctors and health care practitioners,
The Department of Health and Human Services just contacted our office to ask us to spread the word about the new Healthcare Integrity and Protection Data Bank. They will shortly distribute a paper on it by e-mail which I will send out as well.
Not a group that usually does the bidding of DHHS, we none-the-less felt all practitioners and patients would be interested in the latest government health care tracking database, which according to the October 30, 1998 Federal Register notice, is "a national data bank to receive and disclose certain final adverse actions against health care providers, suppliers, or practitioners."
Final adverse actions include: "(1) civil judgments against a health care provider, supplier, or practitioner in Federal or State court related to the delivery of a health care item or service; (2) Federal or State criminal convictions against a health care provider, supplier, or practitioner related to the delivery of a health care item or service; (3) actions by Federal or State agencies responsible for the licensing and certification of health care providers, suppliers, or practitioners; (4) exclusion of a health care provider, supplier, or practitioner from participation in Federal or State health care programs; and (5) any other adjudicated actions or decisions that the Secretary establishes by regulations.
"Final actions are to be reported, regardless of whether such sanctions are being appealed by the subject of the report.
"Groups that have access to this new data bank system include Federal and State government agencies; health plans; and self queries from health care providers, suppliers, or practitioners."
You may read more, particularly the description of a provider, supplier and practitioner, on the Federal Register at http://frwebgate.access.gpo.gov/cgi-bin/.getdoc.cgi?dbname=1998_register&docid=98-29147-filed.
The final rule is not yet published, but the regulation will take effect October 1, 1999.
Twila Brase, RN
President, Citizens' Council on Health Care
1954 University Ave. W., Suite 8
St. Paul, MN 55104
651-646-8935, Fax 651-646-0100
Firearms: A Handbook for Health Professionals
For years, organized medicine has been misusing its authority to turn the public against firearms owners. Prestigious medical journals have abandoned their usually strict peer review standards to publish junk science articles written by anti-gun activists with medical degrees. Their purpose? As one pediatrician put it, to convince Americans that 64 guns are a virus to be eradicated."
Now Doctors for Responsible Gun Ownership and the Claremont Institute offer the antidote to the public health establishment's skewed science. Firearms: A Handbook for Health Professionals is a 25-page booklet that distills the latest criminology research on firearms and presents it in a reader friendly format for health professionals and the general reading public.
The Handbook is available for $5 per copy. Bulk orders are available at a discount and strongly encouraged. Place your order by calling (909) 621-6825 or see our announcement on the Claremont Institute's web page at www.claremont.org.
Timothy W. Wheeler, MD
Director, Doctors for Responsible Gun Ownership
250 West First St., Suite 330
Claremont, CA 91711
(909) 621-6825, Fax (909) 626-8724
Man's Natural Hostility to Ideas
I thoroughly and immensely enjoy reading your journal, and I thank you for sharing your thoughts with me. There is, however, a certain sense of futility, I have concluded, and I challenge you to prove otherwise, that anything and everything known to man is hostile to him. Including his own mind, in spite of the fact that his mind is the sole mean for his survival.
To wit: if I were to suggest to you that you read a book, which I propose you would thoroughly enjoy, but which will also significantly enrich your scope of knowledge, you certainly would dismiss such an outlandish suggestion out of hand. And I mean, out of hand, not after you have looked and evaluated, but out of hand. I rest my case.
The title of this book, in case you have surmounted the innate hostility of this planet, is Capitalism, by George Reisman, published in 1998 by Jamieson Books, Ottawa III, available from the publisher at 1-800-243-0138.
It is my sincere belief that reading this book, and encouraging others to do so, is one of the small but significant steps to negate the hostility of all that is known to us.
Jerry J. Krumlik, MD
The Editor Replies
Dear Dr. Krumlik,
I certainly agree with your insightful comments regarding man's natural hostility to ideas, particularly those that do not originate in his own mind.
Although inimical things are happening to our world that are contrary to political and economic freedom in general and leading to the destruction of medicine (collectivism) in particular, physicians are not learning. They are not reading, and yet, they could counteract much of what is being bandied about by central planners and the media pundits with information contained in such great books as Dr. Orient's Your Doctor Is Not In and Dr. Edward Annis' Code Blue (which if you haven't read them, you should, for they add medical relevance to what Reisman writes in Capitalism.
And yes, we did list Reisman's Capitalism in the News Capsules "Books in Brief" of the Medical Sentinel 1998;3(1):4. Unfortunately, it was not selected for full review, but it was definitely considered.
Keep on spreading the word of capitalism, freedom, and encouraging others to read. Aristotle wrote that leisure was best spent cultivating the mind, and that a man was wealthy when he could break away from tedious labor and the doldrums of every day life to read and learn about the nature of things (Vandals at the Gates of Medicine, pp. 205-206).
In antiquity, Cicero understood the term liberal arts within the humanities to connote the sense of liberating the mind from the inanities of human existence. (See the chapter on "Greco-Roman Medical Ethics" in my book, Vandals, pp. 203-234).
Citizens of this great Republic, particularly physicians, should pay heed, for as Francis Bacon stated, "Knowledge is power."
Miguel A. Faria, Jr., MD
Editor-in-Chief, Medical Sentinel
Crossed Swords: Medicare Private Contracting
Lois Copeland is a dedicated physician. She is providing courageous leadership to protect the freedom of Medicare patients and their doctors. However, her review (Medical Sentinel, July/August 1999) of Medicare Private Contracting --- Paternalism or Autonomy is ill-conceived. The statements in that review are irrelevant to the substantive issue and factually incorrect.
I would have thought that Dr. Copeland would have understood the intellectual and legal support the monograph provides her effort, and welcomed it. At the very least, I would have expected Dr. Copeland to analyze the ideas discussed and presented any differing or complementary views she might have.
Instead, the review essentially consists of an assertion that two statements of fact made in the monograph are not correct. Building from this, the review goes on to belittle my scholarship and to advise me to be more careful in my review of court opinions and statutes. Because I am accused of factual misstatements and a lack of care, I must set the record straight.
Dr. Copeland's focus on the asserted two factual misstatements misses the forest for a few small trees. The statements that she objects to are not relevant to the analysis of the issues. They are part of the narrative explaining the background and effect of Section 4507. More importantly, Dr. Copeland's assertion that they are inaccurate is simply wrong.
Dr. Copeland brought the issue of private contracting to the fore by suing Medicare to obtain a declaratory judgment that private contracting is lawful. The court refused, in Stewart v. Sullivan, to rule on her request because, it said, it could not find a clearly articulated policy against private contracting. The court sidestepped the issue by stating that it was not ripe for adjudication.
As a practical matter, therefore, the court's decision supported private contracting. If Medicare did not have an understandable policy against it, doctors and patients could privately contract... HCFA, however, continued to threaten enforcement of its supposedly non-existent policy. In response Senator Jon Kyl pushed legislation to permit private contracting. Under the threat that the President would veto the Balanced Budget Act [of 1997], however, Congress was forced to settle on what is now Section 4507.
In reciting this background of Section 4507, I stated that the court in Stewart v. Sullivan found that HCFA had not clearly articulated a policy against private contracting --- what I thought was an innocuous and uncontroversial statement of historic fact. Dr. Copeland, however, reacted vehemently to this plain vanilla recitation. She said that the court found that the HHS Secretary had not articulated such a policy and that HCFA did not have the right to make policy, but only to administer policy emanating from the Secretary in a clearly articulated manner.
On the basis of the fact that I referred to HCFA rather than to the Secretary of HHS, Dr. Copeland accuses me of a doubly dastardly deed: "Unfortunately, Mr. Hoff's lack of careful scholarship has enhanced the bureaucrats' power grab and the vulnerability of senior citizens and the physicians who serve them." I was not aware that a reference to HCFA --- an agency within HHS --- rather than to the Secretary would have such an impact.
Dr. Copeland, moreover, fails to mention that later in the same paragraph from which she quotes the offending reference to HCFA, I said that the court found that HHS had not articulated a policy. More importantly, she has build a mountain of accusation from a gossamer distinction. It doesn't matter whether one refers to HCFA or to HHS. For these purposes they are interchangeable. HCFA is an agency within HHS (although the Administrator, like the Secretary is appointed by the President and approved by the Senate)... The Secretary is responsible for the actions of HCFA and accordingly suits challenging HCFA actions are brought against her.
Along these lines, it is interesting to note that Dr. Copeland also complains that I did not interview Secretary Shalala. I doubt that Secretary Shalala would have sat for an interview on this issue or indeed that she had any knowledge to contribute to the discussion. Her views in any event are a matter of public record. United Seniors Association brought suit after the enactment of Section 4507 to challenge the constitutionality of the statute and the underlying Medicare policy (United Seniors Association v. Shalala). The Secretary defended the statute and HCFA's policy against private contracting. She did not distinguish between HCFA and the Department and defended HCFA's policies and actions, It is not likely that she would have taken a different position if interviewed.
Dr. Copeland's second allegation of error is my statement that after the passage of Section 4507 she stopped engaging in private contracting...Perhaps Dr. Copeland decided between the time she gave her affidavit and the preparation of the amicus brief that she would resume private contracting. Or perhaps there is no good explanation for the difference...
Finally, Dr. Copeland complains that I did not interview her. I regret that I did not have that pleasure. The issues are complex --- and made more so by HCFA's inarticulate confusion. To minimize the chances of error, I reviewed the draft of the monograph with the learned counsel who had represented her in Stewart v. Sullivan and who also represented United Seniors Association in United Seniors Association v. Shalala. He did not find any error in my discussion of the facts or the law. It is apparent that checking with him was not only prudent but also most likely to assure accuracy.
The statements in my monograph that Dr. Copeland disputes are in fact accurate.
John S. Hoff
Dr. Copeland Replies
I thank Mr. Hoff for the kind words he spoke about me in the book, but I would have preferred a personal interview prior to its publication.
Lois J. Copeland, MD
Correspondence originally published in the Medical Sentinel 1999;4(6);193-198. Copyright©1999 Association of American Physicians and Surgeons (AAPS).