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Letter to the Director of the NIH: Serious Breaches
From the archives of The Memory Hole

HIV=AIDS Controversy: The Hand in the Till Department

A letter to the director of the National Institutes of Health, Dr. Harold E. Varmus, from a concerned U.S. citizen regarding the questionable doings of one of the director's high profile underlings. This letter to Dr. Varmus was officially posted to misc.health.aids by W. Fred Shaw ([email protected]) on 27 March 1998.

Harold E. Varmus, M.D.
Director
National Institutes of Health
9000 Rockville Pike
Bethesda, MA 20892

March 20, 1998

Dear Dr. Varmus,

As an AIDS activist, I am notifying you of serious breaches of ethical guidelines by the Director of the National Institute of Allergy and Infectious Disease (NIAID), Dr. Anthony Fauci, M.D. This complaint isn't about personalities or superficial public perceptions, but rather something much more insidious: an institutional breakdown in ethics that has concentrated far too much power, authority and blind trust in the hands of a single individual, Dr. Anthony Fauci. Without any doubt, the facts will prove that Dr. Fauci has broken the rules, Dr. Fauci has violated our trust and Dr. Fauci has compromised the most fundamental principles of scientific ethics and integrity.

As you continue to read, please keep in mind that, in practice, Dr. Fauci has been the one single individual in the government who has assumed control over the government's response to the AIDS epidemic, even before HIV was discovered. When the evidence reveals that Fauci has concealed his conflicts of interest in violation of written guidelines, one must conclude that Dr. Fauci's judgment and influence have been for sale all along. Given the budget, mission and pivotal role in protecting the public's health through the guidance of institutional medicine, private enterprise and the governmental regulatory role, the implications arising from Dr. Fauci's misconduct are nothing less than astounding.

Dr. Varmus, this deplorable situation happened on your watch and it has been going on for quite a long time. Accordingly, I have only one question for you: do you intend to take corrective action to prevent a recurrence, or must agency policy be dictated from the streets?

The conduct of Dr. Fauci, and others, has compromised the basic principles of ethics, public trust and the most fundamental concepts that define "scientific integrity". As Director of the NIH and Nobel Laureate, you know better than anyone that these principles cannot be compromised, nor can they be permitted to ever stand apart, from the critical public health mission of the National Institutes of Health. Institute directors and managers are those whom we trust to define the rules, enforce the rules and set the example for everyone else to follow. When there exists flagrant violations of written rules, regulations, guidelines and standards at the highest levels, then only one rational viewpoint exists: there are no standards, no rules and no regulations. Dr. Varmus, tolerance and permissiveness in such matters is no longer an option. If you have standards of ethics, behavior and a working concept of "scientific integrity", then please, enforce these existing rules and standards and instill those concepts that are most important in defining the NIH culture. Dr. Varmus, the future of the public's health rests in your hands -- you are the NIH Director -- the buck stops with you! Here are the facts:

1. Inventors Anthony Fauci, NIAID Director, and NIAID employees Clifford Lane and Joseph Kovacs filed for a patent on May 26, 1995. On December 9, 1997, patent number 5696079 was granted. This is the only patent on record for Fauci and is titled "Immunologic enhancement with intermittent interleukin-2 therapy". It is important to note that this immunotherapy patent covers a product, not merely a concept, as described in the "13 Claims", which is attached and made part of this complaint.

2. The patent described in (1) above was a highly significant expansion of an earlier patent of the same name, patent number 5419900 : "Immunologic enhancement with intermittent interleukin-2 therapy." The earlier patent had been granted to inventors Lane and Kovacs in 1995. In May, 1995, Fauci joined with his employees Lane and Kovacs as a third "inventor". Thus the patent was not only expanded to include Fauci, but it was widely broadened to accommodate diseases other than HIV that fall under the direct management influence and control of Dr. Anthony Fauci, NIAID Director.

3. Dr. Fauci has failed to disclose his financial conflicts in regards to the taxpayer-funded human clinical studies involving IL-2 therapy for HIV infection. Since 1995, these IL-2 human studies have advanced from Phase I trials, through the end of Phase II trials and currently are in the final phase of human trials, Phase III. Throughout this time, these taxpayer-funded clinical studies were conducted under the direction and management of Dr. Lane and Dr. Fauci. NOTE: Dr. Lane's IL-2 financial conflicts were listed in a New England Journal of Medicine article in 1995. It was also disclosed that Dr. Lane, NIAID Clinical Director, was a member of the Board of Directors for Chiron Corporation, the manufacturer of IL-2.

4. Dr. Fauci has failed to disclose his conflicts of interest regarding IL-2 therapy in any of many pertinent publications freely available to the public from the NIH/NIAID Internet web site. Fauci discusses immunotherapy and IL-2 therapy in many of these publications that fail to report his financial interests in the IL-2 product.

5. Dr. Fauci has failed to disclose his conflicts of interest regarding IL-2 therapy in any of the peer-reviewed biomedical journal articles which list Fauci as senior author and in which there appears commentary regarding immunotherapies, including IL-2. As an example, in a journal article concerning IL-2 immunotherapy which lists Dr. Fauci as senior author, there is no disclosure regarding Dr. Fauci's financial interest in the subject matter, despite the fact that Fauci filed the IL-2 patent application only six (6) months earlier. Here is the citation:

Kinter AL, Bende SM, Hardy EC, Jackson R, Fauci, AS. Interleukin 2 induces CD8+ T cell-mediated suppression of human immunodeficiency virus replication in CD4+ T cells and this effect overrides its ability to stimulate virus expression. Proc Natl Acad Sci USA 1995; 92:10985-9, (Nov. 21, 1995).

6. Dr. Fauci has failed to disclose his conflicts of interest regarding IL-2 therapy in any of his public presentations in which he spoke of immunotherapies, including IL-2. This includes Dr. Fauci's presentations at the International AIDS Conferences in which he discussed, almost exclusively, immunotherapeutics, including IL-2.

Dr. Fauci's deplorable conduct represents a perversion of ethical standards for which he, as Director of NIAID, establishes the example for others to follow. Fauci's unacceptable behavior illustrates a breakdown in the ability of the NIH to police its own -- in this particular case, an institute director. Perhaps Congressional intervention to forbid ALL conflicts of interest among NIH employees is long overdue: these public servants cannot serve two masters at the same time.

W. Fred Shaw
AIDS Activist

cc:

Excerpts from NIH web site document:

Guidelines for the Conduct of Research in the Intramural Research Programs at NIH (excerpted)

Michael M. Gottesman, M.D. Deputy Director for Intramural Research, NIH

3rd Edition January, 1997 The National Institutes of Health

Preface
The Guidelines for the Conduct of Research expound the general principles governing the conduct of good science as practiced in the Intramural Research Programs at the National Institutes of Health. They address a need arising from the rapid growth of scientific knowledge, the increasing complexity and pace of research, and the influx of scientific trainees with diverse backgrounds. Accordingly, the Guidelines should assist both new and experienced investigators as they strive to safeguard the integrity of the research process.

The Guidelines were developed by the Scientific Directors of the Intramural Research Programs at the NIH and revised this year by the intramural scientists on the NIH Committee on Scientific Conduct and Ethics.

It is important that every investigator involved in research at NIH read, understand, and incorporate the Guidelines into everyday practice. The progress and excellence of NIH research is dependent on our vigilance in maintaining the highest quality of conduct in every aspect of science.

Financial Conflicts of Interest

Potential conflicts of interest due to financial involvements with commercial institutions may not be recognized by others unless specific information is provided. Therefore, the scientist should disclose all relevant financial relationships, including those of the scientist's immediate family, to the Institute, Center or Division during the planning, conducting and reporting of research studies, to funding agencies before participating in peer review of applications for research support, to meeting organizers before presentation of results, to journal editors when submitting or refereeing any material for publication, and in all written communications and oral presentations.

Patent # 5696079 : Immunologic enhancement with intermittent interleukin-2 therapy

13 CLAIMS

What is claimed is:

1. A method for activating the immune system of patient, comprising the step of administering an amount of IL-2 to said patient that is sufficient to increase the CD4 count in said patient, wherein

(A) said IL-2 is administered in a series of administrations effected intermittently, each of said administrations being continuous over a period of time that is sufficient to achieve an IL-2-induced increase in DNA synthesis in peripheral blood or lymph node cells of said patient, and

(B) each subsequent administration follows the preceding administration in said series by a period of time that is sufficient to allow IL-2 receptor expression in peripheral blood or lymph node cells of said patient to increase, peak and then decrease to 50% of peak value.

2. A method according to claim 1, wherein each of said administrations comprises a dosage of IL-2 of from 1.8 to 24 million international units/day (MU/day).

3. A method according to claim 1, wherein said period of time of each of said administrations is on the order of 5 days.

4. A method according to claim 1, wherein said period of time of each of said administrations is on the order of 3 days.

5. A method according to claim 1, wherein said period of time that each subsequent administration follows the preceding administration is about 4 weeks.

6. A method according to claim 1, wherein said period of time that each subsequent administration follows the preceding administration is sufficient for CD4 counts to increase and then decrease to about 125% of a baseline value.

7. A method according to claim 1, wherein each of said administrations comprises a period of continuous infusion of IL-2.

8. A method according to claim 1, wherein each of said administrations comprises a series of subcutaneous injections of IL-2.

9. A method according to claim 8, wherein said IL-2 is administered in from 1-3 subcutaneous injections per day.

10. A method according to claim 8, wherein said IL-2 is selected from the group consisting of recombinant IL-2, native IL-2, PEG IL-2, liposomal IL-2 and microencapsulated IL-2.

11. A method according to claim 1, wherein each of said administrations is continuous over a period of time that is sufficient to achieve an IL-2-induced increase and peak in DNA synthesis in peripheral blood or lymph node cells of said patient.

12. A kit for activating the immune system of a patient, comprising:

(i) a liquid preparation comprising an amount of IL-2 in a pharmaceutically acceptable carrier and

(ii) instructions on administering said preparation to a patient suffering from an immunological impairment or infectious disease in a series of administrations effected intermittently, such that (A) each of said administrations is continuous over a period of time that is sufficient to achieve an IL-2-induced increase in DNA synthesis in said patient, and (B) each subsequent administration follows the preceding administration in said series by a period of time that is sufficient to allow IL-2 receptor expression in said patient to increase, peak and then decrease to 50% of peak value.

13. A kit according to claim 12, wherein said instructions indicate that each of said administrations is continuous over a period of time that is sufficient to achieve an IL-2-induced increase and peak in DNA synthesis in said patient.

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