VIRUSMYTH HOMEPAGE


AN EYEWITNESS ACCOUNT
Of Gross Irregularities and Medical Incompetence in the Early Clinical Trials of AZT

By Lynn Gannett

2000


Please keep in mind that these two write-ups represent only the "tip of the iceberg," and for everything that is recorded here, there are literally dozens of other examples that I could give.

My information is NOT included in John Lauritsen's book on AZT, simply because neither of us had heard of each other at that time (although I wish we had!). His book documents information related to the Phase II studies of AZT, whereas I was involved with the Phase III studies (ACTG 019). But it was all the same kinds of shocking nonsense, incompetence and fraud.

In addition to ACTG 019 (which was the major study at that time), I also worked on other studies of AZT and ddI (ACTG 002, 016, 020, 081, 116, 117 and 118). Some of these studies included other drugs, such as pentamidine.

I was somewhat young (and naive) at the time, and didn't quite know what to make of what I was witnessing, or what to do with the information that I had documented, having NEVER witnessed anything even remotely similar. In fact, at that point in my life, I didn't even realize that human beings were even CAPABLE of this kind of corrupt, insane, self-motivated behavior. If I had known then what I know now, I would have been much more persistent in my attempts to report this information to the NIH. I don't even have a single letter my communication with them was done entirely over the phone. Which means they could simply deny that these phone conversations ever took place. All I have to offer as evidence that I DID REPORT THIS TO THE NIH AND THEY DELIBERATELY IGNORED MY INFORMATION is my personal testimony, and some handwritten notes that I took at the time (this was in the Spring of 1990). I may be able to locate at least one witness who could corroborate my story (the NIH site monitor for Syracuse).

But the way that I look at this is that it's never too late to report this to the NIH, AGAIN. And the important thing is that I still have ALL of my original documents (an entire box full of material) which I tried to share with them in 1990. I have precise names, patient numbers, dates, lab values, memos, etc. I KNOW that my information is accurate, because I was so thorough and meticulous (not to mention HONEST) in my record-keeping. That's why they hired me I'm an extremely detail-oriented, "numbers" person. Thus, all of my information could, in theory, be verified by referring to the original research forms and NIH documents from that time period, which must still exist and (theoretically) could be obtained through the Freedom of Information Act. Ideally, my second attempts to report this could lead to a Congressional Investigation. That is certainly what I will be calling for. The seriousness of my allegations certainly warrants such an investigation. For the NIH to knowingly ignore serious and credible DOCUMENTED reports of gross scientific misconduct coming from someone working on the INSIDE of these trials if that doesn't constitute scientific "fraud," I don't know what does. Especially when we look at the real-life gruesome outcome of this deliberate refusal to even INVESTIGATE my allegations to see if there was any merit to them (along with all of the other glaringly obvious, telltale signs and warnings coming from around the globe, which were also ignored at that time) all of this intentional "blindness" on the part of the NIH, the FDA, Burroughs Wellcome, etc., led to the unnecessary and unimaginable suffering of countless individuals (of both "HIV+" people and their loved ones), and the unnecessary deaths of (in my view) tens of thousands of people. This dreadful holocaust continues to this day. Parks Mankahlana, couldn't have summed it up better when he said "...the profit takers who are benefiting from the scourge of HIV/AIDS will disappear to the affluent beaches of the world to enjoy wealth accumulated from humankind ravaged by a dreaded disease."

Knowing what I know "first hand" about AZT, and knowing how it should NEVER have received FDA approval under ANY circumstances, this is one of many reasons why I am especially grateful to the members of the Perth group, Peter Duesberg, John Lauritsen, Celia Farber, Anthony Brink and many others for the outstanding work that they have done in documenting the case against AZT.

***

I was an eyewitness (and later a whistle-blower) to gross negligence and fraud in the Phase III clinical trials of AZT (1987 to 1990). I've been saying to people for years that AZT was NEVER proven to be safe or effective. From the particular studies in which I was involved, it would have been impossible to prove anything. The data was such a mess! I now realize that AZT is a deadly poison. All "AIDS drug" trials since that time have been based on the same flawed model. The big difference is that now there is even LESS meaningful oversight, and even MORE of an economic incentive for physicians to enroll patients. And recent drug trials have also been characterized by an absurdly brief follow-up period (24 or 36 weeks, for example), and effectiveness is often said to be determined by "surrogate markers" which have never been proven to relate to actual clinical health and/or increased survival. But, the early AZT studies were like the big "granddaddy" of all of this ensuing insanity!

I did not know John Lauritsen at the time that he wrote his book, AZT: Poison by Prescription (1990), but I later told him that, if I had known him at that time, I could have given him several additional chapters for his book! In this book he meticulously documents serious fraud which took place at other participating hospitals (I was in Syracuse, NY), particularly at a hospital in Boston. When I first read John's book, it was like reading my own autobiography! Talk about deja vu!

In spite of what I witnessed, I was not aware, however, of the deeper problems within "AIDS science" until many years later. It was in 1997 that I first heard about the views of the "AIDS dissidents." After educating myself regarding the many unexplained and nonscientific paradoxes and absurdities of the orthodox "HIV/AIDS" model, and after studying the alternative views proposed by the various "AIDS dissidents," I started doing public speaking on this topic. I especially want to share my story with as many people as possible about the fraud which I witnessed firsthand in the early AZT trials. I always tell people that if the general public knew what I knew about AZT, this so-called "drug" would be banned immediately.

***

My name is Lynn Gannett. As the Data Manager for the first two years and seven months of the NIH-sponsored AIDS clinical trials conducted at the Syracuse, New York, clinic (September 1987 to March 1990), my belief is that the data which came from the Syracuse site is ABSOLUTELY WORTHLESS! I would NEVER trust my health or my life to the results of this so-called "research" or in the hands of these so-called "medical professionals." I can only speculate that if these things occurred at this site, that similar things may have and in all likelihood did occur at the other participating sites. The things that I witnessed at this clinic would HORRIFY any reasonable observer. The level of medical incompetence, unprofessionalism, unethical, dishonest, corrupt, illegal and immoral behavior was shocking and inexcusable. The data was so inaccurate and so full of holes that I often compare it to Swiss cheese. I felt like I was trapped in the middle of an awful movie about "mad scientists." If there was a "rule" that could be broken - they broke it! The following examples outline some of the most egregious examples of what I witnessed:

* The Principal Investigator, an MD, and the Study Coordinator, an RN, showed a huge interest in enrolling as many patients as possible on studies (which would entitle them to more money and perceived prestige) and showed little interest in the research itself - specifically in the integrity, accuracy and completeness of the data.

* The Study Coordinator (and other medical staff responsible for study patients) often displayed a significant lack of understanding and unfamiliarity with the study protocols and important memos concerning their implementation - as though she had not even read them, or had totally misunderstood and misinterpreted them, even in instances pertaining to terminology and procedures FUNDAMENTAL to the protocol itself, often months after the study had been underway.

e.g. In what I consider to have been the most serious, disturbing and grossly incompetent situation that I witnessed, which came dangerously close to resulting in death, and unquestionably resulted in extreme unnecessary suffering, PID #110434, a black, obese, diabetic, HIV+ female with a history of serious heart problems, experienced severe hematologic toxicity from the 081 study drug (AZT), which had progressed to a GRADE IV toxicity by week 24 and resulted in her coming into the emergency room with "severe shortness of breath, fatigue and weakness," and required her to be hospitalized for a total of five days. BECAUSE NO ONE, DOCTOR OR NURSE, SHOWED ANY RESPONSIBILITY FOR, KNOWLEDGE OF, INTEREST IN OR RECOGNITION OF THE IMPORTANCE OF THE EXPLICITLY-DEFINED TOXICITY (ADVERSE REACTION) AND DOSE MANAGEMENT STEPS AND PROCEDURES OUTLINED IN THE PROTOCOL, instead of being taken OFF the AZT due to the Grade IV toxicity, her dose was reduced from 1000 mg/day to 500 mg/day, in complete violation of protocol requirements which explicitly require DISCONTINUATION of study drug. Additionally, early Grade I and Grade II toxicities should have indicated the need for interim lab monitoring of Hemoglobin, especially with this patient's complicated medical history, but instead this patient had NO lab work performed between week 20 (13DEC89) and week 24 (10JAN90), even though she was in for a pentamidine treatment on 20DEC89 and could have easily had a blood sample drawn. At some point during this time interval, her original medical chart was "lost," never to be found again, requiring a new chart to be made up, which subsequently obviously lacked significant information concerning her medical history. I was shocked, outraged and horrified when this whole situation occurred, and documented this gross medical incompetence and blatant violation of protocol requirements as carefully as I could because I wanted everything to be ON RECORD so that no one could later deny it or cover it up. (See attached memo dated 01FEB90 and lab flow chart showing toxicity progression.)

* Patients were ROUTINELY enrolled who failed to meet eligibility requirements, especially when it came to specific required lab values and test ranges (i.e., within the required number of days prior to enrollment). There are many, many examples. Below are a few (also see attached 05OCT89 list of 081 screening lab eligibility failures):

e.g. In the most blatant example, PID #110264C, a female partner of an HIV+ male, was enrolled on study 019 and took study drug for THREE weeks before it was discovered that she was actually HIV NEGATIVE! (The Elisa came back as a false positive but the Western Blot came back negative.) The test results date predated her enrollment on study date. She was also on oral contraceptives at the time, another eligibility violation.

E.g. You might think that this would be the last time a patient would be enrolled without an HIV+ test result "in hand" - not so. PID #110316's HIV+ test results are dated 06JAN89, ONE MONTH AFTER his enrollment date (05DEC88)!

e.g. Other patients had been routinely enrolled without HIV+ test results documentation available, often based simply on referrals from other physicians. An example is PID #110153H, a referral patient from Binghamton who, to my knowledge, has no HIV+ test results in his chart TO THIS DAY! After a year or two of my repeated requests to the Study Coordinator for this information, she finally obtained a LETTER ONLY from the referring physician "verifying" his HIV+ status, who also apparently had no supporting documentation.

* There were COUNTLESS unreported (meaning unreported on the research forms) diagnoses, opportunistic infections, symptoms, concomitant medications, and adverse reactions. Except for "symptoms" (which were asked for at every visit), these significant things (which each REQUIRE reporting) should have been reported on one of several "as needed" or optional case report forms used to track this information - an extra step which was rarely taken. I often observed, as did the RTI (Research Triangle Institute) site monitors, this unreported information recorded or mentioned in the patient's regular medical chart.

E.g. From the 22JUN89 site monitor's report: "Of the six protocol 002 charts which were reviewed for the first critical event verification, four reported death as the first event even though at least one OI [opportunistic infection] has preceded the death. These OI's were not reported. In another instance, it was impossible to determine what had happened to the patient between the time of randomization and death because the records were missing."

* Incorrect lab tests were ROUTINELY ordered (either required labs omitted or unrequired labs ordered by mistake), and the wrong prescriptions were ROUTINELY written (for example, 1200 mg/day instead of 1000 mg/day). When I questioned these and other similar mistakes, I would be chastised by the Principal Investigator and/or Study Coordinator for being too "nit picky" or for inappropriately questioning someone's medical "expertise" since I did not have (nor did my position require) a medical degree.

* Medical lab results were ROUTINELY transcribed incorrectly onto the research forms by the Study Coordinator (who I suspect may have dyslexia - at the very least, she does not have the "detail-oriented" type of mind necessary for this type of research position).

* Syracuse had an unusually high and excessive rate of "no shows" (often meaning "not even scheduled to begin with") and "not dones" compared to the other clinics.

* On a regular basis, I would have to REPEATEDLY request data from the Study Coordinator, and we routinely missed deadlines.

E.g. There was one group of approximately 90 (!) forms which were "missing" for over a year and a half. When these forms were eventually "found," mostly blank, the Study Coordinator filled in much of the information with, in most cases, no supporting documentation or progress notes in the charts. I have always believed that this data was just "fudged" or made up, because there would have been no other written record of these things (such as vital signs).

* Informed consent forms were ROUTINELY backdated, sometimes weeks or even months after enrollment.

E.g. In at least one instance, a patient was asked to sign (and did sign, along with the Principal Investigator and Study Coordinator) an informed consent form for the WRONG study (PID #110076A signed an informed consent for study 116 but was being enrolled on study 117).

* The Principal Investigator and Study Coordinator displayed such open hostility and contempt toward the site monitors that there was a high turnover (4 different site monitors in a 3-year period). These site monitors could have easily uncovered this corruption if they had done their jobs carefully (which the first 3, at least, did NOT do) and over an extended period of time.

* On March 21, 1990, after attempting unsuccessfully for over one year to address and resolve these SERIOUS issues with the Principal Investigator and Study Coordinator, and after watching in horror as the situation worsened severely with the implementation of the DDI studies (see attached memo dated 19MAR90), and after being retaliated against in many vicious and mean-spirited ways by both the Principal Investigator and Study Coordinator merely for repeatedly raising these issues and insisting on some type of corrective action, I felt compelled, in good conscience, to resign my position as Data Manager and immediately report this critical situation to the RTI site monitor.

E.g. After reporting this to the site monitor, she checked with her boss, who in turn checked with her boss, and the decision was made to launch a "special audit and investigation" of the Syracuse site by the program office. I was asked to mail copies of all of my documentation supporting my claims to the site monitor. In a 27MAR90, 1:40 PM, phone call, the site monitor told me that her boss "never heard of anything of this magnitude," and referred to the situation as "uncharted waters."

E.g. In a 27MAR90, 4:00 PM (later that same afternoon), phone call with Carolyn Fassi, who called me from NIH on behalf of Dr. Kantz, she thanked me for bringing these issues to their attention and said it would be unnecessary for me to forward copies of my documentation to the site monitor or to NIH. She also stated that they "can't act directly" based on my claims or supporting documentation, that they would "keep a close eye" on the Syracuse site, that they "won't use my information against the site or me," and ended by saying that he (Dr. Kantz) "may not even need to call me, except to clarify something." In other words, "don't call us, we'll call you." I never received a call from their office or anyone else associated with these studies again.


VIRUSMYTH HOMEPAGE