AIB4.ENG, 20 Giugno 1992, I, Roma

Subject: FDA Documents Show Fraud In AZT Trials

Date: Mar 30 1992 (672 lines)

&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&

J O H N L A U R I T S E N on A I D S

&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&

(from the New York Native of 30 March 1992)

copyright 1992 by John Lauritsen

FDA Documents Show Fraud In AZT Trials

After an arduous three-month battle with the Food and Drug

Administration (FDA), I have finally obtained documents which

describe in detail many acts of fraud committed in the conduct of

the Phase II AZT Trials. It was on the basis of the Phase II

Trials that AZT was approved for marketing by the FDA in 1987.

Anyone who requests government documents under the Freedom

of Information Act should be aware that he's in for a hard time.

If the requested documents are completely innocuous, then the

government will probably lose them through incompetence. If the

documents are not innocuous, then dilatory tactics of every kind

will be employed, on top of the usual incompetence. If the

documents should eventually be found and released, they will be

heavily censored.

On 12 December 1991 I filed my request with the FDA's

Freedom of Information Staff, asking for various documents

pertaining to the multi-center Phase II AZT trials conducted in

1986. My requests comprised the "Establishment Inspection

Report" on the Boston center, written by FDA investigator Pat

Spitzig, and two sets of minutes, written by Jackie Knight and

Mary Gross. Three weeks after filing my request I got an

acknowledgment. When I called the woman who sent it to me, she

said that all three of my requests had been found, and I would

get them soon. A few days later a form letter arrived from

another woman, stating that *none* of my requests could be found,

and my search had been completed. I began calling around until

finally I got a Freedom of Information specialist within the FDA,

Liz Barbakos, who went to bat for me. With her help, the people

in Boston were able to re-find the Establishment Inspection

Report by Pat Spitzig, and the people in Maryland (the FDA's

headquarters) were able to re-find the Jackie Knight minutes,

though not those by Mary Gross. Barbakos said I should receive

them in a few days.

Weeks went by, and nothing arrived. I called Barbakos

again, and she investigated. She called back to explain that the

Jackie Knight minutes would be sent immediately, and that Barbara

Recupero in Boston had had the Spitzig report on her desk for two

weeks, and was waiting for her supervisor to give the OK before

sending it. The next morning I got a conference call, with Liz

Barbakos and Barbara Recupero on the other end. Barbakos said

she wanted me to hear what Recupero had to say. Recupero said

that she had no idea what document I was referring to. I then

called Pat Spitzig, the author of the Boston Inspection Report,

who called Liz Barbakos and told her exactly what the document

was. This put an end to the stonewalling, and I received the

76-page report. Almost every page was heavily censored.

Obviously my difficulty in obtaining the document had nothing to

do with problems in finding it -- they knew where it was all the

time. Rather, the difficulty derived from the FDA's

unwillingness to let the document see the light of day, and the

various censorship decisions that needed to be made once they

realized that further stonewalling would be counterproductive.

The Mary Gross minutes are another story. On the first four

times I called her, she was always "away from her desk", and my

calls were not returned. On the fifth try I finally got her, and

expressed my disbelief that she should be unable to find her own

minutes of a very important meeting. The next day she called to

say that something I said had triggered her memory, and she had

found the minutes. She then faxed them to me, and I found that

they consisted of a half page of nothing. For reasons I'll

explain later in this article, I do not for one minute believe

the minutes she sent me are genuine. Indeed, I regard the phony

minutes I received as one more form of censorship, one more way

the FDA has of circumventing the spirit and the letter of the

Freedom of Information Act.

Background: The Fraudulent Phase II Trials

A bit of background is in order. In the approval process

for a new drug, the most important tests are the Phase II trials,

which are supposed to determine whether or not the new drug is

safe and effective. (The Phase I trials are concerned solely

with toxicity -- whether or not it is possible to administer the

drug to human beings, and if so, to estimate what a proper dose

might be.) The Phase II AZT trials were conducted in 1986, in 12

centers around the country. They were designed as a "double-

blind, placebo-controlled" study, though in practice they were

nothing of the kind.

The Phase II AZT trials were prematurely terminated in the

fall of 1986, owing to what appeared to be a spectacular

difference in death rates between the AZT and the placebo group.

Allegedly only one person in the AZT group died, as compared to

19 in the placebo group. The trials were terminated "for ethical

reasons", so that everyone in the study would have the

opportunity to take the "life-extending" wonder drug. As I have

argued repeatedly since 1987, these mortality data cannot

possibly be correct; not only are they in conflict with mortality

data from other AZT studies, but from the standpoint of common

sense, one cannot expect dramatic health benefits from a drug

that is only injurious to health.

On the basis of hundreds of pages of FDA documents that were

released under the Freedom of Information Act, I wrote an

analysis of the Phase II trials in 1987, concluding that the

study was not only appallingly sloppy, but manifestly

fraudulent.(1) For my accusation of fraud (which I, as the son

of a lawyer, do not make lightly), I relied on the fact that the

investigators had deliberately used bad data, and that they had

covered up the premature unblinding of the study. The Phase II

trials are still relevant today, even though they took place six

years ago. Since these fraudulent trials were the basis for the

FDA's approval of AZT for marketing, the approval itself was

improper and illegal. Consequently, AZT is being marketed

illegally at this very moment.

A document written by Ellen Cooper, the FDA Medical Officer

who reviewed the New Drug Application for AZT, indicated that

many serious violations of the "protocols" of the study had

occurred in all of the centers.(2) (Since protocols represent the

rules of the game, so to speak, to violate them constitutes

cheating.) The Boston center, whose principal investigator was

Robert Schooley, was especially bad. It was so bad that an FDA

investigator recommended that all data from the Boston center "be

excluded from the analysis of the multicenter trial."(3)

A series of FDA meetings were held in order to decide what

to do about the numerous violations of protocol, and in

particular, about the delinquent Boston center. The decision was

made to exclude nothing, to throw in all of the garbage along

with the good data. The rationale for this appalling decision

was two-fold: one, if all of the patients with protocol

violations were excluded, there would be almost nobody left in

the study; and two, including the bad data didn't really change

the results very much. Needless to say, these are the excuses of

crooks and idiots. No ethical scientist would ever knowingly use

bad data. Period.

This, then, is the background for my keen interest in

obtaining the Establishment Inspection Report on the Boston

center. After nine years of research and writing on "AIDS", from

a dissident standpoint, I'm not easily shocked anymore. But this

report succeeded in making my mind reel, from time to time, as it

described innumerable, brazen acts of fraud committed by the

investigators in the conduct of the trial. Even more shocking is

the fact that the FDA, at the very highest level, chose to excuse

and cover up these acts of fraud. For the rest of this article

I'll describe the crimes and blunders that were committed in

Boston in 1986.

The Delinquent Boston Center

In October and November 1986 FDA Inspector Patricia Spitzig

made a "For Cause Inspection" of the Massachusetts General

Hospital clinical center, which was used in the Phase II multi-

center AZT trials. Her findings are contained in her 76-page

"Establishment Inspection Report" (EIR). The principal

investigator at this center was Robert Schooley, MD, who was

assisted by co-investigator Martin Hirsch, MD; Dr. (no first

name cited) Ho, and Teri Flynn, Research Nurse. The "Monitor" --

the man who appeared to be calling the shots -- was Ron Beitman,

an employee of Burroughs Wellcome, the manufacturer of AZT.

(Although the censors attempted to prevent me from knowing

Beitman's name, they slipped up a couple of times.)

(In recent scandals involving the FDA's acceptance of

fraudulent data on silicone breast implants and the drugs Halcion

and Versed, it was disclosed that the FDA basically works on the

Honor System.(4) Drug manufacturers do their tests, all by

themselves, and then present their "data" to the FDA, who assumes

that everything was done honestly and competently. The FDA has

no subpoena power, so even if it found something fishy, it would

be unable to investigate any further. And even if acts of fraud

should be clearly documented, as they were in the Boston case, it

is still likely that the FDA would cover them up.)

The record-keeping at the Boston center was incredibly

sloppy. Often there no indications of when, by whom, or why

entries had been made, erased or changed. The "monitor", Ron

Beitman, appears to have taken the lead in most of the misdeeds

that were committed, though this by no means absolves Schooley,

Hirsch, Ho, and Flynn from culpability. Certainly Schooley, as

principal investigator, ought to have known what was happening.

And co-investigator Martin Hirsch had previously gotten in

trouble over a drug trial:

Dr. Schooley has not been inspected previously; Dr. Hirsch

has, in 1979, covering an Interferon Study. That EIR revealed

errors in the Protocol; no notification of the IRB re Protocol

changes or other Study medications used; subjects were given each

other's drugs; and some of the label color was visible, thereby

breaking the code.(5)

Among others, Spitzig found the following forms of

improprieties in the Boston center:

The current EI revealed numerous deviations, many of them

similar to those cited above in the 1979 EI. The observations

listed on the FD- 483 included: Deaths (two, so far) and adverse

reactions have not been reported to the IRB; undocumented

Protocol deviations including: concomitant meds, subjects not

meeting entrance criteria admitted (two); tests not performed as

frequently as required by the Protocol; adverse reactions not

reported as such on Case Report Forms ("CRF's"). There were

changes made on photocopied CRF's usually with no explanation,

date, or initials; significant observations were not addressed on

CRF's by clinical investigator; some raw records could not be

located and were explained to have been discarded.

Accountability of the Study medication is inadequate; 87

bottles/containers shipped cannot be accounted for; Pharmacy kept

the inventory and it does not correlate with shipping records;

Study medication returned by subjects was not counted, stored

properly, or signed off by the clinical investigator.(6)

In addition, Spitzig found that Schooley and his accomplices

frequently indicated on Case Report Forms that patients were in

the study much longer than they really were. Amazingly, Spitzig

missed the single most serious act of fraud, apparently because

she was unaware that AZT is the abbreviation for the full

chemical name of the drug, "azidothymidine": Patient #1009, who

was already taking AZT, was illegally entered in the study as a

placebo patient. After being in the study for only four weeks,

he dropped out. When he died two months later, he was counted as

a death in the placebo group! More about this later.

It should be explained that the Case Report Forms (CRFs)

were the official recording forms for the study. What was

written on the CRFs became "data" for the study. However,

medical information on patients was also contained in medical

records kept by private physicians, hospitals, and the clinical

center at Massachusetts General Hospital, as well as in patients'

diaries. For virtually every patient in the Boston center, FDA

Investigator Spitzig found serious discrepancies between the

medical records and what was entered on the CRFs.

A note about censorship: Virtually every page of the report

I received was covered with black splotches. The censors

attempted to prevent me from even knowing what the name of the

study was, or that it concerned AIDS and ARC patients, or that it

was testing the drug AZT. There can be no legal justification

for this kind of censorship, and it is clearly in violation of

the principles of the Freedom of Information Act. I have sent a

letter of protest to the FDA, demanding to be given the complete

and uncensored report.

I shall now describe, by category, the major violations that

were uncovered by Spitzig in her investigation of the Boston

center.

Lies about length of time in study

Comparing the CRFs with medical records, FDA investigator

Spitzig found that the CRFs often falsely indicated that patients

had been in the study longer than they really were:

Another general issue applying to a number of subjects in

the Study is that a cursory review of their Case Report Forms

would indicate that they had been on the Study longer than

actually happened. Generally this is due to the fact that Study

records continued to be generated even when the subject had been

dropped from the Study for a period of two weeks to a month.

Examples include: number 1053, [CENSORED] dropped out of the

Study for two weeks from June 19th to July 3rd, and he was off

the Study again on August 11 for a final time due to decreased

white blood cell count. CRF were generated as though he were on

the study through 9-8-86. Number 1057, [CENSORED] was on the

Study for 13 to 14 weeks but the Monitor's Accountability Sheet

indicates that he was on the Study for 16 weeks. The Case Report

Forms showed that he last came to the Clinic during Week 14 and

nothing was returned thereafter. Subject Number 1008, [CENSORED]

was off the Study for a month even though the Accountability

Record indicates that he never left it. He was off the Study

during the Week 6 visit. It is unclear if the Week 8th's

medication was dispensed. In fact during Week 4 the Case Report

Form states that he had pneumonia beginning July 7th and ending

August 7th. And during the week four visit he was not dispensed

any medication. In fact it appears that he was hospitalized then

or soon after although the Case Report Forms do not state that he

wa hospitalized. So he was off the Study medication for at least

a month, but to view the Record of Dispensing of Medication to

him, as an example, D-2 it appears that he was on the Study

pretty regularly for 12 weeks.(7)

This sort of thing is not merely a form of sloppiness. It

is cheating, and it is serious. For one thing, survival rates

were an important issue in the study. Falsely extending the

length of time that a patient was in the study would affect the

statistical projections that were made regarding survival rates.

In addition, falsely extending the length of time patients

were in the study made the final results look more plausible than

they really were. The Phase II trials were designed so that each

patient would be treated for 24 weeks. In practice, when the

study was prematurely terminated, some patients had been treated

for only three or four weeks, and arcane statistical projection

techniques were used to compensate for this violation of the

study design. The official "data" on the Phase II trials,

deriving from the CRFs, indicated that patients were treated for

an average of only 17 weeks. However, if the same kind of

cheating took place in the other 11 centers, as did in Boston,

the average may well have been much less than 17 weeks.

Finally, Schooley and his accomplices profited by lying

about the length of time patients were in the study. It is

stated in Spitzig's report, "The Investigator [Schooley] would be

paid [CENSORED] per patient.... For patients who drop out of the

Study the cost would be 'pro-rated based on the amount of time

the patient was in the Study.'"(8) That is to say, the longer a

patient was in the study, the more money Schooley got. While

this may not amount to grand larceny, it is nevertheless a form

of theft.

Concealment of adverse reactions

The rules of the study indicated clearly that all adverse

reactions were to be recorded on the CRFs and reported

immediately. Schooley et al. often failed to do so, especially

if the patient was on AZT. In theory, the investigators were not

supposed to know who was on AZT and who was on placebo, but there

are many indications in Spitzig's report that they did know, and

that they referred openly to patients' being on AZT. It would

have been easy to determine which medication a patient was on by

having a chemist test the capsules (which in fact many patients

did) or by glancing at blood test results: marked blood

abnormalities could be found in nearly all of the AZT patients.

Spitzig wrote that the study rules stated, "ANY ADVERSE

EXPERIENCE BY A STUDY SUBJECT IS TO BE REPORTED IMMEDIATELY BY

TELEPHONE, FOLLOWED BY A WRITTEN REPORT." She added, "The IRB

requirement that *all* adverse reactions be reported was not met.

None of them were reported."(9)

From the standpoint of the study's "data", many serious

adverse reactions were concealed by not recording them on the

CRFs, even though they were mentioned in the patient's medical

records. And this appeared to be tendentious -- that is,

favoring AZT -- as all except one of the eight cases where

serious adverse reactions were concealed involved patients on

AZT.

For example, patient #1008, on AZT, was hospitalized during

the study, suffering from anemia, headache, dizziness, nausea,

shortness of breath, fever, fatigue, abdominal cramps, chills,

odynophagia, and severe anemia. None of these were listed as

"adverse reactions" on the CRF. This patient later experienced

"extreme postural lightheadedness and felt close to syncope" and

was then transferred to the Emergency Ward, where he received a

blood transfusion. "There was no mention of having received

blood in the Case Report forms for this individual."(10)

Patient #1012, who was on AZT, developed a severe rash.

Although nurse Flynn "agreed that it should have been called an

adverse reaction", it was not recorded on the CRF.(11) Patient

#1053, on AZT, experienced high temperature, nausea, marked

fatigue, paresthesia in the toes, and severe anemia; he received

multiple transfusions; none of these were recorded on the CRF as

being "adverse reactions".(12) Patient #1055, on AZT, suffered

fatigue, nausea, and loss of appetite, and was hospitalized with

a fever of 105 degrees; his CRF said he had experienced no

adverse reactions.(13)

Patient #1009: from AZT to placebo

The real bombshell in Patricia Spitzig's Establishment

Inspection Report concerns patient #1009. Before entering the

study this patient was suffering from severe anemia and

headaches, for which he "was taking Tylenol every four hours

without relief of symptoms." He had received a number of

transfusions, the last one only a week before being entered in

the study as a placebo patient on 29 May 1986. However, the

record for his Week 1 visit on 5 June 1986 states that the

patient "was still taking Azidothymidine as of this visit"!

In other words, patient #1009, who was already taking AZT

and who was suffering from typical AZT toxicities (severe

headaches and anemia), was illegally entered into the study.

Patient #1009 was then assigned to the placebo group, although he

continued to take AZT. He dropped out of the study after being

in it for less than a month, and died on 20 August 1986, two

months after leaving the study. He was then counted as a death

in the placebo group.(14)

Further comment would be superfluous. If this is not fraud,

the word has no meaning.

Disappearing test product

Drug accountability was a major problem at the Boston

center. The test products were not recorded, counted, or stored

properly. Some records, such as the running inventory kept by

the pharmacy, were destroyed. After trying valiantly to make

sense out of total chaos, FDA Investigator Patricia Spitzig gave

up, and stated:

It is not possible from these records to compare the test

article usage against the amount shipped to the C.I., and as

compared to the amount returned to the Sponsor. (FD-483, No. 9)

In fact, the number of bottles (or amount of capsules) used or

unaccounted for varies with the system checked.(15)

It was apparent, at any rate, that a lot of product was

missing. Comparing the number of bottles shipped to the number

that were recorded as received by the pharmacy, Spitzig found

that 87 bottles were missing. Some of the product was

undoubtedly stolen, the code broken, and the AZT sold on the

black market where, as one of the most expensive medications of

all time, it was probably worth its weight in gold. Spitzig

states:

Exhibit C-15 is a July 22, 1986 letter from [CENSORED]

saying that some of the Study Drug, [CENSORED], had been

purchased "on the street". Clemons asked them to be sure

that the Study medications be kept under a "double-lock

system".(16)

As a consequence of the sloppiness with which the test

medications were handled, for two weeks patients #1056 and #1057

received each other's medication. Patient #1056, assigned to

placebo, received AZT for two weeks, and patient #1057, assigned

to AZT, received placebo for two weeks. This is not mentioned on

their CRFs.(17)

There may have been some funny business regarding the labels

of the Study medications, but the Burroughs Wellcome monitor, Ron

Beitman, prevented inquiry in this direction:

It was not possible to review the label of the Study

medication since we were told the monitor had picked up all the

empty and full bottles the week before we arrived and he had

subsequently destroyed them all since. Ex H-6 is a copy of what

the label would have looked like according to R. [CENSORED]....

A seven digit code was written on two records and crossed out but

not explained (1003 [an AZT patient] and 1005 [a placebo

patient]). T. Flynn explained it may be a product code. On

1003's CRF (p. 82) the code was "1017401"; on 1005's CRF, p. 199,

wk. 6, the number is "1118401".(18)

Violations of protocol

Investigator Spitzig listed numerous violations of protocol

for every patient in the Boston center, and it would be tedious

to go into them all. In general, tests were not performed that

should have been, ineligible patients were entered into the

study, records were kept badly, and patients took many

concomitant medications.

In a drug trial it is obviously important to avoid

confounding the results by allowing patients to take drugs other

than the study medications. This is the rationale for study

protocols forbidding the use of particular drugs. Spitzig made

the following observation regarding the Boston center:

Other deviations from the Protocol included undocumented

approval by the Sponsor for concurrent medication used for 11

subjects.... Deviations from the Protocol were allegedly

approved per telcons. These calls were not documented, or noted

in the Case Report Forms. These deviations from the Protocols

were not reported to the IRB.(19)

Patients in the study took the following drugs in addition

to their test medications: Cefadroxil, Erythromycin, Acyclovir,

Wacomil, Ranitidine (Zantac), Hydrocortisone Cream (topical),

Benadryl, Dilantin, Stelazine, Xanax, Halcion, Colace, Compazine,

Tylenol, Lomotil, Excedrin, Keflex, Streptomycin, INH

(isoniazid), Ethambutol, Pyridoxine, and Lithium.

In going through the correspondence file, Spitzig uncovered

an unusual incident, in which the 18-month daughter of patient

#1006 ingested some of his test product, which happened to be

AZT. The incident, which was not mentioned in the Case Report

Forms or any other records, is described by Spitzig as follows:

Dr. Schooley had told us verbally that the subject had kept

the vial of medication at home. He had walked into a room and

seen his daughter sitting on the floor with capsules in her hand.

He had received a call about the incident from a [CENSORED]

hospital. She had taken an unknown number of capsules. Further

followup indicated that between 1 and 3 capsules were missing.

Dr. Schooley meanwhile had called the sponsor firm and had

determined that his subject was on the drug [CENSORED]. Dr

Schooley mentioned verbally speaking with [CENSORED]. However,

there is no mention of his name in the memo of telephone

conversation. He made some comment about calling the Poison

Center but the memo of telephone conversation indicates that the

assessment of the toxicity of the drug was made by [CENSORED].

He said it was "below the acute toxic dose". He made a comment

about the hospital planning to draw blood for samples and, in

fact, the memo makes reference to that as well. T. Flynn

mentioned that the child was taken back (apparently to the

hospital) one more time. There is no additional followup to

indicate the results of the blood sample or checks on the

condition of the child's health. There was no copy of any

hospital treatment record from the [CENSORED] hospital in the

study records.(20)

Obviously, for patient #1006, the trial was no longer blind,

as he was told that his test medication was AZT. It is hard to

think of an innocent explanation for Schooley's neglecting to

mention this incident in the Case Report Forms.

The Coverup

On 30 January 1987 an in-house FDA meeting was held "to

consider whether or not to exclude the data from the Boston

center, (Robert Schooley, P.I.) from the analysis of the AZT

multi-center trial."(21) For some reason Patricia Spitzig was

not present at the meeting.

The meeting was not just a whitewash, it was a total farce.

The eight MDs and three PhDs present appeared to have not the

slightest grasp of the techniques and ethical standards of

professional research. Rather pathetically they posed the

questions:

1. How did the conduct of the study at this center compare with

the other centers and

2. did the recording and record changing irregularities occur at

the two other centers for which Mr Beitman was clinical monitor?

In other words, deplorable as the work at the Boston center

was, might it not be possible that the other centers were just as

bad, or even worse? Mr. El-Hage, apparently a co- investigator

with Patricia Spitzig, said he was unable to answer these

questions, "since written reports of the inspections have not

been received."

No consensus was reached on whether or not to drop out the

Boston center or drop-out individual patients. "It was finally

decided that the situation would be presented to Dr. Young

[Commissioner of the FDA] for his input. It was also agreed that

a second meeting would be scheduled to discuss issues common to

all the study centers e.g. prophylactic medication for OIs, dose

reductions and discontinuations not recorded on the CRFs, poor

screening of patients, etc."(22)

The second meeting was held on 11 February 1987. In

addition to the FDA investigators and the people from the Boston

center, a number of big shots were present, including FDA

Commissioner Frank Young and David Barry, vice president in

charge of research at Burroughs Wellcome. The alleged minutes of

this meeting, as supplied me by Mary Gross, are as follows, in

their entirety:

A meeting was held to discuss FDA's investigation of Dr.

Schooley's facilities.

Dr. Young summarized the meeting by saying that it was clear

from the inspection report that there were some problems in

recordkeeping in the study and he impressed upon Dr. Schooley

the importance of maintaining good records during these trials in

order to help FDA inspectors verify clinical trial activities.

However, these procedural discrepancies were judged not to have

influenced the validity of the data or the ability to draw

conclusions and FDA will include Dr. Schooley's data in the

overall analysis of the zidovudine multicenter trial.

Dr. Young thanked everyone for attending the meeting and Dr.

Schooley expressed appreciation to FDA for the expeditious review

given his data.(23)

It is utterly inconceivable to me that these three brief and

meaningless paragraphs could really be the minutes of such an

important meeting. I do not believe these minutes are genuine

for the following reasons: they are on FDA letterhead, whereas

all other FDA minutes I have seen are on plain paper; the alleged

minutes do not address the issues common to all the test centers;

and the innocuousness of the document is at odds with the

difficulties I had in obtaining it. I had to fight for three

months to get these alleged minutes. If these are the real

thing, then there would have been no need for stonewalling, and I

could have been given them immediately.

In 1989 Sidney Wolfe, director of the non-profit Public

Citizen Health Research Group, charged that under Commissioner

Frank Young, the FDA "is implicitly inviting all of the

industries it regulates to join in the lawlessness."(24) Young

was later forced to resign, in disgrace over the generic drugs

scandal and others.

(Conclusion)

In England, Wellcome PLC, the parent company of Burroughs

Wellcome, recently made the claim that 4000 studies demonstrated

the benefits of AZT. Of course this is pure bluff. If one

devoted a mere ten minutes to studying each of the 4000 alleged

studies, it would take him 667 hours to do so, or, assuming he

worked for 12 hours a day, a total of 56 days.

In fact, the Phase II trials remain the most single

important test of AZT: they were the main basis for the drug's

approval by the FDA; they are still cited as proving that AZT

"extends life"; they were one of the "historical controls" upon

which approval of ddI was based -- and they were fraudulent.

Fraud in drug testing may be common but it should not be

tolerated.

If there were justice in the world, the crooks in the FDA,

NIAID, Burroughs Wellcome, and their accomplices in the medical

profession would pay for their crimes. But it is more important

now to save lives. Right now well over 150,000 people are being

poisoned the nucleoside analogues, AZT, ddI, and ddC. Most of

these are gay men. We must all help sound the tocsin. We must

stop the genocide.

(References) 1. John Lauritsen, "AZT on Trial: Did the FDA Rush

to Judgment -- And Thereby Further Endanger the Lives of

Thousands of People?", New York Native, issue 235, 19 October

1987; reprinted in Chapter II: "AZT on Trial" in Poison By

Prescription: The AZT Story, New York 1990.

2. Ellen Cooper, "Addendum #1 to Medical Officer Review of NDA

19,655", 16 March 1987.

3. Cooper, the same.

4. Gina Kolata, "Questions Raised on Ability of FDA to Protect

Public", The New York Times, 26 January 1992.

5. Patricia Spitzig, FDA Investigator, For Cause Establishment

Inspection Report of Massachusetts General Hospital and Robert

Schooley, MD, October and November 1986.

6. Spitzig, p. 1.

7. Spitzig, p. 26.

8. Spitzig, p. 7.

9.. Spitzig, p. 12.

10. Spitzig, pp. 49-53.

11. Spitzig, p. 59.

12. Spitzig, pp. 61-62.

13. Spitzig, p. 64.

14. Spitzig, pp. 53-55.

15. Spitzig, p. 16.

16. Spitzig, p. 9.

17. Spitzig, p. 70.

18. Spitzig, p. 18.

19. Spitzig, p. 19.

20. Spitzig, p. 47.

21. Jackie Knight, minutes of meeting of 30 January 1987.

22. Jackie Knight, work cited.

23. Mary Gross, minutes of meeting of 11 February 1987.

24. Morton Mintz, "Anatomy of a Tragedy", New York Newsday, 3

October 1989.

&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&

End of display