FDA DOCUMENTS SHOW FRAUD IN AZT TRIALS
By John Lauritsen
New York Native 30 March 1992
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
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
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
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
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
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
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
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
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
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
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. *
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.