Show Fraud In AZT Trials
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.
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.
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.
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.
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.
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.
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.)
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.)
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:
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)
Spitzig found the following forms of improprieties in the Boston
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;
returned by subjects was not counted, stored properly, or signed
off by the clinical investigator.(6)
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
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.
length of time in study
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:
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.
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.
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.
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.
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
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.
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)
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)
#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)
would be superfluous. If this is not fraud, the word has no meaning.
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
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.
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)
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
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)
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:
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)
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.
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.
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
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."
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)
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.
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.
4. Gina Kolata,
"Questions Raised on Ability of FDA to Protect Public",
The New York Times, 26 January 1992.
Spitzig, FDA Investigator, For Cause Establishment Inspection Report
of Massachusetts General Hospital and Robert Schooley, MD, October
and November 1986.
Knight, minutes of meeting of 30 January 1987.
Knight, work cited.
23. Mary Gross,
minutes of meeting of 11 February 1987.
Mintz, "Anatomy of a Tragedy", New York Newsday, 3 October