Scientific and Government Fraud in Research

Back to Adverse Reaction Data / Back to Home


"What the F.D.A. is doing and what the public thinks it's doing are as different as night and day."
Dr. Herbert E. Ley, former FDA Commissioner


The U.S. FDA Approved Products From the Lab That Performed This Research

To this day, the U.S. FDA defends their product approvals based on the type of "research" performed below. If the manufacturer has enough political clout, the FDA will approve the product in almost all circumstances.

Animal ID Alive/Dead Status Date
J24HMFound dead3/21/71
Alive5/19/71
Dead5/16/71
Alive7/14/71
Dead8/11/71
K18LFAlive4/22/71
vanished (dead ?)5/20/71
Alive6/17/71
vanished (dead ?)7/15/71
M25CFFound dead3/6/71
Alive6/18/71
Dead7/16/71
Alive9/10/71
Alive10/8/71
Dead11/5/71
H28MFAlive7/13/71
vanished (dead ?)8/10/71
H15CFAlive7/13/71
vanished (dead ?)8/10/71
G 2HMFound dead3/10/71
Alive8/9/71
A15MMFound dead3/13/71
Alive5/3/71
Dead6/1/71
Alive8/23/71
Dead9/20/71
G16HMFound dead3/9/71
Alive8/9/71
Dead9/7/71
A 6HMFound dead2/25/71
Alive5/3/71
Dead6/1/71
Alive8/23/71
Dead9/20/71
G23HMFound dead3/7/71
Alive8/9/71
Dead9/7/71
E15MMFound dead1/21/72
Alive2/25/72
G 8MMFound dead9/3/71
Alive11/29/71
Dead12/27/71
B19HFAlive6/29/71
vanished (dead ?)7/27/71
Alive8/24/71
vinished (dead ?)9/21/71
Alive10/19/71
vanished (dead ?)11/16/71
Alive (?)2/22/72
B21HFFound dead2/25/71
Alive8/24/71
Dead9/21/71
Alive 10/19/71
Dead11/16/71
Alive2/22/72
B14MFKilled7/30/71
Alive10/19/71
Dead11/16/71
Alive (?)2/22/72
B12HFFound dead9/2/71
Alive10/19/71
Dead11/16/71
Alive (?)2/22/72
B 4CFFound dead9/12/71
Alive10/19/71
Dead11/16/71
Alive (?)2/22/72
D30LFFound dead1/22/72
Alive2/22/72
B15HFFound dead1/25/72
Alive2/22/72
C29LMFound dead3/29/71
Alive6/2/71
Dead6/30/71
C12HMFound dead8/10/71
Alive10/20/71
Dead11/17/71


"What may be added here is that the live/dead status of the experimental animals is not the only 'careless' type of error present in the Observation for Drug Effects. The following are merely a few samples of the way entries are kept on externally visible tissue masses in these animals; most of such tissue masses turn out to be benign or malignant mammary tumors."
  1. Animal M21 (a control female), is said to have developed a tissue mass in the left cervical area; the mass is said to have been initially detected on 6/18/71; at the next observation period on 7/17/71 this animal is checked off as having no tissue masses; however, the next animal on the list (M22 - an exposed female) is now listed as having its tissue mass "larger" (presumably than at the previous observation period); but this particular animal had not been listed as having exhibited any such masses at any time in the past; at the next observation period on 8/13/71, the tissue mass in the control animal is said to be "larger" while the exposed animal is said to have no tissue mass whatsoever.

  2. Animal J16 is said on 2/23/72 under "Tissue Masses - Lesions" to have an abscess in the left inguinal region which is "larger"; no mention of any such abscess is evident for any prior observation.

  3. Animal B26 is said on 12/14/71 under "Tissue Masses - Lesions" that its mass is larger. But no tissue mass in this animal is previously reported. Four weeks later on 1/12/72 a tissue mass is said to have been initially detected on that day.

  4. Animal B27 is said on 9/21/71 to have developed a tissue mass initially detected on that day; at the next observation period on 10/19/71 the mass is said to be unchanged; at the next observation period on 11/16/71 the mass is said to have regressed; at the next two observation periods on 12/14/71 and 1/12/72 this animal is said to be free of tissue masses; on 2/8/72, the next observation period, the mass for this animal is said to be the "same"(!)

  5. Both animals A2 and A3 are said on 9/20/71 to have developed tissue masses initially detected on that day; at the next observation period, on 10/8/71 both of these animals are indicated to be free of any tissue masses; at the next observation period on 11/5/71 it is indicated that both of these masses regressed.

  6. Animal E3 is said on 7/1/71 to have developed a tissue mass initially detected on that day; the following are the results of the six subsequent examinations:

  7. Animal E9 is said on 9/23/71 to have developed a tissue mass initially detected on that day; the following are the results of the four subsequent examinations:

  8. Animal D29 is said on 7/1/71 to have developed a tissue mass initially detected on that day; the following are the results of the seven subsequent examinations:

  9. Animals H26, D12, K25, D5, K17, and D19 each are indicated to have developed more than one tissue mass; in each case, however, observations made subsequently fail to distinguish to which tissue mass they apply.

  10. Animal H19 is said on 11/2/71 to have developed a tissue mass initially detected on that date; the subsequent observation dated 11/30/71 indicates this animal to be free of any tissue masses; at the next observation made on 12/28/71 the mass in this animal is said to be the "same."
“This list of 10 examples involving some 16 animals could be extended further but it is sufficient to make the point that records maintained at Searle on the appearance, persistence or ‘regression’ of tissue masses do not give one much assurance on their reliability.

“One may ask -- can this sort of thing be shrugged off as merely ‘careless’ observations made by those who were supposed to make such observations? Or was this a situation that could be expected to have occurred, given the policy and practice in force in the Department of Pathology and Toxicology at Searle?

“A review of the names of the ‘observers’ entered on these sheets referring to ‘Observations for Drug Effects’ reveals different names for subsequent observations. Question: If whoever observed the animals on a given day and who recorded such observation in his or her notebook, is someone else than the one having observed them at the previous observation period, who made similar observations in some other notebook, how can it be said that a certain tissue mass is the "same" or ‘larger’ or ‘unchanged’? After a certain period in the experiment no names of any observers appear on these records.

“Searle maintains in their last communication (line 10, page 15) ‘In the truest sense, the errors identified by the FDA (in these records) were completely irrelevant to the scientific conclusions of the study...’ We note this evaluation of ‘irrelevant’ by Searle but we cannot agree with it, and the reason for this is very clear:

“The title printed on these ‘Observation for Drug Effects’ is ‘Statistical Work Sheet’; this says that it is reasonable to expect that these ‘careless’ entries must have formed the basis for input for statistical operation which are crucial to the ‘scientific conclusions of the study.’ The methodology used in these statistical operations at Searle (the Horton and Sachs Life-Table procedures) depend completely on the time a certain tissue mass (tumor) is observed and on the time the animals with the mass (and all other animals in that group) died. Now, if the live/dead status of each animals was ‘carelessly’ entered on these ‘Statistical Work Sheets’ as conceded by Searle and if its status as a tumor-bearer at any time was largely in doubt (as demonstrated here) of what value are any of the statistical computations based on this kind of raw input data and would this not affect the ‘scientific conclusions of the study’?

“Searle complains (line 2, page 14) that these records ‘became a subject of considerable levity at the hearing.’ I believe, however, that the members of the Subcommittee are sufficiently knowledgeable in the ways of the world to realize that animals seldom die more than once. However, I would tend to agree with Searle here, that the state of their records on observations collected during the course of this study is indeed no laughing matter.”

[Memorandum from FDA Toxicologist Dr. Adrian Gross, Scientific Investigations Staff to Mr. Carlton Sharp, Chairman, Searle Investigation Task Force, March 15, 1976, Reprinted in U.S. Senate Joint Hearings before the Subcommittee on Health of the Committee on Labor and Public Welfare and the Subcommittee on Administrative Practice and Procedure of the Committee on the Judiciary, "Preclinical and Clinical Testing by the Pharmaceutical Industry, 1976, Part 3," No. Y4.L11/2:P49/2/976/pt.3, CIS# S541-12, page 310-376.]





Back to Adverse Reaction Data / Back to Home