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Qui tam: The Evidence

Our results are summarized in a poster presented at the Biennial Meeting of the American Society for Photobiology in Montreal, June 23-27, 2012.
The Office of Research Integrity (ORI) of the US Public Health Service recommends the analysis of terminal digits that should be random or uniform as a way of analyzing suspicious deviations in data ( The statistician expert, Joel Pitt, and I used the method

An Account of Cover Ups and Government Incompetence

Helene Z. Hill, Ph.D.
described on the ORI website to analyze terminal digits of Coulter counts and colony counts in experimental data generated by Anupam Bishayee, PhD, a post-doctoral fellow in the lab, his boss, Roger W Howell, PhD, the head of the lab and 7 others of the staff. These data were found in the documents that were made available to me by subpoena in Discovery, the period in a lawsuit during which documents and information are exchanged. The evidence of this medical cover up suggests that Bishayee has much to learn about scientific accountability. After viewing the evidence, you will find that the court's ruling was improper and an example of government incompetence. So also were the machinations of the 3 Campus Committees on Research Integrity (CCRI) as well as the US Public Health Service's Office of Research Integrity (ORI).

The Coulter Counter is a counting device that counts individual cells in liquid suspension in a specific volume in order to determine the concentration of the cells. In the laboratory, the numbers of cells in the volume appeared on an LED display and were copied from there by hand onto a chart in a notebook. Colonies are derived from single mammalian cells that are distributed on the surface of tissue culture dishes, allowed to grow in an incubator, subsequently stained, counted by hand and likewise recorded onto a chart in a notebook. The terminal digits vary from 0 to 9 and, in both Coulter and colony counts, are expected to be random or uniform throughout the 10 possible digits. A test known as the Chi Squared test is used to determine the randomness or uniformity. The probability (p-value) is determined from the Chi Squared statistic. It is generally accepted that if the p-value is less than 0.05, the lack of randomness or uniformity of the test set of counts is significant. If the p-value is less than 0.01, the lack of randomness or uniformity would be considered very significant and less that 0.001 would be extremely significant.

We examined 5,155 Coulter count values from 171 experiments performed by Anupam Bishayee, a post-doctoral fellow in the lab, and recorded in the notebook copies obtained during the Discovery period of the Qui tam law suit. The p-value (probability that the terminal digits of those counts was random or uniform) for those counts was 1.22 times 10 raised to the -92 power (91 zeros after the decimal point), a probability extremely close to zero. We also examined, as controls, 2,759 Coulter count values from 99 experiments performed by 8 other members of the laboratory using the same Coulter counter and the p-value for those counts was 0.12. Statisticians would consider that this distribution of the terminal digits of the counts of the others was not significantly different from uniform or random and would have arisen by chance. Bishayees numbers were extremely unlikely to be due to chance.

We also examined terminal digits in Bishayees 3,501 colony counts in 114 experiments and the p-value was 3.56 times 10 raised to the -44 power (43 zeros after the decimal point), an infinitesimal probability. Similar calculations on the 1,556 colony counts in 59 experiments of others as controls gave a p-value of 0.57. Statisticians would consider that Bishayees colony count terminal digits in contrast to the terminal digits of the others are extremely unlikely to be random or uniform and are extremely unlikely to be due to chance.

We also quantified the frequency with which the last two digits in the recorded Coulter counts were the same in Bishayees data and those of others in the laboratory. One would expect the 2 numbers to be the same about 10% of the time. This was true for the counts of the others (10.1%; p-value = 0.38), while for Bishayee, the two were the same 12.3% of the time (p-value 0.000000028), a very small probability.

We examined over time the individual Chi squared Coulter p-values for 288 experiments performed in the lab between February, 1995 and October, 2001. P-values less that 0.01 are very significant and those numbers are very unlikely to have arisen by chance. The p-values for 45 experiments fall below 0.01. All these experiments were performed by Bishayee. Many of the p-values for Bishayee's individual experiments did not fall below 0.01, ruling out the possibility that the Coulter counter was malfunctioning in Bishayee's hands.

In virtually all of the experiments that we analyzed, triplicate samples were taken for each data point. In the course of examining the colony counts, we noticed that the average or near-average of the 3 counts appeared as one of the counts at high frequency. In all, Bishayee and Howell published 8 papers together and did experiments using 7 different types of radioactive isotopes. In fact, the average appeared in 625 out of 925 radioactive triples for a p-value estimate of 7.2 times 10 raised to the -42 power (41 zeros after the decimal point) indicating that this frequency is highly unlikely to have occurred by chance.

Dr Joel Pitts Expert Report demonstrates the various statistical studies that were presented to the Court.

The first CCRI started meeting in April, 2001. Altogether, there were 22 experiments performed by Howell and Lenarczyk that failed to replicate results Bishayee reported in 2 publications, in two types of experiment: the so-called 100% experiments and the so-called 50% (bystander) experiments. Each experiment takes about 2 weeks from start to finish. Even though 18 of the 22 experiments were completed before the letter from the vice-president stating that there was not enough evidence for scientific misconduct, this fact that Bishayee's results could not be reproduced was never revealed to the CCRI, Howell's department chairman, the vice-president for academic affairs, the NIH, the government agency that had granted the $1.42 millions for Howell's studies or the journals in which Bishayee's experimental results were published. In fact, Howell did not acknowledge that Bishayee's experiments could not be repeated until he wrote the document entitled Summary of Experiments some time in 2004. Howell had met with his chairman, Baker, on April 6, 2001, before the CCRI met and sent a memo to Baker memorializing that meeting. The memo fails to indicate that Lenarczyk had already failed to repeat Bishayee's results in 11 attempts to do so. Later, he met with Dr Karen Putterman, the VP for Academic Affairs and implied that no attempts at replication had ever been made.

In his expert report and attached figures Dr Mike Robbins compares two 100% experiments that followed the exact same protocol for tritiated thymidine (a radioactive DNA precursor) survival. One was performed by Bishayee, the other by Howell. In Bishayee's hands, the survival at the highest dose of radioactive tritium was 1/5000th of that for roughly the same dose in Howells hands. In similar fashion, Robbins compared two 50% experiments, one by Bishayee, the other by Howell. In Bishayee's hands, there were 1/70th the survivors for the same dose compared to Howells experiment. In both pairs of experiments, Bishayee's survival curves were straight line exponential while both of Howell's curves inclined to plateau at around 0.5 (100% experiment) and around 0.7 (50% experiment). The only differences for each pair are the performance dates for the experiments.

In similar fashion, Robbins shows the results of all the survival experiments performed by Lenarczyk. None of Lenarczyks survivals show the monotonic exponential decline depicted by Bishayee in the two reports in Radiation Research, or in any of the experiments found in Discovery, even though Lenarczyk followed the same protocols used by Bishayee. In his Expert Report Robbins discusses these results in greater detail. Robbins report also discusses the arguments in favor of the presence of hypoxia in the Helena tubes that were used in most of these experiments to form clusters for incubation in the cold (10 degrees C, about 50 degrees F).

The Case 

Becoming frustrated with my inability to convince 2 Campus Committees on Research Integrity and the Office of Research Integrity (ORI) of the US Public Health Service that research misconduct had occurred, I decided to file a case for qui tam as Dr Fields had recommended. I searched the web and was able to find a lawyer, Sheldon Pincus, Esq, who was willing to take the case. It was, however, the policy of his office not to take cases on contingency. He agreed to charge half his usual fee.  

The charges were filed on October 10, 2003. Two months later, the US attorney's office began investigations that we hoped would lead to their prosecuting the case. In a qui tam case there are three possibilities: 1.) The US attorney can take the case. If this occurs, there is a 95% chance of winning. 2.) The US attorney can rule that the relator can pursue the case on his/her own. If this occurs, there is about a 20% chance of winning. 3.) The US attorney can rule that the case has no merit in which case, it is all over. It took nearly 4 years before the US attorney decided not to take the case but to allow me to pursue it. Meanwhile, much of the material that was released to us during Discovery became available by subpoena and I had an opportunity to examine it in the US attorney's office and afterward as PDF files. In all, more than 30,000 PDF files fell into my hands. Out of this, there were about 400 experiments both by Bishayee and by others in the laboratory that were available for examination. There were plenty of controls (take note, Dr Price of the ORI) and there were plenty of additional experiments by Bishayee.

Motion to Quash

Once the case was in my hands, it was up to me to find expert witnesses. During the course of this hunt, I approached members of the Center for Radiological Research at Columbia University. I had known these individuals well, both on a personal and on a scientific basis. In actual fact, I thought they were my friends. These researchers had published a paper in Cancer Research that was related to two of the papers published by Bishayee and Howell (I was a co-author on one of those papers). At our meeting, Dr Hei acknowledged to me that they had questioned Bishayee's results and that their postdoctoral fellow who had done the research would have more information about that as he had spoken directly with Howell. We were unable to locate this man. As a result, we subpoenaed Dr Hei himself. In response, he filed a motion to quash. In this, he claimed that I was attempting to use him as an unpaid expert. In my response, I denied that. He posted additional objections (cf Hei 08/07/08 and Hei 08/11/08). His motion carried (Cf Cavanaugh's ruling).  This was to be my introduction to the unsympathetic stance that our judge would take.

Several months after that, I received a curious phone call from an old friend and mentor, a highly regarded photo- and radiation biologist at the Brookhaven National Laboratory, Dr Richard Setlow. He told me that he had received a phone call from Dr Hei asking him to tell me to forget the whole thing. Was this an attempt to obstruct justice? And what reason could he have had for doing this? Hei served as president of the Radiation Research Society in 2012-2013. This is the first of several indications that the radiobiological community wants to suppress my findings.

By this time I had secured a radiation biology expert who was far more qualified than Hei. It is a small thing, but Hei, in his publications has demonstrated a lack of knowledge of biochemistry in that he does not know the proper acronym for the nucleoside thymidine, which is dThd. In several publications, he referred to it as dTTP which is the acronym for thymidine triphosphate, a very different compound that is not taken up by cells.

I found two expert witnesses, one a statistician, Dr Joel Pitt, and the other a radiation biologist, Dr Mike Robbins. Both of these filed reports and both were deposed. The defense did not deal with the statistics and only employed one expert who was only given Robbins report to examine and was never privy to the statistician's report. Unlike science, where one hopes to have all of the facts available, law can be selective and need not present all of the information. This is one very important reason why the courts are no place for science to be judged.

I was dumbfounded when I learned who the expert witness for the defense was to be: Dr. Ludwig Feinendegen, a well-known physician who specialized in Nuclear Medicine, the field in Radiation Biology that all of this was about. I knew, or thought I knew, Ludwig well. We had worked together on a grant application to the Department of Energy and he had been a guest in our house for the better part of a week in 2001 or 2002. More than that, he had been our guest at the Explorers Club Annual Dinner, one of the most prestigious (and expensive) social affairs in New York City each year. I had considered asking him to serve as an expert for me, but rejected the idea because I knew that he was also friendly with Howell and I thought he would be too much of a gentleman to accept. How wrong I was.

The Depositions

After a number of false starts and delays, primarily on the part of the defense (the US Attorney told me that that is the way the game is played delay, obfuscate, overwhelm with documents preferably in great disarray) the Depositions began. The original scheduling order indicated that Discovery should be done by October 1, 2008. In fact, it was not finished until January 7, 2010. My attorney, Pincus, told me that he found that the depositions were basically a waste of time. They are required in order to allow the trial to proceed more efficiently, but, of course, we never got to trial.

Lenarczyk, the one who had started the whole thing by reporting the second suspicious experiment to me, had moved to Milwaukee, so the first deposition was held there on October 28, 2008. The two defense lawyers rested in first class comfort at the Intercontinental Hotel (at taxpayer expense) while Pincus and I slept a healthy walk away at a Best Western (at my expense). Lenarczyk was very uneasy throughout the ordeal, but reluctantly acknowledged that he left the New Jersey Medical School because of the unpleasant environment. He did acknowledge the 16 experiments that he had performed that had failed to reproduce Bishayees results. Curiously, Howell was never able to produce 5 of those experiments dealing with the bystander effect the focus of most of the investigations, although we requested them several times. Fortunately, Lenarczyk had retained and sent me copies of the data on spreadsheets. The originals would have been useful had we gone to trial. Cf Lenarczys deposition.

The next to be deposed was Dr Azzam. He had little help to offer. He did not remember a conversation we had had in the summer of 2001 in which he had told me that he had persuaded Howell to get rid of Bishayee. Howell had come up with a list of possible explanations for the inability to replicate Bishayees results (Cf Summary of Experiments) and Azzam's hand was evident in the generation of that highly speculative list. An amusing thing occurred after his deposition had been declared closed. Azzam wanted it reopened so that he could go on record that he had not been a party to any cover-up. Curious. No one had made any mention of cover-up. Cf Azzams deposition.

Howell's deposition followed on the heels of Azzam's. He did not appear very happy about it but anyone who is interested can judge for themselves. (Cf Howells deposition part 1 and part 2). The lawyers got into an interesting argument and nearly came to blows.  I have little else to say about it except that I was quite upset when he implied that I was prejudiced against foreigners, Indians in particular, and that Azzam and Rameshwar concurred. That hardly jibes with the Smith Medal Citation.

Next came Bishayee who was now an Assistant Professor in a state pharmacy school in Ohio. Bishayee had great trouble remembering things, after all, it had been 9 years since he had performed the experiments in question and he made it clear that he had very little understanding of what he had been doing. He denied making up media for the experiments (if not he, then who?) and he, future Pharmacy professor and department chair, denied knowing what deoxycytidine (one of the building blocks of DNA) or, for that matter, cell synchrony, were. Cf Bishayee's deposition.

Department Chairman Stephen Bakers deposition followed Bishayee's. It was by far the shortest of the depositions. His answers, in contrast to the others up to this time, were reasonably direct, to the point and complete. He established that he signed off on grants, that he was responsible for the ethical behavior of members of his department, he acknowledged that Howell had not told him that Bishayee's results could not be repeated and that Howell had not followed up on his promise to report back to him after Lenarczyk would have repeated Bishayee's experiments. It was clear that he had not taken a pro-active role in the affair. Cf  Baker's deposition.

My deposition came next. I was interviewed by the defense attorney who did a masterful job of twisting my words and forcing me to say things that I really did not want to say. Cf Hill's deposition.

The Experts

After the principals had been deposed, the expert reports became due. My experts furiously burned the midnight oil and got their reports in just in the nick of time. Dr Joel Pitt, Chairman of the Department of Computer Science and Mathematics at Georgian Court University in Lakewood, NJ was my statistics expert. He quantified cell counts from the laboratory using a device known as a Coulter counter and found that Bishayee's counts were far from random while those of everyone else in the laboratory were consistent with random. He made the same determination for colony counts and in like manner found Bishayee's counts were far from expected uniform or random while everyone else's were, as expected, consistent with uniform or random. He determined that the frequency with which the rightmost digit in Bishayee's Coulter counts was equal to the next to rightmost was also significantly different from the expected 10% or random as compared to the terminal pairs of others which occurred at a frequency of 10.1%. Lastly, he found that the average of the 3 triple colony counts recorded for each of Bishayee's data points appeared as one of the individual counts at extremely high frequency, in contrast to the triple counts of others which did not contain the average at an unusually high frequency. Pitt in rendering his expert opinion concludes "When we consider the staggering improbability that the patterns evident in Bishayee's data would occur in the ordinary course of research, the conclusion that he fabricated his results and has committed fraudulent research is inescapable". Cf Pitts report and Appendix

Dr Mike Robbins was Associate Director, Brain Tumor Center of Excellence, Section Head, Radiation Oncology-Radiation Biology and Professor of Radiation Oncology-Radiation Biology at Wake Forest Medical School in Winston Salem, NC. His task was to analyze the radiobiological data produced by Bishayee, Lenarczyk, Howell and by me. In his report, he concluded that Bishayee's exponential killing of cells by tritiated thymidine was impossible because tritiated thymidine only kills cells when they are in the DNA-synthesis phase of the cell cycle (S) and no attempt was made to synchronize the cells so that all of them would have been S during their exposure to tritiated thymidine. Furthermore, tritiated thymidine blocks cells from entering S unless deoxycytidine is present and there is no evidence that it was present in any of the questioned experiments. He pointed out that, in contrast to Bishayee's experiments, those biphasic results of Howell and Lenarczyk were entirely consistent with expectations and with other reports in the literature when no deoxycytidine was present. He further concluded that the Helena tubes used by the workers in the lab were hypoxic, in contrast to Howells conclusion in his grant application that hypoxia was minimal. He went point by point through Howell's list of possible reasons why he and Lenarczyk could not reproduce Bishayee's results and argued that there was no evidence for any one of them. Cf Summary of Experiments.

Robbins concludes that in his expert opinion the data generated by Lenarczyk and Howell are exactly what would be expected based on the experimental protocols used and the radiobiological principles discussed. The inabilities to reproduce Bishayee's findings reflect the fact that these data were generated falsely. Cf Robbins report and figures.

Feinendegen took nearly 5 months to respond to Robbins' report in his role as a rebuttal witness, although he was supposed to respond in a month. He was only privy to Robbins report and not to Pitt's analysis. That is the strange way the game is played in judicial circles. He took issue with Robbins' conjecture that tritiated thymidine would block the cell cycle because, he argued, its thymidine concentration was too low due to its high specific activity (amount of radioactivity relative to the amount of chemical thymidine) and in such case, deoxycytidine would not have been necessary to counteract the cell cycle blocking effect. He calculated the slope of Bishayee's survival curves and said that it was as predicted based on radiobiological principles. This could certainly have been true except that when those experiments were analyzed statistically, it was evident that the results were extremely at variance with any expectation of randomness. In fact, there were in all 2048 tritiated thymidine experimental Coulter counts by Bishayee with a p-value for random or uniform terminal digits of 4.7 times 10 to the minus 58th power (57 zeros after the decimal point). In all, there were 1380 tritiated thymidine experimental colony counts with a p-value for random or uniform terminal digits of 3.6 times 10 to the minus 11th power (10 zeros after the decimal point). In all, there were 465 tritiated thymidine experimental triples of which 389 or 84% contained the mean as one of the triples. But Feinendegen was totally unaware of any of these determinations.  

In his report, Feinendegen went through Howell's list of possible explanations for the inability to repeat Bishayee's results (cf Summary of Experiments, justifying each one without, however, finding any evidence for roles in any of Howell's experiments. Cf Feinendegens report.

The last phase of Discovery was the deposition of the 3 experts. My experts were deposed in Pincus' office with the defense paying for their time (with tax payers' money) and Feinendegen was deposed in a motel on Long Island near the Brookhaven National Laboratory where he spent much of his time and I paid for his time, $2000. 

Pitt was deposed on September 2, 2009. He was calm, cool, collected and spoke convincingly and sincerely. He was unflappable. The defense attorney was completely unable to find any flaws in his testimony. Too bad it was totally lost on the Court. Cf Pitt deposition.

There was a great deal of backing and forthing regarding Robbins' and Feinendegen's depositions. Robbins was supposed to be deposed first but Howell wanted to attend and Howell's brother was being operated on that week for an ocular melanoma. In this situation, proton radiation is used and since this was close to Howell's expertise, he wanted to be there. So Feinendegen was scheduled to go first.
Pincus and I arrived at the deposition to find Feinendegen waiting in the meeting room. When I walked in, he came over, threw his arms around me and gave me a big bear hug. I was so shocked that I didn't push him away. If our paths should, heaven forbid, ever cross in the future, I will be sure he never touches me again. Both university lawyers (at tax payers' expense) and Howell were also in attendance. Howell made a big show of taking notes on his computer.

Feinendegen admitted to having retired 16 years before and that he had spent 36 hours preparing his report. He had not seen Pitt's report although, of course, he had seen Robbins'. Pincus explained to me that he was a "rebuttal witness" for Robbins' report only. 

Feinendegen kept wanting to make statements but was not permitted to. He brushed off 3 papers in the literature as irrelevant although high specific activity thymidine, no deoxycytidine and biphasic killing had been observed. He even claimed that one of those papers was irrelevant while admitting he had not read it. He admitted he did not look at the lab protocols. "I relied on the accuracy of the published papers." He claimed to have found many papers in which there was exponential survival without deoxycytidine but he had not cited any of them. In my search of the literature, I found only one.

Q) Do you acknowledge in your review of the Robbins' report that Dr. Robbins compared the protocols and results of Dr. Bishayee versus those of Dr. Lenaryczyk and concluded that the protocols were the same?

A) That I cannot answer the question. I only know that this is a scientific question which is of great importance and it has nothing to
do with the accusation of falsification. It is of enormous importance scientifically, it's fascinating to see this differences coming up and I have come -- let me just add that, in my own career, similar situations where I just failed to reproduce data and I have paper here that I even cited that in my report, a slight change of conditioning now, it may be the page [probably pH], it may be a similarity, it may be the concentration of buffer, it may be the type of buffer, all this influences an experimental outcome, and the lack of reproduction of the second group is a scientific question of great interest, but it has nothing to do with the accusation of falsification. It's of great scientific interest but it does not refer to whether the first data were -- and that was the starting point of it all, was falsified or not. That is a very fascinating topic you are opening up here and it is a fascinating scientific issue and I spent, to finish my answer, to make you aware of what that means, I spent more than the whole year once in order to find out why I could in my own laboratory not reproduce data, and then after a whole year of very precise efforts I found the conditions, what I called conditions, as you referred to that, and then we could reproduce and then we were off.

He referred to a dead html link to support one of his conjectures and he defended Howell for not reporting his inability to replicate Bishayee's results in 22 attempts. Cf Feinendegen's deposition.

Robbins was finally deposed on January 7, 2010. Howell did not attend after all. Leonard, the defense lawyer, did his best to discredit Robbins by emphasizing that he has never worked with tritiated thymidine or even with thymidine, that he had never worked with the bystander effect and that he never visited the laboratory or talked with Lenarczyk. Robbins would not have been much of a Radiation Research Section Head had he not been familiar with these topics in Radiobiology. He twisted Robbins words as he had done with mine. Robbins kept his cool. Cf Robbins deposition.

Once we had wound up Robbins deposition, Discovery was over. There was little to be gained from the depositions except that I knitted 10 sweaters during the questionings, 2 each for my little people: my 2 little granddaughters and my 3 little great grandchildren, 2 boys and a girl. Although the volumes of data did not win the case for me, they provided me with the ammunition I now present on this website and, at this writing, have now published in peer reviewed journals.

Dispositive Motions

Once Discovery is over, each side has the option to file a Motion to Dismiss, also known as a Dispositive Motion. Both sides chose to do this before the deadline of May 25, 2010. On my behalf, my lawyer, Pincus, filed 7 documents: the notice for Summary Judgment (SJ) 2 pages, my statement of undisputed material facts 59 pages, certifications by Pincus (basically the list of documents) 23 pages, my brief (basically the evidence and other cases cited) 48 pages, the order to grant SJ 2 pages, Pincus proof of service 4 pages, and Pincus cover letter to Judge Cavanaugh. The Defense undisputed facts went to 7 pages and their brief was 46 pages. Each side then had the opportunity to respond once more. We filed our reply brief of 18 pages before the deadline on June 21, 2010 and the defense filed theirs of 14 pages after the deadline which should have given us a win but it did not. In his reply brief, Pincus focused on the strength of the science and the experts' opinions and he would have done well in a court of science.

On the other hand, the defense's stance was sarcastic and dismissive. They claimed I had a personal vendetta against the defendants. This was a scientific disagreement that only dealt with one small part of the NIH grant, a dispute regarding methodology and interpretation of data. They emphasized that Bishayee had denied falsifying the data (what did they expect?), in contrast to Poehlman who falsified data on several USPHS grant applications and ultimately admitted it. As for Dr Pitt's analyses, they brushed these off as "certain statistical anomalies". They claimed that I failed to prove that the defendants acted "knowingly, recklessly or with deliberate ignorance". I failed to demonstrate that the data was false, or that, if it were false, it would have made a difference in the funding decisions. They emphasized that the CCRI on 2 occasions unanimously concluded there was insufficient credible evidence, that the ORI supported this decision and that the US Attorney declined to pursue the case, especially after I made my PowerPoint presentation purporting to present new evidence. They referred to the "questionable and self-serving reports of [my] experts", that Howell's only knowing was based on my self-serving suspicions. Furthermore, I had failed to file a formal complaint in 1999 after my first observations. Lastly, I had failed to demonstrate that the data I claimed was false was material to the funding decision.  

Judge Cavanaugh rules

Cavanaugh filed his decision on October 18, 2010. There was no violation of the False Claims Act (FCA).  The FCA has 3 parts. The first part states that the government must have been defrauded in that there was money involved. This was satisfied in that a federal grant was issued based on the grant application filed for the November 1, 1999 deadline. The second requirement is that the defrauder had to have known that he/she was defrauding the government.  The law uses quaint language that the defrauder had to be scienter.  The third requirement is that the fraudulent action had to be material. The judge ruled that Howell was not scienter because he did not know on the date that he filed the grant that the government was being defrauded. Since the expert reports came along after the date of filing, they were immaterial because Howell did not know about them at the time of filing the grant. The judge did not consider that the renewal had any role as a new application, thus, even though Howell might have been knowing at the time of the renewal, that did not matter. The judge brushed aside what Howell did know at the time that he filed the grant: that I had reported to him my suspicion that the dishes that were material to the data in figure 7 of the grant application were devoid of colonies and that my results performing the same protocol did not agree with those of Bishayee. The judge stated that failure to replicate simply means failure to replicate. He hit on my lack of absolute certainty about what I had seen regarding the lack of colonies on the dishes I had examined. Happily for me, he ruled that I was "quixotic" but had not behaved out of malicious intent. This removed the possibility of the defendants turning around and suing me for frivolous action. When it came to Bishayee, the judge ruled that he was neither scienter nor material. This latter in spite of the fact that he had produced pretty much all of the preliminary data that went into the grant application. The judge exonerated Howell for not informing the NIH of his inability to replicate Bishayee's results and he reasoned that even had the NIH known that the reported results had been falsified, it would have made no difference as regards their granting decision.

The Appeal

Even though I knew it was going to be an exercise in futility, I had to give it one last try. The appeal would be heard in the appeals court in Philadelphia. Three judges would preside. Our documents were basically a rehash of what had been said before and the defendants repeated their reliance on the two CCRIs and the ORI rulings.  We filed our appeal on 11/8/10.  The defendants then had an opportunity to reply, we could reply again and then we would sit and wait. After a time, we received word that we were eligible for oral arguments. These took place on 9/13/11. Each side was allotted 15 minutes some of which could be reserved for rebuttal. The court would ask the questions and the lawyers would answer. There was no way that we could have any control over the proceedings. Pincus went first and our 15 minutes began with Judge, Dolores Sloviter, stating that she did not see that any law had been broken and "we're just judges...I never had a science course in my life" (  Case is 10-4364HillvUnivofMedicineDentistryNJetal.wma). Not a very auspicious beginning. Much of the discussion focused on Howell's knowing and Pincus tried valiantly to point out that Howell had concealed from the first CCRI his and Lenarczyk's inability to reproduce Bishayee's results. The appeal ruling came through on October 20, 2011. As expected, Judge Cavanaugh's ruling was sustained. I was informed that at this point the only course of would be to appeal to the US Supreme Court which would be a futile exercise. As I saw it, my only course of action would be to publish the statistical analysis of the raw data that we had amassed, including the arguments made in Robbins' report that Bishayee's tritium experimental results were impossible because tritiated thymidine blocks the cell cycle and no deoxycytidine was present during the experiments to abrogate this effect. I thought this next phase was going to be easy.

NON SEQUITUR (c) (2009-11) Wiley Miller Ink, Inc. Used by permission of Universal Uclick. All rights reserved.

Copyright 2012: Helene Z Hill. Medical Cover Up. All rights reserved.

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