Thetruthnews.info

Are You Being Delphied?

- United Nations Global Strait Jacket (pp. 355 - 357) by Joan Veon

The Rand Corporation in the early 1960s developed the Delphi technique for the purpose of maneuvering segments of the public into accepting predetermined government policies. In the 1970s and '80s, it was ideally used to convince land owners of the merits of accepting joining and general plan maps. Now it is being employed to persuade the public to accept outcome-based education and the licensing of all employees, via endorsements in the Certificate of Initial Mastery (CIM) and Certificate of Advanced Mastery (CAM) programs, a.k.a. school-to-work.

The goal of the Delphi technique is to lead a targeted group of people to a predetermined outcome, while giving the illusion of taking public input and under the pretext of being accountable to the public. For the Delphi to work, it is critical that the targeted group be kept away from knowledgeable people who could lead them away from the Delphier's predetermined outcome.

One variation on the Delphi technique is to use a series of meetings. The attendees are often given a number or a colored card when they enter the room, to determine at which table they are to sit. The purpose of this is to break up the groups of potentially knowledgeable people who arrive together so that they will be sitting with strangers and therefore be subdued.

Typically, at each table is a facilitator, someone who will know which way to help "steer" the group. Usually the people at each table are instructed to answer among themselves some of the questions and arrive at a table consensus. Someone is chosen to speak for the table, most of the time it is the person who has been secretly pre-briefed about the desired Delphi outcome. The table spokesperson is the only one allowed to address the podium and the others have little opportunity to address the podium or the crowd directly.

Anyone knowledgeable enough, or brave enough, to speak out in opposition will not be welcomed. Often they are told from the podium, "We don't have time to discuss that now," or "We discussed that on another date," or “We can discuss that after the meeting.” They will attempt to quiet, isolate, and discredit dissenters. After attending the Delphi meeting, participants may feel uneasy that they are in disagreement with the apparent majority. The Delphi technique is often successful in bluffing people into submission. Don't let them succeed. Call their bluff.

The Delphi technique often uses a series of surveys to bring about "consensus." The surveys are promoted as information gathering regarding the wishes of the targeted public, but in reality they are designed to manipulate the desired outcome. The survey will sometimes use a grading like, "agree all of the time," "agree most of the time," "agree some of the time," "agree not much," "agree never." Or, the survey grading will ask the respondents to use ratings like "most important," "moderately important," "least important."

The questions are typically "loaded" questions. An example is the question asked of Oregon teachers on a Delphi technique survey: "Do you agree or disagree that the following elements of H.B. 3565 [Oregon's Education Act for the 21st Century] will lead to improved student learning if implemented?" The survey listed such items for the teachers to agree or disagree with; "site councils," "increased accountability for school site and districts," "full funding for preschool programs to enable all students to enter school ready to learn," "extended school year," "certificate of initial mastery," etc. The question is patently "loaded." For example, site councils are not charged with improving student learning. Their function is to implement the state law, dole out professional development courses and money to selected teachers, and apply for grants from foundations and the federal government. For the teachers to answer, "agree" or "disagree", that the site councils will lead to improved student learning is misdirecting the respondent.

The Delphi surveys serve to "educate" the people taking the survey. After the first survey is taken, the respondents are given an analysis and told that most people agreed or somewhat agreed on the predetermined outcome. Then usually they are given another survey and asked if they can be flexible and try to rethink the "few remaining" areas of disagreement. When the series of surveys are accomplished, the respondents are told that the majority of respondents achieved "consensus" with whatever direction the pollers wanted in the first place.

These techniques were developed decades ago. The Rand Corporation has more recently been developing games that groups of business people, site council members, organizations, etc., can use to help "sell" people on collectivism, consensus vs. majority rule, etc.

Never, ever compromise when it comes to "right and wrong." With the right attitude you shouldn't care what people think, as long as you are standing up for what is right. Accept persecution gratefully

Post comment

The Lynching of Iraq by James Carroll

Published on Monday, January 8, 2007 by the Boston Globe

The hanging of Saddam Hussein Dec. 30 offered a view into the grotesque reality of what America has sponsored in Iraq, and what Americans saw should inform their response to President Bush's escalation of the war.

The deposed tyrant was mercilessly taunted. As he stood on the threshold of the afterlife and was told to go to hell, the world witnessed a chilling elevation of the ancient curse, making an absolute villain an object of pity.

And then, in chanting the name of Moqtada al-Sadr, whose family had been a particular target of Hussein's his executioners made clear that the execution was an act of tribal revenge, not of national restoration, much less justice. It was a lynching. This Shi'ite brutality is guaranteed to spawn Sunni savagery. Iraq itself is hell.

Officials of the United States, from military commanders in Baghdad to members of the Bush administration in Washington, sought to distance themselves from the bedlam, but they are essential to what happened at the last moments of Saddam's life. Decorum would have been the main note of his death if Americans had managed it, but the execution would have been no less an act of false justice.

The harsh fact is that the Shi'ite dominated government of Nouri al-Maliki, in its contemptible treatment of a man about to die, laid bare the dark truth of Bush's war. This is what revenge looks like, and revenge (not weapons of mass destruction, not democracy) drove the initial US attack on Saddam Hussein every bit as much as it snuffed out his life at the end. The hooded executioners took their cue from George W. Bush.

And why should they not have? Let's remember who this man is. As governor of Texas, he presided over the executions of 152 people, including the first woman put to death in Texas in a century. Her name was Karla Faye Tucker. Bush's response to the world-wide plea raised in her behalf was an astounding display of cruelty, a mocking imitation of the woman begging not to be killed.

Bush rejected appeals for clemency in every death penalty case that came before him. The Texas death chamber, with its lethal injection gurney, is a place of decorum. And savagery. That executions defined the main public distinction that Bush brought to the US presidency sums up the national disgrace, while suggesting also how little surprise there should be that America is presided over now by an executioner-in-chief.

Capital punishment is to individuals what aggressive war is to nations. The 20th century, for all its brutality (or because of it), marked the watershed era when world opinion shifted against both. Once, princes exercised life-and-death power over subjects with unchallenged authority. Once, the only check on a state's freedom to attack another state was its power to do so.

These two absolutes of realpolitik have changed. From the Kellogg-Briand Pact of 1928 to principles laid down at the Nuremberg tribunals to the United Nations itself, wars of aggression stand condemned. The force of state violence is to be exercised only in self-defense or in defense of a victim people, in circumstances defined by international agreement. Similarly, nation after nation has abolished the death penalty, understanding the absurdity of defending human life by destroying human life. If killing can ever be justified, individually or communally, it is only as an absolute last resort. In sum, an international moral consensus has taken shape against unnecessary violence, whether targeting a criminal or a rogue state.

George W. Bush is the impresario of unnecessary violence. America has followed him into the death chamber of this war, and now he wants us to believe that the way out is through more death.

Iraqi loss of life remains mostly unimagined, but every evening on the television news, Americans see the sweet faces of young soldiers who have died in Bush's war. They were heroes, not criminals, yet Bush dragged each one of them up onto a gallows. He positioned them on the trap door, hardly wincing as they then fell through. And now, in perhaps the greatest outrage of all, Bush claims that the way to justify the unnecessary deaths he has caused is to add to them. Escalation is his way of saying, go to hell.

With his lies at the beginning of this war, and his fantasy now that an honorable outcome remains possible, the president is a taunting killer, caught in the act. He lacks nothing but the black hood. Stop this man.

James Carroll's column appears regularly in the Globe.

Copyright 2007 Boston Globe

Comment

Dangerous Deception: Hiding the Evidence of Adverse Drug Effects_NEJM

Alliance for Human Research Protection

Friday, 24 November 2006

FDA's slip-shod approval of defective, harmful drugs, accompanied by rubber stampped endorsements by compromised FDA advisory committees may be reaching a boiling point.

The drug industry's undue influence--on the FDA and its advisory committees that are made up mostly of doctors "on the take"--has resulted in the marketing of lethal drugs, disregarding public safety. The pharmaceutical industry seems to operate on the premise that FDA's marketing license--much like a hunter's license--is a license to kill.

Two articles in the Nov. 23 issue of the New England Journal of Medicine, focus on how Bayer concealed vital drug safety information from the FDA. And how the FDA does nothing when it learns that pharmaceutical giants, such as Bayer, conceal safety data from physicians and from the FDA.

The case in point involves aprotinin (Trasylos) marketed since 1993. Critics had suspected its role in causing renal failure and increased incidence of myocardial infarction, stroke, and encephalopathy. Yet, despite such serious concerns, the FDA did nothing to inform physicians about the suspected lethal risks.

"What put aprotinin on the front page on September 30, however, was the revelation that its manufacturer, Bayer, had hired a private contract research organization to perform its own large observational study of postoperative complications in patients given the drug. The analysis, completed in time for the FDA meeting, reached conclusions similar to those of Mangano et al. It, too, adjusted for a wide variety of clinical characteristics and showed that patients who received aprotinin had higher mortality rates and substantially more renal damage than those given other treatments. But neither Bayer nor its contractor had provided the report to the FDA or even acknowledged its existence before the meeting. "

Bayer continued marketing its lethal drug, much as it had marketed its lethal statin, Baycol--in complete disregard for lives sacrificed, and in disregard for federal law. Dr Michael D E Goodyear of Dalhousie University (Canada) holds institutional review boards (IRBs, Research Ethics Boards in Canada ) responsible for approving unethical trials that result in fraudulent reported findings. [1] Aprotinin and dozens of other lethal drugs entered into the marketplace, and were utilized in clinical practice with little safety data. "We contribute to a process that allows drugs to be marketed on 'what-the-market-will-bear' pricing arrangement severely distorting the economics of health care, in which drug pricing is now the primary driver."

Another current heated controversy surrounds Eli Lilly's aggressive marketing of Zygris for the treatment of sepsis--despite evidence that the drug puts critically ill patients at INCREASED risk of death. Two articles in the October issue of the NEJM focused on the Zigris-Surviving Sepsis Campaign controversy. One critical review by senior investigators at the National Institutes of Health, Drs. Peter Eichacker, Charles Natanson and Robert Danner reveals that Lilly's unde influence in promoting use of its $6,000 drug--is demonstrated not only in its marketing campaign, but in the professional Sepsis Practice Guidelines. www.ahrp.org/cms/content/view/366/27

The other article, Management of Sepsis, is a favorable review by Dr. James Russell who fails to disclose his significant financial ties that present a conflict of interest. [2] The NEJM merely states that Dr. Russell is at the University of British Columbia. It fails to disclose that Dr. Russell is the Medical Officer of a for-profit company, Sirius, "A pharmacogenomics company focused on the discovery, development and commercialization of novel diagnostic tests and treatment protocols." [3 ] Sirius was recently acquired by Bioscience, contracted by Eli Lilly.

We note the contrast between the NEJM editors' cavalier attitude about disclosing authors' conflict of interest, and a specialty journal, Critical Care. The authors of a Sepsis article in Critical Care (June 2006) --including James Russell--are identified as having competing interests: " Eli Lilly and Company provided support for this study. GRB, JFD, JRR, and AFS have all participated in Eli Lilly and Company-sponsored clinical trials, and have all served as consultants for Eli Lilly and Company. WLM, DRN, and DP are employees and stockholders of Eli Lilly and Company." [4]

Only a firewall separating sponsors from the research evaluation process can restore trust in medicine. At present, clinical trials are no more credible than commercial marketing hype--they bear no relation to scientific method or scientific objectivity.

References:

References:

1. Fergusson (Clinical Trials 2005; 2: 218?232)

2. N Engl J Med 2006;355:1699-713.

3. See; BC Investors Advantage, June 6, 2006 at: http://www.bcadvantagefunds.com/

4. Andrew F Shorr1, Gordon R Bernard2, Jean-Francois Dhainaut3, James R Russell 4, William L Macias5, David R Nelson5 and David P Sundin5 Protein C concentrations in severe sepsis: an early directional change in plasma levels predicts outcome, Critical Care, 2006, 10:R92 (doi:10.1186/cc4946)

Contact: Vera Hassner Sharav

veracare@ahrp.orgThis email address is being protected from spam bots, you need Javascript enabled to view it

............................................

THE NEW ENGLAND JOURNAL OF MEDICICE

Dangerous Deception — Hiding the Evidence of Adverse Drug Effects

Jerry Avorn, M.D.

September 30 is becoming a day of infamy for drug safety. On that date in 2004, Merck announced that rofecoxib (Vioxx) doubled the risk of myocardial infarction and stroke, and the company withdrew the drug from the market after 5 years of use in more than 20 million patients. On September 30, 2006, a front-page article in the New York Times reported that the Food and Drug Administration (FDA) had issued a warning that the antifibrinolytic drug aprotinin, widely used to reduce perioperative bleeding in patients undergoing cardiac surgery, could cause renal failure, congestive heart failure, stroke, and death.

Some experts had been concerned about aprotinin (Trasylol) ever since its approval in 1993.1 As Hiatt explains in his Perspective article in this issue of the Journal (pages 2171–2173), one of two epidemiologic studies reported early this year provided support for this concern. In an observational study involving 4374 patients who underwent coronary revascularization,2 Mangano et al. found that patients who were given aprotinin had an incidence of postoperative renal failure requiring dialysis that was more than twice that among patients who received different agents. Among patients undergoing uncomplicated coronary-artery surgery, those given aprotinin had a 55% increase in the incidence of myocardial infarction or heart failure and a 181% increase in the incidence of stroke or encephalopathy. The authors advised against further use of the drug, since safer, cheaper alternatives are available.

After the study was published, the FDA moved to convene an advisory committee to reassess the drug's safety and assembled the relevant data. The committee met on September 21, reviewed the available evidence, and concluded that there was no need for additional warnings on the drug's official labeling. What put aprotinin on the front page on September 30, however, was the revelation that its manufacturer, Bayer, had hired a private contract research organization to perform its own large observational study of postoperative complications in patients given the drug. The analysis, completed in time for the FDA meeting, reached conclusions similar to those of Mangano et al. It, too, adjusted for a wide variety of clinical characteristics and showed that patients who received aprotinin had higher mortality rates and substantially more renal damage than those given other treatments. But neither Bayer nor its contractor had provided the report to the FDA or even acknowledged its existence before the meeting.

Many aspects of the aprotinin saga are familiar to observers of the drug-evaluation process: a product is approved because it is more effective than placebo, worries emerge about its safety, few or no adequately powered controlled trials are conducted to address these issues, and payers spend huge sums on the drug, despite the dearth of evidence that it is better than older, cheaper agents. The health care system has a hard time performing drug-safety analyses, in large part because it relies on the pharmaceutical industry to conduct most research on the risks and benefits of medications. It is naive to expect companies to voluntarily fund studies that could sink lucrative products, the FDA lacks the regulatory clout to require them, and despite the $220 billion we spend on drugs each year, we apparently can't find the resources to provide public support for these studies, even if the results could be of great clinical importance and save millions of dollars. Although a large randomized trial would have provided a valid means of comparing aprotinin with other treatments, no such study has been undertaken on the necessary scale.

The study by Mangano et al. was observational — its subjects were not randomly assigned to the four study groups. Instead, the investigators reviewed numerous variables for each patient and used a propensity score and multivariable methods to adjust for underlying differences among the groups. Although this approach has important limitations, observational studies often provide the only data available for evaluating critical safety issues.

A confirmatory observational study would have lent key support to the conclusions of Mangano et al. — if its findings had been aired. Bayer has admitted that its suppression of the study was "a mistake," but this is not the first time the company has behaved in this manner. When Bayer was accused of hiding data unfavorable to its cholesterol-lowering drug cerivastatin (Baycol) before it was taken off the market in 2001, litigation uncovered a memorandum from a company executive arguing against performing a study of its risk. "If the FDA asks for bad news, we have to give," read the memo, "but if we don't have it, we can't give it to them."3

Other companies have behaved similarly. Although Merck steadfastly denied that Vioxx increased the risk of myocardial infarction while the drug was on the market, it commissioned two epidemiologic studies of the relationship. My colleagues and I performed one of the studies, but when it confirmed an increased risk, Merck dismissed the findings and assailed the methods that it had previously accepted.4 The second study (by the same contract research group involved in the aprotinin affair) also confirmed the association, but its results were not made public until after the drug had been withdrawn from the market.

The problem is not limited to observational studies. A few years ago, it was discovered that some companies had funded multiple clinical trials of their selective serotonin-reuptake inhibitor antidepressants but reported the results of only the favorable trials — distorting the evidence base physicians use in choosing drugs. But the issue is thornier for epidemiologic analyses. Companies can conduct them secretly, even in-house, with the use of a purchased proprietary database, making the results even easier to conceal.

Carefully performed observational studies may provide the best information available about side effects, but propensity scores and other multivariable techniques applied to epidemiologic research cannot always control for all the inevitable selection bias, making the transparency of methods and raw data even more important than in randomized trials. Rather than yielding "virtual randomized trials," the methods available for controlling confounding in observational research can sometimes look better than they work.5 Thus, these studies can inform our understanding only after their methods have been scrutinized closely, fairly, and objectively — but only if the data are available.

On September 30, 1982, six people in the Chicago area died after taking acetaminophen (Tylenol) that had been laced with cyanide. The tragedy riveted the country's attention for months. We should be able to muster at least a fraction of that concern to address more clinically relevant adverse drug effects that could sicken or kill thousands of patients. How can we capture such interest in less sensational problems of medication safety? A good start would be to make a national commitment to publicly supported studies of drug risks so that no company could take possession of critical findings for its own purposes. The results of that research could be discussed openly at an annual conference on the risks and benefits of drugs. To keep everyone's attention focused on medication safety, perhaps the conference could be held every year on September 30.

Source Information Dr. Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital— both in Boston.

An interview with Dr. Avorn can be heard at www.nejm.org.

References

1. Statement on aprotinin. Rockville, MD: Food and Drug Administration, December 30, 1993. (Accessed November 2, 2006, at http://www.fda.gov/bbs/topics/NEWS/NEW00453.html.) 2. Mangano DT, Tudor IC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006;354:353-365. 3. Berenson A. Trial lawyers are now focusing on lawsuits against drug makers. New York Times. May 18, 2003. 4. Burton TM. Merck takes author's name off Vioxx study. Wall Street Journal. May 18, 2004. 5. Sturmer T, Schneeweiss S, Brookhart MA, Rothman KJ, Avorn J, Glynn RJ. Analytic strategies to adjust confounding using exposure propensity scores and disease risk scores. Am J Epidemiol 2005;161:891-898.

6. ~~~~~~~~~~~~~~~~~~~~~~~~ THE NEW ENGLAND JOURNAL OF MEDICICE

OBSERVATIONAL STUDIES OF DRUG SAFETY — APROTININ AND THE ABSENCE OF TRANSPARENCY William R. Hiatt, M.D.

The full safety profile of a new drug is rarely known at the time of approval by the Food and Drug Administration (FDA). Most drug-development programs designed for treatments of symptomatic indications are underpowered to detect any increased risk of rare drug reactions or change in background event rates attributable to the drug. Large, post-marketing, randomized, controlled trials provide robust data on drug safety but may be subject to multiple sources of bias. Observational studies of a drug's effects in clinical practice can offer additional information on risks. The recent discussions of aprotinin (Trasylol, Bayer) by the Cardiovascular and Renal Drugs Advisory Committee of the FDA, which I chair, provide insight into the strengths and weaknesses of using observational data to assess drug safety and highlight the importance of using a transparent and open process when reviewing such data.

Post-marketing observational studies permit the evaluation of drug safety in a large number of patients in a real-world setting, where practice patterns, including off-label use, can be assessed. Such studies have limited ability to determine causation, but they can detect signals that may suggest a safety concern.

In an observational study, decisions to use specific drugs are made by local physicians, according to their perceptions of the risks and benefits for particular patients. Such treatment allocation results in an imbalance in demographic and risk factors between patients given the drug of interest and those given an alternative or no treatment. An imbalance in various clinical factors will directly influence safety outcomes when patients at higher risk receive the drug. Therefore, appropriate statistical methods must be used to adjust for the nonrandom assignment to treatment groups.1

One way to address imbalances between groups is to use a propensity score that incorporates confounders and other covariates into a model predicting the probability of assignment to a particular treatment. This score can be used for adjustment or for matching patients who have similar probabilities of receiving a treatment. Differences in outcomes between treated and untreated patients (or patients treated with a comparison drug) with equal propensity scores provide a less biased estimate of treatment effect.

Aprotinin was approved by the FDA in 1993 as a means of reducing perioperative blood loss and the need for blood transfusion in patients undergoing coronary-artery bypass grafting. Neither the clinical trial database that led to approval nor the numerous randomized, controlled trials conducted after approval identified an association between aprotinin and any short-term increase in the risk of death or nonfatal cardiovascular events or any serious renal toxic effects (except for a transient increase in the serum creatinine concentration). However, in early 2006, two observational studies were published that raised serious concerns about the drug's safety.2 ,3

One study, by Mangano et al.,2 evaluated 4374 patients undergoing coronary-artery bypass surgery. End points were prospectively defined, and data on a large number of clinical variables were collected for each patient. The decision to use aprotinin, aminocaproic acid, or tranexamic acid to inhibit fibrinolysis or to withhold antifibrinolytic therapy was made by the treating physician. Since group assignment was not random, it is not surprising that patients assigned to the group receiving aprotinin were at much higher risk for adverse cardiovascular outcomes than were the other patients in the study, who were treated with alternative therapies. When a propensity score was used in a logistic-regression model to adjust for these baseline differences, aprotinin was associated with a nonsignificant increase in the risk of death (odds ratio, 1.59; 95% confidence interval [CI], 0.76 to 3.34) and with significant increases in the risks of renal events (odds ratio, 2.34; 95% CI, 1.27 to 4.31), cardiovascular events (odds ratio, 1.42; 95% CI, 1.09 to 1.86), and cerebrovascular events (odds ratio, 2.15; 95% CI, 1.14 to 4.06). The authors concluded that "the observed association between aprotinin and serious end-organ damage indicates that continued use is not prudent."

The second study, by Karkouti et al.,3 compared the risks associated with aprotinin with those associated with tranexamic acid in 898 patients undergoing high-risk cardiac surgery. The authors used a propensity score to match patients who had been given the different treatments — an approach that permitted the identification of a population of patients who were subsequently fully matched according to a large number of covariates. Calculations from the study data, performed by the Colorado Prevention Center, indicated no significant difference between the two treatments in the overall risk of myocardial infarction (odds ratio, 1.20; 95% CI, 0.52 to 2.75), stroke (odds ratio, 1.15; 95% CI, 0.56 to 2.40), or death (odds ratio, 0.91; 95% CI, 0.56 to 1.46). However, among patients who had abnormal renal function at baseline, those given aprotinin had a significantly increased risk of postoperative renal dysfunction (odds ratio, 1.69; 95% CI, 1.07 to 2.69). Because this study included fewer patients than the study by Mangano et al., it had less power to detect a safety problem.

These observational studies did not permit a definitive conclusion about cardiovascular or renal risk, but they did raise concern. The FDA appropriately issued a public health advisory about the potential risks posed by aprotinin and urged physicians to monitor their patients carefully for renal, cardiac, and cerebral toxic effects.4 The agency also convened a meeting of the Cardiovascular and Renal Drugs Advisory Committee on September 21, 2006, to evaluate the evidence on the cardiovascular and renal toxic effects of aprotinin. Our committee reviewed the published studies and the global safety and efficacy database submitted by Bayer, which included 45 randomized, controlled trials involving 2249 patients who received aprotinin and 2164 who received placebo. The Bayer safety analysis was confined to the unadjudicated adverse events reported within 7 days after the administration of aprotinin, which included 520 deaths or serious cardiovascular or renal events. The results did not reveal any increased risk of fatal or nonfatal cardiovascular events. According to the Colorado Prevention Center's calculations based on Bayer's data, the odds ratio for death was 1.14 (95% CI, 0.80 to 1.62); for myocardial infarction, 1.17 (95% CI, 0.93 to 1.49); for stroke, 0.71 (95% CI, 0.42 to 1.18); and for renal failure, 1.15 (95% CI, 0.74 to 1.78). Two studies in which myocardial infarctions were adjudicated by an independent review committee showed a nonsignificant increase in the risk of myocardial infarction, with a point estimate of the odds ratio as high as 2.24 (95% CI, 0.56 to 9.00).

How can the results of these trials and the study by Karkouti et al. appear to be so different from the findings of Mangano et al.? Part of the problem may derive from the inability of observational studies to identify and measure all relevant covariates that may influence the outcome; similar studies using a few different covariates can sometimes come to opposite conclusions. FDA advisory committee meetings usually include an independent review of data — either those provided by the sponsor or those used by the authors of relevant published studies. This independent and transparent process becomes even more critical in the evaluation of observational studies, whose conclusions can be highly influenced by the statistical methods used and the inability to identify all confounding factors. Unfortunately, Mangano did not give the FDA or the committee full access to his data, which would have allowed the agency to perform an independent review and analysis to validate his group's findings. Although there are many legitimate concerns with regard to the sharing of data (for instance, confidentiality and the need for informed consent), the lack of independent review greatly limited the committee's ability to draw conclusions from the study. Having reviewed all the data available, the committee decided that there was insufficient evidence to require an additional warning on aprotinin's labeling and agreed that the clinical data supported an acceptable safety and efficacy profile for aprotinin.

Days after the committee meeting, the FDA was made aware of additional observational data from the sponsor that had not been presented at the meeting. Bayer evidently had commissioned an observational study involving 67,000 patients who were given aprotinin.5 According to the initial FDA review of data from that study, aprotinin may be associated with "increased risk for death, kidney failure, congestive heart failure and stroke." The failure of Bayer to disclose all its data on aprotinin seriously undermined the advisory committee process and hindered the safety review.

Although observational studies cannot be definitive (and so should evoke measured responses), they can provide important new safety information that can direct further scientific and regulatory actions — if their findings can be confirmed. Since further analysis of the new data provided by Bayer is ongoing at the FDA, conclusions about the overall safety of aprotinin cannot be drawn at this time. Still, the aprotinin story demonstrates that full disclosure and a transparent process are essential in evaluating the findings of all studies germane to drug safety and the public health.

Source Information Dr. Hiatt is a professor of medicine at the University of Colorado School of Medicine and president of the Colorado Prevention Center — both in Denver — and is the current chair of the Cardiovascular and Renal Drugs Advisory Committee of the FDA. Opinions expressed in this article are those of the author and do not necessarily reflect the opinions of the FDA or the advisory committee. References

1. Rubin DB. Estimating causal effects from large data sets using propensity scores. Ann Intern Med 1997;127:757-763.

2. Mangano DT, Tudor IC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006;354:353-365.

3. Karkouti K, Beattie WS, Dattilo KM, et al. A propensity score case-control comparison of aprotinin and tranexamic acid in high-transfusion-risk cardiac surgery. Transfusion 2006;46:327-338.

4. Food and Drug Administration. Public health advisory: aprotinin injection (marketed as Trasylol). Updated September 29, 2006. (Accessed November 2, 2006, at http://www.fda.gov/cder/drug/advisory/aprotinin.htm.)

5. Idem. FDA statement regarding new Trasylol data. September 29, 2006. (Accessed November 2, 2006, at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01472.html.)

Related Letters:

Judging the Safety of Aprotinin

Mangano D. T., Rieves R. D., Weiss K. D.

N Engl J Med 2006; 355:2261-2262, Nov 23, 2006. Correspondence

This article has been cited by other articles:

* Mangano, D. T., Rieves, R. D., Weiss, K. D. (2006). Judging the Safety of Aprotinin. NEJM 355: 2261-2262

* Drazen, J. M. (2006). Research Replication. NEJM 355: 2252-2253

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

Comment

Dear World Can't Wait Supporter,

World can't Wait. org

Dear World Can't Wait Supporter,

Washington, DC, 1/4/07: As the new Democratic majority started its first day in Congress, with no plans to end the war, repeal the Military Commissions Act or Patriot Act, and numerous declarations that "impeachment is off the table", real opposition to the Bush regime took place outside the Capitol building.

Close to 400 people rallied outside in a protest demanding "BUSH MUST GO: If war crimes, torture, and crimes against humanity are not reason to impeach, what is?" The rally put a clear demand before the new Congress and a challenge to the American people: that the Bush regime cannot be allowed to stay in office and commit further crimes.

An evening program at the National Press Club entitled "Voices for Impeachment" featuring Daniel Ellsberg, Cindy Sheehan, John Nichols, Michael Ratner & Sunsara Taylor, to a disruption of Rham Emanuel's press conference on "ethics reform" by anti-war protesters, hundreds of people made clear their determination not to sit by and allow the Bush regime to continue its crimes with the complicity of Congress.

TORTURE + SILENCE = COMPLICITY Thursday January 11th Actions

The Bush regime has codified torture. Inhumane treatment of prisorners at Abu Ghraib and the secret renditions have been written into law. The president of the United States has the sole authority to decide what torture is. The basic and fundamental right of Habeas Corpus has been officially shredded. People can now be declared an "unlawful enemy combatant" simply for providing what the president decides is "material," including financial or indirect support for hostilities against the U.S.

The government has dramatically expanded the scope of who it can detain to include people anywhere in the world, including within the U.S. For the last five years the US government has been holding thousands of people at the Guantanamo Bay US prison camp without charges.

This unprecedented legalization of torture, designating people as 'enemy combatants,' and the continuing presence of Guantanamo Bay Prison camp is part of a package coming from the Bush regime including a nightmarish occupation of Iraq and now the ominous threat of war against Iran.

On January 11, 2007 marks the fifth year when the detainees from around the world have been in Guantanamo. World Can't Wait joins organizations all over the world to call for Guantanamo to be closed.

Shut Down Guantanamo! No torture!

Events for January 11th are being held in many cities around the country. Please visit http://www.witnesstorture.org to link up with the planned activities.

Order orange jumpsuits and "Torture + Silence = Complicity" bumper stickers on the online store.

TORTURE + SILENCE = COMPLICITY Thursday January 11th Actions

The Bush regime has codified torture. Inhumane treatment of prisorners at Abu Ghraib and the secret renditions have been written into law. The president of the United States has the sole authority to decide what torture is. The basic and fundamental right of Habeas Corpus has been officially shredded. People can now be declared an "unlawful enemy combatant" simply for providing what the president decides is "material," including financial or indirect support for hostilities against the U.S.

The government has dramatically expanded the scope of who it can detain to include people anywhere in the world, including within the U.S. For the last five years the US government has been holding thousands of people at the Guantanamo Bay US prison camp without charges.

This unprecedented legalization of torture, designating people as 'enemy combatants,' and the continuing presence of Guantanamo Bay Prison camp is part of a package coming from the Bush regime including a nightmarish occupation of Iraq and now the ominous threat of war against Iran.

On January 11, 2007 marks the fifth year when the detainees from around the world have been in Guantanamo. World Can't Wait joins organizations all over the world to call for Guantanamo to be closed.

Shut Down Guantanamo! No torture!

Events for January 11th are being held in many cities around the country. Please visit http://www.witnesstorture.org to link up with the planned activities.

Order orange jumpsuits and "Torture + Silence = Complicity" bumper stickers on the online store.

<Comment

Meet the Ground Wave Emergency Network(GWEN)

LINK

The Ground-Wave Emergency Network (GWEN) System

{Editor's Note: GWEN towers are popping up everywhere in America; rural, hilltops, mountain areas, suburbs, and cities. The cover story is that they're supposed to be used for cell phone communications, but as this article reveals, Big Brother has something far more insidious in mind. ..Ken Adachi]

Forward by Byron Weeks Written by Val Valerian

The Ground-Wave Emergency Network (GWEN) is a communications system that the military is in the process of constructing as we speak. It operates in the very-low-frequency (VLF) range, with transmissions between 150 and 175 kHz. This range was selected because its signals travel by means of waves that have a tendency to hug the ground rather than by radiating into the atmosphere. This signal drops off sharply with distance - a single GWEN stations transmits in a 360 circle to a distance of 250 to 300 miles. The entire GWEN system consists of approximately 300 such stations spread across the United States, each with a tower 300-500 feet high. The stations are from 200 to 250 miles apart, so that a signal can go from coast to coast from one station to another. When the system is completed around 1993, the entire civilian population of the United States will be exposed to the GWEN Transmissions. Read Appendix 4 and then re-read this section.

I. APPLICATION OF MILITARY FREQUENCY WEAPONRY

According to a 1982 Air Force review of biotechnology, ELF has a number of potential military uses, including "dealing with terrorist groups, crowd control, controlling breaches of security at military installations, and antipersonnel techniques in tactical warfare." The same report states:

"Electromagnetic systems would be used to produce mild to severe physiological disruption or perceptual dis- tortion or disorientation. They are silent, and counter- measures to them may be difficult to develop."

Between 1980 and 1984 I was in England, and I got to see some illustrations of how some of this technology actually works. During this period, there were a lot of protests, sit-ins and demonstrations by Greenpeace and many other groups against the deployment of Cruise missiles, especially at Greenham Common, which was south of where I was located. In 1983 and 1984 there was a very large presence of military police at the base when the Cruise missiles arrived. Around mid-1984 this presence diminished considerably, and some of the protesters who were outside the base started claiming that they were being irradiated from the base because of physical problems they were unable to link to any other source. This was reported in Electronics Todsy magazine in 1985. The symptoms ranged from skin burns to headaches, drowsiness, menstrual bleeding at abnormal times, bouts of temporary paralysis, faulty speech coordination, and in one case circulatory failure severe enough to require hospitalization. Such a complex series of symptoms fits well with severe EM field exposure. The Ministry Of Defence (MOD) denied that any harmful electromagnetic signal was being used against the women, but did not deny that an electromagnetic signal may be in use which, if below lOmW/cm2, would not, under UK guidelines, be officially acknowledged as harmful. In other words, they lied.

Cases of Deliberate Experimentation on Individuals for Military Purposes In one study over 100 Washington and Oregon state prisoners (recall the discussion of Phase II drug testing in Chapter 5) between 1963 and 1971 had their testicles dosed with radiation to discover what doses would sterilize them. The project was funded by the Atomic Energy Commission at a cost of $1.5 million.

From 1945 to 1947, 18 hospital patients, one of them only five years old, were injected with plutonium to measure how much the body would retain. The injections were represented as "experimental treatments" for the patients' illnesses. This appalling scheme was reviewed in the British Medical Journal in 1987, where it said that the "redeeming feature of the test was that the results were made available to other countries for their use."

II. ADVANCED MIND CONTROL APPLICATIONS

Cross-Referencing

By now you have acquired quite a bit of background knowledg e - it is knowledge that you will need to draw upon to properly understand and evaluate the information in this second section of Chapter 7.

The Psvchology Behind Mind Control and Psychic Warfare

Body identification gives rise to a host of sociological phenomena, the least of which is the mechanistic view that consciousness is a product of the brain, and secondarily that the mind is centered in the brain. Dr. Jose Delgado was one of the chief proponents of this viewpoint. Delgado was the author of the book "Physical Control of the Mind: Toward a Psychocivilized Society". For Delgado, the mind existed only in the brain; to postulate its existence as an independent entity was to him sheer nonsense. He rejected the concept of free will, and proposed that the mind was a functional entity produced by the electrical operations of the brain, and as such should be manipulated and controlled in order to control the behavior of the population. This was a view that seems to be shared by proponents of the New World Order. Delgado, since the mid-1970's, was the director of the Spanish neurophysio- logical laboratory Centro Ramony Cajal. As time went on, his interests shifted from direct stimulation of the brain to the broader area of the biological effects of electromagnetic fields, an area that has been eagerly embraced by the military and political system as a means to achieve their goal of absolute control of the population.

There are several psychological schools of thought that have been adopted by government psycho-scientists and the military to justify mind control. All of them relate to the idea of psychic energy as originating in the human psyche, typified by the work of Carl Jung. The energy originating in the human psyche consists of thoughts, feelings, emotions, and neuro-physiological stimuli and responses. It consists of a physical component that can be measured and an etheric hyper- spacial component that can only be measured by specialized equipment. These schools of thought are as follows:

Suppression of Vital Data in Physics For thousands of years, many discoveries have been suppressed from the populations of the planet in order to keep them in bondage. The burning of the libraries of Alexandria is one example of how information can be suppressed. Another example would be the common technique of suppression of scientific information by alteration of the information itself. Perhaps the most blatant and far reaching alteration of data was the alteration of Maxwell's equations. James Clerk Maxwell was a mathematical genius who lived in the late l9th century. His original work, which is available to covert scientific departments in the government, had the potential to radically alter the entire course of our civilization.

It is certainly clear to most of you by now that the human population can easily manipulated by electronic means using various methods Developed through the military industrial complex. What may not be clear to you is that many of the EM effects can be initiated from outside of what is normally seen as the electromagnetic spectrum. Just as a magnetic field in a wire is at right angles to the current flow, other fields and waveforms exist that are an integral part of the electromagnetic spectrum, yet exist at a certain number of right-angle rotations (orthogonal rotations) away from the electromagnetic field components we are normally accustomed to. If these hyperspacial components, which are not subject to the usual electromagnetic constraints of time and space, are generated and manipulated, they can in turn generate EM effects that have the capability to influence human biology and consciousness.

Let's take a brief look at how and by whom the equations of Maxwell were changed, in order to make subsequent open scientific development that would have influenced civilization in a positive way, impossible:

The Hertzian Conspiracy

In late 1864, James Clerk Maxwell published his epic material on electromagnetic waves. His material dealt not only with electrical and magnetic waves, but also the relativistic/ etherial psycho-active component of these waves (representing electromagnetics of the second order and above). The equations also included transformations that enabled the change from inertial frames of reference to non-inertial frames of reference. Maxwell's original equations were written in Quaternion notation, a complex mathematical system available at that time before Vector Analysis was introduced by Oliver Heaviside. Today's generalized equivalent of Quaternions is Tensors.

In short, Maxwell's original work gave the necessary information for gravitational propulsion and psychoactive devices. Someone somewhere recognized this, for shortly after his death, the mathematician Oliver Heaviside, the chemist Willard Gibbs, and physicist Heinrich Hertz decided to "edit" or "interpret" Maxwells famous equations which were, in the original form, the foundations of electromagnetics and Unified Field Theory (UFT). This "unholy trio, especially Heaviside, disregarded the Quaternions or Scalar components of Maxwells original equations, because they represented potentials and not fields. He thought potentials were akin to "mysticism", because "everybody knows that fields contain mass, and mass cannot be created from apparently nothing, which is what potentials are, both literally and mathematically; they are an accumulation or reservoir of energy. Furthermore, not only did they throw away the gravitational component with the Quatern- ion/Scalar, but also postulated that gravitation and electro- magnetism were mutually exclusive, not interdependent. That was the death blow to subsequent efforts by scientists to realize a functioning unified field theory. Because of this one act, electromagnetism was reduced from its original five dimensions to only four: X, Y, Z, and time. The element of G was removed.

Because of this deliberate act, twenty-two other errors exist today in electromagnetic theory. The very concepts of force, mass and charge are ill-defined, and the so-called "static" electrical charge has been discovered by Quantum mechanics not to be static at all, but to move rotationally by virtue of the quantum mechanical spin. Finally, adding insult to injury, the so-called "imaginary components" of Maxwells original equations as well as the mutilated version of the equations have also been discarded or ignored. With this last error, the door to hyperspacial domains was forever closed, for the present mathematics and physics of electromagnetic theory do not allow for hyperspacial domains (domains out- side of three dimensions), superluminal signals (signals that exceed the speed of light or are infinite in speed), and a unified field theory.

The edited version of Maxwells work, which every physicist and engineer has had to contend with, discards electrogravitation, and avoids the unification of gravitation and electromagnetics. It also prevents the direct engineering of gravitation, space-time, time flow rates, free energy devices, and quantum changes, which is viewed by the altered equations that are vector-based as only a statistical change. The quaternion approach captures the ability to utilize electromagnetics and produce local curvature of spacetime. Heaviside wrote a subset of Maxwell's equations where this capability is excluded.

Dr. Henry Monteith has independently discovered that Maxwell's original quaternion theory was a unified field theory. Einstein assumed, because he only had access to the altered equations, that curving spacetime could only be achieved by the weak gravitational force due to mass, that the local frame would always be a Lorentz frame, which would mean that all operations would be constrained to conservation laws of physics."

In the 1960's the Hertz (Hz) replaced Cycles Per Second. Since, then everyone thinks that all electromagnetic waves are hertzian. Only the upper portion of the spectrum before Infra- red contains Hertzian waves. ELF and ULF are not; waves in biosystems and natural phenomena are not Hertzian in nature.

comment on this