Lynne Born is a longtime alternative health care activist, writer and independent medical researcher.
The Bush administrations policies in the "war on terror" are substantially enriching the pharmaceutical corporations while subjecting the public to dangerously explosive consequences. The pharmaceutical industry spent over $262 million to bring George W. Bush to power during the 2000 election cycle, investing more than any other industry to solidify their power in both Congress and the White House.1 The pharmaceuticals have recouped their investment many times over as Bush has signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and Project BioShield, 2 providing over $7 billion to develop and warehouse millions of doses of new vaccines and drugs as "countermeasures" to biological weapons such as ebola, plague, anthrax and smallpox.
These new drugs and vaccines are exempt from the regular approval process and can be fast tracked to market with no human testing at all,3 an unprecedented step for an industry already responsible for hundreds of thousands of deaths per year. The fact that the current system that produces "standard" pharmaceutical drugs is the third leading cause of death in the United States has been completely overlooked in the rush to bring the pharmaceutical industry into the biowarfare business.4
While the drug companies would like us to believe that these deaths are the unfortunate side effects of a careful and caring industry, they are actually the direct result of the ways in which pharmaceuticals manipulate drug trials and skew research data to produce the positive efficacy and safety results they need to bring new products to market. Building a new class of drugs and vaccines on the foundation of the current flawed and corrupt system, combined with the fact that the pharmaceuticals will be working with ever more infectious and lethal biowarfare agents, has the potential to "fast track" the creation of catastrophic epidemics of the very diseases they are attempting to prevent.
Pharmaceuticals profit from the Homeland Security Act
While the bioterrorism laws provide a new and guaranteed income stream to the pharmaceuticals, Bushs Homeland Security Act of 2002 completes the giveaway by making any bioterror countermeasures mandatory for the entire population of the United States at the sole discretion of the president or the secretary of health and human services.5 In combination with state laws titled Model Emergency Health Powers Act (MEHPA), the government is authorized to quarantine, isolate, imprison or fine anyone who refuses to take these untested drugs and vaccines.6 Detailed plans have already been drawn up by the Pentagon and Department of Defense to use the military to enforce these compulsory injections and medical treatments,7 and state public health departments have used portions of their bioterrorism budget to identify large sites such as stadiums, malls and cinemas to hold mass vaccinations.8
Despite the creation of a massive new market paid for with guaranteed government subsidies and exempt from the usual approval process, the pharmaceuticals pushed for and received even more special treatment. The Homeland Security Act provides full liability protection for the vaccine manufacturers in the first pilot program to be sponsored by Bush under the legislation, the smallpox vaccination program. This liability protection was clearly needed, as the vaccine has caused a vastly higher rate of death and injury than was officially anticipated. But with blanket liability protection, what incentives remain for the pharmaceuticals to develop biowarfare drugs and vaccines that are safe for human use?
Dangers of "standard" pharmaceutical drugs
The pharmaceutical industry already kills well over 100,000 people every year from correctly prescribed drugs in hospitals alone.9 This does not include deaths occurring outside the hospital or from incorrectly prescribed medications, or the millions of disabilities each year. To further put this in perspective, the death rate from illegal drugs is 20,000 per year; the initial death rate from the Union Carbide chemical disaster in Bhopal, India was 20,000; and 58,000 Americans died in the Vietnam War.
Contrary to what most people believe, drug companies, not the Food and Drug Administration (FDA) or independent researchers, finance and control virtually the entire process of testing and bringing new drugs to market. Because pharmaceutical companies finance the vast majority of all drug trials, they design and structure the studies, select and pay researchers, choose the patients, analyze the test results, closely oversee the writing and publication of the final studies and release the drugs through their massive sales network to the medical profession. No independent source confirms or oversees the research, analysis or final conclusions.10
The subjects of drug trials are generally young healthy men, even though the target market for the drug may be women, children or the elderly. Many of the paid subjects are "regulars" who supplement their income by hiding their participation in multiple drug trials when not enough time has passed for the previous drugs to fully leave their systems. The fraud begins at the onset of the drug trial, as drug companies will frequently drop large numbers of subjects who show what the industry classifies as a "sensitivity" or "bad reaction" to the drug. In other words, test subjects who experience exactly the kind of toxic reaction the trial is supposed to be tracking are dropped from the results simply because it occurs early in the trial.
Drugs are frequently tested on much smaller numbers of people and for shorter periods than is generally thought. Psychiatric drug trials typically last only four to six weeks, and no psychiatric drug has ever been shown (i.e., tested) to be safe for long-term use. In many drug trials, only one or two dozen subjects actually finish the trial. Doctors who regularly prescribe Prozac believed that the drug had been tested on more than 10,000 patients before they prescribed it to their patients, a figure they had read in Eli Lilly marketing material. In fact, Dr. Peter Breggin went to great lengths to count the actual number of patients who had completed the trials and found the total number to be 286, a far cry from the thousands that the public had been led to believe.11
While most people believe that a drug that gains FDA approval has gone through many successful drug trials that have proven it to be substantially more effective than the placebo, in fact the entire drug trial system works on a simple "pass/fail" basis. When the company submits the trial results to the FDA and the FDA finds the drug insufficient or even harmful and rejects it, the company can simply drop and manipulate portions of data from the very same trial, submitting different permutations of the numbers over and over again until the FDA finally accepts the drug. It takes only two successful trials, even with small numbers of patients, and includes trials that had been previously rejected by the FDA but later passed with reworked numbers, for the FDA to approve a drug. And the drug does not have to show a substantial benefit over the placebo, only that it is "marginally" better than the placebo.12
Drug companies also systematically obscure adverse drug reactions and even deaths that occur during the trials by simply deleting or mislabeling them in the data submitted to the FDA. Suicides that occurred during the testing of Prozac were systematically mislabeled as "no drug effect" or "depression," so that when the FDA examined the drug data, patient suicides could not be found and counted.13 Suicide was one of the first major problems encountered when Prozac was released on the market, leading to multiple deaths and lawsuits. Most of the very symptoms fueling the current debate about the dangers of anti-depressant drugs were known and documented by the drug companies during the trials, but the drugs were released anyway.
Manipulating research results
Until 1991, 80 percent of drug testing was done by medical university research departments, giving the pharmaceutical companies "brand names" such as Harvard or Stanford Medical School to associate with their research data. Since the 1990s, however, the pharmaceutical companies are cutting costs by using commercial for-profit centers to perform the majority of all drug testing.
It is well documented that if for-profit centers do not produce positive results for pharmaceutical companies, the drug companies take their lucrative contracts to another of the hundreds of competing centers. An analysis of 70 studies of specific cardiac drugs showed that 96 percent of authors with ties to the pharmaceutical company produced favorable results, while only 37 percent of independently funded studies of the same drugs showed favorable results.14 Additionally, many of these centers have been found to have financial stakes in the outcome of their own trials, standing to benefit financially from a drugs approval and subsequent marketing. Many have been sued for deaths and injuries that occurred during fraudulently structured drug trials after producing poor quality data and using inadequately trained investigators to test drugs on subjects who were not informed of the drugs known dangers or told of the financial conflicts of interest.15
Drug companies retain the right to stop the publication of any study that does not show favorable results, including studies that show dangerous or deadly reactions. Should a company-funded study show negative results, drug companies have been known to delay the publication of the negative study, quickly fund a new study that produces a favorable response and then publish only the positive results.16 Dr. James O. Kahn conducted a study that concluded an AIDS vaccine didnt work and had a multimillion dollar lawsuit initiated against him by the corporate funder of the study after it tried unsuccessfully to block publication of the data.17 And since both negative drug data studies and information on the frequency of these heavy-handed tactics are suppressed, we have no way of knowing how many drug studies with negative results have been censored by the very pharmaceutical companies that sponsored them in the first place, even if the drugs release ends up causing multiple injuries and deaths.
Adverse reaction reporting system designed to fail
Most people dont know that the release of a new drug is actually the final phase of the drug trialPhase IV. After the drug has been approved by the FDA, thousands and even millions of patients taking the newly released drug are unknowingly participating in the largest, most poorly controlled medical experiment in the world.
The fraudulent and deceptive practices of the pharmaceuticals continue during Phase IV when adverse reactions of injury and death are supposed to be tracked and reported to determine if the drug should be pulled from the market. However, not only is the adverse reporting system entirely voluntary, but 9099 percent of all adverse reactions are never reported, according to the head of the FDA for most of the 1990s, David Kessler.18 Imagine the true death rate if this fact were taken into account. Forty percent of all doctors dont know that an adverse reporting system even exists. When a group of doctors was studied to determine how many adverse reactions they reported, it was found that only 6 percent of all reactions were reportedand these doctors knew that their rate of reporting adverse reactions was being monitored. And no program or oversight of any kind exists to ensure that reports made directly to the pharmaceutical companies are then reported to the FDAthe process is run entirely on the "honor system."
On the rare occasions when adverse reactions are reported, as much as 50 percent of the basic information, such age or sex, is simply left blank. Additionally, the reporting system is divided into thousands of highly delineated classifications, such as "insomnia," "restlessness," "hyperactivity"160 different terms exist for central nervous system symptoms alone. While it may be good science to have a record of all the various gradations of side effects, this system artificially lowers the percentage of side effect occurrences so the FDA or drug company can say that "less than 1 percent" suffer from any given symptom, making the probability of side effects seem very small. A more accurate use of the classifications would be to tally related symptoms in a family of side effects, for example, adding together "insomnia, restlessness and hyperactivity" for a total percentage of nervous system side effects that would result in higher but more accurate numbers. Eli Lilly classified sexual side effects for Prozac as "decreased libido 1.6 percent, ejaculatory problems 1.9 percent, impotence 1.7 percent," etc., but if you add the numbers of sexual side effects together, the total is closer to 18 percent, a vastly higher number. However, even those numbers are inaccurate, as subsequent studies of Prozac have shown the real percentage of sexual side effects is between 50 and 70 percent of all users.19
Although the number of dangerous effects and deaths are vastly underreported by the drug companies, people notice the problems and stop taking their medications. Fifty to 75 percent of patients quit taking their blood-pressure and cholesterol-lowering medications within one to two years, but the FDA and drug companies keep no record of the vast numbers of patients who drop their medications due to adverse effects.
Marketing department controls drug recalls
These problems are built into the system itself, as the pharmaceutical companies have used their considerable financial muscle to defang the FDA through their powerful congressional lobby, reducing its role to a minimum. Because it works on an honor system, the FDA simply assumes that the drug companies are giving it accurate information. The FDA reviews only a small sample of data, asks a few questions, rarely checks the original data from the trials, accepts the drug label as written verbatim by drug company executives, rarely issues warnings of dangerous effects and has to be bullied and pushed by consumer groups into pulling a drug off the market, even after multiple deaths have already occurred.
The obvious conclusion is that because drugs involve the health and welfare of the public, reporting and tracking adverse drug reactions should be mandatory and all data from the drug trials open to public scrutiny. Currently, only the laborious process of a Freedom of Information Act request will open the drug trial data to the public. Even then, much of the information on adverse reactions or deaths is blacked out by the drug companies as "proprietary trade secrets."
In a profound conflict of interest, as the marketing department attempts to bring sales of a new drug to "blockbuster" status for potential billions of dollars per year, this same marketing department is responsible for tracking and reporting any evidence of harm or death that would take their multimillion-dollar investment off the market. Clearly, this is a system designed to fail with no incentive for change, since the end result has been to produce massive profits for the pharmaceuticals, even at the expense of our lives.
Homeland Security: forced vaccinations and drugs
The existing dangers of standard pharmaceutical medicines can only increase exponentially with the lack of human testing and fast track approval of the newly created class of bioterror drugs and vaccines. Bushs Homeland Security Act allows any untested drug and vaccine to be forced on the public, making refusal a crime. Along with the MEHPA laws20 and already existing public health laws, the government is then authorized to enforce the quarantine of individuals and entire cities, confiscate property from anyone who resists and take control of roads into and out of your city and state, in case anyone might try to leave town to avoid being medicated or vaccinated. The government can also confiscate all communication devices such as telephones or computers, and can seize your house, car, food, clothing and firearms.
The military is authorized to enforce the law, presumably holding down anyone who resists vaccination and escorting resisters or those too ill to take the shots to jail or the quarantine area for isolation, with the length of time to be determined by the state. An "actual" event of bioterrorism isnt even necessary; a "potential" emergency will suffice, and the power to declare this emergency resides entirely with the secretary of health and human services and the president.
Bushs smallpox debacle
The first program deployed through the draconian Homeland Security Act was Bushs smallpox vaccination program. While not mandatory for civilians, vaccination was mandatory for military personnel under threat of court martial, dishonorable discharge or jail. With great fanfare, Bush announced that 500,000 health-care workers would be vaccinated beginning in January 2003, to be followed shortly by 10 million emergency personnel. Right from the start, hundreds of hospitals and health-care unions across the nation refused to participate, citing concerns about adverse effects and compensation problems. By summer 2003, the program had ground to a halt. Numerous states had suspended it due to the high number of deaths and injuries and a lack of volunteers willing to subject themselves to the very real danger of the vaccine with no credible threat of an actual smallpox attack.
While the public was repeatedly told that the expected death rate from the vaccine would be one to two per million, in fact, there have been three deaths among the approximately 36,000 civilians vaccinated (including the few hundred embedded reporters). This makes the actual death rate 80 times higher than what the Centers for Disease Control and Prevention (CDC) told the public to expect. Serious adverse reactions such as brain swelling, heart inflammation, heart attacks, uncontrolled ulceration of the skin and more, are one in 583, seven times higher than the CDCs original guesstimate of one in 4,000. It is virtually certain that even these numbers are vastly underreported since, once again, the adverse reporting system for the program was not mandatory, mirroring the same shoddy and incomplete tracking system that benefits the pharmaceutical industry.
Before the program began, many health-care professionals expressed grave misgivings about reintroducing the live virus in the smallpox vaccine back into the population and accurately predicted the higher rates of death and injury. The National Institute of Allergy and Infectious Diseases has called the smallpox vaccine the most dangerous of all vaccines ever produced, because it contains a live virus of unknown origin. In fact, while the virus in the vaccine is supposed to be cowpox, even the CDC admits that it is not. Several independent labs have analyzed the vaccine and cannot identify the virus, a terrifying fact that is actually verified by the CDC while simultaneously ignored by mainstream medicine.21
Historically, the smallpox vaccine was responsible for so many side effects and deaths during its use that a medical diagnosis "Vaccination Disease" was actually created during the 1800s. Vaccination Disease was diagnosed when the vaccinated patient exhibited exactly the same kinds of skin, heart and lung problems that we see today in Bushs vaccination program. These historical facts are readily uncovered from 200 years of medical literature and were cited by the many voices expressing concern about reintroducing the smallpox vaccine into the public body before the program began.
Bush and the CDC continue to deny the extent of deaths and injuries even at the expense of peoples lives, and the media began to minimize and censor the actual death and injury rates only weeks after they occurred. As the deaths followed one after another in March and April 2003, headlines read "First death: Nurse dies after smallpox vaccination"; "Second worker dies of heart attack after smallpox vaccination"; and "Coroner rules [smallpox] vaccinations contributed to reservists death." Yet, by June 2003, mainstream media articles were not only ignoring the earlier deaths, they continue to use the old, inaccurate figure of one or two deaths per million rather than the newly updated, more truthful numbers.
Even if the program were to end, it is clear that the pharmaceutical industry and the White House have invested considerable political capital in the future of smallpox vaccinations. The first countermeasure, Project BioShield, calls for is the development of millions more doses of yet another smallpox vaccine. Mysteriously, the National Institutes of Health is also investing millions of dollars in eight to 10 additional treatments for smallpox itself, money that increases pharmaceutical profits at the expense of the real, pressing and urgent health-care needs the public faces today.
Bad drugs on steroids
The deadly manipulation and fraud so prevalent in the current pharmaceutical system could lead to explosive consequences when fewer safeguards, less testing and the intentionally fraudulent adverse tracking system are combined with the terrible power of deadly pathogens such as ebola, plague and anthrax. One of the many hazardous provisions of Project BioShield calls for a massive expansion of Americas biological and chemical warfare production by building a network of several dozen new bioweapons laboratories all over the United States. This would turn pharmaceuticals into bioweapons factories, but without the government oversight and safety regulations normally accorded these dangerous pathogens. Because the pharmaceuticals will have to create and store these infectious agents, it is the drug companies in partnership with the U.S. government that are endangering the public, and a groundswell of resistance from the cities where the new labs are to be built has already begun.22
It is an unfortunate fact that the pharmaceutical companies cannot protect us from chemical and biological warfare attacks. Any number of agents could be used, from simple small releases of readily available chemicals to complex, genetically engineered viruses against which no vaccine could ever be created and mass produced in time, even if the vaccines worked. The only effective way to reduce or end the threat of biological and chemical attacks against the United States is to develop "right relations" with other nations around the world by stopping Americas ceaseless march toward imperialist domination.
The next phase of the pharmaceutical "war on terror" will take place in the media and the minds of the public, where more and more "emerging diseases" will be sensationalized in an atmosphere of hysteria and fear, justifying the giveaway of billions of dollars to the drug companies. From the recommendation of the smallpox vaccine for the monkey pox outbreak when the vaccine has never been proven to stop monkey pox infection, or the quarantine of individuals who had only a cough and a mild fever out of fear of SARS, every new cough can be classified as a deadly disease, and every new fever will create fear of an unknown illness to move the public one step closer to acceptance of total vaccination or force feeding of drugs never before tested on humans.
For Bush to purchase millions of doses of a 30-year-old, untested, ineffective and deadly smallpox vaccine without even a threat of a smallpox attack, jeopardizing the lives of uninformed citizens, is a criminal act of biowarfare directed against the American public. Unfortunately, the next round of "protection from biowarfare agents" may not be voluntary, and the newly created pharmaceutical war machine will needlessly drug the American public to death for corporate profits.
1 Public Citizens Congress Watch, The Other Drug War: Big Pharmas 625 Washington Lobbyists (Washington, DC: Public Citizen, July 2001), p. i. The full report is available online at http://www.Citizen.org/congress/"campaign/"special_interest/reports_date/articles.cfm?ID=6537. The pharmaceutical industry spent $177 million on lobbying, $65 million on issue ads and $20 million on campaign contributions. Of the contributions directly to political parties, the majority (68 percent) went to Republicans.
2 The $5.6 billion for the Project BioShield was included in the Homeland Security Appropriations bill signed by Bush on October 1, 2003. See the http://www.whitehouse.gov press release of October 1, 2003.
3 Marc Kaufman, "FDA acts to speed bioterror medicines," Washington Post, May 31, 2002.
4 After a definitive review and close study of medical peer-review journals and government health statistics, these authors found that the American medical system is responsible for hundreds of thousands of deaths and millions of adverse events each year. By Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD, Debora Rasio MD, Dorothy Smith PhD, available online at http://www.mercola.com/2003/nov/26/death_by_medicine.htm.
5 "The secretary shall specify in such [bioterror emergency] declaration the substance or substances that shall be considered covered countermeasures. . ." Homeland Security Act of 2002, Section 304(c)(p)(2)(A)(ii).
6 Model Emergency Health Powers Act (commonly referred to as MEHPA). See Center for Public Law and the Publics Health for State Legislative Activity Table available online at http://www.publichealthlaw.net/Resources/"Modellaws.htm; see also http://www.909shot.com/ActionAlerts/"what_you_need_to_know.htm for updates on which states have passed these draconian laws.
7 Ellen M. Grossman, "U.S. officials mull a military role in enforcing smallpox quarantine," Inside the Pentagon, December 19, 2002; Pamela Hess, "Pentagon plans for smallpox outbreak," United Press International, December 13, 2002.
8 Michelle Hillman, "Smallpox program may be sick," Metro West Daily News, May 17, 2003.
9 Jason Lazarou, Bruce H. Pomeranz and Paul N. Corey, "Incidence of adverse drug reactions in hospitalized patients: A meta analysis of prospective studies," Journal of American Medical Association, April 15, 1998, 279(15): 120005. This study found more than 100,000 deaths per year and 2,000,000 severe side effects in U.S. hospitals alone. However, this study did not include deaths from pharmaceutical drugs that occur outside the hospital, or deaths from prescription errors by doctors or pharmacists. Additionally, because 9099 percent of all adverse drug reactions are never reported (see footnote 18), this figure should be adjusted substantially upwards.
10 Thomas Bodenheimer, "Uneasy allianceclinical investigators and the pharmaceutical industry," New England Journal of Medicine, May 18, 2000, 342(20):153944.
11 Dr. Peter Breggin, The Anti-Depressant Fact Book: What Your Doctor Wont Tell You About Prozac, Zoloft, Paxil, Celexa, and Luvox (Cambridge, Mass.: Perseus Publishing, 2001), p. 148.
12 Dr. David Ginsberg, The Investigators Guide to Clinical Research, CenterWatch, Inc.; 3rd edition (January 2002); Dr. Jay Cohen, Overdose, Jeremy P. Tarcher/Putnam (2001); Stephen Fried, Bitter Pills, Bantam (April 1998).
13 Breggin, p. 6.
14 Henry Thomas Stelfox, Grace Chua, Keith ORourke and Allan S. Detsky, "Conflict of interest in the debate over calcium-channel antagonists," New England Journal of Medicine, January 8, 1998, 338(2):10106.
15 Thomas Bodenheimer and Ronald Collins, "The ethical dilemmas of drugs, money, medicine," Seattle Times, March 15, 2001.
16 Bodenheimer, "Uneasy alliance."
17 Bodenheimer and Collins, "Ethical dilemmas."
18 David Kessler, " Introducing MedWatch: A new approach to reporting medication and device adverse effect and product problems," Journal of American Medical Association, July 2, 1993, 269(21): 276568.
19 M.J. Gitlin "Psychotropic medications and their effects on sexual function: diagnosis, biology and treatment approaches." Journal of Clinical Psychiatry, September 1994, 55(9):40613.; J.G. Modell, C.R. Katholi, J.D Modell and R.I DePalma, "Comparative sexual side effects of bupropion, fluoxetine, paraxetine and sertraline," Clinical Pharmacology and Therapeutics, April 1997, 61(4):47687; A.L. Montejo-Gonzalez, G. Llorca, J.A. Izquierdo, A. Ledesma, M. Bousona, A. Calcedo, J.L. Carrasco, J. Ciudad, E. Daniel, J. De la Gandara, et al; "SSRI-induced sexual dysfunction: fluoxetine, paroxetine, sertraline and fluvoxamine in a prospective, multicenter and descriptive clinical study of 344 patients," Journal of Sex and Marital Therapy, Fall 1997, 23(3):17694; "Dutch study attempts to quality sexual dysfunction profiles among SSRIs," Primary Psychiatry, 1997, 4(7):223; M.D. Waldinger, M.W. Hengeveld, A.H. Zwinderman and B. Oliver, "Effects of SSRI antidepressants on ejaculation: a double-blind, randomized, placebo-controlled study with fluoxetine, fluvoxamine, paroxetine, and sertraline," Journal of Clinical Psychopharmacology, August 1998, 18(4):27481; M.H. Pollack, S. Reiter and P. Hammerness, "Genitourinary and sexual adverse effects of psychotropic medication," International Journal of Psychiatry in Medicine, 1992, 22(4):305 27; K.J. Bender, "New antidepressants: a practical update," Psychiatric Times, February 1995, 12(1):2; and R.M. Hirschfeld, "Management of sexual side effects of antidepressant therapy," Journal of Clinical Psychiatry, 1999, 60 Suppl 14:2730, discussion 315.
20 See http://archive.aclu.org/issues/privacy/Model_health_feature.html for an analysis by the American Civil Liberties Union of the repressive MEHPA laws.
21 Jonathan B. Tucker, Scourge (Grove Press, New York, 2001), p. 37. "The vaccine strain being employed around the world was not cowpox virus that Jenner had used, but an entirely different orthopoxvirus that did not exist in nature and became known as "vaccinia." In 1939, Allan Downie of the University of Liverpool in England determined that vaccinia was genetically distinct from both variola and cowpox
. Where vaccinia virus had come from, and when it had become the primary virus used to vaccinate against smallpox, remained a mystery." And "Public Forum on Smallpox" meeting held by the CDC on June 8, 2002 in St. Louis, Missouri in which Dr. Harold Margolis, CDC senior adviser for smallpox preparedness, stated that vaccinia is not cowpox, but rather a completely different virus.
22 Mark Martin, "Bioweapons proposal worries neighbors," San Francisco Chronicle, February 5, 2003.