Stage 8: Denial

The 8^th and final stage of genocide, according to Gregory H. Stanton’s Eight Stages of Genocide, is denial. While genocide is a term usually reserved for the mass onslaught of a particular race, creed, gender or ethnic group, this case refers to genocide on a broader level. It is used it to describe the large number of American lives lost each year to the struggle of greed, corruption and capital gain of privately owned, publicly traded companies tasked with ailing our sick through “modern medicine”.

http://abagond.wordpress.com/2009/04/16/the-eight-stages-of-genocide/

Mass media, particularly television and now the internet, has proven to the most effective way of reaching almost every American, whether they are at home, work, or on vacation. As more and more cell phones deliver internet access, there is virtually no where media advertising can’t reach you. Through television alone, pharmaceutical companies ensure the average American watches roughly 16 hours of drug commercials each year. With the internet swiftly eliminating print media and now shooting to replace television as a staple American pastime, the pharmaceutical companies have begun to pour large amounts of advertising dollars into the pockets of major internet providers like Google and Yahoo for prime advertising space on various websites.

As the debate on healthcare heats up, pharmaceutical companies insist that these advertisements help reduce the cost of healthcare by raising public awareness. This may be a valid argument if the advertisements were helpful in educating the public or if the cost of advertising did not impact the cost of healthcare. A study conducted by the U.S. General Accounting Office in 2006 found that the sales of a drug increased $2 for every $1 spent on advertising. Additionally, a survey conducted by the U.S. Food and Drug Administration in 2004 found that 65 percent of physicians felt consumer ads confused patients about the risks and benefits of advertised drugs, while 75 percent of physicians felt the ads led "patients to think that the drug works better than it does." While this completely contradicts the claims made by the pharmaceutical companies about the value of their “public messages”, it is not surprising. In 2008, 25 of the 43 warning letters issued by the FDA to pharmaceutical companies were issued by the Division of Drug Marketing, Advertising, and Communications and the Division of New Drugs & Labeling Compliance departments. The majority of these letters address concerns over misleading and false advertising on the part of pharmaceutical companies. The warning letters are drafted by the FDA after auditing various drug company advertising spots; however, even the FDA admits that most of the warning letters are issued after the advertisement has run its course and has already ended and that staffing issues prevent the FDA from auditing all of the commercials that are aired.

http://www.mercurynews.com/top-stories/ci_13809505

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm049750.htm

The reason most pharmaceutical advertisements are not this comprehensive is because this ad was created after two earlier versions of the Yaz ad were found, by the FDA, to be misleading. This was a commercial created by order of, and in response to, an FDA warning letter that directly stated:

“Because the violations described above are serious, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.”

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993

In an article written by Mercury News Columnist Chris O’Brien, he makes the following statement regarding pharmaceutical advertising on the internet:

“At a time when we're trying to reform the national health care system, and rein in costs, the last thing we need to do is to make it easier for drug companies to distort our health care choices. And yet, last week a shameless parade of pharmaceutical companies, advertising firms and Web companies spoke during a two-day hearing to petition the FDA to relax the rules for online drug ads, insisting they [are] just here to help consumers become better informed.”

http://www.mercurynews.com/top-stories/ci_13809505

Denial: the state we, as Americans, would have to be in if we were to believe that pharmaceutical advertisements served any greater purpose than to line the pockets of billion-dollar companies. The state we would have to be in to believe that the money made by these companies went toward improving the human condition instead of just new names and catchy slogans for unproven, unnecessary or ineffective drugs. The state we would have to be in to think that our best interests are served by a government agency, like the FDA, that is primarily staffed and funded by major pharmaceutical companies.

Stage 7: Extermination

Over the past few years, concerns over possible health hazards related to herbal supplements have emerged. The media has released numerous articles through multiple platforms delineating various accounts of men women and children having to be admitted to the hospital because of adverse side effects from “herbal supplements.” Due to the lack of federal regulation on herbal supplements, the average consumer turns to the government “approved” pharmaceuticals to remedy what ails them. Because the natural compounds in herbal supplements cannot be patented, pharmaceutical companies will not spend their money on conducting research on the efficacy and safety of these supplements; leaving these remedies to be tested under independent studies that rarely see publication. If mass media is so timely in producing stories of people suffering adverse reactions to non-pharmaceutical sources, and so fast to attribute these side effects to herbal supplements, why do they choose not to publish research assessing the value or danger in these supplements? The answer is found in the all-mighty advertising dollar.
In media, much like in the dictionary, bank always comes before truth. Pharmaceutical companies spend approximately $2.5 billion annually on Direct to Consumer (DTC) advertising, which means that the media furnishing the ad space has the lion’s share of that $2.5 billion in annual revenue from pharmaceutical companies.

http://www.ncsl.org/Default.aspx?TabId=14461

Pharmaceutical companies, with the help of the media, have done a great job in making “dietary supplements” and “herbal supplements” synonymous in the average consumer’s mind. The problem with this is that herbal supplements are derived from natural herbs, while dietary supplements can be, and often are, composed of synthetic compounds. In fact, most of the articles warning of complications from supplements are actually addressing complications from synthetic compounds, not from herbs.

The media has also made a concerted effort to downplay the efficacy of herbal remedies. One example can be found in an Associated Press article entitled “Experts: Placebo power behind many natural cures” which was reproduced in the Washington Post on November 10 2009, with this opening editorial:

"-- EDITOR'S NOTE: Ten years and $2.5 billion in research have found no cures from alternative medicine. Yet these mostly unproven treatments are now mainstream and used by more than a third of all Americans. This is one in an occasional Associated Press series on their use and potential risks."

However, throughout the story there is no mention of any “potential risk” tied to natural cures, but rather the article primarily focuses on the power of placebo in general.
The first paragraph of the actual AP article opens with:

“People looking for natural cures will be happy to know there is one. Two words explain how it works: "I believe."

While the article goes on to point out that one study on acupuncture found that between a treatment group and a placebo group there was no increased treatment value in acupuncture, it also points out a similar study that found a higher positive response in those who received the actual acupuncture therapy over those who received a placebo therapy. Aside from these two studies, there was no reference to any other scientific studies finding, or even suggesting, the lack of treatment values in “natural cures.” The article quoted Dr. Thomas Schnitzer, a Northwestern University arthritis specialist, in saying “[If it were not for the placebo effect] physicians would not be nearly as successful as we are." This quote was found tucked halfway down the second page of the two page article. Despite this statement, the title “Experts: Placebo power behind many natural cures” does not suggest the placebo effect in medical treatments at all, nor does the prominently displayed Editors Note or the opening paragraph of the AP article. While some may not see this article as a blatant attack on the herbal remedy industry, it unarguably shows a clear bias against natural cures; what it does not show is real scientific evidence on which to base their prejudicial connotations.
http://www.washingtonpost.com/wp-dyn/content/article/2009/11/10/AR2009111007107.html

But could, or would, the media abuse its vast connection with the public to under report or falsely report possible health dangers to the public just because of advertising dollars?

An article titled Death by Pharmaceuticals? - health risks of herbal dietary supplements - Brief Article by Dr. James A. Duke, American Botanist and professor at Tai Sophia in Columbia, states: “The growing health concerns from mass-media articles are being fertilized by trigger-happy journalists, pharmaceutical manufacturers and promoters, and physicians who know so little about herbs, many of them unfamiliar with the statistic from the Journal of the American Medical Association (JAMA) that prescription drugs are killing 140,000 Americans a year. Herbs (usually through abuse or exceeding recommended dosage) are killing fewer than 100.”
http://findarticles.com/p/articles/mi_m0FKA/is_6_63/ai_78476942/

With all of this disorder placed before the average consumer, who reads the headlines of the Post and not the scientifically confusing medical journals, what is a person to do? The old adage “don’t believe everything you hear” is alive and well in this, the Age of Information; and unfortunately, with the virtual limitless expanse of the internet, the truth is getting more and more difficult to uncover. For the average American alive today, the only safe and reliable method in selecting a treatment option, and perhaps also one of the most painful aspects of falling ill, is to do thorough research. While not always 100% reliable, peer reviewed medical studies remain one of the most prestigious sources for unbiased information; just make sure that the name of the organization that conducted the research is not financially backed by a pharmaceutical company.

Stage 6: Preparation

When a lot of money is spent on the introduction of a product, whether it is spent on the research and development of a compound or the marketing and distribution of the final product, it is any company’s top priority, and that of its shareholders, to see a return on investment. It is because of this capitalistic ideology that when the final product does not perform well in the trial phase, the company is motivated to minimize the short comings and emphasize any strength. This is common practice among most, if not all, major industrial companies and usually results in little more than the consumer feeling a bit “short changed” after the purchase. There are some arenas however, where this sort of Caveat Emptor attitude is absolutely unacceptable.

On November 23, 1998, Merck & Co. filled a New Drug Application with the FDA for the approval of Vioxx, a COX-2 non-steroidal anti-inflammatory drug (NSAID) that was marketed as treatment for osteoarthritis, acute pain conditions, and dysmenorrhoea. On May 20, 1999, the FDA approved the drug as a safe and effective treatment for pain, the product launch followed a few days later. By December of 1999, Vioxx had over 40% of new prescriptions in that class of drug.

http://www.merck.com/newsroom/Vioxx/pdf/011_appendix_c_timeline.pdf

In the initial Vioxx drug trials, including Vioxx Gastrointestinal Outcomes Research (VIGOR) study, patients who were taking low dose aspirin as part of a daily regiment to combat cardiovascular problems were excluded as possible participants. This exclusion was done to eliminate possible confounds the aspirin might produce if GI problems were discovered in the trials. Because of this, initial possible complications with NSAID pain relievers and cardiovascular conditions were overlooked. The VIGOR study, in which Vioxx was pitted against Naproxen, was conducted to determine if Vioxx would relieve pain while limiting the risk of GI problems associated with Naproxen. During the VIGOR study, of the 4047 patients in the Vioxx group, 101 patients (2.5%) reported serious cardiovascular (CV) events and 20 patients (0.5%) reported myocardial infarctions (MI). Of the 4029 patients in the Naproxen treatment only 46 patients (1.1%) reported serious cardiovascular (CV) events and only four patients (0.1%) experienced myocardial infarctions (MI). These results were a grim foreshadowing of what was to come for Vioxx and its patients over the next 5 years.

http://www.fda.gov/NewsEvents/Testimony/ucm113235.htm

While no direct correlation could be made between Vioxx and MI due to other confounds in the VIGOR study, over the next couple of years Merck presented erroneous information at numerous promotional conferences in an attempt to minimize the apparent health risks. In addition to directly stating that Vioxx did not pose an increased threat of CV or MI over Naproxen, Merck representatives also downplayed possible harmful drug interaction side effects between Vioxx and Coumadin (a commonly used blood thinning medication). In these presentations Merck also recommend the use of Vioxx at higher doses than what it was approved for by the FDA. In a formal warning letter sent to Raymond Gilmartin, President and CEO of Merck & Co., by the Department of Health and Human Services on September 17, 2001, Thomas W. Abrams, R.Ph., MBA, Director of Division of Drug Marketing, Advertising, and Communications states:

“[Merck] Your minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns. Your misrepresentation of the safety profile for Vioxx is particularly troublesome because we have previously, in an untitled letter, objected to promotional materials for Vioxx that also misrepresented Vioxx’s safety profile.”

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2001/ucm178472.htm

In September of 2004, Merck voluntarily withdrew Vioxx from worldwide markets after a colon-polyp prevention study called APPROVe revealed that after 18 months, Vioxx doubles the patient’s risk of heart attack.

Since its removal, numerous occasions of incomplete data submissions and flawed studies hiding the potential link between Vioxx and cardiovascular complications have been revealed. According to testimony submitted to the Department of Health and Human Services, it costs approximately $1.5 billion to bring a drug to market. Before it was removed from pharmacy counters, Vioxx brought Merck annual sales revenue of $2.5 billion. Over its 5 years on the market, Vioxx did for Merck what any CEO or stockholder of a faulty product could hope, it netted and incredible return in investment, but at what cost? It is estimated that 20 million Americans had taken Vioxx before its withdrawal. Research published in Lancet medical journal estimates that 88,000 Americans suffered heart attacks as a result of adverse reactions from taking Vioxx, and 38,000 of them died.

http://www.npr.org/templates/story/story.php?storyId=5470430

http://www.hhs.gov/asl/testify/2009/04/t20090422d.html

Stage 5: Polarization

Major pharmaceutical companies tout that Direct to Consumer (DTC) advertising is a valued and necessary service provided by them, to educate the public. This education in health is sought by almost every American. An Ipsos Health Poll Conducted in 2005 shows that as many as 91% of consumers want to know as much as they can about their health conditions and how to treat them. While this statistic is not surprising, it shows the need for public health education is important. According to Pfizer’s public policy regarding advertising and promotion, “By helping patients identify problems early, DTC advertising can prevent unnecessary patient suffering and the need for high-cost acute-care medical interventions that result from untreated conditions.”

http://www.pfizer.com/about/public_policy/advertising_and_promotion.jsp

While this may be a valid argument when the information provided in those advertisements is accurate and unbiased, informing the public to erroneous illnesses or exaggerations of the effectiveness of a drug can prove to be more damaging and costly than leaving the education to the medical professionals. In September of 2009 the U.S. Department of Health and Human Services reported that Pfizer was ordered to pay $2.3 billion for fraudulent marketing. It was the largest health care fraud settlement in the history of the Department of Justice. This settlement included hefty fines attached to Pfizer and its subsidiaries for promoting the “off label” use of drugs like Bextra, an anti-inflammatory medication used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. “Off label” use refers to the use of a drug at a higher dose than approved by the FDA or for treatment of other conditions that were not approved by the FDA. Pfizer agreed to pay the settlement amount after allegations that the pharmaceutical company directed its sales staff to instruct heath care professionals to prescribe certain drugs at higher doses or for treatment of ailments the drugs were not approved for.

http://www.hhs.gov/news/press/2009pres/09/20090902a.html

(The following video is somewhat long {about 11 mins} but it is very important in helping to understand and realize some of the things pharmaceutical companies do to completely disregard the very thing they should be focused the most on, public health and well being.)

In this same public policy statement regarding advertising and promotion, Pfizer also claims:

“Two of the most persistent myths about prescription drug advertising are that pharmaceutical companies spend more money on it than on research and development, and that spending on advertising raises the prices of drugs. There is no evidence for either claim. In 2004, pharmaceutical companies spent $38.8 billion on research to develop new treatments for diseases… far more than the $4.15 billion the industry spent on advertising and promotion.”

However, a study conducted by PhD candidate Marc-André Gagnon, and long-time researcher of pharmaceutical promotion, Toronto physician, and Associate Chair of York’s School of Health Policy & Management in the Faculty of Health Joel Lexchin found that, during 2004, the U.S. pharmaceutical industry spent $57.4 billion (24.4%) of the $235.4 billion sales dollars on promotion, versus $31.5 billion (13.4%) for research and development. This discovery was based on data collected directly from the pharmaceutical industry and doctors. This study also found the industry spent an average of $61,000 dollars in promotions, per physician, for the year of 2004.

The figures listed in Pfizer’s public policy only reflected the amount of money spent on DTC advertisement while neglecting to mention the obscene amount of money directed toward the inducement of the medical community in the form of promotional gifts and trips. So when DTC advertising results in a lack of confidence in our pharmaceutical companies and corruption of our medical community by these same companies lead to a mistrust of our doctors, where can we turn for legitimate, unbiased health care advice?

http://www.pfizer.com/about/public_policy/advertising_and_promotion.jsp

http://www.sciencedaily.com/releases/2008/01/080105140107.htm

Stage 4: Organization

“…The FDA is responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable…”

www.fda.gov/ohrms/dockets/ac/04/slides/4018s2_01%20Grant%20slides%20BRMAC%20March%2019.ppt

The FDA is an organization sanctioned to oversee the food and drugs being released to the US population; a publicly funded government institution whose primary interest should be maintaining a high standard of quality for foods and pharmaceuticals. The FDA has recently come under the scrutiny of watch dog groups and government officials due to an increased number of recalled drugs like Vioxx, Celebrex and Brextra. How are these drugs reaching public consumption before they are deemed safe? One explanation may be found in how the FDA is funded. As a government agency, the FDA is slated to be a publicly funded institution; however in 1992 the Prescription Drug User Fee Act (PDUFA) was enacted. This act calls for the FDA to collect “user fees” from the companies that produce human drugs and biological products. This was implemented to help expedite the process of drug approval by providing the FDA with the means of expanding the number of people available to approve certain drugs and biological products. According to the Government Accountability Office, the FDA’s 2009 fiscal year budget totals $2.67 billion. About 23 percent or $613 million of that budget will come from user fees as authorized through PDUFA.

http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm

http://www.gao.gov/new.items/d09523.pdf

In addition to relying on drug companies for over a quarter of their annual funding, the travel budget for the FDA has also been subsidized by pharmaceutical companies.While it is a conflict of interest, and illegal, for the FDA to accept such “gifts” from the industry it is commissioned to oversee, hundreds of FDA employees have accepted millions of dollars in sponsored travel from non-profit organizations whose members, boards and funding come from pharmaceutical and medical device companies. According to the Inspector General of the Department of Health and Human Services, nonprofit groups and universities with membership and financial ties to the pharmaceutical companies paid for roughly a third of the more than 3,600 trips taken by FDA officials between 1999 and 2006.

http://projects.publicintegrity.org/rx/report.aspx?aid=792

It has become grossly apparent that the contributions from the pharmaceutical industry have made it all but impossible for the FDA to sincerely and effectively oversee the prescription drug market. The FDA has fallen host to a dangerous parasite that has turned a once governing body into a shell company through which it launders its dirty money. FDA officials, like blood cells in a once healthy body, have been infiltrated and turned against the integrity of the country’s immune system. Ironically, we are being infected by the same industry we would turn to in search of a vaccine. Is there an herbal remedy for America's disease?

Stage 3: Dehumanization

Dehumanization: The deprivation of human qualities, personality, or spirit.

http://www.merriam-webster.com/dictionary/dehumanization

One clear and tangible example of dehumanization by a pharmaceutical company can be found in the Trovan drug trials conducted in Nigeria during the 1996 meningitis epidemic. During this devastating meningitis outbreak, Pfizer tested a new antibiotic, Trovan, in a field hospital. The Nigerian government claims the trials were conducted illegally while 11 children died and hundreds more were disabled as a result of Trovan. According to the lawsuit filed by the Nigerian government and the Kano State, it is alleged that, in addition to researchers giving children substandard doses of a comparison antibiotic, Pfizer operated under a falsified ethics approval letter while administering a previously untested trial drug to children. It is also alleged that Pfizer did not have signed consent forms for the 200 critically ill children participating in the trial and the trial did not conform to U.S. patient-protection standards.

http://www.forbes.com/2009/04/03/pfizer-kano-trovan-business-healthcare-settlement.html

In a 2007 statement, Pfizer maintained that the trials were conducted legally, safely and with the “full knowledge of the Nigerian government.”

http://www.washingtonpost.com/wp-dyn/content/article/2009/04/03/AR2009040301877.html

As of April of this year (2009), Forbes.com as well as Fox News and other reporting agencies (via Associated Press) rumored that a settlement for $75 million dollars was nearing finalization between Pfizer and the Nigerian government and victims of the study.

http://www.forbes.com/2009/04/03/pfizer-kano-trovan-business-healthcare-settlement.html

According to Forbes.com, Pfizer initially applied to use Trovan for pediatric meningitis based on its trial data. After a Food and Drug Administration audit uncovered “dozens of discrepancies” in its trial records, Pfizer withdrew that use from its application. Pfizer stated its intention to renew its application following results of a global pediatric trial, but the drug maker never had the opportunity. “After approving Trovan for 14 other uses in 1997, the FDA advised Pfizer to pull the drug entirely--two years and more than 2.5 million prescriptions later--citing reports of liver damage in the U.S.”

http://www.forbes.com/2009/04/03/pfizer-kano-trovan-business-healthcare-settlement.html

http://www.foxnews.com/wires/2009Apr03/0,4670,AFNigeriaPfizer,00.html

Pharmaceutical industries that were once built on the fundamental principle of improving the quality of life have abandoned the pursuit of good health in the interest of profit.

Stage 2: Symbolization

One of the problems associated with increased costs of prescription medication in the United States is the money and resources spent to rename, repackage, and create new advertising campaigns for existing drugs. This process is known as “reclassification.”

According to a report released by the Food and Drug Administration for 2003, out of 72 new drug approvals 21 were "innovator" drugs with an active ingredient new to the U.S. market. Of those 21, less than half were considered by the FDA to be a significant improvement compared to drugs already on the market. Nexium, the popular heartburn drug, is just an expensive knockoff of Prilosec, Prevacid, Protonix and Aciphex. Only 16 of the drugs approved in 2007 were new molecular entities, or members of a completely new class of drugs, down 11% from 2006, according to Jim Kumpel, analyst for Friedman, Billings, Ramsey.

http://findarticles.com/p/articles/mi_m0815/is_10_29/ai_n8574368

http://money.cnn.com/2008/02/04/news/companies/fda/index.htm

Another method used by drug companies is the introduction of drugs that do not provide any increased medicinal value. An example of this was uncovered in a study called ALLHAT (Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trail). This study was not sponsored by a drug company. This was an eight year trial that involved 42,000 people and studied the treatment of high blood pressure medication comparing 4 types of drugs. Norvasc, a calcium channel blocker produced by Pfizer; Cardura, a alpha-adrenergic blocker produced by Pfizer; Zestril, a angiotensin-converting enzyme inhibitor sold by Astra and Zeneca: and a generic diuretic (water pill) that has been on the market for 50 years. The results revealed the diuretic was just as effective for lower blood pressure as the prescription drugs and it was better at preventing some of the worst complications of high blood pressure, heart disease, and stroke. The director of the Heart, Lung, and Blood Institute concluded the study by saying, "ALLHAT shows that the diuretics are the best choice to treat hypertension, both medically and economically.” Diuretics were priced at about $37 a year in 2002 as opposed to $715 dollars for Norvasc.

http://allergy.meliatop.com/they-dont-make-em-like-they-use-to.php

The reproduction of existing drugs and the development of drugs that prove to be less effective than generic alternatives is a clear waste of the pharmaceutical company’s resources as well as our money when we are prescribed these medications. The pharmaceutical companies should not be allowed to hide behind the pretext of high “Research & Development” costs when they spend more than twice as much on advertising than they do on research, and their development yields medications that may be more harmful, and often times less effective, than existing drugs. To develop a drug that does slightly better than a placebo is not an acceptable level of improvement. We need to pressure pharmaceutical companies to start developing more effective drugs instead of more effective advertising campaigns.