Those in the system know it is broken but do not make it a top priority to join together to do what is necessary to repair it. See no evil, hear no evil, speak no evil. We’re doing the best we can just putting out today’s fires, and we will cover one another’s backs despite how broken the system is. Nero fiddling while Rome burns.
Example of the Unintegrity of Dysfunctional Systems: The Prescription Medications Approval Process
The pharmaceutical industry provides us with our final example of the many forms the Unintegrity Pandemic takes. This rather detailed example is not only illuminates how massive the Unintegrity Pandemic is, but why there is no one person or group to blame for it. It is also a particularly juicy example because it contains elements of a number of the eight forms of Unintegrity described in this chapter.
Until only a few decades ago, research about the effectiveness and safety of new drugs was primarily conducted by independent universities. This meant that those constructing the research design, selecting how the data would be analyzed, and deciding how to most accurately report the data, were generally in search of whatever the scientific facts turned out to be. As a result, drug research studies published in the medical journals tended to be reliable, even if flawed for other reasons having to do with unconscious scientific bias.
What I mean by this is that most drug studies did not, and still do not, compare the effectiveness level of a drug against the effectiveness of taking nutritional supplements or exercise or other non-pharmaceutical treatments for an illness. As a result, neither physicians nor the public know whether a drug is more effective, as effective or less effective than other non-drug methods of treating the illness for which that drug was developed. I will return to this matter in the “obsession” Unintegrity category further below.
Anyway, for the past few decades, the pharmaceutical industry has been taking greater and greater control over how pharmaceutical research is funded, conducted and reported. Today, the pharmaceutical industry is the primary source of funding for drug effectiveness and “side-effects” research. Today, the pharmaceutical industry has the power to approve how the research is designed and how the data will be analyzed. Today, the pharmaceutical industry owns, and frequently refuses to disclose, the raw research data from which the statistics are compiled.
Mounting evidence indicates that drug companies have been both suppressing and distorting this data, much like the tobacco companies have done. Not surprisingly, the data the drug companies tend to suppress is that which would cast suspicion on either a drug’s effectiveness or its safety. Not only do they manipulate the data, but they mount massive and expensive advertising campaigns to both physicians and the public that too often downplay the risks and over-represent the benefits of a drug.
Why do they do this? Maximizing their own profits is more important to them than being in integrity with serving highest good through protecting the public’s safety. In other words, greed.
But, that’s just the tip of the iceberg. You see, the drug companies are not out the only ones who are of integrity with public safety when it comes to medications. So are the leading medical journals, the governmental organizations responsible for approving drugs for treating specific illnesses (such as the U.S. Food & Drug Administration – FDA), and the insurance companies who issue malpractice insurance policies for physicians.
Here’s how it works: Drug research deemed to be the best constructed and most reliable is published by the world’s leading and most credible medical journals, such as Lancet, the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine. Government organizations responsible for approving drugs for specific uses make their decisions in large part on research deemed worthy of being published in these medical journals. Medical malpractice insurance companies use this same information to determine the ‘standards of care’ to which physicians must adhere in order to be covered if they are sued for malpractice. Makes sense, no?
Think about this. If a pharmaceutical company wants to make sure that a drug, Vioxx for example, comes to market regardless of whether or not this would be out of integrity to do, this can occur because of how the system is set up. All they need to do is this:
1. Human Safety and Effectiveness Trials: Set them up so the majority of the volunteers are not the primary group who would actually be prescribed Vioxx. And, by all means, don’t compare the drug’s effectiveness or incidence of side effects to the non-prescription pain relievers already available to the public at much lower cost.
2. Papers Submitted to Medical Journals & Data Disclosed to the FDA: Keep hidden from any data that points to either inferior effectiveness (say, compared with over-the-counter pain relievers) or risks (that is, chances the drug could cause Iatrogenic Illness in patients the doctors would be required to prescribe the drug to in order to avoid being sued for malpractice).
This example is not fictional. It is real. After being touted as the greatest pain reliever ever for certain conditions, Vioxx was pulled from the shelves because of the severe Iatrogenic Illness it appeared to be causing. (Iatrogenic Illness is the technical term for becoming ill from medical treatment for an illness, in contrast to being ill from the illness itself.) Subsequent lawsuits introduced evidence of unethical research study design and covering up research data that could have prevented the drug from being approved for use. This resulted in juries requiring the manufacturer to pay out huge sums of money as punishment. As this book is being written, there are many more Vioxx lawsuits waiting to be tried.
Not only is this example real, but it is not isolated incident. Other drugs, nutritional supplements and certain artificially produced food substitutes have faced the same fate over the years. Unintegrity-by-greed and collusion is more widespread than most people realize.
