Thursday, Oct 30, 2008
The 2008, first quarter report of deaths and serious injuries associated with drug therapy was recently released by The Institute for Safe Medication Practices, a nonprofit organization whose stated goal is to educate the healthcare community and consumers about safe medication practices. The findings of this report are astounding.
According to the information gathered from data submitted to the U.S. Food and Drug Administration during the first quarter of 2008, there were 20,745 reported serious injuries associated with drug therapy, up 34% from the previous quarter, and up 38% from last year`s average. Even more eye-opening than the number of serious injuries is the number of reported deaths – 4,824 people were reported killed from pharmaceutical drugs in the first quarter of 2008, a 2.6 fold increase from the previous quarter. This figure represents the highest number of patient deaths ever reported in a single quarter as a result of drug therapy. It also accounts for more deaths than those due to homicide during the same period.
It is important to keep in mind that these figures represent quarterly findings. Given the upward trend in both serious injuries and deaths over the past several years due to pharmaceutical drugs, these numbers are expected to continue their rate of increase in quarters and years to come.
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Even if the numbers were to remain the same for the rest of 2008, the total number of reported serious injuries would total 83,000 while the total number of reported deaths would reach nearly 20,000. Again, this is assuming the first quarter findings remain constant – the report emphasizes that the trend has continued to veer upward, indicating that future reports will most likely contain even higher numbers.
What is more striking than these numbers is the fact that they represent only the adverse events that were reported to the FDA during this time period. Since the reporting system is voluntary and almost 85% of the reports come from the pharmaceutical companies themselves, it is obvious that these numbers represent only a miniscule percentage of the total adverse events that are actually occurring. Numerous published scientific reports on adverse event reporting accuracy, including reports from the Journal of the American Medical Association and the U.S. Department of Health and Human Services, have concluded that no more than 10% and in some cases as little as 1-2% of adverse events caused by drugs are even reported to the FDA. Thus, based upon the first quarter data, the actual number of adverse events from drug therapies in the first quarter of 2008 could be anywhere from 207,000 to over 2,000,000 with roughly 23% of these representing deaths.
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While the report goes on to outline, in detail, most of the culprit drugs, including varenicline, heparin, oxycodone, and even acetaminophen (the active drug in Tylenol), its “bigger picture” discovery remains blatantly obvious. Assuming a best case scenario of only a 10% reporting rate, this report essentially spells out the fact that at least 830,000 cases of serious injury or death occur every year in America due to the harmful effects of pharmaceutical drugs, with possibly a quarter of these cases resulting in death.
According to the U.S. Department of Health and Human Services, about 2.5 million people die every year in the United States. Assuming a 10% reporting rate of adverse events to drug therapy based on Q1, 2008 data, it can be concluded that about 8% of the deaths that occur every year in America are due to complications with pharmaceutical drugs. Assuming only a 1% reporting rate, that percentage increases to over 77%. Thus, it can be estimated that the number of people that die every year in the U.S. from adverse drug effects is anywhere from about 192,000 to almost 2,000,000.
To put these numbers into perspective, the National Center for Health Statistics reports that in 2006, 44,572 people died in car accidents, 18,029 from homicide, and 560,102 from all forms of cancer.
It becomes abundantly clear from this report that no one knows for sure exactly how many people are negatively affected by pharmaceutical drugs, but that the number is quite large and is getting increasingly larger. Even on the low end of the estimate spectrum, the data elucidates the obviously prodigious danger of pharmaceutical drugs and the inadequate work being performed by the FDA in protecting the public from dangerous drugs.
Considering the scrutiny with which other industries are regulated and controlled by the FDA, it is shocking that, with even a conservative estimate of about 200,000 yearly deaths related to pharmaceutical drugs, the FDA is hardly phased. The agency continues to pander to pharmaceutical interests, including its support for the industry`s immunity from being held accountable for these “adverse events” under the law.
Perhaps as this type of data becomes more mainstream, the public will forcibly hold the drug cabal accountable for the destruction it is inflicting on American society, and the regulatory agencies accountable for turning a blind eye to the damage being perpetrated against the very people it is supposed to be representing and protecting.