Drug-Induced Latrogenic Disorders

“106,000 people die (annually, in US hospitals) as a result of CORRECTLY prescribed medicines…Overuse of a drug or inappropriate use of a drug would not fall under the category of ‘correctly’ prescribed. Therefore, people who die after ‘overuse’ or ‘inappropriate use’ would be IN ADDITION TO the 106,000 (these numbers do not count out-patients killed by prescription drugs!) and would fall into another or other categories.”

“It is scary how many similarities there are between the drug industry and the mob. The mob makes obscene amounts of money…The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does this industry…

“Otherwise good citizens, when they are part of a corporate group, do things they otherwise wouldn’t do because the group…validate(s) what there’re doing as OK…

“The difference is that all these people in the drug industry look upon themselves as law-abiding citizens, not as citizens who would ever rob a bank. However, when they get together as a group and manage these corporations, something seems to happen. It’s almost like when soldiers commit war crime atrocities. When you’re in a group, it’s easy to do things you otherwise wouldn’t do.” – An unnamed whistle-blowing ex-vice president for Pfizer’s global marketing department.

“In contrast to the drug industry, doctors don’t harm their patients deliberately. And when they do cause harm, either accidentally, or because of the lack of knowledge, or by negligence, they harm only one patient at a time.”

“In the drug industry, bribery is routine and involves large amounts of money. Almost every type of person who can affect the interests of the industry has been bribed: doctors, hospital administrators, cabinet ministers, health inspectors, customs officers, tax assessors, drug registration officials, factory inspectors, pricing officials and political parties.”

“There seems to be no study too fragmented, no hypothesis too trivial, no literature citation too biased or too egoistical, no design too warped, no methodology too bungled, no presentation of results too inaccurate, too obscure, and too contradictory, no analysis too self-serving, no argument too circular, no conclusions too trifling or too unjustified, and no grammar and syntax too offensive for a paper to end up in print.” – Drummond Rennie, deputy editor of JAMA.

“What makes Big Pharma unique in the US is that it outspends all others in laying down cold hard cash into its lobbying efforts (another word for bribing governments that includes not only US Congress but its US federal regulator, the bought and sold Food and Drug Administration).” – Joachim Hagopian

“(As a drug rep) “it’s my job to figure out what a physician’s price is. For some it’s dinner at the finest restaurants, for others it’s enough convincing data to let them prescribe confidently and for others it’s my attention and friendship…but at the most basic level, everything is for sale and everything is an exchange.” – Retired Drug Sales Rep Shahram Ahari

“Before the approval process, the (Big Pharma-connected) sponsor sets up the clinical trial – the drug selected, and the dose and route of administration of the comparison drug (or placebo). Since the trial is designed to have one outcome, is it surprising that the comparison drug may be hobbled – given in the wrong dose, by the wrong method?

“The sponsor pays those who collect the evidence, doctors, and nurses, so is it surprising that in a dozen ways they influence results? All the results flow in to the sponsor, who analyses the evidence, drops what is inconvenient, and keeps it all secret – even from the trial physicians. The manufacturer deals out to the FDA bits of evidence, and pays the FDA (the judge) to keep it secret. Panels (the jury), usually paid consultant fees by the sponsors, decide on FDA approval, often lobbied for by paid grass-roots patient organizations who pack the court (the trick is called ‘astro-turfing’).

“If the trial, under these conditions, shows the drug works, the sponsors pay sub-contractors to write up the research and impart whatever spin they may; they pay ‘distinguished’ academics to add their names as ‘authors’ to give the enterprise credibility, and often publish in journals dependent on the sponsors for their existence.

“If the drug seems no good or harmful, the trial is buried and everyone is reminded of their confidentiality agreements. Unless the trial is set up in this way, the sponsor will refuse to back the trial, but even if it is set up as they wish, those same sponsors may suddenly walk away from it, leaving patients and their physicians high and dry.”

“We have a system where defendant, developers of evidence, police, judge, jury, and even court reporters are all induced to arrive at one conclusion in favour of the new drug.”

“More than 80 million prescriptions for psychiatric drugs are written in the UK every year. Not only are these drugs often entirely unnecessary and ineffective, but they can also turn patients into addicts, cause crippling side-effects – and kill.”

“The annual list of the most common causes of death in the United States, compiled by the Centers for Disease Control and Prevention (CDC), informs public awareness and national research priorities each year. The list is created using death certificates filled out by physicians, funeral directors, medical examiners, and coroners.

“However, a major limitation of the death certificate is that it relies on assigning an International Classification of Disease (ICD) code to the cause of death. As a result, causes of death not associated with an ICD code (including many iatrogenic disorders), such as human and system factors, are not captured.

“…communication breakdowns, diagnostic errors, poor judgment, and inadequate skill can directly result in patient harm and death. We analyzed the scientific literature on medical error to identify its contribution to US deaths in relation to causes listed by the CDC.

“Medical error has been defined as an unintended act (either of omission or commission) or one that does not achieve its intended outcome, the failure of a planned action to be completed as intended (an error of execution), the use of a wrong plan to achieve an aim (an error of planning), or a deviation from the process of care that may or may not cause harm to the patient. Patient harm from medical error can occur at the individual or system level. The taxonomy of errors is expanding to better categorize preventable factors and events. We focus on preventable lethal events to highlight the scale of potential for improvement.”

“We are writing this letter to respectfully ask the Centers for Disease Control and Prevention (CDC) to change the way it collects our country’s national vital health statistics each year. The list of most common causes of death published is very important – it informs our country’s research and public health priorities each year. The current methodology used to generate the list has what we believe to be a serious limitation. As a result, the list has neglected to identify the third leading cause of death in the U.S. – medical error.”

Objectives

Based on 1984 data developed from reviews of medical records of patients treated in New York hospitals, the Institute of Medicine (IOM) estimated that up to 98,000 Americans die each year from medical errors. The basis of this estimate is nearly 3 decades old; herein, an updated estimate is developed from modern studies published from 2008 to 2011.

Results

Using a weighted average of the 4 studies, a lower limit of 210,000 deaths per year was associated with preventable harm in hospitals…the true number of premature deaths associated with preventable harm to patients was estimated at more than 400,000 per year. Serious (but non-lethal) harm seems to be 10- to 20-fold more common than lethal harm.

Conclusions

The epidemic of patient harm in hospitals must be taken more seriously if it is to be curtailed. Fully engaging patients and their advocates during hospital care, systematically seeking the patients’ voice in identifying harms, transparent accountability for harm, and intentional correction of root causes of harm will be necessary to accomplish this goal.

“Medical care in the United States is technically complex at the individual provider level, at the system level, and at the national level. The amount of new knowledge generated each year by clinical research that applies directly to patient care can easily overwhelm the individual physician trying to optimize the care of his patients.”

“Because of increased production demands, providers may be expected to give care in suboptimal working conditions, with decreased staff, and a shortage of physicians, which leads to fatigue and burnout. It should be no surprise that preventable adverse events that harm patients are frighteningly common in this highly technical, rapidly changing, and poorly integrated industry. The picture is further complicated by a lack of transparency and limited accountability for errors that harm patients.“

“There are at least 3 time-based categories of preventable adverse events recognized in patients that are or have been hospitalized. The broadest definition encompasses all unexpected and harmful experience that a patient encounters as a result of being in the care of a medical professional or system because high quality, evidence-based medical care was not delivered during hospitalization. The harmful outcomes may be realized immediately, delayed for days or months, or even delayed many years.“

“There was much debate after the Institute of Medicine (IOM) report about the accuracy of its estimates. In a sense, it does not matter whether the deaths of 100,000, 200,000 or 400,000 Americans each year are associated with PAEs in hospitals….one must hope that the present, evidence-based estimate of 400,000+ deaths per year will foster an outcry for overdue changes and increased vigilance in medical care to address the problem of harm to patients who come to a hospital seeking only to be healed.”