American science and public health is the finest in the world, with
the smartest people working with the latest technologies to prevent and
cure disease. We are exceptional.
That is a common belief held by several million people working within
the medical industrial complex. The problem is, it’s untrue. In fact,
it’s just the opposite. American medicine kills more people
unnecessarily than any other national medical system in the
industrialized world. As Harvard School of Medicine professor Lucian
Leape noted, American medicine kills 3 jumbo jets-worth of patients
every 48 hours.(1)
In this series we review the startling science which suggests that deaths from medical error in the US may be conservatively estimated
at 400,000 annually, while severe injuries from medical error may top
10,000,000.(2,3) This equates to 8 million deaths and 200,000,000
severe injuries due to modern medical medicine during the past twenty
years. It is higher than the casualties from any single conflict or war
in American history.
American citizens should be alarmed that no federal effort is being
made to prevent or reverse this growing trend. What does this reveal
about the medical establishment today? What does it tell us about the
level of training and competency of numerous qualified physicians,
nurses, dentists, nutritionists, hospitals and scientists? And more so,
what can be said about the integrity of pharmaceutical companies, the
federal health agencies and their thousands of employees that keep the
medical machine running? And then what about the roles of mainstream
media, universities and professional institutions and foundations and
the so-called medical experts who are supposed to represent the highest
standards of scientific ethics? Finally, what can be said about the tens
of millions of Americans who are complacent and buy into this
all-pervading establishment?
In retrospect, the nation suffers from severe cognitive dissonance
and lives in denial about health standards and disease. American
medicine feeds upon corruption, greed, malfeasance and self-serving
interests. However, many prominent, respected medical voices have
identified these problems and spoken out against them. This group
includes Harvard professor and former editor of the prestigious New
England Journal of Medicine Dr. Marcia Angell, former FDA Associate
Director for Science and Medicine Dr. David Graham and the CDC’s senior
epidemiologist Dr. William Thompson.
For decades independent journalists have exposed the impropriety of
the medical industrial complex. Here is a list of just some of the
groundbreaking independent investigative reporting exposing the
corruption of mainstream medicine:
Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare- by Peter C. Gøtzsche,
The Truth About the Drug Companies: How They Deceive Us and What to Do About It by Marcia Angell MD
Prozac Nation by Elizabeth Wurtzel
Pharmageddon by David Healy
Doctors Are Gods: Corruption and Unethical Practices in the Medical Profession by David Jacobsen
The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers by Katharine Greider
Overdosed America by John Abramson
Mad in America By Robert Whitaker
Betrayal of Trust : The Collapse of Global Public Health by Laurie Garret
I’m Dancing as Fast as I Can by Barbara Gordon
Racketeering in Medicine: The Suppression of Alternatives by James Carter
Bad Pharma by Ben Goldacre
White Coat, Black Hat: Adventures on the Dark Side of Medicine by Carl Elliot
These authors may be opinion leaders but they are not policymakers.
Policymakers are so firmly in embedded into medicine’s controlled
establishment that they are able to withstand the exposés and
whistleblowers who bring their negligence and failures to public
attention. Negative media, scandals, crimes of science don’t injure
their careers nor their professional standings.
There are many hundreds of original in-depth investigative reports,
including my own Death by Medicine, which required over 5 years of
intensive research by five physicians and doctorates. I have released
many award-winning documentaries such as Death by Medicine, War on
Health, Prescription for Disaster, Silent Epidemic, Autism: Made in the
USA and others. Yet what is the cumulative impact of all this
investigative reporting upon current federal health policies and
regulation? ZERO.
The US spends more money on domestic healthcare than any other
country in the world. Grants and funding have been funnelled to millions
of people, including over 900,000 physicians and nurses, hundreds of
hospitals, pharmaceutical and medical technology companies, but the
end-product is never thoroughly reviewed and assessed for viable
success. Therefore, what incentive is provided to institute change if
only medical failures are rewarded?
Has anyone ever heard of a physician or hospital refunding a
patient’s care after medical error resulted in his or her death? And yet
the public and media have the temerity to praise this medical
paradigm’s leaders as heroes who are fighting the good fight against
cancer, or AIDS or Alzheimer’s and diabetes, without ever questioning
whether or not the entire paradigm might be flawed?
Unfortunately today’s medical establishment and its leaders won’t
change. It’s too large to change. There are too many vested interests
and capitalizing on projected revenues is too entrenched into the
system’s modus operandi. However, this doesn’t mean that we as
individuals cannot change. Harvard Medical School’s Marcia Angell
observed,
“Similar conflicts of interest and biases exist in virtually every
field of medicine, particularly those that rely heavily on drugs or
devices. It is simply no longer possible to believe much of the clinical
research that is published, or to rely on the judgment of trusted
physicians or authoritative medical guidelines. I take no pleasure in
this conclusion, which I reached slowly and reluctantly over my two
decades as an editor of The New England Journal of Medicine.”
“The United States is the only advanced country that permits the
pharmaceutical industry to charge exactly what the market will bear,
whatever it wants”
“The pharmaceutical industry likes to depict itself as a
research-based industry, as the source of innovative drugs. Nothing
could be further from the truth. This is their incredible PR and their
nerve.”
In January 2016 federal multidistrict litigation commenced against
Pfizer over its hugely popular cholesterol-lowering drug, Lipitor. After
a 2012 study found the statin drug increased type 2 diabetes risks by
50 percent among postmenopausal women, Pfizer stands accused of not
providing adequate warning about Lipitor’s life-threatening adverse
effects.(4) Thousands of personal injury lawsuits have been filed
across the country by patients alleging they were harmed by the drug.
Lipitor was launched in 1996 and is the most successful medication in
pharmaceutical history with sales over $131 billion. Predictably,
financial settlements from the lawsuits will amount to a pittance of the
drug’s overall revenues.
Pfizer has knowingly put millions of patients’ health and lives at
risk; nevertheless, following a settlement Pfizer’s business returned to
normal. Nothing fundamentally changed and the corporation’s revenues
simply increased. Since the revelation of the diabetes link, the company
has continued to earn billions on Lipitor sales and no one is being
held accountable. More egregious is that nobody in the mainstream media
speaks about the numerous scandals that plague the medical-industrial
complex and its consistent bottom line to prioritize profit over health.
There is a serious emergency when federal regulatory agencies
continue to approve medications, drugs and vaccines with numerous
harmful and sometimes lethal side effects. Increasingly the FDA and CDC
act as their own critics. Neither is the government blind to its own
deficiencies in healthcare delivery. The Institute of Medicine (IOM), a
part of the United States National Academy of Sciences, states:
“Healthcare in the United States is not as safe as it should be. . . .
Among the problems that commonly occur during the course of providing
healthcare are adverse drug events and improper transfusions, surgical
injuries and wrong-site surgery, suicides, restraint- related injuries
or death, falls, burns, pressure ulcers, and mistaken patient identities
[all of which exact] their cost in human lives.” (5)
The IOM refers to “the nation’s epidemic of medical errors.” A large
percent of these errors are related to adverse drug events (ADEs). An
ADE is a broad term used to describe harm caused by medical intervention
related to drugs, whereas an adverse drug reaction (ADR) involves
injury caused by a medication prescribed at a normal dose. The FDA
states that “ADRs are one of the leading causes of morbidity and
mortality in healthcare.”(6) Dr. Curt Furburg published an article in
the Archives of Internal Medicine proposing sweeping changes throughout
the FDA. Furburg and his colleagues write, “We see eight major problems
with the current system of assessment and assurance of drug safety at
the FDA.” A fundamental problem is the FDA’s initial review for drug
approval that often fails to detect serious ADRs: “A study by the US
General Accountability Office (GAO) concluded that 51% of all approved
drugs had at least one serious ADR that was not recognized during the
approval process.”(7)
Seeing the Bigger Picture
Until recently, public health researchers could cite only isolated
statistics to make their case about the high risks of conventional
medicine. No one had ever analyzed and compiled all the published
literature dealing with injuries and deaths directly associated with
federally protected medical practice.
Over a decade ago, several medical researchers and I spent years
meticulously reviewing the statistical evidence regarding iatrogenic
injury and death—that is, those conditions and deaths induced
inadvertently by a physician or surgeon or by a medical treatment or
diagnostic procedure. Our conclusions were shocking.
Our most stunning analysis was that the total number of deaths caused
by conventional medicine is more than 700,000 per year, making the
American medical system itself the leading cause of death and injury in
the US. The statistics present a grim reality for the American patient.
In contrast, the purported leading causes of death in the United States
today, heart disease and cancer, are responsible for 611,105 and 584,881
annual deaths, respectively. (8) But has there been any improvement in
the last 10 years since our figures were revealed to the world? Hardly.
In 2013, John James, PhD. published an article in the Journal of Patient Safety examining
the prevalence of iatrogenic death in America. James concluded that
more than 400,000 patients die in hospitals each year due to preventable
harm. (9) He also stated that “serious harm seems to be 10- to 20-fold
more common than lethal harm.” (10) In other words, anywhere between 4
million and 8 million Americans are seriously harmed during hospital
admissions annually.
In a recent 2016 report, co-authors Dr. Martin Makary and Dr. Michael
Daniel at Johns Hopkins University School of Medicine estimated that
over 250,000 deaths occur each year due to modern medicine’s errors.
(11) However, the authors concede that the actual figure is far greater
because their statistics only account for hospital deaths and not
outpatient or nursing home settings. During an interview, Dr. Makary
pointed out that death certificates do not reflect medical error. (12)
He went on to state that “Incidence rates for deaths directly
attributable to medical care gone awry haven’t been recognized in any
standardized method for collecting national statistics… The medical
coding system was designed to maximize billing for physician services,
not to collect national health statistics, as it is currently being
used.” (13)
Since population studies on iatrogenic deaths are sorely inadequate,
it is reasonable to project an accurate mortality rate that surpasses
the 797,926 figure we arrived at over a decade ago. In addition, a 2010
study showed that the frequency of ADEs (fatal and otherwise) has
steadily trended upwards over the past years.(14) Nor does research into
medical errors in nursing homes reflect improvement in patient safety. A
2009 study found serious discrepancies in the administration of
medications for nearly 3 out of 4 admissions in nursing facilities. (15)
In another study that evaluated assisted living facilities in South
Carolina, healthcare staff committed errors in the preparation and
administration of medication over 40% of the time. (16)
Given these astounding figures, it’s only right to ask how is it
possible that our regulatory agencies have failed to address our costly
nationwide epidemic of medical errors. To begin our search for answers
we will turn our attention to the FDA, its astonishingly shoddy science
and disturbing corruption that plagues America’s leading federal health
agency.
Blowing the Whistle on Bad Medicine: Dr. David Graham
We decided to publish this information to call attention to the
failure of the American medical system. By exposing the gruesome
statistics, a basis may be established that might encourage competent
and compassionate medical professionals to recognize the inadequacies of
today’s medical establishment and begin to institute progressive
reforms. One such professional is Dr. David Graham, whose testimony
before Congress provides an important context for our discussion.
On November 18, 2004, Dr. David Graham, a former Associate Director
for Science and Medicine in the FDA’s Office of Drug Safety, testified
before the US Senate. Dr. Graham graduated from the Johns Hopkins
University School of Medicine, and trained in Internal Medicine at Yale
and in adult Neurology at the University of Pennsylvania. (17) His
education and extensive experience qualify his expert opinion on the
failures of pharmaceutical drugs.
Dr. Graham told the Senate:
During my career, I believe I have made a real difference for the
cause of patient safety. My research and efforts within FDA led to the
with- drawal from the US market of Omniflox, an antibiotic that caused
hemolytic anemia; Rezulin, a diabetes drug that caused acute liver
failure; Fen-Phen and Redux, weight loss drugs that caused heart valve
injury; and PPA (phenylpropanolamine), an over- the-counter decongestant
and weight loss product that caused hemorrhagic stroke in young women.
My research also led to the withdrawal from outpatient use of Trovan,
an antibiotic that caused acute liver failure and death. I also
contributed to the team effort that led to the withdrawal of Lotronex, a
drug for irritable bowel syndrome that causes ischemic colitis; Baycol,
a cholesterol-lowering drug that caused severe muscle injury, kidney
failure and death; Seldane, an antihistamine that caused heart
arrhythmias and death; and Propulsid, a drug for night-time heartburn
that caused heart arrhythmias and death. . . .
I have done extensive work concerning the issue of pregnancy exposure
to Accutane, a drug that is used to treat acne but can cause birth
defects in some children who are exposed in utero if their mothers take
the drug during the first trimester. During my career, I have
recommended the market withdrawal of twelve drugs. Only two of these
remain on the market today—Accutane and Arava, a drug for the treatment
of rheumatoid arthritis that I and a co-worker believe causes an
unacceptably high risk of acute liver failure and death. (18)
The Los Angeles Times reported that witnesses told the Senate panel
that Merck & Co. and the FDA knowingly had data well before the
approval and licensure of Merck’s Vioxx® painkiller that proved the
drug’s serious cardiovascular health risks. Nevertheless, the FDA
granted it approval without resolving the risks, and Vioxx® was
aggressively.(19)
Testifying about Merck’s Vioxx®, Dr. Graham states:
Today . . . you, we, are faced with what may be the single greatest
drug safety catastrophe in the history of this country or the history of
the world. We are talking about a catastrophe that I strongly believe
could have, should have been largely or completely avoided. But it
wasn’t, and over 100,000 Americans have paid dearly for this failure. In
my opinion, the FDA has let the American people down, and sadly,
betrayed a public trust. (20)
According to Dr. Graham. “Not only did the FDA ignore known risks
from Vioxx® and related drugs but . . . it tried to prevent Graham and
others from publicizing their own research that proved the extent of
these risks.”(21)
Graham’s concerns were echoed by some members of Congress who heard
his testimony. Committee Chairman Charles E. Grassley (R–Iowa) said he
was concerned that the FDA “has a relationship with drug companies that
is too cozy.”(22) Sen. Jeff Bingaman (D–New Mexico) said the problem
was within the FDA’s own culture.“ This culture has been described as
one whereby the pharmaceutical industry, which the FDA is mandated to
regulate, is seen by the FDA as its client instead.(23)
In Graham’s view, drug safety problems began in 1992 with the passage
of a law aimed at getting lifesaving drugs onto the market faster. In
order to increase the FDA approval process, the law forced
pharmaceutical companies to pay for most of the review process’ costs.
That left the FDA “captured by industry,” says Graham. “He who pays the
piper calls the tune.” (24)
The American Society of Health-System Pharmacists reports that Graham
testified “in February [2007] that, had it not been for the protection
of Sen. Charles Grassley (R–Iowa), FDA would have fired him for publicly
speaking out about his concerns about Vioxx® and other drugs.” (25)
Dr. Graham says, “ You need to weed the garden patch of drugs that
aren’t doing what they’re supposed to do. The FDA has not been very good
about that; it likes to cultivate all these weeds.”(26) Dr. Graham
“named five other drugs whose safety is suspect, and noted that ‘the FDA
as currently configured is incapable of protecting America against
another Vioxx®.’” (27) Many media sources present at the hearing, such
as the Los Angeles Times and Medscape Medical News, (28) report that
Graham then added, “ We are virtually defenseless,”(29) but this
sentence does not appear in the final transcript and may have been
stricken from the record.
One report begins, “The American public is ‘virtually defenseless’ if
another medication such as Vioxx® proves to be unsafe after it is
approved for sale, a government drug safety reviewer told a
congressional committee.”(30)
Medicine Today: As Dangerous as Ever
A decade has passed since Dr. Graham’s public statements exposing the
dangerous bad science and corruption and that infests the FDA. It’s
difficult to imagine that such public exposure hasn’t forced the agency
to clean up its act, but the evidence clearly shows that our government
health officials would rather support pharmaceutical profiteering than
the health and safety and American citizens.
The FDA’s questionable operations were put under the spotlight in a 2015 article appearing in JAMA Internal Medicine titled
“ Research Misconduct Identified by the US Food and Drug Administration
Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature,.” The
article is a sobering assessment of the scale of scientific fraud and
deception carried out by the FDA. Author Charles Seife of New York
University examined the nature of the FDA’s inspection of various drug
trials on human participants between 1998 and 2013.
The investigation’s results were stunning:
Fifty-seven published clinical trials were identified for which an
FDA inspection of a trial site had found significant evidence of 1 or
more of the following problems: falsification or submission of false
information, 22 trials (39%); problems with adverse events reporting, 14
trials (25%); protocol violations, 42 trials (74%); inadequate or
inaccurate recordkeeping, 35 trials (61%); failure to protect the safety
of patients and/or issues with oversight or informed consent, 30 trials
(53%); and violations not otherwise categorized, 20 trials (35%). Only 3
of the 78 publications (4%) that resulted from trials in which the FDA
found significant violations mentioned the objectionable conditions or
practices found during the inspection. No corrections, retractions,
expressions of concern, or other comments acknowledging the key issues
identified by the inspection were subsequently published. (31)
These disturbing data suggest that the FDA’s evaluation of
pharmaceuticals for safety and efficacy may be so flawed that only 4% of
all trial results are identified as such. As a result, FDA scientists
and officials responsible for approving drugs to the market are kept
largely uninformed about the egregious scientific misconduct involved in
obtaining study data. Further, these erroneous and fraudulent studies
are published in peer-reviewed scientific literature and accepted as
valid science
Seife commented on the FDA’s staggering scientific impropriety in an article he composed for Slate:
RECORD 4 was one of four large clinical trials that involved
thousands of patients who were recruited at scores of clinical sites in
more than a dozen countries around the world. The trial was used as
evidence that a new anti-blood-clotting agent, rivaroxaban, was safe and
effective. The FDA inspected or had access to external audits of 16 of
the RECORD 4 sites. The trial was a fiasco. At Dr. Craig Loucks’ site in
Colorado, the FDA found falsified data. At Dr. Ricardo Esquivel’s site
in Mexico, there was “systematic discarding of medical records” that
made it impossible to tell whether the study drug was given to the
patients. At half of the sites that drew FDA scrutiny—eight out of
16—there was misconduct, fraud, fishy behavior, or other practices so
objectionable that the data had to be thrown out. The problems were so
bad and so widespread that, contrary to its usual practice, the FDA
declared the entire study to be “unreliable.” Yet if you look in the
medical journals, the results from RECORD 4 sit quietly in The Lancet
without any hint in the literature about falsification, misconduct, or
chaos behind the scenes. This means that physicians around the world are
basing life-and-death medical decisions on a study that the FDA knows
is simply not credible. (32)
How are we supposed to have faith in a medical establishment that is
responsible for the injury and death of thousands of Americans daily?
How else does modern medicine exploit illness for profit and what lies
at the root of this corrupt system? In the next article, we will uncover
more about modern medicine’s deadly repercussions in the lives of
millions of American people.
Endnotes:
- Leape, L. L. 1994. Error in medicine. JAMA, 272 (23):1851–7.
- James, John T. “A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care.” Journal of Patient Safety 9, no. 3 (September 9, 2013): 122-28. Accessed May 9, 2016. doi:10.1097/pts.0b013e3182948a69.
- Cha, Ariana Eunjung. “Researchers: Medical Errors Now Third Leading
Cause of Death in United States.” Washington Post. May 3, 2016. Accessed
May 11, 2016. https://www.washingtonpost.com/news/to-your-health/wp/2016/05/03/researchers-medical-errors-now-third-leading-cause-of-death-in-united-states/.
- Culver AL, Ockene IS, Balasubramanian R, et al. Statin Use and Risk
of Diabetes Mellitus in Postmenopausal Women in the Women’s Health
Initiative. Arch Intern Med. 2012;172(2):144-152. doi:10.1001/archinternmed.2011.625.
- Institute of Medicine, US National Academy of Sciences. November 1999. To Err Is Human: Building a Safer Health System. http://www.iom. edu/Object.File/Master/4/117/ToErr-8pager. pdf (accessed January 25, 2009).
- Center for Drug Evaluation and Research. U.S. Food and Drug
Administration. Preventable Adverse Drug Reactions: A Focus on Drug
Interactions. Last updated July 31, 2002. http:// www.fda.gov/cder/drug/drugReactions/default. htm#ADRs:%20Prevalence%20and%20Inci- dence (accessed January 25, 2009).
- Furberg, C. D., A. A. Levin, P. A. Gross, R. S. Shapiro, and B. L.
Strom. 2006. The FDA and drug safety: a proposal for sweeping changes.
Arch Intern Med 166 (18):1938–42.
- Nichols, Hannah. “Public Health Heart Disease Cancer / Oncology
Stroke The Top 10 Leading Causes of Death in the US.” Medical News
Today. September 21, 2015. Accessed April 21, 2016. http://www.medicalnewstoday.com/articles/282929.php.
- James, John T. “A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care.” Journal of Patient Safety 9, no. 3 (September 9, 2013): 122-28. Accessed May 9, 2016. doi:10.1097/pts.0b013e3182948a69.
- Ibid
- Makary MA, Daniel M. BMJ. 2016 May 3;353:i2139. doi: 10.1136/bmj.i2139.
- Johns Hopkins Medicine. “Medical errors now third leading cause of
death in United States.” ScienceDaily. ScienceDaily, 4 May 2016. <www.sciencedaily.com/releases/2016/05/160504085309.htm>.
- Ibid
- Bourgeois, Florence T., Michael W. Shannon, Clarissa Valim, and
Kenneth D. Mandl. “Adverse Drug Events in the Outpatient Setting: An
11-year National Analysis.” Pharmacoepidemiology and Drug Safety Pharmacoepidem. Drug Safe. 19, no. 9 (September 19, 2010): 901-10. doi:10.1002/pds.1984.
- Tjia, J., Bonner, A., Briesacher, B. A., McGee, S., Terrill, E.,
& Miller, K. (2009). Medication Discrepancies upon Hospital to
Skilled Nursing Facility Transitions. Journal of General Internal Medicine, 24(5), 630–635. http://doi.org/10.1007/s11606-009-0948-2
- Zimmerman S ; Love K ; Sloane PD; et al. Medication administration
errors in assisted living: scope, characteristics, and the importance of
staff training. J Am Geriatr Soc. 2011; 59: 1060-1068
- US Senate Finance Committee. Testimony of David J. Graham, MD, MPH, November 18, 2004. http://finance.senate.gov/hearings/ testimony/2004test/111804dgtest.pdf (accessed January 30, 2009).
- Ibid
- Alonso-Zaldivar, R., FDA Called ‘Defenseless’ Against Unsafe Drugs, Los Angeles Times, November 18, 2004. http://www.mcall.com/topic/ la-111804vioxx_lat,0,7473253.story (accessed January 31, 2009).
- US Senate Finance Committee. Testimony of David J. Graham, MD, MPH, November 18, 2004. http://finance.senate.gov/hearings/ testimony/2004test/111804dgtest.pdf (accessed January 30, 2009).
- National Coalition Against Censorship. FDA Suppressed Vioxx Studies
Despite Evidence of Seri- ous Health Risks, November 25, 2004. http:// www.ncac.org/FDA_Suppressed_Vioxx_Studies (accessed January 30, 2009).
- Alonso-Zaldivar, R., “FDA Called ‘Defense- less’ Against Unsafe Drugs,” Los Angeles Times, November 18, 2004. http://www.mcall.com/ topic/la-111804vioxx_lat,0,7473253.story (accessed January 31, 2009).
- Ibid
- Yale Medicine. FDA’s top safety critic keeps a watchful eye on the
public good, Summer 2005. References • 169 170 •Gary Null, PhD, et al. http://yalemedicine.yale.edu/ym_su05/faces. html (accessed January 31, 2009).
- Young, D., Safety Experts Call for Accountability from FDA, Drug
Firms. American Society of Health-System Pharmacists, March 23, 2007. http://www.ashp.org/import/News/HealthSys- temPharmacyNews/newsarticle.aspx?id=2503 (accessed January 31, 2009).
- Loudon, Manette, interviewer. The FDA Exposed: An Interview With Dr.
David Graham, the Vioxx Whistleblower, parts of this interview appear
in Gary Null’s documentary film, Pre- scription for Disaster,
Garynull.com, August 30, 2005, reprinted by Natural News. http://www. naturalnews.com/011401.html (accessed Janu- ary 31, 2009).
- US Senate Finance Committee. Testimony of David J. Graham, MD, MPH, November 18, 2004. http://finance.senate.gov/hearings/ testimony/2004test/111804dgtest.pdf (accessed January 30, 2009).
- Yale Medicine. FDA’s top safety critic keeps a watchful eye on the public good, Summer 2005. http://yalemedicine.yale.edu/ym_su05/faces. html (accessed January 31, 2009).
- Alonso-Zaldivar, R., FDA Called ‘Defense- less’ Against Unsafe Drugs, Los Angeles Times, November 18, 2004. http://www.mcall.com/ topic/la-111804vioxx_lat,0,7473253.story (accessed January 31, 2009).
- Kelly, J. Harsh criticism lobbed at FDA in Senate Vioxx hearing, Medscape Medical News, November 23, 2004. http://medgenmed.medscape. com/viewarticle/538021_print (accessed January 31, 2009).
- Seife C. Research Misconduct Identified by the US Food and Drug
Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed
Literature. JAMA Intern Med. 2015;175(4):567-577. doi:10.1001/jamainternmed.2014.7774.
- Seife, Charles. “The Food and Drug Administration Covers Up Evidence
of Fraud, Fabrication, and Scientific Misconduct.” Slate Magazine.
February 09, 2015. Accessed April 22, 2016. http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.html.
Supplemental Statistics on Iatrogenic Death in the United States excerpted from Death By Medicine
As shown in Table 1, the estimated total number of iatrogenic
deaths—that is, deaths induced inadvertently by a physician or surgeon
or by medical treatment or diagnostic procedures—in the US annually is
at least 581,926. It is evident that the American medical system is
itself the leading cause of death and injury in the US. By comparison,
approximately 652,091 Americans died of heart disease in 2005, while
559,312 died of cancer.(45) The mortality costs alone exceed $215
billion a year. “Healthcare costs in the United States are growing at an
unsustainable rate,” according to former Senator Ron Wyden, who serves
on the Senate’s Finance Committee, Subcommittee on Healthcare.(46)
The National Coalition on Healthcare reports that annual healthcare
spending in the US has been increasing two to five times the rate of
inflation since 2000.(47) In 2006, Americans spent more than $2.2
trillion on healthcare.(48) Total healthcare spending was $2.4 trillion
in both 2007 and 2008, or $7,900 per person, which represented 17
percent of the gross domestic product (GDP).(70) That’s about 4.3 times
the amount spent on national defense.(71) The total was projected to
reach $3.1 trillion in 2012.(72) The National Coalition on Healthcare
further states:It is estimated that we have spent as a nation nearly 16
trillion dollars on healthcare since 2000, but this expenditure has not
resulted in demonstrably better quality of care or better patient
satisfaction compared to other nations.(73)
Jason Lazarou, MSc, estimated 106,000 annual drug errors in his
groundbreaking 1998 report in the Journal of the American Medical
Association(74) the Institute of Medicine esti-
mated 98,000 annual medical errors. But if we use Dr. Lucian L.
Leape’s 1997 medical and drug error rate of 3 million(75) multiplied by
the 14% fatality rate he used in 1994,76 we find that the number of
deaths would be increased by 216,000, for a total of 797,926 deaths
annually as shown in Table 2.
References:
- Lazarou, J., B. H. Pomeranz, and P. N. Corey. 1998. Incidence of
adverse drug reactions in hospitalized patients: a meta- analysis of
prospective studies. JAMA 279 (15):1200–5.
- Suh, D. C., B. S. Woodall, S. K. Shin, and E. R. Hermes-De Santis.
2000. Clinical and economic impact of adverse drug reactions in
hospitalized patients. Ann Pharmacother 34 (12):1373–9.
- Center for Drug Evaluation and Research. U.S. Food and Drug
Administration. Preventable Adverse Drug Reactions: A Focus on Drug
Inter-
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