Transcript Drug Issues

Drug Issues
Miscellaneous Literature
Deaths from OD of Rx Painkillers Triple in 10
Years
By Kristina Fiore, Staff Writer, MedPage Today
November 01, 2011
Deaths caused by overdoses of prescription
opioid painkillers more than tripled over a
decade, to nearly 15,000 in 2008, CDC
researchers found.
That's up from 4,000 in 1999, Len Paulozzi, MD,
of the CDC, and colleagues reported in
Morbidity and Mortality Weekly Report and in a
Vital Signs brief.
NSAIDs May Up Women's Risk of Crohn's Disease
By Joyce Frieden, News Editor, MedPage Today
Published: November 01, 2011



Reviewed by Robert Jasmer, MD; University of California
WASHINGTON -- Women who use nonsteroidal antiinflammatory drugs -- but not aspirin or acetaminophen
-- have a slightly higher risk of developing Crohn's
disease and ulcerative colitis.
Note that this study was published as an abstract and presented
at a conference. These data and conclusions should be
considered to be preliminary until published in a peer-reviewed
journal.
NSAIDs are so dangerous that it now merits its own
website on negative effects. I do applaud the efforts to
investigate however.
More Hospitalized from NSAID Bleeding
than All American War Casualties
More Hospitalized from NSAID Bleeding
than All American War Casualties
Duration of Treatment With NSAIDs and Impact on Risk of
Death and Recurrent Myocardial Infarction in Patients With
Prior Myocardial Infarction. Olsen et a. May 2010.
Circulation.
Conclusions—Even short-term treatment with
most NSAIDs was associated with increased risk
of death and recurrent MI in patients with prior
MI. Neither short- nor long-term treatment with
NSAIDs is advised in this population, and any
NSAID use should be limited from a
cardiovascular safety point of view.
http://circ.ahajournals.org/content/early/2011/05/09/CIRCULATIONA
HA.110.004671.abstract
Medicare:
Hospital Adverse events. 2010
November 2010. Department of Health and Human Services’ Office
of Inspector General.
• 1 in 7 Medicare patients experience serious harm
because of medical errors and hospital infections each
year, and
• 180,000 patients die, according to a November 2010
study by the Department of Health and Human
Services’ Office of Inspector General.
• That’s nearly double the 98,000 deaths attributed to
preventable errors in the pivotal 2000 report “To Err is
Human,” by the Institute of Medicine, which galvanized
the nation's patient safety movement.
Regular Nonsteroidal Anti-Inflammatory Drug Use and Erectile
Dysfunction.
Gleason et al. Journal of Urology. Received 20 January 2010 published online 21
February 2011.


Nonsteroidal anti-inflammatory drug use and erectile
dysfunction strongly correlated with age with regular
drug use increasing from 34.5% in men at ages 45 to
49 years to 54.7% in men 60 to 69 years old with
erectile dysfunction increasing from 13% to 42%.
Conclusions: These data suggest that regular
nonsteroidal anti-inflammatory drug use is associated
with erectile dysfunction beyond what would be
expected due to age and comorbidity.
FDA System Approves Nonexistent Product from
Nonexistent Company for Human Testing

A sting nailed a company the HHS
authorized to oversee human drug
trials. The absurdities in the
application are belly laugh funny,
but in their rush to keep the money
coming, they approved it.
by Heidi Stevenson
FDA System Approves Nonexistent Product from
Nonexistent Company for Human Testing

First sting:
Congress became suspicious, so they got
together with the General Accountability Office
(GAO) to set up a sting. They sent out an
application for testing of a nonexistent product,
Adhesiabloc, by a nonexistent company,
Device Med-Systems.
FDA System Approves Nonexistent Product from
Nonexistent Company for Human Testing

Second sting:
The name of the fake company was Phake
Medical Devices. The names of the principals
were April Phuls, Timothy Witless, and
Alan Ruse. The company's location was listed
as Chetesville, Arizona.

The applications sailed through.
Compliance With Guideline
Linked to Pneumonia Deaths
Michael Smith, North American Correspondent, MedPage Today
Published: January 20, 2011



Following some treatment guidelines for patients with
nosocomial pneumonia appeared to be associated with an
increased mortality risk, researchers reported.
In an observational study, 34% of patients at risk for multidrugresistant disease and treated empirically according to guidelines
from the American Thoracic Society and the Infectious Diseases
Society of America died within 28 days, according to Daniel
Kett, MD, of the University of Miami, and colleagues.
In contrast, only 20% of patients whose treatment did not
follow the guidelines died,
Uptick in Febrile Seizures Tied to Flu Vaccine
By Todd Neale, Staff Writer, MedPage Today
Published: January 20, 2011
The FDA and CDC have detected an increase in reports
of febrile seizures among children younger than 2 who
received Fluzone, the trivalent inactivated influenza
vaccine made by Sanofi Pasteur.
Fluzone is the only vaccine recommended for use during
the current flu season in infants and children from 6 to
23 months of age.
Secrets of the System
Top Spine Surgeons Reap Royalties, Medicare Bounty
HEALTH INDUSTRY DECEMBER 20, 2010
From 2004 to 2008, Norton performed the thirdmost spinal fusions on Medicare patients in the
country.
The five surgeons are also among the largest
recipients nationwide of payments from medicaldevice giant Medtronic Inc. In the first nine months
of this year alone, the surgeons—Steven Glassman,
Mitchell Campbell, John Johnson, John Dimar and
Rolando Puno—received more than $7 million from
the Fridley, Minn., company.
FDA Warns of Fracture Risk with PPIs
www.medpagetoday.com
By Crystal Phend, Senior Staff Writer, MedPage Today
Published: May 25, 2010
Proton pump inhibitors (PPIs) may increase the risk of
fractures of the hip, wrist, and spine with high-dose or chronic
use, the FDA warned today.
Labeling on drugs in this class -- both prescription and
over-the-counter -- will change to reflect this risk, the agency
said. Prescription PPIs include esomeprazole (Nexium),
dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid),
lansoprazole (Prevacid), pantoprazole (Protonix), and
rabeprazole (Aciphex).
Recurrence up to 3.5 years after antibiotic
treatment of acute otitis media in very young
Dutch children: survey of trial participants


Published 30 June 2009, doi:10.1136/bmj.b2525. Cite this as: BMJ
2009;338:b2525
Conclusion Recurrent acute otitis
media occurred more often in the
children originally treated with
amoxicillin. This is another argument for
judicious use of antibiotics in children
with acute otitis media.
Zocor: FDA Drug Safety Communication:
Ongoing safety review of high-dose Zocor
(simvastatin) and increased risk of muscle injury.
Source: FDA


Safety Announcement
[3-19-2010] Based on review of data from a large
clinical trial and data from other sources, the U.S.
Food and Drug Administration (FDA) is informing the
public about an increased risk of muscle injury in
patients taking the highest approved dose of the
cholesterol-lowering medication, Zocor* (simvastatin)
80 mg, compared to patients taking lower doses of
simvastatin and possibly other drugs in the "statin"
class.
FDA Recommends Temporary Suspension
of Use of Rotavirus Vaccine

By John Gever, Senior Editor; Todd Neale, MedPage Today Staff
Writer Published: March 22, 2010
WASHINGTON -- The FDA is recommending
that clinicians temporarily stop using Rotarix
rotavirus vaccine because of contamination
with viral DNA.
Orlistat and/or Xenical warning



FDA Adds Liver Injury Warning to Diet Drug
WASHINGTON -- The weight-loss medication orlistat,
marketed both by prescription as Xenical (120 mg) and
over-the-counter as Alli (60 mg), will carry a warning
about the potential for severe liver injury, the FDA
announced today.
The agency did note... full story
http://www.medpagetoday.com/InfectiousDisease/Pub
licHealth/tb/20310
Antidepressants Linked to Increased Risk for
Death, Stroke in Postmenopausal Women


Source: December Archives of Internal Medicine, Jordan Smoller, MD,
from Massachusetts General Hospital, Boston,
December 22, 2009 — Postmenopausal women
taking either a tricyclicantidepressant (TCA) or
a selective serotonin-reuptake inhibitor (SSRI)
appear to be at increased risk for all-cause
mortality, and SSRIs users seem to be at
increased risk for hemorrhagic and fatal
stroke, although the absolute event risks are
low, according to an analysis from the
Women's Health Initiative (WHI) study.
Antidepressants Linked to Increased Risk for
Death, Stroke in Postmenopausal Women


TCA use in turn was associated with a 67%
higher relative risk for all-cause death (hazard
ratio [HR], 1.67; 95% confidence interval [CI],
1.33 - 2.09). The TCAs alsoincrease stroke risk,
but not significantly so.
Findings — in the largest cohort of
women yet studied — provide "additional
warning" that antidepressant use does have
certain negative consequences in this
particular demographic.
Recommendations for Prescribing
NSAIDs in the Primary Care Setting
Laurie Barclay, MD


Source: Medscape Medical News December 28, 2009 —
December 15 issue of the American Family Physician
Although NSAIDs are in widespread use,
there are accompanying risks, including:



significant upper gastrointestinal (GI) tract
bleeding (particularly in older persons),
risks in those receiving anticoagulant
therapy, and
risks in patients with a history of upper GI
tract bleeding associated with NSAID use.
Recommendations for Prescribing
NSAIDs in the Primary Care Setting
Laurie Barclay, MD

Despite the cardioprotective qualities of aspirin, other
NSAIDs may have adverse



cardiac effects, including worsening of congestive heart
failure,
increase in blood pressure,
myocardial infarction, and ischemia.
The risk for myocardial infarction is increased with COX-2
inhibitors, although celecoxib, which is the only COX-2
inhibitor still available in the United States, is somewhat
safer regarding cardiovascular effects.
Recommendations for Prescribing
NSAIDs in the Primary Care Setting
Laurie Barclay, MD

Central nervous system adverse effects of
NSAIDs may include:




aseptic meningitis,
psychosis, and
Tinnitus
NSAIDs may also trigger or exacerbate asthma.
In patients with asthma, especially those with nasal
polyps or recurrent sinusitis, NSAIDs and aspirin
should be avoided.
Recommendations for Prescribing
NSAIDs in the Primary Care Setting
Laurie Barclay, MD

During the last 6 to 8 weeks of pregnancy,
NSAIDs should be avoided to prevent
prolonged gestation from inhibition of
prostaglandin synthesis, premature closure of
the ductus arteriosus, and antiplatelet activity
causing maternal and fetal complications.
However, most NSAIDs are likely safe in
pregnancy. In breast-feeding women,
ibuprofen, indomethacin, and naproxen can be
safely used. Parents should be educated
regarding correct NSAID dosing and storage in
childproof containers to prevent accidental
NSAID overdose in children.
Company Recalls Tylenol for Arthritis
By Michael Smith, North American Correspondent, MedPage Today
Published: December 29, 2009



The move expands an earlier partial recall of the product in
November, when five lots were called back after consumers
complained of an "unusual moldy, musty, or mildew-like odor.
It's also the second recall of Tylenol products in two months; a
kids' formulation was recalled in September.
In the arthritis medication, the odor was associated with
nausea, stomach pain, vomiting and diarrhea, the
company said, adding the expanded recall is a precaution.
McNeil makes other Tylenol arthritis products and those
medications remain on sale.
Aspirin kills 400% more people than
H1N1 swine flu

(NaturalNews) The CDC now reports that nearly
4,000 Americans have been killed by H1N1 swine flu.
This number is supposed to sound big and scary,
motivating millions of people to go out and pay good
money to be injected with untested, unproven H1N1
vaccines. But let's put the number in perspective: Did
you know that more than *four times as many people
are killed each year by common NSAID painkillers like
aspirin?*
Aspirin kills 400% more people than
H1N1 swine flu

The July 1998 issue of The American Journal of Medicine explains it as
follows:
"Conservative calculations estimate that approximately
107,000 patients are hospitalized annually for nonsteroidal
anti-inflammatory drug (NSAID)-related gastrointestinal (GI)
complications and at least 16,500 NSAID-related deaths occur
each year among arthritis patients alone."
(Singh Gurkirpal, MD, "Recent Considerations in Nonsteroidal
Anti-Inflammatory Drug Gastropathy", The American Journal of
Medicine, (July 27, 1998, p. 31S)
full story:
http://www.naturalnews.com/027548_swine_flu_vaccines_death_risk.html
Drugs and Falls in the Elderly


Arch Intern Med -- Abstract: Meta-analysis of the Impact of 9
Medication Classes on Falls in Elderly Persons, November 23,
200_http://archinte.ama-assn.org/cgi/content/abstract/169/21/1952)
Background: There is increasing
recognition that the use of certain
medications contributes to falls in
seniors.
Drugs and Falls in the Elderly
An increased likelihood of falling was estimated for
the use of sedatives and hypnotics, neuroleptics
and antipsychotics, antidepressants,
benzodiazepines, and nonsteroidal anti-inflammatory
drugs in studies considered to have
"good" medication and falls ascertainment.
Conclusion The use of sedatives and
hypnotics, antidepressants, and benzodiazepines
demonstrated a significant association with falls in
elderly individuals.
Dutch Pull Pfizer Vaccine Batch After
Infants Die

AMSTERDAM, Nov 5 (Reuters) - Dutch authorities say
they have banned use of a batch of Pfizer Inc's
(PFE.N) Prevenar, or Prevnar, after three infants died
within two weeks of receiving the anti-infection
vaccination.
"On average about 5 to 10 deaths are reported
annually after babies get vaccines," said a
spokeswoman for the Dutch health institute RIVM.
Children Who Get Flu Vaccine Have Three
Times Risk Of Hospitalization For Flu

http://www.sciencedaily.com/releases/2009/05/
090519172045.htm*
Science Daily (May 20, 2009) — The inactivated flu
vaccine does not appear to be effective in preventing
influenza-related hospitalizations in children, especially
the ones with asthma.

In fact, children who get the flu vaccine are more at risk
for hospitalization than their peers who do not get the
vaccine, according to new research that will be
presented on May 19, at the 105th International
Conference of the American Thoracic Society in San
Diego.
Children Who Get Flu Vaccine Have Three
Times Risk Of Hospitalization For Flu


a cohort study of 263 children who were evaluated at
the Mayo Clinic in Minnesota from six months to 18
years of age, each of whom had had laboratoryconfirmed influenza between 1996 to 2006.
children who had received the flu vaccine had three
times the risk of hospitalization, as compared to children
who had not received the vaccine.
"Acupuncture in patients with carpal tunnel
syndrome: A randomized controlled trial“
Yang CP, Hsieh CL, et al, /Clin J Pain/,
2009; 25(4): 327-33.


Acupuncture Treatment as Effective as Drug Therapy for
Carpal Tunnel Syndrome
Subjects in the acupuncture group reported significantly
less nocturnal awakening, as compared to subjects in
the steroid drug group. In addition, subjects in the
acupuncture group reported a significant difference in
distal motor latency compared with subjects in the
steroid group. These results suggest that acupuncture
may be as effective, if not more effective, than steroids
in the treatment of patients with mild-to-moderate CTS.
Gardasil
July 8, 2008 (LifeSiteNews.com)
By Thaddeus M. Baklinski
18 Dead, Thousands Suffer Complications
Growing opposition and flat sales trigger Gardasil
manufacturer Merck stock sell-off
The public interest group Judicial Watch
recently obtained more than 8,000 reports, under the
US Freedom of Information law, of adverse events in
girls and young women after they were injected with
the HPV vaccine Gardasil.
Gardasil
The reports reveal everything from massive
wart outbreaks to seizures, paralysis and
death.
Ten deaths have been reported since
September 2007, bringing the total to 18
since the vaccine was approved for use in
2006.
Zyprexa…Marketed to children and the Elderly
Fox, Douglas Kennedy and AP January 2009




Fox, Douglas Kennedy, Lilly pays $1.42
billion in Zyprexa suit
$36 Billion worth sold “making the fine
seem like a parking ticket”
Clearly the pharmeceutical industry is
interested in profits, not health
http://www.youtube.com/watch?v=o_iXApBe
T5s
Brittany Murphy's Cause of
Death Determined


Posted Feb 4th 2010 12:30PM AOL
According to the coroner's findings, the
32-year-old died of community acquired
pneumonia, iron deficiency anemia and
multiple drug intoxication -- which
included prescription and over-thecounter drugs.
ACG: Low-Dose Naproxen
Increases Ulcer Risk
from Medpage Today October 26, 2009
By Kristina Fiore, Staff Writer. Reviewed by Dori F. Zaleznik, MD;
Associate Clinical Professor of Medicine, Harvard Medical School,
Boston and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse
Planner
SAN DIEGO -- Even at low doses, naproxen
(Aleve, Anaprox, Naprosyn, Naprelan) may
increase the risk of upper gastrointestinal
complications, researchers said here.
ACG: Low-Dose Naproxen
Increases Ulcer Risk (cont’d)


Patients taking a 500-mg/day dose had a 2.5-fold
increased risk of hospitalization from complicated
gastric or duodenal ulcer, while those on the 750mg/day dose had almost a threefold increased risk,
Gurkirpal Singh, MD, of Stanford University, and
colleagues reported at the American College of
Gastroenterology meeting.
The 1,000-mg/day dose carried more than a
threefold increased risk of hospitalization.
March 10, 2009 in Health
A Medical Madoff: Anesthesiologist Faked
Data in 21 Studies

A pioneering anesthesiologist has been
implicated in a massive research fraud
that has altered the way millions of
patients are treated for pain during and
after orthopedic surgeries.
A Medical Madoff: Anesthesiologist Faked
Data in 21 Studies

Over the past 12 years, anesthesiologist Scott
Reuben revolutionized the way physicians provide
pain relief to patients undergoing orthopedic surgery
for everything from torn ligaments to worn-out hips.
Now, the profession is in shambles after an
investigation revealed that at least 21 of Reuben's
papers were pure fiction, and that the pain drugs he
touted in them may have slowed postoperative
healing.
A Medical Madoff: Anesthesiologist Faked
Data in 21 Studies
"We are talking about millions of patients worldwide,
where postoperative pain management has been
affected by the research findings of Dr. Reuben,"
says Steven Shafer, editor in chief of the journal
Anesthesia & Analgesia, which published 10 of
Reuben's fraudulent papers.
A Medical Madoff: Anesthesiologist Faked
Data in 21 Studies
Paul White, another editor at the journal, estimates that
Reuben's studies led to the sale of billions of dollars
worth of the potentially dangerous drugs known as
COX2 inhibitors, Pfizer's Celebrex (celecoxib) and
Merck's Vioxx (rofecoxib), for applications whose
therapeutic benefits are now in question. Reuben was a
member of Pfizer's speaker's bureau and received five
independent research grants from the company. The editors do
not believe patients were significantly harmed by the short-term
use of these COX2 inhibitors for pain management but they say
it's possible the therapy may have prolonged recovery
periods.
CDC Announces Change in Recommendations for use of
Antivirals; Clinicians Should not Prescribe Two Common
Antivirals.
1/14/2006 Sourced from the CDC.



Amantadine and rimantadine should not
be prescribed to treat or prevent
influenza during the 2005-2006 flu
season.
“Predominant strain of influenza (H3N2)
currently circulating in the US shows
that it is resistant to these drugs.”
109 or 120 isolates were resistant.
Mumps epidemic gains steam;
vaccine urged.
4/20/06 USA Today.



“The Iowa Department of Public Health
reports that 64% of the state’s cases have
been in people who got two doses of a
measles-mumps-rubella, or MMR, vaccine.”
“We have absolutely no information to
suggest there’s any problem with the
vaccine”.
“The problem is with the lack of complete
coverage with the vaccine.”
Study: Medical manual’s authors often tied to
drugmakers.
Thursday 4/20/06 USA Today.


“A majority of medical experts who created
the ‘bible’ for diagnosing mental illness have
undisclosed financial links to drugmakers.”
“Some panels overseeing disorders that
require treatment with prescription drugs,
such as schizophrenia and ‘mood disorders’
were 100% filled with experts financially tied
to the pharmaceutical industry, says the
study published in the journal Psychotherapy
and Psychosomatics.”
Antibiotics may have affected Milosevic,
Took unprescribed drug, expert says.
Tuesday 3/14/06 USA Today

“Uges, the Dutch toxicologist, said he
discovered traces of rifampicin in
Milosevic’s system - ‘a drug that
makes the liver extremely active’ and
can undermine the effectiveness of
other medications.”
“Medical Errors Make the Headlines Again. New
Report Doubles Previous Estimate of Annual
Deaths.”
Dynamic Chiropractic 9/27/04


“According to an analysis released by the health care
quality company HealthGrades, up to 195,000
Americans die each year as a result of potentially
preventable, in-hospital medical errors.”
“That figure is nearly twice the number of annual
medical errors-related deaths published in a report by
the Institute of Medicine (IOM) just five years ago,
and make medical mistakes the third-leading cause
of death in the US behind heart disease and cancer.”
Source: HealthGrades Quality Study. Patient Safety in American Hospitals.
Published July 2004
Plavix added to aspirin proves risky.
AP 2006


“People taking the blood thinner Plavix on top
of aspirin to try to prevent heart attacks, as
many doctors recommended, now have good
reason to stop.”
“The drug combination not only didn’t help
most people in a newly released study, but it
unexpectedly almost doubled risk of death,
heart attack, or stroke with those with no
clogged arteries but with conditions like high
blood pressure and high cholesterol.”
Gurkirpal Singh, George Triadafilopoulos, Epidmiology of NSAID induced
gastrointestinal complications. J. Rheumatol 1999, Apr;26 Suppl 56:18-24.
Department of Medicine, Division of Immunology, Stanford University
School of Medicine, Palo Alto, California 94304, USA.


NSAIDs are one of the most commonly used classes of
medications worldwide. 30 million people take NSAIDs daily.
GI complications are the most prevalent category of adverse
drug reactions. Patients with arthritis are the most frequent
users, therefore at greater risk.
NSAID related deaths among patients with RA and OA are even
more startling. It is conservatively estimated that 16,500
NSAID-related deaths occur in these patients every year
in the US.

15th most common cause of death in the US.

Stats DO NOT include nonarthritis indications.
Wolfe, M.D., Lichtenstein, M.D., Singh, M.D.
Gastrointestinal Toxicity of Nonsteroidal Antiinflamatory Drugs. The New
England Journal of Medicine, June 17, 1999, Review Article, Medical
Progress.





113 References.
NSAID agents constitute one of the world’s most widely used classes of drugs,
with more than 70 million prescriptions and more than 30 billion over-thecounter tablets sold annually in the US.
“Although the annual mortality rate is low, it must be emphasized that because
a large number of patients are exposed to NSAIDs often for extended periods of
time, the risk over a lifetime is substantial.”
Hospitalization due to GI complications 103,000/yr. Estimated cost $15,000 to
$20,000 per hospitalization. Annual cost exceeds $2 Billion.
“It has been estimated conservatively that 16,500 NSAID-related
deaths occur among patients with RA and OA every year in the US.”
Wolfe, M.D., Lichtenstein, M.D., Singh, M.D.
Gastrointestinal Toxicity of Nonsteroidal Antiinflamatory Drugs. The New
England Journal of Medicine, June 17, 1999, Review Article, Medical
Progress. (cont’d)





Doses of aspirin as low as 30 mg are sufficient to suppress prostaglandin
synthesis in the gastric mucosa initiating gastric-duodenal mucosal injury,
resulting in the release of oxygen-derived free radicals.
Peptic ulcers-gastroduodenal hemorrhage-perforation-death!
Acetaminophen is nontoxic to the GI mucosa, however, recall that
acetaminophen is a leading cause of end-stage renal disease.
Cox-2 inhibitors will hopefully have a reduced capacity to cause injury to the
gastroduodenal mucosa.
However, Cox-2 inhibitors are also known to cause defects in renal function,
alter the regulation of bone resorption, impair female reproductive physiology,
and increase the rate of thrombotic events in patients with increase risk for
cardiovascular disease.
Dabbs, D.C. and Lauretti, D.C., A Risk Assesment of Cervical
Manipulation vs. NSAIDs for the Treatment of Neck Pain. Journal of
Manipulative and Physiological Therapeutics. Vol. 18, number 8
Oct. 1995; 18:530-6.



“The best evidence indicates that cervical manipulation for neck
pain is much safer than the use of NSAIDs, by as much as a
factor of several hundred times. There is no evidence that
indicates NSAID use is any more effective than cervical
manipulation for neck pain.”
Death rate for NSAID-associated GI problems at 0.04% per yr
amoung OA patients receiving NSAIDs, or 3,200 deaths in the
US per year.
He (Brandt) also noted that there are several animal studies and
human clinical studies that have actually implicated NSAIDs in
the acceleration of joint destruction.
The Association of Acetaminophen, aspirin, and ibuprofen with
respiratory disease and lung function. McKeever et al. American
Journal of Respiratory and Critical Care Medicine. 2005 May
1;171(9).


Cross-sectional analysis using the Third
National Health and Nutrition Examination
Survey.
Conclusion: This study provides further
evidence that the use of acetaminophen is
associated with an increased risk of asthma
and COPD, and with decreased lung function.
FDA MedWatch: Ketek (telithromycin): Reports of
Serious Liver Toxicity.

Annals of Internal Medicine published an
article reporting three patients who
experienced serious liver toxicity following
administration of Ketek (telithromycin).
These cases were reported to FDA
MedWatch.
Source: MedWatch 2006 Safety Summary:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Ketek.
FDA FedWatch: Cylert and Generic Pemoline Products
Withdrawn From the Market Due to Liver Toxicity.


Cylert, a central nervous system
stimulant indicated for the treatment of
ADHD is considered second line therapy
for ADHD because of its association
with life threatening hepatic failure.
Source:
http://imageb.epocrates.com/mailbot/links?EdID=20381927&LinkID=2446
“Antidepressants Get FDA’s “Black Box”
Warning. Linked to Suicidal Thoughts/Behavior
in Children Dynamic Chiropractic Nov. 30, 2004
“On October 15, 2004 the Food and Drug
Administration (FDA) issued a public health
advisory directing manufacturers of all
antidepressant drugs to revise their product
labeling to include a “black box” warning. The
warning is intended to alert health care
providers of an increased risk of suicidal
thoughts and behavior in children being treated
with the drugs.”
Source: FDA launches a multi-pronged strategy to strengthen safeguards for
children treated with antidepressant medications. FDA News, Oct. 15, 2004:
www.fda.gov/bbs/topics/news/2004/NEW01124.html.
“FDA to Probe Antidepressant Risks for Adults…After
Planning Warning for Kids, Agency to Re-Examine
Evidence Suggesting No Danger of Suicide.”
“It’s unclear why some drugs, including
Prozac, Paxil, and Zoloft, could increase
suicidal tendencies only in a small subset
of young people, and not adults. One
theory is that younger people may have
less control over their impulses, or less
ability to cope with or understand an
unexpected drug effect.”
Source: The Wall Street Journal 9/28/04
More Antidepressant Warnings
Investor’s Business Daily Thursday, Dec. 14, 2006
The FDA called for warnings on labels of
antidepressants, cautioning that the
drugs could increase the risk of suicidal
behavior in users up to age 24. The
warning currently is limited to youths
under 18. Drug makers said the
change should not hurt sales.
Antidepressants such as Pfizer’s Zoloft
and Wyeth’s Effexor, garner over $17
billion in annual US sales.
Rate of Breast Cancer Drops
USA Today Friday, Dec. 15, 2006


Breast cancer rates fell 7% in
2003, the year after millions of
older women abandoned hormone
replacement therapy based on the
findings of a government report.
Researchers: Houston’s MD
Anderson Center
“Warning Advised on ADHD Drugs.”
“FDA committee urges strongest notification.”
“…8-7 vote…black box warning”
“…include Ritalin, Adderall, Focalin, Methylin, Metadate,
and Concerta.”
“An FDA report released prior to the meeting said that 25
children and adults had died suddenly from 1999 to 2003
after taking ADHD drugs.”
Source: USA Today Fri/Sat/Sun Feb. 10-12, 2006
“Eczema Drug Labels to warn
of potential cancer risk”



FDA…”black box” warning (long-term safety
of these drugs has not been established.)
Elidel and Protopic
..animals developed cancer in drug studies.
…should not be used on infants.
Source: USA Today 1/26/06
OxyContin





U.S. News and World Report, July 2, 2001
“Not an appropriate use”, “Did the makers of
OxyContin push too hard?”
Virginia residents filed a $5.3 billion class action
lawsuit that alleges Pharma also failed to disclose the
drug’s risks, setting off a wave of OxyContin
addiction and abuse.
Associated deaths jumped 93% between 1997 and
1998.
DEA reported 291 deaths in just 6 states.
NUTLEY, N.J. (July 15) - Mother's little
helper is not so little anymore.




Valium, the drug that revolutionized the treatment of
anxiety and became a cultural icon, is 40 years old
this year.
Invented by chemist Leo Sternbach
Approved for use in 1963, became the country's most
prescribed drug from 1969 to 1982.
The Roche Group, Hoffman-La Roche's parent,
sold nearly 2.3 billion pills stamped with the
trademark ``V'' at its 1978 peak.
Baycol-Cholesterol drug




The Columbus Dispatch, August 9, 2001
“Bayer pulls medicine tied to 31 U.S.Deaths”
Baycol has been linked to significantly more fatal
cases than its competitors, Dr. John Jenkins of the
FDA
Other drugs include Lescol, Lipitor, Mevacor,
Pravachol, Zocor
Baycol-Cholesterol drug


“Every statin has been linked to very rare reports of
the muscle side effect called rhabdomyolysis.”
Baycol is the 12th prescription drug taken off the
market since 1997.
Allergy Pills Overused



Study out of OSU, reported in Columbus Dispatch,
Monday, April 9, 2001
Of 246 North Carolina residents taking prescription
antihistamines, blood tests showed 65 percent didn’t
have allergies.
Skill testing unreliable vs. Blood tests
“Side Effects: As Drug-Sales Teams Multiply, Some
Doctors Shut Them Out”







Wall Street Journal, 6-13-03
“’Arms Race’ by Pfizer, Rivals Boost Pill Prices and
Ire, But No One Dares Retreat.”
“Free Tacos and Piles of Bextra”
90,000 drug industry reps
$12 Billion spent on sales force
$2.76 billon on consumer drug ads.
Result: Prescriptions up 14% to $161 Billion spent on
drugs in 2002!!!!
Antibiotics and Breast Cancer
February 17, 2004 JAMA
The longer that women took the drugs, and the more
prescriptions they took, the greater their risk of
breast cancer.
Bug Mutates into Medical Mystery. Antibiotics,
Heartburn Drugs, Suspected.



“First came stomach cramps, which left Christina Shultz doubled over
and weeping in pain. Then came nausea and fatigue-so overwhelming
she couldn’t get out of bed for days. Just when she thought things
couldn’t get worse, the nastiest diarrhea of her life hit-repeatedly
forcing her into the hospital.”
Bacterial infection: Clostridium difficile
“It may, however, be the lastest example of a common,
relatively benign bug that has mutated because of the overuse
of antibiotics.”
Source: The Washington Post (http://www.washingtonpost.com/wp-srv/front.htm)
Continuous Low-Level Heat Wrap Therapy Provides More Efficacy Than
Ibuprofen and Acetaminophen for Acute Low Back Pain
Scott F. Nadler, DO, et al. SPINE 2002;27:1012-1017
Conclusion. Continuous low-level heat
wrap therapy was superior to both
acetaminophen and ibuprofen for
treating low back pain.
Antibiotics may have affected Milosevic.
Took unprescribed drugs, expert says.

Slobodan Milosevic-died in his jail cell.
“Uges, the Dutch toxicologist, said he
discovered traces of rifampicin in Milosevic’s
system-a drug that ‘makes the liver
extremely active’, and can undermine the
effectiveness of other medication.”
Source: USA Today 3/14/06
How did our society get so
sick?

Two industries primarily responsible


Food Industry
Pharmaceutical Industry
(“The Next Trillion” by Paul Zane Pilzer)
Do you really believe either industry is truly
interested in your health, versus generating profits
by keeping you heavy, unhealthy and drug
dependant?
Medical Mistakes: The 3rd
Leading Cause of Death





JAMA, July 26, 2000 Vol. 284. No. 4
225,000 deaths/yr = 3rd leading cause
of death
3rd only to heart disease and cancer!!
Estimates are for death only and do not
include adverse effects associated with
disability or discomfort.
Estimates are low!
Epidemiology





BMJ March 4, 2000
44,000 to 98,000 unnecessary
deaths/yr and 1,000,000 excess
injuries.
Clinicians inexperienced
New procedures introduced
Extremes of age, complex care, urgent
care, and prolonged hospital stay
Medical Errors




JAMA, July 26, 2000 Vol. 284. No. 4
44,000 to 98,000 die/yr - Medical errors
Of 13 countries, US ranks 12th of 16
indicators (second from the bottom!)
WHO ranked US 15th of 25
industrialized countries
Medical Errors-Patient Risks

“Blunders take 400,000 lives every year, Kaiser head says”
(By Robert A. Rosenblatt, LOS ANGELES TIMES Oakland Tribune,
July 15, 1999)



"Mistakes alone kill more people each year than tobacco,
alcohol, firearms or automobiles."
"If passengers were asked to fly with a commercial airline
organized like most health care, they wouldn’t get on the
plane.“
Kaiser is the US’s largest HMO. The 400,000 deaths per year
caused by medical mistakes is the largest number I have seen
in print so far.
JAMA - Hospital Deaths







JAMA, July 26, 2000 Vol. 284. No. 4
12,000 deaths/yr - unnecessary surgery
7,000 deaths/yr - medication errors in
hospitals
20,000 deaths/yr - other hospital errors
80,000 deaths/yr - nosocomial infections
106,000 deaths/yr - adverse rxn, nonerror
225,000 deaths/yr - iatrogenic causes
Let’s Talk About Error




BMJ March 2000
While reading this article, 8 injured and
one will die.
Likelihood of injury at least 3% in hosp.
“Reported error rates would go up since
we underreport errors and near misses
by a factor of 10.”
Shrimp Dodging Injury Blamed
for Death



Jan. 13, 2006 News Bulletin
Family seeking $10 million in damages,
claiming he died from a neck injury months
after ducking to avoid a shrimp tossed by a
hibachi chef at a Japanese restaurant.
Patient, Jerry Colaitis, 43, died from
complications (infection) caused by neck
surgery he required afterward.
Wall street journal,4/22/03 Page 1, section d
Saying No to the Knife...


Apparently, research now shows that
surgery for back problems, gum
disease, hernias, sinus problems, and
injured kidneys, to name a few, are not
necessary much of the time.
And the effects of the surgery are
apparently often worse than the
condition treated.
Antibiotics and Breast Cancer
February 17, 2004 JAMA
The longer that women took the drugs,
and the more prescriptions they took,
the greater their risk of breast cancer.
Aspirin in Gastric Ulcer

76 year old women

NEJM Levy MD, Vol. 343 Number 12




400 mg. Etodolac 2x/day for RA
1 tablet of enteric-coated aspirin / day
1 mg. of warfarin sodium per day
Endoscopy revealed aspirin tablet intact
with an ulcer of gastric antrum.
Results of Errors








JAMA, July 26, 2000 Vol. 284. No. 4
116 million extra physician visits
77 million extra prescriptions
17 million emergency department visits
8 million hospitalizations
3 million long-term admissions
199,000 additional deaths
$77 billion in extra costs
Error Underreporting



BMJ March 4, 2000
100,000 deaths with many more
incurring injuries at an annual cost of
$9 billion.
“Underreporting of adverse events is
estimated to range from 50%-96%
annually.”
BMJ Statistics




BMJ March 2000
100,000 preventable deaths per year in US
according to the Institute of Medicine
Exceeds the combined deaths and injuries
from motor and air crashes, suicides, falls,
poisonings, and drownings.
Australia produced even higher rates of error.
President Clinton




BMJ March 4, 2000
“44,000 to 98,000 Americans die each year
from medical mistakes.”
The President will ask Congress for $20
million to create a Center for Quality
Improvement and Patient Safety.
Former president of AMA, Dr. Nancy Dickey,
opposed to mandatory reporting.
Chiropractic Manipulation…
The Great Flu Pandemic demonstrated
that patient receiving Osteopathic spinal
manipulation had a greater chance of
survival.
According to RAND, Chiropractors
perform 94% of all spinal manipulation
today.
Muscle Relaxants
“Muscle Relaxants: Overused, Ineffective and
Acute LBP”
Bernstein E, Carey TS, Mills Garrett J. The use of muscle relaxant
medications in acute low back pain. Spine 2004;29(12):1346-51.



Cohort of 1600..MC-LBP.
…while muscle relaxant use was quite common among patients
with acute LBP, the drugs did not help patients return to normal
functioning more quickly than patients not taking muscle
relaxants, and in fact, were associated with an increase in
the time it took for patients to recover from pain.”
Return to functional recovery: 16.2 days vs. 32.4 days ( m.
relaxants)
“Arthritis drugs may boost risk of blood clotting,
heart attacks” AP Friday, April 19, 2002
RE: Vioxx and Celebrex
“New research bolsters the growing
suspicion that some popular arthritis drugs
could increase certain people’s risk of
heart attacks by causing a chemical
imbalance that spurs blood clots.”
Based on University of PA study in Science
“Merck Recalls Blockbuster Arthritis Drug Vioxx”
AOL News 9/30/04
RE: Vioxx
“The arthritis drug Vioxx, used by two million
people around the world, is being pulled
off the market after a study confirmed
long-standing concerns that it raises the
risk of heart attack and stroke, the maker,
Merck and Co., said Thursday.”
“Another drug for pain off market”
Risk vs. benefit for Bextra cited”
USA Today Fri/Sat/Sun, April 8-10, 2005
RE: Bextra
“The Food and Drug Administration announced
Thursday that Pfizer has agreed to stop selling
Bextra, a popular arthritis drug, because its risks
outweigh its benefits”
Black Box warnings will highlight the drugs’
(Celebrex, Ibuprofen, naproxen, etc) risks of
heart attacks, strokes, and bleeding of the
digestive tract
“Methadone overdose killed activist, coroner
reports” Columbus Dispatch 6/12/03
RE: Methadone
“The former grade-school dropout, gang member
and ex-con, whose dramatic turnaround inspired a
recent TV movie, died May 2 of an accidental
overdose of methadone, Franklin County Coroner
Brad Lewis ruled this week”
Note: An occurrence so common it doesn’t even raise an eyebrow anymore!
“Hormone therapy raises dementia, stroke risk”
Columbus Dispatch 5/28/03
RE: Hormone Replacement Therapy,
estrogen and progestin.
“…new research shows women 65 or older
who take the drug face twice the risk of
developing dementia, including Alzheimer’s
disease….higher risk of stroke in those
between 50-79 years old”
Based upon: May 2003 issue of JAMA
“Hormone Therapy is Risky, Study Warns”
Columbus Dispatch 7/9/02
“Hormone replacement therapy…….should not be taken long-term
because it carries more risks than benefits, national researchers…”
“The message is that estrogen plus progestin should not be used for
the prevention of heart disease and other chronic diseases.”
The study had been intended to run until March 2005, but the
study was suspended……….
“The letter informed study participants that for every 10,000
women taking HRT, experts could predict that 7 additional
women would have heart attacks compared to those
getting the placebo.”
“Smallpox plan to be unveiled. Vaccine could
endanger millions” USA Today 12/13-15/2003
“…some authorities fear mass public
vaccinations could put many people
at risk, especially those with
weakened immune systems who are
vulnerable to infection from the live
virus used to make smallpox vaccine,
say numerous smallpox experts”
Headlines related to Smallpox
USA Today 12/13-15/2003
“Individuals must weigh risks of inoculations”
“Disease symptoms, risk of vaccine and
government’s plan”
“For 60 million, the cure may kill”
“States on track to vaccinate public when
liability coverage kick in”
Analgesic overuse among subjects with
headaches, neck and low back pain.
Zwart et al, Neurology, May 11, 2004;62:1540-44


Up to 50% of all cases of chronic headaches are attributable to
medication overuse. (Compared to a person who doesn’t take
them.)
Taking daily analgesics for more than 6 mns:




=20x more likely to suffer chronic migraines.
=10x more likely to suffer nonmigraine HAs.
=3.5x more likely to suffer chronic neck pain.
=3.5x more likely to suffer chronic LBP.
Note: 65,000 persons age 20 and older completed the survey.
“Prescription Drug Use Reaches Epidemic
Proportions” Dynamic Chiropractic Feb 12, 2005



Health, United States, 2004, With Chartbook on Trends in the Health of
Americans. National Center for Health Statistics. Hyattsville, Maryland,
2004.
Citizens taking one drug: 39.1% (1994) to 44.3% (2000)
Citizens taking 3 or more prescription drugs:
11.8% (1994) to 16.5.% (2000)
Seniors taking more than 1 drug, with 50% taking more than 3
drugs.
Children are becoming major consumers of drugs, on par with
parents.
The policy of prescribing multiple drugs simultaneously has
become standard practice for most medical doctors and
hospitals.
“Whooping Cough: Vaccines Not Stopping
Global Rise of Disease” AP, Columbus Dispatch Sunday 4/28/02
“Whooping cough, largely regarded as an infant disease,
is making a global comeback in all age groups.”
“Scientists don’t know why, but they suspect that
protection from immunization wears off after a few
years and that the bug has outsmarted vaccines used
to control it for decades.”
“….bacterium may have evolved that are resistant to
the vaccines used in some countries”
“Heart Attack risks leads to Vioxx Recall”
AP,
Columbus Dispatch Sunday 10/1/04
“Vioxx, the blockbuster arthritis drug
heavily promoted on TV and taken by tens
of millions of people, was pulled from the
market by its maker yesterday after a study
found it doubled the risk of heart attacks
and strokes.”
“Popular antibiotic increases heart risk”
AP, Columbus Dispatch Sunday 9/9/04
“A widely used antibiotic long considered safe
dramatically increases the risk of cardiac arrest,
particularly when taken with some popular drugs
for infections and high blood pressure, a study
found.”
“The drug is erythromycin, which has been on the
market for 50 years and is prescribed for
everything from strep throat to syphilis.”
Source: NEJM 9/9/04
“Drug-Resistant Germs…Hospital Infections
Spread into Community”
AP, Columbus Dispatch Sunday 6/23/02
“Lapses in infection control and overuse of
antibiotics are spawning drug-resistant
germs that are spreading from hospitals
into the community at unprecedented
rates.”
“Super Germs”
Over-The-Counter Drugs
Medication, moderation must mix
Columbus dispatch

“A New York high school track star’s
death from an overdose of the key
ingredient in Ben Gay and other sports
creams is a reminder to take all
medications seriously regardless of how
innocuous they may sem, experts say.”
Mirroring National Trend
Painkill use soaring for Ohioans
Columbus dispatch/AP August 21, 2007


Laura Krietemeyer, 42, a former
neurologist. Neurofibromatosis.
“…..Ohio doctors are more likely to ask
their patients about pain and prescribe
drugs for pain.”
Surgical vs. Nonoperative Treatment for Lumbar
Disk Herniation. The Spine Patient Outcomes
Research Trial (SPORT): a Randomized Trial
Weinstein et al. JAMA 2006;296:2441-50






Second study: JAMA 2006;296:2451-9
Suggests surgery is no more effective than
nonoperative treatments, including
chiropractic, for patients with lumbar disk
herniation causing sciatica.
Pts b/w March 2000 and November 2004
13 multidisciplinary spine clinics in 11 states
501 pts; mean age of 42 yrs.
MRI confirmed and symptoms for at least 6 weeks.
Surgical vs. Nonoperative Treatment for Lumbar
Disk Herniation. The Spine Patient Outcomes
Research Trial (SPORT): a Randomized Trial
Weinstein et al. JAMA 2006;296:2441-50

“Patients are often told that if they delay surgery,
they risk permanent nerve damage, leg weakness,
and even loss of bowel or bladder control. This is not
the case. According to this study, the symptoms will
resolve over a two-year period, even if the patient
does nothing. “

[Deborah Pate, DC commenting]
Elderly Could Live Without Their Flu Shots, New
Study Finds
AP article: The Columbus Dispatch Tuesday Feb. 15, 2005




Chicago- A new study based on more than 3 decades
of US data suggests that giving flu shots to the
elderly has not saved any lives.
NIH study
Study’s lead author: Lone Simonsen
However the CDC and Prevention in Atlanta plans no
change in its advice on who should get flu shots,
saying the NIH research isn’t enough to shift gears.
FDA Calls for Boxed Warning on
Fluoroquinolones
June/July 2008

Patients at higher risk for tendon problems while taking these
antibiotics include those who are:
* over age 60;
* taking corticosteroids;
* recipients of kidney, heart, or lung transplants.


The fluoroquinolones include ciprofloxacin, gemifloxacin,
levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.
Patients should contact their healthcare provider and stop
taking fluoroquinolones at the first symptoms of tendon pain,
swelling, or inflammation. They should also avoid exercise
during this time.
CT scans
Los Angeles Times Staff Writer September 7, 2008
“CT Scans can be better medicine for doctors than for
patients.”



Radiation dose equivalent to more than a dozen standard abdominal
X-rays
MD/DO’s ordered 68.7 million CT scans last year, more than triple the
number in 1995
Generating tens of billions of dollars in billing each year, CT scanning
has become an economic engine for hospitals and doctors, and the
once-exotic million-dollar devices are starting to be found in private
practices.
Medication Mistakes
Archives of Internal Medicine 2008

“On Monday, the Archives of Internal
Medicine published its study of nearly
50 million U.S. death certificates and
found that deaths from medication
mistakes in the home increased by
more than 700 percent over the last 20
years.”
Medication Mistakes
Archives of Internal Medicine 2008

“The increase in deaths was highest
among baby boomers, people in their
40s and 50s. In addition, medical
noncompliance causes more than 40
percent of all nursing home admissions
and adds $200 billion annually to the
U.S. healthcare bill.”
Cutting health costs by paying doctors more?
July 21, 2008 NEW YORK TIMES

Robert Williamson, a 60-year-old
Philadelphia man, recalls the cursory
exam he received a few years ago from
a harried doctor who, Mr. Williamson
says, missed the danger signals and
sent him home. A short time later Mr.
Williamson had a stroke.
Cutting health costs by paying doctors
more?
July 21, 2008 NEW YORK TIMES

For want of a careful examination by a primary-care
doctor, Mr. Williamson became one of countless
Americans each year whose unidentified or undertreated illnesses escalate into medical conditions with
catastrophic personal and economic costs.

Besides incurring $30,000 in hospital bills paid by his
employer’s insurer, Mr. Williamson had to stop
working as a customer service representative at
Philadelphia Gas Works and go on Social Security
disability, at a current cost to taxpayers of $1,900 a
month.
FDA Updates Pancreatitis Warning on
Diabetes Drug





Associated Press story (Free)
The FDA is alerting physicians to six reports of
hemorrhagic or necrotizing pancreatitis in patients using
the diabetes drug exenatide (Byetta).
Two of those patients died.
In October 2007, the agency first warned physicians of a
possible link
between exenatide and acute pancreatitis, but there
were no reports of
hemorrhagic or necrotizing pancreatitis at that time.
The FDA says patients should not be given exenatide if
pancreatitis is
suspected. In addition, the drug should not be restarted
after treatment for confirmed pancreatitis.
Antibiotics account for 19% of emergency
department visits in US for adverse events
Published 15 August 2008, doi:10.1136/bmj.a1324


Adverse events associated with antibiotics result in
more than 142 000 visits a year to hospital
emergency departments in the United States. The
drugs were implicated in 19% of all emergency
department visits for drug related adverse events.
The rate among infants aged 12 months old or
younger was 50% greater than the overall figure, at
15.9 visits per 100 000 prescriptions.
*Red Bull Drink Seen to Increase Stroke
Risk*
By Rob Taylor CANBERRA (Reuters) Aug 15


Just one can of the popular stimulant
energy drink Red Bull can increase the risk of MI or
stroke, even in young people, Australian medical
researchers said on Friday.
The results showed "normal people develop symptoms
normally associated with cardiovascular disease" after
consuming the drink, created in the
1980s by Austrian entrepreneur Dietrich Mateschitz
based on a similar Thai energy drink.
Tons of drugs dumped into wastewater. Discarded
medications end up in drinking water, ongoing report finds.
AP updated 4:16 p.m. ET, Sun., Sept. 14, 2008


U.S. hospitals and long-term care facilities
annually flush millions of pounds of unused
pharmaceuticals down the drain, pumping
contaminants into America's drinking water,
according to an ongoing Associated Press
investigation.
These discarded medications are expired,
spoiled, over-prescribed or unneeded. Some
are simply unused because patients refuse to
take them, can't tolerate them or die with
nearly full 90-day supplies of multiple
prescriptions on their nightstands.
Scariest Hospital Risks
Forbes 2008

At least 1.5 million Americans fall prey to
hospital error every year. The mistakes aren't
exactly minor, either. Between 40,000 and
100,000 people die every year because of
shoddy handiwork, including surgical mishaps
and drug mix-ups. The death toll from
mistakes is at least as bad as that from car
accidents or breast cancer, and maybe as bad
as that from strokes.
Scariest Hospital Risks
Forbes 2008
1.
2.
3.
4.
5.
6.
7.
Surgeon Error
Infected Incisions
Bleeding (blood thinners, etc.)
Getting sicker in hospital
Pneumonia
Infected catheter
Getting the wrong medication
Hypercholesterolaemia
Reasons to be cautious about cholesterol
lowering drugs
BMJ 2008;337:a1493

There are reasons to be cautious about
prescribing all cholesterol lowering drugs.1
The West Midlands Centre for Adverse Drug
Reactions, which produces the Adverse Drug
Reaction Bulletin, has recently issued a
warning via the Food and Drug Administration
(FDA) concerning a potentially increased risk
of cancer associated with simvastatin and
ezetimibe when used in combination
(Vytorin).2
Hypercholesterolaemia
Reasons to be cautious about cholesterol
lowering drugs
(cont’d)


The FDA is apparently investigating a report from the
simvastatin and ezetimibe in aortic stenosis trial. This
trial tested whether lowering low density lipoprotein
cholesterol with Vytorin would reduce the risk of
cardiovascular events in people with aortic stenosis.
A lower overall cardiovascular risk was not found with
Vytorin. However, the trial found that a larger
proportion of subjects treated with Vytorin
were diagnosed with and died from all types of
cancer combined compared with those given
placebo during the five year study.
Merck Paid Elsevier to Publish Phony PeerReview Journal
Tuesday, 05 May 2009
http://www.ahrp.org/cms/content/view/585/9/

“Merck is reported to have created
a fake "peer-reviewed" journal to
present favorable data that made
its potentially fatal drugs—
Fosamax and Vioxx--look good.”
Merck Paid Elsevier to Publish Phony PeerReview Journal
Tuesday, 05 May 2009
http://www.ahrp.org/cms/content/view/585/9/

Documents uncovered during the Australian
class action lawsuit involving 1,000 consumers,
against Merck & Co and its Australian
subsidiary, Merck Sharpe and Dohme, are
shocking even to hardened critics of
pharmaceutical industry corrupt practices.

Reports are swirling about Merck's
underhanded marketing scheme evidently
cooked up to mislead doctors into prescribing
its potentially fatal drugs--Fosamax (for
osteoporosis) and Vioxx (for pain). [1] [2]
Michael Jackson passes away at 50.
Report says he collapsed after taking
prescription drugs.


A report in Britain's The Sun newspaper, citing a
UCLA Medical Center source, claims that Jackson
received an injection of Demerol -- a drug similar to
morphine -- shortly before the incident and began
breathing very shallow shortly after. A photo of a
police 911 computer purportedly from a call related
to Jackson says the subject was "not breathing at
all."
The 'Thriller' superstar has long been addled by
health problems and has had addictions to painkillers
in the past.

AOL: June 26, 2009
Anesthesiology Deaths

In the United States, the public and the medical
specialty of anesthesia were shocked in April 1982 by
the ABC television program 20/20 entitled The Deep
Sleep. Presenting accounts of anesthetic accidents,
the producers stated that, every year, 6,000
Americans die or suffer brain damage related to
these mishaps.[5] In 1983, the British Royal Society
of Medicine and the Harvard Medical School jointly
sponsored a symposium on anesthesia deaths and
injuries, resulting in an agreement to share statistics
and to conduct studies.[6]
Anesthesiology Deaths

By 1984 the American Society of Anesthesiologists
had established the Anesthesia Patient Safety
Foundation. The APSF marked the first use of the
term "patient safety" in the name of professional
reviewing organization.[7] Although anesthesiologists
comprise only about 5% of physicians in the United
States, anesthesiology became the leading medical
specialty addressing issues of patient safety.[8]
Likewise in Australia, the Australian Patient Safety
Foundation was founded in 1989 for anesthesia error
monitoring. Both organizations were soon expanded
as the magnitude of the medical error crisis became
known.
Shut Up or Be Discredited: Merck Threatens Doctors Critical of
Their Drugs
Wednesday, June 10, 2009 by: Joanne Waldron, citizen journalist

(NaturalNews) According to an article in The Australian
by Milanda Rout, the folks at Merck are threatening the
livelihoods of doctors who dare to have negative
opinions about its drugs. Apparently, this fact was
revealed in a very interesting e-mail that surfaced in a
federal courtroom in Melbourne during a class action suit
against Merck & Co and its Australian subsidiary, Merck,
Sharpe and Dohme. Over a thousand Australians
complained that they experienced heart attacks or strokes
from taking Merck's Vioxx drug.
Shut Up or Be Discredited: Merck Threatens Doctors Critical of
Their Drugs
Wednesday, June 10, 2009 by: Joanne Waldron, citizen journalist

Shockingly, the article by Rout states that Merck
employees created a list of doctors and other
researchers who needed to be either "neutralized"
or "discredited" due to the fact that they were
critical of the Vioxx drug.

The methods used to do this included threatening
to cut research funding and attempting to block
academic appointments.
Shut Up or Be Discredited: Merck Threatens Doctors Critical of
Their Drugs
Wednesday, June 10, 2009 by: Joanne Waldron, citizen journalist

The telltale e-mail, according to Rout, stated: "We
may need to seek them [critics of Vioxx] out and
destroy them where they live."

This is pretty scary language, especially
considering most people are under the impression
that pharmaceutical companies are comprised of
benevolent people whose mission is to save lives.
Japanese Data Show Vaccines
Cause Autism
Posted on June 3, 2009 by childhealthsafety

Just months following the US Court of Federal Claims
rejection of the claim that the MMR vaccine causes autism,
here you will see data from formal peer refereed medical
papers showing that vaccines caused autism in Japanese
children and will be doing the same to children around the
world. The number of Japanese children developing
autism rose and fell in direct proportion to the number
of children vaccinated each year.

http://childhealthsafety.wordpress.com/2009/06/03/japvaxa
utism/#Autism_Rose_Fell_With_Vaccinations
Japanese Data Show Vaccines
Cause Autism
Posted on June 3, 2009 by childhealthsafety
FDA Weighs Reduction of Painkiller
ODs
By AP / MATTHEW PERRONE Monday, Jun. 29, 2009

Tylenol, Excedrin, NyQuil. These
household brands and others have
come to symbolize safe, convenient
relief from the aches and pains of
everyday life. But this week the Food
and Drug Administration is focusing on
a seldom-discussed side effect of the
medications: severe liver damage.
FDA Weighs Reduction of Painkiller
ODs
By AP / MATTHEW PERRONE Monday, Jun. 29, 2009


Acetaminophen overdoses send an estimated
56,000 people to the emergency room each
year, according to the FDA.
Despite decades of educational campaigns,
bolstered warnings and other federal actions,
acetaminophen continues to be the leading
cause of liver failure in the U.S.
FDA Weighs Reduction of Painkiller
ODs
By AP / MATTHEW PERRONE Monday, Jun. 29, 2009

But the 4 gram-per-day maximum
dose listed on many medications is just
below levels that can cause potentially
fatal liver injury.
Rebound Acid Reflux with PPIs May
Induce Dependence

SAN FRANCISCO, July 2 -- Proton-pump
inhibitors (Nexium) may cause or
aggravate the very acid-reflux
symptoms they're used to treat,
according to a randomized trial.
Rebound Acid Reflux with PPIs May
Induce Dependence

After a two-month course of esomeprazole
(Nexium), 44% of asymptomatic, healthy
volunteers had clinically significant heartburn,
acid reflux, or dyspepsia, compared with 15%
who had taken placebo (P<0.001), according
to researchers led by Peter Bytzer, MD, PhD,
of Copenhagen University and Køge
University Hospital.
Muscle Injury from Statins Can Hide
Behind Normal Lab Tests
By Crystal Phend, Staff Writer, MedPage Today
Published: July 06, 2009

SAN FRANCISCO, July 6 -- Persistent
muscle pain in patients taking statins
may indicate structural damage to the
muscles even when laboratory tests are
normal, researchers found.
Muscle Injury from Statins Can Hide
Behind Normal Lab Tests
By Crystal Phend, Staff Writer, MedPage Today
Published: July 06, 2009

Biopsy-assessed muscle fiber damage was seen in
about 57% of patients with statin-related myopathy
compared with 0% in controls (P<0.001), Annette
Draeger, MD, of the University of Bern, Switzerland,
and colleagues, reported in the July 7 issue of CMAJ.
But only one of these 44 myopathy patients in
the study had abnormal serum creatine
phosphokinase levels.
Zicam not only risky drug.
AP by Jeff Donn 6/18/09


“Although widely sold for years as a drug for
colds, it was never tested by federal
regulators for safety like other drugs. And
that was perfectly legal….until scores of
consumers lost their sense of smell.”
RE: homeopathic remedies…..buyers beware.
Antibiotics
“Antibiotic useless in treating acute
bronchitis, study finds” AP Friday 5/10/02


Lancet, Cook County Hosp, Rush Medical
College in Chicago
“Some experts said the findings
confirm that antibiotics in general
are useless for acute bronchitis
and that no antibiotics, whatever
the type, should be prescribed for
it.”
Drug Sales Teams
“As Drug-Sales Teams Multiply, Some
Doctors Shut Them Out.”
The Wall Street Journal, Friday 6/13/2003



90,000 drug reps..hiring spree
2002..$12B on drug reps, $2.76 on
drug ads
Prescription drugs up 14% to $161
billion!
Rush Limbaugh





10/10/03, West Palm Beach, Fla.,
aolsvc.news.aol.com/news/article.adp?id=200310101547099900
10
“….he is checking into a rehab center to
‘break the hold this highly addictive
medication has on me.’”
OxyContin and other pain killers
Started taking pain killers “some years ago”
after a doctor prescribed them following
spinal surgery.
His back pain stemming from the surgery
PCB’s
“Farmed salmon high in PCBs, group says”
Washington Post 2003, study by The Environmental Working
Group.



PCP, banned in the late 70’s.
7 of 10 farm salmon, PCP 16x higher
than wild salmon, 4x higher than beef
and other seafood.
“A sharp rise in the consumption of farmed
salmon may be posing a health threat to
millions of Americans because of high levels
of PCBs that have been found in limited
Polybrominated diphenyl
ethers “PBDE”
Flame Retardant Found in Breast Milk
USA Today 9/23/03


The Environmental Working Group, published
in Environmental Health Perspectives
“A toxic chemical used to make furniture,
foam and electronics fire resistant is turning
up in high amounts in the breast milk of
women in the USA.”
Muscle Relaxants
“Muscle Relaxants: Overused, Ineffective and
Acute LBP”
Bernstein E, Carey TS, Mills Garrett J. The use of muscle relaxant
medications in acute low back pain. Spine 2004;29(12):1346-51.



Cohort of 1600..MC-LBP.
…while muscle relaxant use was quite common among patients
with acute LBP, the drugs did not help patients return to normal
functioning more quickly than patients not taking muscle
relaxants, and in fact, were associated with an increase in
the time it took for patients to recover from pain.”
Return to functional recovery: 16.2 days vs. 32.4 days ( m.
relaxants)
Neurontin
“Pfizer settles fraud cae for $430M”
USA Today 5/14/04






Epilepsy drug, Neurontin was market for uses unapproved by
the federal government.
Pfizer’s 2003 revenue was $45.1 B.
Pfizer aggressively market drug for bipolar disorder,
ADD, Lou Gehrig’s disease, drug and alcohol withdrawal
seizures, migraine headaches, and restless leg
syndrome.
Placebo worked as well for bipolar disorder.
“Consultant meetings in Fl, Hawaii, Olympics
Whistler blower made $26.6 million
Overuse of Pain Killers
“Overuse of painkillers increase risk of more
headaches”






Columbus Dispatch, AP 6/15/04
Dr. David Rothner presented info at the American Headache Society.
Of 680 pts, 22% overused nonprescription headache medicine.
“Overuse increases the risk of such side effects as stomach bleeding or
kidney or liver damage…”
“…overmedicating actually can worsen some kids’ headaches,
a syndrome called rebound headache that eventually can spur
almost daily headaces.”
“Parents should do everything they can to get these kids off of the
analgesics.”
32% of adults overuse.
OxyContin
“OxyContin: Doctors target of federal
probe”
The Columbus Dispatch 8/5/02 AP (Washington Post)



OxyContin killed 450 people
Prescribed more than 6 million times in 2001
60-count indictment in May with drug-trafficing
violations.
FDA Panel Votes to Ban Vicodin,
Percocet
AP New York Times July 2009





……… citing the danger posed to the liver by products combining
narcotics with acetaminophen.
The FDA does not have to heed the advice of its expert panels, but it
frequently does, according to the New York Times.
If the FDA follows the panel's recommendation, seven other
prescription drugs combining acetaminophen and narcotics could also
be banned.
In addition, the panel voted to reduce the maximum daily dose of
acetaminophen to less than 4000 mg and the maximum dose in overthe-counter formulations to 325 mg (down from 500 mg).
New York Times story (Free)
Prescription drug abuse skyrocketing
400 percent rise in those admitted for treatment,
government study says

Source: Healthcare on MSNBC.
by Emma
Ashburn updated 7/15/2010 5:09:47 PM ET

WASHINGTON — U.S. officials reported a 400 percent increase
over 10 years in the proportion of Americans treated for
prescription painkiller abuse and said on Thursday the problem
cut across age groups, geography and income.
Prescription drug abuse skyrocketing
400 percent rise in those admitted for treatment,
government study says


The dramatic jump was higher than treatment admission rates
for methamphetamine abuse, which doubled, and marijuana,
which increased by almost half, according to figures from the
Substance Abuse and Mental Health Services Administration.
They said 9.8 percent of hospital admissions for substance
abuse in 2008 involved painkillers, up from 2.2 percent in 1998.
The percentage of people admitted to treatment for alcohol
dropped by 5 percent and for cocaine dropped by 16 percent
over the same period.
Executive Order 2010 – 4S
Establishing the Ohio Prescription Drug Abuse
Task Force
Executive Order 2010 – 4S
Establishing the Ohio Prescription Drug Abuse
Task Force

Prescription drug abuse is a national
public health problem.
“A 2006 Centers for Disease Control report
demonstrated that between 1995 and 2005,
the annual number of unintentional drug
overdose deaths in the United States
more than doubled due to increasing deaths
from prescription drugs.”
Executive Order 2010 – 4S
Establishing the Ohio Prescription Drug Abuse
Task Force

Prescription drug abuse is a national
public health problem.
“The Substance Abuse and Mental Health
Services Administration reported that the
number of admissions for substance
abuse treatment for prescription drugs
increased by 141% from 1998 to 2006.”
Executive Order 2010 – 4S
Establishing the Ohio Prescription Drug Abuse
Task Force

Ohio’s prescription drug abuse problem is an
epidemic.
“In 2007, unintentional drug poisoning became the
leading cause of injury death in Ohio, surpassing
motor vehicle crashes and suicide for the first time
on record. From 1999 to 2007, Ohio’s death rate
due to unintentional drug poisonings
increased more than 300 percent. The increase
in deaths has been driven largely by prescription
drug overdoses caused by opioids (pain
medications). Prescription opioids are
associated with more overdoses than any
other prescription or illegal drug, including
cocaine and heroin.”
Executive Order 2010 – 4S
Establishing the Ohio Prescription Drug Abuse
Task Force

Significant efforts to address the problem of
prescription drug abuse are currently underway.

The Ohio Department of Health
Ohio Department of Alcohol and Drug Addiction Services
The Ohio Office of Criminal Justice Services
The Department of Job and Family Services
The Ohio Attorney General’s Office
The Ohio Medical and Pharmacy Boards
U.S. Senator Sherrod Brown: Drug Enforcement Administration and the
Centers for Medicare and Medicaid Services
Local task forces and working groups

Legislative efforts being undertaken by the Ohio General Assembly.







Executive Order 2010 – 4S
Establishing the Ohio Prescription Drug Abuse
Task Force

Ohio needs a more coordinated, multidisciplinary, multi-jurisdictional approach to the
problem of prescription drug abuse.
“Too many Ohioans have lost their lives
or have been impacted by the
devastating effects of addiction because
of abuse and diversion of prescription
drugs.”
Executive Order 2010 – 4S
Establishing the Ohio Prescription Drug Abuse
Task Force
“Accordingly, I
order the
establishment of
an Ohio
Prescription Drug
Abuse Task Force
(OPDATF).”
What about BWC?
Cost Drivers: Drugs, surgery, hospital-based
care/PT
Statistics: Drugs use skyrocketed from 1998
thru 2003. $59 million to $139 million, with
LESS claims in the system, at the same time
Chiropractic care was basically under assault
regarding chronic pain management.
Result: drug addiction, no improvement in RTW.
Thomas Edison...
“The doctor of the future will give no
medicine, but will interest his patient in
the care of the human frame, in diet,
exercise, and in the cause and
prevention of disease.“
Dorland’s Medical Dictionary
Health is state of mental, physical, and
social well being, and not merely the
absence of disease or infirmity.
Hippocrates..”The Father of Healing”
“Look well to the spine for the cause of
disease.”
Copyright Protection Statement
The material in this packet is under copyright protection and
may not be reproduced in any format without the expressed
written consent of Dr. Ronald J. Farabaugh.
© 2010 Copyright Protected. Dr. Ronald J.
Farabaugh, Inc. All Rights Reserved.