CMS Guidelines For Sale. Adam Harris, M.D.

CMS Guidelines For Sale!
Adam I. Harris, M.D. San Antonio Orthopdic Specialists
Saturday, October 20, 12
Commercial Bias
Commercial Bias
Rampant in the medical literature despite disclosures
Commercial Bias
Rampant in the medical literature despite disclosures How do you read literature?
Commercial Bias
Rampant in the medical literature despite disclosures How do you read literature? Do you check the funding sources of the authors?
Commercial Bias
Rampant in the medical literature despite disclosures How do you read literature? Do you check the funding sources of the authors? If not, you should
Commercial Bias
Rampant in the medical literature despite disclosures How do you read literature? Do you check the funding sources of the authors? If not, you should But do the Experts do the same?
Who are the Experts?

Often the same people whose opinion may be
influenced by $$

Often the same people whose opinion may be
influenced by $$ bias involved
Today, well review one guideline, and the commercial
ACCP Guidelines
ACCP Guidelines
American College of Chest Physicians
ACCP Guidelines
Since the mid 1980s, theyve been dictating how

everybody else should run their practice
ACCP Guidelines

Being fair:
ACCP Guidelines

Being fair: Edition 9 of the guides (2/2012) is more honest
ACCP Guidelines

Being fair: Edition 9 of the guides (2/2012) is more honest Still not 100% free of bias
CMS Adopted the th 8 Edition of The Guides
Why Not the 9
th
Ed?
Why Not the 9
th
Ed?
The SCIP Technical Expert Panel (TEP) regularly
reviews relevant guidelines and has determined in general that only a change with Level I recommendations would affect the SCIP performance measures. The current measure specification for VTE prevention are based on Level IA recommendations.
Why Not the 9
th
Ed?
The SCIP Technical Expert Panel (TEP) regularly
reviews relevant guidelines and has determined in general that only a change with Level I recommendations would affect the SCIP performance measures. The current measure specification for VTE prevention are based on Level IA recommendations. That there are NO current Level I recommendations does not seem to bother the CMS
There are only 10 types of people in the world: those who understand binary, and those who do not.
So it is also with the Government
Two Types of Doctors
Two Types of Doctors

Compliant Doctors Do all of the paperwork Interchangeable Bad Doctors
Have you seen these?
ACCP 8 Edition Guidelines for prevention of DVT
th

Released 2008
th

Released 2008 Shortly after the AAOS released their guidelines
th

Released 2008 Shortly after the AAOS released their guidelines Major changes from the 7 edition bashed the AAOS
th
th
Review of Arthroplasty Recommendations only

I cannot comment on cardiology, general surgery, etc. Lets look at some of the major points made by the ACCP Their work is as significant for what it does not say as it is for what
it does say
How is the ACCP presented to Orthopdists??
How is the ACCP presented to Orthopdists??

An Orthopdic Surgeon gave the following presentation
on DVT prophylaxis:
Orthopdic Surgeons like it simple
Surgery causes DVT
DVT causes PE
PE causes death
Death is bad!
Do Orthopdists really like it this simple
How to read Medical Literature

Was the study well designed/executed?

Was the study well designed/executed? Do the results justify the conclusions/recommendations?

Was the study well designed/executed? Do the results justify the conclusions/recommendations? Are the results/recommendations relevant to your
practice?
Glenn Beck
Dont take my word for it, do your own research
Evident Faults
Inaccurate Assertions Faulty Logic Blind Eye Political Posturing
Critical Review of th Edition ACCP 8 Guidelines: Prevention of DVT in Arthroplasty patients

Assertion # 1
VTE is the most common cause for readmission to the hospital following THR
Does anybody see this today?
Prominently featured on multiple web sites.
Does anybody see this today?
Is this still the fact?
References ACCP Recommendations What is their reference?

One reference
One reference
Seagroatt, Tan, Goldacre, Elective total hip replacment:
incidence, emergency readmission rate, and postoperative mortality BMJ 1991; 303:1431-1435
One reference
incidence, emergency readmission rate, and postoperative mortality BMJ 1991; 303:1431-1435 patients operated in England
11,607 admissions; after exclusions, 7547 THA
One reference
11,607 admissions; after exclusions, 7547 THA Surgery between 1976 and 1985
One reference
11,607 admissions; after exclusions, 7547 THA Surgery between 1976 and 1985 No mention of prophylaxis, if any
One reference
11,607 admissions; after exclusions, 7547 THA Surgery between 1976 and 1985 No mention of prophylaxis, if any 1985We only kept people in bed for 3 days
One reference
11,607 admissions; after exclusions, 7547 THA Surgery between 1976 and 1985 No mention of prophylaxis, if any 1985We only kept people in bed for 3 days That was considered aggressive!
Assertion # 2
The rates of major bleeding in the placebo groups of other randomized trials in THR patients were similar (4%)
Turpie, Levine, et. al. A randomized controlled trial of
a low-molecular-weight heparin (enoxaparin) to prevent deep-vein thrombosis in patients undergoing elective hip surgery. N Engl J Med 1986; 315:925-929
Turpie, Levine, et. al. A randomized controlled trial of Colwell, Spiro, Efficacy and safety of enoxaparin to
prevent deep vein thrombosis after hip arthroplasty. Clin Orthop Relat Res: 1995: 215-222
a low-molecular-weight heparin (enoxaparin) to prevent deep-vein thrombosis in patients undergoing elective hip surgery. N Engl J Med 1986; 315:925-929
Turpie et. al.
Turpie et. al.
Small Study--100 patients
Turpie et. al.

2 patients in the placebo group and 2 in the treatment
Small Study--100 patients group had significant bleeding episodes
Turpie et. al.

1 in the placebo group, died of complications from
heparin after a diagnosis of DVT (adrenal hemorrhage)
Turpie et. al.

1 in the placebo group, died of complications from
heparin after a diagnosis of DVT (adrenal hemorrhage)
(Doesnt the ACCP belittle small studies elsewhere?)

Power Analysis
Power Analysis
Placebo group had 4% observed major bleeding
Power Analysis
Placebo group had 4% observed major bleeding Is this statistically different from 0%?
Power Analysis
Placebo group had 4% observed major bleeding Is this statistically different from 0%? 95% confidence interval to exclude 0%
Power Analysis
Placebo group had 4% observed major bleeding Is this statistically different from 0%? 95% confidence interval to exclude 0% alpha = 0.05
Power Analysis
Placebo group had 4% observed major bleeding Is this statistically different from 0%? 95% confidence interval to exclude 0% alpha = 0.05 Need 74 patients
Power Analysis
Placebo group had 4% observed major bleeding Is this statistically different from 0%? 95% confidence interval to exclude 0% alpha = 0.05 Need 74 patients Therefore, with 50 patients, 4% is not different from 0%
Placebo Sample Size (observed = 4%)

Major Bleeding Real Rate
0% 0.5% 1% 1.5% 2% 2.5% 3%
Sample Size needed

74 149 192 294 763 1491 3635
Colwell et. al.
Colwell et. al.

Large study, four centers, >1900 patients
Colwell et. al.

Large study, four centers, >1900 patients Similar protocols, many groups
Colwell et. al.

Large study, four centers, >1900 patients Similar protocols, many groups placebo, LMWH 10 mg/day, LMWH 30 mg BID,
LMWH 40 mg QD, Heparin SQ 5000 units TID, Heparin 7500 units BID
Colwell et. al.

Only 50 in the placebo group!
Colwell et. al.

Only 50 in the placebo group!
One of the bleeding deaths was from an adrenal

hemorrhage 11 days post op.
Colwell et. al.
Colwell et. al.
Based on intent to treat
Colwell et. al.
Any patient who had at least ONE dose of study drug

was included in the results
Colwell et. al.

No discussion on how many patients did not complete

the therapy or why they did not complete therapy
Colwell et. al.

No discussion on how many patients did not complete

the therapy or why they did not complete therapy
Like most studies, it excludes high risk patients

Colwell et. al.
Colwell et. al.
Used non invasive tests on all patients
Colwell et. al.
All positive tests were verified with venograms
Colwell et. al.
In addition, all patients WERE to have bilateral

venography done at the end of study treatment or on discharge from the hospital (not applicable to the first 24 patients enrolled in the Canada-1 study)
Colwell et. al.
In addition, all patients WERE to have bilateral

venography done at the end of study treatment or on discharge from the hospital (not applicable to the first 24 patients enrolled in the Canada-1 study)
No mention of how many actually had venograms!

Colwell et. al.
Colwell et. al.

Why is the lack of venograms important?
Colwell et. al.

Why is the lack of venograms important? Lack of contrast venography is used to write off
studies concerning multimodal therapies in THA.
Adrenal Hemorrhage?
Adrenal Hemorrhage?
Both in the placebo group
Adrenal Hemorrhage?
Both in the placebo group Both from Canada
Adrenal Hemorrhage?
Both in the placebo group Both from Canada Both Canadian studies lacked venograms on the first 24
patients
Adrenal Hemorrhage?
patients
Both Canadian studies had 50 in the placebo group.
Adrenal Hemorrhage?
patients
Both Canadian studies had 50 in the placebo group. Turpie is from Canada
Subset
Subset
One MUST conclude that the Turpie study is a subset of
the Colwell study, and therefore, therefore not an independent entity.
Subset
One MUST conclude that the Turpie study is a subset of
the Colwell study, and therefore, therefore not an independent entity.
Therefore, only ONE reference is really cited.
The rate of major bleeding in the placebo group of the only small other randomized trial in THR patients was similar (4%).
The rate of major bleeding in the placebo group of the only small other randomized trial in THR patients was similar (4%).
Not quite as powerful a statement!
Now make it complete

The rate of major bleeding in the placebo group of the
only small randomized trial in THR patients was similar (4%). With the limited sample size, the reported rate of 4% in that study is not statistically different from 0%. Conversely, with thousands of patients in treatment arms of chemoprophylaxis studies, the rate of major bleeding is clearly defined and is statistically significant.

The rate of major bleeding in the placebo group of the
only small randomized trial in THR patients was similar (4%). With the limited sample size, the reported rate of 4% in that study is not statistically different from 0%. Conversely, with thousands of patients in treatment arms of chemoprophylaxis studies, the rate of major bleeding is clearly defined and is statistically significant.
Even less of an endorsement for chemoprophylaxis.

Assertion # 3
Aspirin and other antiplatelet drugs provide much less protection against VTE compared with other thromboprophylaxis methods.
PEP trial, Lancet 2000
PEP trial, Lancet 2000 ACCP states The primary effectiveness outcome in
the trial, vascular death, was not significantly reduced by aspirin
PEP trial, Lancet 2000 ACCP states The primary effectiveness outcome in
the trial, vascular death, was not significantly reduced by aspirin Half true
PEP trial
PEP trial
Primary goal was NOT reduction of all vascular deaths
PEP trial
Primary goal was NOT reduction of all vascular deaths Primary goal was to confirm or refute the metaanalysis results that ASA reduced the risk of DVT and PE in various high risk groups.
PEP trial
Results:
PEP trial
Results: Significant reduction of fatal PE, VTE, and proximal

DVT
PEP trial
Results: Significant reduction of fatal PE, VTE, and proximal

DVT
No change in all vascular deaths

PEP trial
PEP trial
Confounding variables?
PEP trial
Confounding variables? ACCP emphasizes that many patients also received
other prophylactic measures
PEP trial
PEP trial DOES analyze these independently
PEP trial
PEP trial DOES analyze these independently
Effect of ASA remains positive
Assertion # 4
If thromboprophylaxis is not used, fatal PE occurs in approximately one patient per 300 elective hip arthroplasties
Dahl et. al., Fatal vascular outcomes follwoing major orthopedic surgery. Thromb Haemost 2005; 93:860-866
Pooled overall mortality and fatal pulmonary embolism for patients undergoing elective hip and knee replacements without prophylaxis could not be calculated.

Pooled overall mortality and fatal pulmonary embolism for patients undergoing elective hip and knee replacements without prophylaxis could not be calculated. It does comment on Hip Fractures
Howie et. al. Venous thromboembolism associated with hip and knee replacement over a ten-year period; A populationbased study
Actually a very good study from the Scottish health registries

Actually a very good study from the Scottish health registries But is makes no comment regarding mortality without thromboprophylaxis
ACCP Doubletalk?
ACCP Doubletalk?
Although metaanalyses [sic] have shown that
thromboprophylaxis with LDUH or aspirin is superior to no thromboprophylaxis, both agents are less effective than other thromboprophylaxis regimens in this highrisk group.
ACCP Doubletalk?
Although metaanalyses [sic] have shown that
thromboprophylaxis with LDUH or aspirin is superior to no thromboprophylaxis, both agents are less effective than other thromboprophylaxis regimens in this highrisk group.
Main reference is 7th edition of the ACCP guides!

ASA vs. Placebo
ASA vs. Placebo
Antiplatlet Trialists Collaboration. Collaborative overview of randomized trials of antiplatelet therapy: III. BMJ 1994; 308:235-246
ASA vs. Placebo
Efficacy for all DVT was moderate
ASA vs. Placebo
Efficacy for all DVT was moderate not specified as symptomatic vs. asymptomatic
ASA vs. Placebo
Efficacy for all DVT was moderate not specified as symptomatic vs. asymptomatic Efficacy for FATAL PE was great! 0.2%
Assertion # 5
VKAs reduce VTE, but are associated with a significant increase in wound hematoma rates.
Freedman, JBJS AM 2000; 82:929-938
No difference in fatal PE with multiple different type of

prophylaxis

prophylaxis
Increased wound complications ONLY with Heparins!


prophylaxis
Increased wound complications ONLY with Heparins! Concludes that the best combination of safety/efficacy is
warfarin, along with IPC.
Lieberman & Hsu, JBJS 87-A(9), Sept 2005; 2097-2112
Concludes the opposite
Concludes the opposite The risk of major postoperative bleeding episodes in patients
taking warfarin was no higher than that in patients treated with a placebo.
Concludes the opposite The risk of major postoperative bleeding episodes in patients In general, the bleeding rates were higher in patients who
were treated with low-molecular-weight heparin.
taking warfarin was no higher than that in patients treated with a placebo.
Mismetti et. al., J. Thrombosis & Haemostasis;2004; 2: 1058-1070
Mismetti et. al., J. Thrombosis & Haemostasis;2004; 2: 1058-1070 Increased bleeding, but not significantly different from LMWH
Mismetti et. al., J. Thrombosis & Haemostasis;2004; 2: 1058-1070 Increased bleeding, but not significantly different from LMWH Trend towards more bleeding with LMWH
Mismetti et. al., J. Thrombosis & Haemostasis;2004; 2: 1058-1070 Increased bleeding, but not significantly different from LMWH Trend towards more bleeding with LMWH Also not different from LMWH re: all PE or all cause mortality
Mismetti et. al., J. Thrombosis & Haemostasis;2004; 2: 1058-1070 Increased bleeding, but not significantly different from LMWH Trend towards more bleeding with LMWH Also not different from LMWH re: all PE or all cause mortality Funded by Sanofi-Synthelabo
Last reference here is the 7th edition of the guidelines
Faulty Logic # 1
Recommended INR 2.0-3.0

Note that there are no references for this
recommendation, only that most studies used this range.

recommendation, only that most studies used this range. protectionor even reduce the risk of bleeding
They threaten that a lower INR may not provide optimal

recommendation, only that most studies used this range. protectionor even reduce the risk of bleeding
They threaten that a lower INR may not provide optimal Again, no references
Faulty Logic # 2
LMWH are highly effective and safe
LMWH Safe??
LMWH Safe??
ACCP admits: The rate of major bleeding was significantly
greater in the patients who started LMWH before surgery than in those who received warfarin
LMWH Safe??
ACCP admits: The rate of major bleeding was significantly ACCP admits to a higher need for transfusion in patients
receiving LMWH regardless of starting time compared to warfarin greater in the patients who started LMWH before surgery than in those who received warfarin
LMWH Safe??
ACCP admits: The rate of major bleeding was significantly ACCP admits to a higher need for transfusion in patients
greater in the patients who started LMWH before surgery than in those who received warfarin receiving LMWH regardless of starting time compared to warfarin ACCP concludes that LMWH are highly effective and safe
Faulty Logic # 3
multimodal strategies are very likely to be effective, they are more complex and more costly than single modality options.
Conclusions from Multimodal Strategies

Study LMWH + IPC vs LMWH + GCS ASA Alone vs ASA + VFP DVT Incidence with IPC with GCS
All DVT Prox. DVT
ACCP Conclusion
0% 29%
32% >95%
(Relative Rate Reduction)
Conclusions from Multimodal Strategies

Study LMWH + IPC vs LMWH + GCS ASA Alone vs ASA + VFP DVT Incidence with IPC with GCS
All DVT Prox. DVT
ACCP Conclusion
0% 29%
32% >95%
LMWH is Good
(Relative Rate Reduction)
Aspirin is BAD
Is Aspirin Really Bad?

Meta-analysis 1996-2006 English Literature3 month all
cause mortality, hip and knee arthroplasty
Treatment arm Xa inhibitors Warfarin Aspirin & IPC Patients identified 14,750 5,006 7,193 All cause mortality 0.47% 0.41% 0.19%
What does ACCP say about Aspirin?

3.1.2 For patients undergoing THR, we recommend
against the use of any of the following: aspirin...as the sole method of thromboprophylaxis. (Grade 1A)

3.1.2 For patients undergoing THR, we recommend 3.2.3 For patients undergoing TKR, we recommend
against the use of any of the following: aspirin...as the sole method of thromboprophylaxis. (Grade 1A) against the use of any of the following as the only method of thromboprophylaxis: aspirin (Grade 1A)...

3.1.2 For patients undergoing THR, we recommend 3.2.3 For patients undergoing TKR, we recommend
against the use of any of the following: aspirin...as the sole method of thromboprophylaxis. (Grade 1A) against the use of any of the following as the only method of thromboprophylaxis: aspirin (Grade 1A)... 3.4.2 For patients undergoing HFS, we recommend against the use of aspirin alone (Grade 1A)
Blind Eye # 1
Blind Eye # 1
Gelfer et. al.; Deep vein thrombosis prevention in joint arthroplasties: continuous enhanced circulation therapy vs low molecular weight heparin J. Arthroplasty, 2006 Feb; 21(2): 206-214
Blind Eye # 1
Gelfer et. al.; Deep vein thrombosis prevention in joint arthroplasties: continuous enhanced circulation therapy vs low molecular weight heparin J. Arthroplasty, 2006 Feb; 21(2): 206-214
CECT + 100 mg ASA/day vs. enoxaparin 40 Q day
Does it qualify?
Does it qualify?
Head to head with an established regimen of LMWH
Does it qualify?
Head to head with an established regimen of LMWH Meets the comparator criteria
Does it qualify?
Head to head with an established regimen of LMWH Meets the comparator criteria Contrast venography
Does it qualify?
Head to head with an established regimen of LMWH Meets the comparator criteria Contrast venography Drop outs were specified 7 in each group
Does it qualify?
Head to head with an established regimen of LMWH Meets the comparator criteria Contrast venography Drop outs were specified 7 in each group SoYES it qualifies
Does it qualify?
Head to head with an established regimen of LMWH Meets the comparator criteria Contrast venography Drop outs were specified 7 in each group SoYES it qualifies Published early 2006, so it could have been included
CECT Results?
CECT Results?
More effective than LMWH
CECT Results?
More effective than LMWH DVT: 4/61 with CECT, 17/60 with LMWH
CECT Results?
More effective than LMWH DVT: 4/61 with CECT, 17/60 with LMWH PE: 1 in LMWH group, 0 in CECT group
CECT Results?
More effective than LMWH DVT: 4/61 with CECT, 17/60 with LMWH PE: 1 in LMWH group, 0 in CECT group THA efficacy: 13/17 LMWH, 0/4 CECT
CECT Results?
More effective than LMWH DVT: 4/61 with CECT, 17/60 with LMWH PE: 1 in LMWH group, 0 in CECT group THA efficacy: 13/17 LMWH, 0/4 CECT With 100 mg Aspirin comparable safety
Cost of CECT?
Cost of CECT?
Saved the hospital an average of >$2,600 per patient!
Blind Eye # 2
DVT PE
AAOS guidelines
AAOS guidelines
Debunk the philosophy that DVT = PE
AAOS guidelines
Debunk the philosophy that DVT = PE By using the same studies [mis]quoted by ACCP
Blind Eye # 3
Mechanical Compression?
AAOS guidelines
AAOS guidelines
There is not a contemporary study that adequately
describes the incidence of major surgical bleeding in patients who have not received prophylaxis, but all reports of mechanical antithrombotic devices are noteworthy for an incidence of major bleeding of less than 1%
Mechanical Compression
Hip Arthroplasty:
Hip Arthroplasty: Approved by the ACCP - only - for high risk of
bleeding patients
bleeding patients
Even then, only until the bleeding risk goes down
bleeding patients
Knee Arthroplasty:
bleeding patients
Knee Arthroplasty: OK if optimal but even then, a Grade IB

bleeding patients
Knee Arthroplasty: OK if optimal but even then, a Grade IB LMWH, high dose, Grade 1A
Blind Eye # 4
The Patient
Major vs. Minor Bleeding

The AAOS notes that the definition of major bleeding
varies, but tends to underestimate the bleeding risks.

The AAOS notes that the definition of major bleeding
varies, but tends to underestimate the bleeding risks. Studies that do report major bleeding do not have follow up on long term results and complications in patients who have major bleeding
Minor Bleeding
No big deal?
Not to the Patient
Not to the Patient

Patients with minor bleeds have:
Not to the Patient

Patients with minor bleeds have: More pain
Not to the Patient

Patients with minor bleeds have: More pain Slower progress in Physical Therapy
Not to the Patient

Patients with minor bleeds have: More pain Slower progress in Physical Therapy Higher infection rate
Not to the Patient

Patients with minor bleeds have: More pain Slower progress in Physical Therapy Higher infection rate Ultimate outcome less favorable
What is the Patients concern?
Symptomatic VTE
Symptomatic VTE
From chronic lymphedema to fatal PE
Symptomatic VTE
Do (m)any patients care about asymptomatic DVT?
Symptomatic VTE
Do (m)any patients care about asymptomatic DVT? Probably not
Political Posturing
ACCP vs. AAOS
AAOS guidelines
AAOS guidelines
Like the ACCP, the literature was graded
AAOS guidelines
Like the ACCP, the literature was graded Similar to the ACCP, the scale was based on the type of
study, and the quality of the recommendations
AAOS guidelines
Like the ACCP, the literature was graded Similar to the ACCP, the scale was based on the type of
study, and the quality of the recommendations
The same studies though, were rated differently
AAOS guidelines
AAOS guidelines
Hip Studies:
AAOS guidelines
Hip Studies: Only 2 were considered good
AAOS guidelines
Hip Studies: Only 2 were considered good Applicability for both was only moderate
AAOS guidelines
Hip Studies: Only 2 were considered good Applicability for both was only moderate Only 1 had wide applicability
AAOS guidelines
Hip Studies: Only 2 were considered good Applicability for both was only moderate Only 1 had wide applicability The quality was considered only fair
AAOS guidelines
AAOS guidelines
Knee Studies
AAOS guidelines
Knee Studies
All studies rated as fair or poor quality
AAOS guidelines
Knee Studies
All studies rated as fair or poor quality 3 studies with wide applicability
AAOS guidelines
Knee Studies
All studies rated as fair or poor quality 3 studies with wide applicability All of poor quality
AAOS guidelines
AAOS guidelines
When only low quality or no evidence were available,
guidelines were developed based on the consensus of expert opinion and the best available evidence
AAOS guidelines
The ACCP doesnt like this statement
AAOS guidelines
The ACCP doesnt like this statement Instead they say: Although the recommendations are
evidence based, we also provide expert, consensusbased suggestions that clinicians might find useful when the evidence is weak
What does the ACCP have to say about the AAOS?
Another slide from the other side
[mis]Quoted by ACCP
[mis]Quoted by ACCP
They claim that the AAOS:
[mis]Quoted by ACCP
Failed to show benefit for any individual agent over

NO TREATMENT
[mis]Quoted by ACCP

NO TREATMENT opinion
All the recommendation are based on expert
[mis]Quoted by ACCP

NO TREATMENT opinion
All the recommendation are based on expert Guidelines not linked to results of their analysis
Other Discrepancies
Discrepancy
Excluding trials before 1995 Expert Opinion Guidelines and analysis
ACCP
BAD: eliminates classic studies
AAOS
GOOD: Techniques have advanced, need relevancy
BAD: Claims that there is Best available when there science AND that ALL is NOT good science AAOS is based on opinion (ACCP states the same) Claims AAOS is not linked Clearly linked and explained
They see it this way!
They see it this way!
Where is the patient?

Buy it still?
Buy it still?
I dont
Buy it still?
I dont
recommendation that I did investigate, was faulty.
I did not investigate EVERY recommendation, but every
How Could This Happen?
Survey of Aspartame studies: correlation of outcome and funding sources
Survey of Aspartame studies: correlation of outcome and funding sources
Meta-Analysis concerning the artificial sweetener

Aspartame by Ralph Walton, M.D., Chair of Psychaitry, Northeastern Ohio Universities College of Medicine Divided studies by funding source 92% of studies independently funded found safety issues with Aspartame 100% of industry funded studies found it to be safe
AAOS Disclosure
AAOS Disclosure
Nine authors
AAOS Disclosure
Nine authors All volunteers
AAOS Disclosure
Nine authors All volunteers None related potential conflict of interest
ACCP Disclosure
ACCP Disclosure
ACCP 8th edition, 2008
ACCP Disclosure
ACCP 8th edition, 2008 Seven authors
ACCP Disclosure
ACCP 8th edition, 2008 Seven authors Six disclosed at least one financial or intellectual
conflict of interest
If money be not thy servant, it will be thy master.

Sir Francis Bacon
Figures dont lie, but liars figure

Ronald Reagan
CMS
CMS
Adopted the
edition recommendations despite the th edition of The Guides publication of the 9
th 8
CMS
Adopted the
edition recommendations despite the th edition of The Guides publication of the 9
th 8
Has $$ bought the Governments Experts also?
Personal Issue
Personal Issue
MSH is a 76 y. o. white female
with atrial fibrillation
Personal Issue
PMH is significant for PMR,
spinal stenosis, both of which have been treated with low to moderate dose steroids for years
Personal Issue
PMH is significant for PMR,
spinal stenosis, both of which have been treated with low to moderate dose steroids for years fragility in the skin
Demonstrated capillary
9/11/10
9/11/10
INR = 2.8
What does it all mean?
If this one guideline is so (apparently) dishonest
Odds are, many others serve the source of funding, and not the patients!
Take home message
Take home message
Read the literature carefully and critically
Take home message

Look at the whole picture of patient safety
Read the literature carefully and critically
Take home message

Look at the whole picture of patient safety With all due respect to Dr. Colwell, even water has to be
Read the literature carefully and critically monitored
Take home message
Take home message
Read and understand the guidelines pertinent to your patient (singular)
Take home message
Understand the commercial bias in the guidelines
Take home message
Understand the commercial bias in the guidelines CYA: Document why youre doing the right thing instead
of the required thing
Take home message
Take home message
Remember, your patients are individuals, not groups!
Take home message

Remember, your patients are individuals, not groups! Do what is best for all of your patients
Take home message

Remember, your patients are individuals, not groups! Do what is best for all of your patients --one patient at a time!
Thank You
Adam I. Harris, M.D.


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CMS Guidelines For Sale!

Adam I. Harris, M.D. San Antonio Orthopdic Specialists

Saturday, October 20, 12

Saturday, October 20, 12

Saturday, October 20, 12

Saturday, October 20, 12

Saturday, October 20, 12

Saturday, October 20, 12

Who are the Experts?

Saturday, October 20, 12

Who are the Experts?

Saturday, October 20, 12

Who are the Experts?

Today, well review one guideline, and the commercial

Saturday, October 20, 12

Saturday, October 20, 12

American College of Chest Physicians

Saturday, October 20, 12

American College of Chest Physicians

Since the mid 1980s, theyve been dictating how

Saturday, October 20, 12

American College of Chest Physicians

Since the mid 1980s, theyve been dictating how

Saturday, October 20, 12

American College of Chest Physicians

Since the mid 1980s, theyve been dictating how

Being fair: Edition 9 of the guides (2/2012) is more honest

Saturday, October 20, 12

American College of Chest Physicians

Since the mid 1980s, theyve been dictating how

CMS Adopted the th 8 Edition of The Guides

Saturday, October 20, 12

Why Not the 9

Saturday, October 20, 12

Why Not the 9

The SCIP Technical Expert Panel (TEP) regularly

Saturday, October 20, 12

Why Not the 9

The SCIP Technical Expert Panel (TEP) regularly

Saturday, October 20, 12

Two Types of Doctors

Saturday, October 20, 12

Two Types of Doctors

Saturday, October 20, 12

Have you seen these?

Saturday, October 20, 12

ACCP 8 Edition Guidelines for prevention of DVT

Saturday, October 20, 12

ACCP 8 Edition Guidelines for prevention of DVT

Saturday, October 20, 12

ACCP 8 Edition Guidelines for prevention of DVT

Saturday, October 20, 12

ACCP 8 Edition Guidelines for prevention of DVT

Saturday, October 20, 12

Review of Arthroplasty Recommendations only

Saturday, October 20, 12

How is the ACCP presented to Orthopdists??

Saturday, October 20, 12