Transcript EBM - Darwin 2009

CHRONIC PAIN MANAGEMENT
Conflicts of Interest.
DR PENNY BRISCOE
ROYAL ADELAIDE HOSPITAL
May 2011.
ACKNOWLEDGEMENTS.
 Presented CME meeting (Melbourne) 2010 –
Reporting National Pain Summit.
Airfares ,accommodation, per diem paid.
 Attended drug launch Sydney 2010 –
Paid my own way.
 Regularly asked to lecture but since 2006 have tried
not to accept payment.
Conflicts of Interest
Exist when a professionals secondary interests
can negatively influence or compromise
his or her primary interests.
Pain Medicine - 10 interests:
 Care Patients.
 Protecting rights research.
 Presenting unbiased information to audiences.
SCHOFFERMAN: PAIN: 2008: 139
Conflicts of Interest
Secondary interests:
 Personal – friendships or animosity.
 Professional – career advancement / funding.
 Financial – monetary or material gain.
SCHOFFERMAN: PAIN: 2008: 139
A conflict of interest exists
if a reasonable observer
finds it plausible that the average person
could be (not necessarily would be)
swayed by the secondary interests.
SCHOFFERMAN: PAIN: 2008: 139
Primary obligation physicians –
provide best care patients.
Primary obligation researchers –
produce new and valid knowledge.
Primary obligation educators –
provide unbiased objective information
SCHOFFERMAN: PAIN: 2008: 139
Primary obligation of industry,
however
is to develop therapies
that produce profits.
Western Medical Model:
Drugs + Interventions
DRUGS + DEVICES.
 Pharmaceutical agents have transformed
treatment of many conditions.
 Therapeutic devices improve QoL.
 Allow people to live longer, and healthier.
 Modern & effective health care relies on these
interventions.
ROGERS: HEALTH EXPECTATIONS: 10: 1-3
Life Expectancies:
 1901 -
males
55 yrs
 2010
79 yrs
females
59yrs
84 yrs.
Improving living standards,  impact infections,
appropriate Rx CVS, Cancers, diabetes etc.
EDUCATION OF NEW THERAPIES
 Balancing needs for knowledge.
 Balancing needs for training of new device
 Access to free samples to trial.
 Doctors time poor.
 Commercial meetings allowing peer
interactions.
Direct to Consumer Advertising.
 Only two countries in the world where
it is fully allowed.
Direct to Consumer Advertising.
 Only two countries in the world where
it is fully allowed.
USA
New Zealand
Direct to Consumer Advertising.
USA 2000 accounted 16% promotional budget
NZ subsidised medicines – impacts costs.
25% consumers believe
advertising equated with safety.
PHARM COMMITTEE: 2004
BUT
ONLY 6% DRUG ADVERTISING
MATERIAL SUPPORTED BY EVIDENCE:
2004 brochures for GP’s in Germany.
22% citations quoted could not be found.
63% citation found but information provided
did not reflect results.
TUFFTS: BMJ: 2004: 328: 485
 527 articles in Spine - odds ratio industry
sponsored study providing +ve result 3.3x
that of other funding sources.
SCHOFFERMAN: PAIN
 In 75% published Industry-Sponsored Trials
(for one product used in Pain Medicine) the
primary outcomes reported differed from
that described in the protocol.
VEDULA: NEJM: 2009: 361:20
4 drug companies - been found guilty of breaching
pharmaceutical industry code of practice.
Deemed serious enough to justify placing
advertisements in the BMJ and other journals.
Mostly complaints lodged by other companies
HAWKES: BMJ:2010
Another company fined on 2 occasions (2 different
products) for promoting off label use. Both fines were
over $1bn
LENZER: BMJ: 2010
Duty of Care.
 Long been duty care between doctor & patient.
 If doctor fails to fullfill this – patient can sue.
 What about the Pharmaceutical companies?
 Could they be held responsible?
 This duty of care would be unique for a company.
 Usually profits are the most important thing for a
corporation to focus on.
 Drugs are a $400 billion industry.
 But most other companies are not as directly
responsible for the well being of their customers.
MILLER: HASTINGS CENTER REPORT: 2010
Duty of Care.
 “Do companies do harm?” – yes
 Products have been released despite the industry
knowing the risks of harm that could occur.
MILLER: HASTINGS CENTER REPORT: 2010
Challenge for doctors to
implement new and less harmful
ways to interact with industry.
Advisory Boards:
Industry relies on expert consultation to aid in
development and testing of new treatments.
Remuneration should be reasonable (market
value) for time and intellectual property.
SCHOFFERMAN: PAIN: 2008: 139
Industry chooses physicians:
1. Potential to become high users.
2. Highly visible, successful and respected.
Link the doctors reputation with the product.
SCHOFFERMAN: PAIN: 2008: 139
Continuing Medical Education
Essential!
http://www.rxpromoroi.org/rapp/exec_sum.html
Continuing Medical Education
Essential!
Industry sponsored CME courses are a very
powerful tool.
It has been estimated that every $1.00 industry
spends on CME – returns $3.56 to industry
http://www.rxpromoroi.org/rapp/exec_sum.html
2000-2004
314 drugs approved FDA.
MILLER:HASTINGS CENTER REPORT:2010
Only 32 were considered “innovative” –
drugs to treat a previously untreated condition
or treat it differently than drugs on the market.
Most new drugs released are “me-to” drugs.
Copies drugs that have been blockbusters for other
companies.
They are rarely tested against the original or
shown to be an improvement.
MILLER:HASTINGS CENTER REPORT:2010
Clinical Trials ignore
Previous Relevant Research
 Researchers , on average, cite less than 21%
previously published studies.
 For papers with at least 5 previous
publications 25% cited 1, & 25% 0!
 These statistics remain the same as numbers
studies increased.
ROBINSON: ANNALS INT MED: 2011
These omissions potentially
skew scientific results, waste taxpayers
money & involve patients in
unnecessary research (and risk).
Most drugs only work in 30 –50%
of people.
CONNOR: GLAXO CHIEF: OUR DRUGS DON’T WORK: 2003.
Patients so often get better or worse
on their own, no matter what we do,
and clinical experience is a poor judge of
what does and doesn’t work.
WHY DO PATIENTS GET BETTER?
1. Appropriate treatments (antibiotics).
2. Natural history (acute back pain).
3. Nonspecific treatment effects including
placebo.
JAMISON: IASP CLINICAL UPDATES: 2011
“The art of medicine consists of
amusing the patient while nature
cures the disease”
VOLTAIRE
“Don’t just do something, stand there!”
Clinicians want to relieve suffering.
We find it difficult to do nothing.
Why do distressed patients get more opioids?
Why send in counseling teams after traumas,
knowing they possibly make things worse?
DOUST, DEL MAR: BMJ: 2004: 328: 474
Are strategies for dealing with
uncertainty being taught in
Medical Schools?
We need to encourage clinicians to be
more open with patients about
limitations of treatments and their
potential for harm.
CHALMERS: BMJ: 2004: 328
Results of placebo controlled studies:
“Any drug can do anything
to any person
at any time”.
ABSENCE OF EVIDENCE ISN’T EVIDENCE
OF ABSENCE.
ALDERSON: BMJ: 328: 476
 RCT – Parachute use to prevent death.
 “Effect of parachute to prevent death
with gravitational challenge has not
been subject to rigorous challenge by
RCT”
SMITH, PELL: BMJ: 2003: 327: 20
Conflicts of Interest. (CsOI)
Biggest issue:
professional responsibility v’s
economic self interest.
Economic:
 Direct profit / salary.
 Derivative income –
professionals expertise / reputation
Conflicts of Interest. (CsOI)
Critical first step is to acknowledge conflicts
are inevitable,
we are all subject to unconscious biases.
Only then can we effectively manage the
conflicts that cannot be avoided.
BRODY: ETHICS THE MEDICAL PROFESSION :2007
Accepting any gifts
large or small,
payments for lecturing or consulting
or industry funding of research
can all stimulate
an unconscious need to reciprocate.
Most professionals believe they can
resist.
Compelling research indicates this is
NOT
the case.
CAIN: JAMA: 2008: 299
 Doctors are mostly unaware of the extent of
commercial influences over their behaviours.
 Doctors believe other doctors are influenced.
 There is no open disclosure to patients.
 Lack of awareness of industry influence
amounts to self deception (at best)
 Or to significant lack of integrity and fidelity,
if the doctor is aware.
ROGERS: HEALTH EXPECTATIONS: 2007
Every physician and researcher
is entitled to make
a fair and reasonable
profit.
Can this ever become an issue?
Can this ever become an issue?
 Perform several procedures when a few will do.
 New and profitable procedure prior efficacy proven.
 Invest Centre to which you refer.
When equally effective treatments exist –
provide one least risk
and then consider cost.
PS40 (2010) Guidelines Relationship
Fellows, Trainees and Industry
“Ultimate beneficiary any relationship must be the patient.”
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CME – organised by ANZCA / Sponsored by Industry.
CME – organised by Industry.
Research Projects.
Industry sponsored employment.
Travel.
PS40 (2010) Guidelines Relationship
Fellows, Trainees and Industry
Way Healthcare Industry can advertise their
products is increasingly being restricted.
Educational avenues remain open for the promotion of
their products.
Medicines Australia Code of Conduct:
Declare all Educational Events.
Declare amount sponsorship provided
PS40 (2010) Guidelines Relationship
Fellows, Trainees and Industry
1.1 “Formal and open acknowledgement by the
Fellow or group if they are in receipt of financial
or material support for any professional
activity.”
1.2 “Any association … does not imply
endorsement.”
Any talk or lecture should be presented in an
unbiased manner, while acknowledging the
support given.
TREATMENT
OF CHRONIC PAIN.
Conflicts of Interest.
 Major health issue currently is the under treatment of the 20% of our populations that
suffer chronic pain.
 This needs to be balanced with the
prevention of harm to our communities by
the abuse, misuse and diversion of
prescription drugs.
PAIN SPECIALISTS
recognise drugs –
limited role,
manage Chronic Pain.
“Fossil Pharming”.
Elderly sell their
opioids to
supplement the
pension!
PAIN MEDICINE 2009: 10:3
Bought
14%
Obtained
free friends /
relatives
HCP 18%
Bought friends
14%
From HCP 18%
Other 12%
60%
Other 12%
Obtained free
60%
DOES THIS MATTER?
Florida:
7 deaths every day
from prescription drug abuse.
AAPM WASHINGTON 2011
OXYCODONE DEATHS VICTORIA
 21 fold increase 2000 –2009
 320 cases described.
 54% deaths drug toxicity.
 52% unintentional.
 20% intentional self harm.
 28% unknown.
Number deaths strongly & significantly associated
supply.
RINTOUL, DOBBIN: 2010
USA
US Figures show prescription painkillers are the new
drug of choice, overtaking marijuana and
cocaine, and opioids.
They cause
more overdose deaths in the US than
cocaine and heroin combined.
5 months
3 States
173 doctors
287 visits
425 prescriptions
narcotics, morphine
425 x 20 = 8,500 tabs
8,500 x $20 = $170,000
$114 million per year
CULPABLE DRIVING?
12 caps heroin, shot of speed, 10 codeine tabs, 10 Xanax tabs
WHAT DOES WORK?