CHRONIC PAIN MANAGEMENTCHRONIC PAIN MANAGEMENTConflicts 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 InterestExist 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 informationSCHOFFERMAN: 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:males females

1901 - 55 yrs 59yrs

2010 79 yrs 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.

USANew 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.

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

SCHOFFERMAN: PAIN

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

Another company fined on 2 occasions (2 different products) for promoting off label use. Both fines were over $1bn

HAWKES: BMJ:2010

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 EducationEssential!

http://www.rxpromoroi.org/rapp/exec_sum.html

Continuing Medical EducationEssential!

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.”

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 Industry1.1 “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.

TREATMENTOF 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.

Elderly sell their opioids to supplement the pension!

PAIN MEDICINE 2009: 10:3

“Fossil Pharming”.

Bought friends14% From HCP 18%

Other 12%

Obtained free60%

14%

Obtained free friends / relatives

60%

Bought

HCP 18%

Other 12%

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 causemore 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?