2
Conflict of interest: full disclosure is essential I surprise people by writing my edito- rials longhand and even more challen- ging my papers, reviews and books. It helps me think sitting at an old fash- ioned desk looking out at my garden at 5 AM. Sometimes a computer steri- lises thought and away from it I am away from the advertisements that pop-up – no I really do not want your mobile phone, shopping discount at supermarket x and to form a new lov- ing relationship. Pop-up advertise- ments are in a way sending a subliminal message which made me think about similar messages which could be embodied in the medical lit- erature. I am writing this with my own pen but next to me are pens from Lipitor and Norvasc, my Post-it today is CoAprovel; my Post-it flags are Zetia and my desk clock is Viagra. I am of course above being influenced even though the paper I write on is from CV Therapeutics. I had planned to write this editorial today my reminder is on my ‘Things to do Today’ pad from the Journal of Sexual Medicine. You may wonder where I am going with this. It’s about the similarity between product placement that is often subtle (the Lipitor pen is much better than the one from Nor- vasc) but visible and the product placement that is hidden or camou- flaged within medical articles. We call this ‘conflict of interest’ and it is timely to consider how to make this as visible as possible in a way that enhances an article or review as well as establishing context. Conflicts of interest should not in any way affect the medical needs of our patients whether in the clinical setting or outside in the form of the written or spoken word. A conflict occurs when a situation arises that has the potential to adversely affect patient care. The most obvious conflict fol- lows from financial inducements to, for example, prescribe one drug above another. The involvement of authors in commercial activity (research grants, shareholding and device patency) may influence the content of a publication. Conflicts can also arise from restrictive practices (cost-related drug prescribing or limited specialist referral), which reduce patient choice. This is wide- spread in the UK with virtually no disclosure to the population affected based, I assume, on the belief that patient ignorance avoids patient action. Journals can also have conflicts. Journals can ask authors of papers to cite references to their journal which enhances their ‘impact factor’ and hence purchases by librarians (1). The higher the impact factor the more likely a major paper of commercial interest (drug study and device study) will be submitted (and accepted), with important financial implications from reprint sales. Case reports adversely affect impact factors, which may be why few journals accept them whereas reviews which cite publications in the same journal are popular. We con- tinue to accept case reports and have defined our position (2). In the July 2006 issue we considered one case report important enough to justify an editorial link (3,4). We are not pre- pared to manipulate our impact factor but like all journals we will continue to seek to improve it. As a medical journal we receive and publish articles from the pharma- ceutical and medical device industries. In doing so we recognise the close links between some authors and these businesses with the potential for bias. Recently, the New York Times high- lighted the problem of ‘Our Conflic- ted Medical Journals’ with disturbing illustrations from the Journal of the American Medical Association and Neuropsychopharmacology (5). It is impossible to adopt a ‘free of conflict’ author policy but essential to enforce full disclosure of any conflict at the end of each article. Our referees are quick to point out any potential con- flict which has been omitted, but they should not have to do so. Trust, how- ever, is important and we do accept that errors of omission can occur unintentionally. The Cleveland Clinic has been in receipt of unwelcome publicity firing Dr Jay Yadav for undisclosed conflict of interest regarding royalty fees for AngioGuard devices (6). Publications may well have been less than complete regarding adverse effects. Previously the CEO of the Cleveland Clinic was found to be in conflict as a sharehol- der and board director of AtriCure Inc whose devices were being evalu- ated at the clinic. In the past, we have expressed concern at the type and mode of presentation of data which has important financial implications if the authors have shares or large research grants (7). IJCP believes it has a vigorous policy in place regarding disclosure but there is always room for improve- ment. We will therefore establish an audit for the next six issues to see how well we are doing. Each article should be followed by a conflict statement (present or not), source of funding (if any) and whether a professional writer was involved. Reader and author feedback is welcome. CONFLICTS OF INTEREST None. FUNDING None. Graham Jackson Editor EDITORIAL doi: 10.1111/j.1742-1241.2006.01153.x ª 2006 The Authors Journal compilation ª 2006 Blackwell Publishing Ltd Int J Clin Pract, October 2006, 60, 10, 1147–1156

Conflict of interest: full disclosure is essential

Embed Size (px)

Citation preview

Page 1: Conflict of interest: full disclosure is essential

Conflict of interest: full disclosure is essential

I surprise people by writing my edito-

rials longhand and even more challen-

ging my papers, reviews and books. It

helps me think sitting at an old fash-

ioned desk looking out at my garden

at 5 AM. Sometimes a computer steri-

lises thought and away from it I am

away from the advertisements that

pop-up – no I really do not want your

mobile phone, shopping discount at

supermarket x and to form a new lov-

ing relationship. Pop-up advertise-

ments are in a way sending a

subliminal message which made me

think about similar messages which

could be embodied in the medical lit-

erature. I am writing this with my

own pen but next to me are pens

from Lipitor and Norvasc, my Post-it

today is CoAprovel; my Post-it flags

are Zetia and my desk clock is Viagra.

I am of course above being influenced

even though the paper I write on is

from CV Therapeutics. I had planned

to write this editorial today – my

reminder is on my ‘Things to do

Today’ pad from the Journal of Sexual

Medicine. You may wonder where I

am going with this. It’s about the

similarity between product placement

that is often subtle (the Lipitor pen is

much better than the one from Nor-

vasc) but visible and the product

placement that is hidden or camou-

flaged within medical articles. We call

this ‘conflict of interest’ and it is

timely to consider how to make this

as visible as possible in a way that

enhances an article or review as well

as establishing context.

Conflicts of interest should not in

any way affect the medical needs of

our patients whether in the clinical

setting or outside in the form of the

written or spoken word. A conflict

occurs when a situation arises that has

the potential to adversely affect patient

care. The most obvious conflict fol-

lows from financial inducements to,

for example, prescribe one drug above

another. The involvement of authors

in commercial activity (research grants,

shareholding and device patency) may

influence the content of a publication.

Conflicts can also arise from restrictive

practices (cost-related drug prescribing

or limited specialist referral), which

reduce patient choice. This is wide-

spread in the UK with virtually no

disclosure to the population affected

based, I assume, on the belief that

patient ignorance avoids patient action.

Journals can also have conflicts.

Journals can ask authors of papers to

cite references to their journal which

enhances their ‘impact factor’ and

hence purchases by librarians (1). The

higher the impact factor the more

likely a major paper of commercial

interest (drug study and device study)

will be submitted (and accepted), with

important financial implications from

reprint sales. Case reports adversely

affect impact factors, which may be

why few journals accept them whereas

reviews which cite publications in the

same journal are popular. We con-

tinue to accept case reports and have

defined our position (2). In the July

2006 issue we considered one case

report important enough to justify an

editorial link (3,4). We are not pre-

pared to manipulate our impact factor

but like all journals we will continue

to seek to improve it.

As a medical journal we receive

and publish articles from the pharma-

ceutical and medical device industries.

In doing so we recognise the close

links between some authors and these

businesses with the potential for bias.

Recently, the New York Times high-

lighted the problem of ‘Our Conflic-

ted Medical Journals’ with disturbing

illustrations from the Journal of the

American Medical Association and

Neuropsychopharmacology (5). It is

impossible to adopt a ‘free of conflict’

author policy but essential to enforce

full disclosure of any conflict at the

end of each article. Our referees are

quick to point out any potential con-

flict which has been omitted, but they

should not have to do so. Trust, how-

ever, is important and we do accept

that errors of omission can occur

unintentionally.

The Cleveland Clinic has been in

receipt of unwelcome publicity firing

Dr Jay Yadav for undisclosed conflict

of interest regarding royalty fees for

AngioGuard devices (6). Publications

may well have been less than complete

regarding adverse effects. Previously

the CEO of the Cleveland Clinic was

found to be in conflict as a sharehol-

der and board director of AtriCure

Inc whose devices were being evalu-

ated at the clinic. In the past, we have

expressed concern at the type and

mode of presentation of data which

has important financial implications if

the authors have shares or large

research grants (7).

IJCP believes it has a vigorous

policy in place regarding disclosure

but there is always room for improve-

ment. We will therefore establish an

audit for the next six issues to see how

well we are doing. Each article should

be followed by a conflict statement

(present or not), source of funding

(if any) and whether a professional

writer was involved. Reader and

author feedback is welcome.

C O N F L I C T S O F I N T E R ES T

None.

F U N D I N G

None.

Graham Jackson

Editor

EDITORIAL d o i : 1 0 . 1 1 1 1 / j . 1 7 4 2 - 1 2 4 1 . 2 0 0 6 . 0 1 1 5 3 . x

ª 2006 The AuthorsJournal compilation ª 2006 Blackwell Publishing Ltd Int J Clin Pract, October 2006, 60, 10, 1147–1156

Page 2: Conflict of interest: full disclosure is essential

R EF E R E N C E S

1 Begley S. Science journals artfully try to

boost their rankings. Wall Street Journal

2006; June 5th: B1.

2 Jackson G. Case reports. Int J Clin

Pract 2005; 59: 381.

3 Puri BK. Neuropsychiatric disorders

presenting with antisocial behaviour.

Int J Clin Pract 2006; 60: 760–1.

4 Doran M, Harvic AK, Larner AJ.

Antisocial behaviour orders: the need to

consider underlying neuropsychiatric dis-

ease. Int J Clin Pract 2006; 60: 861–2.

5 Our Conflicted Medical Journals. New

York Times 2006; July 23rd1 .

6 Cleveland Clinic fires Dr Jay Yadav

for undisclosed conflicts of interest.

theheart.org 2006; August 18th.

7 Jackson G. Calcium antagonists: a

scandal in need of an inquiry. Int J

Clin Pract 2003; 57: 455.

The sad, misunderstood prostate: understanding perceptionsand reality

There is really not much benefit in

being a prostate. You live in a pretty

undesirable location. You get blamed

for a lot of things, receive no accolades

for the hard work you do and your

neighbours are… Well, you get the

point. I recall a friend of mine in resi-

dency who felt that the prostate was

deserving of more credit, so he decided

to extol its virtues by singing its praise:

Its prostate awareness week, prostate

awareness week Hey you fella lend a

hand, let the doctor feel your gland

Its prostate awareness week, prostate

awareness week Come on fella don’t

be shy, raise your rear end to the sky

(Barry Duel, Irvine, CA, USA, unpub-

lished results).1

It was probably funnier when the

resident physician was dancing around

the clinic and we were all overworked

and sleep deprived. But, 13 years later,

it is one of my more memorable

experiences at Harvard.

So why is the prostate so underap-

preciated and ignored? I suppose there

are a lot of potential reasons and we

can all offer some speculation; however,

nothing is better than just asking the

people affected, the patients and the

physician. This is precisely what Kaplan

and Naslund (1) set out to do, and

achieved, in this landmark study. The

goal of their work was to find out what

the perceptions were regarding the pros-

tate and how it correlated with reality.

In summary, they found a tremendous

disconnect between the patient’s per-

ceptions, the physicians goals and what

is best for the prostate. In addition,

they found most parties involved adop-

ted a ‘wait and see’ mentality, rather

than treating the enlarged prostate (EP)

when the symptoms were still minimal

and possibly more manageable.

In the study, they aptly point out

that EP is a natural part of ageing and

that we have treatments (medical and

surgical) to prevent this from becom-

ing problematic. Sounds simple

enough, right? Not so! Patients do not

understand the disease, so they imme-

diately think that any symptom con-

sistent with EP is cancer related, so

they tend not to bring it up. On the

other hand, the physicians, when they

do bring it up, tend to favour a more

conservative approach with watchful

waiting before prescribing symptom

relief. Primary care tends to refer for

surgery, before offering some of the

medications that might actually shrink

the prostate. And finally, the urologists

know medications are effective both

for symptoms and to slow disease pro-

gression, but tend to offer surgery

without discussing medications.

When we put all this together what

does it mean? It means we have a lot

of work to do and we start with educa-

tion. According to the statistics in the

USA (apologies to anyone outside of

the USA reading this: and I would be

happy to review the data from your

country), there were approximately

25 million men with EP in the year

2000 and this number is just getting

bigger (no pun intended) (2). As

drawn out in the paper, only a fraction

of these patients received care. There

are 9268 urologists who presumably

have a good background in prostatic

health. If they all shared the load, they

would only have to see 2697 patients

each (3). In reality, they do not and

the patients end up seeing the ‘good

ol’ primary care physician’ (PCP) who

unfortunately has minimal to no train-

ing in the urological sciences. If they

did have exposure, as many of my col-

leagues have shared with me, it is hold-

ing ‘hooks’ in the operating room. I

am a hybrid in that I have trained in

urology and now practice in primary

care. I am frequently called on by my

peers to assist them in the evaluation

of their patients on urological issues.

What is funny is that they think I am

safe for them and their patients as I do

not wield a scalpel. This emphasises

that in primary care conservative

approaches are definitely favoured over

more aggressive, surgical intervention.

The findings by the authors that show

the urologists will operate on the

patient with EP before offering a trial

of medication is at least not a surprise

to me and my peers in primary care.

No disrespect to my urological col-

leagues, but if all you have is a

hammer, then everything looks like a

1148 EDITORIAL

Journal compilation ª 2006 Blackwell Publishing Ltd Int J Clin Pract, October 2006, 60, 10, 1147–1156No claim to original US government works