BMJ: HARLOT plc: an amalgamation of the world's two oldest professions

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http://bmj.bmjjournals.com/cgi/content/full/327/7429/1442

 

BMJ 2003;327:1442-1445 (20 December), doi:10.1136/bmj.327.7429.1442

 

 

Snakes, ladders, and spinHARLOT plc: an amalgamation of the world's two oldest

professions David L Sackett, director1, Andrew D Oxman, director2 on behalf of

HARLOT plc

1 Trout Research and Education Center, Markdale, ON, Canada N0C 1H0, 2

Department of Health Services Research, Norwegian Directorate for Health and

Social Welfare, Oslo 0031, Norway

 

Correspondence to: D L Sackett sackett

 

Tired of being good but poor, the authors have amalgamated the world's two

oldest professions in a new niche company, HARLOT plc, specialising in How to

Achieve positive Results without actually Lying to Overcome the Truth

 

We've been good. DLS has prohibited sponsors' stockholders, much less employees,

from seats on his data safety and monitoring boards and has enforced the banning

of pharmaceutical reps from the medical wards at McMaster University. ADO has

exposed problems with experts and has promulgated rigorous reviews of research

to inform decisions about health care. In sum, we have established impeccable

reputations for protecting the validity of randomised trials and systematic

reviews, and for exposing lapses in methods, validity, therapeutic claims, and

professional conduct.

We've also been poor. DLS drives a clapped out pick-up truck, and his rowing

boat leaks. ADO wears worn out blue jeans and hasn't had a new pair of shoes for

10 years.

It has finally dawned on us that being good and being poor are causally related:

being good doesn't pay. Accordingly, we have decided that it's time for us to

find out whether being bad pays better. We're combining the world's oldest and

second oldest professions, cashing in on our reputations, and distributing this

confidential prospectus for our new company, HARLOT plc.

HARLOT services

HARLOT plc will provide a comprehensive package of services to discriminating

trial sponsors who don't want to risk the acceptance and application of their

products and policies amid the uncertainties of dispassionate science. Through a

series of blind, wholly owned subsidiaries, we can guarantee positive results

for the manufacturers of dodgy drugs and devices who are seeking to increase

their market shares, for health professional guilds who want to increase the

demand for their unnecessary diagnostic and therapeutic services, and for local

and national health departments who are seeking to implement irrational and self

serving health policies. The tables summarise our services: table 1 shows the

ways we can cook the data in an individual randomised controlled trial; table 2

displays an array of aftercare services for keeping the truth from interfering

with sales and implementation; and table 3 lists the services that we offer to

our non-elite (that is, shallow pockets) customers.

Limited space permits the individual description of only a few of our services.

References for all of them can be obtained by subpoena from our legal

department.

 

View this table:

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Table 1 Stepped care for " me too " drugs or devices and useless screening tests

 

 

 

View this table:

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Table 2 Aftercare programme

 

 

 

View this table:

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Table 3 Non-elite services

 

 

 

 

 

 

Defining medicine

Medicine is politics

" Politics is nothing more than medicine on a grand scale. "

Rudolf Virchow, 18481

Politics is money

" [Politics is] the conduct of public affairs for private advantage. "

Ambrose Bierce, 19112

Ergo, medicine is money

" Pliny says, in so many words, that the cerates and cataplasms, plasters,

collyria, and antidotes, so abundant in his time, as in more recent days, were

mere tricks to make money. "

Oliver Wendell Holmes, 18603

 

 

 

It's the money, dummy

This prospectus is addressed primarily to drug companies, with good reason. One

of them now has 10 products with more than $1bn in sales each, and some 165

million people worldwide take its medicines. Its market capitalisation recently

passed that of Microsoft Corporation and is second only to that of General

Electric. In 2000, the top nine drug companies in the United States had over

$155bn in revenue. The top executives in these companies were paid between $3m

and $17m plus stock options valued between $11m and $73m. Drug companies have

the cake, and they are eating it too. Put simply, we want a piece of that cake.

If you are not a member of this elite club, you may want to skip to table 3,

where we list our bargain basement services. Once we have paid off our

mortgages, we will consider pro bono work. Meanwhile, if you would like our

help, please make sure to send us your credit card number and bank balance.

E-Zee-Me-Too Protocols

Our E-Zee-Me-Too Protocol team provides " stepped care " service for dodgy " me

too " drugs or devices and useless screening tests. With our protocol strategies,

such as those listed in table 1, as long as your " me too " drug isn't a lot worse

than a sip of triple distilled water, we can guarantee you a positive trial. As

you can see from the final column, the cost of this service depends on how many

steps we must climb to generate a foolproof protocol.

Ethics-R-Us

If you purchase our " seamless service " option, your completed protocol will be

immediately presented to one of our Ethics-R-Us outlets (situated in all major

shopping malls), where, for a fee, we can guarantee its approval within 45

minutes. As a Christmas special, we'll toss in our pre-approved, generic consent

forms in which study patients waive their right to receive any information

whatsoever about the risks or side effects of the study treatments. Furthermore,

in light of all the fuss about paying exorbitant bounties and bonuses to

clinicians for sticking patients into trials, every Ethics-R-Us outlet provides

(through our wholly owned subsidiary in Zurich) numbered bank accounts for

hiding each collaborator's payments.

RATs (Research Administration Teams)

To be sure that your E-Z-Me-Too protocol is executed to your advantage, you need

only hire our RATs (Research Administration Teams) to take over the conduct of

your trial. Depending on the trial result you require, we will reveal

randomisation codes and implement contamination, co-intervention, and biased

outcome assessment to meet your every need.

Our RATs also can provide four extraordinary services. Firstly, we will

establish criteria that study patients have to meet before they are " available

for follow up. " In brief, these criteria require that they must survive the

immediate toxicity of your drug before they are included in any analyses.

Secondly, we have devised a clever subversion of the " back the winner " strategy,

which we call " lose the loser. " Once a suitable number of patients taking your

drug seem to be heading for trouble, we will move the study clinic to a new,

secret (to them) location and, when they miss their next appointment, censor

them from all subsequent analyses. Thirdly, we will fax you unblinded interim

analyses after every event, to assist you in stopping the trial as soon as

random variation is leaning in your direction. Finally, if interim analyses just

don't look good, we will show you how to change the study question and end

points to rescue your useless product. Our charges for all this depend on

the number of strategies we have to apply and the depth of your pockets.

FPSU (Find the Pony Statistical Unit)

Our FPSU (Find the Pony Statistical Unit) services include back-stepwise sample

size calculation software (just tell us how many patients you can get, and we'll

instantly tell you the relative risk reduction claims you'll need to fabricate

to justify your trial). We can provide unblinded analyses after every event, so

that you will learn of impressive but irrelevant trends in the data long before

your Data Safety and Monitoring Board does.

Our speciality is data dependent subgroup analysis through the use of the

" Munchausen statistical grid. " This strategy exploits the happy fact that the

number of potential ponies in a muck of trial data is 2n where n = the number of

dichotomised subgroups. Even if your intervention is totally worthless, we'll

keep doubling the number of subgroups until we can emerge from the muck with at

least one pony subgroup in which it seems to work. What is more, we'll then turn

that phoney result over to our BS (Biology and Sociology) brain trust, which

will supply a minimum of three highly plausible theories to support our

otherwise patently unbelievable subgroup result. We reconcile statistical

significance in the face of multiple analyses by simply ignoring this meddlesome

issue.

Ghost Writers in the Sky

Once your data are sufficiently cooked, it is time for us to help you write them

up. Our " Ghost Writers in the Sky " have perfected the " Johnny Mercer strategy "

for reporting indeterminate trials:

 

We " accentuate the positive " by reporting only favourable subgroup analyses.

Moreover, you don't have to settle for just one paper in just one journal. For

no extra charge, we will randomise the sentences in the original article and

submit the suitably camouflaged duplicate publication to a second, unsuspecting

journal. Additional publications (our current record is 42) are available for

correspondingly higher fees, but we warn you at the outset that these fees will

be multiplied by a DVF (déjà vu factor).

 

We " eliminate the negative " by omitting or burying all unfavourable results

where nobody can ever find and report them. After all, what they (patients,

clinicians, regulators, and the public) don't know can't hurt you. We have a

contact in the Wieliczka salt mine who can guarantee burial of negative results

200 metres underground.

 

And we definitely " don't mess with Mr In-Between. " We stay out of the DMZ

(disappointing, minimally important zone) by suppressing equivocal results and

bothersome confidence intervals. We report only relative risk reductions when

absolute risk reductions and numbers needed to treat (NNTs) reveal that your

drug really isn't worth a bean.

 

 

Aftercare

See table 2 for our aftercare programme. To maintain the positive spin on

indeterminate results, we have created three useful pressure groups whose

financial ties to HARLOT plc are carefully concealed.

Our SAFE (Say Anything For a Euro) panel of experts is ready, at the drop of a

banknote, to appear on television, chummy up to reporters, or write favourable

commentaries in leading clinical journals. When prudish editorial policies

restrict their honoraria to $10 000 a year, we can arrange lifelong annuities,

interest-free loans, or tuition-free Oxbridge or Ivy League education for their

offspring. Our SAFE panel will be especially useful as members of committees

writing guidelines for professional societies, where they will ensure

recommendations that will please you and your stockholders.

Our stable of SCUM (Sick Celebrities to Use in the Media) will appear on talk

shows and, apparently by chance, describe their life threatening illnesses and

how your drug saved them. Coupled with saturation campaigns of direct to

consumer advertisements, we can fill doctors' offices with patients who demand

your drug by name or colour.

If the media unearth some authoritative upstart who argues convincingly against

the value of your drug, we can activate our third pressure group, the RCAF

(Rabid Citizens Against Facts). They can swamp switchboards and letters columns

with testimonials favouring your drug, discredit naysayers with accusations of

ulterior motives and unnatural practices, and, if all else fails, send anonymous

death threats.

 

Summary points

We, the authors, are tired of being good but poor, and have decided to sacrifice

the former to overcome the latter

We are therefore amalgamating the world's two oldest professions in a new

company, HARLOT plc, that provides " cradle to (the patient's) grave " services

that will maximise the profits of manufacturers of dodgy drugs and devices

Cashing in on our years of clinical research experience and as yet untarnished

reputations, we can protect your worthless product as we shepherd it through the

minefields sewn by objective scientists, fussy ethics committees, conscientious

journal editors, writers of evidence based guidelines, and licensing bodies

As we work together to create shining examples of the seduction of science

through HARLOTry, your gloss will be our gain

 

 

 

Unfortunately, however, there is always the danger that someone may reveal that

the data simply do not support your claims. This situation calls for our most

extreme (and costly) service, the SHARKS (Striking Horror And Retreat through

Killer Solicitors) squad. They are masters at sending terrifying letters,

threatening damage suits should the recipient continue to slander your drug's

good (if undeserved) name (and cautioning against showing the letter to any

professional body or the media). If all else fails, our SHARKS squad will obtain

an injunction prohibiting the release and activation of offending

recommendations or other damaging reports. The objective here is not to win the

case, but simply to keep everybody from learning that your drug doesn't possess

any real advantages until you've sold tonnes of it.

Contingency agreement

If you faithfully follow our advice, your drug should sell like hot cakes. In

this happy situation, we reserve the right to refund all the fees you've paid us

in return for 0.5% of gross sales in perpetuity. If we reach this mutually

advantageous agreement, we'll throw in, at no extra charge, a safety net for

your lead authors, should they be caught and exposed. Given our worldwide

academic contacts, and for as long as our diminishing reputations survive, we

should have no trouble getting them professorships at prestigious North American

universities.

SALAMI (our how to Succeed in Academic Life Advice and Mentoring Institute) and

other services

Although this prospectus focuses on our primary programme of services for firms

with " me too " drugs and devices or useless screening tests, we also offer

parallel services to others. For example, lazy but ambitious academics can

to SALAMI's services. These include how to instantly size up a roomful

of research celebrities and determine which one you want to be seen talking with

(see figure), and how to get a paper into the Christmas issue of the BMJ.

 

The HARLOT team together with some of our satisfied customers on the road to

riches. We can fabricate the results you need and, for a small extra fee, we can

fabricate the photos you need too, showing you chumming with selected stars of

science and cinema. The truth is in the eye of the beholder, and we can plaster

whatever you want them to see directly on their retinas

 

 

 

 

 

We offered Iain Chalmers stock options in HARLOT plc and co-authorship of this

manuscript. He refused the latter.

Contributors and sources: For potential customers, DLS and ADO both contributed

these brilliant ideas and will fight each other for the credit (and profit). For

libel lawyers, Chalmers did it.

Funding: We paid for the generation of this prospectus out of our own offshore

" DD " bank accounts (generated through " double dipping " by requesting

reimbursement for the same trip from at least two sources).

Competing interest: DLS's competing interests are so great as to warrant an

entire page on the BMJ's website

(http://bmj.com/cgi/content/full/324/7336/539/DC1). They also are on file at

several disciplinary bodies on both sides of the Atlantic. ADO has received an

exorbitant fee (almost as much as a high priced lawyer earns in an hour) from

two pharmaceutical firms on two occasions for showing up. He has benefited from

generous funding from two pharmaceutical firms that have supported his work and

has attended conferences that have been partially supported by pharmaceutical

firms. He would be thrilled to receive more money from the drug industry to

support his research and that of his colleagues, and to pay off his mortgage,

but is afraid that his involvement with DLS may put an end to any chances of

that happening.

References

 

Virchow R. Die offentliche Gesundheitspflege. Medizinische Reform 1848;5:

21-21.

Bierce A. The devil's dictionary. 1911.

Holmes OW. Currents and counter-currents in medical science. In: Huth E,

Murray TJ, eds. Medicine in quotations. Philadelphia: American College of

Physicians, 2000: 291.

 

 

 

 

 

 

 

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