The BMJ “Editors Choice” headline this week was “Key opinion leaders, your time is up”. The editor Fiona Godlee asked “Why is it considered normal for medical leaders to accept personal payment for promoting a company’s drug or device?” She was referring to the BMJ article “Drug Marketing” which interviews former pharma sales representative Kimberly Elliott about  Key Opinion Leaders. “These people are paid a lot of money to say what they say,” she said. “I’m not saying the key opinion leaders are bad, but they are salespeople just like the sales representatives are.” “Influential doctors can earn up to $400 an hour”.

Perhaps a little more surprising is the BBC’s  lazy reporting on the use of anti-inflammatory creams for osteoarthritis “Treat knee pain  with creams call”. The BBC report says that “both tablets and creams containing the drugs had the same effect on knee pain, the study showed”. No comment on how short lived the effects are or how weight loss, exercise, acupuncture or laser might be more effective and have no side effects. Perhaps the BBC should have read their previous report on this matter “Arthritis drugs fail after weeks”. For the public the BBC is also a Key Opinion Leader, it is rightly proud of it’s journalistic independence, but this kind of laziness is same as being “bought”, it’s just that they do it for free !

I was chairing the musculoskeletal session at NAALT last weekend, during the Q&A at the end, one of the expert panel commented that LLLT / cold laser / photobiomodulation research should be published less in the medical laser journals and more in the relevant professional / pathological journals. This got a strong response from some of the conference delegates and the Chair (myself) citing the volume of good clinical work published across a wide range of medical journals and despairing at problem of eminence based practice rather than evidence based. Upon hearing that, Mary Dyson, (former Editor of Gray’s Anatomy) who, for 20 years has insisted on research and wide publication in credible medical journals,  suggested that, perhaps, now it is time to publish in that other  Key Opinion Leader bugle “The Readers Digest”. There was a roar of approval from the other delegates.

You can follow the links above or read the text here

BMJ  2008;336:1402-1403 (21 June), doi:10.1136/bmj.39575.675787.651

http://www.bmj.com/cgi/content/full/336/7658/1402

Feature

Drug marketing

Key opinion leaders: independent experts or drug representatives in disguise?

Ray Moynihan, visiting editor, BMJ

¹ University of Newcastle, Newcastle, New South Wales, Australia

Ray.moynihan@newcastle.edu.au

10.1136/bmj.a17910.1136/bmj.a157

Ray Moynihan examines the role of the influential experts paidby industry to help “educate” the profession and the public

In the world of medicine, “key opinion leader” is the somewhat Orwellian term used to describe the senior doctors who help drug companies sell drugs.¹ These influential doctors are engagedby industry to advise on marketing and help boost sales of newmedicines. Across all specialties, in hospitals and universitieseverywhere, many leading specialists are being paid generousfees to peddle influence on behalf of the world’s biggestdrug companies.

Kimberly Elliott, who was a drug company sales representativefor almost two decades in the United States, puts it directly.”Key opinion leaders were salespeople for us, and we would routinelymeasure the return on our investment, by tracking prescriptionsbefore and after their presentations,” she said. “If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back.”

From the age of 23, Ms Elliott worked for several global drug companies, including Westwood Squibb, SmithKline Beecham, and Novartis, leaving the industry 18 years later, only last year. Many times a top national salesperson, part of her job was developing relationships with local and national opinion leaders, also described as “thought leaders.” Ms Elliott says she would pay these respected doctors $2500 (£1280; 1610) for a single lecture, which was largely based on slides supplied by the company. Sometimes the company would pay the fee to an academic centre, which would then pay the doctor. “These people are paid a lot of money to say what they say,” she said. “I’m not saying the key opinion leaders are bad, but they are salespeople just like the sales representatives are.”

In a candid interview with the BMJ, the medical director at the Association of the British Pharmaceutical Industry, Richard Tiner, agreed key opinion leaders play an important role for drug companies. “Companies will employ consultants to help adviseon marketing strategies . . . and present and speak at conferences,”he said.

Generous earnings

Two recent business intelligence reports on how drug companies identify, recruit, train, and pay their opinion leaders state that influential doctors can earn up to $400 an hour.^{2 3} The reports were produced by a company called Cutting Edge, which works closely with drug company executives, and are available to purchase at around $8000. A publicly available summary of one report shows that some doctors can earn more than $25 000 a year in advisory fees. A press release promoting the other report suggests that the average fee paid to a doctor for a “scientific speech” is more than $3000.⁴ Typically these speechesare delivered at educational events sponsored by companies.

The BMA said that although it might have had agreed fees forits members to be paid as key opinion leaders in the past, ithad not happened recently. The association’s fee guidanceschedule, however, suggests members may charge drug companiesmore than £200 an hour for participation in clinical trials.Although many doctors retain these earnings, it’s importantto note that some donate their payments from drug companiesto charities, or research.

Global phenomenon

Like drug marketing strategies, the use of key opinion leaders is a global phenomenon. In an article for UK based Pharmaceutical Marketing magazine describing the “tricks of the trade,” drug company marketing staff are urged to work routinely with key opinion leaders and try to make them into “product champions.”⁵Importantly, marketing staff should find doctors who will endorsetheir products, “who may be further down the influence ladder,”and then help “raise their profile, and so develop them intoopinion leaders.”

This industry guide says the first steps in recruiting and developinga set of opinion leaders are to “evaluate their views and influencepotential;” build relationships with them; and then providethe doctors with “appropriate communications platforms” so theycan “communicate on your behalf” with other doctors and thewider public. Drug companies are then encouraged to evaluatethe performance of their key opinion leaders continuously toavoid “wasting money on the wrong people.”

Another important trick of the trade is to maintain central databases of opinion leaders. Some small firms even offer special web based software to keep track of opinion leaders and show their return on investment.⁶ One firm offering such software, called KOL, specialises in managing opinion leaders for drug companies. Its website states that although these “thought leaders” in the profession “may not write many prescriptions,” they can “influence thousands of prescribers and hence prescriptions through their research, lectures, publications and their participation on advisory boards, committees, editorial boards, professional societies and guideline/consensus document development.”⁷ Theindustry’s Richard Tiner, accepts that drug companiesoften recruit senior specialists and evaluate the return oninvestment they may bring. They become an integral part of thecompany’s marketing, education, and research strategies.”When these people are receiving a fee, they are in one sensein the employment of the company,” he says, adding that thiswould mean their statements can be scrutinised under the industry’scode of conduct. Asked how senior doctors with long term financialarrangements with drug companies could maintain independence,he said key opinion leaders are “free to speak about other medicines”and their presentations at influential medical meetings are”often quite balanced.”

Transparency

Rejecting the view that doctors paid by industry may paint overlypositive portraits of their sponsors’ products, but concedingthat hyping is not appropriate, Mr Tiner says the best antidoteto these concerns is more transparency. All company paymentsto speakers should be routinely disclosed at medical meetings,he says. Responding to questions about whether such paymentscan be viewed as bribes to induce others to prescribe he said:”I don’t think they are bribes. It’s payment forwork done, rather than a bribe.” He agreed, however, that thework “might help to promote a particular medicine.”

The former sales representative Ms Elliott says drug companiesdesperately need key opinion leaders. “There are a lot of physicianswho don’t believe what we as drug representatives say.If we have a KOL [key opinion leader] stand in front of themand say the same thing, they believe it.” In January last year,after a car crash, and a worker’s compensation claim,Elliott was fired from the company she was then working for.Disillusioned with what she saw as the industry’s increasinglyaggressive marketing strategies, she decided to leave the industryfor good. Today she urges doctors who attend key opinion leaderpresentations to “take them with a grain of salt and go backand do your own research.”

Whose interest?

David Blumenthal, a Harvard University researcher who has studiedthe relationships between industry and the profession, sayscompany payments to key opinion leaders, rather than being corrupt,are simply not in the public interest. “I think these are legalrelationships between consenting adults who have overlappinginterests that are not consistent with the interests of thelarger society or necessarily with the patients served by thesephysicians.” Blumenthal is part of a small but growing globalchorus, which includes advocacy groups No Free Lunch and HealthySkepticism, that is calling for a major winding back of industryinfluence over the medical profession and in particular itseducation.

If industry’s sponsorship of medical education is wound back, it is possible that more independent sources of funding will be secured. Yet if the speakers giving the educationalpresentations in any newly independent forums continue to bethe overpaid “thought leaders” on the drug company payrolls,little, if anything, will have been gained.

Key opinion leaders—what fees can they command? Single lecture or scientific speech US$3000 (source: Marketwire) Hourly rate for influential physicians offering advice—up to $400 (source: Cutting Edge Information) Work for drug companies on clinical trials—More than £200 an hour (source: BMA)

References

10.1136/bmj.a17910.1136/bmj.a157

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Acknowledgments: Miranda Burne designed and edited the BMJ TVsegments accompanying this article, and Troy Teuscher shot thematerial.

Competing interests: None declared.

References

1. Pharma Marketing Glossarywww.pharma-mkting.com/glossary/keyopinionleader.htm
2. Cutting Edge Information. Thought-leader compensation: establishing fair-market value. http://cuttingedgeinfo.com/thoughtleadercompensation/PH106_summary.pdf, summary.
3. Cutting Edge Information. Pharmaceutical opinion leader management. November 2007. www.cuttingedgeinfo.com/pharmaopinionleaders/index.htm#body, summary.
4. Marketwire. Large pharmaceutical companies tend to pay triple what other size companies do for KOL speakers. Press release, 19 March, 2008.www.marketwire.com/mw/release.do?id=834122.
5. Cook J. Practical guide to medical education. Pharmaceutical Marketing 2001;6:14-22.
6. KOL. The opinion leader management service.http://kolonline.com/products-olms.asp.
7. KOL. Opinion leader development. http://kolonline.com/services-development.asp.
8. Spurgeon D. Continuing education should no longer be funded by drug industry, says CMAJ. BMJ 2008;336:742-3.

BBC http://news.bbc.co.uk/1/hi/health/3935785.stm

Arthritis drugs fail after weeks

OA affects joints like the hips and knees

Pain relief creams containing drugs similar to aspirin stop working in patients with osteoarthritis (OA) within weeks, research shows.

Current OA guidelines recommending lotions containing non-steroidal anti-inflammatory drugs should be revised, say the authors.

The Nottingham University scientists found the treatment was no better than a dummy cream after two weeks.

Their findings are reported in the British Medical Journal.

OA is the most common form of arthritis and a major cause of disability in elderly people. About 80% of 80 year olds have it.

I do not think it is a suitable treatment for OA because OA is a chronic condition and requires long term treatment Lead author Weiya Zhang

NSAIDs, such as ibuprofen, are commonly used to treat the pain associated with this condition, but few trials have looked at their effects for longer than two weeks, according to Dr Weiga Zhang and colleagues.

They analysed 13 trials comparing topical NSAIDs (treatments applied to the skin) with dummy treatment or NSAIDs taken in a tablet form in nearly 2,000 patients with OA.

Topical NSAIDs provided better pain relief than the dummy treatment in the first two weeks, but after a fortnight they were no better than the fake treatment.

Short-lived effect

They were less effective than comparable oral versions in the first two weeks of treatment and caused more skin-related side effects such as itch, rash and burning.

Their relief of stiffness also waned after two weeks.

In comparison, oral NSAIDs were an effective long term treatment.

The researchers said guidelines supporting the use of topical NSAIDs for OA should be revised.

Often, a more simple regime of paracetamol or paracetamol and codeine provides perfectly adequate and safer pain relief for many patients with OA A spokeswoman from Arthritis Research Campaign

Lead author Weiya Zhang said: “I would hope in the future when we update the guidelines we would say current evidence only provides support for the use of the drug for the short term period.

“I do not think it is a suitable treatment for OA because OA is a chronic condition and requires long term treatment.

“For acute pain, like pain due to a sport injury, topical NSAIDs might be useful,” he said.

He called for further long term studies over months rather than weeks.

Dr Peter Dawes, consultant rheumatologist and honorary secretary of the British Society of Rheumatology, said: “To show good benefit you have got to show there’s a long term benefit.

“Guidelines are based on the short term data.

“If patients are not getting a long term benefit then they need to have a proper assessment and a look at what are the other forms of treatment that can be used.”

He said OA might not always be the thing causing the pain.

“If you are having symptoms from arthritis and it’s not settling down you may need to have a specialist opinion,” he said.

A spokeswoman from Arthritis Research Campaign said: “We certainly welcome this study which has shown that topical NSAIDs are only of use in helping OA pain over a relatively short time period and are not effective in the longer term.

“It is useful to question the widespread use of NSAIDs, both topical and oral, when, often, a more simple regime of paracetamol or paracetamol and codeine provides perfectly adequate and safer pain relief for many patients with OA,” she said.
http://news.bbc.co.uk/1/hi/health/7466359.stm

Treat knee pain with creams call

Ibuprofen is commonly used to treat knee pain

Gels or creams containing painkillers are better than tablets for chronic knee pain, NHS research suggests.

A study of almost 600 patients aged over 50 found the anti-inflammatory creams worked as well as the oral versions and had fewer side-effects.

And although they cost more initially, topical treatments may save the NHS money in the long run, the Queen Mary University of London researchers said.

It is estimated that a third of over 50s suffer from knee pain.

In half of those the problem is classed as severe.

The most common cause of pain in the knee is osteoarthritis – a condition caused by abnormal wearing of the cartilage.

This is an important message for GPs and patients – that they should consider topical treatments to avoid side effects Professor Steve Field, Royal College of GPs

A total of 585 patients from 26 general practices around the UK took part in the study which looked specifically at non-steroidal anti-inflammatories (NSAIDs) – a class of drugs which includes ibuprofen.

Both tablets and creams containing the drugs had the same effect on knee pain, the study showed.

But those treated with oral medication had more minor adverse effects such as indigestion, increased blood pressure, or worsening asthma.

Uncertainty

NSAIDs are well-known to be associated with sometimes serious side effects but the topical preparations deliver a smaller dose directly to the affected area and so are less likely to cause such problems.

Patients also preferred the gels and creams, the study which is published on the National Institute for Health Research website.

Study leader Professor Martin Underwood, who has since moved to Warwick University, said there had been uncertainty about which to use.

“There has been quite a lot of discouragement about using topical NSAIDs because it was thought they were more expensive and there was not good evidence they were beneficial.”

He added that patients with more widespread pain may find tablets are better and should discuss the choice with their GP.

Royal College of GPs chairman Professor Steve Field said he had always been of the view that oral NSAIDs worked better.

“This is an important message for GPs and patients – that they should consider topical treatments to avoid side effects.”

An Arthritis Research Campaign spokeswoman said GPs had probably under-prescribed topical creams in the past because they did not believe they were as effective.

“But this new research appears to show they both as effective and safer, with fewer of the side affects associated with NSAID tablets,” she added.

BMJ http://www.google.com/url?sa=t&ct=res&cd=4&url=http%3A%2F%2Fbmj.bmjjournals.com%2Fcgi%2Freprint%2F319%2F7225%2F1618.pdf&ei=OTleSPyVI57E0QSpqZSSDA&usg=AFQjCNG_ugDf1lCJ9aSZPmCqj3SQYuvBrw&sig2=E99reZrqCHs3OVN67VAmUA

Seven alternatives to evidence based medicine
David Isaacs, Dominic Fitzgerald
Clinical decisions should, as far as possible, be evidence
based. So runs the current clinical dogma.1 2 We are
urged to lump all the relevant randomised controlled
trials into one giant meta-analysis and come out with a
combined odds ratio for all decisions. Physicians,
surgeons, nurses are doing it3–5; soon even the lawyers
will be using evidence based practice.6 But what if there
is no evidence on which to base a clinical decision?
Participants, methods, and results
We, two humble clinicians ever ready for advice and
guidance, asked our colleagues what they would do if
faced with a clinical problem for which there are no
randomised controlled trials and no good evidence.
We found ourselves faced with several personality
based opinions, as would be expected in a teaching
hospital. The personalities transcend the disciplines,
with the exception of surger y, in which discipline tran-
scends personality. We categorised their replies, on the
basis of no evidence whatsoever, as follows.
Eminence based medicine—The more senior the
colleague, the less importance he or she placed on the
need for anything as mundane as evidence. Experi-
ence, it seems, is worth any amount of evidence. These
colleagues have a touching faith in clinical experience,
which has been defined as ‘‘making the same mistakes
with increasing confidence over an impressive number
of years.”7 The eminent physician’s white hair and bald-
ing pate are called the “halo” effect.
Vehemence based medicine—The substitution of
volume for evidence is an effective technique for brow
beating your more timorous colleagues and for
convincing relatives of your ability.
Eloquence based medicine—The year round suntan,
carnation in the button hole, silk tie, Armani suit, and
tongue should all be equally smooth. Sartorial
elegance and verbal eloquence are powerful substitutes
for evidence.
Providence based medicine—If the caring practitioner
has no idea of what to do next, the decision may be best
left in the hands of the Almighty. Too many clinicians,
unfortunately, are unable to resist giving God a hand
with the decision making.
Diffidence based medicine—Some doctors see a prob-
lem and look for an answer. Others merely see a prob-
lem. The diffident doctor may do nothing from a sense
of despair. This, of course, may be better than doing
something merely because it hurts the doctor’s pride to
do nothing.
Ner vousness based medicine—Fear of litigation is a
powerful stimulus to overinvestigation and overtreat-
ment. In an atmosphere of litigation phobia, the only
bad test is the test you didn’t think of ordering.
Confidence based medicine—This is restricted to
surgeons (table).
Comment
There are plenty of alter natives for the practising
physician in the absence of evidence. This is what
makes medicine an ar t as well as a science.
Contributors: DI and DF each contributed half the jokes and will
both act as guarantors.
Funding: None.
Competing interests: None declared.
1 Evidence Based Medicine Working Group. Evidence-based medicine: a
new approach to teaching the practice of medicine . JAMA 1992;268:
2420-5.
2 Rosenberg W, Donald A. Evidence based medicine: an approach to
clinical problem solving. BMJ 1995;310:1122-6.
3 Sackett DL, Rosenberg WM, Gray JAM, Haynes RB, Richardson WS.
Evidence based medicine: what it is and what it isn’t . BMJ 1996;312:71-2.
4 Solomon MJ, McLeod RS. Surger y and the randomised controlled trial:
past, present and future. Med J Aust 1998;169:380-3.
5 McClarey M. Implementing clinical effectiveness. Nursing Management
1998;5:16-9.
6 EBM and the IMF. J Exponential Salar ies 1999;99:1-9.
7 O’Donnell M. A sceptic’s medical dictionar y. London: BMJ Books, 1997.