Rapid Responses to:

EDITOR'S CHOICE:
Fiona Godlee
Key opinion leaders, your time is up
BMJ 2008; 336: 0 [Full text]
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Rapid Responses published:

[Read Rapid Response] Key Opinion Leader: Are they really worth paying?
Dharmagadda Sreedhar, Virendra SL, Manthan J and Udupa N   (21 June 2008)
[Read Rapid Response] A matter of punctuation.
Henri A. Ménard   (21 June 2008)
[Read Rapid Response] Something missing
Graham Kyle   (23 June 2008)
[Read Rapid Response] Key Opinion Leaders and The Rule 3-30 of Evidence Based Medicine
Enrique J. Sánchez-Delgado   (23 June 2008)
[Read Rapid Response] Haiku Big Pharma Loves You
Hugh Mann   (24 June 2008)
[Read Rapid Response] Re: Something missing
Fiona Godlee   (25 June 2008)

Key Opinion Leader: Are they really worth paying? 21 June 2008
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Dharmagadda Sreedhar,
Lecturer
Manipal - 576104,
Virendra SL, Manthan J and Udupa N

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Re: Key Opinion Leader: Are they really worth paying?

A good medicine would treat effectively the disease or an ailment. If the medicine is really worth, it would bring sales on its own. All that Pharmaceutical companies need to do is communicate the benefits and make available the medicine for immediate test prescription. Unfortunately it is difficult to discover a medicine without unwanted effects hence they rely on aggressive selling by highlighting the health benefits rather than unwanted effects, luring the physicians to prescribe by offering expensive gifts and even pay well renowned specialty doctors for the publicity.

Pharmaceutical companies have understood that it is better to pay lump sum to one renowned specialty doctor than convincing all the doctors in their respective specialty. It is not that all the renowned doctors can be lured to sell medicines. They encounter some genuine doctors who would not agree to vouch or prescribe if the medicine is not worth prescribing. Moreover Articles about Key Opinion Leaders (KOLs) used by drug companies as salesmen would definitely bring awareness among the peers, which would affect the drug companies which are exclusively relying on the KOLs for selling their medicines.

Pharmaceutical companies are now using KOLs in conducting clinical trials, publication of opinion articles and even answering the queries and convincing the peers to prescribe the medicine for which they are sufficiently paid.

However it is time for the pharmaceutical companies to rethink whether it is worth paying these KOLs who some times contribute minimally to the overall sales of their medicines and it is even time for the KOLs to think is it necessary to be called as dignified sales representatives of the drug companies. Instead pharmaceutical companies can spend money in discovering the drugs which are really useful to treat some deadly diseases and the doctors concentrate on treating their patients with best possible treatment option available.

Competing interests: None declared

A matter of punctuation. 21 June 2008
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Henri A. Ménard,
Professor of Medicine
McGill University Health Center, 1650 Cedar Av,Montreal, QC, Canada, H3G 1A4

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Re: A matter of punctuation.

Two prominent MDs were chatting. The first: "Are you a KOL?" The second: "Yes. I think! And you?" The first: "No! I think."

My view: it is about time that this marketing scheme be openly discussed and denounced for what it is: entertaining pseudo-expertise based on pseudo-science i.e. trials designed for regulatory purposes with results that often have little to do with the real world usage of a given product.

Competing interests: None declared

Something missing 23 June 2008
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Graham Kyle,
Consultant ophthalmologist
86 Rodney Street, Liverpool, L1 9AR

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Re: Something missing

The title 'Key Opinion Leader' must include, ex officio, the Editor of the British Medical Journal (BMJ), so I was suprised that Dr Godlee's 'Editor's Choice' (BMJ 2008;336:21 June) did not start with a list of all the Pharmaceutical Companies who have placed adverts in this edition, as well as naming the Companies which have sponsored the research which is reported in the scientific parts of the Journal. Without such support the BMJ would be unlikely to be commercially viable, and she would be out of a job. Medical education and training in this country would be significantly curtailed without Drug Company financial backing.

Competing interests: Have received remuneration from various drug companies for lectures (usually about meducal ethics or law) and have been invited to speak as a 'KOL' in September.

Key Opinion Leaders and The Rule 3-30 of Evidence Based Medicine 23 June 2008
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Enrique J. Sánchez-Delgado,
Internist-Clinical Pharmacologist. Director of Medical Education
Hospital Metropolitano Vivian Pellas, Managua, Nicaragua.

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Re: Key Opinion Leaders and The Rule 3-30 of Evidence Based Medicine

Dear Dr. Godlee

In your Editorial (BMJ 21 June 2008), you mention the necesity of practicing Evidence Based Medicine. It is also essential for the Key Opinion Leaders (KOLs). I believe that an important barrier that make doctors dependant on KOLs is the difficulty for many to evaluate when a trial has not only statistical significance (which is clearly given by p or the confidence interval), but more important, the clinical significance and if it is cost-effective. When the doctors can analize this, their motivation to implement the evidence and motivate their patients will increase, and they will depend less on KOLs.

After analyzing hundreds of trials, I recognized a pattern, which I tested and confirmed to simplify the evaluation of the evidence.

I called this pattern: THE RULE 3-30 OF EVIDENCE BASED MEDICINE.

Basically it means that the trials that are clinically significant and/or cost- effective fulfill at least two of the following characteristics: a Relative Risk Reduction of 30% or more (not less than 20%), an Absolute Risk Reduction of 3% or more (not less than 2%), and a Number Needed to Treat or NNT of 30 or less (not more than 50), that is, for every 30 patients that we treat, we save a life or prevent one clinical event.

This simple rule rapidly identifies the Trials that could have practical clinical applications. The following is a partial list of very successful and well known trials that clearly fulfill THE RULE 3-30 OF EVIDENCE BASED MEDICINE:

ISIS-2, RALES, 4S, CARE, CURE, CLARITY-TIMI 28, ISAR REACT 2, SENIORS, ACCOMPLISH, among many others.

Prof. Enrique Sánchez-Delgado, M.D.

Competing interests: None declared

Haiku Big Pharma Loves You 24 June 2008
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Hugh Mann,
Physician
Eagle Rock, MO 65641 USA

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Re: Haiku Big Pharma Loves You

Medical journals:
the key opinion leaders
indubitably.

Competing interests: None declared

Re: Something missing 25 June 2008
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Fiona Godlee,
Editor, BMJ
BMA House, London WC1H 9JR

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Re: Re: Something missing

I'm grateful to Graham Kyle for giving me another opportunity to emphasise the difference between overt advertising in journals (or indeed sponsorship of trials) and covert and often disproportionate payment of medical leaders to influence other doctors' prescribing decisions. He's right that the BMJ, and therefore my salary, depends in part on revenue from drug advertising, which has the potential to introduce conflict of interest. However, the long established Chinese wall between the BMJ's editorial and advertising sales teams means that editorial decisions are as free from commercial influence as it's possible to make them. He's also right that medical education is currently heavily dependent on money from the pharmaceutical industry. Moves to reduce this dependence deserve active support. In the meantime, greater transparency around who is being paid what by whom and for doing what will help us to work out what is and is not acceptable about the current relationship between industry and the profession. I would be interested to hear the exact arrangement for Dr Kyle's employment as a KOL in September if he is willing to share this.

Competing interests: None declared