Rapid Responses to:

REVIEWS:
Adriane Fugh-Berman
Doctors must not be lapdogs to drug firms
BMJ 2006; 333: 1027 [Full text]
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Rapid Responses published:

[Read Rapid Response] TRIPS and access to medicines for all
Kawaldip Sehmi   (10 November 2006)
[Read Rapid Response] Are Doctors Really Lap Dogs
mike harvey   (11 November 2006)
[Read Rapid Response] All Fluff and no substance: Doctor's as Lapdogs
Peter Lavine, MD   (11 November 2006)
[Read Rapid Response] The beast is ourselves
Aubrey Blumsohn   (12 November 2006)
[Read Rapid Response] Doctors must not be lapdogs to drug firms: even more relevant in the Third World
Felix ID Konotey-Ahulu   (12 November 2006)
[Read Rapid Response] Physicians must not succumb to pharmaceutical pressure
Rajan TD   (12 November 2006)
[Read Rapid Response] Independence from drug companies: Perhaps the most cost effective way to improve health care.
Peter R Mansfield   (12 November 2006)
[Read Rapid Response] Not lapdogs, not pit bulls
Augusto Pimazoni   (15 November 2006)

TRIPS and access to medicines for all 10 November 2006
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Kawaldip Sehmi,
Chairman
Koum-Community Network

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Re: TRIPS and access to medicines for all

When the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) was signed by member countries under the World Trade Organisation's umberella, the opportunity to put into place some of issues now being highlighted by Professor Adriane Fugh-Berma (1) was then. These resurfaced and came to the ageneda in 2001 when the Doha Declaration was made.

Access to medicines for all principle was based upon the notion that pharmaceutical companies are protecting their margins and premiums by promoting artifical scarcity through the use of "compulsory licencing" schemes. This forces the national governments to only licence the production of drugs having no consent from the patent owners as long as these are for their domestic markets only. Parellel imports and other loop holes are closed.

The public relations budgets, the promotional hospitality budgets and the "funny money" budgets used in promoting drugs to the doctors and precribing groups in the developed world are huge. All paid-up weekend trips to inform the doctor of the drug at some major golf and convention centre in some exotic location is one simple means. Ever wondered why most well attended "world conferences" are held in the summer and in exotic locations- the delegates have been paid or sponsored/subsidised to attend on a little jolly!

These costs need to come off from somewhere. The come from the drug margins and final price, ultimately the consumer or the TAX payer! There is no free lunch!

Not all companies are the same. The lead taken by Dr. Khwaja Yunus Hamied of India by offering Triomune (a triple drug cocktail) to HIV/AIDS patients at a fraction of US/UK based costs in the developing world was one such major departure by a drug company. His example stands out.

1) Doctors must not be lapdogs to drug firms Adriane Fugh-Berman BMJ 2006;333:1027 (11 November)

Competing interests: None declared

Are Doctors Really Lap Dogs 11 November 2006
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mike harvey,
pharmacist
sussex uk

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Re: Are Doctors Really Lap Dogs

Good evening Firstly let me say as a patient,health care worker, pharmacist I am a fan of Pharma. I cannot fathom why doctors do not understand that some of their most important "tools" are provided by the assiduous research of new and valuable pharmaceuticals.

You say that you can also use diet and exercise as disease modulators -fine but where would you be without the fruits of very expensive and time consuming research by Pharma?

Calling your profession "lap dogs" as a result of pharmaceutical marketing is really quite pathetic.

If they choose to be lap dogs then so be it...but do they not have discriminatory powers..are they not trained that way ? If so, they should not easly "cave" in to the dynamic innovative elements of Pharma marketing. Shame on them if they do !!!

harvey of sussex

Competing interests: None declared

All Fluff and no substance: Doctor's as Lapdogs 11 November 2006
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Peter Lavine, MD,
Chairman Board of Directors, Medical Society -District of Columbia & practicing Orthopaedic Surgeon
20036

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Re: All Fluff and no substance: Doctor's as Lapdogs

I disagree completely with this overly dramatic and misleading article! In fact, I dont beleive any of the first two paragraph unless the speaker was so offensive that any sponsor would leave.

I have never been told any topic was off limits- ever; there is no reasonable sponsor that would be rejected as implied (so any sponsor is welcome!);there are often competing sponsors; there is no attempt to control content by the sponsors; lawyers, accountants, etc are not required by law to attend CME as physicians are at great expense ($10,000 - $15,000 per year) & most CME credits are not obtained in these types of meetings.

I could go on but this is not a problem or even an issue to be concerned about. It is a silly superficial and argument about an imaginary problem. In fact, there are onerous and excessive PHRMA guidelines that prevent any of this from being a valid issue! So, while this may be an issue in other countries, it is not in the United States.

The real lapdog is Congress that allows the pharmaceutical industy to run public policy, write leglislation, benefit from NIH research without paying for it, group marketing & advertising costs into the viel of "R&D" budgets,and make excessive profits of drugs that cost much less in other countries.

Enough blaming doctors. Focus on the real problems in health care and not the imaginary ones! This article needs to be taken for a walk!

Competing interests: None declared

The beast is ourselves 12 November 2006
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Aubrey Blumsohn,
Consultant
Sheffield Teaching Hospitals, S5 7AU

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Re: The beast is ourselves

Of course Adriane Fugh-Berman is correct that we need to bite something tender and to get out of that lap.

But we are fighting the wrong beast. The beast is not the pharmaceutical industry - it is ourselves.

Pharmaceutical companies sell products under the banner of science. But their only raison d'être is to make money. Industry has to balance genuine hypothesis testing and transparency against commercial interests and the financial consequences of dishonesty. This is not in itself a criticism - it is a simple fact.

It is also of course true that the industry provides products which are often beneficial to our patients. It is equally evident that many actions of industry have not resulted in benefit, and have instead caused harm. More importantly, we are often completely unable to assess the degree of harm, because information is hidden by gag clauses, the threat of litigation, and cozy commercial arrangements between the regulators and industry (1,2).

We, as doctors, have created the atmosphere which has allowed companies to malfunction. We have allowed industry to subvert the rules of science (3). We have watched quietly as governments and academics have colluded with industry to hide information critical to our patients. We have remained silent as our medical schools have churned out graduates who have no knowledge of the dilemmas and scandals of medicine. We have allowed many of our medical journals to become corrupted and timid. We have remained silent as the General Medical Council and other bodies charged with maintaining integrity have taken action against doctors for raising questions of integrity, while ignoring serious concerns brought to their attention (4). We have failed to support our colleagues who have raised concerns.

The soft parts that need biting may well be our own.

Aubrey Blumsohn


1) Godlee F. (2006) Can We Tame the Monster? "Drug companies should not be allowed to evaluate their own products." BMJ 2006;333 http://www.bmj.com/cgi/content/full/333/7558/0-f

2) Healy D (2006). Did regulators fail over selective serotonin reuptake inhibitors? BMJ 333: 92-95.

3) Blumsohn A. (2006)Authorship, ghost-science, access to data and control of the pharmaceutical scientific literature: who stands behind the word? American Association for the Advancement of Science, Professional Ethics Report Vol XIX (3) http://www.aaas.org/spp/sfrl/per/per46.pdf

4) Wilmshurst P. (2006) The General Medical Council - a Personal View. Cardiology News Oct/Nov 2006 14-15 http://www.pinpointmedical.com/cardiology/article_archive/2006/ON06_gmc.pdf

Competing interests: Involved in a dispute with Procter and Gamble Pharmaceuticals over hiding of research data and research Integrity. http://www.slate.com/id/2133061/

Doctors must not be lapdogs to drug firms: even more relevant in the Third World 12 November 2006
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Felix ID Konotey-Ahulu,
Dr Kwegyir Aggrey Distinguished Professor of Human Genetics, University of Cape Coast, Ghana.
Ten Harley Street, London W1N 1AA

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Re: Doctors must not be lapdogs to drug firms: even more relevant in the Third World

Nothing but FULL MARKS is what Adriane Fugh-Berman

deserves for her incisive article [1]. Salaries for

doctors in the Third World, are a mere fraction what

their colleagues whom they had trained and

qualified with on the same day in the UK, USA, and Germany

get.

Therefore, if physicians in the USA and UK appear to

kowtow whenever drug firms agree to sponsor conferences,

and pay for educational trips abroad, with attractive

allowances, imagine the lure dimension in the Third World

when the same thing happens.

Not all drugs exhibited as part of pharma-sponsorships,

are in the best health interest of the people. Drugs that

have been pushed, and pushed, for malaria have been

been causing "furore" in Ghana because of side-effects [2].

When we have plant-based antimalarials like Azadirachta

indica (Neem) that saved me more than once from cerebral

malaria in my childhood [3, 4], and Artemisia annua [5],

we find drug firms recommending and exhibiting Mefloquine

which, in the British National Formulary, is listed as

having 52 (yes, fifty-two) side-effects [6].

If, as Dr Fugh-Berman implies, the phenomenon of physician

lap-dog behaviour is a problem in the USA and the UK,

words are not adequate to describe exactly what is

happening in the Third World, where the drug firms can

pass through trusted friends like the World Health

Organisation and well-meaning Non-Governmental

Organisations to push their wares. Thank you, Adriane for

drawing attention to this.

1 Fugh-Berman A. Doctors must not be lapdogs to drug

firms. BMJ 2006;333: 1027 (November 11)

2 Daily Graphic, Ghana. Furore over Artesunate-

Amodiaquine. May 15 2006, page 23.

3 Konotey-Ahulu FID. Averting a malaria disaster.

Lancet 1999; 354: 258

4 Konotey-Ahulu FID. Ghanaian doctors in malaria

research. Ghanaian Times 2006, Saturday 7 January, p 6.

5 British National Formulary. MEFLOQUINE Side-effects.

2003 September (46): pp 317-318. (BNF.org [British National Formulary])

6 Konotey-Ahulu FID. Epidemiology of malaria (4): The

How? and Which? questions. Ghanaian Times 2006, Saturday

11 February, p 5.

Competing interests: None declared

Physicians must not succumb to pharmaceutical pressure 12 November 2006
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Rajan TD,
Specialist, Skin & Sex Transm Diseases
Consultant, CMPH Med College, Mumbai, India. Tel: 0091-22-66982747

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Re: Physicians must not succumb to pharmaceutical pressure

Professor Adriane Fugh-Berman has hit the nail on the head! There is no doubt that pharmaceutical companies will only sponsor talks or conferences which will improve their bottomline. In the course of the discussion Prof. Fugh-Berman seems to have missed the point that drug manufacturers do not have the same objectives as physicians. While the former are purely businessmen, the latter are expected to provide service with a sense of social responsibility. The physician being the first link with the patient, he is more answerable to society. As both have chosen to do what they desire there should be no comparison of their goals.

Nevertheless, the medical profession seems to be increasingly manipulated by the pharmaceutical industry. This scenario is not just confined to the developed countries and has become a global phenomenon. There was a time when conferences were small affairs with research papers of high quality were presented and the session would end in a day or two. These days conferences - both national and international - are major events like the Olympic Games! They run over three to five days and there are simultaneous sessions in three halls at a time. Research papers of very little significance are presented simply to fill the time-slot made available by the sponsor.

With a large number of sponsors waiting with moneybags the conference organising committees are only too eager to have one more session in one more hall on one more day. Eventually, with so much time available on the conference calendar, papers of little scientific value get selected. The net result: fewer delegates would be found seated in the hall. Most of them would be outside, enjoying the sights and sounds of the city - again, sponsored by some other drug company!

The medical profession is as much to blame as the industry in question. There is no doubt that scientific development and profits must go hand in hand and that dissemination of medical information requires sponsorships from pharmaceutical companies. Yet, the ultimate responsibility lies with the medical profession in not succumbing to the pharma lure. The question is: who will bell the cat?

Competing interests: None declared

Independence from drug companies: Perhaps the most cost effective way to improve health care. 12 November 2006
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Peter R Mansfield,
Director
Healthy Skepticism Inc, 34 Methodist St, Willunga SA 5172 Australia

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Re: Independence from drug companies: Perhaps the most cost effective way to improve health care.

I hope Furg-Berman’s talk is effective for prompting drug companies to cease their involvement in medical education. If so, such talks could be the most cost effective way to improve health care because exposure to drug promotion correlates with suboptimal health care.<1> That includes the subtle promotion in disguise that makes involvement in medical education profitable for drug companies.

The main barrier to progress is doctor’s denial that we are often adversely influenced by drug promotion. This denial arises partly from ignorance of the evidence about drug promotion,<2,3> partly from overconfidence<1> and partly from refusal to believe that evidence because it is seen as insulting our self esteem.<4> We need to move from the illusion that being misled is unlikely or shameful to accepting that it is normal for humans to be vulnerable to misleading promotional techniques.<4> There is no proven method for obtaining more good than harm from exposure to drug promotion<1> so we should all follow Frug-Burman’s call to stop being lapdogs to the pharmaceutical industry.

1. Mansfield PR, Lexchin J, Wen LS, Grandori L, McCoy CP, Hoffman JR, Ramos J, Jureidini JN. Educating Health Professionals about Drug and Device Promotion: Advocates' Recommendations. PLoS Med 2006:3(11): e451 http://medicine.plosjournals.org/perlserv/?request=get- document&doi=10.1371%2Fjournal.pmed.0030451

2. Norris P, Herxheimer A, Lexchin J, Mansfield P. Drug Promotion: What we know, what we have yet to learn. Geneva: World Health Organisation 2005 http://www.haiweb.org/18012006/drugPromodhai12sept.pdf

3. Healthy Skepticism Library www.healthyskepticism.org/library.php

4. Mansfield P. Accepting what we can learn from advertising's mirror of desire. BMJ. 2004 Dec 18;329(7480):1487-8. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=15604193

Competing interests: I am the Director of Healthy Skepticism Inc. www.healthyskepticism.org

Not lapdogs, not pit bulls 15 November 2006
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Augusto Pimazoni,
Medical Marketing Consultant
MED MARK - Medical Marketing Consultants - Brazil

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Re: Not lapdogs, not pit bulls

Dear Dr. Adriane Fugh-Berman:

First of all, for ethical reasons, let me declare my conflict of interests: I am a medical marketing consultant for the pharmaceutical industry in Brazil. As an American trained physician, after my return to my homeland back in the 70's, I could feel the size of ignorance of the poorly formed (or deformed) Brazilian doctors, who are by no means, more or less ignorant than doctors from other underdeveloped (or developing, if you wish) countries. In fact, I would say that even in well developed countries the quality and the level of informarion by doctors is quite variable and "not all doctors are educated equal"

My area of specialty is the development of continuing medical education projects for the pharmaceutical companies who share with me the very basic concept of intelligent medical marketing: promote the global understanding of the pathology first and then let the doctors know about about your products in a balanced and ethical way. But, like drinking an driving, never mix medical information with product promotion. By doing so, the pharmaceutical industry would be promoting its version of social responsability of educating and updating physicians with poor or no access to medical information at all.

Is this an easy task? Obviously not. Most of the drug companies behave just like you said, trying to turn doctors into lapdogs and being very successful on it. How can we transform this promiscuous relationship into an ethical and reliable source of medical information? The answer is: strict regulation and intelligent control of educational materials produced by the pharmaceutical industry. The recent Code of Practice for the Pharmaceutical Industry adopted by The Association of the British Pharmaceutical Industry (ABPI) is probably the best roadmap to let the pharmaceutical industry promote its products and at the same time develop educational projects under strict and intelligent rules by regulatory authorities. Other good example of intelligent regulation was adopted by the Office of Continuing Medical Education, Michigan State University College of Human Medicine in a simple 3 pages document that covers all relevant aspects of the problem.

As a member of the National Health Council of the Brazilian Ministry of Health, I am working in a proposal based on the concepts described above for the implementation of regulatory legislation that would allow freedom with responsibility for the pharmaceutical industry to promote continuing medical education projects.

The big problem with regulatory agencies in less developed countries is that they lack the needed sensitivity, technical background and commom sense to produce effective and intelligent regulatory legislation. They act like dictator pit bulls imposing overdoses of innefective regulations which do nor reflect a consensuous position among the involved parties.

Like everything else in life, fair balance is the key to solve conflicts in an intelligent manner.

Augusto Pimazoni, MD
pimazoni@uol.com.br
Medical Marketing Consultant, Sao Paulo, Brazil

REFERENCES

1. Code of Practice for the Pharmaceutical Industry. The Association of the Bristh Pharmaceutical Industry (ABPI) - 2006. Available at: http://www.abpi.org.uk/links/assoc/PMCPA/Code06use.pdf. Access on October 26, 2006.

2. Continuing Medical Education Program: Relationship with Industry Policy and Procedure. Office of Continuing Medical Education. Michigan State University College of Human Medicine. Available at: http://humanmedicine.msu.edu/medical_education/continuing_ed/ documents/RelationshipwithIndustryPolicyandProcedure.doc Access on October 26, 2006

Competing interests: Medical Marketing Consultant for the Pharmaceutical Industry in Brazil