Pharmas-co-dependence exposed: Would it be time to say, “No thanks”?

Pierre Biron; Martin Plaisance; Paul Lévesque

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Evaluation of industry sponsored CME contents by Institutional Committees.
Fran�ois H�lie

Published on: 14 November 2007
Journals need to generate the standards for reporting
Eddie Vos

Published on: 19 October 2007
Pharmaceutical companies and physicians
David C Rosen

Published on: 12 October 2007

Published on: (14 November 2007)
Page navigation anchor for Evaluation of industry sponsored CME contents by Institutional Committees.
Evaluation of industry sponsored CME contents by Institutional Committees.
Fran�ois H�lie, Research Associate
Other Contributors:
Biron and colleagues present a timely, comprehensive and accurate portrait of how industry interacts with physicians to promote the utilization of drugs for patient care. Unfortunately, industry has too often failed to provide continuous medical education programs covering topics located outside of their immediate marketing strategies. In such a narrow scientific context, fair balance is virtually impossible to reach, th...
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Biron and colleagues present a timely, comprehensive and accurate portrait of how industry interacts with physicians to promote the utilization of drugs for patient care. Unfortunately, industry has too often failed to provide continuous medical education programs covering topics located outside of their immediate marketing strategies. In such a narrow scientific context, fair balance is virtually impossible to reach, thereby putting the reputation of everyone involved at risk during the process. There is a need for approval and supervision of proposals for continuous medical information programs which are prepared by coordinated opinion leaders who have proved their interest in the matter. Such programs could then be overviewed by local institutional committees (e.g. hospitals and universities) dressed in the private industry and clinical research code (i.e. including lawyers and specialists about ethical matters). Until then, Doctors should dissociate from industry when it comes to participating in industry sponsored continuous medical education programs, or else industry provide truly unrestricted grants for these.
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Competing Interests: None declared.
Published on: (19 October 2007)
Page navigation anchor for Journals need to generate the standards for reporting
Journals need to generate the standards for reporting
Eddie Vos, maintains www.health-heart.org
Biron et al outline the influence of Pharma money in medical education and prescribing habits. Money will always find ways to promote, mislead by omission or influence, directly or by proxies, to sell its wares.
Since all drugs and devices have to pass through peer reviewed journals, I suggest to start at this fundamental level and Journals should therefore require that Numbers Needed to Treat and Harm [NN...
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Biron et al outline the influence of Pharma money in medical education and prescribing habits. Money will always find ways to promote, mislead by omission or influence, directly or by proxies, to sell its wares.
Since all drugs and devices have to pass through peer reviewed journals, I suggest to start at this fundamental level and Journals should therefore require that Numbers Needed to Treat and Harm [NNT, NNH] be published for the precise patient groups and for their precise disease outcomes (rather than reporting combined endpoints) and this per year (week, month) of the duration of the study.
It may surprise many that for example in the case of statins, the largest randomized study ever, the Heart Protection Study [HPS], during the 5 years of publishing outcomes has yet to produce these figures for all-cause mortality and hard individual disease outcomes, for women, diabetics (2) and patients with baseline peripheral artery disease (3), their prominent subgroups. Moreover, drug benefit is promoted by combining endpoints, they call them 'events', that more often that not include interventions which are procedures and not disease endpoints -- and that in this case do not affect future heart attacks and mortality.
HPS has combined unusual reporting endpoints such as revascularizations plus amputations (2) or mortality plus aneurysm repairs (3) but without releasing the numbers of overall deaths and hard disease outcomes. It would be a full time job to actually tease some NNTs out of the variety of publications regarding HPS alone. One HPS study author is on record (at 2007 ACC) stating total mortality to be ".. a rather unhelpful endpoint in cardiovascular prevention studies", meaning but not said, presumably, that statins may not save lives in many groups, a fact established for women in HPS [P=0.12; value by this author based on (4)]. Yet, the HPS publications promote statin for every subgroup included (the above ACC link, 2, 3, 4).
Therefore, Journals should generate precise publication guidelines for authors and reviewers and refuse publication when patient-group relevant data with NNTs and NNHs are not clearly given and made available in a publicly accessible Internet format, if not in the journal itself.
The use of 'relative reductions' [RR] should be severely restricted, and avoided in the study abstract when possible, since RR can be as meaningless as the massive RR reduction enjoyed for not being hit by lightning on a golf course by just staying home and reading medical journals.
Returning to the Biron et al issue of Pharma influence, Oxford University in 2006 received another $m78 [they call it a "grant"(5)] from Merck & Co to study its statin plus another of their proprietary drugs in another trial, HPS-2, bringing the total received for their client's statin to well over $m100. The study authors, while employed at Oxford, may only accept Pharma reimbursed travel expenses -while promoting poorly defined 'benefit' (2)- and while their employer's enormous financial stake as Pharma contractor remains an unmentioned conflict of interest (2). Clearly, Journals have a role also to require employer's conflicts at 'non commercial' institutions, i.e. at university departments doing clinical trials for commercial interests.

About the author: Eddie Vos, M. Eng., is consulting forensic engineer (bio) in material failures residing in Sutton (Qc) with a long standing interest into the causes of artery failure. During the last 9 years, he published a non revenue generating website www.health-heart.org with pages concerning cholesterol and homocysteine, two presumed causal players in the genesis of atherosclerosis.
1. Biron et al http://www.cfp.ca/cgi/content/full/53/10/1635
2. Collins R, Armitage J, Parish S, Sleigh P, Peto R; Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet. 2003 Jun 14;361(9374):2005-16. Medline 12814710
3. Heart Protection Study Collaborative Group. Randomized trial of the effects of cholesterol-lowering with simvastatin on peripheral vascular and other major vascular outcomes in 20,536 people with peripheral arterial disease and other high-risk conditions. J Vasc Surg. 2007 Apr;45(4):645-654. Medline 17398372
4. HPS in BioMedCentral [accessed Oct. 19, 2007]
5. http://www.ctsu.ox.ac.uk/pressreleases/2006-05-31/hps2-thrive-press-release [accessed Oct. 19 2007]
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Competing Interests: None declared.
Published on: (12 October 2007)
Page navigation anchor for Pharmaceutical companies and physicians
Pharmaceutical companies and physicians
David C Rosen, family physician
The co-dependency factor is a large one. I would like to add that one way we break that dance is to educate ourselves in how to analyze studies that appear in the journals. We must learn to be intelligently critical of the information that may be presented to us by the experts. Statistics can be manipulated. For eg., the use of relative risk reduction instead of absolute reduction can augment the advantages of a particular...
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The co-dependency factor is a large one. I would like to add that one way we break that dance is to educate ourselves in how to analyze studies that appear in the journals. We must learn to be intelligently critical of the information that may be presented to us by the experts. Statistics can be manipulated. For eg., the use of relative risk reduction instead of absolute reduction can augment the advantages of a particular method of treatment. We must compare the number-needed-to-treat vs the number-needed -to- harm. We must learn how to analyze methodology. Too often results for a certain age group or sex are extrapolated to include groups that were not adequately represented in the study. I would suggest that every college meeting should have a plenary session or at least a seminar where the intelligent analysis is discussed.Perhaps the ministries of health should be supporting more research into non-drug therapies. In the end they might save money. We know that many cardiovascular illnesses, diabetes, osteoporosis, obesity and its ramifications begin in early childhoold. Spending money on wellness education at this stage may reap savings later on.
Dr. David Rosen
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Competing Interests: None declared.