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Stage IV Studies, a Marketing Ploy

I have come to the conclusion that we have revisited the snake-oil era.  The scientist’s standard of performance and that of the medical researcher’s are leagues apart.  The below article exposes the standard that scientists are held to; this site is full of examples of the business standard of research. 

 

Post-market studies (also called stage IV studies) are supposedly for a scientific purpose.  Sometimes they are required when the FDA approves a drugs, such as for the purpose of uncovering side effects.  However, though such is on paper required, the enforcement by the FDA of this “order” is near zero.  Other uses of studies:  A)  to find new uses for a drug, principle for the sake of extended it patent through entry in the Orange Book of the FDA; B) to introduce doctors to a new drug (article below); C) borderline research done to show a drug is better than its competitiors so that their sales force can promote its usage.  Such borderline research for example often does a comparison where the dosage of the two drugs is not equivalent, the populations in the study have been manipulated to produce the desired conclusion; the duration of the study in its published form has the desired conclusion, while a different duration would favor the competition’s drug; the study is done on a subgroup of those who would be taking the drug and that subgroup yields the desired conclusion, and/or simply to manipulate the raw data to arrive at the desired conclusion since raw data is not public information and is thus not submitted to journal which will review the article prior to publication.  For a detail account of this and other marketing usages see Prof. Marcia Angell’s seminal work “The Truth About Drug Companies”.   

http://www.bmj.com/content/344/bmj.e3974?etoc=

Post-marketing studies of new insulins: sales or science?

BMJ 2012; 344 doi: 10.1136/bmj.e3974 (Published 12 June 2012) Cite this as: BMJ 2012;344:e3974

Edwin A M Gale, emeritus professor of diabetic medicine, University of Bristol

 

Edwin Gale’s analysis of registered post-marketing studies of new treatments for diabetes showed that studies of insulin analogues have involved some 400 000 participants worldwide. One company recruited nearly 360 000 individuals. Most studies were performed in middle or low income countries, had limited scientific value, and promoted wider use of more expensive insulins

In 1994 David Kessler and colleagues from the Food and Drug Administration described ways in which pharmaceutical companies could promote their products in a crowded marketplace. These included the “switch campaign” and studies designed to market a drug as well as study its behaviour.1 The switch campaign is designed to persuade prescribers to substitute a new drug for an established but less expensive treatment. The marketing study is a clinical investigation whose predominant objective is to change the prescribing habits of the participating physicians.

The literature on marketing studies is sparse. One example was the ADVANTAGE study (such studies are characterised by their upbeat acronyms) which involved 5557 participants treated with rofecoxib. Access to confidential company documents confirmed that the study was designed as a marketing tool.2 The accompanying editorial pointed out the dubious legality of such studies under US law, and cited guidance issued by the Office of the Inspector General to the effect that “post-marketing research activities should be especially scrutinised to ensure that they are legitimate and not simply a pretext to generate prescriptions of a drug.”3 Recent guidelines from the European Medicines Agency also stress that “such studies should not be performed where the act of conducting the study promotes the use of a medicinal product.”4

Post-marketing studies

Post-marketing research has received little scientific scrutiny. Current procedures to license a drug represent a compromise between the need to make potentially valuable new drugs available without undue delay and the need …

 

This is a standard practice. Because their liver doesn't metabolize their medication as efficiently as a younger person, they are more prone to serious side effects.  Moreover they might require a lower dose, and given that drug companies favor celling the higher dose, this is another reason not to use elderly people whenever possible, even when the drug is mostly likely to be used by the elderly. 

 

Why the exclusion of older people from clinical research must stop

BMJ 2012; 344 doi: 10.1136/bmj.e3445 (Published 21 May 2012);  Cite this as: BMJ 2012;344:e3445

http://www.bmj.com/content/344/bmj.e3445?etoc=

Age bias in clinical research leads to uncertainty about risks and benefits in new treatments for older people. Geoff Watts looks at the barriers to recruitment

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