INTENTIONS AND OMISSIONS IN HEALTH CARE
For being born as Human being all through my professional years, I relished the journey of my life from where I was once to be what I am now as a pharmaceutical and health care consultant. Medicines, the pharmaceutical industry and the healthcare sector are a very broad topic. For more than 35 years I had associated with pharmaceutical and healthcare industry and during those years, I loved being there with them but now I am enjoying here sitting at home writing articles on my known and interesting facts. I am enthused to share my active key-years’ experiences and observations. It gives interested professionals countless possibilities to examine the resources of today’s pharmaceutical weakness and strength.
We know that we all are driven by impulses, needs, strengths and weakness to seek pleasure or avoid pain. So do a consultant and client. When the clients are unsatisfied with their current self, they hire a professional consultant to help them increase their profits or course-correct the direction of the company to the desired self. If we take the collected statistics outline, there are over 10,000 professional consultants in India. At 30% of who have quit their jobs to go full time. Out of that 30%, at least 15% are earning six figures and nearly 1% has crossed over into seven figures income per annum and this is happening only in Information technology and Engineering sector. This is possible with changing times, technology, new alma maters, novel curriculum begotten extrapolated strains of leadership, entrepreneurship and a new breed of companies, which eventually transformed business horizon. In this process, there is also a role for consultants. Traditionally, the function of the consultants was to follow a structured lattice to maximize the utilization of available resources. But now, the focus is on the decision-making, immediate bargain for predictive results or hunt for the best fits, and gauging the outcome from a strategically designed architectural system is crucial to optimizing client care. This generally represents a major change in the course of the company’s vision, mission and direction. At the same time, there is a lurking danger camouflaged right immediate behind in case the designed process gone awry may result in disturbing the lifeline of clients.
As I am a senior consultant, of late, I have been receiving queries from my clients and their top-line executives regarding the impact of the medical company’s field force’s influence on Doctors. I can’t straight away answer this but I can brief some anecdotes of revelations from Indian Medical profession, cited that medical representatives persuasion has nearly 40% influence on their time, more often than all other influences, including patient-related factors.
The focus of this article is on the promotion of medicines to healthcare professionals and the public. We define promotion broadly as all actions taken directly by pharmaceutical companies to enhance product sales. We highlight what is known about the quality of the information transmitted directly to doctors by medical representatives, journal advertising and key opinion leaders and then look at the major effects of these types of promotion on prescribing. We then specifically discuss promotion to the public through direct-to-consumer advertising and its effects. We chose these particular areas to focus on because there is concrete evidence that they affect prescribing patterns. The literature we publish and distribute comes from developing countries where the bulk of the research has been done. We conclude by reviewing initiatives from the pharmaceutical industry, government and non-governmental organizations for the improvement of the regulation of the promotion of pharmaceuticals.
In 2010, I had conducted a pan-Indian study in this regard and this project was duly financed by some interested-group of clients, which I can’t reveal here at this moment. This systematic review of those empirical studies on the effects of promotion on physician behaviour found out that physicians with greater exposure to frequent visits of medical companies field force have a higher prescription volume, prescribed more costly medicines and also led to a more rapid adoption of new medicines promoted by medical companies though they had not fully acquainted with drug-related information and data on clinical trials.
This state of being exposed to the possibility was because of Medical representative’s request or pressure to add products for therapeutic value and made more requests for formulary inclusion of drugs, even though such drugs had not any established therapeutic advantages.
In 2015, I had conducted another systemic study, wherefrom I had examined the effects of exposure to information from pharmaceutical manufacturers on prescribing drug quality, volume and costs. This systematic review focussed solely on interactions between medical representatives and practising physicians. 30 out of the 100 physicians had succumbed to the pressure of velocity and included certain medication as part of interactions promoting a medication. This is predominate because of feelings of reciprocity of obligation brought about by gifts and sponsoring Physicians to foreign tours or supporting Doctors’ tour expenses to conferences. The readers of these articles should not be underestimated as such funding can have a surprisingly large effect.
Many forms of disguised promotion have flourished involving the use of scientific research and educational events to promote medicines’ sales. I would like to invite readers’ attention to the US court cases involving multinational pharmaceutical companies have uncovered a range of promotional activities raising strong ethical and public health concerns, such as the hiring of clinical expert ‘key opinion leaders’ to promote unapproved uses, ghost-writing of scientific articles, instructions to sales staff not to mention specific evidence of harm and efforts to discredit clinicians who raised safety concerns.
Global documentation on patients’ safety:
If we take global documentation on this respect, while the number of medical representatives of the pharmaceutical companies in the US has dropped from a high of 105,000 in 2006 to 60,000 in 2013, the majority of doctors are still willing to see them but no believing them.
In 2015, just over a third of Canadian doctors did not see sales representatives, 11% saw 6 or more a month and in that year there were a total of 3,720,000 visits (Canadian pharmaceutical industry review 2015, 2016).
Studies of oral presentations by medical representatives in Finland, Australia, the US, the Netherlands, and France have found that information of iatrogenic effects is often omitted, and inaccurate information was consistently favourable towards the promoted product.
More recently, a study of the frequency of safety information provided in 1692 promotions to family physicians in four cities in Canada, the US and France found that serious adverse events were rarely mentioned, even for products with US Food and Drug Administration (FDA) “black box warnings” of risks, and the minimum of information judged to be needed for patient safety was provided only 2% of the time.
A 2006 study in Bangladesh found that 34% of the claims in a sample of 116 brochures for family physicians were misleading. Similarly, in Nepal, promotional materials provided to hospital doctors in 2007 failed to mention adverse effects two-thirds of the time, and precautions, contraindications or warnings were only included in 36%. In Sri Lanka, a considerable proportion of drug promotional materials collected in 2015 used poor quality scientific research as references.
The majority of 200 pieces of drug promotional literature collected from departments in an Indian hospital in 2014 satisfied only half of the WHO criteria for rational drug promotion and none fulfilled all of the criteria. The situation in some developed countries was no better.
In Germany in 2004, 94% of the claims in brochures directed at physicians failed to be supported by scientific evidence: in 15% no references were cited; in 22% the references could not be found, and in 63% the relevant study was cited but the claim differed from research results.
As a consultant, I had been through some tough times during my course of endeavour in guiding my clients to implement these stringent norms but I failed as my clients turned deaf years to my advice. Remember, a true consultant should always tell better things to clients, even if they do not implement, leave rest to the fate of clients.
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