Well, it has been a busy few weeks but my new website is created, so this will be my last post to this blog, but not the last time I blog. My new website has a blog where I will continue sharing my thoughts and adventures. Please visit
for lots of information and resources for clinical research in Australia and New Zealand. I hope to hear from you there soon!
Best regards
Wednesday, November 21, 2007
Thursday, November 8, 2007
Evidence standards for dietary supplements
There was an article written on Medscape recently that called for the same standards of evidence to apply to dietary supplements as conventional medicines. As you might expect, many would consider this a contentious issue, and one that has been previously discussed on this blog. I thought you might be interested in the responses to this article on Medscape.
http://www.medscape.com/viewarticle/564261?src=mp
You'll need to log-in to the website, but at least that is free!
http://www.medscape.com/viewarticle/564261?src=mp
You'll need to log-in to the website, but at least that is free!
Thursday, November 1, 2007
And so for something positive....
Coinciding with Research Australia's whirlwind country-wide promotion trip for 'Thank You Day' which acknowledges the efforts of medical researchers, the NHMRC yesterday launched a new book - Great minds in Australian research, which highlights the work of 10 of Australia’s most eminent medical researchers. Here's the press release if you're interested in learning more....
http://www.nhmrc.gov.au:80/news/media/rel07/071031.htm
http://www.nhmrc.gov.au:80/news/media/rel07/071031.htm
Drug promotion in developing countries
Consumers International this week released a report on pharmaceutical marketing practices in developing countries, with a call to better regulation of these practices. http://www.consumersinternational.org/. From reading the Consumers International report, that call is probably justified. It looks like there are some dodgy practices going on by some companies, which disappoints me, since I like to believe pharma companies try to act responsible and ethically. This report release was followed up by a press release from Medicines Australia supporting better practices in developing countries, and distinguishing Australia from the same dodgy practices. http://www.medicinesaustralia.com.au/pages/images/MR%20Oct%203107%20MA%20supports%20robust%20global%20standard.pdf
I had a couple of internal debates pondering this information (and I'm not defending unethical or irresponsible behaviour when I throw these ideas out there), and they were:
1. What is the cultural environment for business in those countries and are pharma companies just doing 'what everyone else does' in those countries to get by? This may seem strange to say, but are we just trying to stamp our ideals on other countries who don't operate in the same way, any differently than, dare I say, trying to stamp our ideas of democracy and equality on other cultures that operate differently?
I've had the opportunity personally to do a business transaction in what might have been termed a 'developing' country in Eastern Europe over the past couple of years, completely unrelated to the industry we are talking about here. I came into the deal with my 'western' ideas of law, ethics, etc only to find they did not fit in this other country. The locals however had no issue with the way things were done. So in this situation, who was right? Should I have imposed my way of thinking on them? If I had, then I probably wouldn't have continued with the business deal, and that would have had its own economic effect on the people I was dealing with. Instead, I chose to trust the locals were operating appropriately for their environment, and continued with the business deal. Perhaps I was at fault, I don't know, but it is not an easy question. Now perhaps over time, this other country might decide to change their way of thinking and doing things, and I think providing lots of perspectives can help them on their journey. But I think it is really for local countries to consider, change, legislate, etc as appropriate for their population, rather than forcing that change from outside because of some perspective we have that differs from them.
2. I think we need to debate what are considered 'bribes' and 'gifts'.
Now the gifts like travel and expensive dinners etc perhaps need to be questionned, as I think they are more likely to be persuasive in prescribing behaviours, whether doctors think they are immune to it or not. But some of the 'gifts' received by the Malaysian doctor in the report included pens, pads, advertising brochures, things you could just as easily source from any number of places, and I would personally consider pretty innocuous.
I know I collect pens or notepads whenever they are freely available, but it probably doesn't influence my decision to buy from, work with, etc that company. I'm just saving myself the money of buying stationary. Is producing advertising brochures and sending them to doctors, any different to the 5-10 electrical /department store brochures and 5-10 restaurant brochures I seem to get from the same companies over and over in my letterbox every week? (Stop the paper waste!... but that's a different issue). Like it or not, these brochures educate me about what is available, particularly when I am short of time and don't necessarily go looking for this information myself, but it doesn't mean I am going to buy what's in them. Yes, the company may be closer to the top of my mind if I am interested in a product, or it may have stimulated an interest in buying that product. But if I am interested in something, it usually just prompts me to seek more information on that product and other suppliers of similar products - either to find a more competitively priced product, or a product with better specification. Maybe I am not the average person in my buying habits, but I find it hard to believe doctors wouldn't use a similar 'prescribing' philosophy, if they really had the best interests of their patients at heart.
In Australia, we have an industry code of conduct, which can be found on the Medicines Australia website, along with a great set of FAQs on the subject advertising and promotional activities. http://www.medicinesaustralia.com.au/pages/page17.asp#anchor18. This is a self-regulated code, so is still subject to easier violation that if legislated.
It should be known that clinical research, and not just marketing promotion, is subject to the same guidelines, because it could be argued by some that clinical research is just early promotional activity. As a company clinical researcher, it became increasingly difficult sometimes to have a friendly working relationship with the clinicians and staff you partner with to complete the studies. Company sponsored clinical research is a very matrixed environment with stakeholders under the umbrella of multiple employers. It is OK for a nurse to share in morning tea or have lunch with you, so long as they pay, but as a pharma company employee, you are made to feel it is not necessarily OK for you to reciprocate, for fear of recriminations over bribery of doctors. And what about the 'stickie notes' that are often provided, which until the advent of electronic data collection forms were the one tool of trade the clinical research associate couldn't live without?
This debate on gifts and what is reasonable is a necessary one. However, with so much publicity about poor practice, it must be difficult for consumers to distinguish between when they are at risk, or when people in other countries are actually the ones at risk. Debate is good, so long as it is contextualised and balanced, and I'm not sure that is the case in the media, leading to a very mistrustful relationship with the drug industry.
I had a couple of internal debates pondering this information (and I'm not defending unethical or irresponsible behaviour when I throw these ideas out there), and they were:
1. What is the cultural environment for business in those countries and are pharma companies just doing 'what everyone else does' in those countries to get by? This may seem strange to say, but are we just trying to stamp our ideals on other countries who don't operate in the same way, any differently than, dare I say, trying to stamp our ideas of democracy and equality on other cultures that operate differently?
I've had the opportunity personally to do a business transaction in what might have been termed a 'developing' country in Eastern Europe over the past couple of years, completely unrelated to the industry we are talking about here. I came into the deal with my 'western' ideas of law, ethics, etc only to find they did not fit in this other country. The locals however had no issue with the way things were done. So in this situation, who was right? Should I have imposed my way of thinking on them? If I had, then I probably wouldn't have continued with the business deal, and that would have had its own economic effect on the people I was dealing with. Instead, I chose to trust the locals were operating appropriately for their environment, and continued with the business deal. Perhaps I was at fault, I don't know, but it is not an easy question. Now perhaps over time, this other country might decide to change their way of thinking and doing things, and I think providing lots of perspectives can help them on their journey. But I think it is really for local countries to consider, change, legislate, etc as appropriate for their population, rather than forcing that change from outside because of some perspective we have that differs from them.
2. I think we need to debate what are considered 'bribes' and 'gifts'.
Now the gifts like travel and expensive dinners etc perhaps need to be questionned, as I think they are more likely to be persuasive in prescribing behaviours, whether doctors think they are immune to it or not. But some of the 'gifts' received by the Malaysian doctor in the report included pens, pads, advertising brochures, things you could just as easily source from any number of places, and I would personally consider pretty innocuous.
I know I collect pens or notepads whenever they are freely available, but it probably doesn't influence my decision to buy from, work with, etc that company. I'm just saving myself the money of buying stationary. Is producing advertising brochures and sending them to doctors, any different to the 5-10 electrical /department store brochures and 5-10 restaurant brochures I seem to get from the same companies over and over in my letterbox every week? (Stop the paper waste!... but that's a different issue). Like it or not, these brochures educate me about what is available, particularly when I am short of time and don't necessarily go looking for this information myself, but it doesn't mean I am going to buy what's in them. Yes, the company may be closer to the top of my mind if I am interested in a product, or it may have stimulated an interest in buying that product. But if I am interested in something, it usually just prompts me to seek more information on that product and other suppliers of similar products - either to find a more competitively priced product, or a product with better specification. Maybe I am not the average person in my buying habits, but I find it hard to believe doctors wouldn't use a similar 'prescribing' philosophy, if they really had the best interests of their patients at heart.
In Australia, we have an industry code of conduct, which can be found on the Medicines Australia website, along with a great set of FAQs on the subject advertising and promotional activities. http://www.medicinesaustralia.com.au/pages/page17.asp#anchor18. This is a self-regulated code, so is still subject to easier violation that if legislated.
It should be known that clinical research, and not just marketing promotion, is subject to the same guidelines, because it could be argued by some that clinical research is just early promotional activity. As a company clinical researcher, it became increasingly difficult sometimes to have a friendly working relationship with the clinicians and staff you partner with to complete the studies. Company sponsored clinical research is a very matrixed environment with stakeholders under the umbrella of multiple employers. It is OK for a nurse to share in morning tea or have lunch with you, so long as they pay, but as a pharma company employee, you are made to feel it is not necessarily OK for you to reciprocate, for fear of recriminations over bribery of doctors. And what about the 'stickie notes' that are often provided, which until the advent of electronic data collection forms were the one tool of trade the clinical research associate couldn't live without?
This debate on gifts and what is reasonable is a necessary one. However, with so much publicity about poor practice, it must be difficult for consumers to distinguish between when they are at risk, or when people in other countries are actually the ones at risk. Debate is good, so long as it is contextualised and balanced, and I'm not sure that is the case in the media, leading to a very mistrustful relationship with the drug industry.
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