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.

Evidence based medicine - how does alternative medicine contribute?

A couple of weeks ago I met a gentleman at a training event I attended and we got to talking about the businesses we were each in. This gentleman was a naturopath and became quite animated when I discussed my interest in clinical research. As can often be the case when you mention a background of working in the drug industry, I quickly found myself trying to defend the industry I've been a part of. This gentleman was very anti-drug/company, with lots of conspiracy theories about why drug companies do what they do, and how messed up the health system is.

For me personally, I fell into the industry as part of my journey as a scientist. All I wanted to do as a scientist was research that would help people, and clinical research seemed one pathway I could follow to do that. Many of the colleagues I meet in the industry have the same vision. However, it seems that because we work for commercial organisations that make money, our intentions are to be questioned.

One of the arguments presented to me was that drug companies do unnecessary clinical trials that cost lots of money, and then use those costs to justify the price we need to pay for medications. From the naturopath's perspective, these trials are unnecessary, as are the drugs, as he claims to be able to heal many people for whom conventional medicine has not worked.

I have no reason to doubt the naturopath's claimed success rate, but also don't have enough evidence to believe him. As a scientist, you will often come up with ideas about how good something is or how it works, only to find when you test those ideas, they don't always stand up to formal review. This can be a heartbreaking moment, but at least the due diligence has been done and the evidence speaks for itself.

I don't think there is anyone in the health profession that would NOT embrace alternative medicine if there was adequate proof that the alternatives worked. Granted, there is alot of anecdotal evidence that some alternatives do work very well for some people. However, as a scientist, I am always looking for evidence. In fact, our conventional health system is increasingly based on the premise of evidence-based medicine. Without evidence, how can a government hope to be selective about the treatments the limited health budget is able to afford? Equally, how can doctors make decisions on the best treatment if there are not comparative studies to help them draw conclusions.

I challenged the naturopath to perform studies to help build the knowledge based around his treatments of choice, so as to improve their reputation and build the body of evidence around alternative therapies. However, he was not personally willing to put his treatments to the test through formalised research - especially since he knows it works. After all, trials are expensive and time consuming, and there is so much paperwork. He'd prefer to leave that to others to do. From an article I recently came across, it would appear however there isn't necessarily much good quality research going on to help his cause... (A systematic review of randomised clinical trials of individualised herbal medicine in any indication http://www.docuticker.com/?p=16983).

If then, drug companies choose to spend their money on trials in order to provide evidence to help prove either way the safety, tolerability and ability of their drugs to work, and then to share that information with doctors proactively, is it any surprise that this then forms the foundations of the health system that doctors dish out and governments help fund?

And it is not only drug companies doing clinical research, so money, while less readily available, can be sought from other more independent sources. Governments, consumer organisations, charities, philanthropic organisations, all fund medical research, including that on humans. To attract the funding, researchers increasingly need to collaborate, produce good scientific questions, and quality output, making it in theory just as within the reach of alternate medicine practicitioners as those in conventional medical research to attract funds to conduct that research.

One argument I've heard for not conducting research in alternative medicine is the individual nature many of those treatments take on, such that it would be hard to compare groups of individuals such as happens in randomised clinical trials. My counter to that however is that is can be just as difficult for drug companies to test their drugs in large populations of people. I think it would be recognised, particularly as scientists understand our genes and diseases better, no two individuals are perfectly alike, nor are the effects they will have from a drug alike. People experience different side effects, they have different success rates with different drugs. It may take doctors some time to define the right dose, or right drug, if it exists for a particular individual for a particular condition. The journey with alternative medicine can be just as much trial and error.

Yes, alternative medicine can work for some people, but it does fail others. I've had personal experience of such a failed journey with someone close. Whether alternative medicine techniques are any more successful on a population basis than conventional medicine, I don't know. I don't believe that conventional medicine has all the answers for everyone, just as alternative medicine does not, so an integrated approach is of value.

I say provide the evidence through formalised clinical research, and whatever the treatment, whether conventional or alternative, and it will lead to health practitioners being more comfortable to offer it as a treatment option for their patients.

It all Action in India!

Over the last week, I have seen so many stories about big pharma operations in India. I can't help wondering if these are new news stories, or the Indian press is very good at highlighting the success India is having attracting and rapidly expanding a very active clinical research environment.

Wyeth, GSK Plc., AstraZeneca Plc., Pfizer Inc. and Sanofi Aventis, are just a few of the big pharma companies with their fingers in the Indian pie, according to reports just over the past 2 weeks. I'm sure it doesn't stop with those few companies. Additionally, the CRO market is also expanding at a rate of knots. One report suggest the Associated Chamber of Commerce and Industry of India (Assocham) projected the domestic Indian CRAMS (Contract research and manufacturing services) market will reach $ 900 million by 2010 and the demand in clinical research will grow from $200 million by end of 2007 to $ 1 billion by 2010 (http://www.expresspharmaonline.com/20071015/westbengalpharmareview01.shtml Pharma Industry in West Bengal: The Road Ahead). That kind of growth potential is enough to get any budding entrepreneur or company executive excited over the possibilities.

One has to ask - how does India plan to maintain control and quality with such rapid growth over so short a period of time. Just getting the trained staff (or training the staff) to meet that demand for services could only be described as an Everest climb at best. Initiatives like the recently announced launch of a new course by The Institute of Clinical Research (India), a global post-graduate diploma in clinical research in association with the Institute of Clinical Research, United Kingdom, will certainly help. But there is no better experience builder than time itself provides, in addition to formal training and mentoring.

If India knows the secret to managing this growth, then it's a secret we could do well to learn here if we are going to continue attracting clinical research to the Pacific and the opportunity that provides for Australia/NZ consumers to access the latest potential cutting edge treatments early.

It will be an interesting journey for all involved I suspect in developing a quality clinical research culture in all the developing nations, seen as the latest hope for controlling spiralling R&D costs through cheaper labour and expansive, relatively naive, population pools.

If these populations are not to be taken advantage of, it is important that consumers involved in the research are also well educated as to their rights, choices and the principles of informed consent. Big pharma and CRO's must take some responsibility in facilitating this education, if only to help develop trust and transparency in their intentions. Only educated consumers will make truly informed decisions about whether to participate in research, and not just participate because it offers a hope of treatment that they wouldn't otherwise have access to due to underfunded or non-existent health facilities. The challenge of educating consumers in a relatively well educated society such as Australia is difficult enough, without adding the challenges of language, education, poverty and access into the mix, as is the case in developing nations.