Friday, December 21, 2012
The Independent on Big Bad Pharma - by Kathryn Abel
Over the past few decades, the pharmaceutical industry has dramatically changed shape. And as a society, our relationship with it has altered alongside. The pharmaceutical industry is dominated now by a few giant companies which merged with smaller competitors giving us the likes of Novartis, Wyeth, Glaxo Smith Kline and Bristol Myers Squibb. The majority of the pharmaceutical market in the United States and the UK, as well as globally, is controlled by a handful of companies. There is obviously good reason for such a business model. In an industry whose upfront costs are enormous, (it costs on average around $1 billion to develop a new compound), it is not hard to see that economy of scale would be a sensible strategy to adopt. So why should we care about our relationship with pharma or how runs it itself?
There are quite a few reasons.
The first reason relates to how drugs are developed for us to use. It used to be the case that pharma wealth was generated in the developed world, for example the United States and Europe. As a result, its clinical trial work was also undertaken within these key market populations. The drugs that your doctor prescribed were likely to have been tested and proven effective in your own population. Today, pharma has moved its focus away from Europe and America. Clinical trials are increasingly undertaken in non-European, non-American, non-Developed World populations. There has been a huge shift towards clinical trials undertaken in India, sub-Saharan Africa, Eastern Europe and South America. You may note that amongst that list China and South East Asia are glaringly missing, given the population and increasing wealth of those regions. But China and other parts of South East Asia have sullied their copy book with pharma by refusing to uphold patent laws and by marketing generic versions of expensively developed drugs at a fraction of the cost, thereby undermining the industry market.
Trialing new products outside Europe and the US is cheaper and easier. Cheaper to employ people to run trials, and easier to recruit participants and to meet the governance processes associated with developing a clinical trial without restrictions on design and data collection. This includes ethical restrictions about incentivising participants for recruitment; it’s not difficult to imagine that smaller incentives are likely to go further in countries where the material need is greater, such as parts of India and South America. It seems the business costs of developing a clinical trial outside of the US, UK and the rest of Europe far outweigh the business benefits of developing clinical trial data to a particular standard in the population to whom you will market the drug in the future.
Today, you are more likely than in the past to be taking a drug whose trial data come exclusively from a population which is not necessarily representative of you. This could be male, non-Caucasian, much younger etc. You may think it doesn’t matter: after all, humans are humans whatever their nationality or culture. Unfortunately, drugs may work differently in different groups and so one population with heart disease, say in India, may respond quite differently to a drug than another population with heart disease, say in the UK. But that’s not so new: women have been taking medicines tested in only men for many decades. And of course, people in the developing economies have been buying and using compounds trialed and tested in America and European populations.
All of these differences mean that The National Institute for Clinical Excellence, or NICE, is increasingly tested by having to make decisions about the use of products in the UK whose clinical trial data do not derive from a population representative of the UK population.
The changing shape of the pharma industry and our changing relationship with it is important. If we believe pharmacological interventions are likely to remain a core part of our therapeutic armamentarium, this changing relationship may alter how, in future, we as a species might experience disease and combat it.
The second reason why should we care about our relationship with pharma relates to a combination of preventable infectious diseases like AIDS and Malaria, and the availability of effective treatments developed by the pharmaceutical industry, which has led to another major change in pharma practice and our relationship with it. This is an example of how, although business is business (so cost-saving strategies like trialing drugs in cheaper environments may come as no surprise), it is tricky for pharma. After all, their business is health. The health of individuals, the health of populations and perhaps particularly, the health of vulnerable populations.
Increasingly, successful business is required to act ethically. In the early 80s, before the AIDS epidemic was at its peak, the possibility that a drug company might be criticised for not providing free drugs to epidemic-ravaged parts of the world was laughable. After all, it has been the pharmaceutical industry, alongside among others, the Gates’ Foundation, which has worked so effectively to fund and develop the very treatments that mean infection with the HIV virus is no longer necessarily lethal.
Companies which invested in, and developed drugs to treat HIV were the subject of far more criticism about ethical practice than companies who had no such compounds on their books. However, companies which make antibiotics are not criticised for not giving them away to those in most need and unable to pay for them.
Like other drugs, a new antibiotic costs millions to develop. But, unlike other drugs, it has to ‘sit on the pharmaceutical company shelf’ until antibiotic resistance deems other compounds no longer effective. This means its value cannot be immediately realised. Furthermore, within a couple of years, hey presto! and the organism for which it was developed is now resistant or the epidemic has reached such proportions in countries with restricted resources, that the company, for ethical, (we can safely assume not for conventional business) reasons, is being impelled to give away its product for free.
Profit vs. People
Antibiotics, anti-viral agents and possibly even vaccines, may simply not represent good business for pharma. Even though most major epidemics caused by infectious agents are preventable through public health measures, such as condom wearing, water sanitation, or mosquito nets, the need for investment in new antibiotics and vaccines remains. Zoonoses such as the SARS and avian flu viruses, as well as gonorrhoea, represent huge potential ongoing health burdens. In the past, it was the pharmaceutical industry on whom we relied to develop new antiviral/antigonorrhoeal agents. Now, less incentive remains for this industry to do so.
And the third reason our relationship with the pharmaceutical Industry and how runs it itself matters is that large pharma conglomerates can control product supply, product price and product demand. We have recent evidence of ways in which price-fixing and market share have been manipulated/divvied between the major players. Larger companies also means less likelihood of smaller companies either being competitive or perhaps taking risks with novel compounds. One business strategy of larger companies is to focus on the money-spinners.
At best, drugs can be developed at relatively little cost, one from the other in a ‘speciation tree’ of new drugs. Such a model might be used in developing anti-cancer drugs where changing small parts of a molecule can distinguish them from competitors in terms of side-effect or indication. Another approach is not to branch the molecules, but to branch the 'indication', or potential market, for an existing compound. The psychotropic drugs, in particular perhaps second generation anti-psychotic (SGA) medications, have been spread far and wide in this way and further away from their original indication for schizophrenia-like psychosis.
These SGA medications are now not only used in adults with schizophrenia but in children, adolescents, in eating disorder, in people with personality disorders, in those who self-harm, in people with bipolar disorder and in a whole range of non-psychotic behavioural presentations. Pregnant women and fetuses are more likely than ever to be exposed to an anti-psychotic compound. Of course, optimising the money generated for a product which is so expensive to develop is not in itself wrong, or indeed a bad idea. The problem, it seems to me, is that finding a new market for a drug, can mean finding a new problem or a new disease. Innovation is no longer necessarily driven by a health need; rather a commercial one.
Antidepressants for all
The antidepressant group of medications, the SSRIs or serotonin reuptake inhibitors, are a similar case in point to the SGAs. Their tentacles have reached far beyond the treatment of depressive disorder. Indeed, some suggest that company strategy has been to invent ‘need disorders’ like the controversial female sexual dysfunction disorder (treated with SSRIs). Critics suggest that clinicians are encouraged by the pharmaceutical industry to develop new diagnostic categories in which to test efficacy of their compounds and develop a new market need. This kind of approach seems to be a change in business model for the pharmaceutical industry, a result, perhaps, of modern business practice generally, but also of the creation of a handful of powerful pharma giants.
So where does that leave us and our relationship with an industry, which, whether we like it or not, we have grown to rely on as a species? My personal view is that we need to change the focus from pharmacological intervention to positive lifestyle changes. In big picture terms, this means more resources should be diverted to global public health and consequently less money will be spent on treating illnesses and disease.
Contrary to popular belief, the pharmaceutical industry is not shy of prevention. In fact, the NHS spends a small fortune on preventive prescribing: cholesterol-lowing medications, heart slowing drugs and the like. We do not expect people to lower their own cholesterol or exercise their heart into a better shape. In my view, pharma has actively encouraged modern man to take a pill rather than take responsibility.
We have become too lazy to exploit the value of public health insights. In large part, we know how to prevent illness and disease, but in large part we refuse to do what is required. We have become greedy, especially in the developed world, expecting both length of life and health in life in spite of our poor life style choices. The pharmaceutical industry may be single-minded - even cynical - in its business before benefit approach, but, it is us, as a society, who allowed this to happen.