The initial “preclinical stage” is where small pharmaceutical research teams (e.g. at universities) do research e.g. lab and animal studies to check safety/bioavailability etc. Articles will be published and conventions will be attended and hopefully, if they’ve discovered something interesting, it will manage to enter the next stage of the process. I think an estimate is that for every 1000 compound looked at only about one will enter the next stage of the process.
The next stage is the clinical trails phase. There are several stages/phases starting with healthy volunteers and then moving onto larger trails on actual patients. This process is very expensive (millions upon millions of pounds) and is only really carried out by the Big Pharma™ companies. And then there are usually final steps (an “approval stage”) to be jumped through for approval depending on the country/region. For every five to start through clinical trails/approval stage it is estimated that only one will make it to final approval and release as a drug.
So maybe one out of five thousand potential chemicals evaluated might make it to the point of being released as a drug. Generally what happens is that the preclinical research is done by small research companies/universities/spin out companies and then Big Pharma™ will buy the rights for any promising looking research (with or without the original researchers being taken on in the continuing process as advisors).
This (after pre-clinical, but before or during clinical trails) is often the stage that research gets buried. There may be many good reasons that a potential drug would get stopped at this stage. It might be that there are other, probably better, drugs in development. There may be other valid scientific concerns. However if the Big Pharma™ company are concerned that a new drug will put a current money-making drug out of use they may buy the research and sit on it. For example there is commonly believed to be several preliminary drugs that would cure Alzheimer’s Disease, but the profits in curing a disease using a short-course of medication it may not be out-weighed by the current profits in treating Alzheimer’s for many declining years of a persons life, so as yet there is no financial incentive to continue with the development of these drugs.
Another category of drug that gets ignored in terms of development is a drug that would only target a small subset of a clinical population. What Big Pharma™ like are drugs called Blockbuster Drugs. Blockbuster Drugs are the big money spinners. Generally a drug becomes a Blockbuster Drug if it’s widely clinically used (by doctors/prescribers) as a standard drug to use for prevalent conditions that often require long term treatement – a lot of Blockbusters Drugs are currently things that treat blood pressure/blood clotting/heart problems/cholesterol i.e. is generally works for a large segment of the population. An important addendum needs adding to this definition however – prevalent conditions, but mostly this only applies to conditions prevalent in the developed world. Obesity, heart problems, pulmonary conditions are on-going problems in richer (older/fatter) nations so drugs that treat these conditions well across a wide spectrum of the population become Blockbuster Drugs. This is the same reason you’ll see psychiatric drugs occasional slip into the Blockbuster Drug lists – mental health conditions are relatively prevalent in the developed world and people tend to take these drugs on the long term, as such Big Pharma™ are happy to oblige in the provision of a whole variety of drugs. (Cynically, especially if the drugs make you put on weight and end up on more drugs </snark>)
What Big Pharma™ doesn’t like are conditions that aren’t common in rich nations, or uncommon conditions, or small genetic subsets of prevalent medical conditions that don’t respond to the standard drugs. Take cancer for example, if you have a common genetic subtype, of a common cancer, that responds well to drugs then you may have a good chance of recovery. Something like testicular cancer has a 90% plus survival rate, if it’s got the “right” genetics, even if it’s caught at a late stage. But if you have an uncommon cancer – say for example Neuroblastoma, a horrendous cancer that affects predominately very young children, where there may only be few hundred suffers worldwide - then Big Pharma™ just aren’t really that interested in helping (and survival rates are as low as 20% 5 years after diagnosis). Unless you have a fashionable illness you're kind of screwed.
Fundamentally, like a lot of things in life, it comes down to money. Big Pharma™ want to make money and they do this by focusing research and development on drugs that they think will do that – and by blocking the development of drugs that may risk the money making potential of their current catalogue. This is great for them but not great for health care as a whole. Arguably all medical conditions will have a genetic component at some level. And every person is an individual – created from their own personal genetics/environment. Drug companies want to find one drug to treat an entire clinical population, whereas the reality of what disease is/humans are, humanity would be better suited to finding a way to one drug tailored to fit that person/disease interaction.
I’ve talked about this from the point of view of drug development seeing as that’s what I know (well, knew). But maybe this logic can be extended to other aspects of health care. Surely the future of medicine should lie in determining the interaction of medical condition with a particular person and applying an individualistic approach to medical treatment. A person would have individualised/tailored drugs/therapy designed specifically for them as an individual and their particular version of their medical condition.
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NB: Emotionally I'm not in a great place right now so I’m not even sure I managed to say what I wanted to say and may continue this theme another day. Numbers I’ve quoted in this post are from memory so don’t jump at me if they’re not exactly right by current research. I left pharmaceutical research in 2007. This was a bit of a flow on consciousness after reading this post by RuftyRoo II.
Noooo..I've just spent a good while writing a half decent reply to this post (which is great btw) and in my rambling half-wit way I managed to write too much and then inadvertantly deleted it!!? I hate it when that happens! I'm going to have caffeine, nicotine and then I'll have another go. I need to get concise, as usual I have too much to say! x
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