Sparrowhawk: You made some very nice points. Let me throw in my two cents. Fast track drug approval is not what most people think it is. Fast track means, that you cut down the FDA approval time by about a year (from two to one year). Fast track does not mean, that you require less clinical trials or studies. So for a normal drug it takes about 11 years to get approved. With fast track it takes about 10 years because most of the time is consumed by the R&D efforts and FDA requirements (phase 1-3), not by the time the FDA reviews the results before approval.
Even if companies go abroad e.g. Switzerland, they have no chance of selling these drugs in Europe or the US unless they come up with the required studies.
Safety is a good thing and nobody wants to be harmed by drugs. The question is when safety becomes an innovation-inhibitor and the benefits of safety do not offset the benefits from otherwise approved innovative drugs. Our current approval system is much too old and much too rigid. The world changes every day. Our knowledge changes, our technology changes and we change. The same is true for our understanding of drugs. Today we know much better, what might harm us. However, the FDA approval system doesn't account for the progress we make. In my eyes it causes the mess we currently see. Small companies or clever scientists cannot enter the pharma market because it is nearly impossible for them to raise billions of dollars and spend ten years conducting trials for the FDA before their drug could get approved. So who is left? Well, the big pharma companies are left and as Juan Enriquez said, they spend double the amount for sales and marketing than for R&D.
In my eyes there are only two possible solutions. One would be to get rid of Phase 2+3 and maybe some other requirements. Instead you could require the CEO's of a pharma company to take the drugs they produce themselves, in order for them to make sure, that the drugs are safe (no company has the interest to harm people, it would ruin itself). This would cut down approval time by half and reduce cost by about 50%. In this case the doctors have to stop blindly following what FDA approved. They and their patients have to start thinking for themselves. This may sound difficult but actually it's just a matter of habit. The other solution would be for government to start a second moon mission, this time in the pharma field. Government wastes so much money everywhere. This money could be used for drug development. If government said, that it wanted to cure cancer, IBD, HIV etc. within 10 years, they could do it in my eyes. They just need to formulate a clear mission to scientists and how they want to get there. I can give you a good example for IBD and what we would need to do:
1) Start sequencing microbiomes for every patient with gut problems (cost for 16S rRNA sequencing: 10-20 dollars per patient and sample). As soon as the results of tens of thousands of people are in, we analyse them, we see correlation and we would know what role the microbiome plays for disease. The next step would be to order labs to produce probiotic strains. The current strains, which are sold in the super market are mostly useless. We need the 500 other strains, living in our guts, which are not sold. Start treating patients, sequence again, see if the microbiome changes. If the microbiome changes and the patient is healthy we know it was the microbiome, if the patient is still ill we might try other bacteria, if this doesn't help, the reason has to be somewhere else.
2) There was a study about viral infections (enterovirus) in Crohn's patients. They were all positive in a study, while only 1 of 15 controls was. Start checking for viruses in gut samples of IBD patients. Check the tens of thousands of results. If a viral infection seems to be there, start developing an antiviral drug that works. Stop suppressing inflammation (this is what ALL current IBD drugs do) and start treating patients. Are they healthy? Yes. Case closed. Are some still ill, go on.
3) We know that genes are implicated in IBD. Ask the best scientists all over the world to develop a working gene therapy scheme (they already have excellent ideas with high safety). Replace the causative mutations. Case closed.
Only government has the resources to do so but instead of producing innovation, government inhibits it. Imagine if government did this for IBD. Within ten years these illnesses would be gone. Government could sell the drugs 100 times cheaper to the patients because it is no company. Currently the IBD patients produce billions of dollars of direct and indirect cost every year. These costs would be gone. Not to mention all the other illnesses, that would benefit from this research (obesity, IBS, colon cancer etc.).
The HIV/AIDS protestors were a great thing. The problem is that they were dying, they had a clear cause and they were a homogeneous group. They had all the requirements for a group to be successful. People with CFS are very heterogeneous, we don't know the cause and many people don't take PWCs for real. But I still hope, that things change now. It can't be, that we have to pay for our own trials. Governments wasted trillions of dollars in Afghanistan, Iraq etc.. Instead of bombing people and starting wars, we should be curing patients!