Number of New Drugs Decreasing While, Research Cost Increase
A recent report from the Government Accounting Office (GAO) was released a couple of months ago and I’d not yet commented on it.
New Drugs Declining, Research Costs Increasing, GAO Says - washingtonpost.com:
This Washington Post article gives a good overview of the situation but what is interesting ot me is the wide range of opinions on what the underlying data means. Some in congress use this data to prove this the system need to change. I don’t think that is necessarily the case. There could be many reasons why costs increase and why productivity hasn’t increased. I tend to be of the opinion that the low lying fruit has been picked over and that more research is needed to find better ways to get the fruit higher up on the tree. Adding additional regulation that does not directly effect safety would be counter-productive.
Heres the actual report.
GAO Report on New Drug Development
Technorati Tags: drug cost, drug development
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March 8th, 2007 at 8:36 am
Ed,
I definitely agree that additional regulation is not the way to go, especially if it hinders the kind of innovation required to develop new drugs. Pharma is still learning and trying to understand how to tackle the tough diseases. Government and industry need to have some patience.
I do think that there need to be some regulations or at least FDA policy against “me too” drugs. That is a waste of R&D time.
March 8th, 2007 at 10:10 am
Deppak, I disagree with your thoughts on me-too drugs. I have seen many cases where the fact that there were several very similar drugs was useful. Consider cholesterol lowering drugs. I know many people who had to switch once or twice to another drug in order to get their cholesterol under control. Most doctors I’ve talked to think it is necessary to have two or three drugs at least in a given therapeutic area.
I also have personal experience in this area related to allergies. At the time, there were three drugs all fairly similar; Zyrtec, Allegra and Claratin. Allegra just didn’t work for me and I ended up using Claratin and it worked wonderfully. Due to genetic differences some drugs just don’t work that well for a small but significant portion of the population.
Also, how do you define me-too drugs? How similar do they need to be? Is it based on how the drug works or the chemical structure? I would rather see it based on how many peoples medical issues are solved by the drugs in aggregate. That is, once say 99% of patients medical problem is met by approved drugs for a certain therapeutic indication, no more are approved.
See my post: http://www.qdinformation.com/qdisblog/2006/11/11/price-pressures-in-pharmaceuticals-and-me-too-drugs/
March 8th, 2007 at 4:37 pm
Ed, your point about different drugs working on different populations is a good one. When I say “me too” drugs I should be more specific. I am referring to drugs with similar chemical structures (e.g. to extend patent life without really improving or changing the drug efficacy or effectiveness). If they are targeting specific medical issues, there should absolutely be multiple choices from different companies, since the factors you list come into play and it probably drives the price down too.
Of course, with molecular medicine, one hopes that the factors that make a particular drug effective for someone and ineffective for someone else will be better understood.
March 8th, 2007 at 5:55 pm
I too have hopes for the so-called personalized medicine. Unfortunately, I think it is currently being used to exclude people from clinical trials rather than truly figure out what is going on. Hopefully that will change. I think if companies concentrate too much on biomarkers and excluding specific patient populations that the FDA may make that part of the labeling and require testing before using a drug.
I’d rather see genetics used to figure out what patient populations will respond to what drugs.
March 12th, 2007 at 7:50 am
If that is the case, I do hope it changes. The next decade will be interesting, both from a regulatory perspective as well as the treatment perspective.
Given the impact of lifestyle and other factors, I don’t believe genetics is sufficient to predict drug response, except as a first pass, and perhaps that might be a good place to start. Personally, I do think that using diagnostics for some (not all) diseases is a good idea. If nothing else, as a prognostic indicator.