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I'm curious to read the book--I write software used to collect data during phase 2 and 3 clinical trials, so I have some understanding of both how trials are de
by bmj 14y ago
I'm curious to read the book--I write software used to collect data during phase 2 and 3 clinical trials, so I have some understanding of both how trials are designed as well as what the regulators are looking for in the data. In my experience, there is a strong push for both good data and preserving the "voice of the patient" from many of the scientists who develop the trials (not necessarily the drugs, but the trials on the drugs). Whether pharma follows this advice is a different story.
Another anecdote: in the 15 or so years my employer has been around, we've only seen a handful of NDAs (new drug applications) go through on the hundreds of studies to which we've supplied software.
All that said, despite receiving my paycheck from big pharma, I'm sympathetic to Goldacre's criticisms. As I mentioned, the founders of my employer (both software folks and clinical scientists) have worked to change the way trials are run in order to provide better data. Whether the sponsors properly use this data is another story.
- kokey 14y agoI've also done a stint in big pharma, on the R&D side, running computational clusters for bio and chemistry modeling. The impression I got was that the majority of work was for improved science in order to create drugs that saves lives or improve it dramatically. The biggest money makers were things that deal with diabetes and heart disease, not things like antidepressants and ED. I think some focus was lost on the business/marketing side where opportunities were pushed and exploited in certain drug lines beyond what was reasonable. I get the impression that most of these issues were before 2006, it's actually not in the best interest of the pharmaceuticals to operate in this manner either if they want to remain in business. The regulators have also caught up. That said, it's easy to see the mistakes in retrospect, this has happened over the history of many drugs that have come and gone.
- bmj 14y agoElectronic data collection in trials (what we do) also has limited reach in clinical trials as a whole right now. Most of the studies we support tend to be for pain medications (think post-operative pain) and more serious conditions, and that lets me sleep a bit better at night. I agree that certain drugs lines tend to be exploited more than others, and it can be easy to paint very broad strokes about pharma generally because of that exploitation.
- pstuart 14y agoAnecdotal "data point": my wife works in the biotech field. For one very large company they had a drug developed that worked but had to be dosed dependent upon weight. Marketing felt that doctors would only use the product if it was simple enough, so they made it a one-size-fits-all dose.
- DanBC 14y agoMedication non-compliance is a big problem. About half the English medication budget (£4.5 billion of £9 billion) is wasted because people don't take their medication correctly. This isn't just the medication for little things either. A major cause of transplanted organ problems is people not taking the meds correctly. Not great sources, but: (http://www.bbc.co.uk/radio4/science/casenotes_20040817.shtml http://www.bbc.co.uk/radio4/science/casenotes_20040817.shtml) (http://www.bbc.co.uk/radio4/science/casenotes_20060509.shtml http://www.bbc.co.uk/radio4/science/casenotes_20060509.shtml)
- kokey 14y agoI suspect this happens a lot. Many drugs should be dosed by weight and even gender yet we only see differential doses for adults and children most of the time. I'm smaller than your average male, so I often tend to reduce my dosage of certain drugs to below what is recommended on the package insert.