> If the current standard of care is a drug and you test against it, aren't you showing it's more effective?
The main issue is that a drug can be more effective than an older drug but still be less effective than taking no drug at all.
But given all the problems, both theoretical and practical, with current drug trials, there is pretty much no guarantee of anything. Just because something makes sense on paper doesn't mean that it's actually true. There are a number of books about the issues with drug trials... Bad Pharma by Ben Goldacre, The Truth About Drug Companies by Marcia Angell, Overdosed America, etc. All of these books cover largely different issues, so imho it's worth reading them all.
No offense, but Marcia Angell has a tenuous grasp in terms of knowledge of the pharmaceutical industry. I would take her opinions with a grain of salt.[1]
If you had read the actual book, you'd know that this article is completely mischaracterizing her arguments. From the article:
> Angell’s attack came at the same time that the FDA was reporting that much like 2011, 2012 has proven to a great year for patients with the approval of 35 innovative drugs.
Here is the actual argument from the book:
"In the five years from 1998 through 2002 [...] 415 new drugs were approved -- an average of 83 per year. Of those, 133 (32 percent) were new molecular entities. The others were variations of old drugs. And of those 133, only 58 were priority review drugs. That averages out to no more than 12 innovative drugs per year, or 14 percent of the total."
"Over the four years beginning in 2000, there were just 32 innovative drugs out of a total of 314 approved drugs. Even in this small collection, only seven came from the top ten U.S. drug companies."
The book was published ten years ago, but if you look at the most recent data from the FDA then it's similar:
In the five years between 2007 and 2011, a total of 119 New Molecular Entities were approved by the FDA. Of these, only 50 were granted priority review, meaning they were classified by the FDA as having the potential to provide a therapy where none exists or providing a therapy which may be potentially superior to existing therapy. Of these 50 priority NMEs, 30 were orphan drugs, meaning they were approved for diseases that affect 200,000 or fewer Americans. Of these, it's not clear how many (if any) were created by large American pharma companies. [1]
Exactly! This quote is entirely wrong: ""In the five years from 1998 through 2002 [...] 415 new drugs were approved -- an average of 83 per year. Of those, 133 (32 percent) were new molecular entities. The others were variations of old drugs. And of those 133, only 58 were priority review drugs. That averages out to no more than 12 innovative drugs per year, or 14 percent of the total.""
Just because it didn't get priority review, doesn't mean it's not innovative.
It just shows how little Angell understands the industry.
The main issue is that a drug can be more effective than an older drug but still be less effective than taking no drug at all.
But given all the problems, both theoretical and practical, with current drug trials, there is pretty much no guarantee of anything. Just because something makes sense on paper doesn't mean that it's actually true. There are a number of books about the issues with drug trials... Bad Pharma by Ben Goldacre, The Truth About Drug Companies by Marcia Angell, Overdosed America, etc. All of these books cover largely different issues, so imho it's worth reading them all.