on November 20, 2004
Henry Miller is a fellow at the Hoover Institute at Stanford University. The articles he posts there are something that my undergrad logic teacher would have to flunk. (Example: If (A) there are drugs in the pipeline, and if (B) FDA must review data to show drugs are safe and effective, then (c) FDA's unreasonable review is the only thing stopping all drugs in the pipeline from working; therefore all drugs should be mass-marketed to human guinea pigs or else people will die from lack of access to drugs.) The conclusion is not supported by his premises, a problem in all Miller's writings. He also ignores history, failing to mention the kind of junk that was sold as cures before FDA came along. In fact the agency was established when the public insisted. Responsible manufacturers joined, struggling with dozens of different state laws and with disreputable competition undercutting them, counterfeiting their products, and selling products contaminated with filth, cheap fillers, and unintended cross-contamination from other ingredients made in the same facilities.
The truth is, there are lots of programs to get drugs, approved or not, to sick people. If only drug companies would manufacture them instead of the many kinds of "me, too" drugs with huge mark-ups, those drugs might be available. However, FDA can't review drugs that no one makes. FDA drug review takes on average barely more than 6 months despite volumes of data, and since someone has to review the data, anyway, that's not much real added time. And aren't you glad it's not drug company marketing departments doing the medical reviews? Peer review journals easily take that long to review the articles of studies submitted to them.
This is not to say FDA is perfect, always right, or no reform is needed. FDA review has changed much since the Food and Drug Modernization laws of drugs and devices since 1997. FDA's problems now are now mostly budgetary; it's entire budget has never even matched the increase NIH gets yearly until FDA was given bioterrorism duties on top of everything else in 2002. Even then, FDA total budget in 2002 sounds like a lot at about $1.3 billion (less than authorized); however, compare that to the NIH budget that year at $22 billion.
Miller's politics would eliminate all federal safety regulations, not just drug review but those for deadly pesticides and other environmental chemicals, and food contaminated by filth, and return to state regulations that even industry doesn't want. If you want to get a taste of his views, go to the Hoover articles website and search his name for the 9 articles posted there to date. If you're willing to challenge these assumptions, first briefly review logic principles (there are a few good logic pages on the web under edu or org pages that can introduce you to logical mistakes). Then check out Miller's articles for free, and see if the argments stand up to the light of day. After that if you enjoy his work, then by all means, exercise your right to buy his book.
on August 20, 2003
While it may be true that some reform at the FDA is needed, the way this book portrays the problem is seriously flawed. This is surprising as it comes from a guy that actually worked at the FDA. The book is filled with number fudging, half truths and ridiculous distortions. For example, the book cited that the FDA raised the bar for clinical research that resulted in the time required for drug development to increase from 8.1 years to 15.2 years from 1960s to 1997 (Page 24). Why is that bad? Remember the law that requires a drug to be effective was only passed in 1962. Back then, a scientifically sound clinical study for effectiveness wasn't even defined. As the science progresses, the bar has to be raised. Moreover, a lot of drugs nowadays have to be taken for years (for example, statin drugs). The only way to know the long term safety of these drugs is to do long term study. Hence, long time required for clinical studies. Even with this kind of rigor, there are still drugs like Baycol out there harming people. In another place, the author quoted that the number of safety discontinuations as a percentage of total new drug introductions in each country were similar - about 4 percent in UK and 3 percent in US. The author thus concluded that a marketed drug will be removed from the market is not appreciable different in the UK and US (page 27). This is number fudging at its best. Sure, 4% and 3% are all small numbers. But 4%/3% is 1.33. That means UK approves 33% more harmful drugs than US. No wonder the FDA is viewed as the "gold standard."
I highly recommened a report by Public Citizen on the brandname drug industry. When people see how profitable they are and how little they actually devote to research, they won't believe all this whining on behalf of these companies.