TO AMERICA'S HEALTH (HOOVER INST PRESS PUBLICATION) Review

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(More customer reviews)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.

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A government monopoly over drug regulation is not sacrosanct. In fact, federal oversight—which vitally affects the availability of drugs to patients in need—is in shambles. The regulatory monopoly of the federal Food and Drug Administration has become, literally, overkill and actually threatens public health. Regulatory reform that introduces competition and incentives to get safe, effective drugs to patients can, however, transform the drug development process and reverse the current upward spiral of time and costs. The public will benefit directly by earlier access to greater numbers of less costly drugs and indirectly by greater robustness and productivity in the pharmaceutical industry.

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