What are the real costs of developing a drug?

Amazon: (Yes, I'm quoting an Amazon book review, but I couldn't find an interview with this guy anywhere. I'd like to see you do better! ...Oh. You can? I take it back)

A masterful work on the exaggerations by Big Pharma on the cost of developing new prescription drugs. Tells detailed stories of the development of erythropoietin (Epo), Ceredase, Replagal, AZT and triple cocktail for AIDS, Cisplatin, Taxol, Erbitux, sulfanilamide, Tagamet, Zantac, Prilosec, Nexium and others. The stories are easy to understand and back up Goozner's contention that most real breakthroughs in drug development are the result of long years of work by academics or in government labs (NIH), and occcasionally by biotech firms, usually not by the Big Pharma companies.

Goozner confirms others in noting that about 4/5ths of "new" drugs, while being new molecules, are similar to others on the market. This consumes most of Big Pharma's research and sales dollars. He shows that simply purifying a drug to sell one of two isomers (left-handed, say, not mixed left- and right-handed) will get a new drug approval from the FDA (Nexium vs. Prilosec, I think). Sometimes this is valuable for patients, but not always. In ibuprofen it does not matter.

Goozner carefully works out the cost of a typical new drug launch at $100 to $200 million, a lot, but not $800. Many details are explained, such as orphan drugs, and access for compassionate use. Some of the perversions of drug trials are exposed, such as failure to compare a new drug with the best previous one. The limitations of newer NSAIDS (Celebrex, Vioxx) and many anticancer drugs are brought out.

This book has good good academic referencing and a good index. So why only 4 stars? The layout, some of the chemistry and some of the pharmacology.

Each paragraph is a gem of understandable prose. From p229: "As the twenty-first century dawned, the drug industry's search for new drugs to replace old ones coming off patent became frenzied. There were fifty-two drugs with more than $1 billion in sales in 2000, but forty-two were slated to lose their patent protection by 2007. The drugs that account for fully half the industry's sales were on the cusp of low-cost, generic competition. But instead of looking for truly innovative medicines, which are dependent on the maturation of biological understanding and even then are difficult to find, an increasing share of the industry's research and development budgets turned to the search replacement ["me-too"] drugs..."