Customer Reviews

The $800 Million Pill: The Truth behind the Cost of New Drugs

5 star:		(6)
4 star:		(4)
3 star:		(2)
2 star:		(2)
1 star:		(0)

 

 

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..." However, I found it hard to read this book for more than 20-40 mintues at a time. There are no tables, graphs, photos, section headings or sub-section headings; it is one continuous mass of text except for chapter headings, most of which are cute, but do not explain what is on the chapter.
Occasionally people are mentioned with no context (Kessler, p145).

Chemically, the most serious error was confusing positional isomers on a benzene ring with left- and right-handed forms of a drug, which depend on the positions of 4 different substituents on a carbon atom (p221). These are called "optical isomers". Only exact mirror image compounds are called enantiomers.

Pharmacologically, Goozner was not aware of the misleading effects of lead time bias (earlier detection on 5-year survival rates in cancer. He overstated the benefits and understated the risks of cisplatin and Taxol, not looking for all-cause death rates. Conversely, he took at face value the claims for anticholesterol and blood pressure drugs, which have very few benefits long-term. He missed that the ALLHAT trial of blood pressure drugs had no placebo (p248), so based on earlier trials that did, no standard drug treatment for moderately high blood pressures is worthwhile. See: Joel M. Kauffman, Bias in Recent Papers on Diets and Drugs in Peer-Reviewed Medical Journals, J. Am. Physicians & Surgeons, 9(1), 11-14 (2004).

Still, this book is a valuable reference to have.

I found this book fascinating, informative and thought-provoking. It examines how the current system for bringing new drugs to market works, what the short-comings of this system are, and how it could be improved to get more benefit from the money that tax-payers and users of health services (whether by paying directly for drugs or through insurance premiums)contribute.

Although this could have become a really dry exercise in economics or a political tirade agains drug companies, instead it contains a series of stories which track the development of some of the major "breakthrough" drugs in recent history. We are introduced to people who dedicated their lives to finding a cure for a single disease and read about the many set-backs and struggles that they had to go through to achieve this goal. The medical information that is explained in the course of these stories was, for me, one of the most interesting aspects of the book

In light of the healthcare debate, this book needs to be updated. The third section on Big Pharma is the real critical information part. I guess America likes the idea of heavy advertising and an army of drug sales people for the me-too drugs, reformulated prescriptions at the same ultra high prices, the lack of real innovation, the overlooking of true research dedication for obscure diseases, etc. This book is too important not to go into a new, expanded edition.

This book is filled with detailed information on drug companies, development and marketing of drugs, federal regulation of drug companies, academic drug research, and some of the interesting characters involved in all of this. It comes across as slightly against big pharma, but not overly so. It may be a touch dry, with a touch more emphasis on the bureaucratic aspects of the drug development process, but definitely worth a read if you're interested in why prescription drugs cost so much in America and where this is all leading. Author of Adjust Your Brain: A Practical Theory for Maximizing Mental Health.

Sometimes a writer's bias is so transparent that you don't even need to develop a rebuttal. You simply acknowledge his bias and respect his right to express his extreme, albeit twisted, view of the world.

Goozner is an economist, I majored in economics in both undergrad and grad school, the rest of my education is in chemistry, molecular biology, business and law. He writes about academic research, I have worked at National Laboratories and well known universities. He writes of the pharmaceutical industry, where I spent nearly a decade. And he writes about the biotechnology industry, where I spent another decade. Amazingly, all my life I have spent discovering and developing drugs. So I think I can say I read this book not as a layman, although at times it seemed to be written by one.

I usually enjoy books that are critical of things. They have a tendency to keep us honest and make us all too aware of our faults. But this book, while laudable for its story telling and historical walkabout, did not really get to a point where it stood on firm ground. So in the end, it was so overstated in its extremism, I could not take it seriously. Any good point that could have been made was underminded in its credibility by statements at times so braced by sheer nonsense, I felt bad for the author. I never did take this book seriously.

Goozer is one of those folks that does not believe the constitution is correct to provide protection to inventions through patents. Nor does he seem to believe in capitalism. Rather, he posits that pure open academic research is all that is needed to develop drugs. To him, the Bahy-Dole Act was a license for the pharmaceutical industry to steal from academia.

He would have us believe that all the great drugs developed today really come from academia. If you believe that, then you believe that the internet, as we now know it, including Amazon.com itself, came 100% from academia. Well no Mr. Goozner, Netscape founders and developers of Mosaic did indeed develop their "inventions" at the University of Illinois, but it took good old capatilism and $$ to turn all that into sophisticated products and tools. That is called fundamental research, basic research, being developed into marketibal products. The goal of academic research is not to develop marketable products, it is to further knowledge. The Bayh-Dole Act briged that basic research to the marketplace and last year alone, "academia" made $4 billion from license fees it recieved from those crooks that stole their technology and passed it off as their own after faking an $800 million investment.

The tens of thousands of industry scientists that spend decades developing drugs based on technology licensed from academia should be insulted by a book claiming they had no role in developing the product. I know I am, and I was in academia once.

Lots of things in his book are just plain wrong. To many to list. No need to, because his fundamental thesis is wrong to. I don't question his telling of all the history though, just his conclusions from it.

Lets take the $800 million. He tells us it costs only $100 million and not $800 million to develop a drug. Well, that is not quite what that number means. The $800 million is the cost for the one drug that made it to market, and the 50 that failed in research. That is called an absorbed cost. You see, the vast majority of drugs that are developed never see the pharmacist's shelf. I worked on one such drug that was abandoned after my company spent over $50 million developing it. Now if you are a stockholder, you think you might want a return on your investment. That one successful drug is it.

If we follow Mr. Goozner to the end of his diatribe, we would find that he literally expects the entire drug industry to be a non-profit industry. Well then, since Amazon.com was created from technology that came from academia, it should declare non-profit status and give away all its profits.

What could have been a strong calling to task on the pharmaceutical industry turned out to be nothing more than the fringe, almost socialist, views of an anticapitalist.

Finally, for an economist I was amazed that he managed to oversimplify how the pharmaecutical industry makes development decisions with all his "me too" drug conclusions. If I have to explain that one I am afraid I am going to have to hop on my pro Posner/Pareto/Coase pedistle and preach, which I don't want to do. That takes me back to my first statements. This author is bias against patents, capitalism, and a little uninformed about science (when he tried to be one, he made it obvious why he is not one). But I did like the walk through history, enough to ignore the misleading filters through which me wanted us to view that history. I gave him an extra star for that one. If you are a social engineer or igorant, you might like this book. If you are at all informed, it will leave you like a parody, amused and nothing more.

I won't discuss the content of the book, as many have already done so. I will merely mention the aspect of the book that struck me the most - Mr Goozner's suggestion that there doesn't need to be a pharmaceutical industry at all. The amount of work that took place at NIH and NIH-funded labs on so many key compounds surprised even me, and I work in Big Pharma clinical development. The perfidy of companies like Burroughs-Wellcome, who resisted working with live HIV after the NIH was ready to hand over a nearly complete clinical program to them for AZT, was breath-taking. The newest industry propaganda website on medical advances (I refuse to provide a link) highlights the development of AZT, Taxol, etc with the implied message that they provided those medicines to the public. Read this, and you won't be able to stomach those Lane Armstrong Schering ads any more.

This is a superbly researched and well written book explaining the scamming of America by Big Pharma. We have the only government in the world which allows this industry to price gouge the citizenry. Please read this book and tell your friends.

You can find out more about this issue at www.rxsanity.org

From the title, you think that you would walk away from this book disgruntled with big pharma. This was not the case (for me at least). This book chronicles a few big name drugs and the work put in to discovering them. In the end I walked away with my support thrown to the pharmaceutical industry and not the average joe. Book was quite redundant and featured more name dropping than a class roster. Easy to understand for those without a science background but could have been 100pages shorter.

I read on this topic with great interest. My family wrestles with drug costs but, at the same time, can attribute being alive and leading productive lives today because of innovative drugs. I have grandparents on medicare, relatives on chronic therapy for everything from high cholesterol to psychological disorders, and others that pay a significant portion of their income to health insurance and/or drugs.

I think the previous reviews of this book sum it up nicely - even those giving it 5 stars seem to agree that the author has an agenda. This is not a thoughtful research style book with provocative insight (is it me or are these books getting harder to find?).

I will not claim to be a policy expert but here are my thoughts.

Americans are capitalists when it comes to everything but their health. It is here that we become socialists. Is that a bad thing? I'm not sure and I grapple with this question myself. When your health is on the line is it fair that people with more means should have access to better healthcare technology? Nobody seems to argue that wealthy people can afford safer cars, live in safer houses and live in safer neighborhoods - that is what success brings right? But when the only cancer drug option costs more than someone can afford it gets sticky. That said - I see a lot of subsidization to help these people both in the government and private sector (charity). When it's your life or your loved one's life on the line it becomes a very personal and understandably complicated issue.

Scientific progress is "community" based and is progressive. A cornerstone of science is that you learn and advance from others - some will turn these innovations to a business that earns a profit and drives further innovation. I agree that pharma/biotech companies don't discover every drug or every drug target but it is they that have the business model to sustain innovation. The profits of this industry, like other industries, drive further innovation that ultimately benefits us.

Drug development is mostly failure. I don't think many people realize this. When I understood how many failures it takes before a drug reaches the market and that the costs of developing drugs keeps going up I can see why drugs costs as much as they do. Simply put - you are not only paying for that new drug you're taking but for the dozens upon dozen of failures that preceded it. The high profit business model is the ONLY WAY to mitigate this risk. Drug companies make huge profit margins but they also invest a greater percentage of their profits back into research and development than any other industry.

Pharma companies have killed their image with all of those "feel good" direct to consumer ads. Shouldn't a doctor prescribe the best drug for each situation based on risk/benefit? And shouldn't these decisions be based on the best facts known at the time and the clinical judgment of the physician? I don't get direct to consumer advertising UNLESS it is purely educational and does not mention or allude to any drug by name. I can understand that when a therapy is available to treat a disease under diagnosed or is emergent that the fastest way to spread the word is through mainstream media.

Even expensive drugs are cheaper than surgery or staying in the hospital (or being institutionalized). It's widely known that for every dollar spent in drug costs you save about 8 dollars in other medical costs.

Bottom line for me is this. I want more innovation. I want my family and friends to get better drugs and avoid the hospital and live better with less pain and suffering. I'm afraid of over regulating the pharma industry simply because I trust the market more than I trust the government. I'm convinced that the pharmaceutical industry has done a hell of lot more to improve human health than it has done to harm it and will continue to do so assuming we don't destroy the business model. Not everyone will be able to afford the latest drugs - but that is where private charity and some government regulation make sense. Don't kill the goose that laid the golden egg because the golden egg is expensive.

With prices for drugs going through the roof, you would think Father Alan Greenspan, who claims to be constantly worried about inflation, would be hysterical about this issue. Not!
Many thanks to the author for throwing darts at the true cause of the problem...the drug companies and their backers in Washington.