Book Reviews by Goozner

Readers with access to either Nature or New Scientist magazine may be interested in these reviews that I wrote. One was of a new book by Stan Finkelstein and Peter Temin called Reasonable Rx, where the physician-economist team called for a breakup of the pharmaceutical industry into separate manufacturing and R&D parts. And the other was of David Michaels' Doubt Is Their Product and Thomas McGarity and Wendy Wagner's Bending Science, which skewer corporate campaigns to undermine sound science.

Here's the lead to the latter review:

REAL science depends on the dispassionate search for truth, said sociologist Robert K. Merton a half-century ago. To claim the mantle of scientist, a researcher must be divorced from preconceived bias or monetary gain, and the work should be subjected to the rigorous scrutiny of a community of peers. At the height of the cold war, Merton's coda provided a ringing defence of Enlightenment values.

But by the time Merton articulated those ideals, the tobacco industry had already set in motion a pseudoscientific strategy that threatened to undermine them. Big Tobacco's advance guard created a non-profit institute, hired scientists and commissioned papers with a single purpose in mind: to cast doubt on what would soon become a flood of evidence proving that smoking kills.

It worked. Public campaigns to combat smoking were delayed for decades; regulation was forestalled. . .

Feel Good Column of the Day

The revival of the musical South Pacific had a big night at the Tonys, and Harold Meyerson, executive editor of The American Prospect and columnist for the Washington Post, had a wonderful column this morning putting both the original version, which ran for five years on Broadway in the late 1940s and early 50s, and its current incarnation in their proper political contexts. In short, its racial themes had much to say about a soon-to-change America then, and (hopefully), our soon-to-change America now. Read and enjoy.

Just one thought before you do, though. Broadway was at the heart of American culture in the early 1950s. Let's hope that the current South Pacific revival isn't an Off-Off-Broadway production, relevant only to those who find their way to the theater house.

Where Are The Dixie Chicks?

I had the opportunity two nights ago to see a sneak preview of Barbara Koppel's new film, "Shut Up and Sing," which documents the fall and anticipated rise of the country singing group The Dixie Chicks. Here's a prediction: Koppel, and her co-filmmaker Cecilia Peck, will win the academy award for best documentary film next year and the Dixie Chicks, once the best-selling female group in American pop culture history, are about to discover a whole new audience.

This is by far Koppel's best cinematic work. The narrative cuts between the December 2002 off-hand comment by lead singer Natalie Maines about not being proud that President Bush was from Texas (it took place at a London concert just a few hours after a million people marched against the looming war in Iraq) and their present travails in Los Angeles trying to rebuild their careers. The film uses classic cinema verite techniques that include everything from touching family scenes to the fevered meetings between the Chicks and their public relations consultants who tried to stem the vicious assaults that extended all the way to the White House.

I'm not a country music fan, and I can honestly say that before seeing the movie, I couldn't identify a Dixie Chicks song if I heard it on the radio. But the film introduces their new album, "Taking the Long Way," and its heartfelt songs, many of them drawn from their recent experiences. I guarantee it will send you running to the CD store. If you like Bonnie Raitt, here's the next generation.

I didn't intend to write about the movie except I saw an interesting post last night on Donkey Rising. It cites a poll of southern voters that showed 57% of southerners now believe the U.S. "should have stayed out of Iraq." Moreover, 56 percent of southerners, compared to 59 percent in the nation as a whole, believe the U.S. should begin withdrawing its troops. In other words, country has gone mainstream.

The media gave extensive coverage to the campaign against the Dixie Chicks, which was orchestrated by extreme right wing groups who organized call-in campaigns to pressure country radio stations to stop playing their records (don't forget, this was the best selling band in country music history). What they never covered was the deep well of support their stance had, not just in liberal free-speech precincts where you'd expect it, but among the thousands of so-called rednecks who continued to fill arenas in the immediate wake of the London incident.

The Chicks are not political people. The movie shows us three young women who somehow found the courage in the face of this massive and unjustified political assault to stick by their convictions, convictions that they only discovered by coming under fire. If you're like me and paid little attention to this extraordinary story as it unfolded, see "Shut Up and Sing," which will be opening around the country later this month. You'll become a fan of these three young women, too.

The Immortality Hustle

Dreams of immortality – or at least delayed senescence – never die. This past summer I joined the crowd by signing up for the Ponce de León 48-and-over baseball league near my home in suburban Washington. This hardball league provides the Boys of Autumn with an opportunity to relive past glories on the diamond. Given that 38 years had passed between starts, my sepia-toned memories of a mediocre high school baseball career had morphed into a few standout moments. I entertained notions of becoming a star.

I quickly got my chance. Down by a run in the late innings of our first game, I led off by slapping a fastball into center field (full disclosure: batting practice machines are 15 mph faster than high hard ones in “Ponce” ball). The next hitter blooped a single to right. Obeying ancient instincts, I took off at the crack of the bat and promptly pulled my left hamstring. Limping gamely into second, I waived off medical assistance and took a short lead. Our best hitter lined meekly into left center. As I shuffled around third, my soft spikes caught on the turf. Pitched forward, I jammed both thumbs into the ground. After brushing off my acute embarrassment, I hobbled home where the ball had mercifully arrived in sufficient time to prevent further harm from sliding.

With the lead platoons of the 75-million-member Baby Boom generation nearing retirement, it is inevitable that some portion of the Me-generation will, like me, get seduced by the Ponce de León myth. And there are plenty of enablers. A small sea of academic entrepreneurs, venture capitalists, government funders, credulous science reporters and think tank gurus are touting prospective biomedical interventions that will lead to a never-ending promised land. Have you heard about the genetically-altered nematode worm that doubled its life span? The magic elixir is just around the corner. And, if you buy now, you can get in on the ground floor.

Science writer Stephen S. Hall helped unleash the longevity bubble in January 2000 with a cover story in the New York Times Magazine that was illustrated by geezers in convertibles living well into their 100s. Though his ostensible subject was the emerging field of stem cell research, he succeeded in publicizing the speculative musings of scientist-entrepreneurs like Michael West of Advanced Cell Therapeutics and William Haseltine of Human Genome Sciences, who predicted the new cellular therapies “may keep us young and healthy forever. The fountain of youth is likely to be found within our own genes.” By the time Hall finished his 2003 book on the subject, which he called “Merchants of Immortality: Chasing the Dream of Human Life Extension,” potential treatments for serious diseases had taken a back seat to longevity research. He knew what sells.

Bioethicists have also been having a field day with this new “field.” Leon R. Kass and his colleagues on the President’s Council on Bioethics took a break from their embryo protection labors to ponder what it all means to have “ageless bodies.” To be fair, their 2003 report “Beyond Therapy” also grappled with the medicalization of childhood hyperactivity, sports doping and mood-altering drugs. But alongside these serious ethical concerns, they included a long section that confounded still undiscovered treatments for the symptoms of aging like memory loss with extending the maximum human lifespan. “The anti-aging medicine of the not-so-distant future would treat what we have usually thought of as the whole, the healthy, human life as a condition to be healed,” the report lamented.

This not-too-distant future became the jumping off point for Charles C. Mann’s Atlantic Magazine article this past May that was headlined “The Coming Death Shortage.” If the optimists are right, Mann worried, we’re headed for a world where grandparents have grandparents, the young wander aimlessly through an endless adolescence waiting for the old to retire, and the miracle of compound interest creates a class of 100-year-old investors who will make today’s wealth divide seem like the golden age of equality. “Instead of helping their juniors begin careers and families, tomorrow’s rich oldsters will be expending their disposable income to enhance their memories, senses and immune systems.”

Mann fretted that these miracle potions will only be available to the rich. Quoting a Centers for Disease Control official, he extrapolated from the $15,000 annual cost of keeping an AIDS patient alive to estimate that paying for anti-aging medicine for the Boomer generation will cost the health care system $1.2 trillion a year. He cited implantable defibrillators as one example of these life-saving technologies that we’ll never be able to afford. Note the sleight of hand. This device allows some people with heart disease to live to their allotted lifespan. But it doesn’t alter its potential length by a single day.

What’s absent from all the talk about longevity is any discussion about what it might take to translate a few elegant science experiments that retard senescence at the cellular level into anything approaching a drug or therapy that might one day be used in humans, not to mention pass regulatory muster at the Food and Drug Administration. Mann’s article predicts the future will be an unequal society where “the very old and very rich (are) on top, beta-testing each new treatment on themselves” while the less well off elderly go without.

During the 1990s, the U.S. government spent billions of dollars researching cures for rare diseases using gene therapy, only to see the field largely collapse after 19-year-old Jesse Gelsinger died in a clinical trial where the researcher failed to disclose his financial stake in the experiment. Memo to future longevity researchers: good luck in getting rich old people to substitute for Jesse.

Before long, the inherent implausibility of this line of research will send its boosters to greener pastures. Already Geron Inc., whose hourglass logo denotes its initial fascination with telomerase, the protein that programs cell death, has switched to pursuing cancer cures. West’s Advanced Cell Therapeutics has moved on to using stem cells to treat disease. But judging from the latest entry in the field, Washington Post reporter Joel Garreau’s “Radical Evolution: the Promise and Peril of Enhancing Our Minds, Our Bodies—And What it Means to be Human,” the speculative bubble still has a ways to run.

Perhaps recognizing that immortality is a thin reed on which to hinge his consulting practice (besides penning an occasion article for the Post, Garreau is a member of the Global Business Network, a scenario-planning organization that lists a number of Fortune 500 companies as clients), “Radical Evolution” reports on a transhumanist movement that seeks to link a high-tech smorgasbord of genetic germ-line manipulation, robotics, infomatics and nanotechnology (he calls them the GRIN technologies) to arrive at a whole new race of beings, which Garreau dubs The Enhanced.

Unless I missed it, he never once uses the word eugenics to describe this movement, freighted as it is with Hitlerian connections. But he does say that “the ability to tinker with our genes offers the astounding promise – and peril – of immortality, which mythically has been the defining difference between gods and mortals. It also offers the possibility of an even greater variety of breeds of humans that there is of dogs.”

Typical of the genre, Garreau sees the emergence of this uber-race as a foregone conclusion. He relies heavily on the work of Gregory Stock, who heads the program on medicine, technology and society at the University of California at Los Angeles’ School of Medicine. Stock, whose 2002 book, “Redesigning Humans” was subtitled “Our Inevitable Genetic Future,” tells Garreau that future parents’ ability to order designer babies with extra chromosomes “does not hinge on some cadre of demonic researchers hidden away in a lab in Argentina trying to pick up where Hitler left off. The coming possibilities will be the inadvertent spin-off of mainstream research that virtually everyone supports.”

Laying aside for a moment the morality of such fantasies, one hungers for some admission that it would take a lot of society’s resources to engineer such a trick. The U.S. government has spent in excess of $60 billion since President Nixon declared war on cancer. The private sector has spent billions more. Yet physicians are still attacking these mutant cells with knives, flame-throwers and poison. Decades of intensive research has recently allowed scientists to add targeted therapies to the mix. So far, it’s added months, not years, to some patients’ lives.

Garreau sweeps away any discussion of scientific difficulties by alluding to Moore’s Law, the famous dictum from the former chief of Intel that the circuitry that can be etched on a single computer chip doubles every 18 months (a law, by the way, that is only a few years away from reaching its physical limits). Technology is advancing so fast that what scientists learned in the past 20 years will be equaled in the next 8 and so on. By 2030 at the latest we’ll reach a point where supercomputers have greater-than-human intelligence; the Internet will have so much power it is a “superorganism”; and biologists will have re-engineered the human genome to produce super-smart people.

Garreau calls this endless scientific speed-up The Curve and its crossover point in the not-too-distant future The Singularity. Consultants must need such titles for their Powerpoint slides. At The Singularity, we will suddenly have living among us (most Boomers, don’t forget, will still be alive) “an ultra-intelligent critter.”

Besides having major implications for how we administer the SATs, these ultra-intelligent critters are going to have a host of technological enhancements at their command. They will be able to stay up for days; live off their fat; rapidly heal wounds; and use thoughts to communicate with similarly equipped people or robots (if I live long enough to get one of these devices, I sure hope no one gives my number out to telemarketers). To bolster these claims, Garreau takes readers on a whirlwind tour of some of the more outlandish projects being pursued by the Defense Advanced Research Projects Agency (DARPA), where the government is seeking to produce the super-soldiers of the future.

DARPA has come up with some amazing things over the years – the Internet, for one. But most of its projects, like any other form of way-out research, never see the light of day because they fail. “The civilian implications of this technology have not escaped us,” especially the fat-burning pill, the researchers tell Garreau. Is there any reason to think they’ll do any better than the billions spent by the pharmaceutical industry on a similar quest?

Assuming the inevitable, Garreau uses the last two-thirds of his book to explore the possible ways mankind might react to this “turning point in history.” His heaven scenario comes from techno-touts like Stock and Ray Kurzweil (who has his own new book out, The Singularity). Kurzweil gobbles 250 pills a day so that he can live long enough to embrace the arrival of the super-intelligent computer

His hell scenario comes largely from Bill Joy, the founder of Sun Microsystems, who, after reading Ted Kaczynski’s “Unabomber Manifesto,” spent six months at his Aspen hideaway penning a long article for Wired magazine entitled “Why the Future Doesn’t Need Us.” Joy believes everything predicted for the GRIN technologies will come to pass, and will either enslave or destroy mankind. Biotechnology will eventually allow crazed individuals like the Unabomber to unleash incurable plagues and nanotechnology will eventually turn into unstoppable gray goo. In a post-9/11 world, this is not an irrational fear.

Garreau stirs environmentalists like Bill McKibben and politicians like Tom Hayden into his hell scenario stew. The former is understandably concerned that rapid technological advance is undermining our fragile ecology. His solution is to encourage mankind to say enough is enough and live a simpler life. Hayden fears we’re opening the door to morally repugnant technologies like human cloning and organ farming. Garreau dismisses those arguments by trotting out the neo-liberal faith that advancing technology will feed the earth’s hungry millions and cure the sick.

How germ-line bioengineering a race of 200-year-old uber-humans will lead to these laudable goals is left to the reader’s imagination. Garreau embraces his prevail scenario. “I elect to light out for the Territory,” he concludes. “I choose to examine the possibility that human nature might continue to evolve and be improvable, and to consider what transformation might actually look like and what it might mean.”

If there is any political philosophy linked to the technology-driven musings of futurists like Joel Garreau, it is libertarianism. Many scientists and technologists fall into this category. It has often been said that scientists want nothing more than to be ignored by the governments that fund them and left alone by the regulators that might one day be called upon to pass judgment on their work products.

In that sense, scientists and futurists are somewhat like the Bubble-era acolytes that gathered around Ken Lay of Enron, whose own technological imperative was that the free market could be imposed on any and every economic activity. California’s ratepayers and Enron’s stockholders paid a heavy price for that hubris before regulators stepped in to clean up the mess.

There’s still plenty of time for us lesser mortals to exert control over what may one day emerge from the billions of dollars our government and capital markets are pouring into the emerging GRIN technologies. That is unless we buy into their promise of everlasting life, always smart and beautiful children and hamstrings that won’t pull. Then, of course, anything goes.

Spreading Fear Like A Virus

Today's Washington Post carries my review of two new books that deal with the much-feared avian flu threat. They are "The Monster At Our Door" by Mike Davis and "Epidemic of Fear" by Marc Siegel. You can find the review here.

NEJM -- "I read every word of this book"

The New England Journal of Medicine this week gave "The $800 Million Pill" its best review to date. Others have been more effusive in their praise (thank you Shannon Brownlee in the Washington Monthly). But the NEJM is the voice of authority in the drug development field, so its kind words are welcome news indeed.

The editors sent me an advanced copy several weeks ago. It's not a common practice, but we had been in touch because I was about to criticize them (in my role as director of the Integrity in Science project at the Center for Science in the Public Interest) for failing to report the conflicts of interest of some of the authors who had recently published primary research papers in their pages. Notwithstanding my boorish behavior, they still published the review.

The editors engaged an M.D. who is also a Ph.D. economist -- Allan Detsky of the University of Toronto -- to review the book. Like most in his field, he quarreled with the anecdote-driven methdology that I -- a mere journalist -- used. But when he turned to my major arguments, he had to admit that I made "a persuasive case." But best of all, he praised my writing! Hey, call me whatever you want. But if you say my writing engaged you, you've got a friend for life.

Here's the final sentences of the review:

"Although the approach Goozner uses in this book is not scientific, I think he makes a persuasive case. The passion of individual scientists pursuing an activity they truly enjoy, not the profit motive, has led to the major technological advances of the past century.

"I will end by saying that I am not one who enjoys reading books slowly. I often skim. In order to read a book from cover to cover, I have to find it truly interesting. I can tell you that I read every word of this book."

For a complete copy of the review, click here:

Volume 351:405 July 22, 2004 Number 4

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

By Merrill Goozner. 297 pp. Berkeley, University of California Press, 2004. $24.95. ISBN 0-520-23945-8.

The pharmaceutical industry claims that it can continue playing a key role in the development of new weapons against disease only if Americans pay prices for medicines that yield very high profits. It also claims that price controls would cause the stream of new products to dry up. Merrill Goozner, a former chief economics correspondent at the Chicago Tribune, comes to a conclusion that is very different from the views espoused by the drug companies. He does so on the basis of a detailed review of the development of drugs to combat cancer and the human immunodeficiency virus, a description of the early successes of therapies developed by the biotechnology industry, and a review of the economics of "me-too" products, such as H2 antagonists, proton-pump inhibitors, and allergy medications. He believes that the private sector's main role is to develop and commercialize therapies that are based on knowledge generated by independent researchers in academia and in government. In his opinion, high prices and big profits are not the key ingredients in pharmaceutical breakthroughs.

On one hand, this book gives the reader lots of interesting and useful background about the people and organizations involved in expanding medical knowledge and in developing drugs. On the other hand, it falls short of what I expected from the title. It is not a detailed forensic accounting of the true cost of developing individual drugs as compared with industry claims. Indeed, the only real discussion of the $800 million pill (the alleged average cost of developing a new drug in the United States) comes in a brief review of a study by the Tufts University Center for the Study of Drug Development that was first published in 1991 and then updated in 2001. There is a brief rebuttal from other organizations in the penultimate chapter of the book, but for a reader looking for definitive "proof" or data, this book falls short. Written in the typical style of investigative journalism, the book comes across as an author's attempt to prove a point, rather than an impartial scientist's effort to answer a question.

Goozner repeatedly comes back to one central theme: that medical innovations start with dedicated and passionate people, most of whom are not employed by the pharmaceutical industry, who are investigating scientific questions. Without these dedicated scientists, none of the innovations described in this book would have occurred. In other words, the development of drugs is not exclusively driven by high profits but, rather, is a collection of efforts. Goozner goes on to suggest some very useful methods for improving the process of drug development with the support of government-funded research (e.g., randomized trials comparing new and existing products, such as the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, known as ALLHAT). Although the approach Goozner uses in this book is not scientific, I think he makes a persuasive case. The passion of individual scientists pursuing an activity they truly enjoy, not the profit motive, has led to the major technological advances of the past century.

I will end by saying that I am not one who enjoys reading books slowly. I often skim. In order to read a book from cover to cover, I have to find it truly interesting. I can tell you that I read every word of this book.

Allan S. Detsky, M.D., Ph.D.
University of Toronto

CSPAN Booknotes appearance

Can't sleep? Turn on CSPAN-2 for its Booknotes program at 5 a.m. on Sunday (EST) and see my appearance at The New America Foundation.

After a brief vacation, regular postings to this site will begin appearing again next week.

Next DC appearance

For those of you living in the Washington, DC area, I'll be appearing at a forum hosted by the New America Foundation on Thursday, July 8 at 12:15 p.m. Talk title: THE $800 MILLION PILL: WHAT DRIVES THE COST OF PRESCRIPTION DRUGS?

NAF is located at 1630 Connecticut Ave. (DuPont circle area) on the 7th floor. If you want to attend, send an r.s.v.p. to buntman@newamerica.net. Come on by!

And now for the good reviews . . .

The Copley News Service this week sent out a review of "The $800 Million Pill" to newspapers in the chain. Hopefully, some will run it in their weekend editions.

Click on to read the review:

Biotech and Big Pharma executives challenged about the high price of prescription drugs repeatedly defend themselves and their companies by citing the high cost of research and development. It costs about $800 million and takes a decade to bring a new drug to market, an industry-funded report from Tufts University found. The industry uses these findings like a shield to deflect criticism from consumers and the insurance lobby. In "The $800 Million Pill," Merrill Goozner, a former chief economics reporter for the Chicago Tribune, crushes the study and the executives' arguments like a tablet in a mortar and pestle.

Using his own analysis as well as public records, independent studies and even industry insiders, he shows that the cost is more likely in the range of $71 million to $250 million. The advertising campaigns for these new drugs, often hyping new versions of treatments already on the market, add millions to the cost of drugs while bringing nothing to the consumer, Goozner says.

"If the industry-funded academic economists at Tufts had factored out the half of industry research that is more properly categorized as corporate waste, their number would have been similar to that of the Global Alliance," a nonprofit that commissioned a team of former drug company executives to build their own model of what it costs to develop a new tuberculosis drug. The estimate: between $115 million to $240 million.

Many a businessman may scoff at Goozner's strident assertions. Ours is a capitalist society and drug companies, like any big business, must navigate competition and regulation while worrying about shareholders and the bottom line. But his book offers an eye-opening tour of the labyrinth that is drug discovery at a crucial time, for consumers traumatized by the wallop they receive with every trip to the pharmacy counter.

Goozner takes his readers into government and private industry labs and offers insights into the decisions made in corporate boardrooms. His heroes are the researchers who toil at the bench, sometimes for decades, driven more by the prospect of scientific breakthrough than the monetary reward of commercializing their discovery.

Eugene Goldwasser spent more than 20 years pursuing a single hormone that stimulates red blood cell production, a crucial discovery for anemia. The discovery paved the way for Amgen to become a biotech success story. It also set off a patent war that serves as an example of how drug prices can often reflect much more than the cost of research and development.

The villains in this tale are the corporate executives. They fund clinical trials simply to help sell yet another blood pressure control medicine, but don't want to spend resources on a long-shot treatment for HIV.

A government lab or researcher funded through taxpayer-supported grants can search for years before finding a molecule that effectively treats disease. Drug companies then sweep in, license the molecule and begin taking credit for all of the work and resources that went into its discovery.

In the end consumers bear the burden of research and development. And they are being double-billed: First, their taxes fund the government research grants, and, later, at the pharmacy, they pay again.

It's unlikely price controls will win Congressional support, Goozner said. He proposes that Congress create an independent institute on clinical practice within the National Institutes of Health, letting it conduct clinical trials that compare existing medicines. It would generate best-practice guidelines for physicians and help Medicare determine which drugs offer too little benefit for too high a price.

He suggests Congress address patent laws that impede research and drive up costs by allowing people to stake claim to products of nature. And he proposes the Food and Drug Administration's approval process for new drugs require new products to be measured against other therapies where they exist.

"Unless the government helps the pharmaceutical industry by reforming its drug approval process in a manner that fosters innovation," Goozner concludes, "the prognosis for the industry is grim."

- Terri Somers.

Send in the Frowns

Nature Magazine, owned by London-based Macmillan Publishers Ltd., is considered one of the world's leading science journals. As a first-time, non-academic author, I should be honored that they chose "The $800 Million Pill" for its lead book review in this week's issue. I've really been looking forward to my first review by someone who comes from the world of science and understands the interplay of scientific and economic realities discussed in the book.

But one has to wonder about what has happened to standards in the scientific publishing world when they asked a "scholar" from the American Enterprise Institute -- an avowedly conservative think tank in Washington, DC that takes considerable funding from the drug industry -- to write the review. Funding for John Calfee's own research, which he discloses at the end of the review, comes in part from pharmaceutical firms.

The editors must have known there no possibility that the review would be positive when they sent it out to Calfee. As they say in England, that hardly seems cricket.

Despite the many positive things Calfee says about my writing and understanding of science and medicine, the review was largely a stale rehash of industry arguments that I debunk in the book. I won't repeat those discussions here.

Rather allow me to point out that Calfee breaks the cardinal rule of fairness in book reviewing. You may quarrel with a person's argument, but you should at least accurately present it at the outset of the review. He failed this basic test by misrepresenting my analysis of the $800 million cost-per-drug figure put out by industry-paid researchers.

He says my analysis largely rests on a Public Citizen analysis and a study by the Global Alliance for TB Drug Development. My narrative does go over those studies and the arguments they've engendered (the industry trade group hired the accounting firm of Ernst and Young to debunk the Public Citizen study). But my own analysis relies on the fact that at least half of industry R&D is wasted on drugs that add nothing to physicians' armamentarium for fighting disease, and thus can more properly be categorized as corporate waste. He also says I "defy sound economic reasoning" by ignoring the "opportunity cost" question of R&D expenditures. In fact, I discuss that at length (I argue it's an expense funded by current drug consumers) and quote academic experts to bolster my argument.

Calfee doesn't mention either of these discussions. He describes my arguments as rehashes of others' studies. Indeed, he ignores the fact that I specifically state at the end of the chapter that if you take these factors into consideration, the $800 million industry figure would be "similar to the Global Alliance" figure. That's hardly "relying" on or "accepting" the results of their study.

There are other points in the review where Calfee makes basic mistakes (he calls Gleevec a biotechnology product) and inaccurately describes what I wrote. But suffice it to say here that when reading reviews by partisans in a debate -- even in the pages of a prestigious journal -- consider the source.

Here's the relevant paragraph from the June 24, 2004 Nature review:

"Relying mainly on non-scholarly critics such as Public Citizen (a lobby
group in Washington DC founded by Ralph Nader) and the Global Alliance for
TB Drug Development, Goozner argues that DiMasi and colleagues grossly
overstated the true costs of developing useful drugs. He accepts instead the
Global Alliance's estimate that discovering and developing a new
tuberculosis drug would cost only US$115-240 million. Essentially, Goozner
argues that the editors and reviewers of the Journal of Health Economics
overlooked some basic methodological flaws in the paper. His argument is
unpersuasive, though, partly because it defies sound economic reasoning on
opportunity costs. It also ignores important limitations in the Global
Alliance's study of developing a hypothetical drug for a single condition
(tuberculosis) and using relatively small clinical trial sizes, non-market
cost data and highly conjectural failure rates."

San Diego Union-Tribune: Another positive review

Click here to find out why one business reporter says The $800 Million Pill "offers an eye-opening tour of the labyrinth that is drug discovery at a crucial time, for consumers traumatized by the wallop they receive with every trip to the pharmacy counter.

"Goozner takes his readers into government and private industry labs and offers insights into the decisions made in corporate boardrooms. His heroes are the researchers who toil at the bench, sometimes for decades, driven more by the prospect of scientific breakthrough than the monetary reward of commercializing their discovery."

Philly Inquirer: "An Enlightening Examination"

The $800 Million Pill convinced a Philadelphia Inquirer scribe. For his review this past weekend, click here.

Review: Dramatic change in the drug industry is inevitable

A brief review of The $800 Million Pill (with a nice picture of the book jacket cover) appeared in the Sunday business section of the Washington Post. S.P. writes that "despite the pharmaceutical industry's desperate efforts to keep things as they are, it is becoming clear that the way drugs are priced, and drug research is financed, will change dramatically over the next decade."

There's a pattern in the early reviews. (For my response to previous reviews, click here.) Reading the book convinces reporters that the industry engages in widespread skullduggery in the name of innovation. The reviewers then raise minor quibbles.

If this pattern holds, the book will have succeeded in my fundamental quest: To change the terms of the debate regarding drug pricing and its relationship to pharmaceutical innovation. That, in this author's humble opinion, will be a tremendous victory for those fighting for fair drug prices and for new cures.

NYC Appearances

I'll be making a round of appearances in New York City on Thursday and Friday. WNYC's Leonard Lopate will host a discussion of The $800 Million Pill at noon Thursday, and I'll be signing copies of the book at Labyrinth Book Store on 112th Street near Columbia on Thursday evening. Then on Friday, I'll be signing books at Columbia's Low Library from 7 p.m. to 10 p.m. along with other graduates of the J-School who've published books in the past year. If you're in town, stop by!

In the Marketplace

The $800 Million Pill got a major publicity boost yesterday from my appearance on Marketplace. To hear the interview with Kai Rysdal, click here (you'll need Real Audio to listen).

The Economist: "Pill-gotten gains"

The April 10th edition of the Economist magazine offered a short but significant review of "The $800 Million Pill." Like Business Week, the unsigned review accepts the essential accuracy of my analysis: that much industry R&D is wasted, and that significant breakthroughs almost always originate in the public sector. But unlike its U.S. rival, the British reviewer read the concluding section of the book with enough care to suggest its key reform -- comparative clinical trials that might dissuade drugmakers from pursuing me-too drugs -- doesn't go far enough. "Alas, such are the powerful entrenched interests in drugmaking that it will take something stronger than a dose of information to calm the current fever over pill-pricing," the review concluded.

Memo to the Economist from this side of the pond: Even getting this one change passed in the current U.S. political environment would be a major victory, and a start toward more comprehensive reform of the medical innovation process.

Business Week Review: I'm right, just not right enough

Business Week gave “The $800 Million Pill” a mixed review in this week’s (April 19th) edition. Reviewer John Carey calls the book “provocative but insufficiently reflective.” I failed, in his view, “to explore further solutions to th(e) dilemma” that drugmakers’ self-interest and public health don’t often coincide.

I’ll return to that criticism. But I first would remind readers that it was never my intention to resolve the drug industry’s moral dilemma or convince industry executives to focus more of their R&D budgets on socially useful products.

What I set out to do (and this is clearly outlined in the introduction) is to debunk the myth, which the drug industry propagates on television, in newspapers, in the halls of Congress, and from the bully pulpit of the executive branch, that unless the industry is allowed to continue charging exorbitant prices and raking in huge profits, innovation will dry up. On that score, I succeeded entirely, in Carey’s view. “He proves that Big Pharma need not require $800 million to develop an important new drug” and that “many drugs were created with government funding – then were sold to consumers at sky-high prices.”

But then he goes on to ask: “Is it really a shock that companies spend a big chunk of their R&D budgets on drugs that sometimes show no clear medical advantage but that bring surefire profits?” The goal of business, after all, is to make money.

Of course it comes as no surprise. But it is not common knowledge. And public policy is being driven by the myth.

I’m a reporter, not an investor. My goals are to counter industry lies, protect the public purse, and expose practices that make health care unaffordable – practices, I might add, that receive scant attention in the pages of Business Week (this has nothing to do with it being a business publication; some of the finest journalism on drug industry practices gets reported in the Wall Street Journal).

That said, I would like to quibble with Carey’s assertion that I failed “to explore further solutions to this dilemma” of how to make drugsmakers self-interest coincide with public health. “Should drugmakers be held to a higher standard than, say auto makers?” he asks at one point. “Do we need new regulations or incentives to prod the industry into focusing more if its R&D on important medical needs?”

I recommend that Carey go back and reread my last chapter. It is chock full of suggested reforms aimed explicitly at getting drug companies to focus more of their R&D budgets on significant medications.

Moreover, as far as holding drugmakers to a higher standard is concerned, allow me to repeat a criticism from an industry insider included in both the opening and closing chapters of the book. It’s not a moral question. Unless the big drug companies figure out how to tackle pressing medical needs, Hoffmann-La Roche's former R&D chief Jurgen Drews wrote in 1999, they will go the way of the dinosaurs. As I said in a Washington Post op-ed last December, when drug consumers and their representatives are properly informed and empowered, they will force the industry to change.

It's A Girl!

And now for a purely personal note: My daughter Rebecca, son-in-law Chris, and grandchild Rachel were joined this morning by grandchild Sarah, who weighed in at 6 pounds, 7 ounces and 19 1/4 inches long. Mazel Tov to the Kuepers family of Naperville, Illinois!

Love,
Grandpa

Washington Monthly -- "This book does for drugs what Fast Food Nation did for fast food"

Plunder drugs: why Americans believe they have to put up with pharmaceutical profiteering
(This review first appeared in March 2004 in the Washington Monthly)
by Shannon Brownlee

The $800 Million Pill: The Truth Behind the Cost of New Drugs
By Merrill Goozner
University of California Press, $ 24.95
I have only two regrets over the life I led in my twenties. I should have gone on that sailing trip to the South Pacific with a group of entomologists seeking to study the insects on the exotic Marquesas Islands, instead of rushing back to "college after my year off. My other regret is once back at school, I failed to heed the advice of the fellow graduate student who told all of us in the biology department at the University of California that we should serape together every penny we had and invest in a startup biotechnology company called Amgen. Had I listened to him, I might be cruising the South Pacific in my own yacht instead of writing book reviews, because anybody who plunked down $ 100 in the mid-1980s on Amgen would have shares worth more than $ 1.5 million today.

Today, Amgen is the world's most successful biotechnology company, hailed regularly by Wall Street and the media as a shining example of the marriage between scientific ingenuity and the American entrepreneurial spirit. It is still headquartered in Thousand Oaks, Calif., the bedroom community of ranch houses and shopping malls an hour west of Los Angeles, where it was founded by a small group of scientists from UCLA in 1980. Back then, the company had no products, no warehouses, no laboratories--merely a handful of investors willing to bet that the fledgling firm could turn ideas into real drugs using recombinant DNA technology. Nine years later, Amgen launched its first product, Epogen, a genetically-engineered form of erythropoietin, one of the proteins made by the body that stimulates the production of red blood cells. Today, the company makes more than $ 5 billion a yeas, a third of which is profit, selling just three products. Epogen alone brings in over $ 1 billion, most of it from about 300,000 Americans on kidney dialysis, who would suffer debilitating anemia without it.

Epogen is truly a wonder drug. It eases many of the miserable symptoms that dialysis brings. But you don't have to be an economist to figure out that it is also incredibly expensive--among the most costly drugs on the market. The federal government picks up the tab for Epogen through the Medicare program that pays for dialysis. The company doesn't try to justify its high price on the basis of manufacturing costs; the recombinant DNA technology used to make Epogen is commonplace. And it long ago earned back its development expenses. Rather, as Merrill Goozner writes, the high price tag placed on Amgen products can only be justified as paying "for the scientists and technicians squirreled away in Thousand Oaks, who are busily searching for the next generation of wonder drugs."

Indeed, that is the mantra that the entire biotechnology and pharmaceutical industry begins chanting whenever the high price Americans pay for their medicine comes up. According to a 2001 Tufts University study--funded by the industry--it costs an average of $ 800 million to get a single new drug to market. But what biotech and Big Pharma companies don't tell you is that the vast majority of the new drugs they bring to market are "me-too drugs," new formulations of existing pharmaceuticals. They also don't tell you that they did not invest a dime in the basic research that produces the majority of breakthrough drugs.

Americans pay twice for the medications they take. First, their taxes go toward the federally-funded basic research that lies behind most such discoveries. The majority of new drugs are based on findings made by dedicated, hard-working, federally funded scientists in universities and government laboratories, not the research arms of drug companies. A recent congressional report found that of the 21 most important drugs introduced between 1965 and 1992, 15 were developed using knowledge and techniques from federally-funded research. Then the public pays astronomically for the drugs once they hit the market.

Why do we put up with the highest drug prices in the world? Because everybody from doctors to legislators, policy-makers, and patients has been bamboozled into believing that the breakthrough drugs of tomorrow will never materialize unless the drug industry makes an ungodly profit.

The $ 800 Million Pill is required reading for anybody who wants to understand the role Big Pharma and biotech companies play in driving up healthcare costs in America. This book does for drugs what Fast Food Nation did for fast food, peeling back the layers of science, clever accounting, and hype to expose the dark side of the nation's most profitable industry. Goozner, former chief economics correspondent for The Chicago Tribune, tells a series of deft and engaging stories about the discovery and development of a half dozen drugs. Amgen's blockbuster blood booster Epogen, for instance, was the product of 20 years of slogging work by Eugene Goldwasser, a soft-spoken, unassuming biochemist at the University of Chicago who in 1977 isolated the protein that formed the basis for the drug.

Then there's Roscoe Brady, the cell biologist who spent his entire career at the National Institutes of Health, taking apart the cellular machinery that lies behind a half-dozen rare genetic disorders and producing the proteins that would later lead to therapies. Brady's first discovery led directly to Ceredase, a drug for treating the devastating symptoms of Gaucher's Disease, which afflicts fewer than 10,000 people worldwide, generally killing them before they reach adulthood. Brady and his NIH colleagues helped Genzyme Corporation, which markets Ceredase, "overcome every obstacle it encountered in the development of [the drug]," Goozner writes. The company then turned around and charged patients as much as $ 350,000 a year for a drug they would have to take for the rest of their lives. When Congress called Genzyme to task for profiteering, the company's CEO, Henri Termeer, fired back in the pages of The Wall Street Journal that the company had every right to charge what the market would bear, because it had risked everything to develop Ceredase. "If we hadn't taken the first step, there would be no market, and no additional research on the disease," Termeer wrote, conveniently forgetting that Roscoe Brady and federal funds had done the lion's share of the work.

In the final third of the book, Goozner uses his skills as an economics and business reporter to full advantage, deconstructing industry accounting methods that allow it to count development costs twice over. He suggests changes to patent law which would close off loopholes that now lead companies to waste time and money squabbling among themselves over patent rights. As one Wall Street analyst quipped about Amgen, some pharmaceutical companies look like great legal departments that happen to make drugs on the side.

My personal favorite among Goozner's suggestions for reform is a new federally-funded institute, dedicated to tracking and comparing medications. I like this idea in part because I suggest the same thing in another magazine. But Goozner and I aren't the only ones who think the National Institutes of Health--or some other agency--should step up to the plate and fund the independent, unbiased research that is desperately needed by doctors, patients, and lawmakers who have been misled for too long into believing that America's health depends upon the pharmaceutical industry staying at the top of Fortune 500.

Shannon Brownlee is a senior fellow at the New America Foundation.

Library Journal Review: A Must Buy!

Here's the review from the Library Journal:

The $800 Million Pill: The Truth Behind the Cost of New Drugs
Goozner, Merrill. . Univ. of California. Mar. 2004. c.296p. bibliog. index. ISBN 0-520-23945-8. $24.95. MED
American expenditures on prescription drugs doubled between 1990 and 2000 and currently account for close to ten percent of total healthcare costs. Concerns about availability to seniors and the poor have led many to question these high costs, which pharmaceutical companies have always justified as necessary to spur the creation of new and better drugs. In this well-researched book, Goozner, former chief economics correspondent at the Chicago Tribune, disputes these claims. He chronicles the actual clinical process by which new drugs come into being, from basic scientific research on disease processes conducted at universities and government labs to the synthesis of new chemicals. Unlike Katharine Greider's The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers - which addresses issues of advertising, marketing, and other questionable practices - Goozner's more scholarly study reveals how the pharmaceutical companies step in to take their profits (hence driving up prices) once the original government-funded research is done. Recommended for larger public libraries and academic collections in public health, medicine, and public policy. - Eris Weaver, Redwood Health Lib., Petaluma, CA