It May Not Be A Great Test — But It's My Test And I'm Sticking With It

April 2, 2004
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by Merrill Goozner

With a quarter million Americans with normal cholesterol levels dropping dead of heart attacks each year, it would be nice to have a simple test that could predict a person’s vulnerability. Some medical scientists think they’ve come up with the answer.

It’s called C-reactive protein, an inflammatory agent in the blood that springs into action when something in the body gets damaged. Proponents of the C-reactive protein thesis think people with elevated levels are at risk of sudden heart attacks. They’ve published a few studies, and garnered lots of attention over the past few years by suggesting a new biomarker of heart failure risk ( the next cholesterol ) is at hand. A number of physicians have even begun routine testing of their patients for C-reactive protein.But today’s New England Journal of Medicine threw a damper on the C-reactive protein thesis. A British study suggested the marker is at best a moderate predictor of sudden heart failure. “Recommendations regarding its use in predicting the likelihood of coronary heart disease may need to be reviewed,” the authors concluded.

Proponents immediately leaped to its defense. The most often quoted source was Dr. Paul Ridker of Harvard Medical School and chief of the cardiovascular unit at Brigham and Women’s Hospital in Boston. He told the Associated Press, the Wall Street Journal and other publications that inflammation is a strong risk factor for sudden heart failure and the C-reactive protein test is the best way to spot it. “My concern is that even in the face of overwhelming evidence that this inexpensive blood test works, we are at risk of moving backward rather than forward,” he said.

A healthy debate among research scientists? Perhaps. And, if you’re a certain age and person at risk (maybe your dad died of a heart attack), you’re probably thinking, the heck with those Brits, it’s time to go get the test.

But let’s play a little mind game. What if I told you Dr. Paul Ridker of Harvard owns the patent to using C-reactive protein as a biomarker of heart disease and it’s licensed to companies making the test. And what if I told you his research has been funded by drug companies that make statins, which lower cholesterol and may be used to combat high levels of C-reactive protein.

Would it change your mind? Would it at least give you pause? Unfortunately, you won’t get the answer to this mind game by reading the papers. Unlike medical journals, news outlets rarely report conflicts of interest when they quote prominent researchers. But you can get the answer yourself. Just go to the Patent and Trademark Office website (http://www.uspto.gov/patft/index.html) and put patent number 6,040,147 into the search engine.

You might be shocked by what it turns up. But in this age of hyper-medical entrepreneurialism, you won’t be surprised.

Publishers Weekly: "An engrossing read"

March 29, 2004
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From Publishers Weekly

In this fascinating critical look at drug and biotech companies, Goozner pulls back the curtain on the process of new drug development and answers two important questions: “where do new drugs come from?” and “what do they cost to invent?” Using case studies that recount the discovery, development and eventual commercialization of a number of significant drugs, including Epogen and the AIDS cocktail, Goozner dismantles the pharmaceutical industry’s assertion that drug prices must be kept high in order to stimulate cutting edge research. The cost of each new discovery averages $800 million, industry officials have claimed. But Goozner argues that citizens are already paying much of that bill: taxpayer-financed medical research, he finds, has played a major role in each important medical discovery. Goozner convincingly argues that new drugs get into the hands of the sick not thanks to drug and biotech companies, but to the passion of dedicated scientists—in both the private sector and the public. A former Chief Economics Correspondent for the Chicago Tribune and an award-winning journalist, Goozer writes with skill and elegance, incorporating anecdote and history in a way that enlivens his research and makes his book an engrossing read. Though the issue of drug costs has been discussed extensively in the media, Goozer’s study puts all the political chatter, news coverage and analysts’ reports into a context where they finally make sense.
Copyright © Reed Business Information, a division of Reed Elsevier Inc. All rights reserved.

Antidepressants and Kids — What you don't know might hurt you

March 29, 2004
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Parents of children on antidepressants received disturbing news last week. The Food and Drug Administration asked manufacturers of popular drugs like Zoloft and Paxil to warn physicians and parents to watch out for hostility, agitation and suicidal tendencies among their kid-patients, especially when they’re first put on the drugs.

The warning, which follows a similar action by British regulators last fall, came out of the FDA’s first full airing of the issue in over a decade. At an advisory committee meeting, FDA officials revealed that tests done on kids for five of seven antidepressants showed “a potential signal” for increased risk of suicide attempts.Unfortunately, these tests were never published in the academic literature. Nor did they appear in the popular press. Rather, if one goes back over the previous decade’s published reports on so-called SSRIs ( it stands for selective serotonin reuptake inhibitors ) one finds almost universal praise for the drugs, including their use in kids.

Indeed, even after the FDA issued its warning last week, most press accounts included statements from prominent researchers cautioning parents against taking their depressed kids off the drugs. Some physicians questioned the wisdom of the FDA action.

But a closer look at those press accounts raises a troubling question. Are consumers getting all the information they need when reading about the latest medical news over their morning coffee?

For instance, the day after the FDA warning, most of the nation’s prominent papers included quotes from psychiatrists expressing fears that the new label might scare off doctors who want to prescribe antidepressants for their patients. “The consequences for not treating depression are very high,” Dr. Madhukar Trivedi, director of the mood disorders program at the University of Texas Southwestern Medical School at Dallas, told the New York Times.

“I worry that patients, family members or physicians might turn away from antidepressants that might be lifesaving,” Eric Hollander, a professor of psychiatry at Mt. Sinai School of Medicine, told the Wall Street Journal.

What the Times didn’t tell its readers was that Dr. Trivedi is also a major contributor to a Texas program developed and funded by drug companies that was designed to convince state Medicaid authorities to step up their use of the drugs in poor children and prison populations. What the Journal didn’t tell its readers was that Dr. Hollander receives numerous grants from antidepressant manufacturers to conduct his research.

USA Today quoted University of California at Los Angeles psychiatrist James McGough, who expressed the hope that “this doesn’t scare doctors away from prescribing antidepressants.” What this 2 million-plus circulation paper didn’t tell its readers was that Dr. McGough’s research in using drugs for treating hyperactivity was funded by Shire Pharmaceuticals.

Unlike the press, medical journals in recent years instituted mandatory conflict of interest disclosure policies. These guardians of the integrity of the medical evidence have become increasingly concerned about how the pharmaceutical industry has taken over what was once a purely academic exercise.

To combat industry’s undue influence, the New England Journal of Medicine a few years ago began requiring authors of articles that appeared in its pages to disclose who funded their studies. The Journal of the American Medical Association, the Lancet and the British Medical Journal adopted similar policies. Their reasoning was scientifically based: Study after study has shown that clinical trials funded by drug manufacturers are much more likely to report positive outcomes than comparable trials funded either by the government or non-profit institutions.

No one should be surprised by those results. Whom did the researchers pick to include in the clinical trials? How did they interpret the data? What conclusions did they report, and what did they hide? The answers to those questions can be subtly or overtly influenced by whoever funds the study. In science, as in life, he who pays the piper calls the tune. And with drug companies increasingly dominating medical research, the published record on many drugs had begun to look like a press release written by the corporations that manufactured them.

This was certainly the case for limited amount of published research on SSRI use in children. When industry funded the studies, their conclusion was nearly unanimous: These drugs are safe, and they work. When independent researchers looked at SSRI use in children, nearly half questioned their efficacy.

And how about the FDA reviewer who looked at the mostly unpublished studies (which were submitted to the agency to win patent extensions)? Twelve out of 15 studies or 80 percent showed they were no better than placebo. No wonder the companies never published them. Why would anyone want to give their kid a drug that had even a remote risk of suicide if there was no proven benefit?

Unfortunately, average readers never got that message. Instead, they were subjected to a steady stream of laudatory coverage in daily newspapers, weekly magazines and ubiquitous television segments. This praise for SSRI use, including their use in kids, was drawn from the published academic record without reporting its funding source.

It’s time for the news industry to follow the lead of the medical literature. When reporters interview the experts, they should always ask: “Oh, and by the way, who funded your study?” Medical journals think doctors should be informed about conflicts of interest so they can properly evaluate the information. Consumers deserve nothing less from the press.

Library Journal Review: A Must Buy!

March 28, 2004
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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

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

March 28, 2004
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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.

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