Overdosed America (45 page)

“Not only was the VIGOR study not stopped, but the
New England Journal of Medicine
article that reported its results didn’t even report that there were more serious cardiovascular complications caused by Vioxx than there were serious GI complications prevented.”

Even so, the article’s claim that Vioxx significantly increased the risk of heart attack only in people who already had cardiovascular disease turned out not to be true. In December 2005 the editors of
The New England Journal of Medicine
issued an “Expression of Concern,” stating that the November 2000 article presenting the results of the VIGOR trial had failed to include three heart attacks that occurred among people taking Vioxx. Why did three heart attacks matter so much? They changed the statistical analysis dramatically: with the three heart attacks included, Merck could no longer claim that Vioxx did not increase risk of heart attacks for healthy people without a history of cardiovascular disease. In other words, the VIGOR trial showed that treating people with Vioxx instead of naproxen significantly increased everyone’s risk of heart attack, whether or not they had a previous history of cardiovascular problems.

Had these true results been published in
The New England Journal of Medicine
in November 2000, Merck probably would have sold a lot less Vioxx. And Merck would probably now be facing a lot fewer than the 27,000 lawsuits that have been filed by people who suffered cardiovascular complications while taking Vioxx.

STATINS

On February 2, 2007, Judy Norsigian, the executive director of Our Bodies Ourselves, and I had an op-ed piece in the
Atlanta Journal-Constitution
. The piece started out:

Today’s “Go Red for Women Day” campaign to increase awareness of heart disease and stroke should be called “See Red for Women Day.”

Despite being endorsed by some of our most trusted institutions like the American Heart Association and the National Heart, Lung, and Blood Institute, this event isn’t just about protecting your health. It’s also about exploiting your concerns about health.

The purpose of the “Go Red” campaign was, ostensibly, to “educate” women that heart disease, while usually silent, is their number-one killer (scary stuff) and to encourage them to “know their numbers,” including their cholesterol numbers. The truth is that below the age of seventy-five, cancer claims seventy-eight percent more lives of women than heart disease. And it also turns out that—as described in
chapter 9
of
Overdosed America—
there still has never been a clinical trial showing that statins are beneficial to women of any age or men over sixty-five who do not already have heart disease or diabetes.

Dr. Jim Wright, the director of the Therapeutics Initiative of British Columbia, and I explained this in a commentary published in
The Lancet
in January 2007. And it’s not even as if there are no data about primary prevention in women. The results from almost 11,000 women without heart disease who participated in clinical trials of statins have been published. The benefit of statins in these 11,000 women? None.

“The results from almost 11,000 women without heart disease who participated in clinical trials of statins have been published. The benefit of statins in these 11,000 women? None.”

The take-away message has not changed: if you want to decrease your risk of heart disease the first things to do are exercise routinely, eat a healthy Mediterranean diet, don’t smoke, drink alcohol in moderation, maintain a healthy body weight, and control the stress in your life. The scientific evidence shows that each of these is more important than cholesterol levels for the vast majority of people. (This holds even for people for whom statins have shown a definite benefit—those who already have heart disease or diabetes, or men at greatly increased risk who don’t yet have heart disease.) Don’t allow yourself to be tricked by the drug companies into believing that lowering your cholesterol level with drugs is the primary way to prevent heart attacks. And don’t let your doctor get tricked into believing this and imposing it on you.

NEXIUM

After cholesterol-lowering drugs, Nexium and its cousins (Prevacid, Protonix, and Aciphex) remain one of the most frequently prescribed classes of drugs. These drugs now cost about five dollars per pill. There is little to no evidence that they are any more effective than over-the-counter Prilosec, which costs seventy-one cents per pill. Perhaps even more important, a recent study shows that taking these drugs for a year increases the risk of hip fracture by forty percent and even more with longer use. This probably happens as a result of decreased absorption of calcium from the stomach when these powerful drugs suppress acid. And there still hasn’t been a good study to determine how many of the people taking these drugs could switch down to less powerful acid-blocking drugs (like Zantac, Tagamet, and Axid—all available over the counter as generics), or even use old-fashioned antacids when needed.

CELEBREX

After the withdrawal of Vioxx and Bextra, Celebrex is the last of the COX-2 selective inhibiting anti-inflammatory drugs remaining on the market. Despite having been found to more than double the risk of cardiovascular complications compared to placebo (albeit at twice the dose recommended for the treatment of osteoarthritis), despite having been found by the FDA to be no less likely than other NSAIDs to cause serious stomach problems, and despite being no more effective at relieving arthritis symptoms and pain than older, less expensive anti-inflammatory drugs, Celebrex remains a blockbuster drug, with sales of about $2 billion in 2006.

FOOD AND DRUG ADMINISTRATION (FDA) OVERSIGHT OF DRUG SAFETY

As a result of the FDA’s questionable handling of drug safety issues such as Vioxx, investigations by two of our most trusted institutions were initiated. The Government Accountability Office (GAO) report, requested by Senator Charles Grassley (R-IA) and Representative Joe Barton (R-TX), was completed in March 2006. The FDA, according to the report,

lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues. The process has been limited by a lack of clarity about how decisions are made and about organizational roles, insufficient oversight by management, and data constraints.

“Despite being no more effective at relieving arthritis symptoms and pain than older, less expensive anti-inflammatory drugs, Celebrex remains a blockbuster drug, with sales of about $2 billion in 2006.”

The Institute of Medicine (IOM) report, undertaken at the request of the FDA, was issued six months later. The IOM found the FDA’s system of tracking post-approval safety issues “outdated and inefficient.” The IOM also called attention to the budget of the FDA division responsible for approving new drugs and overseeing drug safety. Half of this budget, according to the IOM, is paid for by the drug companies themselves, as a consequence of which the FDA’s reporting requirements

are excessively oriented toward supporting speed of [new drug] approval and insufficiently attentive to safety.

One would think these reports, along with the public’s eroding confidence in the FDA, would stimulate swift change. A front page article in the
Wall Street Journal
on March 3, 2007, shows just the opposite. Reporting on the FDA’s bungled attempt to update its system for tracking drug safety issues, the
Journal
article identifies the culture within the FDA as the “root cause” of the failure to improve drug safety monitoring. The executive director of the company that had been hired by the FDA to evaluate its attempt to improve its safety monitoring system told the
Journal
that the FDA asked him to “gut the report, and I refused to do it.” Hardly cause for optimism.

THE MIRAGE OF HEALTH
(1959), BY RENÉ DUBOS

This beautiful book has been drawing me back toward a holistic view of health and disease since I first read it in medical school. Dubos shows that health is rarely found in the latest and greatest drug or medical procedure. Rather, health and disease are far more often the natural consequence of the way that we live and the environment we live in.

THE STRUCTURE OF SCIENTIFIC REVOLUTIONS
(1962), BY THOMAS S. KUHN

A necessary step in becoming a scientific professional (such as a doctor) is, according to Kuhn, learning the unspoken rules about what kinds of information are legitimate and which sources of information are to be trusted. Kuhn dispels the illusion that science proceeds by the unbiased evaluation of all available facts leading to rational conclusions. He shows how scientists adhering to a given paradigm have learned instead to discount as not legitimate any information that is not consistent with the current paradigm. Kuhn’s work helps us understand how so many well-meaning doctors can be distracted by such a narrow swath of the scientific evidence—such as the focus on cholesterol instead of the real determinants of our risk of heart disease.

“[
The Mirage of Health
] has been drawing me back toward a holistic view of health and disease since I first read it in medical school.”

ONE-DIMENSIONAL MAN
(1964), BY HERBERT MARCUSE

Warning: this is a very difficult book, written by a brilliant social theorist thinking in German and writing in English. That said, more than forty years ago Marcuse articulated two fundamental tendencies of our liberal market-based society. First, people’s basic instincts are repressed by society’s “rules” (perceived as the boundaries of acceptable social behavior) and then released (“desublimated”) in ways specifically in accord with prevailing economic interests. Marcuse didn’t foresee the commercialization of medical knowledge, but his analysis still brilliantly informs many of the challenges that we face.

FAST FOOD NATION
(2001), BY ERIC SCHLOSSER

Fast Food Nation
is a must-read for two reasons. First, it explains the health and economic consequences of our transition to fast food as a major component of the American diet. Second, it is a masterpiece of critical writing, giving hope that powerful commercial interests can be confronted by writers with discipline, skill, and a clear mission.

“[
Fast Food Nation
] is a must-read . . . a masterpiece of critical writing.”

UNIVERSITIES IN THE MARKETPLACE
(2003), BY DEREK BOK

Written by a former president of Harvard University, this book explains how universities have relinquished their social responsibility as independent overseers of the integrity of the knowledge that drives our society. The problem is caused not just by the growing dependence of universities on commercial funding of their research (especially in medically related fields), but also by universities now being allowed to own patents on discoveries made by their researchers, creating financial incentives that conflict with impartiality.

ON THE TAKE
(2004), BY JEROME P. KASSIRER, M.D.

From his perch as the editor of
The New England Journal of Medicine
during the 1990s, Dr. Kassirer witnessed a lot of change. The book he wrote after stepping down focuses on the small percentage of doctors who are paid by the drug companies in return for public support of their products. Because doctors are carefully trained to obey the orders of those above them in the hierarchy of authority (much like the military), the endorsement of a company’s product(s) by a so-called key opinion leader translates into a lot of sales.
On the Take
is a particularly important book for practicing physicians because it explains how their trust in the tacit system of medical authority is being exploited.

DR. SUSAN LOVE’S MENOPAUSE AND HORMONE BOOK
(2003), BY SUSAN M. LOVE, M.D., WITH KAREN LINDSEY;
OUR BODIES, OURSELVES: MENOPAUSE
(2006), BY THE BOSTON WOMEN’S HEALTH BOOK COLLECTIVE

Given the politics and bad science involved with menopause, these books provide essential information for women by women.

HOOKED: ETHICS, THE MEDICAL PROFESSION, AND THE PHARMACEUTICAL INDUSTRY
(2007), BY HOWARD BRODY

Dr. Brody is a family physician and ethicist. Disclosure: since the publication of my book, we have become friends. That said, if after reading
Overdosed America
you want to learn more about how the drug companies influence what hardworking, patient-serving doctors believe to be the best way to treat their patients, this is the book for you.

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British drug authorities had mandated a similar warning:
Alan Cowell, “Second Thoughts on Restricting Drugs To Treat Depression in Adolescents,”
New York Times
, September 21, 2004.