Overdosed America (26 page)

With sales lagging so far behind projections, Eli Lilly did the only reasonable thing: it fired the public relations firm that had been in charge of the Xigris account and looked for a new one that could do a better job. According to the
Wall Street Journal,
the winning proposal was titled “The Ethics, the Urgency, and the Potential.” The new campaign would focus the public’s attention not on the merits of the drug itself but on a word that evokes terror and anger in most Americans when it comes to health care: rationing.

In an article titled “To Sell Pricey Drug, Eli Lilly Fuels a Debate Over Rationing,” the
Wall Street Journal
reported that Eli Lilly’s new
PR firm developed a strategy
to convince the public that use of Xigris was being unethically withheld from critically ill patients. Eli Lilly then committed $1.8 million to fund, according to the
Boston Globe,
a task force
charged with developing “national guidelines
for the rationing of expensive intensive-care unit treatment—and to get doctors to openly admit they withhold care from patients who would benefit the least.”

No doubt the critical care doctors on this task force are seeking a legitimate forum in which to develop guidelines to help health professionals with the often agonizing ethical dilemmas that routinely arise in the care of critically ill patients. And no doubt the task force’s report will merit very careful attention for its suggestions about the most responsible and ethical ways to approach these problems. But Eli Lilly’s largesse has another goal as well. The task force’s report and guidelines are at high risk of falling prey to a public relations clamor about the rationing of medical care for critically ill patients, with underuse of Xigris woven seamlessly into the “debate.” One could easily see the case for Xigris developing as an extension of the patients’ rights issue—inappropriately withholding potentially lifesaving drugs from critically ill patients. Rational public debate about the use of Xigris will be at risk of getting drowned out by the public’s emotional response to news reports about de facto rationing. If this happens, the public relations campaign will almost certainly have succeeded in its primary goal of increasing sales of Xigris. Besides, only 265 additional patients have to be treated with Xigris to cover the cost of the ethics task force.

Commercially sponsored public relations campaigns also use nonprofit organizations very effectively to get their message out. Consider the story of social anxiety disorder, or SAD. An investigative article in
Mother Jones
by Brendan Koerner tells the story of how this “disease” was virtually created to sell the cure. According to the psychiatric diagnostic manual, SAD is (or, probably more accurately, was) an “extremely rare” condition. Nonetheless, SmithKline Beecham, the
manufacturer of the antidepressant Paxil, hired a PR firm
to coordinate a broadly targeted educational campaign about the “disease” through three nonprofit organizations: the American Psychiatric Association, the Anxiety Disorders Association of American, and Freedom From Fear. Within a month after the FDA’s approval of Paxil for the treatment of SAD, articles about this “underdiagnosed illness” appeared in the
New York Times
and
Vogue
magazine. The PR campaign was deemed such a success that it earned recognition as the “Best P.R. Program of 1999” by the New York chapter of the Public Relations Society of America. Not surprisingly, Paxil sales increased by 25 percent between 1999 and 2000.

When for-profit money gets cycled through nonprofit organizations, especially trusted service and professional organizations, the commercial goals of the donors become nearly invisible.

Have you ever noticed how much good news about medical progress is on television and in newspapers? With this constant stream of breakthroughs, you would think that by now we would have cured all diseases known to humanity two or three times over.

The narrative is familiar: A medical problem is described; one or more patients suffering from the disease are introduced with whom the viewer or reader can readily identify; experts are interviewed to explain why the discovery or procedure is a breakthrough in terms readily understandable to the public; and the story concludes with a calculation of how many people can be helped by this latest discovery. Temporizing opinions are often included for balance, but the criticism is rarely enough to quash the excitement. Our underlying faith that medical science is progressing in its battle against suffering and death is confirmed. The medium that brought us the message has successfully captured our attention. And the interests of the advertisers are supported by this rosy narrative. All at the same time.

A good example was provided by the press coverage that followed the publication of a 2002 article in the
New England Journal of Medicine:
Researchers concluded that an inexpensive test that measures the level of inflammation in the body, C-reactive protein, or
CRP, can predict a person’s risk of developing cardiovascular disease
(heart attack, ischemic stroke, coronary revascularization, or cardiovascular death) even better than cholesterol levels. The
New England Journal of Medicine
reported that among 28,000 women followed over eight years, the 20 percent with the highest CRP levels were 2.3 times more likely to develop cardiovascular disease than were the 20 percent with the lowest levels. The researchers also concluded that much of this risk would not have been identified by measuring cholesterol levels alone. Finally, according to the article’s authors, identifying people with elevated CRP levels would allow “optimal targeting of statin therapy.” In other words, people with high levels of CRP would be well advised to take statins to decrease their risk of cardiovascular disease.

According to my nonrandom sample, three major newspapers (
the
Boston Globe,
the
New York Times,
and
the
Washington Post
)
and two newsmagazines (
Time
and
Newsweek
) each carried a story about the potential benefit of the new CRP test. Without exception, the stories were enthusiastic: “groundbreaking,” “the most promising advance in a long time,” “paradigm-shaking,” “extremely important,” and “a home run” were among the accolades. It is safe to assume that much of the reading public concluded that this was an important medical breakthrough and requested CRP tests from their doctors.

What’s wrong with this story? The research was spun to make a very small diagnostic improvement look like an important medical “breakthrough” and in the process distract attention from the things that can be easily done to decrease the risk of cardiovascular disease.

The NEJM article reported that the women with the highest CRP levels had 2.3 times more risk of developing cardiovascular disease than the women with the lowest levels. That sounds like a lot. But this is the
relative
risk; comparison of the ratio of the low risk of disease in one group to the even lower risk of disease in another can make very small differences seem very big. The women in this study were quite healthy, and their average age was less than 55, so their underlying risk of suffering heart attacks, strokes, or blocked arteries was quite small. For example, among 1000 women with the highest CRP levels, there was
only slightly more than one (1.3) additional episode
of cardiovascular disease each year than among 1000 women with the lowest CRP levels. All five publications reported that women with elevated CRP levels had double the (relative) risk of cardiovascular disease, but only the
Washington Post
mentioned anything about absolute risk, reporting that the increase was “very small.” With all the talk about “most promising advance in a long time” and “home runs,” readers had few clues that the dramatic-sounding relative risk translated into a minimal absolute risk of about 1 in a 1000.

Nonetheless, concern about even this level of risk is not unreasonable. So how much would statin therapy help? An article by the same group of researchers published in JAMA in 2001 showed that a daily dose of 40 mg of Pravachol significantly reduced CRP levels. But remember: reduction of CRP is a surrogate end point (not clinically important in and of itself), and statins have never been shown in randomized clinical trials to significantly reduce the risk of cardiovascular disease in women without heart disease. Nonetheless, assuming (very generously, because no benefit has yet been proven) that taking Pravachol could decrease the risk of cardiovascular disease in women with higher CRP levels by 40 percent,
less than one episode of cardiovascular disease
per 1000 women would be prevented each year. Forty milligrams of Pravachol per day cost about $1650 per year. This works out to $2 million (in drugs alone, not counting the extra lab tests and doctor visits) to prevent a single episode of cardiovascular disease among healthy women with elevated CRP levels—if in fact Pravachol has any benefit at all. You don’t have to be a doctor to understand that there might be better ways to spend that much money on 1000 women over the course of a year to improve their health and the quality of their lives.

What’s the harm in all this excitement about something that may not be a real breakthrough? The hype creates false hope that moves us further away from real prevention, most of which has to do with a healthy lifestyle, and drains resources needlessly from far more effective health interventions.

Is the reporting of the CRP story typical? Unfortunately it is. A study of
207 medical news stories on television
and in newspapers shows that fewer than one in 10 presented data on absolute risk reduction and only three out of 10 mentioned cost. Only four out of 10 disclosed the financial ties of “experts” to the products they were presenting or discussing. How many times have you ever heard a researcher who worked on a drug company–sponsored study express a negative or even ambivalent opinion in an interview? There is a reason why drug companies establish financial ties with experts. Interviews of these enthusiastic authorities are often better described as infomercials than dispassionate science reporting.

Why the tendency for the media to present medical research in such hyperbolic and uncritical terms? People like to read good news more than bad, and they like to hear about progress and hope. There is another reason, too, though it is an impolite subject.
Gloria Steinem
, founding editor of
Ms.
magazine, stated it quite succinctly: “You don’t get product ads unless you praise the product.”

With advertising of prescription drugs and other medical products having emerged as a major source of revenue for all media (especially television—the greatest source of people’s health information), the pressure to have news content that supports or at least does not directly oppose advertisers’ interests has grown. And therein lies the Achilles’ heel of the media when it comes to medical reporting. Even if medical reporters had the scientific and statistical expertise to cut through commercial spin (an unfair expectation, given that it involves untangling the work of the medical industry’s best and brightest), could they report the truth and stay in business? Unlikely.

The public needs access to independent expert opinion that can counterbalance the enormous influence that the medical industry wields over our beliefs about the best approach to health and medical care. Unfortunately, with rare exceptions (Center for Medical Consumers, the University of British Columbia Therapeutics Initiative, and Public Citizen’s worstpills.org are examples of unbiased sources of information), we are left with medical reporting that is handicapped by a structural disadvantage: the public’s interest gets overwhelmed by the financial resources, political influence, and marketing expertise of the drug industry. As a result, the public often gets commercially biased medical news, and is left more vulnerable than ever to the explicit appeals of advertisers and the subtle persuasion of public relations campaigns.

The successful mass marketing of drugs, tests, and procedures to American consumers—regardless of their true health value—explains a great deal about how the myth of excellence in American medicine is sustained. While there certainly have been many real breakthroughs in research and practice, it turns out that most of the medical news, especially the commercially advantageous news, is too good to be true. Americans, as patients, consumers, and taxpayers, are paying an enormous price for that deception.

Mr. and Mrs.
Wilkins had planned carefully for their retirement. Well into their eighties, they were spending their winters in Florida and the rest of the year in their home about a mile from my office. Besides Mr. Wilkins’ prostate cancer, which was under control, they both enjoyed good health. But one winter, Mr. Wilkins suffered a heart attack.

While he was still in the hospital, his cardiologist recommended that he undergo cardiac catheterization. This is a diagnostic test commonly done after a heart attack to look for blockages in the coronary arteries. The test involves injecting dye into each of the coronary arteries through a small tube, or catheter, so that blood flow can be assessed on x-ray pictures. The test showed that two of Mr. Wilkins’ coronary arteries were partially blocked, and the blockages were too far into the arteries and too diffuse to be opened by a balloon-tipped catheter (a procedure known as angioplasty). So Mr. Wilkins underwent coronary artery bypass surgery to decrease the risk of these arteries becoming completely blocked and causing another heart attack. The surgery involves taking a vein from the leg and attaching it to vessels that bring blood to the heart, providing a “bypass” around the obstructed areas.

Mr. Wilkins came through the surgery without a problem, but over the next few days, pain and redness developed in the area around the incision, and he started to run a low-grade fever. It soon became obvious that an infection had developed in his sternum, where the surgeon had cut through the bone on his way to repair the coronary arteries. The surgeon partially reopened the incision to let the infection drain out and put Mr. Wilkins on antibiotics.