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A computed tomography scan of a healthy heart shows the coronary artery running down the front. A scan showing calcium buildup in the artery could trigger treatment.
A computed tomography scan of a healthy heart shows the coronary artery running down the front. A scan showing calcium buildup in the artery could trigger treatment. (Globe File/ Dr. Vassilios Raptopoulo)

Article urging heart exams shows conflicting interests

Drug firm funded printing in journal

The recommendation carried the seal of approval of an established medical journal: virtually every middle-aged man and woman should be screened routinely for heart disease, using sophisticated and pricey technology to take snapshots of clogged vessels.

Usually, such a seismic shift in medical practice -- it would affect 50 million US adults and easily cost $25 billion or more -- emerges from a government agency or a major professional organization. But the guidelines that appeared earlier this month under the banner of The American Journal of Cardiology reflected the passions of a few dozen researchers.

The story of how the guidelines wound up in that journal illustrates how money and medicine intersect and opens a window into the arcane world of the medical publications that land on doctors' desks and influence the treatment patients receive.

The guidelines appeared in a supplement to the 30,000-circulation journal instead of in its regular pages, meaning that the recommendations, which even the authors concede are not supported by rock-solid evidence, were not subjected to the standard review process.

It also meant the authors had to pay to have their recommendations published. To raise the money, the physicians sent letters of appeal to a half-dozen major pharmaceutical companies, receiving $55,800 from the maker of the blockbuster cholesterol-lowering drug Lipitor, Pfizer Inc., which might benefit if more people are diagnosed with heart disease.

``The whole thing sounds like a conflicted mess, from the recommendations that they're making to the issue of how these journal supplements work," said Dr. Jerome P. Kassirer, top editor of The New England Journal of Medicine through most of the 1990s and an outspoken critic of the intrusion of financial interests into the scientific process.

Cardiovascular disease is the nation's number one cause of death, responsible for more than 900,000 deaths every year. Doctors call it the silent killer because, for many patients, a lethal heart attack or stroke is the first symptom.

``There's a sense of disappointment on everybody's part that we haven't managed to prevent cardiac disease better," said Dr. Pamela Douglas, chief of cardiovascular medicine at Duke University and an author of the new screening guidelines.

So Douglas and the 26 other authors of what they dubbed the Screening for Heart Attack Prevention and Education Task Force Report came up with what they describe as a better way.

It involves two screening tests that, they said, allow doctors to actually see evidence of cardiovascular disease, rather than depending, as doctors do now, on risk factors -- such as age, smoking history, and cholesterol levels -- to suggest there might be problems.

``We need something more than risk factors," said Dr. Victoria L.M. Herrera, a cardiology researcher at Boston University School of Medicine and another author of the guidelines. ``What we're putting forward is the monitoring of an actual disease, to catch it fast and early."

That monitoring would consist of one test showing calcium deposits in blood vessels of the heart and another charting the thickness of the carotid arteries, which carry blood to the brain. The calcium deposits would be identified using a computed tomography or CT scan, a method already widely used to detect a variety of ailments, including certain heart conditions. Blood flow to the brain would be determined using ultrasound technology.

One of the authors of the guidelines estimated that the CT scan would cost $100 to $400 a patient, while the ultrasound would run from $150 to $350. Insurance companies currently cover these tests under some conditions, but industry executives said they have no plans to pay for them on a routine basis.

The authors argue that the tests should become standard for men between ages 45 and 75 and women 55 to 75, much as many older Americans get screened for colon, breast, or prostate cancer. Doctors envision an initial screening with follow-up tests years later. For patients testing positive, physicians would develop treatments that could include surgery, medications, or changes in diet and exercise .

But it has not been proven that such screenings would actually catch more heart disease than is being diagnosed now. And there is concern that CT scans expose patients to radiation, and that one screening test can lead to further procedures, all of which might prove unnecessary.

``While it's certainly true that lots of people die from heart disease, what's not true is that having one of these tests is going to make you less likely to drop dead from heart disease," said Dr. Rita Redberg, a cardiologist at the University of California at San Francisco.

Doctors who wrote the guidelines acknowledged they lack definitive proof that the tests will work better than existing screening tools or that they will reduce the risk of suffering a heart attack, compared with current practice.

``Has that been proven? The answer is no. That needs to be proven," said Dr. P.K. Shah, director of cardiology at Cedars-Sinai Medical Center in Los Angeles and a leader of the task force that generated the recommendations. ``We are hoping this will stir up enough interest that we can get agencies that have the capacity to fund such a study to do a study."

That appears unlikely, at least for now, said Dr. Diane Bild, a medical officer at the National Heart, Lung, and Blood Institute, the logical agency to conduct such research. She said specialists there have already rejected the idea of a head-to-head study looking at how patients who received the high-tech screening fared long term, compared with those screened using more traditional methods.

The institute, Bild said, ``has a lot of competing priorities, and this type of study would be very expensive to conduct, and it just hasn't reached that level where we've gone forward with it."

Authors of the recommendations also got tired of waiting for the support of the American Heart Association and the American College of Cardiology. So, they drafted a document making the case for the tests and then asked The American Journal of Cardiology to publish it.

Journal editor Dr. William C. Roberts told the group that, in contrast to how it works in the regular pages of the magazine, if they wanted their recommendations published, they ``would have to have some financial support."

Dr. Morteza Naghavi, lead author of the guidelines, sent letters soliciting aid to six drug companies. In the letters, which Naghavi supplied to the Globe, he writes that ``the report will be distributed to 100,000 physicians worldwide."

``As a leader in the healthcare industry whose vision will shape the medicine of tomorrow, you are invited to contribute to this nonprofit academic effort," he writes.

Naghavi received a favorable response from Pfizer, whose funding of the report is noted in the journal. In an e-mailed answer to an inquiry from The Globe about its contribution, a company spokeswoman wrote that ``Pfizer feels it is important to provide support for efforts that assess novel approaches to reduce the burden of heart disease."

Naghavi defended taking the money from Pfizer to finance publication, as well as money from pharmaceutical companies to help underwrite the cost of a California meeting of the guideline's authors, including airfare, meals, and hotel rooms.

``It is not a Pfizer-driven guideline," Naghavi said. ``It is a guideline driven by frustration."

The American Journal of Cardiology isn't the only scientific periodical that publishes supplements. But standards for those supplements vary, including whether they're underwritten by industry money. The highest-tier journals, including The New England Journal and The Journal of the American Medical Association, do not publish such supplements or accept cash to print recommendations.

The Annals of Internal Medicine used to publish supplements but accepted outside funding to finance publication only if it came from an agency such as the US Centers for Disease Control and Prevention or a nonprofit foundation.

``If someone approached us and said, `We want to publish this supplement on hypertension, and it's funded by Pfizer,' we would say, `We don't do that,' " said Dr. Christine Laine, senior deputy editor of the Annals. ``Our readers would be naturally suspicious that that content is biased."

About 50 of the 500 journals published by Elsevier Inc., the company that produces The American Journal of Cardiology, have supplements, said Craig Smith, manager of Elsevier's supplement division. Those supplements, Smith said, are intended to showcase educational material, not present the type of groundbreaking research that appears in the regular pages. Because of that, they may not be reviewed by a panel of experts, as other research articles would be.

The existence of supplements is ``part of a much larger problem," said Dr. Arnold S. Relman, editor in chief of The New England Journal from 1977 to 1991. ``It's an example of the growing influence of marketing on the medical information that doctors get, which, in turn, influences what doctors prescribe."

Another facet of that influence is evident in the financial ties of doctors who draft journal articles. Two journals over the last two months, including the Journal of the American Medical Association, suffered black eyes to their reputation after disclosing that study authors had failed to report holdings in companies whose drugs they evaluated.

In an appendix to the heart-screening guidelines, several authors acknowledged that they had financial arrangements or affiliations with drug companies or medical device-makers whose products might be influenced by the recommendations.

Dr. John Rumberger, for instance, is part owner of a diagnostic center in suburban Columbus, Ohio, that specializes in cardiovascular imaging. He has been a proponent of high-tech heart screening for more than two decades and offers the coronary calcium scans at his office for $395 each.

``You believe in what you're doing, so there's nothing wrong in trying to sell what you're doing," said Rumberger, who has spent years fighting for the acceptance of heart screening.

The new guidelines, he said, were necessary to jolt the medical profession and prevent more heart attacks.

``It was time to put out a shock and say, `We need to rethink this,' " Rumberger said, ``rather than wake up in 20 years and say, `Damn, this coronary calcium test was just the thing.' "

To read the guidelines, go to www.ajconline.org/. Stephen Smith can be reached at stsmith@globe.com.

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