Healthy Skepticism Library item: 5736

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Publication type: news

Smith S.
Article urging heart exams shows conflicting interests : Drug firm funded printing in journal
Boston Globe 2006 Jul 25
http://www.boston.com/yourlife/health/diseases/articles/2006/07/25/article_urging_heart_exams_shows_conflicting_interests/

Notes:

Ralph Faggotter’s Comments:

Beware being bamboozled by expensive hi-tech gadgetry which has potentially fatal side effects (in this case due to radiation from CT scans).
The presently accepted, relatively cheap and effective, low-tech, targeted investigations for coronary heart disease are being muscled aside in favour of this expensive and often inappropriately promoted and used ‘Calcium Scoring’ technology in a process which lokks suspiciously like ‘investigation mongering’.

Full text:

Article urging heart exams shows conflicting interests
Drug firm funded printing in journal

By Stephen Smith, Globe Staff | July 25, 2006

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.’ “