http://www.ahrp.org/COI/COI.html
Statin-Cholesterol Guidelines--Industry influenced?
"Of special note is that this study {ALLHAT} tested statins in
patients with higher risk of heart disease--because such patients had
generally shown a greater benefit from statins than do lower risk
patients--yet the outcome was negative."
Wed, 14 Jul 2004
Scientific journal editors are scrambling about how to react to bad
publicity emanating from public disclosure that the scientific reports
they have published are likely to be biased because the authors' had
financial ties to the companies whose drugs / devices they report on
favorably-and that information was withheld from readers.
A newly released survey by the Center for Science for the Public
Interest (CSPI) looked at articles that appeared during a 3 month
period--between December 2003 and February 2004--in four premier
scientific journals--the New England Journal of Medicine, the Journal
of the American Medical Association, Environmental Health Perspectives
and Toxicology and Applied Pharmacology--finding that even in these
journals, 8% of authors failed to disclose conflicts of interest.
Among the reports cited by CSPI whose authors failed to disclose their
financial conflicts: "Frank D. Kolodgie and Renu Virmani, two
scientists at the U.S. Armed Forces Institute of Pathology, failed to
disclose their consulting relationships with 20 companies in the
heart-disease treatment field in a December article in the New England
Journal of Medicine about the formation of plaque in coronary
arteries." [Ref. 1]
Inasmuch as biased science affects public health policies and misleads
treating physicians who may be unwittingly doing harm to patients, is
it not the responsibility of science journals to ensure that they
provide accurate, full information to readers?
Here are two modest recommendations: Journal editors should make an
effort to publish an update, listing articles whose authors failed to
disclose their financial ties to drug companies.
Furthermore, it is essential for journals to retract clinical trial
reports that were based on only partial--favorable-data. The results
are false and misleading, and may be leading physicians to prescribe
medications whose risks outweigh any benefits. [References 2]
The same day that CSPI's survey was reported in the press, the
journal, Circulation, published a report announcing new federally
endorsed recommendations for the treatment of heart disease--more
accurately, recommendations for the increased use of cholesterol
lowering drugs. The recommendations were made by a panel convened by
the National Cholesterol Education Program on the supposition that
they will prevent heart disease. The recommendations will dramatically
increase the use of statins to control cholesterol levels.
Statins sales for the current 26 million Americans taking them reach
$15 billion. The new recommendations will increase the number of users
to 36 million and increase sales to $20.8 billion.
The Wall Street Journal reports today, that the FDA is about to
approve Vytorin, a drug, "which packs two cholesterol fighters into
one pill. It combines Zetia, a cholesterol-blocker from
Schering-Plough Corp., with Merck & Co.'s Zocor, the
second-most-prescribed brand in the class of powerful drugs known as
statins: "Just as heart patients and their doctors are grappling with
updated government guidelines for dramatically lowering cholesterol, a
new drug is about to be approved that is sure to deepen the confusion
over choosing proper treatment." [Ref 3]
Since the NIH recommendations clearly provide statin drug
manufacturers with a mega-billion dollar profit enhancement-and the
rationale is controversial--isn't a bit of skepticism in order?
For starters, why has no one questioned the absence of financial
disclosure by the panel members that recommend the new guidelines?
Have editors of the journal Circulation not heard about disclosure
requirements? [Ref. 4]
Why have reporters failed to ask about possible financial conflicts of
interest that may have a bearing on these recommendations? [Ref. 5]
Why has no one in the mainstream media seen fit to inform the public
that there are scientists around the world who are skeptical about the
intensive statin-cholesterol push, calling it "massive hype" by
"Rent-A-Quote" Doctors? [Ref. 6]
Doesn't good science depend upon open debate?
The new recommendations were immediately endorsed by the National
Heart, Lung and Blood Institute (NHLBI); the American Heart
Association (AHA); and the American College of Cardiology (ACC). But
these institutions have a checkered record of endorsing expensive
treatments that were no better than cheaper ones, and potentially made
matters worse.
For example, the ALLHAT study conducted by NHLBI ("antihypertensive
and lipid lowering to prevent heart attack trial"😉 tested the
effectiveness of both antihypertensive and lipid treatments. It was
published in JAMA (2002) and is cited in the journal, Circulation. The
ALLHAT study was critically reviewed in the British Medical Journal
(2003), noting that in BOTH arms of this government sponsored study
neither expensive treatment endorsed by the AHA and ACC demonstrated
better results than cheaper treatments which proved safer. [Ref 7]
Indeed, a cheap diuretic proved safer and more effective against heart
attack than either expensive calcium channel blockers and ACE
inhibitors or lipid lowering statins which "showed no statistically
significant reduction in cardiovascular disease event rates or in
deaths."
Of special note is that this study tested statins in patients with
higher risk of heart disease--because such patients had generally
shown a greater benefit from statins than do lower risk patients--yet
the outcome was negative.
However, the negative ALLHAT study findings were never publicized and
the PR firm handling Pfizer's marketing of the expensive drug, of
Cardura, didn't challenge the findings because "The reality is no one
promotes a diuretic. So you've got one study that says yes, you should
[use a diuretic], then starting the day after, you've got a $10bn
[sic] industry. . . and 55 promotional events . . . for an ACE
inhibitor..." [Ref 7]
Incredibly, none of the journalists in the major media--including Gina
Kolata (NYT), Rob Stein (Wash Post), Ron Winslow (WSJ), among
others--saw fit to even mention the serious risks associated with
statins. These include: a potential increase in liver enzymes, muscle
aches, weakness, immune system suppression, an increase in cancer
risk, and a serious degenerative muscle tissue condition called
rhabdomyolysis-and the depletion of Q10, the co-enzyme for the
production of cellular energy.
What is Q10? Dr. Peter Langsjoen, an expert cardiologist who has done
original research into Q10, says this co-enzyme "is responsible for
over 80 per cent of energy and if you knock the level of this
essential nutrient down, nothing works as well. Those tissues and
organs that use a lot of energy are the first to be affected. The
heart, for example, uses a huge amount of juice and if you cut it back
with the use of a statin, what you start having first and foremost is
lack of energy -you start getting sluggish. So the clinical
consequences come about gradually and this weakening - fatigue,
getting winded when you're walking up the stairs.It's extremely
widespread. If you look for it, you'll see it in just about every
single new patient who has been on a statin." [Ref. 8]
Science journalists seem to have very short memories about universally
recommended preventive treatments that turned out to increase harm-the
hormone replacement therapy debacle seems to have taught them nothing.
The 2003 BMJ report uncovered evidence of Pfizer financial
largesse-not surprising, the beneficiaries were the endorsers of
Pfizer's high priced cholesterol lowering drugs. Even the NHLBI
investigators walked away from their negative study findings,
insisting: "we know [statins] work." Is this science or faith? The
NHLBI scientists went on to raise questions about their own
methodology.
But Dr. Marcia Angell noted that questions about study results should
be "hypothesis generating" and cannot be assumed as fact until they
are tested. She suggested that what's true of the ALLHAT drug study
"may be true of an awful lot of drugs. A lot of newer drugs may not
only not be better-they may be worse." The problem arises, Dr. Angell
said, because "most drug companies don't want a head to head [study].
And the FDA allows trials to run that are rigged where a drug is
tested against placebo or a drug of the same class that is
inadequately dosed, or they look at the wrong group of people or the
wrong endpoints so their drug looks good." [Ref. 7]
Why, then, have healthcare journalists who reported about statin-sales
boosting recommendations fail to raise questions about the risks of
statins, or to inform readers how much financial support / grants the
manufacturers of statins provide to the three institutions that
endorsed the recommendations?
Must we always have to wait for the British to publish reports that
raise serious questions about healthcare promotions? Must we wait for
the BMJ to investigate unacknowledged financial incentives that may
have persuaded those who promote the increased use of statins and
other expensive new drugs?
~~~~~~~~~~~~~~~~~~~~~
References:
1. THE WALL STREET JOURNAL. Research Conflicts Go Undisclosed Study
Says Medical Journals Don't Effectively Monitor Financial Ties of
Authors. By ROBERT TOMSHO, July 13, 2004; Page D3
http://online.wsj.com/article/0,,SB108967337655561782,00.html
2. British Medical Journal. Efficacy and safety of antidepressants for
children and Adolescents. Jon N Jureidini, et al. online free at:
http://bmj.bmjjournals.com/cgi/content/full/328/7444/879?
See: The Lancet. Selective serotonin reuptake inhibitors in childhood
depression: systematic review of published versus unpublished data.
Craig J Whittington, et al. Volume 363, Number 9418, April 24, 2004,
online free at: http://www.thelancet.com/journal/journal.isa
3. THE WALL STREET JOURNAL. New Option for Fighting Cholesterol FDA Is
Expected to Approve Pill That Mixes Two Drugs; What the Lower Target
Means By SCOTT HENSLEY , July 14, 2004; Page D1
4. NCEPAT Panel: Scott M. Gundy, James I Cleeman, Noel C Mertz, H.
Bryan Brewer, Luther T. Clark, Donald B. Hunninghage, Richard C.
Pasternak, Sidney C. Smith, Neil J. Stone,
5. The New York Times. Experts Set a Lower Low for Cholesterol Levels
By GINA KOLATA July 13, 2004, A-1.
http://www.nytimes.com/2004/07/13/health/13heart.html?hp=&pagewanted=print&position=
WASHINGTON POST. Lower Cholesterol Targets Urged By Rob Stein
http://www.washingtonpost.com/wp-dyn/articles/A44702-2004Jul12.html
THE WALL STREET JOURNAL. New, Lower Goal Is Set for Cholesterol
High-Risk Patients Are Urged to Consider Getting Their LDL Below 70 as
Opposed to 100 By RON WINSLOW July 13, 2004; Page D1
6. See articles and reports by members of The International Network of
Cholesterol Skeptics: "The International Network of Cholesterol
Skeptics (THINCS) is a steadily growing group of scientists,
physicians, other academicians and science writers from various
countries." http://www.thincs.org/Malcolm.htm
7. British Medical Journal. Spin doctors doctors soft pedal data on
antihypertensives. By Jeanne Lenzer, BMJ 2003;326:170 ( 18 January )
http://bmj.bmjjournals.com/cgi/content/full/326/7381/170/DC1
8. See: Nicholas Regush interview Dr. Peter Langsjoen, a pioneering
researcher and cardiologist who has brought considerable attention to
a mighty nutrient called "Co-Enzyme Q10" about the hazards of statins.
Langsjoen has been involved in some of the key original work showing
the link between Q10 depletion and heart disease. His concerns and
warnings about statin use come at a time when statin therapy is being
very aggressively promoted by the drug industry
http://redflagsweekly.com/RFD_Interviews/index.html
Contact: Vera Hassner Sharav
Tel: 212-595-8974
http://www.usatoday.com/news/health/2004-07-12-journal-conflicts_x.htm
Journals, authors cited for conflicts of interest
By Robert Davis, USA TODAY
Some leading scientific and medical journals do not always enforce
their conflict of interest policies with the authors of published
studies, according to a new report. The Center for Science in the
Public Interest found that in some cases the journals did not disclose
contributing authors' financial conflicts of interest even though the
journals' own rules require such disclosures.
"There is a consistent pattern here," says Merrill Goozner, CSPI
project director. "This is an unacceptable level, and the journals
need to take action."
The findings come amid growing concern over the influence that private
industry has on scientific research. For example, journal editors,
including those responsible for some of the content that was studied
by CSPI, are considering requiring drug companies to register all
clinical trials in a database for more accountability.
The study examined 163 articles in The New England Journal of
Medicine, TheJournal of the American Medical Association (JAMA),
Environmental Health Perspectives, and Toxicology and Applied
Pharmacology and found that the authors of 13 articles had relevant
conflicts of interest that were not reported to readers.
The most obvious conflicts were reported, such as when the research
was funded by a company that employs the author. But the CSPI
researchers found hidden conflicts in what Goozner calls "the
margins," in which there was no direct link, but the researcher stood
to benefit from the same industry.
One author of a study on heart disease, for instance, failed to reveal
relationships with 20 companies that made cardiovascular drugs or
devices. "This is important for the general public and the scientific
community because full disclosure gives you another piece of
information for evaluating these studies," Goozner says. "If you hide
the fact that there is a conflict of interest with the researcher,
then you are deceiving people."