Do You Really Need That Statin? This Expert Says No
This is an interview with Barbara H. Roberts, M.D., author of The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs.
Statins are medications that lower cholesterol by inhibiting an
enzyme involved in its production by the liver and other organs. First
approved by the FDA in 1987, statins are arguably the most widely-prescribed medicine
in the industrialized world today — and the most profitable,
representing billions a year in profits to the drug industry. In fact,
Lipitor was the world’s best-selling drug
until its patent expired recently. Yet most trials that prove statins’
effectiveness in preventing cardiac events and death have been funded by
companies and principle investigators who stand to benefit from their
wide use. In February, the FDA warned that statins can increase users’ risk of Type 2 diabetes and memory loss, confusion and other cognition problems.
Barbara H.
Roberts, M.D., is director of the Women’s Cardiac Center at the Miriam
Hospital in Providence, R.I. and associate clinical professor of
medicine at the Alpert Medical School of Brown University. She spent two
years at the National Heart, Lung and Blood Institute of the National
Institutes of Health (NIH), where she was involved in the first clinical
trial that demonstrated a beneficial effect of lowering cholesterol on
the incidence of heart disease. In addition to The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs, she is also author of How to Keep From Breaking Your Heart: What Every Woman Needs to Know About Cardiovascular Disease.
Martha Rosenberg:
Statins have become so popular with adults middle-aged and older in
industrialized countries, they are almost a pharmaceutical rite of
passage. Yet you write in your new book there is little evidence they
are effective in many groups and no evidence they are effective in one
group: women without heart disease. Worse, you provide evidence,
including stories from your own patients, that they are doing serious
harm.
Barbara Roberts: Yes. Every week in my practice I
see patients with serious side effects to statins, and many did not need
to be treated with statins in the first place. These side effects range
from debilitating muscle and joint pain to transient global amnesia,
neuropathy, cognitive dysfunction, fatigue and muscle weakness. Most of
these symptoms subside or improve when they are taken off statins. There
is even growing evidence of a statin link to Lou Gehrig’s disease.
Martha Rosenberg:
One patient you write about caused a fire in her home by forgetting
that the stove was on. Another was a professor who experienced such
memory loss on a statin he could no longer teach; others ended up in
wheelchairs. The only thing more shocking than the side effects you
write about is the apparent blindness of the medical establishment to
them. Until half a year ago, there were practically no warnings at all.
Barbara Roberts:
There is no question that many doctors have swallowed the Kool-Aid. Big
Pharma has consistently exaggerated the benefits of statins and some
physicians used scare tactics so that patients are afraid that if they
go off the statins, they will have a heart attack immediately. Yet high
cholesterol, which the statins address, is a relatively weak risk factor
for developing atherosclerosis. For example, diabetes and smoking are
far more potent when it comes to increasing risk.
Martha Rosenberg:
One group you say should not be given statins at all because there is
no benefit and significant risk is women who have no heart disease.
Barbara Roberts:
In three major studies [1-3] of women without diagnosed heart disease,
but who were at high risk (in one of these studies, each participant had
to have high blood pressure and three other risk factors), 40 women out
of 4,904 on statins had either a heart attack or cardiac death,
compared to 44 women out of 4,836 on placebo. That is not a
statistically significant difference. Since the likelihood of
experiencing a statin side effect is about 20 to 25 percent,
the risk of putting a healthy woman on a statin far outweighs the
benefit. Still, statins are routinely given to this group because the
guidelines are shaped by Big Pharma. The guidelines are not supported by
the evidence, and in the case of healthy women I don’t follow them.
Martha Rosenberg:
You give a story in your book about your 92-year-old patient who had a
total cholesterol of 266, triglycerides of 169, HDL cholesterol of 66,
and LDL cholesterol of 165. Her primary care doctor wanted her to take a
statin, but you did not feel she needed to because she had no evidence
of heart disease, had never smoked, did not have high blood pressure and
was not diabetic.
Barbara Roberts: Yes and today she is 103.5 — and doing fine, never having taken a statin.
Martha Rosenberg: In The Truth About Statins you explain pretty clearly how studies have made statins look more effective and safer than they are. How has this been done?
Barbara Roberts:
First of all, the studies are of short duration, and some of them even
have a “run in” phase during which people are given the drug to see if
they tolerate it. If not, they are not enrolled in the study. Secondly,
study subjects are cherry-picked to exclude the very elderly, people
with liver or kidney disease or those with any chronic illness that
might “muddy” the results —
Martha Rosenberg: In other words, the very people who will be taking them?
Barbara Roberts:
Yes, and of course patients will also be staying on the drugs for life
unlike trial subjects. Then, the data from the studies are usually given
in terms of relative rather than absolute risk. The absolute risk of a
cardiac event is only reduced by a few percentage points by statins and
in some patients, like the women without heart disease we just talked
about, the reduction is not even statistically significant. In some
studies surrogate endpoints like inflammation or artery thickness are
used but a favorable change in surrogate markers does not always
translate into clinical benefit. In addition, many studies use composite
end points, which include not only “hard” end points like heart attack
or death (which are pretty hard to misdiagnose) but also “softer” end
points like the “need” for revascularization or the occurrence of acute
coronary syndromes. For example, studies may be performed in many
countries with very different rates of revascularization procedures,
making use of this as an end point very problematic.
Martha Rosenberg: This brings to mind the JUPITER trial,
which enrolled people without heart disease, with normal levels (less
than 130) of LDL or bad cholesterol, but evidence of increased
inflammation as measured by the hsCRP test and treated them with placebo
or rosuvastatin. JUPITER stood for “Justification for the Use of
Statins in Prevention,” and both the study and its principle
investigator were funded by AstraZeneca, who makes the statin Crestor.
The principal investigator also holds the patent for the hsCRP blood
test. Why was JUPITER regarded as medical science and not marketing?
Barbara Roberts:
Actually, the JUPITER study was criticized to some extent. But you have
to remember that medical journals depend upon Big Pharma for their ads
and reprint orders just as medical centers and medical professionals
rely on Big Pharma for funding. It is a round robin situation that
probably won’t change until the patients, doctors and the public demand
change. As for CRP, it can also rise if a patient has a cold, bronchitis
or is taking post-menopausal hormones.
Martha Rosenberg: You
are very outspoken about the problem of industry shaping and
influencing medical practice, yet you also admit that you accepted Big
Pharma money yourself.
Barbara Roberts:
In 2004, Pfizer asked me to become a speaker, specifically on Lipitor.
I told the drug rep who invited me to be a speaker that I would be
interested in giving talks on gender-specific aspects of cardiac
disease, but not in just talking about their statin, and I gave lectures
in restaurants and hospitals. Despite the fact that Pfizer was
sponsoring my talks, I never failed to point out that there was no
evidence that Lipitor — or any statin — prevented cardiac events in
women who did not have established cardiovascular disease. They
tolerated this until one day a regional manager came to one of my talks,
and then I was disinvited. I was on the speaker’s bureau for another
company, Abbott, but when they began to insist that I use their slides
rather than my own, I gave up being on any Big Pharma speaker’s bureaus.
I write in my book that even though my interactions with drug and
device companies complied with ethical guidelines it does not mean I was
not influenced.
Martha Rosenberg:
In journalism, when a reporter takes money from someone she is writing
about, she is regarded as no longer a reporter but a publicist. Yet
doctors who consult to Pharma are not judged as harshly and most contend
they are not influenced by industry money...
Barbara Roberts: They are wrong. An article in the American Journal of Bioethics in 2003
found that gifts bestow a sense of indebtedness and influence behavior
whether or not the recipient is directly conscious of it. More recently,
research presented at a symposium
at Houston’s Baylor College of Medicine called the Scientific Basis of
Influence and Reciprocity mapped actual changes in the brain when gifts
are received.
Martha Rosenberg:
I was surprised to find recipes in your book and even more surprised by
some of your dietary recommendations, such as avoiding a low-fat diet
and eating a lot of olive oil. A lot of experts have recommended a
low-fat diet.
Barbara Roberts: The
first thing I prescribe to my patients who have low levels of the
“good” or HDL cholesterol is two to three tablespoons of olive oil a
day, and in every case the HDL increases. Olive oil is rich in
polyphenols, which have anti-inflammatory and antioxidant effects.
Several studies [4-5] have shown that the Mediterranean diet reduces
total mortality and especially death from cardiovascular disease, yet it
gets little media attention. The Mediterranean diet is a plant-based
diet that includes colorful vegetables, fruits, whole grains, beans,
cheese, nuts, olive oil, seafood, red wine with meals, and very little
meat.
Martha Rosenberg:
You indict professional medical associations like the American Heat
Association (AHA) for profiteering at the public’s expense by calling
harmful foods healthful in exchange for corporate money.
Barbara Roberts:
For years, the AHA preached the gospel of the low-fat diet, calling it
the “cornerstone” of its dietary recommendations though there was, and
is, no evidence of its benefit. The AHA rakes in millions from food
corporations for the use of its “heart-check mark.” Some of the
so-called heart-healthy foods it has endorsed include Boar’s Head All
Natural Ham, which contains 340 milligrams of sodium in a two-ounce
serving, and Boar’s Head EverRoast Oven Roasted Chicken Breast, which
contains 440 milligrams of sodium in a two-ounce serving. High sodium
intake raises blood pressure, which increases the risk of cardiovascular
disease. In addition, studies have shown that eating processed meat increases the risk of diabetes and atherosclerosis.
Martha Rosenberg:
You are not afraid to express strong opinions. You say that the AHA has
“sold its soul,” that medical centers conducting drug trials for Big
Pharma have become “hired hands” and that one university medical center
is Big Pharma’s “lapdog.” Are you afraid of retaliation from Big Pharma,
medical centers or the colleagues you work with?
Barbara Roberts: I
haven’t received any communiqués from Big Pharma. A few colleagues have
expressed dismay, but I am thick-skinned and hard-headed and don’t care
what they say. My main concern is the health and safety of my patients.
References:
1. http://circ.ahajournals.org/content/121/9/1069.short
2. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(03)12948-0/abstract
3. http://fundacionconfiar.com.ar/capacitacion/Clase_5/Levels%20Results%20of%20AFCAPSTexCAPS.pdf
4. http://www.ncbi.nlm.nih.gov/pubmed/9989963
5. http://www.ncbi.nlm.nih.gov/pubmed/18071168
2. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(03)12948-0/abstract
3. http://fundacionconfiar.com.ar/capacitacion/Clase_5/Levels%20Results%20of%20AFCAPSTexCAPS.pdf
4. http://www.ncbi.nlm.nih.gov/pubmed/9989963
5. http://www.ncbi.nlm.nih.gov/pubmed/18071168
For more by Martha Rosenberg, click here.
For more on health news, click here.
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