Statins OVERSTATED if not High risk heart patient
- From: eml <mmlevy46@xxxxxxxxxxx>
- Date: Fri, 18 Jan 2008 18:03:35 -0800 (PST)
Not high risk heart patient? statins overstated
(page 1 and 2 of 6 page article from business week)
http://tinyurl.com/2spawz
Do Cholesterol Drugs Do Any Good?
Research suggests that, except among high-risk heart patients, the
benefits of statins such as Lipitor are overstated
By John Carey
This Issue
January 28, 2008
Lipitor
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Martin Winn's cholesterol level was inching up. Cycling up hills, he
felt chest pain that might have been angina. So he and his doctor
decided he should be on a cholesterol-lowering medication called a
statin. He was in good company. Such drugs are the best-selling
medicines in history, used by more than 13 million Americans and an
additional 12 million patients around the world, producing $27.8
billion in sales in 2006. Half of that went to Pfizer (PFE) for its
leading statin, Lipitor. Statins certainly performed as they should
for Winn, dropping his cholesterol level by 20%. "I assumed I'd get a
longer life," says the retired machinist in Vancouver, B.C., now 71.
But here the story takes a twist. Winn's doctor, James M. Wright, is
no ordinary family physician. A professor at the University of British
Columbia, he is also director of the government-funded Therapeutics
Initiative, whose purpose is to pore over the data on particular drugs
and figure out how well they work. Just as Winn started on his
treatment, Wright's team was analyzing evidence from years of trials
with statins and not liking what it found.
Yes, Wright saw, the drugs can be life-saving in patients who already
have suffered heart attacks, somewhat reducing the chances of a
recurrence that could lead to an early death. But Wright had a
surprise when he looked at the data for the majority of patients, like
Winn, who don't have heart disease. He found no benefit in people over
the age of 65, no matter how much their cholesterol declines, and no
benefit in women of any age. He did see a small reduction in the
number of heart attacks for middle-aged men taking statins in clinical
trials. But even for these men, there was no overall reduction in
total deaths or illnesses requiring hospitalization--despite big
reductions in "bad" cholesterol. "Most people are taking something
with no chance of benefit and a risk of harm," says Wright. Based on
the evidence, and the fact that Winn didn't actually have angina,
Wright changed his mind about treating him with statins--and Winn, too,
was persuaded. "Because there's no apparent benefit," he says, "I
don't take them anymore."
Wait a minute. Americans are bombarded with the message from doctors,
companies, and the media that high levels of bad cholesterol are the
ticket to an early grave and must be brought down. Statins, the
message continues, are the most potent weapons in that struggle. The
drugs are thought to be so essential that, according to the official
government guidelines from the National Cholesterol Education Program
(NCEP), 40 million Americans should be taking them. Some researchers
have even suggested--half-jokingly--that the medications should be put
in the water supply, like fluoride for teeth. Statins are sold by
Merck (MRK) (Mevacor and Zocor), AstraZeneca (AZN) (Crestor), and
Bristol-Myers Squibb (BMY) (Pravachol) in addition to Pfizer. And it's
almost impossible to avoid reminders from the industry that the drugs
are vital. A current TV and newspaper campaign by Pfizer, for
instance, stars artificial heart inventor and Lipitor user Dr. Robert
Jarvik. The printed ad proclaims that "Lipitor reduces the risk of
heart attack by 36%...in patients with multiple risk factors for heart
disease."
So how can anyone question the benefits of such a drug?
For one thing, many researchers harbor doubts about the need to drive
down cholesterol levels in the first place. Those doubts were
strengthened on Jan. 14, when Merck and Schering-Plough (SGP) revealed
results of a trial in which one popular cholesterol-lowering drug, a
statin, was fortified by another, Zetia, which operates by a different
mechanism. The combination did succeed in forcing down patients'
cholesterol further than with just the statin alone. But even with two
years of treatment, the further reductions brought no health benefit.
DOING THE MATH
The second crucial point is hiding in plain sight in Pfizer's own
Lipitor newspaper ad. The dramatic 36% figure has an asterisk. Read
the smaller type. It says: "That means in a large clinical study, 3%
of patients taking a sugar pill or placebo had a heart attack compared
to 2% of patients taking Lipitor."
Now do some simple math. The numbers in that sentence mean that for
every 100 people in the trial, which lasted 3 1/3 years, three people
on placebos and two people on Lipitor had heart attacks. The
difference credited to the drug? One fewer heart attack per 100
people. So to spare one person a heart attack, 100 people had to take
Lipitor for more than three years. The other 99 got no measurable
benefit. Or to put it in terms of a little-known but useful statistic,
the number needed to treat (or NNT) for one person to benefit is 100.
Compare that with, say, today's standard antibiotic therapy to
eradicate ulcer-causing H. pylori stomach bacteria. The NNT is 1.1.
Give the drugs to 11 people, and 10 will be cured.
A low NNT is the sort of effective response many patients expect from
the drugs they take. When Wright and others explain to patients
without prior heart disease that only 1 in 100 is likely to benefit
from taking statins for years, most are astonished. Many, like Winn,
choose to opt out.
Plus, there are reasons to believe the overall benefit for many
patients is even less than what the NNT score of 100 suggests. That
NNT was determined in an industry-sponsored trial using carefully
selected patients with multiple risk factors, which include high blood
pressure or smoking. In contrast, the only large clinical trial funded
by the government, rather than companies, found no statistically
significant benefit at all. And because clinical trials themselves
suffer from potential biases, results claiming small benefits are
always uncertain, says Dr. Nortin M. Hadler, professor of medicine at
the University of North Carolina at Chapel Hill and a longtime drug
industry critic. "Anything over an NNT of 50 is worse than a lottery
ticket; there may be no winners," he argues. Several recent scientific
papers peg the NNT for statins at 250 and up for lower-risk patients,
even if they take it for five years or more. "What if you put 250
people in a room and told them they would each pay $1,000 a year for a
drug they would have to take every day, that many would get diarrhea
and muscle pain, and that 249 would have no benefit? And that they
could do just as well by exercising? How many would take that?" asks
drug industry critic Dr. Jerome R. Hoffman, professor of clinical
medicine at the University of California at Los Angeles.
Drug companies and other statin proponents readily concede that the
number needed to treat is high. "As you calculated, the NNT does come
out to about 100 for this study," said Pfizer representatives in a
written response to questions. But statin promoters have several
counterarguments. First, they insist that a high NNT doesn't always
mean a drug shouldn't be widely used. After all, if millions of people
are taking statins, even the small benefit represented by an NNT over
100 would mean thousands of heart attacks are prevented.
That's a legitimate point, and it raises a tough question about health
policy. How much should we spend on preventative steps, such as the
use of statins or screening for prostate cancer, that end up
benefiting only a small percentage of people? "It's all about whether
we think the population is what matters, in which case we should all
be on statins, or the individual, in which case we should not be,"
says Dr. Peter Trewby, consultant physician at Darlington Memorial
Hospital in Britain. "What is of great value to the population can be
of little benefit to the individual." Think about buying a raffle
ticket for a community charity. It's for a good cause, but you are
unlikely to win the prize.
.
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