Re: do cholesterol drugs do any good? article from business week

[Guest guest]

Wonderful article. I have saved all 6 pages. Thank-you very much for

posting it.

phine

>

> 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 Carey

>

> This Issue

> January 28, 2008

>

> Lipitor

> Previous IssueNext Issue

> Related Items

> Podcast: Beyond the Cover

> In the Real World, a Slew of Side Effects from Statins

> False Promises on Alzheimer's

>

>

>

[Guest guest]

we should all forward this article to our doctors and our

representatives to show what a farce the FDA is.

ed

>

> 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 Carey

>

> This Issue

> January 28, 2008

>

> Lipitor

> Previous IssueNext Issue

> Related Items

> Podcast: Beyond the Cover

> In the Real World, a Slew of Side Effects from Statins

> False Promises on Alzheimer's

>

>

>

>

> 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, M.

> , 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, 's team was analyzing

> evidence from years of trials with statins and not liking what it

> found.

>

> Yes, 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 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 . Based on the evidence, and the fact that Winn

> didn't actually have angina, 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. 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 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. 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.

>

[Guest guest]

I like the very last sentence,

Not until the country changes the incentives in health care, says

UCLA's Hoffman. " The way our health-care system runs, it is not based

on data, it is based on what makes money. "

what that last sentence means to me is that the disease of high

cholesterol was invented to help the drug companies make money.

phine

>

> we should all forward this article to our doctors and our

> representatives to show what a farce the FDA is.

>

> ed

>

>

>