HEALTH CARE : Do Cholesterol Drugs Do Any Good?
Statins: Looking at the stats
By Duncan Echelson / The Rag Blog / July 14, 2008
Statin pharmaceuticals are marketed ferociously on TV ads and by many MD's. The statins are major money makers for the pharmaceutical companies. For relatively small groups of specific types of patients the real research shows some benefit but for most of the patients taking statins it is based on conjecture, not research.
Not only is there no proven benefit for many of the people taking
statins, there are some rather significant side effects such as severe
muscle pain, memory loss and sexual dysfunction.
There are more than 18 million Americans taking statins and worldwide sales totaled more than 33 billion dollars in 2007.
The history of statins and cholesterol theory make a very interesting
case study of the pharmaceutical and medical industries and is well
worth studying, in order to learn how we can avoid being manipulated
for power and profit.
Just as interesting is learning how medical science can be led into
taking positions that are based on political maneuvering and sloppy
data analysis rather than science.
You might be one of the 18 million people taking statins and if not, I
am sure that you know people who are (friends, siblings, parents). If
so, then please read the series of pieces so you can ask questions,
find answers and make decisions as to whether taking statins is really
a benefit or if it is a danger waste of your health dollars and
efforts.
For step one, in our investigation, I offer you a very well written and referenced article from the Jan. 17, 2008 issue of Business Week magazine. Please note this is only step one of a series of articles and documents to help us understand. The source of this article is surprising but I guarantee you will find it very interesting.
Duncan Echelson is a licensed Acupuncturist/Herbalist who can be found at Oak Hill Oriental Medicine in Austin. His focus is helping people become healthier. He particularly enjoys teaching people simple ways to maintain and improve their health.Do Cholesterol Drugs Do Any Good?
He has great respect for those physicians who truly live by the Hippocratic oath and for those researchers who are dedicated to understanding their study subjects without fear or favor.
In addition, he knows of many cases where the judicious use of pharmaceuticals and medical procedures have been very important for treating disease and trauma.
It is the misuse of pharmaceuticals, medical techniques, and research studies that he finds deeply offensive and drives him to keep up with news and analysis of these fields.
He welcomes comments, favorable or critical. Leads to stories in medicine and pharmaceutical are also welcome.
You can reach him at duncanechelson@gmail.com.
Research suggests that, except among high-risk heart patients, the benefits of statins such as Lipitor are overstated
By John Carey
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.
Statin proponents also argue that when NNTs are calculated after the drugs have been taken for just three or five years, they're misleadingly high. Pfizer says that even though only one heart attack was prevented per 100 people in its trial, "it may be a possibility that several or even all [100] benefit" by reducing their risk of a future heart attack. And the benefit grows when the drugs are taken for more years, backers believe. "It does not make sense to take a statin for five years," says Dr. Scott M. Grundy, chair of the NCEP committee that called for more aggressive statin treatment and director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center at Dallas. "When you take a cholesterol-lowering drug, it is a huge commitment," he says. "You take it for life." Grundy figures the chances of having a heart attack over the course of a lifetime are about 30% to 50% (higher for men than women). Statins, he argues, reduce that risk by about 30%. As a result, taking the drugs for 30 years or more would bring 9 to 15 fewer heart attacks for every 100 people. So only 7 to 11 people would have to take the drugs for life for one to benefit.
Critics reply that this rosier picture requires several leaps of faith. A 30% reduction in heart attacks "is the best-case scenario and not found in many of the studies," says Wright. What's more, statins have been in use now for 20 years, and there's little evidence yet that the NNT decreases the longer people take the drug. Most important, the statin trials of people without existing heart disease showed no reduction in deaths or serious health events, despite the small drop in heart attacks. "We should tell patients that the reduced cardiovascular risk will be replaced by other serious illnesses," says Dr. John Abramson, clinical instructor at Harvard Medical School and author of Overdosed America.
Read the rest of this article here. / Business Week
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