Hold the statins, stat!

 Article taken from pages 10-11 of the January/February Newsletter 2014

By Adriane Fugh-Berman and Charlea Massion

New guidelines released in November 2013 by the American Heart Association (AHA) and the American College of Cardiology (ACC) advised preventing heart attacks by treating cardiovascular risk factors instead of high cholesterol. Seemed like a good idea at first. It turns out, though, that the new guidelines will double the number of people eligible for statins — just one more way for pharmaceutical companies to expand the market to more people who don’t need drugs.

More and more people have become eligible for treatment with cholesterol-lowering medications, especially statins, over the last 25 years. The new guidelines recommend statin use for 33 million Americans — twice as many as were eligible under previous guidelines.1 The new categories of patients for whom statins are recommended include anyone with heart disease, all type 2 diabetics aged 40 to 75, people with LDL cholesterol (low-density lipoprotein, the “bad” cholesterol) above 190, and anyone aged 40 to 75 with a 7.5% or greater risk of developing heart disease in the next decade (as calculated by age, cholesterol levels, blood pressure, and family history of heart attack).

OK, we completely agree that anyone who has already had a heart attack, or whose LDL is over 190, should be on a statin. And many diabetics (especially those with multiple risk factors) should also be on a statin. Where we come to a full stop (Whoa, Nellie!) is with the 7.5% group. The recommendation isn’t targeted at people with a 7.5% risk of dying, or even having a heart attack; it’s a low-risk group with a 7.5% risk of developing heart disease in the next 10 years — people who shouldn’t be on medication at all. Previous U.S. guidelines advocated statins for people with a 20% risk of developing heart disease in the next decade. (In the U.K., it used to be 30%).2 Those seem like more sensible numbers to us.

There’s no rationale for lowering the threshold for treatment to 7.5%. First, of all, there’s no evidence that drug treatment for this group reduces deaths, or even serious illness.3, Second, drugs have risks and, when you give low-risk people a potent drug, the harms quickly outweigh the benefits.

Statins are not benign. In a group of low-risk individuals who have less than 10% risk of developing heart disease in the next decade, 140 people will have to be treated for 5 years to prevent 1 serious cardiovascular event — but about 1 in 5 will develop a drug-induced side effect5 such as diabetes, decreased cognitive function, cataracts, muscle pain or weakness, and sexual dysfunction. Women may be even more likely than men to develop diabetes.6

It gets worse. The AHA and ACC’s proposed risk calculator is flawed: researchers who tested it in studies of populations who have known risks (including the Nurse’s Health Study and the Women’s Health Initiative observational study) found that it mistakenly doubled the number of people at risk!7

According to the World Health Organization, smoking, unhealthy diet, and a lack of exercise account for 80% of cardiovascular disease.8 Giving up smoking is the number one best thing you can do for your cardiovascular health — so do whatever you need to do to quit. If you have Type II diabetes, high cholesterol, high blood pressure, or immediate family members with heart problems, exercising and eating a healthy diet may help reduce your risks. According to a systematic review of 44 trials with more than 18,000 participants, just having doctors give their patients dietary advice can lower rates of both cholesterol and blood pressure.9

If drugs are needed, they should be appropriate to the patient’s condition: someone with high blood pressure and low cholesterol should have their blood pressure treated, not their cholesterol! If you’ve had a heart attack, or have above a 20% or 30% chance of developing heart disease in the next decade, take a statin. But, if your risk of developing heart disease is less than 20%, drug therapy is likely to do more harm than good.

Again, we support treating patients to reduce risk of heart attack instead of just lowering their cholesterol levels. What we’re against is treating healthy, low-risk people with powerful drugs with serious side effects. The guidelines have been controversial, and we support the researchers who want them withdrawn. Back to the drawing board — and, this time, limit the committee to people without any conflicts of interest!

The group that created the recent guidelines is rife with conflicts of interest. Although the AHA and ACC are legitimate medical societies, both take industry money. One of the panel’s two co-chairs, six of fifteen panel members, and half of the ten expert reviewers have conflicts of interest with pharmaceutical manufacturers that make or plan to release cholesterol medications.10 The committee chair had relationships with six statin manufacturers when he was asked to take on the job. And, although he dropped those connections before assuming the chair’s position in 2008, he failed to disclose his recent conflicts of interest in forms he filled out from 2008 to 2012.11

Statins and other cholesterol-lowering drugs are big sellers. Crestor (rosuvastatin), the only statin still on-patent, made more than $5 billion for Astra-Zeneca last year. It’s a mistake to assume that manufacturers of drugs that have gone generic are not still promoting their drugs. Lipitor (atorvastatin), once the best–selling drug in the world, is off-patent but made a respectable $2.3 billion in 2012.12 Many new cholesterol drugs are coming down the pike. Keep your guard up!

References


1. Cortez MF, “Cholesterol Guideline Changes Double Number on Treatments,” Bloomberg News. November 13, 2013. Available online at: http://www.bloomberg.com/news/2013-11-12/cholesterol-guideline-changes-d….

2. Harris SA, “Millions More Could be Prescribed Statins, but Expert Hails Benefits Over Side Effects,” Express UK, November 14, 2013. Available online at:http://www.express.co.uk/news/health/443033/Millions-more-could-be-prescribed-statins-but-expert-hails-benefits-over-side-effects.

3. Abramson JD, Rosenberg HG, Jewell N, et al., “Should People at Low Risk of Cardiovascular Disease Take a Statin?” BMJ 2013; 347:f6123. doi: 10.1136/bmj.f6123. See also Redberg RF, Katz MH, “Reassessing benefits and risks of statins,” NEJM 2012; 367:776.

4. Abramson JD, Redberg RF, “Don’t Give More Patients Statins,” New York Times, November 13, 2013. Available online at: http://www.nytimes.com/2013/11/14/opinion/dont-give-more-patients-statins.html?_r=0; Carter AA, Gomes T, Camacho X, et al., “Risk of Incident Diabetes Among Patients Treated with Statins: Population-based Study,” BMJ 2013; 346:f2610; Leuschen J, Mortensen EM, Frei CR, et al., “Association of Statin Use with Cataracts: a Propensity Score-Matched Analysis,” JAMA Ophthalmol. 2013;131(11): 1427-34.

5. Abramson JD, Rosenberg HG, Jewell N, et al., “Should People at Low Risk of Cardiovascular Disease Take a Statin?” BMJ 2013; 347:f6123. doi: 10.1136/bmj.f6123.

6.  Abramson JD, Redberg RF. Don’t Give More Patients Statins. New York Times November 13, 2013. http://www.nytimes.com/2013/11/14/opinion/dont-give-more-patients-statin….

7.  Ridker P, Cook N, “Statins: New American Guidelines for Prevention of Cardiovascular Disease,” Lancet 2013 (Nov 19). Available online at: http://dx.doi.org/10.1016/S0140-6736(13)62388-0.

8.  World Health Organization, (WHO), Global Status Report on Non-communicable Diseases, Geneva: WHO, 2010. Available online at: http://www.who.int/nmh/publications/ncd_report2010/en/http://www.who.int….

9.  Rees K, Dyakova M, Ward K, et al.,  “Dietary Advice for Reducing Cardiovascular Risk,” Cochrane Database of Systematic Reviews, Issue 3. Article Number CD002128, 2013. DOI: 10.1002/14651858.CD002128.pub4.

10.  Silverman E, “The Cholesterol Guidelines Panel and Conflicts Of Interest,” Posted 11/14/2013. Available online at: http://www.pharmalive.com/cholesterol-guidelines-panelists-and-their-conflicts-of-interest.

11. Lenzer J, “Majority of Panelists on Controversial New Cholesterol Guideline have Current or Recent Ties to Drug Manufacturers,” BMJ 2013; 347:f6989 doi: 10.1136/bmj.f6989.

12. Cortez MF, “Cholesterol Guideline Changes Double Number on Treatments,” Bloomberg News. November 13, 2013. Available online at: http://www.bloomberg.com/news/2013-11-12/cholesterol-guideline-changes-d….