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22 November 2013

New Guidelines for Cholesterol Treatments Represent "Huge Change"

One of the reasons behind the new guidelines may be the fact that all but one of the currently approved statins have come off patent, so the cost of the medications has plummeted; a three-month supply can cost as little as $10.  Drug companies thus need to maintain their revenues by other means.  Following this article from Time, there is a partial list of pharmaceutical and other companies which contribute to the American Heart Association.  The British Medical Journal (BMJ) has just published an article entitled, "Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers", summary available here.

New Guidelines for Cholesterol Treatments Represent “Huge Change”
by Alice Park @aliceparkny, Time.com, 12 November 2013

New guidelines would double the number of Americans on cholesterol-lowering drugs.

Dr. Sanjay Gupta of CNN wondered on Twitter whether we are “waving the white flag” when it comes to helping Americans avoid heart disease. Dr. Eric Topol, a cardiologist and chief academic officer of Scripps Health, tweeted that the doubling of patients on statins, which can lower cholesterol by up to 50%, was “not good.”

But the American Heart Association and the American College of Cardiology remained convinced that the 2002 federal recommendations for when to start people on the drugs needed to be updated. About 33% of U. S. adults have high cholesterol, and less than half are receiving proper treatment, despite the fact that elevated cholesterol levels double the risk of heart disease, the number one killer of adults in the U.S.

Under the new guidelines, people without a history of heart disease can start taking statins if they have a 7.5% higher risk of developing heart problems or stroke in the next 10 years, based on their cholesterol levels, blood pressure, weight, gender, race and smoking status. (You can calculate your 10-year risk here. Warning: it’s a little complicated.) That’s a dramatic change from the 20% higher risk that previous guidelines advised.

The new advice also recommends statins for anyone with type 1 or type 2 diabetes, regardless of whether they have additional heart disease risk factors, between the ages of 40 and 75 years old. Diabetes carries a higher risk of heart disease, in part because of the changes in cholesterol levels.

The lower threshold for statin prescriptions is certainly welcome news for their manufacturers; the drugs have been among the most prescribed class in the U.S. in recent years, and in 2013, rosuvastatin (Crestor) topped the list, earning AstraZeneca $5.4 billion in sales, according to IMS Health.

But the dramatic shift also has some heart experts nervous about how the guidelines will translate in doctors’ offices around the country. For those with a history of heart disease, there is little debate about how beneficial statins can be in preventing second events; studies show that the drugs can significantly lower risk of death from heart events. But for healthy individuals who may have some risk factors for future heart trouble, doctors have always been reluctant to prescribe medications when so much of heart disease is preventable, with proper diet and exercise. “For people with no history of heart disease, but who are trying to prevent heart disease, there is already a tremendous amount of overuse of statins in my view in this country,” says Topol. “So my concern is that the new guidelines will lead to potentially even more promiscuous use of these statins than already exists.”

And as unscientific as the target numbers were, at least they provided patients with a goal, and motivation for changing their diet and exercise habits to lower their cholesterol and potentially reduce their dose or get off their statin medications entirely. “I have worries about how to motivate patients when they don’t have numbers as goals,” says Dr. Steven Nissen, department chair of cardiovascular medicine at the Cleveland Clinic. “The targets served a purpose for sure even though they weren’t scientific.”

But since the last federal guidelines for cholesterol treatment were issued in 2002, two things have happened. First, all but one of the currently approved statins came off patent, so the cost of the medications has plummeted; a three-month supply can cost as little as $10.

Second, more studies have emerged indicating the various ways that statins can help the heart. Not only do the drugs restrict cholesterol production in the liver, but they can also lower levels of inflammation, a process that researchers now believe is the final player in the several-act play that is a heart attack, by aggravating unstable plaques in heart vessels that then send clots to constrict blood flow.

And last summer, a team at Harvard Medical School published the most comprehensive analysis on the safety of statins to date. Based on 135 studies submitted by manufacturers of all seven statins to the Food and Drug Administration to earn approval for their medications, the scientists found that compared to placebo pills, statins raised the risk of diabetes by just 9%; other side effects, including muscle pain, cancer and changes in liver enzymes were not statistically significant.

So while most heart experts welcome the fact that cholesterol-level targets are no longer used to determine who should and shouldn’t be on statins, they need to be convinced that the new calculator will be a better tool for making that decision. “It will be a huge educational challenge,” says Nissen. “How do you now tell patients and doctors that you don’t need to know your [cholesterol] numbers any more, that it’s not about getting to a specific goal? Now it’s you either take a statin or you don’t. Everything else goes out the window.”

The new recommendations inch closer to the idea of putting everyone on a statin, a controversial scenario that a few bold scientists have proposed in recent years. As I reported earlier this year:

Dr. David Agus, professor of medicine at the University of Southern California Keck School of Medicine, recommends that everyone over 40 should discuss statins with their doctor, even if they haven’t had heart problems or are at increased risk for heart disease or diabetes. He says that inflammation is driving a number of aging-related conditions, both in the body and brain, and since studies have shown that statins are a powerful way to dampen the inflammatory response, more people might be living longer if they take advantage of statins. Rory Collins, an epidemiologist at Oxford University, caused an uproar last year when he addressed the European Society of Cardiology with a talk entitled, “The Case for Statins In a Wider Population,” and argued that more people should be availing themselves of the medications, just as they do aspirin.

Nissen notes that the guidelines are guidelines, and not binding, although many primary-care physicians may turn to then for help in determining how best to treat their patients.

For doctors who don’t quite know what to do about the new advice, Nissen suggests having discussions with their patients to make individual decisions about whether they need statins. Depending on how high that individual risk is, both doctor and patient can reach some consensus on whether they are comfortable with using statins.

And the recommendations don’t replace diet and exercise, still the best ways to avoid heart disease. It’s just that they aren’t as easy for patients as popping a pill.


Index of Non-Profit Organizations Receiving Corporate Funding

Integrity in Science


For the fiscal years from 03-04 to 06-07, AHA reports receiving $30,158,173 from pharmaceutical and medical device companies. It also reports an additional $28,246,371 in committed revenues (committed through signed agreements in 06-07) for the 07-08 fiscal year and beyond. (http://www.americanheart.org/presenter.jhtml?identifier=3053329, accessed 1/30/09)

Merck is spending $400,000 to finance an AHA program teaching 40,000 doctors to treat cholesterol according to guidelines. (Wall Street Journal, 6/14/98)

Published a press release urging caution before discontinuing use of Vytorin [cholesterol medication that targets two types of cholesterol]. The non-profit also received $2 million from the Merck/Schering-Plough joint venture that made the drug (Saul, S. Heart Group Backs Drug Made by Ally, New York Times, 1/24/08)

Corporate Contributors greater than $100,000 include: 

AstraZeneca LP
Bristol-Myers Squibb Company
CV Therapeutics
King Pharmaceuticals
KOS Pharmaceuticals
Merck & Co., Inc.
Novartis Pharmaceuticals Corp.
Pfizer, Inc.
Procter & Gamble Company
Reliant Pharmaceuticals
Roche Diagnostics
Taketa Pharmaceuticals North America
Walgreen Co.

American Heart Association 2005 Annual Report

(http://www.americanheart.org/downloadable/heart/1137166221820AHA%2005.pdf; accessed 4/26/06)

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