Turning to drugs and treatments for better health

If the latest information on health and wellness is important to you, you will not want to miss a special live-streamed webcast, “Rethinking Cholesterol,” which will be aired on Thursday, September 24, from 12:30pm to 1:30pm Eastern time. The webcast, which is free to all viewers, is co-sponsored by Reuters, Harvard Health Publishing, the Harvard T.H. Chan School of Public Health, and Harvard Medical School.

Recent science has brought new insights into the importance of controlling cholesterol for maintaining cardiovascular health. LDL (low-density lipoprotein) cholesterol is a potent risk factor for heart and blood vessel disease. New research suggests that when it comes to protecting your heart, the lower your LDL cholesterol, the better.
How you can lower your cholesterol

There is much you can do with your diet to lower LDL cholesterol. Mainly, it is critical to reduce your intake of saturated fat and trans fat. These two forms of fat drive up LDL levels. Saturated fat is found in butter, cheese, other dairy products, and red meat. Trans fat is found in partially hydrogenated oils. By law, trans fats are supposed to be removed from all commercially prepared foods within the next three years. But until then, you need to carefully read food labels to avoid trans fat.

It is best to replace saturated and trans fat with polyunsaturated fats (soybean, corn, and sunflower oils) and monounsaturated fats (olive oil), which lower LDL levels. But you might be surprised to learn that cutting back on cholesterol-rich foods is of little help. Most cholesterol in your bloodstream is produced by the body and does not come from your food. Getting plenty of fiber may also help to lower cholesterol levels. Regular exercise is also important because it helps you control body weight and can raise levels of HDL (high-density lipoprotein) cholesterol, which helps sweep fat from the bloodstream.
When you need a little more help than lifestyle changes alone

If diet and exercise don’t bring your cholesterol down to a healthy level, there are medications that can help. Statins have been the mainstay of drug therapy to lower LDL cholesterol. Statins are sometimes given in combination with ezetimibe, a drug that reduces cholesterol absorption in the intestine.

Powerful new medications, called PCSK9 inhibitors, have just recently become available. These medications are antibodies that promote the removal of LDL cholesterol from the bloodstream into the liver, where it can be processed. PCSK9 inhibitors can dramatically lower LDL cholesterol to levels not previously seen with other medications. But they must be given by injection under the skin, and currently, they are very expensive. Only time will tell if these low LDL levels translate into lower risk of heart and blood vessel disease, and if there may be unexpected side effects from driving LDL cholesterol levels so low.
Learn more about cholesterol and heart health from Harvard experts

If you want to understand more about cholesterol and cardiovascular disease — and the latest science and evidence-based recommendations to protect your heart — tune into this webcast on Thursday, September 24, from 12:30pm to 1:30pm Eastern time.

These issues will be discussed by four Harvard experts:

    Patrick O’Gara, Director, Clinical Cardiology and Executive Medical Director, Shapiro Cardiovascular Center at Brigham and Women’s Hospital; Professor, Harvard Medical School.
    JoAnn Manson, Professor of Medicine, Harvard Medical School; Chief, Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital; Professor in the Department of Epidemiology, Harvard T.H. Chan School of Public Health.
    Paul Ridker, Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital; Eugene Braunwald Professor of Medicine; Professor in the Department of Epidemiology, Harvard T.H. Chan School of Public Health.
    Frank Sacks, Professor of Medicine, Harvard Medical School; Professor of Cardiovascular Disease Prevention, Department of Nutrition, Harvard T.H. Chan School of Public Health.

Bill Berkrot of Reuters will moderate the conversation. You also might be interested our recent post about dietary fats and heart health by Dr. JoAnn Manson and her colleague Dr. Shari Bassuk. If you saw last month’s news headlines declaring that saturated fat is no longer deemed harmful to your heart, you may be (understandably!) confused. After all, for years, clinicians and scientists have recommended reducing saturated fat for heart health. Is it time to rethink this advice? Hardly. Here’s the deal.

The research that sparked the recent news splash was an analysis by Canadian researchers of up to a dozen long-term observational studies of diet that included a total of 90,000 to 339,000 participants from various countries. These study volunteers reported on the foods they typically ate. Researchers then tracked the health of these folks for years, sometimes decades. The analysis found no association between consumption of saturated fat — dairy foods (e.g., cheese, butter, and milk) and meats are two main sources — and future risk of coronary heart disease, ischemic stroke (strokes resulting from a blocked vessel), diabetes, or deaths from cardiovascular disease or all causes. Less surprisingly, the analysis also found that trans fats are harmful to health, with the highest intakes of trans fat linked to a 21% higher risk of coronary heart disease and a 33% higher mortality rate compared with the lowest intakes. The findings were published on August 12 in the medical journal The BMJ.

Unfortunately, the news coverage of this analysis often missed a key point. It’s not just the amount of saturated fat you eat, it’s also what you replace those calories with (the quality of your overall diet) that affects your health. Most people naturally tend to keep their calorie intake at a constant level over time (scientists call this “calorie preservation”). If they cut saturated fat calories out of their diet, the missing calories have to come from somewhere else (“calorie substitution”). People with lowered saturated fat intake may replace those calories with other unhealthy foods such as refined carbohydrates (e.g., white bread, white rice) or sugary beverages. So although they are eating less fat, their overall diet is no better — and may even be worse — than people who don’t try to limit saturated fat. .

Numerous studies show that substituting unsaturated fat — found in fish, nuts, and plant oils — for saturated fat improves health. For example, a careful analysis of observational findings from the Nurses’ Health Study, in which my colleagues and I (JEM) tracked 80,000 initially healthy female nurses for many years, suggested that replacing just 5% of calories from saturated fat with calories from unsaturated fat cuts risk of coronary heart disease by 42% and is more effective at preventing heart attacks than simply reducing overall fat intake. Short-term dietary trials also show heart benefits of lowering saturated fat intake while boosting unsaturated fat intake, including improvements in blood cholesterol levels and insulin sensitivity.

The most harmful type of dietary fat is trans fat, also known as partially hydrogenated vegetable oil. These fats are a double whammy: they boost the “bad” LDL cholesterol and lower the “good” HDL cholesterol. New government regulations are reducing the presence of artificial trans fats in the food supply, but such fats are still found in many products. What’s the take-home message? The type of fat does in fact matter, so choose foods with healthy unsaturated fat (fish, nuts, and most plant oils), limit foods high in saturated fat (butter, whole milk, cheese, coconut and palm oil, and red meats), and try to avoid foods with trans fat. Achieving the last goal can be tricky. In supermarkets, check package labels carefully. The best way to tell if trans fat is present is to read the ingredient list; if the phrase “partially hydrogenated oil” appears, then trans fats are indeed lurking.

Many experts and professional societies, including the American Heart Association, advise a dietary pattern that (1) emphasizes vegetables (richly colored vegetables, including dark leafy greens, are best, and white potatoes don’t count), fresh fruits, and whole grains (whole-grain cereals, breads, rice, and pasta); (2) includes fish, beans, nuts and seeds, poultry, low-fat dairy products, and non-tropical plant oils (such as canola or olive oil, but not coconut or palm oil); and (3) limits sweets, sugary drinks, and red meats. Well-known examples are the Mediterranean and DASH diets. People who eat such diets have consistently had much better health outcomes than those who do not. It’s not a situation any of us would wish for. What if you had a terminal illness like cancer or ALS (Lou Gehrig’s disease), or a rare, debilitating disease, and knew there was treatment that might help you, but was not yet approved by the FDA? Fortunately, there is a way to gain access to experimental treatments or drugs. Your doctor can request their use through the FDA’s “expanded access” or “compassionate use” programs.

But some patients and doctors seeking treatment through these programs have felt the process was just too long. And when time is short, delays of any kind are intolerable. Since 2014, 21 states have enacted legislation to help speed up this process. These laws, called “right-to-try” laws, enable patients to bypass the cumbersome FDA process and allow doctors to request certain medications (which have already been FDA-tested for safety, but are not yet on the market) directly from the drug companies that manufacture them.

This may sound good in theory, but getting medications before they are available to everyone is risky — even for those with “nothing to lose.” Drugs that haven’t been thoroughly tested may cause side effects that obliterate any potential benefits, making the precious time left to these people far more miserable than it need be. And doctors who want to weigh the risks and benefits of such treatments are effectively in the dark; they have no way to access the information that would help them counsel patients well.

These laws also raise broad ethical issues. Asking your doctor to ask to prescribe a drug that’s still under development requires that you know this is even possible. It is likely that these requests will perpetuate already significant inequalities in healthcare and favor those with access, resources, and money.

There are also concerns about the unintended consequences of bypassing the usual FDA process. If providing a drug to a very small number of people interferes with the usual testing of a promising medication, then the benefits for all are trumped by the needs of the very few.

In an effort to tackle some of these issues, one pharmaceutical company is working with New York University School of Medicine’s Division of Medical Ethics to address patients’ requests for its medications. A committee that includes medical experts, bioethicists, and patient representatives meets to consider each medication request. The goal is to consider each request in a thoughtful, fair, and consistent way.

The rapid emergence of right-to-try legislation opens the door to broader choices for patients, but they are no guarantee that patients’ requests will actually be granted. These laws do not force pharmaceutical companies to provide experimental drugs, or health insurance companies to pay for them. In fact, for example, Colorado right-to-try laws explicitly allow insurance companies to deny coverage altogether — not just for the experimental medication — to patients who use investigational drugs. So right-to-try laws may, in reality, do little to improve access.

The shortcomings of right-to-try laws are disheartening. However, in February of this year, the FDA proposed a revised and “faster” process for expanded access to investigational treatments. This may be a way to address two powerful competing needs: getting help swiftly to those whose time is short and making sure that the medications we offer are distributed in an equitable and safe way/


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