Drug prices keep rising, with no end in sight

By Trudy Lieberman
Rural Health News Service

Recently a tweet from Lauren Sausser, a fine health reporter I know in South Carolina, caught my eye. “Crazy drug prices became personal. My dad will start Keytruda regimen on Friday, $15,000 per infusion, once every three weeks indefinitely.” The high cost of pharmaceuticals had hit home!

Her 61-year-old father, Jim McCallister, who lives in Spartanburg, S.C., had been diagnosed with a melanoma discovered during a routine skin exam a few weeks earlier. It had spread to his lungs. Doctors recommended the drug, which uses the body’s immune system to attack cancer cells and has showed promise in treating aggressive melanomas.

McCallister’s employer-provided insurance is paying for most of his treatment, and the family is looking into Merck’s co-pay program. In the meantime, McCallister faces several thousand dollars of out-of-pocket costs.

McCallister may be lucky cost-wise. But the fact remains: Somebody is paying for the high cost of Keytruda and other new drugs coming on the market. Sausser said her dad asked if insurance would cover the drug. “The doctor told him they would find some way.”

That’s the nub of the dilemma. For many like McCallister, there may be help, often from the drug companies themselves in the form of patient assistance plans. Remember drug company AstraZeneca’s ads for some of its costly drugs: “AstraZeneca may be able to help”? Sometimes state or local government programs, private charities, nonprofit agencies, or coupon programs help patients pay for their drugs. Patients who can’t get help from any of those sources often go without.

None of the assistance programs, however, attack the underlying prices for the drugs, which pharmaceutical makers can set according to what the market will bear. They can pretty much do whatever they want with little push back from those who end up paying the bills – governments, insurers and patients. The U.S. has no cost controls, and government doesn’t negotiate drug prices the way many other countries do.

So the price of commonly prescribed drugs like the EpiPen, a shot that stops life-threatening allergic reactions, has risen to more than $600 for two pens. In 2009 two pens cost $100. The price for Abilify, an antipsychotic, has risen 113 percent between 2007 and 2014, and the cholesterol-lowering drug Crestor has climbed 103 percent over the same time period, according to The Campaign for Sustainable Rx Pricing, a group of employers, insurers, and unions that are trying to raise public awareness of high drug prices.

That helps explain why Medicare recently reported its spending on prescription drugs increased more than 17 percent in 2014 even though the number of claims from the program’s 38 million beneficiaries rose only 3 percent.

Medicare’s prescription drug law was never meant to pay all a person’s drug expenses. This year once a beneficiary and her drug plan have paid $3,310 for medicines, she reaches the coverage gap where she must pay the cost of most of her drugs. If she spends, out of her own pocket, another $4,850 for drugs this calendar year, she qualifies for catastrophic coverage and pays only 5 percent of all her remaining drugs for the year.

The trouble is that with prices so high, it’s easy to end up in the coverage gap paying out-of-pocket. Even protection offered by catastrophic coverage may not be enough. That’s especially true for people taking high-priced specialty drugs.

In 2013, about 3 million people were in this predicament. “Not a lot of people pay above the threshold, but those who do can pay through the nose,” says Tricia Neuman, senior vice president of the Kaiser Family Foundation.

Escalating drug prices affect everyone – even those not taking expensive drugs or not on Medicare. High drug prices affect all insurance premiums sooner or later.

Not long ago I spotted a letter to the editor in USA Today from Heather Block, age 53, who has Stage 4 breast cancer. She was calling for patients to organize and build a network to help craft solutions for the problem of skyrocketing drug prices.

I talked to Block about this. Her zeal and interest in organizing patients reminded me of the early days of the consumer movement in the 1960s when citizens organized to pass legislation to make the marketplace safer and more fair. With drugs, Block says, it’s hard to organize people because of drug assistance programs that take the sting out of prices and make patients less willing to work against the companies, the presence of disease advocacy groups funded by the pharmaceutical industry, and a general reluctance to speak up for fear of jeopardizing their own health and survival.

She’s asking for consumers to share their stories at this email: h3ath3rblock@gmail.com.

What problems are you having paying for prescription drugs? Write to Trudy at trudy.lieberman@gmail.com.

KentuckyOne Health promoting whole-food, plant-based diet, named No. 1 for heart health by U.S. news panel of experts

One in every eight Kentuckians suffers from diabetes, and the state ranks 12th in adult obesity, with 31.6 percent of its adults obese and 39 percent suffering high blood pressure, according to the State of Obesity report. These diagnosis generally results in recommendations for exercise and changes in diet, but what kind of diet?

KentuckyOne Health is promoting the Ornish Diet, a whole-food, plant-based diet that is naturally low in both fat and refined carbohydrates. The hospital chain says it is the only health-care provider in the state to offer the diet, starting in Louisville in July 2015 and in Lexington in October.

The diet was named the No. 1 Best Heart-Healthy Diet for the sixth year in a row by U.S. News & World Report. The magazine ranked it fourth Best Diabetes Diet, 11th Best Diet for Healthy Eating and 11th best overall diet. Nutrition and health experts determined the U.S. News rankings after reviewing information on 38 diet plans.

The first group of KentuckyOne patients using the diet averaged a loss of 7.5 pounds; three patients lowered their blood-pressure medication; and one patient who had diabetes came off his insulin and another is discussing coming off cholesterol medication after 25 years, according to a KentuckyOne news release.

The diet is part of the Ornish Reversal Program, which also includes exercise, meditation and cardiac rehabilitation strategies that include group support, the release said.

“It’s been amazing to see the interest we’ve had in the program from people across the state,” said Alice Bridges, vice president of healthy communities for KentuckyOne. “So much so, that even we’ve been surprised by it. I think we’re at a tipping point culturally where there is more openness to this kind of lifestyle change.”

In Kentucky, the Ornish Reversal Program is reimbursed for qualified and eligible members of Medicare and Anthem and Aetna insurance plans, and there is a discount for self-paying patients, says the release.

Dangerous and stealthy, non-alcoholic fatty liver disease is on the rise, but is reversible with weight loss and exercise

Many Kentuckians and other Americans are walking around with a liver disease that has the potential of progressing to cirrhosis, which can then lead to liver failure, and don't even know it, according to a Houston Methodist Hospital news release.

It's called non-alcoholic fatty liver disease. NAFLD is caused by the buildup of extra fat in the liver that is not caused by alcohol. And while it is normal for the liver to contain some fat, if more than 5 to 10 percent of its total weight is fat, it is considered a fatty liver.

“Data has shown that nearly 30 million Americans have NAFLD. Many times it is missed until the person’s liver enzyme levels are high,” Dr. Howard Monsour, chief of hepatology at Houston Methodist Hospital, said in the release.

Alcohol, drugs, obesity, high cholesterol and diabetes, which are more common in Kentucky than the rest of the nation, can all be causes of fatty liver. The release notes that those with Metabolic Syndrome often also have fatty liver.

Metabolic Syndrome is a combination of health conditions in one person that include abdominal obesity, high blood pressure, increased fasting glucose levels and abnormal cholesterol levels. More than one-third of adults in the U.S. suffer from this syndrome.

Fatty liver in its early stages is harmless, but it can advance to a condition called nonalcoholic steatohepatitis (NASH), then to cirrhosis. But the good news is, if it is caught early, it is a totally reversible condition through slow, methodical weight loss and exercise.

“Much like Type 2 diabetes, NAFLD can be cured with proper diet and exercise,” Monsour said. “If you lose 12 percent of your current weight, no matter how much you weigh, you can eliminate fat from your liver.”

Most people with fatty liver or NASH have no symptoms, but some have fatigue, weakness and loss of appetite, or pain in the center or right upper part of the belly. "These symptoms might also get worse after heavy drinking," the release notes.

Those with fatty liver shouldn't overindulge in food or alcohol because it can make the condition worse, "and possibly lead them straight to a heart disease and/or liver failure," the release warns.

Fatty liver is the leading cause of chronic liver disease and is the third most common reason for liver transplants in the U.S., according to the American Liver Foundation. Between five and 20 percent of people with fatty liver will develop serious liver disease, according to the release

“The key is to catch it early and many times it may not be discovered until a routine checkup,” Monsour said. “If you start to experience symptoms, see a doctor as soon as you can. Letting it go without evaluation can lead to a very difficult, unhealthy life.”

One of every three U.S. adults have a combination of risk factors that increase their risk for heart disease and diabetes

More than one-third of adults in the U.S. have a combination of health conditions that put them at higher risk of heart disease and diabetes, and this condition affects nearly half of adults aged 60 and older, according to a new study recently published in the Journal of the American Medical Association.

Image: healthyanswers.com

This combination of health conditions, when found in one person, is called metabolic syndrome. It includes abdominal obesity, high blood pressure, increased fasting glucose levels and abnormal cholesterol levels.

The study collected data gathered by the federal Centers for Disease Control and Prevention from adults 20 and older from 2003 to 2012. It found that about a third had a metabolic symdrome in 2011-12, and nearly half of those 60 and older did. Among those 20 to 39, the rate was 18 percent.

The study report says these were "concerning observations" because of the country's aging population. Hispanics, at 39 percent, were found to have the highest prevalence of metabolic syndrome among ethnic groups. Women had a higher prevalence than men in all age groups.

The American Heart Association says the best way to control the risk factors contributing to metabolic syndrome are to lose weight and increase physical activity. It also encourages patients to routinely monitor their weight, blood glucose, cholesterol and blood pressure and treat these risk factors according to established guidelines.

Study concludes that fasting can reduce cholesterol levels for people in danger of developing diabetes

New research suggests that occasional fasting can help pre-diabetics from developing diabetes, which is more common in Kentucky than most states.

After 10 to 12 hours of fasting, the body looks for other energy sources to sustain itself, so it removes LDL (bad) cholesterol from fat cells and converts it into energyaccording to researchers at the Intermountain Heart Institute at Intermountain Medical Center in Murray, Utah.

"Fasting has the potential to become an important diabetes intervention," in addition to lifestyle changes and weight loss, said Benjamin Home, the lead researcher.

The study focused on prediabetics between the ages of 30 to 69 with at least three of the following metabolic risk factors: a large waistline, a high triglyceride (type of fat in the blood) level, a low HDL (good) cholesterol level, high blood pressure and high blood sugar after fasting.

"Over a six-week period cholesterol levels decreased by about 12 percent in addition to the weight loss," Home said. "Because we expect that the cholesterol was used for energy during the fasting episodes and likely came from fat cells, this leads us to believe fasting may be an effective diabetes intervention."

The removal of LDL cholesterol from the fat cells for energy use should help stop insulin resistance, which happens when the pancreas keeps producing more and more insulin until it can't make enough for the body, and the blood sugar rises. "The fat cells themselves are a major contributor to insulin resistance, which can lead to diabetes," he said. "Because fasting may help to eliminate and break down fat cells, insulin resistance may be frustrated by fasting."

Home noted that although fasting might be effective for protecting against diabetes, the results were not immediate. "How long and how often people should fast for health benefits are additional questions we're just beginning to examine." (Read more)

A byproduct of cholesterol that acts like estrogen explains the link between high cholesterol and breast cancer

The link between high cholesterol and breast cancer can now be explained.

It is not the cholesterol itself, but a "byproduct of cholesterol (that) functions like the hormone estrogen to fuel the growth and spread of the most common types of breast cancer," researchers at the Duke University Cancer Institute report, according to Newswise.

Estrogen is known to "feed an estimated 75 percent of all breast cancers," Newswise reports. So basically, cholesterol creates a "byproduct" that acts like estrogen and "feeds" the breast cancer, the researches concluded.

This is the first time a link between high cholesterol and breast cancer has been explained, especially in post-menopausal women, according to the study, which also suggests that changes in diet or taking statins and other medication to reduce cholesterol may offer "simple ways to reduce breast cancer risk," Newswise reports.

Although studies have shown a connection between obesity and breast cancer, as well as high cholesterol and breast cancer, the reason for these connections had not been explained, said senior author Donald McDonnell, chair of the Department of Pharmacology and Cancer Biology at Duke: “What we have now found is a molecule – not cholesterol itself, but an abundant metabolite of cholesterol, called 27HC – that mimics the hormone estrogen and can independently drive the growth of breast cancer.”

The researchers also found that the more enzyme that makes the cholesterol byproduct that is present, the more aggressive the tumor.

When test animals took anti-estrogen drugs such as tamoxifen, or when they quit receiving the cholesterol byproduct, the cancer was inhibited, according to Newswise.

Nelson said in the article that there was also a potential association between the cholesterol byproduct and the development of resistance to the anti-estrogen tamoxifen. Data also suggest the cholesterol byproduct may reduce the effectiveness of commonly used breast cancer therapies.

These findings suggest that women who have breast cancer and high cholesterol who take statins will  have increased benefit, Newswise reports, because it will decrease their resistance to commonly used breast cancer therapies.

Further research will "include clinical studies to verify the suggested potential outcomes and to determine if this cholesterol byproduct plays a role in other cancers," McDonnel said.

New guidelines for cholesterol management spark controversy; faulty risk calculator could lead to over-prescribing statins

The American College of Cardiology and the American Heart Association released new guidelines for cholesterol management, a new formula to assess heart attack and stroke risk, and guidelines for lifestyle modifications and weight management to reduce heart attack and stroke risk.

“These guidelines will be helpful to all physicians and their patients, but they will be particularly relevant in Kentucky, where nearly 70 percent of Kentuckians are overweight or obese, we are the third highest state in rates of high blood pressure, five Kentucky counties are among the least active in the U.S. and the incidence of diabetes is above the national average,” Dr. Susan Smyth, director of the Gill Heart Institute at the University of Kentucky, said in an e-mail.

However, some experts have questioned the new guidelines, and the new formula for calculating cardiovascular risk appears to overstate the risk value used to determine who should receive cholesterol-lowering statin drugs.

"There may be no single perfect score that we can use to give statins the 'thumbs up' or 'thumbs down' for our patients without established cardiovascular disease," Smyth said. "Ultimately, physicians have many different tools at their disposal to evaluate CV risk in their patients, and they will review all of the available evidence to make a determination about who may be likely to benefit from statin therapy."

The new guidelines also change how statins should be prescribed. The drugs have been given to lower cholesterol to a specific numerical value, but now it is suggested that moderate to high doses of statins be given to patients who fall within four identified groups of patients who have been determined to get the most benefit from the drug:

• already diagnosed with heart disease or stroke
• with an LDL {"bad" cholesterol) of 190 mg/dL or higher, who may have genetic risk
• aged between 40 and 75, with Type 2 diabetes and high LDL levels, but without heart disease or stroke
• with an estimated 10-year risk of cardiovascular disease of 7.5 percent or higher who are between 40 and 75, without heart disease or stroke, but with high LDL levels.  

Instead of focusing strictly on patients' LDL and total cholesterol, the new guidelines suggest physicians treat patients based on their overall risk of heart disease or stroke, of which cholesterol levels are just one part, according to the report.

The guidelines in the report also call for lifestyle modification, including adhering to a heart-healthy diet, which includes vegetables, fruits, whole grains, low-fat dairy, poultry, fish, beans and healthy oils and nuts; 30 to 40 minutes of exercise three to four times a week; avoidance of tobacco products, and maintenance of healthy weight.

The guidelines use a cardiovascular risk calculator that considers age, race, sex, diabetes, smoking habits, blood pressure and low HDL, or "good" cholesterol levels, among other considerations.

But a problem has been identified with the risk calculator, so worrisome that a past president of the College of Cardiology called for a halt to the implementation of the new guidelines, reports Gina Kolata of The New York Times. The calculator appears to overestimate the risk group so greatly, Kolata reports, that it could mistakenly suggest that millions more people should be candidates for statin drugs.

"It's stunning," the cardiologist, Dr. Steven Nissen, chief of cardiovascular medicine of the Cleveland Clinic, told Kolata. "We need a pause to further evaluate this approach before it is implemented on a widespread basis."

After an emergency, closed-door meeting on Saturday night, the two organizations that published the guidelines said "that while the calculator was not perfect, it was a major step forward, and that the guidelines already say patients and doctors should discuss treatment options rather than blindly follow a calculator," Kolata reports.

Dr Sidney Smith, the executive chairman of the guideline committee, told Kolata that "the association would examine the flaws found in the calculator and determine if changes were needed."

Two Harvard Medical School professors, Dr. Paul M. Ridker and Dr. Nancy Cook, had pointed out the calculator was not working among the populations it was tested on by the guideline makers a year earlier, during an independent review for the National Institutes of Health's National Heart, Lung, and Blood Institute, which originally developed the guidelines, Kolata reports.

Dr. Donald Lloyd-Jones, co-chairman of the guidelines task force and chairman of the department of preventive medicine at Northwestern University, told Kolata that "the committee thought the researchers had been given these results."

Ridker and Cook evaluated the calculator again after they saw the guidelines and found that it over- predicted risk by 75 to 150 percent, depending on the population, Kolata reports. They wrote in The Lancet, a British medical journal, that the miscalibration be "reconciled and addressed" before implementation, saying: "If real, such systematic overestimation of risk will lead to considerable over-prescription."

Some doctors are concerned that because many people are already "leery of statins, the public would lose its trust in the guidelines or the heart associations," Kolata reports. Currently, it is only obvious that those in the highest risk groups, such as those who have heart attacks, strokes or have diabetes, should take statins, she reports.

UK and Purdue researchers find a compound in watermelon that fights 'bad' cholesterol and arterial plaque in lab rats

A study from the University of Kentucky and Purdue University showed that mice fed a diet including watermelon juice had lower weight, cholesterol and arterial plaque than a control group. The findings, reported in the Journal of Nutritional Biochemistry, suggest that citrulline, a compound found in watermelon, plays a role in cardiovascular health. "We were interested in citrulline because previous studies showed that it may lower blood pressure,"  Shubin Saha, a Purdue Extension vegetable specialist and study co-author, told Medical Xpress. "We didn't see a lowering of blood pressure, but these other changes are promising."

"The researchers fed two groups of mice diets high in saturated fat and cholesterol," MX reports. "Half the mice received water containing 2 percent watermelon juice, while the others received the same amount of water supplemented with a solution that matched the carbohydrate content of the watermelon juice. The mice that consumed watermelon juice gained about 30 percent less weight than the control group and had about 50 percent less LDL cholesterol - the so-called bad cholesterol. The experimental group also had about a 50 percent reduction in plaque in their arteries, as well as elevated levels of citrulline." Sibu Saha, a professor of surgery at UK, explained that the researchers are not sure at what molecular level the citrulline is working, but that is their next step.

Shubin Saha was excited about the dual benefit of the findings. "Twenty percent of each year's watermelon crop is wasted either because the fruit is visibly unappealing to consumers or because some growers find it too expensive to pay for harvesting as prices drop during the height of watermelon season." The wasted melons, he explained, could be put to use extracting these very beneficial compounds.  (Read more)

Study finds 'the link between cholesterol and cancer is clear'

University of Rochester Medical Center scientists have verified a link between cholesterol and cancer with new genetic evidence, raising the possibility that cholesterol medications such as statin drugs could be used for cancer prevention or to augment existing cancer treatment.

"The link between cholesterol and cancer is clear," senior study author Hartmut Land said, "but it's premature to say that [cholesterol-lowering drugs] are the answer." Still, The Times of India reports that the data gathered by the research team at the James P. Wilmot Cancer Center at URMC "supports several recent population-based studies that suggest individuals who take cholesterol-lowering drugs may have a reduced risk of cancer, and, conversely that individuals with the highest levels of cholesterol seem to have an elevated risk of cancer." 

Millions of Americans take cholesterol-lowering drugs prescribed by physicians. The drugs work by blocking the action of key enzymes in the liver, which synthesizes cholesterol. The Times story explains that "clinical trials also are evaluating statins as a tool against cancer, and some previous studies suggest that when used in combination with chemotherapy, statins might make chemotherapy more effective by sensitizing certain cancer cells to chemotherapy-induced cell death. Land, however, urges caution and further study. Doctors do not know the appropriate statin dose for cancer prevention or treatment of cancer-related conditions. Side effects cannot be ignored either, and little research has distinguished between the responses among people who take statins."

See the study in the online journal Cell Reports by clicking here.