Price-fixing collusion: Another reason for drug price gouging

A large group of U.S. states accused key players in the generic drug industry of a broad price-fixing conspiracy, moving on Tuesday to widen an earlier lawsuit to add many more drug makers and medicines in an action that sent some company shares tumbling.

Mylan Labs CEO, Heather Bresch, was sworn in before a House Oversight and Government Reform Committee hearing on the Rising Price of EpiPens, at the Capitol in Washington September 21, 2016. The lawsuit, brought by the attorneys general of 45 states and the District of Columbia, accused 18 companies and subsidiaries and named 15 medicines. Shares of Pennsylvania-based Mylan, named as one of the defendants, closed down 6.6 percent.

The states said the drug makers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market. The companies sometimes agreed on price increases in advance, the states added.

The states said company leaders had communicated directly to agree on their companies’ shares of the market for a delayed-release version of a common antibiotic, doxycycline.

“It is our belief that price-fixing is systematic, it is pervasive, and that a culture of collusion exists in the industry,” Connecticut Attorney General George Jepsen, who is leading the case, told a news conference in Hartford.

Mylan said in a statement it had found no evidence of price-fixing by the company or any of its employees, and vowed to defend itself vigorously. Mysteriously, the company’s second-ranking official, has received more than $50 million in compensation over the past three years, last year making more than its CEO Rajiv Malik.

“Mylan has deep faith in the integrity of its president Malik, and stands behind him fully,” the company said.

Emcure, also a defendant in the case, did not immediately respond to a request for comment.

Two former executives of Emcure’s subsidiary Heritage Pharmaceuticals pleaded guilty in January to federal charges of conspiring to fix prices and divide up the market for doxycycline and the diabetes drug glyburide. The two men, former Heritage president Jason Malek and former chairman and chief executive Jeffrey Glazer, reached a deal with 41 states and territories in which they each agreed to pay penalties of $25,000 and cooperate with the state probe.

Soaring drug prices from both branded and generic drug manufacturers have sparked outrage and investigations in the United States.

Executives like Mylan’s Bresch and former Turing Pharmaceuticals CEO Martin Shkreli have been called in front of Congress to defend the cost of their products.

MORE COMPANIES TARGETED

      The original complaint, filed in December, targeted Mylan, Heritage, Aurobindo Pharma USA Inc, Citron Pharma LLC, Mayne Pharma USA Inc and Teva Pharmaceuticals USA Inc.

The states are pressing a new complaint that would add Novartis AG’s unit Sandoz, India-based Sun Pharmaceutical Industries Ltd, Endo International PLC’s unit Par Pharmaceutical, Dr. Reddy’s Laboratories, Apotex Corp, Glenmark Generics Ltd, Lannett Company Inc, Alkem Laboratories Ltd’s unit Ascend Laboratories and Cadila Healthcare Ltd’s unit Zydus Pharmaceuticals Inc.

Jepsen said the investigation is continuing, and that claims would likely be brought against more companies, and possibly executives, in the future.

The news hurt shares of companies named in the expanded suit that are traded in the United States. In addition to Mylan’s drop, Lannett lost 13.7 percent. Shares of Endo were up 7 percent, but down from their 12 percent peak before the news of the amended lawsuit.

Teva spokeswoman Denise Bradley said the company denied the allegations. Endo spokeswoman Heather Lubeski said the company would vigorously defend itself against the claims. Other companies did not immediately respond to requests for comment.

The expansion of the suit requires the court’s permission.

The original lawsuit centered on just two medicines, delayed-release doxycycline and glyburide.

The price of doxycycline rose from $20 for 500 tablets to $1,849 between October 2013 and May 2014, according to U.S. Senator Amy Klobuchar, a Minnesota Democrat who had been pressing for action on high drug prices.

The amended complaint would expand the number of drugs to include glipizide-metformin and glyburide-metformin, which are among the most commonly used diabetes treatments.

Others include: acetazolamide, which is used to treat glaucoma and epilepsy, the blood pressure medicine fosinopril; the anti-anxiety medicine meprobamate; and the calcium channel blocking agent nimodipine.

The U.S. Justice Department is conducting a parallel criminal investigation. On Friday, the department asked the Pennsylvania court presiding over the lawsuit to put the lawsuit’s discovery process on hold, saying it could interfere with the criminal probe.

Connecticut Assistant Attorney General Joseph Nielsen said recently that states would likely oppose that request, which could slow the lawsuit.

     This should provide a sober reminder that, despite the profuse numbers of “free market,” enthusiasts, government vigilance and intervention are absolutely necessary to prevent the public from being robbed!

 

 

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WHAT CONSTITUTES A HEALTHY BREAKFAST?

Although there are sound medical reasons for eating breakfast every day, when I look at the typical breakfast food offerings at many restaurants, supermarkets, and food trucks, and I think about the health of our nation, it’s sad! Muffins, bagels, donuts, pancakes, waffles, French toast sticks… Want some bacon, sausage, or fried potatoes with that, sir?

We are traditionally led to believe that a “well-balanced breakfast” consists of a big bowl of cereal and a few decorative strawberries on top, with a tall glass of orange juice. We believe that you need the calcium in that milk, that vitamin C in that orange juice, and the carbs in that cereal for energy. But do you?

Eating like this may be okay once in a while, but if you do so often, I guarantee these foods will make you both fat and sick, sooner or later!

Why are familiar breakfast foods not great for you?

Simply put, to the cells in your body, a bowl of cereal, or a bagel, or a piece of toast, or a muffin are all no different than a dessert. Processed carbohydrates and sugars cause blood sugar and insulin levels to rise. The insulin easily ushers all that sugar into your fat cells, where it becomes stored energy, also known as body fat.

The animal fats in bacon, sausage, and butter can clog up arteries and lead to heart attacks and strokes. Cured meats and other processed foods a cause trouble for several reasons, especially because the high salt content causes us to retain water and pushes the blood pressure up. This is all a recipe for weight gain, obesity, high blood pressure and cholesterol… and eventually, heart disease.

So… what should we eat for breakfast?

The answer is basic healthy eating advice: fruits and vegetables, whole (unprocessed) grains, and healthy proteins and fats. This is not a trend, this is not a hippie opinion. The evidence is overwhelming. And I love bacon. But, I treat it with respect because it can (and does) cause great harm to the human body if eaten often.

But many people need more guidance than just a list of food groups, including how to do so when you have a busy life.

So here’s what I suggest:

If you’re often on the go, your may need something quick, easy, transportable, and budget-friendly. So, try putting together an easy fruit/yogurt/grain/nut bowl every single day. Here’s a possible three-ingredient recipe:

  • Frozen fruit: berries, mixed fruit, fruit with kale bits, whatever. Fruit is frozen at the peak of freshness, so the quality and vitamin content can be better than what’s in the produce aisle. Try buying large bags of frozen mixed berries at the wholesale club or discount grocery, as they are much more economical than fresh and don’t go bad.
  • Nuts and/or seeds and/or grains of your preference: for example, unsalted nuts, toasted seeds or grains, or a combination such as a low-sugar granola.
  • Your favorite yogurt, ideally plain or low-sugar.
  • Eggs are no longer considered anathema, so an occasional one or two are OK, and consider hard-boiled, especially if you’re on the go.
  • More leisurely breakfast at home: You might add whole-grain toast, but make sure it contains whole grain on the label, contains less than 180 mg. of sodium and fewer than 110 calories per slice, with no saturated or trans-fats. But be careful what spread you place on top: Instead of butter, consider cholesterol-lowering sterols/stanols such as Benecol, but others containing olive oil are also acceptable.

Why is this a healthy breakfast?

The fruit is not a token sprinkle, nor a decorative touch. The fruit makes up the bulk of this meal. There’s fiber in the fruit (but little in most juices), and plant sugars in their natural form, not to mention healthy fat in the nuts, and protein in the yogurt. A low-sugar yogurt will leave us feeling more satisfied, for longer. We won’t get the insulin spike that triggers hunger pangs (unlike when we eat processed carbs).

If you want to step it up a notch, ditch the dairy. We can get plenty of calcium and other vitamins from leafy greens and other veggies, so take your choice. At any rate, consider yogurt, for it contains not only creamy protein and probiotics, which can be weighed against the recognized risks of regular consumption of animal products that should be limited as much as possible. The rest is up to you.

Enjoy!

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A Little Known Toxin, Acrylamide, and Reasons to be Concerned

Acrylamide is a neurotoxin and probable carcinogen (cancer causing agent) formed when certain starchy foods, such as wheat and potatoes, are cooked at high temperatures (>248 degrees Fahrenheit). It can also be produced when coffee and cocoa beans are roasted. It is also found in surprisingly high amounts in prune juice and some types of canned olives. Although no level of exposure is absolutely safe, amounts of acrylamide consumed by most adults are believed to represent a very low level of risk. Nevertheless, there are steps you should be aware of in order to reduce your exposure.

What levels are considered “safe”

Exposure to even extremely small amounts of acrylamide may very slightly increase cancer risk, which has led the State of California to require a cancer warning on foods providing more than 0.2 mcg of acrylamide per daily serving (below which there is no known significant risk of cancer), although up to 140 mcg is permitted before a warning regarding reproductive toxicity is required. The U.S. EPA also uses this higher 140 mcg amount as its reference dose for risk to the nervous system.

How much is in what we eat?
An adult weighing 150 lb consumes about 35 mcg of acrylamide per day (0.5 mcg/kg of bodyweight). This is well below the 140 mcg EPA limit, although exceeds California’s very stringent limit of 0.2 mcg, noted above.

In the U.S., fried potato products (i.e., French fries, potato chips, roasted potatoes) account for the greatest source of acrylamide in the diet, accounting for up to 38% of average exposure for adults, followed by crackers, cookies and cakes (17%), bread (14%), snacks such as roasted nuts, and popcorn (14%), cereal products (9%), and lastly, coffee (8%).  High amounts of acrylamide are also found in products that you might not expect, such as in prune juice and canned olives.

A study of prune products purchased in Canada, for example, disclosed that regular pitted prunes contained about 10 mcg of acrylamide per 7 prunes but organic pitted prunes contained only about one-third of that amount.; however, organic prune juice contained even higher amounts of acrylamide — about 100 mcg per 5 oz serving (a small glass), while regular prune juice contained about half that amount.

Canned black olives can contain as much as 8 mcg of acrylamide per 5 olives, while California-style green ripe olives contain much lower amounts — about 1 mcg per 5 olives.

To get a better sense of how much acrylamide this may be (and how this compares to the EPA’s limit of 140 mcg of acrylamide per day) see the table below:

Estimated amounts of acrylamide in common foods

Food Serving size Acrylamide per serving (mcg)
French fries, oven-baked 2.5 ounces (about 12 fries, depending on size) 48.8 mcg
Prune juice 5 ounces 30 mcg to 100 mcg
French fries, restaurants 2.5 ounces (about 12 fries, depending on size) 28.3 mcg
Potato chips 1 ounce (about 15 chips) 17.9 mcg
Canned black olives 5 olives 3.2 to 8 mcg
Breakfast cereal 2 ounces (1/4 cup) 6.6 mcg
Brewed coffee 8 ounces 1.9 mcg
California-style green ripe olives 5 olives 1 mcg

Coffee
Green coffee beans contain asparagine (it is the second-highest concentration amino acid in coffee beans) as well as sucrose (sugar). When roasted, significant amounts of acrylamide can be produced; however, brewed coffee (most of which is water) contains only about 2 mcg per 8-ounce cup, as shown above.

Cocoa and chocolate
As with coffee beans, cocoa beans are typically roasted during processing, resulting in the production of acrylamide. FDA tests of various cocoa powders and dark chocolate baking bars in 2002 showed amounts of acrylamide ranging from 0.29 mcg to 4.5 mcg per serving; however, there was no detectable acrylamide found in a popular milk chocolate bar.

It is likely that raw cacao contains much lower concentrations of acrylamide than cocoa and dark chocolate, as it is not roasted at high temperatures: For example, Viva Naturals claims that it’s raw cacao is lightly roasted at a maximum temperature of 114 degrees Fahrenheit, and Navitas Organics claims it is fermented only with the heat of sunlight for 24 to 48 hours. There is no regulatory definition of the term “raw” on foods, but it tends to mean minimally processed without high heat.

What can you do to reduce your acrylamide intake?

Potatoes
Limit your intake of roasted, baked and fried potatoes, chips, etc. Store raw potatoes in a cool dry place, such as a pantry or cupboard — not in the refrigerator, as the cold temperature increases the amount of sugars in potatoes, increasing acrylamide generation during high-heat cooking. Fry at the lowest possible temperature for the shortest possible amount of time (aim for a golden yellow color rather than golden brown). Soaking sliced potatoes in water for 15 to 30 minutes (or for 5 minutes in warm, slightly salted water) before frying or roasting may also reduce acrylamide formation.

Prunes and Olives
Limit your intake of prune juice. Choose green olives over black.

Coffee
Several factors can modestly reduce the amount of acrylamide in your coffee when prepared at home:

  • Choose coffee made from Arabica beans, which contain lower amounts of asparagine than Robusta beans. However, be aware that this won’t guarantee lower acrylamide, since amounts are also affected by roasting time, temperature, etc.
  • Store coffee before using for longer periods of time. Acrylamide levels in commercial ground coffee and beans decrease over time when stored in their original container. Reductions of 40—60% have been reported in coffees stored at room temperature over a period of 6—12 months.
  • Plunger pot and filtered, drip brew coffee preparation typically results in less acrylamide than coffee prepared by decoction (such as Turkish coffee) and pressure preparation (French press, expresso).

Cocoa and chocolate
Milk chocolate and alkalized cocoa products may contain less acrylamide than non-alkalized dark chocolate, but, unfortunately, will also contain lower amounts of healthy flavanols. As noted earlier, “raw” is likely to be low in acrylamide while, as shown in most tests, relatively high in beneficial flavanols.

The bottom line:
Acrylamide is a neurotoxin and probable carcinogen formed when cooking certain foods at high temperatures. Fried and roasted potato products are the greatest source of dietary acrylamide exposure in the U.S. Prune juice has particularly high amounts. Brewed coffee and cocoa contain small amounts of acrylamide. It is possible to reduce exposure to acrylamide by avoiding certain foods and modifying the way you prepare potatoes and coffee, as discussed above.

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ANALYSIS OF TRUMP: THE PSYCHIATRISTS FINALLY STEP FORWARD

The Goldwater rule: Section 7.3 of the American Psychiatric Association, code 2013, states “It is unethical for a psychiatrist to offer a professional opinion on a public figure unless he or she has conducted an examination and has been granted proper authorization for such a statement”. But this doctrine does not extend to information derived from the professional analysis of public behavior that could endanger the security of an entire nation, or even the world!

Thus a large body of professionals has broken this self-imposed silence and recently released a book entitled “The Dangerous Case of Donald Trump: 27 Psychiatrists and Mental Health Experts Assess a President”, Edited by Bandy X Lee, M.D.

When assessing Trump’s behavior, the layman often states that he is “crazy like a fox,” implying that, as a presumably rational human being, Trump is merely cleverly twisting and manipulating information as a ploy to gain some advantage for the benefit of his political followers and/or society at large. But, as made amply clear by this large group of well-qualified mental health professionals, this is clearly not the case! Accuracy requires the removal of the word “fox” from this statement above, simply yielding “crazy like a crazy.” Moreover, the frequently expressed sentiment that Trump, once reaching the White House, will pivot to a rational demeanor, is clearly refuted by these experts, which, as they presciently state, will only worsen. These professional opinions also transcend all political affiliations.

Through the opinions written by this large number of mental health professionals, an overwhelming unanimity is expressed: We are dealing with a dangerously and psychopathically ill individual. The eccentricities of Trump’s behavior are known by almost everyone, but they are often misinterpreted: Examples include distorting facts and outright lying (he had the largest inaugural crowd ever), megalomania (he knows more than the generals), bullying and denigration of rivals (crooked Hillary, low energy Bush, little Marco, etc), excessive need for adulation (as demonstrated by the sycophantic and apparently forced statements made by his cabinet members), lack of empathy (let’s injure family members of terrorists), paranoid delusions (Obama has wiretapped the Trump Tower), intolerance of criticism, failure to admit errors, revering foreign despots whom he wishes to emulate, and many others.

As one pages through the psychiatric opinions of the book noted above, it is apparent that Trump’s many bizarre characteristics stem from serious mental aberrations that many would consider “psychotic.”  The disease name that most often crops up is that of “malignant narcissism,” a serious disorder that underlies his many delusions, distortions and lies, which actually represent extreme overreactions from deep-seated feelings of shame and inferiority. Making matters even more dangerous, he actually believes them to be true!

These professionals are especially fearful of the proximity of this individual to the nuclear trigger. They believe that he is capable of—through an episode of rage or irrationality—triggering a major war. The consensus of these professionals is that such a dangerously ill individual should be removed from office by any legal means as soon as possible. Thus it is important for all responsible citizens to understand what is at stake and to act accordingly.

Above all, read this book, and if you agree with me that it is important, spread the word far and wide!

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OBESITY: AN UNKNOWN CAUSE OF CANCER

Obesity-related cancers rising, threatening gains in U.S. cancer rates

The rates of 12 obesity-related cancers rose by 7 percent from 2005 to 2014, an increase that is threatening to reverse progress in reducing the rate of cancer in the United States, U.S. health officials said on Tuesday.

According to the U.S. Centers for Disease Control and Prevention, more than 630,000 people in the United States were diagnosed with a cancer linked with being overweight or obese in 2014.

Obesity-related cancers accounted for about 40 percent of all cancers diagnosed in the United States in 2014. Although the overall rate of new cancer diagnoses has fallen since the 1990s, rates of obesity-related cancers have been rising.

“Today’s report shows in some cancers we’re going in the wrong direction,” Dr. Anne Schuchat of the CDC said on a conference call with reporters.

According to the International Agency for Research on Cancer, 13 cancers are associated with overweight and obesity. They include meningioma, multiple myeloma, adenocarcinoma of the esophagus, and cancers of the thyroid, postmenopausal breast, gallbladder, stomach, liver, pancreas, kidney, ovaries, uterus and colon and rectum (colorectal).

In 2013-2014, about two out of three U.S. adults were considered overweight or obese. CDC researchers used the U.S. cancer statistics database to see how obesity was affecting cancer rates. Although cancer rates rose in 12 of these cancers from 2005 to 2012, colorectal cancer rates fell by 23 percent, helped by increases in screening, which prevents new cases by finding growths before they turn into cancer.

Cancers not associated with overweight and obesity fell by 13 percent.

Not surprisingly, about half of Americans are not aware of this link. The findings suggest that U.S. healthcare providers need to make clear to patients the link between obesity and cancer, and encourage patients to achieve a healthy weight.

These trends are concerning, There are many good reasons to strive for a healthy weight, and now you can add cancer to the list. However, the science linking cancer to obesity is still evolving, and it is not yet clear whether losing weight will help individuals either prevent cancer or ameliorate it once a cancer has taken root.

What is clear is that obesity can raise an individual’s risk of cancer, and that risk is likely to be reduced by maintaining a healthy weight. But in any event, why take that risk

 

 

 

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COLON CANCER: STRATEGIES FOR PREVENTION AND DETECTION

A new report shows that what you eat really can be preventive

More than 130,000 men and women are told they have colon or rectal cancer every year, making it the third most commonly diagnosed cancer, according to the American Cancer Society.

But a new report from the American Institute for Cancer Research and the World Cancer Research Fund provides new evidence that the right eating and exercise plan can really help lower your risk of developing the disease.

In the report, researchers analyzed 99 studies with data on 29 million people.

“The findings are clear that diet and lifestyle play a major role,” says lead author Edward L. Giovannucci, M.D., Sc.D., professor of nutrition and epidemiology at the Harvard TH Chan School of Public Health. “Despite its prevalence, colorectal cancer is a highly preventable disease.”

Foods To Eat More Of

It’s long been suspected that eating more whole grains will reduce your risk of colon cancer, but this is the first time that it has been confirmed.

“Until recently, there had not been many studies that directly examined whole grain intake and subsequent colorectal cancer risk in large populations,” says Giovannucci. “But now we have enough research to say the link has strong evidence.”

In fact, eating about three servings of whole grains a day can lower colorectal cancer risk by 17 percent. (One serving is equal to 1 cup of ready-to-eat cereal, a slice of bread, or ½ cup of cooked rice or pasta.)

Why do whole grains help?

“Fiber is one of the keys to prevention of colon cancer,” says Michael A. Valente, M.D., a colorectal surgeon at the Cleveland Clinic, who was not involved in the AICR/WCRF report. “But we suspect that it’s really the thousands of nutrients, minerals, and other natural chemical compounds present in foods that are high in fiber—such as whole grains and fruits and vegetables—that are helping to prevent cancer, not just the fiber itself.”

Many of these compounds have what the report called “plausible anti-carcinogenic properties.” Which is why, in addition to eating more whole grains, it’s smart to increase consumption of fiber-rich fruits and vegetables as well.

Foods To Cut Back On

The researchers found that eating a lot of red meat (such as beef and pork) and processed meat (such as bacon, cold cuts, and sausage) were potentially harmful.

Every 1.8 ounces a day of processed meat increased risk by as much as 16 percent, while eating more than about 17½ ounces of red meat a week was labeled a “probable cause” of colorectal cancer.

One theory as to why these meats increase colon cancer risk is that they have high levels of iron derived from blood, which has been shown to promote the growth of colorectal tumors.

The connection between alcohol and colorectal cancer was also “convincing,” according to the report, and was especially strong for those who drink more than 30 grams per day (the equivalent of about two glasses of wine, or two cocktails or two beers).

“If you do consume alcohol, keep your intake moderate,” recommends Giovannucci.

Other Steps You Can Take

Getting more whole grains and veggies, and less meat may have another risk-reducing benefit: helping you to maintain a healthy weight. According to the report, there is strong, convincing evidence that people who are overweight are more likely to develop colon cancer.

All types of physical activity—not just formal exercise—was protective, too, with the most active people having about 20 percent lower risk of colon (but not rectal) cancer than the least active.

The report did not cover screening for colon cancer, but it’s a preventive move that deserves mention, and detailed below. Colorectal cancer usually develops over 10 to 15 years without causing symptoms. Most cases start as noncancerous polyps in the lining of the large intestine or the rectum. Detecting and removing polyps prevents them from developing into cancer.

You should have a colonoscopy every five to 10 years staring at age 50.

And if you have a close relative who had colorectal cancer, you should be even more vigilant about changing your lifestyle and getting regular screenings.

“Having a first-degree relative (mother, father, sibling) with the disease increases your risk by nearly 100 percent compared to the average person,” says N. Jewel Samadder, M.D., a gastroenterologist at the Mayo Clinic and expert with the American Gastroenterological Association.

If that’s you, experts recommend that, in addition to improving your diet, weight, and activity level, you start getting colonoscopies at age 40.

Can a Daily Aspirin add to Prevention of Colon Cancer?

New guidelines suggest aspirin can prevent some forms of cancer, but taking one isn’t a good idea for everyone

A recent analysis by the U.S. Preventive Services Task Force suggests that aspirin might lower your risk of certain cancers, especially colon cancer if it’s taken long term. But you shouldn’t take aspirin for cancer prevention alone. That’s because the drug also poses risks—in particular the risk of dangerous bleeding in the stomach and brain—that may outweigh its possible protective effect against cancer.

But if you and your doctor decide that taking a daily, low-dose aspirin (81 mg, or a “baby aspirin”) is a good way to reduce your risk of heart disease, then think of a reduced risk of colon cancer as a bonus.

Considerable research going back decades shows that taking low-dose aspirin can help prevent heart attacks and ischemic strokes (the kind caused by blood clots) in people at high risk for cardiovascular disease. Now, researchers at the Preventive Services Task Force, an independent, volunteer panel of experts in prevention and evidenced-based medicine, have looked back at those studies to see what effect aspirin might have had on the risk of cancer. Combined data from three large studies involving 47,464 people suggested that, compared to people who didn’t take aspirin, those who did reduced their risk of colon cancer by about 40 percent, but only 10 to 19 years after they started taking the drug.

Uncertain Benefits vs. Known Harms

Encouraging results make a compelling case for ongoing, high-quality research looking at various cancers, but current evidence doesn’t support taking aspirin solely to prevent colon cancer. The evidence to date has to be interpreted cautiously, because it comes largely from a small set of older trials on cardiovascular disease prevention that were not set up to study the effect of aspirin on cancer. As a result, one cannot issue a blanket recommendation for the use of aspirin specifically for prevention of any cancers.

 EARLY DETECTION OF CANCER: WHAT YOU NEED TO KNOW

Been putting off that colonoscopy? A new review evaluates the other screening options.

Colonoscopy has long been touted as the gold standard for colon cancer screening, recommended for all adults starting at age 50. With colon cancer expected to kill more than 49,000 Americans this year, getting a colonoscopy is currently the best way to reduce your risk. But, many people avoid colonoscopy because it includes an unpleasant 12-hour prep that includes drinking copious amounts of laxative and many trips to the bathroom, followed by the procedure itself, which costly and typically requires anesthesia.

Instead, consumers may want to opt for one of the two at-home colon-cancer screening tests available by prescription.

A new review published in JAMA by David Lieberman, M.D., professor of medicine and chief of gastroenterology at Oregon Health and Science University in Portland, concludes that home tests may be a decent first-step screener—although patients still need a colonoscopy if the kits find a worrisome result. What’s more, the kits can miss polyps, including precancerous growths that a doctor can spot and remove at the time of the colonoscopy.

                AT-HOME KITS

     FIT Test (Fecal Immunochemical Test)

The second most commonly prescribed colon-cancer screening test in the U.S. after colonoscopies, FIT tests have been in use for about 10 years.

The FIT test requires sending a single small fecal sample to a lab, which is then tested for blood. It’s a test that should be repeated annually, unlike colonoscopy, which is typically required just once every 10 years.

A person may have a cancer that isn’t bleeding at the time of the test, but that same tumor may bleed and be detected when the person is retested the following year. Research shows that this type of test detects cancer with 79 percent accuracy. But about five percent of tests deliver “false positive” results—which result in patients having to go for follow-up colonoscopies.

       Multitarget Stool DNA Test

This test goes by the brand name Cologuard. It requires shipping an entire bowel movement to the lab. In addition to testing for blood, Cologuard looks for DNA from cancer cells scraped from the intestinal wall by feces as it passes through.

Studies have shown that this type of test detects cancer with 92 percent accuracy. However, 14 percent of tests deliver false positive results—far higher than the FIT test.

Another concern with this test is its sheer newness. Because Cologuard only received Food and Drug Administration approval in 2014, there are no studies showing that people who choose this screening method avoid dying of colon cancer in the long-term.

Studies also have not yet established the appropriate interval between testing, though the U.S. Preventive Services Task Force (USPSTF), an independent panel of health experts that advises the government, recommends repeating the test every one or three years.

           BOTTOM LINE FOR SCREENING

If you have a personal or family history of colon cancer, then regular colonoscopies clearly are the best choice. For the rest of us, the best approach is less clear, but until more research data are available, colonoscopy (sadly) is still the safest route.

Sorry to disappoint!

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VALUE OF FRUIT AND VEGETABLE CONSUMPTION: MORE IMPORTANT NEWS

A recent large study assessed the correlation between food intake and cardiovascular disease and deaths in the Middle East, South America, Africa, or south Asia. A link was brought to light between increased fruit, vegetable, and legume consumption with a lower risk of cardiovascular and total mortality. Maximum benefits could be derived for total mortality at three to four servings of any of these components per day (equivalent to 12 to 17 ounces per day) .

This study evaluated 135,335 individuals aged 35 to 70 years without cardiovascular disease. Enrollees were selected from 613 communities in 18 low-income, middle-income, and high-income countries in seven geographical regions: North America and Europe, South America, the Middle East, south Asia, China, southeast Asia, and Africa. Their diet involved country-specific food frequency questionnaires at baseline. The data contained demographic factors, socioeconomic status (education, income, and employment), lifestyle (smoking, physical activity, and alcohol intake), health history and medication use, and family history of cardiovascular disease.

The main outcomes were cardiovascular diseases of all types, cardiovascular mortality, non-cardiovascular mortality, and total mortality. They assessed the correlations between fruit, vegetable, and legume consumption with risk of cardiovascular disease events and mortality.

The study covered 10 years beginning in 2003, and was concluded at the end of March, 2017. Combined mean fruit, vegetable and legume intake averaged 3.9 servings per day. During a median 7.4 years of follow-up, the following events were reported: 4784 major cardiovascular disease events, 1649 cardiovascular deaths, and 5796 total deaths.

Higher total fruit, vegetable, and legume intake displayed an inverse correlation with major cardiovascular diseases and total mortality in the models adjusted for age, sex, and random effects. The overall hazard ratio for total mortality was lowest for three to four servings per day compared with the groups taking substantially less.  Interestingly, there was no additional decrease in hazards with higher consumption.

Fruit intake was related to lower risk of cardiovascular, non-cardiovascular, and total mortality.

Legume intake was also inversely linked with non-cardiovascular death and total mortality.

For vegetables, raw vegetable intake strongly correlated with a lower risk of total mortality.  In contrast, cooked vegetable intake exhibited a modest benefit against mortality. 

                 Conclusion

This study adds further support for what we have recommending for many years. In general, dietary patterns in the U.S. have been trending in this direction, but for many, obesity seems to be nullifying much potential benefit. I was a bit surprised by the suggestion that raw vegetables might be better than their raw counterparts, but any firm conclusions will await further study.

Although the study did not detail the causes for reductions of non-cardiovascular mortality, from what we already know, it is likely that various cancers were likely prevented as well.

 

 

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UNNEEDED MEDICAL CARE: A CONTRIBUTOR TO HIGH COSTS

Unnecessary medical care is common in the United States, and a fear of malpractice seems to be an important driver for ordering unneeded tests and treatments, a new survey found.  Other factors include patient demand and doctors’ desire to boost profits, the researchers said.

“Unnecessary medical care is a leading driver of the higher health insurance premiums affecting every American,” said study senior author Dr. Martin Makary, professor of surgery and health policy at Johns Hopkins University School of Medicine in Baltimore.

Unneeded medical care accounts for a large chunk of wasted health care resources and costs in the United States and leads to about $210 billion in extra spending each year, according to the National Academy of Medicine.

The researchers surveyed more than 2,000 U.S. doctors in a wide variety of specialties and found that most believed 15 to 30 percent of medical care is not needed, including 22 percent of prescription medications, 25 percent of medical tests, 11 percent of procedures and 21 percent of overall medical care.

Leading reasons cited by the doctors for overuse of medical resources were fear of malpractice (85 percent), patient pressure/request (59 percent), difficulty accessing prior medical records (38 percent), and profit (17 percent).

Specialists and doctors with at least 10 years of experience after residency were more likely to believe that doctors perform unnecessary procedures when they stand to profit, according to the study.

“Interestingly, but not surprisingly, physicians implicated their colleagues [more so than themselves] in providing wasteful care. This highlights the need to objectively measure and report wasteful practices on a provider or practice level so that individual providers can see where they might improve,” said study co-author Dr. Daniel Brotman, a professor of medicine at Hopkins.

The respondents said the best ways to reduce unneeded care include training medical residents on appropriateness criteria for care (55 percent), easy access to outside health records (52 percent), and more evidence-based practice guidelines (51.5 percent).

“Most doctors do the right thing and always try to, however, today ‘too much medical care’ has become an endemic problem in some areas of medicine. A new physician-led focus on appropriateness is a promising homegrown strategy to address the problem,” Makary said in a university news release.

WHAT CAN THE INDIVIDUAL PATIENT DO?

These data suggest some appropriate responses for individual patients: First, when any test such as an X-ray of the back, neck, or elsewhere, is recommended, one should question its need. Furthermore, can the test be done at a later date and how much will any given result affect the resulting treatment? Many suspected ailments will subside with time and render any testing unnecessary. Will the management be altered regardless of the test’s outcome? If not, maybe it can be avoided altogether. Moreover, don’t insist on a given test or procedure if the physician believes it is unnecessary or can wait until later—even if you have insurance that with cover much of the cost. Before any prescription is given, ask whether cheaper alternatives—especially generics—are just as effective. Even more important, perhaps a given prescription can be avoided altogether without any consequences to health.

These are some of the tips that can empower patients to participate in reduction of overall costs of healthcare in this entire nation.

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NUTS: DESPITE THE NAME, THEY MAY BE A PANACEA

Eating almonds on a regular basis may help boost levels of the good (HDL) cholesterol while simultaneously improving the way it removes cholesterol from the body. According to researchers, who, in a recent study, compared the levels and function of high–density lipoprotein (HDL cholesterol) in people who ate almonds every day, to comparable levels of the same group of people when they ate a muffin instead. The researchers found that while participants were on the almond diet, their HDL levels and functionality improved. The study, published in the Journal of Nutrition, builds on previous research on the effects of almonds on cholesterol–lowering diets. The researchers wanted to see if almonds could not just increase the HDL levels but also improve the function of this component, which works by gathering cholesterol from tissues, like the arteries, and helping to transport it out of the body.
HDL is very small when it gets released into circulation, and acts like a garbage bag that slowly gets bigger and more spherical as it gathers cholesterol from cells and tissues before depositing them in the liver to be broken down.
Depending on how much cholesterol it has collected, HDL cholesterol is categorized into various subpopulations, which range from the very small to the larger, more mature forms. The researchers hoped that eating almonds would result in more larger particles, which would signal improved HDL function.
In a controlled–feeding study, 48 men and women with elevated LDL cholesterol participated in two six–week diet periods. In both, their diets were identical except for the daily snack. On the almond diet, participants received 43 grams — about a handful — of almonds a day. During the control period, they received a banana muffin instead. The researchers found that, compared to the control diet, the almond diet increased HDL particles to their largest size and most mature stage — by 19 percent. They were able to show that there were more larger particles in response to consuming the almonds compared to not consuming almonds, which would translate to the smaller particles doing what they’re supposed to be doing. They’re going to tissues and pulling out cholesterol, getting bigger, and taking that cholesterol to the liver for removal from the body. An increase in this particular HDL subpopulation is meaningful, because the particles have been shown to decrease overall risk of cardiovascular disease.
If people incorporate almonds into their diet, they should expect multiple benefits, including ones that can improve heart health. Obviously, they’re not a cure–all, but when eaten in moderation – and especially when eaten instead of a food of lower nutritional value – they’re a great addition to an already healthy diet. Other nuts may provide similar benefits, but they have not been studied in this fashion. Nevertheless, they may provide other benefits as well, such as in cancer prevention, as we present below.

A recent study showed that nut and peanut butter consumption can reduce the risk of esophageal and gastric cancer. Previous studies had suggested that nut consumption has been associated with decreased risk of colorectal, endometrial, lung, and pancreatic cancers. Polyphenols, fiber, vitamins, and minerals in nuts may confer this observed protective effect. Up to now, no prospective study has evaluated the effect of nut consumption on esophageal and gastric cancers. The objective was to evaluate the associations between nut and peanut butter consumption and the risk of esophageal and gastric cancers and their different subtypes. The most recent study used data from the NIH-AARP Diet and Health Study, which enrolled 566,407 persons who were 50–71 years old at baseline (1995–1996). The median follow-up time was 15.5 years. Intakes of nuts and peanut butter were assessed through the use of a validated food-frequency questionnaire. Statistical models estimated risks for esophageal and gastric cancers. Compared with those who did not consume nuts or peanut butter [lowest category of consumption], participants in the highest category of nut consumption had a lower risk of developing the most common type of stomach cancer  The same association was also seen for peanut butter consumption.

This information is added to what we already know about nuts in general. Almost all nuts provide good sources of caloric energy, primarily from unsaturated fats (oils), they are useful also for lowering cholesterol. Moreover, the essential amino acids contained in nuts are vital for constructing protein, i.e., the building blocks for our muscles and other tissues. Although each type of nut does not supply, in itself, a complete source of these amino acids, consuming a variety of nuts will provide a complete complement of the various necessary (essential) components. Other nutritional elements provided by nuts include folic acid, vitamin E, potassium, magnesium, and calcium. Especially noteworthy is their uniformly low sodium content, a highly desirable feature (provided that no salt is added). They also contain polyphenols, bioactive constituents that seem to be beneficial to heart health that extends beyond other dietary constituents.

During the past 20 years, mounting evidence indicates that consuming all nuts (including peanuts and peanut butter) at least twice weekly provides substantial protection from cardiovascular disease and overall death rates as compared to those consuming them only rarely or not at all. These desirable results seem to share the stage with almonds, as noted above, primarily through the rearranging of cholesterol components, and despite a substantial caloric content, nuts have less tendency to promote obesity, probably because of their prominent satiating effect. For unknown reasons, nuts also appear to prevent diabetes, another contributor to cardiovascular disease. Research studies have also indicated that, if the “Mediterranean” diet, which, in itself is healthy, is supplemented by extra mixed nuts (one ounce daily) and extra virgin olive oil (one quart total per week), substantial additional reductions of cardiovascular disease and stroke can be accomplished.

The bottom line? Forget the junk food and opt for any kind of nuts, whether with meals or as free-standing snacks!

 

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SOME HEALTHY SNACKING STRATEGIES

                           

How can you keep snacking from derailing your healthy eating program, not to mention weight control? Try these tips.

Don’t skip meals. Skipping meals may seem like a good way to cut calories, but in fact this just makes you so hungry later in the day that you’re vulnerable to devouring mega-portions of snack food in order to supply your body with easily digested sugars.

Keep junk food out of the house. There’s a lot of truth to the old joke about the “see-food diet” — you see food and you eat it. The opposite is also true. If you don’t have junk food lying around, the sight of it won’t tempt you, so don’t even bring it home. After all, you can’t eat what isn’t there. Or, if someone in your household tends to have chips or other unhealthful snacks, put them out of sight.

Snack mindfully. Have you ever watched a show on television with a bag of chips or pint of ice cream in hand, only to find that it was all gone before you knew it? This type of mindless eating can pack on a lot of unwanted calories. The solution is simple. Try not to snack while doing something else like surfing the Web, watching TV, or working at your desk. Instead, stop what you’re doing for a few minutes and pay attention to your snack. Savoring a piece of fine chocolate can be more satisfying than gobbling down a whole chocolate bar.

Remember, you can take it with you. Think ahead and carry a small bag of healthful snacks in your purse or the glove compartment of your car. If you have a healthy snack handy — preferably, one you really like — you won’t turn in desperation to the calorie-laden cookies at the coffee counter or the candy. My preference is a wide variety of nuts—peanuts, pistachios, etc. It’s best to consume them in their salt-free form. Popcorn is also a viable option, but again without salt or other high caloric additives. Additional ideas are provided in a previous post: http://www.mortontavel.com/2015/04/05/

Zero in on hunger. Before you snack, ask yourself, “Am I truly hungry?” Many of us mistake emotions, such as stress and fatigue, for hunger. If the answer is yes (your stomach feels hollow, your head is achy), make sure you’re not confusing hunger with thirst. Drink an 8-ounce glass of water, then wait 10 to 15 minutes. If you’re still hungry, have a healthful snack.

Know your cravings. If you want a snack, but you’re not hungry, attack cravings from a psychological level. Ask yourself how you’re feeling. Lonely? Bored? Stressed? Then, ask yourself the bigger question: Will food fix this problem? The answer is always no. Eating a cookie, for example, won’t address a problem at work that you’re worried about. Go for a walk around the block, do a few stretches, put on some music, or choose another simple activity that might distract you or boost your mood. Then if you still want the food, fine. Ask yourself what food you really want. Then eat only a small amount, and make it good. If you’re craving chocolate, for example, eat one small square and savor it. It’s important that you snack on what you’re craving rather than deny the craving. Eating around a craving may only cause you to eat more because the craving isn’t satisfied.

Hopefully, these tips might make life a bit more pleasant and free of that undesirable excess weight!

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Health benefits of physical activity: A recent update explaining how much and what kind is most effective.

   A recent review clearly explains the health benefits of physical activity and exercise; virtually everyone can benefit from becoming more physically active. Most international guidelines recommend a goal of 150 min/week of moderate-to-vigorous intensity physical activity. Many agencies have translated these recommendations to indicate that this volume of activity is the minimum required for health benefits. However, recent evidence has challenged this threshold-centered messaging as it may not be evidence-based and may create an unnecessary barrier to those who might benefit greatly from simply becoming more active. This review summarizes recent information that has examined the relationship between physical activity and health status.

The Findings

Assessment of a large body of data (based largely on epidemiological studies consisting of large cohorts) have demonstrated a dose–response relationship between physical activity and premature mortality and the primary and secondary prevention of several chronic medical conditions. The relationships between physical activity and health outcomes are generally curvilinear such that marked health benefits are observed with relatively minor volumes of physical activity. These findings challenge current threshold-based messaging related to physical activity and health. They emphasize that clinically relevant health benefits can be accrued by simply becoming more physically active. This information is summarized nicely on the following Video:    http://links.lww.com/HCO/A42.

Conclusion: There’s hope for us all!

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DIETARY FATS AND HEART HEALTH: HERE ARE THE FACTS

The American Heart Association (AHA) has issued a new “Presidential Advisory” on dietary fats and cardiovascular disease to “set the record straight” on the dangers of saturated fats.

The statement by the American Heart Association, June 15, continues to strongly recommend replacing saturated fats with poly- and monounsaturated vegetable oil to help prevent heart disease.

The statement also recommends that the shift from saturated to unsaturated fats should occur simultaneously in an overall healthful dietary pattern, such as DASH (Dietary Approaches to Stop Hypertension) (http://www.mortontavel.com/2013/05/02/) or the Mediterranean diets, and that “good carbohydrates,” such as whole grains and whole fruits, are other appropriate foods to substitute for saturated fats.

“We want to set the record straight on why well-conducted scientific research overwhelmingly supports limiting saturated fat in the diet,” stated lead author, Frank Sacks, MD, professor of cardiovascular disease prevention at the Harvard T.H. Chan School of Public Health, Boston, Massachusetts.

Outside nutritional experts were fully supportive of the advisory, describing it as “an outstanding paper,” “exacting in its review of the evidence,” and “full of common sense.”

The AHA leadership decided that they needed to put out a new advisory on diet — particularly fats — because of various commentators on nutrition suggesting that saturated fat was innocuous, which has been widely covered in the media, but these comments were not scientifically based.

Unfortunately, a great deal of attention has been paid to controversial new studies that are not scientifically rigorous. A growing trend of media articles focusing on small studies suggests that some saturated fats are “good for you.”  Some people suggest that eating butter and full-fat milk is beneficial. And coconut oil is a fad right now — but it is actually a saturated fat, which raises your LDL [low-density lipoprotein], so the AHA wanted to look at the issue again.

The AHA president issued an advisory identifying this as a key issue that needed attention. Conclusions were based on careful scientific review, organized in a very systematic way, involving experts from a wide range of fields who have looked very carefully at the literature. Then the recommendations were thoroughly vetted and passed through multiple levels of peer review and scientific advisory committees across the entire AHA. This statement focused on fats — what fats should we be eating — and they concluded very strongly that we all should eat less saturated fats, and these can be replaced by polyunsaturated and monounsaturated fats. This recommendation was supported by multiple scientific studies that demonstrated that by lowering intake of saturated fat and replaced it with polyunsaturated vegetable oil, cardiovascular disease is reduced by approximately 30%. In addition, several studies found that coconut oil — which is predominantly saturated fat but widely touted as healthy — raised LDL cholesterol the same way as did other saturated fats found in butter, meat, and palm oil.

Their message is that “polyunsaturated fats are the best fats to eat. They are found mainly in vegetable oils such as soy bean oil, peanut oil, corn oil. Monounsaturated fats, found in sunflower oil, olive oil, nuts, and avocado, are also okay — much better than saturated fats, and may be as healthy as polyunsaturated fats.”

The last few years has seen an increase in knowledge on benefits of polyunsaturated fats. They are associated with a reduction in total mortality and no compensatory increase in death from other causes; they are also associated with a reduction in insulin resistance, helpful in combating diabetes.

   The AHA document is full of common sense. It is not controversial, but saturated fat is scientific code for animal fat. This statement is telling us to eat less meat, but they are not actually using those words, possibly to avoid alienating livestock farmers. There is now a weight of evidence that plant foods — which are very low in saturated fat — are beneficial. It has been shown time and time again that these foods can reduce heart disease.

    Thus here is a clear statement that should allow us all to react sensibly!

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