August 19th, 2014

Unbelievable! FDA Approves New Sleep Drug Despite Lots of Questions Unanswered

Introduction:

The FDA recently announced the approval of a new type of sleeping pill from Merck known as Belsomna® (suvorexant) despite significant safety concerns. This approval calls into question whether the FDA is more concerned about protecting the health of Americans or aiding drug companies in achieving higher profits.

Previously, the FDA had declined to approve Belsomna®. So what changed? It is quite an interesting story.

Background Data:

Over the course of a year, over one-half of the U.S. population will have difficulty falling asleep. About 33% of the population experiences insomnia on a regular basis with 17% of the population claiming that insomnia is a major problem in their lives. Many use over-the-counter sedative medications to combat insomnia, while others seek stronger prescription medications from their physicians. Each year up to 12.5% of adults in the U.S. receive prescriptions for drugs to help them sleep. These drugs are the sedative-hypnotic drugs such as

  • alprazolam (Alprazolam, Xanax)
  • chlordiazepoxide (Librium)
  • diazepam (Valium)
  • eszopiclone (Lunesta)
  • flurazepam (Dalmane)
  • quazepam (Doral)
  • ramelteon (Rozerem)
  • temazepam (Restoril)
  • triazolam (Halcion)
  • zaleplon (Sonata)
  • zolpidem tartrate (Ambien)

All of these drugs are associated with significant risks. Problems with these drugs include the fact that most are highly addictive and very poor candidates for long-term use. Common side effects include dizziness, drowsiness, and impaired coordination. It is important not to drive or engage in any potentially dangerous activities while on these drugs. Alcohol should never be consumed with these drugs and could be fatal.

The most serious side effects of the conventional sleeping pills and anti-anxiety drugs relate to their effects on memory and behavior. Because these drugs act in a powerful manner on brain chemistry, significant changes in brain function and behavior can occur including an increased risk for dementia. Severe memory impairment and amnesia of events can also occur, as well as nervousness, confusion, hallucinations, bizarre behavior, extreme irritability and aggressiveness. They have also been shown to increase feelings of depression, including suicidal thinking.

Numerous population-based studies have also found that regular use of sleeping pills increases early mortality risk. Some of these studies have found that the use of sleeping pills predicted an increased risk of death from cancer. But, the strongest explanation for the increased risk of mortality with sleeping pill use is that it is associated with an increased frequency of depression. Considerable evidence shows that depression is also associated with an increased risk for an early death.

Because of the increased awareness of the problems with sedative-hypnotic drugs, pharmaceutical companies are focusing on developing new types of sleeping pills. In particular, Merck has been focusing on getting approval for Belsomra®. It is a new type of drug that alters the signaling of orexins, neurotransmitters responsible for regulating the sleep-wake cycle.

New Data:

In July 2013, the FDA rejected Merck’s application to approve Belsomra® because of side effect issues. So, what changed in one year? Merck simply lowered the dosage recommendation. By doing so, they reduced the frequency and severity of side effects – with next day hangover and impaired mental function being the most significant. But, there are still side effect risks at the lower dosage and the new lower dosage is not consistent with the dosage levels used by most patients in the 3 published double-blind, placebo-controlled trials.

Nonetheless, the FDA approved Belsomra® at 4 different strengths — 5 mg, 10 mg, 15 mg, and 20 mg. There is a warning that the total recommended dosage in one day should not exceed 20 mg. In contrast, the largest and longest published clinical trial to date used dosages of 30 or 40 mg per day.

The news report from the FDA stated it was determined that Belsomra® was effective based on 3 clinical trials involving more than 500 participants, but of these participants with insomnia, only 124 actually took the drug at the newly approved levels, the others took 30 mg, 40 mg, or even higher dosages. Hard to imagine that a drug was approved at a lower dosage based primarily on research using much higher dosage levels and with such a very small sample size of participants.

Evidently, one of the big concerns that the FDA had back in July 2013 was the effect of the drug on next day driving. So, the FDA asked Merck to perform next day driving tests in both male and female participants after taking 20 mg the night before. Results still showed those who took the 20 mg dose proved to be impaired drivers. The FDA’s response is for Merck to advise physicians to tell patients taking this dosage level that they should not drive or engage in other activities requiring full alertness. The agency also stated that patients taking lower doses also should know about the risk for impaired driving the day after because sensitivity to the drug varies from person to person.

Commentary:

So, the drug will put you to sleep at night, but it will impair your mental function so severely that you should not drive the next day? That does not seem like a good trade off. Bottom line is that I think it extremely unwise for physicians to prescribe or patients to take Belsomra®. There may be rare exceptions, for example, the drug may be suitable for people who need to be completely sedated and there is no concern of mental function the next day. But, for people living in the world in need of good sleep, I strongly recommend natural alternatives.

As a reader of my Natural Facts Newsletter, you are likely familiar with natural strategies that I recommend for improving sleep quality detailed in my free book to new subscribers: Stress, Anxiety, and Insomnia: What the Drug Companies Won’t Tell You and Your Doctor Doesn’t Know. There are safe and effective strategies to get a good night’s sleep. You are welcome to pass this link on to your family and friends, as too many people are getting hurt or dying from these prescription drugs.

Reference:
FDA News Release. FDA approves new type of sleep drug, Belsomra. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409950.htm

August 14th, 2014

Free Webinar – Understanding the Telomere Theory of Aging and What You Can Do About It

happy-couple-23

Are telomeres the key to aging?

The latest, and most likely, program theory of aging is the telomere shortening theory. Telomeres are the end-cap segments of DNA (our genetic material). Each time a cell replicates, a small piece of DNA is taken off the end of each chromosome. The shorter the telomere gets, the more it affects gene expression. The result is cellular aging and an increased risk for immune dysfunction, heart disease, cancer, Alzheimer’s disease, and other degenerative diseases.

Join Dr. Michael Murray for his complimentary webinar: Understanding the Telomere Theory of Aging and What You Can Do About It

During this webinar you will learn the key dietary and supplement strategies that impact telomeres.  After his presentation you will be able to ask your questions through the live forum.

Here’s the link to reserve your spot on Wednesday, August 20th at 6:00pm PT / 9:00pm ET: Understanding the Telomere Theory of Aging and What You Can Do About It

This webinar will be highly informative and will help you understand the impact your diet can have on your telomeres.

August 13th, 2014

Free Webinar – Real Strategies to Boost the Immune System

Young woman having flu blowing her nose

Do you find yourself or your loved ones always getting sick during the cold and flu season?

Join Dr. Murray on his upcoming live webinar: Real Strategies to Boost the Immune System.

The natural product industry has some fantastic products for colds and the flu, but improving immune health goes well beyond taking a magic herbal bullet to help fight off a cold.

During this complimentary webinar, Dr. Murray will show you what really works in preventing getting sick during the “cold and flu season”. You will also have a chance to personally ask him your questions at the end so that you can create the best strategy for your own wellness.

Just click on this link to sign up for the complimentary webinar now: Real Strategies to Boost the Immune System.

August 13th, 2014

Endive – Healing Food Facts

Endive - Healing Food Facts

Endive – Healing Food Facts

Endive is a chicory green that is today, much more popular in Europe than in the United States. Although its recognition is growing, it is still largely under valued. Endive is a member of the Compositae family, along with artichokes, dandelions, and lettuce. Chicory is a native of the Mediterranean region where it grew along roadsides, and has been consumed since ancient Greek and Roman times. In 1616, chicory began being cultivated in Germany, from where it soon spread throughout Europe. Chicory greens were brought to the United States by immigrants and planted in vegetable gardens across the country. In the 1800s, in Flanders, a technique for growing chicons in a dark space was discovered, creating what is today referred to as Belgian endive. A mild-flavored blanched vegetable, Belgian endive instantly became a hit in Paris’ haute cuisine circles. Cultivation of endive increased when it was discovered it could be used as a coffee extender. Today mixing chicory with coffee is still popular in French and Creole cuisine.

Nutritional Highlights:

  • Each leaf of endive only contains 1 calorie.
  • Belgian endive is an excellent source of vitamins A and C, as well as fiber.

Health Benefits:

  • Belgian endive consists of 95% water, and has a low calorie content of 7.5 calories per cup.
  • Endive is an excellent source of carotenes, which can aid in insomnia and help ‘purify the blood’.

Try endive out in your daily diet. For a great hors d’oeuvre, serve endive petals with dip or filled with smoked salmon, goat cheese, spiced walnuts, baby shrimp, or even pâté. Adding endive to a salad, adds a refreshing and slightly bitter element. Toss Belgian endive with pears, Gorgonzola, and walnuts with a raspberry vinaigrette for a crowd-pleasing dish. Another quick side dish is to sauté endive and sprinkle it with parmesan cheese, lemon juice, honey and salt. Are you already an endive fan? If not, consider trying it this week!

August 12th, 2014

Resveratrol Shown to Improve Memory and Brain Function

Introduction:

Resveratrol is a plant compound similar to flavonoids. It is found in low levels in the skin of red grapes, red wine, cocoa powder, baking chocolate, dark chocolate, peanuts, and mulberry skin. Red wine is perhaps the most recognized source of resveratrol, however, red wine contains only one milligram per glass. Most resveratrol supplements use Japanese knotweed (Polygonum cuspidatum) as the source.

There has been a great deal of hype regarding resveratrol supplements, and a recent clinical study from Germany shows that it definitely produces results in improving memory and brain function in elderly subjects.

Background Data:

Resveratrol has received a lot of attention as a longevity aid, but its scientific basis relies primarily on test tube and animal studies – there are only a few published human studies at this time, and many questions to be answered.

Resveratrol activates an enzyme known as sirtuin 1 that plays an important role in the regulation of cellular life spans; it also promotes improved insulin sensitivity. Either of these two effects might explain its ability to extend lifespan.

In terms of brain health, a 2010 clinical study in humans showed that resveratrol supplementation at a single dosage of 250 or 500 mg could improve blood flow to the brain, but it had no effect on mental function in this study.

New Data:

Researchers in Germany at the NeuroCure Cluster of Excellence and the Max Planck Institute for Human Cognitive and Brain Sciences wanted to know the effect of resveratrol on brain function and memory in healthy overweight older adults. Twenty-three participants (ages 50-75) took 200 mg daily of the natural supplement for 26 weeks, while another 23 matched controls took a placebo.

Here were the results of the trial:

  • The use of resveratrol resulted in a significant impact on the ability to remember words compared with placebo.
  • Resveratrol users showed a significant increase in functional connectivity of the hippocampus – the area of the brain involved with the formation, organization, and storage of memory.
  • The resveratrol group experienced a decline in glycated hemoglobin (HbA1c), which indicates improved blood sugar control.
  • Resveratrol reduced body fat percentage and increased blood levels of leptin, a hormone that regulates how much fat is stored in the body and also helps with weight loss and suppression of food intake.

The authors concluded that their findings provided evidence that use of resveratrol supplements can enhance memory along with better hippocampus function and improved glucose metabolism. These are all positive factors for a healthy aging brain.

Commentary:

Over the past few months I have featured several studies that reflect nutritional approaches for improving brain health, memory, and/or the prevention of age-related mental decline or Alzheimer’s disease. There are a lot of natural products to choose from, but the basic underlying goals and effects are quite similar. You have to reduce inflammation, control blood sugar levels, provide necessary building blocks with super nutrition, and protect the brain from damage by consuming antioxidants from the diet and through supplementation.

While resveratrol shows some compelling data as detailed above, my feeling is that it can’t do the job well enough by acting alone. It needs to be part of bigger approach that focuses on diet, lifestyle, and proper supplementation. In regards to supplementation, there are four primary recommendations I make to people to help them design a foundation nutritional supplement program:

#1. Take a high quality multiple vitamin and mineral supplement providing at least the recommended dietary intake for all vitamins and minerals.

#2. Take extra plant-based antioxidants like flavonoid-rich extracts like grapeseed or pine bark extract; curcumin (Theracurmin); a “greens drink” product; resveratrol; or some other broad-spectrum antioxidant.

#3. Take a high quality fish oil product to provide 1,000 mg EPA+DHA daily for general health or up to 3,000 mg EPA+DHA if you have an inflammatory condition; cardiovascular disease; depression, ADHD, multiple sclerosis, or any other brain or nerve disorder; or any of the 60+ health conditions shown to respond or be prevented by fish oils.

#4. Take enough vitamin D3 (typically 2,000-4,000 IU daily) to elevate your blood levels to the optimal range (50-80 ng/ml).

Also, realize that in the study described above, benefits to the brain were secondary to improvements in blood sugar control. This highlights the importance of using PGX, which I think is the most important supplement in North America today given its effects in supporting proper blood sugar control and weight loss.

Reference:

Witte AV, Kerti L, Margulies DS, Flöel A. Effects of resveratrol on memory performance, hippocampal functional connectivity, and glucose metabolism in healthy older adults. J Neurosci. 2014 Jun 4;34(23):7862-70.

August 5th, 2014

Are Side Effects the Achilles’ Heel of Widespread Use of Statins to Lower Cholesterol?

Introduction:

Recently, the American Heart Association (AHA) and American College of Cardiology (ACC) released new guidelines that increased the focus on prescribing statins to lower LDL cholesterol levels. With the new guidelines, it is estimated that in the United States, 44 percent of men and 22 percent of women would meet the criteria for taking a statin.

The answer to the question “Do the New Guidelines for Statins Make Sense” is yes only if the criteria is providing further big profits to the drug industry. There is no question that elevated cholesterol and triglyceride levels greatly increase the risk of death due to cardiovascular disease (CVD). Yet while the drug companies (the AHA and the ACC) would like us all to believe that it’s as simple as taking a statin drug to reduce your risk of a heart attack or stroke, it’s just not that simple. Cholesterol-lowering statin drugs are sold primarily under the premise that they will save lives by lowering cholesterol levels, but in reality they have not demonstrated an ability to extend life in over 75% of the patients these drugs are currently prescribed for.

A recent letter to the editor of the Journal of the American College of Cardiology offers a very interesting perspective. The title of the letter pretty much states the issue: Is Myopathy the Achilles’ Heel of Statins? Differences Between the New Cholesterol Treatment Guidelines and Everyday Clinical Practice. This letter questions the safety of widespread promotion of statin use, and calls to attention the discrepancy in side effect rates reported by drug companies compared to what physicians in practice actually observe.

Background Data:

The debate on the use of any treatment should be one of risk versus benefit. With statins, it seems that the benefits have been grossly overstated, while side effects are minimized.

First, let’s take a look at the benefit. Research does show that in people with a history of a heart attack, stroke, or current signs and symptoms of existing CVD, statins do produce some benefits in reducing deaths due to a heart attack. However, large evaluations of studies in people without a history of heart attack or stroke, who took statin drugs and lowered their LDL cholesterol, have shown they did not live any longer than the people in the placebo group. Even in patients at a high risk for a heart attack results have shown that the use of statin therapy did help these patients live longer.

In terms of risk, it has long been known that statin medications have many side effects including:
• Liver problems and elevated liver function tests.
• Interference with the manufacture of Coenzyme Q10 (CoQ10) – a key substance responsible for energy production within our body.
• Muscle damage including rhabdomyolysis, the breaking down of muscle tissue that can prove fatal.
• Nerve damage is 26 times higher in statin users, compared to the normal population.
• Impaired mental functions can occur in some patients with prolonged use.
• Possible increased risk of cancer and heart failure with long-term use.
• Increased muscle damage caused by exercise and reduced exercise capacity.
• Diabetes and obesity – A 2012 study by the Mayo Clinic found that the use of statins in postmenopausal women increased the risk for type 2 diabetes by 71%.

New Data:

The muscle damage that statins can cause is referred to as “statin-induced myopathy.” It can range in severity to general stiffness, fatigue, and weakness (myopathy); to pain (myalgia); severe inflammation (myositis); and major destruction of the muscle (rhabdomyolysis). The standard line from the drug companies is that statin-induced myopathy occurs in just 1 in 10,000 patients prescribed statins. However, that number does not reflect “real world” occurrence.

Drug companies arrive at the low occurrence rate by preselecting the patients in the studies excluding those with a higher risk for statin-induced myopathy and then they use very strict criteria on what is myopathy. For example, there is an enzyme in muscle cells called creatine kinase (CK) that will leak into the blood if the muscle cell is severely damaged. Most clinical trials of statins used an elevation of 10 times the upper limit normal as signifying myopathy. The problem is that this sort of elevation is a very rare manifestation of myopathy.

More common are symptoms such as stiffness and weakness, and/or muscle pain. In many of the trials the patients were not interviewed for these sort muscle complaints. Was the failure to ask the patient if they were experiencing these side effects an oversight or a cover-up?

How common are symptoms of myopathy in statin users based upon observational studies? It looks like nearly 10%. In other words, about 1,000 times more common than what the drug companies are claiming. That is a big difference.

Commentary:

If you did not get a chance to attend my free webcast and chat on An Honest Appraisal of Statins and Their Alternatives – you can access a recording of the webinar by clicking here: An Honest Appraisal of Statins and Their Alternatives.

Also, you can download a free PDF of my book on Cholesterol and Heart Health – What the Drug Companies Won’t Tell You and Your Doctor Doesn’t Know. Feel free to forward it to any friend or family member that can benefit from it.

The bottom line is that there are safer and more effective strategies in the primary prevention of CVD than taking a statin.

References:

Rallidis LS, MD; Anastasiou-Nana M. Is Myopathy the Achilles’ Heel of Statins? Differences Between the New Cholesterol Treatment Guidelines and Everyday Clinical Practice. J Am Coll Cardiol. 2014;63(21):2300-2301

See also:
Rallidis LS, Fountoulaki K, Anastasiou-Nana M. Managing the underestimated risk of statin-associated myopathy. Int J Cardiol. 2012 Sep 6;159(3):169-76.