Why a Vascular Surgeon Ditched Statins for Good

Why I’ve ditched statins for good – Telegraph 11/7/14, 2:04 PM http://www.telegraph.co.uk/health/10717431/Why-Ive-ditched-statins-for-good.html

As experts clash over proposals that millions more of us take statins to prevent heart disease and stroke, a vascular surgeon explains why he feels better without them.

statins_2860668aDr Haroun Gajraj: ‘After looking more closely at the research, I’d concluded that statins were not going to save me from a heart attack and that my cholesterol levels were all but irrelevant.

By Haroun Gajraj 9:50PM GMT 23 Mar 2014

When I had a routine health check-up eight years ago, my cholesterol was so high that the laboratory thought there had been a mistake. I had 9.3 millimoles of cholesterol in every litre of blood — almost twice the recommended maximum. It was quite a shock.

The GP instantly prescribed statins, the cholesterol-lowering drugs that are supposed to prevent heart disease and strokes. For eight years, I faithfully popped my 20mg atorvastatin pills, without side effects. Then, one day last May, I stopped. It wasn’t a snap decision; after looking more closely at the research, I’d concluded that statins were not going to save me from a heart attack and that my cholesterol levels were all but irrelevant.

When I informed my GP of my decision three months later, I wasn’t entirely honest. Rather than say I was sceptical about the drugs, I told my doctor I’d quit the statins because they were causing pain in my arm. He didn’t bat an eyelid. Evidence from the drug industry published this month – evidence I suspect was heavily reliant on data from the drug industry, as Dr James Le Fanu pointed out on these pages last week – may suggest that side effects are uncommon, but previous studies have found that one in five people on statins suffers adverse side effects, from muscle pain and diarrhoea to memory loss and blurred vision.

The GP simply suggested I try another brand of statin. The sooner the better, he said, given that I’d already been off my prescription for three months. “Hang on,” I said. “Could you give me a blood test first?” When the results came back, he was amazed that my total blood cholesterol was lower than when I’d been on statins. After three months without the pills, it was 5.4mmol/l (5.4 millimoles per litre of blood) compared with 5.7 mmol/l a year earlier.

The only major changes I’d made to my lifestyle since coming off statins were eliminating sugar (including alcohol and starchy foods such as bread) and eating more animal fat. Many experts now believe that sugar is emerging as a true villain in the heart-disease story; while after decades of demonisation, saturated fat has been acquitted of causing heart disease by a recent “meta” analysis of 70 studies by Cambridge University.

Typically, I was eating red meat three or four times a week and enjoying butter, full-fat milk and plenty of eggs. You would have thought that after three months on a diet so high in saturated fat, my cholesterol would have shot back up to pre-statin levels — but no, it came down and has stayed down seven months on. Not only that, but my levels of LDL (so-called bad cholesterol) were also lower than when I’d been on statins, and my ratio of HDL (so-called good cholesterol) to LDL was under four for the first time, an excellent sign, according to medical wisdom.

Not that I cared about any of this. Yes, it was the statins that originally reduced my cholesterol levels so dramatically. But so what? I believe that high cholesterol has been a scapegoat for too long. Yes, it may, in some circumstances, be an indicator of heart disease but there is no evidence of a causal link.

In my view, high total blood cholesterol or high LDL levels no more cause heart attacks than paramedics cause car crashes, even though they are present at the scene. Just lowering cholesterol with drugs without sorting out the dietary and lifestyle factors that actually cause heart disease is nonsensical. Besides, there are plenty of other, more reliable indicators of heartdisease risk.

What further astonished my GP was that on these indicators I was now apparently better off in other ways than when I’d been on statins. My blood pressure was down. For the first time in years, I was slimmer, especially around the belly. My triglycerides — a type of blood fat with a causal link to heart disease — were lower than at any time in the preceding eight years. My fasting blood glucose was at the optimum level, whereas a year earlier it had been too high. My total white blood count — a marker of inflammation — was lower. My blood test for a marker called glycated haemoglobin (A1c), high levels of which are associated with heart disease and overall mortality, were bang on normal. Finally, my level of c-reactive protein (CRP) — a protein that rises in response to inflammation — was extremely low. So, biochemically, I was in excellent shape, better than when I’d been on the statins.

“Have you taken up running?” asked my bemused GP. No, I’d always run. For years, I’d exercised three times a week, eaten plenty of fish, refrained from smoking and tried to keep my stress levels low. The only thing I’d changed was my intake of sugar and animal fat.

That check-up was seven months ago and now, at 58, I’m not on a single tablet. My GP is happy. I feel better than I have in years and, at the same time, deeply concerned about proposals advising even wider use of statins. Until 2005, statins were prescribed only to those with at least a 30 per cent or greater risk of having a heart attack within 10 years. This was then reduced to a 20 per cent risk. Now, draft NHS guidelines would have them dished out to those with just a 10 per cent risk — in other words, most men over the age of 50 and most women over the age of 60.

I am a vascular surgeon. Before founding a private clinic in Dorset 11 years ago, specialising in varicose veins, I worked in the NHS for 13 years. Back then, I didn’t question medical guidance on cholesterol, and thought statins were a wonder drug. And so they probably are, for men who have heart disease — not necessarily because they lower cholesterol, but because they may cut other risks such as the inflammation-marker CRP. Exercise, weight loss and omega 3 supplements also lower CRP. But what about other groups — women, the elderly and people like me who have not been diagnosed with heart disease?

The evidence that we will benefit from cholesterol-lowering drugs is ambiguous at best. The 2011 Hunt 2 study, one of the most recent and largest, followed 52,000 men and women in Norway aged 20-74 with no pre-existing heart disease, for 10 years. The results for women were crystal clear. The lower a woman’s total cholesterol, the greater her risk of dying, either of heart disease or anything else, including cancer. This reflects findings in previous studies. For men, high cholesterol was associated with heart disease and death from other causes. But so, too, was low cholesterol — below 5mmol/l. Again, this is only an association, not a causal link. A range of between 5mmol/l and 7mmol/l was the optimum level.

Guess what? This is already the national average. In addition, numerous studies have linked high cholesterol levels with increased longevity in the elderly. As for me, I have not been diagnosed with heart disease, and nobody in my family has had a heart attack. However, all four of my paternal uncles and my sister have diabetes. Research from Canada, published last year in the BMJ, has shown that statins raise the risk of diabetes, so that gives me little faith. The controversy over these drugs was reignited last week when Prof Sir Rory Collins from Oxford University warned that doctors’ hesitancy about prescribing them to those at risk could cost lives.

GPs are, by definition, generalists. They don’t have time to read and analyse data from every paper on every medical condition. Even so, in a recent survey by Pulse magazine, six in 10 GPs opposed the draft proposal to lower the risk level at which patients are prescribed statins. And 55 per cent said they would not take statins themselves or recommend them to a relative, based on the proposed new guidelines. If that doesn’t speak volumes, I don’t know what does. How we moderate © Copyright of Telegraph Media Group Limited 2014


The Best Kale Salad You’ll Ever Know

The Best Kale Salad You’ll Ever Know20141102-104503.jpg

Serves 1

4 large handfuls of kale, hard stems removed and discarded
1 tablespoon olive oil
1 teaspoon rice vinegar
1 teaspoon tahini
1 teaspoon miso paste
Juice of 1 lime
1 ripe avocado, cubed
125g cooked beluga lentils, or similar type
Bunch of fresh, flat leaf parsley, roughly chopped
1 tablespoon pumpkin seeds

Place the kale leaves in a bowl and add the olive oil, rice vinegar, tahini, miso and lime juice and massage with your hands for a few minutes. The leaves will start to soften as the dressing breaks down the cell wall of the kale.

Stir in the avocado, lentils and parsley and season to taste.

Serve topped with pumpkin seeds.

This salad can be eaten right away, but it also makes for a perfect take to work lunch as the kale leaves are resistant to becoming overly soggy by the time you’re ready to chow down.

Recipe adapted from Deliciously Ella’s Marinated Kale Salad recipe


Potluck: Community on the Edge of Wilderness

by Ana Maria Spagna

51E73NiGn6L._SY344_BO1,204,203,200_“In Potluck, Ana Maria Spagna explores the enduring human connection to place, journeying from Tijuana to a California beach to Utah’s canyon country–and, always, back to the sparsely populated valley in the North Cascades she calls home.

Potluck homes in on the everyday gatherings that, over time, define a community: a makeshift wedding, an art gallery opening, a farewell potluck, a work party, a campfire, a political caucus, a funeral. “What connects us?” Spagna asks, and she reveals, again and again, the gift of community–easy and uneasy, deep and enduring and essential.”  Amazon Book Review

“So many writers romanticize rural life, and so few address its true difficulties and rewards. Ana Maria Spagna never flinches: In this wry, wise, and beautifully written collection of essays, she takes a deep, honest look at her life in a small community, and teaches all of us something about ourselves and our neighbors.” –Michelle Nijhuis, contributing editor, High Country News

The Earth Knows My Name

The Earth Knows My Name:  Food, Culture, and Sustainability in the Gardens of Ethnic Americans914503

by Patricia Klindienst

“Patricia Klindienst crossed the country to write this book, inspired by a torn and faded photograph that shed new light on the story of her Italian immigrant family’s struggle to adapt to America. She gathered the stories of urban, suburban, and rural gardens created by people rarely presented in books about American gardens: Native Americans, immigrants from across Asia and Europe, and ethnic peoples who were here long before our national boundaries were drawn—including Hispanics of the Southwest, whose ancestors followed the Conquistadors into the Rio Grande Valley, and Gullah gardeners of the Sea Islands off the coast of South Carolina, descendants of African slaves.

As we lose our connection to the soil, we no longer understand the relationship between food and a sense of belonging to a place and a people. In The Earth Knows My Name, Klindienst offers a lyrical exploration of how the making of gardens and the growing of food help ethnic and immigrant Americans maintain and transmit their cultural heritage while they put roots down in American soil. Through their work on the land, these gardeners revive cultures in danger of being lost. Through the vegetables, fruits, and flowers they produce, they share their culture with their larger communities. And in their reverent use of natural resources they keep alive a relationship to the land all but lost to mainstream American culture.

With eloquence and passion, blending oral history and vivid description, Klindienst has created a book that offers a fresh and original way to understand food, gardening, and ethnic culture in America. In this book, each garden becomes an island of hope and offers us a model, on a sustainable scale, of a truly restorative ecology.”  Amazon Book Review

Pumpkin Soup

Pumpkin puree is high in fiber, Vitamins A, C, K, as well as calcium, iron and folate. images Serves: 5


3 tablespoons coconut oil, olive oil, or any fat of choice

1 medium yellow onion, chopped

1 medium apple, cored and chopped ( I prefer a sweet-tart variety)

2 carrots, chopped

2 cups broth (veg or chicken)

1½ cup pumpkin or winter squash puree

2-3 sage leaves (whole)

⅔ cup canned coconut milk

2 tablespoons maple syrup (amount depending on apple and pumpkin sweetness, do to taste)

2 teaspoons (or less) lime juice, to taste

Sea salt to taste


In a large sauce pan, heat your oil/fat over medium heat. Stir in your onion, carrots, and apples. Saute for 5-10 minutes until wilted and soft. Stir in the broth and sage leaves. Bring to a simmer. Simmer for 15-20 minutes. Remove the sage leaves. Puree the soup (in batches if necessary) in your blender or food processor until creamy and no chunks remain. Return to your saucepan and add the remaining ingredients. Heat gently and adjust seasonings to taste. Serve topped with walnuts. Enjoy a simple supper of Pumpkin Soup, a plateful of fresh apple slices, and a spinach salad.

Deep Nutrition

51WQ6vfAzQLDeep Nutrition:  Why Your Genes Need Traditional Food

by Catherine Shanahan MD & Luke Shanahan

“Deep Nutrition illustrates how our ancestors used nourishment to sculpt their anatomy, engineering bodies of extraordinary health and beauty. The length of our limbs, the shape of our eyes, and the proper function of our organs are all gifts of our ancestor’s collective culinary wisdom. Citing the foods of traditional cultures from the Ancient Egyptians and the Maasai to the Japanese and the French, the Shanahans identify four food categories all the world’s healthiest diets have in common, the Four Pillars of World Cuisine. Using the latest research in physiology and genetics, Dr. Shanahan explains why your family’s health depends on eating these foods. In a world of competing nutritional ideologies, Deep Nutrition gives us the full picture, empowering us to take control of our destiny in ways we might never have imagined.” Amazon Book Review

Deep Nutrition is an approved textbook for these health professionals and can be purchased using CEU monies. See the Numedix website for more information.
Registered Dietitians
Diet Technicians
Certified Diabetes Educators
Certified Athletic Trainers
Marriage & Family Therapists
Licensed Clinical Social Workers
Licensed Educational Psychologists
Licensed Professional Clinical Counselors

‘Medical Food’ Bests Ibuprofen in Chronic Low Back Pain

Paulsafe_image.phpine Anderson October 07, 2014

Theramine, a “medical food” containing an amino acid blend (AAB), significantly improves chronic low back pain and reduces inflammation compared with low-dose ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), or a combination of these 2 treatments, results of a new study show.

This is the second study looking at theramine in low back pain. The first (Am J Ther. 2012;19:108-114) compared this medical food with another NSAID, naproxen.

“Now we have done 2 multicenter, double-blind trials showing the effectiveness of theramine, not only on pain but also inflammation, and we are not seeing significant side effects,” commented study author David S. Silver, MD, president and chief operating officer, Targeted Medical Pharma Inc, Los Angeles, California.

Observers have expressed both encouragement and reservation about this study, which was published online September 18 in the American Journal of Therapeutics.

Dietary Amino Acids

Back pain affects up to 90% of people during their lifetime. Chronic low back pain is the number one cause of time lost from work, said Dr Silver.

NSAIDs are frequently prescribed to treat chronic back pain, and among these, ibuprofen is the most commonly prescribed.

It’s believed that patients with chronic pain have decreased levels of neurotransmitters responsible for pain inhibition and control of inflammation, the authors note. There’s evidence in plasma of a deficiency of amino acid precursors that are important to chronic pain modulation, said Dr Silver, a rheumatologist who has treated patients with fibromyalgia in his Los Angeles, California, practice.

It’s not possible to treat pain by boosting amino acids through the diet, Dr Silver said. “You can’t just take amino acids and hope that you’re going to produce neurotransmitters” to control pain, he said. Dietary amino acids may not be adequately absorbed, may be deaminated by the liver before crossing the blood-brain barrier, and may not be taken up by the appropriate neurons, he noted.

Current pain therapies don’t adequately address these issues, said Dr Silver. NSAIDs, for example, are only moderately effective in relieving pain and are associated with significant gastrointestinal adverse effects. Other pain treatments, including muscle relaxants and opioid analgesics, have limited efficacy, may produce sedation and constipation, can be used inappropriately, or can lead to addiction issues.

“We think theramine fits very nicely into that void,” said Dr Silver.

As a “medical food,” theramine does not require US Food and Drug Administration preapproval; however, everything in the product must be GRAS (generally recognized as safe), said Dr Silver. “The claims [of a medical food] must be specifically for the nutritional management of a disease when a distinct nutritional requirement that cannot be met through regular diet is recognized,” he said.

The claims of medical foods must be supported by clinical studies, unlike dietary supplements or nutraceuticals, which can’t make disease claims and don’t require clinical studies, he added.

Through its cellular technology, theramine is designed to specifically target precursors to neurotransmitters involved in pain and inflammation (acetylcholine, histamine, serotonin, D-serine, and nitric oxide).

Multicenter Study

The new eight-site, three-arm study was funded by Targeted Medical Pharma. It included 122 patients aged 18 to 75 years who had back pain lasting longer than 6 weeks, with pain present on 10 of 14 days, and evidence of at least moderate pain.

The individual study sites were entirely responsible for recruiting study participants, said Dr Silver.  Patients were not paid to participate in the study and were reimbursed only for reasonable expenses, such as travel costs.

The patients were randomly assigned to one of three groups: two AAB tablets twice a day with one ibuprofen placebo; ibuprofen (400 mg once daily) with two AAB placebos twice a day; or two AAB tablets twice daily with ibuprofen (400 mg once a day).

The researchers used the lowest recommended dose of ibuprofen because, explained Dr Silver, “we didn’t feel that utilizing placebo for patients with chronic pain was ethical, and we didn’t want to expose patients to a higher risk of NSAID-induced complications by using high-dose therapy.”

After 28 days, participants were evaluated by using the Roland-Morris Disability Index and the Oswestry Disability Scale (primary endpoints), as well as a visual analogue scale (VAS).

Significant Improvement

The study showed that in both the AAB and combined therapy groups, pain assessments were considerably and statistically significantly improved compared with the ibuprofen-alone group. In the AAB-alone group, the Roland-Morris Disability Index score fell by 50.3% and the Oswestry Disability Scale score fell by 41.91% (P < .05 for both vs ibuprofen).

In the combination group, the Roland-Morris Index fell by 63.1% and the Oswestry Disability Scale score fell by 62.15% (P < .05 for both vs ibuprofen). Similar results were observed with use of the VAS.

The study also showed improvements in measurements of inflammation in patients taking AAB. From blood samples, researchers found that in the AAB-alone group, the C-reactive protein (CRP) level fell by 47.05% and the interleukin-6 (IL-6) level fell by 23.55% (P < .001 for both vs ibuprofen). In the combined group, CRP fell by 35.99% and IL-6 fell by 43.1% (P < .001 for both).

Interestingly, in the ibuprofen alone group, levels of CRP rose by 60.1% and IL-6 rose by 12.65%.

Dr Silver noted that the previous head-to-head study of theramine and naproxen also showed a reduction in inflammatory markers in persons taking the medical food. “So not only is it a pain-relieving agent, but it does seem to reduce inflammation.”

Since CRP indicates inflammation, which may be involved in heart disease, theramine could also have cardioprotective qualities, said Dr Silver, although he stressed that this has not been studied.

It’s not clear why inflammatory markers increased in patients taking ibuprofen in this study, said Dr Silver. Again, this was the second time that his research group has shown this effect. It could be because NSAIDs are antiprostaglandin drugs and not necessarily anti-inflammatory drugs, he said.

He added that rheumatologists don’t rely on NSAIDs “as our big anti-inflammatory agents,” but rather on other medicines, such as methotrexate, an antifolate drug used to treat some autoimmune diseases, such as rheumatoid arthritis.

None of the patients taking theramine in this new study experienced any significant adverse effects, said Dr Silver. No gastrointestinal adverse effects were observed or reported.

The overall results suggest that theramine can be used as a primary therapy or an adjunct to ibuprofen, said the authors.

Although a dose of two AAB capsules twice daily was used in the study, Dr Silver has used up to eight a day to treat some patients. However, he doesn’t think there would be any benefit beyond that. “At some point, you’re going to get a threshold effect,” he said.

Other Populations

Dr Silver is investigating the effectiveness of theramine in other patients with pain. He and his colleagues are studying this product in chronic migraine and are finalizing a plan to study it in military personnel with back pain. Another study will investigate theramine in patients who have had a hemorrhoidectomy, in whom narcotics are contraindicated because of constipation issues.

Theramine is available in pharmacies but since it’s classified as a medical food, it must be used under medical supervision, said Dr Silver.

When approached for a comment, Lynn Webster, immediate past president, American Academy of Pain Medicine (AAPM) and vice president, scientific affairs, PRA Health Science, said he was heartened by the study.

“We ought to be encouraged about research in areas that can provide us with any type of medication that is safer,” he told Medscape Medical News. “It appears that this whole new class offers hope that we will be able to have fairly effective therapies for some conditions, particularly for pain, that are safer than what we have now.”

Also asked to comment, Christopher Standaert, MD, professor, Rehabilitation Medicine, University of Washington, Seattle, said he couldn’t provide “a formal comment” because he felt he didn’t know enough about the relevant pharmacology and serum chemistry to determine the validity of the study from that perspective.

However, he did raise some issues “to think about.” These included the following:

  1. The study was of a commercial product. It was apparently performed by the company that makes that product and conducted at commercial sites funded by the same manufacturer.
  2. The paper doesn’t include the raw data on outcomes — only percentages of improvement — and doesn’t discuss issues such as the success of blinding and patient adherence.
  3. There is little information on the study patients and how they were recruited.
  4. Although the authors discuss the negative aspects of NSAIDs, they don’t say much about potential downsides of the drug under study.

The study was funded by Targeted Medical Pharma, maker of theramine. Dr Silver is president of the company. Dr Standaert has disclosed no relevant financial relationships.

Am J Ther. Published online September 18, 2014. Abstract

Medscape Medical News © 2014  WebMD, LLC

Send comments and news tips to news@medscape.net.

Cite this article: ‘Medical Food’ Bests Ibuprofen in Chronic Low Back Pain. Medscape. Oct 07, 2014.

The Disease Delusion

The Disease Delusion:  Conquering the Causes of Chronic Illness for a Healthier, Longer, Happier Life

by Dr. Jeffrey S. Bland51R7UvSrDBL._AA160_

“For decades, Dr. Jeffrey Bland has been on the cutting edge of Functional Medicine, which seeks to pinpoint and prevent the cause of illness, rather than treat its symptoms. Managing chronic diseases accounts for three quarters of our total healthcare costs, because we’re masking these illnesses with pills and temporary treatments, rather than addressing their underlying causes, he argues. Worse, only treating symptoms leads us down the path of further illness.

In The Disease Delusion, Dr. Bland explains what Functional Medicine is and what it can do for you. While advances in modern science have nearly doubled our lifespans in only four generations, our quality of life has not reached its full potential. Outlining the reasons why we suffer chronic diseases from asthma and diabetes to obesity, arthritis and cancer to a host of other ailments, Dr. Bland offers achievable, science-based solutions that can alleviate these common conditions and offers a roadmap for a lifetime of wellness.”  Amazon Book Review