Tag Archives: heart attack

The Knock On Niacin – Big Pharma At It Again

Two new reports recently came out that said niacin, vitamin B3, is not effective for the prevention of heart disease or stroke. And, in fact, it might be dangerous. The studies also concluded that it might be so dangerous is shouldn’t be recommended at all. This is not an uncommon response when nutrients are studied, especially ones that reduce the market share for billion dollar statin medications.

Two studies recently published in the New England Journal of Medicine found that while niacin does reduce triglycerides, raise “good” (HDL) cholesterol, and reduce “bad” (LDL) cholesterol, it did not reduce the risk of heart attack or stroke.

Big PharmaI have several problems with the new information that’s been plastered all over the media recently about the recent studies:

Problem #1:

While two studies were performed, the largest of the two was funded by Merck Pharmaceuticals. It had over 25,000 participants while the other study, funded by the NIH, had just over 3,000 people. Merck clearly has an interest in driving down the sales of niacin as it would likely increase the sales of their cholesterol lowering drugs Zocor and Zetia. As an added note, niacin sales have tripled since 2002. Wouldn’t it be a perfect time to get a study that shows it’s dangerous or ineffective?

Problem #2:

These published trials do not reflect the clinical experience of doctors around the country who’ve been recommending niacin for decades. Research and a doctor’s clinical observations are often different. Which one do you believe?

Problem #3:

These trials focused on high-risk patients, almost all of whom were already taking statins and had low LDL levels. Would you see more benefit in clinical trials if these patients had different lipid profiles, or in those who did not already have heart disease? The populations they studied were already being treated intensively. It’s unlikely they were going to benefit by just one more treatment (niacin in this case).  As a matter of fact, in the Merck funded study they clearly state they cannot say whether niacin might be beneficial for patients at even higher risk of having a heart attack or stroke or those with higher LDL levels.

Problem #4:

Statins are particularly ineffective with potentially serious side effects, yet we don’t see reports on the news telling us to stay away from them. This is likely the powerful pull Big Pharma has on media and medicine. A full 98% of people who take statins see no benefit. Zero percent avoid death by taking a statin and only 1.6% avoid a survivable heart attack, and 0.4% are helped by preventing a stroke. Compare that to the side effects where 2% develop diabetes and 10% develop muscle damage as a result of taking that statin and the numbers don’t add up.

I think the real lesson of these studies (both on niacin and ones published on statins) is that inflammation, not necessarily the cholesterol itself, is the problem. If you address those factors, you will live a long, cardiovascular disease-free life.

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Health Doesn’t Come In A Pill

PillsWe live in an instant gratification society. It permeates every aspect of our lives. From the way we consume our news with 24 hours news networks or online surfing, to the way we gossip with Facebook, our desire for things to be done now(!) is staggering.

The same applies to our health. We want results, and we want it yesterday. The problem? There is no quick fix for anything in terms of your health. We’ve become accustomed to seeing the ads on TV that promise results with just one simple pill per day. We’re so accustomed to it, we’re starting to believe it. Heck, some people believe it so much, they demand it! Unfortunately, health doesn’t come in a pill.

But my doctor promises me that if I take my high blood pressure medication, my statin, and my baby aspirin just once per day, I’ll live a long, healthy life!

Yes, yes. That is a comforting thought isn’t it? The problem is it isn’t true. Check out this information:

Statins: For those who took statins for at least 5 years with no history of heart disease:*

  • 98% saw no benefit
  • 0% were helped by being saved from death
  • 1.6% were helped by preventing a heart attack
  • 0.4% were helped by preventing a stroke
  • 2% were harmed by developing diabetes
  • 10% were harmed by muscle damage

Aspirin: For those who took it daily for a year with no history of heart disease:*

  • 99.94% saw no benefit
  • 0% were helped by avoiding death
  • 0.05% were helped by preventing a non-fatal heart attack
  • 0.01% were helped by preventing a non-fatal stroke
  • 0.03% were harmed by developing a major bleeding event

Blood Pressure Medications: For those who took them for mild hypertension:*

  • 100% saw no benefit
  • 9% were harmed by medication side effects and stopped the drug

(*Statistics gathered from www.thennt.com)

Isn’t it amazing that you’re more likely to be harmed by these medications than you are to be helped? So, given that these drugs are so popular and prescribed so widely, why don’t they work? Health doesn’t come in a pill. Our medical model is flawed and flawed greatly. There are too many factors to assume one can take a pill and live longer or healthier. And most medical doctors receive very little, if any, training in nutrition.

You must fuel your body properly. This means a healthy diet and exercise. Those things work. Those things take time and effort. Obviously, time and effort don’t fit with our current lifestyle of “I want it now.” We need to change our lifestyle.

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New Guidelines on Cardiovascular Disease Miss Mark

Well, they’re at it again. New guidelines on reducing cardiovascular disease risk have been released. They’ve called these “much anticipated,” however, I call them “inconsistent with research” and “likely to cause more harm than good.” The guidelines, appearing in Circulation, are likely to change clinical practice, unfortunately. They are the result of collaborations among the American Heart Association, the American College of Cardiology, and other organizations.

Essentially, it makes it far easier for physicians to prescribe statins (cholesterol lowering medication). It will likely result in tens of millions more Americans begin put on these medications.

Let’s start with the things that I do agree with in the new recommendations.

Obesity

There’s no single, ideal diet for weight loss. Intensive, supervised lifestyle changes for at least 6 months received strong endorsement. This is important. We offer professionally supervised weight loss programs at our office for the simple reason that it reduces the risk of many diseases and it can be very difficult to manage alone.

That’s it. That’s all I agree with. The rest of the recommendations fail to actually focus on the problem: INFLAMMATION! They focus far too much on treating cholesterol without any actual targets in mind to treat.

Inflammation

“The traditional view of atherosclerosis [hardening of the arteries] as a lipid storage disease [cholesterol accumulation] crumbles in the face of extensive and growing evidence that inflammation participates centrally in all stages of this disease, from the initial lesion to the end-stage thrombotic [clot forming] complications.” This quote is from a great study that reviews the mechanism behind cardiovascular disease. I added the information in the brackets to make it easier to understand.

The pharmaceutically-driven marketing and media would have you believe that high cholesterol alone will cause it simply to accumulate in your vessels eventually narrowing them so much they can no longer deliver enough blood to your brain or heart. Or alternatively, the narrowing causes a clot to form only to be dislodged and sent “downstream” where it gets caught in smaller arteries causing a heart attack or stroke.  This just isn’t true! Want to know what actually happens!!!?

How you actually get atherosclerosis:

Inflammation is central to this process. It begins with inflammatory changes in the cells that line your blood vessels. These cells are collectively called the endothelium. The cells begin to express adhesion molecules. These molecules do what they sound like – they make things stick! However, they don’t make cholesterol stick, they attract monocytes (a type of white cell), which then travel through the walls of our arteries (BAD) under the influence of various proinflammatory molecules designed to attract more white cells. Once within the arterial wall, the monocytes continue to undergo inflammatory changes, transform into another type of white cell called a macrophage, swallow up cholesterol, and they become what is called a foam cell. T lymphocytes (another type of white cell) also migrate into the arterial wall, where they release proinflammatory cytokines (messengers) that amplify the inflammatory activity. Through these inflammatory processes, the initial lesion of atherosclerosis, called the fatty streak, is formed. This continues to evolve to cause the dangerous atherosclerotic plaque, but every step along the way involves inflammation!

There you go – as you can see, it is not caused simply by the accumulation of “too much” cholesterol as it floats through your blood stream. It all starts because of inflammation. Without the inflammatory process the white cells of our body cannot penetrate the walls of our vessels. If they cannot get into the walls of our vessels, they cannot swallow up cholesterol and begin to build plaque. It really is that simple.

So what causes inflammation?

That’s a great question and very easy to answer. Poor diet and low levels of exercise cause inflammation to build leading to atherosclerosis. A diet that is high in refined sugar increases inflammation. A diet that is low in antioxidants (brightly colored fruits and vegetables) increases inflammation. And exercise is inherently anti-inflammatory; therefore, low levels of exercise drive up inflammation. Here are the basic diet and exercise recommendations everyone should follow:

Diet

Every time you eat, have a source of healthy protein (chicken, fish, grass-fed beef, bison, etc.) and a fruit or a vegetable. Make the emphasis on vegetables. Keep grain (yes, even whole grains) to a small portion of your diet (no more than once per day).

Exercise

Combine resistance training with cardiovascular training. Get at least 45 minutes of moderate activity 3 times per week. High intensity interval training is very beneficial.

If you incorporate these things into your life, you’ll avoid inflammation and you’ll live a long, healthy life without statins!!!

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Drugs shown to have no benefit (and some risks) for diabetics

The results of a new study in diabetics has shown that adding drugs to drive blood pressure and blood-fats lower than current targets did not prevent heart problems, and in some cases caused harmful side effects.  This study was launched 10 years ago by the federal government to see if lowering blood sugar, blood fats or blood pressure would reduce heart attacks and strokes in diabetics.  The results showed that the drugs had no effect on reducing incidence of heart attack or stroke and for some caused serious side effects.

The results were called ‘disappointing’ but from my perspective this couldn’t be better news.  Had this study had positive outcomes it would have given another reason why every diabetic should be on more drugs to ‘protect their hearts.’

The studies were presented Sunday at an American College of Cardiology conference and published on the Internet by the New England Journal of Medicine.

They involved people with Type 2 diabetes — the most common form and the one rising because of the obesity epidemic. Diabetics have more than double the risk of dying of heart attacks or strokes than people without the disease.

The first piece of the study — about blood sugar — was stopped two years ago, when researchers saw more instead of less risk with that approach.

For the blood-fat study, researchers led by Columbia University’s Dr. Henry Ginsburg recruited more than 5,500 diabetics who also had another health risk, such as high blood pressure or cholesterol.

All were given a statin — cholesterol-lowering pills sold as Lipitor and Zocor.  Half also were given Abbott Laboratories’ blockbuster drug, TriCor; the rest got dummy pills. TriCor is a fibrate, a drug that lowers blood fats called trigylcerides while boosting “good” cholesterol.

Nearly five years later, the groups had similar rates of heart attacks and strokes.

The blood-pressure part of the study was led by Dr. William Cushman, preventive medicine chief at Veterans Affairs Medical Center in Memphis, Tennessee. About 4,700 diabetics were treated with various medicines to keep their systolic blood pressure — the top number — either below 140 or below 120.

The intense treatment did not reduce the number of heart attacks, although it prevented more strokes, a less common problem. Side effects were greater with the intense treatment.  (Excerpt from usatoday.com)

The question raised in the article I read was ‘what should diabetics do then?’  First of all, they ask this question like medication is the only answer for these people.  Many millions of people have type II diabetes or are on their way to having it.  The first thing that should be done is avoid the disease in the first place.  Type II diabetes is not a disease in the classic sense.  It is no more a disease than obesity is a disease.  It can be avoided with a healthy lifestyle.  Proper nutrition should be a class in school just like science or math.  The fact that children learn more about the planet Mars than they do about how to truly eat nutritiously is ridiculous. I am not suggesting the sciences are not important, but I bet most kids couldn’t tell you the difference between a carbohydrate, a fat and a protein other than ‘fat is bad for you’ (which is wrong anyway).  True nutrition in which carbohydrates are emphasized less and healthy fats are emphasized more would go along way to reducing the health care crisis in this country.  The low fat paradigm will not work because it is inconsistent with human physiology.

I am not so naive to think that if children were educated from a young age about health and nutrition that we could prevent every case of type II diabetes.  With that said ‘what do diabetics do then?’  They change their lifestyles immediately upon diagnosis. It’s as simple as that.  I have many patients who have been diagnosed with type II diabetes and we routinely improve their outcomes with diet and supplementation.  The solution is simple; change the diet to a low carbohydrate diet, increase exercise and support them with supplementation designed to increase insulin sensitivity.  The trick is not to lower blood sugar intensely (as this study’s goal was) it is to change their hormonal picture.  While on our program blood sugar levels do decrease because of the diet but the real change is insulin regulation.

In the article I read the answer to the question ‘what do diabetics do?’ was answered by what most would consider a prominent physician.  He said:

Focus on healthy diets and lifestyles, and take tried-and-true medicines that doctors recommend now to control health risks, said several experts, including Dr. Clyde Yancy, a Baylor University cardiologist and president of the American Heart Association.

I agree totally with the first part of the statement although I am sure the “diet” he is referring to is of the low fat variety which will not work for diabetics.  Diabetes is a disease (an I use ‘disease’ lightly) of carbohydrate metabolism.  Eating a low fat diet forces one to eat more carbohydrates.  Where is the logic in that!?

The second part of the statement is completely and totally ridiculous.  He tells us we should use “tried-and-true medicines that doctors recommend now to control health risks.”  The medications used in this study are the very drugs that almost every medical physician in this country would call “tried and true ways” to reduce cardiovascular disease.  Find me a medical physician who has any answer besides medication Lipitor or Zocor for lowering cholesterol and I’ll be surprised.  They did not make mention of the specific drugs they used to lower blood sugar or blood pressure but I am sure they are the common ones I see everyday in practice.  A statement like the one from Dr. Yancy simply doesn’t make sense in the context of what was studied.

Type II diabetes is a disease almost exclusively brought on by years of dietary indiscretions.  The fix is not drugs and this study shows that.  The fix is diet and lifestyle modification in which people significantly reduce carbohydrate consumption and begin to exercise.  Doing this improves health outcomes and has no side effect to worry about.  Depending on chemicals to do the job for you won’t work.

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More Pharmaceutical Cover-Ups

Type II diabetes is a major problem in this country.  Type II diabetes is caused from years of eating poorly and can lead to serious health problems such as heart attack, heart failure and even death.  In the US 23.6 million people have diabetes.  The pharmaceutical industry knows this and makes a host of drugs to treat this disease, when it is most easily treated with diet and exercise.  One of these drugs is Avandia and new research shows it is very dangerous.

Avandia is an oral diabetes medication that works by making the body’s cells more sensitive to insulin.  A low carbohydrate diet and exercise also have the same effect, but without the risk of death.  Now, the FDA is recommending that Avandia be removed from the market.  GlaxoSmithKline, the drug’s maker, disagrees of course and from the outset has sought to cover up the potential problems with the drug.  Reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.  What if those people had been on an intensive diet and exercise program instead?  Avandia also caused 304 deaths in the third quarter of 2009.

GlaxoSmithKline has attempted to cover up the information and it has been shown they did not warn the public of the dangers despite knowing more than 10 years ago that it was dangerous.  The reason?  It was a huge seller.  Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006.  An upcoming bipartisan multiyear senate investigation sharply criticized GlaxoSmithKline for not waring of the potentially deadly side effects.

‘Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,’ concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.

Mr. Baucus said of the report, ‘Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.’ (From The NY Times)

The first mistake is that you should never trust a pharmaceutical company.  They are the most deceitful companies in existence and are only interested in big profits, even if it destroys lives.  They seek to cover up unfavorable information and when confronted with the proof  they attempted a cover up, simply deny or “disagree” with the findings.

Unfortunately, there is an internal battle within the FDA.  Some are adamant that this drug should be removed.  This comes from the public safety arm of the FDA.  Other are not so sure.  The FDA has requested that GlaxoSmithKline undertake a study to prove whether this drug actually does cause heart problems.  First of all, this is a dangerous undertaking because the drug has already been shown to cause these problems, hence the reason the FDA is recommending it be removed from the market.  Secondly, asking the drug’s maker to conduct the study is like asking the family dog to watch your food for you while you go to the bathroom. Nothing good can come of it.

Senator Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. David Graham and Dr. Kate Gelperin (who are part of the FDA and have recommended it be removed) over their counterparts who approve medicines and deal more directly with drug makers.

‘It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,’ Mr. Grassley said. ‘The Avandia case may be the most alarming example of the problem with this setup.’

Below is an exerpt from the NY Times article about the process through with Avandia has gone and shows that it has been known for years that this is dangerous.

The Senate investigation — the result of years of digging through more than 250,000 internal company documents — concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.

In November 2003, for instance, the company completed a study in which diabetics given Avandia had far more heart problems than those given placebos. Two months later, the World Health Organization sent the company an alert linking Avandia to heart ailments. In a June 2004 meeting, the company’s Global Safety Board said a hard look should be taken at all Avandia clinical trials for more signs of heart problems, documents show.

European regulators had earlier ordered GlaxoSmithKline to conduct a study — called the Record trial — to examine Avandia’s heart risks because hints of these problems appeared in the company’s earliest trials.. But the Senate report shows that by at least 2004, company executives were aware that the Record trial was going so poorly that it would never answer the heart question with any kind of certainty.

So company executives gathered dozens of Avandia studies and sifted their combined data. Called a meta-analysis, this combined look found first in 2005 and in an updated look in 2006 that Avandia increased the risks of serious heart problems by nearly a third, the Senate investigation shows. Because two-thirds of diabetics die of heart problems, this was hugely worrying.

In 2005, executives revealed the results of their meta-analysis to the F.D.A., and in 2006 they provided the agency with the underlying data.

Two large company-sponsored trials — called Dream and Adopt — were published near the end of 2006, and each provided more hints that Avandia hurts the heart, the documents show. In a March 2007 meeting of the company’s Diabetes Franchise Cardiology Advisory Board, advisers called the safety worries found in these many studies “disquieting.” Negotiations with agency officials about how and whether to alert the public continued.

All while this is going on, GlaxoSmithKline continued to market the drug aggresively, all the while knowing it was dangerous.  The senate inquiry shows that as far back at 1999 there were attempts to silence doctors who spoke out publicly about Avandia.

Dr. John Buse, a professor of medicine at the University of North Carolina, gave presentations at scientific meetings suggesting that Avandia had heart risks. GlaxoSmithKline executives complained to his supervisor and hinted of legal action against him, according to the Senate inquiry. Dr. Buse eventually signed a document provided by GlaxoSmithKline agreeing not to discuss his worries about Avandia publicly. The report cites a separate episode of intimidation of investigators at the University of Pennsylvania. GlaxoSmithKline said that it “does not condone any effort to silence” scientific debate, and that it disagrees with allegations that it tried to silence Dr. Buse. Still, it said the situation “could have been handled differently.”

Again, there is a plethora of proof that:

A) GlaxoSmithKline knew this was dagerous for years and did nothing about it.
B) They actively engaged in covering up the data.
C) Tried to suppress and intimidate doctors who spoke out publicly about the drug.

GlaxoSmithKline will probably get a slap on the wrist for this, but they should be fined billions.  Avandia is only one example of how crooked the pharmaceutical industry is.  Until we get the lobbying money out of politics things will continue as is and people will continue to get hurt by corporate giants that have no regard for peoples’ health and safety.

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